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Clinical NLP Lab 29

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: OBJECTIVE The authors examined which , if any , research design features and patient characteristics would significantly differ between successful and unsuccessful antidepressant trials . METHOD Clinical trial data were review ed for nine antidepressants approved by the Food and Drug Administration between 1985 and 2000 . From the antidepressant research programs on these medications , 52 clinical trials were included in the study . The authors evaluated trial design features , patient characteristics , and difference in response between placebo and antidepressant . RESULTS Nine trial design features and patient characteristics were present in the research programs for all nine of the antidepressants . The severity of depressive symptoms before patient r and omization , the dosing schedule ( flexible versus fixed ) , the number of treatment arms , and the percentage of female patients were significantly associated with the difference in response to antidepressant and placebo . The duration of the antidepressant trial , number of patients per treatment arm , number of sites , and mean age of the patients were similar in successful trials ( with a greater antidepressant-placebo difference ) and less successful trials ( with a smaller antidepressant-placebo difference ) . CONCLUSIONS These findings may help in the design of future antidepressant trials Pharmacotherapy and psychotherapy are generally effective treatments for major depressive disorder ( MDD ) ; however , research suggests that patient preferences may influence outcomes . We examined the effects of treatment preference on attrition , therapeutic alliance , and change in depressive severity in a longitudinal r and omized clinical trial comparing pharmacotherapy and psychotherapy . Prior to r and omization , 106 individuals with MDD reported whether they preferred psychotherapy , antidepressant medication , or had no preference . A mismatch between preferred and actual treatment was associated with greater likelihood of attrition , fewer expected visits attended , and a less positive working alliance at session 2 . There was a significant indirect effect of preference match on depression outcomes , primarily via effects of attendance . These findings highlight the importance of addressing patient preferences , particularly in regard to patient engagement , in the treatment of MDD OBJECTIVE The authors examined the association of treatment preferences with treatment initiation , adherence , and clinical outcome among nonsenior adult and senior primary care patients with depression . METHODS Sixty primary care participants meeting DSM-IV criteria for major depression were r and omly assigned to receive treatment congruent or incongruent with their primary stated preference . Participants received either 20 weeks of escitalopram , with monitoring by a care manager , or 12 weekly sessions of interpersonal psychotherapy followed by two monthly booster sessions . Adherence to treatment and depression severity were reassessed at weeks 4 , 8 , 12 , and 24 . RESULTS Participants expressed stronger preferences for psychotherapy than for antidepressant medication . Preference strength was a more sensitive measure of outcome than was congruence versus incongruence of preference with the assigned treatment . Across age groups , preference strength was significantly associated with treatment initiation and 12-week adherence rate but not with depression severity or remission . CONCLUSIONS A continuous measure of preference strength may be a more useful measure in clinical practice than preferences per se . Future research should focus on whether and how greater facilitation of the treatment decision-making process between patient and clinician influences clinical outcome Rejection of catheters is generally thought to be due to patients pulling out their catheters , but we found circumstantial evidence for this in only one third of cases . Some catheters with smaller balloons drop out spontaneously , perhaps owing to laxity of the pelvic floor or urethral dilatation caused by repeated catheterisation , and others are expelled forcibly , presumably owing to uninhibited contractions of the bladder . Urinary catheters may therefore drop out , be pushed out , or be pulled out . The life expectancy of catheters in this group of patients suggests the type of catheter that should be used . We recommend cheaper latex catheters and think that expensive \" long life \" silicon catheters are inappropriate in most long stay patients . Rejection of catheters is common in poorly mobile old people with cognitive impairment . It is associated with urethral trauma and may result in septicaemia . Long term catheterisation should therefore be considered only when other methods to promote continence and provide comfort have failed.3 Further work is needed to determine why some patients pull out their catheters and whether bladder stabilising drugs might reduce episodes of spontaneous rejection of catheters Background : Clinicians and research ers have question ed whether participants in r and omized control trials ( RCTs ) are representative of patients in the broader clinical population . Method : We compared the demographic , clinical , and personality characteristics of patients ( N=256 ) with major depressive disorder ( MDD ) receiving antidepressant medication or interpersonal therapy as part of an RCT investigation ( n=105 ) versus in a clinic ( n=151 ) . The RCT and clinic protocol s were identical with the exception of recruitment procedures ( advertisement versus physician referral ) and assignment to treatment ( r and omized versus nonr and omized ) . Results : No significant differences emerged between the RCT participants and clinic patients for sex , age , marital status , and education . Overall , clinic patients were no more severely depressed compared to RCT participants ; there was , however , a significant interaction effect . Response rates were significantly higher for RCT participants versus clinic patients . Those participating in the RCT scored significantly higher on a personality scale assessing preference for novel experiences compared to those in the clinic . Conclusions : Differences in clinical and personality variables between those receiving treatment for MDD as part of an RCT versus in a clinic exist ; however , the clinical significance of these differences remains in question , as these variables were unrelated to treatment outcome . Depression and Anxiety , 2009 . © 2009 Wiley‐Liss , A new wave of meta-analyses suggests that antidepressants are no better than placebo for major depressive disorder ( MDD ) , and therefore , antidepressants not only do n't work , but even worse , they harm patients because of the risk of adverse effects . The authors analyzed data from all antidepressant studies su bmi tted to the Food and Drug Administration for registration ( including failed studies with inordinately high placebo reponses ) , or used a met analysis filter and selected those few studies that meet those criteria . In aggregate , the data , at best , show a clinical ly trivial advantage of the antidepressants over placebo in acute r and omized trials . However , their conclusions range from antidepressants do n't work at all to the antidepressants should be reserved only for the most seriously depressed patients . Kirsch is capitalizing on this trend with his recently published book . I view this debate through my perspective of over 25 years of clinical experience , serving as a rater for clinical trials , planning and conducting National Institute of Mental Health and industry efficacy and effectiveness clinical trials , and consulting to the pharmaceutical industry . The real story , I believe , is a bit more complicated . Give everyone with fever penicillin and many will improve . Compare penicillin to placebo and on average , you would find no difference . Why ? Most people with fever have viral infections or non-penicillin sensitive bacterial infections that are time limited ( eg , common upper respiratory infections ) . One could reasonably conclude that penicillin does n't work and we should all take chicken soup instead . Give everyone with MDD an antidepressant and many will improve . Compare any given antidepressant to placebo and on average , you should find no difference . Yet , a difference does exist and even if the trials have an overall small effect size in favor of antidepressants , it is not quite accurate to state that antidepressants are equal to placebo . Why ? If that were true , then in a third of the trials placebo would beat antidepressants , in a third of the trials antidepressants would beat placebo , and the remaining third of the trials it would be a tie . MDD is analogous to fever . It is a heterogeneous , nonspecific syndrome that is the final common pathway of multiple dysregulated psychological and brain processes . Genetic epidemiological studies strongly suggest that stress is a causal factor and that the persistence or The assumption that depressed patients who are assigned to placebo in antidepressant clinical trials are exposed to substantial morbidity and mortality has not been based on research data . Because of worldwide concern about placebo use and the implication s of our earlier findings of no increased suicide risk in placebo-treated patients , we conducted a replication study in a new patient sample . We assessed suicide risk and symptom reduction among placebo-treated patients participating in antidepressant clinical trials for two recently approved antidepressants , venlafaxine ER and citalopram , which were unavailable during our previous study . Among 23,201 participant patients , 32 committed suicide and 172 attempted suicide . Rates of suicide and attempted suicide did not differ significantly among the placebo- and drug-treated groups . Based on patient exposure years , annual rates of suicide and attempted suicide were 0.5 and 6.7 % with placebo , 0.9 % with active comparator ( rates for attempted suicide are unavailable ) , and 0.6 and 6.3 % with investigational antidepressants . Symptom reduction was 47.9 % with investigational drugs ( n = 1172 ) , 47.5 % with active comparators ( n = 161 ) , and 35.5 % with placebo ( n = 606 ) . These data may inform discussion s about the use of placebo in antidepressant clinical trials \n Output:\n " }, { "from": "agent", "value": "Differences were not seen with psychotherapy compared to antidepressants , alternative therapies or active intervention controls .\nCONCLUSIONS In conclusion , the combination of psychotherapy and antidepressants for depression may provide a slight advantage whereas antidepressants alone and psychotherapy alone are not significantly different from alternative therapies or active intervention controls .\nThese data suggest that type of treatment offered is less important than getting depressed patients involved in an active therapeutic program ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: We investigated whether intensive computerized cognitive training in schizophrenia could improve working memory performance and increase signal efficiency of associated middle frontal gyri ( MFG ) circuits in a functionally meaningful manner . Thirty schizophrenia participants and 13 healthy comparison participants underwent fMRI scanning during a letter N-back working memory task . Schizophrenia participants were then r and omly assigned to either 80 h ( 16 weeks ) of cognitive training or a computer games control condition . After this intervention , participants completed a second fMRI N-back scanning session . At baseline , during 2-back working memory trials , healthy participants showed the largest and most significant activation in bilateral MFG , which correlated with task performance . Schizophrenia participants showed impaired working memory , hypoactivation in left MFG , and no correlation between bilateral MFG signal and task performance . After training , schizophrenia participants improved their 2-back working memory performance and showed increased activation in left MFG . They also demonstrated a significant association between enhanced task performance and right MFG signal , similar to healthy participants . Both task performance and brain activity in right MFG after training predicted better generalized working memory at 6-month follow-up . Furthermore , task performance and brain activity within bilateral MFG predicted better occupational functioning at 6-month follow-up . No such findings were observed in the computer games control participants . Working memory impairments in schizophrenia and its underlying neural correlates in MFG can be improved by intensive computerized cognitive training ; these improvements generalize beyond the trained task and are associated with enduring effects on cognition and functioning 6 months after the intervention This study examined the link between executive function and functional outcome in schizophrenia to identify useful psychological intervention targets and explore how executive function changes affect social functioning and symptoms . Participants from two r and omized controlled trials ( n = 63 ) with poor social functioning , positive and negative symptoms , and cognitive impairment completed seven measures of executive function . Three cognitive factors were extracted : verbal working memory , response inhibition speed , and stimulus-driven responding . Participants received individual cognitive remediation therapy ( CRT ) ( n = 18 ) , a control therapy ( occupational therapy activities ) ( n = 14 ) , or treatment as usual ( n = 19 ) . Only the CRT group improved on verbal working memory . No group improved on the other factors . Although verbal working memory was significantly associated with social functioning and symptom severity 3 months after baseline , change in this factor did not predict change in either functional outcome . There was a significant interaction between group and the stimulus-driven responding factor , and for the CRT group only , a change to a more externally focused responding style was associated with reduced social problems and symptoms . Regardless of treatment type , increased response inhibition speed was associated with reduced negative symptoms . Stimulus-driven responding and response inhibition speed may therefore make useful targets for intervention BACKGROUND This paper investigates the durability of the effects of cognitive remediation therapy ( CRT ) . In a r and omised control trial , CRT was compared with a control therapy ( intensive occupational therapy activities ) , matched for length of therapist contact . The main three cognitive outcomes , ( i ) number of categories achieved on the Wisconsin Card Sort Test , ( ii ) age-scaled score on the Digit Span subtest of the WAIS-R , and ( iii ) mean number of moves on the Tower of London test , were chosen because they are known to be problematic in schizophrenia . In addition , a wide variety of other outcomes ( symptoms , social functioning , self-esteem and cognition ) were assessed . At the end of treatment , CRT conferred a benefit to people with schizophrenia in cognition and self-esteem [ Schizophr . Bull . 25 ( 1999 ) 291 ] . This study investigates these outcomes 6 months after the therapies were withdrawn . METHOD Participants were assessed at baseline , posttreatment and 6-month follow-up ( n=17 for the CRT group ; n=16 for the control therapy group ) . In addition to the functioning measures , data on use of services and cost of therapy were collected . RESULTS The effects of CRT on cognition were still apparent at follow-up , particularly in the memory domain . When these cognitive improvements reached a criterion threshold , there were also improvements in social behaviour and symptoms . The gains made in self-esteem disappeared following the withdrawal of therapy . The economic analysis showed overall reductions in the care packages of both patient groups but there was a significant increase in day-care costs for patients who have received CRT . This additional use of day care may confer further advantages to the CRT group , such as improved social functioning and quality of life . CONCLUSIONS The overall results of this first trial of a novel CRT approach have produced encouraging results which merit further investigation Cognitive remediation training has been shown to improve both cognitive and social cognitive deficits in people with schizophrenia , but the mechanisms that support this behavioral improvement are largely unknown . One hypothesis is that intensive behavioral training in cognition and /or social cognition restores the underlying neural mechanisms that support targeted skills . However , there is little research on the neural effects of cognitive remediation training . This study investigated whether a 50 h ( 10-week ) remediation intervention which included both cognitive and social cognitive training would influence neural function in regions that support social cognition . Twenty-two stable , outpatient schizophrenia participants were r and omized to a treatment condition consisting of auditory-based cognitive training ( AT ) [ Brain Fitness Program/auditory module ~60 min/day ] plus social cognition training ( SCT ) which was focused on emotion recognition [ ~5 - 15 min per day ] or a placebo condition of non-specific computer games ( CG ) for an equal amount of time . Pre and post intervention assessment s included an fMRI task of positive and negative facial emotion recognition , and st and ard behavioral assessment s of cognition , emotion processing , and functional outcome . There were no significant intervention-related improvements in general cognition or functional outcome . fMRI results showed the predicted group-by-time interaction . Specifically , in comparison to CG , AT+SCT participants had a greater pre-to-post intervention increase in post central gyrus activity during emotion recognition of both positive and negative emotions . Furthermore , among all participants , the increase in post central gyrus activity predicted behavioral improvement on a st and ardized test of emotion processing ( MSCEIT : Perceiving Emotions ) . Results indicate that combined cognition and social cognition training impacts neural mechanisms that support social cognition skills BACKGROUND The ratio of scalp-recorded brain responses occurring 50 msec after paired clicks ( S2-evoked P50/S1-evoked P50 ) serves as a measure of sensory gating . An abnormally large ratio is commonly found in schizophrenia and is considered as a sign of reduced sensory gating or otherwise dysfunctional organization of the auditory/verbal system as a factor contributing to psychopathology and cognitive dysfunction in schizophrenia . This initial r and omized clinical trial compared the efficacy of two 4-week , computer-based cognitive training methods that emphasize either auditory discrimination and verbal memory or a broader range of cognitive functions in schizophrenia . METHODS Thirty-nine schizophrenia patients ( ICD-F20.0 diagnosis ) were assigned to Cognitive Exercises ( CE ) or Cognitive Package ( Cogpack ) . The M50 , the magnetoencephalographic analogue of electroencephalographic P50 , and performance on verbal learning and memory tests were used to evaluate training effects . RESULTS As expected , patients exhibited higher pretreatment gating ratios than 28 age-matched healthy comparison participants . Gating ratios decreased after CE but not after Cogpack . Cognitive test performance improved more after CE than after Cogpack . CONCLUSIONS Appropriately specific psychological training changes the neural performance in schizophrenia , normalizing sensory and cognitive function Blinding embodies a rich history spanning over two centuries . Most research ers worldwide underst and blinding terminology , but confusion lurks beyond a general comprehension . Terms such as single blind , double blind , and triple blind mean different things to different people . Moreover , many medical research ers confuse blinding with allocation concealment . Such confusion indicates misunderst and ings of both . The term blinding refers to keeping trial participants , investigators ( usually health-care providers ) , or assessors ( those collecting outcome data ) unaware of the assigned intervention , so that they will not be influenced by that knowledge . Blinding usually reduces differential assessment of outcomes ( information bias ) , but can also improve compliance and retention of trial participants while reducing biased supplemental care or treatment ( sometimes called co-intervention ) . Many investigators and readers naïvely consider a r and omised trial as high quality simply because it is double blind , as if double-blinding is the sine qua non of a r and omised controlled trial . Although double blinding ( blinding investigators , participants , and outcome assessors ) indicates a strong design , trials that are not double blinded should not automatically be deemed inferior . Rather than solely relying on terminology like double blinding , research ers should explicitly state who was blinded , and how . We recommend placing greater credence in results when investigators at least blind outcome assessment s , except with objective outcomes , such as death , which leave little room for bias . If investigators properly report their blinding efforts , readers can judge them . Unfortunately , many articles do not contain proper reporting . If an article cl aims blinding without any accompanying clarification , readers should remain sceptical about its effect on bias reduction OBJECTIVE The early application of cognitive rehabilitation may afford long-term functional benefits to patients with schizophrenia . This study examined the two-year effects of an integrated neurocognitive and social-cognitive rehabilitation program , cognitive enhancement therapy ( CET ) , on cognitive and functional outcomes in early-course schizophrenia . METHODS Early-course out patients ( mean+/-SD illness duration = 3.19+/-2.24 years ) with schizophrenia or schizoaffective disorder were r and omly assigned to CET ( N=31 ) or enriched supportive therapy ( EST ) ( N=27 ) , an illness management intervention utilizing psychoeducation and applied coping strategies , and treated for two years . Multivariate composite indexes of cognitive , social adjustment , and symptom domains were derived from assessment batteries administered annually by computer-based tests and raters not blind to treatment assignment . RESULTS Of the 58 participants who were r and omly assigned and treated , 49 and 46 completed one year and two years of treatment , respectively . Intent-to-treat analyses showed significant differential effects favoring CET on social cognition , cognitive style , social adjustment , and symptomatology composites during the first year of treatment . After two years , moderate effects ( d=.46 ) were observed favoring CET for enhancing neurocognitive function . Strong differential effects ( d>1.00 ) on social cognition , cognitive style , and social adjustment composites remained at year 2 and also extended to measures of symptomatology , particularly negative symptoms . CONCLUSIONS CET appears to be an effective approach to the remediation of cognitive deficits in early schizophrenia that may help reduce disability in this population . The remediation of such deficits should be an integral component of early intervention programs treating psychiatrically stable schizophrenia out patients Effects of both domain-specific and broader cognitive remediation protocol s have been reported for neural activity and overt performance in schizophrenia ( SZ ) . Progress is limited by insufficient knowledge of relevant neural mechanisms . Addressing neuronal signal resolution in the auditory system as a mechanism contributing to cognitive function and dysfunction in schizophrenia , the present study compared effects of two neuroplasticity-based training protocol s targeting auditory – verbal or facial affect discrimination accuracy and a st and ard rehabilitation protocol on magnetoencephalographic ( MEG ) oscillatory brain activity in an auditory paired-click task . SZ were r and omly assigned to either 20 daily 1-hour sessions over 4 weeks of auditory – verbal training ( N = 19 ) , similarly intense facial affect discrimination training ( N = 19 ) , or 4 weeks of treatment as usual ( TAU , N = 19 ) . Pre-training , the 57 SZ showed smaller click-induced posterior alpha power modulation than did 28 healthy comparison participants , replicating Popov et al. ( 2011b ) . Abnormally small alpha decrease 300–800 ms around S2 improved more after targeted auditory – verbal training than after facial affect training or TAU . The improvement in oscillatory brain dynamics with training correlated with improvement on a measure of verbal learning . Results replicate previously reported effects of neuroplasticity-based psychological training on oscillatory correlates of auditory stimulus differentiation , encoding , and updating and indicate specificity of cortical training effects Background In a previous report we showed that cognitive training fostering auditory-verbal discrimination and working memory normalized magnetoencephalographic ( MEG ) M50 gating ratio in schizophrenia patients . The present analysis addressed whether training effects on M50 ratio and task performance are mediated by changes in brain oscillatory activity . Such evidence should improve underst and ing of the role of oscillatory activity in phenomena such as M50 ratio , the role of dysfunctional oscillatory activity in processing abnormalities in schizophrenia , and mechanisms of action of cognitive training . Methodology /Principal Findings Time-locked and non-time-locked oscillatory activity was measured together with M50 ratio in a paired-click design before and after a 4-week training of 36 patients r and omly assigned to specific cognitive exercises ( CE ) or st and ard ( comparison ) cognitive training ( CP ) . Patient data were compared to those of 15 healthy controls who participated in two MEG measurements 4 weeks apart without training . Training led to more time-locked gamma-b and response and more non-time-locked alpha-b and desynchronization , moreso after CE than after CP . Only after CE , increased alpha desynchronization was associated with normalized M50 ratio and with improved verbal memory performance . Thus , both types \n Output:\n " }, { "from": "agent", "value": "Cognitive remediation therapy seems to provide a neurobiological enhancing effect in schizophrenia .\nSeveral studies provide evidence of an improved functional connectivity after cognitive training , suggesting a neuroplastic effect of therapy through mechanisms of functional reorganization .\nNeurocognitive and social-cognitive training may have a cumulative effect on neural networks involved in social cognition .\nThe variety of proposed programs , imaging tasks , and techniques may explain the heterogeneity of observed neural improvements ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: OBJECTIVES Comparison of Reverse Foam Sclerotherapy of the great saphenous vein ( GSV ) combed with sapheno-femoral junction ( SFJ ) ligation to st and ard ( Babcock ) stripping and invagination ( Pin ) stripping in a prospect i ve clinical series . DESIGN Prospect i ve clinical series . MATERIAL S AND METHODS 90 consecutive limbs of 82 patients with incompetence of the GSV result ing in varicose veins were prospect ively r and omised into 3 groups of 30 , treated by SFJ ligation and either reverse foam sclerotherapy , st and ard stripping or invagination stripping of the GSV . Outcomes were assessed post-operatively and at 2-weeks follow-up . Peri-operative blood loss ( 24 hrs ) , analgesic requirement , bruising and residual varicosities were assessed . Bruising was assessed by both patients and independent assessors using question naires . RESULTS SFJ ligation plus reverse foam sclerotherapy of the GSV was associated with significantly less blood loss , bruising and post-op discomfort than either of the stripping techniques . ( p<0.001 , Mann-Whitney ) CONCLUSION St and ard stripping of the GSV and invagination stripping are not associated with major discomfort and problems in the early post-operative period . SFJ ligation and GSV reverse foam sclerotherapy yielded greater patient satisfaction with less post-op bruising and discomfort and reduced analgesic requirements Endovenous laser ablation ( EVLA ) and radiofrequency ablation ( RFA ) are both associated with excellent technical , clinical and patient‐reported outcomes for the treatment of varicose veins . The aim of this study was to compare the techniques in a r and omized clinical trial BACKGROUND Ultrasound-guided foam sclerotherapy and endovenous laser ablation are widely used alternatives to surgery for the treatment of varicose veins , but their comparative effectiveness and safety remain uncertain . METHODS In a r and omized trial involving 798 participants with primary varicose veins at 11 centers in the United Kingdom , we compared the outcomes of foam , laser , and surgical treatments . Primary outcomes at 6 months were disease-specific quality of life and generic quality of life , as measured on several scales . Secondary outcomes included complications and measures of clinical success . RESULTS After adjustment for baseline scores and other covariates , the mean disease-specific quality of life was slightly worse after treatment with foam than after surgery ( P=0.006 ) but was similar in the laser and surgery groups . There were no significant differences between the surgery group and the foam or the laser group in measures of generic quality of life . The frequency of procedural complications was similar in the foam group ( 6 % ) and the surgery group ( 7 % ) but was lower in the laser group ( 1 % ) than in the surgery group ( P<0.001 ) ; the frequency of serious adverse events ( approximately 3 % ) was similar among the groups . Measures of clinical success were similar among the groups , but successful ablation of the main trunks of the saphenous vein was less common in the foam group than in the surgery group ( P<0.001 ) . CONCLUSIONS Quality -of-life measures were generally similar among the study groups , with the exception of a slightly worse disease-specific quality of life in the foam group than in the surgery group . All treatments had similar clinical efficacy , but complications were less frequent after laser treatment and ablation rates were lower after foam treatment . ( Funded by the Health Technology Assessment Programme of the National Institute for Health Research ; Current Controlled Trials number , IS RCT N51995477 . ) OBJECTIVES This study aims to compare the efficacy and side effects of foam sclerotherapy of the saphenous veins with or without post-treatment compression using graduated elastic stockings . DESIGN This is a prospect i ve open r and omised controlled trial conducted in two centres . PATIENTS AND METHODS Sixty patients with incompetent great ( GSV ) or small saphenous veins ( SSV ) underwent ultrasound-guided foam sclerotherapy . R and omisation was conducted immediately after sclerotherapy to two parallel groups , one ( CG ) with compression stockings ( 15 - 20 mmHg worn during the day , for 3 weeks ) and the other ( WCG ) without compression . Efficacy of sclerotherapy and all of the side effects were assessed , including side effects in the treated region . On days 14 and 28 , clinical and duplex ultrasound ( DUS ) assessment s were performed by independent experts . Patients also completed quality of life ( QOL ) , symptom question naires and provided satisfaction scores . RESULTS Five men and 55 women ranging in age from 32 to 78 ( mean 57 years ) years were included : 29 in the WCG and 31 in the CG group . On day 28 , abolition of venous reflux and occlusion of the vein was obtained in 100 % of the cases in both groups . The length of the occluded vein was the same in both groups ( mean 36 cm for the GSV and 30 cm for the SSV ) as was the mean diameter of the occluded vein ( 5 mm ) . Symptoms and QOL question naires showed equivalent improvement in both groups on day 28 compared to pre-treatment assessment s. Side effects were few with no statistical difference between the two groups . Patient satisfaction scores were high in both groups for the outcome of sclerotherapy results , and good or very good for compression in 50 % of the CG cases . CONCLUSION We found no difference between compression and control groups when comparing efficacy , side effects , satisfaction scores , symptoms and QOL . Further studies are required to establish the role of compression in sclerotherapy and to evaluate other compression strategies OBJECTIVES Comparison of sapheno-femoral ligation and stripping ( SFL/S ) versus endovenous laser ablation ( EVLA , 980-nm ) in the treatment of great saphenous vein ( GSV ) insufficiency , using local tumescent anaesthesia . DESIGN R and omised , single centre trial . MATERIAL S AND METHODS Patients with GSV incompetence and varicose veins were r and omised to either SFL/S or EVLA . At days 1 , 2 , 3 , 7 , 10 , and 14 post-treatment , patients completed question naires on pain and quality of life . Recurrent varicose veins were evaluated by Duplex ultrasound ( DUS ) performed at 1 and 6 weeks , and 6 and 12 months . RESULTS 130 legs in 121 patients were treated by SFL/S ( n=68 ) or EVLA ( n=62 ) . Significantly more post-treatment pain was noted after EVLA at days 7 , 10 and 14 ( p<0.01 ; p<0.01 ; p=0.01 ) , more hindrance in mobility at days 7 ( p<0.01 ) and 10 ( p=0.01 ) , and in self care ( p=0.03 ) and daily activities ( p=0.01 ) at day 7 compared to SFL/S. DUS at 1-year follow-up showed 9 % recurrences ( 5/56 ) after EVLA and 10 % ( 5/49 ) after SFL/S. CONCLUSION Both SFL/S and EVLA , using local tumescent anaesthesia , were well tolerated , with no difference in short-term recurrence rate . In the second week after EVLA , patients experienced significantly more pain result ing in restricted mobility , self care and daily activity compared to Introduction : Chronic venous insufficiency is the most common vascular disease in the adult population . However , r and omized clinical trials ( RCTs ) comparing therapeutic options are limited . Patients and Methods : A total of 180 patients with saphenofemoral junction and great saphenous reflux detected on duplex were r and omized to either ultrasound-guided radiofrequency ablation ( RFA ) or st and ard surgical treatment . The study participants blindly chose an assignment card that placed them in either group A ( ultrasound-guided RFA of the great saphenous vein [ GSV ] ; n = 90 ) ; or group B ( surgical management n = 90 ) . Patients were followed up for 24 months . Results : The primary occlusion rate in group A was 94.5 % versus 100 % in group B. Radiofrequency ablation had a lower overall complication rate ( P = .02 ) and shorter post-intervention hospital stay ( P = .001 ) . Kaplan-Meier analysis showed no significant differences in recurrence rates at 24 months follow-up ( P = .45 ) . Radiofrequency ablation was significantly more expensive ( P = .003 ) . Conclusion : Great saphenous vein occlusion was achieved efficiently in 94 % of our group using RFA with minimal complications and obvious advantages as compared to st and ard surgery Endovenous laser ablation ( EVLA ) is a popular minimally invasive treatment for varicose veins . Surgical treatment , featuring junctional ligation and inversion stripping , has shown excellent clinical and cost effectiveness . The clinical effectiveness of both treatments was compared within a r and omized trial AIM Major side effects after endovenous laser ablation ( EVLA ) are pain and bruising . The aim of this study was to compare outcome and side effects after EVLA of incompetent great saphenous veins ( GSV ) with a 1 470 nm diode laser ( Ceralas E , biolitec ) using a power of 15 or 25 W. METHODS Between 28 November 2007 and 15 January 2008 , 40 consecutive patients ( 40 legs ) with an incompetent GSV were treated by EVLA . The patients were r and omized in two groups . In Group A ( 20 patients ) was used a 15-W-power laser and in Group B ( 20 patients ) a 25-W-power laser was used . All patients were re-examined after 1 , 10 and 30 days clinical ly and by Duplex for complications and occlusion in the treated vein segment in a st and ardized way . RESULTS There was no significant difference concerning gender , age , C of CEAP , body mass index or diameter of the treated vein . In Group A a mean of 465 mL tumescence fluid ( TF ) was used and in Group B TF was of 433 mL. In Group A the mean linear endovenous energy density ( LEED ) was 109.7 J/cm and in Group B 132.6 J/cm . The subgroup Bsub included 16 patients of Group B with a comparable mean LEED of 115.8 J/cm . In all groups occlusion of the treated veins was achieved for all patients . The diameter of the GSV reduced at 3 cm below the sapheno-femoral junction from 1.1 to 0.6 cm , 1.0 to 0.6 cm and 0.9 to 0.6 cm respectively in the three groups . The modified CEAP clinical score improved significantly in all groups . In Group A patients have been administered analgesic tablets for a shorter period . There was also a trend to less postinterventional pain and analgesic use in Group A , but it was not significant . Ecchymosis was rare in both groups ( 8 in Group A , 7 in Group B ) . CONCLUSIONS In this prospect i ve r and omized comparative study the power of the laser did not influence the occlusion rate when a high LEED with comparable values was used . In both groups pain and ecchymoses were less frequent in this study with a 1 470 nm diode laser than reported in studies with 810 - 980 nm systems . A lower power level significantly reduced use of analgesic tablets BACKGROUND Great saphenous vein ( GSV ) incompetence is the most common cause of superficial venous insufficiency . Radiofrequency catheter ablation ( RFA ) is superior to conventional ligation and stripping , and endovenous laser treatment ( EVL ) has emerged as an effective alternative to RFA . This r and omized study evaluated RFA and EVL for superficial venous insufficiency due to GSV incompetence and compared early and 1-year results . METHODS Between June 2006 and May 2008 , patients with symptomatic primary venous insufficiency due to GSV incompetence were r and omized to RFA or EVL . Patients with bilateral disease were r and omized for treatment of the first leg and received the alternative method on the other . Pretreatment examination included a leg assessment using the Venous Clinical Severity Score ( VCSS ) and CEAP classification . Patients completed the Chronic Venous Insufficiency Question naire 2 ( CIVIQ2 ) . RFA was performed with the ClosurePlus system ( VNUS Medical Technologies , Sunnyvale , Calif ) . EVL was performed with the EVLT system ( AngioDynamics Inc , Queensbury , NY ) . Early ( 1-week and 1-month ) postoperative results of pain , bruising , erythema , and hematoma were recorded . Duplex ultrasound ( DU ) imaging was used at 1 week and 1 year to evaluate vein status . VCSS scores and CEAP clinical class were recorded at each postoperative visit , and quality of life ( QOL ) using CIVIQ2 was assessed at 1 month and 1 year . RESULTS The study enrolled 118 patients ( 141 limbs ) : 46 ( 39 % ) were r and omized to RFA and 48 ( 40 % ) to EVL , and 24 ( 20 % ) had bilateral GSV incompetence . At 1 week , one patient in the RFA group had an open GSV and \n Output:\n " }, { "from": "agent", "value": "Conclusions A lack of evidence as to the optimal strategy for compression has result ed in a marked variation in clinical practice ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: Objective : To determine the efficacy of “ simultaneous ” bilateral cochlear implantation ( both implants placed during a single surgical procedure ) by comparing bilateral and unilateral implant use in a large number of adult subjects tested at multiple sites . Design : Prospect i ve study of 37 adults with postlinguistic onset of bilateral , severe to profound sensorineural hearing loss . Performance with the bilateral cochlear implants , using the same speech processor type and speech processing strategy , was compared with performance using the left implant alone and the right implant alone . Speech underst and ing in quiet ( CNCs and HINT sentences ) and in noise ( BKB-SIN Test ) were evaluated at several postactivation time intervals , with speech presented at 0 ° azimuth , and noise at either 0 ° , 90 ° right , or 90 ° left in the horizontal plane . APHAB question naire data were collected after each subject underwent a 3-wk “ bilateral deprivation ” period , during which they wore only the speech processor that produced the best score during unilateral testing , and also after a period of listening again with the bilateral implants . Results : By 6-mo postactivation , a significant advantage for speech underst and ing in quiet was found in the bilateral listening mode compared with either unilateral listening modes . For speech underst and ing in noise , the largest and most robust bilateral benefit was when the subject was able to take advantage of the head shadow effect ; i.e. , results were significantly better for bilateral listening compared with the unilateral condition when the ear opposite to the side of the noise was added to create the bilateral condition . This bilateral benefit was seen on at least one of the two unilateral ear comparisons for nearly all ( 32/34 ) subjects . Bilateral benefit was also found for a few subjects in spatial configurations that evaluated binaural redundancy and binaural squelch effects . A subgroup of subjects who had asymmetrical unilateral implant performances were , overall , similar in performance to subjects with symmetrical hearing . The question naire data indicated that bilateral users perceive their own performance to be better with bilateral cochlear implants than when using a single device . Conclusions : Findings with a large patient group are in agreement with previous reports on smaller groups , showing that , overall , bilateral implantation offers the majority of patients advantages when listening in simulated adverse conditions OBJECTIVE An aging American population carries a high prevalence of profound sensorineural hearing loss . We examined the performance of multichannel cochlear implant recipients in a large data base of adult subjects . DESIGN Nonconcurrent prospect i ve study of a national cohort with multivariate regression analysis of preoperative and postoperative performance variables in multichannel cochlear implant recipients . We applied models of prediction established in previous studies to the observed results . SETTING Referral centers with active cochlear implant programs . PATIENTS Adolescents and adults with profound hearing loss ( N = 749 ; age range , 14 - 91 years ) . MAIN OUTCOME MEASURE Postoperative monosyllabic word recognition . RESULTS The population 65 years and older demonstrated a clinical ly insignificant 4.6%-smaller postoperative word score compared with the population younger than 65 years . When duration of deafness exceeded 25 years , elderly recipients demonstrated higher word scores than their younger counterparts . A more significant factor affecting outcomes is the ratio of duration of deafness to age at implantation . CONCLUSIONS Age at implantation carried relatively little predictive value for postoperative performance in subjects 65 years and older . Although a small decrement in mean speech recognition scores was evident , the clinical significance of this difference is question able when all of the results observed in elderly patients are considered . A shorter percentage of life spent in severe-to-profound sensorineural hearing loss suggests a foundation of acoustic/auditory processing in the elderly cohort that may mitigate potential physiological effects associated with advanced age . This study confirms and extends previous observations that duration of profound deafness and residual speech recognition carry higher predictive value than the age at which an individual receives an implant PURPOSE The purpose of this study was to examine the rate of progress in the 2nd implanted ear as it relates to the 1st implanted ear and to bilateral performance in adult sequential cochlear implant recipients . In addition , this study aim ed to identify factors that contribute to patient outcomes . METHOD The authors performed a prospect i ve longitudinal study in 21 adults who received bilateral sequential cochlear implants . Testing occurred at 6 intervals : prebilateral through 12 months postbilateral implantation . Measures evaluated speech recognition in quiet and noise , localization , and perceived benefit . RESULTS Second ear performance was similar to 1st ear performance by 6 months postbilateral implantation . Bilateral performance was generally superior to either ear alone ; however , participants with shorter 2nd ear length of deafness ( < 20 years ) had more rapid early improvement and better overall outcomes than those with longer 2nd ear length of deafness ( > 30 years ) . All participants reported bilateral benefit . CONCLUSIONS Adult cochlear implant recipients demonstrated benefit from 2nd ear implantation for speech recognition , localization , and perceived communication function . Because performance outcomes were related to length of deafness , shorter time between surgeries may be warranted to reduce negative length-of-deafness effects . Future study may clarify the impact of other variables , such as preimplant hearing aid use , particularly for individuals with longer periods of deafness Objective : The purpose of the study was to investigate sound localization with bilateral and unilateral cochlear implants . Design : Sound localization tests were performed on 20 bilaterally implanted MED-EL COMBI 40/40 + users . All subjects were bilaterally implanted during adolescence or later . Sound localization was tested in the frontal horizontal plane by using 9 equally spaced loudspeakers and speech-shaped noise bursts at r and omized levels . Results : The group of subjects who were bilaterally deafened after 5 to 6 yr of age ( 18 subjects ) showed a statistically significant improvement in sound localization when using both implants , compared with when using only one . The mean deviation between the presentation azimuth and the response azimuth was 16.6 ° when using both implants , which was on average 37.1 ° smaller than when using one implant only . When adjusted for the localization error that was constant across loudspeakers , the mean deviation was 15.9 ° for bilateral implant use , representing an improvement of 30.1 ° over unilateral implant use . Statistical analysis showed that in this group , performance measures were not correlated with subject details such as age at onset of deafness or duration of unilateral implant use . In contrast , subjects who were bilaterally deafened before 6 yr of age ( 2 subjects ) did not show a benefit in sound localization from bilateral implants . Conclusions : Bilateral cochlear implants offer a substantial benefit in sound localization to late-deafened , late-implanted subjects . The very limited data from early-deafened subjects implanted at a later age could suggest that these subjects may not benefit in sound localization from bilateral cochlear implants . It is possible that early implantation for early deafened subjects might allow better acquisition of spatial hearing , thus leading to improved localization performance PURPOSE In this study , the authors sought to compare speech perception and localization in subjects who wear 1 cochlear implant ( unilateral CI ) or 1 cochlear implant and hearing aid ( CI+HA ) and then receive a second cochlear implant ( bilateral CI ) , and to evaluate the importance of the duration between implant surgeries and duration of deafness . METHOD Nine subjects were tested on speech perception in quiet , and 13 subjects were tested on speech perception and localization in noise using an array of 8 loudspeakers . All subjects were tested with unilateral CI prior to bilateral implantation and then again with bilateral CI after at least 3 months of bilateral experience . RESULTS No significant difference was found between bilateral CI and unilateral CI on averaged speech perception in quiet performance . A significant benefit was found for bilateral CI on averaged speech perception in noise and on localization . Nonsignificant correlations were found for duration between surgeries , duration of deafness , and duration of bilateral use . CONCLUSIONS Improvements for speech perception and localization played in background noise were indicated for most subjects after they received their 2nd implant . The correlations should be reassessed with a larger number of subjects to appropriately evaluate the effects of duration between surgeries , duration of deafness , and duration of bilateral use Objective : To evaluate the benefits of bilateral electrical stimulation for hearing-impaired adult subjects using the Nucleus 24 cochlear implant in a multicenter study , and to compare and quantify performance on speech perception measures in quiet and in noise and localization ability for unilateral and bilateral cochlear implant use . Design : Repeated single subject measures were carried out for each subject , with each subject serving as their own control . Assessment of unilateral and bilateral listening conditions for performance on tests of speech comprehension and sound localization were performed . Speech comprehension measures were performed in quiet at 0 degree azimuth and in the presence of background noise simultaneously presented from the same speaker and spatially separated by 90 degrees , at S+45 ° N45 ° and at S−45 ° N+45 ° . Test material s included Freiburger monosyllabic words , Oldenburger sentences , and the Hochmair-Schulz-Moser sentences . Tests of localization were performed in the horizontal plane with 12 speaker locations 30 degrees apart using a shortened sentence stimulus from the Hochmair-Schulz-Moser sentences at two possible presentation levels of 55 and 70 dB sound pressure level for assessment of directionality . The binaural advantage provided by bilateral stimulation was calculated with respect to each ear separately , classified as either the better or poorer performing ear for each speech material in quiet and in noise test conditions . For localization of sound , the binaural advantage was compared with left and right ears separately . Paired comparisons for performance data in all conditions were carried out by considering measurements for each subject in different conditions as paired observations and applying the Student ’s t test to determine the statistical difference between the data sets . Setting : Tertiary referral centers with a cochlear implant program . Patients : Thirty-seven profoundly hearing-impaired adults were enrolled in the study , 22 simultaneously and 15 sequentially bilaterally implanted . All patients received the Nucleus 24 cochlear implant and used the Nucleus SPrint or ESPrit 3 G speech processor , with the vast majority using the ACE speech coding strategy . Results : For spatially separated speech in noise conditions , an interaural performance advantage for the ear closest to the speech source ( i.e. , with a superior signal to noise ratio ) compared with that for the ear closest to the noise source ( i.e. , with an inferior signal to noise ratio ) is consistently demonstrated regardless of whether it is the better or poorer performing ear closest to the speech signal . This is referred to as a significant binaural head-shadow benefit , result ing in a mean improvement between −10 dB and −11.4 dB in the critical signal to noise ratio required for 50 % speech comprehension for the Olden-burger sentences and a mean improvement in the maximum score of 42 % to 55 % for the ear closest to the speech signal over the ear farthest away for the Hochmair-Schulz-Moser sentences . Bilateral stimulation is always observed to provide a performance advantage over the unilateral listening condition for either ear when ipsilateral to the noise source . In addition , as demonstrated by approximately half the subjects tested in noise with the Hochmair-Schulz-Moser sentences , a performance advantage of bilateral stimulation may be observed over the better ear alone when positioned ipsilateral to the speech signal , which is referred to as a binaural squelch effect . On average , for the group , this result ed in a statistically significant improvement in speech comprehension scores of 8 % in the bilateral listening condition compared with the scores for the better ear alone . Through assessment of comprehension of coincidental speech in noise and speech in quiet , a significant benefit of binaural redundancy was noted for the group for Oldenburger sentence scores in noise and in quiet compared with unilateral scores for either ear and for the Freiburger monosyllabic words in quiet in comparison with the better ear alone scores . Binaural stimulation also led to a significant improvement in localization ability over either monaural condition , with the root mean square degrees of error reduced by 38 degrees compared with that observed for unilateral stimulation . Conclusion : Similar to what has been observed for bilateral acoustic stimulation in the past , bilateral electrical stimulation provides the foundation for the potential advantages of the head-shadow effect , providing a binaural head-shadow benefit and binaural auditory processing such as binaural redundancy and binaural squelch effects , all of which combine to lead to improved speech comprehension over unilateral listening conditions . The combination of improved speech comprehension and improved localization ability made available through bilateral electrical stimulation provides the necessary foundation to further assist the hearing-impaired listener to better cope with communication in the everyday listening situation both in noise and in quiet Objectives : To investigate whether a squelch effect occurs in the first 3 years after simultaneous bilateral cochlear implantation and to investigate whether this effect increases during follow-up . Study Design : Prospect i ve study as part of a multicenter r and omized controlled trial that compares simultaneous bilateral cochlear implantation to sequential and unilateral cochlear implantation . Setting : Tertiary referral center . Patients : Nineteen postlingually deafened adults . Intervention : Simultaneous bilateral cochlear implantation . Main Outcome Measure : The squelch effect , measured yearly with a speech-intelligibility-in-noise test with spatially separated sources . Bilateral results were compared to unilateral results in which the cochlear implant at the noise side was turned off . The squelch effect was investigated for the patients ’ best performing ear and for the left and right ears separately . Results : In 13 individual patients , a squelch effect was present after 1 year . This number increased during follow-up years . On group level , a squel \n Output:\n " }, { "from": "agent", "value": "The literature has shown that duration of deafness , age at onset of deafness , etiology of hearing loss , and preoperative speech perception score are ( inversely ) related to unilateral cochlear implantation outcome in adults .\nOne would expect that these factors would also affect sequential bilateral implantation outcome .\nHowever , the best available evidence to date shows that advanced age , a long duration of deafness , or a long interval between implantations should not be considered negative factors when considering sequential bilateral cochlear implantation" } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: BACKGROUND No long-term impact has yet been observed with the use of the social-influences approach to school-based smoking prevention for youth . However , whether this lack of impact is due to method ologic problems with the studies or to the failure of the interventions is unclear . The Hutchinson Smoking Prevention Project ( HSPP ) , conducted from September 1984 through August 1999 , aim ed to attain the most rigorous r and omized trial possible to determine the long-term impact of a theory-based , social-influences , grade 3 - 12 intervention on smoking prevalence among youth . METHODS Forty Washington school districts were r and omly assigned to the intervention or to the control condition . Study participants were children enrolled in two consecutive 3rd grade s in the 40 districts ( n = 8388 ) ; they were followed to 2 years after high school . The trial achieved high implementation fidelity and 94 % follow-up . Data were analyzed with the use of group-permutation methods , and all statistical tests were two-sided . RESULTS No significant difference in prevalence of daily smoking was found between students in the control and experimental districts , either at grade 12 ( difference [ Delta ] = 0.2 % , 95 % confidence interval [ CI ] = -4.6 % to 4.4 % , and P = .91 for girls ; Delta = 0.3 % , 95 % CI = -5.0 % to 5.5 % , and P = .89 for boys ) or at 2 years after high school ( Delta = -1.4 % , 95 % CI = -5.0 % to 1.6 % , and P = .38 for girls ; Delta = 2.6 % , 95 % CI = -2.5 % to 7.7 % , and P = .30 for boys ) . Moreover , no intervention impact was observed for other smoking outcomes , such as extent of current smoking or cumulative amount smoked , or in subgroups that differ in a priori specified variables , such as family risk for smoking . CONCLUSION The rigor of the HSPP trial suggests high credence for the intervention impact results . Consistent with previous trials , there is no evidence from this trial that a school-based social-influences approach is effective in the long-term deterrence of smoking among youth Our objective was to verify the effectiveness of a program based on the Life Skills Training approach with a greater extent than usual , not applied by teachers and a very high degree of reliability regarding the implementation of the expected content . Twenty-eight secondary schools in Granada ( Spain ) were r and omly assigned to the intervention or control group . The students in the intervention group received 21 one-hour sessions in the first year and 12 one-hour sessions in the second year , whereas those in the control group received no health education or preventive sessions . Students completed question naires before and after the first year of sessions , before and after the second year , and at 1 year after the program . All five question naires were completed by 77 % of the 1048 students initially enrolled in the study . The results suggest that the program had no preventive effects either immediately or at 1 year after its application . Application of the Life Skills Training approach does not appear to prevent the onset of smoking but may prove effective for avoiding escalation of the consumption levels of tobacco or other problematic drugs Background Smoking rates are projected to increase substantially in developing countries such as South Africa . Purpose The aim of this study was to test the efficacy of two contrasting approaches to school-based smoking prevention in South African youth compared to the st and ard health education program . One experimental program was based on a skills training/peer resistance model and the other on a harm minimization model . Method Thirty-six public schools from two South African provinces , KwaZulu-Natal and the Western Cape , were stratified by socioeconomic status and r and omized to one of three groups . Group 1 ( comparison ) schools ( n = 12 ) received usual tobacco use education . Group 2 schools ( n = 12 ) received a harm minimization curriculum in grade s 8 and 9 . Group 3 schools ( n = 12 ) received a life skills training curriculum in grade s 8 and 9 . The primary outcome was past month use of cigarettes based on a self-reported question naire . Result Five thous and two hundred sixty-six students completed the baseline survey . Of these , 4,684 ( 89 % ) completed at least one follow-up assessment . The net change in 30-day smoking from baseline to 2-year follow-up in the control group was 6 % compared to 3 % in both harm minimization ( HM ) and life skills training ( LST ) schools . These differences were not statistically significant . Intervention response was significantly moderated by both gender and race . The HM intervention was more effective for males , whereas the life skills intervention was more effective for females . For black African students , the strongest effect was evident for the HM intervention , whereas the strongest intervention effect for “ colored ” students was evident for the LST group . Conclusion The two experimental curricula both produced similar overall reductions in smoking prevalence that were not significantly different from each other or the control group . However , the impact differed by gender and race , suggesting a need to tailor tobacco and drug use prevention programs . More intensive intervention , in the classroom and beyond , may be needed to further impact smoking behavior Tobacco and drug use remain major public health concerns . The aim of this study was to evaluate the effectiveness of a school health intervention program using life skills training ( LST ) to reduce tobacco and drug use among Thai high school students . A r and omized pretest and post-test comparative design was used to evaluate the effectiveness of the LST program . A total of 170 Thai students in grade s 7 - 12 were r and omly selected . The students in the control group received the tobacco and drug education curriculum normally provided ; the intervention group received a LST program that provided information and skills specifically related to drug and tobacco use . Students in the school health intervention program had statistically significant positive effects regarding knowledge level , attitudes , and the development of refusal , decision-making , and problem-solving skills . The results showed that a LST program was effective for preventing tobacco and drug use in Thai high school students This paper evaluates a smoking prevention intervention aim ed at vocational school students , consisting of an existing Dutch in-school program ( three lessons each lasting 50 min ) and a computer-based tailored out-of-school program ( three tailored letters with smoking prevention messages mailed to students ' homes ) . Nineteen schools that already participated in the in-school program were r and omly assigned to the in-school or to the combined in-school and out-of-school condition . The remaining 17 schools were r and omly assigned to the out-of-school condition or to the control group . Effect outcomes were assessed at 6 , 12 and 18 months after a pre-test , and were based on initiation among never-smokers and continuation among ever-smokers . Twelve months after the pre-test ( post-test 2 ) , the in-school intervention was successful in preventing vocational school students from continuing to smoke , compared with students in the control condition [ odds ratio ( OR ) = 0.49 ; 95 % confidence interval ( CI ) = 0.29 - 0.84 ] . Eighteen months after the pre-test ( post-test 3 ) , the tailored out-of-school intervention was successful in preventing smoking initiation , compared with students in the control condition ( OR = 0.42 ; 95 % CI = 0.18 - 0.96 ) . The effect of the combined approach was not larger than the sum of the effects of the in-school and the out-of-school effects This study used Complier Average Causal Effect analysis ( CACE ; see G. Imbens & D. Rubin , 1997 ) to examine the impact of an adaptive approach to family intervention in the public schools on rates of substance use and antisocial behavior among students ages 11 - 17 . Students were r and omly assigned to a family-centered intervention ( N = 998 ) in 6th grade and offered a multilevel intervention that included ( a ) a universal classroom-based intervention , ( b ) the Family Check-Up ( selected ; T. J. Dishion & K. Kavanagh , 2003 ) , and ( c ) family management treatment ( indicated ) . All services were voluntary , and approximately 25 % of the families engaged in the selected and indicated levels . Participation in the Family Check-Up was predicted by 6th- grade teacher ratings of risk , youth reports of family conflict , and the absence of biological fathers from the youths ' primary home . Relative to r and omized matched controls , adolescents whose parents engaged in the Family Check-Up exhibited less growth in alcohol , tobacco , and marijuana use and problem behavior during ages 11 through 17 , along with decreased risk for substance use diagnoses and police records of arrests by age 18 BACKGROUND The prevalence of adolescent smoking has been increasing rapidly in China . Theory-based smoking prevention programmes in schools may be an effective approach in preventing smoking among Chinese adolescents . METHODS A school-level cluster r and omized controlled trial was conducted among 7th and 8th grade students ( N = 2343 ) in four junior high schools in southern China during 2004 - 06 . The theory-based , multi-level intervention was compared with the st and ard health curriculum . Outcome measures comprised changes in students ' smoking-related knowledge , attitudes and behaviour . RESULTS The mean knowledge scores from baseline to the 1- and 2-year follow-ups increased more in the intervention group than in the control group , whereas there was little change in attitude scores . At the 1-year follow-up ( the total sample ) , the interventions reduced the probability of baseline experimental smokers ' escalating to regular smoker [ 7.9 vs 18.3 % ; adjusted odds ratio ( OR ) 0.34 , 95 % confidence interval ( CI ) 0.12 - 0.97 , P = 0.043 ] , but did not reduce the probability of baseline non-smokers ' initiating smoking ( 7.9 vs 10.6 % ; adjusted OR 0.86 , 95 % CI 0.54 - 1.38 , P = 0.538 ) . At the 2-year follow-up ( only 7th grade students ) , similar proportions of baseline non-smokers initiated smoking in the intervention group and the control group ( 13.5 vs 13.1 % ) , while a possibly lower proportion of baseline experimental smokers escalated to regular smoking in the intervention group than the control group ( 22.6 vs 40.0 % ; adjusted OR 0.43 , 95 % CI 0.12 - 1.57 , P = 0.199 ) . CONCLUSIONS This multi-level intervention programme had a moderate effect on inhibiting the escalation from experimental to regular smoking among Chinese adolescents , but had little effect on the initiation of smoking . The programme improved adolescents ' smoking-related knowledge , but did not change their attitudes towards smoking This study tested the hypothesis that cigarette smoking adoption among adolescents could be suppressed by providing school-based videotape instruction for resisting social influences to smoke . The utilization of same-age peer leaders was also varied to test whether their participation in the classroom would enhance program effects . Seventh grade students ( N = 540 ) from one junior high school in Southern California were r and omly assigned by classrooms ( N = 15 ) to : ( a ) videotape instruction , ( b ) videotape instruction plus peer leader involvement , or ( c ) survey-only . Seventh grade students ( N = 234 ) in a second junior high school served as a measurement-only control . Assessment s were conducted at the beginning and end of the academic year . Results revealed a marked suppression in the onset of both experimental and regular smoking among those students exposed to the pressure resistance training with peer leader involvement . Pressure resistance training without peer leader involvement produced a more variable and less powerful effect on students ' smoking behavior . Data collected on students ' use of alcohol and marijuana revealed a generalized suppression effect , albeit weaker than for tobacco , among those students exposed to the social resistance training with peer leader involvement . Results provide further encouraging support for the use of peer-led pressure resistance training in preventing adolescent drug use In this article , we examine the impact of two universal , grade 1 preventive interventions on the onset of tobacco smoking as assessed in early adolescence . The classroom-centered ( CC ) intervention was design ed to reduce the risk for tobacco smoking by enhancing teachers ' behavior management skills in first grade and , thereby , reducing child attention problems and aggressive and shy behavior-known risk behaviors for later substance use . The family-school partnership ( FSP ) intervention targeted these early risk behaviors via improvements in parent-teacher communication and parents ' child behavior management strategies . A cohort of 678 urban , predominately African-American , public school students were r and omly assigned to one of three Grade 1 classrooms at entrance to primary school ( age 6 ) . One classroom featured the CC intervention , a second the FSP intervention , and the third served as a control classroom . Six years later , 81 % of the students completed audio computer-assisted self-interviews . Relative to controls , a modest attenuation in the risk of smoking initiation was found for students who had been assigned to either the CC or FSP intervention classrooms ( 26 % versus 33 % ) ( adjusted relative risk for CC/control contrast=0.57 , 95 % confidence interval ( CI ) , 0.34 - 0.96 ; adjusted relative risk for FSP/control contrast=0.69 , 95 % CI , 0.50 - 0.97 ) . Results lend support to targeting the early antecedent risk behaviors for tobacco smoking OBJECTIVE To examine the effectiveness of a drug abuse prevention program in reducing the initiation and escalation of smoking in a sample of predominantly minority junior high school girls . METHODS The 15-session prevention program teaches \n Output:\n " }, { "from": "agent", "value": "Principal findings were not sensitive to inclusion of booster sessions in curricula or to whether they were peer-led or adult-led .\nDifferentiation into tobacco-only or multifocal curricula had a similar effect on the primary findings .\nFew trials assessed outcomes by gender : there were significant effects for females at both follow-up periods , but not for males .\nRCTs of baseline never-smokers at longest follow-up found an overall significant effect with average 12 % reduction in starting smoking compared with controls , but no effect for all trials pooled at ≤1 year .\nHowever , combined social competence/social influences curricula showed a significant effect at both follow-up periods ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: BACKGROUND Mild perioperative hypothermia , which is common during major surgery , may promote surgical-wound infection by triggering thermoregulatory vasoconstriction , which decreases subcutaneous oxygen tension . Reduced levels of oxygen in tissue impair oxidative killing by neutrophils and decrease the strength of the healing wound by reducing the deposition of collagen . Hypothermia also directly impairs immune function . We tested the hypothesis that hypothermia both increases susceptibility to surgical-wound infection and lengthens hospitalization . METHODS Two hundred patients undergoing colorectal surgery were r and omly assigned to routine intraoperative thermal care ( the hypothermia group ) or additional warming ( the normothermia group ) . The patient 's anesthetic care was st and ardized , and they were all given cefam and ole and metronidazole . In a double-blind protocol , their wounds were evaluated daily until discharge from the hospital and in the clinic after two weeks ; wounds containing culture-positive pus were considered infected . The patients ' surgeons remained unaware of the patients ' group assignments . RESULTS The mean ( + /- SD ) final intraoperative core temperature was 34.7 + /- 0.6 degrees C in the hypothermia group and 36.6 + /- 0.5 degrees C in the normothermia group ( P < 0.001 ) Surgical-wound infections were found in 18 of 96 patients assigned to hypothermia ( 19 percent ) but in only 6 of 104 patients assigned to normothermia ( 6 percent , P = 0.009 ) . The sutures were removed one day later in the patients assigned to hypothermia than in those assigned to normothermia ( P = 0.002 ) , and the duration of hospitalization was prolonged by 2.6 days ( approximately 20 percent ) in hypothermia group ( P = 0.01 ) . CONCLUSIONS Hypothermia itself may delay healing and predispose patients to wound infections . Maintaining normothermia intraoperatively is likely to decrease the incidence of infectious complications in patients undergoing colorectal resection and to shorten their hospitalizations OBJECTIVE To compare the effectiveness for prevention of central venous and arterial catheter colonization of 3 skin antisepsis with 1 of 3 antiseptic solutions : 10 % aqueous povidone iodine ( aqueous PI ) , 2 % aqueous chlorhexidine gluconate ( aqueous CG ) , and 0.5 % alcoholic chlorhexidine gluconate ( alcoholic CG ) . DESIGN Prospect i ve , r and omized controlled trial . SETTING Intensive care unit in a teaching hospital . METHODS Patients were r and omly assigned to 1 of the 3 skin antisepsis groups . The distal tips of catheters were semiquantitatively cultured when the catheters were no longer necessary or if there was a suspicion of catheter-related infection . Rates of catheter colonization , catheter-related sepsis , and catheter-related bacteremia were compared among the 3 groups . RESULTS A total of 631 catheters were included in the study ( 194 from the aqueous PI group , 211 from the aqueous CG group , and 226 from the alcoholic CG group ) . The incidence of catheter colonization was significantly lower in the alcoholic CG than in the aqueous PI group ( 14.2 % vs 24.7 % ; relative risk , 0.5 [ 95 % confidence interval , 0.3 - 0.8 ; P < .01 ] ) ; it was also significantly lower in the aqueous CG group than in the aqueous PI group ( 16.1 % vs 24.7 % ; relative risk , 0.6 [ 95 % confidence interval , 0.4 - 0.9 ; P = .03 ] ) . There were no significant differences between the aqueous CG and the alcoholic CG groups . Incidences of catheter-related bacteremia were similar for all 3 groups . The aqueous and alcoholic CG solutions were superior to the aqueous PI solution in preventing catheter colonization due to gram-positive bacteria . CONCLUSIONS The aqueous and alcoholic CG solutions for cutaneous antisepsis were similarly effective in preventing colonization of central venous catheters and arterial catheters . Both had significantly lower incidences of colonization than did the aqueous PI solution ; this effect seems to be related to the CG solutions ' more efficacious prevention of colonization with gram-positive bacteria BACKGROUND Orthopedic surgical procedures involving the foot and ankle are associated with high rates of infection . The optimal method of preparing the skin and nails for foot and ankle surgery remains unknown . OBJECTIVE This study was conducted to compare the efficacy of 4 different methods of skin and nail preparation of the foot using various antiseptic solutions . METHODS In this prospect i ve , r and omized study , 4 methods of skin and nail preparation were compared in terms of their efficacy in eliminating bacteria from the hallux nailfold and first web space of the normal foot in 28 healthy adult volunteers . Efficacy was determined by evaluating the difference in the total bacterial load before and after skin preparation . The foot-preparation solutions evaluated were 4 % chlorhexidine gluconate , 70 % isopropyl alcohol , and 7.5 % to 10 % povidone-iodine . RESULTS The addition of alcohol to povidone-iodine was found to increase the efficacy of the preparation method . The nailfold remained contaminated after any of the preoperative skin- and nail-preparation methods studied . LIMITATIONS This study did not measure clinical ly relevant infections , and the results may not correlate with decreased rates of infection after surgery . CONCLUSION Incorporation of alcohol and povidone-iodine into the preoperative skin- and nail-preparation process may help reduce the bacterial load . Every effort should be made to lower the risk of contamination from the nail The effects of alcohol , chlorhexidine cream and iodophor cream on the infectious complications associated with intravenous catheters were studied . One hundred and fifty patients were r and omly allocated into each antiseptic group . Daily cleansing and disinfecting the cut down wounds were done with the above antiseptics . Minor surgical wound infections were found in one patient in the alcohol and iodophor group compared to five in the chlorhexidine group . Phlebitis complicated four patients , two in the iodophor group and one in each of the remaining groups . Only one patient in the chlorhexidine group had septicaemia due to A. antitratus . Thirty-four catheter tips ( 22.7 % ) yielded bacteria on culture . Incidence of positive tip cultures was significantly higher in the chlorhexidine group than in the other two . The rates of positive tip cultures correlated with duration of catheterization . It is concluded that alcohol is the antiseptic of choice for cut down wounds . Application of antiseptic cream to the wounds was less effective than alcohol and this practice should be discouraged The optimum duration of antimicrobial prophylaxis in elective gastric cancer surgery is still open to question . This multicentre r and omized clinical trial compared a single‐dose with a multiple‐dose regimen of antimicrobial prophylaxis for prevention of surgical‐site infection Estimating the cost of hospital infection has become a matter of increasing interest in terms of health economics . This study aim ed to assess the accuracy of economic studies on hospital infections , using surgical site infection ( SSI ) as an example . A search was performed for original articles reporting the cost of SSI , published in the English language between 1996 and 2005 . For the critical review , the period of cost tracking , classification of costs and cost counting methods were noted . Fifteen articles met the inclusion criteria . The costs of SSI vary according to surgical procedures , country , publication year , study design and accounting method . Only two studies estimated the additional cost of SSI after discharge . All 15 studies included healthcare costs and none measured patient/family re sources . In 10 studies , the costs were calculated based on accounting . Three studies used estimated costs from the ratio of costs to charges and two studies used charge data in place of cost data . It will become increasingly important for future studies to perform multi-centre prospect i ve surveys , establish a st and ard method for cost accounting , include the cost of healthcare services following hospitalization and consider the morbidity cost to patients themselves from a societal perspective OBJECTIVE The purpose of this study was to compare the efficacy of chlorhexidine and povidone iodine for cleansing the operative field for vaginal surgery . STUDY DESIGN This was a r and omized controlled trial that compared 10 % povidone iodine and 4 % chlorhexidine gluconate as surgical scrubs . Our primary end point was the proportion of contaminated specimens ( defined as total bacterial colony counts of > /=5000 colony-forming units ) per group found throughout the surgical procedures . All patients received st and ard infection prophylaxis that included preoperative intravenous antibiotics . Immediately before antibiotic administration and baseline aerobic and anaerobic cultures of the vaginal flora were obtained , which were followed by cultures at 30 minutes after the surgical scrub and hourly thereafter throughout each patient 's surgery . RESULTS A total of 50 patients were enrolled between October 2002 and September 2003 . There were no differences between the povidone iodine ( n = 27 ) and chlorhexidine ( n = 23 ) groups with respect to age , race , exogenous hormone use , body mass index , gravity , parity , preoperative mean colony counts , or operative time . Among the first set of intraoperative specimens ( which were obtained 30 minutes after the surgical scrub ) , 63 % of the cultures ( 17/27 ) from the povidone iodine group and 22 % of the cultures ( 5/23 ) from the chlorhexidine group were classified as contaminated ( P = .003 ; relative risk , 6.12 ; 95 % CI , 1.7 , 21.6 ) . Subsequent cultures failed to demonstrate significant differences . CONCLUSION Chlorhexidine gluconate was more effective than povidone iodine in decreasing the bacterial colony counts that were found in the operative field for vaginal hysterectomy BACKGROUND Previous studies have demonstrated higher infection rates following orthopaedic procedures on the foot and ankle as compared with procedures involving other areas of the body . Previous studies also have documented the difficulty of eliminating bacteria from the forefoot prior to surgery . The purpose of the present study was to evaluate the efficacy of three different surgical skin-preparation solutions in eliminating potential bacterial pathogens from the foot . METHODS A prospect i ve study was undertaken to evaluate 125 consecutive patients undergoing surgery of the foot and ankle . Each lower extremity was prepared with one of three r and omly selected solutions : DuraPrep ( 0.7 % iodine and 74 % isopropyl alcohol ) , Techni-Care ( 3.0 % chloroxylenol ) , or ChloraPrep ( 2 % chlorhexidine gluconate and 70 % isopropyl alcohol ) . After preparation , quantitative culture specimens were obtained from three locations : the hallux nailfold ( the hallux site ) , the web spaces between the second and third and between the fourth and fifth digits ( the toe site ) , and the anterior part of the tibia ( the control site ) . RESULTS In the Techni-Care group , bacteria grew on culture of specimens obtained from 95 % of the hallux sites , 98 % of the toe sites , and 35 % of the control sites . In the DuraPrep group , bacteria grew on culture of specimens obtained from 65 % of the hallux sites , 45 % of the toe sites , and 23 % of the control sites . In the ChloraPrep group , bacteria grew on culture of specimens from 30 % of the hallux sites , 23 % of the toe sites , and 10 % of the control sites . ChloraPrep was the most effective agent for eliminating bacteria from the halluces and the toes ( p < 0.0001 ) . CONCLUSIONS The use of effective preoperative preparation solution is an important step in limiting surgical wound contamination and preventing infection , particularly in foot and ankle surgery . Of the three solutions tested in the present study , the combination of chlorhexidine and alcohol ( ChloraPrep ) was most effective for eliminating bacteria from the forefoot prior to surgery BACKGROUND Currently , there are various antiseptics used for cleaning the skin before surgery , but there is no st and ard procedure in practice . Chlorhexidine and povidone-iodine are the most preferred compounds among antiseptics . Both are proved to be safe and effective for skin disinfection . In this study , our aim was to investigate the combined effects of chlorhexidine and povidone-iodine on the skin 's flora before neurosurgical intervention , consecutively . METHODS R and omly , 50 cranial and 50 spine neurosurgery cases were assigned to the study . The first culture was obtained after hair removal and before cleaning the skin with any antiseptic . The second culture was obtained after the skin had been cleaned with chlorhexidine for 3 minutes . Then , the skin was cleaned twice with povidone-iodine for 30 seconds , and the third and fourth cultures were taken from the skin incision area . Bacteria were identified by means of st and ard laboratory identification methods . Positive culture results were compared statistically among order of cultures obtained . RESULTS In the \n Output:\n " }, { "from": "agent", "value": "Chlorhexidine should be used preferentially for preoperative antisepsis in clean-contaminated surgery" } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: OBJECTIVE : To determine whether residents perceived oral , face-to-face feedback about their continuity clinic performance as better than a similar , written version . DESIGN : Single-blind , r and omized controlled trial . SETTING : Two university-based , internal medicine residency clinics . PARTICIPANTS : All 68 internal medicine and combined program ( medicine-pediatrics , medicine-psychiatry , medicine-neurology , and preliminary year ) residents and their clinic preceptors . MEASUREMENTS AND MAIN RESULTS : Residents at each program were separately r and omized to oral or written feedback sessions with their clinic preceptors . The oral and written sessions followed similar , structured formats . Both groups were later sent question naires about aspects of the clinic . Sixty-five ( 96 % ) of the residents completed the question naire . Eight of the 19 questions dealt with aspects of feedback . A feedback scale was developed from the survey responses to those eight questions ( α=.86 ) . There were no significant differences in the responses to individual questions or in scale means ( p>.20 ) between the two feedback groups . When each university was analyzed separately , one had a higher scale mean ( 3.10 vs 3.57 , p=.047 ) , but within each university , there were no differences between the oral and written feedback groups ( p>.20 ) . CONCLUSIONS : No differences were observed between the oral and written feedback groups . In attempting to provide better feedback to their residents , medical educators may better apply their efforts to other aspects , such as the frequency of their feedback , rather than the form of its delivery Second-year medical students performed a head-to-toe screening physical examination on trained patient instructors ( PIs ) as a high-stakes examination before beginning clinical clerkships . PIs completed a 138-item checklist and instructed the students in the proper performance of any incorrectly executed or omitted items . To assess the accuracy of the PI ratings , ' monitor ' PIs watching the encounter by video completed checklists for 11 retests of failed students in 2001 and for 28 r and omly selected encounters in 2002 . Checklist-level discrepancies measured by mean absolute checklist difference were 8 % in 2001 and 9 % in 2002 . Case-level mean difference between raters in 2002 was -2.9 % . The inter-rater reliability for a single rater , estimated by the intra-class correlation coefficient for total encounter scores , was 0.95 . The assessment and feedback were well received by the students . The Head-to-Toe examination provides a reliable assessment of a student 's ability to carry out a complete screening physical examination . Patient instructors can be trained to acceptable accuracy and reliability despite the length and complexity of the exercise , and can provide effective feedback and teaching targeted to individual student deficiencies Learning proper techniques in physical examinations is m and atory for a physician . Although students may examine each other in early training , examination of the female pelvis does not readily conform to this reciprocity . A r and omized study was conducted , comparing teaching methods utilizing professional patients or plastic models . Training on a professional patient significantly increased a student 's chance of palpating one or both ovaries , reduced the student 's anxiety about performing a pelvic examination , and may have improved the student 's gentleness . Costs of the professional patient method were minimal . It is recommended that teaching pelvic examinations with the professional patient replace teaching on the plastic model PURPOSE : To evaluate two smoking-cessation practice exercises , one using st and ardized patients ( SPs ) , the other using role playing by medical students . METHOD : In the spring of 1994 all 120 first-year University of California , San Francisco , School of Medicine Students were given lectures on the health effects of smoking and how physicians can help patients quit . Afterward some of the students were r and omly assigned to two groups in which to practice counseling patients : Group 1 ( n = 35 ) used SPs , Group 2 ( n = 37 ) used role playing . Each of the Group 1 students practice d smoking-cessation techniques with an SP ; the SP evaluated the student on cognitive and communication skills , assigned an overall rating , and provide feedback using a st and ardized form . The Group 2 students ( as well as the 48 students not assigned to a group ) role-played in pairs and used the same form to provide feedback . All the students evaluated their respective practice practice s. Two weeks later 24 Group 1 and 31 Group 2 students participated in a clinic-skills- assessment exercise using SPs . As in the Group 1 practice exercise , each student was evaluated by an SP on cognitive and communication skills and assigned an overall rating . Data were analyzed through a number of statistical methods . The cost of the SP program was determined . RESULTS : The Group 1 students rated their practice exercise much more favorably than did the Group 2 students . However , there was no significant difference between the groups in their ratings by the SPs on the clinical -skills- assessment exercise . The use of SPs cost a great deal more than did the use of role playing . CONCLUSION : Although the students rated the SPs higher than they did the role playing , the two tools produced similar levels of skills attainment . The data suggest that having students practice smoking-cessation techniques through role playing may be as effective as using the more extensive SPs Purpose To compare two methods of teaching physical assessment , a traditional faculty-taught course and a course with components taught by specially trained st and ardized patients ( SPs ) , with respect to students ' performances and costs . Method Medical students in their second year and without preliminary course work in physical assessment were taught by faculty-led small groups . Students in their first year were taught by faculty-led lecture — demonstrations and exercises led by physical examination teaching associates ( PETAs ) . Both groups of students were tested with a performance-based examination that involved six identical stations . The costs of both courses were calculated using faculty and SP salaries . Results There was no difference in students ' performances on two of the stations , those involving the eye and abdominal examinations . The class that had been taught by PETAs , however , demonstrated a statistically significant performance advantage on the remaining four stations . The cost saving from using the PETAs was conservatively estimated at $ 24,155 . Conclusion Specially trained SPs can effectively teach the normal physical examination to medical students and are a less expensive alternative to traditional faculty small-group teaching methods The area of communication skills in adolescent medicine is emerging as a distinct and important part of the undergraduate curriculum . An appropriate level of confidence in dealing with the adolescent population is deemed a necessary educational requirement . Skills in psychosocial communication with adolescents differ from those required for younger patients and adults ; they include discussing confidentiality and adolescent risk-taking activities . Simulated patients can be used effectively in teaching and evaluating of communication skills . However , there is no report of using adolescent simulated patients to teach communication skills . The evidence available is inconclusive regarding the teaching time required to promote retention of communication skills , although a recent review suggests that one day ’s training or less is not effective . Long-term retention of these skills has been supported by only one paper , suggesting a need to follow students over time to ascertain the effect of communication skills training . Our study addressed two questions : ( 1 ) does feedback from a simulated adolescent patient and simulated mother lead to improvements in fourth-year medical students ’ psychosocial interviewing of adolescent patients ? and ( 2 ) does this skill persist following the intervention A class of 100 second-year medical students was r and omly divided into two groups for instruction in the techniques of the gynecologic examination . Each group received a lecture and a demonstration film . The control group then had practical instruction on office or clinic patients . The study group was instructed by specially trained clinical teaching associates who acted both as professional patients and as teachers . After practice in clinics and offices , both groups received a common evaluation by gynecologists and teaching associates . Students who were instructed by clinical teaching associates performed better on subsequent pelvic examinations and demonstrated superior communications skills compared with the control group Two nonphysician mothers were each trained to give a consistent and authentic history of a child 's common medical problem . At the beginning of a Pediatric Clerkship , one half the students were r and omly assigned to interview one of the trained mothers . The interviews were videotaped and then replayed in an evaluative feedback session with each student . At the end of the clerkship these students were rated significantly higher on the process of interviewing than those students who did not have the initial evaluative feedback session OBJECTIVES Facing dramatic reductions of inpatient beds and fewer faculty tutors , the Queen 's University medical school has had to consider alternatives to the traditional inpatient encounter for the early acquisition of clinical skills . The purpose of this study was to investigate the feasibility and impact on students of a model for a first-year clinical skills course , using exclusively st and ardized patients in place of in patients , and using a smaller ratio of faculty to students . DESIGN Twenty volunteers were selected from the first-year class of 75 students to participate as the experimental group . The remaining 55 students formed the control group . SETTING Queen 's University medical school , Ontario , Canada . SUBJECTS First-year medical students . RESULTS In measures of student satisfaction with the amount of performance feedback received during the course , there was a non-significant trend towards greater satisfaction among the experimental group compared to the control group . This occurred despite a tutor to student ratio of 1.5:10 in the experimental group compared to 3:10 in the control group . In the student evaluation of their tutors , mean scores for the two groups were 4.28 for the experimental group and 4 . 06 for the control group ( P = 0.10 ) . The mean OSCE scores for the two groups were 76.4 for the experimental group and 76.5 for the control group ( P = 0.93 ) . There is no practical or statistical difference in either of these two scores . CONCLUSIONS We conclude that this new model is feasible , was well received by the students and that the reduced tutor to student ratio and lack of inpatient encounters did not appear to adversely affect their learning The increasing difficulty in obtaining appropriate hospitalized patients to give enlarging classes of medical students their first exposure to abnormal physical findings has led to the development of an instructor-patient program . Sixteen community residents with relatively stable respiratory , cardiovascular , musculoskeletal , or neurological findings were recruited and trained as instructor- patients to teach the technical elements of the examination of the affected organ system . Evaluation of the technical skills of 46 second-year students trained by instructor- patients and those of 41 r and omly selected students trained in these skills by physician instructors demonstrated that the two have comparable technical skills five to eight weeks after the training sessions . Faculty recruitment , instructor-patient recruitment and training , and evaluation are discussed PURPOSE : This r and omized controlled study compared the interviewing skills of first-year medical students receiving feedback primarily from st and ardized patients ( SPs ) with those of students receiving feedback primarily from faculty . METHOD : All 154 first-year students at the University of Oklahoma College of Medicine in 1993 - 94 were video-taped to assess baseline and post-instruction interviewing skills . All the students , r and omized to one of three study groups , attended two four-hour workshops on interviewing skills . Instruction in the groups was as similar as possible except in the matter of who provided feedback . Two rating systems were used to rate the videotaped interviews for performances of targeted skills . RESULTS : Complete , usable data were available for 120 ( 78 % ) of the students . Skill ratings using the Arizona Clinical Interview Rating Scale were significantly higher for the “ types of questions used ” and “ use of empathy ” items in the SP-led feedback group . No significant difference in ratings was detected among the groups as measured by the Rotor Interactional Analysis System . CONCLUSION : The SPs were at least as effective as the faculty in effecting behavioral changes in the first-year medical students ' interviewing skills \n Output:\n " }, { "from": "agent", "value": "Although feedback from the patient 's perspective is generally recommended , most SPs provided feedback on clinical skills and communication skills .\nDISCUSSION There appear to be no clear st and ards with regard to effective feedback training for SPs ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: Background Therapeutic decisions in atrial fibrillation ( AF ) are often influenced by assessment of bleeding risk . However , existing bleeding risk scores have limitations . Objectives We sought to develop and vali date a novel bleeding risk score using routinely available clinical information to predict major bleeding in a large , community-based AF population . Methods We analysed data from Outcomes Registry for Better Informed Treatment of Atrial Fibrillation ( ORBIT-AF ) , a prospect i ve registry that enrolled incident and prevalent AF patients at 176 US sites . Using Cox proportional hazards regression , we identified factors independently associated with major bleeding among patients taking oral anticoagulation ( OAC ) over a median follow-up of 2 years ( interquartile range = 1.6–2.5 ) . We also created a numerical bedside risk score that included the five most predictive risk factors weighted according to their strength of association with major bleeding . The predictive performance of the full model , the simple five-item score , and two existing risk scores ( hypertension , abnormal renal/liver function , stroke , bleeding history or predisposition , labile INR , elderly , drugs/alcohol concomitantly , HAS-BLED , and anticoagulation and risk factors in atrial fibrillation , ATRIA ) were then assessed in both the ORBIT-AF cohort and a separate clinical trial population , Rivaroxaban Once-daily oral direct factor Xa inhibition compared with vitamin K antagonism for prevention of stroke and embolism trial in atrial fibrillation ( ROCKET-AF ) . Results Among 7411 ORBIT-AF patients taking OAC , the rate of major bleeding was 4.0/100 person-years . The full continuous model ( 12 variables ) and five-factor ORBIT risk score ( older age [ 75 + years ] , reduced haemoglobin/haematocrit/history of anaemia , bleeding history , insufficient kidney function , and treatment with antiplatelet ) both had good ability to identify those who bled vs. not ( C-index 0.69 and 0.67 , respectively ) . These scores both had similar discrimination , but markedly better calibration when compared with the HAS-BLED and ATRIA scores in an external validation population from the ROCKET-AF trial . Conclusions The five-element ORBIT bleeding risk score had better ability to predict major bleeding in AF patients when compared with HAS-BLED and ATRIA risk scores . The ORBIT risk score can provide a simple , easily remembered tool to support clinical decision making OBJECTIVES The objective of this study was to compare the predictive performance of bleeding risk-estimation tools in a cohort of patients with atrial fibrillation ( AF ) undergoing anticoagulation . BACKGROUND Three bleeding risk-prediction schemes have been derived for and vali date d in patients with AF : HEMORR(2)HAGES ( Hepatic or Renal Disease , Ethanol Abuse , Malignancy , Older Age , Reduced Platelet Count or Function , Re-Bleeding , Hypertension , Anemia , Genetic Factors , Excessive Fall Risk and Stroke ) , ATRIA ( Anticoagulation and Risk Factors in Atrial Fibrillation ) , and HAS-BLED ( Hypertension , Abnormal Renal/Liver Function , Stroke , Bleeding History or Predisposition , Labile International Normalized Ratio , Elderly , Drugs/Alcohol ) . Τhe relative predictive values of these bleeding scores have not previously been compared . METHODS We analyzed the data set from the AMADEUS ( Evaluating the Use of SR34006 Compared to Warfarin or Acenocoumarol in Patients With Atrial Fibrillation ) trial , a multicenter , r and omized , open-label noninferiority study that compared fixed-dose idraparinux with adjustable-dose oral vitamin K antagonist therapy in patients with AF . The principal safety outcome was any clinical ly relevant bleeding event , which was a composite of major bleeding plus clinical ly relevant nonmajor bleeding . RESULTS The HAS-BLED score performed best in predicting any clinical ly relevant bleeding , reflected both in net reclassification improvement ( 10.3 % and 13 % improvement compared with HEMORR(2)HAGES and ATRIA , respectively ) and receiver-operating characteristic ( ROC ) analyses ( c-indexes : 0.60 vs. 0.55 and 0.50 for HAS-BLED vs. HEMORR(2)AGES and ATRIA , respectively ) . Using decision-curve analysis , the HAS-BLED score demonstrated superior performance compared with ATRIA and HEMORR(2)HAGES at any threshold probability for clinical ly relevant bleeding . HAS-BLED was the only score that demonstrated a significant predictive performance for intracranial hemorrhage ( c-index : 0.75 ; p = 0.03 ) . An ATRIA score > 3 was not significantly associated with the risk for any clinical ly relevant bleeding on Cox regression or on ROC analysis ( c-index : 0.50 ; p = 0.87 ) . CONCLUSIONS All 3 tested bleeding risk-prediction scores demonstrated only modest performance in predicting any clinical ly relevant bleeding , although the HAS-BLED score performed better than the HEMORR(2)HAGES and ATRIA scores , as reflected by ROC analysis , reclassification analysis , and decision-curve analysis . Only HAS-BLED demonstrated a significant predictive performance for intracranial hemorrhage . Given its simplicity , the HAS-BLED score may be an attractive method for the estimation of oral anticoagulant-related bleeding risk for use in clinical practice , supporting recommendations in international guidelines Context Guidelines for prescribing anticoagulants in atrial fibrillation do not use contemporary stroke rates or account for intracranial bleeding risk . Contribution The authors studied 6-year rates of ischemic stroke and intracranial hemorrhage in 13559 adults with nonvalvular atrial fibrillation . They calculated ischemic stroke rates in patients receiving and not receiving warfarin ( treatment benefit ) and intracranial hemorrhage rates ( treatment harm ) . Benefit minus harm ( net treatment benefit ) was highest in patients with previous stroke , age older than 84 years , and others with high stroke risk . Caution Patients received warfarin according to clinical judgment , not r and omly . Implication Age and other stroke risk factors should drive the decision to use warfarin in atrial fibrillation . The Editors Warfarin anticoagulation is very efficacious in preventing thromboembolism ( primarily ischemic stroke but also systemic thromboembolism ) in patients with atrial fibrillation and is highly effective in practice ( 1 , 2 ) . Nonetheless , warfarin therapy increases the risk for major hemorrhage and is burdensome for both physicians and patients . Therefore , clinical guidelines ( 3 , 4 ) recommend warfarin only for patients with atrial fibrillation who are considered to be at intermediate or high risk for ischemic stroke . However , these risk-based anticoagulation guidelines have substantial limitations . First , they do not explicitly account for the risk for fatal and disabling hemorrhage due to warfarin . Second , they are primarily based on studies conducted more than 15 years ago . Recent studies ( 2 , 5 , 6 ) of patients with atrial fibrillation suggest a lower absolute risk for stroke while not receiving warfarin therapy , perhaps reflecting better treatment of hypertension or other risk factors . Finally , the net clinical benefit of risk-based recommendations for anticoagulation in patients with atrial fibrillation has not been demonstrated in large population s followed for long periods . In our observational study , we quantify the net clinical benefit of warfarin anticoagulation , defined as the estimated reduction in rate of thromboembolism , mainly ischemic stroke , minus 1.5 times the estimated increase in rate of intracranial hemorrhage attributable to warfarin therapy in st and ard stroke risk subgroups in the community-based cohort of patients in the ATRIA ( AnTicoagulation and Risk Factors In Atrial Fibrillation ) Study . Methods Study Population The ATRIA Study cohort consists of 13559 adults with diagnosed nonvalvular atrial fibrillation who received care within Kaiser Permanente of Northern California , a large integrated health care delivery system . Cohort assembly is described in detail elsewhere ( 2 , 7 ) . In brief , we identified patients with a diagnosis of atrial fibrillation between 1 July 1996 and 31 December 1997 by search ing outpatient data bases for internal medicine or cardiology visits in which an International Classification of Diseases , Ninth Revision , Clinical Modification ( ICD-9-CM ) , diagnosis of atrial fibrillation ( 427.31 ) was assigned and by search ing electrocardiographic data bases for a diagnosis of atrial fibrillation . The date of the first diagnosis of atrial fibrillation during the period of cohort assembly was considered the patient 's index date . Cohort assembly was finalized by November 1998 , and the cohort was followed through 30 September 2003 with a combination of retrospective ( back to July 1996 ) and prospect i ve ( through September 2003 ) review of health plan data bases and medical records . Patients who died or withdrew from the health plan during follow-up were censored at their date of death or on the last day of the month in which they terminated their membership . Date of death was ascertained from health plan clinical or administrative files , the California Automated Mortality Linkage System , or the Social Security Administration Death Master File . The institutional review boards at Massachusetts General Hospital and the Kaiser Foundation Research Institute approved the research . Patient Characteristics We search ed data bases of clinical inpatient and ambulatory visits ( outpatient clinic and emergency department ) during the 5 years before each patient 's index date to identify previously diagnosed ischemic stroke , heart failure , coronary heart disease , and hypertension by using relevant ICD-9-CM codes ( 2 ) . We used a vali date d , comprehensive health plan diabetes registry to identify patients with diabetes mellitus . Ascertainment of these stroke risk factors was vali date d against review of sample s of outpatient medical records ; crude agreement was high ( 78 % to 96 % ) , and corresponding statistics ranged from 0.51 to 0.89 . Of note , stroke risk prediction based on risk factors ascertained in the ATRIA Study was in good agreement with risk schemes generated by pooled r and omized trial and chart-based cohort study data ( 2 , 810 ) . Information from medical care received at both health plan and nonhealth plan facilities was obtained through these data bases . Data on age and sex were obtained from administrative data bases . Warfarin Exposure We determined warfarin exposure on the basis of information from automated clinical , pharmacy , and laboratory data bases by using methods described elsewhere ( 2 ) . We vali date d this computerized approach in 1207 patients by comparing it with warfarin status documented in their medical record at the time of an outcome event ; the result ing statistic was 0.84 . Nearly all discrepancies were due to transient discontinuation of warfarin treatment . If medical chart review of an outcome event showed that the patient stopped receiving warfarin within 5 days before the event , the event was considered to take place while the patient was receiving warfarin . For patients considered to be receiving warfarin , an adapted linear interpolation method was used to determine the person-time spent in the therapeutic international normalized ratio ( INR ) range of 2.0 to 3.0 ( 11 ) . If the interval between consecutive INR measurements was greater than 8 weeks , the INR person-time for this period was considered not available . Outcome Assessment Thromboembolic Events We search ed hospitalization and billing cl aims data bases through 30 September 2003 for primary ICD-9-CM discharge diagnoses that indicated potential thromboembolism , including ischemic stroke and other systemic embolism ( ICD-9-CM codes available on request ) ( 2 ) . For both potential thromboembolic events and hemorrhagic events , medical record analysts obtained the relevant medical records by using a structured protocol . We did not investigate hospitalizations with the selected discharge diagnosis codes in a secondary position , because such hospitalizations rarely were prompted by new thromboembolic events . We estimate that our rates of ischemic stroke would have been increased relatively by 6 % had we review ed all such hospitalizations ( 2 ) . We defined a vali date d ischemic stroke as a sudden neurologic deficit lasting more than 24 hours , corresponding to a vascular territory in the absence of primary hemorrhage , that was not explained by other causes ( for example , trauma or infection ) . We defined a valid peripheral embolism as being identified by radiographic imaging , intraoperative examination , or pathologic findings ( with no atherosclerotic disease in the affected artery ) . Thromboembolic events occurring after hospital admission , generally as a complication of medical care , were not included as outcome events . Two members of the physician outcomes review committee review ed all potential thromboembolic events by using a formal protocol . Disagreements were resolved by a third committee member or by a consulting neurologist , if needed . Intracranial Hemorrhage We search ed hospitalization and billing data bases for primary and secondary discharge diagnoses of intracranial hemorrhage , including intraparenchymal , subdural , subarachnoid , and other hemorrhage ( ICD-9-CM codes available on request ) . We excluded intracranial hemorrhage associated with a concomitant discharge diagnosis of major trauma ( ICD-9-CM codes 852.1 , 852.3 , 852.5 , and 853.1 ) and events not leading to hospitalization or those that occurred as a complication of a hospitalization for another problem . Net Clinical Benefit We defined the core net clinical benefit of warfarin therapy in atrial fibrillation as the annualized rate of thromboembolic events ( TE rate ) prevented minus the annualized rate of intracran \n Output:\n " }, { "from": "agent", "value": "Conclusions Compared with HAS-BLED , the ORBIT score does not perform better in predicting major bleeding events in anticoagulated atrial fibrillation patients .\nMore anticoagulated AF patients and major bleeding events were categorized as low risk when using ORBIT" } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: Background Achieving higher rates of partner HIV testing and couples testing among pregnant and postpartum women in sub-Saharan Africa is essential for the success of combination HIV prevention , including the prevention of mother-to-child transmission . We aim ed to determine whether providing multiple HIV self-tests to pregnant and postpartum women for secondary distribution is more effective at promoting partner testing and couples testing than conventional strategies based on invitations to clinic-based testing . Methods and Findings We conducted a r and omized trial in Kisumu , Kenya , between June 11 , 2015 , and January 15 , 2016 . Six hundred antenatal and postpartum women aged 18–39 y were r and omized to an HIV self-testing ( HIVST ) group or a comparison group . Participants in the HIVST group were given two oral-fluid-based HIV test kits , instructed on how to use them , and encouraged to distribute a test kit to their male partner or use both kits for testing as a couple . Participants in the comparison group were given an invitation card for clinic-based HIV testing and encouraged to distribute the card to their male partner , a routine practice in many health clinics . The primary outcome was partner testing within 3 mo of enrollment . Among 570 participants analyzed , partner HIV testing was more likely in the HIVST group ( 90.8 % , 258/284 ) than the comparison group ( 51.7 % , 148/286 ; difference = 39.1 % , 95 % CI 32.4 % to 45.8 % , p < 0.001 ) . Couples testing was also more likely in the HIVST group than the comparison group ( 75.4 % versus 33.2 % , difference = 42.1 % , 95 % CI 34.7 % to 49.6 % , p < 0.001 ) . No participants reported intimate partner violence due to HIV testing . This study was limited by self-reported outcomes , a common limitation in many studies involving HIVST due to the private manner in which self-tests are meant to be used . Conclusions Provision of multiple HIV self-tests to women seeking antenatal and postpartum care was successful in promoting partner testing and couples testing . This approach warrants further consideration as countries develop HIVST policies and seek new ways to increase awareness of HIV status among men and promote couples testing . Trial Registration Clinical Trials.gov NCT02386215 BACKGROUND Frequent testing of individuals at high risk of HIV is central to current prevention strategies . We aim ed to determine if HIV self-testing would increase frequency of testing in high-risk gay and bisexual men , with a particular focus on men who delayed testing or had never been tested before . METHODS In this r and omised trial , HIV-negative high-risk gay and bisexual men who reported condomless anal intercourse or more than five male sexual partners in the past 3 months were recruited at three clinical and two community-based sites in Australia . Enrolled participants were r and omly assigned ( 1:1 ) to the intervention ( free HIV self-testing plus facility-based testing ) or st and ard care ( facility-based testing only ) . Participants completed a brief online question naire every 3 months , which collected the number of self-tests used and the number and location of facility-based tests , and HIV testing was subsequently source d from clinical records . The primary outcome of number of HIV tests over 12 months was assessed overall and in two strata : recent ( last test ≤2 years ago ) and non-recent ( > 2 years ago or never tested ) testers . A statistician who was masked to group allocation analysed the data ; analyses included all participants who completed at least one follow-up question naire . After the 12 month follow-up , men in the st and ard care group were offered free self-testing kits for a year . This trial is registered with the Australian New Zeal and Clinical Trials Registry , number ACTRN12613001236785 . FINDINGS Between Dec 1 , 2013 , and Feb 5 , 2015 , 182 men were r and omly assigned to self-testing , and 180 to st and ard care . The analysis population included 178 ( 98 % ) men in the self-testing group ( 174 person-years ) and 165 ( 92 % ) in the st and ard care group ( 162 person-years ) . Overall , men in the self-testing group had 701 HIV tests ( 410 self-tests ; mean 4·0 tests per year ) , and men in the st and ard care group had 313 HIV tests ( mean 1·9 tests per year ) ; rate ratio ( RR ) 2·08 ( 95 % CI 1·82 - 2·38 ; p<0·0001 ) . Among recent testers , men in the self-testing group had 627 tests ( 356 self-tests ; mean 4·2 per year ) , and men in the st and ard care group had 297 tests ( mean 2·1 per year ) ; RR 1·99 ( 1·73 - 2·29 ; p<0·0001 ) . Among non-recent testers , men in the self-testing group had 74 tests ( 54 self-tests ; mean 2·8 per year ) , and men in the st and ard care group had 16 tests ( mean 0·7 per year ) ; RR 3·95 ( 2·30 - 6·78 ; p<0·0001 ) . The mean number of facility-based HIV tests per year was similar in the self-testing and st and ard care groups ( mean 1·7 vs 1·9 per year , respectively ; RR 0·86 , 0·74 - 1·01 ; p=0·074 ) . No serious adverse events were reported during follow-up . INTERPRETATION HIV self-testing result ed in a two times increase in frequency of testing in gay and bisexual men at high risk of infection , and a nearly four times increase in non-recent testers , compared with st and ard care , without reducing the frequency of facility-based HIV testing . HIV self-testing should be made more widely available to help increase testing and earlier diagnosis . FUNDING The National Health and Medical Research Council , Australia In the GRADE approach , r and omized trials start as high- quality evidence and observational studies as low- quality evidence , but both can be rated down if a body of evidence is associated with a high risk of publication bias . Even when individual studies included in best- evidence summaries have a low risk of bias , publication bias can result in substantial overestimates of effect . Authors should suspect publication bias when available evidence comes from a number of small studies , most of which have been commercially funded . A number of approaches based on examination of the pattern of data are available to help assess publication bias . The most popular of these is the funnel plot ; all , however , have substantial limitations . Publication bias is likely frequent , and caution in the face of early results , particularly with small sample size and number of events , is warranted Reaching universal HIV-status awareness is crucial to ensure all HIV-infected patients access antiretroviral treatment ( ART ) and achieve virological suppression . Opportunities for HIV testing could be enhanced by offering self-testing in population s that fear stigma and discrimination when accessing conventional HIV Counselling and Testing ( HCT ) in health care facilities . This qualitative research aims to examine the feasibility and acceptability of unsupervised oral self-testing for home use in an informal settlement of South Africa . Eleven in-depth interviews , two couple interviews , and two focus group discussion s were conducted with seven healthcare workers and thirteen community members . Thematic analysis was done concurrently with data collection . Acceptability to offer home self-testing was demonstrated in this research . Home self-testing might help this population overcome barriers to accepting HCT ; this was particularly expressed in the male and youth groups . Nevertheless , pilot interventions must provide evidence of potential harm related to home self-testing , intensify efforts to offer quality counselling , and ensure linkage to HIV/ART-care following a positive self-test result Background : Self-testing may increase HIV testing and decrease the time people with HIV are unaware of their status , but there is concern that absence of counseling may result in increased HIV risk . Setting : Seattle , Washington . Methods : We r and omly assigned 230 high-risk HIV-negative men who have sex with men to have access to oral fluid HIV self-tests at no cost versus testing as usual for 15 months . The primary outcome was self-reported number of HIV tests during follow-up . To evaluate self-testing 's impact on sexual behavior , we compared the following between arms : non – HIV-concordant condomless anal intercourse and number of male condomless anal intercourse partners in the last 3 months ( measured at 9 and 15 months ) and diagnosis with a bacterial sexually transmitted infection ( STI : early syphilis , gonorrhea , and chlamydial infection ) at the final study visit ( 15 months ) . A post hoc analysis compared the number of STI tests reported during follow-up . Results : Men r and omized to self-testing reported significantly more HIV tests during follow-up ( mean = 5.3 , 95 % confidence interval = 4.7 to 6.0 ) than those r and omized to testing as usual ( 3.6 , 3.2 to 4.0 ; P < 0.0001 ) , representing an average increase of 1.7 tests per participant over 15 months . Men r and omized to self-testing reported using an average of 3.9 self-tests . Self-testing was noninferior with respect to all markers of HIV risk . Men in the self-testing arm reported significantly fewer STI tests during follow-up ( mean = 2.3 , 95 % confidence interval = 1.9 to 2.7 ) than men in the control arm ( 3.2 , 2.8 to 3.6 ; P = 0.0038 ) . Conclusions : Access to free HIV self-testing increased testing frequency among high-risk men who have sex with men and did not impact sexual behavior or STI acquisition IMPORTANCE Self-testing for HIV infection may contribute to early diagnosis of HIV , but without necessarily increasing antiretroviral therapy ( ART ) initiation . OBJECTIVE To investigate whether offering optional home initiation of HIV care after HIV self-testing might increase dem and for ART initiation , compared with HIV self-testing accompanied by facility-based services only . DESIGN , SETTING , AND PARTICIPANTS Cluster r and omized trial conducted in Blantyre , Malawi , between January 30 and November 5 , 2012 , using restricted 1:1 r and omization of 14 community health worker catchment areas . Participants were all adult ( ≥16 years ) residents ( n = 16,660 ) who received access to home HIV self-testing through resident volunteers . This was a second-stage r and omization of clusters allocated to the HIV self-testing group of a parent trial . INTERVENTIONS Clusters were r and omly allocated to facility-based care or optional home initiation of HIV care ( including 2 weeks of ART if eligible ) for participants reporting positive HIV self-test results . MAIN OUTCOMES AND MEASURES The preplanned primary outcome compared between groups the proportion of all adult residents who initiated ART within the first 6 months of HIV self-testing availability . Secondary outcomes were uptake of HIV self-testing , reporting of positive HIV self-test results , and rates of loss from ART at 6 months . RESULTS A significantly greater proportion of adults in the home group initiated ART ( 181/8194 , 2.2 % ) compared with the facility group ( 63/8466 , 0.7 % ; risk ratio [ RR ] , 2.94 , 95 % CI , 2.10 - 4.12 ; P < .001 ) . Uptake of HIV self-testing was high in both the home ( 5287/8194 , 64.9 % ) and facility groups ( 4433/8466 , 52.7 % ; RR , 1.23 ; 95 % CI , 0.96 - 1.58 ; P = .10 ) . Significantly more adults reported positive HIV self-test results in the home group ( 490/8194 [ 6.0 % ] vs the facility group , 278/8466 [ 3.3 % ] ; RR , 1.86 ; 95 % CI , 1.16 - 2.97 ; P = .006 ) . After 6 months , 52 of 181 ART initiators ( 28.7 % ) and 15 of 63 ART initiators ( 23.8 % ) in the home and facility groups , respectively , were lost from ART ( adjusted incidence rate ratio , 1.18 ; 95 % CI , 0.62 - 2.25 , P = .57 ) . CONCLUSIONS AND RELEVANCE Among Malawian adults offered HIV self-testing , optional home initiation of care compared with st and ard HIV care result ed in a significant increase in the proportion of adults initiating ART . TRIAL REGISTRATION clinical trials.gov Identifier : NCT01414413 \n Output:\n " }, { "from": "agent", "value": "Across all RCTs , there was no indication of harm attributable to HIVST and potential increases in risk-taking behaviour appeared to be minimal .\nHIVST is associated with increased uptake and frequency of testing in RCTs .\nSuch increases , particularly among those at risk who may not otherwise test , will likely identify more HIV-positive individuals as compared to st and ard testing services alone ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: Background —Tai Chi Chuan ( TTC ) exercise has beneficial effects on the components of physical condition and can produce a substantial reduction in the risk of multiple falls . Previous studies have shown that short term TCC exercise did not improve the scores in the single leg stance test with eyes closed and the sit and reach test . There has apparently been no research into the effects of TCC on total body rotation flexibility and heart rate responses at rest and after a three minute step test . Methods —In this cross sectional study , 28 male TCC practitioners with an average age of 67.5 years old and 13.2 years of TCC exercise experience were recruited to form the TCC group . Another 30 sedentary men aged 66.2 were selected to serve as the control group . Measurements included resting heart rate , left and right single leg stance with eyes closed , modified sit and reach test , total body rotation test ( left and right ) , and a three minute step test . Results —Compared with the sedentary group , the TCC group had significantly better scores in resting heart rate , three minute step test heart rate , modified sit and reach , total body rotation test on both right and left side ( p<0.01 ) , and both right and left leg st and ing with eyes closed ( p<0.05 ) . According to the American Fitness St and ards , the TCC group attained the 90th percentile rank for sit and reach and total body rotation test , right and left . Conclusion —Long term regular TCC exercise has favourable effects on the promotion of balance control , flexibility , and cardiovascular fitness in older adults Of 22 r and omized trials of rehabilitation with exercise after myocardial infa rct ion ( MI ) , one trial had results that achieved conventional statistical significance . To determine whether or not these studies , in the aggregate , show a significant benefit of rehabilitation after myocardial infa rct ion , we performed an overview of all r and omized trials , involving 4,554 patients ; we evaluated total and cardiovascular mortality , sudden death , and fatal and nonfatal reinfa rct ion . For each endpoint , we calculated an odds ratio ( OR ) and 95 % confidence interval ( 95 % CI ) for the trials combined . After an average of 3 years of follow-up , the ORs were significantly lower in the rehabilitation than in the comparison group : specifically , total mortality ( OR = 0.80 [ 0.66 , 0.96 ] ) , cardiovascular mortality ( OR = 0.78 [ 0.63 , 0.96 ] ) , and fatal reinfa rct ion ( OR = 0.75 [ 0.59 , 0.95 ] ) . The OR for sudden death was significantly lower in the rehabilitation than in the comparison group at 1 year ( OR = 0.63 [ 0.41 , 0.97 ] ) . The data were compatible with a benefit at 2 ( OR = 0.76 [ 0.54 , 1.06 ] ) and 3 years ( OR = 0.92 [ 0.69 , 1.23 ] ) , but these findings were not statistically significant . For nonfatal reinfa rct ion , there were no significant differences between the two groups after 1 ( OR = 1.09 [ 0.76 , 1.57 ] ) , 2 ( OR = 1.10 [ 0.82 , 1.47 ] ) , or 3 years ( OR = 1.09 [ 0.88 , 1.34 ] ) of follow-up . The observed 20 % reduction in overall mortality reflects a decreased risk of cardiovascular mortality and fatal reinfa rct ion throughout at least 3 years and a reduction in sudden death during the 1st year after infa rct ion and possibly for 2 - 3 years . With respect to the independent effects of the physical exercise component of cardiac rehabilitation , the relatively small number of \" exercise only \" trials , combined with the possibility that they may have had a formal or informal nonexercise component precludes the possibility of reaching any definitive conclusion . To do so would require a r and omized trial of sufficient size to distinguish between no effect and the most plausible effect based on the results of this overview Background Falls are a significant public health problem . Thirty to fifty percent of the elderly of 65 years and older fall each year . Falls are the most common type of accident in this age group and can result in fractures and subsequent disabilities , increased fear of falling , social isolation , decreased mobility , and even an increased mortality . Several forms of exercise have been associated with a reduced risk of falling and with a wide range of physiological as well as psychosocial health benefits . Tai Chi Chuan seems to be the most promising form of exercise in the elderly , but the evidence is still controversial . In this article the design of a r and omized clinical trial is presented . The trial evaluates the effect of Tai Chi Chuan on fall prevention and physical and psychological function in older adults . Methods / Design 270 people of seventy years and older living at home will be identified in the files of the participating general practitioners . People will be asked to participate when meeting the following inclusion criteria : have experienced a fall in the preceding year or suffer from two of the following risk factors : disturbed balance , mobility problems , dizziness , or the use of benzodiazepines or diuretics . People will be r and omly allocated to either the Tai Chi Chuan group ( 13 weeks , twice a week ) or the no treatment control group . The primary outcome measure is the number of new falls , measured with a diary . The secondary outcome measures are balance , fear of falling , blood pressure , heart rate , lung function parameters , physical activity , functional status , quality of life , mental health , use of walking devices , medication , use of health care services , adjustments to the house , severity of fall incidents and subsequent injuries . Process parameters will be measured to evaluate the Tai Chi Chuan intervention . A cost-effectiveness analysis will be carried out alongside the evaluation of the clinical results . Follow-up measurements will be collected at 3 , 6 and 12 months after r and omization . Discussion As far as we know this is the first trial in Europe considering Tai Chi Chuan and fall prevention . This project will answer a pragmatic research question regarding the efficacy of Tai Chi Chuan regarding fall reduction Older adults with type 2 diabetes have mobility impairment and reduced fitness . This study aim ed to test the efficacy of the “ Tai Chi for Diabetes ” form , developed to address health-related problems in diabetes , including mobility and physical function . Thirty-eight older adults with stable type 2 diabetes were r and omized to Tai Chi or sham exercise , twice a week for 16 weeks . Outcomes included gait , balance , musculoskeletal and cardiovascular fitness , self-reported activity and quality of life . Static and dynamic balance index ( −5.8 ± 14.2 ; p = 0.03 ) and maximal gait speed ( 6.2 ± 11.6 % ; p = 0.005 ) improved over time , with no significant group effects . There were no changes in other measures . Non-specific effects of exercise testing and /or study participation such as outcome expectation , socialization , the Hawthorne effect , or unmeasured changes in health status or compliance with medical treatment may underlie the modest improvements in gait and balance observed in this sham-exercise-controlled trial . This Tai Chi form , although developed specifically for diabetes , may not have been of sufficient intensity , frequency , or duration to effect positive changes in many aspects of physiology or health status relevant to older people with diabetes PURPOSE To examine the effects of a 12-week tai chi program on quality of life and exercise capacity in patients with heart failure . METHODS Thirty patients with chronic stable heart failure and left ventricular ejection fraction < or = 40 % ( mean [ + /- SD ] age , 64 + /- 13 years ; mean baseline ejection fraction , 23 % + /- 7 % ; median New York Heart Association class , 2 [ range , 1 to 4 ] ) were r and omly assigned to receive usual care ( n = 15 ) , which included pharmacologic therapy and dietary and exercise counseling , or 12 weeks of tai chi training ( n = 15 ) in addition to usual care . Tai chi training consisted of a 1-hour class held twice weekly . Primary outcomes included quality of life and exercise capacity . Secondary outcomes included serum B-type natriuretic peptide and plasma catecholamine levels . For 3 control patients with missing data items at 12 weeks , previous values were carried forward . RESULTS At 12 weeks , patients in the tai chi group showed improved quality -of-life scores ( mean between-group difference in change , -25 points , P = 0.001 ) , increased distance walked in 6 minutes ( 135 meters , P = 0.001 ) , and decreased serum B-type natriuretic peptide levels ( -138 pg/mL , P = 0.03 ) compared with patients in the control group . A trend towards improvement was seen in peak oxygen uptake . No differences were detected in catecholamine levels . CONCLUSION Tai chi may be a beneficial adjunctive treatment that enhances quality of life and functional capacity in patients with chronic heart failure who are already receiving st and ard medical therapy PURPOSE This study evaluated the effect of Tai Chi Chuan ( TCC ) on the autonomic nervous modulation in older persons . METHODS Twenty TCC practitioners and 20 normal controls were included in this study . The stationary state spectral heart rate variability ( HRV ) measures between TCC practitioners and normal controls , and the sequential changes in HRV measures after classical Yang 's TCC were compared . RESULTS The total power , very low-frequency power , low-frequency power , normalized low-frequency power , and low-/high-frequency power ratios in TCC practitioners were all significantly higher than those of normal controls , whereas the heart rate and systolic and diastolic blood pressures were not different between these two groups of subjects . After TCC , the normalized high-frequency power increased significantly from 22.8 + /- 14.6 normalized units ( nu ) before TCC to 28.2 + /- 16.1 nu 30 min after TCC and to 30.6 + /- 18.4 nu 60 min after TCC . In contrast , the low-/high-frequency power ratio decreased significantly from 2.5 + /- 2.4 before TCC to 1.8 + /- 1.4 30 min after TCC and to 2.2 + /- 2.9 60 min after TCC . The heart rate , systolic blood pressure , diastolic blood pressure , mean arterial blood pressure , and pulse pressure also decreased sequentially after TCC . CONCLUSION The short-term effect of TCC was to enhance the vagal modulation and tilt the sympathovagal balance toward deceased sympathetic modulation in older persons . TCC might be good health-promoting calisthenics for older persons OBJECTIVE To estimate the incremental effects on cost and quality of life of cardiac rehabilitation after an acute coronary syndrome . DESIGN Open r and omised controlled trial with 1 year 's follow-up . Analysis was on an intention-to-treat basis . SETTING Two tertiary hospitals in Sydney . INTERVENTION 18 sessions of comprehensive exercise-based outpatient cardiac rehabilitation or conventional care as provided by the treating doctor . PARTICIPANTS 113 patients aged 41 - 75 years who were self-caring and literate in English . Patients with uncompensated heart failure , uncontrolled arrhythmias , severe and symptomatic aortic stenosis or physical impairment were excluded . MAIN OUTCOME MEASURES Costs ( hospitalisations , medication use , outpatient visits , investigations , and personal expenses ) ; and measures of quality of life . Incremental cost per quality -adjusted life year ( QALY ) saved at 1 year ( this estimate combines within- study utility effects with reported 1-year risk of survival and treatment effects of rehabilitation on mortality ) . Sensitivity analyses around a base case estimate included alternative assumptions of no treatment effect on survival , 3 years of treatment effect on survival and variations in utility . RESULTS The estimated incremental cost per QALY saved for rehabilitation relative to st and ard care was 42,535 US dollars when modelling included the reported treatment effect on survival . This increased to 70,580 US dollars per QALY saved if treatment effect on survival was not included . The results were sensitive to variations in utility and ranged from 19,685 US dollars per QALY saved to rehabilitation not being cost-effective . CONCLUSIONS The effects on quality of life tend to reinforce treatment advantages on survival for patients having postdischarge rehabilitation after an acute coronary syndrome . The estimated base case incremental cost per QALY saved is consistent with those historically accepted by decision making authorities such as the Pharmaceutical Benefits Advisory Committee In this study , 126 patients ( 90 males , average age 56 years , range 39 - 80 ) were r and omised to Wu Chian-Ch'uan style Tai Chi ( 38 ) , aerobic exercise ( 41 ) or a non-exercise support group ( 47 ) following acute myocardial infa rct ion . Patients attended twice weekly for three weeks then weekly for a further five weeks . Heart rate and blood pressure were recorded before and after each session . Over the 11 sessions of exercise there was a negative trend in diastolic blood pressure only in the Tai Chi group ( Rs = 0.79 , p < 0.01 ) . Significant trends in systolic blood pressure occurred in both exercise groups ( Rs = 0.64 and 0.63 , both p < 0.05 ) . Only four ( 8 % ) patients completed the support group eight-week programme which was less than the number completing Tai Chi ( 82 % ; p < 0.001 ) and aerobic exercise groups ( 73 % ; p < 0.001 ) BACKGROUND / AI \n Output:\n " }, { "from": "agent", "value": "Preliminary evidence suggests that Tai Chi Chuan can be an unconventional form of cardiac rehabilitation , being an adjunctive therapy in the treatment of patients with stable coronary artery disease ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: PURPOSE To report the short-term clinical outcomes and acute and late treatment-related genitourinary ( GU ) and gastrointestinal ( GI ) toxicities in patients with intermediate- and high-risk prostate cancer treated with dose-escalated stereotactic body radiation therapy ( SBRT ) . METHODS AND MATERIAL S Between 2011 and 2014 , 24 patients with prostate cancer were treated with SBRT to the prostate gl and and proximal seminal vesicles . A high-dose avoidance zone ( HDAZ ) was created by a 3-mm expansion around the rectum , urethra , and bladder . Patients were treated to a minimum dose of 36.25 Gy in 5 fractions , with a simultaneous dose escalation to a dose of 50 Gy to the target volume away from the HDAZ . Acute and late GU and GI toxicity outcomes were measured according to the National Cancer Institute Common Terminology Criteria for Adverse Events toxicity scale , version 4 . RESULTS The median follow-up was 25 months ( range , 18 - 45 months ) . Nine patients ( 38 % ) experienced an acute grade 2 GU toxicity , which was medically managed , and no patients experienced an acute grade 2 GI toxicity . Two patients ( 8 % ) experienced late grade 2 GU toxicity , and 2 patients ( 8 % ) experienced late grade 2 GI toxicity . No acute or late grade ≥3 GU or GI toxicities were observed . The 24-month prostate-specific antigen relapse-free survival outcome for all patients was 95.8 % ( 95 % confidence interval 75.6%-99.4 % ) , and both biochemical failures occurred in patients with high-risk disease . All patients are currently alive at the time of this analysis and continue to be followed . CONCLUSIONS A heterogeneous prostate SBRT planning technique with differential treatment volumes ( low dose : 36.25 Gy ; and high dose : 50 Gy ) with an HDAZ provides a safe method of dose escalation . Favorable rates of biochemical control and acceptably low rates of acute and long-term GU and GI toxicity can be achieved in patients with intermediate- and high-risk prostate cancer treated with SBRT Objectives To evaluate the feasibility of intensity-modulated radiotherapy with simultaneous integrated boost to the dominant intraprostatic lesion for definitive treatment of prostate cancer . Material s and Methods Patients were deemed eligible for the study if they had histologically proven stage cT2-T3 N0M0 prostate adenocarcinoma . In addition < 20 % risk of lymph nodal involvement according to Roach formula , was required for enrollment . Patients were treated with intensity-modulated radiotherapy with simultaneous integrated boost technique to the dominant intraprostatic lesion defined by magnetic resonance imaging . The prescribed dose to the prostate and seminal vesicles was 72 Gy ( 1.8 Gy per fraction ) . The dose delivered to the intraprostatic lesion received was 80 Gy ( 2 Gy per fraction ) . Acute gastrointestinal ( GI ) and genitourinary ( GU ) toxicity was evaluated weekly during treatment , and at 1 and 3 months thereafter . Late GI and GU toxicity was evaluated by Kaplan Meier method . Results Forty patients were deemed evaluable . Acute and late GI and GU toxicity were evaluated in all patients . Two patients ( 5 % ) developed acute grade 3 GI toxicity and 1 patient ( 2.5 % ) developed acute grade 3 GU toxicity . No grade 4 acute GI or GU toxicity occurred . With a median follow-up of 19 months ( interquartile range , 15 to 26 mo ) , the 2-year actuarial cumulative incidence of grade ≥2 rectal toxicity was 9.5 % . The 2-year actuarial cumulative incidence of grade ≥2 urinary toxicity was 13.3 % . Conclusions Treatment related acute toxicity was low in our cohort . Prolonged observation with a larger series of patients is necessary to evaluate late toxicity and local control PURPOSE To report the primary endpoint of biochemical progression-free survival ( b-PFS ) and secondary survival endpoints from ASCENDE-RT , a r and omized trial comparing 2 methods of dose escalation for intermediate- and high-risk prostate cancer . METHODS AND MATERIAL S ASCENDE-RT enrolled 398 men , with a median age of 68 years ; 69 % ( n=276 ) had high-risk disease . After stratification by risk group , the subjects were r and omized to a st and ard arm with 12 months of and rogen deprivation therapy , pelvic irradiation to 46 Gy , followed by a dose-escalated external beam radiation therapy ( DE-EBRT ) boost to 78 Gy , or an experimental arm that substituted a low-dose-rate prostate brachytherapy ( LDR-PB ) boost . Of the 398 trial subjects , 200 were assigned to DE-EBRT boost and 198 to LDR-PB boost . The median follow-up was 6.5 years . RESULTS In an intent-to-treat analysis , men r and omized to DE-EBRT were twice as likely to experience biochemical failure ( multivariable analysis [ MVA ] hazard ratio [ HR ] 2.04 ; P=.004 ) . The 5- , 7- , and 9-year Kaplan-Meier b-PFS estimates were 89 % , 86 % , and 83 % for the LDR-PB boost versus 84 % , 75 % , and 62 % for the DE-EBRT boost ( log-rank P<.001 ) . The LDR-PB boost benefited both intermediate- and high-risk patients . Because the b-PFS curves for the treatment arms diverge sharply after 4 years , the relative advantage of the LDR-PB should increase with longer follow-up . On MVA , the only variables correlated with reduced overall survival were age ( MVA HR 1.06/y ; P=.004 ) and biochemical failure ( MVA HR 6.30 ; P<.001 ) . Although biochemical failure was associated with increased mortality and r and omization to DE-EBRT doubled the rate of biochemical failure , no significant overall survival difference was observed between the treatment arms ( MVA HR 1.13 ; P=.62 ) . CONCLUSIONS Compared with 78 Gy EBRT , men r and omized to the LDR-PB boost were twice as likely to be free of biochemical failure at a median follow-up of 6.5 years Background : In prior retrospective studies , we assessed a number of prostate tumor tissue biomarkers that were associated independently with the clinical outcome of men treated with radiotherapy ( RT ) ± and rogen deprivation therapy ( ADT ) . In this report , the associations of selected biomarkers with biochemical or clinical disease failure ( BCDF ) were prospect ively evaluated in men with T1‐T3 prostate cancer on a r and omized hypofractionation trial . Methods : Biomarkers were analyzed in 263 of 303 men r and omly assigned to st and ard vs moderate hypofractionation . Median follow‐up was 65.9 months . Archival tissue was analyzed for Ki‐67 ( n = 231 ) , MDM2 ( n = 209 ) , p16 ( n = 195 ) , Cox‐2 ( n = 126 ) , p53 ( n = 206 ) , bcl2 ( n = 223 ) , bax ( n = 210 ) , and PKA ( n = 160 ) . The base model for multivariable Fine‐Gray regression analysis included treatment assignment and risk groups . All statistical tests were two‐sided . Results : Each biomarker was tested one at a time relative to the base model and selected for inclusion in multivariable analysis . Ki‐67 ( hazard ratio [ HR ] = 2.31 , 95 % confidence interval [ CI ] = 1.19 to 4.48 , P = .01 ) and bcl2&bax ( HR = 2.19 , 95 % CI = 1.08 to 4.46 , P = .03 ) were statistically significantly related to higher BCDF and were independently statistically significant when considered jointly ( Ki‐67 : HR = 2.26 , 95 % CI = 1.12 to 4.58 , P = .02 ; bcl2&bax : HR = 2.14 , 95 % CI = 1.03 to 4.41 , P = .04 ) . At 2.5 years postradiotherapy , the C‐index of Ki‐67 was 73.2 % , while for the base model was only 46.2 % ; Ki‐67 was the most statistically significant when tested without bcl2&bax . Conclusions : In this prospect i ve multiple biomarker analysis in men with prostate cancer treated with RT±ADT , both Ki‐67 and bcl2&bax were independently related to early BCDF ; however , Ki‐67 alone is indicated to be the most clinical ly meaningful by C‐index analysis and is universally available PURPOSE To give a preliminary report of clinical and treatment factors associated with toxicity in men receiving high-dose radiation therapy ( RT ) on a phase 3 dose-escalation trial . METHODS AND MATERIAL S The trial was initiated with 3-dimensional conformal RT ( 3D-CRT ) and amended after 1 year to allow intensity modulated RT ( IMRT ) . Patients treated with 3D-CRT received 55.8 Gy to a planning target volume that included the prostate and seminal vesicles , then 23.4 Gy to prostate only . The IMRT patients were treated to the prostate and proximal seminal vesicles to 79.2 Gy . Common Toxicity Criteria , version 2.0 , and Radiation Therapy Oncology Group/European Organization for Research and Treatment of Cancer late morbidity scores were used for acute and late effects . RESULTS Of 763 patients r and omized to the 79.2-Gy arm of Radiation Therapy Oncology Group 0126 protocol , 748 were eligible and evaluable : 491 and 257 were treated with 3D-CRT and IMRT , respectively . For both bladder and rectum , the volumes receiving 65 , 70 , and 75 Gy were significantly lower with IMRT ( all P<.0001 ) . For grade ( G ) 2 + acute gastrointestinal/genitourinary ( GI/GU ) toxicity , both univariate and multivariate analyses showed a statistically significant decrease in G2 + acute collective GI/GU toxicity for IMRT . There were no significant differences with 3D-CRT or IMRT for acute or late G2 + or 3 + GU toxicities . Univariate analysis showed a statistically significant decrease in late G2 + GI toxicity for IMRT ( P=.039 ) . On multivariate analysis , IMRT showed a 26 % reduction in G2 + late GI toxicity ( P=.099 ) . Acute G2 + toxicity was associated with late G3 + toxicity ( P=.005 ) . With dose-volume histogram data in the multivariate analysis , RT modality was not significant , whereas white race ( P=.001 ) and rectal V70 ≥15 % were associated with G2 + rectal toxicity ( P=.034 ) . CONCLUSIONS Intensity modulated RT is associated with a significant reduction in acute G2 + GI/GU toxicity . There is a trend for a clinical ly meaningful reduction in late G2 + GI toxicity with IMRT . The occurrence of acute GI toxicity and large ( > 15 % ) volumes of rectum > 70 Gy are associated with late rectal toxicity PURPOSE Perirectal spacing , whereby bio material s are placed between the prostate and rectum , shows promise in reducing rectal dose during prostate cancer radiation therapy . A prospect i ve multicenter r and omized controlled pivotal trial was performed to assess outcomes following absorbable spacer ( SpaceOAR system ) implantation . METHODS AND MATERIAL S Overall , 222 patients with clinical stage T1 or T2 prostate cancer underwent computed tomography ( CT ) and magnetic resonance imaging ( MRI ) scans for treatment planning , followed with fiducial marker placement , and were r and omized to receive spacer injection or no injection ( control ) . Patients received postprocedure CT and MRI planning scans and underwent image guided intensity modulated radiation therapy ( 79.2 Gy in 1.8-Gy fractions ) . Spacer safety and impact on rectal irradiation , toxicity , and quality of life were assessed throughout 15 months . RESULTS Spacer application was rated as \" easy \" or \" very easy \" 98.7 % of the time , with a 99 % hydrogel placement success rate . Perirectal spaces were 12.6 ± 3.9 mm and 1.6 ± 2.0 mm in the spacer and control groups , respectively . There were no device-related adverse events , rectal perforations , serious bleeding , or infections within either group . Pre-to postspacer plans had a significant reduction in mean rectal V70 ( 12.4 % to 3.3 % , P<.0001 ) . Overall acute rectal adverse event rates were similar between groups , with fewer spacer patients experiencing rectal pain ( P=.02 ) . A significant reduction in late ( 3 - 15 months ) rectal toxicity severity in the spacer group was observed ( P=.04 ) , with a \n Output:\n " }, { "from": "agent", "value": "This review shows encouraging results for focal dose escalation to the IDN with acceptable short- to medium-term side effects and biochemical disease control rates ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: OBJECTIVES To investigate the importance of medical and dental factors in aspiration pneumonia in an older veteran population . DESIGN Prospect i ve enrollment of subjects with retrospective analysis of data . SETTING Department of Veterans Affairs outpatient clinic , inpatient ward , and nursing home . PARTICIPANTS 358 veterans age 55 and older ; 50 subjects with aspiration pneumonia . MEASUREMENTS Demographic and medical data ; functional status ; health-related behaviors ; dental care utilization ; personal oral hygiene ; comprehensive dental examination ; salivary assays including IgA antibodies ; and cultures of saliva , throat , and dental plaques . RESULTS Two logistic regression models produced estimates of significant risk factors . One model using dentate patients included : requiring help with feeding ( odds ratio ( OR ) = 13.9 ) , chronic obstructive pulmonary disease ( COPD ) ( OR = 4.7 ) , diabetes mellitus ( OR = 3.5 ) , number of decayed teeth ( OR = 1.2 ) , number of functional dental units ( OR = 1.2 ) , presence of important organisms for decay , Streptococcus sobrinus in saliva ( OR = 6.2 ) , and periodontal disease , Porphyromonous gingivalis in dental plaque ( OR = 4.2 ) , and Staphylococcus aureus presence in saliva ( OR = 7.4 ) . The second model , containing both dentate and edentulous patients included : requiring help with feeding ( OR = 4.7 ) , COPD ( OR = 2.5 ) , diabetes mellitus ( OR = 1.7 ) , and presence of S. aureus in saliva ( OR = 8.3 ) . CONCLUSION This study supports the significance of oral and dental factors while controlling for established medical risk factors in aspiration pneumonia incidence Objective : To assess the prevalence of oral colonization by respiratory pathogens in a group of ICU patients , with specific attention to dental plaque and the oral mucosa . Design : Prospect i ve , nonr and omized study with age-matched controls . Setting s : Medical ICU in a tertiary-care Veterans Affairs Medical Center and a dental school outpatient preventive dentistry clinic . Patients : Nonconsecutive , unselected patients admitted to the medical ICU during a 2-month period ; controls were age-matched patients seen for the first time in the preventive dentistry clinic . Interventions : None . Measurements : Oral hygienic status was assessed in both groups using a semiquantitative system . Quantitative cultures of dental plaque and buccal mucosa were done within 12 hrs of medical ICU admission and every third day thereafter until discharge/death from the medical ICU . In controls , cultures of plaque and buccal mucosa were done on the initial visit only . Severity of illness of medical ICU patients was quantitated using the Acute Physiology and Chronic Health Evaluation ( APACHE II ) system and McCabe-Jackson criteria . Main Results : Oral hygiene of medical ICU patients was poor . These patients had a mean plaque score ( 1.9 ± 0.2 ) that was significantly greater than that same score seen in out patients of the preventive dentistry clinic ( 1.4 ± 0.1 ; p < .005 ) . Plaque and /or oral mucosa of 22 ( 65 % ) of 34 medical ICU patients were colonized by respiratory pathogens , in contrast to only four ( 16 % ) of 25 preventive dentistry clinic patients ( p < .005 ) . The potential respiratory pathogens cultured from medical ICU patients included methicillinresistant Staphylococcus aureus , Pseudomonas aeruginosa , and ten genera of Gram-negative bacilli . Colonization by respiratory pathogens was statistically associated with concomitant antibiotic therapy within the medical ICU group of patients , but not with severity of illness . Although medical ICU patients tended to have more dental plaque than preventive dentistry clinic patients , there was no statistically significant association noted between the presence of dental plaque and respiratory pathogen colonization . Conclusions : These findings suggest that bacteria commonly causing nosocomial pneumonia colonize the dental plaque and oral mucosa of intensive care patients . In many cases , this colonization occurs by large numbers of bacteria . Dental plaque may be an important reservoir of these pathogens in medical ICU patients . Efforts to improve oral hygiene in medical ICU patients could reduce plaque load and possibly reduce oropharyngeal colonization OBJECTIVE To study the dental status and colonization of dental plaque by aerobic pathogens and their relation with nosocomial infections in intensive care unit ( ICU ) patients . DESIGN A prospect i ve study in a medical ICU of a university-affiliated hospital . PATIENTS Consecutive patients admitted to the ICU during a 3-mo period . INTERVENTIONS Dental status was assessed by the same investigator using a score adapted from the \" Caries-Absent-Occluded \" ( CAO ) index ( referred to in the U.S. as DMFT [ Decayed-Missing-Filled Teeth ] index ) . The amount of dental plaque on premolars was assessed using a semiquantitative score . Quantitative cultures of dental plaque , nasal secretions , tracheal aspirates , and urine were done at admission ( day 0 ) and every fifth day until death or discharge . An additional study was done in eight patients to serially compare dental plaque , salivary , and tracheal aspirate cultures during a 2-wk period . MEASUREMENTS AND MAIN RESULTS Fifty-seven patients were included in the main study . Due to the variability in their ICU stay , 29 patients could be examined on day 0 only ( group A ) , 15 patients on days 0 and 5 ( group B ) , and 13 patients on days 0 , 5 , and 10 ( group C ) . The mean dental CAO score was 16 + /- 8 and did not change during the ICU stay . The dental plaque score was < or = 1 in 70 % of patients on day 0 ; > or = 2 in 50 % of patients on day 5 ; and > or = 2 in 90 % of patients on day 10 . Dental plaque cultures were positive at 10(3 ) colony-forming units/mL for aerobic pathogens in 23 % of patients on day 0 ; 39 % of patients on day 5 ; and 46 % of patients on day 10 . In groups B and C , mean dental plaque score and frequency of plaque colonization increased from days 0 to 5 and from days 5 to 10 . A high bacterial concordance was found between dental plaque and tracheal aspirate cultures , and in the additional study , between salivary and dental plaque cultures . Twenty-one patients developed a nosocomial infection in the ICU . Dental plaque colonization on days 0 and 5 was significantly associated with the occurrence of nosocomial pneumonia and bacteremia ( sensitivity 0.77 ; specificity 0.96 ; positive predictive value 0.87 ; negative predictive value 0.91 ; relative risk 9.6 ) . In six cases of nosocomial infection , the pathogen isolated from dental plaque was the first identified source of nosocomial infection . CONCLUSIONS The amount of dental plaque increased during the ICU stay . Colonization of dental plaque was either present on admission or acquired in 40 % of patients . A positive dental plaque culture was significantly associated with subsequent nosocomial infections . Dental plaque colonization by aerobic pathogens might be a specific source of nosocomial infection in ICU patients BACKGROUND Pneumonia is one of the most common nosocomial infections in hospitalized patients . The risk of nosocomial pneumonia increases with age , severity of acute illness and preexisting co-morbid conditions . Ventilator-associated pneumonia ( VAP ) significantly increases morbidity , length of stay , re source utilization and mortality . The purpose of this study was to determine whether adherence to a ventilator weaning protocol ( WP ) and the use of chlorhexidine gluconate ( CH ) oral rinse for oral hygiene would decrease the incidence of VAP in surgical ICU patients . METHODS A prospect i ve study was conducted over a period of 10 months ( October 1998-July 1999 ) in surgical ICU patients requiring mechanical ventilation ( n = 95 ) . During the first 5 months , a WP was applied to all patients requiring mechanical ventilation . During the following 5 months , a CH 0.12 % oral rinse administered twice daily was added to the protocol , initiated on ICU admission in all intubated patients . The data collection included age , gender , race , risk factors , co-morbid conditions , severity of the acute illness ( APACHE II ) at admission , duration of ventilation , ICU and total-hospital length of stay , and incidence of VAP and in-hospital mortality rates . Both WP and WP+CH groups were compared using the National Nosocomial Infection Surveillance ( NNIS ) and hospital data bases as historic controls . RESULTS The institution of the WP alone led only to a slight decrease in the incidence of VAP but a significant reduction in the median duration of mechanical ventilation by 40 % ( 4.5 days , p < 0.008 ) . The addition of CH to the WP led to a significant reduction and delay in the occurrence of VAP ( 37 % overall , 75 % for late VAP , p < 0.05 ) . The median duration of mechanical ventilation in this group was similar to that of the WP group . There was no significant difference in the overall hospital or ICU length of stay between the groups . CONCLUSIONS Improved oral hygiene via topical CH application in conjunction with the use of a WP is effective in reducing the incidence of VAP and the duration of mechanical ventilation in surgical ICU patients OBJECTIVES Aspiration of oral secretions and their bacteria is increasingly being recognized as an important factor in pneumonia . We investigated whether oral care lowers the frequency of pneumonia in institutionalized older people . DESIGN Survey . SETTING Eleven nursing homes in Japan . PARTICIPANTS Four hundred seventeen patients r and omly assigned to an oral care group or a no oral care group . INTERVENTION Nurses or caregivers cleaned the patients ' teeth by toothbrush after each meal . Swabbing with povidone iodine was additionally used in some cases . Dentists or dental hygienists provided professional care once a week . MEASUREMENTS Pneumonia , febrile days , death from pneumonia , activities of daily living , and cognitive functions . RESULTS During follow-up , pneumonia , febrile days , and death from pneumonia decreased significantly in patients with oral care . Oral care was beneficial in edentate and dentate patients . Activities of daily living and cognitive functions showed a tendency to improve with oral care . CONCLUSION We suggest that oral care may be useful in preventing pneumonia in older patients in nursing homes Abstract Objectives : To document in intensive care unit ( ICU ) patients the effect of dental plaque antiseptic decontamination on the occurrence of plaque colonization by aerobic nosocomial pathogens and nosocomial infections . Design : Single-blind r and omized comparative study . Setting : A 16-bed adult intensive care unit in a university hospital . Patients : Patients consecutively admitted in the ICU with a medical condition suggesting an ICU stay of 5 days and requiring mechanical ventilation . Interventions : After r and omization , the treated group received dental plaque decontamination with 0.2 % chlorhexidine gel , three times a day during the ICU stay . The control group received st and ard oral care . Specific measurements : Dental status was assessed by the Caries-Absent-Occluded index ; the amount of dental plaque was assessed by a semi-quantitative plaque index . Bacterial sampling of dental plaque , nasal and tracheal aspirate , blood , and urine cultures were done on days 0 , 5 , 10 , and every week . Main results : Sixty patients were included ; 30 in the treated group and 30 in the control one ( mean age : 51±16 years ; mean Simplified Acute Physiological Score II : 35±14 points ) . On admission , no significant differences were found between both groups for all clinical and dental data . Compared with the control group , the nosocomial infection rate and the incidence densities related to risk exposition were significantly lower in the treated group ( 18 vs 33‰ days in the ICU and 10.7 vs 32.3‰ days of mechanical ventilation ; P<0.05 ) . These results were consistent with a significant preventive effect of the antiseptic decontamination ( Odds Ratio : 0.27 ; 95 % CI : 0.09 ; 0.80 ) with a 53 % relative risk reduction . There was a trend to a reduction of mortality , length of stay , and duration of mechanical ventilation . Conclusions : An antiseptic decontamination of dental plaque with a 0.2 % chlorhexidine gel decreases dental bacterial colonization , and may reduce the incidence of nosocomial infections in ICU patients su bmi tted to mechanical ventilation BACKGROUND Decreasing the levels of bacteria in the oropharynx should reduce the prevalence of nosocomial pneumonia . OBJECTIVES To test the effectiveness of 0.12 % chlorhexidine gluconate oral rinse in decreasing microbial colonization of the respiratory tract and nosocomial pneumonia in patients undergoing open heart surgery . M \n Output:\n " }, { "from": "agent", "value": "REVIEW ERS ' CONCLUSIONS 1 .\nOral colonization by respiratory pathogens , fostered by poor oral hygiene and periodontal diseases , appears to be associated with nosocomial pneumonia .\n2 ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: Aims Mineralocorticoid receptor antagonists ( MRAs ) improve outcomes in patients with heart failure and reduced left ventricular ejection fraction ( HFrEF ) , but their use is limited by hyperkalaemia and /or worsening renal function ( WRF ) . BAY 94 - 8862 is a highly selective and strongly potent non-steroidal MRA . We investigated its safety and tolerability in patients with HFrEF associated with mild or moderate chronic kidney disease ( CKD ) . Methods and results This r and omized , controlled , phase II trial consisted of two parts . In part A , the safety and tolerability of oral BAY 94 - 8862 [ 2.5 , 5 , or 10 mg once daily ( q.d . ) ] was assessed in 65 patients with HFrEF and mild CKD . In part B , BAY 94 - 8862 ( 2.5 , 5 , or 10 mg q.d . , or 5 mg twice daily ) was compared with placebo and open-label spironolactone ( 25 or 50 mg/day ) in 392 patients with HFrEF and moderate CKD . BAY 94 - 8862 was associated with significantly smaller mean increases in serum potassium concentration than spironolactone ( 0.04–0.30 and 0.45 mmol/L , respectively , P < 0.0001–0.0107 ) and lower incidences of hyperkalaemia ( 5.3 and 12.7 % , respectively , P = 0.048 ) and WRF . BAY 94 - 8862 decreased the levels of B-type natriuretic peptide ( BNP ) , amino-terminal proBNP , and albuminuria at least as much as spironolactone . Adverse events related to BAY 94 - 8862 were infrequent and mostly mild . Conclusion In patients with HFrEF and moderate CKD , BAY 94 - 8862 5–10 mg/day was at least as effective as spironolactone 25 or 50 mg/day in decreasing biomarkers of haemodynamic stress , but it was associated with lower incidences of hyperkalaemia and WRF BACKGROUND We evaluated the role of aldosterone as a mediator of renal inflammation and fibrosis in a rat model of aldosterone/salt hypertension using the selective aldosterone blocker , eplerenone . METHODS Unnephrectomized , Sprague-Dawley rats were given 1 % NaCl ( salt ) to drink and r and omized to receive treatment for 28 days : vehicle infusion ( control ) ; 0.75 microg/hour aldosterone subcutaneous infusion ; or aldosterone infusion + 100 mg/kg/day oral dose of eplerenone . Blood pressure and urinary albumin were measured and kidneys were evaluated histologically . Renal injury , inflammation , and fibrosis were assessed by immunohistochemistry , in situ hybridization , and reverse transcription-polymerase chain reaction ( RT-PCR ) . RESULTS Aldosterone/salt induced severe hypertension compared to controls ( 220 + /- 4 mm Hg vs. 131 + /- 4 mm Hg , P < 0.05 ) , which was partially attenuated by eplerenone ( 179 + /- 4 mm Hg , P < 0.05 ) . In aldosterone/salt treated rats , renal histopathologic evaluation revealed severe vascular and glomerular sclerosis , fibrinoid necrosis and thrombosis , interstitial leukocyte infiltration , and tubular damage and regeneration . Aldosterone/salt increased circulating osteopontin ( 925.0 + /- 80.2 ng/mL vs. 53.6 + /- 6.3 ng/mL ) and albuminuria ( 75.8 + /- 10.9 mg/24 hours vs. 13.2 + /- 3.0 mg/24 hours ) compared to controls and increased expression of proinflammatory molecules . Treatment with eplerenone reduced systemic osteopontin ( 58.3 + /- 4.2 ng/mL ) , albuminuria ( 41.5 + /- 7.2 mg/24 hours ) , and proinflammatory gene expression : osteopontin ( OPN ) , monocyte chemoattractant protein-1 ( MCP-1 ) , interleukin-6 ( IL-6 ) , and interleukin-1beta ( IL-1beta ) . CONCLUSION These findings indicate that aldosterone/salt-induced renal injury and fibrosis has inflammatory components involving macrophage infiltration and cytokine up-regulation . Attenuation of renal damage and inflammation by eplerenone supports the protective effects of aldosterone blockade in hypertensive renal disease IMPORTANCE Steroidal mineralocorticoid receptor antagonists , when added to a renin-angiotensin system blocker , further reduce proteinuria in patients with chronic kidney disease but may be underused because of a high risk of adverse events . OBJECTIVE To evaluate the safety and efficacy of different oral doses of the nonsteroidal mineralocorticoid receptor antagonist finerenone , given for 90 days to patients with diabetes and high or very high albuminuria who are receiving an angiotensin-converting enzyme inhibitor or an angiotensin receptor blocker . DESIGN , SETTING , AND PARTICIPANTS R and omized , double-blind , placebo-controlled , parallel-group study conducted at 148 sites in 23 countries . Patients were recruited from June 2013 to February 2014 and the study was completed in August 2014 . Of 1501 screened patients , 823 were r and omized and 821 received study drug . INTERVENTIONS Participants were r and omly assigned to receive oral , once-daily finerenone ( 1.25 mg/d , n = 96 ; 2.5 mg/d , n = 92 ; 5 mg/d , n = 100 ; 7.5 mg/d , n = 97 ; 10 mg/d , n = 98 ; 15 mg/d , n = 125 ; and 25 mg/d , n = 119 ) or matching placebo ( n = 94 ) for 90 days . MAIN OUTCOMES AND MEASURES The primary outcome was the ratio of the urinary albumin-creatinine ratio ( UACR ) at day 90 vs at baseline . Safety end points were changes from baseline in serum potassium and estimated glomerular filtration rate . RESULTS The mean age of the participants was 64.2 years ; 78 % were male . At baseline , 36.7 % of patients treated had very high albuminuria ( UACR ≥300 mg/g ) and 40.0 % had an estimated glomerular filtration rate of 60 mL/min/1.73 m2 or lower . Finerenone demonstrated a dose-dependent reduction in UACR . The primary outcome , the placebo-corrected mean ratio of the UACR at day 90 relative to baseline , was reduced in the finerenone 7.5- , 10- , 15- , and 20-mg/d groups ( for 7.5 mg/d , 0.79 [ 90 % CI , 0.68 - 0.91 ; P = .004 ] ; for 10 mg/d , 0.76 [ 90 % CI , 0.65 - 0.88 ; P = .001 ] ; for 15 mg/d , 0.67 [ 90 % CI , 0.58 - 0.77 ; P<.001 ] ; for 20 mg/d , 0.62 [ 90 % CI , 0.54 - 0.72 ; P < .001 ] ) . The prespecified secondary outcome of hyperkalemia leading to discontinuation was not observed in the placebo and finerenone 10-mg/d groups ; incidences in the finerenone 7.5- , 15- , and 20-mg/d groups were 2.1 % , 3.2 % , and 1.7 % , respectively . There were no differences in the incidence of the prespecified secondary outcome of an estimated glomerular filtration rate decrease of 30 % or more or in incidences of adverse events and serious adverse events between the placebo and finerenone groups . CONCLUSIONS AND RELEVANCE Among patients with diabetic nephropathy , most receiving an angiotensin-converting enzyme inhibitor or an angiotensin receptor blocker , the addition of finerenone compared with placebo result ed in improvement in the urinary albumin-creatinine ratio . Further trials are needed to compare finerenone with other active medications . TRIAL REGISTRATION clinical trials.gov Identifier : NCT1874431 \n Output:\n " }, { "from": "agent", "value": "Interestingly , recent evidence suggests that MR signaling is increased by Rac1 activation , independent of lig and binding to MR , and that Rac1 was shown to be activated by angiotensin II and diabetic conditions [ 5 ] .\nThere are many convincing data suggesting that MRAs may provide additional reno-protective effects in patients experiencing the aldosterone escape phenomenon during RAS blockade treatment [ 6 ] ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: Background A protective effect on injury risk in youth sports through neuromuscular warm-up training routines has consistently been demonstrated . However , there is a paucity of information regarding the quantity and quality of coach-led injury prevention programmes and its impact on the physical performance of players . Objective The aim of this cluster-r and omised controlled trial was to assess whether different delivery methods of an injury prevention programme ( FIFA 11 + ) to coaches could improve player performance , and to examine the effect of player adherence on performance and injury risk . Method During the 2011 football season ( May – August ) , coaches of 31 tiers 1–3 level teams were introduced to the 11 + through either an unsupervised website or a coach-focused workshop with and without additional on-field supervisions . Playing exposure , adherence to the 11 + , and injuries were recorded for female 13-year-old to 18-year-old players . Performance testing included the Star Excursion Balance Test ( SEBT ) , single-leg balance , triple hop and jumping-over-a-bar tests . Results Complete preseason and postseason performance tests were available for 226 players ( 66.5 % ) . Compared to the unsupervised group , single-leg balance ( OR=2.8 ; 95 % CI 1.1 to 4.6 ) and the anterior direction of the SEBT improved significantly in the onfield supervised group of players ( OR=4.7 ; 95 % CI 2.2 to 7.1 ) , while 2-leg jumping performance decreased ( OR=−5.1 ; 95 % CI −9.9 to −0.2 ) . However , significant improvements in 5 of 6 reach distances in the SEBT were found , favouring players who highly adhered to the 11 + . Also , injury risk was lower for those players ( injury rate ratio , IRR=0.28 , 95 % CI 0.10 to 0.79 ) . Conclusions Different delivery methods of the FIFA 11 + to coaches influenced players ’ physical performance minimally . However , high player adherence to the 11 + result ed in significant improvements in functional balance and reduced injury risk Objective To evaluate the effectiveness of neuromuscular training in reducing the rate of acute knee injury in adolescent female football players . Design Stratified cluster r and omised controlled trial with clubs as the unit of r and omisation . Setting 230 Swedish football clubs ( 121 in the intervention group , 109 in the control group ) were followed for one season ( 2009 , seven months ) . Participants 4564 players aged 12 - 17 years ( 2479 in the intervention group , 2085 in the control group ) completed the study . Intervention 15 minute neuromuscular warm-up programme ( targeting core stability , balance , and proper knee alignment ) to be carried out twice a week throughout the season . Main outcome measures The primary outcome was rate of anterior cruciate ligament injury ; secondary outcomes were rates of severe knee injury ( > 4 weeks ’ absence ) and any acute knee injury . Results Seven players ( 0.28 % ) in the intervention group , and 14 ( 0.67 % ) in the control group had an anterior cruciate ligament injury . By Cox regression analysis according to intention to treat , a 64 % reduction in the rate of anterior cruciate ligament injury was seen in the intervention group ( rate ratio 0.36 , 95 % confidence interval 0.15 to 0.85 ) . The absolute rate difference was −0.07 ( 95 % confidence interval −0.13 to 0.001 ) per 1000 playing hours in favour of the intervention group . No significant rate reductions were seen for secondary outcomes . Conclusions A neuromuscular warm-up programme significantly reduced the rate of anterior cruciate ligament injury in adolescent female football players . However , the absolute rate difference did not reach statistical significance , possibly owing to the small number of events . Trial registration Clinical trials NCT00894595 Groin injuries cause major problems in sports and particularly in football . Exercise is effective in treating adductor-related groin pain , but no trials have been published regarding the specific prevention of groin pain or prevention specifically targeting overuse injuries in sport using exercise programs . We performed a cluster-r and omized trial including 55 football clubs representing 1211 players . The clubs were r and omized to an exercise program aim ed at preventing groin injuries ( n=27 ) or to a control group training as usual ( n=28 ) . The intervention program consisted of six exercises including strengthening ( concentric and eccentric ) , coordination , and core stability exercises for the muscles related to the pelvis . Physiotherapists assigned to each club registered all groin injuries . Twenty-two clubs in each group completed the study , represented by 977 players . There was no significant effect of the intervention ( HR=0.69 , 95 % CI 0.40 - 1.19 ) . The risk of a groin injury was reduced by 31 % , but this reduction was not significant . A univariate analysis showed that having had a previous groin injury almost doubles the risk of developing a new groin injury and playing at a higher level almost triples the risk of developing a groin injury Background The incidence rate of soccer injuries is among the highest in sports , particularly for adult male soccer players . Purpose To investigate the effect of the ‘ The11 ’ injury prevention programme on injury incidence and injury severity in adult male amateur soccer players . Study design Cluster-r and omised controlled trial . Methods Teams from two high-level amateur soccer competitions were r and omly assigned to an intervention ( n=11 teams , 223 players ) or control group ( n=12 teams , 233 players ) . The intervention group was instructed to perform The11 in each practice session during one soccer season . The11 focuses on core stability , eccentric training of thigh muscles , proprioceptive training , dynamic stabilisation and plyometrics with straight leg alignment . All participants of the control group continued their practice sessions as usual . Results In total , 427 injuries were recorded , affecting 274 of 456 players ( 60.1 % ) . Compliance with the intervention programme was good ( team compliance=73 % , player compliance=71 % ) . Contrary to the hypothesis , injury incidences were almost equal between the two study groups : 9.6 per 1000 sports hours ( 8.4–11.0 ) for the intervention group and 9.7 ( 8.5–11.1 ) for the control group . No significant differences were found in injury severity , but a significant difference was observed in the location of the injuries : players in the intervention group sustained significantly less knee injuries . Conclusions This study did not find significant differences in the overall injury incidence or injury severity between the intervention and control group of adult male soccer players . More research is recommended , focusing on injury aetiology and risk factors in adult male amateur soccer players Objective To examine the effect of a comprehensive warm-up programme design ed to reduce the risk of injuries in female youth football . Design Cluster r and omised controlled trial with clubs as the unit of r and omisation . Setting 125 football clubs from the south , east , and middle of Norway ( 65 clusters in the intervention group ; 60 in the control group ) followed for one league season ( eight months ) . Participants 1892 female players aged 13 - 17 ( 1055 players in the intervention group ; 837 players in the control group ) . Intervention A comprehensive warm-up programme to improve strength , awareness , and neuromuscular control during static and dynamic movements . Main outcome measure Injuries to the lower extremity ( foot , ankle , lower leg , knee , thigh , groin , and hip ) . Results During one season , 264 players had relevant injuries : 121 players in the intervention group and 143 in the control group ( rate ratio 0.71 , 95 % confidence interval 0.49 to 1.03 ) . In the intervention group there was a significantly lower risk of injuries overall ( 0.68 , 0.48 to 0.98 ) , overuse injuries ( 0.47 , 0.26 to 0.85 ) , and severe injuries ( 0.55 , 0.36 to 0.83 ) . Conclusion Though the primary outcome of reduction in lower extremity injury did not reach significance , the risk of severe injuries , overuse injuries , and injuries overall was reduced . This indicates that a structured warm-up programme can prevent injuries in young female football players . Trial registration IS RCT N10306290 QUESTION Is an injury prevention program consisting of 10 exercises design ed to improve stability , muscle strength , co-ordination , and flexibility of the trunk , hip and leg muscles ( known as The11 ) cost effective in adult male amateur soccer players ? DESIGN Cost-effectiveness analysis of a cluster-r and omised controlled trial . PARTICIPANTS 479 adult male amateur soccer players aged 18 - 40 years . INTERVENTION The intervention group was instructed to perform the exercises at each training session ( 2 to 3 sessions per week ) during one soccer season . The exercises focus on core stability , eccentric training of thigh muscles , proprioceptive training , dynamic stabilisation , and plyometrics with straight leg alignment . The control group continued their usual warm-up . OUTCOME MEASURES All injuries and costs associated with these injuries were compared between groups after bootstrapping ( 5000 replications ) . RESULTS No significant differences in the proportion of injured players and injury rate were found between the two groups . Mean overall costs in the intervention group were € 161 ( SD 447 ) per athlete and € 256 ( SD 555 ) per injured athlete . Mean overall costs in the control group were € 361 ( SD 1529 ) per athlete and € 606 ( SD 1944 ) per injured athlete . Statistically significant cost differences in favour of the intervention group were found per player ( mean difference € 201 , 95 % CI 15 to 426 ) and per injured player ( mean difference € 350 , 95 % CI 51 to 733 ) . CONCLUSIONS The exercises failed to significantly reduce the number of injuries in male amateur soccer players within one season , but did significantly reduce injury-related costs . The cost savings might be the result of a preventive effect on knee injuries , which often have substantial costs due to lengthy rehabilitation and lost productivity . TRIAL REGISTRATION NTR2416 The injury rate in football is high , and effective injury prevention methods are needed . An exercise program , the \" 11 , \" has been design ed to prevent the most common injury types in football . However , the effect of such a program on performance is not known . The aim of this r and omized-controlled trial was to investigate the effect of the \" 11 \" on performance after a 10-week training period . Thirty-four adolescent female football players were r and omly assigned to either an intervention ( n=18 ) or a control group ( n=16 ) . The \" 11 \" is a 15-min program consisting of ten exercises for core stability , lower extremity strength , balance and agility . Performance tests included isokinetic and isometric strength protocol s for the quadriceps and hamstrings , isometric hip adduction and abduction strength , vertical jump tests , sprint running and soccer skill tests . There was no difference between the intervention and control groups in the change in performance from the pre- to post-test for any of the tests used . In conclusion , no effect was observed on a series of performance tests in a group of adolescent female football players using the \" 11 \" as a structured warm-up program Background : Risk factors for soccer injuries and possibilities for prevention have been discussed by several authors , but only a few have investigated the effectiveness of preventive interventions . Purpose : The aim of the present study was to evaluate the effects of a prevention program on the incidence of soccer injuries in male youth amateur players . Study Design : Prospect i ve controlled intervention study . Methods : Seven soccer teams took part in a prevention program that focused on education and supervision of coaches and players , while seven other teams were instructed to train and play soccer as usual . Over 1 year all injuries were documented weekly by physicians . Complete weekly injury reports were available for 194 players . Results : The incidence of injury per 1000 hours of training and playing soccer was 6.7 in the intervention group and 8.5 in the control group , which equates to 21 % fewer injuries in the intervention group . The greatest effects were observed for mild injuries , overuse injuries , and injuries incurred during training . The prevention program had greater effects in low-skill than in high-skill teams . Conclusions : The incidence of soccer injuries can be reduced by preventive interventions , especially in low skill level youth teams . Coaches and players need better education regarding injury prevention strategies and should include such interventions as part of their regular training A set of exercises -- the \" 11\"--have been selected to prevent football injuries . The purpose of this cluster-r and omized controlled trial was to investigate the effect of the \" 11 \" on injury risk in female youth football . Teams were r and omized to an intervention ( n=59 teams , 1091 players ) or a control group ( n=54 teams , 1001 players ) . The intervention group was taught the \" 11 , \" exercises for core stability , lower extremity strength , neuromuscular control and agility , to be used as a 15-min warm-up program for football training over an 8-month season . A total of 396 players ( 20 % ) sustained 483 injuries . No difference was observed in the overall injury rate between the intervention ( 3.6 injuries/1000 h , confidence interval ( CI ) 3.2 - 4.1 ) and control group ( 3.7 , CI 3.2 - 4.1 ; RR=1.0 , CI 0.8 - 1.2 ; P=0.94 ) nor in the incidence for any type of injury . During the first 4 months of \n Output:\n " }, { "from": "agent", "value": "Conclusions This systematic review and meta- analysis indicated that use of F-MARC injury prevention programs , particularly the ‘ 11 + ’ program , decreases the risk of injuries among soccer players ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: Publication bias , sometimes known as the \" file-drawer problem \" or \" funnel-plot asymmetry , \" is common in empirical research . The authors review the implication s of publication bias for quantitative research synthesis ( meta- analysis ) and describe existing techniques for detecting and correcting it . A new approach is proposed that is suitable for application to meta-analytic data sets that are too small for the application of existing methods . The model estimates parameters relevant to fixed-effects , mixed-effects or r and om-effects meta- analysis contingent on a hypothetical pattern of bias that is fixed independently of the data . The authors illustrate this approach for sensitivity analysis using 3 data sets adapted from a commonly cited reference work on research synthesis ( H. M. Cooper & L. V. Hedges , 1994 ) Background Epidemiologic evidence suggests that cognitive and physical activities are associated with better cognition in late life . The present study was conducted to examine the possible benefits of four structured lifestyle activity interventions and compare their effectiveness in optimizing cognition for older adults with mild cognitive impairment ( MCI ) . Method and Findings This was a 12-month cluster r and omized controlled trial . 555 community-dwelling Chinese older adults with MCI ( 295 with multiple-domain deficits ( mdMCI ) , 260 with single-domain deficit ( sdMCI ) ) were recruited . Participants were r and omized into physical exercise ( P ) , cognitive activity ( C ) , integrated cognitive and physical exercise ( CP ) , and social activity ( S , active control ) groups . Interventions comprised of one-hour structured activities three times per week . Primary outcome was Clinical Dementia Rating sum of boxes ( CDR-SOB ) scores . Secondary outcomes included Chinese versions of Alzheimer ’s Disease Assessment Scale - Cognitive subscale ( ADAS-Cog ) , delayed recall , Mini-Mental State Examination , Category Verbal Fluency Test ( CVFT ) and Disability Assessment for Dementia – Instrumental Activities of Daily Living ( DAD-IADL ) . Percentage adherence to programs and factors affecting adherence were also examined . At 12th month , 423 ( 76.2 % ) completed final assessment . There was no change in CDR-SOB and DAD-IADL scores across time and intervention groups . Multilevel normal model and linear link function showed improvement in ADAS-Cog , delayed recall and CVFT with time ( p<0.05 ) . Post-hoc subgroup analyses showed that the CP group , compared with other intervention groups , had more significant improvements of ADAS-Cog , delayed recall and CVFT performance with sdMCI participants ( p<0.05 ) . Overall adherence rate was 73.3 % . Improvements in ADAS-Cog and delayed recall scores were associated with adherence after controlling for age , education , and intervention groups ( univariate analyses ) . Conclusions Structured lifestyle activity interventions were not associated with changes in everyday functioning , albeit with some improvements in cognitive scores across time . Higher adherence was associated with greater improvement in cognitive scores . Factors to enhance adherence should be specially considered in the design of psychosocial interventions for older adults with cognitive decline . Trial Registration Clinical Trials.gov BACKGROUND Participation in leisure activities has been associated with a lower risk of dementia . It is unclear whether increased participation in leisure activities lowers the risk of dementia or participation in leisure activities declines during the pre clinical phase of dementia . METHODS We examined the relation between leisure activities and the risk of dementia in a prospect i ve cohort of 469 subjects older than 75 years of age who resided in the community and did not have dementia at base line . We examined the frequency of participation in leisure activities at enrollment and derived cognitive-activity and physical-activity scales in which the units of measure were activity-days per week . Cox proportional-hazards analysis was used to evaluate the risk of dementia according to the base-line level of participation in leisure activities , with adjustment for age , sex , educational level , presence or absence of chronic medical illnesses , and base-line cognitive status . RESULTS Over a median follow-up period of 5.1 years , dementia developed in 124 subjects ( Alzheimer 's disease in 61 subjects , vascular dementia in 30 , mixed dementia in 25 , and other types of dementia in 8) . Among leisure activities , reading , playing board games , playing musical instruments , and dancing were associated with a reduced risk of dementia . A one-point increment in the cognitive-activity score was significantly associated with a reduced risk of dementia ( hazard ratio , 0.93 [ 95 percent confidence interval , 0.90 to 0.97 ] ) , but a one-point increment in the physical-activity score was not ( hazard ratio , 1.00 ) . The association with the cognitive-activity score persisted after the exclusion of the subjects with possible pre clinical dementia at base line . Results were similar for Alzheimer 's disease and vascular dementia . In linear mixed models , increased participation in cognitive activities at base line was associated with reduced rates of decline in memory . CONCLUSIONS Participation in leisure activities is associated with a reduced risk of dementia , even after adjustment for base-line cognitive status and after the exclusion of subjects with possible pre clinical dementia . Controlled trials are needed to assess the protective effect of cognitive leisure activities on the risk of dementia OBJECTIVES Investigate the psychometric characteristics of the coping self-efficacy ( CSE ) scale , a 26-item measure of one 's confidence in performing coping behaviors when faced with life challenges . DESIGN Data came from two r and omized clinical trials ( N1=149 , N2=199 ) evaluating a theory-based Coping Effectiveness Training ( CET ) intervention in reducing psychological distress and increasing positive mood in persons coping with chronic illness . METHODS The 348 participants were HIV-seropositive men with depressed mood who have sex with men . Participants were r and omly assigned to intervention and comparison conditions and assessed pre- and post-intervention . Outcome variables included the CSE scale , ways of coping , and measures of social support and psychological distress and well-being . RESULTS Exploratory ( EFA ) and confirmatory factor analyses ( CFA ) revealed a 13-item reduced form of the CSE scale with three factors : Use problem-focused coping ( 6 items , alpha=.91 ) , stop unpleasant emotions and thoughts ( 4 items , alpha=.91 ) , and get support from friends and family ( 3 items , alpha=.80 ) . Internal consistency and test-retest reliability are strong for all three factors . Concurrent validity analyses showed these factors assess self-efficacy for different types of coping . Predictive validity analyses showed that residualized change scores in using problem- and emotion-focused coping skills were predictive of reduced psychological distress and increased psychological well-being over time . CONCLUSIONS The CSE scale provides a measure of a person 's perceived ability to cope effectively with life challenges , as well as a way to assess changes in CSE over time in intervention research The results of a r and omized controlled trial of repetition-lag training in older adults with amnestic mild cognitive impairment ( aMCI ) are reported . A modified repetition-lag training procedure with extended encoding time and strategy choice was used . The training required discriminating studied words from non-studied lures that were repeated at varying intervals during the test phase . Participants were assessed pre/post using untrained measures of cognition and self-report question naires . Primary outcome measures were recall of unrelated word pairs both immediately following presentation and following a delay . Secondary outcomes were a measure of attention , cognitive flexibility , and visual working memory . Participants were also asked to report on the frequency of cognitive failures and mood before and after training . Participants ( N = 31 ) were r and omized into either the treatment or a no-contact control group and attended the clinic twice per week over a four week period . Twenty-four participants completed the study ( twelve in each group ) . Results indicated that the training group improved at recalling unrelated word pairs after a delay . There were no significant effects of training on other outcomes , self-reported cognitive failures or mood . The results are discussed along with suggestions for future research BACKGROUND This paper describes the development and validation of the Memory Inventory for Chinese ( MIC ) , for measuring the awareness of memory deficits in the Chinese population with Alzheimer 's disease ( AD ) . METHODS A combination of qualitative and quantitative approaches was adopted . The MIC was developed with focus group discussion and pilot testing . It has a patient and a caregiver version . A consecutive series of 79 new out- patients with the National Institute of Neurological and Communicative Disorders and Stroke and the Alzheimer 's Disease and Related Disorder Association ( NINCDS-ADRDA ) criteria of probable and possible AD and 20 non-demented elderly subjects were recruited . RESULTS A high internal consistency was found , with Cronbach alpha of 0.89 for the patient version and 0.90 for the caregiver version of MIC . The inter-rater reliability was satisfactory . For validity assessment , the caregiver score of the MIC correlated significantly with cognitive score of the subject as assessed by the Mini-Mental State Examination ( rp = -0.37 ; p < 0.01 ) . The Memory Deficit Awareness Score , calculated by subtracting the patient score from the caregiver score , correlated significantly with clinician ratings of awareness of memory impairment ( rs = -0.67 ; p < 0.01 ) . CONCLUSIONS The MIC appears to be a culturally appropriate and valid instrument for the measurement of awareness of memory deficits in Chinese patients with AD . Potential applications of the MIC should be further explored in other subtypes of dementia and in prospect i ve studies Background : Evidence as to the benefits of nonpharmacological interventions for the boundary state between normal aging and dementia [ mild cognitive impairment or a Clinical Dementia Rating ( CDR ) of 0.5 ] remains weak due to a lack of positive controls . Aims : To directly compare the effects of cognitive interventions ( CI ) , physical activities ( PA ) and a group reminiscence approach ( GRA ) , we conducted a pilot study on the basis of a cluster r and omized controlled trial design . Method : A total of 127 participants aged > 74 years with a CDR of 0.5 were cluster r and omized into three groups for CI , PA and GRA . The intervention lasted 12 weeks and consisted of weekly group sessions and home assignments . Mini-Mental State Examination ( MMSE ) , Trail Making Test part A ( TMT-A ) , word fluency ( WF ) , 6-meter walk time and Quality of Life ( QOL ) Face Scale scores were evaluated as primary outcomes . Results : Methodology -related benefits of CI and PA were found for MMSE scores and walk time , respectively . TMT-A , WF and QOL Face Scale scores improved irrespective of the method ologies used . Conclusions : Our findings suggest that CI and PA may be beneficial to cognitive and physical abilities , respectively . Executive functions and QOL may improve irrespective of the intervention method ologies used OBJECTIVE This study evaluates the efficacy at 12 months of a computer-based cognitive training ( CBCT ) program , adjunctive to traditional cognitive training ( TCT ) , on the basis of pen- and -paper exercises . METHODS Sixty patients with multi-domain mild cognitive impairment and mild Alzheimer 's disease who were already receiving cognitive training , recruited from a day hospital , were assigned into two groups following a simple r and omization procedure ( computerized r and om numbers ) : ( i ) a group that received CBCT during 3 months and TCT ( CBCT + TCT ) , n = 37 , and ( ii ) a group that received only TCT , n = 23 . Patients were assessed at baseline and after 3 and 12 months of treatment by a neuropsychologist blinded to group assignment , with a neuropsychological battery ( primary outcomes ) and measures of decision making , memory complaints , and emotional disturbances . RESULTS With the use of repeated- measures analyses of covariance , the CBCT + TCT group showed less anxiety symptoms ( F = 5.13 , p = 0.03 , d = 1.12 ) and less disadvantageous choices ( F = 4.70 , p = 0.04 , d = 0.89 ) in decision making than the TCT group at 12 months . No significant improvement or worsening was observed in the other measures examined . However , positive effect sizes favoring the CBCT + TCT group were observed in all variables . CONCLUSIONS The addition of a CBCT program was effective in anxiety and decision making but had no significant effects on outcomes in basic cognitive functions in patients who were already receiving cognitive training , possibly due to a ceiling effect . Future studies should compare the efficacy of CBCT with TCT in naïve patients BACKGROUND Subjects with a mild cognitive impairment ( MCI ) have a memory impairment beyond that expected for age and education yet are not demented . These subjects are becoming the focus of many prediction studies and early intervention trials . OBJECTIVE To characterize clinical ly subjects with MCI cross-sectionally and longitudinally . DESIGN A prospect i ve , longitudinal inception cohort . SETTING General community clinic . PARTICIPANTS A sample of 76 consecutively evaluated subjects with MCI were compared with 234 healthy control subjects and 106 patients with mild Alzheimer disease ( AD ) , all from a community setting as part of the Mayo Clinic Alzheimer 's Disease Center/Alzheimer 's Disease Patient Registry , Rochester , Minn. MAIN OUTCOME MEASURES The 3 groups of individuals were compared on demographic factors and measures of cognitive function including the \n Output:\n " }, { "from": "agent", "value": "Computerized studies appeared to benefit mood ( depression , anxiety , and apathy ) compared to controls , while therapist-based interventions and multimodal interventions had more impact on ADLs and metacognitive outcomes than control conditions ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: OBJECTIVE Youth in war-affected regions are at risk for poor psychological , social , and educational outcomes . Effective interventions are needed to improve mental health , social behavior , and school functioning . This r and omized controlled trial tested the effectiveness of a 10-session cognitive-behavioral therapy (CBT)-based group mental health intervention for multisymptomatic war-affected youth ( aged 15 - 24 years ) in Sierra Leone . METHOD War-affected youth identified by elevated distress and impairment via community screening were r and omized ( stratified by sex and age ) to the Youth Readiness Intervention ( YRI ) ( n = 222 ) or to a control condition ( n = 214 ) . After treatment , youth were again r and omized and offered an education subsidy immediately ( n = 220 ) or waitlisted ( n = 216 ) . Emotion regulation , psychological distress , prosocial attitudes/behaviors , social support , functional impairment , and posttraumatic stress disorder ( PTSD ) symptoms were assessed at pre- and postintervention and at 6-month follow-up . For youth in school , enrollment , attendance , and classroom performance were assessed after 8 months . Linear mixed-effects regressions evaluated outcomes . RESULTS The YRI showed significant postintervention effects on emotion regulation , prosocial attitudes/behaviors , social support , and reduced functional impairment , and significant follow-up effects on school enrollment , school attendance , and classroom behavior . In contrast , education subsidy was associated with better attendance but had no effect on mental health or functioning , school retention , or classroom behavior . Interactions between education subsidy and YRI were not significant . CONCLUSION YRI produced acute improvements in mental health and functioning as well as longer-term effects on school engagement and behavior , suggesting potential to prepare war-affected youth for educational and other opportunities . Clinical trial registration information-Trial of the Youth Readiness Intervention ( YRI ) ; http:// clinical trials.gov ; NCT01684488 This study evaluated the effects of Group Triple P with Chinese parents on parenting and child outcomes as well as outcomes relating to child academic learning in Mainl and China . Participants were 81 Chinese parents and their children in Shanghai , who were r and omly allocated to an intervention group or wait-list control group . Parents in the intervention condition received Group Triple P training , and parents and children were assessed at three/two time points . Compared with the control group , parents in the intervention group reported significant improvements in child adjustment problems , parenting practice s , parental adjustment , and parenting self-efficacy at post- assessment . Moreover , there was a significant increase in parents ’ satisfaction with children ’s academic achievement and a reduction in children ’s academic problem behaviors at post-intervention . All these effects were maintained at 6-month follow-up . There was also a significant increase in the child report of positive parenting at post-intervention OBJECTIVE To assess the efficacy of trauma-focused cognitive behavioral therapy ( TF-CBT ) delivered by non clinical facilitators in reducing posttraumatic stress , depression , and anxiety and conduct problems and increasing prosocial behavior in a group of war-affected , sexually exploited girls in a single-blind , parallel- design , r and omized,+ controlled trial . METHOD Fifty-two 12- to 17-year-old , war-affected girls exposed to rape and inappropriate sexual touch in the Democratic Republic of Congo were screened for trauma , depression and anxiety , conduct problems , and prosocial behavior . They were then r and omized to a 15 session , group-based , culturally modified TF-CBT ( n = 24 ) group or a wait-list control group ( n = 28 ) . Primary analysis , by intention-to-treat , involving all r and omly assigned participants occurred at pre- and postintervention and at 3-month follow-up ( intervention group only ) . RESULTS Compared to the wait list control , the TF-CBT group experienced significantly greater reductions in trauma symptoms ( F(1,49 ) = 52.708 , p<0·001 , χ(p)2 = 0.518 ) . In addition , the TF-CBT group showed a highly significant improvement in symptoms of depression and anxiety , conduct problems , and prosocial behavior . At 3-months follow-up the effect size ( Cohen 's d ) for the TF-CBT group was 2.04 ( trauma symptoms ) , 2.45 ( depression and anxiety ) , 0.95 ( conduct problems ) , and -1.57 ( prosocial behavior ) . CONCLUSIONS A group-based , culturally modified , TF-CBT intervention delivered by non clinical ly trained Congolese facilitators result ed in a large , statistically significant reduction in posttraumatic stress symptoms and psychosocial difficulties among war-affected girls exposed to rape or sexual violence . Clinical trial registration information-An RCT of TF-CBT with sexually-exploited , war-affected girls in the DRC ; http:// clinical trials.gov/ ; NCT01483261 BACKGROUND The Democratic Republic of Congo ( DRC ) has been home to the world 's deadliest conflict since World War II and is reported to have the largest number of child soldiers in the world . Despite evidence of the debilitating impact of war , no group-based mental health or psychosocial intervention has been evaluated in a r and omised controlled trial for psychologically distressed former child soldiers . METHOD A r and omised controlled trial involving 50 boys , aged 13 - 17 , including former child soldiers ( n = 39 ) and other war-affected boys ( n = 11 ) . They were r and omly assigned to an intervention group , or wait-list control group . The intervention group received a 15-session , group-based , culturally adapted Trauma-Focused Cognitive-Behavioural Therapy ( TF-CBT ) intervention . Assessment interviews were completed at baseline , postintervention and 3-month follow-up ( intervention group ) . RESULTS Analysis of Covariance ( ANCOVA ) demonstrated that , in comparison to the wait-list control group , the TF-CBT intervention group had highly significant reductions in posttraumatic stress symptoms , overall psychosocial distress , depression or anxiety-like symptoms , conduct problems and a significant increase in prosocial behaviour ( p < .001 for all ) . Effect sizes were higher when former child soldier scores were separated for sub- analysis . Three-month follow-up of the intervention group found that treatment gains were maintained . CONCLUSIONS A culturally modified , group-based TF-CBT intervention was effective in reducing posttraumatic stress and psychosocial distress in former child soldiers and other war-affected boys Objective : The objective of this study is to assess the efficacy of an intervention design ed to promote resilience in young children living with their HIV-positive mothers . Design / methods : HIV-positive women attending clinics in Tshwane , South Africa , and their children , aged 6–10 years , were r and omized to the intervention ( I ) or st and ard care ( S ) . The intervention consisted of 24 weekly group sessions led by community care workers . Mothers and children were in separate groups for 14 sessions , followed by 10 interactive sessions . The primary focus was on parent – child communication and parenting . Assessment s were completed by mothers and children at baseline and 6 , 12 and 18 months . Repeated mixed linear analyses were used to assess change over time . Results : Of 390 mother – child pairs , 84.6 % ( I : 161 and S : 169 ) completed at least two interviews and were included in the analyses . Children 's mean age was 8.4 years and 42 % of mothers had been ill in the prior 3 months . Attendance in groups was variable : only 45.7 % attended more than 16 sessions . Intervention mothers reported significant improvements in children 's externalizing behaviours ( ß = –2.8 , P = 0.002 ) , communication ( ß = 4.3 , P = 0.025 ) and daily living skills ( ß = 5.9 , P = 0.024 ) , although improvement in internalizing behaviours and socialization was not significant ( P = 0.061 and 0.052 , respectively ) . Intervention children reported a temporary increase in anxiety but did not report differences in depression or emotional intelligence . Conclusion : This is the first study demonstrating benefits of an intervention design ed to promote resilience among young children of HIV-positive mothers . The intervention was specifically design ed for an African context and has the potential to benefit large numbers of children , if it can be widely implemented Background There is an urgent need for effective , affordable interventions to prevent child mental health problems in low- and middle-income countries . Aims To determine the effects of a universal pre-school-based intervention on child conduct problems and social skills at school and at home . Method In a cluster r and omised design , 24 community pre-schools in inner-city areas of Kingston , Jamaica , were r and omly assigned to receive the Incredible Years Teacher Training intervention ( n = 12 ) or to a control group ( n = 12 ) . Three children from each class with the highest levels of teacher-reported conduct problems were selected for evaluation , giving 225 children aged 3–6 years . The primary outcome was observed child behaviour at school . Secondary outcomes were child behaviour by parent and teacher report , child attendance and parents ’ attitude to school . The study is registered as IS RCT N35476268 . Results Children in intervention schools showed significantly reduced conduct problems ( effect size ( ES ) = 0.42 ) and increased friendship skills ( ES = 0.74 ) through observation , significant reductions to teacher-reported ( ES = 0.47 ) and parent-reported ( ES = 0.22 ) behaviour difficulties and increases in teacher-reported social skills ( ES = 0.59 ) and child attendance ( ES = 0.30 ) . Benefits to parents ’ attitude to school were not significant . Conclusions A low-cost , school-based intervention in a middle-income country substantially reduces child conduct problems and increases child social skills at home and at school Flaws in the design , conduct , analysis , and reporting of r and omised trials can cause the effect of an intervention to be underestimated or overestimated . The Cochrane Collaboration ’s tool for assessing risk of bias aims to make the process clearer and more OBJECTIVE To evaluate the effect of a preventative intervention in Jamaican basic schools on child behaviour and parent-teacher contacts . DESIGN AND METHODS Five basic schools in Kingston , Jamaica , were r and omly assigned to an intervention ( n = 3 ) or control ( n = 2 ) condition . Intervention involved seven whole-day teacher workshops using the Incredible Years Teacher Training Programme supplemented by fourteen lessons on social and emotional skills in each class . Within each classroom ( n = 27 ) , children were screened for behaviour difficulties through teacher report and children with the greatest difficulties were selected for evaluation of outcomes ( 135 children ) . Teachers'reports of child behaviour using the Strengths and Difficulties Question naire and of the quality of teacher-parent contacts were collected at the beginning and end of the school year Multilevel regression analyses controlling for school and classroom were used to evaluate the effects of intervention on child behaviour . RESULTS Significant benefits of intervention were found for children 's conduct problems ( regression coefficient ( b ) = -0.62 , 95 % confidence interval ( CI ) : -0.01 , -1.23 ) , hyperactivity ( b = -0.84 , 95 % CI : -1.57 , -0.11 ) and peer problems ( b = -1.24 , 95 % CI : -1.89 , -0.59 ) . The effect sizes were 0.26 for conduct problems , 0.36 for hyperactivity and 0.71 for peer problems . No significant benefits were found for the prosocial and emotional problems subscales . The intervention also result ed in increases in the number of positive teacher-parent contacts ( p < 0.0001 ) . No benefits were found for the number of negative teacher-parent contacts . CONCLUSION This is a promising approach for reducing children 's externalizing behaviour and peer problems and for improving the quality of teachers ' contacts with parents of children with behaviour problems CONTEXT Prior qualitative work with internally displaced persons in war-affected northern Ug and a showed significant mental health and psychosocial problems . OBJECTIVE To assess effect of locally feasible interventions on depression , anxiety , and conduct problem symptoms among adolescent survivors of war and displacement in northern Ug and a. DESIGN , SETTING , AND PARTICIPANTS A r and omized controlled trial from May 2005 through December 2005 of 314 adolescents ( aged 14 - 17 years ) in 2 camps for internally displaced persons in northern Ug and a. INTERVENTIONS Locally developed screening tools assessed the effectiveness of interventions in reducing symptoms of depression and anxiety , ameliorating conduct problems , and improving function among those who met study criteria and were r and omly allocated ( 105 , psychotherapy-based intervention [ group interpersonal psychotherapy ] ; 105 , activity-based intervention [ creative play ] ; 104 , wait-control group [ individuals wait listed to receive treatment at study end ] ) . Intervention groups met weekly for 16 weeks . Participants and controls were reassessed at end of study . MAIN OUTCOME MEASURES Primary measure was a decrease in score ( denoting improvement ) on a depression symptom scale . Secondary measures were improvements in scores on anxiety , conduct problem symptoms , and function scales . Depression , anxiety , and conduct problems were assessed using the Acholi Psychosocial Assessment Instrument with a minimum score of 32 as the lower limit for clinical ly significant symptoms ( maximum scale score , 105 ) . RESULTS Difference in change in adjusted mean score for depression symptoms between group interpersonal psychotherapy and control \n Output:\n " }, { "from": "agent", "value": "Our meta- analysis supports the use of psychosocial interventions as a feasible and effective way to reduce disruptive behaviour problems among children in LMIC .\nOur study provides strong evidence for child-focused and behavioural parenting interventions , interventions across age ranges and interventions delivered in groups ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: Background The objective of this study was to evaluate the efficacy and toxicity of infusional 5-fluorouracil ( 5-FU ) , folinic acid and oxaliplatin ( modified FOLFOX-6 ) in patients with advanced gastric cancer ( AGC ) , as first-line palliative combination chemotherapy . We also analyzed the predictive or prognostic value of germline polymorphisms of c and i date genes associated with 5-FU and oxaliplatin . Methods Seventy-three patients were administered a 2 hour infusion of oxaliplatin ( 100 mg/m2 ) and folinic acid ( 100 mg/m2 ) followed by a 46 hour continuous infusion of 5-FU ( 2,400 mg/m2 ) . Genomic DNA from the patients ' peripheral blood mononuclear cells was extracted . Ten polymorphisms within five genes were investigated including TS , GSTP , ERCC , XPD and XRCC . Results The overall response rate ( RR ) was 43.8 % . Median time to progression ( TTP ) and overall survival ( OS ) were 6.0 months and 12.6 months , respectively . Toxicities were generally tolerable and manageable . The RR was significantly higher in patients with a 6-bp deletion homozygote ( -6 bp/-6 bp ) in TS-3'UTR ( 55.0 % vs. 30.3 % in + 6 bp/+6 bp or + 6 bp/-6 bp , p = 0.034 ) , and C/A or A/A in XPD156 ( 52.0 % vs. 26.1 % in C/C , p = 0.038 ) . The -6 bp/-6 bp in TS-3'UTR was significantly associated with a prolonged TTP and OS . In a multivariate analysis , the 6-bp deletion in TS-3'UTR was identified as an independent prognostic marker of TTP ( hazard ratio = 0.561 , p = 0.032 ) . Conclusion Modified FOLFOX-6 chemotherapy appears to be active and well tolerated as first line chemotherapy in AGC patients . The 6-bp deletion in TS-3'UTR might be a c and i date to select patients who are likely to benefit from 5-FU based modified FOLFOX-6 in future large scale trial Purpose : To investigate the prognostic role of thymidylate synthase ( TS ) polymorphisms in gastric cancer patients treated with radical surgery and fluorouracil-based adjuvant chemotherapy . Experimental Design : Ninety gastric cancer cases were identified among 187 patients previously enrolled in prospect i ve case-control studies for disease susceptibility . Patients were genotyped for a G/C nucleotide change within a triple 28 bp variable number of t and em repeat sequence in the TS 5′-untranslated region ( 5′-UTR ) and a 6 bp deletion in the TS 3′-untranslated region ( 3′-UTR ) . According to available functional data , patients with 5′-UTR 2R/2R , 2R/3C , 3C/3C genotypes were classified as low TS producers ( 5′-UTRlow ) and patients with 5′-UTR 3G/3 G , 3G/3C , 2R/3 G genotypes as high TS producers ( 5′UTRhigh ) . Patients with 3′-UTR del6/del6 and del6/ins6 genotypes were classified as low TS producers ( 3′-UTRlow ) and patients with 3′-UTR ins6/ins6 genotype as high TS producers ( 3′-UTRhigh ) . The prognostic analysis was based on 5′-UTR/3′-UTR combined genotypes . Results : Ten patients ( 11 % ) were 5′-UTRhigh/3′-UTRhigh , 36 patients were 5′-UTRhigh/3′-UTRlow , 19 patients were 5′-UTRlow/3′-UTRhigh , and 25 patients were 5′-UTRlow/3′-UTRlow . 5′-UTRlow/3′-UTRlow patients showed the best outcome and the threshold of statistical significance was achieved in the comparison of disease-free survival and overall survival with 5′-UTRhigh/3′-UTRlow patients and 5′-UTRhigh/3′-UTRhigh patients . The presence of at least one high TS expression genotype showed independent adverse prognostic role in multivariate analysis . Conclusions : The prognostic role of TS polymorphisms in gastric cancer deserves further investigation because the adverse effect of high TS expression genotypes may be a relevant information to improve adjuvant chemotherapeutic strategies In this marker evaluation study , we tested whether distinct patterns of functional genomic polymorphisms in genes involved in drug metabolic pathways and DNA repair that predict clinical outcome to 5-fluorouracil (5-FU)/oxaliplatin chemotherapy in patients with advanced colorectal cancer could be identified . Functional polymorphisms in DNA-repair genes XPD , ERCC1 , XRCC1 , XPA , and metabolising genes glutathione S-transferase GSTP1 , GSTT1 , GSTM1 , and thymidylate synthase ( TS ) were assessed retrospectively in 106 patients with refractory stage IV disease who received 5-FU/oxaliplatin combination chemotherapy , using a polymerase chain reaction-based RFLP technique . Favourable genotypes from polymorphisms in XPD-751 , ERCC1 - 118 , GSTP1 - 105 , and TS-3′-untranslated region ( 3′UTR ) that are associated with overall survival were identified . After adjustment for performance status , the relative risks of dying for patients who possessed the unfavourable genotype were : 3.33 for XPD-751 ( P=0.037 ) , 3.25 for GSTP1 - 105 ( P=0.072 ) , 2.05 for ERCC1 - 118 ( P=0.037 ) , and 1.65 for TS-3′UTR ( P=0.091 ) when compared to their respective beneficial genomic variants . Combination analysis with all four polymorphisms revealed that patients possessing ⩾2 favourable genotypes survived a median of 17.4 months ( 95 % confidence interval ( CI ) : 9.4 , 26.5 ) compared to 5.4 months ( 95 % CI : 4.3 , 6.0 ) in patients with no favourable genotype . Patients who carried one favourable genotype demonstrated intermediate survival of 10.2 months ( 95 % CI : 6.8 , 15.3 ; P<0.001 ) . Polymorphisms in the TS-3′UTR and GSTP1 - 105 gene were also associated with time to progression . After adjustment for performance status , patients with an unfavourable TS-3′UTR genotype had a relative risk of disease progression of 1.76 ( P=0.020 ) and those with the unfavourable GSTP1 - 105 genotype showed a relative risk of progression of 2.00 ( P=0.018 ) . The genomic polymorphisms XPD-751 , ERCC1 - 118 , GSTP1 - 105 , and TS-3′UTR may be useful in predicting overall survival and time to progression of colorectal cancer in patients who receive 5-FU/oxaliplatin chemotherapy . These findings require independent prospect i ve confirmation Oxaliplatin and irinotecan have proven effective in the treatment of gastric cancer . We attempted to determine whether single nucleotide polymorphisms in ERCC1 , GST , TS and UGT1A1 predicted overall survival in gastric cancer patients receiving FOLFOX and /or FOLFIRI chemotherapy . Total genomic DNA was extracted from the whole blood of patients . The PCR-restriction fragment length polymorphism technique was applied in order to detect the known variant sites of ERCC1 , GST , TS and UGT1A1 . The response rate of FOLFOX ( N=75 ) was 24 % . Grade 3 - 4 neutropenia and neurotoxicity were observed at frequencies of 34.7 and 16 % , respectively . TTP and OS of first-line administration of FOLFOX ( N=35 ) were 3.1 months ( 95 % CI , 0.1 - 6.1 months ) and 13.9 months ( 95 % CI , 12.2 - 15.6 months ) , respectively . Only the GSTM1 positive genotype exhibited a significantly better time to progression ( P=0.023 ) . However , significant genotypic variation of TS , GST and ERCC1 , which was assumed to affect the activity of oxaliplatin , was not observed to affect RR , toxicity and overall survival . The response rate of FOLFIRI ( N=74 ) was 23 % . Grade 3 - 4 neutropenia and diarrhea were observed in 55.4 and 9.5 % of cases , respectively . TTP and OS of first-line administration of FOLFIRI ( N=33 ) was 4.9 months ( 95 % CI , 3.5 - 6.4 months ) and 19.0 months ( 95 % CI , 8.5 - 29.5 months ) . The low expression type ( 2R/2R , 2R/3C and 3C/3C ) of TS was associated with a high incidence of grade > or=3 neutropenia . However , significant genotypic variation of UGT1A1 , which was assumed to affect irinotecan toxicity , was not observed to affect RR , toxicity or survival . In this study , the GSTM1 positive genotype evidence d a significantly better time to progression in cases of advanced gastric cancer being treated with FOLFOX . The low expression type ( 2R/2R , 2R/3C and 3C/3C ) of TS was associated with a high incidence of grade > or=3 neutropenia in cases of advanced gastric cancer treated with FOLFIRI BACKGROUND This clinical trial assessed the efficacy of pemetrexed combined with oxaliplatin ( PEMOX ) in patients with advanced gastric cancer ( AGC ) . PATIENTS AND METHODS Forty-four patients with untreated AGC were enrolled to evaluate response rate ( RR ) . Patients received pemetrexed ( 500 mg/m(2 ) ) with vitamin supplementation and oxaliplatin ( 120 mg/m(2 ) ) every 21 days for six cycles or until disease progression occurred . RESULTS Median age was 62 years ( range 26 - 76 ) . The majority of patients ( 93 % ) had metastatic disease . Sixteen of the 44 patients achieved confirmed response [ RR 36 % ; 95 % confidence interval ( CI ) 22 % to 52 % ] ; four complete responses and 12 partial responses ( complete and partial responses according to the RECIST guidelines are the confirmed-responses observed in the study population ) . Median time to tumor progression ( TTP ) was 6.2 months ( 95 % CI 4.3 - 7.5 ) and median survival was 10.8 months ( 95 % CI 7.7 - 17.2 ) . A total of 220 cycles were administered , with a median of six cycles . Most common grade 3/4 toxic effects were neutropenia in 41 % of patients ( 19 % of cycles ) and thrombocytopenia in 11 % of patients ( 4 % of cycles ) . Treatment delays or dose reductions for toxicity occurred in 10 % and 5 % of cycles , respectively . CONCLUSIONS PEMOX is active and well tolerated in AGC . RR , TTP , and survival were comparable to those achieved in studies using different 5-fluorouracil (5-FU)-oxaliplatin combinations , without the inconvenience of prolonged 5-FU schedules Purpose The aim of this study was to assess whether genetic polymorphisms in p53 , glutathione S-transferase P1 ( GSTP1 ) , GSTM1 , excision repair cross complementing group 1 ( ERCC1 ) and X-ray repair cross-complementing group 1 ( XRCC1 ) genes are associated with clinical outcome of gastric cancer patients treated with oxaliplatin-based adjuvant chemotherapy . Methods The genetic polymorphisms in p53 , GSTP1,GSTM1 ( null ) , ERCC1 and XRCC1 were determined in 102 gastric cancer patients treated with oxaliplatin-based adjuvant chemotherapy using polymerase chain reaction-ligation detection reaction method . Results Among the five studied polymorphisms , p53 codon 72 Pro/Pro , GSTP1 codon 105 Ile/Ile , and XRCC1 codon 399 Gln/Gln + Arg/Gln were associated with poor relapse-free survival and overall survival ( P < 0.05 ) ; and the prognostic effect was retained in the Cox multivariate analysis . Combination analysis with the three polymorphisms using the Kaplan – Meier method and Cox multivariate analysis revealed that the relapse-free and overall survivals significantly increase with the number of favorable genotypes ( P < 0.05 ) . No significant association was found between the GSTM1 ( null ) or the ERCC1 codon 118 genotypes and the clinical outcome ( P > 0.05 ) . Conclusion Testing for p53 Arg72Pro \n Output:\n " }, { "from": "agent", "value": "Conclusion Polymorphisms of ERCC1 , GSTs , TS and MTHFR were closely associated with clinical outcomes of GC patients treated with platinum/5-Fu-based chemotherapy .\nStudies with large sample size using the method of multi-variant analyses may help us to give more persuasive data on the putative association in future" } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: Background There are not many studies exploring parity differences in early lactation performance and the results obtained are fairly often contradictory . The present study investigated the effect of different maternity home practice s in St. Petersburg , Russia , as well as of physiological breast engorgement and maternal mood , on milk production in primi- and multiparous women on day four . The amount of milk was studied in relation to the duration of \" nearly exclusive \" breastfeeding . Methods 176 mother-infant pairs were r and omised into four groups according to an experimental two-factor design taking into account infant location and apparel . Data were recorded in the delivery ward at 25–120 minutes postpartum and later in the maternity ward . Group I infants ( n = 37 ) were placed skin-to-skin in the delivery ward while Group II infants ( n = 40 ) were dressed and placed in their mother 's arms . Both groups later roomed-in in the maternity ward . These infants had the possibility of early suckling during two hours postpartum . Group III infants ( n = 38 ) were kept in a cot in the delivery and maternity ward nurseries with no rooming-in . Group IV infants ( n = 38 ) were kept in a cot in a delivery ward nursery and later roomed-in in the maternity ward . Equal numbers per group were either swaddled or clothed . Episodes of early suckling were noted . Number of breastfeeds , amount of milk ingested ( recorded on day 4 postpartum ) and duration of \" nearly exclusive \" breastfeeding were recorded . Intensity of breast engorgement was recorded and a Visual Analogue Scale measured daily maternal feelings of being \" low/blue \" . Results On day four , multiparas had lower milk production than primiparas when they were separated from their infants and breastfeeding according to the prescriptive schedule ( 7 times a day ; Group III ) . In contrast , there was no difference in milk production between multi- and primiparous mothers in the groups rooming-in and feeding on dem and ( Groups I , II and IV ) , although multiparas had higher numbers of feedings than primiparas . In addition during the first three days postpartum , multiparous mothers had higher perception of physiological breast engorgement and lower intensity of feeling \" low/blue \" than primiparous mothers . Early suckling was shown to positively affect milk production irrespective of parity . Thus Group I and II infants who suckled within the first two hours after birth ingested significantly more milk on day 4 than those who had not ( 284 and 184 ml respectively , SE = 14 and 27 ml , p = 0.0006).Regression analyses evaluated factors most important for milk production and found in Groups I and II for primiparous women that early suckling , intensity of breast engorgement and number of breastfeeds on day 3 were most important . Intensity of feeling \" low/blue \" was negatively related to amount of milk ingested . The significant factor for multiparous women was early suckling . Similar results were obtained in Groups III and IV ; however , in primiparous mothers , engorgement was the most important factor and in multiparous women it was rooming-in . Amount of milk produced on day 4 was strongly correlated to a duration of \" nearly exclusive \" breastfeeding ( p < 0.0001 ) . Conclusion The present data show that ward routines influence milk production . As our data suggest that milk production in primi- and multiparous women may be differently influenced or regulated by complex factors , further research is needed Background A small , non-blinded , RCT ( r and omised controlled trial ) had reported that oral antibiotics reduced the incidence of mastitis in lactating women with Staphylococcus aureus ( S. aureus)- colonized cracked nipples . We aim ed to replicate the study with a more rigorous design and adequate sample size . Methods Our intention was to conduct a double-blind placebo-controlled trial to determine if an antibiotic ( flucloxacillin ) could prevent mastitis in lactating women with S. aureus-colonized cracked nipples . We planned to recruit two groups of 133 women with S. aureus-colonized cracked nipples . Results We spent over twelve months su bmi tting applications to five hospital ethics committees and seven funding bodies , before commencing the trial . Recruitment to the trial was very slow and only ten women were r and omized to the trial after twelve months , and therefore the trial was stopped early . Conclusions In retrospect we should have conducted a feasibility study , which would have revealed the low number of women in these Melbourne hospitals ( maternity wards and breastfeeding clinics ) with damaged nipples . The appropriate use of antibiotics for breastfeeding women with cracked nipples still needs to be tested Objective : The purpose s of this study were to compare the efficacy of amoxicillin and cephradine for the treatment of sporadic acute puerperal mastitis ( SAPM ) and to evaluate the microbiology and clinical parameters of this infection . Methods : We conducted a prospect i ve , r and omized , single-blinded study comparing amoxicillin , 500 mg orally q 8 h for 7 days , and cephradine , 500 mg orally q 6 h for 7 days . The diagnostic criteria for SAPM included a temperature of ≥37.56 ℃ ( ≥99.6 ℉ ) and erythema and tenderness of the breast(s ) . Results : Twenty-seven consecutive out patients with SAPM were evaluated for admission to the study , and 25 of these were enrolled . The mean temperature at enrollment was 38.17 ℃ ( 100.7 ℉ ) , with a mean WBC count of 11,440/μl . The most frequent bacterial isolates from expressed milk were Staphylococcus aureus ( 7 ) , staphylococcal species ( coagulase negative ) ( 8) , and α-hemolytic streptococci ( 4 ) . There were no significant differences between the 2 antibiotic regimens in cure rate , mean days to resolution of symptoms , or recurrence within 30 days . Both of the treatment failures and 1 of the 3 recurrences within 30 days were amoxicillin-treated patients whose cultures grew S. aureus . Conclusions : Oral amoxicillin and cephradine appear equally effective in the treatment of SAPM . Staphylococci were the most frequent isolates from the milk of women with mastitis OBJECTIVE to study the effect of birth centre care on the duration of breast feeding , breast feeding complications , and women 's experiences of breast feeding . DESIGN r and omised controlled trial . SETTING in-hospital birth centre at South Hospital , Stockholm , and st and ard obstetric care in the Greater Stockholm area . SUBJECTS 1230 women with expected date of birth between October 1989 and February 1992 , interested in participating in a birth centre trial , and meeting medical low-risk criteria . 617 women were allocated to the experimental group offered birth centre care ( EG ) , and 613 to the control group offered st and ard obstetric care ( CG ) . MAIN OUTCOME MEASURES duration of breast feeding , breast feeding complications such as sore nipples , engorgement , milk stasis , and mastitis , and women 's experiences of breast feeding . FINDINGS no difference was found between EG and CG in the duration of breast feeding . Ninety-three per cent in both groups were breast feeding exclusively two months post partum . The average number of months of breast feeding , exclusively or partly , when investigated one year after the birth was 8.6 in EG and 8.5 in CG . No difference was observed in women 's experiences of breast feeding , but rather more women in EG than in CG reported sore nipples , 36 % and 30 % respectively ( p = 0.03 ) , and milk stasis , 26 % and 19 % respectively ( p = 0.002 ) . CONCLUSIONS birth centre care had no effect on the duration of breast feeding , or on women 's experiences of breast feeding . Prenatal attitudes were probably more significant predictors of these outcomes than differences in the two modes of maternity care in this population of highly breast feeding-motivated women . The larger proportion of sore nipples and milk stasis in the EG might have been due to earlier discharge , or to midwives less skilled in assisting with breast feeding at the birth centre than in the postpartum wards Background It has proven difficult to reach World Health Organization ( WHO ) recommendations that infants be exclusively breastfed from birth to six months of age [ 1 , 2 ] , yet there is limited knowledge about interventions that are effective in increasing breastfeeding initiation and duration . Particularly lacking is evidence about how to maintain breastfeeding rates in countries which already have a high initiation of breastfeeding . This study aims to determine whether mid-pregnancy breastfeeding education , with a focus on either attitudes to breastfeeding or on technical aspects of breastfeeding , has an effect on rates of breastfeeding initiation and duration . Secondary aims of the study are to : explore what factors might affect the duration of breastfeeding and evaluate the interventions from the participant and childbirth facilitator perspectives . Methods / Design A r and omised controlled trial ( RCT ) design will be used . Women having their first baby , and planning to give birth as public patients at the Royal Women 's Hospital ( RWH ) , Melbourne , will be approached at 18–20 weeks of pregnancy and invited to participate in the study . Participants will be r and omly allocated to a control group or one of two group interventions : a previously design ed and trialled tool to teach practical aspects of breastfeeding or an exploration of family attitudes to breastfeeding . The latter was developed and piloted by the investigators in conjunction with the group facilitators , prior to trial commencement . The interventions are planned to take place at 20–25 weeks . Data will be collected by question naire at recruitment , at interview in hospital after the birth and by telephone interview six months later . Medical/obstetric outcomes will be obtained from the medical record . The sample size ( 972 ) was calculated to identify an increase in breastfeeding initiation from 75 to 85 % and an increase from 40 to 50 % in breastfeeding at six months The research undertaken in this study utilized a case-control group nested within a prospect i ve cohort which was followed for the first 3 months postpartum . Mothers with mastitis and their controls were requested to complete a self-report question naire design ed to investigate the association between the potential risk factors , identified from the literature , and lactation mastitis . Logistic regression analyses of the possible risk factors were performed separately for mothers who had not breastfed Obviously and those mothers who had breastfed at least one infant prior to this lactation/nalysis showed blocked duct(s ) and increased levels of stress were the significant pre icors for mastitis in mothers who had breastfed a previous infant and blocked duct(s ) , restriction from a tight bra , attachment difficulties , and nipple pain during a feed were the significant predictors for mastitis in first time breastfeeding mothers Recommendations for the care of the nipple postpartum are numerous and variable . Cracks and fissures in the nipple must be prevented to prevent mastitis . A r and omized prospect i ve study shows that it does not matter whether powder or ointments or nothing is placed on the nipples after nursing . The incidence of cracked nipples is not significantly changed by theses measures . For the prevention of mastitis the general measures for the prevention of hospital acquired infections are necessary and more important than modifications of the nipple care OBJECTIVES to further compare acupuncture treatment and care interventions for the relief of inflammatory symptoms of the breast during lactation and to investigate the relationship between bacteria in the breast milk and clinical signs and symptoms . DESIGN r and omised , non-blinded , controlled trial of acupuncture and care interventions . SETTING a midwife-led breast feeding clinic in Sweden . PARTICIPANTS 205 mothers with 210 cases of inflammatory symptoms of the breast during lactation agreed to participate . The mothers were r and omly assigned to one of three treatment groups , two of which included acupuncture among the care interventions and one without acupuncture . All groups were given essential care . Protocol s , which included scales for erythema , breast tension and pain , were maintained for each day of contact with the breast feeding clinic . A Severity Index ( SI ) for each mother and each day was created by adding together the scores on the erythema , breast tension and pain scales . The range of the SI was 0 ( least severe ) to 19 ( most severe ) . FINDINGS no significant difference was found in numbers of mothers in the treatment groups , with the lowest possible score for severity of symptoms on contact days 3 , 4 or 5 . No statistically significant differences were found between the treatment groups for number of contact days needed until the mother felt well enough to discontinue contact with the breast feeding clinic or for number of mothers prescribed antibiotics . Significant differences were found in the mean SI scores on contact days 3 and 4 between the non-acupuncture group and the two acupuncture groups . Mothers with less favourable outcomes ( 6 contact days , n=61 ) were , at first contact with the midwife , more often given advice on correction of the baby 's attachment to the breast . An obstetrician was called to examine 20 % of the mothers , and antibiotic treatment was prescribed for 15 % of the study population . The presence of Group B streptococci in the breast milk was related to less favourable outcomes . KEY CONCLUSIONS AND IMPLICATION S FOR PRACTICE if acupuncture treatment is acceptable to the mother , this , together with care interventions such as correction of breast feeding position and babies ' attachment to the breast , might be a more expedient and less invasive choice of treatment than the use of oxytocin nasal spray . Midwives , nurses or medical \n Output:\n " }, { "from": "agent", "value": "We found no significant differences for mastitis in three trials of specialist breastfeeding education with usual care ( one trial ) ; anti-secretory factor cereal ( one trial ) ; and mupirocin , fusidic acid ointment or breastfeeding advice ( one trial).Generally we found no differences in any of the trials for breastfeeding initiation or duration ; or symptoms of mastitis .\nAUTHORS ' CONCLUSIONS There was insufficient evidence to show effectiveness of any of the interventions , including breastfeeding education , pharmacological treatments and alternative therapies , regarding the occurrence of mastitis or breastfeeding exclusivity and duration .\nAn urgent need for further adequately powered research is needed into this area to conclusively determine the effectiveness of these interventions" } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: Background Cancer patients receiving chemotherapy are at increased risk of thrombosis . Nadroparin has been demonstrated to reduce the incidence of venous and arterial thrombotic events ( TEs ) by about 50 % in cancer out patients receiving chemotherapy . The aims of this retrospective analysis were to evaluate the thromboembolic risk and the benefit of thromboprophylaxis according to type of chemotherapy . Methods Cancer out patients were r and omly assigned to receive subcutaneous injections of nadroparin or placebo . The incidence of symptomatic TEs was assessed according to the type of chemotherapy . Results were reported as risk ratios with associated 95 % CI and two-tailed probability values . Results 769 and 381 patients have been evaluated in the nadroparin and placebo group , respectively . In the absence of thromboprophylaxis , the highest rate of TEs was found in patients receiving gemcitabine- ( 8.1 % ) or cisplatin-based chemotherapy ( 7.0 % ) . The combination of gemcitabine and cisplatin or carboplatin increased the risk to 10.2 % . Thromboprophylaxis reduced TE risk by 68 % in patients receiving gemcitabine ; with a further decrease to 78 % in those receiving a combination of gemcitabine and platinum . Conclusions This retrospective analysis confirms that patients undergoing chemotherapy including gemcitabine , platinum analogues or their combination are at higher risk of TEs . Our results also suggest that out patients receiving chemotherapy regimens including these agents might achieve an increased benefit from thromboprophylaxis with nadroparin . Clinical Trial registration number : NCT Lenalidomide plus dexamethasone is effective in the treatment of multiple myeloma ( MM ) but is associated with an increased risk of venous thromboembolism ( VTE ) . This prospect i ve , open-label , r and omized sub study of a phase 3 trial compared the efficacy and safety of thromboprophylaxis with low-dose aspirin ( ASA ) or low-molecular-weight heparin ( LMWH ) in patients with newly diagnosed MM , treated with lenalidomide and low-dose dexamethasone induction and melphalan-prednisone-lenalidomide consolidation . Overall , 342 patients who did not have clinical indications or contraindications to antiplatelet or anticoagulant therapy were r and omly assigned to receive ASA 100 mg/d ( n = 176 ) or LMWH enoxaparin 40 mg/d ( n = 166 ) . The incidence of VTE was 2.27 % in the ASA group and 1.20 % in the LMWH group . Compared with LMWH , the absolute difference in the proportion of VTE was 1.07 % ( 95 % confidence interval , -1.69 - 3.83 ; P = .452 ) in the ASA group . Pulmonary embolism was observed in 1.70 % of patients in the ASA group and none in the LMWH group . No arterial thrombosis , acute cardiovascular events , or sudden deaths were reported . No major hemorrhagic complications were reported . In previously untreated patients with MM receiving lenalidomide with a low thromboembolic risk , ASA could be an effective and less-expensive alternative to LMWH thromboprophylaxis PURPOSE Studies by the Veterans Administration Cooperative Studies Program and Cancer and Leukemia Group B ( CALGB ) suggested that the addition of warfarin to chemotherapy might enhance response and /or survival in small-cell lung cancer ( SCLC ) . This r and omized study evaluated the effect of warfarin with chemotherapy and radiation therapy in limited-stage SCLC . PATIENTS AND METHODS Patients were r and omized to receive warfarin or no warfarin . All patients received three cycles of doxorubicin , cyclophosphamide , and etoposide ( ACE ) . Cycles 4 and 5 ( cisplatin , cyclophosphamide , and etoposide [ PCE ] ) were given concurrently with radiation therapy . Three cycles of ACE were given after chemoradiation therapy , but were discontinued due to a high rate of pulmonary toxicity . RESULTS There were no significant differences in response rates , survival , failure-free survival , disease-free survival , or patterns of relapse between the warfarin-treated and control groups . In patients treated according to the initial design , an increase in failure-free survival seen with warfarin treatment approached significance ( P = .07 ) . Preamendment results , while not significant , did not have superimposable treatment survival curves . A l and mark analysis at 8 months showed a median survival time after the l and mark for complete responders of 33 months with warfarin treatment compared with < or = 13.75 months for complete or partial responders not treated with warfarin ( P = .05 ) . Differences between the complete responders in this preamendment population were not significant ( P = .103 ) . CONCLUSION Warfarin does not appear to improve outcome significantly in limited-stage SCLC . However , the differences in some variables between population s before the protocol amendment correspond to the favorable effects of anticoagulants observed in previous studies PURPOSE Initial heparinization followed by vitamin K antagonists is the treatment of choice for patients with venous thromboembolism . There is controversy whether known malignancy is a risk factor for recurrences and bleeding complications during this treatment . Furthermore , the incidence of such events in these patients is dependent on the achieved International Normalized Ratio ( INR ) . The aim of this study was to assess the incidence of venous thromboembolic recurrence and major bleeding among patients with venous thromboembolism in relation to both malignancy and the achieved INR . PATIENTS AND METHODS In a retrospective analysis , the INR-specific incidence of venous thromboembolic and major bleeding events during oral anticoagulant therapy was calculated separately for patients with and without malignancy . Eligible patients participated in two multicenter , r and omized clinical trials on the initial treatment of venous thromboembolism . Patients were initially treated with heparin ( st and ard or low-molecular weight ) . Treatment with vitamin K antagonists was started within 1 day and continued for 3 months , with a target INR of 2.0 to 3.0 . RESULTS In 1,303 eligible patients ( 264 with malignancy ) , 35 recurrences and 12 bleeds occurred . Patients with malignancy , compared with nonmalignant patients , had a clinical ly and statistically significantly increased overall incidence of recurrence ( 27.1 v 9.0 , respectively , per 100 patient-years ) as well as bleeding ( 13.3 v 2.1 , respectively , per 100 patient-years ) . In both groups of patients , the incidence of recurrence was lower when the INR was above 2.0 compared with below 2.0 . CONCLUSION Although adequately dosed vitamin K antagonists are effective in patients with malignant disease , the incidence of thrombotic and bleeding complications remains higher than in patients without malignancy Background Advanced pancreatic cancer , in addition to its high mortality , is characterized by one of the highest rates of venous thromboembolic events ( VTE ) as compared to other types of cancer . Enoxaparin , a low molecular weight heparin ( LMWH ) , has proven to be effective for the prevention and treatment of VTE in surgical and general medical patients . Results of some small studies suggest that this benefit might extend to patients with cancer , however , enoxaparin is not currently indicated for this use . This phase IIb study was design ed to analyze the efficacy of enoxaparin in patients with locally advanced or metastatic pancreatic cancer undergoing systemic chemotherapy . Methods The aim of this prospect i ve multicenter trial is to compare concomitant treatment with enoxaparin to no anticoagulation in 540 patients . Primary endpoint is the incidence of clinical ly relevant VTE ( symptomatic deep venous thrombosis ( DVT ) of the leg and /or pelvic and /or pulmonary embolism ( PE ) ) within the first 3 months . Secondary endpoints include the incidence of symptomatic and asymptomatic VTE after 6 , 9 and 12 months as well as remission at 3 , 6 , 9 and 12 months , overall survival and bleeding . Trial registration : is rct n.org identifier CCT-NAPN-16752 , controlled-trials.com identifier : IS RCT N02140505 . Results An interim analysis for safety performed after inclusion of 152 patients revealed no increased risk of bleeding ( 5 pts vs. 6 pts , Chi2 : 0.763 ) . Conclusion PROSPECT is a pivotal study in elucidating the role of low molecular weight heparins in advanced pancreatic cancer . Its results will lead to a new underst and ing of the role of heparins in the prevention of venous thromboembolism and of their effect on survival , remission rates and toxicity of chemotherapeutic regimens Background The heterogeneity statistic I2 , interpreted as the percentage of variability due to heterogeneity between studies rather than sampling error , depends on precision , that is , the size of the studies included . Methods Based on a real meta- analysis , we simulate artificially ' inflating ' the sample size under the r and om effects model . For a given inflation factor M = 1 , 2 , 3 , ... and for each trial i , we create a M-inflated trial by drawing a treatment effect estimate from the r and om effects model , using si2MathType@MTEF@5@5@+=feaagaart1ev2aaatCvAUfKttLearuWrP9MDH5MBPbIqV92AaeXatLxBI9gBaebbnrfifHhDYfgasaacPC6xNi = xH8viVGI8Gi = hEeeu0xXdbba9frFj0xb9qqpG0dXdb9aspeI8k8fiI+fsY = rqGqVepae9pg0db9vqaiVgFr0xfr = xfr = xc9adbaqaaeGaciGaaiaabeqaaeqabiWaaaGcbaGaem4Cam3aa0baaSqaaiabdMgaPbqaaiabikdaYaaaaaa@2FBE@/M as within-trial sampling variance . Results As precision increases , while estimates of the heterogeneity variance τ2 remain unchanged on average , estimates of I2 increase rapidly to nearly 100 % . A similar phenomenon is apparent in a sample of 157 meta-analyses . Conclusion When deciding whether or not to pool treatment estimates in a meta- analysis , the yard-stick should be the clinical relevance of any heterogeneity present . τ2 , rather than I2 , is the appropriate measure for this purpose OBJECTIVE To study the efficacy of daily low-dose aspirin ( 81 mg orally ) in decreasing the incidence of venous thromboembolic events ( VTEs ) in patients with multiple myeloma receiving pegylated doxorubicin , vincristine , and decreased-frequency dexamethasone , plus thalidomide ( DVd-T ) . PATIENTS AND METHODS In this phase 2 clinical trial of DVd-T , conducted by the Clevel and Clinic Foundation from August 2001 to October 2003 , 105 patients were enrolled . The first 35 patients experienced increased numbers of VTEs . von Willebr and levels and platelet aggregation to ristocetin before and after treatment with DVd-T increased significantly , suggesting a pathophysiology involving platelet-endothelial interaction . Aspirin was added to the regimen , thus generating 3 patient groups : group 1 received aspirin from the start of DVd-T treatment before the study began ( 58 patients ) , group 2 received aspirin after the start of DVd-T treatment and after the study began ( 26 patients ) , and group 3 did not receive daily low-dose aspirin during the study ( 19 patients ) . Two patients being treated with warfarin for other indications were excluded from the study . The primary end point for this study was the incidence of VTE in the form of either deep venous thrombosis or pulmonary embolism . Secondary end points were the time to the first VTE , time to the composite end point of death or first VTE , and incidence of bleeding complications . RESULTS After a median follow-up of 24 months , on an intent-to-treat basis , 26 posttreatment VTEs occurred after a median of 90 days , with 19 % occurring in group 1 , 15 % in group 2 , and 58 % in group 3 . Following multivariate time-to-event analysis , aspirin use continued to be associated with lower relative risk of VTE ( hazard ratio , 0.22 ; confidence interval , 0.10 - 0.47 ; P<.001 ) and of the composite end point ( hazard ratio , 0.28 ; confidence interval , 0.15 - 0.51 ; P<.001 ) . CONCLUSION Daily low-dose aspirin ( 81 mg orally ) given to patients with newly diagnosed and relapsed/refractory multiple myeloma who were receiving DVd-T reduced the incidence of VTEs without an increase in bleeding complications BACKGROUND Children with acute lymphoblastic leukemia ( ALL ) have a substantial risk for thromboembolism ( TE ) that is related to L-asparaginase-induced antithrombin ( AT ) deficiency and placement of central venous lines . Recent in vitro studies showed that the anticoagulant effects of low-molecular-weight heparin were profoundly affected \n Output:\n " }, { "from": "agent", "value": "Antithrombin , evaluated in one study involving paediatric patients , had no significant effect on VTE or on major bleeding when compared with no antithrombin .\nAUTHORS ' CONCLUSIONS In this second up date , we confirmed that primary thromboprophylaxis with LMWH significantly reduced the incidence of symptomatic VTE in ambulatory cancer patients treated with chemotherapy .\nIn addition , the uLMWH semuloparin , which is not commercially available , significantly reduced the incidence of symptomatic VTE ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: Background and Objectives Femoral nerve block ( FNB ) , a commonly used postoperative pain treatment after total knee arthroplasty ( TKA ) , reduces quadriceps muscle strength essential for mobilization . In contrast , adductor canal block ( ACB ) is predominately a sensory nerve block . We hypothesized that ACB preserves quadriceps muscle strength as compared with FNB ( primary end point ) in patients after TKA . Secondary end points were effects on morphine consumption , pain , adductor muscle strength , morphine-related complications , and mobilization ability . Methods We performed a double-blind , r and omized , controlled study of patients scheduled for TKA with spinal anesthesia . The patients were r and omized to receive either a continuous ACB or an FNB via a catheter ( 30-mL 0.5 % ropivacaine given initially , followed by a continuous infusion of 0.2 % ropivacaine , 8 mL/h for 24 hours ) . Muscle strength was assessed with a h and held dynamometer , and we used the percentile change from baseline for comparisons . The trial was registered at clinical trials.gov ( Identifier : NCT01470391 ) . Results We enrolled 54 patients , of which 48 were analyzed . Quadriceps strength as a percentage of baseline was significantly higher in the ACB group compared with the FNB group : ( median [ range ] ) 52 % [ 31–71 ] versus 18 % [ 4–48 ] , ( 95 % confidence interval , 8–41 ; P = 0.004 ) . There was no difference between the groups regarding morphine consumption ( P = 0.94 ) , pain at rest ( P = 0.21 ) , pain during flexion of the knee ( P = 0.16 ) , or adductor muscle strength ( P = 0.39 ) ; neither was there a difference in morphine-related adverse effects or mobilization ability ( P > 0.05 ) . Conclusions Adductor canal block preserved quadriceps muscle strength better than FNB , without a significant difference in postoperative pain Purpose Providing effective analgesia for total knee arthroplasty ( TKA ) patients remains challenging . Femoral nerve block ( FNB ) offers targeted pain control ; however , its effect on motor function , related fall risk and impact on rehabilitation has been the source of controversy . Adductor canal block ( ACB ) potentially spares motor fibres of the femoral nerve , but the comparative effect of the two approaches has not yet been well defined due to considerable variability in pain perception . Our study compares both single-shot FNB and ACB , side to side , in the same patients undergoing bilateral TKA . Methods Sixty patients scheduled for bilateral TKA were r and omised to receive ultrasound-guided FNB on one leg and ACB on the other , in addition to combined spinal epidural anaesthesia . The primary outcome was comparative postoperative pain in either extremity at six to eight , 24 and 48 hours postoperatively . Secondary comparative outcomes included motor strength ( manually and via dynamometer ) , physical therapy milestones and patient satisfaction . Results While pain levels were lowest at six to eight hours postoperatively and increased thereafter ( P < 0.001 ) , no significant differences were seen between extremities at any time point with regard to pain in the quantitative comparison using visual analogue scale ( VAS ) scores ( P = 0.4154 ) , motor strength ( P = 0.7548 ) , physical therapy milestones or patient satisfaction . However , in the qualitative comparison , a significant proportion of patients reported the leg receiving ACB to be more painful than that receiving FNB at 24 h [ 50.9 % ( n = 30 ) vs 25.42 % ( n = 15 ) , P = 0.0168 ) ] . Conclusions Although we could not confirm a benefit in motor function between ACB and FNB , given the equivalent analgesic potency combined with its potentially lower overall impact if neuropraxia should occur , ACB may represent an attractive alternative to FNB Background There are several methods for postoperative analgesia for knee surgery . The commonly utilized method is multimodal analgesia based on continuous femoral nerve block . The aim of this study was to investigate the application of continuous adductor canal block for analgesia after total knee replacement and compare this method with continuous femoral nerve block . Methods Sixty patients scheduled for total knee replacement from June 2013 to March 2014 were r and omly divided into a femoral group and an adductor group . Catheters were placed under the guidance of nerve stimulation in the femoral group and under the guidance of ultrasound in the adductor group . Operations were performed under combined spinal and epidural anesthesia . After the operations , 0.2 % ropivacaine was given at a speed of 5 ml/h through catheters in all patients . Visual analogue scale ( VAS ) pain scores at rest and while moving were noted at 4 , 24 , and 48 hours after the operation , and quadriceps strength was also assessed at these time‐points . Secondary parameters such as doses of complementary analgesics and side effects were also recorded . Results There were no significant differences between the groups in VAS pain scores at rest or while moving , at 4 , 24 , or 48 hours after the operation ( P > 0.05 ) . At these time‐points , mean quadriceps strengths in the adductor group were 3.0 ( 2.75‐3.0 ) , 3.0 ( 3.0‐4.0 ) , and 4.0 ( 3.0‐4.0 ) , respectively , all of which were significantly stronger than the corresponding means in the femoral group , which were 2.0 ( 2.0‐3.0 ) , 2.0 ( 2.0‐3.0 ) , and 3.0 ( 2.0‐4.0 ) , respectively ( P < 0.05 ) . There were no significant differences between the groups in doses of complementary analgesics or side effects ( P > 0.05 ) . X‐ray images of some patients showed that local anesthetic administered into the adductor canal could diffuse upward and reach the femoral triangle . Conclusions Continuous adductor canal block with 0.2 % ropivacaine could be used effectively for analgesia after total knee replacement . Compared with continuous femoral nerve block , this analgesic method has similar analgesic effects and is associated with less weakness of quadriceps muscle Background : This prospect i ve double-blinded , r and omized controlled trial compared adductor canal block ( ACB ) with femoral nerve block ( FNB ) in patients undergoing total knee arthroplasty . The authors hypothesized that ACB , compared with FNB , would exhibit less quadriceps weakness and demonstrate noninferior pain score and opioid consumption at 6 to 8 h postanesthesia . Methods : Patients received an ACB or FNB as a component of a multimodal analgesic . Quadriceps strength , pain score , and opioid consumption were assessed on both legs preoperatively and at 6 to 8 , 24 , and 48 h postanesthesia administration . In a joint hypothesis test , noninferiority was first evaluated on the primary outcomes of strength , pain score , and opioid consumption at 6 to 8 h ; superiority on each outcome at 6 to 8 h was then assessed only if noninferiority was established . Results : Forty-six patients received ACB ; 47 patients received FNB . At 6 to 8 h postanesthesia , ACB patients had significantly higher median dynamometer readings versus FNB patients ( median [ interquartile range ] , 6.1 kgf [ 3.5 , 10.9 ] ( ACB ) vs. 0 kgf [ 0.0 , 3.9 ] ( FNB ) ; P < 0.0001 ) , but was not inferior to FNB with regard to Numeric Rating Scale pain scores ( 1.0 [ 0.0 , 3.5 ] ACB vs. 0.0 [ 0.0 , 1.0 ] FNB ; P = 0.019 ) , or to opioid consumption ( 32.2 [ 22.4 , 47.5 ] ACB vs. 26.6 [ 19.6 , 49.0 ] ; P = 0.0115 ) . At 24 and 48 h postanesthesia , there was no significant statistical difference in dynamometer results , pain scores , or opioid use between the two groups . Conclusion : At 6 to 8 h postanesthesia , the ACB , compared with the FNB , exhibited early relative sparing of quadriceps strength and was not inferior in both providing analgesia or opioid intake Total knee replacement ( TKR ) produces severe postoperative pain . Peripheral nerve blocks can be used as analgesic adjuncts for TKR , but the efficacy of femoral nerve blocks alone is controversial . The sciatic nerve innervates posterior regions of the knee ; thus , performance of both sciatic and femoral nerve blocks may be necessary to improve analgesia after TKR . We performed this study to determine whether peripheral nerve blocks improve analgesia after TKR . In a r and omized , double-blind fashion , 36 patients undergoing TKR received either femoral , sciatic-femoral , or sham nerve blocks after a st and ardized spinal anesthetic . Further postoperative analgesia was provided by patient-controlled IV morphine and ketorolac . Pain at rest and with physical therapy , morphine use , nausea , pruritus , sedation , and patient satisfaction were assessed . Patients receiving peripheral nerve blocks reported better analgesia at rest for at least 8 h after transfer to the hospital ward ( P < 0.05 ) . Morphine use was decreased by approximately 50 % in the peripheral nerve block groups until the second postoperative day ( P < 0.02 ) . Side effect profiles and patient satisfaction were similar between groups . We conclude that femoral nerve blocks improve analgesia and decrease morphine use after TKR . The addition of a sciatic nerve block to the femoral nerve block did not further improve analgesic efficacy . Implication s : Performance of femoral nerve blocks improves analgesia and decreases the need for morphine after total knee replacement surgery . The addition of a sciatic nerve block to the femoral nerve block does not provide additional benefits . ( Anesth Analg 1998;87:93 - 7 Background and Objectives Adductor canal block ( ACB ) has been suggested as an analgesic alternative to femoral nerve block ( FNB ) for procedures on the knee , but its effect on quadriceps motor function is unclear . We performed a r and omized , blinded study to compare quadriceps strength following adductor canal versus FNB in volunteers . Our hypothesis was that quadriceps strength would be preserved following ACB , but not FNB . Secondary outcomes included relative preservation of hip adduction and degree of balance impairment . Methods The ACB was performed in one leg and the FNB in the contralateral leg in 16 volunteers using a r and omized block sequence . For all blocks , 15 mL of 3 % chloroprocaine was injected under ultrasonographic guidance . Maximal voluntary isometric contraction of knee extension and hip adduction was measured at baseline and at 30 and 60 minutes after block . After 60-minute assessment s were complete , the second block was placed . A test of balance ( Berg Balance Scale ) was performed 30 minutes after the first block only . Results Quadriceps strength and balance scores were similar to baseline following ACB . Following FNB , there was a significant reduction in quadriceps strength ( 95.1 % ± 17.1 % vs 11.1 % ± 14.0 % ; P < 0.0001 ) and balance scores ( 56 ± 0 vs 37 ± 17.2 ; P = 0.02 ) compared with baseline . There was no difference in hip adductor strength ( 97.0 % ± 10.8 % vs 91.8 % ± 9.6 % ; P = 0.17 ) . Conclusions Compared with FNB , ACB results in significant quadriceps motor sparing and significantly preserved balance Background : Whether decreasing the local anesthetic concentration during a continuous femoral nerve block results in less quadriceps weakness remains unknown . Methods : Preoperatively , bilateral femoral perineural catheters were inserted in subjects undergoing bilateral knee arthroplasty ( n = 36 ) at a single clinical center . Postoperatively , right-sided catheters were r and omly assigned to receive perineural ropivacaine of either 0.1 % ( basal 12 ml/h ; bolus 4 ml ) or 0.4 % ( basal 3 ml/h ; bolus 1 ml ) , with the left catheter receiving the alternative concentration/rate in an observer- and subject-masked fashion . The primary endpoint was the maximum voluntary isometric contraction of the quadriceps femoris muscles the morning of postoperative day 2 . Equivalence of treatments would be concluded if the 95 % CI for the difference fell within the interval −20%–20 % . Secondary endpoints included active knee extension , passive knee flexion , tolerance to cutaneous electrical current applied over the distal quadriceps tendon , dynamic pain scores , opioid requirements , and ropivacaine consumption . Results : Quadriceps maximum voluntary isometric contraction for limbs receiving 0.1 % ropivacaine was a mean ( SD ) of 13 ( 8) N · m , versus 12 ( 8) N · m for limbs receiving 0.4 % [ intrasubject difference of 3 ( 40 ) percentage points ; 95 % CI −10–17 ; P = 0.63 ] . Because the 95 % CI fell within prespecified tolerances , we conclude that the effect of the two concentrations were equivalent . Similarly , there were no statistically significant differences in secondary endpoints . \n Output:\n " }, { "from": "agent", "value": "Conclusions The present study suggests that TKA patients who receive ACB can achieve similar or even better recovery of quadriceps strength and mobilization ability than those treated with FNB .\nTaken as a whole , ACB may be a better analgesia strategy after TKA at present" } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: Until 1990 , the survival of children with acute lymphoblastic leukaemia ( ALL ) in Russia was below 10 % . To establish a protocol feasible under conditions there , ALL-MB 91 was design ed to avoid prolonged bone marrow aplasia , thereby reducing needs for extensive supportive care , blood transfusions , long-lasting hospitalization and costs . High-dose therapies were avoided , anthracycline use was limited and CNS radiation therapy only foreseen in high-risk patients ( about 30 % ) . This was r and omized against a modified BFM protocol . From 1995 to 2002 , 834 patients of age up to 18 years were registered in 10 centres and 713 received after central r and omization the allocated risk-stratified treatment . After a median follow-up of 7 years , the event-free survival ( EFS ) was 67±3 % on ALL-MB 91 ( N=358 ) vs 68±3 % on ALL-BFM 90 m ( N=355 ) . The overall survival ( OS ) was 71±3 % vs 74±2 % , respectively . Anaemia , thrombocytopenia , agranulocytosis > 10 days and hospitalization ( median 35 vs 68 days ) were lower on ALL-MB 91 ( P<0.01 , N=197 ) . While EFS and OS were similar with both protocol s , ALL-MB 91 significantly incurred fewer toxicity and re source requirements and , therefore , has been increasingly used across Russia In a series of 40 patients treated with L-asparaginase for various neoplastic diseases , 6 patients had generalized anaphylactic reactions to L-asparaginase . Each of these reactors had antibodies detectable by passive hemagglutination , but precipitins were detectable in only one of this group of six patients . That patient had received two courses of the enzyme . 1 wk after the anaphylactic reaction , complement-fixing antibodies were present in all the patients that were studied . Specific reagin antibodies ( IgE ) were demonstrated in one patient by the release of histamine from his leukocytes after incubation in vitro with L-asparaginase . Binding of L-asparaginase to serum antibodies after incubation in vitro was detected by selective precipitation of the complexes with 30 % ammonium sulfate or by ultracentrifugation . Total inactivation of the enzyme did not occur even at optimal proportions or at antibody excess . Passive hemagglutinating antibodies to L-asparaginase were present in all patients who had an allergic reaction at least 1 day before the reaction occurred , when that sample was available , and were absent in all patients who did not manifest clinical allergy . Titration of antibodies by passive hemagglutination may thus provide a means of predicting impending anaphylaxis in this system , particularly when coupled with a sudden decrease in circulating levels of L-asparaginase activity BACKGROUND l-asparaginase is a universal component of treatment for childhood acute lymphoblastic leukaemia , and is usually administered intramuscularly . Pegylated Escherichia coli asparaginase ( PEG-asparaginase ) has a longer half-life and is potentially less immunogenic than the native Escherichia coli ( E coli ) preparation , and can be more feasibly administered intravenously . The aim of the Dana-Farber Cancer Institute Acute Lymphoblastic Leukaemia Consortium Protocol 05 - 001 ( DFCI 05 - 001 ) was to compare the relative toxicity and efficacy of intravenous PEG-asparaginase and intramuscular native E colil-asparaginase in children with newly diagnosed acute lymphoblastic leukaemia . METHODS DFCI 05 - 001 enrolled patients aged 1 - 18 years with newly diagnosed acute lymphoblastic leukaemia from 11 consortium sites in the USA and Canada . Patients were assigned to an initial risk group on the basis of their baseline characteristics and then underwent 32 days of induction therapy . Those who achieved complete remission after induction therapy were assigned to a final risk group and were eligible to participate in a r and omised comparison of intravenous PEG-asparaginase ( 15 doses of 2500 IU/m(2 ) every 2 weeks ) or intramuscular native E colil-asparaginase ( 30 doses of 25 000 IU/m(2 ) weekly ) , beginning at week 7 after study entry . R and omisation ( 1:1 ) was unmasked , and was done by a statistician-generated allocation sequence using a permuted blocks algorithm ( block size of 4 ) , stratified by final risk group . The primary endpoint of the r and omised comparison was the overall frequency of asparaginase-related toxicities ( defined as allergy , pancreatitis , and thrombotic or bleeding complications ) . Predefined secondary endpoints were disease-free survival , serum asparaginase activity , and quality of life during therapy as assessed by PedsQL surveys . All analyses were done by intention to treat . This study is registered with Clinical Trials.gov , number NCT00400946 . FINDINGS Between April 22 , 2005 , and Feb 12 , 2010 , 551 eligible patients were enrolled . 526 patients achieved complete remission after induction , of whom 463 were r and omly assigned to receive intramuscular native E colil-asparaginase ( n=231 ) or intravenous PEG-asparaginase ( n=232 ) . The two treatment groups did not differ significantly in the overall frequency of asparaginase-related toxicities ( 65 [ 28 % ] of 232 patients in the intravenous PEG-asparaginase group vs 59 [ 26 % ] of 231 patients in the intramuscular native E colil-asparaginase group , p=0·60 ) , or in the individual frequency of allergy ( p=0·36 ) , pancreatitis ( p=0·55 ) , or thrombotic or bleeding complications ( p=0·26 ) . Median follow-up was 6·0 years ( IQR 5·0 - 7·1 ) . 5-year disease-free survival was 90 % ( 95 % CI 86 - 94 ) for patients assigned to intravenous PEG-asparaginase and 89 % ( 85 - 93 ) for those assigned to intramuscular native E colil-asparaginase ( p=0·58 ) . The median nadir serum asparaginase activity was significantly higher in patients who received intravenous PEG-asparaginase than in those who received intramuscular native E colil-asparaginase . Significantly more anxiety was reported by both patients and parent-proxy in the intramuscular native E colil-asparaginase group than in the intravenous PEG-asparaginase group . Scores for other domains were similar between the groups . The most common grade 3 or worse adverse events were bacterial or fungal infections ( 47 [ 20 % ] of 232 in the intravenous PEG-asparaginase group vs 51 [ 22 % ] of 231 patients in the intramuscular E colil-asparaginase group ) and asparaginase-related allergic reactions ( 14 [ 6 % ] vs 6 [ 3 % ] ) . INTERPRETATION Intravenous PEG-asparaginase was not more toxic than , was similarly efficacious to , and was associated with decreased anxiety compared with intramuscular native E colil-asparaginase , supporting its use as the front-line asparaginase preparation in children with newly diagnosed acute lymphoblastic leukaemia . FUNDING National Cancer Institute and Enzon Pharmaceuticals Much progress has been made in the biological characterization of acute lymphoblastic leukemia ( ALL ) . Many biologic features with prognostic significance have been used together with clinical factors to define patient groups for risk-adapted therapy . However , it is well recognized that the prognostic significance of virtually all variables depends on the type and intensity of treatment . The differences in risk classification , eligibility ( eg upper or lower age limit ) and composition of ethnic or racial population have made it difficult to compare results between study groups . The comparison is further complicated by the inclusion of only subsets of patients in some publications . In October 1985 , an international workshop ( organized by R Mastrangelo ) was held in Rome during which recommendations were made to report study results by common , easily available criteria ( age and presenting leukocyte count ) ; to collect prospect ively information on organ involvement , immunphenotype , genetics and treatment response ; and to use st and ard statistical methods to analyze data .4 Despite this effort , different risk classifications continue to be used , and a large number of clinical trials had been conducted on subgroups of ALL , especially in the USA . In 1993 , the US National Cancer Institute organized a workshop for the US cooperative study groups and major institutions to develop uniform risk criteria . The recommendations published in 19965 were more widely accepted . The major groups defined by age and leukocyte count were identical to that of the Rome workshop ( Table 1 ) . While the importance of cytogenetics and molecular genetics were recognized , they were not included in the risk criteria because the tests were not widely available at that time . BACKGROUND Minimal residual disease ( MRD ) is the most sensitive and specific predictor of relapse risk in children with acute lymphoblastic leukaemia ( ALL ) during remission . We assessed whether treatment intensity could be adjusted for children and young adults according to MRD risk stratification . METHODS Between Oct 1 , 2003 and June 30 , 2011 , consecutive children and young adults ( aged 1 - 25 years ) with ALL from the UK and Irel and were recruited . Eligible patients were categorised into clinical st and ard , intermediate , and high risk groups on the basis of a combination of National Cancer Institute ( NCI ) criteria , cytogenetics , and early response to induction therapy , which was assessed by bone marrow blast counts taken at days 8 ( NCI high-risk patients ) and 15 ( NCI st and ard-risk patients ) after induction began . Clinical st and ard-risk and intermediate-risk patients were assessed for MRD . Those classified as MRD low risk ( undetectable MRD at the end of induction [ day 29 ] or detectable MRD at day 29 that became undetectable by week 11 ) were r and omly assigned to receive one or two delayed intensification courses . Patients had received induction , consolidation , and interim maintenance therapy before they began delayed intensification . Delayed intensification consisted of pegylated asparaginase on day 4 ; vincristine , dexamethasone ( alternate weeks ) , and doxorubicin for 3 weeks ; and 4 weeks of cyclophosphamide and cytarabine . Computer r and omisation was done with stratification by MRD result and balancing for sex , age , and white blood cell count at diagnosis by method of minimisation . Patients , clinicians , and data analysts were not masked to treatment allocation . The primary outcome was event-free survival ( EFS ) , which was defined as time to relapse , secondary tumour , or death . Our aim was to rule out a 7 % reduction in EFS in the group given one delayed intensification course relative to that given two delayed intensification courses . Analyses were by intention to treat . This trial is registered , number IS RCT N07355119 . FINDINGS Of 3207 patients registered in the trial overall , 521 MRD low-risk patients were r and omly assigned to receive one ( n=260 ) or two ( n=261 ) delayed intensification courses . Median follow-up of these patients was 57 months ( IQR 42 - 72 ) . We recorded no significant difference in EFS between the group given one delayed intensification ( 94·4 % at 5 years , 95 % CI 91·1 - 97·7 ) and that given two delayed intensifications ( 95·5 % , 92·8 - 98·2 ; unadjusted odds ratio 1·00 , 95 % CI 0·43 - 2·31 ; two-sided p=0·99 ) . The difference in 5-year EFS between the two groups was 1·1 % ( 95 % CI -5·6 to 2·5 ) . 11 patients ( actuarial relapse at 5 years 5·6 % , 95 % CI 2·3 - 8·9 ) given one delayed intensification and six ( 2·4 % , 0·2 - 4·6 ) given two delayed intensifications relapsed ( p=0·23 ) . Three patients ( 1·2 % , 0 - 2·6 ) given two delayed intensifications died of treatment-related causes compared with none in the group given one delayed intensification ( p=0·08 ) . We recorded no significant difference between groups for serious adverse events and grade 3 or 4 toxic effects ; however , the second delayed intensification course was associated with one ( < 1 % ) treatment-related death , and 74 episodes of grade 3 or 4 toxic effects in 45 patients ( 17 % ) . INTERPRETATION Treatment reduction is feasible for children and young adults with ALL who are predicted to have a low risk of relapse on the basis of rapid clearance of MRD by the end of induction therapy . FUNDING Medical Research Council and Leukaemia and Lymphoma Research BACKGROUND To evaluate if dissolution of asparaginase in lidocaine can relieve pain of an intramuscular injection in children without changes in bioavailability . PROCEDURE The study was design ed as a double-blinded study , \n Output:\n " }, { "from": "agent", "value": "The fixed effects pooled odds ratio after adjusting for publication bias was 2.49 ( 95 % CI 1.62 - 3.83 ) , indicating a significantly higher risk of hypersensitivity for IV over IM PEG-ASP .\nAlthough administering PEG-ASP through IV is preferable for patients , it poses a significantly higher risk of hypersensitivity when compared with IM administration , especially for HR patients ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: OBJECTIVE Substantiated cases of child sexual abuse ( CSA ) in the United States have declined significantly over the past decade . This may , or may not , reflect change in the underlying rate in the general population . This study examines age-cohort differences in the prevalence of self-reported CSA experiences of men and women aged 18 - 59 years in a community-based sample from a comparable western nation . METHOD In April 2000 , we completed a cross-sectional , telephone-based survey of a r and omly selected national sample of men and women in Australia . Volunteers ( 876 males , 908 females ) answered a range of questions about health status and sexuality , including unwanted sexual experiences before the age of 16 years . Of selected adults with publicly-listed telephone numbers , 61 % agreed to participate . There were few differences between the volunteers and the Australian population on demographic variables and health indicators . RESULTS Non-penetrative CSA was twice as common among women ( 33.6 % ) than men ( 15.9 % ) . Approximately 12 % of women and 4 % of men reported unwanted penetrative experiences . CSA was reported significantly less often by younger males , with a linear decline from the oldest to youngest men . Among all females who had intercourse before age 16 , older women were much more likely than younger women to say they were an unwilling partner on the first occasion . If first intercourse occurred at age 16 or later , there were no age-cohort differences in risk of first-time abuse . Self-reported \" openness \" and \" comfort \" during the telephone interviews was not systematic ally related to prevalence of CSA . CONCLUSION These population -based findings provide evidence of a decline in the underlying rate of CSA in Australia . Although every measure of CSA inevitably is flawed to some extent , these trends in self-report complement official statistics that show substantial decline in recent years OBJECTIVES This study examined the extent to which being abused and /or neglected in childhood increases a person 's risk for promiscuity , prostitution , and teenage pregnancy . METHODS A prospect i ve cohorts design was used to match , on the basis of age , race , sex , and social class , cases of abused and /or neglected children from 1967 to 1971 with nonabused and nonneglected children ; subjects were followed into young adulthood . From 1989 to 1995 1196 subjects ( 676 abused and /or neglected and 520 control subjects were located and interviewed . RESULTS Early childhood abuse and /or neglect was a significant predictor of prostitution for females ( odds ratio [ OR ] = 2.96 ) . For females , sexual abuse ( OR = 2.54 ) and neglect ( OR = 2.58 ) were associated with prostitution , whereas physical abuse was only marginally associated . Childhood abuse and neglect were not associated with increased risk for promiscuity or teenage pregnancy . CONCLUSIONS These findings strongly support a relationship between childhood victimization and subsequent prostitution . The presumed causal sequence between childhood victimization and teenage pregnancy may need to be reevaluated Childhood sexual and physical abuse have been linked to adolescent and adult risky sexual behaviors , including early sexual debut , an increased number of sexual partners , unprotected sex , alcohol and drug use during sex and sexual violence . This paper explores these relationships among both men and women who report histories of childhood abuse from representative sample s of communities in three countries in southern and eastern Africa ( South Africa , Zimbabwe and Tanzania ) . Data were collected as part of a 3-year r and omized community trial to rapidly increase knowledge of HIV status and to promote community responses through mobilisation , mobile testing , provision of same-day HIV test results and post-test support for HIV . The results indicate that reported childhood sexual and physical abuse is high in all three setting s , also among men , and shows strong relationships with a range of sexual risk behaviors , including age at first sex ( OR −0.6 ( CI : −0.9 , −0.4 , p < 0.003)—among men , OR −0.7 ( CI : −0.9 , −0.5 , p < 0.001)—among women ) , alcohol ( OR 1.43 ( CI : 1.22 , 1.68 , p < 0.001)—men , OR 1.83 ( CI : 1.50 , 2.24 , p < 0.001)—women ) and drug use ( OR 1.65 ( CI : 1.38 , 1.97 , p < 0.001)—men , OR 3.14 ( CI : 1.95 , 5.05 , p < 0.001)—women ) and two forms of partner violence — recent forced sex ( OR 2.22 ( CI : 1.66 , 2.95 , p < 0.001)—men , OR 2.76 ( CI : 2.09 , 3.64 , p < 0.001)—women ) and ever being hurt by a partner ( OR 3.88 ( CI : 2.84 , 5.29 , p < 0.001)—men , OR 3.06 ( CI : 2.48 , 3.76 , p < 0.001)—women ) . Individuals abused in childhood comprise between 6 and 29 % of young adult men and women living in these African setting s and constitute a population at high risk of HIV infection Low self-esteem and depression are strongly correlated in cross-sectional studies , yet little is known about their prospect i ve effects on each other . The vulnerability model hypothesizes that low self-esteem serves as a risk factor for depression , whereas the scar model hypothesizes that low self-esteem is an outcome , not a cause , of depression . To test these models , the authors used 2 large longitudinal data sets , each with 4 repeated assessment s between the ages of 15 and 21 years and 18 and 21 years , respectively . Cross-lagged regression analyses indicated that low self-esteem predicted subsequent levels of depression , but depression did not predict subsequent levels of self-esteem . These findings held for both men and women and after controlling for content overlap between the self-esteem and depression scales . Thus , the results supported the vulnerability model , but not the scar model , of self-esteem and depression OBJECTIVE This article examined links between childhood maltreatment and risky sexual behavior ( early sexual contact , promiscuity , prostitution ) and HIV in adulthood . DESIGN Using a prospect i ve cohort design , physically and sexually abused and neglected children ( ages 0 - 11 ) with documented cases during 1967 - 1971 were matched with nonmaltreated children and followed into adulthood . MAIN OUTCOME MEASURES Early sexual contact , promiscuity , and prostitution were assessed through in-person interviews and official records ( prostitution ) at approximate age 29 ( N=1196 ) . HIV tests were conducted at approximate age 41 ( N=631 ) . RESULTS Child maltreatment was associated with prostitution ( OR=2.47 , 95 % CI=1.35 - 4.50 ) and early sexual contact ( OR=1.73 , 95 % CI=1.24 - 2.40 ) . Prevalence of HIV in the abuse/neglect group was twice that in controls ( OR=2.35 , 95 % CI=.64 - 8.62 ) , although this difference did not reach conventional levels of statistical significance . SEM provided significant support for a model linking child abuse and neglect to prostitution through early sexual contact and a marginal link to HIV through prostitution . CONCLUSION These findings provide prospect i ve evidence that maltreated children are more likely to report sexual contact before age 15 , engage in prostitution by young adulthood , and test positive for HIV in middle adulthood BACKGROUND Cross-sectional studies have shown that intimate partner violence and gender inequity in relationships are associated with increased prevalence of HIV in women . Yet temporal sequence and causality have been question ed , and few HIV prevention programmes address these issues . We assessed whether intimate partner violence and relationship power inequity increase risk of incident HIV infection in South African women . METHODS We did a longitudinal analysis of data from a previously published cluster-r and omised controlled trial undertaken in the Eastern Cape province of South Africa in 2002 - 06 . 1099 women aged 15 - 26 years who were HIV negative at baseline and had at least one additional HIV test over 2 years of follow-up were included in the analysis . Gender power equity and intimate partner violence were measured by a sexual relationship power scale and the WHO violence against women instrument , respectively . Incidence rate ratios ( IRRs ) of HIV acquisition at 2 years were derived from Poisson models , adjusted for study design and herpes simplex virus type 2 infection , and used to calculate population attributable fractions . FINDINGS 128 women acquired HIV during 2076 person-years of follow-up ( incidence 6.2 per 100 person-years ) . 51 of 325 women with low relationship power equity at baseline acquired HIV ( 8.5 per 100 person-years ) compared with 73 of 704 women with medium or high relationship power equity ( 5.5 per 100 person-years ) ; adjusted multivariable Poisson model IRR 1.51 , 95 % CI 1.05 - 2.17 , p=0.027 . 45 of 253 women who reported more than one episode of intimate partner violence at baseline acquired HIV ( 9.6 per 100 person-years ) compared with 83 of 846 who reported one or no episodes ( 5.2 per 100 person-years ) ; adjusted multivariable Poisson model IRR 1.51 , 1.04 - 2.21 , p=0.032 . The population attributable fractions were 13.9 % ( 95 % CI 2.0 - 22.2 ) for relationship power equity and 11.9 % ( 1.4 - 19.3 ) for intimate partner violence . INTERPRETATION Relationship power inequity and intimate partner violence increase risk of incident HIV infection in young South African women . Policy , interventions , and programmes for HIV prevention must address both of these risk factors and allocate appropriate re sources . FUNDING National Institute of Mental Health and South African Medical Research Council Recent reports of sexually transmitted infection-rate increases among men indicate the need for renewed study of male sexual risk behavior to aid development of up date d and novel risk reduction interventions . Men who have childhood sexual abuse ( CSA ) histories consistently report frequent sexual risk behavior . The objective of this sturdy is to explore whether posttraumatic stress disorder ( PTSD ) and depression are moderators and /or mediators of the association between CSA and sexual risk in adult men . A cross-sectional survey study employing r and om digit dial recruitment was administered to men aged 18–49 years from Philadelphia County . Two bundred ninety eight men were recruited and screened for CSA history , administered items from the Posttraumatic Stress Diagnostic Scale ( PDS ) and Center for Epidemiologic Studies —Depression ( CES-D ) , and asked to estimate their number of lifetime sexual partners ( LSPs ) . Effects of sociodemographic characteristics , CSA , PTSD , and depression on the number of LSPs were modeled using Poisson regression . Results show that 197 ( 66 % ) men participated ; 43 ( 22 % ) had CSA histories . CSA was significantly associated with PTSD/depression ( P=.03 ) . Four sociodemographic variables ( age , race , sexual identity , and education ) , CSA ( incidence rate ratio , IRR=1.47 , P<.001 ) , PTSD ( IRR=1.19 , P=.04 ) , depression ( IRR=1.29 , P=.001 ) , all 2-way interactions , and the 3-way CSA/PTSD/depression interaction ( IRR=11.00 , P<.001 ) were associated with the number of LSPs ( R2=0.27 ) . In conclusion , sexual partnership patterns unique to men with CSA histories and comorbid PTSD/depression appear to lead to substantially higher numbers of LSPs . Estimates of this relationship may have been biased toward the null by underreporting that can occur with phone surveys . Cross-sectional studies do not support causal inferences ; however , the identification of a moderating and mediating influence of PTSD/depression on the relationship between CSA and sexual risk behavior is important and suggests the need for future studies with larger sample s that examine trajectories for CSA , psychiatric illness , and sexual partnerships This study examined the comparability and predictive validity of three approaches to the measurement of child maltreatment . Adolescents ( N = 160 , aged 11 - 17 ) were r and omly selected from the open caseload of a child protection agency . Global ratings of maltreatment severity were made by three reporting sources : research ers on the basis of protection agency case files , protection agency social workers , and the adolescents themselves . Ratings were made of five types of maltreatment : physical , sexual , emotional , neglect , and exposure to family violence . Self-reported ( YSR ) and caretaker-reported ( CBCL ) adjustment measures were also obtained for each subject . Results indicated that over 90 % of the sample had experienced more than one type of maltreatment . Comparison of ratings across sources indicated considerable disagreement with respect to judgments of maltreatment occurrence and severity . Relative to professional ratings , adolescent ratings were better predictors of externalizing and internalizing symptomatology in both univariate and multivariate analyses OBJECTIVE Two distinct \n Output:\n " }, { "from": "agent", "value": "There was a similar association between childhood sexual abuse in general and subsequent risky sexual behaviors in both females and males .\nThere were nonsignificant overall and subgroup differences between males and females .\nChildhood sexual abuse is a significant risk factor for a syndemic of risky sexual behaviors and the magnitude is similar both in females and males ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: OBJECTIVE This study was undertaken to compare outcomes after anterior colporrhaphy with and without a solvent dehydrated cadaveric fascia lata graft . STUDY DESIGN A total of 162 women were enrolled in a prospect i ve , r and omized trial that evaluated the impact of a solvent dehydrated cadaveric fascia lata patch on recurrent anterior vaginal prolapse . Subjects were r and omly assigned to st and ard colporrhaphy with or without a patch . Before and after surgery , subjects were evaluated by both the Baden-Walker and pelvic organ prolapse quantification systems . \" Failure \" was defined as stage II anterior wall prolapse or worse . RESULTS Of 154 women r and omly assigned ( 76 patch : 78 no patch ) , all underwent surgery and 153 ( 99 % ) returned for follow-up . Sixteen women ( 21 % ) in the patch group and 23 ( 29 % ) in the control group experienced recurrent anterior vaginal wall prolapse ( P = .229 ) . Only 26 % of all recurrences were symptomatic . Concomitant transvaginal Cooper 's ligament sling procedures were associated with a dramatic decrease in recurrent prolapse ( odds ratio [ OR ] 0.105 , P < .0001 ) . CONCLUSION Solvent dehydrated fascia lata as a barrier does not decrease recurrent prolapse after anterior colporrhaphy . Transvaginal bladder neck slings were associated with a significant reduction in the risk of recurrent anterior wall prolapse Introduction and hypothesisThe objective of this study was to assess the effect of the tension-free vaginal mesh ( Prolift ™ ) procedure on the non-treated and initially unaffected vaginal compartments . Methods This prospect i ve observational cohort study involved 150 patients who underwent a Prolift ™ procedure . Pelvic organ prolapse ( POP ) quantification and evaluation of prolapse symptoms with vali date d question naires was performed pre-operatively and 6 and 12 months postoperatively . Primary outcome was the rate of POP stage ≥II in the non-treated vaginal compartments . Results Twenty-three percent of all patients developed a de novo POP stage ≥II in the untreated compartment . This occurred in 46 % and 25 % of patients after an isolated anterior and isolated posterior Prolift ™ , respectively . Conclusion Tension-free vaginal mesh treatment of one vaginal compartment seems to provoke the development of vaginal prolapse in initially unaffected vaginal compartments , particularly after an isolated anterior Prolift ™ procedure OBJECTIVES This prospect i ve , r and omised study investigated whether a prophylactic procedure , performed during colposacropexy for prolapse repair , prevents ex novo postoperative incontinence . Sixty-six consecutive continent patients with advanced prolapse were r and omised into two groups : group A underwent sacropexy combined with a Burch colposuspension ; no anti-incontinence procedure was performed in group B patients . METHODS Work-up included clinical assessment ( Halfway System and International Continence Society [ ICS ] classification for prolapse and Ingelman Sunderberg scale for incontinence ) , the Urogenital Distress Inventory and Impact Incontinence Quality of Life question naires , urogynaecologic ultrasound scans , and complete urodynamic testing that included the urethral pressure profile and Valsalva leak point pressure with reduced prolapse . Check-ups were done at 3 , 6 , 12 mo postoperatively and then yearly . Mean follow-up time was 39.5 mo . RESULTS The mean age ( + /- st and ard deviation ) was 62+/-9 yr . All patients presented with grade ( G ) 3 - 4 prolapse . Postoperative incontinence was present in 12 of the 34 patients in group A : 7 G1 ; 4 G2 , and 1 G3 . Postoperative incontinence was present in 3 of the 32 patients in group B : 2 G1 , 1 G3 . The frequency of postoperative incontinence was significantly greater in patients who had undergone colposuspension ( p<0.05 ) . CONCLUSIONS These preliminary data cast doubt on whether colposuspension should be performed during sacropexy for severe urogenital prolapse as prophylaxis for postoperative incontinence because it seems to emerge as overtreatment . Incontinence developed ex novo in 35 % of continent patients treated with colposuspension combined with sacropexy Introduction and hypothesisThe surgical management of multi-compartment prolapse is challenging and often requires a combination of techniques . This study evaluates anterior vaginal mesh repair , sacrospinous hysteropexy and posterior fascial plication in women with anterior compartment dominated uterovaginal prolapse . Methods Consecutive women who underwent the aforementioned surgery were prospect ively evaluated . Main outcome measures included objective ( pelvic organ prolapse quantification stage < 2 ) and subjective success rates , patient satisfaction , functional outcomes and complications . Results One hundred and seventeen women were eligible , and 100 agreed to participate . At 12 months , objective success rate at the anterior compartment was 87 % and at all compartments , 75 % . Subjective success was 84 % , and mean patient satisfaction was 8.5/10 . There were no stage 3 or 4 recurrences at any site . Conclusions The combination of anterior vaginal mesh , sacrospinous hysteropexy and posterior fascial plication is reasonably effective in restoring the anatomy and achieving favourable bladder , bowel and sexual function OBJECTIVE To compare changes in urinary symptoms before and after pelvic organ prolapse ( POP ) surgery , using either laparoscopic sacrocolpopexy ( LSC ) or transvaginal porcine dermis hammock placement with sacrospinous ligament suspension ( VS ) . MATERIAL S AND METHODS Data were prospect ively collected from all women undergoing POP surgery between May 2001 and October 2009 . Pre- and postoperative urinary symptoms , Urinary Distress Inventory ( UDI ) , and Urinary Impact Question naires ( UIQ ) scores were compared within and between groups . A generalized linear model was used for multivariate analysis . RESULTS Out of the 151 patients included , 87 patients underwent LSC , and 64 VS . Overall , after a median follow-up of 32.4 months , POP surgery improved urinary frequency ( P = 0.006 ) , voiding difficulty ( P = 0.001 ) , stress urinary incontinence ( SUI ) ( P = 0.001 ) , but not urgency ( P = 0.29 ) . VS was more effective in treating SUI ( P < 0.001 vs. 0.52 ) while LSC more effective on voiding difficulty ( P = 0.01 vs. 0.08 ) . Postoperative de novo symptoms were observed in 35.8 % of patients with no difference between the groups ( P = 0.06 ) . UDI ( P = 0.04 ) and UIQ ( P = 0.01 ) scores were significantly lower after surgery . However , LSC significantly improved UDI ( P = 0.03 ) with no effect on UIQ ( P = 0.29 ) scores while VS significantly improved both scores ( P = 0.02 and 0.001 , respectively ) . Upon multivariate analysis , only the improvement in the impact of urinary symptoms on daily living was independently associated to VS ( OR = 5.45 [ 95 % confidence interval 2.20 - 13.44 ] , P = 0.01 ) . CONCLUSION Most preoperative urinary symptoms decreased after POP surgery with equivalent proportion of de novo symptoms after vaginal and laparoscopic approaches OBJECTIVE The purpose of this study was to compare 2 anti-incontinence procedures in women who had severe genital prolapse and potential stress incontinence . STUDY DESIGN In addition to vaginal reconstructive surgery , 50 patients with stage II or higher anterior defect and a positive stress test result with prolapse reduction received either tension-free vaginal tape or plication of the endopelvic fascia . Preoperative evaluation included history , physical examination , stress test , and urodynamic assessment . Data were analyzed with the Student t test , the Fisher 's exact test , and the Wilcoxon signed-rank test . RESULTS The median follow-up time was similar for both groups , 26 and 24 months . Subjective ( 96 % vs 64 % ; P=.01 ) and objective ( 92 % vs 56 % ; P<.01 ) continence rates were higher after the tension-free vaginal tape procedure . Time for the resumption of spontaneous voiding , rates of urinary retention , or de novo urge incontinence were similar in the 2 groups . CONCLUSION Tension-free vaginal tape can be recommended for patients with prolapse and occult stress incontinence OBJECTIVE Polypropylene mesh in the treatment of genital prolapse in women was introduced at the turn of the millennium with the rationale of decreasing surgical invasiveness , reinforcing weak tissues and to possibly complement insufficient surgical techniques . Prospect i ve r and omized studies comparing traditional and modern operations are lacking . SUBJECT Prospect i ve multicentre r and omized study . SETTING Department of Obstetrics and Gynaecology , The First Faculty of Medicine , Charles University in Prague . SUBJECT AND METHOD A prospect i ve multicentre trial was approved by the Ministry of Health of the Czech Republic and registered with the FDA planning to recruit 500 patients with vaginal prolapse , 18 years of age and over , undergoing surgery at 5 major urogynaecologic centres . The patients were divided into three groups according to prolapse predominance . The surgical techniques used were : anterior and posterior prolift , and r and omly allocated total prolift or sacrospinous fixation . The examination setup included lower urinary tract ultrasound , MRI , POP-Q assessment and QoL question naires before surgery and six and 24 month after the surgery . CONCLUSION Preliminary analysis of partial data of 225 women showed an acceptable rate of complications and a better success rate in the mesh groups , whereas operation time and blood loss was lower in the classical operation group . Quality of life question naires documented that all the methods used have comparably good results . The surgical techniques used are acceptable methods for pelvic organ prolapse repair with low complication rates and excellent impact on the subjective perception of the patient 's quality of life Introduction and hypothesisEndoFast Reliant ™ system is a novel technology for pelvic organ prolapse ( POP ) repair that attaches mesh directly with metal fasteners . Methods This was a prospect i ve multicenter study in 20 women who underwent vaginal POP repair to evaluate safety and efficacy . The patients were followed for 12 months , using POP-Q measures , question naires on symptoms ( PFDI ) , and sexual function ( FSFI ) . Results No intraoperative complications occurred . Prolapse has been anatomically resolved ( < stage 2 ) in 85 % at 1-year follow-up ( 17/20 patients ) . Pelvic Floor Distress Inventory ( PFDI ) scores showed significant improvement for 1 year in symptoms related to prolapse ( 4.1–0.7 , p < 0.001 ) and bladder ( 1.4–0.7 , p = 0.06 ) but not to rectum . Female Sexual Function Index ( FSFI ) scores did not change significantly . One case of mesh exposure was found ( 5 % ) and treated conservatively . No migration of fasteners was observed on X-ray . Conclusions The EndoFast Reliant ™ system was found safe and efficacious . Future studies are needed to evaluate its advantages over techniques using trocars Introduction and hypothesisThe optimal duration of urethral catheterization during and after pelvic reconstructive surgery is not established . This study investigated the optimal duration of urinary catheterization in patients undergoing anterior vaginal repair with or without other vaginal surgeries . Methods A total of 90 patients were included from April 2007 to March 2008 . They were r and omly divided into 2 , 3 , and 4 days urinary catheterization groups based on the color of the question naire papers they blindly chose . After catheter removal , the amount of post-void residual urine was used to measure the efficacy of bladder emptying . Differences between groups were determined using Chi-square test , Fisher 's exact test , or Kruskal – Wallis test , as appropriate . Results No significant differences were found in the amount of post-void residual urine between the three catheterization groups . Conclusions Our findings suggest that the duration of urethral catheterization after anterior colporrhaphy need not exceed 2 days Introduction and hypothesisVaginal mesh kits are increasingly used in the management of pelvic organ prolapse . This study aim ed to determine similarity of outcomes of the Anterior Prolift ® with Perigee ® systems for anterior compartment prolapse . Methods Consecutive women undergoing Perigee ® or Anterior Prolift ® for symptomatic stage 2 or greater anterior vaginal prolapse were prospect ively evaluated . Main outcome measures included objective and subjective success rates , perioperative outcomes , patient satisfaction , and complications . Results One hundred and six women ( Prolift , 52 ; Perigee , 54 ) completed question naires , and 91 ( Prolift , 46 ; Perigee , 45 ) were examined postoperatively . At follow-up ( Prolift : median , 11.0 ; range , 5–23 months ; Perigee : median , 11.5 ; range , 6–23 months ) , objective success rates ( Prolift , 89 % ; Perigee , 80 % ; p = 0.23 ) , subjective success rates ( Prolift , 94 % ; Perigee , 96 % ; \n Output:\n " }, { "from": "agent", "value": "Results Continent women undergoing anterior compartment prolapse surgery have a lower rate of de novo stress urinary incontinence ( SUI ) after anterior repair than armed mesh procedures ( grade A ) .\nData are conflicting on whether colposuspension should be performed prophylactically in continent women undergoing sacral colpopexy ( grade C ) .\nNo clear conclusion can be made regarding the management of continent women undergoing prolapse surgery without occult SUI .\nIn continent women undergoing POP surgery with occult SUI the addition of continence surgery reduces the rate of postoperative SUI ( grade A ) .\nIn women with prolapse and SUI symptoms prolapse procedures alone ( transobturator mesh and anterior repair ) are associated with low success rates for SUI .\nConcomitant continence procedures reduce the risk of postoperative SUI ( grade B ) ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: BACKGROUND The treatment of chronic leg ulcers remains a stubborn problem in many patients . Topical 2 % ketanserin ointment , a 5HT2-serotoninergic blocking agent , has been reported to improve healing of decubitus , venous , diabetic and ischaemic ulcers . METHOD The present double-blind intra-individual comparative study was performed in 12 women with diabetes presenting with at least two similar leg ulcers . In each subject , the two lesions were r and omly assigned to be treated for 8 weeks by 2 % ketanserin ointment or its unmedicated vehicle . OBJECTIVE assessment s of the dynamics of wound healing were performed using computerized morphometry . Evaluations were performed at 2-week intervals for 8 weeks . RESULTS A significant decrease in relative wound area was observed on the ketanserin-treated ulcers compared with the placebo group . CONCLUSION Topical ketanserin is a valuable therapy for difficult-to-treat leg ulcers OBJECTIVE : A r and omized controlled trial to evaluate the effectiveness of a polyhexamethylene biguanide ( PHMB ) foam dressing compared with a similar non-antimicrobial foam for the treatment of superficial bacterial burden , wound-associated pain , and reduction in wound size . SETTING AND PARTICIPANTS : This study was conducted in 2 wound healing clinics-a university hospital-based clinic and a community-based clinic . Forty-five chronic wound subjects , stratified to either foot or leg ulcers , were followed for 5 weeks . METHODS : A multicenter , prospect i ve , double-blind , pilot , r and omized controlled clinical trial with 3 study visits ( Weeks 0 , 2 , 4 ) documented pain and local wound characteristics using NERDS and STONEES clinical criteria to determine superficial bacterial damage or deep/surrounding infection . RESULTS : The use of PHMB foam dressing was a significant predictor of reduced wound superficial bacterial burden ( P = .016 ) at week 4 as compared with the foam alone . Pain reduction was also statistically significant at week 2 ( P = .0006 ) and at week 4 ( P = .02 ) in favor of the PHMB foam dressings . Polymicrobial organisms were recovered at week 4 in 5.3 % in the PHMB foam dressing group versus 33 % in the control group ( P = .04 ) . Subjects r and omized to the PHMB foam dressing had a 35 % median reduction in wound size by week 4 , compared with 28 % in the control group . CONCLUSIONS : PHMB foam dressing successfully reduced chronic wound pain and bacterial burden Chronic skin ulcers such as diabetic ulcers and venous leg ulcers are increasing and are a costly problem in healthcare . We have developed a novel artificial dermis , collagen/gelatin sponge ( CGS ) , which is capable of sustained release of basic fibroblast growth factor ( bFGF ) for more than 10 days . The objective of this study was to investigate the safety and efficacy of CGS impregnated with bFGF in the treatment of chronic skin ulcers . Patients with chronic skin ulcers that had not healed in at least 4 weeks were treated with CGS impregnated with bFGF at 7 or 14 μg/cm(2 ) after debridement , and the wound bed improvement was assessed 14 days after application . Wound bed improvement was defined as a granulated and epithelialized area on day 14 with a proportion to the baseline wound area after debridement of 50 % or higher . The wound area , the wound area on day 14 , and the granulation area on day 14 were independently measured by blinded review ers in a central review using digital images of wounds taken with a calibrator . Patients were followed up until 28 days after application to observe the adverse reactions related to the application of CGS . From May 2010 to June 2011 , 17 patients were enrolled and , in 16 patients , the wound bed improved . Among the r and omized patients in step 2 , no significant difference was seen between the low-dose group and the high-dose group . No serious adverse reactions were observed . Adverse reactions with a clear causal relationship to the study treatment were mild and patients quickly recovered from them . This study is the first-in-man clinical trial of CGS and showed the safety and efficacy of CGS impregnated with bFGF in the treatment of chronic skin ulcers . This combination therapy could be a promising therapy for chronic skin ulcers OBJECTIVE To assess whether topical morphine is pharmacologically effective in relieving pain from ulcers caused by arterial insufficiency and identify whether this effect is central ly or peripherally mediated . METHOD The analgesic effect of a topically applied hydrogel containing 0.5 % of morphine was evaluated in a double-blind , placebo-controlled , three-way crossover pilot study involving nine patients with painful arterial leg ulcers . All patients had a baseline pain intensity of at least 5 on a 10-point numeric rating scale . They received the following three treatments in r and om order : morphine hydrogel plus a subcutaneous ( SC ) placebo infusion ; placebo gel plus a SC infusion of 5 mg morphine over six hours and a placebo gel plus a SC placebo infusion . Each treatment lasted one day . Pain was assessed during the first 24 hours after application of the hydrogel and the start of the subcutaneous infusion . RESULTS There was a statistically significant difference between average baseline pain scores and those reported during treatment , but this difference was not clinical ly relevant . The three treatments did not differ in terms of the pain relief provided . CONCLUSION Topical morphine does not have a clinical ly relevant analgesic effect in patients with painful arterial leg ulcers . Further research should focus on ulcers of other aetiology OBJECTIVE To determine the healing effect of topical becaplermin gel vs hydrogel dressing on hypertensive leg ulcers . DESIGN R and omized , double-blind , parallel-assignment , controlled study . SETTING Ambulatory or hospitalized patients from 17 dermatology departments . PATIENTS Among 64 consecutive r and omized patients with 1 or more hypertensive leg ulcers who fulfilled all inclusion criteria , 59 received the allocated intervention , and findings were analyzed . INTERVENTION Becaplermin gel ( human recombinant platelet-derived growth factor-BB , 0.1 % , in hydrogel ) or hydrogel dressing was applied , both in doses of 1 cm/cm(2 ) , once daily for 8 weeks . Follow-up continued for 4 weeks beyond the final gel application . MAIN OUTCOME MEASURES The primary end point was complete wound closure rate after 8 weeks of treatment . Secondary end points were percentages of patients with complete wound closure at week 12 ; changed ulcer area after treatment vs baseline ; and changed ulcer-related pain and health-related quality of life during the study . RESULTS Complete wound closure rates were comparable after 8 weeks for becaplermin ( 5 of 28 patients ) and hydrogel ( 3 of 31 patients ) ( 8 percentage-point difference ; 95 % confidence interval , -10 % to 26 % ) . No statistically significant differences were observed between the 2 groups for percentages of complete closure at week 12 , changed ulcer area at week 8 , or changed ulcer-related pain and quality of life during the study ( P > .05 for all comparisons ) . CONCLUSIONS Topical becaplermin gel is not superior to hydrogel dressing for hypertensive leg ulcer wound closure . Surgical management by grafting remains the most promising treatment strategy but requires further evaluation . Trial Registration clinical trials.gov Identifier : NCT00970697 BACKGROUND Elase is a widely used ointment consisting of a combination of 2 proteolytic enzymes , fibrinolysin and desoxyribonuclease ( DNAse ) . It is said to promote debridement of necrotic and purulent debris from skin ulcers . OBJECTIVE Our purpose was to assess the efficacy and safety of this ointment and its components in the treatment of chronic ulcers of the lower extremity . METHODS This was a double-blind , r and omized , prospect i ve study of 84 patients with leg ulcers exhibiting necrotic and purulent debris , who were treated for 21 days with twice-daily applications of the ointment , fibrinolysin , DNAse , or who received the ointment vehicle ( placebo ) . We assessed 6 efficacy features : ulcer size , purulent exu date , necrotic tissue , erythema , pain , and overall condition of the lesion at days 8 , 15 , and 21 after initiation of treatment . We also assessed the frequency of adverse effects . RESULTS All treatments produced some improvement in the efficacy parameters and overall condition of the ulcers by week 3 , but no statistically significant difference was found when compared with placebo . No serious adverse effects were noted . A later retrospective re analysis of the data found a statistically significant reduction of purulent exu date only at days 3 and 7 of treatment in the group treated with the complete ointment , but not in the other features . CONCLUSION The proteolytic ointment provides no long-term clinical benefit in reducing purulent exu date , pain , erythema , necrotic tissue , or overall condition of chronic leg ulcers when compared with either of its two components or placebo OBJECTIVE To evaluate the performance ( efficacy , safety and acceptability ) of a new micro-adherent absorbent dressing ( UrgoClean ® ) compared with a hydrofiber dressing ( Aquacel ® ) in the local management of venous leg ulcers , in the debridement stage . METHOD A non-inferiority European r and omised controlled clinical trial ( RCT ) was conducted in 37 centres , on patients presenting with venous or predominantly venous , mixed aetiology leg ulcers at their sloughy stage ( with more than 70 % of the wound bed covered with slough at baseline ) . Patients were followed over a 6-week period and assessed weekly . The primary judgement criteria was the relative regression of the wound surface area after the 6-week treatment period . Secondary endpoints were the relative reduction of sloughy tissue and the percentage of patients presenting with a debrided wound . RESULTS Altogether , 159 patients were r and omised to either UrgoClean ( test group ; n=83 ) or Aquacel ( control group ; n=76 ) dressings . Regarding the wound healing process predictive factors ( wound area , duration , ABPI value , recurrence ) , at baseline , the two groups were well balanced , for both wound and patient characteristics . Compression therapy was administered to both groups and after a median 42-day treatment period , the percentage of relative reduction of the wound surface area was very similar ( -36.9 % vs -35.4 % in the UrgoClean and control groups , respectively ) . When considering the secondary criteria at week 6 , the relative reduction of sloughy tissue was significantly higher in the UrgoClean group than in the control group ( -65.3 % vs -42,6 % ; p=0.013 ) . The percentage of debrided wounds was also significantly higher in the test group ( 52.5 % vs 35.1 % ; p=0.033 ) . CONCLUSION This ' EARTH ' RCT confirmed that the UrgoClean dressing has similar efficacy and safety compared to Aquacel . However , UrgoClean also showed better autolytic properties than the control group in the management of venous leg ulcers at the sloughy stage . The new UrgoClean dressing therefore represents a promising therapeutic option within the current range of autolytic dressings available . DECLARATION OF INTEREST This study was sponsored by a grant from the pharmaceutical company Laboratoires Urgo . S. Bohbot and O. Tacca are employees of Laboratoires Urgo . S. Meaume , J. Dissemond and G. Perceau have received monetary compensation as presenters for Laboratoires Urgo . Data management and statistical analyses were conducted independently by Vertical ( Paris , France ) Abstract Aims / Introduction Dysregulated inflammatory response is believed to be an important factor in the pathogenesis of several late complications of diabetes mellitus . β‐Glucans are potent inducers of immune function . The present r and omized , double blind , two‐center , placebo‐controlled study was undertaken to explore safety , tolerability and efficacy of soluble β‐1,3/1,6‐glucan ( SBG ) as a local treatment of diabetic foot ulcers . Material s and Methods A total of 60 patients with type 1 or 2 diabetes and lower extremity ulcers ( Wagner grade 1–2 , Ankle/Brachial Index ≥0.7 ) received SBG or a comparator product ( methylcellulose ) locally three times weekly up to 12 weeks in addition to conventional management scheme . A total of 54 patients completed the study . Results A tendency for shorter median time to complete healing in the SBG group was observed ( 36 vs 63 days , P = 0.130 ) . Weekly percentage reduction in ulcer size was significantly higher in the SBG group than in the methylcellulose group between weeks 1–2 , 3–4 and 5–6 ( P < 0.05 ) . The proportion of ulcers healed by week 12 was also in favor of SBG ( 59 % vs 37 % , P = 0.09 ) , with a significantly higher healing incidence in the SBG group at week 8 ( 44 % vs 17 % , P = 0.03 ) . SBG was safe and well tolerated . There was a clinical ly significant difference regarding the incidence of serious adverse events in favor of the \n Output:\n " }, { "from": "agent", "value": "There is insufficient evidence to determine whether the choice of topical agent or dressing affects the healing of arterial leg ulcers" } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: We measured energy expenditure ( MREE ) and nitrogen excretion ( UUN ) in patients with severe head injury r and omized to early parenteral ( TPN , n = 21 ) or jejunal ( ENT , n = 27 ) feeding with identical formulations . The MREE rose to 2400 + /- 531 kcal/day in both groups and remained at 135 % + /- 26 % to 146 % + /- 42 % of predicted energy expenditure over 4 weeks . Nitrogen excretion peaked the second week at 33.4 + /- 10 ( TPN ) and 31.2 + /- 7.5 ( ENT ) g N/day . Both routes were equally effective at meeting nutritional goals ( 1.2 x MREE , 2.5 g protein/kg/day intake , stabilized albumin and transferrin levels ) . Infections were equally frequent : 1.86 episodes/TPN patient versus 1.89 episodes/ENT patient . While patient charges were much greater for TPN , the hospital costs were similar for TPN and ENT support regimens . These findings show that patients with head injuries are hypermetabolic for weeks , that only 27 % are capable of spontaneously eating nutritional requirements by discharge , and that either TPN or ENT support is equally effective when prescribed according to individual measurements of MREE and nitrogen excretion BACKGROUND & AIMS Nutritional monitoring of rapid turnover visceral protein is important in the recognition of malnutrition in patients admitted to the Intensive Care Unit ( ICU ) . We studied prealbumin and retinol-binding protein in patients who received three different kinds of artificial nutrition in order to evaluate the appropriateness of artificial nutrition . METHODS 45 consecutive head injury patients received enteral ( Group A ) , parenteral ( Group B ) or both enteral and parenteral nutrition ( Group C ) at r and om . We considered these parameters : prealbumin , retinol binding protein and nitrogen balance before ( T1 ) , after 3 ( T2 ) , 7 ( T3 ) and 11 ( T4 ) days after the beginning of study . Statistical analysis was performed with Kruskal-Wallis test and Bonferroni 's t -test . RESULTS Plasma prealbumin and Retinol binding protein ( RBP ) showed an increasing of basal values during the study period in all groups ( < < 0.0001 ) and more significantly in group A ( Enteral nutrition P < 0 . 001 vs Total parenteral nutrition ( TPN ) and Enteral P < < 0.01 vs Enteral and parenteral nutrition ) . CONCLUSION Data obtained in the present study indicate that a laboratory is essential for monitoring nutritional assessment and for checking the appropriateness of nutritional therapy . We found prealbumin to be the most sensitive measure and found it to be the test of choice for early assessment and intervention BACKGROUND Although early enteral feeding clearly reduces septic morbidity after blunt and penetrating trauma , data for head-injured patients are conflicting . This study examines the effects of early vs delayed enteral feedings on outcome in patients with severe closed-head injuries with a Glasgow Coma Scale ( GCS ) score greater than 3 and less than 11 . METHODS Thirty patients were prospect ively r and omized to receive an immune-enhancing diet ( Impact with fiber ) early ( initiated < 72 hours after trauma ) delivered via an endoscopically placed nasoenteric tube ( Stay-Put ) or late ( administered after gastric ileus resolved ) . This formula was continued for 14 days or until the patient tolerated oral feeding . Goal rate of nutrition was 21 nonprotein cal/kg/d and 0.3 g N/kg/d . RESULTS Two patients in the early group were excluded due to inability to place the tube , and one patient in the late group died before 72 hours . Five of the remaining 27 died , 1 in the early group and 4 in the late group . There were no significant differences between the groups in length of stay , intensive care unit ( ICU ) days , significant infection , or GCS score . However , major infection correlated inversely with admission GCS score ( R = -0.6 , p < .003 ) . Time to reach a GCS score of 14 was significantly longer in patients with significant infections compared with those without ( p < .02 ) . CONCLUSIONS No difference in length of stay or infectious complications is shown in patients with severe closed-head injury when they are given early vs delayed feeding using an immune-enhancing formula . Severity of the head injury is closely associated with significant infection This prospect i ve r and omized controlled clinical trial compares the effects of early parenteral nutrition and traditional delayed enteral nutrition upon the outcome of head-injured patients . Thirty-eight head-injured patients were r and omly assigned to receive total parenteral nutrition ( TPN ) or st and ard enteral nutrition ( SEN ) . Clinical and nutritional data were collected on all patients until death or for 18 days of hospitalization . Survival and functional recovery were monitored in survivors for 1 year . Of the 38 patients , 18 were r and omized to the SEN group and 20 to the TPN group . Demographically , the two groups of patients were similar on admission . There was no significant difference in the severity of head injury between the two groups as measured by the Glasgow Coma Scale ( p = 0.52 ) . The outcome for the two groups was quite different , with eight of the 18 SEN patients dying within 18 days of injury , whereas no patient in the TPN group died within this period ( p less than 0.0001 ) . The basis for the improved survival in the TPN patients appears to be improved nutrition . The TPN patients had a more positive nitrogen balance ( p less than 0.06 ) , and a higher serum albumin level and total lymphocyte count . More adequate nutritional status may have improved the patients ' immunocompetence , result ing in decreased susceptibility to sepsis . The data from this study strongly support the favorable effect of early TPN on survival from head injury Fifty-one brain-injured patients with peak 24-hour admission Glasgow Coma Scale ( GCS ) scores of 4 to 10 were prospect ively r and omly assigned to receive total parenteral ( TPN ) or enteral ( EN ) nutrition . Patients were studied from hospital admission to 18 days postinjury . Outcome was assessed by the Glasgow Outcome Scale at 3 months , 6 months , and 1 year postinjury . The TPN group received a significantly higher cumulative mean intake of protein than the EN group ( mean + /- st and ard error of the mean : 1.35 + /- 0.12 vs. 0.91 + /- 0.9 gm/kg/day ; p = 0.004 ) . Mean cumulative caloric balance was also significantly higher in the TPN than in the EN group ( 75.6 % + /- 5.13 % vs. 59 % + /- 4.26 % ; p = 0.02 ) . Nitrogen balance was significantly more negative in the EN group during the 1st week postinjury ( p = 0.002 ) . The incidence of pneumonia , urinary tract infections , septic shock , and infections was not significantly different between groups . Classic nutritional assessment parameters such as anergy screens , total lymphocyte counts , and albumin levels were not significantly different between groups . The 11 patients in the EN group who did not tolerate tube feedings for 1 week postinjury had a significantly higher incidence of septic shock ( p = 0.008 ) . The change over time in GCS scores between groups was significantly different , with the TPN group showing a mean four-point increase in GCS score compared with a three-point increase in the EN group ( p = 0.02 ) . At 3 months the TPN group had a significantly higher percentage of favorable outcomes ( 43.5 % vs. 17.9 % , respectively ; p = 0.05 ) . At 6 months , 43.5 % of the TPN group had a favorable outcome while 32.1 % of the EN group had a favorable outcome ( p = 0.29 ) . By 1 year , 47.8 % of the TPN group and 32.1 % of the EN group had a favorable outcome ( p = 0.20 ) . In conclusion , more calories and protein usually can be administered to acute brain injury patients via the TPN route than by EN feedings via nasogastric or nasoduodenal routes . Traditional parameters for nutritional assessment are not useful in study ing the efficacy of nutritional support during the first 2 weeks after head injury . Neurological recovery from head injury occurs more rapidly in patients with better early nutritional support OBJECTIVE To compare metabolic , nutritional and epidemiological data in two groups of patients , one receiving total enteral nutrition , via nasoenteric tube , and one receiving both enteral and parenteral nutrition . DESIGN A prospect i ve , r and omized study . SETTING A general ICU , with both medical and surgical patients , in a big regional University and National Health Service hospital . PATIENTS 24 patients requiring Intensive Care after major surgery or because suffering from severe head injury or major neurological impairment . INTERVENTIONS All patients initially received total parenteral nutrition : after 4 days 12 patients were \" weaned \" to total enteral nutrition and 12 stayed on mixed parenteral and enteral nutrition . LABORATORY INVESTIGATIONS AND OBSERVATIONAL DATA : Blood levels of albumin , prealbumin , transferrin , ALT , AST , bilirubin , blood urea , blood glucose , total linfocite count , and nutritional and epidemiological data such as nitrogen balance , calorie intake , diarrhea incidence , blood and sputum cultures and radiologic evidence of pneumonia are analysed . RESULTS At T1 , NET patients were able to reduce their nitrogen losses ( 0.27.1 g/kg + /-0.12 vs 0.35 + /- 0.13 at TO ; p < 0.05 ) and improve nitrogen balance ( -9 + /- 7 vs -2 + /- 6 at T0 ; p < 0.05 ) ; they also had a better total linfocite count ( 2034 + /- 304 vs. 1413 + /- 360 of the MISTA group ; p < 0.05 ) , and a lower incidence of pneumonia as documented by sputum cultures and radiograms . CONCLUSIONS Patients fed with both parenteral and enteral nutrition did no better than those on total enteral nutrition as far as nutritional and metabolic indices were concerned ; they also seemed more prone to infections than those on total enteral nutrition , indicating that mixed nutrition may result in more stable feeding , but this does not seem to have any beneficial nutritional , immunological and metabolic effect A comparative nutritional study in brain-injured patients ( BIP ) was performed to assess the influence of a combined enteral-parenteral nutrition ( CN ) and a total parenteral nutrition ( TPN ) on protein catabolism in the early posttraumatic period . 20 male BIP ( Glasgow coma scale 5–7 ) were r and omized to one of the two feeding regimes . Nutritional support was based on 150–175 % basic energy expenditure . Amino acid intake was 1.4 g/kg/day in the TPN and 2.4 g/kg/day in the CN group . Negative nitrogen balance ( NNB ) averaged x ( SEM=3.06 g/m2/day ) in the TPN group and x ( SEM=2.33 g/m2/day ) in the CN group . Between both feeding regimes not statistically significant differences could be observed concerning mortality , N-balance , creatinine and 3-methylhistidine excretions . Protein concentration of the regurgitated gastric fluid was significantly higher in the CN than in the TPN study group . Data imply that both alimentary regimes are of similar value , but BIP with imparired gastric function , such as high tube reflux , are better treated by TPN Animal investigations suggest that administration of hyperosmolar total parenteral nutrition ( TPN ) solutions may potentiate cerebral edema following head injury . Intravenous nutrition ( TPN ) is often required after head injury due to intolerance to enteral feeding ( EN ) . This study evaluates the effect of TPN on intracranial pressure ( ICP ) measurements in severely brain-injured patients . Ninety-six severely brain-injured patients were r and omly assigned to receive TPN or EN and were studied from hospital admission until 18 days postinjury . The TPN was started within 48 hours postinjury and the EN was started when tolerated . Peak daily ICP was not significantly different on admission and over time ( overall mean + /- st and ard error of the mean 32.01 + /- 1.62 for TPN versus 32.5 + /- 1.25 for EN ) . Intracranial pressure was greater than 20 mm Hg in 75 % of TPN patients and 73 % of EN patients . Conventional therapy failed to control elevated ICP in 36 % of TPN patients and 38 % of EN patients . Of these patients , subsequent barbiturate therapy failed to control ICP in 56 % of TPN patients and 64 % of EN patients . Serum osmolality was not significantly different between groups at admission or over the course of the study . The TPN group tended to have higher mean serum glucose levels for the first 13 days postinjury , while the EN group had a higher mean serum glucose content thereafter , but these differences were not statistically significant . This study shows that TPN \n Output:\n " }, { "from": "agent", "value": "Enteral nutrition : jejunal versus gastric .\nREVIEW ER 'S CONCLUSIONS This review suggests that early feeding may be associated with a trend towards better outcomes in terms of survival and disability ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: Background Little is known about the factors associated with frequency of emergency department visits ( FEDV ) in chronic obstructive pulmonary disease ( COPD ) patients with recurrent exacerbations . Objective To characterize the use of emergency department ( ED ) services in patients with COPD exacerbation and identify factors associated with FEDV . Design A prospect i ve , multicenter cohort study . Patients Three hundred eighty-eight patients were included . Fifty-two percent were women and the median age was 69 years ( interquartile range 62–76 ) . Measurements Using a st and ard question naire , consecutive ED patients with COPD exacerbation were interviewed . The number of ED visits in the previous year was retrospectively collected . Results Over the past year , this cohort reported a total of 1,090 ED visits because of COPD exacerbation . Thirteen percent of COPD patients had 6 or more ED visits , accounting for 57 % of the total ED visits in the past year . Multivariate analysis showed that patients with an increased FEDV were more likely to be Hispanic ( incidence rate ratio [ IRR ] 1.97 , 95 % confidence interval [ CI ] 1.16–3.33 ) , to have more severe COPD as determined by previous hospitalizations ( IRR 2.06 , 95 % CI 1.51–2.82 ) , prior intubations ( IRR 1.49 , 95 % CI 1.02–2.18 ) , prior use of systemic corticosteroids ( IRR 1.57 , 95 % CI 1.16–2.13 ) and methylxanthine ( IRR 1.48 , 95 % CI 1.04–2.12 ) , and less likely to have a primary care provider ( IRR 0.51 , 95 % CI 0.31–0.82 ) . Conclusions Our results suggest that both disease and health care-related factors were associated with FEDV in COPD exacerbation . Multidisciplinary efforts through primary care provider follow-up should be assessed to test the effects on reducing the high morbidity and cost of recurrent COPD exacerbations Pulmonary rehabilitation is beneficial for patients with chronic lung disease . However , long-term maintenance has been difficult to achieve after short-term treatment . We evaluated a telephone-based maintenance program after pulmonary rehabilitation in 172 patients with chronic lung disease recruited from pulmonary rehabilitation graduates . Subjects were r and omly assigned to a 12-month maintenance intervention with weekly telephone contacts and monthly supervised reinforcement sessions ( n = 87 ) or st and ard care ( n = 85 ) and followed for 24 months . Except for a slight imbalance between sexes , experimental and control groups were equivalent at baseline and showed similar improvements after rehabilitation . During the 12-month intervention , exercise tolerance ( maximum treadmill workload and 6-minute walk distance ) and overall health status ratings were better maintained in the experimental group together with a reduction in hospital days . There were no group differences for other measures of pulmonary function , dyspnea , self-efficacy , generic and disease-specific quality of life , and health care use . By 24 months , there were no significant group differences . Patients returned to levels close to but above prerehabilitation measures . We conclude that a maintenance program of weekly telephone calls and monthly supervised sessions produced only modest improvements in the maintenance of benefits after pulmonary rehabilitation It was postulated that home hospitalisation ( HH ) of selected chronic obstructive pulmonary disease ( COPD ) exacerbations admitted at the emergency room ( ER ) could facilitate a better outcome than conventional hospitalisation . To this end , 222 COPD patients ( 3.2 % female ; 71±10 yrs ( mean±sd ) ) were r and omly assigned to HH ( n=121 ) or conventional care ( n=101 ) . During HH , integrated care was delivered by a specialised nurse with the patient 's free-phone access to the nurse ensured for an 8‐week follow-up period . Mortality ( HH : 4.1 % ; controls : 6.9 % ) and hospital readmissions ( HH : 0.24±0.57 ; controls : 0.38±0.70 ) were similar in both groups . However , at the end of the follow-up period , HH patients showed : 1 ) a lower rate of ER visits ( 0.13±0.43 versus 0.31±0.62 ) ; and 2 ) a noticeable improvement of quality of life ( Δ St George 's Respiratory Question naire ( SGRQ ) , −6.9 versus −2.4 ) . Furthermore , a higher percentage of patients had a better knowledge of the disease ( 58 % versus 27 % ) , a better self-management of their condition ( 81 % versus 48 % ) , and the patient 's satisfaction was greater . The average overall direct cost per HH patient was 62 % of the costs of conventional care , essentially due to fewer days of inpatient hospitalisation ( 1.7±2.3 versus 4.2±4.1 days ) . A comprehensive home care intervention in selected chronic obstructive pulmonary disease exacerbations appears as cost effective . The home hospitalisation intervention generates better outcomes at lower costs than conventional care Background Hospital readmission for acute exacerbation of COPD ( AE COPD ) occurs in up to 30 % of patients , leading to excess morbidity and poor survival . Physiological risk factors predict readmission , but the impact of modifiable psychosocial risk factors remains uncertain . We aim ed to evaluate whether psychosocial risk factors independently predict readmission for AE COPD in patients referred to early discharge services ( EDS ) . Methods This prospect i ve cohort study included 79 patients with AE COPD cared for by nurse led EDS in the UK , and followed up for 12 months . Data on lung function , medical comorbidities , previous hospital admissions , medications , and sociodemographics were collected at baseline ; St George 's Respiratory Question naire ( SGRQ ) , Hospital Anxiety and Depression Scale ( HADS ) , and social support were measured at baseline , 3 and 12-months . Exploratory multivariate models were fitted to identify psychosocial factors associated with readmission adjusted for known confounders . Results 26 patients were readmitted within 90 days and 60 patients were readmitted at least once during follow-up . Depression at baseline predicted readmission adjusted for sociodemographics and forced expiratory volume in 1 second ( odds ratio 1.30 , 95 % CI 1.06 to 1.60 , p = 0.013 ) . Perceived social support was not significantly associated with risk of readmission . Home ownership was associated with the total number of readmissions ( B = 0.46 , 95 % CI -0.86 to -0.06 , p = 0.024 ) . Compared with those not readmitted , readmitted patients had worse SGRQ and HADS scores at 12 months . Conclusion Depressive symptoms and socioeconomic status , but not perceived social support , predict risk of readmission and readmission frequency for AE COPD in patients cared for by nurse-led EDS . Future work on reducing dem and for unscheduled hospital admissions could include the design and evaluation of interventions aim ed at optimising the psychosocial care of AE COPD patients managed at home Objectives : To determine the effects of a nurse led intermediate care programme in patients who have been hospitalised with an acute exacerbation of chronic obstructive pulmonary disease ( AE COPD ) . Design : R and omised controlled trial . Setting : Community and hospital care in west London . Participants : 122 patients with COPD . Intervention : A care package incorporating initial pulmonary rehabilitation and self-management education , provision of a written , personalised COPD action plan , monthly telephone calls and 3 monthly home visits by a specialist nurse for a period of 2 years . Main outcome measure : Hospital readmission rate . Secondary outcomes : Unscheduled primary care consultations and quality of life . Results : There were no differences in hospital admission rates or in exacerbation rates between the two groups . Self-management of exacerbations was significantly different and the intervention group were more likely to be treated with oral steroids alone or oral steroids and antibiotics , and the initiators of treatment for exacerbations were statistically more likely to be the patients themselves . 12 patients in the control group died during the 2 year period , eight as a result of COPD , compared with six patients in the intervention group , of whom one died from COPD . This is a significant difference . When the numbers were adjusted to reflect the numbers still alive at 2 years , in the intervention group patients reported a total of 171 unscheduled contacts with their general practitioner ( GP ) and in the control group , 280 contacts . The number needed to treat was 0.558—ie , for every one COPD patient receiving the intervention and self-management advice , there were 1.79 fewer unscheduled contacts with the GP . Conclusions : An intermediate care package incorporating pulmonary rehabilitation , self-management education and the receipt of a written COPD action plan , together with regular nurse contact , is associated with a reduced need for unscheduled primary care consultations and a reduction in deaths due to COPD but did not affect the hospital readmission rate BACKGROUND Patients with depression and poorly controlled diabetes , coronary heart disease , or both have an increased risk of adverse outcomes and high health care costs . We conducted a study to determine whether coordinated care management of multiple conditions improves disease control in these patients . METHODS We conducted a single-blind , r and omized , controlled trial in 14 primary care clinics in an integrated health care system in Washington State , involving 214 participants with poorly controlled diabetes , coronary heart disease , or both and coexisting depression . Patients were r and omly assigned to the usual-care group or to the intervention group , in which a medically supervised nurse , working with each patient 's primary care physician , provided guideline -based , collaborative care management , with the goal of controlling risk factors associated with multiple diseases . The primary outcome was based on simultaneous modeling of glycated hemoglobin , low-density lipoprotein ( LDL ) cholesterol , and systolic blood-pressure levels and Symptom Checklist-20 ( SCL-20 ) depression outcomes at 12 months ; this modeling allowed estimation of a single overall treatment effect . RESULTS As compared with controls , patients in the intervention group had greater overall 12-month improvement across glycated hemoglobin levels ( difference , 0.58 % ) , LDL cholesterol levels ( difference , 6.9 mg per deciliter [ 0.2 mmol per liter ] ) , systolic blood pressure ( difference , 5.1 mm Hg ) , and SCL-20 depression scores ( difference , 0.40 points ) ( P<0.001 ) . Patients in the intervention group also were more likely to have one or more adjustments of insulin ( P=0.006 ) , antihypertensive medications ( P<0.001 ) , and antidepressant medications ( P<0.001 ) , and they had better quality of life ( P<0.001 ) and greater satisfaction with care for diabetes , coronary heart disease , or both ( P<0.001 ) and with care for depression ( P<0.001 ) . CONCLUSIONS As compared with usual care , an intervention involving nurses who provided guideline -based , patient-centered management of depression and chronic disease significantly improved control of medical disease and depression . ( Funded by the National Institute of Mental Health ; Clinical Trials.gov number , NCT00468676 . ) OBJECTIVE Patients with chronic obstructive pulmonary disease ( COPD ) and a history of frequent exacerbations are a target population of particular interest from both a clinical and an economic st and point . The objective of this study was to evaluate the effectiveness of a program design ed specifically to manage patients in this subgroup . PATIENTS AND METHODS This was a 1-year r and omized controlled trial design ed to compare the effectiveness of a specific program ( SP ) with that of conventional management ( CM ) in a group of patients with a high frequency of exacerbations ( 3 or more per year ) . Within-group and between-group comparisons were carried out for a number of variables related to the patients medical care , dyspnea , health-related quality of life ( HRQL ) , inhalation technique , and pulmonary function . RESULTS A total of 26 patients were enrolled in the study ( all men ) . The mean ( SD ) age was 73 ( 8) years , and mean forced expiratory volume in 1 second ( FEV1 ) expressed as a percentage of the reference value was 43 % ( 15 % ) . Exacerbations requiring hospital care ( emergency department visits and /or admission ) decreased in both groups : by 24.4 % ( P not significant ) in the CM group and 44.1 % ( P=.061 ) in the SP group . Hospital admissions decreased 73.3 % in the SP group and increased 22 % in the CM group ( P < .001 ) . While length of hospital stay decreased 77.3 % in the SP group , this figure almost doubled in the CM group ( P=.014 ) . Dyspnea , HRQL , and inhalation technique improved in both groups . FEV1 fell by 46 mL/year in the CM group and increased 10 mL/year in the SP group ( P not significant ) . CONCLUSIONS The use of a simple program to manage selected patients with a history of frequent exacerbations produces a significant reduction in the number of hospital admissions , an improvement in HRQL , and may improve prognosis OBJECTIVE To determine the long-term effects on total healthcare costs of the Improving Mood : Promoting Access to Collaborative Treatment ( IMPACT ) program for late-life de \n Output:\n " }, { "from": "agent", "value": "Use of urgent healthcare in patients with COPD was significantly reduced by complex interventions ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: Aim To assess the extent to which bone marrow scintigraphy ( BMS ) makes the interpretation of leucocyte scintigraphy ( LS ) easier and improves its diagnostic value . Methods Seventy-three 111In LSs , 99mTc hydroxymethylene diphosphonate bone scintigraphies ( BSs ) and 99mTc sulfur colloid BMSs were performed in 60 patients with suspected infection related to a hip prosthesis or knee prosthesis , either in situ ( + group , n=43 ) or after removal for septic loosening ( −group , n=30 ) . Bacteriological sample s were obtained from all patients . LS was interpreted together with BS ( LS-BS ) or with BMS ( LS-BMS ) by three independent readers . Results The concordance among readers , estimated by the kappa test , was average with LS-BS ( κ/κm coefficients=0.58 , 0.58 and 0.46 , respectively , for the three pairs of readers ) and excellent with LS-BMS ( κ/κm coefficients=1.00 for the three pairs of readers ) . With LS-BS , 64/219 interpretations were equivocal whereas only one was equivocal with LS-BMS . Sensitivity , specificity and accuracy of LS-BMS were , respectively , 80 % , 94 % and 91 % in the+group , and 33 % , 100 % and 93 % in the−group . Conclusion We conclude that ( 1 ) the interpretation of the results for LS-BMS is very easy , in contrast to LS-BS ; ( 2 ) the diagnostic value of LS-BMS for detecting infected joint prostheses is good ; and ( 3 ) additional data are needed to assess the accuracy of LS-BMS when the prosthesis has been removed Purpose This study aims to assess and compare the value of FDG PET with combined 111In-labeled leukocyte/99mTc-sulfur colloid bone marrow ( WBC/BM ) imaging for diagnosing infection in hip and knee prostheses . Methods In this prospect i ve study , patients with painful hip or knee arthroplasty , who were scheduled to undergo clinical and diagnostic evaluation for prosthesis revision , were included . They have been studied by using FDG PET and WBC/BM scan . This study was institutional review board approved and Health Insurance Portability and Accountability Act compliant . All patients provided written informed consent . Results A total of 134 hip and 87 knee prostheses , suspected of being either infected or noninfectious loosening , were evaluated . All 221 prostheses underwent FDG PET , whereas both WBC/BM imaging and FDG PET were performed in 88 prostheses . The initial analysis of data from the WBC/BM images demonstrated somewhat suboptimal results compared with those of FDG PET scans on 88 patients . In addition , some patients were not willing to undergo both procedures and therefore participate in this study . Therefore , a decision was made to eliminate WBC/BM imaging from the procedures for the remainder of this research study . This decision was reached partly because of the significant radiation dose delivered from labeled WBC and safety issues related to preparing these labeled cells . Final diagnosis was based on microbiological examinations of the surgical specimens in 125 prostheses and joint aspirations combined with the clinical follow-up of 6 months or more in 86 prostheses . The sensitivity , specificity , positive predictive value , and negative predictive value of FDG PET in hip prostheses were 81.8 % , 93.1 % , 79.4 % , and 94.0 % , respectively , and in knee prostheses were 94.7 % , 88.2 % , 69.2 % , and 98.4 % , respectively . The sensitivity , specificity , positive predictive value , and negative predictive value of WBC/BM imaging in hip prostheses were 38.5 % , 95.7 % , 71.4 % , and 84.6 % , respectively , and in knee prostheses were 33.3 % , 88.5 % , 25.0 % , and 92.0 % , respectively . In those cases that underwent both FDG PET and WBC/BM imaging , there was a trend ( P = 0.0625 ) toward a higher sensitivity for FDG PET in hip prostheses , whereas other comparisons did not show any significant differences between the 2 imaging modalities . Conclusions Based on this study , the diagnostic performance of FDG PET scan in detecting infection in painful hip and knee prostheses is optimal for routine clinical application . Considering the complexity and costs of WBC/BM imaging and related safety issues associated with this preparation , FDG PET seems to be an appropriate alternative for assessing these patients PURPOSE To prospect ively determine the accuracy of computed tomography ( CT ) in the detection of painful infection at the site of hip prosthesis before surgery . MATERIAL S AND METHODS Helical CT examinations of hip prostheses were prospect ively performed before surgery after a st and ard clinical and radiologic examination of 65 patients . CT scans and conventional radiographs were review ed for periprosthetic bone abnormalities , and CT scans were review ed for periprosthetic soft-tissue abnormalities ( joint distention , fluid-filled bursae , and fluid collection in muscles and perimuscular fat ) . Patients subsequently underwent revision arthroplasty within 1 month , and infection was diagnosed in 12 ( 19 % ) patients . RESULTS Infection was detected clinical ly in 25 % of patients . Periprosthetic bone abnormalities did not allow differentiation of infection from complications not related to sepsis , except for periostitis , with 100 % specificity but only 16 % sensitivity . Soft-tissue findings were accurate for detection of infection , with 100 % sensitivity and 87 % specificity . Fluid collection in muscles and perimuscular fat had a 100 % positive predictive value , and absence of joint distention had a 96 % negative predictive value . CONCLUSION CT is accurate in the diagnosis of painful infection at the site of a hip prosthesis on the basis of soft-tissue findings , whereas periprosthetic bone abnormalities are not useful Aim To analyse the role played by bone scintigraphy in the diagnosis of infected joint prostheses . Methods The study included 77 patients , aged 32–77 years , in whom infection of a joint prosthesis ( 48 hip , 29 knee ) was suspected . In all patients the following examinations were performed consecutively : a two-phase 99mTc methylene diphosphonate ( 99mTc-MDP ) bone scan , a 99mTc hexamethylproplyene amine oxime ( 99mTc-HMPAO ) labelled white blood cell ( WBC ) scan , and a 99mTc microcolloid bone marrow ( BM ) scan . The minimum interval between examinations was 48 h. The diagnoses were based on data obtained from bacteriological cultures . Results The bone scan was positive in all patients and 28 of them had an infection ( sensitivity 100 % , specificity 0 % ) . The WBC scan was positive in 61 patients but only 27 had an infection . The WBC scan was negative in 16 patients , and the possibility of infection was discarded in 15 of these cases ( sensitivity 96 % , specificity 30 % ) . The results of the bone marrow scan were not compatible with those of the WBC scan ( suggestive of infection ) in 27 patients : 26 of them had prosthesis infection . The results of both examinations were compatible in the other 34 patients and the possibility of infection was discarded in 33 of these patients ( sensitivity 92.8 % , specificity 98 % ) . The addition of a BM scan to a WBC scan decreased the sensitivity from 96 % to 92.8 % but increased specificity from 30 % to 98 % . The addition of a bone scan to this dual combination did not alter the results . Conclusions When infection of a prosthesis is suspected the diagnostic procedure should start with a WBC scan followed , if positive , by a BM scan . This procedure reduces the cost , the time required for a diagnosis , and the dose of radiation received by the patient Ten per cent of patients with hip replacement will eventually complain of significant pain after surgery , often requiring a revision arthroplasty . The majority of these patients experience aseptic loosening rather than infection . Despite significant advances made in diagnostic imaging , distinguishing infection from aseptic loosening remains a significant challenge . Imaging using fluorodeoxyglucose ( FDG ) positron emission tomography ( PET ) has been reported to have excellent sensitivity in detecting infections associated with hip prostheses . However , in some studies , a high rate of false positive results has been reported , especially when increased tracer uptake adjacent to the prosthesis ( which is not surrounded by bone ) is used as the sole criterion for diagnosing infection . The objective of this investigation was to determine the optimal criteria for diagnosing periprosthetic infection , thereby avoiding false positive results in this setting . A total of 41 total hip arthroplasties from 32 patients and for whom complete clinical follow-up was available were included in this analysis . The location and intensity of FDG uptake were determined for each scan . Final diagnosis was made by microbiology , histopathology , surgical findings and clinical follow-up . Patients who did not undergo surgery were followed up to at least 9 months . Twelve patients were proven eventually to have periprosthetic infection . Images from 11 of these patients displayed increased tracer uptake along the interface between bone and prosthesis . The intensity of the increased tracer uptake varied from mild to moderate , with st and ardized uptake values less than 2 . In contrast , images from uninfected , loose hip prostheses revealed very intense uptake around the head or neck of the prosthesis with st and ardized uptake values as high as 7 . It is concluded that the intensity of increased FDG uptake is less important than the location of increased FDG uptake when FDG PET is used to diagnose periprosthetic infection in patients with hip arthroplasty . Using increased uptake as the sole criterion for diagnosing infection will result in false positive results in this setting To determine the value of immunoscintigraphy ( IS ) with antigranulocyte monoclonal antibodies ( Mab ) in the diagnosis of subacute or chronic infection of hip prostheses , we prospect ively studied 57 patients ( 23 women and 34 men ; age 29–92 years , mean 72.7 years ) sent to our institution in the past 6 years for clinical suspicion of septic loosening of a hip prosthesis . Nineteen patients had bilateral prostheses and one of them was studied twice . A total of 78 prostheses were examined . All patients had three-phase bone scans followed by IS with technetium-99 m antigranulocyte Mab BW 250/183 . Intervals between bone scans and IS varied from 2 days to 4 weeks . Final diagnosis was assessed by culture in 48 cases ( articular puncture or intraoperative sampling ) and by clinical follow-up of at least 8 months in 30 cases . Twelve prostheses were considered septic and 66 non-septic . The overall sensitivity and specificity were 92 % and 64 % respectively for bone scans , 67 % and 75 % for IS and 67 % and 84 % for both modalities together . In three cases , IS was doubtful and the final clinical diagnosis was negative for infection . False-positive results were observed in the presence of massive loosening of the prosthesis or in association with metaplastic peri-articular bone formation . In three of the four false-negative results , infection was proven only after enrichment of the culture , and the bacterium wasStaphylococcus epidermidis . In 12/33 ( 36 % ) positive bone scans IS allowed the diagnosis of infection to be excluded . Overall accuracy of both modalities together was 81 % and the negative predictive value was 93 % , which compares favourably with the results reported for other non-invasive methods We compared the accuracy of fluorine-18 labelled 2-fluoro-2-deoxy-d-glucose positron emission tomography ( 18FDG PET ) with that of technetium-99 m hexamethylpropylene amine oxime leucocyte scintigraphy ( LS ) in the detection of infected hip prosthesis . Seventeen patients with a hip prosthesis suspected for infection were prospect ively included and underwent 99mTc-methylene diphosphonate bone scintigraphy ( BS ) , LS and an 18FDG-PET scan within a 2-week period . Seven volunteers with ten asymptomatic hip prostheses were used as a control group and underwent BS and an 18FDG-PET scan . Bacteriology of sample s obtained by surgery or by needle aspiration and /or clinical follow-up for up to 6 months were used as the gold st and ard . Planar images of BS and LS ( 4 and 24 h p.i . ) were acquired , followed by single-photon emission tomography ( SPET ) LS images ( after 4 h ) . These images were scored as positive or negative by two experienced readers . The 18FDG-PET scans of the patients were compared with the tracer distribution pattern in the asymptomatic control group and with \n Output:\n " }, { "from": "agent", "value": "Of the currently used imaging techniques , leukocyte scintigraphy has satisfactory accuracy in confirming or excluding periprosthetic hip infection .\nAlthough not significantly different , combined leukocyte and bone marrow scintigraphy was the most specific imaging technique .\nFDG PET has an appropriate accuracy in confirming or excluding periprosthetic hip infection , but may not yet be the preferred imaging modality because of limited availability and relatively higher cost ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: OBJECTIVE It is often believed that people overeat the foods they like . We investigated whether environmental cues such as packaging and container size are so powerful that they can increase our intake of foods that are less palatable . DESIGN , SETTING , AND PARTICIPANTS In a 2 x 2 between-subjects design , 158 moviegoers in Philadelphia ( 57.6 % male ; 28.7 years ) were r and omly given a medium ( 120 g ) or a large ( 240 g ) container of free popcorn that was either fresh or stale ( 14 days old ) . Following the movie , consumption measures were taken , along with measures of perceived taste . OUTCOME MEASURES AND RESULTS Moviegoers who were given fresh popcorn ate 45.3 % more popcorn when it was given to them in large containers . This container-size influence is so powerful that even when the popcorn was disliked , people still ate 33.6 % more popcorn when eating from a large container than from a medium-size container . CONCLUSIONS AND IMPLICATION S Even when foods are not palatable , large packages and containers can lead to overeating . The silver lining of these findings may be that portion size can also be used to increase the consumption of less preferred healthful foods , such as raw vegetables Young and Nestle suggested that the increase in the portion size of food products evident in the United States during the past 20 years may be responsible for the epidemic of overweight and obesity . They based their conclusion on statistical correlations . The purpose of the present study was to provide experimental evidence to support their proposal . Cornell undergraduate students were given access to a buffet lunch on Monday , Wednesday , and Friday and were told this was a test of flavor enhancers . They were instructed to eat as much or as little as they wanted . On the same days of the following week , the subjects were divided into 3 groups . Each group was served either 100 % , 125 % , or 150 % of the amount of food they had consumed the previous week . When larger amounts were served , significantly greater amounts of food were consumed . Each of the 4 foods that comprised the meal ( soup , pasta , breadsticks , ice cream ) increased significantly in proportion to the portion size . The data clearly support the hypothesis proposed by Young and Nestle and support the powerful role that environment plays in determining energy intake and potential increases in body weight In an effort to define human cortical gustatory areas we review ed functional neuroimaging data for which coordinates st and ardized in Talairach proportional space were available . We observed a wide distribution of peaks within the insula and parietal and frontal opercula , suggesting multiple gustatory regions within this cortical area . Multiple peaks also emerged in the orbitofrontal cortex . However , only two peaks , both in the right hemisphere , were observed in the caudolateral orbitofrontal cortex , the region likely homologous to the secondary taste area described in monkeys . Overall significantly more peaks originated from the right hemisphere suggesting asymmetrical cortical representation of taste favoring the right hemisphere Almost 50 years ago Neel proposed a hypothesis to explain the prevalence of obesity and diabetes in modern society — the ‘ thrifty gene ’ hypothesis . The fundamental basis of the hypothesis was that , in our early evolutionary history , genes , that promoted efficient fat deposition would have been advantageous because they allowed their holders to survive at periods of famine . In modern society , such genes are disadvantageous because they promote fat deposition in preparation for a famine that never comes , and the result is widespread obesity and diabetes . In recent years I , and others , have question ed some of the fundamental assumptions of this hypothesis — particularly focusing on whether differential survival of lean against obese in famines provides sufficient selective pressure for the spread of so-called ‘ thrifty genes ’ . These arguments have been criticized because famines not only affect survival but also fecundity , and obese people would be expected to sustain fecundity longer in the face of food shortages . In this paper , I show that the reduced fecundity argument is flawed because famines are almost universally followed by periods of enhanced fecundity , which offsets the decline observed during the famine itself . The net effect of famines on fecundity is consequently insufficient to rescue the thrifty gene idea . Elsewhere , I have suggested an alternative scenario that subsections of the population have a genetic predisposition to obesity due to an absence of selection , combined with genetic drift . The scenario presented earlier was based on evidence from prehistory concerning the release of our ancestors from heavy predation pressure around 2 million years ago . I suggest here that this is one of a number of potential scenarios based on r and om genetic drift that may explain the specific aetiology of the obesity epidemic . Together , these alternatives , based on central notion that genetic drift rather than positive selection was a dominant factor , may be called the ‘ drifty gene ’ hypothesis AIM Persuasive marketing techniques , such as promotional characters , influence children 's food preferences and requests for foods . The aim of this research was to describe the techniques used to market unhealthy foods and beverages to children on Sydney free-to-air television . METHODS Marketing techniques design ed to appeal to children were identified from international literature and summarised into a systematic coding tool . Using this tool , the marketing techniques used in a r and om sample of 100 unique food advertisements , broadcasted on Sydney free-to-air television , were coded . Frequency of marketing techniques was analysed overall and for use in advertisements marketing unhealthy foods , emotionally or verbally appealing to parents , or featuring child actors . RESULTS Advertisers ' use of persuasive techniques generally did not differ by type of food advertised . Marketing techniques with greater prominence in unhealthy food advertising were palatability ( 54 % of unhealthy food advertisements ) , convenience ( 52 % ) , fantasy/imagination ( 28 % ) , fun/happiness ( 17 % ) and cartoon characters ( 9 % ) . Advertisements emotionally appealing to parents ( 24 % ) were significantly more likely to make general health or nutrition statements ( 38 % vs. 17 % ) , and appealed to children concurrently through fun/happiness and fantasy/imagination appeals . Children were depicted in advertisements as eating with friends or family , situated within the home and frequently snacking on less healthy foods . CONCLUSIONS Food and beverage advertisers use a range of visual , audio and emotive techniques to appeal to children and their parents that do not discriminate by the type of food advertised . The range and complexity of these techniques complicate the restriction of their use in food advertising to children OBJECTIVE To examine whether parents offering a sticker reward to their child to taste a vegetable the child does not currently consume is associated with improvements in children 's liking and consumption of the vegetable . DESIGN A r and omized controlled trial evaluated the effectiveness of exposure only ( EO ) and exposure plus reward ( E + R ) , relative to a control group , on children 's liking and consumption of a target vegetable . Assessment s were conducted at baseline and 2 weeks from baseline ( post-intervention ) . Follow-up assessment s were conducted at 4 weeks and 3 months from baseline . SETTING The study took place in Adelaide , South Australia . Participants were self-selected in response to local media advertisements seeking to recruit parents finding it difficult to get their children to eat vegetables . SUBJECTS Participants were 185 children ( 110 boys , seventy-five girls ) aged 4 - 6 years and their primary caregiver/parent ( 172 mothers , thirteen fathers ) . RESULTS The E + R group was able to achieve more days of taste exposure . Both EO and E + R increased liking at post-intervention compared with control and no further change occurred over the follow-up period . All groups increased their intake of the target vegetable at post-intervention . Target vegetable consumption continued to increase significantly over the follow-up period for E + R and control but not for EO . CONCLUSIONS The findings provide support for the effectiveness of using a sticker reward with a repeated exposure strategy . In particular , such rewards can facilitate the actual tastings necessary to change liking BACKGROUND Because people eat most of what they serve themselves , any context ual cues that lead them to over-serve should lead them to over-eat . In building on the size-contrast illusion , this research examines whether the size of a bowl or serving spoon unknowingly biases how much a person serves and eats . METHODS The 2 x 2 between-subjects design involved 85 nutrition experts who were attending an ice cream social to celebrate the success of a colleague in 2002 . They were r and omly given either a smaller ( 17 oz ) or a larger ( 34 oz ) bowl and either a smaller ( 2 oz ) or larger ( 3 oz ) ice cream scoop . After serving themselves , they completed a brief survey as their ice cream was weighed . The analysis was conducted in 2003 . RESULTS Even when nutrition experts were given a larger bowl , they served themselves 31.0 % more ( 6.25 vs 4.77 oz , F(1 , 80 ) = 8.05 , p < 0.01 ) without being aware of it . Their servings increased by 14.5 % when they were given a larger serving spoon ( 5.77 vs 5.04 oz , F(1 , 80)=2.70 , p = 0.10 ) . CONCLUSIONS People could try using the size of their bowls and possibly serving spoons to help them better control how much they consume . Those interested in losing weight should use smaller bowls and spoons , while those needing to gain weight -- such as the undernourished or aged -- could be encouraged to use larger ones . Epidemiologic implication s are discussed OBJECTIVE We tested the effect on energy intake of increasing the portion size of all foods and beverages served over 2 consecutive days . DESIGN The study used a r and omized crossover design . SUBJECTS/ SETTING Subjects were 32 adults from a university community . INTERVENTION For 2 consecutive days in each of 3 weeks , subjects ate their main meals in a controlled setting and were given snacks for consumption between meals . We used the same two daily menus each week , but varied the portion sizes of all foods and beverages served in a given week ( either 100 % , 150 % , or 200 % of baseline amounts ) . MAIN OUTCOME MEASURES Energy intake and ratings of hunger and satiety were measured . STATISTICAL ANALYSES PERFORMED A linear mixed model with repeated measures was used . RESULTS There was a significant effect of portion size on energy intake in both men and women ( P<0.0001 ) . Increasing portions by 50 % increased daily energy intake by 16 % ( women : 335 kcal/day ; men : 504 kcal/day ) , and increasing portions by 100 % increased intake by 26 % ( women : 530 kcal/day ; men : 812 kcal/day ) . Energy intake did not differ between the 2 days of each week . Daily ratings of fullness were lowest in the 100 % portion condition ( P=0.0004 ) , but did not differ significantly in the 150 % and 200 % conditions . CONCLUSIONS Increasing the portion size of all foods result ed in a significant increase in energy intake that was sustained over 2 days . These data support suggestions that large portions are associated with excess energy intake that could contribute to increased body weight \n Output:\n " }, { "from": "agent", "value": "Increased intake of energy-dense foods high in fat and sugar is not only adding more energy , but may also corrupt neural functions of brain systems involved in nutrient sensing as well as in hedonic , motivational and cognitive processing ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: Background A commonly reported problem with the conduct of multicentre r and omised controlled trials ( RCTs ) is that recruitment is often slower or more difficult than expected , with many trials failing to reach their planned sample size within the timescale and funding originally envisaged . The aim of this study was to explore factors that may have been associated with good and poor recruitment in a cohort of multicentre trials funded by two public bodies : the UK Medical Research Council ( MRC ) and the Health Technology Assessment ( HTA ) Programme . Methods The cohort of trials was identified from the administrative data bases held by the two funding bodies . 114 trials that recruited participants between 1994 and 2002 met the inclusion criteria . The full scientific applications and subsequent trial reports su bmi tted by the trial teams to the funders provided the principal data sources . Associations between trial characteristics and recruitment success were tested using the Chi-squared test , or Fisher 's exact test where appropriate . Results Less than a third ( 31 % ) of the trials achieved their original recruitment target and half ( 53 % ) were awarded an extension . The proportion achieving targets did not appear to improve over time . The overall start to recruitment was delayed in 47 ( 41 % ) trials and early recruitment problems were identified in 77 ( 63 % ) trials . The inter-relationship between trial features and recruitment success was complex . A variety of strategies were employed to try to increase recruitment , but their success could not be assessed . Conclusion Recruitment problems are complex and challenging . Many of the trials in the cohort experienced recruitment difficulties . Trials often required extended recruitment periods ( sometimes supported by additional funds ) . While this is of continuing concern , success in addressing the trial question may be more important than recruitment alone This paper reports findings on parental engagement in a community-based parent training intervention . As part of a r and omized trial , 821 parents were offered group-based Triple P as a parenting skills prevention program . Program implementation was conducted by practitioners . The intervention was implemented between Waves 1 and 2 of a longitudinal study , with a participation rate of 69 % and a retention rate of 96 % . The study finds that a practitioner-led dissemination can achieve recruitment and completion rates that are similar to those reported in research er-led trials . Second , the study found that different factors are associated with the various stages of the parental engagement process . Family-related organizational and timing obstacles to participation primarily influence the initial stages of parental involvement . The strength of neighborhood networks plays a considerable role at the participation and completion stages of parental engagement . The general course climate and the intensity of program exposure predict the utilization of the program several months after the delivery Background As the number of r and omised controlled trials of medicines for children increases , it becomes progressively more important to underst and the experiences of parents who are asked to enrol their child in a trial . This paper presents a narrative review of research evidence on parents ' experiences of trial recruitment focussing on qualitative research , which allows them to articulate their views in their own words . Discussion Parents want to do their best for their children , and socially and legally their role is to care for and protect them yet the complexities of the medical and research context can challenge their fulfilment of this role . Parents are simultaneously responsible for their child and cherish this role yet they are dependent on others when their child becomes sick . They are keen to exercise responsibility for deciding to enter a child in a trial yet can be fearful of making the ' wrong ' decision . They make judgements about the threat of the child 's condition as well as the risks of the trial yet their interpretations often differ from those of medical and research experts . Individual parents will experience these and other complexities to a greater or lesser degree depending on their personal experiences and values , the medical situation of their child and the nature of the trial . Interactions at the time of trial recruitment offer scope for negotiating these complexities if practitioners have the flexibility to tailor discussion s to the needs and situation of individual parents . In this way , parents may be helped to retain a sense that they have acted as good parents to their child whatever decision they make . Summary Discussing r and omised controlled trials and gaining and providing informed consent is challenging . The unique position of parents in giving proxy consent for their child adds to this challenge . Recognition of the complexities parents face in making decisions about trials suggests lines for future research on the conduct of trials , and ultimately , may help improve the experience of trial recruitment for all parties PURPOSE Loss of participants in r and omized clinical trials threatens the validity of study findings . The purpose of this study was to determine pre-r and omization predictors of study completion status throughout the course of a r and omized clinical trial involving young children with type 1 diabetes and their primary caregivers . METHODS An intervention to improve adherence to the diabetes treatment regimen was delivered as part of the child 's regular 3-month diabetes clinic visit . The study protocol involved 7 clinic visits across 18 months for the Immediate Treatment group and 9 clinic visits across 24 months for the Delayed Treatment group . Among those who completed the study and regardless of treatment group , participants were categorized into two groups : On-Time Completers ( n=41 ) and Late Completers ( n=39 ) . Demographic , disease , and psychosocial characteristics of children and their primary caregivers measured prior to study r and omization were tested for their association with the participants ' completion status ( i.e. , On-Time Completers , Late Completers , or Withdrawals ) . RESULTS Of the 108 participants , 28 ( 25.9 % ) withdrew and 80 ( 74.1 % ) completed the study . On-Time Completers ( i.e. , study completed within 4 months of expected date ) were more likely to have private insurance and primary caregivers with some college education . Late Completers ( i.e. , study completion took longer than 4 months ) were more likely to be boys and to have primary caregivers who reported mild to moderate levels of depression . Children who subsequently withdrew from the study reported poorer diabetes-related quality of life and poorer school-related quality of life at study inception and were more likely to have primary caregivers who did not work outside the home . CONCLUSIONS Pre-r and omization screening of participants on both demographic and psychological variables may help identify those at greatest risk for study withdrawal or poor study protocol adherence , permitting the investigators to develop retention strategies aim ed at this high-risk group Background Despite important implication s for the budgets , statistical power and generalisability of research findings , detailed reports of recruitment and retention in r and omised controlled trials ( RCTs ) are rare . The NOURISH RCT evaluated a community-based intervention for first-time mothers that promoted protective infant feeding practice s as a primary prevention strategy for childhood obesity . The aim of this paper is to provide a detailed description and evaluation of the recruitment and retention strategies used . Methods A two stage recruitment process design ed to provide a consecutive sampling framework was used . First- time mothers delivering healthy term infants were initially approached in postnatal wards of the major maternity services in two Australian cities for consent to later contact ( Stage 1 ) . When infants were approximately four months old mothers were re-contacted by mail for enrolment ( Stage 2 ) , baseline measurements ( Time 1 ) and subsequent r and om allocation to the intervention or control condition . Outcomes were assessed at infant ages 14 months ( Time 2 ) and 24 months ( Time 3 ) . Results At Stage 1 , 86 % of eligible mothers were approached and of these women , 76 % consented to later contact . At Stage 2 , 3 % had become ineligible and 76 % could be recontacted . Of the latter , 44 % consented to full enrolment and were allocated . This represented 21 % of mothers screened as eligible at Stage 1 . Retention at Time 3 was 78 % . Mothers who did not consent or discontinued the study were younger and less likely to have a university education . Conclusions The consent and retention rates of our sample of first time mothers are comparable with or better than other similar studies . The recruitment strategy used allowed for detailed information from non-consenters to be collected ; thus selection bias could be estimated . Recommendations for future studies include being able to contact participants via mobile phone ( particularly text messaging ) , offering home visits to reduce participant burden and considering the use of financial incentives to support participant retention . Trial registration Australian and New Zeal and Clinical Trials Registry Number The hierarchy of evidence in assessing the effectiveness of interventions or treatments is explained , and the gold st and ard for evaluating the effectiveness of interventions , the r and omised controlled trial , is discussed . Issues that need to be considered during the critical appraisal of r and omised controlled trials , such as assessing the validity of trial methodology and the magnitude and precision of the treatment effect , and deciding on the applicability of research results , are discussed . Important terminologies such as r and omisation , allocation concealment , blinding , intention to treat , p values , and confidence intervals are explained OBJECTIVES To operationalize a comprehensive description of attrition , including pre- inclusion , dropout , and attrition due to intermittent missing data , and to test a predictive model of attrition using a data set from a r and omized controlled intervention in pediatric asthma . METHODS Participants included children , ages 4 - 12 , diagnosed with asthma and their caregivers . Demographic variables and outcome measures of asthma morbidity were examined in 327 families to determine their association with attrition . RESULTS Families who did not complete r and omization and the intervention tended to have younger caregivers than did completers . Caregiver age emerged as the most consistent predictor of pre- inclusion and dropout attrition . There were no significant predictors of attrition due to intermittent missing data . CONCLUSION Younger caregivers may be at particular risk for attrition in pediatric asthma intervention studies and warrant special attention by investigators OBJECTIVE To examine attrition variables in r and omized controlled trials of cognitive behavioral interventions for children with chronic illnesses . METHODS We examined attrition rates reported on 40 r and omized cognitive behavioral interventions published in six pediatric research journals , during the years 2002 - 2007 . Intervention focus was limited to children with a chronic medical condition , such as asthma , obesity , arthritis , diabetes , cancer , sickle cell disease , and cystic fibrosis . RESULTS Mean rate of enrollment refusal was 37 % ( range 0 - 75 % ) . Mean attrition rate was 20 % ( range 0 - 54 % ) for initial follow-up and 32 % ( range 0 - 59 % ) for extended follow-up . Of the review ed articles , 40 % included a CONSORT diagram . CONCLUSIONS Strategies that can be used to limit attrition include tailoring recruitment to the study population , providing personalized feedback , maintaining consistent study procedures , providing incentives , and using intensive tracking measures . There is a need for st and ardized definitions and reporting of attrition rates in r and omized cognitive behavioral intervention studies OBJECTIVES Survival rates for childhood cancer have improved substantially partly as a result of national and international r and omized clinical trials ( RCT ) . However , the decision for families is complex and emotional . Our aim was to describe the views of mothers of children newly diagnosed with ALL regarding consent to r and omized controlled trials . DESIGN Qualitative interview to explore mothers knowledge , and reasons for involving their child in RCTs . Interviews took place in mothers ' homes . PARTICIPANTS Fifty mothers of children with newly diagnosed ALL ( age 4 - 16 years ; mean = 7.4 ) recruited through research nurses at outpatient appointments . RESULTS All but three families had consented for their child to be treated in the RCT , although there was wide variation in their underst and ing of the aims , costs and benefits . Most mothers reported the aim of the trial to compare ' old ' and ' new ' treatments . CONCLUSION Despite detailed verbal and written information , mothers were poorly informed about the purpose of the trial , and possibility of side effects . Individual preferences for either st and ard or new treatment were routinely reported . The data raise questions about the extent to which families give truly informed consent to recruitment of their child to an RCT A significant percentage of children with disruptive behavior disorders do not receive mental health assistance . Utilization is lowest among groups whose children are at greatest risk . To increase the availability , accessibility , and cost efficacy of parent training programs , this prospect i ve r and omized trial compared a large group community-based parent training program to a clinic-based individual parent training ( PT ) programs . All families of junior kindergartners in the Hamilton public and separate school boards were sent a checklist regarding problems at home . Those returning question naires above the 90th percentile were block r and omly assigned to : ( 1 ) a 12-week clinic-based individual parent training ( Clinic/Individual ) , ( 2 ) a 12-week community-based large group parent training ( Community/Group ) , or ( 3 ) a waiting list control condition . Immigrant families , those using English as a second language , and parents of children with severe behaviour problems were significantly more likely to enroll in Community/Groups than Clinic/Individual PT . Parents in Community/Groups reported greater improvements in behaviour problems at home and better maintenance of these gains at 6-month follow-up . A cost analysis showed that , with groups of 18 families , Community/Groups are more than six times as cost effective as Clinic/Individual programs Women with inadequate prenatal care were recruited to a multi-component parenting intervention study . Because it was anticipated that this high-risk population might present challenges to retention , a variety of strategies were employed to maintain their participation in the study . This report review s the results of these retention efforts and compares the population that completed the study versus those that terminated prior to study completion . Two hundred and eighty-six women were r and omized to an intervention or control group . Careful tracking of the mothers , offering incentives for completing various study activities and providing a culturally competent staff were among the strategies employed to maintain participation . Comparison \n Output:\n " }, { "from": "agent", "value": "Parent characteristics ( e.g. ethnicity , age , education , socioeconomic status ( SES ) ) were the most commonly reported predictors of participation for both recruitment and retention .\nBeing young , less educated , of an ethnic minority and having low SES appear to be barriers to participation in RCTs although there was little agreement between studies .\nConclusion Parent characteristics may predict participation of children and their families to RCTs ; however , there was a lack of consensus .\nWhilst sociodemographic variables may be useful in identifying which groups are least likely to participate they do not provide insight into the processes and barriers to participation for children and families ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: OBJECTIVE For long-term treatment effects , patients with subacute back pain need to adhere to treatment recommendations beyond the prescribed exercise treatment . Adherence rates are as low as 30 % , so we developed a cognitive-behavioural training programme to enhance patients ' self-efficacy , maximise severity perceptions and reduce barrier perceptions . METHOD A 2 x 4 ( group x time ) repeated measurement design was applied . Forty-seven patients with non-specific , subacute back pain were r and omly assigned to a training group ( exercise treatment plus cognitive-behavioural training programme ) or a control group ( exercise treatment only ) . RESULTS Repeated measures ANOVA revealed significant main and interaction effects ; the training group reported enhanced self-efficacy and severity perceptions , reduced barrier perceptions , and self-reported that they exercised more often than the control group over time . However , no group differences regarding pain intensity emerged . CONCLUSION Our findings demonstrate that a short and inexpensive cognitive-behavioural training programme is an effective tool to enable back pain patients to follow treatment recommendations on a regular basis . PRACTICE IMPLICATION S The short and simple intervention can easily be conducted by personnel , other than psychologists , i.e. , physiotherapists STUDY OBJECTIVES To underst and reasons for compliance and non-compliance with a home based exercise regimen by patients with osteoarthritis of the knee . DESIGN A qualitative study , nested within a r and omised controlled trial , examining the effectiveness of physiotherapy in reducing pain and increasing mobility in knee osteoarthritis . In the intervention arm , participants undertook a series of simple exercises and repositioning of the kneecap using tape . In depth interviews were conducted with a subset of participants in the intervention arm using open ended questions , guided by a topic schedule , to encourage patients to describe their experiences and reflect on why they did or did not comply with the physiotherapy . Interviews were audiotaped , fully transcribed and analysed thematically according to the method of constant comparison . A model explaining factors influencing compliance was developed . SETTING Patients were interviewed at home . The study was nested within a pragmatic r and omised controlled trial . PARTICIPANTS Twenty participants in the intervention arm of the r and omised trial were interviewed three months after they had completed the physiotherapy programme . Eight were interviewed again one year later . MAIN RESULTS Initial compliance was high because of loyalty to the physiotherapist . Reasoning underpinning continued compliance was more complex , involving willingness and ability to accommo date exercises within everyday life , the perceived severity of symptoms , attitudes towards arthritis and comorbidity and previous experiences of osteoarthritis . A necessary precondition for continued compliance was the perception that the physiotherapy was effective in ameliorating unpleasant symptoms . CONCLUSIONS Non-compliance with physiotherapy , as with drug therapies , is common . From the patient 's perspective , decisions about whether or not to comply are rational but often can not be predicted by therapists or research ers . Ultimately , this study suggests that health professionals need to underst and reasons for non-compliance if they are to provide supportive care and trialists should include qualitative research within trials whenever levels of compliance may have an impact on the effectiveness of the intervention We investigated the effects of home-based daily exercise on joint mobility , functional capacity , pain , and depression in patients with ankylosing spondylitis ( AS ) . The patients were r and omly assigned to a wait-list control group or to an exercise-therapy group . The exercise-therapy group performed a 20-min exercise program once per day for 8 consecutive weeks . After 8 weeks , compared with the control group , the exercise group showed improvements in joint mobility ( cervical flexion , extension , shoulder flexion , abduction , hip abduction , and knee flexion ) , finger – floor distance , and functional capacity . Pain and depression scores were significantly lower after the exercise program in the exercise group than in the control group . These findings indicate that exercise therapy increases joint mobility and functional capacity , and decreases pain and depression in patients with AS . Home-based exercise , which is easily accessible to patients , might be an effective intervention for AS Concern has been raised about the lack of participant compliance in diary studies that use paper- and -pencil as opposed to electronic formats . Three studies explored the magnitude of compliance problems and their effects on data quality . Study 1 used r and om signals to elicit diary reports and found close matches to self-reported completion times , matches that could not plausibly have been fabricated . Studies 2 and 3 examined the psychometric and statistical equivalence of data obtained with paper versus electronic formats . With minor exceptions , both methods yielded data that were equivalent psychometrically and in patterns of findings . These results serve to at least partially mollify concern about the validity of paper diary methods OBJECTIVE Treatment recommendations for fibromyalgia ( FM ) include regular physical exercise . In this prospect i ve study we examined predictors for adherence to stretching and aerobic exercises in women provided with an individualized home based program . METHODS Thirty-nine women kept exercise diaries for 12 weeks . RESULTS For both types of exercise , women who were less physically fit at baseline engaged in more exercise during the program . Yet for stretching , more lower body pain at baseline predicted engaging in less stretching exercise over time , whereas for aerobic exercise , more baseline upper body pain predicted more exercise over time . As time passed , participants with higher baseline physical fitness and /or older age were reducing their aerobic exercise practice at significantly faster rates , as were those women with higher baseline stress . CONCLUSION Given that adequate levels of adherence were limited to about half of the participants for both types of exercise , steps to reduce barriers to exercise ( e.g. , stress ) need to be taken when prescribing exercise in the treatment of FM OBJECTIVE Great efforts have been made to find effective treatments for back pain . Nevertheless , the effectiveness of a particular treatment can depend on patient compliance . The objective of this study was to prospect ively investigate whether patients ' demographic factors , clinical factors , external barriers in following the treatment , and perceptions of disability , quality of life , depression , and control over health were predictive of compliance with a physical therapy program carried out with patients with low back pain . METHODS This was an exploratory prospect i ve cohort study that was carried out in New York City during 1999 . All study participants answered a question naire at the initial clinical evaluation by a physical therapist and were followed during the treatment . The study assessed compliance with the three treatment regimens that were prescribed for every patient : attending scheduled physical therapy sessions , following a program of home exercises , and watching back-education videotapes . Depending on the individual patient , the planned treatment program could last from 2 to 6 weeks . The study employed a battery of instruments to measure patient characteristics that included perceived functional limitations , perceived quality of life , depression , and their beliefs about their health . Student 's t tests and chi-square tests were used to determine if non- and low-compliant patients differed significantly from high-compliant patients . Logistic regression was used to estimate adjusted odds ratios expressing the association of selected variables with compliance . RESULTS We found that 51 % of the patients were either noncompliant or low-compliant overall with the low back pain treatment program . There were differences in compliance behavior among the three treatment regimens , with compliance being highest for watching the back-education videotapes and lowest for doing the home exercises . Poor compliance overall was positively associated with the expectation of barriers in following the proposed treatment , with comorbidity , and with longer duration of treatment in this program . CONCLUSIONS The findings of our study indicate that patient compliance with back pain treatment is a serious and complex problem . Nevertheless , while this study was only an exploratory one , we believe that the results of this study can be used by care providers to identify patients likely to become noncompliant and also by research ers to plan specific studies on the effectiveness of treatment programs for patients with low back pain The aim of this study was to examine the effects of threat appraisal ( perceived susceptibility to re-injury or retarded rehabilitation and perceived severity of injury ) and coping appraisal ( self-efficacy , treatment efficacy and outcome value ) , in the framework of Protection Motivation Theory ( PMT ) , on compliance to a sports physiotherapist 's prescribed modalities and rest . During extensive developmental work , a Sports Injury Rehabilitation Beliefs Survey was constructed with 19 items to assess the PMT components . Five compliance measures were developed from physiotherapist and patient surveys . Data from 62 subjects ( 68 % female , mean + /- S.D. age 21.7 + /- 2.85 years , and involved in many recreational and competitive activities ) were obtained from a single university-based sports injury clinic , in a prospect i ve study . The study revealed that over half the subjects were subsequently non-compliant to some degree . Greater perceptions of both susceptibility to retarded rehabilitation and injury severity , at the first appointment , were related to subsequent non-compliant behaviour . Greater self-efficacy in the ability to perform prescribed rehabilitation modalities , stronger beliefs in the treatment efficacy , and higher value attached to rehabilitation , were all related to compliant behaviour . Compliance to restricted activity ( or rest ) was only related to greater perceptions of susceptibility . The findings provide some support for PMT in this context and offer a basis for design ing sports therapist interventions which focus on threat and coping appraisal Paper diaries are commonly used in health care and clinical research to assess patient experiences . There is concern that patients do not comply with diary protocol s , possibly invalidating the benefit of diary data . Compliance with paper diaries was examined with a paper diary and with an electronic diary that incorporated compliance-enhancing features . Participants were chronic pain patients and they were assigned to use either a paper diary instrumented to track diary use or an electronic diary that time-stamped entries . Participants were instructed to make three pain entries per day at predetermined times for 21 consecutive days . Primary outcome measures were reported vs actual compliance with paper diaries and actual compliance with paper diaries ( defined by comparing the written times and the electronically-recorded times of diary use ) . Actual compliance was recorded by the electronic diary . Participants su bmi tted diary cards corresponding to 90 % of assigned times ( + /-15 min ) . However , electronic records indicated that actual compliance was only 11 % , indicating a high level of faked compliance . On 32 % of all study days the paper diary binder was not opened , yet reported compliance for these days exceeded 90 % . For the electronic diary , the actual compliance rate was 94 % . In summary , participants with chronic pain enrolled in a study for research were not compliant with paper diaries but were compliant with an electronic diary with enhanced compliance features . The findings call into question the use of paper diaries and suggest that electronic diaries with compliance-enhancing features are a more effective way of collecting diary information Attrition in an experimental osteoarthritis intervention was studied among 364 ( 130 male ) volunteers ( ages 60 - 87 ) . Subjects were r and omly assigned to control , social support , education , or combined treatment groups . A series of discriminant function analyses showed that the final intervention groups were more homogeneous than the original sample s. The most robust predictor of attrition was having either high or very low depression scores . Social support variables were predictors of poor attendance in the social support group , indicating possible attrition bias in evaluating this treatment . The results indicate that psychosocial variables may be the best predictors of attrition in health intervention research among older subjects , and that variables related to attrition can be related to the content of the intervention BACKGROUND AND PURPOSE This correlational study describes factors that are related to patient compliance with exercise regimens during physical therapy . We investigated whether patient compliance was related to characteristics of the patient or the patient 's illness , to the patient 's attitude , or to the physical therapist 's behavior . SUBJECTS AND METHODS Of a r and om sample of 300 physical therapists in private practice in the Netherl and s , 222 therapists responded to a question naire survey . Eighty-four respondents also made audio recordings . Material s of the study were 1,931 registration forms , 1,837 audio-recorded sessions of physical therapy sessions , and 1,681 patient question naires . RESULTS The results show that the three main factors related to noncompliance were ( 1 ) the barriers patients perceive and encounter , ( 2 ) the lack of positive feedback , and ( 3 ) the degree of helplessness . The first factor , the barriers patients perceive and encounter , shows the strongest relation with noncompliance . The results also show that noncompliance is more strongly related to the characteristics of the illness than to the illness , a bad prognosis is negatively related to compliance , and much hindrance of the complaint is positively related to compliance . There was no difference between men and women with regard to patient compliance , but less educated patients were slightly more compliant than more highly educated patients . CONCLUSION AND DISCUSSION These correlational findings can be used to formulate hypotheses of cause and effect in future clinical research . Future research should take into account the type and efficacy of therapeutic exercise for different diseases . For physical therapy practice , it seems important that physical therapists carefully explore which problems patients encounter in their efforts to comply and that they seek solutions to those problems in mutual cooperation with their patients OBJECTIVE : To examine whether the relationships between psychological factors and rehabilitation adherence after knee surgery differ as a function of age . DESIGN AND SETTING : Participants completed inventories of self-motivation , social support , athletic identity , and psychological distress before anterior cruciate ligament ( ACL ) reconstruction . After surgery , participants recorded their completion of home rehabilitation exercises and cryotherapy , and the sport rehabilitation professionals providing their treatment reported on the patients ' attendance at , and adherence during , rehabilitation sessions . SUBJECTS : Sixty-one individuals with acute ACL tears . ME \n Output:\n " }, { "from": "agent", "value": "The review included twenty high quality studies investigating barriers to treatment adherence in musculoskeletal population s. There was strong evidence that poor treatment adherence was associated with low levels of physical activity at baseline or in previous weeks , low in-treatment adherence with exercise , low self-efficacy , depression , anxiety , helplessness , poor social support/activity , greater perceived number of barriers to exercise and increased pain levels during exercise ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: Background : Although effective treatment of depressed patients requires regular follow-up contacts and symptom monitoring , an efficient method for assessing treatment outcome is lacking . We investigated responsiveness to treatment , reproducibility , and minimal clinical ly important difference of the Patient Health Question naire-9 ( PHQ-9 ) , a st and ard instrument for diagnosing depression in primary care . Methods : This study included 434 intervention subjects from the IMPACT study , a multisite treatment trial of late-life depression ( 63 % female , mean age 71 years ) . Changes in PHQ-9 scores over the course of time were evaluated with respect to change scores of the SCL-20 depression scale as well as 2 independent structured diagnostic interviews for depression during a 6-month period . Test-retest reliability and minimal clinical ly important difference were assessed in 2 subgroups of patients who completed the PHQ-9 twice exactly 7 days apart . Results : The PHQ-9 responsiveness as measured by effect size was significantly greater than the SCL-20 at 3 months ( −1.3 versus −0.9 ) and equivalent at 6 months ( −1.3 versus −1.2 ) . With respect to structured diagnostic interviews , both the PHQ-9 and the SCL-20 change scores accurately discriminated patients with persistent major depression , partial remission , and full remission . Test-retest reliability of the PHQ-9 was excellent , and its minimal clinical ly important difference for individual change , estimated as 2 st and ard errors of measurement , was 5 points on the 0 to 27 point PHQ-9 scale . Conclusions : Well-vali date d as a diagnostic measure , the PHQ-9 has now proven to be a responsive and reliable measure of depression treatment outcomes . Its responsiveness to treatment coupled with its brevity makes the PHQ-9 an attractive tool for gauging response to treatment in individual patient care as well as in clinical research OBJECTIVES The authors examine whether physician education has enduring effects on treatment of depression . METHODS Depressed primary care patients initiating antidepressant treatment from primary care clinics of a staff-model health maintenance organization were studied . Quasi-experimental and before- and -after comparisons of physician practice s , supplemented with patient surveys , were used to compare the process of care and depression outcomes . Intervention consisted of extensive physician education that spanned a 12-month period . This included case-by-case consultations , didactics , academic detailing ( eg , clearly stating the educational and behavioral objectives to individual physicians ) , and role-play of optimal treatment . Main outcome measures were divided into two groups . Quasi-experimental sample s included : ( 1 ) antidepressant medication selection and ( 2 ) adequacy ( dosage and duration ) of pharmacotherapy . Survey sample s included : ( 3 ) intensity of follow-up ; ( 4 ) physician delivered educational messages regarding depression treatment ; ( 5 ) patient satisfaction ; and ( 6 ) depression outcomes . RESULTS No lasting educational effect was observed consistently in any of the outcomes measured . CONCLUSIONS There was no enduring improvement in the treatment of depression for primary care patients . Depression treatment guidelines were achieved contemporaneously , however , for intervention patients enrolled in a multifaceted program of collaborative care during the training period . These results suggest that continuing programs of reorganized service delivery to support the role of a primary care physician ( eg , on-site mental health personnel , close monitoring of patient progress and adherence ) , in addition to physician training , are essential for the success of guideline implementation \n Output:\n " }, { "from": "agent", "value": "These were influenced by GPs ' experience ( years in practice ) , and perceived time spent dealing with depression ( involvement ) .\nUse of the question naire enabled more experienced GPs to relinquish control , encourage patient involvement , and offer alternative sources of help .\nThey felt less responsible for overall care .\nLess experienced , and less involved GPs found question naires supportive through increasing their confidence in asking difficult questions , and were encouraged to look for depression , which they might previously have avoided .\nUsing mental health question naires helped GPs feel more confident in detecting and managing depression , and there was greater willingness to use question naires than found in previous studies .\nMost GPs sought reduced responsibility in ongoing care , using question naires to involve patients and pass responsibility to them or other agencies" } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: Purpose . To evaluate the effectiveness of autologous fibrin tissue adhesive ( auto-FTA ) in reducing blood loss during cementless total hip arthroplasty ( THA ) . Methods . From September 2000 to August 2001 , 100 patients who predonated 400 ml of autologous blood were r and omised to undergo either st and ard treatment with auto-FTA ( auto-FTA group ) or st and ard treatment alone ( control group ) . The volume of postoperative blood loss and the decrease in haemoglobin level were measured . All patients were followed up for 3 years to evaluate the rate of bone ingrowth and heterotopic ossification . Results . The mean postoperative blood loss was 580 ml ( st and ard deviation [ SD ] , 240 ml ) in the auto-FTA group and 810 ml ( SD , 341 ml ) in the control group ; the difference was significant ( 230 ml , p<0.001 ) . The decrease in haemoglobin concentration was 17 g/l ( SD , 11 g/l ) in the auto-FTA group and 22 g/l ( SD , 12 g/l ) in the control group . The difference was significant ( 5 g/l , p=0.03 ) . The percentage of total blood loss of > 1200 ml in any single patient was significantly lower in the auto-FTA group ( 4 % ) than in the control group ( 20 % ) [ p=0.01 ] . Conclusion . Auto-FTA is a safe and effective means of reducing perioperative blood loss in THA The ideal method of providing tranexamic acid ( TXA ) for decreasing hemoglobin drop after TKA is still controversial . In this clinical trial , 200 patients were r and omly allocated to four groups . In group 1,500 mg TXA was administered intravenously . In group 2 , the joint irrigated with 3 g of TXA in 100 cc of saline . In group 3 , 1.5 g of TXA was injected through the drain . Group 4 did not take TXA . Albeit all methods had a statistical effect on hemoglobin drop , drainage and number of transfused units when compared to controls , but intravenous injection of TXA seems to be much more effective in terms of reducing hemoglobin drop and transfused units ; and what 's more TXA injection by drain is more effective regarding to reducing postoperative drainage In surgical practice , hemostasis is used to minimize postoperative bleeding in total knee arthroplasty . We performed a prospect i ve r and omized study to determine the influence of tourniquet use and the timing of its release on amount of bleeding . Eighty four patients ( 96 knees ) were scheduled for total knee arthroplasty and r and omly divided into three groups . Posterior cruciate retaining bicompartmental total knee prostheses were used in all . In group I , no tourniquet was used . In group II , a tourniquet was used and was deflated for hemostasis once all components had been inserted . In group III , the tourniquet was deflated after wound closure and application of a compressive dressing . Mean blood drainage , mean volume of blood transfusion , hemoglobin ( Hb ) and hematocrit ( Hct ) values and operative time were compared between the three groups . Mean blood drainage was 810 mL ( 300 - 1300 ) in groups I 720 mL ( 240 - 1200 ) in group II and 705 mL ( 250 - 1150 ) in group III ( p = 0.062 ) . The Hb and Hct values , tourniquet time ( for groups II and III ) and volume of blood transfusion were similar . The operative time was significantly longer for first group ( p = 0.012 ) . Using tourniquet and its intraoperative release with hemostasis , does not reduce blood loss in total knee arthroplasty , but using tourniquet reduces operation time significantly Purpose The surgical stress of total knee arthroplasty ( TKA ) procedure and the application of intra-operative pneumatic thigh tourniquet increases local fibrinolytic activity , which contributes significantly to post-operative blood loss . Tranexamic acid , an antifibrinolytic drug , is commonly used to control post-operative blood loss . The recommended mode of administration of tranexamic acid is either oral or intravenous . However , the mechanism of action of the tranexamic acid points towards the possible effectiveness it may have following local/intra-articular application . This prospect i ve , double-blinded , r and omized preliminary study evaluated the efficacy of intra-articular tranexamic acid in reducing TKA-associated post-operative blood loss . Methods Fifty consenting patients with osteoarthritis of the knee scheduled for primary unilateral cemented-TKA were r and omly allocated to one of the two groups : Tranexamic Acid ( TA ) group ( n = 25 , 500 mg/5 ml tranexamic acid ) and the control group ( n = 25 , 5 ml 0.9 % saline ) . The drug and control solution were administered intra-articularly through the drain tube immediately after the wound closure . Parameters related to blood loss ( drop in haemoglobin , haematocrit differential ) and the drain output [ volume ( ml ) ] were compared between the two groups . Results On a comparative basis , TA-group obtained significant reduction in the drain output [ 95 % CI : 360.41–539.59 , p < 0.001 ] at 48 h post-operatively . Even though the control group received sixfold more blood transfusion than TA-group , it showed a greater drop in haemoglobin and haematocrit ( p < 0.05 ) . Conclusions Local application of tranexamic acid seems to be effective in reducing post-TKA blood loss as well as blood transfusion requirements . Level of evidence Therapeutic study , Level II In recent years , the application of fibrin sealant has been shown to be efficacious in the management of intraoperative and postoperative hemostasis . We design ed a prospect i ve r and omized controlled clinical trial to assess the efficacy of two different dosages of fibrin sealant ( 5 and 10 ml ) in patients undergoing total knee arthroplasty , as compared with the untreated control group . A total of 90 patients entered the study , r and omly assigned to one of the three groups : treatment with 5 ml fibrin sealant ( 30 patients ) , with 10 ml fibrin sealant ( 30 patients ) or no treatment ( 30 patients ) . A statistically significant difference in the mean reduction of hemoglobin concentrations was found on the first postoperative day in the treated groups as compared with the controls : 5 ml fibrin sealant ( 2.6 mg/dl ) and 10 ml fibrin sealant ( 2.5 mg/dl ) vs. controls ( 3.7 mg/dl ) ( P = 0.024 ) . The mean number of blood transfusions was significantly lower in the treated groups : 5 ml ( 0.5 ) and 10 ml ( 0.3 ) of fibrin sealant vs. controls ( 1 ) ( P = 0.0019 ) . Functional recovery was also better in the treated groups : on the seventh day , the joint ROM ( range of motion ) was statistically superior in the 5 ml group ( 96.5 ° ) and 10 ml group ( 98.8 ° ) as compared with the controls ( 75.5 ° ) ( P < 0.0001 ) . This study supports the efficacy of administering fibrin sealant in the perioperative management of bleeding after total knee arthroplasty and shows that a 5 ml dosage yields a comparable outcome to the 10 ml dosage previously reported in the literature Purpose Several studies have investigated effectiveness of fibrin spray or bipolar sealer to control peri-operative bleeding and reduce the need for blood transfusion , but a direct comparison between the two methods has not been previously performed . We conducted a prospect i ve r and omised trial , with st and ard electrocautery as a control group . Methods In our investigation , 95 patients were r and omised to one of three parallel groups receiving ( 1 ) 10 mL of topical fibrin spray before closure , ( 2 ) haemostasis with radiofrequency energy using a bipolar sealer , and ( 3 ) st and ard electrocautery . All patients and staff apart from the surgeons were blinded until data analysis was complete . Peri-operative blood loss has been calculated using a formula described by Ward and Gross ( considering estimated patient blood volume , pre- and post-operative haemoglobin and haematocrit levels ) , with mention of eventual blood re-infusion or transfusion , at given intervals from surgery ( 6 , 24 , 48 , 72 hours ) . Results Mean blood loss was lower for both methods investigated , compared to the control group at every time interval considered , although differences were stronger for fibrin spray [ Quixil ] . Mean blood saving at the given intervals from surgery ( 6–24–48–72 hours ) was respectively 96 ml , 129 ml , 296 ml , and 121 ml for bipolar sealer [ Aquamantys ] and 235 ml , 368 ml , 642 ml , and 490 ml for fibrin spray . These results are statistically significant ( p = 0.05 ) for fibrin spray at every interval compared to control values , while a significance is detectable for bipolar sealer only at 48 hours after surgery . Conclusions The fibrin spray group had the best performance in terms of blood loss , significantly reduced in comparison with the control group and bipolar sealer group . Blood loss reduction for the bipolar sealer was remarkable only at 48 hours , compared with the control group . Blood loss reduction for fibrin spray was significant at every time interval considered . Differences between the two treatments investigated and the control group narrowed slightly at 72 hours , as an expression of spontaneous homeostasis . Notable is the fact that blood volume saved with fibrin spray at 24 and 48 hours is comparable to the volume of at least one blood unit . A cost-effectiveness analysis should be considered in term of expense , biological risks ( related to blood transfusion or human-derived products use ) and bleeding-related complications Background The antifibrinolytic tranexamic acid reduces surgical blood loss , but studies have not identified an optimal regimen . Questions / purpose sWe studied different dosages , timings , and modes of administration to identify the most effective regimen of tranexamic acid in achieving maximum reduction of blood loss in TKA . Methods We prospect ively studied five regimens ( four intravenous , one local ; 40 patients each ) with a control group ( no tranexamic acid ) . The four intravenous ( 10-mg/kg dose ) regimens included ( 1 ) intraoperative dose ( IO ) given before tourniquet deflation , ( 2 ) additional preoperative dose ( POIO ) , ( 3 ) additional postoperative dose ( IOPO ) , and ( 4 ) all three doses ( POIOPO ) . The fifth regimen was a single local application ( LA ) . Two independent parameters of drain loss and total blood loss , calculated by the hemoglobin balance method , were evaluated statistically . Results Both parameters were reduced in all five regimens as against the control . A significant reduction in drain loss was seen in the POIO , IOPO , and POIOPO groups whereas total blood loss was significantly reduced in the POIO , POIOPO , and LA groups . The POIOPO group had the least drain loss ( 303 mL ) and least total blood loss ( 688 mL ) . The IO group had the greatest drain loss and the IOPO group the greatest total blood loss . Conclusions Single-dose tranexamic acid did not give effective results . The two-dose regimen of POIO was the least amount necessary for effective results . When compared against the control , this regimen produced reduction of drain loss and total blood loss , whereas the IOPO regimen did not . The three-dose regimen of POIOPO produced maximum effective reduction of drain loss and total blood loss . Level of Evidence Level I , therapeutic study . See Guidelines for Authors for a complete description of levels of evidence Background Total knee arthroplasty is associated with a significant postoperative blood loss even without any form of perioperative anticoagulation . Methods The potential role of QUIXIL ® , a fibrin sealant used in orthopaedic surgery to control blood loss and avoid blood transfusions in patients undergoing total knee arthroplasty was evaluated in a prospect i ve r and omized trial with twenty-four patients diagnosed with primary osteoarthritis of the knee . Results Results showed that application of 2 ml QUIXIL ® adds costs to treatment without reducing the number of transfused red blood cell counts and postoperative haemoglobin loss . However , significant lower levels of postoperative fluid loss ( P = 0.026 ) was detected in QUIXIL ® treated patients . Conclusion Regarding cost effectiveness and benefit no indication for the use of 2 ml QUIXIL ® fibrin sealant in st and ard knee arthroplasty could be proofed statistically Tranexamic acid ( TEA ) , an inhibitor of fibrinolysis , reduces blood loss after routine total knee replacement ( TKR ) . However , controversy persists regarding the dosage and timing of administration of this drug during surgery . We performed a prospect i ve r and omised controlled study to examine the optimum blood-saving effect of TEA in minimally invasive TKR . We r and omly assigned 151 patients who underw \n Output:\n " }, { "from": "agent", "value": "Tranexamic acid administered either orally , topically , intravenously or in combination decreased blood loss , increased the post-operative haemoglobin level , decreased the number of patients receiving blood transfusions and minimised the length of stay .\nA similar result was found for fibrin spray in total hip arthroplasty .\nHowever , for total knee arthroplasty , the outcome was blurred .\nTourniquet use was uniformly not significant in the measured parameters .\nTranexamic acid is useful in managing anaemia and blood loss .\nFibrin sealant also has this potential , but is not more potent than tranexamic acid .\nTourniquet use is not advantageous" } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: For the early career research er or PhD student about to have a leading role in a clinical trial , it would be a tremendous help to have a ‘ How to ’ guide , consisting of advice and key literature to help the research er move successfully along the initial trial pathway from research question to protocol completion . While the ideal trial team should include experienced trialists , who participate in the preparatory research meetings , this support is not always available . The PREPARE Trial guide is intended to assist the early career research er in this situation , but not replace an experienced trial team and regular research meetings . The guide may also serve as preparation for research meetings , or part of curricula for courses on research methodology , to be used by experienced PhD supervisor , trialist or lecturer . Evidence from r and omised controlled trials ( RCTs ) is often wasted1 2 ( for a collection of papers relating to this issue , please see http:// research waste.net/ ) . Many trials are not published , and hence the results are not reported , which is indeed a waste . There are many reasons for this waste , but we believe that at least some trials are discontinued because of poor trial planning . Similarly , many completed and published trials suffer from fundamental flaws or poor conduct due to lack of preparation and careful planning . Some flaws in the conception or planning phase prior to the finalised trial protocol and registration are difficult to rectify once the trial starts . For example , patients may decline participation if the study involves delaying or withholding treatment , or if the experimental condition is deemed unfeasible by patients . This can be avoided , for example , by involving patients in the planning of the trial or by conducting pilot or feasibility studies prior to the full-scale trial . In many cases , the planning of a trial is as least as important as Context Some guidelines recommend splinting for symptomatic treatment of base-of-thumb osteoarthritis . Contribution In this r and omized trial , nighttime splinting had no effect compared with usual care after 1 month , but it clinical ly significantly reduced patients ' pain and disability after 12 months . Caution The study was not blinded , and the splints were custom-made . Implication Nighttime splinting is an effective treatment of base-of-thumb osteoarthritis . The Editors Base-of-thumb osteoarthritis ( BTOA ) is a relatively common condition affecting middle-age and older persons ( 1 ) . Base-of-thumb osteoarthritis induces pain and closure of the first web , which in turn causes an alteration of the thumbindex pinch and , therefore , limitation in h and function ( 1 ) . The consequences of BTOA have been specifically evaluated and compared with osteoarthritis of digits 2 to 5 of the interphalangeal joints ( 2 ) . Substantial pain and similar pain and disability levels were observed in both osteoarthritis locations , and results suggested that h and osteoarthritis ( base of thumb or interphalangeal joints ) is as cumbersome as a rheumatoid arthritis of the h and for some people ( 3 , 4 ) . Few treatments have been specifically assessed in BTOA . The European League Against Rheumatism recently proposed 11 evidence -based recommendations for the management of h and osteoarthritis ( 5 ) . Among these , 3 specifically concern BTOA : intra-articular corticosteroid injections for painful flares , surgery when conservative treatments have failed , and splints to prevent or correct lateral angulation and flexion deformity . However , no r and omized trials with placebo or nonsplint comparison have been done to support this recommendation . Two small ( 26 and 21 participants each ) head-to-head , r and omized , controlled trials ( RCTs ) found better pain relief with a full splint ( covering the thumb base and wrist ) than with a half splint ( covering only the thumb base ) ( 6 , 7 ) . However , these studies did not examine the effect on disability or closure of the first web . More recently , a small RCT compared 2 splints and exercise regimens and found no short-term differences ( 8) . The conclusions of the European League Against Rheumatism st and ing committee on splints for BTOA was that apart from expert opinion , placebo-controlled or nonsplint-controlled research evidence [ is ] required ( 5 ) . We conducted an RCT to assess the efficacy of splinting for BTOA on pain at 1 month . Secondary objectives were to assess the efficacy of splinting for BTOA on pain and disability at 12 months and safety and adherence with splinting for BTOA . Methods Design We conducted a 12-month , open-label , parallel-group , multicenter RCT in 2 tertiary care hospitals ( Cochin Hospital and Lariboisire Hospital , Paris , France ) after method ological and reporting guidelines ( 9 , 10 ) . Participants We screened all patients who consulted with physicians ( mostly rheumatologists ) for disabling BTOA during outpatient visits at tertiary care hospitals or at private practice s for inclusion in the trial and invited them to participate . Inclusion criteria were pain at the base of the thumb 30 mm or greater on a visual analogue scale ( VAS ) ( range , 0 to 100 mm ) , age 45 to 75 years , radiographic evidence of at least 2 of 4 radiographic items ( osteophytes , joint space narrowing , subchondral bone sclerosis , or subchondral cysts ) , and at least 1 of 2 clinical items ( trapeziometacarpal joint enlargement or closure of the first web ) at the trapeziometacarpal joint . Other h and joints could be affected . Exclusion criteria were posttraumatic osteoarthritis , crystal arthritis , inflammatory arthritis , neurologic disorder involving the upper limb , h and or wrist trauma within the past 2 months , previous h and surgery , collagen diseases ( the Dupuytren syndrome , the Marfan syndrome , or the EhlersDanlos syndrome ) , h and or wrist infiltration within 2 months , skin disease interfering with wearing the splint , having already worn a splint for BTOA ( that is , splinting had been previously proposed ) , having bilateral BTOA with no predominant symptomatic side , psychiatric disorder needing treatment adaptation in the past 3 months , inability to speak or write French , and pregnancy . Ethics Approval The local ethics committee approved the study protocol , and all patients gave written informed consent to participate . Intervention Patients were r and omly assigned to receive a custom-made neoprene splint to be worn at night or to usual care . The splint was a rigid rest orthosis recommended for use only at night . It covered the base of the thumb and the thenar eminence but not the wrist ( Figure 1 ) . Splints were made by 3 trained occupational therapists , who adjusted the splint for each patient so that the first web could be opened and the thumb placed in opposition with the first long finger . Patients were encouraged to contact the occupational therapist if they felt that the splint needed adjustment , pain increased while wearing the splint , or they had adverse effects ( such as skin erosion ) . Figure 1 . Dorsal view ( top ) and palmar view ( bottom ) of a custom-made neoprene splint for base-of-thumb osteoarthritis . Because no treatment can be considered the gold st and ard in this situation , patients in the control and intervention groups received usual care at the discretion of their physician ( general practitioner or rheumatologist ) . We decided not to use a placebo because , to our knowledge , no placebo for splinting has achieved successful blinding of patients , as recommended ( 11 ) . Furthermore , use of a placebo could underestimate the treatment effect ( 12 ) . R and omization and Allocation Concealment We r and omly assigned patients who met the inclusion criteria and agreed to participate . The r and omization process was central ized at the coordinating office ( Clinical Research Unit , Cochin Hospital ) , which had no involvement in enrollment , follow-up , or assessment of participants . A statistician made a computer-generated r and omization list ( with a block size of 6 and stratified by center ) at the coordinating office . Once the screening process was complete , the investigator sent a fax to the coordinating office . The coordinating office r and omly assigned the patient to a treatment and faxed the investigator the allocated treatment . Patients r and omly assigned to wear the custom-made neoprene splint were sent information on an appointment time to meet with 1 of the 3 trained occupational therapists to adjust the splint within 1 week after inclusion . Outcome Measures Our primary outcome was change in pain level assessed on a VAS ( 0 to 100 mm ) from baseline to 1 month . Secondary outcomes were change in measures of h and disability at 1 month , as well as change in pain level and measures of disability at 12 months . Two independent , trained physicians of physical medicine and rehabilitation ( who were not involved in patients ' treatment ) assessed several clinical and radiographic ( structural ) variables at enrollment ( baseline ) and at 1 , 6 , and 12 months . Clinical Variables We assessed several clinical variables at each visit . We assessed pain during the previous 48 hours ( VAS , 0 to 100 mm ) . A clinical ly relevant success at the individual level was defined by the following improvement thresholds : greater than 10 , 15 , and 20 mm on a 0- to 100-mm VAS for pain ( 13 ) . H and disability was assessed by using the Cochin H and Functional Scale score ( 0 = low level of disability ; 90 = high level of disability ) ( 3 , 4 , 14 ) . We also assessed patient global perceived disability ( VAS , 0 to 100 mm ) and patient global assessment ( semiquantitative scale of 6 points : worse , the same , weakly improved , fairly improved , much improved , or totally improved ) at 1 , 6 , and 12 months . We considered patients who responded at least fairly as having improved . We assessed pinch strength by using an electronic dynamometer ( Amplifier HDM , Socit Biometrics France , Parc Club Orsay Universit , Orsay , France ) ( 15 , 16 ) . We tested pinch strength 3 times ( 1 minute apart ) and recorded the highest value , and we also assessed pain during pinch ( VAS , 0 to 100 mm ) . Thumb mobility , evaluated by the Kap and ji index thumb opposition ( 0 to 10 for each side ) and counter-opposition subscales ( 0 to 4 for each side ) ( 0 = impossible to do ) , was also assessed ( 1719 ) . Closure of the first web ( at baseline and 12 months ) was examined . A photograph of both h and s was taken with the patient sitting on a chair , palms of the h and s and wrists resting on a table in front . We asked patients to put the thumb in maximal abduction ( Figure 2 ) . One physician calculated the angle between the line measured along the medial side of the thumb after the axis of the first and second phalanges and the line measured along the lateral side of the index after the axis of the first and second phalanges by using a goniometer . We assessed intrarater reliability on the 40 first measures as good , with an intraclass correlation coefficient of 0.96 . Figure 2 . First web closure and measurement of maximal abduction . Top . Example of a closure of the first web in base-of-thumb osteoarthritis . Bottom . Measurement of the angle in maximal abduction . The angle between the line measured along the medial side of the thumb after the axis of the first and second phalanges and the line measured along the lateral side of the index after the axis of the first and second phalanges was calculated by using a goniometer . Radiographic Variables Patients had st and ardized radiography of the h and at baseline and 12 months . Images of both h and s , palm down , were taken on the same film . To obtain optimal positioning , we asked patients to sit in front of the radiography table and rest their palms comfortably on the table . One experienced reader ( blinded to treatment allocation and any order of patients undergoing radiography ) assessed the radiographs . We blinded films for date s and names , and baseline and follow-up films were mixed . We assessed radiographic evidence of progression of This article introduces the approach of GRADE to rating quality of evidence . GRADE specifies four categories-high , moderate , low , and very low-that are applied to a body of evidence , not to individual studies . In the context of a systematic review , quality reflects our confidence that the estimates of the effect are correct . In the context of recommendations , quality reflects our confidence that the effect estimates are adequate to support a particular recommendation . R and omized trials begin as high- quality evidence , observational studies as low quality . \" Quality \" as used in GRADE means more than risk of bias and so may also be compromised by imprecision , inconsistency , indirectness of study results , and publication bias . In addition , several factors can increase our confidence in an estimate of effect . GRADE provides a systematic approach for considering and reporting each of these factors . GRADE separates the process of assessing quality of evidence from the process of making recommendations . Judgments about the strength of a recommendation depend on more than just the quality of evidence Fregni F , Imamura M , Chien HF , Lew HL , Boggio P , Kaptchuk TJ , Riberto M , Hsing WT , Battistella LR , Furlan A : Challenges and recommendations for placebo controls in r and omized trials in physical and rehabilitation medicine : A report of the International Placebo Symposium Working Group . Compared with other specialties , the field of physical and rehabilitation medicine has not received the deserved recognition from clinicians and research ers in the scientific community . One of the reasons is the lack of sound evidence to support the traditional physical and rehabilitation medicine treatments . The best way to change this disadvantage is through a well conducted clinical research , such as st and ard placebo- or sham-controlled r and omized clinical trials . Therefore , having placebo groups in clinical trials is essential to improve the level of evidence -based practice in physical and re \n Output:\n " }, { "from": "agent", "value": "No significant effect was found at short-term or for different types of splints .\nNo studies reported HR-QoL. CONCLUSIONS Splinting demonstrated a moderate to large effect for pain and small to moderate effect for function in the medium-term but not in the short term ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: Background The minimum local analgesic concentration ( MLAC ) has been defined as the median effective local analgesic concentration ( EC50 ) in a 20-ml volume for epidural analgesia in the first stage of labor . The aim of this study was to determine the relative local anesthetic sparing efficacies of intravenous and epidural fentanyl by comparison of their effects on the MLAC of bupivacaine . Methods In this double-blind , r and omized , prospect i ve study , 84 parturients at ≤ 7-cm cervical dilation who requested epidural analgesia were allocated to one of two groups . After lumbar epidural catheter placement , 20 ml bupivacaine ( n = 44 ) or bupivacaine with 3 & mgr;g/ml ( 60 & mgr;g ) fentanyl ( n = 40 ) was administered . The plain bupivacaine group then received 60 & mgr;g intravenous fentanyl . The bupivacaine – fentanyl group received intravenous saline . The concentration of bupivacaine was determined by the response of the previous patient in that group to a higher or lower concentration using up – down sequential allocation . Analgesic efficacy was assessed using 100-mm visual analog pain scores , with ≤ 10 mm within 30 min defined as effective . Results The MLAC of bupivacaine – intravenous fentanyl was 0.064 % wt/vol ( 95 % confidence interval , 0.049–0.080 ) , and the MLAC of bupivacaine – epidural fentanyl was 0.034 % wt/vol ( 95 % confidence interval , 0.017–0.050 ) . Epidural fentanyl significantly increased the analgesic potency of bupivacaine by a factor of 1.88 ( 95 % confidence interval , 1.09–3.67 ) compared with intravenous fentanyl . The epidural fentanyl group demonstrated significantly higher dermatomal spread ( P = 0.0064 ) and increased pruritus ( P = 0.01 ) . Conclusions Epidural fentanyl significantly reduced the MLAC of bupivacaine when compared with intravenous fentanyl for the parturients in this study . The significantly enhanced local anesthetic sparing , dermatomal level , and pruritus with epidural fentanyl suggest a primarily spinal site of action OBJECTIVE To evaluate the effects of epidural analgesia using 0.2 % Ropivacaine on the mother , newborn and during labor . METHODS This study was conducted at the Zeynep Kamil Obstetric , Gynecology , and Pediatric Research and Training Hospital in Istanbul , Turkey , between July 2003 and April 2004 . Eighty pregnant women of 37 - 41 weeks ' gestation were enrolled in the study . Forty cases received epidural analgesia ( group 1 ) and the control group composed 40 cases ( group 2 ) . Duration of labor , systolic and diastolic blood pressures at initial , 15th , 30th , 45th and 60th minutes , and number of breathing per minute , pulse rates , fetal heart rates and presence of motor block were recorded . Blood gas assessment s from the umbilical cord , 1st and 5th minute Apgar scores were noted following the delivery . Way of delivery , adverse effects and complications of the epidural analgesia were recorded . RESULTS Mean age of the cases was 24.79 + /- 4.72 years . Duration between full cervical dilation and delivery ( phase 2 ) was significantly longer in group 1 ( p<0.01 ) . Sixty minutes systolic arterial pressure was significantly lower in group 1 ( p<0.05 ) . In group 1 , diastolic arterial pressures at 15th , 45th , 60th minutes ( p<0.01 ) and 30th minute ( p<0.05 ) were significantly lower when compared to the initial values . No significant differences were recorded in terms of breathing rates , umbilical cord CO2 , O2 , pH levels and Apgar scores between the 2 groups . The most common adverse effect of epidural analgesia was sedation ( 59 % ) . The second dose of Ropivacaine was needed in 24 ( 61.5 % ) cases in group 1 . In group 1 , 29 ( 74.4 % ) patients expressed their pleasure as very good regarding the epidural analgesia . CONCLUSION Epidural analgesia , if administered by a specialist to a properly selected patient at proper time , leads to a comfortable delivery by relieving the pain . It can be performed safely after taking an informed consent Purpose Epidural analgesia is associated with hyperthermia during labor and presumably causes it , although no convincing mechanism has been postulated . It seems likely that fever associated with pyrogenic factors related to labor is suppressed by opioids , whereas it is expressed normally in patients given epidural analgesia . We examined this hypothesis and the possible etiology of temperature elevation in labor . Methods In this prospect i ve , r and omized , controlled study , we assessed 201 parturients during spontaneous labor . Analgesia was r and omly provided with one of four treatment groups : ( 1 ) epidural ropivacaine alone , ( 2 ) IV remifentanil alone , ( 3 ) epidural ropivacaine plus IV remifentanil , and ( 4 ) epidural ropivacaine plus IV acetaminophen . At r and omization , patients were normothermic . Intrapartum hyperthermia ( ≥38 ° C ) was correlated to the analgesic technique . Results The maximum increase in oral temperature was greatest in the ropivacaine group ( 0.7 ± 0.6 ° C ) and least in the remifentanil group ( 0.3 ± 0.4 ° C ; P = 0.013 ) . The percentage of patients who became hyperthermic ( ≥38 ° C ) during the first 6 h of labor was greatest in the ropivacaine group ( 14 % ) and least in the remifentanil-alone group ( 2 % ) , but the difference was not statistically significant . The maximum forearm-finger gradients were lower ( less vasoconstriction ) in the remifentanil group when compared to the gradients in patients with epidural analgesia ( 1.4 ± 1.8 vs 3.0 ± 1.7 , respectively ; P < 0.001 ) . Conclusion Our results are consistent with the theory that low-dose opioids inhibit fever in patients not given epidural analgesia . However , in view of the negative results , the hypothesis of epidural-induced hyperthermia may be question able Background Reports indicate that the administration of epidural analgesia for pain relief during labor interferes with labor and increases cesarean deliveries . However , only a few controlled trials have assessed the effect of epidural analgesia on the incidence of cesarean delivery . The authors ' primary purpose in this r and omized study was to evaluate the effects of epidural analgesia on the rate of cesarean deliveries by providing a suitable alternative : patient-controlled intravenous analgesia . Methods Seven hundred fifteen women of mixed parity in spontaneous labor at full term were r and omly assigned to receive either epidural analgesia or patient-controlled intravenous meperidine analgesia . Epidural analgesia was maintained with a continuous epidural infusion of 0.125 % bupivacaine with 2 micro gram/ml fentanyl . Patient-controlled analgesia was maintained with 10 - 15 mg meperidine given every 10 min as needed using a patient-controlled pump . Procedures recorded in a manual that prescribed the intrapartum management were followed for each woman r and omized in the study . Results A total of 358 women were r and omized to receive epidural analgesia , and 243 ( 68 % ) of these women complied with the epidural analgesia protocol . Similarly , 357 women were r and omized to receive patient-controlled intravenous meperidine analgesia , and 259 ( 73 % ) of these women complied with the patient-controlled intravenous analgesia protocol . Only five women who were r and omized and received patient-controlled intravenous meperidine analgesia according to the protocol crossed over to epidural analgesia due to inadequate pain relief . There was no difference in the rate of cesarean deliveries between the two analgesia groups using intention-to-treat analysis based on the original r and omization ( epidural analgesia , 4 % [ 95 % CI : 1.9 - 6.2 % ] compared with patient-controlled intravenous analgesia , 5 % [ 95 % CI : 2.6 - 7.2 % ] ) . Similar results were observed for the analysis of the protocol -compliant groups ( epidural analgesia , 5 % [ 95 % CI : 2.6 - 8.5 % ] compared with patient-controlled intravenous analgesia , 6 % [ 95 % CI : 3 - 8.9 % ] ) . Women who received epidural analgesia reported lower pain scores during labor and delivery compared with women who received patient-controlled intravenous analgesia . Conclusions Epidural analgesia was not associated with increased numbers of cesarean delivery when compared with a suitable alternative method of analgesia OBJECTIVE To estimate the effect of epidural analgesia on the Friedman labor curve . METHODS This study was a secondary analysis of a previously reported r and omized trial of the effects of patient‐controlled epidural analgesia during labor compared with patient‐controlled meperidine on cesarean delivery rate . All subjects had a singleton , cephalic , nonanomalous fetus at or beyond 37 weeks ' gestation . This secondary analysis was limited to women who had cervical dilatation commencing of at least 3 cm ( ie , active phase of labor ) . RESULTS A total of 459 women were r and omized . Twenty‐five women were excluded for a cervix less than 3 cm dilated , leaving 220 women allocated to patient‐controlled epidural analgesia and 214 to patient‐controlled intravenous meperidine available for analysis . There were no significant demographic differences between the two groups , including age , race , gestational age , and cervix on admission . The active phase of labor was 1 hour longer in the epidural‐treated group ( 6.0 ± 3.2 hours versus 5.0 ± 3.2 hours , P < .001 ) . The rate of cervical dilation was significantly less with epidural analgesia ( 1.4 cm/h versus 1.6 cm/h , P < .002 ) . The duration of the second stage tended to be longer in the epidural group ( 1.1 ± 1.5 hours versus 0.9 ± 1.0 hours , P = .079 ) . CONCLUSION Epidural analgesia prolonged the active phase of labor by 1 hour compared with Friedman 's original criteria Background Whether epidural analgesia for labor prolongs the active-first and second labor stages and increases the risk of vacuum-assisted delivery is a controversial topic . Our study was conducted to answer the question : does lumbar epidural analgesia with lidocaine affect the progress of labor in our obstetric population ? Method 395 healthy , nulliparous women , at term , presented in spontaneous labor with a singleton vertex presentation . These patients were r and omized to receive analgesia either , epidural with bolus doses of 1 % lidocaine or intravenous , with meperidine 25 to 50 mg when their cervix was dilated to 4 centimeters . The duration of the active-first and second stages of labor and the neonatal apgar scores were recorded , in each patient . The total number of vacuum-assisted and cesarean deliveries were also measured . Results 197 women were r and omized to the epidural group . 198 women were r and omized to the single-dose intravenous meperidine group . There was no statistical difference in rates of vacuum-assisted delivery rate . Cesarean deliveries , as a consequence of fetal bradycardia or dystocia , did not differ significantly between the groups . Differences in the duration of the active-first and the second stages of labor were not statistically significant . The number of newborns with 1-min and 5-min Apgar scores less than 7 , did not differ significantly between both analgesia groups . Conclusion Epidural analgesia with 1 % lidocaine does not prolong the active-first and second stages of labor and does not increase vacuum-assisted or cesarean delivery rate BACKGROUND Epidural analgesia initiated early in labor ( when the cervix is less than 4.0 cm dilated ) has been associated with an increased risk of cesarean delivery . It is unclear , however , whether this increase in risk is due to the analgesia or is attributable to other factors . METHODS We conducted a r and omized trial of 750 nulliparous women at term who were in spontaneous labor or had spontaneous rupture of the membranes and who had a cervical dilatation of less than 4.0 cm . Women were r and omly assigned to receive intrathecal fentanyl or systemic hydromorphone at the first request for analgesia . Epidural analgesia was initiated in the intrathecal group at the second request for analgesia and in the systemic group at a cervical dilatation of 4.0 cm or greater or at the third request for analgesia . The primary outcome was the rate of cesarean delivery . RESULTS The rate of cesarean delivery was not significantly different between the groups ( 17.8 percent after intrathecal analgesia vs. \n Output:\n " }, { "from": "agent", "value": "No studies reported on rare but potentially serious adverse effects of epidural analgesia .\nEpidural analgesia appears to be effective in reducing pain during labour .\nHowever , women who use this form of pain relief are at increased risk of having an instrumental delivery .\nEpidural analgesia had no statistically significant impact on the risk of caesarean section , maternal satisfaction with pain relief and long-term backache and did not appear to have an immediate effect on neonatal status as determined by Apgar scores ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: CONTEXT Although epidemiological studies have reported protective effects of religion and spirituality on mental health , it is unknown whether spirituality can be used as an intervention to improve psychological well-being . OBJECTIVE To evaluate the efficacy of a home study -based spirituality program on mood disturbance in emotionally distressed patients . DESIGN , SETTING , AND PARTICIPANTS A non-blinded , r and omized , wait list-controlled trial of 165 individuals with mood disturbance [ score of > 40 on the Profile of Mood States ( POMS ) ] were recruited from primary care clinics in a Canadian city between August 2000 and March 2001 . INTERVENTIONS Participants were r and omized to a spirituality group ( an 8-week audiotaped spirituality home- study program ) , a mindfulness meditation-based stress reduction group ( attendance at facilitated classes for 8 weeks ) , or a wait-list control group ( no intervention for 12 weeks ) . MAIN OUTCOME MEASURES Primary outcomes were mood disturbance , measured using POMS , and quality of life , measured using the SF-36 , a short-form health survey with 36 questions . The POMS and the SF-36 were completed at baseline , at 8 weeks , and at 12 weeks . RESULTS At the end of the 8-week intervention period , the mean POMS score improvement was -43.1 ( -45.7 % ) for the spirituality group , -22.6 ( -26.3 % ) for the meditation group , and -10.3 ( 11.3 % ) for the control group ( P<.001 for spirituality vs control group ; P=.034 for spirituality vs meditation group ) . Mean improvement in the SF-36 mental component summary score was 14.4 ( 48.6 % ) for the spirituality group , 7.1 ( 22.3 % ) for the meditation group , and 4.7 ( 16.1 % ) for the control group ( P<.001 for spirituality vs control group ; P=.029 for spirituality vs meditation group ) . At 12 weeks , POMS and SF-36 scores remained significantly different from baseline for the spirituality group Background Although several studies have reported positive effects of mindfulness-based stress reduction ( MBSR ) intervention on psychological well-being , it is not known whether these effects are attributable to a change in mindfulness . Purpose The aim of this study is to compare the effects of MBSR to a waiting-list control condition in a r and omized controlled trial while examining potentially mediating effects of mindfulness . Methods Forty women and 20 men from the community with symptoms of distress ( mean age 43.6 years , SD = 10.1 ) were r and omized into a group receiving MBSR or a waiting-list control group . Before and after the intervention period , question naires were completed on psychological well-being , quality of life , and mindfulness . Results Repeated measures multiple analysis of variance ( MANCOVAs ) showed that , compared with the control group , the intervention result ed in significantly stronger reductions of perceived stress ( p = 0.016 ) and vital exhaustion ( p = 0.001 ) and stronger elevations of positive affect ( p = 0.006 ) , quality of life ( p = .009 ) , as well as mindfulness ( p = 0.001 ) . When mindfulness was included as a covariate in the MANCOVA , the group effects on perceived stress and quality of life were reduced to non significance . Conclusion Increased mindfulness may , at least partially , mediate the positive effects of mindfulness-based stress reduction intervention Objective : The underlying changes in biological processes that are associated with reported changes in mental and physical health in response to meditation have not been systematic ally explored . We performed a r and omized , controlled study on the effects on brain and immune function of a well‐known and widely used 8‐week clinical training program in mindfulness meditation applied in a work environment with healthy employees . Methods : We measured brain electrical activity before and immediately after , and then 4 months after an 8‐week training program in mindfulness meditation . Twenty‐five subjects were tested in the meditation group . A wait‐list control group ( N = 16 ) was tested at the same points in time as the meditators . At the end of the 8‐week period , subjects in both groups were vaccinated with influenza vaccine . Results : We report for the first time significant increases in left‐sided anterior activation , a pattern previously associated with positive affect , in the meditators compared with the nonmeditators . We also found significant increases in antibody titers to influenza vaccine among subjects in the meditation compared with those in the wait‐list control group . Finally , the magnitude of increase in left‐sided activation predicted the magnitude of antibody titer rise to the vaccine . Conclusions : These findings demonstrate that a short program in mindfulness meditation produces demonstrable effects on brain and immune function . These findings suggest that meditation may change brain and immune function in positive ways and underscore the need for additional research Purpose . To determine if participation in a Wellness-Based Mindfulness Stress Reduction intervention decreases the effect of daily hassles , psychological distress , and medical symptoms . Design . A r and omized controlled trial of a stress reduction intervention with a 3-month follow-up . Setting . A university setting in West Virginia . Subjects . A total of 103 adults , with 59 in the intervention group and 44 in the control group . Eight-five percent of subjects completed the intervention . Fifty-nine percent and 61 % of the intervention and control subjects completed the study , respectively . Intervention . The intervention consisted of an 8-week group stress reduction program in which subjects learned , practice d , and applied “ mindfulness meditation ” to daily life situations . The control group received educational material s and were encouraged to use community re sources for stress management . Measures . The Daily Stress Inventory assessed the effect of daily hassles , the Revised Hopkins Symptom Checklist measured psychological distress , the Medical Symptom Checklist measured number of medical symptoms , and a Follow-up Question naire measured program adherence . Results . Intervention subjects reported significant decreases from baseline in effect of daily hassles ( 24 % ) , psychological distress , ( 44 % ) , and medical symptoms ( 46 % ) that were maintained at the 3-month follow-up compared to control subjects ( repeated measures analysis of variance [ ANOVA ] ; p < .05 ) . Conclusions . Self-selected community residents can improve their mental and physical health by participating in a stress reduction intervention offered by a university wellness program OBJECTIVES Patients with chronic obstructive lung disease ( COPD ) suffer from significant dyspnea and may benefit from complementary and alternative medicine ( CAM ) therapies aim ed at mitigating symptoms . The objective of this study was to test the efficacy of a mindfulness-based breathing therapy ( MBBT ) on improving symptoms and health-related quality of life in those with COPD . DESIGN We conducted a r and omized controlled trial of 8-week mindfulness-based breathing therapy ( MBBT ) compared to support groups to test efficacy on improving symptoms and health-related quality of life in those with COPD . SETTING The setting for this study was an academic-affiliated veterans healthcare system . SUBJECTS The subjects consisted of 86 patients with COPD . INTERVENTIONS MBBT included weekly meetings practicing mindfulness mediation and relaxation response . OUTCOME MEASURES The main outcome measure was a post 6-minute-walk test ( 6MWT ) Borg dyspnea assessment . Other outcome measures included health-related quality of life measures , 6MWT distance , symptom scores , exacerbation rates , and measures of stress and mindfulness . Analysis of covariance compared differences in outcomes between groups ; paired t test evaluated changes within groups . RESULTS Participants were predominantly elderly men with moderate to severe COPD . We found no improvements in dyspnea ( post 6MWT Borg difference between the MBBT and support group was 0.3 ( 95 % confidence interval [ CI ] : -1.1 , 1.7 ) . We found no differences between groups in almost all other outcome measures by either intention-to-treat analysis or within the subset that completed assigned group sessions . For the physical summary scale of the generic Short Form-36 for Veterans , the difference between outcomes favored the support group ( 4.3 , 95 % CI : 0.4 , 8.1 ) . Participant retention was low compared to mind-body trials that r and omize from CAM wait lists . CONCLUSIONS This trial found no measurable improvements in patients with COPD receiving a mindfulness-based breathing CAM therapy compared to a support group , suggesting that this intervention is unlikely to be an important therapeutic option for those with moderate-to-severe COPD Objective : Health-related quality of life ( HRQOL ) is often much reduced among individuals with multiple sclerosis ( MS ) , and incidences of depression , fatigue , and anxiety are high . We examined effects of a mindfulness-based intervention ( MBI ) compared to usual care ( UC ) upon HRQOL , depression , and fatigue among adults with relapsing-remitting or secondary progressive MS . Methods : A total of 150 patients were r and omly assigned to the intervention ( n = 76 ) or to UC ( n = 74 ) . MBI consisted of a structured 8-week program of mindfulness training . Assessment s were made at baseline , postintervention , and 6 months follow-up . Primary outcomes included disease-specific and disease-aspecific HRQOL , depression , and fatigue . Anxiety , personal goal attainment , and adherence to homework were secondary outcomes . Results : Attrition was low in the intervention group ( 5 % ) and attendance rate high ( 92 % ) . Employing intention-to-treat analysis , MBI , compared with UC , improved nonphysical dimensions of primary outcomes at postintervention and follow-up ( p < 0.002 ) ; effect sizes , 0.4–0.9 posttreatment and 0.3–0.5 at follow-up . When analyses were repeated among subgroups with clinical ly relevant levels of preintervention depression , fatigue , or anxiety , postintervention and follow-up effects remained significant and effect sizes were larger than for the total sample . Conclusions : In addition to evidence of improved HRQOL and well-being , these findings demonstrate broad feasibility and acceptance of , as well as satisfaction and adherence with , a program of mindfulness training for patients with MS . The results may also have treatment implication s for other chronic disorders that diminish HRQOL . Classification of evidence : This trial provides Class III evidence that MBI compared with UC improved HRQOL , fatigue , and depression up to 6 months postintervention For people at risk of depressive relapse , mindfulness-based cognitive therapy ( MBCT ) has an additive benefit to usual care ( H. F. Coelho , P. H. Canter , & E. Ernst , 2007 ) . This study asked if , among patients with recurrent depression who are treated with antidepressant medication ( ADM ) , MBCT is comparable to treatment with maintenance ADM ( m-ADM ) in ( a ) depressive relapse prevention , ( b ) key secondary outcomes , and ( c ) cost effectiveness . The study design was a parallel 2-group r and omized controlled trial comparing those on m-ADM ( N = 62 ) with those receiving MBCT plus support to taper/discontinue antidepressants ( N = 61 ) . Relapse/recurrence rates over 15-month follow-ups in MBCT were 47 % , compared with 60 % in the m-ADM group ( hazard ratio = 0.63 ; 95 % confidence interval : 0.39 to 1.04 ) . MBCT was more effective than m-ADM in reducing residual depressive symptoms and psychiatric comorbidity and in improving quality of life in the physical and psychological domains . There was no difference in average annual cost between the 2 groups . Rates of ADM usage in the MBCT group was significantly reduced , and 46 patients ( 75 % ) completely discontinued their ADM . For patients treated with ADM , MBCT may provide an alternative approach for relapse prevention The inability to cope successfully with the enormous stress of medical education may lead to a cascade of consequences at both a personal and professional level . The present study examined the short-term effects of an 8-week meditation-based stress reduction intervention on premedical and medical students using a well-controlled statistical design . Findings indicate that participation in the intervention can effectively ( 1 ) reduce self-reported state and trait anxiety , ( 2 ) reduce reports of overall psychological distress including depression , ( 3 ) increase scores on overall empathy levels , and ( 4 ) increase scores on a measure of spiritual experiences assessed at termination of intervention . These results ( 5 ) replicated in the wait-list control group , ( 6 ) held across different experiments , and ( 7 ) were observed during the exam period . Future research should address potential long-term effects of mindfulness training for medical and premedical students UNLABELLED Mindfulness meditation training has stress reduction benefits in various patient population s , but its effects on biological markers of HIV-1 progression are unknown . The present study tested the efficacy of an 8-week Mindfulness-based stress reduction ( MBSR ) meditation program compared to a 1-day control seminar on CD4 + T lymphocyte counts in stressed HIV infected adults . A single-blind r and omized controlled trial was conducted with enrollment and follow-up occurring between November 2005 and December 2007 . A diverse community sample of 48 HIV-1 infected adults was r and omized and entered treatment in either an 8-week MBSR or a 1-day control stress reduction education seminar . The primary outcome was circulating counts of CD4 + T lymphocytes . Participants in the 1-day control seminar showed declines in CD4 + T lymphocyte counts whereas counts among participants in the 8-week MBSR program were \n Output:\n " }, { "from": "agent", "value": "Evidence supports that MBSR improves mental health and MBCT prevents depressive relapse ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: Background Most HIV-1 transmission in Africa occurs among HIV-1-discordant couples ( one partner HIV-1 infected and one uninfected ) who are unaware of their discordant HIV-1 serostatus . Given the high HIV-1 incidence among HIV-1 discordant couples and to assess efficacy of interventions for reducing HIV-1 transmission , HIV-1 discordant couples represent a critical target population for HIV-1 prevention interventions and prevention trials . Substantial regional differences exist in HIV-1 prevalence in Africa , but regional differences in HIV-1 discordance among African couples , has not previously been reported . Methodology /Principal Findings The Partners in Prevention HSV-2/HIV-1 Transmission Trial ( “ Partners HSV-2 Study ” ) , the first large HIV-1 prevention trial in Africa involving HIV-1 discordant couples , completed enrollment in May 2007 . Partners HSV-2 Study recruitment data from 12 sites from East and Southern Africa were used to assess HIV-1 discordance among couples accessing couples HIV-1 counseling and testing , and to correlate with enrollment of HIV-1 discordant couples . HIV-1 discordance at Partners HSV-2 Study sites ranged from 8–31 % of couples tested from the community . Across all study sites and , among all couples with one HIV-1 infected partner , almost half ( 49 % ) of couples were HIV-1 discordant . Site-specific monthly enrollment of HIV-1 discordant couples into the clinical trial was not directly associated with prevalence of HIV-1 discordance , but was modestly correlated with national HIV-1 counseling and testing rates and access to palliative care/basic health care ( r = 0.74 , p = 0.09 ) . Conclusions / Significance HIV-1 discordant couples are a critical target for HIV-1 prevention in Africa . In addition to community prevalence of HIV-1 discordance , national infrastructure for HIV-1 testing and healthcare delivery and effective community outreach strategies impact recruitment of HIV-1 discordant couples into HIV-1 prevention trials Background The reproductive decisions made by PLHIV and their partners have a long-term consequences for the survival and wellbeing of their families and a society at large . Evidence relating to fertility and reproductive intentions among PLHIV is rare , despite the fact that more than 80 % of PLHIV are of reproductive age . The aim of the study was to determine fertility desire and associated factors among PLHIV attending ART clinic in Fitche Hospital . Methods A facility based cross-sectional study design with both quantitative and qualitative data collection methods was employed from February21-April 20th , 2013 . The study participants were selected by using simple r and om sampling technique . A pre- tested structured question naire was used to collect data . Both bivariate and multivariate logistic regressions were used to identify associated factors . Result The prevalence of fertility desire of PLHIV in Fitche Hospital was 133(39.1 % ) with 95 % CI of ( 34.3 % -44.3 % ) . This study identified that factors found to be associated with fertility desire were : - Age from 18 - 29y [ AOR = 3.95 , 95 % CI : 1.69 - 9.22 ) and 30 - 39y ( AOR = 3.91 , 95 % CI : 1.90 -8.19 ) ] , marital length ≤4y [ AOR = 5.49 , 95 % CI : 2.08 - 14.51 ) , within 5 - 9y ( AOR = 4.80 , 95 % CI : 2.14 - 10.78 ) and 10 - 14y ( AOR = 2.82 , 95 % CI : 1.19 -6.63 ] , had not biological living children [ AOR = 11.42 , 95 % CI : 3.27 - 39.90 ) and had more than one child ( AOR = 3.67 , 95 % CI : 1.27 - 10.62 ) ] , community pressure [ AOR = 3.67 , 95 % CI : 1.54 - 8.70 ] , partner fertility [ AOR = 7.18 , 95 % CI : 3.39 - 15.22 ) ] , duration HIV diagnosis≤1y[AOR = 4.99 , 95 % CI : 1.91 - 13.09 ] , disclosed HIV serostatus [ AOR = 3.9 , 95 % CI : 1.37 - 11.10 ] and partner sero-difference [ AOR = 2.05 , 95 % CI : 1.01- 4.15 ] were some of the factors significantly associated with fertility desire . Conclusion The prevalence of fertility desire of PLHIV in the study area was 39.1 % . In this study : - age , marital length , biological child , partner , community pressure , duration of HIV-diagnosis , discordant HIV-test and disclosure of HIV-serostatus to partner were demonstrated to have more associations with fertility desire among PLHIV , therefore , these factors should be emphatically considered during PLHIV 's reproductive health program development HIV care and treatment setting s provide an opportunity to reach people living with HIV/AIDS ( PLHIV ) with prevention messages and services . Population -based surveys in sub-Saharan Africa have identified HIV risk behaviors among PLHIV , yet data are limited regarding HIV risk behaviors of PLHIV in clinical care . This paper describes the baseline sociodemographic , HIV transmission risk behaviors , and clinical data of a study evaluating an HIV prevention intervention package for HIV care and treatment clinics in Africa . The study was a longitudinal group-r and omized trial in 9 intervention clinics and 9 comparison clinics in Kenya , Namibia , and Tanzania ( N = 3538 ) . Baseline participants were mostly female , married , had less than a primary education , and were relatively recently diagnosed with HIV . Fifty-two percent of participants had a partner of negative or unknown status , 24 % were not using condoms consistently , and 11 % reported STI symptoms in the last 6 months . There were differences in demographic and HIV transmission risk variables by country , indicating the need to consider local context in design ing studies and using caution when generalizing findings across African countries . Baseline data from this study indicate that participants were often engaging in HIV transmission risk behaviors , which supports the need for prevention with PLHIV ( PwP ) . Trial Registration Clinical Trials.gov Introduction Stable heterosexual HIV-1 serodiscordant couples in Africa have high HIV-1 transmission rates and are a critical population for evaluation of new HIV-1 prevention strategies . The Partners PrEP Study is a r and omized , double-blind , placebo-controlled trial of tenofovir and emtricitabine-tenofovir pre-exposure prophylaxis to decrease HIV-1 acquisition within heterosexual HIV-1 serodiscordant couples . We describe the trial design and characteristics of the study cohort . Methods HIV-1 serodiscordant couples , in which the HIV-1 infected partner did not meet national guidelines for initiation of antiretroviral therapy , were enrolled at 9 research sites in Kenya and Ug and a. The HIV-1 susceptible partner was r and omized to daily oral tenofovir , emtricitabine-tenofovir , or matching placebo with monthly follow-up for 24–36 months . Results From July 2008 to November 2010 , 7920 HIV-1 serodiscordant couples were screened and 4758 enrolled . For 62 % ( 2966/4758 ) of enrolled couples , the HIV-1 susceptible partner was male . Median age was 33 years for HIV-1 susceptible and HIV-1 infected partners [ IQR ( 28–40 ) and ( 26–39 ) respectively ] . Most couples ( 98 % ) were married , with a median duration of partnership of 7.0 years ( IQR 3.0–14.0 ) and recent knowledge of their serodiscordant status [ median 0.4 years ( IQR 0.1–2.0 ) ] . During the month prior to enrollment , couples reported a median of 4 sex acts ( IQR 2–8 ) ; 27 % reported unprotected sex and 14 % of male and 1 % of female HIV-1 susceptible partners reported sex with outside partners . Among HIV-1 infected partners , the median plasma HIV-1 level was 3.94 log10 copies/mL ( IQR 3.31–4.53 ) and median CD4 count was 496 cells/µL ( IQR 375–662 ) ; the majority ( 64 % ) had WHO stage 1 HIV-1 disease . Conclusions Couples at high risk of HIV-1 transmission were rapidly recruited into the Partners PrEP Study , the largest efficacy trial of oral PrEP . ( Clinical Trials.gov NCT00557245 OBJECTIVE To survey the attitudes of human immunodeficiency virus (HIV)–serodiscordant couples interested in assisted reproduction and better characterize their motivations for reproducing . METHODS A prospect ively design ed question naire and open-ended interview of 50 consecutive HIV-serodiscordant couples interested in undergoing assisted reproduction to avoid transmission of virus were studied . Demographic characteristics and attitudes regarding beginning a family were obtained . By design , males were HIV seropositive ( age , 38.0 ± 5.4 years , range 26–51 years ) and healthy . Women were HIV seronegative ( age , 34.5 ± 5.1 years , range 24–45 years ) . Most couples were married ( 44 of 50 ) and in long-term relationships ( duration of relationship , 8.9 ± 4.9 years , range 1–20 years ) . RESULTS Before presentation , nine of 50 couples had conceived and delivered a child ( three of nine instances with knowledge of paternal HIV status ) . Previous timed intercourse occurred in 8 % of couples ( four of 50 ) . Six individuals stated they would proceed with timed intercourse if no other alternatives existed . Forty-eight percent said they would prefer artificial insemination with donor sperm in lieu , if assisted reproduction failed or were unavailable . Forty-three percent of respondents would pursue “ posthumous conception ” if cryopreserved sperm or embryos were available in the event of the partner 's death . Most couples discussed the possibility of single parenting ( 45 of 50 ; 90 % ) or the possibility for adoptive parenting ( 29 of 50 ; 58 % ) . Couples were aware of risk , and 92 % ( 46 of 50 ) understood that their child might contract HIV . CONCLUSION Human immunodeficiency virus – serodiscordant couples are actively seeking reproductive assistance and often consider or practice unsafe measures to achieve pregnancy . Reproductive issues and concerns unique to these couples need to be addressed before treatment Outlined is our experience with couples in whom the male was both human immunodeficiency virus ( HIV ) seropositive and a haemophiliac who underwent assisted reproductive technologies ( ART ) in order to attain family goals while minimizing the risk of HIV transmission . We report their demographics , attitudes towards assisted reproduction , and ART performance and outcomes . The study included HIV serodiscordant couples ( n = 11 ) who underwent ART at a university-based infertility practice from August 1997 to May 2002 . Prior to treatment , couples prospect ively completed a survey regarding their demographics and attitudes towards assisted reproduction . All couples underwent ART and pregnancy outcomes were analysed . The majority of the patients were fully employed , college-educated , in good health , married and motivated to have a child while minimizing the risk of HIV transmission . Eleven couples underwent 25 cycles of ART [ 19 in vitro fertilization ( IVF ) cycles ; five frozen embryo transfer cycles ; and one oocyte donation cycle ] result ing in nine successful pregnancies . The ongoing/delivered pregnancy rate per initiated IVF cycle was 42.1 % per embryo transfer . Eight of 11 ( 72.7 % ) couples achieved a successful pregnancy . More than half ( six of 11 ; 54.5 % ) the couples conceived during their initial attempt . Four of nine ( 44.4 % ) pregnancies were multiple gestations , including three sets of triplets . All female recipients tested seronegative for HIV at 3 and 6 months post-embryo transfer . All delivered babies ( n = 8) tested seronegative for HIV at birth and 3 months postpartum . Four pregnancies are currently ongoing . ART should be considered for HIV serodiscordant couples with haemophilia who desire to have children in order to minimize the risk of viral infection IMPORTANCE A key factor in assessing the effectiveness and cost-effectiveness of antiretroviral therapy ( ART ) as a prevention strategy is the absolute risk of HIV transmission through condomless sex with suppressed HIV-1 RNA viral load for both anal and vaginal sex . OBJECTIVE To evaluate the rate of within-couple HIV transmission ( heterosexual and men who have sex with men [ MSM ] ) during periods of sex without condoms and when the HIV-positive partner had HIV-1 RNA load less than 200 copies/m \n Output:\n " }, { "from": "agent", "value": "The results of this systematic review suggest that many individuals in HIV-serodiscordant relationships have fertility desires/intentions , although the prevalence is particularly heterogeneous in LMIC in comparison to HIC .\nWell-known factors such as younger age and a fewer number of living children were consistently associated with increased fertility desires/intentions ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: Given that retention rates for weight-loss trials have not significantly improved in the past 20 years , identifying effective techniques to enhance retention is critical . This paper describes a conceptual and practical advance that may have improved retention in a behavioral weight-loss trial-the novel application of motivational interviewing techniques to diffuse ambivalence during interactive group-based orientation sessions prior to r and omization . These orientation sessions addressed ambivalence about making eating and exercise behavior changes , ambivalence about joining a r and omized controlled trial , and unrealistic weight-loss expectations . During these sessions , overweight and obese men and women learned about the health benefits of modest weight loss as well as trial design , the importance of a control condition , r and om assignment and the impact of dropouts . Participants were then divided into groups of three or four , and asked to generate two pros and two cons of being assigned to a control condition and an active condition . Participants shared their pros and cons with the larger group , while the investigator asked open-ended questions , engaged in reflective listening and avoided taking a ' pro-change ' position . Retention was high , with 96 % of the participants ( N = 162 ) completing 18-month clinic visits Background Research increasingly supports the conclusion that well- design ed programs delivered over the Internet can produce significant weight loss compared to r and omized controlled conditions . Much less is known about four important issues addressed in this study : ( 1 ) which recruitment methods produce higher eHealth participation rates , ( 2 ) which patient characteristics are related to enrollment , ( 3 ) which characteristics are related to level of user engagement in the program , and ( 4 ) which characteristics are related to continued participation in project assessment s. Methods We recruited overweight members of three health maintenance organizations ( HMOs ) to participate in an entirely Internet-mediated weight loss program developed by HealthMedia , Inc. Two different recruitment methods were used : personal letters from prevention directors in each HMO , and general notices in member newsletters . The personal letters were sent to members diagnosed with diabetes or heart disease and , in one HMO , to a general membership sample in a particular geographic location . Data were collected in the context of a 2 × 2 r and omized controlled trial , with participants assigned to receive or not receive a goal setting intervention and a nutrition education intervention in addition to the basic program . Results A total of 2311 members enrolled . Bivariate analyses on aggregate data revealed that personalized mailings produced higher enrollment rates than member newsletters and that members with diabetes or heart disease were more likely to enroll than those without these diagnoses . In addition , males , those over age 60 , smokers , and those estimated to have higher medical expenses were less likely to enroll ( all P < .001 ) . Males and those in the combined intervention were less likely to engage initially , or to continue to be engaged with their Web program , than other participants . In terms of retention , multiple logistic regressions revealed that enrollees under age 60 ( P < .001 ) and those with higher baseline self-efficacy were less likely to participate in the 12-month follow-up ( P = .03 ) , but with these exceptions , those participating were very similar to those not participating in the follow-up . Conclusions A single personalized mailing increases enrollment in Internet-based weight loss . eHealth programs offer great potential for recruiting large numbers of participants , but they may not reach those at highest risk . Patient characteristics related to each of these important factors may be different , and more comprehensive analyses of determinants of enrollment , engagement , and retention in eHealth programs are needed Introduction Diabetes self-management education interventions in community gathering places have been moderately effective , but very few studies of intervention effectiveness have been conducted among African Americans with type 2 diabetes . This paper describes a church-based diabetes self-management education intervention for African Americans , a r and omized controlled trial to evaluate the intervention , and baseline characteristics of study participants . Methods A New DAWN : Diabetes Awareness & Wellness Network was conducted among 24 churches of varying size in North Carolina . Each church recruited congregants with type 2 diabetes and design ated a diabetes advisor , or peer counselor , to be part of the intervention team . Participants were enrolled at each church and r and omized as a unit to either the special intervention or the minimal intervention . The special intervention included one individual counseling visit , twelve group sessions , three postcard messages from the participant 's diabetes care provider , and twelve monthly telephone calls from a diabetes advisor . Baseline data included measures of weight , hemoglobin A1c , blood pressure , physical activity , dietary and diabetes self-care practice s , and psychosocial factors . The study to evaluate the intervention ( from enrollment visit to last follow-up ) began in February 2001 and ended in August 2003 . Results Twenty-four churches ( with 201 total participants ) were r and omized . Sixty-four percent of the participants were women . On average , the participants were aged 59 years and sedentary . They had an average of 12 years of education , had been diagnosed with diabetes for 9 years , had a body mass index of 35 , had a hemoglobin A1c level of 7.8 % , and had a reported dietary intake of 39 % of calories from fat . Conclusion A New DAWN is a culturally sensitive , church-based diabetes self-management education program for African Americans with type 2 diabetes that is being evaluated for effectiveness in a r and omized controlled trial . The outcomes of A New DAWN will contribute to the literature on community-based interventions for minority population s and help to inform the selection of approaches to improve diabetes care in this population OBJECTIVE To evaluate a clinic-based multimedia intervention for diabetes education targeting individuals with low health literacy levels in a diverse population . RESEARCH DESIGN AND METHODS Five public clinics in Chicago , Illinois , participated in the study with computer kiosks installed in waiting room areas . Two hundred forty-four subjects with diabetes were r and omized to receive either supplemental computer multimedia use ( intervention ) or st and ard of care only ( control ) . The intervention includes audio/video sequences to communicate information , provide psychological support , and promote diabetes self-management skills without extensive text or complex navigation . HbA(1c ) ( A1C ) , BMI , blood pressure , diabetes knowledge , self-efficacy , self-reported medical care , and perceived susceptibility of complications were evaluated at baseline and 1 year . Computer usage patterns and implementation barriers were also examined . RESULTS Complete 1-year data were available for 183 subjects ( 75 % ) . Overall , there were no significant differences in change in A1C , weight , blood pressure , knowledge , self-efficacy , or self-reported medical care between intervention and control groups . However , there was an increase in perceived susceptibility to diabetes complications in the intervention group . This effect was greatest among subjects with lower health literacy . Within the intervention group , time spent on the computer was greater for subjects with higher health literacy . CONCLUSIONS Access to multimedia lessons result ed in an increase in perceived susceptibility to diabetes complications , particularly in subjects with lower health literacy . Despite measures to improve informational access for individuals with lower health literacy , there was relatively less use of the computer among these participants OBJECTIVE The purpose of the study was to investigate the effect of comorbid depression on glycemic control and on response to a telemedicine case management intervention for elderly , ethnically diverse diabetic patients . RESEARCH DESIGN AND METHODS Medicare beneficiaries in underserved areas were participants ( n = 1,665 ) in the Informatics for Diabetes Education and Telemedicine ( IDEATel ) project and r and omized to a telemedicine case management intervention or usual care . The data analyzed include baseline demographics ( age , sex , race/ethnicity , marital status , insulin use , years of education , years of diabetes , and pack-years smoked ) and measures of glycemic control ( HbA(1c ) [ A1C ] ) , comorbidity , diabetes symptom severity , functional disability and depression , and 1-year ( n = 1,578 ) A1C . The association between depression and glycemic control was analyzed cross-sectionally and prospect ively . RESULTS At baseline , there was a significant correlation between depression and A1C and a trend for depression to predict A1C when other factors were controlled . However , in prospect i ve analyses , depression did not predict change in A1C , either in the control or intervention group . CONCLUSIONS In this large sample of elderly diabetic patients , a weak relationship between depression and A1C was found , but depression did not prospect ively predict change in glycemic control . Thus , there is no evidence that depression should be used to exclude patients from interventions . Also , we should evaluate the impact of depression on outcomes other than glycemic control Background : The prevalence of type 2 diabetes and diabetesrelated morbidity and mortality is higher among low-income Hispanics when compared to that of Whites . However , little is known about how to effectively promote self-management in this population . Purpose : The objectives were first to determine the feasibility of conducting a r and omized clinical trial of an innovative self-management intervention to improve metabolic control in low-income Spanish-speaking individuals with type 2 diabetes and second to obtain preliminary data of possible intervention effects . Methods : Participants for this pilot study were recruited from a community health center , an elder program , and a community-wide data base developed by the community health center , in collaboration with other agencies serving the community , by surveying households in the entire community . Participants were r and omly assigned to an intervention ( n = 15 ) or a control ( n = 10 ) condition . Assessment s were conducted at baseline and at 3 months and 6 months postr and omization . The intervention consisted of 10 group sessions that targeted diabetes knowledge , attitudes , and self-management skills through culturally specific and literacysensitive strategies . The intervention used a cognitivebehavioral theoretical framework . Results : Recruitment rates at the community health center , elder program , and community registry were 48 % , 69 % , and 8 % , respectively . Completion rates for baseline , 3-month , and 6-month assessment s were 100 % , 92 % , and 92 % , respectively . Each intervention participant attended an average of 7.8 out of 10 sessions , and as a group the participants showed high adherence to intervention activities ( 93 % turned in daily logs , and 80 % self-monitored glucose levels at least daily ) . There was an overall Group × Time interaction ( p = .02 ) indicating group differences in glycosylated hemoglobin over time . The estimated glycosylated hemoglobin decrease at 3 months for the intervention group was −0.8 % ( 95 % confidence intervals = −1.1 % , −0.5 % ) compared with the change in the control group ( p = .02 ) . At 6 months , the decrease in the intervention group remained significant , −0.85 % ( 95 % confidence intervals = −1.2 , −0.5 ) , and the decrease was still significantly different from that of the controls ( p = .005 ) . There was a trend toward increased physical activity in the intervention group as compared to that of the control group ( p = .11 ) and some evidence ( nonsignificant ) of an increase in blood glucose self-monitoring in the intervention participants but not the control participants . Adjusting for baseline depressive scores , we oberved a significant difference in depressive symptoms between intervention participants and control participants at the 3-month assessment ( p = .02 ) . Conclusions : Low-income Spanish-speaking Hispanics are receptive to participate in diabetes-related research . This study shows that the pilot-tested diabetes self-management program is promising and warrants the conduct of a r and omized clinical trial PURPOSE The purpose of this study was to examine reasons for nonparticipation and drop out in a diabetes self-management intervention . METHODS A total of 468 recently screen-detected patients , receiving usual care or intensive pharmacological treatment , were invited and r and omized into either a control or intervention condition , consisting of a brief self-management course . A nonresponse survey was conducted , and participants , non participants , and dropouts were compared on sociodemographic variables , diabetes attitudes , and self-care . RESULTS A total of 227 patients consented and were allocated to the control ( n=108 ) or intervention group ( n=119 ) . Two hundred forty-one patients declined participation , 41 dropped out , and 78 completed the intervention . Major reasons for refusal and drop out were hesitancy toward research and practical barriers . Non participants were less educated and reported higher self-management , while participation also varied by treatment and disease duration : intensively treated patients were more likely to participate in their first year , and usual-care patients participated more often 2 to 3 years after diagnosis . Dropouts had a lower education level but did not differ on any other measure . CONCLUSION Participants , non participants , and dropouts did not differ in their attitudes toward diabetes , but the intervention did attract patients with lower self-care . Variations in participation by treatment and disease duration suggest that patients prefer self-management interventions at different times depending on their medical treatment . Finally , education appears to be the most important factor determining participation . Alternative strategies are needed to attract and retain patients with low education Background US Latinos have greater prevalence of type 2 diabetes ( diabetes ) , uncontrolled diabetes and diabetes co-morbidities compared to non-Latino Whites . They also have lower literacy levels and are more likely to live in poverty . Interventions are needed to improve diabetes control among low-income Latinos . Methods and design This r and omized clinical trial tested the efficacy of a culturally- and literacy-tailored diabetes self-management intervention ( Latinos en Control ) on glycemic control among low-income Latinos with diabetes , compared to usual care ( control ) . Participants were recruited from five community health centers ( CHCs ) in Massachusetts . \n Output:\n " }, { "from": "agent", "value": "Franklin GM , Kahn LB , Baxter J , Marshall JA , Hamman RF .\nSensory neuropathy in non-insulin-dependent diabetes mellitus : the San Luis Valley Diabetes Study .\nGross R , Olfson M , Gameroff MJ .\nDepression and glycemic control in Hispanic primary care patients with diabetes ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: Composite outcomes , in which multiple end points are combined , are frequently used as primary outcome measures in r and omized trials and are often associated with increased statistical efficiency . However , such measures may prove challenging for the interpretation of results . In this article , we examine the use of composite outcomes in major clinical trials , assess the arguments for and against them , and provide guidance on their application and reporting . To assess incidence and quality of reporting , we systematic ally review ed the use of composite end points in clinical trials in Annals of Internal Medicine , BMJ , Circulation , Clinical Infectious Diseases , Journal of the American College of Cardiology , JAMA , Lancet , New Engl and Journal of Medicine , and Stroke from 1997 through 2001 using a sensitive search strategy . We selected for review 167 original reports of r and omized trials ( with a total of 300 276 patients ) that included a composite primary outcome that incorporated all-cause mortality . Sixty-three trials ( 38 % ) were neutral both for the primary end point and the mortality component . Sixty trials ( 36 % ) reported significant results for the primary outcome measure but not for the mortality component . Only 6 trials ( 4 % ) were significant for the mortality component but not for the primary composite outcome , whereas 19 trials ( 11 % ) were significant for both . Twenty-two trials ( 13 % ) were inadequately reported . Our review suggests that reporting of composite outcomes is generally inadequate , implying that the results apply to the individual components of the composite outcome rather than only to the overall composite . Current guidelines for the undertaking and reporting of clinical trials could be revised to reflect the common use of composite outcomes in clinical trials AIMS The efficacy and safety of the dipeptidyl peptidase-4 inhibitor , linagliptin , added to ongoing metformin therapy , were assessed in patients with Type 2 diabetes who had inadequate glycaemic control ( HbA(1c ) ≥ 7.5 to ≤ 10 % ; ≥ 58.5 to ≤ 85.8 mmol/mol ) with metformin alone . METHODS Patients ( n=333 ) were r and omized to receive double-blind linagliptin ( 1 , 5 or 10 mg once daily ) or placebo or open-label glimepiride ( 1 - 3 mg once daily ) . The primary outcome measure was the change from baseline in HbA(1c ) at week 12 in patients receiving combination therapy compared with metformin alone . RESULTS Twelve weeks of treatment result ed in a mean ( sem ) placebo-corrected lowering in HbA(1c ) levels of 0.40 % ( ± 0.14 ) ; 4.4 mmol/mol ( ± 1.5 ) for 1 mg linagliptin , 0.73 % ( ± 0.14 ) ; 8.0 mmol/mol ( ± 1.5 ) for 5 mg , and 0.67 % ( ± 0.14 ) ; 7.3 mmol/mol ( ± 1.5 ) for 10 mg . Differences between linagliptin and placebo were statistically significant for all doses ( 1 mg , P = 0.01 ; 5 mg and 10 mg , P < 0.0001 ) . The change in mean ( sem ) placebo-corrected HbA(1c ) from baseline was -0.90 % ( ± 0.13 ) ; -9.8 mmol/mol ( ± 1.4 ) for glimepiride . Adjusted and placebo-corrected mean changes in fasting plasma glucose were -1.1 mmol/l for linagliptin 1 mg ( P = 0.002 ) , -1.9 mmol/l for 5 mg and -1.6 mmol/l for 10 mg ( both P < 0.0001 ) . One hundred and six ( 43.1 % ) patients reported adverse events ; the incidence was similar across all five groups . There were no hypoglycaemic events for linagliptin or placebo , whereas three patients ( 5 % ) receiving glimepiride experienced hypoglycaemia . CONCLUSIONS The addition of linagliptin to ongoing metformin treatment in patients with Type 2 diabetes was well tolerated and result ed in significant and clinical ly relevant improvements in glycaemic control , with 5 mg linagliptin being the most effective dose The objectives of this study were to evaluate the efficacy and tolerability of glimepiride plus extended release metformin ( MET ) on glycemic control in patients with type-2 diabetes mellitus uncontrolled on monotherapy with sulfonylurea or MET . This was a prospect i ve , open-labeled , multicentric study over 12 weeks . Patients who were diagnosed with type-2 diabetes and were uncontrolled on monotherapy with single oral hypoglycemic agents such as glimepiride or MET and characterized by glycosylated hemoglobin ( HbA1c ) ≥7 % and ⩽10 % and fasting plasma glucose ( FPG ) ≥ 140 mg/dL were enrolled in this study . Treatment regimen was started at 1 mg of glimepiride plus 500 mg of MET once a day and was titrated to next dose level depending on the clinician 's judgment , not exceeding a total daily dose of 8 mg of glimepiride and 2000 mg of MET . After 12-weektreatment , glimepiride plus MET combination showed improvement in metabolic control as assessed by changes in HbA1c , FPG , and post pr and ial glucose ( PPG ) . Primary efficacy parameter , HbA1c , was significantly reduced to ( 7.65 ± 1.70 ) at the end of the treatment from the baseline value ( 8.35 ± 0.93 ) ( P < 0.001 ) . Of the patients , 65.79 % showed ≥0.5 % reduction in HbA1c and or HbA1c < 7 % at the end of the therapy . FPG and PPG were significantly reduced at the end of the therapy as compared with baseline values ( P < 0.001 ) . Moreover , the lipid profile was also improved during the treatment period . The addition of glimepiride to MET is an effective treatment for patients inadequately controlled on sulfonylurea or Met alone . A combination of glimepiride with MET achieves good glycemic control with better tolerability profile CONTEXT Although weight reduction is a recommended goal in type 2 diabetes mellitus ( T2DM ) , weight loss is linked to impaired survival in patients with some chronic cardiovascular diseases . OBJECTIVE To assess the association of weight and weight change with mortality and non-fatal cardiovascular outcomes ( hospitalisation , myocardial infa rct ion and stroke ) in T2DM patients with cardiovascular co-morbidity and the effect of pioglitazone-induced weight change on mortality . SETTING AND PARTICIPANTS We assessed in a post hoc analysis body weight and weight change in relation to outcome in 5202 patients from the PROactive trial population who had T2DM and evidence of pre-existing cardiovascular disease . Patients were r and omized to treatment with pioglitazone or placebo in addition to their concomitant glucose-lowering and cardiovascular medication . Mean follow up was 34.5 months . MAIN OUTCOME MEASURE The impact of body weight and body weight change on all-cause mortality , cardiovascular mortality , on non-fatal cardiovascular events and on hospitalisation . RESULTS The lowest mortality was seen in patients with BMI 30 - 35 kg/m(2 ) at baseline . In comparison to this ( reference group ) , patients in the placebo group with BMI < 22 kg/m(2 ) ( Hazard Ratio ( 95 % confidence intervals ) 2.96 [ 1.27 to 6.86 ] ; P=0.012 ) and BMI 22 to 25 kg/m(2 ) ( HR 1.88 [ 1.11 to 3.21 ] ; P=0.019 ) had a higher all-cause mortality . Weight loss was associated with increased total mortality ( HR per 1 % body weight : 1.13 [ 1.11 to 1.16 ] ; P<0.0001 ) , with increased cardiovascular mortality , all-cause hospitalisation and the composite of death , myocardial infa rct ion and stroke . Weight loss of ≥7.5 % body weight ( seen in 18.3 % of patients ) was the strongest cut-point to predict impaired survival ( multivariable adjusted HR 4.42 [ 3.30 to 5.94 ] . Weight gain was not associated with increased mortality . Weight gain in patients treated with pioglitazone ( mean+4.0±6.1 kg ) predicted a better prognosis ( HR per 1 % weight gain : 0.96 [ 0.92 to 1.00 ] P=0.037 ) compared to patients without weight gain . CONCLUSION Among patients with T2DM and cardiovascular co-morbidity , overweight and obese patients had a lower mortality compared to patients with normal weight . Weight loss but not weight gain was associated with increased mortality and morbidity . There may be an \" obesity paradox \" in patients with type 2 diabetes and cardiovascular risk . The original PROactive trial is registered as an International St and ard R and omized Controlled Trial ( Number IS RCT N NCT00174993 ) AIM to evaluate the efficacy and safety of adding sitagliptin or glimepiride to the treatment regimen of patients with type 2 diabetes mellitus and inadequate glycaemic control on metformin monotherapy . METHODS patients with type 2 diabetes and an HbA(1c ) of 6.5 - 9.0 % while on a stable dose of metformin ( ≥ 1500 mg/day ) combined with diet and exercise for at least 12 weeks were r and omized in a double-blind manner to receive either sitagliptin 100 mg daily ( N = 516 ) or glimepiride ( starting dose 1 mg/day and up-titrated , based upon patient 's self-monitoring of blood glucose results , to a maximum dose of up to 6 mg/day ) ( N = 519 ) for 30 weeks . The primary analysis assessed whether sitagliptin is non-inferior to glimepiride in reducing HbA(1c ) at week 30 ( based on the criterion of having an upper bound of the 95 % CI less than the prespecified non-inferiority bound of 0.4 % ) . RESULTS the mean baseline HbA(1c ) was 7.5 % in both the sitagliptin group ( n = 443 ) and the glimepiride group ( n = 436 ) . After 30 weeks , the least squares ( LS ) mean change in HbA(1c ) from baseline was -0.47 % with sitagliptin and -0.54 % with glimepiride , with a between-group difference ( 95 % CI ) of 0.07 % ( -0.03 , 0.16 ) . This result met the prespecified criterion for declaring non-inferiority . The percentages of patients with an HbA(1c ) < 7.0 % at week 30 were 52 and 60 % in the sitagliptin and glimepiride groups , respectively . The LS mean change in fasting plasma glucose from baseline ( 95 % CI ) was -0.8 mmol/l ( -1.0 , -0.6 ) with sitagliptin and -1.0 mmol/l ( -1.2 , -0.8 ) with glimepiride , for a between-group difference ( 95 % CI ) of 0.2 mmol/l ( -0.1 , 0.4 ) . The percentages of patients for whom hypoglycaemia was reported were 7 % in the sitagliptin group and 22 % in the glimepiride group ( percentage-point difference = -15 , p < 0.001 ) . Relative to baseline , sitagliptin was associated with a mean weight loss ( -0.8 kg ) , whereas glimepiride was associated with a mean weight gain ( 1.2 kg ) , yielding a between-group difference of -2.0 kg ( p < 0.001 ) . CONCLUSIONS in patients with type 2 diabetes and inadequate glycaemic control on metformin monotherapy , the addition of sitagliptin or glimepiride led to similar improvement in glycaemic control after 30 weeks . Sitagliptin was generally well tolerated . Compared to treatment with glimepiride , treatment with sitagliptin was associated with a lower risk of hypoglycaemia and with weight loss versus weight gain ( Clinical Trials.gov : NCT00701090 ) AIM To assess whether there is a difference in the effects of vildagliptin and glimepiride on glucose fluctuation in patients with type 2 diabetes mellitus ( T2DM ) using continuous glucose monitoring ( CGM ) . METHODS This was an open-label , r and omized cross-over study conducted in T2DM patients . A total of 24 patients ( age : 58.3 ± 5.56 years , baseline HbA1c : 7.6 ± 0.50 % ) who were on stable metformin monotherapy ( 500 - 3000 mg ) were enrolled , \n Output:\n " }, { "from": "agent", "value": "The remaining adverse events , including mortality , did not show any differences between both groups .\nA greater effectiveness is seen in the glimepiride/metformin association , which should not be diminished by slight differences in adverse effects , with absence of severe hypoglycaemia in over 98 % of patients under treatment .\nThe association of glimepiride/metformin , both due to cost as well as effectiveness and safety , may be the preferential treatment for most DM2 patients , and it offers a potential advantage in refractory hyperglycemic population s , tolerant to treatment" } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: OBJECTIVE To identify the effect of vibratory stimuli applied to the plantar region on the balance of women 60 years or older . DESIGN A r and omized controlled trial ( blinded assessor ) . SETTING University research laboratory . PARTICIPANTS All women ( N=30 ; age , ≥60y ) selected had a balance deficit , assessed by using the One-Leg Stance test with eyes open ( EO ) . INTERVENTIONS Participants were r and omly divided into an experimental group , which received vibratory stimuli , and a control group , which received no intervention . MAIN OUTCOME MEASURES Functional reach ( FR ) test and center-of-pressure ( CoP ) sway area ( force platform ) . RESULTS There was a significant difference in the time factor of the experimental group for the FR test and CoP sway area with eyes closed ( EC ) . For the group × time interaction , there was improvement in balance in anterior-posterior ( AP ) CoP sway velocity with EO and EC . There also was improvement in CoP sway area with EC . CONCLUSION Vibratory stimuli applied to the plantar region have beneficial effects on balance in women 60 years or older , with greater effectiveness in anterior displacement , postural control of the AP axis , and the EC condition This study investigated the effects on st and ing balance of r and om vibrations applied to the plantar side of the feet by vibrating insoles in subjects with neuropathy and nondisabled subjects . In four different conditions ( eyes open or closed and with or without an attention-dem and ing task [ ATD ] ) , subjects with neuropathy secondary to diabetes mellitus ( n = 17 ) and nondisabled subjects ( n = 15 ) stood for 60 s on vibrating insoles placed on a force plate . During each condition , the insoles were turned on for 30 s and off for 30 s ( r and om order ) . The calculated balance measures were mean velocity of the center of pressure displacements and root-mean-square of the velocity of these displacements in the anteroposterior and mediolateral directions . In subjects with neuropathy , an interaction effect between vibration and an ADT was found for balance . No effects of vibration on balance were found in nondisabled subjects . Vibrating insoles improved st and ing balance in subjects with neuropathy only when attention was distracted . Improvement of the insoles and their activation is needed to make their implementation in daily living possible and effective Noise can enhance the detection and transmission of weak signals in certain nonlinear systems , via a mechanism known as stochastic resonance . Here we show that input noise can be used to improve motor control in humans . Specifically , we show that the postural sway of both young and elderly individuals during quiet st and ing can be significantly reduced by applying subsensory mechanical noise to the feet . We further demonstrate with input noise a trend towards the reduction of postural sway in elderly subjects to the level of young subjects . These results suggest that noise-based devices , such as r and omly vibrating shoe inserts , may enable people to overcome functional difficulties due to age-related sensory loss BACKGROUND One of the more pervasive effects of aging is loss of cutaneous sensation , which appears to correlate with impaired postural control and increased risk of falling . This study examined the potential for compensating for the destabilizing effects of reduced cutaneous sensitivity by placing a raised edge underneath the perimeter of the plantar foot surface , so as to facilitate sensation from the stability boundaries of the base of support . METHODS The main experiment involved 14 healthy older adults ( aged 65 - 73 ) selected because they were known , from a previous study , to have moderate plantar cutaneous insensitivity . We also report results of an initial experiment involving 7 healthy young adults ( aged 23 - 31 ) . In both experiments , we studied effects of the plantar facilitation on control of rapid stepping reactions evoked by unpredictable postural perturbation , applied via sudden platform movement in forward , backward , and lateral directions . We also studied effects on \" feet-in-place \" responses evoked by continuous pseudor and om platform motion in mediolateral and anteroposterior directions . Subjects were blindfolded in all tests . RESULTS Plantar facilitation reduced the incidence of \" extra \" limb movements , beyond the initial step , during forward-step reactions in the older adults . There also appeared to be an improved ability to control feet-in-place reactions : young subjects were better able to recover balance without stepping when falling backward ( given instructions to \" try not to step \" ) , and both young and older subjects reduced the extent to which the center of foot pressure approached the posterior foot boundary during continuous anteroposterior platform motion . CONCLUSIONS This study provides evidence that mechanical facilitation of sensation from the boundaries of the plantar surface of the foot can improve the efficacy of certain types of stabilizing reactions evoked by unpredictable postural perturbation . The results may be directly transferable to the design of special footwear insoles to reduce instability and risk of falling in older adults Stochastic resonance ( SR ) occurs when the detection of a subthreshold signal is aided by the presence of r and om energy fluctuations in the signal modality , commonly called noise . SR is counterintuitive because such noise usually worsens performance . Nonetheless , SR has been demonstrated both theoretically and experimentally in human sensory systems . Using a psychophysically sophisticated paradigm , we show that SR aids the detection of vibrating touch stimuli presented to the foot soles of both healthy elderly people with elevated vibrotactile thresholds and healthy young people with normal vibrotactile thresholds . The results also suggest that it is possible to know a priori the amount of noise needed for optimal SR effects given the degree to which the signal is subthreshold . Thus , SR may be practical as a rehabilitative aid for individuals with elevated sensory thresholds BACKGROUND AND PURPOSE Visual feedback related to weight distribution and center-of-pressure positioning has been shown to be effective in increasing stance symmetry following stroke , although it is not clear whether functional balance ability also improves . This study compared the relative effectiveness of visual feedback training of center-of-gravity ( CoG ) positioning with conventional physical therapy following acute stroke . SUBJECTS Forty-six people who had strokes within 80 days before the study , result ing in unilateral hemiparesis , and who were in need of balance retraining participated . METHODS AND MATERIAL S Initially , subjects were r and omly assigned to visual feedback or conventional physical therapy groups for balance retraining until 16 subjects per group were recruited . The next 14 subjects were assigned to a control group . All subjects received physical therapy and occupational therapy ( regular therapy ) 2 hours a day , and subjects in the 2 experimental groups received additional balance training 30 minutes a day until discharge . The visual feedback group received information about their CoG position as they shifted their weight during various activities . The conventional therapy group received verbal and tactile cues to encourage symmetrical stance and weight shifting . Static ( postural sway ) and activity-based measures of balance ( Berg Balance Scale , gait speed , and the Timed \" Up & Go \" Test ) were contrasted across the 3 groups at baseline , at discharge , and at 1 month following discharge using an analysis of variance for repeated measures . RESULTS All groups demonstrated marked improvement over time for all measures of balance ability , with the greatest improvements occurring in the period from baseline to discharge . No between-group differences were detected in any of the outcome measures . CONCLUSION AND DISCUSSION Visual feedback or conventional balance training in addition to regular therapy affords no added benefit when offered in the early stages of rehabilitation following stroke OBJECTIVES To test whether subsensory vibratory noise applied to the sole of the foot using a novel piezoelectric vibratory insole can significantly improve sensation , enhance balance , and reduce gait variability in elderly people , as well as to determine the optimal level of vibratory noise and whether the therapeutic effect would endure and the user 's sensory threshold would remain constant during the course of a day . DESIGN A r and omized , single-blind , crossover study of 3 subsensory noise stimulation levels on 3 days . SETTING Balance and gait laboratory . PARTICIPANTS Healthy community-dwelling elderly volunteers ( N=12 ; age , 65 - 90y ) who could feel the maximum insole vibration . INTERVENTIONS A urethane foam insole with the piezoelectric actuators delivering subsensory vibratory noise stimulation to the soles of the feet . MAIN OUTCOME MEASURES Balance , gait , and timed Up and Go ( TUG ) test . RESULTS The vibratory insoles significantly improved performance on the TUG test , reduced the area of postural sway , and reduced the temporal variability of walking at both 70 % and 85 % of the sensory threshold and during the course of a day . Vibratory sensation thresholds remained relatively stable within and across study days . CONCLUSIONS This study provides proof of concept that the application of the principle of stochastic resonance to the foot sole sensory system using a new low-voltage piezoelectric technology can improve measures of balance and gait that are associated with falls . Effective vibratory noise amplitudes range from 70 % to 85 % of the sensory threshold and can be set once daily To study risk factors for falling , we conducted a one-year prospect i ve investigation , using a sample of 336 persons at least 75 years of age who were living in the community . All subjects underwent detailed clinical evaluation , including st and ardized measures of mental status , strength , reflexes , balance , and gait ; in addition , we inspected their homes for environmental hazards . Falls and their circumstances were identified during bimonthly telephone calls . During one year of follow-up , 108 subjects ( 32 percent ) fell at least once ; 24 percent of those who fell had serious injuries and 6 percent had fractures . Predisposing factors for falls were identified in linear-logistic models . The adjusted odds ratio for sedative use was 28.3 ; for cognitive impairment , 5.0 ; for disability of the lower extremities , 3.8 ; for palmomental reflex , 3.0 ; for abnormalities of balance and gait , 1.9 ; and for foot problems , 1.8 ; the lower bounds of the 95 percent confidence intervals were 1 or more for all variables . The risk of falling increased linearly with the number of risk factors , from 8 percent with none to 78 percent with four or more risk factors ( P less than 0.0001 ) . About 10 percent of the falls occurred during acute illness , 5 percent during hazardous activity , and 44 percent in the presence of environmental hazards . We conclude that falls among older persons living in the community are common and that a simple clinical assessment can identify the elderly persons who are at the greatest risk of falling BACKGROUND AND PURPOSE Assessment of the quality of r and omized controlled trials ( RCTs ) is common practice in systematic review s. However , the reliability of data obtained with most quality assessment scales has not been established . This report describes 2 studies design ed to investigate the reliability of data obtained with the Physiotherapy Evidence Data base ( PEDro ) scale developed to rate the quality of RCTs evaluating physical therapist interventions . METHOD In the first study , 11 raters independently rated 25 RCTs r and omly selected from the PEDro data base . In the second study , 2 raters rated 120 RCTs r and omly selected from the PEDro data base , and disagreements were resolved by a third rater ; this generated a set of individual rater and consensus ratings . The process was repeated by independent raters to create a second set of individual and consensus ratings . Reliability of ratings of PEDro scale items was calculated using multirater kappas , and reliability of the total ( summed ) score was calculated using intraclass correlation coefficients ( ICC [ 1,1 ] ) . RESULTS The kappa value for each of the 11 items ranged from.36 to.80 for individual assessors and from.50 to.79 for consensus ratings generated by groups of 2 or 3 raters . The ICC for the total score was.56 ( 95 % confidence interval=.47-.65 ) for ratings by individuals , and the ICC for consensus ratings was.68 ( 95 % confidence interval=.57-.76 ) . DISCUSSION AND CONCLUSION The reliability of ratings of PEDro scale items varied from \" fair \" to \" substantial , \" and the reliability of the total PEDro score was \" fair \" to \" good . The present r and omized controlled pilot study was conducted to determine the feasibility of the study protocol and the effects of four-week-long sessions involving stochastic resonance whole-body vibration ( SR-WBV ) training on chair rising in elderly individuals . Twenty elderly participants were divided into a SR-WBV group or a sham group . Peak force , rate of force development , rising time , time to stabilization and total time during chair rising performance were investigated . Intraclass correlation coefficients , Mann-Whitney U-tests and Wilcoxon signed-ranked tests were used . Low volume SR-WBV over 12 training sessions might provide a safe treatment method Objective : To investigate the effect of a local vibration stimulus training programme on postural sway and gait in stroke patients . Design : A r and omized controlled trial with two groups : a local vibration stimulus training programme group and a sham group . Setting : Inpatient rehabilitation centre . Subjects : Thirty-one chronic stroke patients . Interventions : Both groups underwent a st and ard rehabilitation programme . The local vibration stimulus training programme group ( n = 16 ) participated in the local vibration stimulus training programme for 30 minutes a day , five times a week , for six weeks . The sham group ( n = 15 ) participated in a sham local vibration stimulus training programme for 30 minutes a day , five times a week , for six weeks . Main measures : A forceplate was used to measure postural sway under two conditions : st and ing with eyes open and eyes closed . Gait ability was measured using the GAITRite system . Results : In postural sway , greater improvements in the postural sway distance with eyes-open ( –11.91 vs. 0.80 ) and eyes-closed ( \n Output:\n " }, { "from": "agent", "value": "Results There was reduction in center of pressure velocity and displacement especially with eyes closed using vibration in healthy elderly subjects and this effect was greater in elderly faller and patients with more balance deficiency .\nVibration programme training increased speed of walking , cadence , step time and length in stroke subjects .\nThe vibratory insoles significantly improved performance on the Timed Up and Go and Functional Reach tests in older people .\nConclusion Vibration was effective on balance improvement in elderly subject especially elderly with more balance deficiency and it can improve gait parameters in patients with greater baseline variability" } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: BACKGROUND AND AIMS Small colorectal polyps are encountered frequently and may be incompletely removed during colonoscopy . The optimal technique for removal of small colorectal polyps is uncertain . The aim of this study was to compare the incomplete resection rate ( IRR ) by using EMR or cold snare polypectomy ( CSP ) for the removal of small adenomatous polyps . METHODS This was a prospect i ve r and omized controlled study from a tertiary-care referral center . A total of 358 patients who satisfied the inclusion criteria ( polyp sized 6 - 9 mm ) were r and omized to the EMR ( n = 179 ) and CSP ( n = 179 ) groups , and their polyps were treated with conventional EMR or CSP , respectively . After polypectomy , an additional 5 forceps biopsies were performed at the base and margins of polypectomy sites to assess the presence of residual polyp tissue . The EMR and CSP sample s were compared to assess the IRR . RESULTS Among a total of 525 polyps , 415 ( 79.0 % ) were adenomatous polyps , and 41 ( 16.4 % ) were advanced adenomas . The overall IRR for adenomatous polyps was significantly higher in the CSP group compared with the EMR group ( 18/212 , 8.5 % vs 3/203 , 1.5 % ; P = .001 ) . Logistic regression analysis revealed that the CSP procedure was a stronger risk factor for the IRR ( odds ratio [ OR ] 6.924 ; 95 % confidence interval [ CI ] , 2.098 - 24.393 ; P = .003 ) . In addition , piecemeal resection was the most important risk factor for the IRR ( OR 28.696 ; 95 % CI , 3.620 - 227.497 ; P = .001 ) . The mean procedure time for polypectomy was not significantly different between the EMR and CSP groups ( 5.5 ± 2.7 vs 4.7 ± 3.4 minutes ; P = .410 ) . None of these patients presented with delayed bleeding . There were no severe adverse events related to the biopsies . CONCLUSIONS EMR was significantly superior to CSP for achieving complete endoscopic resection of small colorectal polyps . Patients with piecemeal resection of polyps had a higher risk for incomplete resection . ( Clinical trial registration number : Hongwei-1102 - 12 . ) BACKGROUND AND STUDY AIMS Cold snare polypectomy is an established method for the resection of small colorectal polyps ; however , significant incomplete resection rates still leave room for improvement . We aim ed to assess the efficacy of cold snare endoscopic mucosal resection ( CS-EMR ) , compared with hot snare endoscopic mucosal resection ( HS-EMR ) , for nonpedunculated polyps sized 6 - 10 mm . PATIENTS AND METHODS This study was a dual-center , r and omized , noninferiority trial . Consecutive adult patients with at least one nonpedunculated polyp sized 6 - 10 mm were enrolled . Eligible polyps were r and omized ( 1:1 ) to be treated with either CS-EMR or HS-EMR . Both methods involved submucosal injection of a methylene blue-tinted normal saline solution . The primary noninferiority end point was histological eradication evaluated by postpolypectomy biopsies ( noninferiority margin - 10 % ) . Secondary outcomes included occurrence of intraprocedural bleeding , clinical ly significant postprocedural bleeding , and perforation . RESULTS Among 689 patients screened , 155 patients with 164 eligible polyps were included ( CS-EMR n = 83 , HS-EMR n = 81 ) . The overall rate of histological complete resection was 92.8 % in the CS-EMR group and 96.3 % in the HS-EMR group ( difference 3.5 % ; 95 % confidence interval [ CI ] - 4.15 to 11.56 ) , showing noninferiority of CS-EMR compared with HS-EMR . CS-EMR was shown to be noninferior both for polyps measuring 6 - 7 mm ( CS-EMR 93.3 % ; HS-EMR 100 % ; 95 % CI - 7.95 to 21.3 ) and those of 8 - 10 mm ( 92.5 % vs. 94.7 % , respectively ; 95 % CI - 7.91 to 13.16 ) . Rates of intraprocedural bleeding were similar between the two groups ( CS-EMR 3.6 % , HS-EMR 1.2 % ; P = 0.30 ) . No clinical ly significant postprocedural bleeding or perforation occurred in either group . CONCLUSIONS CS-EMR appears to be a valuable modification of the st and ard cold snare technique , obviating the need to use diathermy for nonpedunculated colorectal polyps sized 6 - 10 mm BACKGROUND AND AIMS Curability is associated with resection width and depth in polypectomy . We evaluated the resection width and depth achieved with hot snare polypectomy ( HSP ) and cold snare polypectomy ( CSP ) for small colorectal polyps . METHODS In this single-center , prospect i ve , r and omized controlled study , patients with rectal or rectosigmoid polyps ≤10 mm in diameter were treated with HSP or CSP . Resection width was evaluated as mucosal defect size , measured immediately postprocedure and 1 day later . Resection depth was histologically evaluated using obtained specimens . RESULTS Fifty-two patients were enrolled . Mean lesion size was 5.6 mm with HSP ( n = 27 ) and 5.8 mm with CSP ( n = 25 ) . Mean mucosal defect diameter immediately after HSP and CSP was 5.1 mm and 7.5 mm , respectively ( P < .001 ) . The diameter 1 day after the procedure increased by 29 % ( 95 % confidence interval [ CI ] , 17%-41 % ) with HSP and decreased by 25 % ( 95 % CI , 18%-32 % ) with CSP ( P < .001 ) . Muscularis mucosa was obtained similarly with HSP and CSP ( 96 % [ 95 % CI , 82%-99 % ] vs 92 % [ 95 % CI , 75%-98 % ] ; P = .603 ) . Submucosal tissue was obtained significantly more frequently with HSP than with CSP ( 81 % [ 95 % CI , 63%-92 % ] vs 24 % [ 95 % CI , 11%-43 % ] ; P < .001 ) . CONCLUSIONS The resection width immediately after CSP was larger than that after HSP but was significantly smaller at day 1 after resection . Although the resection depth after CSP was more superficial , muscularis mucosa was obtained in most specimens . Thus , CSP has sufficient resection width and depth to enable complete polyp resection and potentially has a superior safety profile than HSP BACKGROUND Both cold-only snare and hot polypectomy snare are used for the removal of small colorectal polyps . OBJECTIVE To compare the outcome of cold snare polypectomy of small colorectal polyps with a snare exclusively design ed as a cold snare versus cold snare polypectomy by using a traditional polypectomy snare . DESIGN Prospect i ve , r and omized , controlled study . SETTING Municipal hospital in Japan . INTERVENTIONS Patients with colorectal polyps 10 mm or smaller in diameter were r and omized to dedicated cold snare ( dedicated cold snare group ) or traditional cold snare ( traditional cold snare group ) . The primary outcome measure was complete resection rates by cold snaring based on pathological examination . Secondary outcomes included bleeding within 2 weeks after polypectomy and identification of submucosal arteries and injured arteries in the resected specimens . RESULTS Seventy-six patients having 210 eligible polyps were r and omized : dedicated cold snare group , N = 37 ( 98 polyps ) and traditional cold snare group , N = 39 ( 112 polyps ) . Patient demographic characteristics including the number , size , and shape of the polyps removed were similar in the 2 groups . The complete resection rate was significantly greater with the dedicated cold than with the traditional cold snare ( 91 % [ 89/98 ] vs 79 % [ 88/112 ] , P = .015 ) , with a marked difference with 8- to 10-mm polyps , both flat and pedunculated . Immediate bleeding and hematochezia rates were similar ( 19 % vs 21 % , P = .86 ; 5.4 % vs 7.7 % , P = .69 ) . No delayed bleeding occurred . Histology demonstrated a similar prevalence of arteries and injured arteries in the submucosa ( 33 % [ 32/96 ] vs 30 % [ 31/104 ] , P = .59 ; 3.1 % [ 3/96 ] vs 6.7 % [ 7/104 ] , P = .24 ) . LIMITATIONS Small sample size , single-center study . CONCLUSION Polypectomy by using a dedicated cold snare result ed in complete polyp removal more often than did cold snaring with a traditional snare , especially polyps 8 to 10 mm in diameter , whether flat or pedunculated . ( CLINICAL TRIAL REGISTRATION NUMBER NCT02036047 . BACKGROUND Cold snare techniques are widely used for removal of diminutive and small colorectal polyps . The influence of resection technique on the effectiveness of polypectomy is unknown . We therefore compared st and ard cold snare polypectomy with a newly described suction pseudopolyp technique , for completeness of excision and for complications . PATIENTS AND METHODS In this single-center study , 112 patients were r and omized to cold snare polypectomy or the suction pseudopolyp technique . Primary outcome was endoscopic completeness of excision . Consensus regarding the endoscopic assessment of completeness of excision was st and ardized and aided by chromoendoscopy . Secondary outcomes included : completeness of histological excision , polyp \" fly away \" and retrieval rates , early bleeding ( 48 hours ) , delayed bleeding ( 2 weeks ) , and perforation . RESULTS 148 polyps were removed , with size range 3 - 7 mm , 60 % in the left colon , and 90 % being sessile . Regarding completeness of excision ( with uncertain findings omitted ) : endoscopically , this was higher with the suction pseudopolyp technique compared with cold snare polypectomy but not statistically significantly so ( 73/74 [ 98.6 % ] vs. 63/68 [ 92.6 % ] ; P = 0.08 ) . A trend towards a higher complete histological excision rate with the suction pseudopolyp technique was also not statistically significant ( 45/59 [ 76.3 % ] vs. 37/58 [ 63.8 % ] ; P = 0.14 ) . Polyp retrieval rate was not significantly different ( suction 68/76 [ 89.5 % ] vs. cold snare 64/72 [ 88.9 % ] ; P = 0.91 ) . No perforation or bleeding requiring hemostasis occurred in either group . CONCLUSION In this study both polypectomy techniques were found to be safe and highly effective , but further large multicenter trials are required . Clinical trial registration at www . clinical trials.gov : NCT02208401 BACKGROUND The bleeding risk after cold snare polypectomy in anticoagulated patients is not known . OBJECTIVE To compare the bleeding risk after cold snare polypectomy or conventional polypectomy for small colorectal polyps in anticoagulated patients . DESIGN Prospect i ve r and omized controlled study . SETTING Municipal hospital in Japan . INTERVENTIONS Anticoagulated patients with colorectal polyps up to 10 mm in diameter were enrolled . Patients were r and omized to polypectomy with either cold snare technique ( Cold group ) or conventional polypectomy ( Conventional group ) without discontinuation of warfarin . The primary outcome measure was delayed bleeding ( ie , requiring endoscopic intervention within 2 weeks after polypectomy ) . Secondary outcome measures were immediate bleeding and retrieval rate of colorectal polyps . RESULTS Seventy patients were r and omized ( 159 polyps ) : Cold group ( n = 35 , 78 polyps ) and Conventional group ( n = 35 ; 81 polyps ) . The patients ' demographic characteristics including international normalized ratio and the number , size , and shape of polyps removed were similar between the 2 techniques . Immediate bleeding during the procedure was more common with conventional polypectomy ( 23 % [ 8/35 ] ) compared with cold polypectomy ( 5.7 % [ 2/35 ] ) ( P = .042 ) . No delayed bleeding occurred in the Cold group , whereas 5 patients ( 14 % ) required endoscopic hemostasis in the Conventional group ( P = .027 ) . Complete polyp retrieval rates were identical ( 94 % [ 73/78 ] vs 93 % [ 75/81 ] ) . The presence of histologically demonstrated injured arteries in the submucosal layer with cold snare \n Output:\n " }, { "from": "agent", "value": "Conclusions : CSP and HSP may result in the same complete resection rates for polyps ≤10 mm ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: In recent work , we showed that putatively adaptive emotion regulation strategies , such as re appraisal and acceptance , have a weaker association with psychopathology than putatively maladaptive strategies , such as rumination , suppression , and avoidance ( e.g. , Aldao & Nolen-Hoeksema , 2010 ; Aldao , Nolen-Hoeksema , & Schweizer , 2010 ) . In this investigation , we examined the interaction between adaptive and maladaptive emotion regulation strategies in the prediction of psychopathology symptoms ( depression , anxiety , and alcohol problems ) concurrently and prospect ively . We assessed trait emotion regulation and psychopathology symptoms in a sample of community residents at Time 1 ( N = 1,317 ) and then reassessed psychopathology at Time 2 ( N = 1,132 ) . Cross-sectionally , we found that the relationship between adaptive strategies and psychopathology symptoms was moderated by levels of maladaptive strategies : adaptive strategies had a negative association with psychopathology symptoms only at high levels of maladaptive strategies . In contrast , adaptive strategies showed no prospect i ve relationship to psychopathology symptoms either alone or in interaction with maladaptive strategies . We discuss the implication s of this investigation for future work on the context ual factors surrounding the deployment of emotion regulation strategies Background : Deficits in emotion regulation skills are possible factors maintaining major depressive disorder ( MDD ) . Therefore , the aim of the study was to test whether integrating a systematic emotion regulation training ( ERT ) enhances the efficacy of routine inpatient cognitive behavioral therapy ( CBT ) for MDD . Methods : In a prospect i ve r and omized controlled trial , 432 in patients meeting criteria for MDD were assigned to receive either routine CBT or CBT enriched with an intense emotion regulation skills training ( CBT-ERT ) . Results : Participants in the CBT-ERT condition demonstrated a significantly greater reduction in depression ( response rates - CBT : 75.5 % , CBT-ERT : 84.9 % ; remission rates - CBT : 51.1 % , CBT-ERT : 65.1 % ) . Moreover , CBT-ERT participants demonstrated a significantly greater reduction of negative affect , as well as a greater increase of well-being and emotion regulation skills particularly relevant for mental health . Conclusions : Integrating strategies that target emotion regulation skills improves the efficacy of CBT for MDD OBJECTIVE To describe an adapted version of dialectical behavior therapy for adolescents with bipolar disorder . METHOD The dialectical behavior therapy intervention is delivered over 1 year and consists of two modalities : family skills training ( conducted with individual family units ) and individual therapy . The acute treatment period ( 6 months ) includes 24 weekly sessions ; sessions alternate between the two treatment modalities . Continuation treatment consists of 12 additional sessions tapering in frequency through 1 year . We conducted an open pilot trial of the treatment , design ed as an adjunct to pharmacological management , to establish feasibility and acceptability of the treatment for this population . Participants included 10 patients ( mean age 15.8 + /- 1.5 years , range 14 - 18 ) receiving treatment in an outpatient pediatric bipolar specialty clinic . Symptom severity and functioning were assessed quarterly by an independent evaluator . Consumer satisfaction was also assessed posttreatment . RESULTS Feasibility and acceptability of the intervention were high , with 9 of 10 patients completing treatment , 90 % of scheduled sessions attended , and high treatment satisfaction ratings . Patients exhibited significant improvement from pre- to posttreatment in suicidality , nonsuicidal self-injurious behavior , emotional dysregulation , and depressive symptoms . CONCLUSIONS Dialectical behavior therapy may offer promise as an approach to the psychosocial treatment of adolescent bipolar disorder Background : Emotion-focused cognitive behavioral therapy ( ECBT ) is a new form of CBT with emotion regulation components . This form of treatment is suggested to be employed to improve dysregulation of anxiety and other kind of emotions in anxious children . This study observed and compared the effectiveness of CBT and ECBT on anxiety symptoms ; sadness and anger management ; and cognitive emotion regulation strategies in children with separation anxiety disorder ( SAD ) . Material s and Methods : This study is a r and omized clinical trial . Subjects were 30 children from 9 to 13-years-old ( 15 girls and 15 boys ) with diagnosis of SAD , being r and omly assigned to CBT , ECBT , and control groups ( five girls and five boys in each group ) . Subject children in CBT group participated in 10-h weekly sessions within Coping Cat manual ; whereas , subject children in ECBT group contributed in 12-h weekly sessions within ECBT . The control group received no treatment . The Screen for Child Anxiety Related Emotional Disorders ( SCARED ; child and parent forms ) , Children 's Emotion Management Scale ( CEMS ; anger and sadness forms ) , and Cognitive Emotion Regulation Question naire ( CERQ ) tests administered to all subjects in pretest , posttest , and the follow-up measurement ( 3 months later ) . Analysis of covariance ( ANCOVA ) repeated measure and Kruskal-Wallis were applied to analyze data by Statistical Package for Social Sciences ( SPSS ) software package ( v. 20 ) . Results : CBT and ECBT ; demonstrated no significant difference in reducing separation anxiety and total anxiety symptoms from parent and children 's reports . ECBT effectively increased anger coping and decreased negative cognitive strategies and dysregulation of anger in children , both in posttest and follow-up . Also , ECBT reduced sadness dysregulation and increased sadness coping , though these significant advantages were lost in 3 months later follow-up . CBT reduced negative cognitive strategies in follow-up and increased sadness coping in posttest . None of treatments affected on anger and sadness inhibition and positive cognitive coping in separation anxious children . Conclusion : ECBT , in comparison with CBT ; effectively improved emotion regulation strategies in children with separation anxiety OBJECTIVE To evaluate the effectiveness of Emotion Regulation Training ( ERT ) , a 17-session weekly group training for adolescents with borderline personality disorder ( BPD ) symptoms . METHOD One hundred nine adolescents with borderline traits ( 73 % meeting the full criteria for BPD ) were r and omized to treatment as usual only ( TAU ) or ERT + TAU . Outcome measurements included severity of BPD symptoms , general psychopathology , and quality of life . Multilevel analyses were conducted on an intent-to-treat basis . Clinical significant change was determined by normative comparisons on a primary outcome measurement . RESULTS Independent of treatment condition , the two groups improved equally on the severity of BPD symptoms , general psychopathology , and quality of life . Nineteen percent of the ERT group was remitted according to the cutoff score after treatment ( at 6 months ) versus 12 % of the control group . Follow-up assessment s in the ERT group at 12 months showed some further improvement ( 33 % remittance ) . With regard to predictors of outcomes , adolescents with higher levels of depression or attention-deficit/hyperactivity disorder or oppositional-defiant disorder at baseline and who reported a history of abuse had worse outcomes , regardless of treatment condition . The attrition rate for the ERT sessions was remarkably low ( 19 % ) . CONCLUSIONS Early interventions for BPD symptoms in adolescence are feasible and necessary . No additional effect of ERT over TAU could be demonstrated in the present study . There is a clear need for developing effective interventions for adolescents with persistent BPD symptomatology . Clinical trial registration information-Evaluation of Group Training for Adolescents ( Emotion Regulation Training ) with Emotion Regulation Problems : A R and omized Controlled Clinical Trial ; http://trailregister.nl/ ; IS RCT N97589104 This study presents the outcomes of mediator analyses as part of a r and omized controlled trial of Cognitive-Behavioural Therapy ( CBT ) for young people who engage in deliberate self-harm ( DSH ) . The study involved 90 people , aged 15 - 35 years , who were r and omly assigned to CBT in addition to treatment as usual or to treatment as usual only . The findings showed that changes in DSH were partially mediated by changes in emotion-regulation difficulties , particularly difficulties with impulse control and goal -directed behaviours . In addition , the potential mediating role of symptoms of depression , anxiety and suicidal cognitions was examined . Although the CBT intervention significantly reduced depression , anxiety and suicidal cognitions , these measures of symptom severity did not play a mediating role . These findings suggest that interventions for DSH should not primarily focus on mental disorders associated with DSH , but should be DSH-specific and should target specific emotion-regulation difficulties This study evaluated the efficacy of Integrated Family and Cognitive-Behavioral Therapy ( IFCBT ) , a multisystems treatment for adolescent drug abuse , versus a Drugs Harm Psychoeducation curriculum ( DHPE ) . A r and omized controlled trial assessed youth and parents at baseline and at 1 , 3 and 6-month posttreatment points . Youth participants ( N=43 ) met diagnostic criteria for one or more psychoactive substance use disorders with most youth meeting criteria for alcohol and marijuana use disorders . IFCBT produced significant reductions in posttreatment substance use when compared against DHPE . Throughout the 6-month posttreatment period , youth receiving IFCBT used alcohol an average of 2.03 days each month , which was significantly lower than the average number of 6.06 days that DHPE youth used alcohol during the same period . Similarly , youth receiving IFCBT used marijuana an average of 5.67 days each month during the initial 6 posttreatment months which was also significantly lower than the average number of 13.83 days that DHPE youth used marijuana each month during the same period . IFCBT also reduced rates of any marijuana use and produced significant changes in targeted psychosocial risk and protective factors . IFCBT youth exhibited significantly higher levels of rational problem solving and learning strategy skills , and significantly lower levels of problem avoidance when compared with DHPE youths . IFCBT parents exhibited significantly more adaptive scores on communication , involvement , control , and values/norms indices when compared with DHPE parents . No iatrogenic effects were exhibited among youth in either IFCBT or DHPE conditions on the outcome measures examined . The present study findings suggest that IFCBT is a promising approach for the treatment of adolescents with psychoactive substance use disorders \n Output:\n " }, { "from": "agent", "value": "This is the first meta- analysis that summarizes the effectiveness for existing interventions to improve ER in youth .\nThe results suggest that interventions can enhance ER in youth , and that these improvements correlate with improvements in psychopathology ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: The reported association of low-back pain and musculoskeletal disorders contributed to the examination of the lumbar spine and hip extensor activation patterns in back pain sufferers during walking . Seventeen idiopathic low-back pain male subjects and 16 healthy volunteers participated in the study . Hip joint ROMs in the sagittal plane and neuromuscular activities of erector spinae [ L3 , T12 ] , gluteus maximus and biceps femoris were recorded on one r and omly selected body side in each group . Analysis using the Student 's t-test revealed significant differences for hip joint range of motion , stride time and significantly earlier onsets of the lumbar spine and hip extensors of the back pain sufferers compared with the healthy controls . It is assumed , that low-back disorders are related to changes of the lumbar spine and hip extensor recruitment pattern OBJECTIVE To investigate the recruitment of the vastus medialis obliquus ( VMO ) and vastus lateralis during voluntary tasks that challenge the stability of the knee and to evaluate whether there is a change in the coordination of the postural response by the central nervous system in subjects with patellofemoral pain syndrome ( PFPS ) . DESIGN Cross-sectional . SETTING University laboratory in Australia . PARTICIPANTS Thirty-seven subjects with PFPS and 37 asymptomatic sex-matched controls . INTERVENTIONS Not applicable . MAIN OUTCOME MEASURES Recordings of electromyographic activity of the VMO , vastus lateralis , tibialis anterior , and soleus were made by using surface electrodes . Subjects rose onto their toes ( rise task ) or rocked back on their heels ( rock task ) in a visual choice-reaction time task . Electromyographic onsets were determined by using a computer algorithm and were verified visually . RESULTS Our results confirm that , in asymptomatic subjects , contraction of the VMO and vastus lateralis occurs as part of the feed-forward postural response associated with ankle movements in st and ing , and the contraction of these separate heads of the quadriceps group occurs simultaneously . However , when subjects with PFPS perform identical tasks , the electromyographic onset of the vastus lateralis occurs before that of the VMO . CONCLUSION These findings indicate a difference in motor control in subjects with PFPS . They also support the hypothesized relation between changes in the timing of activity of the vastii and PFPS and provide the theoretic rationale to support physiotherapy treatment commonly used in the management of PFPS Background Inappropriate control of the vastus medialis oblique and vastus lateralis muscles by the central nervous system can contribute to maltracking of the patella . Hypothesis The activation timing and amplitude of the vastus medialis oblique and vastus lateralis muscles will be different between normal subjects and patients with patellofemoral pain . Study Design Controlled laboratory study . Methods Subjects with patellofemoral pain and asymptomatic control subjects performed maximum voluntary knee extension contractions initiated from a flexed and an extended position . The activation timing and amplitude of the vastus lateralis and vastus medialis oblique muscles were quantified from the recorded electromyographic signals . Results There were no between-group differences in activation timing . The activation amplitude of the vastus medialis oblique and vastus lateralis muscles of the patellofemoral pain subjects was altered to the greatest extent during eccentric contractions and differed significantly from that of control subjects . Conclusions The activation amplitudes of the vastus medialis oblique and vastus lateralis muscles of subjects with patellofemoral pain are consistent with a laterally tracking patella during eccentric contractions . Clinical Relevance The findings suggest the clinical importance of determining whether altered activation patterns are sensitive to rehabilitation , and , if so , if subjective reports of knee joint pain and function parallel changes in the activation patterns as a result of rehabilitation BACKGROUND AND PURPOSE Physical therapy rehabilitation strategies are commonly directed at the alteration of muscle recruitment in functional movements . The aim of this study was to investigate whether feedforward strategies of the vasti in people with patellofemoral pain syndrome can be changed by a physical therapy treatment program in a r and omised , double blind , placebo controlled trial . SUBJECTS Forty ( 25 female , 15 male ) subjects aged 40 yrs or less ( 27.2+/-7.8 yrs ) . METHODS Subjects were allocated to either a placebo treatment or a physical therapy intervention program . The postural challenge used as the outcome measure was not included in the training program . Electromyography ( EMG ) onsets of vastus medialis obliquus ( VMO ) , vastus lateralis ( VL ) , tibialis anterior and soleus were assessed before and after the six week st and ardised treatment programs . RESULTS At baseline the EMG onset of VL occurred prior to that of VMO in both subject groups . Following physical therapy intervention there was a significant change in the time of onset of EMG of VMO compared to VL with the onsets occurring simultaneously . This change was associated with a reduction in symptoms . In contrast , following placebo intervention the EMG onset of VL still occurred prior to that of VMO . CONCLUSION AND DISCUSSION The results indicate that the feedforward strategy used by the central nervous system to control the patella can be restored . Importantly , the data suggest that this intervention produced a change that was transferred to a task that was not specifically included in the training program . Furthermore , the change in motor control was associated with clinical improvement in symptoms Objective To examine the effect of the application of tape over the patella on the onset of electromyographic ( EMG ) activity of vastus medialis obliquus ( VMO ) relative to vastus lateralis ( VL ) in participants with and without patellofemoral pain syndrome ( PFPS ) . Design R and omised within subject . Setting sUniversity laboratory . Participants Ten participants with PFPS and 12 asymptomatic controls . Interventions Three experimental taping conditions : no tape , therapeutic tape , and placebo tape . Main Outcome Measures Electromyographic onset of VMO and VL assessed during the concentric and eccentric phases of a stair stepping task . Results When participants with PFPS completed the stair stepping task , the application of therapeutic patellar tape was found to alter the temporal characteristics of VMO and VL activation , whereas placebo tape had no effect . In contrast , there was no change in the EMG onset of VMO and VL with the application of placebo or therapeutic tape to the knee in the asymptomatic participants . Conclusions These data support the use of patellar taping as an adjunct to rehabilitation in people with PFPS OBJECTIVE To determine the effects of a weight-bearing rehabilitation program on quadriceps and gluteus medius electromyographic activity , pain , and function in subjects diagnosed with patellofemoral pain syndrome ( PFPS ) . DESIGN Pretest and posttest 6-week intervention study . SETTING Musculoskeletal research laboratory . PARTICIPANTS Fourteen subjects diagnosed with PFPS and 14 healthy control subjects volunteered to participate in this study . No subjects withdrew from the study because of adverse effects . INTERVENTION Subjects diagnosed with PFPS participated in a 6-week rehabilitation program . The rehabilitation program consisted of weight-bearing exercises that focused on strengthening the quadriceps and hip abductor musculature . MAIN OUTCOME MEASURES Electromyographic onsets of the vastus medialis oblique ( VMO ) and vastus lateralis and onset and duration of the gluteus medius were collected during a stair-stepping task that was performed during the pretest and posttest . A visual analog scale ( VAS ) and Functional Index Question naire ( FIQ ) were administered at pretest and posttest and each week of the intervention . RESULTS Vastus lateralis and VMO onset timing differences ( vastus lateralis electromyographic onset minus VMO electromyographic onset ) and VAS and FIQ scores significantly improved for patients diagnosed with PFPS . Vastus lateralis and VMO onset timing in the PFPS group were significantly different from those in the control group at baseline and were not significantly different from the control group after the intervention . We did not find differences in gluteus medius onsets or duration of activity . CONCLUSIONS Subjects diagnosed with PFPS responded favorably and quickly to a therapeutic exercise program that incorporated quadriceps and hip musculature strengthening . The efficacy of the therapeutic exercise program used in this study should be further investigated in a larger subject population Many variables have retrospectively been associated with the presence of anterior knee pain . Very few prospect i ve data exist , however , to determine which of these variables will lead to the development of anterior knee pain . It was our purpose in this study to determine the intrinsic risk factors for the development of anterior knee pain in an athletic population over a 2-year period . Before the start of training , 282 male and female students enrolled in physical education classes were evaluated for anthropometric variables , motor performance , general joint laxity , lower leg alignment characteristics , muscle length and strength , static and dynamic patellofemoral characteristics , and psychological parameters . During this 2-year follow-up study , 24 of the 282 students developed patellofemoral pain . Statistical analyses revealed a significant difference between those subjects who developed patellofemoral pain and those who did not concerning quadriceps and gastrocnemius muscle flexibility , explosive strength , thumb-forearm mobility , reflex response time of the vastus medialis obliquus and vastus lateralis muscles , and the psychological parameter of seeking social support . However , only a shortened quadriceps muscle , an altered vastus medialis obliquus muscle reflex response time , a decreased explosive strength , and a hypermobile patella had a significant correlation with the incidence of patellofemoral pain . We concluded that the latter four parameters play a dominant role in the genesis of anterior knee pain and we therefore deem them to be risk factors for this syndrome \n Output:\n " }, { "from": "agent", "value": "A trend was demonstrated towards a delayed onset of VMO relative to VL in those with AKP in comparison to those without .\nHowever not all AKP patients demonstrate a VMO-VL dysfunction , and this is compounded by normal physiological variability in the healthy population ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: OBJECTIVE Docosahexaenoic acid ( DHA ) might help prevent or attenuate posttraumatic stress disorder ( PTSD ) symptoms . We examined the efficacy and safety of DHA for preventing PTSD ( DSM-IV ) after severe accidental injury . METHOD From December 2008 to August 2013 , we conducted a r and omized , double-blind , placebo-controlled trial of 110 accident-injured patients consecutively admitted to an intensive care unit of the National Disaster Medical Center in Tokyo , Japan . All patients were taught about their psychological reactions to accidental injury for 20 minutes and were r and omly assigned to receive 1,470 mg/d of DHA plus 147 mg/d of eicosapentaenoic acid ( EPA ; n = 53 ) or placebo ( n = 57 ) for 12 weeks . The primary outcome was total score on the Clinician-Administered PTSD Scale ( CAPS ) at 3-month follow-up . Secondary outcomes included PTSD diagnosis ( full-blown or partial PTSD ) . Adherence to the interventions was assessed by erythrocyte fatty acid composition . RESULTS At 3 months , the CAPS total score revealed no differences between the 2 groups ( 10.78 in the DHA group vs 9.22 in the placebo group ; n = 100 ; P = .572 ) . We found that 11.1 % of the DHA group and 5.5 % of the placebo group developed PTSD . The erythrocyte level of DHA and EPA in the DHA group was significantly elevated compared to the placebo group ( P < .01 ) . CONCLUSIONS Docosahexaenoic acid supplementation was not superior to placebo for the secondary prevention of PTSD symptoms at 3 months after severe accidental injury . The efficacy of a different ratio of DHA and EPA and higher doses of omega-3 fatty acids as secondary prevention of PTSD remains to be determined . TRIAL REGISTRATION Clinical Trials.gov Identifier : NCT00671099 BACKGROUND Polyunsaturated fatty acids ( PUFAs ) are intrinsic cell membrane components and closely involved in neurotransmission and receptor function . Lower omega-3 levels are associated with increased risk of coronary artery disease ( CAD ) , increases in cardiac events in CAD patients , and depression . We sought to examine relationships between depression and serum levels of omega-3 and omega-6 PUFAs in patients recovering from acute coronary syndromes ( ACS ) . METHODS We carried out a case-control study of serum PUFA levels and current major depression in 54 age- and sex-matched pairs approximately 2 months following ACS . RESULTS Depressed patients had significantly lower concentrations of total omega-3 and docosahexaenoic acid ( DHA ) , and higher ratios of arachidonic acid ( AA ) to DHA , AA to eicosapentaenoic acid ( EPA ) , and n-3 to n-6 than controls . There were no baseline differences in any potential risk or protective factors for depression . CONCLUSIONS Results are consistent with previous reports in depressed patients without CAD , and with literature concerning omega-3 levels and risk of CAD events . Dietary , genetic , and hormonal factors may all play a role in both depression and CAD . Both prospect i ve studies and r and omized trials are needed to help clarify the interrelationships Objectives : Somatic symptoms are common in depressive disorder and are similar to sickness behaviors due to inflammatory activation after cytokine administration . Omega-3 polyunsaturated fatty acids ( PUFAs ) are natural anti-inflammatory agents and may reduce inflammation-induced behavioral changes . The aim of this study was to investigate the role of PUFAs on the development of somatic symptoms and depression in patients of hepatitis C virus infection ( HCV ) receiving interferon-alpha therapy ( IFN-α ) in a prospect i ve manner . Methods : In this 24-week , prospect i ve cohort study , 43 patients with chronic HCV ongoing IFN-α therapy were assessed with the mini-international neuropsychiatric interview for major depressive episodes and neurotoxicity rating scale ( NRS ) for somatic symptoms . Results : One-third later developed IFN-α-induced depression ( depression ( DEP ) group ) . As compared to subjects without depression , DEP group had higher NRS scores ( P < 0.001 ) , lower eicosapentaenoic acid ( EPA ) levels ( P = 0.038 ) at week 2 . Somatic symptoms , regardless of painful/non-painful characteristics , had positive association with arachidonic acid ( P < 0.05 ) , and negative association with EPA ( P < 0.05 ) . Conclusion : This study implies that early intervention with omega-3 PUFAs might be a promising strategy to prevent depression and somatic symptoms in patients receiving cytokine therapy BACKGROUND It is suggested that a low intake of fish and /or n-3 PUFA is associated with depressed mood . However , results from epidemiologic studies are mixed , and r and omized trials have mainly been performed in depressed patients , yielding conflicting results . OBJECTIVE We investigated the effect of eicosapentaenoic acid ( EPA ) and docosahexaenoic acid ( DHA ) on mental well-being in a double-blind , placebo-controlled trial . DESIGN Independently living individuals ( n = 302 ) aged > or = 65 y were r and omly assigned to consume 1800 mg/d EPA+DHA , 400 mg/d EPA+DHA , or placebo capsules for 26 wk . Changes in mental well-being were assessed as the primary outcome with the Center for Epidemiologic Studies Depression Scale ( CES-D ) , Montgomery-Asberg Rating Scale ( MADRS ) , Geriatric Depression Scale ( GDS-15 ) , and Hospital Anxiety and Depression Scale ( HADS-A ) . RESULTS Plasma concentrations of EPA+DHA increased by 238 % in the high-dose and 51 % in the low-dose fish-oil group compared with the placebo group , reflecting excellent compliance . Baseline CES-D scores ranged from 5.9 to 6.8 in the 3 groups and were not significantly different between groups . Mean changes in CES-D scores after 26 wk were -0.2 , 0.2 , and -0.4 ( P = 0.87 ) in the high-dose fish oil , low-dose fish oil , and placebo groups , respectively . Treatment with neither 1800 mg nor 400 mg EPA+DHA differentially affected any of the measures of mental well-being after 13 or 26 wk of intervention compared with placebo . CONCLUSIONS In this r and omized , double-blind , placebo-controlled trial we observed no effect of EPA+DHA supplementation for 26 wk on mental well-being in the general older population studied . This trial was registered at clinical trials.gov as NCT00124852 The efficacy of omega-3 fatty acids for maintaining a better mental state has not been examined among working population s. We aim ed to explore the effectiveness of omega-3 fatty acids for hospital nurses . In a multi-center r and omized trial , 80 junior nurses were r and omly allocated to either omega-3 fatty acids ( 1200 mg/day of eicosapentaenoic acid and 600 mg/day of docosahexaenoic acid ) or identical placebo pills for 13 weeks . The primary outcome was the total score of the Hospital Anxiety and Depression Scale ( HADS ) , determined by a blinded rater at week 26 from the study enrolment . Secondary outcomes included the total score of the HADS at 13 and 52 weeks ; incidence of a major depressive episode ; severity of depression , anxiety , insomnia , burnout , and presenteeism ; utility scores ; and adverse events at 13 , 26 and 52 weeks . The mean HADS score at baseline was 7.2 . At 26 weeks , adjusted mean scores on the HADS were 6.32 ( 95 % CIs of st and ard errors : 5.13 , 7.52 ) in the intervention and 6.81 ( 5.57 , 8.05 ) in the placebo groups , respectively . The coefficient of the group by time interaction was not statistically significant at 0.58 ( -1.35 , 2.50 ; P = 0.557 ) . Although the intervention group showed significant superiority on the HADS score at 52 weeks , depression severity at 52 weeks , insomnia severity at 13 weeks , and absolute presenteeism at 26 weeks , no significant superiority or inferiority was observed on the other outcomes . The additive value of omega-3 fatty acids was not confirmed regarding mental state and self-evaluated work efficiency Psychiatric disorders in general , and major depression and anxiety disorders in particular , account for a large burden of disability , morbidity and premature mortality worldwide . Omega-3 polyunsaturated fatty acids ( PUFAs ) have a range of neurobiological activities in modulation of neurotransmitters , anti-inflammation , anti-oxidation and neuroplasticity , which could contribute to psychotropic effects . Here we review ed recent research on the benefits of omega-3 PUFA supplements in prevention against major depression , bipolar disorders , interferon-α-induced depression patients with chronic hepatitis C viral infection , and posttraumatic stress disorder . The biological mechanisms underlying omega-3 PUFAs ’ psychotropic effects are proposed and review ed . Nutrition is a modifiable environmental factor that might be important in prevention medicine , which have been applied for many years in the secondary prevention of heart disease with omega-3 PUFAs . This review extends the notion that nutrition in psychiatry is a modifiable environmental factor and calls for more research es on prospect i ve clinical studies to justify the preventive application of omega-3 PUFAs in daily practice Objective This study examined the dose-dependent effects of eicosapentaenoic acid ( EPA ) and docosahexaenoic acid ( DHA ) supplementation on heart rate variability ( HRV ) at rest and during st and ard laboratory stress tasks . We also investigated whether EPA + DHA supplementation was associated with changes in mood state . Methods This placebo-controlled , double-blind , r and omized , three-period crossover trial ( 8-week treatment , 6-week washout ) compared two doses of EPA + DHA supplementation ( 0.85 and 3.4 g/d ) in 26 adults with elevated triglycerides . After each treatment period , HRV was assessed during an acute stress protocol that included a resting baseline , st and ard laboratory stress tasks ( speech task and cold pressor ) , and recovery periods . In addition , mood state was assessed . Results Root mean square of successive differences in interbeat interval and total power increased 9.9 % and 20.6 % , respectively , after the high dose relative to placebo ( Tukey p = .016 and .012 , respectively ) . The low dose was not significantly different from the high dose or placebo dose . There was a trend for a treatment effect on high-frequency HRV ( p = .058 ) , with 21.0 % greater power observed after the high dose compared with placebo ( Tukey p = .052 ) . Mood did not differ between treatments , and there was no association between mood state and HRV . Conclusions In healthy adults with elevated triglycerides , supplementation of 3.4 g/d EPA + DHA result ed in greater HRV , whereas 0.85 g/d EPA + DHA had no effect . These results indicate that EPA + DHA supplementation may improve autonomic tone in adults at increased risk for cardiovascular disease within 8 weeks . Trial Registration NCT00504309 ( Clinical Trials.gov ) OBJECTIVE To determine whether supplementation with the long-chain omega-3 polyunsaturated fatty acids eicosapentaenoic ( EPA ) and docosahexaenoic acid ( DHA ) affects behavioral symptoms and cognitive impairments in children 6 - 12 years of age diagnosed with attention-deficit/hyperactivity disorder ( ADHD ) . STUDY DESIGN The r and omized , double-blind placebo-controlled 16 weeks trial was conducted with 95 children diagnosed with ADHD according to DSM-IV criteria . Behavior was assessed by parents , teachers and investigators using st and ardized rating scales and question naires . Further outcome variables were working memory , speed of information processing and various measures of attention . For a subgroup of 81 participants , erythrocyte membrane fatty acid composition was analyzed before and after the intervention . RESULTS Supplementation with the omega-3 fatty acid mix increased EPA and DHA concentrations in erythrocyte membranes and improved working memory function , but had no effect on other cognitive measures and parent- and teacher-rated behavior in the study population . Improved working memory correlated significantly with increased EPA , DHA and decreased AA ( arachidonic acid ) Observational studies have linked lower omega-3 ( n-3 ) polyunsaturated fatty acids ( PUFAs ) and higher omega-6 ( n-6 ) PUFAs with inflammation and depression , but r and omized controlled trial ( RCT ) data have been mixed . To determine whether n-3 decreases proinflammatory cytokine production and depressive and anxiety symptoms in healthy young adults , this parallel group , placebo-controlled , double-blind \n Output:\n " }, { "from": "agent", "value": "Subgroup analysis showed that the association of treatment with reduced anxiety symptoms was significantly greater in subgroups with specific clinical diagnoses than in subgroups without clinical conditions .\nThe anxiolytic effect of omega-3 PUFAs was significantly better than that of controls only in subgroups with a higher dosage ( at least 2000 mg/d ) and not in subgroups with a lower dosage ( < 2000 mg/d ) .\nConclusions and Relevance This review indicates that omega-3 PUFAs might help to reduce the symptoms of clinical anxiety ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: BACKGROUND Studies with pertuzumab , a novel anti-HER2 antibody , show improved efficacy when combined with the established HER2-directed antibody trastuzumab in breast cancer therapy . We investigated the combination of pertuzumab or trastuzumab , or both , with docetaxel and the combination of pertuzumab and trastuzumab without chemotherapy in the neoadjuvant setting . METHODS In this multicentre , open-label , phase 2 study , treatment-naive women with HER2-positive breast cancer were r and omly assigned ( 1:1:1:1 ) central ly and stratified by operable , locally advanced , and inflammatory breast cancer , and by hormone receptor expression to receive four neoadjuvant cycles of : trastuzumab ( 8 mg/kg loading dose , followed by 6 mg/kg every 3 weeks ) plus docetaxel ( 75 mg/m(2 ) , escalating , if tolerated , to 100 mg/m(2 ) every 3 weeks ; group A ) or pertuzumab ( loading dose 840 mg , followed by 420 mg every 3 weeks ) and trastuzumab plus docetaxel ( group B ) or pertuzumab and trastuzumab ( group C ) or pertuzumab plus docetaxel ( group D ) . The primary endpoint , examined in the intention-to-treat population , was pathological complete response in the breast . Neither patients nor investigators were masked to treatment . This study is registered with Clinical Trials.gov , number NCT00545688 . FINDINGS Of 417 eligible patients , 107 were r and omly assigned to group A , 107 to group B , 107 to group C , and 96 to group D. Patients given pertuzumab and trastuzumab plus docetaxel ( group B ) had a significantly improved pathological complete response rate ( 49 of 107 patients ; 45·8 % [ 95 % CI 36·1 - 55·7 ] ) compared with those given trastuzumab plus docetaxel ( group A ; 31 of 107 ; 29·0 % [ 20·6 - 38·5 ] ; p=0·0141 ) . 23 of 96 ( 24·0 % [ 15·8 - 33·7 ] ) women given pertuzumab plus docetaxel ( group D ) had a pathological complete response , as did 18 of 107 ( 16·8 % [ 10·3 - 25·3 ] ) given pertuzumab and trastuzumab ( group C ) . The most common adverse events of grade 3 or higher were neutropenia ( 61 of 107 women in group A , 48 of 107 in group B , one of 108 in group C , and 52 of 94 in group D ) , febrile neutropenia ( eight , nine , none , and seven , respectively ) , and leucopenia ( 13 , five , none , and seven , respectively ) . The number of serious adverse events was similar in groups A , B , and D ( 15 - 20 serious adverse events per group in 10 - 17 % of patients ) but lower in group C ( four serious adverse events in 4 % of patients ) . INTERPRETATION Patients given pertuzumab and trastuzumab plus docetaxel ( group B ) had a significantly improved pathological complete response rate compared with those given trastuzumab plus docetaxel , without substantial differences in tolerability . Pertuzumab and trastuzumab without chemotherapy eradicated tumours in a proportion of women and showed a favourable safety profile . These findings justify further exploration in adjuvant trials and support the neoadjuvant approach for accelerating drug assessment in early breast cancer . FUNDING F Hoffmann-La Roche BACKGROUND We present the combined results of two trials that compared adjuvant chemotherapy with or without concurrent trastuzumab in women with surgically removed HER2-positive breast cancer . METHODS The National Surgical Adjuvant Breast and Bowel Project trial B-31 compared doxorubicin and cyclophosphamide followed by paclitaxel every 3 weeks ( group 1 ) with the same regimen plus 52 weeks of trastuzumab beginning with the first dose of paclitaxel ( group 2 ) . The North Central Cancer Treatment Group trial N9831 compared three regimens : doxorubicin and cyclophosphamide followed by weekly paclitaxel ( group A ) , the same regimen followed by 52 weeks of trastuzumab after paclitaxel ( group B ) , and the same regimen plus 52 weeks of trastuzumab initiated concomitantly with paclitaxel ( group C ) . The studies were amended to include a joint analysis comparing groups 1 and A ( the control group ) with groups 2 and C ( the trastuzumab group ) . Group B was excluded because trastuzumab was not given concurrently with paclitaxel . RESULTS By March 15 , 2005 , 394 events ( recurrent , second primary cancer , or death before recurrence ) had been reported , triggering the first scheduled interim analysis . Of these , 133 were in the trastuzumab group and 261 in the control group ( hazard ratio , 0.48 ; P<0.0001 ) . This result crossed the early stopping boundary . The absolute difference in disease-free survival between the trastuzumab group and the control group was 12 percent at three years . Trastuzumab therapy was associated with a 33 percent reduction in the risk of death ( P=0.015 ) . The three-year cumulative incidence of class III or IV congestive heart failure or death from cardiac causes in the trastuzumab group was 4.1 percent in trial B-31 and 2.9 percent in trial N9831 . CONCLUSIONS Trastuzumab combined with paclitaxel after doxorubicin and cyclophosphamide improves outcomes among women with surgically removed HER2-positive breast cancer . ( Clinical Trials.gov numbers , NCT00004067 and NCT00005970 . To assess anti-tumor activity of sequential epirubicin/cyclophosphamide followed by docetaxel with the r and omized addition of celecoxib in HER2 negative patients or trastuzumab in HER2 positive patients . From May 2004 till October 2007 , 340 patients with stage II and III breast adenocarcinoma , ineligible for breast conserving surgery , received eight sequential three weekly cycles of EC-D [ epirubicin ( 75 mg/m2)–cyclophosphamide ( 750 mg/m2 ) for four cycles followed by docetaxel ( 100 mg/m2 ) for four cycles ] . HER2-negative patients ( N = 220 ) were r and omized to receive concomitantly with docetaxel celecoxib 800 mg/day during cycles 5–8 or no additional treatment , while HER2-positive patients confirmed by FISH ( N = 120 ) were r and omized to trastuzumab concomitant to docetaxel ( 8 mg/kg then 6 mg/kg IV every 3 weeks ) or no additional preoperative treatment . In the HER2 negative group , pCR ( grade 1 and 2 of Chevallier ’s classification ) was observed in 11.5 and 13 % of patients treated without and with neoadjuvant Celecoxib , respectively . In the HER2 positive group , pCR rate reached 26 % in those who received neoadjuvant trastuzumab versus 19 % in the others . There was no unexpected toxicity , no cardiac toxicity , and no toxic death . Triple negative breast cancers experience the highest pCR rate of 30 % . Celecoxib is not likely to improve pCR rates in addition to EC-D in patients with HER2-negative tumor . In HER2-positive tumor patients , trastuzumab added to ECD leads to increased pCR rates . It was the only combination to deserve further study according to the two-stage Fleming ’s design used in this trial Background A r and omized Phase II study evaluated the activity of weekly paclitaxel versus its combination with trastuzumab for treatment of patients with advanced breast cancer overexpressing HER-2 . Patients and methods Among 124 patients r and omized , 123 are assessable for toxicity and 118 for response . Patients received weekly paclitaxel single agent ( 80 mg/m2 ) or combined with trastuzumab ( 4 mg/kg loading dose , then weekly 2 mg/kg ) . HER-2 overexpression was determined by immunohistochemistry ( IHC ) . Patients with 2+/3 + IHC scores were eligible . IHC was compared with HER-2 serum extracellular domain ( ECD ) . Results Patient characteristics were similar in the two arms . Both treatments were feasible and well tolerated with no grade 4 hematologic toxicity . No patient developed cardiac toxicity . The combined treatment was statistically significant superior for overall response rate ( ORR ) ( 75 % vs. 56.9 % ; P = 0.037 ) , particularly in the subset of IHC 3 + patients ( 84.5 % vs. 47.5 % ; P = 0.00050 ) . A statistically significant better median time to progression was seen in the subgroup with IHC 3 + ( 369 vs. 272 days ; P = 0.030 ) and visceral disease ( 301 vs. 183 days ; P = 0.0080 ) treated with combination . Multivariable analysis of predictive factors showed that only IHC score retained statistically significant value for ORR ( P = 0.0035 ) . Conclusion Weekly paclitaxel plus trastuzumab is highly active and safe and it is superior to paclitaxel alone in patients with IHC score of 3 + BACKGROUND The monoclonal antibody trastuzumab has survival benefit when given with chemotherapy to patients with early , operable , and metastatic breast cancer that has HER2 ( also known as ERBB2 ) overexpression or amplification . We aim ed to assess event-free survival in patients with HER2-positive locally advanced or inflammatory breast cancer receiving neoadjuvant chemotherapy with or without 1 year of trastuzumab . METHODS We compared 1 year of treatment with trastuzumab ( given as neoadjuvant and adjuvant treatment ; n=117 ) with no trastuzumab ( 118 ) , in women with HER2-positive locally advanced or inflammatory breast cancer treated with a neoadjuvant chemotherapy regimen consisting of doxorubicin , paclitaxel , cyclophosphamide , methotrexate , and fluorouracil . R and omisation was done with a computer program and minimisation technique , taking account of geographical area , disease stage , and hormone receptor status . Investigators were informed of treatment allocation . A parallel cohort of 99 patients with HER2-negative disease was included and treated with the same chemotherapy regimen . Primary endpoint was event-free survival . Analysis was by intention to treat . This study is registered , number IS RCT N86043495 . FINDINGS Trastuzumab significantly improved event-free survival in patients with HER2-positive breast cancer ( 3-year event-free survival , 71 % [ 95 % CI 61 - 78 ; n=36 events ] with trastuzumab , vs 56 % [ 46 - 65 ; n=51 events ] without ; hazard ratio 0.59 [ 95 % CI 0.38 - 0.90 ] ; p=0.013 ) . Trastuzumab was well tolerated and , despite concurrent administration with doxorubicin , only two patients ( 2 % ) developed symptomatic cardiac failure . Both responded to cardiac drugs . INTERPRETATION The addition of neoadjuvant and adjuvant trastuzumab to neoadjuvant chemotherapy should be considered for women with HER2-positive locally advanced or inflammatory breast cancer to improve event-free survival , survival , and clinical and pathological tumour responses . FUNDING F Hoffmann-La Roche BACKGROUND Trastuzumab , a recombinant monoclonal antibody against HER2 , has clinical activity in advanced breast cancer that overexpresses HER2 . We investigated its efficacy and safety after excision of early-stage breast cancer and completion of chemotherapy . METHODS This international , multicenter , r and omized trial compared one or two years of trastuzumab given every three weeks with observation in patients with HER2-positive and either node-negative or node-positive breast cancer who had completed locoregional therapy and at least four cycles of neoadjuvant or adjuvant chemotherapy . RESULTS Data were available for 1694 women r and omly assigned to two years of treatment with trastuzumab , 1694 women assigned to one year of trastuzumab , and 1693 women assigned to observation . We report here the results only of treatment with trastuzumab for one year or observation . At the first planned interim analysis ( median follow-up of one year ) , 347 events ( recurrence of breast cancer , contralateral breast cancer , second nonbreast malignant disease , or death ) were observed : 127 events in the trastuzumab group and 220 in the observation group . The unadjusted hazard ratio for an event in the trastuzumab group , as compared with the observation group , was 0.54 ( 95 percent confidence interval , 0.43 to 0.67 ; P< \n Output:\n " }, { "from": "agent", "value": "There was no significant increase in a risk of high- grade neutropenia or leukopenia in patients receiving trastuzumab .\nTreatment with trastuzumab is associated with a significantly higher risk of high- grade infection and febrile neutropenia ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: Abstract Variability in patients ' response to interventions in pain and other clinical setting s is large . Many explanations such as trial methods , environment or culture have been proposed , but this paper sets out to show that the main cause of the variability may be r and om chance , and that if trials are small their estimate of magnitude of effect may be incorrect , simply because of the r and om play of chance . This is highly relevant to the questions of ‘ How large do trials have to be for statistical accuracy ? ’ and ‘ How large do trials have to be for their results to be clinical ly valid ? ’ The true underlying control event rate ( CER ) and experimental event rate ( EER ) were determined from single‐dose acute pain analgesic trials in over 5000 patients . Trial group size required to obtain statistically significant and clinical ly relevant ( 0.95 probability of number‐needed‐to‐treat within ±0.5 of its true value ) results were computed using these values . Ten thous and trials using these CER and EER values were simulated using varying group sizes to investigate the variation due to r and om chance alone . Most common analgesics have EERs in the range 0.4–0.6 and CER of about 0.19 . With such efficacy , to have a 90 % chance of obtaining a statistically significant result in the correct direction requires group sizes in the range 30–60 . For clinical relevance nearly 500 patients are required in each group . Only with an extremely effective drug ( EER>0.8 ) will we be reasonably sure of obtaining a clinical ly relevant NNT with commonly used group sizes of around 40 patients per treatment arm . The simulated trials showed substantial variation in CER and EER , with the probability of obtaining the correct values improving as group size increased . We contend that much of the variability in control and experimental event rates is due to r and om chance alone . Single small trials are unlikely to be correct . If we want to be sure of getting correct ( clinical ly relevant ) results in clinical trials we must study more patients . Credible estimates of clinical efficacy are only likely to come from large trials or from pooling multiple trials of conventional ( small ) size & NA ; The efficacy of ketorolac , a non‐steroidal anti‐inflammatory drug , in the management of moderate to severe pain in adults , has led us to conduct a trial of this analgesic in children following tonsillectomy . Children were r and omized to receive intramuscular ( i.m . ) ketorolac ( 1 mg/kg , EXP group , n = 45 ) or saline ( CTL group , n = 42 ) at the completion of surgery . Intravenous ( i.v . ) fentanyl ( 0.5 & mgr;g/kg/dose ) was administered in repeated doses postoperatively . Pain intensity was measured using both the Oucher and the Children 's Hospital of Eastern Ontario Pain Scale ( CHEOPS ) to allow for comparison between self‐report and behavioral measures of pain intensity . Severity of postoperative bleeding was measured using a 4‐point rating scale . The EXP group had a significant reduction in total fentanyl dose ( mean : 35.9 & mgr;g ) compared to the CTL group ( mean : 48.3 & mgr;g , t = −2.21 , P < 0.03 ) . There was a statistically significant decrease in pre‐fentanyl CHEOPS scores in the Post‐Anesthesia Care Unit ( PACU ) in the ketorolac group ( F ( 2,30 ) = 5.34 , P < 0.01 ) , but not in the saline group ( F ( 2.24 ) = 2.46 , P > 0.05 ) . In the first hour postoperatively , the CHEOPS demonstrated significant decreases in pain intensity scores in response to opioids , in both groups . In the PACU , children were unable to provide a self‐report of pain intensity potentially due to a variety of factors ( e.g. , emergence delirium , agitation , excitement , sedation , and /or pain ) . However , during the remainder of the postoperative stay , the photographic scale of the Oucher was a more valid measure of pain intensity than the CHEOPS . There were no differences between the 2 groups in the severity of postoperative bleeding . Children in the EXP group were discharged significantly earlier ( i.e. , 30 min , t = −2.22 , P < 0.03 ) . Our data demonstrate that i.m . administration of ketorolac , at the end of surgery , significantly reduces opioid requirements and shortens length of stay without any evidence of increased bleeding . In addition , our data suggest that the patient 's altered level of consciousness and attention span may diminish the utility of self‐report measures of pain intensity in the immediate postoperative period Prophylactic administration of analgesics before surgery can decrease the intraoperative anaesthetic requirement and decrease pain during the early postoperative period . In a doubleblind , placebocontrolled study involving 90 healthy ASA physical status I or II children undergoing bilateral myringotomy , we compared the postoperative analgesic effects of oral acetaminophen and ketorolac , when administered 30 min before induction of anaesthesia . Patients were r and omized to receive saline ( 0.1 ml · kg−1 ) , acetaminophen ( 10 mg · kg−1 ) or ketorolac ( 1 mg · kg−1 ) diluted in cherry syrup to a total volume of 5 ml . Anaesthesia was induced and maintained with halothane and nitrous oxide via a face mask . Postoperative pain was assessed by a blinded observer using an objective pain scale . The three study groups were similar with respect to demographic data , duration of anaesthesia and surgery , induction behaviour , oxygen saturation , incidence of postoperative emesis and , recovery times . The ketorolac group had lower postoperative pain scores and required less frequent analgesic therapy in the early postoperative period compared with the acetaminophen and placebo groups . In contrast , there were no differences in pain scores or analgesic requirements between the acetaminophen and the placebo groups . We conclude that the preoperative administration of oral ketorolac , but not acetaminophen , provided better postoperative pain control than placebo in children undergoing bilateral myringotomy . RésuméL’administration prophylactique d’analgésiques avant la chirurgie peut diminuer les besoins anesthésiques peropératoires et la douleur durant la période postopératoire immédiate . Quatrevingtdix enfants avec un état physique ASA I ou II devant subir une myringotomie bilatérale participent à cette étude à doubleinsu avec un groupe contrôleplacebo . Sont comparés les effets analgésiques postopératoires de l’acétaminophène et du kétoralac administrés par voie orale 30 minutes avant l’induction anesthésique . Les patients reçoivent au hasard soit de la solution saline ( 0.1 ml · kg−1 ) , soit de l’acétaminophène ( 10 mg · kg−1 ) , soit du kétoralac ( 1 mg · kg−1 ) . Chacune des préparations est diluée dans un sirop à saveur de cerise pour faire un total de 5 ml . L’induction et l’entretien de l’anesthésie se font avec de l’halothane et du protoxyde d’azote administrés par masque . Un observateur non informé du médicament donné au patient évalue la douleur postoperatoire à l’aide d’une échelle de douleur objective . Les variables démographiques , la durée de l’anesthésie et de la chirurgie , le comportement à l’induction , la saturation artérielle en oxygène , l’incidence des vomissements postopératoires et le temps d’éveil sont comparables entre les trois groupes . Les patients du groupe kétoralac ont un pointage de douleur postopératoire plus bas que ceux des groupes acétaminophène et placebo , et Us nécessitent moins souvent un supplément analgésique . D’autre part , il n’ya pas de différence entre les groupes acétaminophène et placebo pour la douleur et les besoins analgésiques postopératoires . En conclusion , le kétoralac , mais pas l’acétaminophène , administré par la bouche avant la chirurgie assure une meilleure analgésie postopératoire qu’un placebo chez les enfants subissant une myringotomie bilatérale We studied the analgesic efficacy of tramadol 2 mg kg(-1 ) for post-operative analgesia after day-case adenoidectomy in children aged 1 - 3 yr . Eighty children were allocated r and omly to receive tramadol 2 mg kg(-1 ) i.v . or placebo immediately after induction of anaesthesia . Anaesthesia was induced with alfentanil 10 microg kg(-1 ) and propofol 4 mg kg(-1 ) followed by mivacurium 0.2 mg kg(-1 ) for tracheal intubation . Anaesthesia was continued with sevoflurane in nitrous oxide and oxygen . All children were given ibuprofen rectally at approximately 10 mg kg(-1 ) before the start of surgery . Post-operative pain and recovery assessment s were performed by a nurse blinded to the analgesic treatment using the Aldrete recovery score , the pain/discomfort scale and measurement of recovery times . Rescue medication ( pethidine in increments of 5 mg i.v . ) was administered according to the pain scores . A post-operative question naire was used to evaluate the need for analgesia at home up to 24 h after operation . Rescue analgesic at home was rectal or oral ibuprofen 125 mg . Children in the tramadol group required fewer pethidine doses than those in the placebo group ( P = 0.014 ) . Forty-five per cent of children receiving tramadol did not require post-operative analgesia at all compared with 15 % of children receiving placebo ( P = 0.003 ) . Recovery times and the incidence of adverse effects were similar in the two groups in the recovery room and at home . The requirement for rectal ibuprofen at home did not differ between groups UNLABELLED In this r and omized , double-blinded , placebo-controlled , prospect i ve study , we evaluated the analgesic efficacy of dextromethorphan 0.5 mg/kg or 1.0 mg/kg p.o . 1 h before adenotonsillectomy in 57 children 6 - 12 yr of age . Anesthetic management was st and ardized . Morphine 0.075 mg/kg i.v . and acetaminophen 25 - 35 mg/kg p.r . were administered after anesthetic induction but before the start of surgery . A 4-point behavioral score ( 1 = asleep , 2 = awake and calm , 3 = awake and crying , 4 = thrashing ) was recorded on admission to and discharge from the postanesthesia care unit ( PACU ) . In the PACU , pain was assessed with Children 's Hospital of Eastern Ontario Pain Scale ( CHEOPS ) and recorded every 15 min until the patient was transferred to the day surgery unit ( DSU ) . In the DSU , patients rated their pain using a 10-cm baseline 0 - 10 visual analog pain scale ( VAS ) every 30 min until they were discharged home . A 24-h VAS was obtained by phone interview , and parental satisfaction was scored ( yes/no ) regarding their child 's postoperative analgesia . Morphine 0.025 mg/kg i.v . was administered to children with CHEOPS score > 6 , who verbalized pain , or who were crying in any consecutive 5-min observation periods in the PACU . Total morphine consumption was recorded . The study groups were comparable with respect to demographic variables . We were unable to detect any differences between study groups with respect to postoperative morphine consumption , CHEOPS , behavior scores , VAS , or parental satisfaction . IMPLICATION S Premedication with dextromethorphan 0.5 or 1.0 mg/kg p.o . does not improve postoperative analgesia in school-aged children who receive preemptive morphine 0.075 mg/kg i.v . and acetaminophen 25 - 35 mg/kg p.r . during nitrous oxide and desflurane anesthesia for adenotonsillectomy After umbilical hernia surgery , and wound infiltration with bupivacaine 0.5 % , 17 children were given ketorolac 0.5 mg.kg-1 , with 18 controls receiving only the wound infiltration . No child experienced severe pain , but moderate pain was noted in patients in both groups . Objective and subjective pain scores were not different statistically at any point up to the morning after surgery Administration of analgesics before surgery can decrease the intra-operative anesthetic requirement and pain during the early post-operative period ( pre-emptive analgesia ) . The objective of this study was to evaluate an intra-muscular preparation of ketoprofen as analgesic in mild to moderate pain in children . In a double-blind placebo-controlled study , 91 healthy ASA I or II children undergoing squint opthalmic surgery was undertaken in the Ophthalmic Services at King Abdel-Aziz University Hospital Riyadh . The postoperative analgesic effects of intra-muscular pethidine and ketoprofen , just after the induction of anesthesia were compared . Patients were r and omized to receive ketoprofen ( 1 mg W kg-1 ) , pethidine ( 1 mg W kg-1 ) or saline ( 0.1 ml W kg-1 ) . Anesthesia was induced and maintained with halothane and nitrous oxide via \n Output:\n " }, { "from": "agent", "value": "Placebo control groups can be used in paediatric analgesic studies to demonstrate internal sensitivity" } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: Background Concomitant injuries to secondary structures have been proposed as a major cause of failure of anterior cruciate ligament reconstruction . Purpose Our purpose was to determine the relationship between meniscal status at the time of anterior cruciate ligament reconstruction and ultimate long-term function and stability . Study Design Prospect i ve cohort study . Methods We prospect ively studied 63 patients for an average of 10.4 years after arthroscopically assisted bone-patellar tendon-bone anterior cruciate reconstruction . All surgeries were performed between 1988 and 1991 ; concomitant meniscal surgery was performed if necessary . Subjects were divided into subgroups relative to the integrity of their menisci at the end of the reconstruction procedure ( intact meniscus , partial meniscectomy , complete meniscectomy ) . Results Patients who had undergone any degree of meniscal resection reported significantly more subjective complaints and activity limitations than those with intact menisci . Subjective International Knee Documentation Committee and Lysholm scores were lower in the meniscectomy subgroups than in the meniscus-intact group . Objective testing revealed a significantly lower ability to perform the single-legged hop in the meniscectomy subgroups . Ligament stability based on instrumented laxity measurements was not significantly different between the subgroups . Radiographic abnormalities were also more common in the subgroups that had undergone meniscectomy . Conclusions The menisci should be repaired if at all possible , especially in the setting of anterior cruciate ligament reconstruction , for optimal functional outcome and patient satisfaction PURPOSE To evaluate the clinical results of anterior cruciate ligament ( ACL ) reconstruction in patients with ACL-deficient knee in 2 similar groups of patients . TYPE OF STUDY A prospect i ve r and omized comparison of patellar tendon ( PT ) versus semitendinosus and gracilis tendon ( STG ) autografts for ACL reconstruction . METHODS Between 1994 and 1996 , 85 consecutive male patients with chronic ACL-deficient knees underwent arthroscopically assisted reconstruction with either autologous PT or double-loop STG ( 4-str and ) graft . PT grafts were used in patients with even-numbered birth date s and STG grafts for those with odd-numbered birth date s. Preoperatively , no significant differences between the 2 groups were noted with respect to age , level of activity , and degree of laxity ( chi-square analysis ) . A st and ardized rehabilitation program was used for both groups postoperatively that included immediate active extension and early weight bearing and gradual flexion . Return to sports was permitted 8 months postoperatively . Assessment of the patients was carried out using a question naire , clinical assessment , Lysholm knee scores , the International Knee Documentation Committee scale , and radiological examination . RESULTS At a mean follow-up of 81 months , there was no significant difference between the 2 groups with respect to subjective complaints ( recurrent giving way , functional level ) or objective laxity evaluation , including KT-1000 measurement or return to sports . Loss of extension of < or = 5 degrees was greater in the PT group ( 12 patients , 30 % ) than in the STG group ( 8 patients , 17 % ) . There was loss of flexion of < or = 15 degrees in 5 patients ( 12 % ) in the PT group and 1 patient ( 2.2 % ) in the STG group . Anterior knee pain was recorded in 10 patients ( 24 % ) in the PT group and 3 patients ( 5 % ) in the STG group . The Lysholm knee score was 91.6 and 92.7 for the PT and STG groups , respectively , and the Tegner activity score decreased from 8.9 preoperatively for both groups to 7.9 for the PT group and 7.8 for the STG group . CONCLUSION In this study , the 2 groups had comparable results in terms of patient satisfaction , activity level , and knee function . Our study showed that patellofemoral problems and loss of knee motion are more frequent in patients with PT grafts than in those with STG grafts . LEVEL OF EVIDENCE Level I , R and omized Controlled Trial Background There are still controversies about graft selection for primary anterior cruciate ligament reconstruction . Prospect i ve r and omized long-term studies are needed to determine the differences between the material s. Hypothesis Five years after anterior cruciate ligament reconstruction , there is a difference between hamstring and patellar tendon grafts in development of degenerative knee joint disease . Study Design R and omized controlled trial ; Level of evidence , 1 . Methods From June 1999 to March 2000 , 64 patients were included in this prospect i ve study . A single surgeon performed primary arthroscopically assisted anterior cruciate ligament reconstruction in an alternating sequence . In 32 patients , anterior cruciate ligament reconstruction was performed with hamstring tendon autograft , whereas in the other 32 patients , anterior cruciate ligament reconstruction was performed with patellar tendon autograft . Results At the 5-year follow-up , no statistically significant differences were seen with respect to the Lysholm score , clinical and KT-2000 arthrometer laxity testing , anterior knee pain , single-legged hop test , or International Knee Documentation Committee classification results ; 23 patients ( 82 % ) in the hamstring tendon group and 23 patients ( 88 % ) in the patellar tendon group returned to their preinjury activity levels . Graft rupture occurred in 2 patients from the hamstring tendon group ( 7 % ) and in 2 patients from the patellar tendon group ( 8 % ) . Grade B abnormal radiographic findings were seen in 50 % ( 13/26 ) of patients in the patellar tendon group and in 17 % ( 5/28 ) of patients in the hamstring tendon group ( P = . 012 ) . Conclusion Both hamstring and patellar tendon grafts provided good subjective outcomes and objective stability at 5 years . No significant differences in the rate of graft failure were identified . Patients with patellar tendon grafts had a greater prevalence of osteoarthritis at 5 years after surgery Background : The purpose of this study was to further delineate the outcome of arthroscopically assisted anterior cruciate ligament reconstruction in 125 patients who had previously been followed for two to five years . One of the original 125 patients was excluded from the present study because of insufficient follow-up , and an additional group of 101 patients was added . All 225 patients in the present study were followed for a minimum of six years . Methods : Patients were r and omly assigned to reconstruction with a double-str and ed semitendinosus-gracilis graft with use of a two‐incision technique ( group I ) , reconstruction with a patellar ligament graft with use of a two‐incision technique ( group II ) , or reconstruction with a patellar ligament graft with use of a single‐incision endoscopic technique ( group III ) . The groups were compared with regard to the rate of graft failure , the amount of instability , knee strength , radiographic signs of degenerative changes , and functional outcome . Results : There was no significant difference among the three groups with regard to the rate of graft failure , the amount of knee instability , or the functional outcome . A normal or nearly normal functional outcome was recorded for 208 ( 92 % ) of the 225 patients . There were significant differences among the groups with regard to quadriceps muscle-strength deficits : group I had fewer patients with deficits than group III , and groups I and III both had fewer patients with deficits than group II ( p = 0.04 ) . There also were significant differences among the groups with regard to hamstring muscle-strength deficits : group III had fewer patients with deficits than group II , and group II had fewer patients with deficits than group I ( p < 0.01 ) . Twelve knees ( 16 % ) in group I , six knees ( 8 % ) in group II , and eight knees ( 11 % ) in group III showed radiographic evidence of progressive degenerative changes , but the differences among the three groups were not significant . Conclusion : Although 11.6 % of the 225 knees had radiographic evidence of degenerative arthritis at a minimum of six years after arthroscopically assisted reconstruction of the anterior cruciate ligament , the choice of graft and the technique of reconstruction did not seem to affect the rate of development of these changes \n Output:\n " }, { "from": "agent", "value": "However , the patient-reported outcomes in these studies were not different .\nRadiographic evidence of osteoarthritis was inconsistent between autograft choices .\nConclusion This level II systematic review demonstrates no difference in major clinical results between graft types with the exception of increased anterior knee and kneeling pain .\nThere exists a potential for increased incidence of osteoarthritis in the patellar tendon group but increased sample size is required ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: Background Repetitive Transcranial Magnetic Stimulation ( rTMS ) is an effective treatment for Major Depressive Disorder ( MDD ) , and is based upon delivery of focal high-energy pulses of electromagnetic stimulation . We postulated that delivery of rTMS at the subject ’s individual alpha frequency ( synchronized TMS , or sTMS ) would achieve efficacy with lower energy of stimulation . We developed a device that rotates neodymium cylindrical magnets at three locations along the midline above the subject ’s scalp to impart low-energy , sinusoidal-waveform magnetic brain stimulation over a broad area , and performed this efficacy study . Method Fifty-two subjects with MDD were enrolled in a r and omized , sham controlled , double-blind treatment study ( Trial Registration : NCT01683019 ) . Forty-six subjects were included in the final analysis . Most subjects received concurrent antidepressant medications that remained unchanged during the study . Subjects were r and omized to three treatment groups : 1 ) active sTMS with a fixed frequency at the subject ’s alpha frequency ; 2 ) active sTMS with a r and om stimulus frequency that varied between 8 Hz and 13 Hz ; and , 3 ) sham sTMS . 20 half-hour sTMS sessions were administered 5 days per week for 4 weeks . Results Subjects with either fixed or r and om frequency active sTMS had statistically significantly greater percentage reduction in depression severity compared to sham ( 48.5 % vs. 19.3 % , respectively ; p = 0.001 ) . No significant difference was found between fixed and r and om groups ( p = 0.30 ) . No significant side effects were reported . Conclusions These results suggest that sTMS may be an effective treatment for MDD BACKGROUND Theta-burst transcranial magnetic stimulation ( TBS ) has been shown to induce potent and long lasting effects on cortical excitability . In a previous open study , we demonstrated safety , tolerability and antidepressant properties of continuous TBS ( cTBS ) in major depression ( MD ) . The present study was aim ed to evaluate the therapeutic efficacy of cTBS in depressed patients using a double-blind , sham-controlled design . METHODS Twenty nine patients with MD were r and omized to receive either active cTBS to the right dorsolateral prefrontal cortex ( n=15 ) or sham cTBS ( n=14 ) for 10 consecutive work days . After the 10th session , patients who received sham TBS were crossed over to active cTBS which consisted of 10 daily sessions . Patients who received active cTBS continued with the same treatment protocol for additional 10 treatments . Each treatment session consisted of 3600 stimuli at an intensity of 100 % of the active motor threshold . Severity of depression was assessed weekly . RESULTS Overall , there was no significant difference in the degree of clinical improvement between active and sham cTBS groups . However , in patients whose medication status remained unchanged before the trial ( n=8 ) and in those who were medication-free ( n=3 ) , active cTBS result ed in a significantly greater reduction of Hamilton depression scores as compared to sham cTBS . LIMITATIONS A small sample size , confounding effect of medication and short treatment period . CONCLUSIONS Our results suggest that the antidepressant effect of cTBS is modest , yet it might be beneficial to patients nonresponsive to ongoing pharmacological treatment . A direct comparison between cTBS and conventional rTMS protocol s is warranted Objectives : Transcranial direct current stimulation ( tDCS ) has demonstrated some efficacy in treatment-resistant major depression ( TRD ) . The majority of previous controlled studies have used anodal stimulation to the left dorsolateral prefrontal cortex ( DLPFC ) and a control location such as the supraorbital region for the cathode . Several open-label studies have suggested effectiveness from anodal stimulation to the left DLPFC combined with cathodal stimulation to the right DLPFC . Thus , this study evaluated the efficacy of tDCS using anodal stimulation to the left DLPFC and cathodal stimulation to the right DLPFC compared to sham tDCS . Methods : Subjects between the ages of 18 and 65 were recruited from a tertiary care university hospital . Twenty-four subjects with TRD and a 17-item Hamilton Rating Scale for Depression greater than 21 were r and omized to receive tDCS or sham tDCS . The rates of remission were compared between the two treatment groups . Results : The remission rates did not differ significantly between the two groups using an intention to treat analysis . More subjects in the active tDCS group had failed a course of electroconvulsive therapy in the current depressive episode . Side effects did not differ between the two groups and in general the treatment was very well tolerated . Conclusion : Anodal stimulation to the left DLPFC and cathodal stimulation to the right DLPFC was not efficacious in TRD . However , a number of method ological limitations warrant caution in generalizing from this study . Ongoing , controlled studies should provide further clarification on the efficacy of this stimulation configuration in TRD . Clinical Trials.gov Identifier : NCT01078948 Although accelerated repetitive Transcranial Magnetic Stimulation ( rTMS ) paradigms and intermittent Theta-burst Stimulation ( iTBS ) may have the potency to result in superior clinical outcomes in Treatment Resistant Depression ( TRD ) , accelerated iTBS treatment has not yet been studied . In this registered r and omized double-blind sham-controlled crossover study , spread over four successive days , 50 TRD patients received 20 iTBS sessions applied to the left dorsolateral prefrontal cortex ( DLPFC ) . The accelerated iTBS treatment procedure was found to be safe and result ed in immediate statistically significant decreases in depressive symptoms regardless of order/type of stimulation ( real/sham ) . While only 28 % of the patients showed a 50 % reduction of their initial Hamilton Depression Rating Scale score at the end of the two-week procedure , this response rate increased to 38 % when assessed two weeks after the end of the sham-controlled iTBS protocol , indicating delayed clinical effects . Importantly , 30 % of the responders were considered in clinical remission . We found no demographic predictors for response . Our findings indicate that only four days of accelerated iTBS treatment applied to the left DLPFC in TRD may lead to meaningful clinical responses within two weeks post stimulation Flaws in the design , conduct , analysis , and reporting of r and omised trials can cause the effect of an intervention to be underestimated or overestimated . The Cochrane Collaboration ’s tool for assessing risk of bias aims to make the process clearer and more BACKGROUND Studies of repetitive transcranial magnetic stimulation ( rTMS ) in depression have mostly involved once-daily treatment , with positive but modest clinical results . This study tested the efficacy and safety of twice-daily rTMS over 2 weeks . METHOD Thirty-eight depressed subjects enrolled in a double-blind , sham-controlled trial of twice-daily rTMS ( left prefrontal cortex , 10 Hz , 110 % intensity , 1500 stimuli per session ) over 2 weeks . Mood and neuropsychological functioning were assessed weekly by blind raters , using the Montgomery-Asberg Depression Rating Scale ( MADRS ) as the primary outcome measure , plus the Hamilton Rating Scale for Depression ( HRSD ) and self-report measures . After the blind period , 22 subjects continued with once-daily rTMS to receive a total of 6 weeks of active rTMS . RESULTS Subjects were moderately treatment resistant . Active treatment result ed in significantly greater improvement than sham over the 2-week blind period on one outcome measure only ( MADRS p<0.05 ) . Subjects showed further improvement over the 6 weeks of active rTMS . Neuropsychological test scores did not change significantly . CONCLUSIONS rTMS given twice daily was effective and safe , with no adverse neuropsychological effects BACKGROUND We tested whether transcranial magnetic stimulation ( TMS ) over the left dorsolateral prefrontal cortex ( DLPFC ) is effective and safe in the acute treatment of major depression . METHODS In a double-blind , multisite study , 301 medication-free patients with major depression who had not benefited from prior treatment were r and omized to active ( n = 155 ) or sham TMS ( n = 146 ) conditions . Sessions were conducted five times per week with TMS at 10 pulses/sec , 120 % of motor threshold , 3000 pulses/session , for 4 - 6 weeks . Primary outcome was the symptom score change as assessed at week 4 with the Montgomery-Asberg Depression Rating Scale ( MADRS ) . Secondary outcomes included changes on the 17- and 24-item Hamilton Depression Rating Scale ( HAMD ) and response and remission rates with the MADRS and HAMD . RESULTS Active TMS was significantly superior to sham TMS on the MADRS at week 4 ( with a post hoc correction for ine quality in symptom severity between groups at baseline ) , as well as on the HAMD17 and HAMD24 scales at weeks 4 and 6 . Response rates were significantly higher with active TMS on all three scales at weeks 4 and 6 . Remission rates were approximately twofold higher with active TMS at week 6 and significant on the MADRS and HAMD24 scales ( but not the HAMD17 scale ) . Active TMS was well tolerated with a low dropout rate for adverse events ( 4.5 % ) that were generally mild and limited to transient scalp discomfort or pain . CONCLUSIONS Transcranial magnetic stimulation was effective in treating major depression with minimal side effects reported . It offers clinicians a novel alternative for the treatment of this disorder In previous studies , fast repetitive transcranial magnetic stimulation ( rTMS ) with a frequency > 1 Hz demonstrated substantial antidepressant effects compared to sham rTMS . However , it is not clear whether fast rTMS is superior to slow rTMS ( frequency < or = 1 Hz ) which is safe at therapeutically promising higher intensities . The aim of this double-blind study was to compare the action of fast , slow and sham rTMS . Eighteen patients with pharmacotherapy-resistant major depression were r and omized to receive fast ( 10 Hz ) , slow ( 0.3 Hz ) or sham rTMS with 250 stimuli/day for 5 successive days . rTMS was applied at 90 % motor threshold intensity to the left dorsolateral prefrontal cortex . Scores on the Hamilton Depression Rating Scale ( HDRS ) , but not on the Montgomery-Asberg Depression Rating Scale ( MADRS ) , showed a statistically significant time x group interaction with a reduction of 19 % after slow rTMS . However , the effect was clinical ly marginal and not reflected by self-rating scores . Verbal memory and reaction performance were not impaired after rTMS , and there was even a statistically significant time x group interaction with improvement of verbal memory performance after fast rTMS . In conclusion , this study further supported the safety of rTMS but does not show any clinical ly meaningful antidepressant efficacy of rTMS at 250 daily stimuli over 5 days in pharmacotherapy-refractory major depression It has been 30 years since the discovery that repeated electrical stimulation of neural pathways can lead to long-term potentiation in hippocampal slices . With its relevance to processes such as learning and memory , the technique has produced a vast literature on mechanisms of synaptic plasticity in animal models . To date , the most promising method for transferring these methods to humans is repetitive transcranial magnetic stimulation ( rTMS ) , a noninvasive method of stimulating neural pathways in the brain of conscious subjects through the intact scalp . However , effects on synaptic plasticity reported are often weak , highly variable between individuals , and rarely last longer than 30 min . Here we describe a very rapid method of conditioning the human motor cortex using rTMS that produces a controllable , consistent , long-lasting , and powerful effect on motor cortex physiology and behavior after an application period of only 20 - 190 OBJECTIVE High-frequency left-side repetitive transcranial magnetic stimulation ( rTMS ) and low-frequency stimulation to the right prefrontal cortex have both been shown to have antidepressant effects , but doubts remain about the magnitude of previously demonstrated treatment effects . The authors evaluated sequentially combined high-frequency left-side rTMS and low-frequency rTMS to the right prefrontal cortex for treatment-resistant depression . METHOD The authors conducted a 6-week double-blind , r and omized , sham-controlled trial in 50 patients with treatment-resistant depression . Three trains of low-frequency rTMS to the right prefrontal cortex of 140 seconds ' duration at 1 Hz were applied daily , followed immediately by 15 trains of 5 seconds ' duration of high-frequency left-side rTMS at 10 Hz . Sham stimulation was applied with the coil angled at 45 degrees from the scalp , resting on the side of one wing of the coil . The primary outcome variable was the score on the Montgomery-Asberg Depression Rating Scale . RESULTS There was a significantly greater response to active than sham stimulation at 2 weeks and across the full duration of the study . A significant proportion of the study group receiving active treatment met response ( 11 of 25 [ 44 % ] ) or remission ( nine of 25 [ 36 % ] ) criteria by study end compared to the sham stimulation group ( two of 25 [ 8 % ] and none of 25 respectively ) . CONCLUSIONS Sequentially applying both high-frequency left-side rTMS and low-frequency rTMS to the right prefrontal cortex , has substantial treatment efficacy in patients \n Output:\n " }, { "from": "agent", "value": "Several non‐invasive brain stimulation treatments seem efficacious across different outcome metrics .\nAll‐cause discontinuation rates indicate no differences between sham and active treatment .\nThere were no differences in all‐cause discontinuation rates .\nThe strongest evidence was for high‐frequency rTMS over the left DLPFC .\nIntermittent TBS provides an advance in terms of reduced treatment duration .\ntDCS is a potential treatment for non‐treatment resistant depression .\nTo date , there is not sufficient published data available to draw firm conclusions about the efficacy and acceptability of TBS and sTMS" } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: The effectiveness of psychological treatments for PTSD is likely to be enhanced by improved underst and ing of the factors involved in maintaining the disorder . Ehlers and Clark [ A cognitive model of persistent posttraumatic stem disorder Behav . Res . Ther . 38 ( 2000 ) 319 - 345 ] recently proposed a cognitive model of maintenance . The current study aim ed to investigate several cognitive factors highlighted in Ehlers and Clark 's model using a prospect i ve design . Fifty-seven victims of physical or sexual assault participated in the study . Cognitive factors were assessed within 4 months of assault and victims were followed-up 6 and 9 months after the assault . Cognitive variables which significantly predicted PTSD severity at both follow-ups were : cognitive processing style during assault ( mental defeat , mental confusion , detachment ) ; appraisal of assault sequelae ( appraisal of symptoms , perceived negative responses of others , permanent change ) ; negative beliefs about self and world ; and maladaptive control strategies ( avoidance/safety seeking ) . Relationships between early appraisal s , control strategies , and processing styles and subsequent PTSD severity remained significant after statistically controlling for gender and perceived assault severity . These findings support the cognitive model of PTSD proposed by Ehlers and Clark and suggest that effective treatment will need to address these cognitive factors Acute stress disorder ( ASD ) is a precursor of chronic posttraumatic stress disorder ( PTSD ) . Twenty-four participants with ASD following civilian trauma were given 5 sessions of either cognitive-behavioral therapy ( CBT ) or supportive counseling ( SC ) within 2 weeks of their trauma . Fewer participants in CBT ( 8 % ) than in SC ( 83 % ) met criteria for PTSD at posttreatment . There were also fewer cases of PTSD in the CBT condition ( 17 % ) than in the SC condition ( 67 % ) 6 months posttrauma . There were greater statistically and clinical ly significant reductions in intrusive , avoidance , and depressive symptomatology among the CBT participants than among the SC participants . This study represents the 1st demonstration of successful treatment of ASD with CBT and its efficacy in preventing chronic PTSD OBJECTIVE The purpose of this study was to prospect ively evaluate the onset , overlap , and course of posttraumatic stress disorder ( PTSD ) and major depression following traumatic events . METHOD The occurrence of PTSD and major depression and the intensity of related symptoms were assessed in 211 trauma survivors recruited from a general hospital 's emergency room . Psychometrics and structured clinical interview ( the Structured Clinical Interview for DSM-III-R and the Clinician-Administered PTSD Scale ) were administered 1 week , 1 month , and 4 months after the traumatic event . Heart rate was assessed upon arrival at the emergency room for subjects with physical injury . Twenty-three subjects with PTSD and 35 matched comparison subjects were followed for 1 year . RESULTS Major depression and PTSD occurred early on after trauma ; patients with these diagnoses had similar recovery rates : 63 survivors ( 29.9 % ) met criteria for PTSD at 1 month , and 37 ( 17.5 % ) had PTSD at 4 months . Forty subjects ( 19.0 % ) met criteria for major depression at 1 month , and 30 ( 14.2 % ) had major depression at 4 months . Comorbid depression occurred in 44.5 % of PTSD patients at 1 month and in 43.2 % at 4 months . Comorbidity was associated with greater symptom severity and lower levels of functioning . Survivors with PTSD had higher heart rate levels at the emergency room and reported more intrusive symptoms , exaggerated startle , and peritraumatic dissociation than those with major depression . Prior depression was associated with a higher prevalence of major depression and with more reported symptoms . CONCLUSIONS Major depression and PTSD are independent sequelae of traumatic events , have similar prognoses , and interact to increase distress and dysfunction . Both should be targeted by early treatment interventions and by neurobiological research This report examines initial distress levels , course of symptoms , incidence of posttraumatic stress disorder ( PTSD ) , predictors of short-term outcome , and value of prophylactic counseling in a consecutive series of 40 ambulant trauma clinic attenders with minor road traffic accident ( RTA ) injuries . Subjects were r and omly allocated to intervention and monitoring groups following assessment at a mean of 7 days posttrauma and reassessed at 3 months using a variety of st and ard rating scales . Seventy-five percent reported significant levels of distress at 1 week posttrauma . By 3 months this had decreased sharply to 35 % , and 22 % were significantly impaired by clinical assessment . Incidence of PTSD over 3 months was estimated at 19 % and point prevalence at 3 months posttrauma was 9 % . High initial distress , increasing age , and high levels of perceived threat were significant independent predictors of morbidity , and no significant differences in outcome were found between intervention and monitoring groups at 3 months Two studies of assault victims examined the roles of ( a ) disorganized trauma memories in the development of posttraumatic stress disorder ( PTSD ) , ( b ) peritraumatic cognitive processing in the development of problematic memories and PTSD , and ( c ) ongoing dissociation and negative appraisal s of memories in maintaining symptomatology . In the cross-sectional study ( n = 81 ) , comparisons of current , past , and no-PTSD groups suggested that peritraumatic cognitive processing is related to the development of disorganized memories and PTSD . Ongoing dissociation and negative appraisal s served to maintain PTSD symptoms . The prospect i ve study ( n = 73 ) replicated these findings longitudinally . Cognitive and memory assessment s completed within 12-weeks postassault predicted 6-month symptoms . Assault severity measures explained 22 % of symptom variance ; measures of cognitive processing , memory disorganization , and appraisal s increased prediction accuracy to 71 % A prospect i ve longitudinal study assessed 967 consecutive patients who attended an emergency clinic shortly after a motor vehicle accident , again at 3 months , and at 1 year . The prevalence of posttraumatic stress disorder ( PTSD ) was 23.1 % at 3 months and 16.5 % at 1 year . Chronic PTSD was related to some objective measures of trauma severity , perceived threat , and dissociation during the accident , to female gender , to previous emotional problems , and to litigation . Maintaining psychological factors , that is , negative interpretation of intrusions , rumination , thought suppression , and anger cognitions , enhanced the accuracy of the prediction . Negative interpretation of intrusions , persistent medical problems , and rumination at 3 months were the most important predictors of PTSD symptoms at 1 year . Rumination , anger cognitions , injury severity , and prior emotional problems identified cases of delayed onset BACKGROUND Dissociative symptoms during trauma predict post-traumatic stress disorder ( PTSD ) , but they are often transient . It is controversial whether they predict chronic PTSD over and above what can be predicted from other post-trauma symptoms . AIMS To investigate prospect ively the relationship between dissociative symptoms before , during and after a trauma and other psychological predictors , and chronic PTSD . METHOD Two sample s of 27 and 176 road traffic accident survivors were recruited . Patients were assessed shortly after the accident and followed at intervals over the next 6 months . Assessment s included measures of dissociation , memory fragmentation , data -driven processing , rumination and PTSD symptoms . RESULTS All measures of dissociation , particularly persistent dissociation 4 weeks after the accident , predicted chronic PTSD severity at 6 months . Dissociative symptoms predicted subsequent PTSD over and above the other PTSD symptom clusters . Memory fragmentation and data -driven processing also predicted PTSD . Rumination about the accident was among the strongest predictors of subsequent PTSD symptoms . CONCLUSIONS Persistent dissociation and rumination 4 weeks after trauma are more useful in identifying those patients who are likely to develop chronic PTSD than initial reactions BACKGROUND Psychological debriefing is widely used for trauma victims but there is uncertainty about its efficacy . We have previously reported a r and omised controlled trial which concluded that at 4 months it was ineffective . AIMS To evaluate the 3-year outcome in a r and omised controlled trial of debriefing for consecutive subjects admitted to hospital following a road traffic accident . METHOD Patients were assessed in hospital by the Impact of Event Scale ( IES ) , Brief Symptom Inventory ( BSI ) and question naire and re-assessed at 3 months and 3 years . The intervention was psychological debriefing as recommended and described in the literature . RESULTS The intervention group had a significantly worse outcome at 3 years in terms of general psychiatric symptoms ( BSI ) , travel anxiety when being a passenger , pain , physical problems , overall level of functioning , and financial problems . Patients who initially had high intrusion and avoidance symptoms ( IES ) remained symptomatic if they had received the intervention , but recovered if they did not receive the intervention . CONCLUSIONS Psychological debriefing is ineffective and has adverse long-term effects . It is not an appropriate treatment for trauma victims This research represents the first controlled treatment study of hypnosis and cognitive- behavioral therapy ( CBT ) of acute stress disorder ( ASD ) . Civilian trauma survivors ( N=87 ) who met criteria for ASD were r and omly allocated to 6 sessions of CBT , CBT combined with hypnosis ( CBT-hypnosis ) , or supportive counseling ( SC ) . CBT comprised exposure , cognitive restructuring , and anxiety management . CBT-hypnosis comprised the CBT components with each imaginal exposure preceded by a hypnotic induction and suggestions to engage fully in the exposure . In terms of treatment completers ( n=69 ) , fewer participants in the CBT and CBT-hypnosis groups met criteria for posttraumatic stress disorder at posttreatment and 6-month follow-up than those in the SC group . CBT-hypnosis result ed in greater reduction in reexperiencing symptoms at posttreatment than CBT . These findings suggest that hypnosis may have use in facilitating the treatment effects of CBT for posttraumatic stress BACKGROUND It is unclear what psychological help should be offered in the aftermath of traumatic events . Similarly , there is a lack of clarity about the best way of identifying people who are unlikely to recover from early posttraumatic symptoms without intervention . OBJECTIVE To determine whether cognitive therapy or a self-help booklet given in the initial months after a traumatic event is more effective in preventing chronic posttraumatic stress disorder ( PTSD ) than repeated assessment s. DESIGN R and omized controlled trial . Patients Motor vehicle accident survivors ( n = 97 ) who had PTSD in the initial months after the accident and met symptom criteria that had predicted persistent PTSD in a large naturalistic prospect i ve study of a comparable population . SETTING Patients were recruited from attendees at local accident and emergency departments . INTERVENTIONS Patients completed a 3-week self-monitoring phase . Those who did not recover with self-monitoring ( n = 85 ) were r and omly assigned to receive cognitive therapy ( n = 28 ) , a self-help booklet based on principles of cognitive behavioral therapy ( n = 28 ) , or repeated assessment s ( n = 29 ) . MAIN OUTCOME MEASURES Symptoms of PTSD as assessed by self-report and independent assessors unaware of the patient 's allocation . Main assessment s were at 3 months ( posttreatment , n = 80 ) and 9 months ( follow-up , n = 79 ) . RESULTS Twelve percent ( n = 12 ) of patients recovered with self-monitoring . Cognitive therapy was more effective in reducing symptoms of PTSD , depression , anxiety , and disability than the self-help booklet or repeated assessment s. At follow-up , fewer cognitive therapy patients ( 3 [ 11 % ] ) had PTSD compared with those receiving the self-help booklet ( 17 [ 61 % ] ; odds ratio , 12.9 ; 95 % confidence interval , 3.1 - 53.1 ) or repeated assessment s ( 16 [ 55 % ] ; odds ratio , 10.3 ; 95 % confidence interval , 2.5 - 41.7 ) . There was no indication that the self-help booklet was superior to repeated assessment s. On 2 measures , high end-state functioning at follow-up and request for treatment , the outcome for the self-help group was worse than for the repeated assessment s group . CONCLUSIONS Cognitive therapy is an effective intervention for recent-onset PTSD . A self-help booklet was not effective . The combination of an elevated initial symptom score and failure to improve with self-monitoring was effective in identifying a group of patients with early PTSD symptoms who were unlikely to recover without intervention A r and omized trial was performed in which imaginal exposure ( IE ) and cognitive therapy ( CT ) were compared in the treatment of chronic posttraumatic stress disorder ( PTSD ) . Patients who continued to meet PTSD caseness at the end of a 4-week symptom-monitoring baseline period ( n = 72 ) were r and omly allocated to either IE or CT . There was a significant improvement in all measures over treatment and at follow-up , although there were no significant differences between the 2 treatments at any assessment . A significantly greater number of patients who showed worsening over treatment received IE , although this effect was not found at follow-up . Patients who worsened showed a \n Output:\n " }, { "from": "agent", "value": "Cognitive behavioral therapy was more effective than supportive counseling in preventing chronicity of PTSD symptoms ; however , in most available studies it remained unclear whether supportive counseling facilitated or retarded recovery , compared with no intervention .\nA brief CBT program given in the first month of trauma was not superior to repeated assessment ; however , a course of CBT of up to 16 sessions given at 1 - 4 months after trauma was superior to self-help , repeated assessment , and no intervention .\nThese include the way of working through traumatic memories and the impact of the interventions on patients ' interpretations of their PTSD symptoms ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: Objective To evaluate the effectiveness of register based , yearly chlamydia screening . Design Controlled trial with r and omised stepped wedge implementation in three blocks . Setting Three regions of the Netherl and s : Amsterdam , Rotterdam , and South Limburg . Participants 317 304 women and men aged 16 - 29 years listed on municipal registers at start of trial . Intervention From March 2008 to February 2011 , the Chlamydia Screening Implementation programme offered yearly chlamydia screening tests . Postal invitations asked people to use an internet site to request a kit for self collection of sample s , which would then be sent to regional laboratories for testing . Treatment and partner notification were done by the general practitioner or at a sexually transmitted infection clinic . Main outcome measures Primary outcomes were the percentage of chlamydia tests positive ( positivity ) , percentage of invitees returning a specimen ( uptake ) , and estimated chlamydia prevalence . Secondary outcomes were positivity according to sex , age , region , and sociodemographic factors ; adherence to screening invitations ; and incidence of self reported pelvic inflammatory disease . Results The participation rate was 16.1 % ( 43 358/269 273 ) after the first invitation , 10.8 % after the second , and 9.5 % after the third , compared with 13.0 % ( 6223/48 031 ) in the control block invited at the end of round two of the intervention . Chlamydia positivity in the intervention blocks at the first invitation was the same as in the control block ( 4.3 % ) and 0.2 % lower at the third invitation ( odds ratio 0.96 ( 95 % confidence interval 0.83 to 1.10 ) ) . No substantial decreases in positivity were seen after three screening rounds in any region or sociodemographic group . Among the people who participated three times ( 2.8 % of all invitees ) , positivity fell from 5.9 % to 2.9 % ( odds ratio 0.49 ( 0.47 to 0.50 ) ) . Conclusions There was no statistical evidence of an impact on chlamydia positivity rates or estimated population prevalence from the Chlamydia Screening Implementation programme after three years at the participation levels obtained . The current evidence does not support a national roll out of this register based chlamydia screening programme . Trial registration NTR 3071 ( Netherl and s Trial Register , www.trialregister.nl ) Study objective : To assess whether opportunistic and postal screening strategies for Chlamydia trachomatis can be compared with usual care in a r and omised trial in general practice . Design : Feasibility study for a r and omised controlled trial . Setting : Three West of Scotl and general medical practice s : one rural , one urban/deprived , and one urban/affluent . Participants : 600 women aged 16–30 years , 200 from each of three participating practice s selected at r and om from a sample of West of Scotl and practice s that had expressed interest in the study . The women could opt out of the study . Those who did not were r and omly assigned to one of three groups : postal screening , opportunistic screening , or usual care . Results : 38 % ( 85 of 221 ) of the approached practice s expressed interest in the study . Data were collected successfully from the three participating practice s. There were considerable workload implication s for staff . Altogether 124 of the 600 women opted out of the study . During the four month study period , 55 % ( 81 of 146 ) of the control group attended their practice but none was offered screening . Some 59 % ( 80 of 136 ) women in the opportunistic group attended their practice of whom 55 % ( 44 of 80 ) were offered screening . Of those , 64 % ( 28 of 44 ) accepted , representing 21 % of the opportunistic group . Forty eight per cent ( 59 of 124 ) of the postal group returned sample s. Conclusion : A r and omised controlled trial comparing postal and opportunistic screening for chlamydial infection in general practice is feasible , although re source intensive . There may be problems with generalising from screening trials in which patients may opt out from the offer of screening OBJECTIVE : To estimate completion rate and acceptability of home screening for sexually transmitted infections ( STIs ) compared with clinic-based screening in a prospect i ve cohort study . METHODS : The first 462 women enrolled in the Contraceptive Choice Project were screened at the 12-month follow-up for Chlamydia trachomatis and Neisseria gonorrhoeae using str and displacement analysis of self-collected vaginal swabs . In a telephone interview , participants were given a choice of no-cost screening with swabs mailed to the participant 's home ( home-based ) or screening that was available at area family planning clinics without an appointment ( clinic-based ) . The clinic-based group also included women who elected to screen with their regular provider according to the clinician 's normal practice . We analyzed the rates of screening , including patient preference and the proportion of completed tests by testing method . RESULTS : Women were more likely to choose to screen for STIs at home than at a clinic or with their own medical provider ( 75.7 % compared with 16.1 % compared with 8.2 % , P<.001 ) . Women choosing clinic testing were more likely to be African American than those choosing home testing . African-American women constituted 42 % of the clinic group compared with 28 % of the home group ( relative risk [ RR ] 1.63 , 95 % confidence interval [ CI ] 1.14–2.31 ) . The groups did not differ in other demographic characteristics , STI risk factors , or access to health care . Overall , 228 women ( 56.6 % ) completed screening . Women who chose home-based testing were more likely to complete a test compared with all clinic-based testers ( 64.6 % compared with 31.6 % , RR 2.04 , 95 % CI 1.51–2.76 ) . CONCLUSION : Women overwhelmingly preferred to screen for STIs at home . Future interventions to increase screening rates in young women should consider alternative screening strategies such as home-based or patient-controlled testing . LEVEL OF EVIDENCE : Background : Screening has been recommended to reduce the prevalence and morbidity associated with genital chlamydia infection in the United Kingdom . Methods : We describe the rationale and study design of the Chlamydia Screening Studies ( ClaSS ) , a collaborative project design ed to evaluate screening outside genitourinary medicine clinics . A non-selective , active screening approach in 16–39 year olds r and omly sample d from 27 general practice lists in the Bristol and Birmingham areas formed the basis of interlinked studies : a case-control study was used to investigate factors to improve the targeting of screening ; participants with chlamydia were invited to enrol in a r and omised controlled trial to evaluate partner notification conducted in primary care ; and laboratory based studies were used to assess the best specimens and tests . We also explored psychosocial effects of screening and partner notification and modelled the cost effectiveness of the programme . Conclusion : Results from four pilot practice s show that mailing of specimens for chlamydia testing is feasible but that it is difficult to achieve high response rates with postal screening . The high prevalence of asymptomatic infection in men suggests that efforts to screen men for chlamydia should be strengthened Objective : The objective of this study was to determine whether home-based screening for sexually transmitted infections ( STIs ) is acceptable , feasible , and increases the proportion of women screened among low-income women in São Paulo , Brazil . Study Design : Eight hundred eighteen women were r and omized to receive a clinic appointment or a kit for home-based STI self- collection and testing . All participants collected 2 vaginal swabs , one for polymerase chain reaction detection of chlamydia , gonorrhea , and trichomoniasis and another for a self-conducted rapid test for trichomoniasis . Results : Slightly more women responded to the initiative within 2 weeks in the home group ( 80 % ) than in the clinic group ( 76 % ) with younger women showing improved response to home-based screening . Ninety-four percent of home group participants successfully completed self- collection and self-testing on their first attempt . Conclusions : Home-based self- collection and self-testing was acceptable , feasible , and result ed in a slightly higher response rate . Home sampling and testing provide promising alternatives to clinic-based STI screening across diverse context The effect of 2 population -based outreach screening strategies that used in-home sampling was compared with usual care practice s for Chlamydia trachomatis infection . All 30,439 persons 21 - 23 years old in Aarhus County , Denmark , were divided r and omly into 3 groups : group 1 ( n=4500 ) had a home sampling kit mailed directly to their central ly registered home address ; group 2 ( n=4500 ) had a reply card mailed to their home address with which a home sampling kit could be ordered ; and group 3 ( n=21,439 ) had access to usual care . For women in groups 1 and 2 , the relative risks of being tested were 4.1 ( 95 % confidence interval [ CI ] , 3.8 - 4.4 ) and 3.5 ( 95 % CI , 3.2 - 3.9 ) , respectively , compared with usual care . The corresponding figures for men were 19.1 ( 95 % CI , 16.0 - 22.8 ) and 11.8 ( 95 % CI , 9.8 - 14.2 ) , respectively . Both screening strategies were highly effective , but men benefited the most from having the home sampling kit provided directly Urogenital infections caused by Chlamydia trachomatis are common and may cause female infertility and ectopic pregnancy . Such infections are treatable but as C trachomatis often causes no symptoms they may remain undetected . As screening for C trachomatis reduces the number of complications,1 and self reportable screening criteria seem to have a low predictive value for infection,2 testing people not seeking medical care seems relevant . C trachomatis can be detected by amplification of DNA from urine and vaginal secretions— sample s that can be obtained at home and mailed directly to the laboratory . 3 4 Usually a swab sample is taken by a doctor but if a patient can collect a sample at home this may result in improved screening rates and thus more infections being detected . We r and omised all 17 high schools in Aarhus County into two screening groups . In the home sampling group the females were asked to collect two urine sample s and one vaginal flush sample 3 and the males were asked to collect one first OBJECTIVE : To determine whether the use of home-based , self-obtained vaginal swabs among women who were treated for Chlamydia infection can increase rescreening rates in comparison with clinic-based rescreening , and to identify subgroups in which rescreening could be enhanced using self-obtained vaginal swabs . METHODS : Two r and omized trials were conducted : one with enrollment in sexually transmitted disease ( STD ) clinics and the other in family planning clinics . Study participants were recruited from STD ( n=880 ) and family planning clinics ( n=412 ) in three cities . Females aged 16 years or older who were treated for Chlamydia infection were r and omly assigned to the home group ( swab collection kits mailed to home ) or the clinic group ( made clinic appointments ) for rescreening at 3 months after treatment , with reminder calls about 2 weeks before the scheduled rescreening date . RESULTS : Groups were similar with respect to age and other demographic characteristics . Women assigned to the home group had higher rescreening rates than those in the clinic group . In STD clinics , rescreening rates were 26.7 % ( home ) compared with 19.1 % ( clinic ) ( P=.01 ) . In family planning clinics , rescreening rates were 40.8 % ( home ) compared with 20.7 % ( clinic ) ( P<.001 ) . Among women reached by reminder calls , rescreening rates were also significantly higher in the home groups : 43.5 % compared with 33.0 % in STD clinic participants and 59.2 % compared with 37.8 % in family planning clinic participants ( both P<.05 ) . The rates of reinfection ranged from 12.9 % to 19.4 % , and the differences by group were not statistically significant ( P≥.3 ) . CONCLUSION : In STD and family planning clinics , use of home-based , self-obtained vaginal swabs result ed in significant increases in rescreening rates compared with rescreening in the clinic . Home-based specimen collection can be an alternative to clinic-based rescreening for Chlamydia infection in women . CLINICAL TRIAL REGISTRATION : Clinical trials.gov , www . clinical trials.gov , NCT 00132457 . LEVEL OF EVIDENCE : Background Rescreening patients after treatment of Chlamydia trachomatis or Neisseria gonorrhoeae infection has had high yield but low rates of participation . Goal The goal of this study was to determine if rescreening for gonorrhea and chlamydial infection in a largely urban sexually transmitted disease population would be more successful if individuals were given the option of su bmi tting a specimen for testing through the mail . Study Design We conducted a r and omized clinical trial involving 122 patients of whom 62 were assigned to clinic rescreening and 60 were given the option of either mailing a specimen for testing or going to a clinic for rescreening . Results Twenty-seven patients ( 45 % ) given the option of either rescreening in the clinic or through the mail and 20 ( 32 % ) assigned to clinic rescreen \n Output:\n " }, { "from": "agent", "value": "The review provides evidence that home-based testing results in greater uptake of STI screening in females ( 14 - 50 years ) than clinic-based testing without compromising quality in the developed world ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: This phase 3 prospect i ve r and omized trial evaluated the efficacy and long-term safety of erythropoietin ( EPO ) with or without granulocyte colony-stimulating factor plus supportive care ( SC ; n = 53 ) versus SC alone ( n = 57 ) for the treatment of anemic patients with lower-risk myelodysplastic syndromes . The response rates in the EPO versus SC alone arms were 36 % versus 9.6 % , respectively , at the initial treatment step , 47 % in the EPO arm , including subsequent steps . Responding patients had significantly lower serum EPO levels ( 45 % vs 5 % responses for levels < 200 mU/mL vs > or = 200 mU/mL ) and improvement in multiple quality -of-life domains . With prolonged follow-up ( median , 5.8 years ) , no differences were found in overall survival of patients in the EPO versus SC arms ( median , 3.1 vs 2.6 years ) or in the incidence of transformation to acute myeloid leukemia ( 7.5 % and 10.5 % patients , respectively ) . Increased survival was demonstrated for erythroid responders versus nonresponders ( median , 5.5 vs 2.3 years ) . Flow cytometric analysis showed that the percentage of P-glycoprotein(+ ) CD34(+ ) marrow blasts was positively correlated with longer overall survival . In comparison with SC alone , patients receiving EPO with or without granulocyte colony-stimulating factor plus SC had improved erythroid responses , similar survival , and incidence of acute myeloid leukemia transformation BACKGROUND The hematological and quality of life ( QoL ) changes associated with darbepoetin alfa ( DA ) therapy were assessed in anemic patients with previously untreated low- and intermediate-1-risk myelodysplastic syndrome ( MDS ) . PATIENTS AND METHODS Fifty-three patients received DA administered subcutaneously once a week for 24 weeks . Treatment was initiated at 150 microg fixed dose and was doubled if after the first 12 weeks there was no or suboptimal erythroid response . RESULTS The final response rate was 24/53 ( 45 % ) , with 21 major and three minor responses . Most of the responses ( 21/24 ; 87.5 % ) were obtained at the dose of 150 microg . With a median follow-up of 9.4 months , 17 patients maintain their response . Treatment was well tolerated with no relevant side-effects . MDS progression was observed in one case . Increases in hemoglobin levels were positively correlated with improved QoL scores using both the linear analog scale assessment ( energy level , r = 0.429 , P = 0.036 ; daily activities , r = 0.653 , P < 0.001 ; overall well-being , r = 0.457 , P = 0.024 ) and the Functional Assessment of Cancer Therapy-Anemia question naire ( r = 0.247 , P = 0.025 ) . In multivariate analysis , only low levels ( < 200 IU/l ) of endogenous erythropoietin predicted response to DA therapy . CONCLUSIONS DA is an active , safe and well tolerated treatment for anemia in a substantial proportion of patients with low- and intermediate-1-risk MDS , and has a positive impact on the patients ' Patients with myelodysplastic syndromes ( MDS ) often develop anaemia result ing in frequent transfusions and fatigue . Darbepoetin alfa is an erythropoiesis‐stimulating agent ( ESA ) approved for treating chemotherapy‐induced anaemia . This single‐arm , phase 2 study examined the efficacy of darbepoetin alfa 500 μg every 3 weeks ( Q3W ) for treating anaemia in low‐risk MDS patients ( after 6 weeks , poor responders received darbepoetin alfa 500 μg every 2 weeks ) . The primary end‐point was the incidence of erythroid responses ( International Working Group criteria ) after 13 weeks of therapy . Secondary end‐points included the incidence of erythroid responses at weeks 28 and 55 , [ or weeks 27 and 53 for dose escalations to every two weeks ( Q2W ) ] , and safety parameters . Analyses were stratified by the patient ’s previous ESA therapy status [ ESA‐naïve ( n = 144 ) vs. prior ESA‐treated ( n = 62 ) ] . After 13 weeks of therapy , 49 % of ESA‐naïve patients and 26 % of prior ESA‐treated patients achieved a major erythroid response . After 53/55 weeks , 59 % of ESA‐naïve patients and 34 % of prior ESA‐treated patients achieved a major erythroid response ; 82 % of ESA‐naïve patients and 55 % of prior ESA‐treated patients achieved target haemoglobin of 110 g/l . Thromboembolic or related adverse events occurred in 2 % of patients ; no pulmonary embolisms were reported . In conclusion , darbepoetin alfa , 500 μg Q3W appeared well tolerated and increased haemoglobin levels in low‐risk MDS patients Abstract Background : Current guidelines support the use of erythropoiesis-stimulating agents for the treatment of anemia associated with low-risk myelodysplastic syndromes ( MDS ) . Design and methods : Single-arm , open-label , multi-center , phase 2 trial that evaluated the efficacy and safety of darbepoetin alfa ( DA ) in patients with low or intermediate-risk MDS , hemoglobin < 100 g/L , erythropoietin ( EPO ) levels < 500 IU/L and transfusion requirements < 2 units/month over the preceding 2 months . Erythroid response ( major [ MaR ] or minor [ MiR ] ) and fatigue ( Functional Assessment of Cancer Therapy – Fatigue [ FACT-F ] ) were evaluated at 8 , 16 and 24 weeks . DA was initiated at 300 μg weekly . For patients who did not achieve MaR by 8 weeks , filgrastim 300 μg weekly was added . Clinical trial registration : clinical trials.gov identifier : NCT01039350 . Results : Forty-four patients ( 72.7 % transfusion independent ) were included . Median age was 76.0 years ( range 41.3–92.4 ) , 54.5 % were male , and 90.9 % presented ECOG Status ( 0–1 ) . Eighteen patients received filgrastim . An erythroid response was achieved by 31 of 44 patients ( 70.5 % ) at week 8 ( 47.7 % MaR , 22.7 % MiR ) , 31 of 44 patients ( 70.5 % ) at week 16 ( 61.4 % MaR , 9.1 % MiR ) , and 32 of 44 patients ( 72.7 % ) at week 24 ( 61.3 % MaR , 11.4 % MiR ) . Mean ( 95 % CI ) change in FACT-F at week 24 was 3.61 ( 0.72 to 6.51 ) . Baseline EPO levels < 100 IU/L were a predictive factor of response . DA was well tolerated . Four mild ( two iron deficiencies , flu syndrome and headache ) and one fatal ( thromboembolic event ) adverse events were considered related to darbepoetin alfa . Conclusions : A fixed dose of 300 μg of darbepoetin alfa weekly ( with or without filgrastim ) seems to be an effective and safe treatment for anemic patients with low or intermediate-risk MDS , low transfusion burden and EPO levels < 500 IU/L. Results may not be extrapolable to unselected MDS patients The myelodysplastic syndromes ( MDSs ) are heterogeneous with respect to clinical characteristics , pathologic features , and cytogenetic abnormalities . This heterogeneity is a challenge for evaluating response to treatment . Therapeutic trials in MDS have used various criteria to assess results , making cross- study comparisons problematic . In 2000 , an International Working Group ( IWG ) proposed st and ardized response criteria for evaluating clinical ly significant responses in MDS . These criteria included measures of alteration in the natural history of disease , hematologic improvement , cytogenetic response , and improvement in health-related quality of life . The relevance of the response criteria has now been vali date d prospect ively in MDS clinical trials , and they have gained acceptance in research studies and in clinical practice . Because limitations of the IWG criteria have surfaced , based on practical and reported experience , some modifications were warranted . In this report , we present recommendations for revisions of some of the initial criteria Darbepoetin ( DAR ) , with or without granulocyte colony-stimulating factor ( G-CSF ) , has proved effective in treating anemia in patients with lower-risk myelodysplastic syndrome ( MDS ) , but its effects on quality of life ( QoL ) and exercise functioning are less well established . In this phase II study ( no. NCT00443339 ) , lower-risk MDS patients with anemia and endogenous erythropoietin ( EPO ) level < 500 IU/L received DAR 500 μg once every 2 weeks for 12 weeks , with G-CSF added at week 12 in non-responders . Physical performance was assessed with the 6-min walking test and , for fit patients , maximal oxygen consumption ( VO2max ) . QoL was evaluated using SF-36 and FACT-An tests . In 99 patients , erythroid response rate according to IWG 2006 criteria was 48 and 56 % at 12 and 24 weeks , respectively . Addition of G-CSF rescued 22 % of non-responders . In 48 % of the responders , interval between darbepoetin injections could be increased for maintenance treatment . Serum EPO level was the only independent predictive factor of response at 12 weeks , and its most discriminant cutoff value was 100 IU/L. QoL and VO2max showed improvement over time in responders , compared with non-responders . With a median follow-up of 52 months , median response duration was not reached , and 3-year cumulative incidence of acute myeloid leukemia and overall survival ( OS ) was 14.5 and 70 % , respectively . Baseline transfusion dependence , International Prognostic Score System ( IPSS ) , and Revised IPSS accurately predicted OS from treatment onset . Tolerance of darbepoetin was good . In conclusion , this regimen of darbepoetin every 2 weeks yielded high response rates and prolonged response duration . Objective improvement in exercise testing and in patient-reported QoL confirms the clinical relevance of anemia correction with erythropoiesis-stimulating agents To evaluate efficacy , safety , changes in biological features , and quality of life ( QoL ) in low-risk anemic patients with MDS treated with darbepoetin alfa ( DPO ) , 41 patients received DPO 150 μg weekly for 24 weeks . The dose was increased to 300 μg weekly in non-responsive patients . During treatment , 10/17 ( 59 % ) transfusion-dependent ( TD ) and 13/23 ( 56 % ) transfusion-free ( TF ) patients responded . In TF patients , Hb increased from 9.2 ± 0.9 g/dL to 10.3 ± 1.4 g/dL by 24 weeks ( p = 0.004 ) . The mean response duration was 22 weeks ( 95 % CI : 19.7–24.0 ) in TF patients compared with 15.1 weeks ( 95 % CI : 13.3–17.5 ) in TD patients . Response to treatment was associated with increases in QoL. Decreases in the percentage of apoptotic progenitor cells ( p = 0.007 ) and CD34 + cells ( p = 0.005 ) were observed . These results confirm previous studies demonstrating the safety and efficacy of DPO in anemic patients with MDS . Biological changes and improvement in QoL were associated with response . Adequate dosing is to be determined This Phase II study evaluated darbepoetin alfa ( DA ) in 24 patients with predominantly low or intermediate‐1 risk myelodysplastic syndrome ( MDS ) . Intra‐patient dose escalation of DA was undertaken in three 6‐week dose cohorts until a major erythroid response was achieved : 4.5 mcg/kg/week , 9 mcg/kg/week , and 9 mcg/kg/week plus granulocyte‐colony stimulating factor ( G‐CSF ) 2.5 mcg/kg twice weekly . Patients with refractory anemia with ringed sideroblasts ( RARS ) commenced DA at 9 mcg/kg/week . The weight‐based dosing regimen translated into a median starting DA dose of 390 mcg/week . Erythroid responses were observed in 16/24 patients ( 67 % ; 12 major and 4 minor ) , with a median response duration of 11 months in major responders . Addition of G‐CSF generated a major erythroid response in 7/15 patients ( 47 % ) who suboptimally responded to DA alone . DA was well tolerated , except for worsening of baseline mild hypertension and renal insufficiency in one patient with diabetes . IP \n Output:\n " }, { "from": "agent", "value": "QoL , transfusion rates and haemoglobin levels improved with treatment .\nThis meta‐ analysis suggests that DA treatment can be useful for improving erythroid response in MDS patients with anaemia , even among patients previously treated with ESA" } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: OBJECTIVES : Inflammatory bowel disease ( IBD ) , especially Crohn 's disease ( CD ) , probably results from failure to downregulate a chronic Th1 intestinal inflammatory process . Induction of a Th2 immune response by intestinal helminths diminishes Th1 responsiveness . This study evaluates the safety and effectiveness of helminthic ova in the treatment of active IBD . METHODS : We studied four patients with active CD and three with ulcerative colitis ( UC ) . In an initial treatment and observation period , a single dose of 2500 live Trichuris suis eggs was given orally , and patients were followed every 2 wk for 12 wk . Baseline medications were continued at the same dose throughout the study . Safety was monitored by following the patients ' clinical status and laboratory studies at regular intervals . Patients also were monitored regularly using the Crohn 's Disease Activity Index , Simple Clinical Colitis Activity Index ( SCCAI ) , and the Inflammatory Bowel Disease Quality of Life Index ( IBDQ ) . To assess safety and efficacy with repetitive doses , two patients with CD and two with UC were given 2500 ova at 3-wk intervals as maintenance treatment using the same evaluation parameters . RESULTS : During the treatment and observation period , all patients improved clinical ly without any adverse clinical events or laboratory abnormalities . Three of the four patients with CD entered remission according to the Crohn 's Disease Activity Index ; the fourth patient experienced a clinical response ( reduction of 151 ) but did not achieve remission . Patients with UC experienced a reduction of the Clinical Colitis Activity Index to 57 % of baseline . According to the IBD Quality of Life Index , six of seven patients ( 86 % ) achieved remission . The benefit derived from the initial dose was temporary . In the maintenance period , multiple doses again caused no adverse effects and sustained clinical improvement in all patients treated every 3 wk for > 28 wk . CONCLUSION : This open trial demonstrates that it is safe to administer eggs from the porcine whipworm , Trichuris suis , to patients with CD and UC . It also demonstrates improvement in the common clinical indices used to describe disease activity . The benefit was temporary in some patients with a single dose , but it could be prolonged with maintenance therapy every 3 wk . The study suggests that it is possible to downregulate aberrant intestinal inflammation in humans with helminths BACKGROUND In the past 20 - 30 years , there has been an increase in prevalence of allergic respiratory diseases , particularly amongst children . This study is a prospect i ve analysis of the postnatal maturation of T-helper cell ( Th ) responses to aeroallergens in atopic and non-atopic infants . METHODS We measured mononuclear-cell proliferative and cytokine responses to specific allergens and tetanus toxoid in blood sample s from atopic and non-atopic infants every 6 months from birth to 2 years of age . Cytokine analyses of responses to housedust-mite allergen used ELISA and reverse-transcriptase PCR . We also measured responses to Fel d1 ( cat allergen ) and tetanus toxoid . FINDINGS Sample s from 18 atopic and 13 non-atopic infants showed low-level Th2-skewed allergen-specific responses at birth , with little accompanying specific interferon-gamma production . Neonatal Th2 responses were lower in the atopic group than in the non-atopic group ; the differences were significant for interleukin-4 ( mRNA : beta-actin ratio 0.48 [ SE 0.15 ] vs 0.15 [ 0.06 ] , p=0.049 ) , interleukin-6 ( 4750 [ 48 ] vs 1352 [ 51 ] pg/mL culture fluid , p=0.003 ) , interleukin-10 ( 1162 [ 228 ] vs 485 [ 89 ] , p=0.015 ) , and interleukin-13 ( 7.1 [ 0.9 ] vs 0.9 [ 0.3 ] , p=0.008 ) . There was rapid suppression of Th2 responses during the first year of life in non-atopic children , but there was consolidation of responses in atopic children , associated with defective neonatal interferon-gamma production . INTERPRETATION The continuation of fetal allergen-specific Th2 responses during infancy is a defining feature of the inductive phase of atopic disease , and is associated with decreased capacity for production of the Th1 cytokine interferon y by atopic neonates . These findings provide a plausible mechanism for persistence of the fetal Th2 responses during early childhood in atopic individuals and subsequent expression of disease We determined the effect of inhaled corticosteroid , budesonide , on the release of the anti-inflammatory cytokine , interleukin-10 ( IL-10 ) , and of pro-inflammatory cytokines , macrophage inflammatory protein-1alpha ( MIP-1alpha ) , interferon-gamma ( IFN-gamma ) , and granulocyte-macrophage colony-stimulating factor ( GM-CSF ) , from blood monocytes and alveolar macrophages of mild asthmatic subjects in a double-blind , cross-over , placebo-controlled study . Budesonide reduced bronchial hyperresponsiveness and improved baseline FEV1 . Alveolar macrophages were obtained by bronchoalveolar lavage performed at the end of each treatment phase . IL-10 from blood monocytes was not altered , but both IL-10 mRNA and protein expression from alveolar macrophages stimulated by lipopolysaccharide and IL-1beta were increased after corticosteroid therapy . By contrast , alveolar macrophages released significantly less MIP-1alpha , IFN-gamma , and GM-CSF after steroid treatment . In comparison to alveolar macrophages from normal nonasthmatic volunteers , those from asthmatic patients released more MIP-1alpha , IFN-gamma , and GM-CSF but lower amounts of IL-10 particularly at baseline and after IL-1beta stimulation . The ability of steroids to inhibit pro-inflammatory cytokines but to enhance the anti-inflammatory cytokine such as IL-10 may contribute to their beneficial actions in asthma . Asthma is characterized by alveolar macrophages exhibiting both an enhanced capacity to release pro-inflammatory cytokines and a reduced capacity to produce IL-10 BACKGROUND & AIMS Interleukin 10 ( IL-10 ) is a cytokine with immunosuppressive and anti-inflammatory activities . Gene-targeted IL-10-deficient mice develop a chronic intestinal inflammatory disease that is reminiscent of Crohn 's disease . The present double-blind r and omized multicenter trial was design ed to evaluate the safety , tolerance , and pharmacokinetics of IL-10 in Crohn 's disease . METHODS Forty-six patients with active steroid-resistant Crohn 's disease were treated with one of five doses of recombinant human IL-10 ( 0.5 , 1 , 5 , 10 , or 25 micrograms/kg ) or placebo administered once daily by intravenous bolus injection over 7 consecutive days . RESULTS Treatment was safe and well tolerated , and no evidence for IL-10 accumulation was observed at the end of the treatment period . At the end of the study , Crohn 's disease activity scores were 179 in IL-10-treated patients and 226 in patients receiving placebo . The proportion of patients that experienced a complete remission at any time in the 3-week follow-up period was 50 % in the IL-10 group and 23 % in placebo-treated patients . CONCLUSIONS These results indicate that IL-10 administered as a daily bolus injection over 1 week is safe and well tolerated and may be clinical ly efficacious BACKGROUND Immunotherapy involves the modulation of allergen-specific T-cell responses , either T(H)2-to-T(H)1 immune deviation or , in bee venom-treated patients , induction of IL-10 production by CD4+CD25 + T cells . IL-10-producing CD4+CD25 + regulatory T cells have emerged as potential mediators of immune tolerance in numerous murine models of immunopathology . OBJECTIVE The aim of this study was to evaluate the role of IL-10 production and CD4+CD25 + T cells in the response to grass pollen immunotherapy . METHODS P BMC s were isolated from patients after 1 year of grass pollen immunotherapy and from matched untreated atopic and healthy control subjects . After 6 days of in vitro stimulation with Phleum pratense , production of IL-10 , IL-5 , IL-4 , and IFN-gamma and proliferation and numbers of CD4+CD25 + T cells were measured . T cells were then stimulated for a further 5 hours with phorbol 12-myristate 13-acetate and ionomycin and assessed for intracellular IL-10 by means of flow cytometry . RESULTS Patients undergoing immunotherapy produced significantly more IL-10 than atopic control subjects ( patients undergoing immunotherapy , 116 + /- 21 pg/mL [ n = 11 ] ; atopic patients , 30 + /- 5 pg/mL [ n = 11 ] ; P < .001 ) , and the number of CD4+CD25 + cells identified after allergen stimulation was also greater in the immunotherapy group . The numbers of CD4+CD25 + T cells correlated positively with activation as measured by proliferation in both of the control groups but not in the immunotherapy group . Moreover , only T cells from patients undergoing immunotherapy were positive for intracellular IL-10 , and these were almost exclusively CD4+CD25 + cells . CONCLUSION Grass pollen immunotherapy results in a population of circulating T cells that express the IL-10(+ ) CD4+CD25 + phenotype in response to allergen restimulation OBJECTIVE To determine the safety and clinical effects of interleukin 10 ( IL-10 ) treatment of psoriasis . DESIGN AND METHODS In an open-label phase 2 trial , 10 patients with psoriasis subcutaneously received recombinant human IL-10 over a 7-week period in a dosage of 8 microg/kg daily ( n=5 ) or 20 microg/kg 3 times per week ( n=5 ) . Patients were followed up for an additional 5 weeks . RESULTS The treatment was well tolerated . Antipsoriatic effects were found in all but 1 patient . A significant decrease of the psoriasis area and severity index by 55.3 % + /- 11.5 % ( mean + /- SEM ) was observed ( P<.02 ) . The antipsoriatic efficiency was confirmed by histological examination . Heterogeneity in the effectiveness was found among the patients , but seems to be independent of the dosage regimen . However , a tendency to a better response was found in the patients who received 20-microg/kg IL-10 3 times per week . Decreasing response in the delayed-type hypersensitivity reaction against recall antigens indicated immunosuppressive effects . Moderate effects on hematopoietic cells were observed . CONCLUSIONS Our data suggest that IL-10 therapy for psoriasis is safe and possibly clinical ly effective . Consequently , its value in psoriasis and similar immune diseases should be further determined . Dose-finding , placebo-controlled , double-blind trials are necessary now BACKGROUND To study the epidemiology of childhood-onset type 1 insulin-dependent diabetes in Europe , the EURODIAB collaborative group established in 1988 prospect i ve geographically-defined registers of new cases diagnosed under 15 years of age . This report is based on 16 362 cases registered during the period 1989 - 94 by 44 centres representing most European countries and Israel and covering a population of about 28 million children . METHODS Multiple sources of ascertainment were used in most centres to vali date the completeness of registration by the capture-recapture method . Trends in incidence during the period were analysed by Poisson regression , the data from centres within each country being pooled . FINDINGS The st and ardised average annual incidence rate during the period 1989 - 94 ranged from 3.2 cases per 100000 per year in the Former Yugoslav Republic of Macedonia to 40.2 cases per 100000 per year in two regions of Finl and . By pooling over all centres , the annual rate of increase in incidence was 3.4 % ( 95 % CI 2.5 - 4.4 % ) , but in some central European countries it was more rapid than this . Pooled over centres and sexes , the rates of increase were 6.3 % ( 4.1 - 8.5 % ) for children aged 0 - 4 years , 3.1 % ( 1.5 - 4.8 % ) for 5 - 9 years , and 2.4 % ( 1.0 - 3.8 % ) for 10 - 14 years . INTERPRETATION The results confirm a very wide range of incidence rates within Europe and show that the increase in incidence during the period varied from country to country . The rapid rate of increase in children aged under 5 years is of particular concern BACKGROUND Why asthma is rare in rural subsistence societies is not clear . We tested the hypotheses that the risk of asthma is reduced by intestinal parasites or hepatitis A infection , and increased by exposure to dust-mite allergen or organophosphorus insecticides in \n Output:\n " }, { "from": "agent", "value": "suggest that these helminths can inhibit the responsiveness to skin allergy testing and minimize asthma symptoms .\nEvidence provided by in vitro studies suggests that helminthiases inhibit T helper 1- and T helper 2-type immune responses .\nThis opens new therapeutic possibilities for the treatment of immune system diseases" } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: We determined myofibrillar and mitochondrial protein fractional synthesis rates ( FSR ) , intramuscular signaling protein phosphorylation , and mRNA expression responses after isolated bouts of resistance exercise ( RE ) , aerobic exercise ( AE ) , or in combination [ termed concurrent exercise ( CE ) ] in sedentary middle-aged men . Eight subjects ( age = 53.3 ± 1.8 yr ; body mass index = 29.4 ± 1.4 kg·m(2 ) ) r and omly completed 8 × 8 leg extension repetitions at 70 % of one repetition-maximum , 40 min of cycling at 55 % peak aerobic power output ( AE ) , or ( consecutively ) 50 % of the RE and AE trials ( CE ) . Biopsies were obtained ( during a primed , constant infusion of l-[ring-(13)C(6)]phenylalanine ) while fasted , and at 1 and 4 h following postexercise ingestion of 20 g of protein . All trials increased mitochondrial FSR above fasted rates ( RE = 1.3-fold ; AE = 1.5 ; CE = 1.4 ; P < 0.05 ) , although only CE ( 2.2 ) and RE ( 1.8 ) increased myofibrillar FSR ( P < 0.05 ) . At 1 h postexercise , phosphorylation of Akt on Ser(473 ) ( CE = 7.7 ; RE = 4.6 ) and Thr(308 ) ( CE = 4.4 ; RE = 2.9 ) , and PRAS40 on Thr(246 ) ( CE = 3.8 ; AE = 2.5 ) increased ( P < 0.05 ) , with CE greater than AE for Akt Ser(473)-Thr(308 ) and greater than RE for PRAS40 ( P < 0.05 ) . Despite increased phosphorylation of Akt-PRAS40 , phosphorylation of mammalian target of rapamycin ( Ser(2448 ) ) remained unchanged ( P > 0.05 ) , while rpS6 ( Ser(235/236 ) ) increased only in RE ( 10.4 ) ( P < 0.05 ) . CE and AE both result ed in increased peroxisome proliferator receptor-γ coactivator 1-α ( PGC1α ) expression at 1 h ( CE = 2.9 ; AE = 2.8 ; P < 0.05 ) and 4 h ( CE = 2.6 ; AE = 2.4 ) and PGC1β expression at 4 h ( CE = 2.1 ; AE = 2.6 ; P < 0.05 ) . These data suggest that CE-induced acute stimulation of myofibrillar and mitochondrial FSR , protein signaling , and mRNA expression are equivalent to either isolate mode ( RE or AE ) . These results occurred without an interference effect on muscle protein subfractional synthesis rates , protein signaling , or mRNA expression This study was design ed to evaluate the effects of enriching an essential amino acid ( EAA ) mixture with leucine on muscle protein metabolism in elderly and young individuals . Four ( 2 elderly and 2 young ) groups were studied before and after ingestion of 6.7 g of EAAs . EAAs were based on the composition of whey protein [ 26 % leucine ( 26 % Leu ) ] or were enriched in leucine [ 41 % leucine ( 41 % Leu ) ] . A primed , continuous infusion of L-[ring-2H5]phenylalanine was used together with vastus lateralis muscle biopsies and leg arteriovenous blood sample s for the determinations of fractional synthetic rate ( FSR ) and balance of muscle protein . FSR increased following amino acid ingestion in both the 26 % ( basal : 0.048 + /- 0.005%/h ; post-EAA : 0.063 + /- 0.007%/h ) and the 41 % ( basal : 0.036 + /- 0.004%/h ; post-EAA : 0.051 + /- 0.007%/h ) Leu young groups ( P < 0.05 ) . In contrast , in the elderly , FSR did not increase following ingestion of 26 % Leu EAA ( basal : 0.044 + /- 0.003%/h ; post-EAA : 0.049 + /- 0.006%/h ; P > 0.05 ) but did increase following ingestion of 41 % Leu EAA ( basal : 0.038 + /- 0.007%/h ; post-EAA : 0.056 + /- 0.008%/h ; P < 0.05 ) . Similar to the FSR responses , the mean response of muscle phenylalanine net balance , a reflection of muscle protein balance , was improved ( P < 0.05 ) in all groups , with the exception of the 26 % Leu elderly group . We conclude that increasing the proportion of leucine in a mixture of EAA can reverse an attenuated response of muscle protein synthesis in elderly but does not result in further stimulation of muscle protein synthesis in young subjects Objectives To examine associations between sarcopenia , obesity , and sarcopenic obesity and risk of cardiovascular disease ( CVD ) and all-cause mortality in older men . Design Prospect i ve cohort study . Setting British Regional Heart Study . Participants Men aged 60–79 years ( n = 4,252 ) . Measurements Baseline waist circumference ( WC ) and midarm muscle circumference ( MAMC ) measurements were used to classify participants into four groups : sarcopenic , obese , sarcopenic obese , or optimal WC and MAMC . The cohort was followed for a mean of 11.3 years for CVD and all-cause mortality . Cox regression analyses assessed associations between sarcopenic obesity groups and all-cause mortality , CVD mortality , CVD events , and coronary heart disease ( CHD ) events . Results There were 1,314 deaths , 518 CVD deaths , 852 CVD events , and 458 CHD events during follow-up . All-cause mortality risk was significantly greater in sarcopenic ( HR = 1.41 , 95 % CI = 1.22–1.63 ) and obese ( HR = 1.21 , 95 % CI = 1.03–1.42 ) men than in the optimal reference group , with the highest risk in sarcopenic obese ( HR = 1.72 , 95 % CI = 1.35–2.18 ) , after adjustment for lifestyle characteristics . Risk of CVD mortality was significantly greater in sarcopenic and obese but not sarcopenic obese men . No association was seen between sarcopenic obesity groups and CHD or CVD events . Conclusion Sarcopenia and central adiposity were associated with greater cardiovascular mortality and all-cause mortality . Sarcopenic obese men had the highest risk of all-cause mortality but not CVD mortality . Efforts to promote healthy aging should focus on preventing obesity and maintaining muscle mass Muscle mass decreases with age , leading to \" sarcopenia , \" or low relative muscle mass , in elderly people . Sarcopenia is believed to be associated with metabolic , physiologic , and functional impairments and disability . Methods of estimating the prevalence of sarcopenia and its associated risks in elderly population s are lacking . Data from a population -based survey of 883 elderly Hispanic and non-Hispanic white men and women living in New Mexico ( the New Mexico Elder Health Survey , 1993 - 1995 ) were analyzed to develop a method for estimating the prevalence of sarcopenia . An anthropometric equation for predicting appendicular skeletal muscle mass was developed from a r and om sub sample ( n = 199 ) of participants and was extended to the total sample . Sarcopenia was defined as appendicular skeletal muscle mass (kg)/height2 ( m2 ) being less than two st and ard deviations below the mean of a young reference group . Prevalences increased from 13 - 24 % in persons under 70 years of age to > 50 % in persons over 80 years of age , and were slightly greater in Hispanics than in non-Hispanic whites . Sarcopenia was significantly associated with self-reported physical disability in both men and women , independent of ethnicity , age , morbidity , obesity , income , and health behaviors . This study provides some of the first estimates of the extent of the public health problem posed by sarcopenia We recently demonstrated that muscle protein synthesis was stimulated to a similar extent in young and elderly subjects during a 3-h amino acid infusion . We sought to determine if a more practical bolus oral ingestion would also produce a similar response in young ( 34 + /- 4 yr ) and elderly ( 67 + /- 2 yr ) individuals . Arteriovenous blood sample s and muscle biopsies were obtained during a primed ( 2.0 micromol/kg ) constant infusion ( 0.05 micromol.kg(-1).min(-1 ) ) of L-[ring-2H5]phenylalanine . Muscle protein kinetics and mixed muscle fractional synthetic rate ( FSR ) were calculated before and after the bolus ingestion of 15 g of essential amino acids ( EAA ) in young ( n = 6 ) and elderly ( n = 7 ) subjects . After EAA ingestion , the rate of increase in femoral artery phenylalanine concentration was slower in elderly subjects but remained elevated for a longer period . EAA ingestion increased FSR in both age groups by approximately 0.04%/h ( P < 0.05 ) . However , muscle intracellular ( IC ) phenylalanine concentration remained significantly higher in elderly subjects at the completion of the study ( young : 115.6 + /- 5.4 nmol/ml ; elderly : 150.2 + /- 19.4 nmol/ml ) . Correction for the free phenylalanine retained in the muscle IC pool result ed in similar net phenylalanine uptake values in the young and elderly . EAA ingestion increased plasma insulin levels in young ( 6.1 + /- 1.2 to 21.3 + /- 3.1 microIU/ml ) but not in elderly subjects ( 3.0 + /- 0.6 to 4.3 + /- 0.4 microIU/ml ) . Despite differences in the time course of plasma phenylalanine kinetics and a greater residual IC phenylalanine concentration , amino acid supplementation acutely stimulated muscle protein synthesis in both young and elderly individuals The ability to maintain skeletal muscle mass appears to be impaired in insulin-resistant conditions , such as type 2 diabetes , that are characterized by muscle lipid accumulation . The current study investigated the effect of acutely increasing lipid availability on muscle protein synthesis . Seven healthy young male volunteers underwent a 7-h intravenous infusion of l-[ring-2H5]phenylalanine on two r and omized occasions combined with 0.9 % saline or 10 % Intralipid at 100 mL/h . After a 4-h “ basal ” period , a 21-g bolus of amino acids was administered and a 3-h hyperinsulinemic-euglycemic clamp was commenced ( “ fed ” period ) . Muscle biopsy specimens were obtained from the vastus lateralis at 1.5 , 4 , and 7 h. Lipid infusion reduced fed whole-body glucose disposal by 20 % . Furthermore , whereas the mixed muscle fractional synthetic rate increased from the basal to the fed period during saline infusion by 2.2-fold , no change occurred during lipid infusion , despite similar circulating insulin and leucine concentrations . This “ anabolic resistance ” to insulin and amino acids with lipid infusion was associated with a complete suppression of muscle 4E-BP1 phosphorylation . We propose that increased muscle lipid availability may contribute to anabolic resistance in insulin-resistant conditions by impairing translation initiation Maximizing anabolic responses to feeding and exercise is crucial for muscle maintenance and adaptation to exercise training . We hypothesized that enriching a protein drink with leucine would improve anabolic responses to resistance exercise ( RE : 6 × 8 knee-extension repetitions at 75 % of 1-RM ) in both young and older adults . Groups ( n = 9 ) of young ( 24 ± 6 y , BMI 23 ± 2 kg m-2 ) and older men ( 70 ± 5 y , BMI 25 ± 2 kg m-2 ) were r and omized to either : ( i ) RE followed by Slim-Fast Optima ( SFO 10 g PRO ; 24 g CHO ) with 4.2 g of leucine ( LEU ) or , ( ii ) RE + SFO with 4.2 g of alanine ( ALA ; isonitrogenous control ) . Muscle biopsies were taken before , immediately after , and 1 , 2 and 4 h after RE and feeding . Muscle protein synthesis ( MPS ) was measured by incorporation of [ 1 , 2 - 13C2 ] leucine into myofibrillar proteins and the phosphorylation of p70S6K1 by immunoblotting . In young men , both area under the curve ( AUC ; FSR 0 - 4 h P < 0.05 ) and peak FSR ( 0. \n Output:\n " }, { "from": "agent", "value": "Our results highlight that optimization of exercise and amino acid-based nutrition is sufficient to induce a comparable MPS response between young and older individuals .\nHowever , the exercise volume completed and /or the amino acid/protein dose and leucine content must exceed a certain threshold to stimulate equivalent MPS rates in young and older adults , below which age-related muscle anabolic resistance may become apparent" } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: OBJECTIVE . The study tested whether a combined environmental and educational intervention solely promoting water consumption was effective in preventing overweight among children in elementary school . METHODS . The participants in this r and omized , controlled cluster trial were second- and third- grade rs from 32 elementary schools in socially deprived areas of 2 German cities . Water fountains were installed and teachers presented 4 prepared classroom lessons in the intervention group schools ( N = 17 ) to promote water consumption . Control group schools ( N = 15 ) did not receive any intervention . The prevalence of overweight ( defined according to the International Obesity Task Force criteria ) , BMI SD scores , and beverage consumption ( in glasses per day ; 1 glass was defined as 200 mL ) self-reported in 24-hour recall question naires , were determined before ( baseline ) and after the intervention . In addition , the water flow of the fountains was measured during the intervention period of 1 school year ( August 2006 to June 2007 ) . RESULTS . Data on 2950 children ( intervention group : N = 1641 ; control group : N = 1309 ; age , mean ± SD : 8.3 ± 0.7 years ) were analyzed . After the intervention , the risk of overweight was reduced by 31 % in the intervention group , compared with the control group , with adjustment for baseline prevalence of overweight and clustering according to school . Changes in BMI SD scores did not differ between the intervention group and the control group . Water consumption after the intervention was 1.1 glasses per day greater in the intervention group . No intervention effect on juice and soft drink consumption was found . Daily water flow of the fountains indicated lasting use during the entire intervention period , but to varying extent . CONCLUSION . Our environmental and educational , school-based intervention proved to be effective in the prevention of overweight among children in elementary school , even in a population from socially deprived areas BACKGROUND The consumption of beverages that contain sugar is associated with overweight , possibly because liquid sugars do not lead to a sense of satiety , so the consumption of other foods is not reduced . However , data are lacking to show that the replacement of sugar-containing beverages with noncaloric beverages diminishes weight gain . METHODS We conducted an 18-month trial involving 641 primarily normal-weight children from 4 years 10 months to 11 years 11 months of age . Participants were r and omly assigned to receive 250 ml ( 8 oz ) per day of a sugar-free , artificially sweetened beverage ( sugar-free group ) or a similar sugar-containing beverage that provided 104 kcal ( sugar group ) . Beverages were distributed through schools . At 18 months , 26 % of the children had stopped consuming the beverages ; the data from children who did not complete the study were imputed . RESULTS The z score for the body-mass index ( BMI , the weight in kilograms divided by the square of the height in meters ) increased on average by 0.02 SD units in the sugar-free group and by 0.15 SD units in the sugar group ; the 95 % confidence interval ( CI ) of the difference was -0.21 to -0.05 . Weight increased by 6.35 kg in the sugar-free group as compared with 7.37 kg in the sugar group ( 95 % CI for the difference , -1.54 to -0.48 ) . The skinfold-thickness measurements , waist-to-height ratio , and fat mass also increased significantly less in the sugar-free group . Adverse events were minor . When we combined measurements at 18 months in 136 children who had discontinued the study with those in 477 children who completed the study , the BMI z score increased by 0.06 SD units in the sugar-free group and by 0.12 SD units in the sugar group ( P=0.06 ) . CONCLUSIONS Masked replacement of sugar-containing beverages with noncaloric beverages reduced weight gain and fat accumulation in normal-weight children . ( Funded by the Netherl and s Organization for Health Research and Development and others ; DRINK Clinical Trials.gov number , NCT00893529 . ) OBJECTIVE To study whether service of a free school lunch has an impact on weight development and food intake among pupils at a lower secondary school , and to assess the association between self-perceived school behaviour and food intake . DESIGN A controlled intervention study involving service of a free healthy school lunch to 9th grade pupils took place over 4 months , from January to May 2007 . Weight and height were measured before and after the intervention . The pupils also completed a short FFQ and a question naire concerning self-perceived school behaviour and the classroom environment before and after the intervention . A healthy food score was calculated using the FFQ data . SETTING All 9th grade rs at three different lower secondary schools in southern Norway were invited to participate . One school was r and omly selected as the intervention school . SUBJECTS Fifty-eight pupils ( 91 % ) from the intervention school and ninety-two pupils ( 77 % ) from the control schools participated . RESULTS BMI did not increase among the girls at the intervention school , but increased significantly among the boys at the intervention school and among the control school groups . The healthy food score correlated positively with the trait ' satisfied with schoolwork ' ( P < 0.001 ) . Fifteen per cent of the variance in food score could be explained by gender and the trait ' satisfied with schoolwork ' . CONCLUSIONS Serving of a healthy free school lunch to secondary -school pupils may result in restricted weight gain . Further studies are needed to clarify the impact of school meals on overweight and academic performance OBJECTIVE To determine whether a multicomponent health promotion intervention for Dutch adolescents ( defined as persons between 12 and 14 years of age ) would be successful in influencing body composition and dietary and physical activity behavior in both the short and long terms . DESIGN R and omized controlled trial . SETTING Ten intervention and 8 control prevocational secondary schools . PARTICIPANTS A total of 1108 adolescents ( mean age , 12.7 years ) . Intervention An interdisciplinary program with an adapted curriculum for 11 lessons in biology and physical education and environmental change options . MAIN OUTCOME MEASURES Body height and weight , waist circumference , 4 skinfold thickness measurements , and dietary and physical activity behavior data . RESULTS Multilevel analyses showed that the intervention remained effective in preventing unfavorable increases in important measures of body composition after 20-month follow-up in girls ( biceps skinfold and sum of 4 skinfolds ) and boys ( triceps , biceps , and subscapular skinfolds ) . Consumption of sugar-containing beverages was significantly lower in intervention schools both after intervention ( boys : -287 mL/d ; 95 % confidence interval [ CI ] , -527 to -47 ; girls : -249 ; -400 to -98 ) and at 12-month follow-up ( boys : -233 ; -371 to -95 ; girls : -271 ; -390 to -153 ) . For boys , screen-viewing behavior was significantly lower in the intervention group after 20 months ( -25 min/d ; 95 % CI , -50 to -0.3 ) . No significant intervention effects on consumption of snacks or active commuting to school were found . CONCLUSION The Dutch Obesity Intervention in Teenagers program result ed in beneficial effects on the sum of skinfold thickness measurements in girls and consumption of sugar-containing beverages in both boys and girls in both the short and long terms OBJECTIVE Our purpose was to measure the agreement , reliability , construct validity , and feasibility of a measurement tool to assess systematic review s ( AMSTAR ) . STUDY DESIGN AND SETTING We r and omly selected 30 systematic review s from a data base . Each was assessed by two review ers using : ( 1 ) the enhanced quality assessment question naire ( Overview of Quality Assessment Question naire [ OQAQ ] ) ; ( 2 ) Sacks ' instrument ; and ( 3 ) our newly developed measurement tool ( AMSTAR ) . We report on reliability ( interobserver kappas of the 11 AMSTAR items ) , intraclass correlation coefficients ( ICCs ) of the sum scores , construct validity ( ICCs of the sum scores of AMSTAR compared with those of other instruments ) , and completion times . RESULTS The interrater agreement of the individual items of AMSTAR was substantial with a mean kappa of 0.70 ( 95 % confidence interval [ CI ] : 0.57 , 0.83 ) ( range : 0.38 - 1.0 ) . Kappas recorded for the other instruments were 0.63 ( 95 % CI : 0.38 , 0.78 ) for enhanced OQAQ and 0.40 ( 95 % CI : 0.29 , 0.50 ) for the Sacks ' instrument . The ICC of the total score for AMSTAR was 0.84 ( 95 % CI : 0.65 , 0.92 ) compared with 0.91 ( 95 % CI : 0.82 , 0.96 ) for OQAQ and 0.86 ( 95 % CI : 0.71 , 0.94 ) for the Sacks ' instrument . AMSTAR proved easy to apply , each review taking about 15 minutes to complete . CONCLUSIONS AMSTAR has good agreement , reliability , construct validity , and feasibility . These findings need confirmation by a broader range of assessors and a more diverse range of review Objective : To assess the efficacy of a school-based intervention programme to reduce the prevalence of overweight in 6 to 10-year-old children . Design : Cluster-r and omized , controlled study .Subjects : A total of 3135 boys and girls in grade s 1–4 were included in the study . Methods : Ten schools were selected in Stockholm county area and r and omized to intervention ( n=5 ) and control ( n=5 ) schools . Low-fat dairy products and whole-grain bread were promoted and all sweets and sweetened drinks were eliminated in intervention schools . Physical activity ( PA ) was aim ed to increase by 30 min day−1 during school time and sedentary behaviour restricted during after school care time . PA was measured by accelerometry . Eating habits at home were assessed by parental report . Eating disorders were evaluated by self-report . Results : The prevalence of overweight and obesity decreased by 3.2 % ( from 20.3 to 17.1 ) in intervention schools compared with an increase of 2.8 % ( from 16.1 to 18.9 ) in control schools ( P<0.05 ) . The results showed no difference between intervention and controls , after cluster adjustment , in the longitudinal analysis of BMI sds changes . However , a larger proportion of the children who were initially overweight reached normal weight in the intervention group ( 14 % ) compared with the control group ( 7.5 % ) , P=0.017 . PA did not differ between intervention and control schools after cluster adjustment . Eating habits at home were found to be healthier among families with children in intervention schools at the end of the intervention . There was no difference between children in intervention and control schools in self-reported eating disorders . Conclusions : A school-based intervention can reduce the prevalence of overweight and obesity in 6 to 10-year-old children and may affect eating habits at home . The effect of the intervention was possibly due to its effect on healthy eating habits at school and at home rather than on increased levels of PA OBJECTIVE To evaluate the effect of a 3-year after-school physical activity ( PA ) intervention on aerobic fitness and percent body fat ( % BF ) . METHODS In total , 18 schools were r and omized into intervention or control arms . Measurements were made at the beginning and end of the third , fourth and fifth grade s. Fitness was measured with heart rate response to a bench-stepping task.%BF and bone density were measured with dual-energy x-ray absorptiometry . The intervention included 40 min of academic enrichment activities , during which healthy snacks were provided , and 80 min of moderate-to-vigorous PA ( MVPA ) . RESULTS Data analyses were performed on 206 youths who remained in the same schools for the 3-year period , who were measured at all six time points and , for the intervention group , who attended at least 40 % of the sessions in each of the 3 years . The group by time interactions were significant for fitness ( p < 0.01 ) and % BF ( p < 0.05 ) . Children in intervention schools improved in fitness and % BF during the school years and returned to levels similar to those in control schools during the summers . Over the six measurement points , the intervention group increased more than the control group in bone density ( p < 0.01 ) , fat-free soft tissue ( p < 0.01 ) , weight ( p < 0.01 ) , height ( p < 0.01 ) , and body mass index ( p < 0.05 ) . CONCLUSIONS An after-school program focusing on MVPA had a beneficial effect on fitness and body composition . During the summers , the beneficial effect of the previous year 's participation on fitness and % BF was lost . This highlights the importance of year-round programs to promote healthy growth in youths CONTEXT Some observational studies have found an association between television viewing and child and adolescent adiposity . OBJECTIVE To assess the effects of reducing television , videotape , and video game use on changes in adiposity , physical activity , and dietary intake . DESIGN R and omized controlled school-based trial conducted from September 1996 to April 1997 . SETTING Two sociodemographically and scholastically matched public elementary schools in San Jose , Calif. PARTICIPANTS Of 198 third- and \n Output:\n " }, { "from": "agent", "value": "Results show modest impact of a broad range of environmental strategies on anthropometric outcomes ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: STUDY OBJECTIVE To compare the hypnotic effects of a bedtime dose of zolpidem , triazolam , and placebo . DESIGN \" Double-blind , r and omized , placebo- and active-controlled , parallel-group \" trial . SETTING Six Canadian hospitals . PATIENTS 357 patients ( aged 19 to 71 years ) hospitalized the night before a surgical procedure . INTERVENTIONS At bedtime , each patient received either zolpidem 10 mg , triazolam 0.25 mg , or placebo , and was allowed to sleep for a maximum of 8 hours . MEASUREMENTS Outcome measures were subjective in nature and included a morning question naire , visual analog scales , and observation forms by study personnel . All continuous variables were analyzed by analysis of variance . All categorical data were compared using the Cochran-Mantel-Haenszel ( CMH ) test , and the percentage of patients asleep was compared using a CMH chi-square analysis . When significant overall treatment effects were observed , pairwise comparisons were undertaken . Compared with the placebo group , the following parameters were significantly ( p < 0.001 ) different in the zolpidem and triazolam groups : sleep latency was shorter , total sleep time was longer , patients fell asleep more easily , and the number of patients awake 2 hours after drug administration was lower . There were no differences between any groups in next-morning somnolence or ability to concentrate . Both drugs were well tolerated , with adverse event incidence rates nearly identical to placebo . CONCLUSIONS In patients suffering from transient insomnia , a single dose of zolpidem 10 mg was as effective as triazolam 0.25 mg , and both were more effective than placebo and were well tolerated OBJECTIVES To improve nighttime sleep in nursing home patients . DESIGN Controlled clinical trial . SETTING Eight community nursing homes enrolled two at a time . PARTICIPANTS Of 1,077 patients assessed in the eight nursing homes , 638 ( 59 % ) were eligible , and consent was obtained for 273 ( 43 % of those eligible ) . Of the 230 who underwent baseline assessment s , 173 completed the immediate-intervention phase of the trial ( 77 in the intervention group and 96 in the control group ) . A total of 160 subjects completed the intervention ( 77 in the immediate-intervention group and 83 in the delayed-intervention phase ) . INTERVENTION Trained research staff provided the intervention , which included daytime physical activity and attempts to keep subjects out of bed , evening bright light exposure , a consistent bedtime routine , nighttime care routines design ed to minimize sleep disruption , and strategies to reduce nighttime noise . Subjects from one nursing home received the intervention ( Group 1 ) , whereas subjects in the second nursing home served as a control group ( Group 2 ) ; then Group 2 received the intervention . MEASUREMENTS Primary outcomes included measures of sleep recorded using wrist actigraphy in all subjects and polysomnography in a subgroup of subjects . Secondary measures included assessment s of mood and behavior using the Neuropsychiatric Inventory , the Geriatric Depression Scale , and behavioral observations . RESULTS There were no significant differences in any of the primary actigraphic sleep outcome measures between the intervention and control group after the immediate-intervention phase of the trial . In the 160 subjects who completed the intervention , there were no significant changes in any actigraphic measure of nighttime sleep , nor were there any significant changes in measures of sleep in the 45 subjects who had baseline and intervention polysomnography . CONCLUSION This multicomponent , nonpharmacological intervention conducted by trained research staff had no effect on nighttime sleep in this sample of nursing home patients . Enhanced nonpharmacological interventions should be developed and tested and combined with environmental interventions to mitigate noise when feasible . Adjunctive drug therapy may be needed to improve sleep in a substantial proportion of this population and should be tested in addition to nonpharmacological interventions in rigorous clinical trials The purpose of this study was to develop and test the Verran and Snyder-Halpern ( VSH ) Sleep Scale , an instrument to subjectively measure sleep characteristics . Four major sleep factors and their associated characteristics were proposed for the Sleep Scale . Subjects completed three r and omly ordered sleep question naires on three consecutive weekday mornings within the first two hours after arising . Scales included the VSH Sleep Scale , a sleep question naire and a sleep log . The VSH Sleep Scale had a reliability coefficient of .82 ( theta ) . Construct validity was examined by factor analysis and correlations between Sleep Scale items and corresponding items on the two other study instruments . Scale validity also was assessed by the known groups method . Beginning support for the validity of the VSH Sleep Scale is provided Experimental sleep deprivation in healthy humans affects levels of ghrelin and leptin , two primary hormones involved in energy balance that regulate appetite and body weight . No study to date has examined levels of these hormones in patients with chronic insomnia . In this study , men diagnosed with primary insomnia using DSM-IV criteria ( n=14 ) and age and body weight comparable healthy control men ( n=24 ) underwent polysomnography . Circulating levels of ghrelin and leptin were measured at 2300h , 0200h and 0600h . As compared to controls , insomnia patients showed less total sleep time , stage 2 and REM sleep and decreased sleep efficiency and more stage 1 sleep than controls ( p's<.05 ) . Ghrelin levels across the night were significantly lower in insomnia patients ( p<.0001 ) . Leptin was not significantly different between the groups . In conclusion , decreased nocturnal ghrelin in insomnia is consistent with findings for nighttime levels in sleep deprivation studies in healthy sleepers . These findings suggest that insomnia patients have a dysregulation in energy balance that may play a role in explaining prospect i ve weight gain in this population OBJECTIVES The sleep of nursing home residents is fragmented by frequent awakening episodes associated , at least in part , with environmental variables , including noise and light changes . The purpose of this study was to improve sleep by reducing the frequency of nighttime noise and light changes . PARTICIPANTS AND SETTING Two hundred sixty-seven incontinent nursing home residents in eight nursing homes . DESIGN A r and omized control group design with a delayed intervention for the control group . MEASUREMENTS Bedside noise and light monitors recorded the number of 2-minute intervals at night with peak sounds recorded above 50 dBs and the number of light changes of at least 10 lux between adjacent 2-minute intervals . Daytime behavioral observations measured sleep and in-bed time during the day , and wrist activity was used to estimate sleep at night . Awakening events associated with the environmental variables were derived from the wrist activity data . INTERVENTION A behavioral intervention implemented between 7:00 p.m. and 6:00 a.m. that involved feedback to nursing home staff about noise levels and implementation by research staff of procedures to both abate noise ( e.g. , turn off unwatched television sets ) and to individualize nighttime incontinence care routines to be less disruptive to sleep . RESULTS Noise was reduced significantly , from an average of 83 intervals per night with peak noises recorded above 50 dBs to an average of 58 intervals per night in the group that received the initial intervention , whereas noise in the control group showed no change ( MANOVA group x time P < .001 ) . All 10-dB categories of noise from 50 to 90 + dBs were reduced , and light changes were reduced from an average of four per night per resident to two per night ( P < .001 ) . Despite these significant changes in the environmental variables , there was a significant differential improvement in the intervention group on only two night sleep measures : awakening associated with a combination of noise plus light ( P < .001 ) and awakening associated with light ( P < .001 ) . However , there was a significant correlation between change in noise and change in percent sleep from baseline to intervention ( r = -.29 , P < .05 ) , suggesting that the intervention did not reduce noise to low enough levels to produce a significant improvement in sleep . The intervention effects on all environmental variables were replicated in the delayed intervention group , who again showed significant improvement on the same sleep measures . Observations of day sleep and in-bed time did not change over the phases of the trial for either group . CONCLUSION The significant reductions in noise and light events result ing from the intervention did not lead to significant improvements in the day sleep and most night sleep measures . An intervention that combines both behavioral and environmental strategies and that addresses daytime behavioral factors associated with poor sleep ( e.g. , excessive time in bed ) would potentially be more effective in improving the night sleep and quality of life of nursing home residents Insomnia is a common phenomenon in cancer patients ; nevertheless , there are only a few intervention results published covering this topic . We examined the effects of a multi-modal psychological sleep management programme combining relaxation techniques , sleep hygiene , cognitive techniques and advice in stimulus control technique on various sleep and quality -of-life variables . We compared two intervention groups up to 6 months after treatment , one with progressive muscle relaxation ( n=80 ) , the other with autogenic training ( n=71 ) . A control group ( n=78 ) received only a st and ard rehabilitation programme . It was a heterogeneous sample of adult patients ( mean age 58 years ) predominantly with breast , kidney or prostate cancer staying for 3 or 4 weeks in an oncological rehabilitation clinic . In comparison to the control group , the analysis of variance for repeated measures ( R-MANOVA ) showed significant improvements over time , indicating that intervention group participants benefited with moderate- or large-scale effects on sleep latency ( p<0.001 ) , sleep duration ( p<0.001 ) , sleep efficiency ( p<0.001 ) , sleep quality ( p<0.001 ) , sleep medication ( p<0.05 ) and daytime dysfunction ( p<0.05 ) . In quality -of-life subscales , there was mainly improvement over time . This may indicate a benefit of the rehabilitation treatment in general . No evidence was found for any differences between the two intervention groups . The results suggest that the use of a multi-modal psychological sleep intervention could enhance various sleep parameters and well being of patients . The efficacy on quality of life is still under review Objective Because of around-the-clock activities , environmental noise and light are among the many causes of sleep disturbance in an intensive care unit ( ICU ) . The implementation of guidelines may potentially change behavior rules and improve sleep quality . Design A prospect i ve interventional study , observing the effects of simple nighttime guidelines on light and noise levels in an ICU . Setting A modern surgical ICU , subdivided into six identical three-bed rooms . Patients Critically ill adult patients . Intervention Between two observation periods , five guidelines were implemented to decrease both light and noise during the night shift in the patient ’s room . Measurement Light levels and noise levels were obtained using a luxmeter and a sound level meter [ A-weighted decibels ( dB ) scale ] and were monitored continuously from 11 pm to 5 am both before ( period P1 ) and after ( period P2 ) the implementation of guidelines . Main Results Similar patient ’s gravity and nursing workload scores were observed between P1 and P2 . A low mean ( < 5 Lux ) and maximal light level were measured during both P1 and P2 . The implementation of guidelines lowered mean light disturbance intensity with a greater variability of light during P2 . All noise levels were high and corresponded more to a quiet office for noise level equivalents and to a busy restaurant for peak noise levels during both P1 and P2 . Guidelines decreased the noise level equivalent ( P1 , 51.3 dB ; P2 , 48.3 dB ) , peak noise level ( P1 , 74.9 dB ; P2 , 70.8 dB ) , and the number of acoustic identified alarms ( P1 , 22.1 dB ; P2 , 15.8 dB ) during P2 . Conclusion The night light levels were low during both periods , and lowering the light levels induced a greater variation of light , which may impair sleep quality . All measured noise levels were high during both periods , which could contribute to sleep disturbance , and the implementation of guidelines significantly lowers some important noise levels . The background noise level was unchanged Background : Insomnia is a prevalent health complaint that is often difficult to evaluate reliably . There is an important need for brief and valid assessment tools to assist practitioners in the clinical evaluation of insomnia complaints . Objective : This paper reports on the clinical validation of the Insomnia Severity Index ( ISI ) as a brief screening measure of insomnia and as an outcome measure in treatment research . The psychometric properties ( internal consistency , concurrent validity , factor structure ) of the ISI were evaluated in two sample s of insomnia patients . Methods : The first study examined the internal consistency and concurrent validity of the ISI in 145 patients evaluated for insomnia at a sleep disorders clinic . Data from the ISI were compared to those of a sleep diary measure . In the second study , the concurrent validity of the ISI was evaluated in a sample of 78 older patients who participated in a r and omized-controlled trial of behavioral and pharmacological therapies for insomnia . Change scores on the ISI over time were compared with those obtained from sleep diaries and polysomnography . Comparisons were also made between ISI scores obtained from patients , significant others , and clinicians . Results : The results of Study 1 showed that the ISI has adequate internal consistency and is a reliable self-report measure to evaluate perceived sleep difficulties . The results from Study 2 also indicated that the ISI is a valid and sensitive measure to detect changes in perceived sleep difficulties with treatment . In addition , there is a close convergence between scores obtained from the ISI patient 's version and those from the clinician 's and significant other 's versions . Conclusions : The present findings indicate that the ISI is a reliable and valid instrument to quantify perce \n Output:\n " }, { "from": "agent", "value": "FINDINGS Little evidence for the nursing interventions , sleep hygiene , music , natural sound and vision , stimulation of acupoints , relaxation , massage and aromatherapy is found .\nHowever , large effect size of interventions were found when using massage , acupuncture and music , natural sounds or music videos .\nThe use of sleep hygiene and relaxation , on the other h and , produced only small effects ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: Overwhelming evidence shows the quality of reporting of r and omised controlled trials ( RCTs ) is not optimal . Without transparent reporting , readers can not judge the reliability and validity of trial findings nor extract information for systematic review s. Recent method ological analyses indicate that inadequate reporting and design are associated with biased estimates of treatment effects . Such systematic error is seriously damaging to RCTs , which are considered the gold st and ard for evaluating interventions because of their ability to minimise or avoid bias . A group of scientists and editors developed the CONSORT ( Consoli date d St and ards of Reporting Trials ) statement to improve the quality of reporting of RCTs . It was first published in 1996 and up date d in 2001 . The statement consists of a checklist and flow diagram that authors can use for reporting an RCT . Many leading medical journals and major international editorial groups have endorsed the CONSORT statement . The statement facilitates critical appraisal and interpretation of RCTs . During the 2001 CONSORT revision , it became clear that explanation and elaboration of the principles underlying the CONSORT statement would help investigators and others to write or appraise trial reports . A CONSORT explanation and elaboration article was published in 2001 alongside the 2001 version of the CONSORT statement . After an expert meeting in January 2007 , the CONSORT statement has been further revised and is published as the CONSORT 2010 Statement . This up date improves the wording and clarity of the previous checklist and incorporates recommendations related to topics that have only recently received recognition , such as selective outcome reporting bias . This explanatory and elaboration document-intended to enhance the use , underst and ing , and dissemination of the CONSORT statement-has also been extensively revised . It presents the meaning and rationale for each new and up date d checklist item providing examples of good reporting and , where possible , references to relevant empirical studies . Several examples of flow diagrams are included . The CONSORT 2010 Statement , this revised explanatory and elaboration document , and the associated website ( www.consort-statement.org ) should be helpful re sources to improve reporting of r and omised trials Background The only three r and omized trials on the treatment of MTSS were all performed in military population s. The treatment options investigated in this study were not previously examined in athletes . This study investigated if functional outcome of three common treatment options for medial tibial stress syndrome ( MTSS ) in athletes in a non-military setting was the same . Methods The study design was r and omized and multi-centered . Physical therapists and sports physicians referred athletes with MTSS to the hospital for inclusion . 81 athletes were assessed for eligibility of which 74 athletes were included and r and omized to three treatment groups . Group one performed a grade d running program , group two performed a grade d running program with additional stretching and strengthening exercises for the calves , while group three performed a grade d running program with an additional sports compression stocking . The primary outcome measure was : time to complete a running program ( able to run 18 minutes with high intensity ) and secondary outcome was : general satisfaction with treatment . Results 74 Athletes were r and omized and included of which 14 did not complete the study due a lack of progress ( 18.9 % ) . The data was analyzed on an intention-to-treat basis . Time to complete a running program and general satisfaction with the treatment were not significantly different between the three treatment groups . Conclusion This was the first r and omized trial on the treatment of MTSS in athletes in a non-military setting . No differences were found between the groups for the time to complete a running program . Trial registration CCMO ; The effect of low-energy laser therapy on shin splints was examined in a r and omized study with an unblinded design . Constripts from the Jutl and Dragoon regiment with shin splints were given either active laser treatment ( 40 mW in 60 sec per cm tender tibia edge ) or placebo laser . All patients were exempted from normal duty concerning activities like running and march . Forty-nine patients participated in the study , 23 in the laser group and 26 in the control group . From the start the study was design ed to be double-blind , but by accident the code was broken towards the end of the study . We found no significant differences between the groups regarding pain visual analog score and readiness to return to active duty after 14 days Objective The purpose of this study was to describe the results of two treatment regimens for medial tibial stress syndrome ( MTSS ) ; a grade d running programme and the same running programme with additional shockwave therapy ( extracorporeal shockwave therapy ; ESWT ) . Design A prospect i ve observational controlled trial . Setting Two different sports medicine departments . Participants 42 athletes with MTSS were included . Intervention Patients from one hospital were treated with a grade d running programme , while patients from the other hospital were treated with the same grade d running programme and focused ESWT ( five sessions in 9 weeks ) . Main Outcome Measures Time to full recovery ( the endpoint was being able to run 18 min consecutively without pain at a fixed intensity ) . Results The time to full recovery was significantly faster in the ESWT group compared with the patients who only performed a grade d running programme , respectively 59.7±25.8 and 91.6±43.0 days ( p=0.008 ) . Conclusions This prospect i ve observational study showed that MTSS patients may benefit from ESWT in addition to a grade d running programme . ESWT as an additional treatment warrants further investigation in a prospect i ve controlled trial with the addition of r and omisation and double blinding Objective To study the additional effect of a pneumatic leg brace with st and ard rehabilitation for the treatment of medial tibial stress syndrome ( MTSS ) in recruits . Methods In a single blinded r and omized study , 15 recruits ( age 17 - 22 ) followed a rehabilitation programme consisting of leg exercises and a grade d running programme . Recruits performed daily exercises and ran three times a week . The running programme consisted of 6 consecutive phases . One group was , after r and omization , additionally provided with a pneumatic leg brace . Follow-up was provided every other week . Days to completing the running programme was the primary outcome measure , the Sports Activity Rating Scale ( SARS ) score and satisfaction with the treatment were secondary outcome measures . Results In total 14 recruits completed the rehabilitation programme . No differences were found in the number of days until phase six of the running schedule was finished between the brace and the control group ( Brace 58.8 ± 27.7 ( mean ± SD ) vs Non-Brace 57.9 ± 26.2 ( mean ± SD , p = 0.57 ) . Also no differences were found in the SARS scores between the groups . Overall satisfaction with the treatment was 6.4 ± 1.1 ( mean ± SD ) on a 1 - 10 scale for the brace group and 7.1 ± 0.7 ( mean ± SD ) for the control group ( p = 0.06 ) . Comfort of the brace was assessed as 4.8 ± 1.3 ( mean ± SD ) on a 1 - 10 scale . Conclusions No additional large effect of the pneumatic leg brace could be found in recruits and wearing of the brace was not feasible , since the wearing comfort was low OBJECTIVE The purpose of this study was twofold : to determine whether asymptomatic distance runners exhibit cortical tibial abnormalities on CT and to determine the diagnostic accuracy of CT in athletes with medial tibial stress syndrome . MATERIAL S AND METHODS A cross-sectional study with high-resolution CT of both tibiae was performed on 41 subjects : 20 asymptomatic distance runners , 11 distance runners with unilateral or bilateral pain due to medial tibial stress syndrome ( 14 painful tibiae ) , and 10 volunteers not involved in a sport . The group was composed of 13 women and 28 men , ranging in age from 18 to 26 years . A total of 82 tibiae , 14 painful and 68 painless , were evaluated . On the basis of CT findings , tibiae were classified in three groups , and correlation between CT classification and symptoms was made . RESULTS Among distance runners , the presence of CT abnormalities was found in 14 ( 100 % ) of 14 painful tibiae in patients with medial tibial stress syndrome and in 8 ( 16.6 % ) of 48 painless tibiae . The difference was statistically significant ( p < 0.001 , Fisher 's exact test ) . Sensitivity , specificity , positive predictive value , negative predictive value , and accuracy of CT in diagnosing medial tibial stress syndrome were 100 % , 88.2 % , 63.6 % , 100 % , and 90.2 % , respectively . CONCLUSION High-resolution CT has high diagnostic accuracy in depicting medial tibial stress syndrome . Cortical abnormalities can also be seen in some asymptomatic distance runners Purpose To identify the incidence of medial tibial stress syndrome ( MTSS ) in a group of naval recruits undergoing a 10-week basic training period and to determine potential risk factors . Method One hundred and twenty-four recruits ( 84 men and 40 women ) were followed prospect ively during basic training . Anthropometric and lower limb biomechanical data were recorded at the start of the program along with injury history and previous sporting activity for the 3 months prior to enlisting . Recruits were monitored during training for development of medial tibial strees syndrome and were asked to complete an exit interview at the end of the program . Results Forty recruits ( 22 men and 18 women ) developed medial tibial stress syndrome , giving an incidence of 35 % . A significant relationship existed between gender and medial tibial stress syndrome ( P= .012 ) , with female recruits more likely to develop medial tibial stress syndrome than male recruits ( 53 % vs 28 % ) . A risk estimate revealed a relative risk of 2.03 . The biomechanical results indicated a more pronated foot type ( P= .002 ) in the medial tibial stress syndrome group when compared to the control group . A risk estimate established that recruits with a more pronated foot type had a relative risk of 1.70 . Conclusion Identifying a pronated foot type prior to training may help reduce the incidence of medial tibial stress syndrome by early intervention to control abnormal pronation . Findings of a higher incidence of medial tibial stress syndrome among female recruits require further investigation Diagnosis and management strategies for shin splints in active duty military population s closely resemble those in civilian athletic population s. There is a paucity of evidence supporting the use of many of these interventions . The purpose of this study was to present data on the Shin Saver orthosis as a treatment for shin splints in an active duty military population and to review current condition management . Twenty-five subjects diagnosed with shin splints by a U.S. Army physical therapist were r and omly assigned to a shin orthosis treatment group or a control group . There was no significant difference between treatment and control groups in days to finish a 0.5-mile run pain free . Visual analog scales for pain at intake versus after 1 week of relative rest revealed no significant improvement in symptoms in either group . Current best- practice guidelines support a treatment program of rest , cryotherapy , and a graduated walk-to-run program Background Although the exact cause of medial tibial stress syndrome is unclear , changes in bone metabolism are likely to be involved . Hypothesis Localized low bone mineral density at the junction of the middle and distal thirds of the tibia in patients with medial tibial stress syndrome develops in conjunction with the symptoms ; these changes are reversible and are not inherited . Study Design Prospect i ve cohort study . Methods Bone mineral density in 14 adult male athletes with long-st and ing medial tibial stress syndrome was measured when they were symptomatic and after recovery ( mean follow-up , 5.7 years ) . Repeat measurements were also made prospect ively in 13 nonathlete control subjects and single measurements were made in 18 healthy athletes . Results Bone mineral density was 9 % ± 11 % higher in the proximal tibia but 11 % ± 12 % lower in the tibial region corresponding to pain in patients when compared with nonathlete control subjects . It increased by 19 % ± 11 % in the region of pain after recovery from symptoms and , at follow-up , was no lower than in nonathlete control subjects . Conclusion Athletes with medial tibial stress syndrome and increased scintigraphic uptake regain normal tibial bone mineral density after recovery from symptoms . Initially localized low bone mineral density is not an inherited condition , but instead may develop in conjunction with the symptoms \n Output:\n " }, { "from": "agent", "value": "Conclusion None of the studies are sufficiently free from method ological bias to recommend any of the treatments investigated .\nOf those examined , ESWT appears to have the most promise" } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: PURPOSE To determine whether macrophage colony-stimulating factor ( M-CSF ) reduces the incidence and duration of febrile neutropenia during three courses of intensive consolidation therapy and whether it shortens time to complete consolidation therapy . PATIENTS AND METHODS In 198 adult patients with acute myeloid leukemia ( AML ) in complete remission ( CR ) , M-CSF ( 8 x 10(6 ) U/d ) or placebo was administered from 1 day after the end of each consolidation chemotherapy for 14 days . RESULTS The duration and incidence of febrile neutropenia was significantly reduced by 34 % ( P = .00285 ) and 17 % ( P = .02065 ) , respectively , in 88 assessable patients in the M-CSF group compared with those in 94 assessable patients in the placebo group . Patients in the M-CSF group had 565 days and 133 episodes of febrile neutropenia during 7,901 days at risk , while patients in the placebo group had 977 days and 185 episodes during 9,077 days at risk . The median period required to finish the three courses of consolidation therapy was 93 days in the M-CSF group , which was significantly shorter than 110 days in placebo group ( P = .0050 ) . In the M-CSF group , the recovery of neutrophils and platelets was significantly faster ( P = .0348 and P = 0.0364 , respectively ) , the administration of systemic antimicrobial agents tended to be less ( P = .0839 ) , and the frequency of platelet transfusion ( P = .0259 ) and the total volume of transfused platelets ( P = .0292 ) were significantly less . However , there was no significant difference in the disease-free survival . CONCLUSION M-CSF significantly reduced the incidence and duration of febrile neutropenia during the intensive consolidation therapy , and shortened the time to complete consolidation chemotherapy in AML Prospect i ve studies have shown rapid engraftment using granulocyte-colony-stimulating factor-mobilized peripheral blood stem cells ( G-PBSCs ) for allogeneic transplantation , though the risks for graft-versus-host disease ( GVHD ) may be increased . It was hypothesized that the use of G-CSF to prime bone marrow ( G-BM ) would allow rapid engraftment without increased risk for GVHD compared with G-PBSC . Patients were r and omized to receive G-BM or G-PBSCs for allogeneic stem cell transplantation . The study was design ed ( beta < .8 ) to detect a difference in the incidence of chronic GVHD of 33 % ( alpha < .05 ) . The plan was to recruit 100 patients and to conduct an interim analysis when the 6-month follow-up point was reached for the first 50 patients . Fifty-seven consecutive patients were recruited ( G-BM , n = 28 ; G-PBSC , n = 29 ) . Patients in the G-PBSC group received 3-fold more CD34(+ ) and 9-fold more CD3(+ ) cells . Median times to neutrophil ( G-BM , 16 days ; G-PBSC , 14 days ; P < .1 ) and platelet engraftment ( G-BM , 14 days ; G-PBSC , 12 days ; P < .1 ) were similar . The use of G-PBSC was associated with steroid refractory acute GVHD ( G-BM , 0 % ; G-PBSC , 32 % ; P < .001 ) , chronic GVHD ( G-BM , 22 % ; G-PBSC , 80 % ; P < .02 ) , and prolonged requirement for immunosuppressive therapy ( G-BM , 173 days ; G-PBSC , 680 days ; P < .009 ) . Survival was similar for the 2 groups . Compared with G-PBSC , the use of G-BM result ed in comparable engraftment , reduced severity of acute GVHD , and less subsequent chronic GVHD The optimal induction for older adults with acute myeloid leukemia ( AML ) is unknown . Several anthracyclines have been proposed , but the data remain equivocal . Additionally , few prospect i ve trials of priming with hematopoietic growth factors to cycle leukemia cells prior to induction chemotherapy have been conducted . Three hundred and sixty-two older adults with previously untreated AML were r and omized to either daunorubicin , idarubicin or mitoxantrone with a st and ard dose of cytarabine as induction therapy . In addition , 245 patients were also r and omized to receive granulocyte-macrophage colony-stimulating factor ( GM-CSF ) or placebo beginning 2 days prior to induction chemotherapy and continuing until marrow aplasia . No difference was observed in the disease-free overall survival or in toxicity among patients receiving any of the 3 induction regimens or among those receiving growth factor or placebo for priming . However , the complete remission rate for the first 113 analyzable patients , who did not participate in the priming study and started induction therapy 3 to 5 days earlier than those who did , was significantly higher ( 50 % versus 38 % ; P = .03 ) . None of the anthracyclines is associated with improved outcome in older adults . Priming with hematopoietic growth factor did not improve response when compared with placebo . Furthermore , delaying induction therapy in older adults may lead to a lower complete remission rate In an attempt to improve induction chemotherapy for older patients with acute myeloid leukemia (AML),1314 patients were r and omized to 1 of 3 induction treatments for 2 courses of DAT ( daunorubicin , cytarabine , and thioguanine ) 3 + 10 , ADE ( daunorubicin , cytarabine , and etoposide ) 10 + 3 + 5 , or MAC ( mitoxantrone-cytarabine ) . The remission rate in the DAT arm was significantly better than ADE ( 62 % vs 50 % ; P = .002 ) or MAC ( 62 % vs 55 % ; P = .04 ) . This benefit was seen in patients younger and older than 70 years . There were no differences between the induction schedules with respect to overall survival at 5 years ( 12 % vs 8 % vs 10 % ) . A total of 226 patients were r and omized to receive granulocyte colony-stimulating factor ( G-CSF ) or placebo as supportive care from day 8 after the end of treatment course 1 . The remission rate or survival were not improved by G-CSF , although the median number of days to recover neutrophils to 1.0 x 10(9)/L was reduced by 5 days . Patients who entered remission ( n = 371 ) were r and omized to stop after a third course ( DAT 2 + 7 ) or after 6 courses , ie , a subsequent COAP ( cyclophosphamide , vincristine , cytarabine , and prednisolone ) , DAT 2 + 5 , and COAP . The relapse risk ( 81 % vs 73 % ) , disease-free survival ( 16 % vs 23 % ) , and overall survival at 5 years ( 23 % vs 22 % ) did not differ between the 3-course or 6-course arms . In addition to a treatment duration r and omization , 362 patients were r and omized to receive 12-month maintenance treatment with low-dose interferon , but no benefit was seen with respect to relapse risk , disease-free survival , or overall survival Background : This study was performed to examine the feasibility and toxicity of the combination of mitoxantrone , fludarabine , cytarabine as bolus ( B ) or continuous infusion ( CI ) and granulocyte- colony stimulating factor ( G-CSF ) in patients with recurrent and refractory acute myeloid leukemia ( AML ) . Patients and Methods : 29 patients with relapsed ( n = 17 ) or refractory ( n = 12 ) AML were treated with the Mito-FLAG protocol consisting of mitoxantrone ( 7 mg/m2 , days 1/3/5 ) , fludarabine ( 15mg/m2 , every 12 h , days 1–5 ) , cytarabine ( Ara-C ) as bolus infusion ( 1000 mg/m2 over 1 h , every 12 h , days 1–5 ) ( n = 15 ) or as continuous infusion ( 100–150 mg/m2 over 24 h , days 1–5 ) ( n = 14 ) , and G-CSF ( 5 µg/ kg/day , day 0 until a neutrophile count of 0.5 ×109/l ) . Results : 17 patients ( 59 % ) and 1 patient ( 3 % ) achieved complete remission ( CR ) and partial remission ( PR ) , respectively ; thus the overall response rate was 62 % . Following Mito-FLAG , 5 patients with CR underwent high-dose therapy ( HDT ) with allogeneic ( n = 2 ) or autologous ( n = 3 ) stem cell transplantation (SCT).With a median follow-up of 28 ( range 6–54 ) months , 4 transplanted patients are alive in CR ( n = 2 ) or in relapse ( n = 2 ) . The median duration of event-free survival ( EFS ) and overall survival ( OS ) was 3.2 and 6.8 months , and probabilities of EFS and OS after 1 year were 14 and 34 % , respectively . The 1-year rates for EFS and OS in this group were 18 and 53 % , respectively . Median duration of WHO grade 4 granulocytopenia and thrombocytopenia was 20 and 23 days , respectively . Nonhematological side effects were moderate , predominantly reaching WHO grade s 1–2 . Neutropenic fever was seen in 85 % of courses , with a median duration of 4 ( 1–38 ) days . Four patients ( 14 % ) suffered an early death because of aplasia ( n = 2 ) , pneumonia ( n = 1 ) or progressive AML ( 1 nonresponding patient ) . Conclusions : Our data suggest that the Mito-FLAG protocol is feasible and can be safely performed with both schedules of Ara-C. In this study the regimens have shown high efficacy and acceptable toxicity in patients with relapsed or refractory AML . We currently examine the importance of bolus versus continuous infusion of Ara-C as part of the Mito-FLAG regimen in a prospect i ve r and omized multicenter trial The role of glycosylated recombinant human granulocyte colony-stimulating factor ( G-CSF ) in the induction treatment of older adults with acute myeloid leukemia ( AML ) is still uncertain . In this trial , a total of 722 patients with newly diagnosed AML , median age 68 years , were r and omized into 4 treatment arms : ( A ) no G-CSF ; ( B ) G-CSF during chemotherapy ; ( C ) G-CSF after chemotherapy until day 28 or recovery of polymorphonuclear leukocytes ; and ( D ) G-CSF during and after chemotherapy . The complete remission ( CR ) rate was 48.9 % in group A , 52.2 % in group B , 48.3 % in group C , and 64.4 % in group D. Analysis according to the 2 x 2 factorial design indicated that the CR rate was significantly higher in patients who received G-CSF during chemotherapy ( 58.3 % for groups B + D vs 48.6 % for groups A + C ; P = .009 ) , whereas no significant difference was observed between groups A + B and C + D ( 50.6 % vs 56.4 % , P = .12 ) . In terms of overall survival , no significant differences were observed between the various groups . Patients who received G-CSF after chemotherapy had a shorter time to neutrophil recovery ( median , 20 vs 25 days ; P < .001 ) and a shorter hospitalization ( mean , 27.2 vs 29.7 days ; P < .001 ) . We conclude that although priming with G-CSF can improve the CR rate , the use of G-CSF during and /or after chemotherapy has no effect on the long-term outcome of AML in older patients St and ard intensive induction therapy is tolerated poorly by elderly patients with acute myeloblastic leukemia ( AML ) . We treated 19 elderly patients with AML , including seven with a prior myelodysplastic syndrome ( MDS ) with a combination of low dose cytarabine , hydroxyurea , and GM‐CSF . The percentage of blasts in S‐phase was evaluated prior to and 24 hr after starting the GM‐CSF infusion . Cell cycle analysis was performed by flow cytometry using propidium iodine staining with fluorescein isothiocyanate‐conjugated monoclonal antibody to the myeloid antigen CD 33 The role of granulocyte colony stimulating factor ( G‐CSF ) as supportive therapy following intensive induction chemotherapy for acute myeloid leukaemia ( AML ) in adults was investigated in a r and omized trial . G‐CSF ( Lenograstim , 263 μg/d ) or placebo was administered from day 8 after the end of chemotherapy until neutrophil recovery to 0·5 × 109/l ( or for up to 10 d ) . Eight hundred and three patients were entered . Neutrophil recovery was quicker with G‐CSF ( P < 0 \n Output:\n " }, { "from": "agent", "value": "In summary , colony-stimulating factors should not be given routinely to acute myelogenous leukemia patients post-chemotherapy since they do not affect overall survival or infectious parameters including the rate of bacteremias and invasive fungal infections" } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: The determination of anticarious effects of topically administered fluorine compounds is usually based on short-time cross-sectional or longitudinal studies . In a comparison made for a period of more than seven years the anticarious effects of amine fluorides administered to selected groups of test subjects have been studied under controlled clinical experimental conditions The purpose of the present study was to evaluate the effect of fluoride upon the stain-inducing capacity of chlorhexidine . Ninety-one children , 13 years of age , volunteered for the experiment . Three test dentifrices were used , containing 0.1 % NaF , 0.1 % NaF + 2 % chlorhexidine , and 2 % chlorhexidine respectively . The experiment was carried out as a double-blind test , and the degree of staining was recorded after 1 and 2 years . Four methods were used for stain scoring . The results after 1 year showed that chlorhexidine induced less stain when applied together with fluoride than when applied alone . After 2 years this difference disappeared , indicating that fluoride only retarded chlorhexidine-induced staining of teeth A double-blind , clinical trial involving 923 children and extending over 4 years was carried out on the Isle of Wight . It investigated the additional protection against dental caries result ing when Aluminum salts have demonstrated anticaries activity in a number of laboratory and animal studies . The aim of this double-blind , pilot , clinical trial was to evaluate the effect of an alum ( Al ) mouthrinse on dental caries formation both by itself and in combination with an ADA-approved sodium fluoride ( F ) dentifrice . A total of 260 caries-prone children residing in a low-F area were preselected for the study and scored independently for caries by two experienced examiners . After using gender , age , and initial DMFT(S ) scores for baseline stratification , the subjects were assigned to one of three treatment regimens : ( 1 ) placebo mouthrinse and F dentifrice , ( 2 ) Al mouthrinse and placebo dentifrice , and ( 3 ) Al mouthrinse and F dentifrice . The alum mouthrinse contained 500 ppm Al and the sodium fluoride dentifrice contained 1100 ppm F. Rinsing was supervised at school on weekdays for 30 sec/day , while the dentifrices were used ad libitum at home . Subjects were reexamined for caries and oral health after six and twelve months . Both examiners found that children who used Al mouthrinse , in conjunction with either placebo or F dentifrices , had lower caries incidence than those who used placebo mouthrinse/F dentifrice combination ; but the differences were statistically significant for only one of the examiners . No evidence of deleterious effects to the oral tissues was observed . The results of this pilot clinical trial demonstrated that daily supervised use of an alum mouthrinse inhibited caries development in decay-prone children at least as effectively as a F dentifrice A r and omized , double blind clinical trial of the caries inhibition effects of dentifrices containing respectively monofluorophosphate and amine fluoride was performed . A third control group used a toothpaste without fluoride . A total number of 2008 schoolchildren ranging in age from 6 to 8 years and living in Strasbourg ( France ) participated in this study . After a baseline examination three groups were constructed with the block r and omization technic . The caries inhibition effects of the three dental pastes were compared after 3 years of unsupervised use . The monofluorophosphate dentifrice showed a reduction of 7.02 % for DMFT , 5.17 % for DMFS and 25.26 % for the df rate . The reduction of amine fluoride dentifrice caries was respectively 21.62 % for DMFT , 20.94 % for DMFS and 48.66 % for the df rate This study aim ed to determine whether incidence density ( ID ) calculations of caries incidence rates would provide a more sensitive means of detecting caries – preventive effects than would traditional techniques . A secondary analysis was conducted using data from a 1981 study in which three dentifrices were compared in a double – blind r and omized clinical trial . Subjects were examined at baseline and 1 , 2 and 3 years after baseline . Three – year DMFS increments were calculated for 1,754 subjects attending the baseline and 3–year examinations . Caries ID rates then were calculated for 2,661 subjects who had at least two examinations , using each surface 's net increment ( –1 , 0 or + 1 ) as the numerator and the surface 's time at risk as the denominator . Despite theoretical advantages , the ID method did not alter the conclusions drawn using DMFS increments , apparently because ( a ) subjects lost to follow – up were similar to those completing the study , and ( b ) loss to follow – up was similar among treatment groups The effect of reducing the abrasivity of toothpaste on dental caries was observed in a 3-year clinical trial involving 1106 11 - 13-year-old Berkshire schoolchildren were divided into three groups ; Group 1 were allocated a low abrasivity paste containing 0.8 % sodium monofluorophosphate , Group 2 a paste of conventional abrasivity also containing 0.8 % sodium monofluorophosphate and Group 3 a low abrasivity non-fluoride paste . After 3 years the net DMFS increments ( clinical and radiographic scores combined ) were 4.22 in Group 1 , 4.72 in Group 2 and 6.43 in Group 3 . The differences between Groups 1 and 3 and between Groups 2 and 3 were highly significant ( P less than 0.001 ) . The mean increment in Group 1 was lower than in Group 2 but did not reach statistical significance . Reducing the abrasivity of the toothpaste had no meaningful effect on the st and ard of oral hygiene and prevalence of gingivitis as measured by the Gingival and Plaque Indices In a 3-year , 4-year and 5-year studies , the authors tested clinical ly and radiographically the caries-inhibiting efficiency of topically applied amine fluoride in defined groups ( fluoride group with Elmex fluid and Elmex tooth-paste for unsupervised dental and oral hygiene at home , placebo group and control group ) . After the fifth study year , the caries increment in the children who were 11 years of age at this time had decreased by 30.6 % ( DMF/T index ) and 32.1 % ( DMF/S index ) OBJECTIVE To examine the effect of reported toothbrushing frequency and method of rinsing after brushing on caries experience and increment . METHODS Data are presented from 2621 adolescents ( mean age 12.5 years at outset ) participating in a 3-year double-blind caries clinical trial . At baseline , examiners question ed each participant about their toothbrushing habits , and at subsequent examinations , this information was obtained using a self-administered computer-based question naire . Participants used a fluoride-containing dentifrice throughout and clinical examinations were conducted using a mirror , CPITN probe and fibre-optic transillumination . RESULTS The reported brushing frequency increased throughout the trial . Caries experience at baseline was inversely related to toothbrushing frequency with mean DMFS=9.66 , 8.12 and 7.63 respectively for < 1/day , 1/day and > 1/day brushers ( P<0.001 ) . Mean 3-year DMFS increments of 8.90 , 6.63 and 5.48 ( P<0.01 ) were observed in those reporting to brush < 1/day , 1/day or > 1/day , on not less than two of the three clinical examinations during the trial . Caries increment was also significantly related to the cl aim ed method used to rinse post-brushing . Overall frequency of brushing and rinsing method accounted for over 50 % of the explained variance in the ANOVA model used to analyse the DMFS increments . CONCLUSIONS Stated toothbrushing frequency and rinsing method after brushing were found to be strongly correlated with caries experience and caries increment . These factors should be reflected in the design of oral health education material and taken into account in the design and analysis of caries clinical trials The purpose of this double blind clinical trial was to determine the anticaries activity of a dentifrice containing 0.78 % sodium monofluorophosphate in a silica gel abrasive base compared with a placebo under conditions of supervised brushing . 1154 schoolchildren , ages 9 - 12 , were recruited in a non-fluori date d semi-rural area of northeastern Connecticut . Subjects were stratified according to school , grade and sex , and then r and omly divided into two groups . Each school day , children brushed their teeth for 1 min under supervision by project personnel . Weekend and vacation usage was ad libitum . Caries examinations and radiographic readings were performed by the same examiner ( J.R. ) . After 12 months , the 996 subjects examined showed that the group using the test dentifrice had significantly ( less than 0.05 ) lower DMFT ( 25.0 % ) and DMFS ( 19.1 % ) increments than the group using the placebo . After 24 months the 876 subjects examined showed that the test group continued to have significantly lower DMFT ( 24.5 % ) and DMFS ( 24.7 % ) increments than the placebo group . Surface protection after 24 months ranged from 22.1 % for occlusal to 37.1 % for interproximal surfaces The relationship between oral hygiene and dental caries incidence in 11-year-old children . A 3-year R and om tests made in school children of the Ludwigsburg district showed that after 3 years of uncontrolled use , the number of new DMF surfaces is smaller in children using Na2PO3F toothpaste and regularly cleaning their teeth than in the corresponding placebo groups . The caries-inhibiting effect was statistically significant ( significance level p=0.05 % ) . The increase in caries impact in school children regularly but insufficiently cleaning their teeth was also significant in the placebo groups AN important part of research in clinical dentistry /~ is to measure the effect of agents used in the prevention of dental caries . This is achieved by the use of the controlled clinical trial . In conducting a clinical trial of a caries preventive agent , the investigator wishes to make an unbiased assessment of its effect on the greatest number of individuals possible , within the limitations of available re sources . It is of primary importance to be able to measure this effect in numerical terms . This enables a comparison to be made between the new agent and established procedures , and gives an indication of the reduction in clinical treatment loads which might result from its use in a public health programme , and ultimately the cost benefit which might be expected . The investigator tries to assess therefore , by how much dental decay will be reduced by the agent , in comparison with the amount which would be likely to occur if it were not used . The measurement of the agent ’s effect is achieved by selecting a test and a control group of subjects . If the test group receives the agent , and the control group receives either nothing at all , or preferably , an inactive substitute , it will be possible , over the course of time , to compare the differences between the groups in the amount of decay which is observed . The amount of dental decay which occurs during the trial represents the ’ caries increment ’ over the period , and must be determined separately for each group . Caries increment is usually measured by the DMF Index , which is basically a count of the number of teeth in the mouth which are decayed , plus the number A 3-year clinical trial was carried out in France just after fluoride toothpaste was allowed to be sold on the mass market . The aim was to assess the caries preventive effect of a toothpaste containing the maximum fluoride level permitted by the EEC ( 1.2 % SMFP ) . The trial started with 1318 10 - 12-yr-old children from a wide socioeconomic background in a typical French community . Test toothpaste was given to 659 children whereas the remaining 659 children obtained the same toothpaste without the fluoride additive . The brushing was unsupervised and performed by the children at home . Dental caries was assessed by clinical and radiographic examinations . 1061 children completed the trial . An interview carried out at the final examination identified a group of 116 uncooperative children ( less than five brushings a week on average ) who were not included in the statistical analysis . The following mean reductions were found : 26 % for DMFT , 27 % for DMFS , and 39 % for DMFSU . The DMFS index for approximal , buccal-lingual and occlusal surfaces showed caries reductions of 32 % , 25 % , and 22 % , respectively . The trial demonstrated a highly significant effectiveness of the 1.2 % SMFP toothpaste in a French population Prior to the start of the present investigation , 578 children in the 10–12 year age-group in Ballerup-Malov municipality ( a suburban area near Copenhagen ) had participated in a 30-months investigation of the caries-inhibiting effect of a dentifrice containing sodium monofluorophosphate . At the end of this 30-month study , a group of 172 children , selected at r and om , were examined for incidence of plaque and gingivitis . At this point the supervised toothbrushing at school ceased , as did the supplying of dentifrice to the families . One year later ( i.e. 42 months after the start of the basic experiment ) , the children were re-examined . The results of the investigation led to the following conclusions : 1 . The incidence of plaque and gingivitis was identical in the fluoride group and the control group at both first and second examination . This suggests that using a dentifrice containing sodium monofluorophosphate - up to three times a day - for 30 months does not increase the incidence of plaque or gingivitis in children . 2 . At the time of the second examination ( \n Output:\n " }, { "from": "agent", "value": "The effect of fluoride toothpaste increased with higher baseline levels of D(M)FS , higher fluoride concentration , higher frequency of use , and supervised brushing , but was not influenced by exposure to water fluoridation .\nThere is little information concerning the deciduous dentition or adverse effects ( fluorosis ) .\nREVIEW ER 'S CONCLUSIONS Supported by more than half a century of research , the benefits of fluoride toothpastes are firmly established .\nTaken together , the trials are of relatively high quality , and provide clear evidence that fluoride toothpastes are efficacious in preventing caries" } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: BACKGROUND Previous , uncontrolled studies have suggested that first-line treatment with gefitinib would be efficacious in selected patients with non-small-cell lung cancer . METHODS In this phase 3 , open-label study , we r and omly assigned previously untreated patients in East Asia who had advanced pulmonary adenocarcinoma and who were nonsmokers or former light smokers to receive gefitinib ( 250 mg per day ) ( 609 patients ) or carboplatin ( at a dose calculated to produce an area under the curve of 5 or 6 mg per milliliter per minute ) plus paclitaxel ( 200 mg per square meter of body-surface area ) ( 608 patients ) . The primary end point was progression-free survival . RESULTS The 12-month rates of progression-free survival were 24.9 % with gefitinib and 6.7 % with carboplatin-paclitaxel . The study met its primary objective of showing the noninferiority of gefitinib and also showed its superiority , as compared with carboplatin-paclitaxel , with respect to progression-free survival in the intention-to-treat population ( hazard ratio for progression or death , 0.74 ; 95 % confidence interval [ CI ] , 0.65 to 0.85 ; P<0.001 ) . In the subgroup of 261 patients who were positive for the epidermal growth factor receptor gene ( EGFR ) mutation , progression-free survival was significantly longer among those who received gefitinib than among those who received carboplatin-paclitaxel ( hazard ratio for progression or death , 0.48 ; 95 % CI , 0.36 to 0.64 ; P<0.001 ) , whereas in the subgroup of 176 patients who were negative for the mutation , progression-free survival was significantly longer among those who received carboplatin-paclitaxel ( hazard ratio for progression or death with gefitinib , 2.85 ; 95 % CI , 2.05 to 3.98 ; P<0.001 ) . The most common adverse events were rash or acne ( in 66.2 % of patients ) and diarrhea ( 46.6 % ) in the gefitinib group and neurotoxic effects ( 69.9 % ) , neutropenia ( 67.1 % ) , and alopecia ( 58.4 % ) in the carboplatin-paclitaxel group . CONCLUSIONS Gefitinib is superior to carboplatin-paclitaxel as an initial treatment for pulmonary adenocarcinoma among nonsmokers or former light smokers in East Asia . The presence in the tumor of a mutation of the EGFR gene is a strong predictor of a better outcome with gefitinib . ( Clinical Trials.gov number , NCT00322452 . Purpose : Patients with epidermal growth factor receptor (EGFR)-mutant lung adenocarcinoma develop acquired resistance to EGFR tyrosine kinase inhibitors ( TKI ) after a median of 10 to 16 months . In half of these cases , a second EGFR mutation , T790 M , underlies acquired resistance . We undertook this study to examine the clinical course of patients harboring the T790 M mutation following progression on TKI . Experimental Design : EGFR-mutant lung cancer patients with acquired resistance to EGFR TKIs were identified as part of a prospect i ve rebiopsy protocol in which postprogression tumor specimens were collected for molecular analysis . Postprogression survival and characteristics of disease progression were compared in patients with and without T790 M . Results : We identified T790 M in the initial rebiopsy specimens from 58 of 93 patients ( 62 % , 95 % CI : 52–72 ) . T790 M was more common in biopsies of lung/pleura tissue and lymph nodes than in more distant sites ( P = 0.014 ) . Median postprogression survival was 16 months ( interquartile range = 9–29 months ) ; patients with T790 M had a significantly longer postprogression survival ( P = 0.036 ) . Patients without T790 M more often progressed in a previously uninvolved organ system ( P = 0.014 ) and exhibited a poorer performance status at time of progression ( P = 0.007 ) . Conclusions : Among patients with acquired resistance to EGFR TKIs , the presence of T790 M defines a clinical subset with a relatively favorable prognosis and more indolent progression . Knowledge of T790 M status is therefore important both for the clinical care of these patients and for the optimal design and interpretation of clinical trials in this setting . Clin Cancer Res ; 17(6 ) ; 1616–22 . © 2010 AACR Purpose : Whether bevacizumab enhances the effect of the epidermal growth factor receptor ( EGFR ) inhibitor gefitinib on EGFR mutant non – small cell lung cancers ( NSCLCs ) remains unknown . We conducted a phase II trial to investigate the efficacy and safety of gefitinib when combined with bevacizumab as first-line therapy in patients with advanced NSCLC harboring EGFR gene mutations . Methods : In this trial , 42 patients with a performance status of 0 to 2 received gefitinib ( 250 mg/d ) and bevacizumab ( 15 mg/kg , every 3 weeks ) . The primary end point of this study was the 1-year progression-free survival ( PFS ) rate . We assumed that a 1-year PFS rate of 55 % would indicate potential usefulness and that a 1-year PFS rate of 40 % would constitute the lower limit of interest . Results : Forty-two patients were enrolled in the study with a median age of 73 ( range 42–86 ) years . Activating EGFR gene mutations included exon 19 deletion ( 57 % ) and L858R point mutations in exon 21 ( 38 % ) . The objective response rate was 73.8 % and included two complete responses . The 1-year PFS rate and median PFS time were 56.7 % ( 95 % confidence interval [ CI ] 39.9–70.5 ) and 14.4 months ( 95 % CI 10.1–19.2 ) , respectively . The median PFS differed significantly between EGFR exon 19 deletion and the L858R point mutation ( 18.0 versus 9.4 months , respectively ; p = 0.006 ) . The median overall survival had not yet been reached . Severe adverse events included grade 3 skin rash ( 15 % ) , hypertension ( 17 % ) , aspartate transaminase/alanine aminotransferase elevation ( 17 % ) , proteinuria ( 7 % ) , intracranial hemorrhage ( 2 % ) , and grade 4 perforation of the digestive tract ( 2 % ) . There were no treatment-related deaths . Conclusion : Gefitinib in combination with bevacizumab as first-line therapy seems to be a favorable and well-tolerated treatment for patients with advanced NSCLC with activating EGFR gene mutations , especially those with EGFR exon 19 deletion mutations , although the primary end point was not met because the lower limit of the CI was less than 40 % BACKGROUND NEJ002 study , comparing gefitinib with carboplatin ( CBDCA ) and paclitaxel ( PTX ; Taxol ) as the first-line treatment for advanced non-small cell lung cancer ( NSCLC ) harboring an epidermal growth factor receptor ( EGFR ) mutation , previously reported superiority of gefitinib over CBDCA/PTX on progression-free survival ( PFS ) . Subsequent analysis was carried out mainly regarding overall survival ( OS ) . MATERIAL S AND METHODS For all 228 patients in NEJ002 , survival data were up date d in December , 2010 . Detailed information regarding subsequent chemotherapy after the protocol treatment was also assessed retrospectively and the impact of some key drugs on OS was evaluated . RESULTS The median survival time ( MST ) was 27.7 months for the gefitinib group , and was 26.6 months for the CBDCA/PTX group ( HR , 0.887 ; P=0.483 ) . The OS of patients who received platinum throughout their treatment ( n=186 ) was not statistically different from that of patients who never received platinum ( n=40 ) . The MST of patients treated with gefitinib , platinum , and pemetrexed ( PEM ) or docetaxel ( DOC , Taxotere ; n=76 ) was around 3 years . CONCLUSIONS No significant difference in OS was observed between gefitinib and CBDCA/PTX in the NEJ002 study , probably due to a high crossover use of gefitinib in the CBDCA/PTX group . Considering the many benefits and the risk of missing an opportunity to use the most effective agent for EGFR-mutated NSCLC , the first-line gefitinib is strongly recommended BACKGROUND Activating mutations in EGFR are important markers of response to tyrosine kinase inhibitor ( TKI ) therapy in non-small-cell lung cancer ( NSCLC ) . The OPTIMAL study compared efficacy and tolerability of the TKI erlotinib versus st and ard chemotherapy in the first-line treatment of patients with advanced EGFR mutation-positive NSCLC . METHODS We undertook an open-label , r and omised , phase 3 trial at 22 centres in China . Patients older than 18 years with histologically confirmed stage IIIB or IV NSCLC and a confirmed activating mutation of EGFR ( exon 19 deletion or exon 21 L858R point mutation ) received either oral erlotinib ( 150 mg/day ) until disease progression or unacceptable toxic effects , or up to four cycles of gemcitabine plus carboplatin . Patients were r and omly assigned ( 1:1 ) with a minimisation procedure and were stratified according to EGFR mutation type , histological subtype ( adenocarcinoma vs non-adenocarcinoma ) , and smoking status . The primary outcome was progression-free survival , analysed in patients with confirmed disease who received at least one dose of study treatment . The trial is registered at Clinical Trials.gov , number NCT00874419 , and has completed enrolment ; patients are still in follow-up . FINDINGS 83 patients were r and omly assigned to receive erlotinib and 82 to receive gemcitabine plus carboplatin ; 82 in the erlotinib group and 72 in the chemotherapy group were included in analysis of the primary endpoint . Median progression-free survival was significantly longer in erlotinib-treated patients than in those on chemotherapy ( 13.1 [ 95 % CI 10.58 - 16.53 ] vs 4.6 [ 4.21 - 5.42 ] months ; hazard ratio 0.16 , 95 % CI 0.10 - 0.26 ; p<0.0001 ) . Chemotherapy was associated with more grade 3 or 4 toxic effects than was erlotinib ( including neutropenia in 30 [ 42 % ] of 72 patients and thrombocytopenia in 29 [ 40 % ] patients on chemotherapy vs no patients with either event on erlotinib ) ; the most common grade 3 or 4 toxic effects with erlotinib were increased alanine aminotransferase concentrations ( three [ 4 % ] of 83 patients ) and skin rash ( two [ 2 % ] patients ) . Chemotherapy was also associated with increased treatment-related serious adverse events ( ten [ 14 % ] of 72 patients [ decreased platelet count , n=8 ; decreased neutrophil count , n=1 ; hepatic dysfunction , n=1 ] vs two [ 2 % ] of 83 patients [ both hepatic dysfunction ] ) . INTERPRETATION Compared with st and ard chemotherapy , erlotinib conferred a significant progression-free survival benefit in patients with advanced EGFR mutation-positive NSCLC and was associated with more favourable tolerability . These findings suggest that erlotinib is important for first-line treatment of patients with advanced EGFR mutation-positive NSCLC . FUNDING F Hoffmann-La Roche Ltd ( China ) ; Science and Technology Commission of Shanghai Municipality BACKGROUND Non-small-cell lung cancer with sensitive mutations of the epidermal growth factor receptor ( EGFR ) is highly responsive to EGFR tyrosine kinase inhibitors such as gefitinib , but little is known about how its efficacy and safety profile compares with that of st and ard chemotherapy . METHODS We r and omly assigned 230 patients with metastatic , non-small-cell lung cancer and EGFR mutations who had not previously received chemotherapy to receive gefitinib or carboplatin-paclitaxel . The primary end point was progression-free survival ; secondary end points included overall survival , response rate , and toxic effects . RESULTS In the planned interim analysis of data for the first 200 patients , progression-free survival was significantly longer in the gefitinib group than in the st and ard-chemotherapy group ( hazard ratio for death or disease progression with gefitinib , 0.36 ; P<0.001 ) , result ing in early termination of the study . The gefitinib group had a significantly longer median progression-free \n Output:\n " }, { "from": "agent", "value": "Conclusions : In patients with advanced NSCLC harbouring exon 19 deletions , TKIs are associated with better OS compared with conventional chemotherapy ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: The purpose of this in vitro biomechanical study is to determine the force attenuation capacity of four different hip protectors ( KPH1 , KPH2 , Safehip , and Safetypants ) in falling simulations in elderly subjects ( falls to the side ) . The simulated falling conditions were created by a biomechanical testing system , which consisted of an impact pendulum , surrogate pelvis and femur , and two load cells . Three series of impact experiments were conducted in an ascending order ( low , moderate- , and high-force experiments ) , each exceeding the literature -provided average ( + /- 1 SD ) fracture threshold ( 3100 + /- 1200 N ) of the proximal femur of elderly women with a mean age of 71 years . Using a low impact force of 4330 N , the trochanteric soft tissue ( 20-mm-thick polyethylene foam ) attenuated the peak femoral impact force to 3740 N and , accordingly , the KPH1 protector to 590 N , KPH2 to 510 N , Safehip to 1080 N , and Safetypants to 790 N. Thus , in this low force experiment , all tested protectors could reduce the peak impact force entered into the proximal femur below the aforementioned average fracture threshold area ( 3100 + /-1200 N ) of the proximal femur of elderly women . With a moderate impact force of 7230 N , the soft tissue attenuated the peak femoral impact force to 6130 N , and the protectors to 780 N , 760 N , 2240 N , and 2760 N , respectively . Thus , with this impact force , only the KPH hip protectors could reduce the impact force clearly below the fracture threshold area . In the final series of the experiment , the peak femoral impact force was set to be so high ( 10,840 N ) that the protector , if effective , should prevent the hip fracture in almost all cases and situations . The trochanteric soft tissue attenuated this peak impact force to 9190 N , and the tested protectors to 1360 N , 1170 N , 4640 N , and 5770 N. Thus , with the KPH protectors the force received by the proximal femur remained below the average force required to fracture the proximal femur of elderly women , whereas with the two other protectors the impact force entered into the proximal femur clearly exceeded this threshold value . In conclusion , the test results showed that , of the four tested hip protectors , the anatomically design ed energy-shunting and energy-absorbing KPH protectors can provide an effective impact force attenuation in a sideways-fall simulation in the elderly , whereas the force attenuation capacity of the two other protectors seems more limited . However , the true efficacy of any protector in the prevention of hip fractures can only be evaluated in r and omized clinical trials R and omized trials in which the unit of r and omization is a community , worksite , school or family are becoming widely used in the evaluation of life-style interventions for the prevention of disease . The increasing interest in adopting a cluster r and omization design is being matched by rapid method ological developments . In this paper we describe several of these developments . Brief mention is also made of issues related to economic analysis and to the planning and conduct of meta-analyses for cluster r and omization trials . Recommendations for reporting are also discussed OBJECTIVES To investigate the effect of use of external hip protectors on occurrence of hip fracture . DESIGN R and omized controlled trial , with r and omization at the individual level . SETTING residential aged-care facilities in urban areas of New South Wales , Australia . PARTICIPANTS 174 women , aged 75 years and older , who had had two or more falls or one fall requiring hospital admission in the previous 3 months , and who lived in hostels or nursing homes . Eighty-six subjects were in the intervention group and 88 in the control group . INTERVENTION Use of external hip protectors and encouragement by nurses to use the protectors . MEASUREMENTS Follow-up visits at approximately 2 weeks and 2 , 10 and 18 months to determine falls and fall injury ( including hip fracture ) ; we also measured adherence to hip protector use . RESULTS The mean age of participants was 85 ; they lived in 32 different aged-care facilities , two-thirds of which were nursing homes . Intervention and control groups had similar baseline characteristics , with a mean Barthel index of 58 at enrollment and a mean Short Portable Mental Status Question naire score of six errors , indicating severe disability and major cognitive impairment . During follow-up , a mean of 4.6 falls per person occurred . There was no difference in mortality , with 28 deaths in each group . Eight hip fractures occurred in the intervention group and seven in the control group ( hazard ratio 1.46 ; 95 % confidence interval 0.53 - 4.51 ) . No hip fractures occurred when hip protectors were being worn as directed . Adherence was about 57 % over the duration of the study and hip protectors were worn at the time of 54 % of falls in the intervention group . Adherence varied markedly between institutions , but the greatest was about 80 % . CONCLUSION Hip protectors were not effective in reducing the incidence of hip fractures in this study , but because of low statistical power , a reduction in risk of hip fracture of up to 50 % may not have been detected . There was limited adherence with their use , result ing in a large number of falls occurring without hip protectors in place . All hip fractures in the intervention group occurred when hip protectors were not being used Abstract : A method to protect the hips during falls could effectively reduce the incidence of hip fractures . We report the results of the first hip protector trial in Japan , performed between July 1996 , and September 1999 . One hundred and sixty-four elderly female residents of nursing homes , with Activities of Daily Living above the wheelchair level , agreed to participate in this study . Among them , 88 were r and omly selected to wear a hip protector and 76 controls did not . All falls and result ing injuries were recorded daily . In anthropometric measurements and ultrasonic bone evaluation , no significant differences were found between the two groups , except in height . During an average of 377 days , the wearers and the non-wearers fell a total of 131 and 90 times , respectively . Among the wearers , there were two non-hip fractures and one hip fracture , so the annual hip fracture rate was calculated at 1.2 % , against 8 hip fractures among the non-wearers , or 9.7 % per year . The hip fracture rate was significantly lower among the wearers than non-wearers , while the annual number of falls per subject and the distribution of fallers remained the same . According to Cox ’s proportional hazard regression analysis , the effect of the hip protector on hip fracture prevention was independent of anthropometric data , ultrasonic bone assessment values or number of falls . Moreover , even after limiting the subjects to fallers only , the annual hip fracture rate in non-wearers was higher than in wearers ( 19.8 % vs 2.0 % ) and the annual hip fracture rate per fall in wearers was lower than that in non-wearers ( 0.8 % vs 8.2 % ) . It was thus concluded that the hip protector is a beneficial device for the prevention of hip fractures OBJECTIVES To evaluate the effectiveness of a multifaceted , nonpharmaceutical intervention on incidence of falls and fallers . DESIGN Prospect i ve , cluster-r and omized , controlled 12-month trial . SETTING Six community nursing homes in Germany . PARTICIPANTS Long-stay residents ( n = 981 ) aged 60 and older ; mean age 85 ; 79 % female . INTERVENTIONS Staff and resident education on fall prevention , advice on environmental adaptations , progressive balance and resistance training , and hip protectors . MEASUREMENTS Falls , fallers , and fractures . RESULTS The incidence density rate of falls per 1,000 resident years ( RY ) was 2,558 for the control group ( CG ) and 1,399 for the intervention group ( IG ) ( relative risk ( RR ) = 0.55 , 95 % confidence interval ( CI ) = 0.41 - 0.73 ) . Two hundred forty-seven ( 52.3 % ) fallers were detected in the CG and 188 ( 36.9 % ) in the IG ( RR = 0.75 , 95 % CI = 0.57 - 0.98 ) . The incidence density rate of frequent fallers ( > 2/year ) was 115 ( 24.4 % ) for the CG and 66 ( 13.0 % ) for the IG ( RR = 0.56 , 95 % CI = 0.35 - 0.89 ) . The incidence density rate of hip fractures per 1,000 RY was 39 for the CG and 43 for the IG ( RR = 1.11 , 95 % CI = 0.49 - 2.51 ) . Other fractures were diagnosed with an incidence density rate of 52 per 1,000 RY for CG and 41 per 1,000 RY for IG ( RR = 0.78 , 95 % CI = 0.57 - 1.07 ) . CONCLUSION The incidence density rate of falls and fallers differed considerably between the control and intervention groups . The study was underpowered to demonstrate a significant difference of hip or nonhip fractures . Because of a low fracture rate in both groups , the investigation of fracture rates would have required a larger sample size to detect an effect of the intervention CONTEXT Several r and omized controlled trials have been performed to examine the effectiveness of external hip protectors in reducing the incidence of hip fractures , but the results are controversial . OBJECTIVE To examine the effectiveness of hip protectors in reducing the incidence of hip fractures in an elderly high-risk population . DESIGN , SETTING , AND PARTICIPANTS R and omized controlled trial of elderly persons aged 70 years or older , who have low bone density , and are at high risk for falls . Participants lived in apartment houses for the elderly , homes for the elderly , and nursing homes in Amsterdam and surrounding areas in the Netherl and s. They were enrolled in the study between March 1999 and March 2001 ; the mean follow-up was 69.6 weeks . Of the 830 persons who were screened , 561 persons were enrolled . INTERVENTION External hip protector . Both groups received written information on bone health and risk factors for falls . MAIN OUTCOME MEASURE Time to first hip fracture . Survival analysis was used to include all participants for the time they participated . RESULTS In the intervention group , 18 hip fractures occurred vs 20 in the control group . Four hip fractures in the intervention group occurred while an individual was wearing a hip protector . At least 4 hip fractures in the intervention group occurred late at night or early in the morning . Both in univariate analysis ( log-rank P = .86 ) and in multivariate analysis ( hazard ratio [ HR ] , 1.05 ; 95 % confidence interval [ CI ] , 0.55 - 2.03 ) , no statistically significant difference between the intervention group and control group was found with regard to time to first hip fracture . In addition , the per protocol analysis in compliant participants did not show a statistically significant difference between the groups ( HR , 0.77 ; 95 % CI , 0.25 - 2.38 ) . CONCLUSION The hip protector studied was not effective in preventing hip fractures Abstract : Hip fracture is associated with a higher mortality rate in men than in women . However , mean age of men and women with hip fracture differs markedly . Thus , some of the differences in the clinical pattern and outcome between genders could be related to different ages . To avoid the influence of age on gender-specific outcome , we analyzed prefracture conditions and hip fracture outcome in a cohort of men and of age-matched women . Risk factors for low bone mass were recorded in 106 men ( mean age ± SD , 80.3 ± 9.3 years ) and 264 age-matched women ( mean age 81.4 ± 8.0 ) with hip fracture . We compared mortality rate , survival , years of potential life lost and modification of housing conditions . These outcomes were prospect ively assessed during an average 3.6 years follow-up ( up to 7 years ) . Men with hip fracture differed from age-matched hip-fractured women by a higher alcohol and tobacco consumption , a greater frequency of living in couple , and by less prevalent fractures . Mortality rate after hip fracture was significantly higher in men ( RR = 1.74 , 95 % CI 1.34–2.24 ) . Since mortality is higher in the general male population , we compared reduction in life expectancy taking into account the gender-specific mortality rate . The excess mortality in each age-group of hip-fractured patients , which was measured during the whole follow-up period , and is an estimate of death attributable to fracture , did not differ between genders . Reduction in life expectancy due to hip fracture was similar in both genders ( 5.9 ± 4.5 and 5.8 ± 4.8 years , in men and women , respectively ; NS ) , but the proportion of the years of life lost was higher in men ( 70 ± 33 % ) than in women ( 59 ± 42 % , p < 0.01 ) . It was concluded that for the same age , mortality rate after hip fracture was higher in men than in women . Although the reduction in life expectancy was similar in both genders , the \n Output:\n " }, { "from": "agent", "value": "Thus , there is little evidence to support the use of hip protectors outside the nursing home setting ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: Transplacentally acquired antibody to influenza A virus was measured by a microneutralization test and a radioimmunoprecipitation assay in cord blood obtained from infants at a large urban county hospital in 1975 - 1978 . R and om sample s tested before epidemic periods were a measure of susceptibility of the population . Twenty-six infants from whom cord sera were available had culture-documented infections with influenza A/Victoria ( H3N2 ) virus when younger than four months . The direct correlation between age at the time of infection and level of antibody measured in cord serum ( P less than 0.002 ) suggested a protective effect of transplacentally acquired antibody . None of fourteen acute-phase serum specimens obtained early in the course of culture-positive infections of young infants had detectable antibody to influenza A viral hemagglutinin by the sensitive radioimmunoprecipitation test . Because passively transferred maternal antibody to influenza virus may prevent symptomatic infection in young infants , vaccination of pregnant women could be beneficial BACKGROUND There are limited data on the efficacy of vaccination against confirmed influenza in pregnant women with and those without human immunodeficiency virus ( HIV ) infection and protection of their infants . METHODS We conducted two double-blind , r and omized , placebo-controlled trials of trivalent inactivated influenza vaccine ( IIV3 ) in South Africa during 2011 in pregnant women infected with HIV and during 2011 and 2012 in pregnant women who were not infected . The immunogenicity , safety , and efficacy of IIV3 in pregnant women and their infants were evaluated until 24 weeks after birth . Immune responses were measured with a hemagglutination inhibition ( HAI ) assay , and influenza was diagnosed by means of reverse-transcriptase-polymerase-chain-reaction ( RT-PCR ) assays of respiratory sample s. RESULTS The study cohorts included 2116 pregnant women who were not infected with HIV and 194 pregnant women who were infected with HIV . At 1 month after vaccination , seroconversion rates and the proportion of participants with HAI titers of 1:40 or more were higher among IIV3 recipients than among placebo recipients in both cohorts . Newborns of IIV3 recipients also had higher HAI titers than newborns of placebo recipients . The attack rate for RT-PCR-confirmed influenza among both HIV-uninfected placebo recipients and their infants was 3.6 % . The attack rates among HIV-uninfected IIV3 recipients and their infants were 1.8 % and 1.9 % , respectively , and the respective vaccine-efficacy rates were 50.4 % ( 95 % confidence interval [ CI ] , 14.5 to 71.2 ) and 48.8 % ( 95 % CI , 11.6 to 70.4 ) . Among HIV-infected women , the attack rate for placebo recipients was 17.0 % and the rate for IIV3 recipients was 7.0 % ; the vaccine-efficacy rate for these IIV3 recipients was 57.7 % ( 95 % CI , 0.2 to 82.1 ) . CONCLUSIONS Influenza vaccine was immunogenic in HIV-uninfected and HIV-infected pregnant women and provided partial protection against confirmed influenza in both groups of women and in infants who were not exposed to HIV . ( Funded by the Bill and Melinda Gates Foundation and others ; Clinical Trials.gov numbers , NCT01306669 and NCT01306682 . ) Background Pregnant women were suspected to be at particular risk when H1N1pnd09 influenza became p and emic in 2009 . Our primary objective was to compare the immune responses conferred by MF59 ® -adjuvanted vaccine ( Focetria ® ) in H1N1pnd09-naïve pregnant and non-pregnant women . The secondary aims were to compare influences of dose and adjuvant on the immune response . Methods The study was nested in the Copenhagen Prospect i ve Studies on Asthma in Childhood ( COPSAC2010 ) pregnancy cohort in 2009 - 2010 and conducted as a single-blinded block-r and omised [ 1∶1∶1 ] controlled clinical trial in pregnant women after gestational week 20 : ( 1 ) 7.5 µg H1N1pnd09 antigen with MF59-adjuvant ( Pa7.5 µg ) ; ( 2 ) 3.75 µg antigen half MF59-adjuvanted ( Pa3.75 µg ) ; ( 3 ) 15 µg antigen unadjuvanted ( P15 µg ) ; and in non-pregnant women receiving ( 4 ) 7.5 µg antigen full adjuvanted ( NPa7.5 µg ) . Blood sample s were collected at baseline , 3 weeks , 3 and 10 months after vaccination , adverse events were recorded prospect ively . Results 58 pregnant women were allocated to Pa7.5 µg and 149 non-pregnant women were recruited to NPa7.5 µg . The sero-conversion rate was significantly increased in non-pregnant ( NPa7.5 µg ) compared with pregnant ( Pa7.5 µg ) women ( OR = 2.48 [ 1.03–5.95 ] , p = 0.04 ) and geometric mean titers trended towards being higher , but this difference was not statistically significant ( ratio 1.27 [ 0.85–1.93 ] , p = 0.23 ) . The significant titer increase rate showed no difference between pregnant ( Pa7.5 µg ) and non-pregnant ( NPa7.5 µg ) groups ( OR = 0.49 [ 0.13–1.85 ] , p = 0.29 ) . Conclusion Our study suggests the immune response to the 7.5 µg MF59-adjuvanted Focetria ® H1N1pnd09 vaccine in pregnant women may be diminished compared with non-pregnant women . Trial Registration Clinical Trials.gov NCT01012557 BACKGROUND Although pregnant women are at increased risk of severe illness following influenza infection , there is relatively little information on the immunogenicity of influenza vaccines administered during pregnancy . METHODS We conducted a clinical trial that enrolled 120 pregnant women in which participants were r and omly assigned to receive an inactivated 2009 H1N1 influenza vaccine containing either 25 μg or 49 μg of hemagglutinin ( HA ) in a 2-dose series with a 21-day period between administration of the first and second doses . RESULTS Following the first vaccination , HA inhibition ( HAI ) titers of ≥1:40 were detected in 93 % ( 95 % confidence interval [ CI ] , 82%-98 % ) of subjects who received the 25-μg dose and 97 % ( 95 % CI , 88%-100 % ) of subjects receiving the 49-μg dose . In cord blood sample s , HAI titers of ≥1:40 were found in 87 % ( 95 % CI , 73%-96 % ) of sample s from the 25-μg dose group and in 89 % ( 95 % CI , 76%-96 % ) from the 49-μg dose group . Microneutralization titers tended to be higher than HAI titers , but the patterns of response were similar . CONCLUSIONS In pregnant women , 1 dose of an inactivated 2009 H1N1 influenza vaccine containing 25 μg of HA elicited an antibody response typically associated with protection against influenza infection . Efficient transplacental transfer of antibody was also documented Background . Pregnant women are a high-risk group for influenza-associated complications and hospitalizations . Methods . To examine the immunogenicity of a monovalent 2009 influenza A ( H1N1 ) vaccine among pregnant women , a prospect i ve cohort study was performed at 2 medical institutes of obstetrics in Japan . One hundred fifty subjects received 2 subcutaneous doses of vaccine 3 weeks apart . The hemagglutination inhibition antibody titer was measured in serum sample s collected at 3 time points : before vaccination , 3 weeks after the first dose , and 4 weeks after the second dose . Results . The first dose of vaccine induced a ≥10-fold rise in the average level of antibody . The seroresponse rate ( ≥4-fold rise ) was 91 % , and the seroprotection rate ( postvaccination titer ≥1:40 ) was 89 % . The second dose of vaccine conferred little additional induction of antibodies . Similar immune responses were observed irrespective of body mass index before pregnancy , trimester , or age at vaccination . However , lesser immune response was shown in subjects who had received the 2009–2010 seasonal influenza vaccine before the H1N1 vaccination . Conclusions . A single dose of vaccine induced an adequately protective level of immunity in pregnant women . The potential interference with seasonal vaccination requires a more thorough investigation to prepare for future influenza p and emics BACKGROUND Pregnant women are at increased risk of complications following influenza infection . Vaccination is the most effective preventive strategy . This survey aim ed to determine the levels of uptake of influenza vaccine in pregnant women in Western Australia ( WA ) , the proportion of women offered vaccination as part of antenatal care , and women 's attitudes toward influenza vaccination in pregnancy . METHODS Computer assisted telephone interviews were conducted with 416 r and omly selected women who were pregnant during the 2012 influenza vaccination season . RESULTS Influenza vaccination coverage was 23 % . Predictors of vaccination included believing that vaccination is safe for the infant , having been recommended vaccination by an antenatal care provider , and attending a general practitioner for most antenatal care . The majority ( 74 % ) of unvaccinated women reported that they would have the vaccine if their antenatal care provider recommended it . DISCUSSION General practitioners lead the way in antenatal influenza vaccination in WA . Vaccination coverage can be improved if recommending and offering influenza vaccination becomes a routine part of antenatal care This study aim ed to comprehensively describe inflammatory responses to trivalent influenza virus vaccine ( TIV ) among pregnant women and determine whether responses differ compared to non‐pregnancy OBJECTIVE To assess the effect of seasonal influenza vaccination during pregnancy on laboratory-confirmed influenza in infants to 6 months of age . DESIGN Nonr and omized , prospect i ve , observational cohort study . SETTING Navajo and White Mountain Apache Indian reservations , including 6 hospitals on the Navajo reservation and 1 on the White Mountain Apache reservation . PARTICIPANTS A total of 1169 mother-infant pairs with mothers who delivered an infant during 1 of 3 influenza seasons . MAIN EXPOSURE Maternal seasonal influenza vaccination . MAIN OUTCOME MEASURES In infants , laboratory-confirmed influenza , influenza-like illness ( ILI ) , ILI hospitalization , and influenza hemagglutinin inhibition antibody titers . RESULTS A total of 1160 mother-infant pairs had serum collected and were included in the analysis . Among infants , 193 ( 17 % ) had an ILI hospitalization , 412 ( 36 % ) had only an ILI outpatient visit , and 555 ( 48 % ) had no ILI episodes . The ILI incidence rate was 7.2 and 6.7 per 1000 person-days for infants born to unvaccinated and vaccinated women , respectively . There was a 41 % reduction in the risk of laboratory-confirmed influenza virus infection ( relative risk , 0.59 ; 95 % confidence interval , 0.37 - 0.93 ) and a 39 % reduction in the risk of ILI hospitalization ( relative risk , 0.61 ; 95 % confidence interval , 0.45 - 0.84 ) for infants born to influenza-vaccinated women compared with infants born to unvaccinated mothers . Infants born to influenza-vaccinated women had significantly higher hemagglutinin inhibition antibody titers at birth and at 2 to 3 months of age than infants of unvaccinated mothers for all 8 influenza virus strains investigated . CONCLUSIONS Maternal influenza vaccination was significantly associated with reduced risk of influenza virus infection and hospitalization for an ILI up to 6 months of age and increased influenza antibody titers in infants through 2 to 3 months of age OBJECTIVE : To evaluate the efficacy of double vaccination with the 2009 p and emic influenza A ( H1N1 ) vaccine during pregnancy . METHODS : A study of the 2009 H1N1 vaccine was conducted in 128 pregnant women , who were between 8 and 32 weeks of gestation in October 2009 , to monitor the immune response to vaccination and the change in antibody positivity rate and to assess the imm \n Output:\n " }, { "from": "agent", "value": "This review provides comparative analysis of the effect of vaccination timing on maternal immunogenicity and protection of the infant that is informative and relevant to current vaccine scheduling for pregnant women" } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: A double-blind , r and omized trial was performed with 51 patients suffering from focal ischemic lesions in the territory of the middle cerebral artery . Intravenous infusions of 10 % glycerol in 0.9 % NaCI - 5 % glucose solutions were administered twice daily for 6 days to 26 patients , and the same amount of NaCI - glucose solutions to 25 controls . Glycerol did not reduce mortality ( 9 deaths in each group ) . The functional recovery was assessed by repeated neurological examinations during the 4 month trial . Glycerol significantly improved global performances and motor and sensory functions in patients with moderate disability , but its effect on global performances was transient . The patients with severe disability were not improved at all Abstract A double-blind evaluation of the effects of glycerol administration intravenously for 4 or 6 days in patients with acute stroke was completed in a stroke centre . Fifty-four patients with acute cerebral infa rct ion and eight patients with spontaneous intracerebral haemorrhage were admitted to the study . The neurological status was evaluated by use of a neurological scoring system . Patients with cerebral infa rct ion treated with glycerol showed significant improvement in neurological status compared to the patients treated with placebo ( The effects of intravenous glycerol and intravenous dextrose were compared using a double-blind trial in twenty-seven patients with acute stroke . Administration continued for up to 6 days . A st and ard scoring system was used for neurological evaluation . There was no difference in mortality or in improvement in neurological score between the two groups The results of clinical trials investigating various therapies in acute ischemic stroke have been inconsistent . The effect of glycerol therapy and a combination therapy of glycerol and dextran was evaluated in a double-blind , placebo-controlled study . Repeated neurologic examinations ( Day 0 , Weeks 1 , 6 , 12 , and 24 ) according to a modified Mathew score were performed on 62 patients . Statistical analysis showed no superiority of either treatment compared with placebo in acute ischemic stroke . A retrospective estimation of the Type II error of the study yielded approximately p = 0.25 . A major side effect was hemolysis in 98 % of patients treated with glycerol 1 . In patients with acute strokes entering a large ongoing r and omised double-blind controlled trial of intravenous glycerol therapy , the extent and pathogenesis of any ensuing haemolysis were evaluated using st and ard clinical investigations and in vitro techniques . 2 . Twenty patients received 10 % glycerol in saline ( 500 ml over 4 h on 6 consecutive days ) and 15 received corresponding control treatment with saline . 3 . Intravascular haemolysis was evident after the first infusion ; compared with the controls the glycerol group had i ) a greater mean reduction in serum haptoglobin concentration ( P less than .05 ) , and ii ) a greater proportion exhibiting haemoglobinaemia ( P = 0.03 ) . 4 . After 6 days of glycerol treatment , the mean reduction in haemoglobin concentration was only 0.8 g more than in controls ; this difference being neither clinical ly nor statistically significant . 5 . Glycerol therapy was not associated with haemoglobinuria , renal insufficiency or disseminated intravascular coagulation . 6 . Exposure of red blood cells to 1 - 10 % glycerol in vitro did not induce haemolysis per se ; on re-exposure to lower concentrations lysis ensued provided a minimum osmotic gradient was present . 7 . Whilst taking st and ard dosage regimes of glycerol , the stroke patients we studied manifested a degree of intravascular haemolysis but its consequences were not clinical ly significant ; lysis probably ensued after venous blood acquiring high glycerol concentrations mixed with blood containing little or no glycerol Background and Purpose This clinical trial investigates the effectiveness of intravenous glycerol therapy in patients with acute cortical infa rct ion in whom intracerebral hemorrhage was rigorously excluded . Methods Within 48 hours of symptoms from their first ischemic stroke , 113 hospital in patients were r and omized into the trial , provided that hemorrhage was excluded by computed tomography and informed consent was obtained . Patients were stratified into alert , semicoma , and coma groups using the Glasgow Coma Scale . Treatment was allocated according to a double-blind , r and omized protocol ; 56 patients received 500 mL of 10 % glycerol in saline over 4 hours on 6 consecutive days , and 57 patients received corresponding placebo treatment with saline . Using a variety of objective scoring systems , patient follow-up was up to 6 months . Results Corresponding measures of outcome in the glycerol and placebo groups were similar . At 6 months , respective mortality rates were 17 of 56 and 16 of 57 , and mean ±SD improvements in scores were 9.98±14.40 vs 10.51±12.68 ( long-term ) , 1.12±7.20 vs 1.57±6.30 ( prognostic ) , −1.94±5.53 vs −2.06±5.34 ( Glasgow Coma Scale ) , and 21.72±23.40 vs 11.94± 18.10 ( Barthel Index rating in survivors ) . Hemolysis ( generally sub clinical ) was the only adverse effect . Conclusions There was no clinical ly or statistically significant difference in outcome between the groups ; a trend toward greater functional recovery among survivors was evident after treatment with glycerol A prospect i ve study of 93 acute stroke patients r and omly selected by type of antiedema treatment given ( hypertonic glicerol infusion plus dexamethasone versus dexamethasone alone ) failed to elicit any statistically significant difference between the two treatments on survival rates and quality of survival 7 and 30 days after the stroke The treatment of the acute phase of stroke creates a difficult problem to the clinician . The presently used drugs lead to controversial results . The progress in knowledge of the pathogenesis of cerebral damage underlines the determinant role of the metabolic deficits in the ischemic areas . The effect on the clinical symptomatology of patients in the acute phase of stroke was studied during a double-blind comparative clinical trial with an alcaloid of Vinca minor ( Pervincamine ) which acts favorably against disturbances of oxydative glucose metabolism and of cerebral microcirculation . 20 patients divided into two homogeneous groups received during 5 days either Pervincamine ( 4 ampoules of 3 ml = 60 mg vincamine p.d . ) + glycerol , or glycerol + placebo administered by i.v . infusion . Clinical ly the results indicate a greater improvement of the neurological status ( objectivated by a neurological scale ) with vincamine treatment than with placebo . Statistically the analysis confirms the highly significant effect of vincamine on motility of lower and upper limbs ( p less than 0.02 ) and the significant effect on cranial nerves ( homonymous hemianopsia and conjugated deviation of eyes ) ( p less than 0.05 ) and on the sphincter control level ( p less than 0.05 ) Intravenous administration of glycerol has been used in an effort to improve the prognosis for patients with acute cerebral infa rct ion . Fifty patients were treated actively and 56 served as a control group . The neurological status before , during and after treatment for six days was assessed by a score system . The patients were grouped according to the initial score . Those with the highest and lowest scores did not improve from glycerol infusion . However , the treated patients with intermediate scores , where the prognosis is known to be dubious , showed a significant improvement compared to the controls . The mortality was not influenced . No undesirable side-effects from glycerol were registered Background and Purpose Hitherto , treatment of acute cerebral hemorrhage with intravenous glycerol has not been evaluated in rigorous clinical studies with sufficient patient numbers . Methods We undertook a double-blind , stratified and r and omized , placebo-controlled clinical trial . Only patients with a first stroke admitted to the hospital within 24 hours after onset of symptoms were recruited , provided computed tomography confirmed hemorrhage and informed consent was obtained . After stratification into alert , semicoma , and coma subgroups using the Glasgow Coma Scale , 107 patients received active treatment ( 500 ml of 10 % glycerol in saline by intravenous infusion over 4 hours on 6 consecutive days ) and 109 were given corresponding saline treatment . Using a variety of objective scoring systems , patients were followed up for up to 6 months . Results At follow-up , all measures of outcome in the treated and control groups were very similar . At 6 months , respective mortality rates were 37 of 107 and 33 of 109 . Corresponding mean±SD improvements in Sc and inavian Stroke Study Group scores were 8.35±16.9 versus 11.55±15.6 ( long-term ) and 0.64±7.3 versus 2.40±6.9 ( prognostic ) , and improvements in the Barthel Index ratings were 10.72±24.7 versus 13.95±23.3 , respectively . Glasgow Coma Scale score improvements in the survivors were 0.81±1.5 and 1.16±1.7 in the treated and control groups , respectively . Hemolysis ( generally sub clinical ) was the only adverse effect of glycerol noted . Conclusions In the absence of any clinical ly or statistically significant difference in outcome between the treated and control groups , this trial provides no justification for glycerol therapy following acute cerebral The effects of intravenous glycerol in elderly patients with recent onset of acute ischaemic stroke were evaluated in a double-blind r and omised controlled trial . 173 patients received either 500 ml of a 10 % solution of glycerol in physiological saline or 500 ml of physiological saline administered intravenously over 4 h daily for 6 consecutive days . The number of deaths within the first week was 10 ( 12 % ) in the glycerol group versus 26 ( 30 % ) in the controls . Subsequent mortality up to 12 months was similar in the two groups and a survival analysis confirmed a beneficial effect of treatment ( p less than 0.02 ) . The neurological and functional recovery of survivors , their length of hospital stay , and the proportion able to return to live in their own home were similar in the two groups . The improvement in survival time with glycerol was achieved without serious adverse effects and without an increase in the proportion of survivors with severe residual disability 10 percent glycerol was given for 6 days to 30 patients who had had acute ischaemic cerebral infa rct ion , and the results were compared with those obtained after treating 31 similar patients with dexamethasone ( 16 mg . per 24 hours for 6 days ) . 1 patient treated with glycerol died of haemoglobinuria and acute renal failure . 6 patients treated with dexamethasone died--3 from cerebral oedema and 3 from non-neurological complications ( pulmonary embolism , myocardial infa rct ion , and aspiration pneumonia ) . Improvement was significantly greater in the glycerol group after 8 and 15 days . No improvement was noted using either glycerol or dexamethasone in 7 patients with spontaneous intracerebral haemorrhage 56 patients with acute ischemic cerebral infa rct ion were r and omly allocated to intravenous treatment for 6 days with either 500 ml of a 10 % glycerol solution or 500 ml of a 5 % dextrose solution ( placebo ) . The neurological status of the patients was evaluated by a blinded investigator before the beginning of the treatment , after 2 weeks and again after 6 months . According to the initial degree of neurological deficit , patients were stratified into a mild , intermediate and severe group ( using a scoring system ) . After 2 weeks there was significantly less neurological deficit in the total glycerol-treated group than in the placebo group ( 2p less than 0.02 ) . This favourable effect of glycerol was even greater in the patients with an initially intermediate degree of neurological deficity ( 2p less than 0.01 ) . After 6 months there was no difference between the total glycerol-treated and the placebo group . A beneficial effect of glycerol treatment , however , was still demonstrable in the intermediate group ( 2p less than 0.05 ) . Mortality was not influenced by glycerol treatment . No side effects of the glycerol treatment could be detected . Intravenous administration of 10 % glycerol can thus be recommended in patients with acute cerebral infa rct ion Long-term beta blockade for perhaps a year or so following discharge after an MI is now of proven value , and for many such patients mortality reductions of about 25 % can be achieved . No important differences are clearly apparent among the benefits of different beta blockers , although some are more convenient than others ( or have slightly fewer side effects ) , and it appears that those with appreciable intrinsic sympathomimetic activity may confer less benefit . If monitored , the side effects of long-term therapy are not a major problem , as when they occur they are easily reversible by changing the beta blocker or by discontinuation of treatment . By contrast , although very early IV \n Output:\n " }, { "from": "agent", "value": "Haemolysis seems to be the only relevant adverse effect of glycerol treatment .\nThis systematic review suggests a favourable effect of glycerol treatment on short term survival in probable or definite ischaemic stroke , but the magnitude of the treatment effect may be minimal ( as low as a 3 % reduction in odds ) .\nThe lack of evidence of benefit in long term survival does not support the routine or selective use of glycerol treatment in patients with acute stroke" } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: Purpose of the study Cognitive stimulation therapy ( CST ) is a widely used , evidence -based intervention for people with dementia ( PwD ) . Although design ed as a 14 session , twice weekly intervention , many services in the UK deliver CST once a week for 14 weeks . However , this method of delivery has yet to be evaluated . In addition , CST does not include any formal carer training . This study aim ed to evaluate the effectiveness of once weekly CST and determine any additional impact when enhanced with a carer training program . Design and methods A single blind , r and omized controlled trial was conducted . Sixty eight PwD and their carers were recruited through three community Memory Assessment Services . PwD and their carers were r and omized to one of three conditions : CST plus carer training , CST only , or a wait list control . PwD were administered st and ardized measures of cognition , quality of life , and quality of relationship with carer at baseline and the 15 week follow-up . Results There were no baseline differences across the three groups . At follow-up , there were no significant differences between PwD in the three groups on any outcomes . Implication s Weekly CST with or without carer training may not be an effective form of delivery . Several possible explanations for the outcomes are proposed . Weekly CST may not offer the necessary “ dose ” required to combat decline , and equally the carer training may have been too brief to have made a difference . Services currently offering weekly CST should collect routine outcome data to support its use and provide practice -based evidence The purpose oF this study was to examine the eFFects oF 3 behavioral interventions on aFFect and mood in nursing home residents with Alzheimer 's disease . In a pre — post design , 90 residents with Alzheimer 's disease were r and omized to 3 groups : supervised walking , comprehensive exercise ( walking plus strength training , balance , and Flexibility exercises ) , and social conversation ( casual rather than therapeutic themes ) . Interventions were provided 5 days a week and progressed up to 30 minutes per session over 16 weeks . Interventions were conducted primarily indoors . Outcome measures included the Lawton Observed AFFect Scale , Alzheimer Mood Scale , and Dementia Mood Assessment . At posttest , participants receiving comprehensive exercise exhibited higher positive and lower negative aFFect and mood . The social conversation group exhibited the least positive and most negative mood and aFFect . Results suggest that exercise programs be emphasized in long-term care , particularly whole-body involvement rather than walking alone BACKGROUND The conduct of r and omized , controlled trials of nonpharmacologic treatments presents specific challenges that are not adequately addressed in trial reports . OBJECTIVE To develop an extension of the CONSORT ( Consoli date d St and ards of Reporting Trials ) Statement for trials of nonpharmacologic treatments . DESIGN A consensus meeting was organized to develop an extension of the CONSORT Statement that addresses r and omized trials of nonpharmacologic treatments . To prepare for the meeting , a survey was conducted to identify the specific issues for discussion . SETTING Consensus meeting in Paris , France . PARTICIPANTS A total of 33 experts attended the meeting . The experts were method ologists ( n = 17 ) ; surgeons ( n = 6 ) ; editors ( n = 5 ) ; and clinicians involved in rehabilitation ( n = 1 ) , psychotherapy ( n = 2 ) , education ( n = 1 ) , and implantable devices ( n = 1 ) . MEASUREMENTS Experts indicated which of the 22 items on the CONSORT checklist should be modified or which additional items should be added specifically for nonpharmacologic treatments . During a 3-day consensus meeting , all items were discussed and additional method ological issues related to nonpharmacologic research were identified . RESULTS The consensus was that 11 items on the CONSORT checklist needed some modifications for nonpharmacologic trials : item 1 ( title and abstract ) , item 3 ( participants ) , item 4 ( interventions ) , item 7 ( sample size ) , item 8 ( r and omization ) , item 11 ( blinding ) , item 12 ( statistical methods ) , item 13 ( participant flow ) , item 15 ( baseline data ) , item 20 ( discussion : interpretation ) , and item 21 ( generalizability ) . In addition , the meeting participants added 1 item related to implementation of the intervention . LIMITATION Evidence was not always available to support the inclusion of each checklist item . CONCLUSION The methods and processes used to develop this extension could be used for other reporting guidelines . The use of this extension to the CONSORT Statement should improve the quality of reporting r and omized , controlled trials assessing nonpharmacologic treatments [ Purpose ] The purpose of this study was to investigate the effect of cognitive rehabilitation including tasks of cognitive training on performance of everyday activities in elderly people with early-stage Alzheimer ’s disease . [ Subjects and Methods ] Forty-three elderly people ( 15 men , 28 women ) with a diagnosis of Alzheimer ’s disease who had a Mini-Mental State Examination ( MMSE ) score of 18 or above were r and omly assigned to two groups : the cognitive rehabilitation group ( experimental ) and control group . This study used a r and omized controlled trial design . Cognitive rehabilitation is consisted of 8 sessions , each lasting 60 minutes ( individual 30 min , group 30 min ) . The eight weekly individual sessions of cognitive rehabilitation were performed consisting of an individualized intervention focusing on a personally meaningful goal . The eight weekly group sessions involved practicing time- and -place orientation , matching faces and names , and learning memory and sustaining attention . [ Results ] Significant improvements were observed in rating of occupation performance and satisfaction , Quality of Life in Alzheimer ’s Disease ( QOL-AD ) , and the orientation subscale of the MMSE in the experimental group , whereas participants in the control group did not show any significant difference in any tests between before and after the intervention . [ Conclusion ] Cognitive rehabilitation including tasks of cognitive training is an effective intervention for improving performance and satisfaction with respect to activities of daily living and specific cognitive functions The purpose of this study was to examine the beneficial effects of a new cognitive intervention program design ed for the care and prevention of dementia , namely Learning Therapy . The training program used systematized basic problems in arithmetic and Japanese language as training tasks . In study 1 , 16 individuals in the experimental group and 16 in the control group were recruited from a nursing home . In both groups , all individuals were clinical ly diagnosed with senile dementia of the Alzheimer type . In study 2 , we performed a single-blind , r and omized controlled trial in our cognitive intervention program of 124 community-dwelling seniors . In both studies , the daily training program using reading and arithmetic tasks was carried out approximately 5 days a week , for 15 to 20 minutes a day in the intervention groups . Neuropsychological measures were determined simultaneously in the groups both prior to and after six months of the intervention . The results of our investigations indicate that our cognitive intervention using reading and arithmetic problems demonstrated a transfer effect and they provide convincing evidence that cognitive training maintains and improves the cognitive functions of dementia patients and healthy seniors Background Currently available pharmacological and non-pharmacological treatments have shown only modest effects in slowing the progression of dementia . Our objective was to assess the impact of a long-term non-pharmacological group intervention on cognitive function in dementia patients and on their ability to carry out activities of daily living compared to a control group receiving the usual care . Methods A r and omized , controlled , single-blind longitudinal trial was conducted with 98 patients ( follow-up : n = 61 ) with primary degenerative dementia in five nursing homes in Bavaria , Germany . The highly st and ardized intervention consisted of motor stimulation , practice in activities of daily living , and cognitive stimulation ( acronym MAKS ) . It was conducted in groups of ten patients led by two therapists for 2 hours , 6 days a week for 12 months . Control patients received treatment as usual . Cognitive function was assessed using the cognitive subscale of the Alzheimer 's Disease Assessment Scale ( ADAS-Cog ) , and the ability to carry out activities of daily living using the Erlangen Test of Activities of Daily Living ( E-ADL test ) at baseline and after 12 months . Results Of the 553 individuals screened , 119 ( 21.5 % ) were eligible and 98 ( 17.7 % ) were ultimately included in the study . At 12 months , the results of the per protocol analysis ( n = 61 ) showed that cognitive function and the ability to carry out activities of daily living had remained stable in the intervention group but had decreased in the control patients ( ADAS-Cog : adjusted mean difference : -7.7 , 95 % CI -14.0 to -1.4 , P = 0.018 , Cohen 's d = 0.45 ; E-ADL test : adjusted mean difference : 3.6 , 95 % CI 0.7 to 6.4 , P = 0.015 , Cohen 's d = 0.50 ) . The effect sizes for the intervention were greater in the subgroup of patients ( n = 50 ) with mild to moderate disease ( ADAS-Cog : Cohen 's d = 0.67 ; E-ADL test : Cohen 's d = 0.69 ) . Conclusions A highly st and ardized , non-pharmacological , multicomponent group intervention conducted in a nursing-home setting was able to postpone a decline in cognitive function in dementia patients and in their ability to carry out activities of daily living for at least 12 months . Trial Registration http://www.is rct n.com Identifier : IS RCT BACKGROUND A recent Cochrane review of reality orientation therapy identified the need for large , well- design ed , multi-centre trials . AIMS To test the hypothesis that cognitive stimulation therapy ( CST ) for older people with dementia would benefit cognition and quality of life . METHOD A single-blind , multi-centre , r and omised controlled trial recruited 201 older people with dementia . The main outcome measures were change in cognitive function and quality of life . An intention-to-treat analysis used analysis of covariance to control for potential variability in baseline measures . RESULTS One hundred and fifteen people were r and omised within centres to the intervention group and 86 to the control group . At follow-up the intervention group had significantly improved relative to the control group on the Mini-Mental State Examination ( P=0.044 ) , the Alzheimer 's Disease Assessment Scale - Cognition ( ADAS-Cog ) ( P=0.014 ) and Quality of Life - Alzheimer 's Disease scales ( P=0.028 ) . Using criteria of 4 points or more improvement on the ADAS-Cog the number needed to treat was 6 for the intervention group . CONCLUSION The results compare favourably with trials of drugs for dementia . CST groups may have worthwhile benefits for many people with dementia BACKGROUND There is good evidence for the benefits of short-term cognitive stimulation therapy for dementia but little is known about possible long-term effects . AIMS To evaluate the effectiveness of maintenance cognitive stimulation therapy ( CST ) for people with dementia in a single-blind , pragmatic r and omised controlled trial including a sub study with participants taking acetylcholinesterase inhibitors ( AChEIs ) . METHOD The participants were 236 people with dementia from 9 care homes and 9 community services . Prior to r and omisation all participants received the 7-week , 14-session CST programme . The intervention group received the weekly maintenance CST group programme for 24 weeks . The control group received usual care . Primary outcomes were cognition and quality of life ( clinical trial registration : IS RCT N26286067 ) . RESULTS For the intervention group at the 6-month primary end-point there were significant benefits for self-rated quality of life ( Quality of Life in Alzheimer 's Disease ( QoL-AD ) P = 0.03 ) . At 3 months there were improvements for proxy-rated quality of life ( QoL-AD P = 0.01 , Dementia Quality of Life scale ( DEMQOL ) P = 0.03 ) and activities of daily living ( P = 0.04 ) . The intervention subgroup taking AChEIs showed cognitive benefits ( on the Mini-Mental State Examination ) at 3 ( P = 0.03 ) and 6 months ( P = 0.03 ) . CONCLUSIONS Continuing CST improves quality of life ; and improves cognition for those taking AChEIs BACKGROUND A recent r and omised controlled trial on Cognitive Stimulation Therapy ( CST ) identified the need to evaluate its more long-term benefits for people with dementia . This study evaluates the effectiveness of a weekly maintenance CST programme for people with dementia in residential care . METHOD Thirty-five people with dementia were included , following on from a seven-week twice-weekly study of CST . The maintenance CST sessions ran in two residential homes using a once a week programme of CST over an additional 16 weeks . Two control homes did not receive the maintenance intervention . RESULTS Using repeated measures ANOVAS , there was a continuous , significant improvement in cognitive function ( MMSE ) for those receiving MCST ( CST+maintenance CST sessions ) as compared to CST alone or no treatment ( p = 0.012 ) . There were no effects on quality of life , behaviour or communication following maintenance sessions . The initial cognitive improvements following CST were only sustained at follow-up when followed by the programme of maintenance CST sessions . CONCLUSIONS The cognitive benefits of CST can be maintained by weekly sessions for around 6 months . A large-scale , multi-centre maintenance CST trial is required to clarify potential longer-term benefits of maintenance CST for dementia Background / A \n Output:\n " }, { "from": "agent", "value": "Cognitive interventions are safe and effective for residents with dementia in LTC .\nHowever , while it seems clear that cognitive benefits can specifially be assigned to these forms of intervention , further research is necessary to clarify whether the effects on BPSD and QoL reflect unspecific changes due to additional attention ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: This study set out to determine whether screening can be psychologically harmful to healthy adults . A prospect i ve controlled study was carried out on 215 healthy adults attending a by-invitation coronary heart disease screening clinic in general practice . The general health question naire was used as an indicator of recent psychological distress . Patients attending the screening clinic had significantly lower subjective psychological distress than an unscreened group of 225 age-matched controls , indicating that we may well be screening an already psychologically healthy sub-group . The main finding was that patients ' own assessment of their psychological distress was significantly increased three months after screening compared with that of controls , who showed a non-significant decrease . It is concluded that there is a real risk of causing distress by screening healthy adults and that this possibility has largely been ignored by previous studies . Possible explanations and implication s of these findings are discussed , particularly in the light of increased pressure from many quarters for more screening services to be set up in general practice A total of 96 patients with moderate elevations of low-density lipoprotein ( LDL ) cholesterol were r and omly assigned to 4 different double-blind treatment regimens : placebo ; colestipol 5 g and lovastatin 20 mg/day ( C5 + L20 ) ; colestipol 10 g and lovastatin 20 mg/day ( C10 + L20 ) ; and lovastatin 40 mg/day ( L40 ) . During 12 weeks of therapy , C10 + L20 achieved the greatest reduction in total cholesterol ( -32 % ) and LDL cholesterol ( -48 % ) levels from baseline . This combination also exhibited significantly greater reductions in LDL cholesterol levels than the C5 + L20 and L40 groups ( p < 0.01 ) . The differences in total and LDL cholesterol reduction between the C5 + L20 and L40 groups were not significant . Similar changes and differences between treatments were seen in apolipoprotein B levels . Whereas mean total apolipoprotein A-I levels increased with all treatments ( p < 0.05 ) , lipoprotein particles A-I were significantly increased in the C10 + L20 group ( p < 0.01 ) only . Results demonstrate that the combination of low-dose lovastatin ( 20 mg/day ) with low-dose colestipol ( 5 or 10 g/day ) produces LDL cholesterol reductions equal to or greater than higher doses of lovastatin ( 40 mg/day ) . In addition , low-dose combinations are > 25 % more cost-effective than high-dose monotherapy The cost of screening for hypercholesterolaemia in a clinical trial was investigated at a primary health care centre . A convenience sample of the population was screened for inclusion in a study of the effectiveness of a lipid lowering programme . Included in the study were adults 30 - 59 years of age with a S-Cholesterol of 6.50 - 7.79 mmol l-1 at r and omization , plus two previous values > or = 6.50 mmol l-1 at screening and selection , with at least two other cardiovascular risk factors . In total 447 persons were screened and 37 were r and omized into the lipid lowering programme . The mean cost per r and omized person was estimated at about SEK 7500 ( Swedish Crowns ) . An analysis of different inclusion criteria for treatment was also carried out . The cost of finding a patient to treat in the clinical trial was estimated to be more than three times as high with a total cholesterol cut-off point of 7.80 mmol l-1 compared with a cut-off point of 5.20 mmol l-1 This cost-benefit analysis attempts to translate the clinical findings of the Helsinki Heart Study ( HHS ) and published results regarding additional cardiovascular conditions into economic terms meaningful to US managed care providers . The study has the following 3 key objectives : to define the cost effectiveness of gemfibrozil in the prevention of coronary heart disease ( CHD ) ; to assess the net impact of gemfibrozil on total treatment costs for CHD ; and to identify those patient groups for whom gemfibrozil therapy is most cost effective . In order to reach these findings a cost-effectiveness model was constructed based on original clinical data provided by the HHS , published findings for CHD risk and cost of treatment in the US , expert opinion and extension of HHS to other cardiovascular conditions , and documented costs and treatment protocol s of US Medicaid and privately managed health care programmes . The model was applied to the California Medicaid ( Medi-Cal ) programme to estimate costs of hyperlipidaemia therapy using gemfibrozil . In parallel , savings to Medi-Cal from averted coronary events were estimated . From these data , the net expected savings to Medi-Cal were calculated . The probability of experiencing CHD varies with cholesterol level , age , sex and risk factors such as smoking , hypertension and diabetes . Therefore , it is possible to use risk-factor profiles to define groups of individuals with low , moderate or high risk of experiencing acute myocardial infa rct ion ( AMI ) or sudden cardiac death . The probability of a cardiac event within 5 years ranges from 1.1 % in a 45-year-old low risk male to over 36 % in a 55-year-old high risk male . The average total cost of CHD care was found to be US$ 22,271 within 5 years . Using the probability of a CHD event to calculate the expected 5-year cost of CHD care produces a range from US$ 242 in the 45-year-old low risk male to US$ 8084 in the 55-year-old high risk male . Treatment with gemfibrozil reduces the probability of AMI and sudden cardiac death events by 34 % , as demonstrated in the HHS . Therefore , the corresponding probability ranges are reduced to 0.7 % in the 45-year-old low risk male and 27.3 % in the 55-year-old high risk male after treatment with gemfibrozil . The expected cost of a coronary event is reduced by US$ 82 and US$ 1997 , respectively . ( ABSTRACT TRUNCATED AT 400 WORDS Over the past decade the efficacy and cost of medical interventions have been subject to increasing scrutiny with quantitative techniques , such as the r and omized controlled trial and cost-effectiveness analysis . Such studies provide invaluable guidance for the clinician choosing from a limited range of options in caring for an individual patient . However , in the field of health policy myriad competing programs , services , institutions , and interests must be weighed . Unfortunately , quantitative methods are virtually always used to compare two , or at most a few , alternative strategies . Since the relative cost effectiveness of an intervention may appear radically different depending on the alternative . . Twenty-four factories or other occupational groups , employing 18 210 men aged 40 to 59 , were formed into matched pairs . One of each pair was allocated r and omly to receive a five to six year programme of medical examinations and intervention to reduce the levels of the main coronary risk factors . Men at factories in the intervention group were given advice on dietary reduction of plasma cholesterol concentrations , stopping or reducing cigarette smoking , regular exercies for the sedentary and reduced energy intake for the overweight , and hypertension was treated . The programme was delivered mainly through existing occupational medical services , helped by a small central staff . Personal consultations were largely confined to men with a high risk of developing coronary heart disease . Changes in risk factors were assessed by regular st and ardised examinations of r and om sample s of men . The spread of information by general propag and a proved easy , but a change in habits seemed to require personal contact . Small but significant reductions occurred , mainly in the high-risk group , but these were not sustained when pressure was relaxed STUDY OBJECTIVE : To evaluate the cost effectiveness and equity of a community based cardiovascular disease prevention programme . DESIGN : A prospect i ve cross sectional design . SETTING : A community based intervention to reduce cardiovascular disease in the district of Norsjö ( n = 5500 ) , Sweden . The intervention was aim ed at both the general population and at individuals thought to be at special risk , the emphasis being on changing dietary habits and reducing cholesterol concentrations . PARTICIPANTS : The participants were men and women aged 30 - 60 years . MAIN RESULTS : The mean serum cholesterol concentration in the Norsjö population was reduced by nearly 20 % during the first six years of intervention . It was estimated that the programme 's overall total societal costs were 363,000 pounds and estimates of the cost per year of life saved ranged from 14,900 pounds to net savings , according to different assumptions . Taking only health care costs and savings into account , the cost per year of life saved ranged from 1100 pounds to 4050 pounds . The results varied between different sex and age groups , but not between social classes . Even if a causal relationship exists between low cholesterol concentrations and excess mortality , the estimated side effects of lowering cholesterol values in Norsjö were negligible in comparison with the expected benefits . CONCLUSIONS : The community based intervention in Norsjö seems to be cost effective even under conservative assumptions . The approach used seems to have benefited all social classes . Cost effectiveness analyses that take consequences for equity into account are valuable tools in decision making BACKGROUND Advances in the treatment of cardiovascular disease have increased costs ; annual cardiovascular healthcare expenditure in the United States currently exceeds $ 100 billion . Physicians and third-party payers need to assess the economic impact of treatments that reduce cardiovascular morbidity and mortality . METHODS AND RESULTS The Sc and inavian Simvastatin Survival Study is a r and omized , double-blind , placebo-controlled trial in which simvastatin reduced the risk of death by 30 % ( P=.0003 ) over the median follow-up period of 5.4 years in patients with previous myocardial infa rct ion or stable angina pectoris as a result of a 42 % reduction in the risk of coronary deaths ( P=.00001 ) . In the present report , data prospect ively collected from hospital admissions were analyzed to evaluate the impact of simvastatin on healthcare re source use and perform a cost-minimization analysis . In the placebo group ( n=2223 ) , there were 1905 hospitalizations ( average duration , 7.9 days ) for acute cardiovascular events or coronary revascularization procedures among 937 patients , whereas in the simvastatin group ( n=2221 ) , there were 1403 such hospitalizations ( average duration , 7.1 days ) among 720 patients ( all differences , P<.0001 ) . The corresponding number of hospital days was 15089 and 9951 in the two groups , respectively ( 34 % reduction , P<.0001 ) . In the United States , the result ing reduction in hospitalization costs over the 5.4 years of the trial would be $ 3872 per patient , reducing the effective cost of simvastatin by 88 % to $ 0.28 per day . CONCLUSIONS In addition to reducing mortality and morbidity in coronary heart disease patients , simvastatin markedly reduces use of hospital services , thus off setting most of its cost Abstract Objective : To measure the costs and cost effectiveness of the Oxcheck cardiovascular risk factor screening and intervention programme . Design : Cost effectiveness analysis of a r and omised controlled trial using clinical and economc data taken from the trial . Setting : Five general practice s in Luton and Dunstable , Engl and . Subjects : 2205 patients who attended a health check in 1989 - 90 and were scheduled for re-examination in 1992 - 3 ( intervention group ) ; 1916 patients who attended their initial health check in 1992 - 3 ( control group ) . Participants were men and women aged 35 - 64years . Intervention : Health check conducted by nurse , with health education and follow up according to degree of risk . Main outcome measures : Cost of health check programme ; cost per 1 % reduction in coronary risk . Results : Health check and follow up cost £ 29.27 per patient . Estimated programme cost per 1 % reduction in coronary risk per participant was between £ 1.46 and £ 2.25 ; it was nearly twice as much for men as women . Conclusions : The cost to the practice of implementing Oxcheck-style health checks in an average sized practice of 7500 patients would be £ 47 000 , a proportion of which could be paid for through staff pay reimbursements and B and Three health promotion target payments . This study highlights the considerable difficulties faced when calculating the costs and benefits of a health promotion programme . Economic evaluations should be integrated into the protocol s of r and omised controlled trials to enable judgments to be made on the relative cost effectiveness of different prevention strategies . Key messages Research was undertaken to estimate the cost of the health checks and relate the cost to changes in the relative risk of cardiovascular disease The immediate cost of implementing Oxcheck-style health checks in an average sized practice of 7500 patients would be £ 47 000 , which is comparable with the immediate cost of a cervical screening programme The actual costs to the practice would be substantially reduced by staff pay reimbursements and health promotion target payments Further research is required to estimate the wider costs of health checks result ing from the additional use of health care BACKGROUND The National Cholesterol Education Program recommends achievement of a defined target level of low-density lipoprotein cholesterol ( LDL-C ) for the treatment of hypercholesterolemia . They endorse the use of niacin and /or sequestrants as the first line of therapy to achieve such target LDL-C level . This recommendation has not been compared with the use of lovastatin as initial therapy if multidrug regimens are required to achieve goal LDL-C. METHODS Pro \n Output:\n " }, { "from": "agent", "value": "CONCLUSIONS : There is lack of data on cost effectiveness of cholesterol lowering interventions in the general practice setting .\nThe cost effectiveness of cholesterol lowering in general practice deteriorates when all relevant costs are taken into account and when efficacy is corrected for community effectiveness .\nCholesterol lowering intervention is more cost effective in men compared with women and in patients with coronary heart disease compared with persons without coronary heart disease ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: The clinical question at issue , whether it is possible to combine implants and natural teeth via fixed bridges , is of current interest . The treatment of the subjects of this prospect i ve study was performed between June 1984 and December 1986 . This article presents the 5-year results of the study . The consecutive patient material comprised 23 patients with Applegate Kennedy Class I residual dentition in the m and ible and a complete maxillary denture . All 23 patients were provided with implants ad modum Brånemark in each m and ibular quadrant . One side was r and omized to rehabilitation with fixed bridge between the distal tooth of the residual dentition and an implant ; the other side received a free-st and ang bridge on 2 implants . The fixture survival rate was 88 % . No difference was found between the two sides . Bridge stability was 89 % for the implant bridges and 91 % for the combination bridges . The change in marginal bone level at the implants was small during the 5-year follow up period ( on average 0.1 - 0.3 mm ) and with no difference between the two sides . In conclusion , it was not possible to demonstrate any higher risk of implant or prosthetic failure for tooth-implant fixed bridges compared with implant-supported bridges This study conducted a longitudinal prospect i ve clinical study of the single-crystal sapphire ( Al2O3 ) cylindrical screw-shaped endosteal dental implant , and attempted to establish clinical parameters to evaluate implant success or failure . Twenty-eight m and ibular implants ( 17 patients ) were placed . After six weeks ' healing , 23 implants in 15 patients served as distal abutments for fixed prostheses ( baseline ) . Implants were evaluated for bleeding index , crevicular fluid volume index , plaque accumulation index , radiographic index , mobility index , and patient comfort . Any implant failing in three of these criteria or implants removed were judged as failures . After 10 years , of the 21 baseline implants recalled ( two implants were lost to recall ) , 17 were fully functional , for an 81 % success rate . The use of qualitative and quantitative clinical evaluation parameters as utilized in this study appears to be important and useful in assessment s of the clinical serviceability of dental implants . These parameters can be used in human clinical trials as well as in experimental animal studies PURPOSE The use of implants for prosthetic rehabilitation of partially edentulous patients is increasing . However , the possibilities of placing implants in the posterior part of the m and ible are often limited . The purpose of this longitudinal study with 10 years of follow-up was to evaluate the use of short implants supporting fixed partial dentures ( FPD ) in the posterior part of the m and ible , and to compare implant supported FPDs to tooth-implant supported FPDs . MATERIAL S AND METHODS The patient material comprised 23 patients with residual m and ibular anterior teeth , and each patient received FPDs unilaterally . On one side the FPD was supported by two implants , and on the other side by one implant and one tooth , thus permitting intraindividual comparison . The distribution of the two types of FPDs in each jaw was r and omized . Implant success rates , marginal bone changes , and mechanical complications were studied . RESULTS The tooth-implant connection did not demonstrate any negative influences on the overall success rates for the 10-year period , nor were the shorter implants found to be less favorable . CONCLUSION It is suggested that a prosthetic construction supported by both a tooth and an implant may be recommended as a predictable and reliable treatment alternative in the posterior m and ible OBJECTIVES To assess prospect ively over 10 years the incidences of technical and /or biological complications and failures occurring in a cohort of consecutive partially edentulous patients with fixed reconstructions on implants of the ITI Dental Implant System . METHODS Eighty-nine patients were available , 34 ( 38.2 % ) were male , 55 ( 61.8 % ) were female . At the 10-year examination ( range 8 - 12 years ) , they were 58.9 years old ( range 28 - 88 years ) . RESULTS Single crowns ( SC ) : 48 patients had been restored with 69 SC on 69 implants . Five of the implants with the crowns were lost because of biological failures . Two crowns ( 2.9 % ) were remade because of technical failures . Total failure amounted to seven ( 10 % ) . Implant borne fixed partial dentures ( I-I FPD ) : In 29 patients who had been restored with 33 implant borne suprastructures , the total number of failed I-I FPD was 2 ( 6.1 % ) . Tooth-implant borne fixed partial dentures ( I-T FPD ) : In 21 patients , 22 mixed tooth-implant borne reconstructions were constructed . The number of failed FPD reached 7 ( 31.8 % ) . Statistically significantly fewer biological failures occurred with I-I FPD compared with the I-T FPDs ( ANOVA , Bonferroni , P=0.022 ) . The I-T FPDs experienced statistically significantly more frequent technical failures compared with the other two groups of suprastructures ( P=0.003 , 0.031 ) . Consequences of complications : The occurrence of loss of retention as a complication increased the odds ratio ( OR ) to 17.6 ( P<0.001 ) to end up in a technical failure . Similarly , the event of a porcelain fracture increased the OR for the suprastructure to be a failure at 10 years to 11.0 ( P < or = 0.004 ) . Treatment of periimplantitis increased the OR to 5.44 ( P < or = 0.011 ) to result in a biological failure compared with implants in which this type of treatment was not applied . CONCLUSION The three groups of suprastructures demonstrated marked differences in their patterns of failures and complications . Complications increased the risk for failure . Support by CRF , University of Berne , Switzerl and PURPOSE This long-term follow-up study aim ed to compare the outcome of fixed prostheses supported by teeth and implants and by freest and ing implants only . MATERIAL S AND METHODS From prosthesis insertion up to 14 years ( mean 6.5 y ) , 18 patients were followed . Implant-supported prostheses with and without tooth connection were compared within the same jaw . The tooth-implant prostheses were supported by 30 implants and 30 teeth , and the freest and ing prostheses were supported by 48 implants . Implant outcome , marginal bone stability , and mechanical complications were recorded . RESULTS Neither implant mobility nor fractures of any component of the implants were observed . No prosthesis complications were observed , and the same applied for crown cement failure and intrusion of teeth . Only one periapical lesion was detected at the first follow up . The annual change of the marginal bone level around connected and freest and ing implants did not differ significantly . The mean marginal bone loss ( over the 2 groups ) for the first 6 months amounted to 1.08 mm . After the first 6 months , an annual marginal bone loss of 0.015 mm was observed . There was no difference between the 3 connection types ( single implant connected to single tooth , multiple implants and /or multiple teeth connected with single connector , and multiple connectors ) for the first 6 months or thereafter . The marginal bone loss ( over the 3 groups ) for the first 6 months was 1.15 mm . After the first 6 months , the annual bone loss ( over the 3 groups ) amounted to 0.015 mm . CONCLUSION Based on the results of this study , splinting teeth with implants for implant-supported fixed prostheses did not affect the long-term outcome in comparison to freest and ing implants In 123 patients , 339 implants were connected to 313 teeth by means of fixed partial prostheses ( test ) and followed up for 1.5 - 15 years ( mean : 6.5 ) . In another ad r and om selected 123 patients , 329 implants were connected to each other by means of 123 freest and ing fixed partial prostheses ( control ) and were followed up for 1.3 - 14.5 years ( mean : 6.2 ) . The aim of this study was to compare both treatment modalities with each other based on implant , tooth and prosthesis complications . The cumulative implant success , based on implant immobility and /or lack of implant fractures after loading , in the test and control groups amounted to 95 % and 98.5 % , respectively . Although in the test group 10 implants versus only 1 in the control group failed , a regression analysis of the survival data , based on the cox proportional hazards model , revealed no significant difference . In the test group periapical lesions ( 3.5 % ) , tooth fracture ( 0.6 % ) and tooth extraction due to fatal decay or periodontitis ( 1 % ) were observed , besides tooth intrusion ( 3.4 % ) and crown cement failure ( 8 % ) . Framework fracture occurred in 3 patients . In the control group , only 2 abutment screws fractured . The treatment of partial edentulism by means of oral implants was beneficial for our patients . Because of a clear tendency of more implant failures ( mobility or fractures ) and tooth complications in the tooth-implant connected prostheses , the freest and ing solution is the primary option to be considered . To avoid intrusion of abutment teeth , the connection , if made , should be completely rigid Intramobile cylinder ( IMZ ) implants with either of two coatings , hydroxyapatite ( HA ) or titanium plasma-flame ( TPF ) , as distal abutments for combined tooth implant-supported restorations , were compared in 313 partially edentulous m and ibles with respect to postprosthetical failure patterns and complication frequencies in a r and omized multicenter clinical trial . Within the treatment protocol s , the two coatings do not show evidence of different efficacy with respect to occurrence of postprosthetical integration deficiency ( ID ) or functional deficiency ( FD ) . Statistical equivalence for an absolute effect of + /-15 % in event-free survival could only be demonstrated for FD , not for ID , however . Intent-to-treat and per- protocol population analyses gave consistent results . Hazards of occurrence of ID and FD , adjusted for years of follow-up , were estimated for ID as 7 % per year ( 95%CI 4 - 10 % per year ) with HA and 5 % per year ( 95%CI 3 - 7 % per year ) with TPF , and for FD as 5 % per year ( 95%CI 3 - 7 % per year ) with HA and 4 % per year ( 95%CI 2 - 6 % per year ) with TPF . The 5-year cumulative success rates for no ID were 69.5 % ( 95%CI 58 - 81 % ) with HA and 82.2 % ( 95%CI 74 - 91 % ) with TPF . With respect to frequencies of complications , there was no relevant statistically significant difference between the two coatings 49 patients participated in a prospect i ve study of treatment of total or partial edentulism with fixed prosthodontics supported by Bioceram sapphire implants . 15 patients were treated for maxillary or m and ibular edentulism , and 7 for a missing maxillary anterior tooth . The remaining 27 patients , with Applegate-Kennedy Class I-IV residual dentitions , were treated with fixed bridges supported by free-st and ing implants , or bridges supported by teeth and implants . Implant success , prosthesis stability , radiographic marginal bone level as well as parameters for peri-implant health were evaluated . The study began in 1982 , and clinical treatment of the last patients was completed in 1988 , i.e. , a follow-up period ranging from 7 to 13 years . Of the patients treated for total m and ibular edentulism , one implant fractured after 6 years in situ . The bone implant score ( BIS ) values for those implants were at the time for the bridge cementation 63.5 + /- 1.4 and at 1 , 2 , 3 and 5 year follow-ups 62.1 + /- 1.4 , 61.9 + /- 1.5 , 61.5 + /- 1.6 , and 60.95 + /- 1.3 , respectively . The success rate was 100 % , 100 % and 97.7 % for the m and ible at 3 , 5 and 10 years , respectively . Of the 7 edentulous patients treated with maxillary fixed bridges , 6 implants in 1 patient had to be removed after 1 year in service . Another 2 patients lost all their implants , 6 each , after 36 months . 6 implants in the 4th patient did not fulfil the criteria for success and were rated as failures at the four year follow-up . The success rate was thus 58.1 % , 44.2 % and 44.2 % for the maxilla at 3 , 5 and 10 year follow-ups , respectively . Of the 7 patients in whom single missing teeth were replaced , 1 implant in the premolar region was lost during the 1st year post-operatively , but no other complications or changes in BIS were observed . Of the 27 patients treated for partial edentulism ( 56 implants total ) 1 implant , of a 4-unit free st and ing maxillary bridge fractured after 6 years and was later replaced . There were no statistically significant differences in BIS changes for the implants when used as abutments for partial maxillary or m and ibular edentulism . The cumulative success rates for the impl \n Output:\n " }, { "from": "agent", "value": "Despite a high survival of FPDs , biological and technical complications are frequent .\nThis , in turn , means that substantial amounts of chair time have to be accepted by the clinician following the incorporation of implant-supported FPDs ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: Because no completely effective antiemetic exists for the prevention of postoperative nausea and vomiting ( PONV ) , we hypothesize that a multimodal approach to management of PONV may reduce both vomiting and the need for rescue antiemetics in high-risk patients . After IRB approval , women undergoing outpatient laparoscopy were r and omized to one of three groups . Group I ( n = 60 ) was managed by using a predefined multimodal clinical care algorithm . Patients undergoing the same surgical procedure who received a st and ard balanced outpatient anesthetic with ondansetron 4 mg ( Group II , n = 42 ) or placebo ( Group III , n = 37 ) prophylaxis were chosen to establish baseline incidence of nausea and vomiting . None of the Group I patients vomited before discharge , compared with 7 % in Group II ( P = 0.07 ) and 22 % in Group III ( P = 0.0003 ) . However , one patient ( 2 % ) in Group I required treatment for symptoms in the postanesthesia care unit , compared with 24 % in Group II ( P < 0.0001 ) and 41 % in Group III ( P < 0.0001 ) . Time to discharge-ready was significantly shorter in Group I ( 128 , 118–139 min ; mean , 95 % confidence interval ) versus Group II ( 162 , 145–181 min;P = 0.0015 ) and Group III ( 192 , 166–222 min;P = 0.0001 ) . Patient satisfaction with control of PONV was not different between Group I and Group II . Return to normal daily activity and overall satisfaction were not different among groups . Multimodal management result ed in a 98 % complete response rate and a 0 % incidence of vomiting before discharge ; however , this improvement did not result in an increased level of patient satisfaction when compared with routine monotherapy prophylaxis . We conclude that both multimodal management and routine monotherapy antiemetic prophylaxis result ed in an increased level of patient satisfaction than symptomatic treatment in this high-risk population . Implication s Use of a multimodal clinical care algorithm eliminates predischarge vomiting and improves satisfaction in patients undergoing outpatient laparoscopy Preoperative anxiety has been suggested as a predictor of postoperative nausea and vomiting ( PONV ) , but supporting data are lacking . We quantified the added predictive value of preoperative anxiety to established predictors of PONV in 1389 surgical in patients undergoing various procedures , by using multivariate logistic regression analysis . Investigated predictors were a history of PONV or motion sickness , smoking , sex , age , ethnicity , body mass index , ASA physical status , surgery type , duration of anesthesia , anesthetic technique , and postoperative opioid analgesia . Anxiety was measured by the Spielberger State-Trait Anxiety Inventory and the Amsterdam Preoperative Anxiety and Information Scale . The outcome was the occurrence of PONV in the first 24 h after surgery . The area under the receiver operating characteristic curve of a multivariate ( logistic regression ) model including sex , age , smoking , history of PONV or motion sickness , surgery type , and anesthetic technique was 0.72 ( 95 % confidence interval , 0.70–0.74 ) . There was a weak but significant association of anxiety with PONV , but the addition of anxiety to the model did not further increase the area under the receiver operating characteristic curve . Therefore , routine preoperative measurement of anxiety does not seem warranted , provided that the other predictors are already considered Background It is commonly stated that risk factors for postoperative nausea are the same as for vomiting . The authors design ed a prospect i ve study to identify and differentiate the risk factors for postoperative nausea and vomiting in various surgical population s in a clinical audit setting . Methods The study included 671 consecutive surgical in patients , aged 15 yr or more , undergoing various procedures . The study focused on postoperative nausea visual analog scale scores every 4 h and vomiting episodes within 72 h. Both vomiting and retching were considered as emetic events . Patient- , anesthesia- , and surgery-related variables that were considered to have a possible effect on the proportion of patients experiencing postoperative nausea and /or vomiting were examined . The bivariate Dale model for binary correlated outcomes was used to identify selectively the potential risk factors of postoperative nausea and vomiting . Results Among the 671 patients in the study , 126 ( 19 % ) reported one or more episodes of nausea , and 66 patients ( 10 % ) suffered one or more emetic episodes during the studied period . There was a highly significant association between the two outcomes . Some risk factors were predictive of both nausea and vomiting ( female gender , nonsmoking status , and general anesthesia ) . History of migraine and type of surgery were mainly responsible for nausea but not for vomiting . The predictive effect of risk factors was controlled for postoperative pain and analgesic drugs . Conclusion This study shows that differences exist in risk factors of postoperative nausea and vomiting . These could be explained by differences in the physiopathology of the two symptoms Risk scores to predict the occurrence of postoperative vomiting ( PV ) or nausea and vomiting that were developed for adult patients do not fit for children , because several risk factors are difficult to assess or are usually not applicable in pediatric patients ( e.g. , smoking status ) . Thus , in the present study , we sought to develop and to vali date a simple score to predict PV in children ( POVOC-score ) . Development and validation of the new score was based on data from 4 independent institutions of 1257 children ( aged 0–14 yr ) undergoing various types of surgery under general anesthesia without antiemetic prophylaxis . Preoperatively , several potential risk factors were recorded . Postoperatively , the occurrence of PV was observed for up to 24 h. The data set was r and omly split into an evaluation set ( n = 657 ) that was analyzed using a forward logistic regression technique and a validation set ( n = 600 ) that was used to confirm the accuracy of prediction by means of the area under a receiver operating characteristic curve . Four independent risk factors for PV were identified in the final analysis : duration of surgery ≥30 min , age ≥3 yr , strabismus surgery , and a positive history of PV in the children or PV/postoperative nausea and vomiting in relatives ( mother , father , or siblings ) . The incidence of PV was 9 % , 10 % , 30 % , 55 % , and 70 % for 0 , 1 , 2 , 3 , and 4 risk factors observed . Using these incidences as cut-off values in the validation data set , the area under the receiver operating characteristic curve was 0.72 ( 95 % confidence interval : 0.68–0.77 ) . Our data suggest that PV can be predicted with an acceptable accuracy using a four-item simplified risk score In this prospect i ve , r and omized , double-blind study , we compared the efficacy and safety of ondansetron and metoclopramide in the treatment of postoperative nausea and vomiting ( PONV ) . One hundred seventyfive patients with PONV during recovery from anesthesia for gynecological laparoscopy were treated intravenously with either ondansetron 4 mg ( 58 patients ) , metoclopramide 10 mg ( 57 patients ) , or placebo ( 60 patients ) . Early antiemetic efficacy ( abolition of vomiting within 10 min and of nausea within 30 min from the administration of the study drugs with no further vomiting or nausea episodes during the first hour ) was obtained in 54 of 58 patients ( 93.1 % ) in the ondansetron group , in 38 of 57 patients ( 66.7 % ) in the metoclopramide group , and in 21 of 60 patients ( 35 % ) in the placebo group ( P < 0.001 ) . This difference was still significant when controlling for age , body weight , history of motion sickness , previous PONV episodes , duration of anesthesia , and intraoperative fentanyl consumption using a logistic model . Early antiemetic efficacy was inversely related to the amount of fentanyl administered during anesthesia , regardless of treatment . According to the Kaplan-Meier method , the probability of remaining PONV-free for 48 h after a successful treatment was 0.59 ( 95 % confidence interval 0.45 - 0.71 ) in the ondansetron group , 0.45 ( 0.29 - 0.60 ) in the metoclopramide group , and 0.33 ( 0.15 - 0.53 ) in the placebo group ( P = 0.003 ) . In conclusion , ondansetron 4 mg is more effective than metoclopramide 10 mg and placebo in the treatment of established PONV . ( Anesth Analg 1997;85:395 - 9 Supplemental oxygen maintained during and for 2 h after colon resection halves the incidence of nausea and vomiting . Whether supplemental oxygen restricted to the intraoperative period is sufficient remains unknown . Similarly , the relative efficacy of supplemental oxygen and ondansetron is unknown . We tested the hypothesis that intraoperative supplemental oxygen reduces the incidence of postoperative nausea and vomiting . Patients ( n = 240 ) undergoing gynecological laparoscopy were given a st and ardized isoflurane anesthetic . After induction , they were r and omly assigned to the following three groups : routine oxygen administration with 30 % oxygen , balance nitrogen ( 30 % Oxygen group ) , supplemental oxygen administration with 80 % oxygen , balance nitrogen ( 80 % Oxygen group ) , and Ondansetron 8 mg ( immediately after induction ) , combined with 30 % oxygen , balance nitrogen ( Ondansetron group ) . The overall incidence of nausea and /or vomiting during the initial 24 postoperative h was 44 % in the patients assigned to 30 % oxygen and 30 % in the Ondansetron group , but only 22 % in those given 80 % oxygen . The incidence was thus halved by supplemental oxygen and was significantly less than with 30 % oxygen . There were , however , no significant differences between the 30 % oxygen and ondansetron groups , or between the ondansetron and 80 % oxygen groups . We conclude that supplemental oxygen effectively prevents postoperative nausea and vomiting after gynecological laparoscopic surgery ; furthermore , ondansetron is no more effective than supplemental oxygen . IMPLICATION S Supplemental oxygen reduces the risk of postoperative nausea and vomiting ( PONV ) as well or better than 8 mg of ondansetron . Because oxygen is inexpensive and essentially risk-free , supplemental oxygen is a preferable method of reducing PONV BACKGROUND Untreated , one third of patients who undergo surgery will have postoperative nausea and vomiting . Although many trials have been conducted , the relative benefits of prophylactic antiemetic interventions given alone or in combination remain unknown . METHODS We enrolled 5199 patients at high risk for postoperative nausea and vomiting in a r and omized , controlled trial of factorial design that was powered to evaluate interactions among as many as three antiemetic interventions . Of these patients , 4123 were r and omly assigned to 1 of 64 possible combinations of six prophylactic interventions : 4 mg of ondansetron or no ondansetron ; 4 mg of dexamethasone or no dexamethasone ; 1.25 mg of droperidol or no droperidol ; propofol or a volatile anesthetic ; nitrogen or nitrous oxide ; and remifentanil or fentanyl . The remaining patients were r and omly assigned with respect to the first four interventions . The primary outcome was nausea and vomiting within 24 hours after surgery , which was evaluated blindly . RESULTS Ondansetron , dexamethasone , and droperidol each reduced the risk of postoperative nausea and vomiting by about 26 percent . Propofol reduced the risk by 19 percent , and nitrogen by 12 percent ; the risk reduction with both of these agents ( i.e. , total intravenous anesthesia ) was thus similar to that observed with each of the antiemetics . All the interventions acted independently of one another and independently of the patients ' baseline risk . Consequently , the relative risks associated with the combined interventions could be estimated by multiplying the relative risks associated with each intervention . Absolute risk reduction , though , was a critical function of patients ' baseline risk . CONCLUSIONS Because antiemetic interventions are similarly effective and act independently , the safest or least expensive should be used first . Prophylaxis is rarely warranted in low-risk patients , moderate-risk patients may benefit from a single intervention , and multiple interventions should be reserved for high-risk patients Background Intraoperative hypovolemia is common and is a potential cause of organ dysfunction , increased postoperative morbidity , length of hospital stay , and death . The objective of this prospect i ve , r and omized study was to assess the effect of goal -directed intraoperative fluid administration on length of postoperative hospital stay . Methods One hundred patients who were to undergo major elective surgery with an anticipated blood loss greater than 500 ml were r and omly assigned to a control group ( n = 50 ) that received st and ard intraoperative care or to a protocol group ( n = 50 ) that , in addition , received intraoperative plasma volume expansion guided by the esophageal Doppler \n Output:\n " }, { "from": "agent", "value": "Modern PONV risk research began in the 1990s with publication of studies using logistic regression analysis to simultaneously identify multiple independent PONV predictors and publication of meta-analyses and systematic review s. This literature shows that female gender post-puberty , nonsmoking status , history of PONV or motion sickness , childhood after infancy and younger adulthood , increasing duration of surgery , and use of volatile anesthetics , nitrous oxide , large-dose neostigmine , or intraoperative or postoperative opioids are well established PONV risk factors .\nPossible risk factors include history of migraine , history of PONV or motion sickness in a child 's parent or sibling , better ASA physical status , intense preoperative anxiety , certain ethnicities or surgery types , decreased perioperative fluids , crystalloid versus colloid administration , increasing duration of anesthesia , general versus regional anesthesia or sedation , balanced versus total IV anesthesia , and use of longer-acting versus shorter-acting opioids .\nEarly-phase menstruation , obesity and lack of supplemental oxygen are disproved risk factors .\nCurrent risk scoring systems have approximately 55%-80 % accuracy in predicting which patient groups will suffer PONV ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: Oxytocin has numerous prosocial and antipsychotic-like effects in animals . Prosocial effects of acute intranasal oxytocin administration have also been reported in human subjects . We conducted a r and omized , placebo-controlled trial testing the effects of twice daily intranasal oxytocin treatment for 14 days on psychotic symptoms and social cognition in patients with schizophrenia . PANSS scores declined significantly and several social cognition measures improved significantly or nearly significantly in oxytocin ( N=11 ) but not placebo ( N=9 ) recipients . Our results suggest that , in addition to reducing classic psychotic symptoms , oxytocin may diminish certain social cognition deficits that are not improved by current antipsychotic medications BACKGROUND Social impairments are central to the syndrome of autism . The neuropeptide oxytocin ( OT ) has been implicated in the regulation of social behavior in animals but has not yet been examined in autistic subjects . METHODS To determine whether autistic children have abnormalities in OT , midday plasma sample s from 29 autistic and 30 age-matched normal children , all prepubertal , were analyzed by radioimmunoassay for levels of OT . RESULTS Despite individual variability and overlapping group distributions , the autistic group had significantly lower plasma OT levels than the normal group . OT increased with age in the normal but not the autistic children . Elevated OT was associated with higher scores on social and developmental measures for the normal children , but was associated with lower scores for the autistic children . These relationships were strongest in a subset of autistic children identified as aloof . CONCLUSIONS Although making inferences to central OT functioning from peripheral measurement is difficult , the data suggest that OT abnormalities may exist in autism , and that more direct investigation of central nervous system OT function is warranted The impact of lithium on arginine vasopressin ( AVP ) release has implication s for our underst and ing of the pathophysiology and treatment of mood disorders and for the interpretation of neuroendocrine studies . In this secondary analysis of neuroendocrine , data from 23 patients with chronic major depressive disorder , 41 patients with bipolar disorder and 18 healthy controls , we examine the relationship between lithium therapy , AVP levels and the cortisol response to the dexamethasone/corticotropin-releasing hormone ( dex/CRH ) test . These data demonstrate that patients taking lithium have elevated post-dexamethasone AVP levels compared to both healthy controls and patients not on lithium BACKGROUND Previously , we found that mean plasma concentrations of arginine vasopressin ( AVP ) , but not of oxytocin ( OT ) , were higher in depressed patients than in healthy controls . Plasma AVP concentrations were positively correlated to clinical ly rated psychomotor retardation . To further explore this previously reported relation we studied psychomotor retardation by means of an activity monitor , which is a more fine-focused and more objective instrument to analyze motor retardation than a clinical rating scale . METHODS Plasma AVP and OT concentrations , and day- and nighttime wrist activity were measured in 48 in- and out patients with major depression and 30 healthy controls during a period of 5 consecutive days and nights . RESULTS Principal components analysis revealed three components of motor activity : motor activity during wakefulness , motor activity during sleep , and the awake/sleep time ratio . In patients and controls an inverse relationship between plasma AVP concentrations and motor activity during wakefulness was found . Patients with elevated AVP plasma levels showed increased motor activity during sleep . CONCLUSIONS These results suggest that high plasma AVP levels are related to the clinical picture of daytime psychomotor retardation and nighttime motor activity in major depression . Mean plasma OT concentrations were not related to measures of motor activity Both oxytocin ( OT ) and vasopressin ( AVP ) are known to modulate social behavior , and dysfunction in both systems has been postulated as a potential cause of certain psychiatric disorders that involve social behavioral deficits . In particular , there is growing interest in intranasal OT as a potential treatment for certain psychiatric disorders , and preliminary pre- clinical and clinical studies suggest efficacy in alleviating some of the associated symptoms . However , the vast majority of research participants in these studies have been male , and there is evidence for sexually differentiated effects of nonapeptides in both humans and non-human animals . To date , no study has investigated the effect of intranasal OT on brain function in human males and females within the same paradigm . Previously , in a r and omized , placebo-controlled , double-blind fMRI study , we reported effects of intranasal OT and AVP on behavior and brain activity of human males as they played an interactive social game known as the Prisoner 's Dilemma Game . Here , we present findings from an identical study in human females , and compare these with our findings from males . Overall , we find that both behavioral and neural responses to intranasal OT and AVP are highly sexually differentiated . In women , AVP increased conciliatory behavior , and both OT and AVP caused women to treat computer partners more like humans . In men , AVP increased reciprocation of cooperation from both human and computer partners . However , no specific drug effects on behavior were shared between men and women . During cooperative interactions , both OT and AVP increased brain activity in men within areas rich in OT and AVP receptors and in areas playing a key role in reward , social bonding , arousal and memory ( e.g. , the striatum , basal forebrain , insula , amygdala and hippocampus ) , whereas OT and AVP either had no effect or in some cases actually decreased brain activity in these regions in women . OT treatment rendered neural responses of males more similar to responses of females in the placebo group and vice versa , raising the prospect of an inverted u-shaped dose response to central OT levels . These findings emphasize the need to fully characterize the effects of intranasal OT and AVP in both males and females and at multiple doses before widespread clinical application will be warranted Of heuristic value in underst and ing the neurochemistry of major depression is whether the hypothalamo-pituitary-adrenocortical ( HPA ) axis hyperactivity that occurs in this illness can be related to putative neurotransmitter dysfunction(s ) . Cholinergic neurotransmission stimulates hypothalamic corticotropin releasing hormone ( CRH ) and arginine vasopressin ( AVP ) secretion , both of which stimulate pituitary corticotropin ( ACTH ) secretion , but whether the HPA axis in humans is activated only by doses of cholinergic agonists that produce noxious side effects remains controversial . To test the hypothesis of increased cholinergic sensitivity in major depression , physostigmine ( PHYSO ) , a reversible cholinesterase inhibitor , was administered to patients and control subjects at a dose that elevated plasma ACTH , cortisol , and AVP concentrations but produced few or no side effects . Exogenous AVP also was administered to determine if it would augment the effect of low-dose PHYSO on the HPA axis . Twelve premenopausal or estrogen-replaced female major depressives , 12 individually matched female control subjects , eight male major depressives , and eight matched male control subjects underwent four test sessions 5 - 7 days apart : PHYSO ( 8 microg/kg IV ) , AVP ( 0.08 U/kg IM ) , PHYSO + AVP , and saline control . Serial blood sample s were taken before and after pharmacologic challenge and analyzed for ACTH1 - 39 , cortisol , and AVP . Estradiol and testosterone were also measured at each test session . PHYSO ( 8 microg/kg ) significantly increased plasma ACTH , cortisol , and AVP , while producing no side effects in approximately half the subjects and predominantly mild side effects in the other half . These hormone increases following PHYSO occurred primarily in the female depressives and the male control subjects and were not significantly related to the presence or absence of side effects . The greater the ACTH and AVP responses to PHYSO , the stronger their correlation , suggesting that AVP may have been acting as a secretagogue for ACTH . Administered AVP significantly increased the secretion of ACTH in the patients and control subjects to a similar degree , and AVP given after PHYSO did not augment the HPA axis response to a greater degree in the depressives than in the control subjects . Plasma estradiol and testosterone were within the normal range for all four groups of subjects and were not significantly related to their HPA axis hormone responses . The study results support the hypothesis of heightened cholinergic sensitivity in premenopausal female , but not in male , patients with major depression . The low dose of PHYSO used may represent a useful paradigm for central cholinergic stimulation of the HPA axis OBJECTIVE These studies were design ed to evaluate the efficacy and tolerability of the first nonpeptide vasopressin V(1b ) receptor antagonist , SSR149415 , in the treatment of major depressive disorder ( MDD ) and generalized anxiety disorder ( GAD ) . METHOD Studies were r and omized 8-week , double-blind , placebo-controlled trials evaluating 100- and 250-mg twice daily doses of SSR149415 , placebo , and escitalopram 10 mg/day or paroxetine 20 mg/day , conducted from August 2006 through February 2008 . Participants met the Diagnostic and Statistical Manual of Mental Disorders , Fourth Edition , Text Revision criteria for MDD or GAD . Baseline Montgomery-Asberg Depression Rating Scale ( MADRS ) and Hamilton Depression Rating Scale ( HDRS ) total scores were ≥ 24 and 18 , respectively , and in the GAD trial baseline Hamilton Anxiety Rating Scale ( HARS ) score was ≥ 22 . Primary efficacy variables included changes from baseline in total score on HDRS or HARS and MADRS , and the secondary variable included changes in the Clinical Global Impressions-Severity of Illness score ( CGI-S ) . A 4-week , double-blind , placebo-controlled study evaluating the effect of 100- and 250-mg twice daily doses of SSR149415 on the hypothalamic-pituitary-adrenal ( HPA ) axis in MDD patients was also conducted . RESULTS In the GAD trial , SSR149415 did not separate from placebo on the primary ( HARS-100 mg : P = .29 ; 250 mg : P = .21 ) and secondary ( CGI-S-100 mg : P = .18 ; 250 mg : P = .24 ) outcome measures , while paroxetine demonstrated efficacy ( HARS : P = .003 ; CGI-S : P = .01 ) . In 2 MDD trials , SSR149415-treated patients did not show significant improvement from baseline on any outcome measure compared with placebo-treated patients ( HDRS-100 mg : P = .21 and .48 , respectively ; 250 mg : P = .22 and P = .46 , respectively ; CGI-S-100 mg : P = .64 and P = .82 , respectively ; 250 mg : P = .33 and P = .08 , respectively ) . In the third MDD study , SSR149415 250 mg ( P = .04 ) , but not escitalopram ( P = .15 ) , demonstrated significant improvement compared to placebo on the HDRS total score at week 8 . SSR149415 had no deleterious effects on the HPA axis . CONCLUSIONS These studies demonstrate that SSR149415 may not be useful for the treatment of GAD and that its antidepressant potential needs to be further evaluated . TRIAL REGISTRATION Clinical Trials.gov identifiers : NCT00374166 ( Sanofi ID number : DFI5880 ) , NCT00361491 ( Sanofi ID number : DFI5879 ) , NCT00358631 ( Sanofi ID number : DFI5878 ) , NCT01606384 ( Sanofi ID number : PDY5467 ) Human beings exhibit substantial interpersonal trust-even with strangers . The neuroactive hormone oxytocin facilitates social recognition in animals , and we examine if oxytocin is related to trustworthiness between humans . This paper reports the results of an experiment to test this hypothesis , where trust and trustworthiness are measured using the sequential anonymous \" trust game \" with monetary payoffs . We find that oxytocin levels are higher in subjects who receive a monetary transfer that reflects an intention of trust relative to an unintentional monetary transfer of the same amount . In addition , higher oxytocin levels are associated with trustworthy behavior ( the reciprocation of trust ) . Absent intentionality , both the oxytocin and behavioral responses are extinguished . We conclude that perceptions of intentions of trust affect levels of circulating oxytocin Background There are no effective medications for the treatment of social cognition/function deficits in autism spectrum disorder ( ASD ) , and adult intervention literature in this area is sparse . Emerging data from animal models and genetic association studies as well as early , single-dose intervention studies suggest that the oxytocin system may be a potential therapeutic target for social cognition/function deficits in ASD . The primary aim of this study was to examine the safety/therapeutic effects of intranasal oxytocin versus placebo in adults with ASD , with respect to the two core symptom domains of social cognition/functioning and repetitive behaviors . Methods This was a pilot , r and om \n Output:\n " }, { "from": "agent", "value": "There is no convincing evidence that peripheral ADH or OT might be reliable biomarkers in psychiatric disorders ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: BACKGROUND Poor growth and delayed maturation in children with sickle cell disease ( SCD ) may be due , in part , to mild zinc deficiency . OBJECTIVE The objective was to determine the effects of zinc supplementation on growth and body composition in children with SCD . DESIGN Forty-two prepubertal children ( 20 girls and 22 boys ) aged 4 - 10 y with SCD-SS were r and omly assigned to receive 10 mg elemental Zn/d in cherry syrup ( zinc group ) or cherry syrup alone ( control group ) . The 2 groups were stratified by sex and initial height status . Dietary intakes were evaluated and anthropometric , high-precision knee-height , and plasma zinc measurements were made at baseline and at 3 , 6 , and 12 mo . Body composition was determined every 6 mo with dual-energy X-ray absorptiometry , and z scores for anthropometric variables were computed from national reference data . Longitudinal-mixed-effects analysis was used to test for differences between the groups over the 12-mo observation period . RESULTS Thirty-eight children completed the study . No significant differences were observed at baseline . After 12 mo , the zinc group had significantly greater mean ( + /- SE ) increases in height ( 0.66 + /- 0.29 cm/y ) , sitting height ( 0.97 + /- 0.40 cm/y ) , knee height ( 3.8 + /- 1.2 mm/y ) , and arm circumference z scores ( 0.27 + /- 0.12 cm/y ) . Height-for-age and weight-for-age z scores decreased significantly by 0.11 + /- 0.04 and 0.13 + /- 0.05 , respectively , in the control group but did not change significantly in the zinc group . CONCLUSIONS Prepubertal children with SCD-SS may have zinc deficiency and may benefit from zinc supplementation to improve linear growth and weight gain Objective There are some reports in which a condition of zinc deficiency and its associated outcomes with a change in concentration of serum copper among the thalassemic patients has been highlighted . The aim of this prospect i ve study was to determine the serum zinc and copper levels in children with beta-thalassemia major . Methods In this cross sectional study all children under 12 years affected by beta thalassemia major ( 40 patients ) were evaluated for serum zinc and copper levels in Qazvin thalassemia center ( Qazvin , Iran ) in 2007 . Serum measurements for zinc and copper were performed by atomic absorption spectrophotometer . Findings The mean concentrations of serum zinc and copper levels were 67.35±20.38 and 152.42±24.17 µg/dl respectively . Twenty-six ( 65 % ) of thalassemic patients had zinc concentration under 70 µg/dl ( hypozincemia ) . None of the thalassemic children had copper deficiency . No significant correlation between serum zinc level with age , weight , height , body mass index , duration of blood transfusion , desferrioxamine dose and ferritin level was observed in thalassemic patients ( P=0.3 ) . Conclusion This study revealed that hypozincemia is common in thalassemic patients , but in contrast , there is no copper deficiency . Further evaluation in this regard is recommended Objective In beta thalassemic patients , tissue damage occurs due to oxidative stress and it happens because of the accumulation of iron in the body . This study was conducted to determine the effect of zinc and vitamin E supplementation on antioxidant status in beta-thalassemic major patients . Methods This double blind r and omized clinical trial was carried out on 120 beta thalassemic patients older than 18 years . Patients were r and omly categorized in four groups . Zinc ( 50mg/day ) and vitamin E ( 400mg/day ) supplements were administered for former and latter group , respectively . In the third group both supplements were administered in similar doses . The fourth ( control ) group received no supplement . The effect of supplementations on serum zinc and vitamin E , superoxide dismutase ( SOD ) , glutathione peroxidase ( GPX ) , total antioxidant capacity ( TAC ) and body mass index ( BMI ) were measured at the beginning and the end of the study . Findings Serum zinc levels in group 1 and 3 were significantly increased ( P<0.007 and P<0.005 , respectively ) . Serum vitamin E levels in group 2 and 3 were also increased significantly ( P<0.001 ) . Mean GPX activity in group1 , 2 and 3 decreased significantly ( P<0.015 , P<0.032 and P<0.029 , respectively ) . Mean SOD activity and TAC did not show significant change after supplementation . BMI had significant increase in all treated groups ( P<0.001 ) . Conclusion Our results suggest that beta thalassemic patients have enhanced oxidative stress and administration of selective antioxidants may preclude oxidative damage Zinc deficiency is a common nutritional problem in adult sickle‐cell disease ( SCD ) patients . Hyperzincuria and increased requirement of zinc due to continued hemolysis in SCD are probable bases for zinc deficiency in these patients . Zinc deficiency affects adversely T‐helper1 ( TH1 ) functions and cell mediated immunity and interleukin (IL)‐2 production is decreased in zinc deficient subjects . We hypothesized that zinc supplementation will improve T‐helper1 function and decrease incidence of infections in patients with SCD . We tested this hypothesis in 32 SCD subjects who were divided in three groups ( Grs A , B , and C ) . Grs A ( n = 11 ) and B ( n = 10 ) were zinc deficient based on cellular zinc criteria and Gr C ( n = 11 ) were zinc sufficient . Gr A subjects were observed for 1 year ( baseline ) , following which they received zinc acetate ( 50 to 75 mg of elemental zinc orally daily ) for 3 years . Gr B subjects were observed for 1 year ( baseline ) , following which they received placebo for 1 year and then switched to zinc supplementation ( 50 to 75 mg of elemental zinc orally daily ) for 2 years . Gr C subjects did not receive any intervention inasmuch as they were zinc sufficient . Prolonged zinc supplementation result ed in an increase in lymphocyte and granulocyte zinc ( P = 0.0001 ) , and an increase in interleukin‐2 production ( P = 0.0001 ) , decreased incidence of documented bacteriologically positive infections ( P = 0.0026 ) , decreased number of hospitalizations and decreased number of vaso‐occlusive pain crisis ( P = 0.0001 ) . The predominant pathogens isolated were staphylococci and streptococci involving the respiratory tract and aerobic gram‐negative bacteria , particularly Escherichia coli , involving the urinary tract . Further confirmation of our observations will require prospect i ve studies of zinc supplementation in a larger number of SCD patients . Am . J. Hematol . 61:194–202 , 1999 . © 1999 Wiley‐Liss , The toxicity of oral zinc was investigated in patients hospitalized for chronic leg ulcers . Untoward effects were monitored by reference to clinical tolerance , hematological , hepatic and renal parameters , and serum concentrations of copper and iron . The investigation was conducted by comparing two groups of patients who initially did not differ significantly with regard to ulcer area , hemoglobin , leukocytes , copper , iron and zinc . Both groups had serum zinc concentrations in the lower normal range . One group was treated with 3 daily doses of 220 mg oral zinc sulfate and the other with placebo , and hence , untoward effects of zinc should have become manifest in the zinc-treated group . This was not the case . Therefore , oral zinc appears to be well tolerated clinical ly and does not cause hematological , renal or hepatic toxicity . In view of the increasing interest in and range of indications for zinc , particularly in conditions associated with cellular immunological hyporeactivity , this finding is a prerequisite for the institution of clinical zinc therapy Previously , we have documented primary testicular failure in adult male subjects with sickle cell anemia . We have also reported the occurrence of zinc deficiency and suggested that and rogen deficiency may be related to zinc deficiency in such patients . In this study , we present data with respect to the effect of oral zinc supplementation on serum testosterone levels in adult male patients with sickle cell anemia . An increase in serum testosterone , neutrophil zinc , and neutrophil alkaline phosphatase activity was observed in the zinc‐supplemented group in comparison with the group on placebo . Additionally , body weight increased and serum lactic dehydrogenase activity decreased in response to zinc supplementation . We conclude that and rogen deficiency in adult male subjects with sickle cell anemia is correctable with zinc supplementation and that the determination of neutrophil zinc and alkaline phosphatase activity in the neutrophils may be utilized as good indicators of body zinc status in such subjects Abstract In a controlled trial on the effect of oral zinc sulphate in the healing of sickle-cell leg ulcers , the healing-rate in the treatment group was three times faster than in the placebo group \n Output:\n " }, { "from": "agent", "value": "According to the results , there is no evidence from r and omised controlled trials to indicate any benefit of zinc supplementation with regards to serum zinc level in patients with thalassaemia .\nThere is mixed evidence on the benefit of using zinc supplementation in people with sickle cell disease ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: The authors hypothesized that the placement of the interspinous implant would show a similar clinical outcome to the posterior lumbar interbody fusion ( PLIF ) in patients having spinal stenosis with mild segmental instability and that this method would be superior to PLIF without significantly affecting degeneration at the adjacent segments . Forty two adult patients having degenerative spinal stenosis with mild segmental instabilit who underwent implantation of Coflex ™ ( Spine motion , Germany ) or PLIF at L4 - 5 between January 2000 and December 2003 were consecutively selected and studied for one-year clinical outcome . At 12 months after surgery , both groups showed a significant improvement in the visual analogue scale score and Oswestry disability index score for both lower extremity pain and low back pain . However , the range of motion at the upper adjacent segments ( L3 - 4 ) increased significantly after surgery in the PLIF group , which was not manifested in the Coflex ™ group during the follow-up . The authors assumed that interspinous implantation can be an alternative treatment for the spinal stenosis with segmental instability in selected conditions posing less stress on the superior adjacent level than PLIF OBJECT To assess the safety and efficacy of the DIAM implant , the authors compared the mean 12-month outcomes in patients who underwent lumbar surgery with DIAM placement and in those who underwent lumbar surgery only . METHODS Of 62 patients who underwent simple lumbar surgery ( laminectomy and /or microdiscectomy ) in a 24-month period , 31 underwent concomitant surgical placement of a DIAM interspinous process spacer ( 33 devices total ) . Radiographic imaging , pain scores , and clinical assessment s were obtained postoperatively to a mean of 12 months ( range 8 - 25 months ) . Patients who did not undergo implantation of an interspinous process spacer ( Group C ) were compared with and stratified against patients who underwent placement of a DIAM implant ( Group D ) . In Group D , no statistically significant differences were noted in anterior or posterior disc height when comparing patients pre- and postoperatively . Compared with Group C , a relative kyphosis of less than 2 degrees was noted on postoperative images obtained in Group D. No statistically significant differences in visual analog scale ( VAS ) pain scores or MacNab outcomes were noted between Groups C and D at a mean of 12 months of follow up . Complications in Group D included three intraoperative spinous process fractures and one infection . CONCLUSIONS After simple lumbar surgery , the placement of a DIAM interspinous process spacer did not alter disc height or sagittal alignment at the mean 12-month follow-up interval . No adverse local or systemic reaction to the DIAM was noted . No difference in VAS or MacNab outcome scores was noted between the groups treated with or without the DIAM implants , particularly when the DIAM was used to alleviate low-back pain The authors report a series of 43 patients suffering from lower limb pain , almost constantly associated with chronic or acute backpain , treated by microsurgical nerve root decompression and by implantation of a soft intervertebral prothesis ( DIAM ) . Satisfying results were obtained in 97 % of cases , inducing the authors to consider the device a reliable tool for curing low-back pain and sciatica . Selection criteria are exposed and discussed OBJECT This study was conducted to compare the quality of life ( QOL ) in patients with neurogenic intermittent claudication ( NIC ) secondary to lumbar spinal stenosis ( LSS ) . Using the 36-Item Short Form ( SF-36 ) question naire , the authors compared the results obtained in patients treated with the X STOP Interspinous Process Decompression ( IPD ) System with those obtained in patients who underwent nonoperative therapies . METHODS Patients with LSS were enrolled in a prospect i ve 2-year multicenter study and r and omized either to the X STOP or nonoperative group . The SF-36 survey was used to assess the QOL before treatment and at 6 weeks , 6 months , 1 year , and 2 years posttreatment . An analysis of variance was used to compare individual pre- and posttreatment mean SF-36 domain scores between the two groups and within each treatment group . At all posttreatment time points , the authors observed the following : ( 1 ) mean domain scores in X STOP-treated patients were significantly greater than those in patients treated nonoperatively , with the exception of the mean General Health ( GH ) , Role Emotional , and Mental Component Summary scores at 2 years ; and ( 2 ) mean posttreatment domain scores documented in X STOP-treated patients were significantly greater than mean pretreatment scores , with the exception of mean GH scores at 6 , 12 , and 24 months . CONCLUSIONS The results of this study demonstrate that the X STOP device is significantly more effective than nonoperative therapy in improving the QOL in patients with LSS . The results are comparable with those reported in other studies involving traditional decompressive techniques for LSS and suggest that the X STOP implant can provide an effective treatment compared with nonoperative and conventional surgical therapies Study Design . A r and omized , controlled , prospect i ve multicenter trial comparing the outcomes of neurogenic intermittent claudication ( NIC ) patients treated with the interspinous process decompression system ( X STOP ) with patients treated nonoperatively . Objective . To determine the safety and efficacy of the X STOP interspinous implant . Summary of Background Data . Patients suffering from NIC secondary to lumbar spinal stenosis have been limited to a choice between nonoperative therapies and decompressive surgical procedures , with or without fusion . The X STOP was developed to provide an alternative therapeutic treatment . Methods . 191 patients were treated , 100 in the X STOP group and 91 in the control group . The primary outcomes measure was the Zurich Claudication Question naire , a patient-completed , vali date d instrument for NIC . Results . At every follow-up visit , X STOP patients had significantly better outcomes in each domain of the Zurich Claudication Question naire . At 2 years , the X STOP patients improved by 45.4 % over the mean baseline Symptom Severity score compared with 7.4 % in the control group ; the mean improvement in the Physical Function domain was 44.3 % in the X STOP group and −0.4 % in the control group . In the X STOP group , 73.1 % patients were satisfied with their treatment compared with 35.9 % of control patients . Conclusions . The X STOP provides a conservative yet effective treatment for patients suffering from lumbar spinal stenosis . In the continuum of treatment options , the X STOP offers an attractive alternative to both conservative care and decompressive surgery Abstract . A first-generation implant for non-rigid stabilization of lumbar segments was developed in 1986 . It included a titanium interspinous blocker and an artificial ligament made of dacron . Following an initial observational study in 1988 and a prospect i ve controlled study from 1988 to 1993 , more than 300 patients have been treated for degenerative lesions with this type of implant with clinical and mechanical follow-up . After careful analysis of the points that could be improved , a second-generation implant called the \" Wallis \" implant , was developed . This interspinous blocker , which was made of metal in the preliminary version , is made of PEEK ( polyetheretherketone ) in the new model . The overall implant constitutes a \" floating \" system , with no permanent fixation in the vertebral bone , to avoid the risk of loosening . It achieves an increase in the rigidity of destabilized segments beyond normal values . The clinical trials of the first-generation implant provided evidence that the interspinous system of non-rigid stabilization is efficacious against low-back pain due to degenerative instability and free of serious complications . The first-generation devices achieved marked , significant resolution of residual low-back pain . These results warrant confirmation . A r and omized clinical trial and an observational study of the new implant are currently underway . Non-rigid fixation clearly appears to be a useful technique in the management of initial forms of degenerative intervertebral lumbar disc disease . This method should rapidly assume a specific role along with total disc prostheses in the new step-wise surgical strategy to obviate definitive fusion of degenerative intervertebral segments . At present , the Wallis system is recommended for lumbar disc disease in the following indications : ( i ) discectomy for massive herniated disc leading to substantial loss of disc material , ( ii ) a second discectomy for recurrence of herniated disc , ( iii ) discectomy for herniation of a transitional disc with sacralization of L5 , ( iv ) degenerative disc disease at a level adjacent to a previous fusion , and ( v ) isolated Modic I lesion leading to chronic low-back pain A technique is described for widening the lumbar vertebral canal in the treatment of lumbar stenosis . This method , which preserves part of the posterior arches , has the aim of avoiding the instability which accompanies extensive laminectomies of the whole lumbar spine . The preservation of the posterior arches allows a ligamentoplasty to be made with dacron in stable spines and a combined fusion with internal fixation applied to the posterior arches to be made in cases of spondylolisthesis . The results of a prospect i ve series of 32 patients have confirmed the effectiveness of the method both on the stenosis and on the post-operative spinal stability Study Design A prospect i ve cohort study of patients with lumbar spinal stenosis recruited from the practice s of orthopedic surgeons and neurosurgeons throughout Maine . Objective To assess 1‐year outcomes of patients with lumbar spinal stenosis treated surgically or nonsurgically . Summary of Background Data No r and omized trials and few nonexperimental studies have compared surgical and nonsurgical treatment of patients with lumbar spinal stenosis . The authors ' goal was to assess 1‐year outcomes of patients with lumbar spinal stenosis treated surgically or nonsurgically . Methods Eligible , consenting patients participated in baseline interviews and were then mailed follow‐up question naires at 3 , 6 , and 12 months . Clinical data were obtained from a physician question naire . Outcomes included patient‐reported symptoms of leg and back pain , functional status , disability , and satisfaction with care . Results One hundred forty‐eight patients with lumbar spinal stenosis were enrolled , of whom 81 were treated surgically and 67 treated nonsurgically . On average , patients in the surgical group had more severe imaging findings and symptoms and worse functional status than patients in the nonsurgical group at entry . Few patients with mild symptoms were treated surgically , and few patients with severe symptoms were treated nonsurgically . However , of the patients with moderate symptoms , a similar percent were treated surgically or nonsurgically . One year after study entry , 28 % of nonsurgically and 55 % of surgically treated patients reported definite improvement in their predominant symptoms ( P = 0.003 ) . For patients with moderate symptoms , outcomes for surgically treated patients were also improved compared with those of nonsurgically treated patients . Surgicla treatment remained a significant determinant of 1‐year outcome , even after adjustment for differences between treatment groups at entry ( P = 0.05 ) . The maximal benefit of surgery was observed by the time of the first follow‐up evaluation , which was at 3 months . Although few nonsurgically treated patients experienced a worsening of their condition , there was little improvement in symptoms and functional status compared with study entry . Conclusions At a 1‐year evaluation of patient‐reported outcomes , patients with severe lumbar spinal stenosis who were treated surgically had greater improvement than patients treated nonsurgically . Comparisons of outcomes by treatment received must be made cautiously because of differences in baseline characteristics . A determination of whether the outcomes observed persist requires long‐term follow‐up Background Lumbar spinal stenosis ( LSS ) is often a position-dependent condition that is aggravated in extension and relieved in flexion . Methods Ten consecutive elderly patients with LSS were assessed postoperatively by magnetic resonance imaging and the Swiss Spinal Stenosis Question naire . Cross-sectional areas of the dural sac and intervertebral foramina at the stenotic level were measured postoperatively and compared with the preoperative values . Results Postoperatively the cross-sectional area of the dural sac increased 16.6 mm2 or 22.3 % and intervertebral foramina increased 22 mm2 or 36.5 % . The intervertebral angle and the posterior disc height changed significantly . Seventy percent of the patients were satisfied with the surgical outcome . Conclusion This new surgical method is effective in elderly LSS patients STUDY DESIGN A prospect i ve cohort study of patients with lumbar spinal stenosis recruited from the practice s of orthopedic surgeons and neurosurgeons throughout Maine . OBJECTIVE To assess 4-year outcomes for patients with lumbar spinal stenosis treated surgically or nonsurgically . SUMMARY OF BACKGROUND DATA Surgery for lumbar spinal stenosis has increased dramatically despite the lack of r and omized trials comparing surgical with nonsurgical treatments . Long-term evaluation of surgical series has documented deterioration in initial symptomatic improvement , but few studies have compared long-term outcomes of surgical and nonsurgical treatment . METHODS Eligible , consenting patients had baseline interviews with mailed follow-up question naires at 3 , 6 , and 12 months , then annually thereafter . Clinical data were obtained at baseline from a physician question naire . Outcomes included patient-reported symptoms of leg and back pain , functional status , and satisfaction . RESULTS Of 148 patients with lumbar spinal stenosis initially enrolled , 4-year outcomes were available on 119 patients ( 80.4 % ) : 67 of 81 ( 83 % ) treated surgically and 52 of 67 ( 78 % ) treated nonsurgically . The surgically treated patients had more severe symptoms \n Output:\n " }, { "from": "agent", "value": "The biomechanical studies with all the devices showed that ISPs have a beneficial effect on the kinematics of the degenerative spine .\nStudies on the other devices show satisfactory outcome to varying degrees .\nHowever , due to small number and poor design of the studies , it is difficult to clearly define indications for their use in lumbar degenerative disease .\nLumbar ISPs may have a potential beneficial effect in select group of patients with degenerative disease of the lumbar spine ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: Newly diagnosed patients with acute graft-versus-host disease ( GvHD , grade s I-IV ; n = 211 ) were given 6-methylprednisolone ( 6MPred ) 2 mg/kg per day for 5 consecutive days ; 150 patients ( 71 % ) tapered 6MPred on day + 5 and were considered responders ; 61 patients ( 29 % ) could not taper their steroid dose and were considered nonresponders . The cumulative incidence of transplant-related mortality ( TRM ) for responders and nonresponders is , respectively , 27 % and 49 % ( P = .009 ) , and the 5-year survival is 53 % and 35 % ( P = .007 ) . Nonresponders on day + 5 ( n = 61 ) were r and omized to receive 6MPred 5 mg/kg per day for 10 days alone ( n = 34 ) or in combination with rabbit anti-thymocyte globulin ( ATG , 6.25 mg/kg in 10 days ; n = 27 ) . The 2 groups were balanced for clinical and GvHD characteristics . One month after r and omization , 26 % had a complete response ; 23 % , a partial response ; 33 % , stable GvHD ; 10 % , worsened ; and 8 % , died . There was no significant difference in response , TRM , and survival between the non-ATG and ATG group . In conclusion , 5 days of prednisolone as first-line therapy of acute GvHD identifies patients with different risk of TRM , and second-line therapy with a combination of 6MPred + ATG does not improve patient outcome , compared with 6MPred alone SUMMARY Patients with hematological malignancies undergoing allogeneic marrow transplantation from HLA-identical siblings were entered into a r and omized study to determine whether the prophylactic administration of horse anti-human thymocyte globulin ( ATG ) would decrease the incidence or severity of graft-versus-host disease ( GVHD ) . Patients were conditioned with high-dose cyclophosphamide and total body irradiation before grafting and received methotrexate after grafting . When marrow engraftment was documented ( median 16.5 days after transplantation ) , patients were r and omized either to receive or not to receive horse ATG , 7 mg/kg , i.v . , every other day for six doses . Twenty-nine patients received ATG and 27 patients did not . Both groups were comparable with respect to diagnoses , disease status , age , sex , donor-recipient sex match , and supportive care . Administration of ATG was associated with fever and chills in most patients , but was otherwise well tolerated . Patients receiving ATG had no delay in recovery of peripheral granulocyte or platelet counts , did not require increased platelet support , and did not have more infectious complications . No significant difference in either incidence or severity of GVHD was noted between patients receiving and those not receiving prophylactic ATG , although GVHD , if it developed , tended to be less severe among patients receiving ATG . Survival and causes of death were also comparable between groups . Thus , administration of horse ATG after documentation of marrow engraftment in recipients of HLA-identical allogeneic marrow grafts had neither significant toxicity nor beneficial effect BACKGROUND Graft-versus-host disease ( GVHD ) is a major cause of morbidity and mortality after allogeneic haematopoietic cell transplantation from unrelated donors . Anti-T-cell globulins ( ATGs ) might lower the incidence of GVHD . We did a prospect i ve , r and omised , multicentre , open-label , phase 3 trial to compare st and ard GVHD prophylaxis with ciclosporin and methotrexate with or without anti-Jurkat ATG-Fresenius ( ATG-F ) . METHODS Between May 26 , 2003 , and Feb 8 , 2007 , 202 patients with haematological malignancies were central ly r and omly assigned using computer-generated centre-stratified block r and omisation between treatment groups receiving ciclosporin and methotrexate with or without additional ATG-F. One patient in the ATG-F group did not undergo transplantation , thus 201 patients who underwent transplantation with peripheral blood ( n=164 ; 82 % ) or bone marrow ( n=37 ; 18 % ) grafts from unrelated donors after myeloablative conditioning were included in the full analysis set , and were analysed according to their r and omly assigned treatment ( ATG-F n=103 , control n=98 ) . The primary endpoint was severe acute GVHD ( aGVHD ) grade III-IV or death within 100 days of transplantation . The trial is registered with the numbers DRKS00000002 and NCT00655343 . FINDINGS The number of patients in the ATG-F group who had severe aGVHD grade III-IV or who died within 100 days of transplantation was 12 and 10 ( 21.4 % , 95 % CI 13.4 - 29.3 ) , respectively , compared with 24 and nine ( 33.7 % , 24.3 - 43.0 ) patients , respectively , in the control group ( adjusted odds ratio 0.59 , 95 % CI 0.30 - 1.17 ; p=0.13 ) . The cumulative incidence of aGVHD grade III-IV was 11.7 % ( 95 % CI 6.8 - 19.8 ) in the ATG-F group versus 24.5 % ( 17.3 - 34.7 ) in the control group ( adjusted hazard ratio [ HR ] 0.50 , 95 % CI 0.25 - 1.01 ; p=0.054 ) , and cumulative incidence of aGVHD grade II-IV was 33.0 % ( n=34 ; 95 % CI 25.1 - 43.5 ) in the ATG-F group versus 51.0 % ( n=50 ; 95 % CI 42.0 - 61.9 ) in the control group ( adjusted HR 0.56 , 0.36 - 0.87 ; p=0.011 ) . The 2-year cumulative incidence of extensive chronic GVHD was 12.2 % ( n=11 ; 95 % CI 7.0 - 21.3 ) versus 42.6 % ( n=34 ; 95 % CI 33.0 - 55.0 ; adjusted HR 0.22 , 0.11 - 0.43 ; p<0.0001 ) . There were no differences between treatment groups with regard to relapse , non-relapse mortality , overall survival , and mortality from infectious causes . INTERPRETATION The addition of ATG-F to GVHD prophylaxis with ciclosporin and methotrexate result ed in decreased incidence of acute and chronic GVHD without an increase in relapse or non-relapse mortality , and without compromising overall survival . The use of ATG-F is safe for patients who are going to receive a haematopoietic cell transplantation from matched unrelated donors . FUNDING Fresenius Biotech Summary : In total , 94 patients with homozygous beta thalassemia were r and omized to two different conditioning regimens : busulfan 600 mg/m2+cyclophosphamide 200 mg/kg or busulfan 16 mg/kg+cyclophosphamide 200 mg/kg and antilymphocyte globulin ( 47 in each group ) , for bone marrow transplantation , to see whether increased myeloablation or increased immunosuppression would reduce rejection . Busulfan pharmacokinetics in determining outcome was evaluated . There was no significant difference in engraftment , graft-versus-host disease , rejection , and overall and disease-free survival in the two groups . Systemic exposure to busulfan was significantly higher in the 600 mg/m2 group , but in both groups there was a wide interindividual variation in the busulfan kinetics . Six patients rejected the graft , two in the busulfan 600 mg group and four in busulfan 16 mg group ( P=0.677 CI −0.17 , 0.07 ) , but in five patients ( pharmacokinetic data not available in one patient ) who rejected the graft busulfan first dose trough level ( Cmin-1 ) was below 150 ng/ml while it was above this level in the 66 of 68 patients with successful engraftment ( P⩽0.001 ) . This r and omized trial shows that rejection is influenced by busulfan levels and suggests that monitoring of busulfan levels and dose adjustment based on first-dose kinetics may reduce the risk of rejection We have previously shown that hemopoietic stem cell transplant ( HSCT ) recipients can be stratified on day+7 as having low , intermediate or a high risk of transplant-related mortality ( TRM ) . With the aim of reducing TRM and GVHD , intermediate and high-risk patients ( n=170 ) were r and omized to receive anti-thymocyte globulin ( ATG , thymoglobuline ) on day+7 ( n=84 ) or no treatment ( n=86 ) ( controls ) . There was a reduction of TRM from 35 % in controls to 29 % in ATG patients ( P=0.3 ) , of acute GVHD III – IV from 15 to 5 % ( P=0.02 ) and of chronic GVHD from 26 to 11 % ( P=0.03 ) ; survival was comparable . The predictive value of the day+7 score on TRM was confirmed for controls ( 19 vs 42 % for intermediate vs high risk , respectively , P=0.03 ) , whereas ATG abrogated this predictive effect ( 29 vs 29 % ) . ATG reduced GVHD ( P=0.006 ) in high-risk patients , but not in patients with an intermediate risk . In conclusion , we confirm that TRM can be predicted on the basis of day+7 laboratory values , after alternative donor HSCT ; in high- , but not intermediate-risk patients , the administration of ATG on day+7 reduces GVHD . These results may represent a platform for risk-adapted post transplant immune modulation One hundred nine patients with hematologic malignancies , undergoing bone marrow transplants ( BMT ) from unrelated donors , were r and omized in 2 consecutive trials to receive or not to receive antithymocyte globulin ( ATG ) in the conditioning regimen , as follows : ( A ) 54 patients ( median age , 28 years ; 39 % with advanced disease ) were r and omized to no ATG ( n = 25 ) versus 7.5 mg/kg rabbit ATG ( Thymoglobulin ; Sangstat , Lyon , France ) ( n = 29 ) ; ( B ) 55 patients ( median age , 31 years , 71 % with advanced disease ) were r and omized to no ATG ( n = 28 ) versus 15 mg/kg rabbit ATG ( n = 27 ) . Grade III-IV graft-versus-host disease ( GVHD ) was diagnosed in 36 % versus 41 % ( P = .8 ) in the first and in 50 % versus 11 % ( P = .001 ) in the second trial . Transplant-related mortality ( TRM ) , relapse , and actuarial 3-year survival rates were comparable in both trials . In fact , despite the reduction of GVHD in the second trial , a higher risk for lethal infections ( 30 % vs 7 % ; P = .02 ) was seen in the arm given 15 mg/kg ATG . Extensive chronic GVHD developed overall more frequently in patients given no ATG ( 62 % vs 39 % ; P = .04 ) , as confirmed by multivariate analysis ( P = .03 ) . Time to 50 x 10(9)/L platelets was comparable in the first trial ( 21 vs 24 days ; P = .3 ) and delayed in the ATG arm in the second trial ( 23 vs 38 days ; P = .02 ) . These trials suggest that ( 1 ) 15 mg/kg ATG before BMT significantly reduces the risk for grade III-IV acute GVHD , ( 2 ) this does not translate to a reduction in TRM because of the increased risk for infections , and ( 3 ) though survival is unchanged , extensive chronic GVHD is significantly reduced in patients receiving ATG Acute graft-versus-host disease is a major problem in allogeneic bone-marrow transplantation . We performed a r and omized study to compare the effectiveness of two regimens in the prevention of acute graft-versus-host disease . Thirty-five patients received methotrexate alone , and 32 received methotrexate , antithymocyte globulin , and prednisone . Of the patients who received methotrexate alone , 48 per cent had acute graft-versus-host disease , as compared with 21 per cent of those who received methotrexate , antithymocyte globulin , and prednisone ( P = 0.01 ) . The age of the recipient was a significant factor in the development of acute graft-versus-host disease : Older patients had a higher incidence of the disease ( P = 0.001 ) . We conclude that the combination of methotrexate , antithymocyte globulin , and prednisone significantly decreased the incidence \n Output:\n " }, { "from": "agent", "value": "AUTHORS ' CONCLUSIONS Our systematic review suggests that the addition of ATG during allogeneic HSCT significantly reduces the incidence of severe grade s ( II to IV ) of acute GvHD , whereas the incidence of overall acute GVHD ( grade s I to IV ) was not significantly lowered .\nThis indicates a reduction of the severity but not the incidence of acute GVHD .\nHowever , this effect did not lead to a significant improvement of overall survival , which may be due to the severe potential side effects of the consecutively increased immunosuppression ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: Despite formal recommendations for dietary change to reduce the incidence of ischaemic heart disease , the acceptability and effectiveness of the proposed diets have not been well investigated in population based studies . In this preliminary investigation of nutritional advice in a well population , subjects in one group practice were r and omized to receive either dietary instruction or simple follow up without instruction . The dietary recommendations were well received , and a substantial proportion of subjects reported altering their diets in accordance with them . There were modest beneficial changes in plasma lipid levels among men . Thus , using general practice as an avenue for promoting dietary change is feasible , and may be effective among men The effect on serum high density lipoprotein subfractions of a low fat diet with a high ratio of polyunsaturated-to-saturated fatty acids was studied in 38 middle-aged volunteers ( 19 men and 19 women ) in North Karelia , Finl and . The mean serum HDL2 cholesterol decreased from 32 + /- 2 mg/dl ( mean + /- SE ) to 28 + /- 2 mg/dl ( p less than 0.001 ) during the experimental diet and returned to 33 + /- 2 mg/dl ( p less than 0.001 ) after a return to the original diet . No changes were observed in the concentration of HDL3 cholesterol . A highly significant decrease was observed in serum apoprotein A-I concentration , but not in apoprotein A-II concentration during the experimental diet . It is concluded that a low-fat , high-P/S ratio diet lowers LDL and HDL2 cholesterol in healthy volunteers , but does not influence the level of HDL3 subfraction A community-based education program was conducted for persons found to be hypercholesterolemic by screening during cardiovascular surveys , in an urban population , to evaluate the feasibility and effect of the program in primary prevention of coronary heart disease . The subjects were men and women aged 40 - 64 living in the suburbs of Osaka whose serum total cholesterol was between 240 and 299 mg/dl in both the 1988 and the 1989 surveys . Persons with hypothyroidism , those taking medication for hypercholesterolemia or hypertension , and with a history of stroke and coronary heart disease were excluded . Of the 111 persons who were eligible , 104 persons were recruited for the program on March , 1989 . The 104 persons were r and omly assigned to either an intensive education group ( n = 51 ) or a usual education group ( n = 53 ) . For the intensive education group , seven education classes were held from April to November , 1989 . Lectures , practice sessions , interviews , and spot cholesterol measurements were conducted in a local community center . The usual education group received a letter with results from the 1989 survey and dietary instruction in April 1989 and an education class in September 1989 . Mean serum cholesterol in the intensive education group showed a 10.0 mg/dl greater reduction in September 1989 and a 9.0 mg/dl greater reduction in March 1990 than in the usual education group ( p less than 0.05 ) while mean HDL-cholesterol did not change in either groups . The intensive education group reported a larger decrease in the dietary frequency of chicken egg , poultry skin and small fishes , foods which are rich in saturated fat and cholesterol . The frequency of fatty meat , butter and fish eggs was low in both groups and did not differ between the two groups after the one-year program . These results indicate that a population -based education program is feasible and effective in reducing serum total cholesterol of hypercholesterolemic persons Aims /hypothesisThe study aim ed to compare the effects of a 2 year intervention with a low-fat diet ( LFD ) or a low-carbohydrate diet ( LCD ) , based on four group meetings to achieve compliance . Methods This was a prospect i ve r and omised parallel trial involving 61 adults with type 2 diabetes consecutively recruited in primary care and r and omised by drawing ballots . Patients that did not speak Swedish could not be recruited . The primary outcomes in this non-blinded study were weight and HbA1c . Patients on the LFD aim ed for 55–60 energy per cent ( E% ) and those on LCD for 20 E% from carbohydrate . Results The mean BMI and HbA1c of the participants were 32.7 ± 5.4 kg/m2 and 57.0 ± 9.2 mmol/mol , respectively . No patients were lost to follow-up . Weight loss did not differ between groups and was maximal at 6 months : LFD −3.99 ± 4.1 kg ( n = 31 ) ; LCD −4.31 ± 3.6 kg ( n = 30 ) ; p < 0.001 within groups . At 24 months , patients on the LFD had lost −2.97 ± 4.9 kg and those on LCD −2.34 ± 5.1 kg compared with baseline ( p = 0.002 and p = 0.020 within groups , respectively ) . HbA1c fell in the LCD group only ( LCD at 6 months −4.8 ± 8.3 mmol/mol , p = 0.004 , at 12 months −2.2 ± 7.7 mmol/mol , p = 0.12 ; LFD at 6 months −0.9 ± 8.8 mmol/mol , p = 0.56 ) . At 6 months , HDL-cholesterol had increased with the LCD ( from 1.13 ± 0.33 mmol/l to 1.25 ± 0.47 mmol/l , p = 0.018 ) while LDL-cholesterol did not differ between groups . Insulin doses were reduced in the LCD group ( 0 months , LCD 42 ± 65 E , LFD 39 ± 51 E ; 6 months , LCD 30 ± 47 E , LFD 38 ± 48 E ; p = 0.046 for between-group change ) . Conclusions /interpretationWeight changes did not differ between the diet groups , while insulin doses were reduced significantly more with the LCD at 6 months , when compliance was good . Thus , aim ing for 20 % of energy intake from carbohydrates is safe with respect to cardiovascular risk compared with the traditional LFD and this approach could constitute a treatment alternative . Trial registration : Clinical Trials.gov NCT01005498 Funding : University Hospital of Linköping Research Funds , Linköping University , the County Council of Östergötl and , and the Diabetes Research Centre of Linköping The Trial of Antihypertensive Interventions and Management is a multicenter r and omized trial design ed to examine the diastolic blood pressure response of various combinations of pharmacological and dietary interventions in the treatment of mild hypertension ( diastolic blood pressure 90 - 100 mm Hg ) . Eight hundred and seventy-eight participants at 110 - 160 % of ideal weight were r and omly allocated to nine drug/diet treatment groups receiving either a placebo , chlorthalidone ( 25 mg ) , or atenolol ( 50 mg ) , combined with a usual , a weight loss , or a low sodium/high potassium diet The primary outcome was diastolic blood pressure change from baseline to 6 months . Seven hundred and eighty-seven participants had follow-up data . The mean baseline diastolic blood pressure was 93.8 mm Hg ; 55.9 % of the participants were male , and the weight loss diet group lost an average of 4.7 kg . Multiple comparisons were accounted for in the analysis . A significantly greater lowering of diastolic blood pressure ( 12.4 mm Hg ) was achieved in the atenolol group compared with either the low sodium/high potassium diet group ( 7.9 mm Hg , p=0.001 ) or weight loss group ( 8.8 mm Hg , p=0.006 ) . Adding weight loss to chlorthalidone significantly enhanced blood pressure lowering ( 15.1 mm Hg ) when compared with the diuretic alone ( 10.8 mm Hg , p=0.002 ) , but adding a low sodium/high potassium diet ( 12.2 mm Hg , p=0.029 ) did not In the short-term treatment of mild hypertension where diastolic blood pressure is the sole consideration , drugs outperform diet , and weight loss is beneficial , especially with diuretics The individual effects of dietary cholesterol and fat saturation on plasma lipoprotein concentrations were determined in an ethnically diverse population of normolipidemic young men ( 52 Caucasian , 32 non-Caucasian ) . The experimental diets contained approximately 200 or 600 mg/d of cholesterol , 36 - 38 % of calories as fat , and high or low proportions of saturated and polyunsaturated fat ( polyunsaturated/saturated fat ratio approximately 0.8 vs 0.3 ) . At the lower cholesterol intake , the high saturated fat diet had only a modest effect on LDL cholesterol in Caucasians ( + 6 mg/dl-1 ) and none in non-Caucasians . 600 mg cholesterol with high saturated fat led to a substantial mean increase in LDL cholesterol , which was significantly greater in Caucasian than in non-Caucasian subjects ( + 31 mg/dl vs 16 mg/dl , P < 0.005 ) . 600 mg cholesterol with increased polyunsaturated fat gave a mean LDL increase of 16 mg/dl , lower than found when the same high cholesterol intake was coupled with increased saturated fat . Variation in cholesterol rather than the proportions of saturated and polyunsaturated fat had the most influence on LDL-cholesterol levels . Among non-Caucasians it was the only significant factor Background Determinants of dietary changes obtained with a nutritional intervention promoting the Mediterranean diet have been rarely evaluated . Aim To identify predictors of higher success of an intervention aim ed to increase adherence to a Mediterranean diet ( MeDiet ) in individuals at high cardiovascular risk participating in a trial for primary prevention of cardiovascular disease : the PREDIMED ( PREvención con DIeta MEDiterránea ) trial . C and i date predictors included demographic and socioeconomic characteristics , cardiovascular risk factors , and baseline dietary habits . Methods A total of 1,048 asymptomatic subjects aged 55–80 years allocated to the active intervention groups ( subjects in the control group were excluded ) . Participants ’ characteristics were assessed at baseline among subjects . Dietary changes were evaluated after 12 months . Main outcome measures were : attained changes in five dietary goals : increases in ( 1 ) fruit consumption , ( 2 ) vegetable consumption , ( 3 ) monounsaturated fatty acid (MUFA)/saturated fatty acid ( SFA ) ratio , and decreases in ( 4 ) sweets and pastries consumption , ( 5 ) and meat consumption . Univariate and multivariate logistic regression analyses were used to examine associations between the c and i date predictors and likelihood of attaining optimum dietary change ( improved adherence to a MeDiet ) . Results Among men , positive changes toward better compliance with the MeDiet were more frequent among non-diabetics , and among those with worse dietary habits at baseline ( higher consumption of meat , higher SFA intake , lower consumption of fruit and vegetables ) . Among women , marital status ( married ) and worse baseline dietary habits ( high in meats , low in fruits and vegetables ) were the strongest predictors of success in improving adherence to the MeDiet . Conclusions Some participant characteristics ( marital status and baseline dietary habits ) could contribute to predicting the likelihood of achieving dietary goals in interventions aim ed to improve adherence to a MeDiet , and may be useful for promoting individualized long-term dietary changes and improving the effectiveness of dietary counseling BACKGROUND The Women 's Health Initiative Dietary Modification ( DM ) R and omized Controlled Trial evaluated the effects of a low-fat dietary pattern on chronic disease incidence , with breast cancer and colorectal cancer as primary outcomes . The trial protocol also listed ovarian cancer and endometrial cancer as outcomes that may be favorably affected by the intervention . METHODS A total of 48,835 postmenopausal women were r and omly assigned during 1993 - 1998 to a DM intervention ( n = 19,541 ) or comparison ( usual diet ; n = 29,294 ) group and followed up for an average of 8.1 years . The intervention goal was to reduce total fat intake to 20 % of energy and to increase consumption of vegetables , fruits , and grains . Cancer outcomes were verified by pathology report review . We used weighted log-rank tests to compare incidence of invasive cancers of the ovary and endometrium , total invasive cancer , and invasive cancers at other sites between the groups . All statistical tests were two-sided . RESULTS Ovarian cancer risk was lower in the intervention than in the comparison group ( P = .03 ) . Although the overall ovarian cancer hazard ratio ( HR ) was not statistically significantly less than 1.0 , the hazard ratio decreased with increasing intervention duration ( P(trend ) = .01 ) . For the first 4 years , the risk for \n Output:\n " }, { "from": "agent", "value": "Included cohort studies in children and adults most often do not suggest any relationship between total fat intake and later measures of weight , body fatness or change in body fatness .\nHowever , there was a suggestion that lower fat intake was associated with smaller increases in weight in middle-aged but not elderly adults , and in change in BMI in the highest validity child cohort .\nTrials where participants were r and omised to a lower fat intake versus usual or moderate fat intake , but with no intention to reduce weight , showed a consistent , stable but small effect of low fat intake on body fatness : slightly lower weight , BMI and waist circumference compared with controls .\nGreater fat reduction and lower baseline fat intake were both associated with greater reductions in weight .\nThis effect of reducing total fat was not consistently reflected in cohort studies assessing the relationship between total fat intake and later measures of body fatness or change in body fatness in studies of children , young people or adults" } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: New psychiatric out- patients with depressive , phobic , and anxiety neurosis were r and omly allocated to out-patient care or to one of two types of day hospital treatment , one specialising in psychotherapy and the other offering all forms of day care . Of 106 patients who entered the study , 78 had assessment s of psychiatric symptomatology and social adjustment both before treatment and after 4 , 8 and 24 months . There was no significant difference in outcome between depressive , phobic , and anxiety neurosis , and no overall difference in response to treatment between the three types of care . Suicidal symptoms were significantly less common in out- patients . In many respects , neurotic disorder can be regarded as a single syndrome Day treatment remains a core component in many community mental health programs for persons with severe mental disorders throughout the United States . Many other mental health centers are moving away from day treatment toward psychosocial and vocational rehabilitation programs . Empirical research directly comparing these two systems of organizing outpatient services is needed . In this study the authors compared a rehabilitative day treatment program in one small city with a similar program in a nearby city that changed from day treatment to a supported employment model . Clients who were enrolled in community support services during a baseline year prior to the change and during a follow-up year after the change ( 71 in the program that changed and 112 in the other ) were evaluated during both intervals . In the program that changed , competitive employment improved from 25.4 % to 39.4 % for all clients , and from 33.3 % to 55.6 % for those clients who had been regular attenders of day treatment during the baseline . Hours worked and wages earned similarly improved after the program change . For all work variables , clients who had not worked during the baseline year accounted for the improvements in outcome . Meanwhile , employment remained stable in the day treatment program . No negative outcomes were detected . These results indicate that eliminating day treatment and replacing it with a supported employment program can improve integration into competitive jobs in the community A one-year cohort of patients from a defined catchment area with acute functional disorders were allocated at r and om to brief care ( experimental group ) or st and ard care ( control group ) in hospital to examine the effect of shortening hospital stay on the clinical and social functioning of patients and the distress abnormal functioning caused to others . A total of 127 patients were interviewed on entry to the study , and 106 were followed up . The brief care group had significantly shorter mean and median lengths of stay than the control group , but there was no difference between the groups in the number of days spent in hospital during subsequent admissions . The groups were well matched for clinical and social variables . Rates of improvement over 13 weeks were essentially the same by all measures of outcome , including the Present State Examination and Patient 's Behaviour Assessment Scale , which was developed for the study to measure deterioration in behaviour and social functioning and adverse effects and distress on others . There was no difference between the two groups in burden to the community supporting services , social security requirements , or GP attendances . Improvement rates were nearly identical on all measures within and across diagnostic subgroups . Brief care result ed in a 33 % reduction in average length of stay compared with the year before but was associated with a corresponding increase in day hospital use . The short-stay policy continued the year after the study finished . The findings confirm the value of shortening hospital stay and improving day care facilities for most localities OBJECTIVE Despite the frequent use of the Positive and Negative Syndrome Scale ( PANSS ) for rating the symptoms of schizophrenia , the clinical meaning of its total score and of the cut-offs that are used to define treatment response ( e.g. at least 20 % or 50 % reduction of the baseline score ) are as yet unclear . We therefore compared the PANSS with simultaneous ratings of Clinical Global Impressions ( CGI ) . METHOD PANSS and CGI ratings at baseline ( n = 4091 ) , and after one , two , four and six weeks of treatment taken from a pooled data base of seven pivotal , multi-center antipsychotic drug trials on olanzapine or amisulpride in patients with exacerbations of schizophrenia were compared using equipercentile linking . RESULTS Being considered \" mildly ill \" according to the CGI approximately corresponded to a PANSS total score of 58 , \" moderately ill \" to a PANSS of 75 , \" markedly ill \" to a PANSS of 95 and severely ill to a PANSS of 116 . To be \" minimally improved \" according to the CGI score was associated with a mean percentage PANSS reduction of 19 % , 23 % , 26 % and 28 % at weeks 1 , 2 , 4 and 6 , respectively . The corresponding figures for a CGI rating \" much improved \" were 40 % , 45 % , 51 % and 53 % . CONCLUSIONS The results provide a better framework for underst and ing the clinical meaning of the PANSS total score in drug trials of schizophrenia patients with acute exacerbations . Such studies may ideally use at least a 50 % reduction from baseline cut-off to define response rather than lower thresholds . In treatment resistant population s , however , even a small improvement can be important , so that a 25 % cut-off might be appropriate BACKGROUND Patient-clinician communication is central to mental healthcare but neglected in research . AIMS To test a new computer-mediated intervention structuring patient-clinician dialogue ( DIALOG ) focusing on patients ' quality of life and needs for care . METHOD In a cluster r and omised controlled trial , 134 keyworkers in six countries were allocated to DIALOG or treatment as usual ; 507 people with schizophrenia or related disorders were included . Every 2 months for 1 year , clinicians asked patients to rate satisfaction with quality of life and treatment , and request additional or different support . Responses were fed back immediately in screen displays , compared with previous ratings and discussed . Primary outcome was subjective quality of life , and secondary outcomes were unmet needs and treatment satisfaction . RESULTS Of 507 patients , 56 were lost to follow-up and 451 were included in intention-to-treat analyses . Patients receiving the DIALOG intervention had better subjective quality of life , fewer unmet needs and higher treatment satisfaction after 12 months . CONCLUSIONS Structuring patient-clinician dialogue to focus on patients ' views positively influenced quality of life , needs for care and treatment satisfaction The effects of day care therapy for a period of 6 months upon patients with schizophrenia were studied through comparison with schizophrenia out patients at four facilities in Japan . The clinical features of the 31 day care patients and 30 out patients were evaluated by the hospital staff using the Positive and Negative Syndrome Scale ( PANSS ) and Global Assessment Scale ( GAS ) , and by the patients ' close relatives using the Katz Adjustment Scale ( KAS ) before and after 6 months of treatment . Day care patients showed a significant decrease in the general pathological score of PANSS and GAS , but out patients did not show any comparable improvement . As for KAS scores , similar improvement was observed for both the day care patients and out patients After 6 months , 43 % of the day care patients improved on the post-/pre- PANSS total scores ratio , as against only 13 % of the out patients . In addition , 13 % of the out patients were readmitted due to an exacerbation of their symptoms , whereas all day care patients were able to remain at home for 6 months . This study clearly demonstrated that day care therapy for patients with schizophrenia was more effective than the usual out patients treatment setting . Further therapeutic efforts ( e.g. psycho-education ) in day care therapy are needed in order to improve family member 's evaluation of the patient Emerging models of cognitive-behavioral treatment ( CBT ) offer promising new intervention strategies in the psychotherapy of schizophrenia . These models , however , have not been integrated into community support programs and evaluated in comparison to st and ard community treatments . This study examined differences in outcomes of clients who received long-term day treatment program services ( DTP ) compared to clients who received individual CBT that was included as part of their DTP treatment . Twenty-four clients were r and omly assigned to DTP treatment or CBT/DTP treatment . Data on st and ardized measures of psychosocial functioning , symptomatology and rehospitalizations were collected over the course of three years of treatment . Analysis of variance with repeated measures was conducted to evaluate the effects of type of treatment ( CBT/DTP and DTP ) and time ( dependent variable scores taken at the end of treatment years one , two and three ) on the three outcome variables . Results indicate significant improvement for the CBT/DTP group compared to the DTP group in the patterns of change over time for psychosocial functioning and symptomology . In addition to this significant group/time interaction the time factor was also significant for both variables . For rehospitalizations the time factor was significant and the group/time factor was nonsignificant . Implication s for service delivery to persons with schizophrenia and suggestions for future research are discussed BACKGROUND Postnatal depression affects one in ten women within 6 months of childbirth . The most effective treatment strategy for postnatal depression is not clear . METHODS This prospect i ve , naturalistic study of the treatment of postnatal depression compared 30 women treated at a specialised psychiatric day hospital with 30 women treated using routine primary care ( RPC ) . Clinical , marital and social adjustment were assessed on three occasions over 6 months using : the Edinburgh Postnatal Depression Question naire ( EPDS ) ; the Clinical Interview schedule ( CIS ) ; the Anxiety Subscale of the Hospital Anxiety and Depression Scale ; the Dyadic Adjustment Scale ( DAS ) ; and the Work Leisure and Family Life Question naire-Modified ( WLFLQ-M ) . RESULTS There were no significant differences between the two groups at baseline . However , there were significant differences in outcome at 3 and 6 months follow-up for all outcome measures except the DAS . At 6 month follow-up 21 of the PBDU group were no longer depressed compared with 7 of the RPC group . CONCLUSIONS A specialised day hospital is a more effective treatment setting for postnatal depression than routine primary care . LIMITATIONS OF THE STUDY The study is not an RCT , so systematic bias is possible . The sample size is relatively small and the duration of follow-up relatively short The authors r and omly assigned 79 in patients with nonchronic schizophrenia or affective disorder to either an intensive experimental day program called \" transitional treatment \" or a control treatment -- weekly clinical ly believed to require intensive posthospital treatment to make the transition to the community . Although initially there was a significantly higher dropout rate from the control condition , at the point of discharge from the two programs as well as at 6- and 12-month follow-up there was no difference in outcome . Direct costs for the transitional treatment , however , were much higher BACKGROUND Data on effectiveness of acute day hospital treatment for psychiatric illness are inconsistent . AIMS To establish the effectiveness and costs of care in a day hospital providing acute treatment exclusively . METHOD In a r and omised controlled trial , 206 voluntarily admitted patients were allocated to either day hospital treatment or conventional wards . Psychopathology , treatment satisfaction and subjective quality of life at discharge , 3 months and 12 months after discharge , readmissions to acute psychiatric treatment within 3 and 12 months , and costs in the index treatment period were taken as outcome criteria . RESULTS Day hospital patients showed significantly more favourable changes in psychopathology at discharge but not at follow-up . They also reported higher treatment satisfaction at discharge and after 3 months , but not after 12 months . There were no significant differences in subjective quality of life or in readmissions during follow-up . Mean total support costs were higher for the day hospital group . CONCLUSIONS Day hospital treatment for voluntary psychiatric patients in an inner-city area appears more effective in terms of reducing psychopathology in the shortterm and generates greater patient satisfaction than conventional in-patient care , but may be more costly A prospect i ve r and omized comparative study on the effectiveness of psychiatric day treatment and inpatient treatment is described . The target population consisted of patients who would normally have been admitted to an open inpatient unit . Outcome indicators were psychopathology , social functioning , interpersonal functioning , social network and social support . No differences in effectiveness were found between the two forms of treatment , although more patients accepted and completed day treatment , and day patients were more satisfied . Although a uniform treatment programme for both departments was established , distinct differences did arise in the actual treatment programme offered to the patients . The duration of treatment for the day patients was considerably longer , and the intensity of treatment was more low‐key . No striking differences in the amount of medication prescribed and in the occurrence of crisis situations ( including suicide ) were found . Day treatment turns out to be a realistic alternative for 33 % of all patients admitted for inpatient treatment . It was not possible to predict which type of patient in particular is suitable for day treatment The authors estimated components of variance and intraclass correlation coefficients ( ICCs ) to aid in the design of complex surveys and community intervention studies by analyzing data from the Health Survey for Engl and 1994 . This cross-sectional survey of English adults included data on a range of lifestyle risk factors and health outcomes . For the survey , households were sample d in 720 postal code sectors nested within 177 district health authorities and 14 regional health authorities . Study subjects were adults aged 16 years or more . ICCs and components of variance were estimated from a nested r and om-effects analysis of variance . Results are presented at the district health authority , postal code sector , and household levels . Between-cluster variation was evident at each level of clustering . In these data , ICCs were inversely related to cluster size , but design effects could be substantial when the cluster size was large . Most ICCs were below 0.01 at the district health authority level , and they were mostly below 0.05 at the postal code sector level . At the household level , many ICCs were in the range of 0.0 - 0.3 . These data may provide useful information for the design of epidemiologic studies in which the units sample d or allocated range in size from households to large administrative areas The authors compared \n Output:\n " }, { "from": "agent", "value": "Data on time spent as an inpatient seem to support this finding but are poorly reported .\nPoorly reported economic data from decades ago suggested that day hospitals were more costly to establish and run than outpatient care but took no account of other costs such as inpatient stay ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: Objective Heart failure patients are regularly admitted to hospital and frequently use multiple medication . Besides intentional changes in pharmacotherapy , unintentional changes may occur during hospitalisation . The aim of this study was to investigate the effect of a clinical pharmacist discharge service on medication discrepancies and prescription errors in patients with heart failure . Setting A general teaching hospital in Tilburg , the Netherl and s. Method An open r and omized intervention study was performed comparing an intervention group , with a control group receiving regular care by doctors and nurses . The clinical pharmacist discharge service consisted of review of discharge medication , communicating prescribing errors with the cardiologist , giving patients information , preparation of a written overview of the discharge medication and communication to both the community pharmacist and the general practitioner about this medication . Within 6 weeks after discharge all patients were routinely scheduled to visit the outpatient clinic and medication discrepancies were measured . Main outcome measure The primary endpoint was the frequency of prescription errors in the discharge medication and medication discrepancies after discharge combined . Results Forty-four patients were included in the control group and 41 in the intervention group . Sixty-eight percent of patients in the control group had at least one discrepancy or prescription error against 39 % in the intervention group ( RR 0.57 ( 95 % CI 0.37–0.88 ) ) . The percentage of medications with a discrepancy or prescription error in the control group was 14.6 % and in the intervention group it was 6.1 % ( RR 0.42 ( 95 % CI 0.27–0.66 ) ) . Conclusion This clinical pharmacist discharge service significantly reduces the risk of discrepancies and prescription errors in medication of patients with heart failure in the 1st month after discharge Abstract Background : Increased life expectancy is associated with an increased prevalence of chronic diseases and drug consumption . Changes often occur in the medication regimen after hospitalization . The extent and nature of these changes and the adherence of elderly patients have not yet been fully investigated . Objective : To investigate the extent and reasons for modifications to the medication regimens of elderly patients and their adherence to treatment during the first month following hospital discharge . Methods : This was a prospect i ve cohort study of 198 patients aged ≥65 years in the Acute Geriatric Ward , Beilinson Hospital , Rabin Medical Center , Israel . Clinical , demographic and medication regimen data were recorded for all patients at an interview conducted prior to discharge . After 1 month , the patient , caregiver or general practitioner ( GP ) were interviewed regarding the extent and reasons for modifications to the medication regimen and adherence to treatment . Results : At 1-month post-discharge , on average , 36.7 % of patient medications had been modified compared with the discharge prescription . No modification was found in 16 % of patients . During the observation month , 62 % of prescribed long-term medications were taken without modification as recommended at discharge and during follow-up , 50 % of all changes were characterized by the addition of a drug or an increase in dosage , and 26 % , 16 % and 8 % consisted of cancelling , omission or switching within the same medication type , respectively . Seventy percent of medication regimen changes were based on specialists ’ recommendations or secondary to a change in the patients ’ medical state , and 13 % , 8 % , 3 % and 6 % were as a result of poor adherence , adverse effects , administrative restrictions and other reasons , respectively . There was no correlation between medication regimen change and age , gender , physical function , cognitive function and length of hospital stay . Patients discharged home experienced less regimen modification than those discharged elsewhere ( p = 0.02 ) . Patients who visited their GP only once experienced less regimen modification ( p = 0.03 ) . Regression analysis showed that the only factors affecting medication regimen changes were GP visits and chronic diseases ( p < 0.01 , R2 = 0.09 ) . The overall mean adherence among 145 home-dwelling patients was 96.7 % . Twenty-seven percent and 6 % were under- and over-adherent , respectively , to at least one drug ; under-adherence was more widespread than over-adherence . No correlation was found between the overall mean adherence and other clinical parameters or regimen change . However , non-adherence to at least one drug was associated with more medication regimen changes ( p = 0.001 ) , was more common in patients discharged with prescriptions for seven or more drug types per day ( p = 0.01 ) and was associated with failing to visit the patient ’s GP 1 month after discharge ( p = 0.02 ) . Conclusion : The majority of elderly patients experienced modifications in their medication regimen during the first month following hospital discharge . Thirty percent of patients were non-adherent to at least one drug . To improve adherence to a hospital medication regimen , patients should be encouraged to visit their GP and the number of long-term drugs should be reduced OBJECTIVE To examine the reliability and validity of the Medication Adherence Individual Review -Screening Tool ( MedAdhIR-ST ) for assessing medication adherence in a community-dwelling elderly population . DESIGN A prospect i ve , observational pilot study comparing the reliability and validity of the MedAdhIR-ST and the Medication Adherence Question naire ( MAQ ) . SETTING Independent senior-housing apartments and senior centers in Wake County , North Carolina . PARTICIPANTS Eligible subjects included individuals 60 years of age or older who were living in the community and managing their own medication regimens . INTERVENTIONS Each subject was asked to participate in two assessment visits , two weeks ( + /- 3 days ) apart , in which the questions of the MedAdhIR-ST and MAQ were administered . MAIN OUTCOME MEASURE Medication adherence . RESULTS Both tools showed moderate-to-high test/retest reliability in the study population ( correlation coefficient of 0.632 for MAQ , and 0.699 for MedAdhIR-ST ) , and moderate internal consistency ( Cronbach 's a of 0.551 and 0.584 , respectively ) . Moderate concordance in the ability to assess adherence was observed between MedAdhIR-ST and MAQ ( positive correlation coefficient of 0.450 ) . When compared with refill records , MedAdhIR-ST was slightly more sensitive ( 67 % vs. 43 % ) and specific ( 60 % vs. 50 % ) for detecting adherence and nonadherence , respectively , compared with MAQ . Exploratory factor analysis indicated that MedAdhIR-ST is multidimensional . CONCLUSION MedAdhIR-ST appears to be a reliable and valid tool for screening nonadherence in a community-dwelling elderly population BACKGROUND Despite the availability of proven therapies , outcomes in patients with heart failure ( HF ) remain poor . In this 2-stage , multicenter trial , we evaluated the effect of a disease management program on clinical and economic outcomes in patients with HF . METHODS AND RESULTS In Stage 1 , a pharmacist or nurse assessed each patient and made recommendations to the physician to add or adjust angiotensin-converting enzyme ( ACE ) inhibitors and other HF medications . Before discharge ( Stage 2 ) , patients were r and omized to a patient support program ( PSP ) ( education about HF , self-monitoring , adherence aids , newsletters , telephone hotline , and follow-up at 2 weeks , then monthly for 6 months after discharge ) or usual care . In Stage 1 ( 766 patients ) ACE inhibitor use increased from 58 % on admission to 83 % at discharge ( P < .0001 ) , and the daily dose ( in enalapril equivalents ) increased from 11.3 + /- 8.8 mg to 14.5 + /- 8.8 mg ( P < .0001 ) . In Stage 2 ( 276 patients ) there was no difference in ACE inhibitor adherence , but a reduction in cardiovascular-related emergency room visits ( 49 versus 20 , P = .030 ) , hospitalization days ( 812 versus 341 , P = .003 ) , and cost of care ( 2,531 Canadian dollars less per patient ) in favor of the PSP . CONCLUSION Simple interventions can improve ACE inhibitor use and patient outcomes Abstract Objectives . Many hospital admissions are due to inappropriate medical treatment , and discharge of fragile elderly patients involves a high risk of readmission . The present study aim ed to assess whether a follow-up programme undertaken by GPs and district nurses could improve the quality of the medical treatment and reduce the risk of readmission of elderly newly discharged patients . Design and setting . The patients were r and omized to either an intervention group receiving a structured home visit by the GP and the district nurse one week after discharge followed by two contacts after three and eight weeks , or to a control group receiving the usual care . Patients . A total of 331 patients aged 78 + years discharged from Glostrup Hospital , Denmark , were included . Main outcome measures . Readmission rate within 26 weeks after discharge among all r and omized patients . Control of medication , evaluated 12 weeks after discharge on 293 ( 89 % ) of the patients by an interview at home and by a question naire to the GP . Results . Control-group patients were more likely to be readmitted than intervention-group patients ( 52 % v 40 % ; p = 0.03 ) . In the intervention group , the proportions of patients who used prescribed medication of which the GP was unaware ( 48 % vs. 34 % ; p = 0.02 ) and who did not take the medication prescribed by the GP ( 39 % vs. 28 % ; p = 0.05 ) were smaller than in the control group . Conclusion . The intervention shows a possible framework securing the follow-up on elderly patients after discharge by reducing the readmission risk and improving medication control Lowering blood pressure ( BP ) in stroke survivors reduces the risk of recurrent stroke . We tested the hypothesis that a nurse-led nonpharmacologic intervention would lower the BP of participants in an intervention group compared with a control group . A total of 349 patients who had sustained acute stroke or transient ischemic attack were r and omly assigned to either usual care or to 4 home visits by a nurse . During the visits , the nurse measured and recorded BP and provided individually tailored counseling on a healthy lifestyle . A total of 303 patients completed the 1-year follow up . No change in systolic BP was noted in either the intervention group or the control group . Because of an increase in diastolic BP in the control group ( P = .03 ) , a difference in mean diastolic BP between the 2 groups was found at follow-up ( P = .007 ) . Mean BP at follow-up was 139/82 mm Hg in the intervention group and 142/86 mm Hg in the control group . Linear regression analysis demonstrated that BP at the point of discharge was the strongest predictor of BP 1 year later ( P < .0001 ) . The proportion of patients on antihypertensive medication increased in the intervention group ( P = .002 ) . Patients were compliant with antihypertensive therapy , and 92 % of the hypertensive patients in the intervention group followed the advice to see a general practitioner ( GP ) for BP checkups . At follow-up , 187 patients ( 62 % ) were hypertensive , with no difference in the rate of hypertension seen between the groups . Our data indicate that home visits by nurses did not result in a lowering of BP . Patients complied with antihypertensive therapy and GP visits in the case of hypertension . Nonetheless , the majority of patients were hypertensive at the 1-year follow up UNLABELLED An integrated care intervention including education , coordination among levels of care , and improved accessibility , reduced hospital readmissions in chronic obstructive pulmonary disease ( COPD ) after 1 year . This study analyses the effectiveness of this intervention in terms of clinical and functional status , quality of life , lifestyle , and self-management , under the hypothesis that changes in these factors could explain the observed reduction in readmissions . A total of 113 exacerbated COPD patients ( 14 % female , mean ( SD ) age 73(8 ) years , FEV(1 ) 1.2(0.5 ) l ) were recruited after hospital discharge in Barcelona , Spain , and r and omly assigned ( 1:2 ) to integrated care ( IC ) ( n=44 ) or usual care ( UC ) ( n=69 ) . The intervention consisted of an individually tailored care plan at discharge shared with the primary care team and access to a specialized case manager nurse through a web-based call centre . After 1 year of intervention , subjects in the intervention group improved body mass index by 1.34 kg/m(2 ) . Additionally , they scored better in self-management items : COPD knowledge 81 % vs. 44 % , exacerbation identification 85 % vs. 22 % , exacerbation early treatment 90 % vs. 66 % , inhaler adherence 71 vs. 37 % , and inhaler correctness 86 vs. 24 % . There were no differences in the evolution of dyspnea , lung function , quality of life scores , lifestyle factors , or medical treatment . CONCLUSIONS This IC trial improved disease knowledge , and treatment adherence , after 1 year of intervention , suggesting that these factors may play a role in the prevention of severe COPD exacerbations triggering hospital admissions OBJECTIVE : To compare medication adherence calculated from four different data sources including a pill count and self-report obtained during a home medication history , as well as calculations based on refill frequency derived from a provincial prescription cl aims data \n Output:\n " }, { "from": "agent", "value": "Conclusion nurse-led and nurse-collaborative interventions moderately improved adherence among discharged older adults ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: One-quarter of neonatal deaths are attributed to infections . Maternal h and washing with soap may prevent neonatal sepsis . We examined impact of intensive h and washing promotion on h and washing behavior of mothers of neonates . In Matlab , Bangladesh , we r and omly allocated pregnant women at 28–32 weeks ' gestation to intensive h and washing promotion or control . Behavior change communicators used a participatory approach to motivate maternal h and washing with soap and provided soap and h and washing stations . In the neonatal period , we observed soap and water at h and washing places and , at the end of the neonatal period , we estimated impact on maternal h and washing by structured observation . Among 253 women enrolled , intervention households were between 5.7 and 15.2 times as likely as control households to have soap and water present at the h and washing station in the baby 's sleeping area . Intervention mothers washed h and s with soap 4.1 times as frequently as controls ( 95 % CI 2.55–6.59 ) ; h and washing with soap at recommended times was infrequent in both intervention ( 9 % ) and control ( 2 % ) groups . Intensively promoting h and washing with soap result ed in increased availability of soap and water at h and washing places , but only a modest increase in maternal h and washing with soap . Novel approaches to motivating h and washing behavior to protect newborns should be developed and evaluated BACKGROUND Effective prevention and control of diarrhoea requires caregivers to comply with a suite of proven measures , including exclusive breastfeeding , h and washing with soap , correct use of oral rehydration salts , and zinc administration . We aim ed to assess the effect of a novel behaviour change intervention using emotional drivers on caregiver practice of these behaviours . METHODS We did a cluster r and omised controlled trial in Lusaka Province , Zambia . A r and om sample of 16 health centres ( clusters ) were selected from a sampling frame of 81 health centres in three of four districts in Lusaka Province using a computerised r and om number generator . Each cluster was r and omly assigned 1:1 to either the intervention-clinic events , community events , and radio messaging-or to a st and ard care control arm , both for 6 months . Primary outcomes were exclusive breastfeeding ( self-report ) , h and washing with soap ( observation ) , oral rehydration salt solution preparation ( demonstration ) , and zinc use in diarrhoea treatment ( self-report ) . We measured outcome behaviours at baseline before start of intervention and 4 - 6 weeks post-intervention through repeat cross-sectional surveys with mothers of an infant younger than 6 months and primary caregivers of a child younger than 5 years with recent diarrhoea . We compared outcomes on an intention-to-treat population between intervention and control groups adjusted for baseline behaviour . The study was registered with Clinical Trials.gov , number NCT02081521 . FINDINGS Between Jan 20 and Feb 3 , 2014 , we recruited 306 mothers of an infant aged 0 - 5 months ( 156 intervention , 150 st and ard care ) and 343 primary caregiver of a child aged 0 - 59 months with recent diarrhoea ( 176 intervention , 167 st and ard care ) at baseline . Between Oct 20 to Nov 7 , 2014 , we recruited 401 mothers of an infant 0 - 5 months ( 234 intervention , 167 st and ard care ) and 410 primary caregivers of a child 0 - 59 months with recent diarrhoea ( 257 intervention , 163 st and ard care ) at endline . Intervention was associated with increased prevalence of self-reported exclusive breastfeeding of infants aged 0 - 5 months ( adjusted difference 10·5 % , 95 % CI 0·9 - 19·9 ) . Other primary outcomes were not affected by intervention . Cluster intervention exposure ranged from 11 - 81 % , measured by participant self-report with verification questions . Comparison of control and intervention clusters with coverage greater than 35 % provided strong evidence of an intervention effect on oral rehydration salt solution preparation and breastfeeding outcomes . INTERPRETATION The intervention may have improved exclusive breastfeeding ( assessed by self-reporting ) , but intervention effects were diluted in clusters with low exposure . Complex caregiver practice s can improve through interventions built around human motives , but these must be implemented more intensely . FUNDING Absolute Return for Kids ( ARK ) and Comic Relief Background H and washing is a cost-effective way of preventing communicable diseases such as respiratory and food-borne illnesses . However , h and washing rates are low in developing countries . Target 7C of the seventh Millennium Development Goals was to increase by half the proportion of people with sustainable access to safe drinking water and basic sanitation by 2015 . Studies have found that better access to improved water sources and sanitation is associated with higher rates of h and washing . Objective Our goal was to describe h and washing behaviour and identify the associated factors in Vietnamese households . Design Data from 12,000 households participating in the Vietnam Multiple Indicator Cluster Survey 2011 were used . The survey used a multistage sampling method to r and omly select 100 clusters and 20 households per cluster . Self-administered question naires were used to collect data from a household representative . Demographic variables , the presence of a specific place for h and washing , soap and water , access to improved sanitation , and access to improved water sources were tested for association with h and washing behaviour in logistic regression . Results Almost 98 % of households had a specific place for h and washing , and 85 % had cleansing material s and water at such a place . The prevalence of h and washing in the sample was almost 85 % . Educational level , ethnicity of the household head , and household wealth were factors associated with h and washing practice ( p<0.05 ) . Those having access to an improved sanitation facility were more likely to practise h and washing [ odds ratio (OR)=1.69 , 95 % confidence interval ( CI ) : 1.37–2.09 , p<0.001 ] , as were those with access to improved water sources ( OR=1.74 , 95 % CI : 1.37–2.21 , p<0.001 ) . Conclusions Households with low education , low wealth , belonging to ethnic minorities , and with low access to improved sanitation facilities and water sources should be targeted for interventions implementing h and washing practice . In addition , the availability of soap and water at h and washing sites should be increased and practical teaching programs should be deployed in order to increase h and washing rates BACKGROUND Diarrhoea and respiratory infections are the two biggest causes of child death globally . H and washing with soap could substantially reduce diarrhoea and respiratory infections , but prevalence of adequate h and washing is low . We tested whether a scalable village-level intervention based on emotional drivers of behaviour , rather than knowledge , could improve h and washing behaviour in rural India . METHODS The study was done in Chittoor district in southern And hra Pradesh , India , between May 24 , 2011 , and Sept 10 , 2012 . Eligible villages had a population of 700 - 2000 people , a state-run primary school for children aged 8 - 13 years , and a preschool for children younger than 5 years . 14 villages ( clusters ) were selected , stratified by population size ( < 1200 vs > 1200 ) , and r and omly assigned in a 1:1 ratio to intervention or control ( no intervention ) . Clusters were enrolled by the study manager . R and om allocation was done by the study statistician using a r and om number generator . The intervention included community and school-based events incorporating an animated film , skits , and public pledging ceremonies . Outcomes were measured by direct observation in 20 - 25 households per village at baseline and at three follow-up visits ( 6 weeks , 6 months , and 12 months after the intervention ) . Observers had no connection with the intervention and observers and participant households were told that the study was about domestic water use to reduce the risk of bias . No other masking was possible . The primary outcome was the proportion of h and washing with soap at key events ( after defecation , after cleaning a child 's bottom , before food preparation , and before eating ) at all follow-up visits . The control villages received a shortened version of the intervention before the final follow-up round . Outcome data are presented as village-level means . FINDINGS H and washing with soap at key events was rare at baseline in both the intervention and control groups ( 1 % [ SD 1 ] vs 2 % [ 1 ] ) . At 6 weeks ' follow-up , h and washing with soap at key events was more common in the intervention group than in the control group ( 19 % [ SD 21 ] vs 4 % [ 2 ] ; difference 15 % , p=0·005 ) . At the 6-month follow-up visit , the proportion h and washing with soap was 37 % ( SD 7 ) in the intervention group versus 6 % ( 3 ) in the control group ( difference 31 % ; p=0·02 ) . At the 12-month follow-up visit , after the control villages had received the shortened intervention , the proportion h and washing with soap was 29 % ( SD 9 ) in the intervention group and 29 % ( 13 ) in the control group . INTERPRETATION This study shows that substantial increases in h and washing with soap can be achieved using a scalable intervention based on emotional drivers . FUNDING Wellcome Trust , SHARE Background We analyzed data from the baseline assessment of a large intervention project to describe typical h and washing practice s in rural Bangladesh , and compare measures of h and cleanliness with household characteristics . Methods We r and omly selected 100 villages from 36 districts in rural Bangladesh . Field workers identified 17 eligible households per village using systematic sampling . Field workers conducted 5-hour structured observations in 1000 households , and a cross-sectional assessment in 1692 households that included spot checks , an evaluation of h and cleanliness and a request that residents demonstrate their usual h and washing practice s after defecation . Results Although 47 % of caregivers reported and 51 % demonstrated washing both h and s with soap after defecation , in structured observation , only 33 % of caregivers and 14 % of all persons observed washed both h and s with soap after defecation . Less than 1 % used soap and water for h and washing before eating and /or feeding a child . More commonly people washed their h and s only with water , 23 % after defecation and 5 % before eating . Spot checks during the cross sectional survey classified 930 caregivers ( 55 % ) and 453 children ( 28 % ) as having clean appearing h and s. In multivariate analysis economic status and water available at h and washing locations were significantly associated with h and cleanliness among both caregivers and children . Conclusions A minority of rural Bangladeshi residents washed both h and s with soap at key h and washing times , though rinsing h and s with only water was more common . To realize the health benefits of h and washing , efforts to improve h and washing in these communities should target adding soap to current h and rinsing practice Background In Bangladesh diarrhoeal disease and respiratory infections contribute significantly to morbidity and mortality . H and washing with soap reduces the risk of infection ; however , h and washing rates in infrastructure-restricted setting s remain low . H and washing stations – a dedicated , convenient location where both soap and water are available for h and washing – are associated with improved h and washing practice s. Our aim was to identify a locally feasible and acceptable h and washing station that enabled frequent h and washing for two subsequent r and omized trials testing the health effects of this behaviour . Methods We conducted formative research in the form of household trials of improved practice s in urban and rural Bangladesh . Seven c and i date h and washing technologies were tested by nine to ten households each during two iterative phases . We conducted interviews with participants during an introductory visit and two to five follow up visits over two to six weeks , depending on the phase . We used the Integrated Behavioural Model for Water , Sanitation and Hygiene ( IBM-WASH ) to guide selection of c and i date h and washing stations and data analysis . Factors presented in the IBM-WASH informed thematic coding of interview transcripts and context ualized feasibility and acceptability of specific h and washing station design s. Results Factors that influenced selection of c and i date design s were market availability of low cost , durable material s that were easy to replace or replenish in an infrastructure-restricted and shared environment . Water storage capacity , ease of use and maintenance , and quality of material s determined the acceptability and feasibility of specific h and washing station design s. After examining technology , psychosocial and context ual factors , we selected a h and washing system with two different water storage capacities , each with a tap , st and , basin , soapy water bottle and detergent powder for pilot testing in preparation for the subsequent r and omized trials . Conclusions A number of context ual , psychosocial and technological factors influence use of h and washing stations at five aggregate levels , from habitual to societal . In interventions that require a h and washing station to facilitate frequent h and washing with soap , elements of the technology , such as capacity , durability and location(s ) within the household are key to high feasibility and acceptability . More than one h and washing station per household may be required . IBM-WASH helped guide the research and research in-turn helped vali date the framework In this study , we report on the results of a trial of an intervention to improve five food hygiene behaviors among mothers \n Output:\n " }, { "from": "agent", "value": "Hygiene promotion programmes are likely to be most successful if they use multi-modal approaches , combining infrastructural improvement with ' soft ' hygiene promotion which addresses a range of determinants rather than just education about disease transmission" } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: Prognosis studies are investigations of future events or the evaluation of associations between risk factors and health outcomes in population s of patients ( 1 ) . The results of such studies improve our underst and ing of the clinical course of a disease and assist clinicians in making informed decisions about how best to manage patients . Prognostic research also informs the design of intervention studies by helping define subgroups of patients who may benefit from a new treatment and by providing necessary information about the natural history of a disorder ( 2 ) . There has recently been a rapid increase in the use of systematic review methods to synthesize the evidence on research questions related to prognosis . It is essential that investigators conducting systematic review s thoroughly appraise the method ologic quality of included studies to be confident that a study 's design , conduct , analysis , and interpretation have adequately reduced the opportunity for bias ( 3 , 4 ) . Caution is warranted , however , because inclusion of method ologically weak studies can threaten the internal validity of a systematic review ( 4 ) . This follows abundant empirical evidence that inadequate attention to biases can cause invalid results and inferences ( 5 - 9 ) . However , there is limited consensus on how to appraise the quality of prognosis studies ( 1 ) . A useful framework to assess bias in such studies follows the basic principles of epidemiologic research ( 10 , 11 ) . We focus on 6 areas of potential bias : study participation , study attrition , prognostic factor measurement , confounding measurement and account , outcome measurement , and analysis . The main objectives of our review of review s are to describe methods used to assess the quality of prognosis studies and to describe how well current practice s assess potential biases . Our secondary objective is to develop recommendations to guide future quality appraisal , both within single studies of prognostic factors and within systematic review s of the evidence . We hope this work facilitates future discussion and research on biases in prognosis studies and systematic review s. Methods Literature Search and Study Selection We identified systematic review s of prognosis studies by search ing MEDLINE ( 1966 to October 2005 ) using the search strategy recommended by McKibbon and colleagues ( 12 ) . This strategy combines broad search terms for systematic review s ( systematic review .mp ; meta- analysis .mp ) and a sensitive search strategy for prognosis studies ( cohort , incidence , mortality , follow-up studies , prognos * , predict * , or course ) . We also search ed the reference lists of included review s and method ologic papers to identify other relevant publications . We restricted our search to English- language publications . One review er conducted the search and selected the studies . Systematic review s , defined as review s of published studies with a comprehensive search and systematic selection , were included if they assessed the method ologic quality of the included studies by using 1 or more explicit criteria . We excluded studies if they were meta-analyses of independent patient data only , if their primary goal was to investigate the effectiveness of an intervention or specific diagnostic or screening tests , or if they included studies that were not done on humans . Data Extraction and Synthesis Individual items included in the quality assessment of the systematic review s were recorded as they were reported in the publication ( that is , the information that would be available to readers and future review ers ) . We review ed journal Web sites and contacted the authors of the systematic review s for additional information when authors made such an offer in their original papers . When review s assessed different study design s by using different sets of quality items , we extracted only those items used to assess cohort studies . We constructed a comprehensive list of distinct items that the review s used to assess the quality of their included studies . The full text of each review was screened . All items used by the review authors to assess the quality of studies were extracted into a computerized spreadsheet by 1 review er . Two experienced review ers , a clinical epidemiologist and an epidemiologist , independently synthesized the quality items extracted from the prognosis review s to determine how well the systematic review s assessed potential biases . We did this in 3 steps : 1 ) identified distinct concepts or domains addressed by the quality items ; 2 ) grouped each extracted quality item into the appropriate domain or domains ; and 3 ) identified the domains necessary to assess potential biases in prognosis studies . We then used this information to assess how well the review s ' quality assessment included items from the domains necessary to assess potential biases . After completing each of the first 3 steps , the review ers met to attempt to reach a consensus . The consensus process involved each review er presenting his or her observations and results , followed by discussion and debate . A third review er was available in cases of persistent disagreement or uncertainty . In the first step , all domains addressed by the quality items were identified . The first review er iteratively and progressively defined the domains as items were extracted from the included review s. The second review er defined domains from a r and om list of all extracted quality items . Limited guidance was provided to the review ers so that their assessment s and definitions of domains would be independent . The review ers agreed on a final set of domains that adequately and completely defined all of the extracted items . In the second step , review ers independently grouped each extracted item into the appropriate domains . Review ers considered each extracted item by asking , What is each particular quality item addressing ? or What are the review 's authors getting at with the particular quality assessment item ? . Items were grouped into the domain or domains that best represented the concepts being addressed . For example , the extracted items at least 80 % of the group originally identified was located for follow-up and follow-up was sufficiently complete or does n't jeopardize validity were each independently classified by both review ers as assessing the domain completeness of follow-up adequate , whereas the extracted item quantification and description of all subjects lost to follow-up was classified as assessing the domain completeness of follow-up described . In the third step , we identified the domains necessary to assess potential biases . Each review er considered the ability of the identified domains to adequately address , at least in part , 1 of the following 6 potential biases : 1 ) study participation , 2 ) study attrition , 3 ) prognostic factor measurement , 4 ) confounding measurement and account , 5 ) outcome measurement , and 6 ) analysis . Domains were considered to adequately address part of the framework if information garnered from that domain would inform the assessment of potential bias . For example , both review ers judged that the identified domain study population represents source population or population of interest assessed potential bias in a prognosis study , whereas the domain research question definition did not , although the latter is an important consideration in assessing the inclusion of studies in a systematic review . Finally , on the basis of our previous ratings , we looked at whether each review included items from the domains necessary to assess the 6 potential biases . We calculated the frequency of systematic review s by assessing each potential bias and the number of review s that adequately assessed bias overall . From this systematic synthesis , we developed recommendations for improving quality appraisal in future systematic review s of prognosis studies . We used Microsoft Access and Excel 2002 ( Microsoft Corp. , Redmond , Washington ) for data management and SAS for Windows , version 9.1 ( SAS Institute , Inc. , Cary , North Carolina ) for descriptive statistics . Role of the Funding Sources The funding sources , the Canadian Institutes of Health Research , the Canadian Chiropractic Research Foundation , the Ontario Chiropractic Association , and the Ontario Ministry of Health and Long Term Care , did not have a role in the collection , analysis , or interpretation of the data or in the decision to su bmi t the manuscript for publication . Results We identified 1384 potentially relevant articles . Figure 1 shows a flow chart of studies that were included and excluded . Figure 2 shows the number of review s identified by year of publication . We excluded 131 systematic review s of prognosis studies that did not seem to include any quality assessment of the included studies ; this represented 44 % of prognosis review s. We included 163 review s of prognosis studies in our analysis ( 13 - 175 ) . The most common topics were cancer ( 15 % ) , musculoskeletal disorders and rheumatology ( 13 % ) , cardiovascular ( 10 % ) , neurology ( 10 % ) , and obstetrics ( 10 % ) . Other review s included a wide range of health and health care topics . Sixty-three percent of the review s investigated the association between a specific prognostic factor and a particular outcome ; the remainder investigated multiple prognostic factors or models . The number of primary studies included in each systematic review ranged from 3 to 167 ( median , 18 [ interquartile range , 12 to 31 ] ) . A complete description of the included review s is available from the authors on request . Figure 1 . Flow diagram of inclusion and exclusion criteria of systematic review s. Figure 2 . Number of systematic review s of prognosis studies identified over time . Quality Items One hundred fifty-three review s provided adequate detail to allow extraction of quality items . Eight hundred eighty-two distinct quality items were extracted from the review s. Most review s developed their own set of quality items , with only a few applying criteria from previous review s. Most quality items Study Type – Prevalence ( prospect i ve cohort ) Level of Evidence Pre clinical data showed anticancer effects of statins in melanoma , but meta‐analyses could not demonstrate a reduced melanoma incidence in statin users . Rather than preventing occurrence , statins might reduce growth and metastatic spread of melanomas and ultimately improve survival . In this population ‐based study , we investigated the relationship between statin use and survival of melanoma patients . Patients ≥18 years who were diagnosed with cutaneous melanoma ( Breslow thickness > 1 mm ) and registered in the Eindhoven Cancer Registry and in PHARMO Data base Network between 1 January 1998 and 31 December 2010 were eligible . The hazard ratio ( HR ) of all‐cause mortality was calculated by employing adjusted time‐dependent and time‐fixed Cox proportional hazard models . Disease‐specific survival was estimated by means of 3‐year relative survival rates ( RSR ) . A control cohort of r and omly selected patients using statins from PHARMO Data base Network matched on age and gender was used to compare RSR of statin users to the general population . After melanoma diagnosis , 171 of 709 patients used statins . Use of statins showed a nonsignificantly decreased hazard of death ( adjusted HR 0.76 , 95 % confidence interval [ CI ] 0.50–1.61 ) . After stratification for gender , male but not female statin users showed a favorable outcome compared to nonusers ( HR 0.57 , 95 % CI 0.32–0.99 ; HR 1.22 , 95 % CI 0.62–2.38 , respectively ) . Three‐year RSR for male statin users tended to be higher than for nonusers ( 91 % vs. 80.5 % , P = 0.06 ) , no differences were observed in women ( 87.1 % vs. 92.5 % , P = 0.76 ) . Statin use was not associated with an improved survival of melanoma patients . The trend for better survival of male in contrast to female statin users warrants further research Background : Pre clinical evidence from lung cancer cell lines and animal models suggest that statins could have anticancer properties . We investigated whether statin users had reduced risk of cancer-specific mortality in a population -based cohort of lung cancer patients . Methods : Newly diagnosed lung cancer patients , from 1998 to 2009 , were identified from English cancer registry data and linked to the UK Clinical Practice Research Data link , providing prescription records , and to Office of National Statistics mortality data up to 2012 . Cox regression models were used to calculate HRs for cancer-specific mortality and 95 % confidence intervals ( CI ) by statin use before and after diagnosis , and to adjust these HRs for potential confounders . Results : In 3,638 lung cancer patients , there was some evidence that statin use after diagnosis was associated with reduced lung cancer – specific mortality ( adjusted HR , 0.89 ; 95 % CI , 0.78–1.02 ; P = 0.09 ) . Associations were more marked after 12 prescriptions ( adjusted HR , 0.81 ; 95 % CI , 0.67–0.98 ; P = 0.03 ) and when lipophilic statins were investigated ( adjusted HR , 0.81 ; 95 % CI , 0.70–0.94 ; P = 0.01 ) , but were attenuated in some sensitivity analyses . Furthermore , in 11,051 lung cancer patients , statin use before diagnosis was associated with reduced lung cancer – specific mortality ( adjusted HR , 0.88 ; 95 % CI , 0.83–0.93 ; P < 0.001 ) . Conclusions : There was some evidence that lung cancer patients who used statins , and particularly simvastatin , had reduced rates of cancer-specific mortality . Impact : These findings should first be confirmed in observational studies , but provide some support for conducting r and omized controlled trials of simvastatin as adjuvant cancer therapy in lung cancer patients . Cancer Epidemiol Biomarkers Prev ; 24(5 ) ; 833–41 . © 2015 AACR Lipid-lowering drugs are used for the prevention of cardiovascular diseases . Statins are the most commonly used lipid-lowering drugs . Evidence from pre clinical and observational studies suggests that statins might improve the prognosis of breast cancer patients . We analyzed data from the German MARIEplus study , a large prospect i ve population -based cohort of patients aged 50 and older , who were diagnosed with breast cancer between 2001 and 2005 . For overall mortality , breast-cancer specific mortality , and non-breast-cancer mortality , we included 3189 patients with invasive breast cancer stage I – IV , and for recurrence risk 3024 patients with breast cancer stage I – III . We used Cox proportional hazards models to assess the association with self-reported lipid-lowering drug use at recruitment . We stratified by study region , tumor grade , and estrogen/progesterone receptor status , and adjusted for age , tumor size , nodal status , metastases ( stage I – IV only ) , menopausal hormone treatment , mode \n Output:\n " }, { "from": "agent", "value": "Statin therapy has potential survival benefit for patients with malignancy ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: BACKGROUND : High-frequency neuromuscular electrical stimulation increases exercise tolerance in patients with advanced chronic obstructive pulmonary disease ( COPD patients ) . However , it is conceivable that its benefits are more prominent in patients with better-preserved peripheral muscle function and structure . OBJECTIVE : To investigate the effects of high-frequency neuromuscular electrical stimulation in COPD patients with better-preserved peripheral muscle function . Design : Prospect i ve and cross-over study . METHODS : Thirty COPD patients were r and omly assigned to either home-based , high-frequency neuromuscular electrical stimulation or sham stimulation for six weeks . The training intensity was adjusted according to each subject 's tolerance . Fat-free mass , isometric strength , six-minute walking distance and time to exercise intolerance ( Tlim ) were assessed . RESULTS : Thirteen ( 46.4 % ) patients responded to high-frequency neuromuscular electrical stimulation ; that is , they had a post/pre ΔTlim > 10 % after stimulation ( unimproved after sham stimulation ) . Responders had a higher baseline fat-free mass and six-minute walking distance than their seventeen ( 53.6 % ) non-responding counterparts . Responders trained at higher stimulation intensities ; their mean amplitude of stimulation during training was significantly related to their fat-free mass ( r = 0.65 ; p<0.01 ) . Logistic regression revealed that fat-free mass was the single independent predictor of Tlim improvement ( odds ratio [ 95 % CI ] = 1.15 [ 1.04 - 1.26 ] ; p<0.05 ) . CONCLUSIONS : We conclude that high-frequency neuromuscular electrical stimulation improved the exercise capacity of COPD patients with better-preserved fat-free mass because they tolerated higher training stimulus levels . These data suggest that early training with high-frequency neuromuscular electrical stimulation before tissue wasting begins might enhance exercise tolerance in patients with less advanced COPD INTRODUCTION In severely disabled patients who are not capable of following formal pulmonary rehabilitation ( PR ) and /or tolerating higher training intensities , neuromuscular electrical stimulation ( NMES ) has been successfully utilized as a localized training method . MATERIAL S AND METHODS In this non-r and omized controlled observational study 50 patients with severe chronic obstructive pulmonary disease ( COPD ) , who were allocated into two groups . Endurance training group ( ET ) ( n= 27 ) and NMES group ( n= 23 ) . To compare the effects of NMES and ET on health-related quality of life ( HRQOL ) , exercise capacity , muscle strength , dyspnea , psychological status , and body composition in patients with severe COPD . Before and after PR program , the study parameters were assessed using the Medical Research Council ( MRC ) scale , incremental and endurance shuttle walking tests ( ISWT , ESWT ) , manual muscle testing ( MMT ) , the St. George 's Respiratory Question naire ( SGRQ ) , bioelectrical impedance analysis , and the Hospital Anxiety and Depression Scale ( HADS ) . RESULTS After the PR program , walking distance and endurance time significantly increased in both groups ( p < 0.001 for each ) , whereas the MRC scores of both groups significantly decreased ( p < 0.001 for each ) . In the ET group , significant decreases were noted in all domains of SGRQ and HADS . In the NMES group , significant improvements were observed in the HADS scores and in all SGRQ domain except symptom domain . No significant differences were observed between the NMES and ET groups regarding the changes from baseline to after PR program in walking distance ( p= 0.140 ) , endurance time ( p= 0.376 ) , the MRC ( p= 0.540 ) , HRQOL ( p > 0.05 ) and HADS ( p > 0.05 ) scores , body-mass index ( BMI ) ( p= 0.49 ) , fat-free mass ( FFM ) ( p= 0.50 ) and fat-free mass index ( FFMI ) ( p= 0.94 ) . CONCLUSION NMES can be used as an effective treatment strategy in PR programs for peripheral muscle training in patients with severe COPD Cross-education enhances the performance of muscles not directly involved in the chronic conditioning of the muscles in a remote limb . Substantial cross-education occurs after training with eccentric contractions or with contractions evoked by electromyostimulation ( EMS ) . Since during EMS and eccentric contractions , skin and muscle afferents are activated that have excitatory effects on contralateral homologous muscles , it was hypothesized that exercise training with stimulated vs. voluntary eccentric contractions would lead to greater cross-education . Thirty-two women were r and omly assigned to a voluntary ( Vol ) , an EMS , or remote EMS ( rEMS ) exercise group and performed 840 voluntary or stimulated eccentric contractions over 6 weeks . All subjects , including nonexercising controls ( Con ) , were tested pre- and posttraining for maximal voluntary and stimulated isometric and eccentric quadriceps strength . Ipsilateral voluntary and stimulated forces increased in all groups . Changes in EMG activity paralleled those in voluntary force in each limb . No changes occurred in grip strength . The great contra- and ipsilateral strength gains after EMS training were most likely related to an additive effect of EMS and muscle lengthening Introduction Chronic obstructive pulmonary disease ( COPD ) has systemic repercussions that can lead to peripheral muscle dysfunction . Muscle atrophy reduces aerobic capacity , greatly limiting activities of daily living and quality of life . Pulmonary rehabilitation is the gold st and ard treatment for these patients , however , patients may not be able to reach sufficient training intensities for benefits to occur . Technologies such as functional electrical stimulation ( FES ) are currently being adapted and tested to enhance exercise training . We hypothesise that FES coupled with cycling ( FES-cycling ) will improve maximal uptake of oxygen ( VO2 ) and aerobic capacity more than endurance training with placebo stimulation . Methods A r and omised , single-blind , placebo-controlled crossover trial will be carried out to evaluate the effects of FES-cycling on VO2 during endurance exercise on a cycle ergometer in patients with COPD . 25 patients with COPD will carry out two 30 min sessions at a constant load ; one session with active and one with placebo FES . The primary outcome is oxygen uptake recorded with a metabolic measurement system . Secondary outcomes include ventilation equivalent for oxygen , ventilation equivalent for carbon dioxide , cardiac output , lactate values , perceived dyspnoea and perceived muscle fatigue . Results and conclusions Approval has been granted by our Institutional Review Board ( Comité de Protection des Personnes Nord-Ouest 3 ) . The results of the trial will be presented at national and international meetings and published in peer- review ed journals . Trial registration number NCT02594722 Muscle dysfunction is a major problem in chronic obstructive pulmonary disease ( COPD ) , particularly after exacerbations . We thus asked whether neuromuscular electrostimulation ( NMES ) might be directly useful following an acute exacerbation and if such a therapy decreases muscular oxidative stress and /or alters muscle fibre distribution . A pilot r and omised controlled study of NMES lasting 6 weeks was carried out in 15 in- patients ( n=9 NMES ; n=6 sham ) following a COPD exacerbation . Stimulation was delivered to the quadriceps and hamstring muscles ( 35 Hz ) . Primary outcomes were quadriceps force and muscle oxidative stress . At the end of the study , quadriceps force improvement was statistically different between groups ( p=0.02 ) , with a significant increase only in the NMES group ( median ( interquartile range ) 10 ( 4.7–11.5 ) kg ; p=0.01 ) . Changes in the 6-min walking distance were statistically different between groups ( p=0.008 ) , with a significant increase in the NMES group ( 165 ( 125–203 ) m ; p=0.003 ) . NMES did not lead to higher muscle oxidative stress , as indicated by the decrease in total protein carbonylation ( p=0.02 ) and myosin heavy chain carbonylation ( p=0.01 ) levels . Finally , we observed a significant increase in type I fibre proportion in the NMES group . Our study shows that following COPD exacerbation , NMES is effective in counteracting muscle dysfunction and decreases muscle oxidative stress BACKGROUND Skeletal muscle dysfunction and exercise intolerance are common in severe chronic obstructive pulmonary disease ( COPD ) . We assessed the effectiveness of neuromuscular electrical stimulation ( NMES ) as a home-based exercise therapy . METHODS In this double-blind , placebo-controlled trial , undertaken across three UK National Health Service sites , we r and omly assigned ( 1:1 ) adults with COPD , a forced expiratory volume in 1 s ( FEV1 ) less than 50 % predicted , and incapacitating breathlessness ( Medical Research Council dyspnoea scale ≥4 ) to receive active or placebo NMES , daily over a 6-week period . R and omisation was by an independent system using minimisation to balance age , GOLD stage , and quadriceps strength . Participants and outcome assessors were masked to group allocation . The primary endpoint was change in 6-min walk test ( 6MWT ) distance at 6 weeks . Analysis was by intention to treat . The trial was registered as IS RCT N15985261 and is now closed . FINDINGS Between June 29 , 2012 , and July 4 , 2014 , we enrolled 73 participants , of whom 52 participants were r and omly assigned ; 25 to receive active NMES and 27 to placebo NMES . Change in 6MWT distance was greater in the active NMES group ( mean 29·9 [ 95 % CI 8·9 to 51·0 ] ) compared with in the placebo group ( -5·7 [ -19·9 to 8·4 ] ; mean difference at 6 weeks 35·7 m [ 95 % CI 10·5 to 60·9 ] ; p=0·005 ) . Sensitivity analyses for complete-cases and adjustment for baseline values showed similar results . 6 weeks after stopping the intervention the effect waned ( 7·3 m [ 95 % CI -32·5 to 47·0 ] ; p=0·50 ) . The proportion of participants who had adverse events was similar between groups ( five [ 20 % ] in the active NMES group and nine [ 33 % ] in the placebo group ) . Two participants , one from each group , reported persistent erythema , which was considered to be possibly related to NMES and the use of adhesive electrodes . INTERPRETATION NMES improves functional exercise capacity in patients with severe COPD by enhancing quadriceps muscle mass and function . These data support the use of NMES in the management of patients unable to engage with conventional pulmonary rehabilitation . More work is needed to study how to maintain the effect . FUNDING National Institute for Health Research AIMS Patients with chronic heart failure ( CHF ) exhibit detrimental changes in skeletal muscle that contribute to their impaired physical performance . This study investigates the possibility of counteracting these changes by chronic low-frequency electrical stimulation ( CLFS ) of left and right thigh muscles . METHODS AND RESULTS ( mean+/-SD ) 32 CHF patients ( 53+/-10 years ) with an LVEF of 22+/-5 % , NYHA II-IV , undergoing optimized drug therapy , were r and omized in a CLFS group ( CLFSG ) or a control group ( controls ) . The groups differed in terms of the intensity of stimulation , which elicited strong muscle contractions only in the CLFSG , whereas the controls received current input up to the sensory threshold without muscle contractions . Functional capacity was assessed by peak VO(2 ) , work capacity , and a 6-min-walk ( 6-MW ) . Muscle biopsies were analyzed for myosin heavy chain ( MHC ) isoforms , citrate synthase ( CS ) and glyceraldehydephosphate dehydrogenase ( GAPDH ) activities . Peak VO(2)(mlmin(-1)kg -1 ) increased from 9.6+/-3.5 to 11.6+/-2.8 ( P<0.001 ) in the CLFSG , and decreased from 10.6+/-2.8 to 9.4+/-3.2 ( P<0.05 ) in the controls . The increase in the CLFSG was paralleled by increases in maximal workload ( P<0.05 ) and oxygen uptake at the anaerobic threshold ( P<0.01 ) . The corresponding values of the controls were unchanged , as also the 6-MW values , the MHC isoform distribution , and both CS and GAPDH activities . In the CLFSG , the 6-MW values increased ( P<0.001 ) , CS activity was elevated ( P<0.05 ) , GAPDH activity decreased ( P<0.01 ) , and the MHC isoforms were shifted in the slow direction with increases in MHCI at the expense of MHCIId/x ( P<0.01 ) . CONCLUSIONS Our results suggest that CLFS is a suitable treatment to counteract detrimental changes in skeletal muscle and to increase exercise capacity in patients with severe CHF Exercise intolerance in chronic obstructive pulmonary disease ( COPD ) results from a complex interaction between central \n Output:\n " }, { "from": "agent", "value": "NMES , when applied in isolation , increased quadriceps force and endurance , 6MWD and time to symptom limitation exercising at a submaximal intensity , and reduced the severity of leg fatigue on completion of exercise testing .\nIt may increase VO2peak , but the true effect on this outcome measure could be trivial .\nAlthough there were no additional gains in quadriceps force with NMES plus conventional exercise training , there was evidence of an increase in 6MWD .\nFurther , in people who were the most debilitated , the addition of NMES may have accelerated the achievement of a functional milestone , that is , the first time someone sits out of bed" } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: Objective The purpose of this r and omized study was to evaluate the influence of immediate multilayer compression b and ages before application of elastic stockings in the acute phase of deep-vein thrombosis ( DVT ) on development of the post-thrombotic syndrome ( PTS ) . Methods Sixty-nine patients with acute symptomatic DVT were r and omized to immediate b and aging ( n = 34 ) or no b and aging ( n = 35 ) . After reduction of edema sized-to-fit elastic stockings were applied in all patients after 7–14 days . Follow-up visits and non-invasive examinations were planned after 7 , 30 and 90 days and 1 year . Venous outflow resistance ( VOR ) was measured by strain gauge plethysmography . Thrombosis score ( TS ) and reflux were measured by duplex scanning . After one year patients were evaluated for clinical PTS using both the clinical scale of the CEAP classification and the Villalta score . Results Improvement of clinical symptoms and decrease of leg circumference was better on day 7 in the b and aging group , but after 1 and 3 months clinical symptoms had improved equally in both groups . In 7 patients in the no-b and aging group a b and age was applied after all because of persistent edema after 10 days . There were no differences in VOR , TS and reflux . Using the CEAP classification the incidence of PTS was 39 % in patients with b and ages and 42 % in patients without b and ages ( RR 0.91 , 95 % CI 0.50–1.66 ) . Using the Villalta score the incidence of PTS was resp . 29 and 33 % ( RR 0.87 , 95 % CI 0.41–1.8 ) . There was no difference in severity of PTS . Conclusion Immediate multilayer compression b and aging in the acute phase of DVT is effective in reducing edema and complaints in the first week , but has no effect on thrombus regression , valve incompetence and the development of clinical PTS after 1 year BACKGROUND Post-thrombotic syndrome varies from mild oedema to incapacitating swelling with pain and ulceration . We investigated the rate of post-thrombotic syndrome after a first episode of deep-vein thrombosis and assessed the preventive effect of direct application of a sized-to-fit grade d compression stocking . METHODS Patients with a first episode of venogram-proven proximal deep-vein thrombosis were r and omly assigned no stockings ( the control group ) or made-to-measure grade d compression elastic stockings for at least 2 years . Post-thrombotic syndrome was assessed with a st and ard scoring system that combined clinical characteristics and objective leg measurements . Patients were assessed every 3 months during the first 2 years , and every 6 months thereafter for at least 5 years . The cumulative incidence of mild-to-moderate post-thrombotic syndrome was the primary outcome measure . FINDINGS Of the 315 consecutive out patients considered for inclusion , 44 were excluded and 77 did not consent to take part . 194 patients were r and omly assigned compression stockings ( n = 96 ) or no stockings ( n = 98 ) . The median follow-up was 76 months ( range 60 - 96 ) in both groups . Mild-to-moderate post-thrombotic syndrome ( score > or = 3 plus one clinical sign ) occurred in 19 ( 20 % ) patients in the stocking group and in 46 ( 47 % ) control-group patients ( p < 0.001 ) . 11 ( 11 % ) patients in the stocking group developed severe post-thrombotic syndrome ( score > or = 4 ) , compared with 23 ( 23 % ) patients in the control group ( p < 0.001 ) . In both groups , most cases of post-thrombotic syndrome occurred within 24 months of the acute thrombotic event . INTERPRETATION About 60 % of patients with a first episode of proximal deep-vein thrombosis develop post-thrombotic syndrome within 2 years . A sized-to-fit compression stocking reduced this rate by about 50 % BACKGROUND Graduated elastic compression ( GEC ) stockings have been demonstrated to reduce the morbidity associated with post-thrombotic syndrome . The ideal length or compression strength required to achieve this is speculative and related to physician preference and patient compliance . The aim of this study was to evaluate the hemodynamic performance of four different stockings and determine the patient 's preference . METHODS Thirty-four consecutive patients ( 40 legs , 34 male ) with post-thrombotic syndrome were tested with four different stockings ( Mediven plus open toe , Bayreuth , Germany ) of their size in r and om order : class 1 ( 18 - 21 mm Hg ) and class II ( 23 - 32 mm Hg ) , below-knee ( BK ) and above-knee thigh-length ( AK ) . The median age , Venous Clinical Severity Score , Venous Segmental Disease Score , and Villalta scale were 62 years ( range , 31 - 81 years ) , 8 ( range , 1 - 21 ) , 5 ( range , 2 - 10 ) , and 10 ( range , 2 - 22 ) , respectively . The C of C0 - 6EsAs , d , pPr , o was C0 = 2 , C2 = 1 , C3 = 3 , C4a = 12 , C4b = 7 , C5 = 12 , C6 = 3 . Obstruction and reflux was observed on duplex in 47.5 % legs , with deep venous reflux alone in 45 % . Air plethysmography was used to measure the venous filling index ( VFI ) , venous volume , and time to fill 90 % of the venous volume . Direct pressure measurements were obtained while lying and st and ing using the PicoPress device ( Microlab Elettronica , Nicolò , Italy ) . The pressure sensor was placed underneath the test stocking 5 cm above and 2 cm posterior to the medial malleolus . At the end of the study session , patients stated their preferred stocking based on comfort . RESULTS The VFI , venous volume , and time to fill 90 % of the venous volume improved significantly with all types of stocking versus no compression . In class I , the VFI ( mL/s ) improved from a median of 4.9 ( range , 1.7 - 16.3 ) without compression to 3.7 ( range , 0 - 14 ) BK ( 24.5 % ) and 3.6 ( range , 0.6 - 14.5 ) AK ( 26.5 % ) . With class II , the corresponding improvement was to 4.0 ( range , 0.3 - 16.2 ) BK ( 18.8 % ) and 3.7 ( range , 0.5 - 14.2 ) AK ( 24.5 % ) . Median stocking pressure ( mm Hg ) as measured with the PicoPress in class I was 23 ( range , 12 - 33 ) lying and 27 ( range , 19 - 39 ) st and ing ( P < .0005 ) and in class II was 28 ( range , 21 - 40 ) lying and 32 ( range , 23 - 46 ) st and ing ( P < .0005 ) . There was a significant but weak correlation ( Spearman ) between stocking interface pressure measured directly with the PicoPress and the VFI improvement ( baseline VFI-compression VFI ) at r = .237 ; P = .005 . Twenty-one patients ( legs ) changed their preference of compression and 38 % of these ( 8/21 patients , 9/21 legs ) preferred an AK-GEC stocking . CONCLUSIONS Compression significantly improved all hemodynamic parameters on air plethysmography . However , the hemodynamic benefit did not significantly change with the class or length of stocking . These results support the liberal selection of a GEC stocking based on patient preference Although below-knee compression elastic stockings ( CES ) are effective for the prevention of the postthrombotic syndrome ( PTS ) , a substantial number of patients with deep venous thrombosis still develop PTS . In the present open-label , r and omized clinical trial , we compared thigh-length with below-knee CES for the prevention of PTS . A total of 267 patients with the first episode of proximal deep venous thrombosis were r and omized to wear either thigh-length or below-knee CES for 2 years . After 3 , 6 , 12 , 18 , 24 , and 36 months , they were assessed for PTS manifestations according to the Villalta scale . PTS developed in 44 ( 32.6 % ) of the 135 patients r and omized to thigh-length CES and in 47 ( 35.6 % ) of the 132 allocated to below-knee CES , for an adjusted hazard ratio of 0.93 ( 95 % confidence interval , 0.62 - 1.41 ) . Severe PTS developed in 3 patients in each group . CES-related side effects developed in 55 ( 40.7 % ) of the 135 patients allocated to thigh-length CES and in 36 ( 27.3 % ) of those r and omized to the below-knee group ( P = .017 ) , and led to premature discontinuation of their use in 29 ( 21.5 % ) and 18 ( 13.6 % ) patients , respectively . We conclude that thigh-length CES do not offer a better protection against PTS than below-knee CES and are less well tolerated Objective Post-thrombotic syndrome is a chronic complication of acute deep venous thrombosis in the lower extremity . The role of graduated compression stockings in the prevention of post-thrombotic syndrome has been studied with opinion being divided on the beneficial effects . We aim to answer this question with a r and omized controlled study that uses multiple scoring instruments to assess post-thrombotic syndrome . Methods Sixty-nine consecutive patients with acute deep venous thrombosis diagnosed by duplex ultrasonography were r and omized to treatment with graduated compression stockings or no graduated compression stockings . Venous Clinical Severity Score and Villalta-Pr and oni Score , commonly used scoring systems , were used to appraise post-thrombotic syndrome at 3 , 6 , 12 , 18 , and 24 months following diagnosis of deep venous thrombosis . In both scoring systems , the individual either had post-thrombotic syndrome or no post-thrombotic syndrome . Cumulative incidence was computed using Kaplan – Meier analysis . Relative risk was assessed for age , obesity , varicose veins , and iliofemoral deep venous thrombosis . Results As measured by both Villalta-Pr and oni Score and Venous Clinical Severity Score instruments , the graduated compression stockings group had a lower incidence of post-thrombotic syndrome compared to the control group , but only when one month was used as cut off time for the first diagnosis of post-thrombotic syndrome . When 6 or 12 months were used , there was no difference in the incidence of post-thrombotic syndrome between the two groups . The burden of post-thrombotic syndrome was significantly more when the Villalta-Pr and oni Score instrument ( ∼75 % ) was used as compared to the Venous Clinical Severity Score instrument ( ∼30 % ) at 24 months ’ follow-up . Obesity was the only statistically significant predictor for the development of post-thrombotic syndrome . Conclusion As assessed by both Villalta-Pr and oni Score and Venous Clinical Severity Score instruments , use of graduated compression stockings does not reduce the incidence of post-thrombotic syndrome . There is a significant difference in the incidence post-thrombotic syndrome as detected by Villalta-Pr and oni Score and Venous Clinical Severity Score instruments with incidence of post-thrombotic syndrome dependent on instrument and cut off time interval used to assess post-thrombotic syndrome . However , larger prospect i ve studies are required to confirm these differences Objective To study whether stopping elastic compression stockings ( ECS ) after 12 months is non-inferior to continuing them for 24 months after proximal deep venous thrombosis . Design Multicentre single blind non-inferiority r and omised controlled trial . Setting Outpatient clinics in eight teaching hospitals in the Netherl and s , including one university medical centre . Participants Patients compliant with compression therapy for 12 months after symptomatic , ultrasound proven proximal deep venous thrombosis of the leg . Interventions Continuation or cessation of ECS 12 months after deep venous thrombosis . Main outcome measures The primary outcome was the incidence of post-thrombotic syndrome 24 months after diagnosis of deep venous thrombosis , as assessed by the st and ardised Villalta scale in an intention to treat analysis . The predefined non-inferiority margin was 10 % . The main secondary outcome was quality of life ( VEINES-QOL/Sym ) . Results 518 patients compliant with ECS and free of post-thrombotic syndrome were r and omised one year after diagnosis of deep venous thrombosis to stop or continue ECS therapy for another year . In the stop-ECS group , 51 of 256 patients developed post-thrombotic syndrome , with an incidence of 19.9 % ( 95 % confidence interval 16 % to 24 % ) . In the continue-ECS group , 34 of 262 patients developed post-thrombotic syndrome ( incidence 13. \n Output:\n " }, { "from": "agent", "value": "There was very limited evidence available for adverse effects and quality of life ( QoL ) .\nThere is very limited evidence for adverse effects , patient satisfaction , QoL , and compliance rates .\nThere is low-certainty evidence favouring use of intermittent pneumatic compression devices compared to a control device for the treatment of severity owing to different measurements used by the studies reporting on this outcome and small studies of short duration .\nThere is moderate-certainty evidence of improved QoL but possible increased adverse effects related to compression device use owing to small studies of short duration ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: Introduction : We investigated the health-related quality of life ( HRQoL ) of long-term prostate cancer patients who received leuprorelin acetate in microcapsules ( LAM ) for and rogen-deprivation therapy ( ADT ) . Methods : The observational study was carried out by 30 office-based German urologists in 536 prostate cancer ( PCa ) patients treated for ≥5 years with LAM and in 116 patients of an age-matched control group ( CG ) . Data on HRQoL and health status was collected prospect ively using vali date d question naires QLQ-C30 , QLQ-PR25 and Karnofsky Index . Data on effectiveness ( clinical response , prostate specific antigen [ PSA ] , testosterone ) and safety was collected retrospectively from patients ' health records . We used descriptive statistics to analyze the data . Results : The mean treatment duration was 8.6 years ( range 4.5 - 19.8 years ) . General health status ( QLQ-C30 ) was comparable for both groups . Differences were observed regarding physical - and role functioning . ADT patients rated single items slightly worse than CG . Karnofsky-Index showed comparable high values ( median of 90 % ) . QLQ-PR25 revealed more PCa-related symptoms for ADT patients . Within 6 months , median PSA level declined > 90 % and median testosterone levels declined below castration level from 4.0 to 0.2 ng/mL. Clinical response ( European Organisation for Research and Treatment of Cancer criteria ) was observed in at least 90 % of ADT patients . Conclusions : Long-term ADT with LAM is a well-accepted , tolerated , effective , and low-burden treatment option for patients with advanced , hormone-sensitive PCa BACKGROUND Enzalutamide ( formerly called MDV3100 ) targets multiple steps in the and rogen-receptor-signaling pathway , the major driver of prostate-cancer growth . We aim ed to evaluate whether enzalutamide prolongs survival in men with castration-resistant prostate cancer after chemotherapy . METHODS In our phase 3 , double-blind , placebo-controlled trial , we stratified 1199 men with castration-resistant prostate cancer after chemotherapy according to the Eastern Cooperative Oncology Group performance-status score and pain intensity . We r and omly assigned them , in a 2:1 ratio , to receive oral enzalutamide at a dose of 160 mg per day ( 800 patients ) or placebo ( 399 patients ) . The primary end point was overall survival . RESULTS The study was stopped after a planned interim analysis at the time of 520 deaths . The median overall survival was 18.4 months ( 95 % confidence interval [ CI ] , 17.3 to not yet reached ) in the enzalutamide group versus 13.6 months ( 95 % CI , 11.3 to 15.8 ) in the placebo group ( hazard ratio for death in the enzalutamide group , 0.63 ; 95 % CI , 0.53 to 0.75 ; P<0.001 ) . The superiority of enzalutamide over placebo was shown with respect to all secondary end points : the proportion of patients with a reduction in the prostate-specific antigen ( PSA ) level by 50 % or more ( 54 % vs. 2 % , P<0.001 ) , the soft-tissue response rate ( 29 % vs. 4 % , P<0.001 ) , the quality -of-life response rate ( 43 % vs. 18 % , P<0.001 ) , the time to PSA progression ( 8.3 vs. 3.0 months ; hazard ratio , 0.25 ; P<0.001 ) , radiographic progression-free survival ( 8.3 vs. 2.9 months ; hazard ratio , 0.40 ; P<0.001 ) , and the time to the first skeletal-related event ( 16.7 vs. 13.3 months ; hazard ratio , 0.69 ; P<0.001 ) . Rates of fatigue , diarrhea , and hot flashes were higher in the enzalutamide group . Seizures were reported in five patients ( 0.6 % ) receiving enzalutamide . CONCLUSIONS Enzalutamide significantly prolonged the survival of men with metastatic castration-resistant prostate cancer after chemotherapy . ( Funded by Medivation and Astellas Pharma Global Development ; AFFIRM Clinical Trials.gov number , NCT00974311 . ) Background : Most patients receiving docetaxel-based chemotherapy for castration resistant prostate cancer ( CRPC ) will eventually progress , and the optimal interventions for these patients are controversial . The objective of our study is to evaluate the clinical efficacy and safety of pharmacological interventions for CRPC patients progressing after docetaxel-based chemotherapy . Methods : A systematic review and Bayesian network meta- analysis of the literature was carried out according to st and ard methods . Major electronic data bases including PubMed , Web of Science and Embase were search ed until Jan 2017 . Hazard ratios ( HRs ) and odds ratios ( ORs ) with corresponding 95 % credible intervals ( CrIs ) were used to estimate the association . Results : 17 R and omized Controlled Trials ( RCTs ) comprising 14 different interventions with 12347 patients were enrolled . Compared with control arms , Abiraterone Acetate ( HR : 0.70 , 95%CrI : 0.63 - 0.79 ) , Cabazitaxel ( HR : 0.70 , 95%CrI : 0.51 - 0.95 ) and Enzalutamide ( HR : 0.63 , 95%CrI : 0.53 - 0.75 ) presented similar benefits in term of OS . Enzalutamide showed superiority over PFS and PSA response with a highest probability to rank 1 . Moreover , sensitivity analysis showed that Abiraterone Acetate ( HR : 0.71 , 95%CrI : 0.63 - 0.78 ) exhibited the most efficacious intervention of being rank 1 in term of OS compared with control arms , followed by Cabazitaxel and Cetuximab . On the other h and , Abiraterone Acetate ( OR : 0.86 , 95%CrI : 0.35 - 2.03 ) presented no significant toxicities compared with control arms . Conclusions : Our results demonstrated that Abiraterone Acetate might be the optimal intervention for CRPC patients after docetaxel failure with acceptable tolerability . Future well- design ed RCTs and systematic review s are needed to vali date these findings Summary Background Long-term hormone therapy has been the st and ard of care for advanced prostate cancer since the 1940s . STAMPEDE is a r and omised controlled trial using a multiarm , multistage platform design . It recruits men with high-risk , locally advanced , metastatic or recurrent prostate cancer who are starting first-line long-term hormone therapy . We report primary survival results for three research comparisons testing the addition of zoledronic acid , docetaxel , or their combination to st and ard of care versus st and ard of care alone . Methods St and ard of care was hormone therapy for at least 2 years ; radiotherapy was encouraged for men with N0M0 disease to November , 2011 , then m and ated ; radiotherapy was optional for men with node-positive non-metastatic ( N+M0 ) disease . Stratified r and omisation ( via minimisation ) allocated men 2:1:1:1 to st and ard of care only ( SOC-only ; control ) , st and ard of care plus zoledronic acid ( SOC + ZA ) , st and ard of care plus docetaxel ( SOC + Doc ) , or st and ard of care with both zoledronic acid and docetaxel ( SOC + ZA + Doc ) . Zoledronic acid ( 4 mg ) was given for six 3-weekly cycles , then 4-weekly until 2 years , and docetaxel ( 75 mg/m2 ) for six 3-weekly cycles with prednisolone 10 mg daily . There was no blinding to treatment allocation . The primary outcome measure was overall survival . Pairwise comparisons of research versus control had 90 % power at 2·5 % one-sided α for hazard ratio ( HR ) 0·75 , requiring roughly 400 control arm deaths . Statistical analyses were undertaken with st and ard log-rank-type methods for time-to-event data , with hazard ratios ( HRs ) and 95 % CIs derived from adjusted Cox models . This trial is registered at Clinical Trials.gov ( NCT00268476 ) and ControlledTrials.com ( IS RCT N78818544 ) . Findings 2962 men were r and omly assigned to four groups between Oct 5 , 2005 , and March 31 , 2013 . Median age was 65 years ( IQR 60–71 ) . 1817 ( 61 % ) men had M+ disease , 448 ( 15 % ) had N+/X M0 , and 697 ( 24 % ) had N0M0 . 165 ( 6 % ) men were previously treated with local therapy , and median prostate-specific antigen was 65 ng/mL ( IQR 23–184 ) . Median follow-up was 43 months ( IQR 30–60 ) . There were 415 deaths in the control group ( 347 [ 84 % ] prostate cancer ) . Median overall survival was 71 months ( IQR 32 to not reached ) for SOC-only , not reached ( 32 to not reached ) for SOC + ZA ( HR 0·94 , 95 % CI 0·79–1·11 ; p=0·450 ) , 81 months ( 41 to not reached ) for SOC + Doc ( 0·78 , 0·66–0·93 ; p=0·006 ) , and 76 months ( 39 to not reached ) for SOC + ZA + Doc ( 0·82 , 0·69–0·97 ; p=0·022 ) . There was no evidence of heterogeneity in treatment effect ( for any of the treatments ) across prespecified subsets . Grade 3–5 adverse events were reported for 399 ( 32 % ) patients receiving SOC , 197 ( 32 % ) receiving SOC + ZA , 288 ( 52 % ) receiving SOC + Doc , and 269 ( 52 % ) receiving SOC + ZA + Doc . Interpretation Zoledronic acid showed no evidence of survival improvement and should not be part of st and ard of care for this population . Docetaxel chemotherapy , given at the time of long-term hormone therapy initiation , showed evidence of improved survival accompanied by an increase in adverse events . Docetaxel treatment should become part of st and ard of care for adequately fit men commencing long-term hormone therapy . Funding Cancer Research UK , Medical Research Council , Novartis , Sanofi-Aventis , Pfizer , Janssen , Astellas , NIHR Clinical Research Network , Swiss Group for Clinical Cancer Research Background : Bicalutamide is a widely used , relatively non-toxic anti- and rogen , particularly when used in combination with and rogen deprivation . In men on combined and rogen blockade ( CAB ) , the typical dose is 50 mg per day . For men receiving monotherapy with bicalutamide anti- and rogen , the dose is 150 mg per day . The objective was to determine the PSA response rate to increasing bicalutamide to 150 mg per day in men who develop castrate-resistant prostate cancer ( CRPC ) on CAB with goserelin acetate and bicalutamide 50 mg per day . Methods : A national , multicentre , phase 2 , open-label study in men on CAB with a rising PSA>2.0 . The primary end point of the trial was PSA response at 12 months , defined as a decline by 50 % or more compared with baseline value . Partial response was defined as a PSA decline of 10–49 % . Secondary end points were duration of PSA response , change in slope of serum PSA , change in ratio of free PSA : total PSA at 3 months , 6 months and 12 months as compared with baseline ; duration of the bicalutamide withdrawal response after discontinuation ; the rate of cardiovascular events ; and toxicity . The study was initially planned to accrue 100 patients , but was closed early due to diminishing accrual . Results : Sixty-four patients were accrued ; 61 patients received trial treatment and constituted the intention-to-treat ( ITT ) cohort . 70 % were M0 . Among 59 evaluable ITT patients , 13 ( 22 % ) patients had a > 50 % PSA decline , 5 ( 8 % ) had a decline between 10 and 50 % , 4 ( 7 % ) had stabilization and 37 ( 63 % ) had PSA progression . The median duration was 3.7 months ( 95 % confidence interval of 0.92–6.21 months ) . Conclusion : In patients with early biochemical failure on CAB with bicalutamide 50 mg , an increase in dose to 150 mg of bicalutamide result ed in a \n Output:\n " }, { "from": "agent", "value": "Conclusions Early st and ard ADT can reduce symptoms of disease progression and may extend progression-free and overall survival .\nEarly st and ard ADT is increasingly combined with new antihormonal drugs in castration-sensitive metastatic prostate cancer to gain additional survival and quality of life benefits .\nCombined treatment at the time of development of castration-resistant disease is well established" } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: Prognosis studies are investigations of future events or the evaluation of associations between risk factors and health outcomes in population s of patients ( 1 ) . The results of such studies improve our underst and ing of the clinical course of a disease and assist clinicians in making informed decisions about how best to manage patients . Prognostic research also informs the design of intervention studies by helping define subgroups of patients who may benefit from a new treatment and by providing necessary information about the natural history of a disorder ( 2 ) . There has recently been a rapid increase in the use of systematic review methods to synthesize the evidence on research questions related to prognosis . It is essential that investigators conducting systematic review s thoroughly appraise the method ologic quality of included studies to be confident that a study 's design , conduct , analysis , and interpretation have adequately reduced the opportunity for bias ( 3 , 4 ) . Caution is warranted , however , because inclusion of method ologically weak studies can threaten the internal validity of a systematic review ( 4 ) . This follows abundant empirical evidence that inadequate attention to biases can cause invalid results and inferences ( 5 - 9 ) . However , there is limited consensus on how to appraise the quality of prognosis studies ( 1 ) . A useful framework to assess bias in such studies follows the basic principles of epidemiologic research ( 10 , 11 ) . We focus on 6 areas of potential bias : study participation , study attrition , prognostic factor measurement , confounding measurement and account , outcome measurement , and analysis . The main objectives of our review of review s are to describe methods used to assess the quality of prognosis studies and to describe how well current practice s assess potential biases . Our secondary objective is to develop recommendations to guide future quality appraisal , both within single studies of prognostic factors and within systematic review s of the evidence . We hope this work facilitates future discussion and research on biases in prognosis studies and systematic review s. Methods Literature Search and Study Selection We identified systematic review s of prognosis studies by search ing MEDLINE ( 1966 to October 2005 ) using the search strategy recommended by McKibbon and colleagues ( 12 ) . This strategy combines broad search terms for systematic review s ( systematic review .mp ; meta- analysis .mp ) and a sensitive search strategy for prognosis studies ( cohort , incidence , mortality , follow-up studies , prognos * , predict * , or course ) . We also search ed the reference lists of included review s and method ologic papers to identify other relevant publications . We restricted our search to English- language publications . One review er conducted the search and selected the studies . Systematic review s , defined as review s of published studies with a comprehensive search and systematic selection , were included if they assessed the method ologic quality of the included studies by using 1 or more explicit criteria . We excluded studies if they were meta-analyses of independent patient data only , if their primary goal was to investigate the effectiveness of an intervention or specific diagnostic or screening tests , or if they included studies that were not done on humans . Data Extraction and Synthesis Individual items included in the quality assessment of the systematic review s were recorded as they were reported in the publication ( that is , the information that would be available to readers and future review ers ) . We review ed journal Web sites and contacted the authors of the systematic review s for additional information when authors made such an offer in their original papers . When review s assessed different study design s by using different sets of quality items , we extracted only those items used to assess cohort studies . We constructed a comprehensive list of distinct items that the review s used to assess the quality of their included studies . The full text of each review was screened . All items used by the review authors to assess the quality of studies were extracted into a computerized spreadsheet by 1 review er . Two experienced review ers , a clinical epidemiologist and an epidemiologist , independently synthesized the quality items extracted from the prognosis review s to determine how well the systematic review s assessed potential biases . We did this in 3 steps : 1 ) identified distinct concepts or domains addressed by the quality items ; 2 ) grouped each extracted quality item into the appropriate domain or domains ; and 3 ) identified the domains necessary to assess potential biases in prognosis studies . We then used this information to assess how well the review s ' quality assessment included items from the domains necessary to assess potential biases . After completing each of the first 3 steps , the review ers met to attempt to reach a consensus . The consensus process involved each review er presenting his or her observations and results , followed by discussion and debate . A third review er was available in cases of persistent disagreement or uncertainty . In the first step , all domains addressed by the quality items were identified . The first review er iteratively and progressively defined the domains as items were extracted from the included review s. The second review er defined domains from a r and om list of all extracted quality items . Limited guidance was provided to the review ers so that their assessment s and definitions of domains would be independent . The review ers agreed on a final set of domains that adequately and completely defined all of the extracted items . In the second step , review ers independently grouped each extracted item into the appropriate domains . Review ers considered each extracted item by asking , What is each particular quality item addressing ? or What are the review 's authors getting at with the particular quality assessment item ? . Items were grouped into the domain or domains that best represented the concepts being addressed . For example , the extracted items at least 80 % of the group originally identified was located for follow-up and follow-up was sufficiently complete or does n't jeopardize validity were each independently classified by both review ers as assessing the domain completeness of follow-up adequate , whereas the extracted item quantification and description of all subjects lost to follow-up was classified as assessing the domain completeness of follow-up described . In the third step , we identified the domains necessary to assess potential biases . Each review er considered the ability of the identified domains to adequately address , at least in part , 1 of the following 6 potential biases : 1 ) study participation , 2 ) study attrition , 3 ) prognostic factor measurement , 4 ) confounding measurement and account , 5 ) outcome measurement , and 6 ) analysis . Domains were considered to adequately address part of the framework if information garnered from that domain would inform the assessment of potential bias . For example , both review ers judged that the identified domain study population represents source population or population of interest assessed potential bias in a prognosis study , whereas the domain research question definition did not , although the latter is an important consideration in assessing the inclusion of studies in a systematic review . Finally , on the basis of our previous ratings , we looked at whether each review included items from the domains necessary to assess the 6 potential biases . We calculated the frequency of systematic review s by assessing each potential bias and the number of review s that adequately assessed bias overall . From this systematic synthesis , we developed recommendations for improving quality appraisal in future systematic review s of prognosis studies . We used Microsoft Access and Excel 2002 ( Microsoft Corp. , Redmond , Washington ) for data management and SAS for Windows , version 9.1 ( SAS Institute , Inc. , Cary , North Carolina ) for descriptive statistics . Role of the Funding Sources The funding sources , the Canadian Institutes of Health Research , the Canadian Chiropractic Research Foundation , the Ontario Chiropractic Association , and the Ontario Ministry of Health and Long Term Care , did not have a role in the collection , analysis , or interpretation of the data or in the decision to su bmi t the manuscript for publication . Results We identified 1384 potentially relevant articles . Figure 1 shows a flow chart of studies that were included and excluded . Figure 2 shows the number of review s identified by year of publication . We excluded 131 systematic review s of prognosis studies that did not seem to include any quality assessment of the included studies ; this represented 44 % of prognosis review s. We included 163 review s of prognosis studies in our analysis ( 13 - 175 ) . The most common topics were cancer ( 15 % ) , musculoskeletal disorders and rheumatology ( 13 % ) , cardiovascular ( 10 % ) , neurology ( 10 % ) , and obstetrics ( 10 % ) . Other review s included a wide range of health and health care topics . Sixty-three percent of the review s investigated the association between a specific prognostic factor and a particular outcome ; the remainder investigated multiple prognostic factors or models . The number of primary studies included in each systematic review ranged from 3 to 167 ( median , 18 [ interquartile range , 12 to 31 ] ) . A complete description of the included review s is available from the authors on request . Figure 1 . Flow diagram of inclusion and exclusion criteria of systematic review s. Figure 2 . Number of systematic review s of prognosis studies identified over time . Quality Items One hundred fifty-three review s provided adequate detail to allow extraction of quality items . Eight hundred eighty-two distinct quality items were extracted from the review s. Most review s developed their own set of quality items , with only a few applying criteria from previous review s. Most quality items BACKGROUND Disodium ethylenediaminetetraacetic acid ( EDTA ) reduced adverse cardiac outcomes in a factorial trial also testing oral vitamins . This report describes the intent-to-treat comparison of the 4 factorial groups overall and in patients with diabetes . METHODS This was a double-blind , placebo-controlled , 2 × 2 factorial multicenter r and omized trial of 1,708 post-myocardial infa rct ion ( MI ) patients ≥50 years of age and with creatinine ≤2.0 mg/dL r and omized to receive 40 EDTA chelation or placebo infusions plus 6 caplets daily of a 28-component multivitamin-multimineral mixture or placebo . The primary end point was a composite of total mortality , MI , stroke , coronary revascularization , or hospitalization for angina . RESULTS Median age was 65 years , 18 % were female , 94 % were Caucasian , 37 % were diabetic , 83 % had prior coronary revascularization , and 73 % were on statins . Five-year Kaplan-Meier estimates for the primary end point was 31.9 % in the chelation + high-dose vitamin group , 33.7 % in the chelation + placebo vitamin group , 36.6 % in the placebo infusion + active vitamin group , and 40.2 % in the placebo infusions + placebo vitamin group . The reduction in primary end point by double active treatment compared with double placebo was significant ( hazard ratio 0.74 , 95 % CI 0.57 - 0.95 , P = .016 ) . In patients with diabetes , the primary end point reduction of double active compared with double placebo was more pronounced ( hazard ratio 0.49 , 95 % CI 0.33 - 0.75 , P < .001 ) . CONCLUSIONS In stable post-MI patients on evidence -based medical therapy , the combination of oral high-dose vitamins and chelation therapy compared with double placebo reduced clinical ly important cardiovascular events to an extent that was both statistically significant and of potential clinical relevance BACKGROUND Although multivitamins are widely used , there are limited prospect i ve studies investigating their association with both long- and short-term risk of cardiovascular disease ( CVD ) . OBJECTIVE The objective was to investigate how multivitamin use is associated with the long- and short-term risk of CVD . DESIGN A prospect i ve cohort study was conducted of 37,193 women from the Women 's Health Study aged ≥45 y and free of CVD and cancer at baseline who were followed for an average of 16.2 y. At baseline , women self-reported a wide range of lifestyle , clinical , and dietary factors . Women were categorized into 1 ) no current use and 2 ) current use of multivitamins . Duration and up date d measures over the course of the follow-up to address short-term effects were also considered . Women were followed for major CVD events , including myocardial infa rct ion ( MI ) , stroke , and CVD death . RESULTS During the follow-up , 1493 incident cases of CVD [ defined as myocardial infa rct ion ( MI ) , stroke , and CVD death ] occurred . In multivariable analyses , multivitamin use compared with no use was not associated with major CVD events ( HR : 1.01 ; 95 % CI : 0.89 , 1.15 ) , MI ( HR : 1.04 ; 95 % CI : 0.84 , 1.27 ) , stroke ( HR : 0.99 ; 95 % CI : 0.83 , 1.18 ) , or CVD death ( HR : 1.10 ; 95 % CI : 0.84 , 1.45 ) . A nonsignificant inverse association was observed between baseline multivitamin use and major CVD events among women aged ≥70 y ( P-interaction = 0.04 ) and those consuming <3 servings/d of fruit and vegetables ( P-interaction = 0.01 ) . When updating information on multivitamin use during the course of follow-up , no associations were observed for major CVD events ( HR : 0.91 ; 95 % CI : 0.82 , 1.02 ) , MI ( HR : 0.89 ; 95 % CI : 0.74 , 1.06 ) , stroke ( HR : 0.91 ; 95 % CI : 0.78 , 1.06 ) , and CVD death ( HR : 0.91 ; 95 % CI : 0.71 , 1.16 ) . CONCLUSIONS In this study of middle-aged and elderly women , neither baseline nor time-varying multivitamin use was associated with the long-term risk of major CVD events , MI , stroke , cardiac revascularizations , or CVD death . Additional studies are needed to clarify the role of multivitamins on CVD Purpose To prospect ively evaluate the association of vitamin/mineral supplementation with cancer , cardiovascular , and all-cause mortality . Methods In the Heidelberg cohort of the European Prospect i ve Investigation into Can \n Output:\n " }, { "from": "agent", "value": "Conclusions : Our meta- analysis of clinical trials and prospect i ve cohort studies demonstrates that MVM supplementation does not improve cardiovascular outcomes in the general population" } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: Arbekacin ( ABK ) was approved and widely used in Japan for treatment of patients infected with MRSA , and TDM was introduced in clinical practice . The Japanese Society of Chemotherapy and the Japanese Society of Therapeutic Drug Monitoring decided to develop a clinical practice guidelines for TDM of ABK for the following reasons . First , although the daily dose of 150e200 mg was approved in Japan , recent PK- PD studies revealed that higher serum concentration is required to achieve better clinical efficacy and several findings concerning the usefulness of higher dosage regimen have obtained recently . Second , although maximal concentrations that obtained immediately after the end of administration ( Cmax ) w as generally adopted , the serum concentration at 1 h after initiation of administration ( peak serum con- centration ( Cpeak ) ) proved to be more suitable as an efficacy indicator of aminoglycosides . Lastly , as ABK is approved only in Japan , no international practice guideline for TDM has not been available in ABK to date . This guideline evaluated the scientific data associated with serum ABK monitoring and provided rec- ommendations based on the available evidence . Potential limitations of this guideline , however , include the findings that few prospect i ve clinical trials of TDM of ABK are available in the treatment of MRSA infections and that most of the published literature describes observational studies BACKGROUND Voriconazole is a triazole agent with excellent antifungal activity against Aspergillus species . However , despite its potential advantages , the occurrence of unpredictable toxicities might be critical in immunocompromised patients . The aim of this study was to analyze risk factors for voriconazole-related severe adverse events ( SAEs ) . METHODS This prospect i ve observational study was conducted in Korean patients with hematological malignancies and invasive aspergillosis on intravenous voriconazole therapy between June 2008 and April 2009 . RESULTS Of the 25 patients enrolled , eight ( 32 % ) showed voriconazole-related SAEs , which included hepatotoxicities ( n=5 ) , cardiac tachyarrhythmias ( n=2 ) , and neurotoxicity ( n=1 ) . Sex , age , underlying hematological malignancies , voriconazole dose , the co-administration of a proton pump inhibitor , and CYP2C19 genotype were not found to be related to the occurrence of SAEs . However , trough plasma concentrations of voriconazole were found to be significantly higher in the patients with an SAE : median 6.32 mg/l ( interquartile range ( IQR ) 2.86 - 9.71 mg/l ) vs. median 2.15 mg/l ( IQR 0.92 - 4.00 mg/l ) ; p=0.011 . Receiver operating characteristic curve analysis identified a cut-off trough concentration for SAEs of 5.83 mg/l ( sensitivity 62.5 % and specificity 94.1 % ) . Furthermore , multivariate analysis showed that a trough concentration of ≥ 5.83mg/l was the only significant independent risk factor of an SAE . CONCLUSIONS This study shows that therapeutic drug monitoring is indicated in patients with a voriconazole-related SAE and that dose adjustment is required if the trough concentration of voriconazole exceeds 5.83 mg/l Seventy-one allograft recipients receiving voriconazole , in whom complete clinical , microbiologic and pharmacokinetic data were available , were studied to determine the efficacy of voriconazole in preventing fungal infections . The length of voriconazole therapy was 6–956 days ( median 133 ) . The total number of patient-days on voriconazole was 13 805 ( ∼38 years ) . A total of 10 fungal infections were seen in patients on voriconazole ( 18 % actuarial probability at 1 year ) : C and ida glabrata ( n=5 ) , C and ida krusei ( n=1 ) , Cunninghamella ( n=1 ) , Rhizopus ( n=2 ) and Mucor ( n=1 ) . Two of the four zygomycosis cases were preceded by short duration s of voriconazole therapy , but prolonged itraconazole prophylaxis . The plasma steady-state trough voriconazole levels around the time the infection occurred were < 0.2 , < 0.2 , 0.33 , 0.55 , 0.63 and 1.78 μg/ml in the six c and idiasis cases . Excluding the four zygomycosis cases , all the six c and idiasis cases were seen among the 43 patients with voriconazole levels of ⩽2 μg/ml and none among the 24 with levels of > 2 μg/ml ( P=0.061 ) . We conclude that voriconazole is effective at preventing aspergillosis . However , breakthrough zygomycosis is seen in a small proportion of patients . The role of therapeutic voriconazole monitoring with dose adjustment to avoid breakthrough infections with fungi that are otherwise susceptible to the drug needs to be explored prospect ively BACKGROUND Blood levels of voriconazole , a first line therapy for invasive aspergillosis , may correlate with adverse events and treatment response . However , no r and omized controlled studies have been conducted to evaluate the clinical utility of routine therapeutic drug monitoring ( TDM ) of voriconazole . This study aim ed to determine whether routine TDM of voriconazole reduces drug adverse events or improves treatment response in invasive fungal infections . METHODS This was a r and omized , assessor-blinded , controlled , single center trial . One hundred ten adult patients were r and omly assigned to TDM or non-TDM groups . In the TDM group , voriconazole dosage was adjusted ( target range , 1.0 - 5.5 mg/L ) according to the serum trough level measured on the fourth day after initiation of voriconazole . The non-TDM group received a fixed , st and ard dosage . Voriconazole-related adverse events were monitored , and treatment response was assessed three months after the initiation of therapy . RESULTS Baseline characteristics including the CYP2C19 genotype were comparable between the two groups . While the incidence of adverse events was not different between the TDM group and the non-TDM group ( both 42 % ; P = .97 ) , the proportion of voriconazole discontinuation due to adverse events was significantly lower in the TDM group than in the non-TDM group ( 4 % vs 17 % ; P = .02 ) . A complete or partial response was observed in 81 % ( 30 of 37 ) of patients in the TDM group compared to 57 % ( 20 of 34 ) in the non-TDM group ( P = .04 ) . CONCLUSIONS Routine TDM of voriconazole may reduce drug discontinuation due to adverse events and improve the treatment response in invasive fungal infections . CLINICAL TRIAL REGISTRATION NCT00890708 ABSTRACT Voriconazole prophylaxis is common following lung transplantation , but the value of therapeutic drug monitoring is unknown . A prospect i ve , observational study of lung transplant recipients ( n = 93 ) receiving voriconazole prophylaxis was performed . Serum voriconazole troughs ( n = 331 ) were measured by high-pressure liquid chromatography . The median initial and subsequent troughs were 1.91 and 1.46 μg/ml , respectively . The age of the patient directly correlated with initial troughs ( P = 0.005 ) . Patients that were ≥60 years old and cystic fibrosis patients were significantly more likely to have higher and lower initial troughs , respectively . In 95 % ( 88/93 ) of patients , ≥2 troughs were measured . In 28 % ( 25/88 ) and 32 % ( 28/88 ) of these patients , all troughs were ≤1.5 μg/ml or > 1.5 μg/ml , respectively . Ten percent ( 10/93 ) and 27 % ( 25/93 ) of the patients developed invasive fungal infection ( tracheobronchitis ) and fungal colonization , respectively . The median troughs at the times of positive and negative fungal cultures were 0.92 and 1.72 μg/ml ( P = 0.07 ) . Invasive fungal infections or colonization were more likely with troughs of ≤1.5 μg/ml ( P = 0.01 ) and among patients with no trough of > 1.5 μg/ml ( P = 0.007 ) . Other cutoff troughs correlated less strongly with microbiologic outcomes . Troughs correlated directly with aspartate transferase levels ( P = 0.003 ) , but not with other liver enzymes . Voriconazole was discontinued due to suspected toxicity in 27 % ( 25/93 ) of the patients . The troughs did not differ at the times of suspected drug-induced hepatotoxicity , central nervous system ( CNS ) toxicity , or nausea/vomiting and in the absence of toxicity . Voriconazole prophylaxis was most effective at troughs of > 1.5 μg/ml . A cutoff for toxicity was not identified , but troughs of > 4 μg/ml were rare . The data support a target range of > 1.5 to 4 μg/ml There are limited data on the relationship between voriconazole levels and clinical outcomes relative to invasive aspergillosis ( IA ) . We therefore analyzed the association between initial voriconazole trough blood levels and clinical responses of IA in patients with hematologic malignancies . All adult patients treated with voriconazole in a tertiary care hospital in Seoul , South Korea , between August 2009 and April 2011 were identified from pharmacy records . Initial voriconazole trough levels were routinely measured 1 week after therapy and patient responses were classified as success ( complete or partial response ) or failure ( stable response , progression of disease , or death ) at 2 weeks post-therapy . Fifty-two patients , involving 2 ( 4 % ) proven , 29 ( 56 % ) probable , and 21 ( 40 % ) possible IA infections , were included . Of these , 11 ( 21 % ) had initial voriconazole levels of ≤ 2 mg/l and the remaining 41 ( 79 % ) had > 2 mg/l . There were slightly fewer successful responses ( 45 % , 5/11 ) in the patients with initial voriconazole levels ≤ 2 mg/l than in those with voriconazole levels > 2 mg/l ( 51 % , 21/41 ) , but the difference was not statistically significant ( P= 0.73 ) . Neutropenia ( OR 0.1 , P= 0.008 ) and immunosuppression ( OR 0.1 , P= 0.004 ) were independently associated with 2-week successful response after voriconazole therapy . In conclusion , initial voriconazole trough levels may not significantly affect clinical outcomes of IA at 2 weeks after voriconazole therapy in patients with hematologic malignancies . Further studies of prospect i ve design are needed to establish the optimal procedure for voriconazole drug monitoring Background Genetic polymorphisms of cytochrome P450 enzymes , especially CYP2C19 influence voriconazole pharmacokinetics . However , the impact of CYP2C19 genetic polymorphisms on the therapeutic efficacy and toxicity of voriconazole therapy are not well established . Material s and Methods In this prospect i ve observational study , we analyzed all consecutive adult patients with hematologic diseases who were treated for invasive aspergillosis ( IA ) with voriconazole between January 2011 and June 2012 . CYP2C19 genotype and routine therapeutic drug monitoring of voriconazole were performed . The target range for voriconazole trough levels was 1 - 5.5 mg/L. Results A total of 104 consecutive patients were enrolled , including 39 homozygous extensive metabolizers ( EMs , 38 % ) , 50 heterozygous extensive metabolizers ( HEMs , 48 % ) , and 15 poor metabolizers ( PMs , 14 % ) . The initial voriconazole trough levels were 1.8 , 2.7 , and 3.2 mg/L in EMs , HEMs , and PMs , respectively ( P = 0.068 ) . Out-of-range initial trough levels were most frequently observed in EMs ( 46 % ) followed by HEMs ( 26 % ) and PMs ( 0 % ) ( P = 0.001 ) . The frequency of initial trough levels < 1 mg/L but not > 5.5 mg/L differed significantly among the 3 groups ( P = 0.005 ) . However , treatment response , all-cause and IA-attributable mortality , and the occurrence of voriconazole-related adverse events did not differ significantly among the 3 groups ( P = 0.399 , P = 0.412 , P = 0.317 , and P = 0.518 , respectively ) . Conclusions While none of the initial voriconazole trough levels in PMs was outside the target range , subtherapeutic initial trough levels were frequent in EMs . Although there was no significant relationship between CYP2C19 genotype and either the clinical outcomes of IA or toxicity of voriconazole , further large-scale multicenter studies using clinical data from homogeneous \n Output:\n " }, { "from": "agent", "value": "A trough concentration > 3.0 mg/L is associated with increased hepatotoxicity , particularly for the Asian population , and > 4.0 mg/L is associated with increased neurotoxicity" } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: We evaluated the effect of an herbal tea preparation on infantile colic in a prospect i ve double-blind study . The use of tea eliminated the colic in 19 ( 57 % ) of 33 infants , whereas placebo was helpful in only 9 ( 26 % ) of 35 ( p < 0.01 ) . The mean colic score was significantly improved in tea-treated infants . No significant differences were noted between groups regarding number of night wakings Objective : Massage therapy has been consistently shown to increase weight gain in preterm infants . The mechanism of this presumed improved metabolic efficiency is unknown . We conducted the following trial to test the hypothesis that massage therapy reduces energy expenditure in growing healthy preterm infants . Study Design : A prospect i ve , r and omized , cross-over design study was conducted in 10 healthy , appropriate weights for gestational age , gavage fed preterm infants . Each infant was studied twice : after a period of either 5 days of massage therapy , or after a period of 5 days without massage therapy . Infants were r and omized to 5 days of massage followed by 5 days of no massage ( n = 5 ) or the opposite sequence ( n = 5 ) . During the massage therapy period , massage was provided daily for three 15 minute periods at the beginning of each 3 hour period every morning . Metabolic measurements were performed by indirect calorimetry , using the Deltatrac II Metabolic cart . Results : Energy expenditure was significantly lower in infants after the 5 day massage therapy period ( 59.6 ± 3.6 Kcal/Kg/ 24 hours ) than after the period without ( 63.1 ± 5.4 Kcal/Kg/ 24 hours ) ( p = 0.05 ) . Conclusions : Energy expenditure is significantly lowered by 5 days of massage therapy in metabolically and thermally stable preterm infants . This decrease in energy expenditure may be in part responsible for the enhanced growth caused by massage therapy ABSTRACT . We assessed the effectiveness of an odor ( familiar or unfamiliar ) in soothing healthy full-term newborns undergoing a routine heel stick . Forty-four breast-fed newborns were r and omly assigned to one of four groups : Before the heel stick , Group 1 was naturally familiarized with their mother 's milk odor , Group 2 was familiarized with a vanilla smell , and Groups 3 and 4 did not received any familiarization . During and after the heel stick , Group 1 was presented with their mother 's milk odor , Group 2 was presented with the familiar vanilla , Group 3 was presented with an unfamiliar odor , and Group 4 was a control group . Infants ' crying , grimacing , and head movements were analyzed before , during , and after the heel stick . Results show that infants who smelled a familiar odor ( their mother 's milk or vanilla ) cried and grimaced significantly less during the recovery phase compared with the heel stick phase . Infants who were presented with an unfamiliar odor or no odor showed no significant changes during recovery . Moreover , infants who smelled their mother 's milk exhibited significantly less motor agitation during the heel stick compared with the other groups . These findings indicate that smelling a familiar odor reduces agitation during the heel stick and diminishes distress after the procedure Oil massage of newborns has been practised for generations in the Indian sub-continent ; however , oils may vary from potentially beneficial , e.g. sunflower seed oil , to potentially toxic , e.g. mustard oil . The study was carried out to gain insights into oil-massage practice s and acceptability of skin barrier-enhancing emollients in young , preterm Bangladeshi neonates . Preterm infants of <33 weeks gestational age were r and omized to high-linoleate sunflower seed oil , Aquaphor Original Emollient Ointment ™ , or the comparison group ( usual care ) . A survey was administered at admission to assess routine skin-care practice s prior to admission and at discharge to assess acceptability of emollient therapy during hospitalization . Oil massage was given to 83 ( 21 % ) of 405 babies before hospital admission , 86 % ( 71/83 ) of whom were delivered at home . Application of oil , most commonly mustard oil ( 88 % , 73/83 ) , was started within one hour of birth in 51 cases ( 61 % ) and was applied all over the body ( 89 % , 74/83 ) one to six ( mean 2.2 ) times before admission . Of infants who received emollient therapy in the hospital , 42 % ( n=32 ) of mothers reported that the emollient applied in the hospital was better than that available at home , and only 29 % would use the same oil ( i.e. mustard oil ) in the future as used previously at home . No problems result ed from use of emollient in the hospital . Topical therapy with sunflower seed oil or Aquaphor was perceived by many families to be superior to mustard oil . If caregivers and health professionals can be motivated to use inexpensive , available emollients , such as sunflower seed oil that are beneficial , emollient therapy could have substantial public-health benefit Objective . Methylxanthines and doxapram are currently used to treat apnea of prematurity but are not fully effective and often present undesirable side effects . The present study examines whether exposure to an odor known to modulate the infant 's respiratory rate could reduce the frequency of apneic spells . Method . Fourteen preterm newborns born at 24 to 28 gestational weeks presenting recurrent apnea despite caffeine and doxapram therapy were exposed to a pleasant odor diffused during 24 hours in the incubator . Efficiency of the olfactory treatment was judged by comparing frequency and severity of apneas occurring during the day of odorization with that observed the day before ( baseline ) and the day after ( posttreatment control ) . Apnea was defined as any complete cessation of breathing movements for > 20 seconds , or less if associated with hypoxia or bradycardia . Results . Concerning all types of apneas , a diminution of 36 % was observed and seen in 12 of 14 infants . Apneas without bradycardia were reduced ( 44 % ) during the day with odorization , and this diminution affected all the infants . The frequency of apnea with moderate bradycardia ( heart rate between 70 and 90 beats per minute ) was maintained while the frequency of apnea associated with severe bradycardia ( heart rate < 70 beats per minute ) decreased strongly ( 45 % ) and affected all the infants . No side effects were observed . Conclusion . The introduction of a pleasant odor in the incubator is of therapeutic value in the treatment of apneas unresponsive to caffeine and doxapram BACKGROUND Echinacea products are among the most popular phytomedicines on the North American market . Since at least half of all pregnancies are unplanned , many women inadvertently use echinacea in their first trimester . Presently , there is a paucity of information regarding the gestational safety of this herb . The primary objective of this study was to evaluate the safety of echinacea in pregnancy when used for upper respiratory tract ailments . PATIENTS AND METHODS The study group consisted of women who were prospect ively followed up after contacting the Motherisk Program regarding the gestational use of echinacea . This cohort was disease-matched to women exposed to nonteratogenic agents by maternal age , alcohol , and cigarette use . Rates of major and minor malformations between the groups were compared . RESULTS A total of 206 women were enrolled in the study group after using echinacea products during pregnancy ; 112 women used the herb in the first trimester . There were a total of 195 live births , including 3 sets of twins , 13 spontaneous abortions , and 1 therapeutic abortion . Six major malformations were reported , including 1 chromosomal abnormality , and 4 of these malformations occurred with echinacea exposure in the first trimester . In the control group , there were 206 women with 198 live births , 7 spontaneous abortions , and 1 therapeutic abortion . Seven major malformations were reported . There were no statistical differences between the study and control groups for any of the end points analyzed . CONCLUSIONS This first prospect i ve study suggests that gestational use of echinacea during organogenesis is not associated with an increased risk for major malformations We assessed the effects of a familiar odor during routine blood draws in healthy preterm newborns . Infants were observed as they were undergoing either a capillary puncture on the heel ( heelstick ) or a venous puncture on the h and . During the procedure , one third of the infants were presented with an odor they had been familiarized with prior to the procedure , one third of the infants were presented with an odor , they had not been previously exposed to , and one third were presented with no odor . Heelsticks elicited more behavioral distress than venipunctures . Infants who were presented with a familiar odor during venipuncture showed no significant increase in crying and grimacing during the procedure compared to baseline levels . By comparison , infants presented with an unfamiliar odor or with no odor either during the heelstick or the venipuncture had a significant increase in crying and grimacing . When the pain was milder , i.e. , during a venipuncture , and a familiar odor was presented , infants showed little to no crying . These results are consistent with a body of evidence on early memory and olfactory competence in fetuses and newborns Acute bronchitis , although mostly caused by viral infections , is commonly treated with antibiotics . As antibiotics should only be prescribed upon strict indication , treatment options like a liquid herbal drug preparation from the roots of Pelargonium sidoides ( EPs 7630 ) gain more and more interest . To evaluate the efficacy and safety of treatment with EPs 7630 in patients with acute bronchitis , a multi-centre , prospect i ve , open observational study was conducted in 440 study sites located in Germany . A total of 2099 patients aged 0 - 93 years with productive cough for less than six days without indication for treatment with antibiotics were given EPs 7630-solution in an age-dependent dosage for 14 days . The primary outcome criterion was the mean change of the Bronchitis Severity Score ( BSS : cough , sputum , rales/rhonchi , chest pain at cough , dyspnoea ) from baseline to patient 's individual last observation . During treatment , the mean BSS of all patients decreased from 7.1+/-2.9 points at baseline to 1.0+/-1.9 points at patients ' individual last visit . Subgroup analysis for children showed a decrease of mean BSS from 6.3+/-2.8 points to 0.9+/-1.8 points and analysis of children younger than three years showed a decrease of mean BSS from 5.2+/-2.5 points to 1.2+/-2.1 points . Adverse events occurred in 26/2099 ( 1.2 % ) patients . Serious adverse events were not reported . In conclusion , EPs 7630 is an effective and well tolerated treatment of acute bronchitis in adults , children and infants outside the strict indication for antibiotic treatment An open post-marketing surveillance study was conducted to examine the treatment effect and safety of EPs 7630-solution in the treatment of acute bronchitis in children . This study included a total of 742 children ( aged between 0 and 12 years ) with acute bronchitis ( 83.4 % ) or acute exacerbations of chronic bronchitis ( 14.3 % ) , who were treated with different doses of the herbal drug for up to 14 days . Five bronchitis specific symptoms ( BSS ) were summed up to give an overall measure of disease severity . Non-specific disease symptoms ( loss of appetite , diarrhoea , headache , vomiting , and fever ) were also recorded , together with adverse events and overall ratings of efficacy and tolerability . The overall BSS score decreased during treatment from 6.0+/-3.0 points at baseline to 2.7+/-2.5 points after 7 days and to 1.4+/-2.1 points after 14 days . Remission or improvement in at least 80 % of patients was recorded for all the individual component symptoms . The proportion of patients suffering from non-specific symptoms also substantially improved during treatment . For example , loss of appetite was present in 65.8 % of patients at study begin , but only in 27.6 % at the time point of last observation visit . In 88.3 % of cases , the responsible physician rated the treatment as successful . Adverse events were minor and transitory . In conclusion , EPs 7630-solution was shown to be a safe and an effective treatment option for acute bronchitis or acute exacerbations of chronic bronchitis in children OBJECTIVE The aim of this study was to determine the presence and absence of acupuncture ear points in healthy neonates . DESIGN This was a prospect i ve observational study performed at a university teaching hospital . SUBJECTS The subjects were healthy neonates . We compared male and female neonates , right and left lobe , term and preterm deliveries , and cesarean sections versus vaginal deliveries . Examinations took place on the fifth day after delivery and were performed by a neuronal pen ( SVESA 1070 , SVESA GmbH , Munich , Germany ) . An integrated optical signal detected the ear points that were assigned to the Chinese ear map . MAIN OUTCOME MEASURES This study looked at the presence and absence of acupuncture ear points in neonates . RESULTS There were 27 male neonates and 23 female neonates . In 66 % of neonates , no points at all were found . We detected 0 - 4 points on the right lobe and 0 - 2 points \n Output:\n " }, { "from": "agent", "value": "Most promising was the study situation in aromatherapy .\nThis review shows that there is no such evidence yet" } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: OBJECTIVE To observe the effect of nitroglycerin patch on treatment of preterm labour and to identify the mechanism responsible for arrest of preterm labour with nitroglycerin patch . METHODS Sixty women diagnosed as threatened preterm labour were divided into two groups : group of nitroglycerin patch therapy ( n = 30 ) , and group of magnesium sulfate and salbutamol sulfate therapy ( n = 30 ) . Nitroglycerin patch was applied to the abdomen of patients . Measurement of cortictrophin-releasing hormone ( CRH ) levels in maternal plasma was performed by radioimmunoassay . RESULTS The mean time of pregnancy prolongation was 25 days in the nitroglycerin patch group , and 8 days in the magnesium sulfate and salbutamol sulfate group . The mean level of CRH concentration in nitroglycerin patch group before treatment was ( 257 + /- 61 ) ng/L , and it was decreased sharply to ( 38 + /- 17 ) ng/L after treatment . Those were ( 248 + /- 60 ) ng/L and ( 56 + /- 22 ) ng/L respectively in the magnesium sulfate and salbutamol sulfate group . CONCLUSION Reduction of CRH secretion may be the mechanism of nitroglycerin patch on preterm labour therapy . It may act as an effective , safe , well-tolerated , and non-invasive method for treatment of preterm labour OBJECTIVE Our r and omized , double-blind , placebo-controlled trial of transdermal nitroglycerin ( GTN ) for preterm labour demonstrated a significant reduction in neonatal morbidity and mortality . The objective of this study was to evaluate developmental performance in the children born to women who participated in the GTN trial after one year and two years of follow-up . METHODS The Ages and Stages Question naires ( ASQ ) were used for the assessment s , and five domains of child development ( communication , gross motor skills , fine motor skills , problem-solving , and personal social skills ) were evaluated . Supplementary analyses were performed after stratifying study subjects by gestational age at birth ( < 28 , 28 to 32 , 33 to 36 , ≥ 37 weeks ) or by defining study subjects as normal or abnormal using st and ard cut-offs . RESULTS A total of 153 infants born to women who participated in the GTN trial were included in the initial follow-up . Among them , 111 ( 72.5 % ) children ( 55 in the GTN arm and 56 in the placebo arm ) at 12 months of age and 83 ( 54.2 % ) children ( 42 in the GTN arm and 41 in the placebo arm ) at 24 months of age completed the full ASQ . There were no differences in ASQ total score and five subscores between the GTN arm and the placebo arm at the one-year and two-year follow-up evaluations , in overall study subjects , or after stratifying study subjects by gestational age . A trend towards reduced abnormalities in the GTN arm at the two-year follow-up was observed , although there was no statistical significance . CONCLUSION Maternal GTN use for preterm labour had no impact on children 's long-term development , but larger studies are needed to confirm the preliminary findings of this study PURPOSE to compare the effectiveness of transdermal nitroglycerin with oral nifedipine in the inhibition of preterm delivery . METHODS a clinical essay has been performed with 50 women in preterm delivery , r and omly divided into two groups , 24 receiving oral nifedipine ( 20 mg ) , and 26 , transdermal nitroglycerin ( 10 mg patch ) . Patients with a single gestation , between the 24th and the 34th weeks and diagnosis of preterm delivery were selected . Women with fetal malformation and clinical or obstetric diseases were excluded . The variables analyzed were : effective tocolysis , time needed for tocolysis , recurrence frequency , progression to preterm delivery , and side effects . RESULTS tocolysis efficacy in the first 12 hours was similar between the groups ( nitroglycerin : 84.6 % versus nifedipine : 87.5 % ; p=0.50 ) . The time average time needed for tocolysis was also similar ( 6.6 versus 5.8 hours ; p=0.30 ) . There was no difference between the groups , concerning the recurrence of preterm delivery ( 26.9 versus 16.7 % ; p=0.30 ) , and neither in the rate of preterm delivery within 48 hours ( 15.4 versus 12.5 % ; p=0.50 ) . Nevertheless , the cephalea rate was significantly higher in the Nitroglycerin Group ( 30.8 versus 8.3 % ; p=0.04 ) . CONCLUSIONS transdermal nitroglycerin has presented similar effectiveness to oral nifedipine to inhibit preterm delivery in the first 48 hours , however with higher cephalea frequency Fig. 1 . Study population . There is a need for an effective tocolytic drug that has fewer side effects than those in use . Ritodrine , a beta adrenergic agonist , is effective up to 48 h after treatment but has no beneficial effects on perinatal mortality and is associated with increased maternal morbidity . Recent studies suggest that glyceryl trinitrate ( GTN ) , a NO donor , may be an effective tocolytic agent w1–4x . We have compared the efficacy and side effects of GTN with ritodrine for the treatment of preterm labor in a r and omized trial conducted at Corniche Hospital , Abu Dhabi , United Arab Emirates , from September 1996 to July 1998 . Women with singleton pregnancies between 23 and 34 weeks ’ gestation with intact amniotic membranes were considered if they presented with painful , regular contractions ( ) 20yh ) documented by external tocography , and yor cervical dilatation of 2 cm or more . Women with known contraindications to tocolysis or known tocolytic exposure during current pregnancy were excluded . Out of 403 women , 132 were r and omly assigned to receive GTN ( ns67 ) or ritodrine ( ns65 ) OBJECTIVE This study was undertaken to assess the effectiveness of glyceryl trinitrate ( GTN ) patches in comparison with beta2 sympathomimetics ( beta2 ) for the treatment of preterm labor . STUDY DESIGN A multicenter , multinational , r and omized controlled trial was conducted in tertiary referral teaching hospitals . Women in threatened preterm labor with positive fetal fibronectin or ruptured membranes between 24 and 35 weeks ' gestation were recruited and r and omly assigned to either beta2 or GTN with rescue beta2 tocolysis if moderate-to-strong contractions persisted at 2 hours . Obstetric and neonatal outcomes were assessed . RESULTS Two hundred thirty-eight women were recruited and r and omly assigned , 117 to beta2 and 121 to GTN . On a strict intention-to-treat basis , there was no significant difference in the time to delivery using Kaplan-Meier curves ( P = .451 ) . At 2 hours , 27 % of women receiving beta2 had moderate or stronger contractions compared with 53 % in the GTN group ( P < .001 ) . This led to 35 % of women in the GTN group receiving rescue treatment . If delivery or requirement for beta2 rescue are regarded as treatment failure , then a significant difference was observed between the 2 arms ( P = .0032 ) . There were no significant differences in neonatal outcomes . CONCLUSION GTN is a less efficacious tocolytic compared with ss2 sympathomimetics OBJECTIVE We assessed the ability of maternal plasma corticotropin-releasing hormone measurements to predict preterm delivery in the setting of a pilot study comparing transdermal glyceryl trinitrate with st and ard beta-mimetic therapy for preterm labor and to determine the effect of these tocolytics on maternal plasma corticotropin-releasing hormone concentrations . STUDY DESIGN Twenty-six consecutive patients with preterm labor were r and omized to tocolytic treatment with transdermal glyceryl trinitrate ( n=13 ) or intravenous albuterol ( n=13 ) . RESULTS Plasma corticotropin-releasing hormone immunoreactivity levels were higher in women who were delivered within 7 days ( 41.4+/-13.5 pmol/L ) than in those continuing to term ( 14.2+/-2.4 pmol/L , p=0.011 ) and were not altered by treatment . Two women in each of the treatment groups delivered within 7 days of the initiation of treatment , two women in the glyceryl trinitrate group were changed to albuterol because of persistence of contractions . Glyceryl trinitrate treatment was associated with significantly fewer maternal side effects . Neither treatment altered umbilical artery Doppler ultrasonographic findings . CONCLUSION Transdermal glyceryl trinitrate is better tolerated than intravenous albuterol but may be no more efficacious than albuterol for the treatment of preterm labor . Biologic markers such as plasma corticotropin-releasing hormone levels may be an important method of identifying women at high risk of preterm delivery In the Obstetrics and Gynaecological Department of the National Research Institute of Mother and Child between January 1998 and December 1998 , sixty women with premature uterine contractions were treated . 30 women were treated using transdermal nitroglicerin ( Nitroderm ) and 30 using Fenoterol . There was no difference between age , parity and gestational age at the beginning of this study . The authors compared the efficiency , tolerance and safety of transdermal nitroglicerin and beta-mimetics used for premature uterine contraction suppression . The frequency and intensity of adverse effects were also evaluated OBJECTIVE The objective of the study was the estimation of the influence of oral supplementation with low-dose l-arginine on feto-placental circulation in women with threatened preterm labor . STUDY DESIGN Oral administration of 3 g of L-arginine daily or placebo as a supplement to st and ard tocolytic therapy was tried in 70 women with threatened preterm delivery , r and omly assigned to the L-arginine ( n=37 ) or placebo ( n=33 ) groups . Twenty-five and 20 completed the study , respectively . Doppler velocimetry of pulsatility indices ( PI ) of the umbilical ( UA ) and middle cerebral ( MCA ) arteries as well as pregnancy outcome and biochemical markers of nitric oxide synthesis ( plasma amino acid and nitrite/nitrate levels , as well as 24 h nitrite/nitrate excretion with urine ) were estimated . RESULTS Starting from the second week of therapy , the UA PI values were significantly lower in the L-arginine group than in the placebo group . Moreover , treatment with L-arginine caused a significant increase in MCA PI and cerebro-placental ratio ( CPR ) values . The changes in feto-placental circulation in the L-arginine group were not associated with any signs of increased nitric oxide synthesis . CONCLUSION Oral supplementation with low doses of L-arginine changed feto-placental blood flow distribution in patients with threatened preterm labor . The exact mechanism of L-arginine action on feto-placental circulation requires further investigation OBJECTIVE This secondary analysis of a r and omized placebo-controlled trial was to hypothesize on mechanisms for the improved neonatal outcomes with the use of nitroglycerin ( GTN ) for preterm labor . STUDY DESIGN Women in the original trial who delivered at term were excluded . A composite of severe neonatal outcomes , gestational age at delivery , and corticosteroid use in addition to Kaplan-Meier survival analysis to assess time from r and omization to delivery were examined . RESULTS A decrease in composite neonatal outcome ( relative risk , 0.21 ; 95 % confidence interval , 0.05 - 0.81 ; P = .018 ) with GTN ( n = 39 ) compared with placebo ( n = 38 ) was primarily due to a 23 day prolongation of pregnancy ( P = .019 ) and a trend ( P = .04 ) toward completing a course of corticosteroids in the subgroup r and omized prior to 28 weeks ' gestation . CONCLUSION We hypothesize that GTN has a gestational age-dependent reduction in neonatal outcomes as a result of pregnancy prolongation and corticosteroid administration OBJECTIVE To evaluate tocolytic efficacy of transdermal glyceryl trinitrate ( GTN ) in comparison to fenoterol per infusionem in a prospect i ve r and omized multicenter study . PATIENTS AND METHODS 50 pregnant women between 27 and 35 weeks of gestation with preterm labour were treated with either GTN patches ( 0.4 - 0.8 mg/h ) or fenoterol per infusionem ( 60 - 120 micrograms/h ) up to stop of contractions or 35 weeks in maximum . The primary outcomes were the prolongation of gestation by 48 h , 7 days or up to 37 weeks of gestation as well as the neonatal outcome . The progression of cervical ripening and maternal side effects during tocolysis were assessed as secondary outcome criteria . RESULTS There was no difference in successful tocolysis for 48 h and 7 days in both groups , whereas significantly more women passed 37 weeks after GTN therapy . So mean duration of pregnancy , birth weight and height were greater , whereas transfer into neonatal care unit was significantly rare after GTN . There \n Output:\n " }, { "from": "agent", "value": "Overall , these studies were underpowered to identify differences between groups for most outcomes .When nitric oxide donors were compared with other tocolytic drugs there was no significant evidence that nitric oxide donors performed better than other tocolytics ( betamimetics , magnesium sulphate , a calcium channel blocker or a combination of tocolytics ) in terms of pregnancy prolongation , although nitric oxide donors appeared to be associated with a reduction in most adverse effects , apart from headache .\nThere was no significant difference between groups for infant morbidity or mortality outcomes .\nAUTHORS ' CONCLUSIONS There is currently insufficient evidence to support the routine administration of nitric oxide donors in the treatment of threatened preterm labour" } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: BACKGROUND / AIMS The effect of vitamin E administration on clinical and laboratory parameters of liver function and on markers of fibrogenesis was assessed in patients with mild to moderate alcoholic hepatitis in a double blind placebo controlled r and omized trial . METHODS Twenty-five patients received 1000 I.U. of vitamin E per day , while 26 patients received placebo for 3 months . The patients were followed for 1 year after entry into the trial . RESULTS Vitamin E did not result in significant greater decreases in serum aminotransferases and serum bilirubin or in greater increases in serum albumin as compared with placebo . Prothrombin time did not change , while serum creatinine remained in the normal range . Monocyte nuclear nuclear factor-kappa B binding activity decreased in patients who remained abstinent , regardless of whether they received vitamin E. As regards markers of hepatic fibrogenesis , vitamin E treatment decreased serum hyaluronic acid ( P<0.05 ) while serum aminoterminal peptide of type III procollagen did not change in either group . Four patients in the treatment group and five in the placebo group died during the 1-year study . CONCLUSIONS Vitamin E treatment improves serum hyaluronic acid but has no beneficial effects on tests of liver function in patients with mild to moderate alcoholic hepatitis BACKGROUND & AIMS Severe alcoholic hepatitis ( AH ) is a life-threatening disease for which adequate oral nutritional support is recommended . We performed a r and omized controlled trial to determine whether the combination of corticosteroid and intensive enteral nutrition therapy is more effective than corticosteroid therapy alone in patients with severe AH . METHODS We enrolled 136 heavy consumers of alcohol ( age , 18 - 75 y ) with recent onset of jaundice and biopsy-proven severe AH in our study , performed at 18 hospitals in Belgium and 2 in France , from February 2010 through February 2013 . Subjects were assigned r and omly ( 1:1 ) to groups that received either intensive enteral nutrition plus methylprednisolone or conventional nutrition plus methylprednisolone ( controls ) . In the intensive enteral nutrition group , enteral nutrition was given via feeding tube for 14 days . The primary end point was patient survival for 6 months . RESULTS In an intention-to-treat analysis , we found no significant difference between groups in 6-month cumulative mortality : 44.4 % of patients died in the intensive enteral nutrition group ( 95 % confidence interval [ CI ] , 32.2%-55.9 % ) and 52.1 % of controls died ( 95 % CI , 39.4%-63.4 % ) ( P = .406 ) . The enteral feeding tube was withdrawn prematurely from 48.5 % of patients , and serious adverse events considered to be related to enteral nutrition occurred in 5 patients . Regardless of group , a greater proportion of patients with a daily calorie intake less than 21.5 kcal/kg/day died ( 65.8 % ; 95 % CI , 48.8 - 78.4 ) than patients with a higher intake of calories ( 33.1 % ; 95 % CI , 23.1%-43.4 % ) ( P < .001 ) . CONCLUSIONS In a r and omized trial of patients with severe AH treated with corticosteroids , we found that intensive enteral nutrition was difficult to implement and did not increase survival . However , low daily energy intake was associated with greater mortality , so adequate nutritional intake should be a main goal for treatment . Clinical Trials.gov number : NCT01801332 BACKGROUND & AIMS An earlier pilot study from our liver unit suggested benefit from treatment with pentoxifylline ( PTX ) , an inhibitor of tumor necrosis factor ( TNF ) , in severe acute alcoholic hepatitis . The aim of the present study was to evaluate this treatment in a larger cohort of patients . METHODS One hundred one patients with severe alcoholic hepatitis ( Maddrey discriminant factor > or = 32 ) entered a 4-week double-blind r and omized trial of PTX ( 400 mg orally 3 times daily ) vs. placebo . Primary endpoints of the study were the effect of PTX on ( 1 ) short-term survival and ( 2 ) progression to hepatorenal syndrome . On r and omization , there were no differences in demographic and clinical characteristics or laboratory values ( including TNF ) between the 2 groups . RESULTS Twelve ( 24.5 % ) of the 49 patients who received PTX and 24 ( 46.1 % ) of the 52 patients who received placebo died during the index hospitalization ( P = 0.037 ; relative risk , 0.59 ; 95 % confidence interval , 0.35 - 0.97 ) . Hepatorenal syndrome was the cause of death in 6 ( 50 % ) and 22 ( 91.7 % ) patients ( P = 0.009 ; relative risk , 0.29 ; 95 % confidence interval , 0.13 - 0.65 ) . Three variables ( age , creatinine level on r and omization , and treatment with PTX ) were independently associated with survival . TNF values on r and omization were not predictive of survival ; however , during the study period they increased markedly in nonsurvivors compared with survivors in both groups . CONCLUSIONS Treatment with PTX improves short-term survival in patients with severe alcoholic hepatitis . The benefit appears to be related to a significant decrease in the risk of developing hepatorenal syndrome . Increasing TNF levels during the hospital course are associated with an increase in mortality rate UNLABELLED Steroids improve the outcome in alcoholic hepatitis ( AH ) , but up to 40 % of patients fail to respond adequately . Interleukin-2 ( IL-2 ) exacerbates steroid resistance in vitro . We performed a prospect i ve study to determine if intrinsic steroid sensitivity correlates with response to steroids in individuals with severe AH and if IL-2 receptor blockade can reverse this . Peripheral blood mononuclear cells ( P BMC s ) were isolated from 20 patients with AH and a Maddrey 's score > 32 . Patients were treated with oral prednisolone plus full supportive measures . Clinical resistance to oral steroid treatment was defined as a drop in serum bilirubin of < 25 % within 7 days or death within 6 months . In vitro steroid resistance was measured in P BMC using the dexamethasone suppression of lymphocyte proliferation assay and repeated after the addition of the anti-IL-2 receptor ( anti-CD25 ) monoclonal antibody , basiliximab . Suppression of lymphocyte proliferation < 60 % was considered to indicate steroid resistance . In all , 82 % ( 9/11 ) of in vitro steroid-resistant patients were dead at 6 months as compared to 21 % ( 2/9 ) of steroid-sensitive patients ( P = 0.03 ) . Similarly , 91 % ( 10/11 ) of in vitro steroid-resistant patients failed to show a significant fall in bilirubin at day 7 as compared to 44 % ( 4/9 ) of steroid-sensitive patients ( P < 0.05 ) . Basiliximab improved the maximal proliferation count in 91 % ( 10/11 ) of in vitro steroid-resistant patients ( P = 0.003 ) . CONCLUSION Clinical outcome of steroid therapy in this patient cohort correlated with in vitro steroid resistance . IL-2 blockade improved in vitro steroid sensitivity . This suggests that intrinsic lack of steroid sensitivity may contribute to poor clinical response to steroids in severe AH . IL-2 receptor blockade represents a possible mechanism to overcome this Chronic obstructive pulmonary disease ( COPD ) is a common , progressive respiratory disease that causes great morbidity and mortality despite treatment . Tumor necrosis factor alpha ( TNF-alpha ) plays a central role as a pro-inflammatory cytokine in COPD . TNF-alpha release is markedly inhibited by phosphodiesterase type 4 ( PDE4 ) inhibitors that have proven efficacious in COPD clinical trials . The aim of this study was to compare the in vitro activities of the novel selective PDE4 inhibitors CI-1044 compared to well-known PDE4 inhibitors , rolipram and cilomilast , and to the glucocorticoid dexamethasone at reducing lipopolysaccharide (LPS)-induced TNF-alpha release in whole blood from COPD patients and healthy subjects . In the whole blood from COPD patients pre-incubation with PDE4 inhibitors or dexamethasone result ed in a dose-dependent inhibition of LPS-induced TNF-alpha release with IC(50 ) values of 1.3+/-0.7 , 2.8+/-0.9 microM , higher to 10 microM and lesser than 0.03 microM for CI-1044 , rolipram , cilomilast and dexamethasone , respectively . We observed a similar inhibition in the whole blood from healthy volunteers with , however , higher IC(50 ) values . These results indicate that CI-1044 inhibits in vitro LPS-induced TNF-alpha release in whole blood from COPD patients better than rolipram and cilomilast and suggested that it could be a useful anti-inflammatory therapy in COPD Two hundred eighty-one alcoholic patients were prospect ively evaluated by clinical , biochemical , and histologic parameters during a 4-yr period to assess their prognosis . They were stratified into four categories of injury : 1 ) fatty liver ( 26 patients ) , 2 ) acute alcoholic hepatitis ( 106 ) , 3 ) cirrhosis ( 39 ) , and 4 ) cirrhosis with superimposed alcoholic hepatitis ( 111 ) . The rate of survival and variables correlating with survival varied according to the group . At 48 months , 70 % of the patients with fatty liver were alive , 58 % in the alcoholic hepatitis group , 49 % in cirrhosis , and 35 % in alcoholic hepatitis superimposed upon cirrhosis . Within group one , deaths were due to causes unrelated to liver disease . In the alcoholic hepatitis group , factors significantly correlating with survival were ascites , alanine amino-transferase levels , grams of alcohol consumed , continuation of alcohol intake , and clinical severity of disease . Survival in patients of group three correlated significantly with prothrombin time and histologic severity score . Patients with combined cirrhosis and alcoholic hepatitis exhibited the worst prognosis , with the most significant predictors of survival being age , grams of alcohol consumed , the ratio of serum aminotransferases ( AST : ALT ) and the histologic and clinical severity of the disease . Although a different pattern of correlates was observed for each pathologic level of injury , knowledge of the various correlates aids in prognostic assessment IMPORTANCE Prednisolone or pentoxifylline is recommended for severe alcoholic hepatitis , a life-threatening disease . The benefit of their combination is unknown . OBJECTIVE To determine whether the addition of pentoxifylline to prednisolone is more effective than prednisolone alone . DESIGN , SETTING , AND PARTICIPANTS Multicenter , r and omized , double-blind clinical trial conducted between December 2007 and March 2010 in 1 Belgian and 23 French hospitals of 270 patients aged 18 to 70 years who were heavy drinkers with severe biopsy-proven alcoholic hepatitis , as indicated by recent onset of jaundice in the prior 3 months and a Maddrey score of at least 32 . Duration of follow-up was 6 months . The last included patient completed the study in October 2010 . None of the patients were lost to follow-up for the main outcome . INTERVENTION Patients were r and omly assigned to receive either a combination of 40 mg of prednisolone once a day and 400 mg of pentoxifylline 3 times a day ( n=133 ) for 28 days , or 40 mg of prednisolone and matching placebo ( n=137 ) for 28 days . MAIN OUTCOMES AND MEASURES Six-month survival , with secondary end points of development of hepatorenal syndrome and response to therapy based on the Lille model , which defines treatment nonresponders after 7 days of initiation of treatment . RESULTS In intention-to-treat analysis , 6-month survival was not different in the pentoxifylline-prednisolone and placebo-prednisolone groups ( 69.9 % [ 95 % CI , 62.1%-77.7 % ] vs 69.2 % [ 95 % CI ; 61.4%-76.9 % ] , P = .91 ) , corresponding to 40 vs 42 deaths , respectively . In multivariable analysis , only the Lille model and the Model for End-Stage Liver Disease score were independently associated with 6-month survival . At 7 days , response to therapy assessed by the Lille model was not significantly different between the 2 groups ( Lille model score , 0.41 [ 95 % CI , 0.36 - 0.46 ] vs 0.40 [ 95 % CI , 0 \n Output:\n " }, { "from": "agent", "value": "Best Practice Advice 7 : Presence of systemic inflammatory response syndrome ( SIRS ) on admission is associated with an increased risk of multi‐organ failure ( MOF ) syndrome .\nMethylprednisolone does not improve survival beyond 28 days , and the benefits for < 28 days are modest ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: In the present study , we used positron emission tomography to investigate changes in regional cerebral blood flow ( rCBF ) during a general anesthetic infusion set to produce a gradual transition from the awake state to unconsciousness . Five right-h and ed human volunteers participated in the study . They were given propofol with a computer-controlled infusion pump to achieve three stable levels of plasma concentrations corresponding to mild sedation , deep sedation , and unconsciousness , the latter defined as unresponsiveness to verbal comm and s. During awake baseline and each of the three levels of sedation , two scans were acquired after injection of an H215O bolus . Global as well as regional CBF were determined and correlated with propofol concentrations . In addition , blood flow changes in the thalamus were correlated with those of the entire scanned volume to determine areas of coordinated changes . In addition to a generalized decrease in global CBF , large regional decreases in CBF occurred bilaterally in the medial thalamus , the cuneus and precuneus , and the posterior cingulate , orbitofrontal , and right angular gyri . Furthermore , a significant covariation between the thalamic and midbrain blood flow changes was observed , suggesting a close functional relationship between the two structures . We suggest that , at the concentrations attained , propofol preferentially decreases rCBF in brain regions previously implicated in the regulation of arousal , performance of associative functions , and autonomic control . Our data support the hypothesis that anesthetics induce behavioral changes via a preferential , concentration-dependent effect on specific neuronal networks rather than through a nonspecific , generalized effect on the brain We investigated the effects of the general anesthetic agent propofol on cerebral structures involved in the processing of vibrotactile information . Using positron emission tomography ( PET ) and the H(2)(15)O bolus technique , we measured regional distribution of cerebral blood flow ( CBF ) in eight healthy human volunteers . They were scanned under five different levels of propofol anesthesia . Using a computer-controlled infusion , the following plasma levels of propofol were targeted : Level W ( Waking , 0 microg/ml ) , Level 1 ( 0.5 microg/ml ) , Level 2 ( 1.5 microg/ml ) , Level 3 ( 3.5 microg/ml ) , and Level R ( Recovery ) . At each level of anesthesia , two 3-min scans were acquired with vibrotactile stimulation of the right forearm either on or off . The level of consciousness was evaluated before each scan by the response of the subject to a verbal comm and . At Level W , all volunteers were fully awake . They reported being slightly drowsy at Level 1 , they had a slurred speech and slow response at Level 2 , and they were not responding at all at Level 3 . The following variations in regional CBF ( rCBF ) were observed . During the waking state ( Level W ) , vibrotactile stimulation induced a significant rCBF increase in the left thalamus and in several cortical regions , including the left primary somatosensory cortex and the left and right secondary somatosensory cortex . During anesthesia , propofol reduced in a dose-dependent manner rCBF in the thalamus as well as in a number of visual , parietal , and prefrontal cortical regions . At Level 1 through 3 , propofol also suppressed vibration-induced increases in rCBF in the primary and secondary somatosensory cortex , whereas the thalamic rCBF response was abolished only at Level 3 , when volunteers lost consciousness . We conclude that propofol interferes with the processing of vibrotactile information first at the level of the cortex before attenuating its transfer through the thalamus While ubiquitous , pharmacological manipulation of consciousness remains poorly defined and incompletely understood ( Prys-Roberts , 1987 ) . This retards anesthetic drug development , confounds interpretation of animal studies conducted under anesthesia , and limits the sensitivity of clinical monitors of cerebral function to intact perception . Animal and human studies propose a functional “ switch ” at the level of the thalamus , with inhibition of thalamo-cortical transmission characterizing loss of consciousness ( Alkire et al. , 2000 ; Mashour , 2006 ) . We investigated the effects of propofol , widely used for anesthesia and sedation , on spontaneous and evoked cerebral activity using functional magnetic resonance imaging ( fMRI ) . A series of auditory and noxious stimuli was presented to eight healthy volunteers at three behavioral states : awake , “ se date d ” and “ unresponsive . ” Performance in a verbal task and the absence of a response to verbal stimulation , rather than propofol concentrations , were used to define these states clinical ly . Analysis of stimulus-related blood oxygenation level-dependent signal changes identified reductions in cortical and subcortical responses to auditory and noxious stimuli in se date d and unresponsive states . A specific reduction in activity within the putamen was noted and further investigated with functional connectivity analysis . Progressive failure to perceive or respond to auditory or noxious stimuli was associated with a reduction in the functional connectivity between the putamen and other brain regions , while thalamo-cortical connectivity was relatively preserved . This result has not been previously described and suggests that disruption of subcortical thalamo-regulatory systems may occur before , or even precipitate , failure of thalamo-cortical transmission with the induction of unconsciousness Applying graph theoretical analysis of spontaneous BOLD fluctuations in functional magnetic resonance imaging ( fMRI ) , we investigated whole-brain functional connectivity of 11 healthy volunteers during wakefulness and propofol-induced loss of consciousness ( PI-LOC ) . After extraction of regional fMRI time series from 110 cortical and subcortical regions , we applied a maximum overlap discrete wavelet transformation and investigated changes in the brain 's intrinsic spatiotemporal organization . During PI-LOC , we observed a breakdown of subcortico-cortical and corticocortical connectivity . Decrease of connectivity was pronounced in thalamocortical connections , whereas no changes were found for connectivity within primary sensory cortices . Graph theoretical analyses revealed significant changes in the degree distribution and local organization metrics of brain functional networks during PI-LOC : compared with a r and om network , normalized clustering was significantly increased , as was small-worldness . Furthermore we observed a profound decline in long-range connections and a reduction in whole-brain spatiotemporal integration , supporting a topological reconfiguration during PI-LOC . Our findings shed light on the functional significance of intrinsic brain activity as measured by spontaneous BOLD signal fluctuations and help to underst and propofol-induced loss of consciousness Background : Anesthetics may affect the regional cerebral blood flow ( rCBF ) response associated with increased brain activity in humans . rCBF was measured as auditory stimulus rate was increased during propofol and thiopental administration . Methods : After informed consent , 10 right-h and ed male volunteer participants ( aged 33.5 ± 10.4 yr , weighing 74.5 ± 8.4 kg ) received thiopental ( n = 4 ) or propofol ( n = 6 ) intravenously at stepwise target concentrations of propofol 1.2 and 2.5–3 , or thiopental 4 and 7–9 & mgr;g/ml , representing sedative and hypnotic drug concentrations . The latter made volunteers unresponsive to voice or mild stimulation . Quantitative positron emission tomographic brain images were obtained at 0 , 20 , and 40 auditory words per minute at each drug concentration . Using SPM99 analysis , 10-mm spherical regions of interest were identified by peak covariation of word rate with rCBF across all conditions and drug concentrations . Individual mean rCBF responses in these and primary auditory cortex ( Heschl ’s gyri ) were obtained . Results : Significant increases in rCBF with auditory word rate occurred in temporal lobes bilaterally at baseline ( significance , T = 4.95 ) . There was no change in this response during sedation ( T = 5.60 ) . During unresponsiveness seven of 10 participants had a diminished response in the left temporal lobe ( T = 3.18 ) . Global CBF , corrected for changes in Pco2 ( 3 % · mmHg Pco2−1 ) , was reduced 15 % by sedation and 27 % during unresponsiveness . Conclusion : The presence of propofol or thiopental does not affect the rCBF response to increasing stimulus rate during consciousness . Thus , changes in rCBF activation patterns with sedative concentrations of these drugs represent effects on brain activity itself . The neuroanatomical targets of drug effect on memory and attention may be revealed by changes in rCBF patterns associated with these cognitive activities Background : Dynamic action of anesthetic agents was compared at cortical and subcortical levels during induction of anesthesia . Unconsciousness involved the cortical brain but suppression of movement in response to noxious stimuli was mediated through subcortical structures . Methods : Twenty-five patients with Parkinson disease , previously implanted with a deep-brain stimulation electrode , were enrolled during the implantation of the definitive pulse generator . During induction of anesthesia with propofol ( n = 13 ) or sevoflurane ( n = 12 ) alone , cortical ( EEG ) and subcortical ( ESCoG ) electrogenesis were obtained , respectively , from a frontal montage ( F3–C3 ) and through the deep-brain electrode ( p0–p3 ) . In EEG and ESCoG spectral analysis , spectral edge ( 90 % ) frequency , median power frequency , and nonlinear analysis dimensional activation calculations were determined . Results : Sevoflurane and propofol decreased EEG and ESCoG activity in a dose-related fashion . EEG values decreased dramatically at loss of consciousness , whereas there was little change in ESCoG values . Quantitative parameters derived from EEG but not from ESCoG were able to predict consciousness versus unconsciousness . Conversely , quantitative parameters derived from ESCoG but not from EEG were able to predict movement in response to laryngoscopy . Conclusion : These data suggest that in humans , unconsciousness mainly involves the cortical brain , but that suppression of movement in response to noxious stimuli is mediated through the effect of anesthetic agents on subcortical structures Background Functional magnetic resonance imaging of blood oxygenation level – dependent signal changes offers a very promising approach to investigate activated neural networks during anesthesia . Methods Sixteen healthy male volunteers , assigned into two groups of eight subjects ( isoflurane group , control group ) , were investigated by functional magnetic resonance imaging during different experimental conditions . The isoflurane group successively breathed air ( baseline condition ) , isoflurane in air ( 0.42 vol% inspiratory ; isoflurane condition ) and air again ( recovery condition ) while performing a visual search task , whereas the control group breathed air during all experimental conditions . Functional magnetic resonance images were acquired during the entire experimental session . In addition , reaction times and error rates were recorded . Results A significant isoflurane-related decrease ( z > 3.1 corresponding to P < 0.001 ) in task-induced brain activation was found in three distinct cortical regions : the right anterio-superior insula ( Talairach coordinates : x = 32 , y = 22 , z = 8) and the banks of the left and right intraparietal sulcus ( Talairach coordinates : x = −34 , y = −36 , z = 32 ; x = 22 , y = −60 , z = 41 , respectively ) . Subcortical structures ( lateral geniculate nucleus ) and the primary cortices ( motor cortex , visual cortex ) were not affected . All measured parameters indicated a nearly complete recovery of the affected networks within 5 min . Conclusions Our findings indicate that subanesthetic isoflurane affected task-induced activation in specific neural networks rather than causing a global decrease in functional activation Background This study was design ed to identify neuroanatomical locations of propofol 's effects on episodic memory by producing minimal and maximal memory impairment during conscious sedation . Drug-related changes in regional cerebral blood flow ( rCBF ) were located in comparison with rCBF increases during a simple word memory task . Methods Regional cerebral blood flow changes were assessed in 11 healthy volunteers using H215O positron emission tomography ( PET ) and statistical parametric mapping ( SPM99 ) at 600 and 1,000 ng/ml propofol target concentrations . Study groups were based on final recognition scores of auditory words memorized during PET scanning . rCBF changes during propofol administration were compared with those during the word memory task at baseline . Results Nonoverlapping memory effects were evident : low ( n = 4 ; propofol concentration 523 ± 138 ng/ml ; 44 ± 13 % decrement from baseline memory ) and high ( n = 7 ; 829 ± 246 ng/ml ; 87 ± 6 % decrement from baseline ) groups differed in rCBF reductions primarily in right-sided prefrontal and parietal regions , close to areas activated in the baseline memory task , particularly R dorsolateral prefrontal cortex ( Brodmann area 46 ; x , y , z = 51 , 38 , 22 ) . The medial temporal lobe region exhibited relative rCBF increases . Conclusions As amnesia becomes maximal , rCBF reductions induced by propofol occur in brain regions identified with working memory processes . In contrast , medial temporal lobe structures were resistant to the global CBF decrease associated with propofol sedation . The authors postulate that the episodic memory effect of propofol is produced by interference with distributed cortical processes necessary for normal memory function rather than specific effects on medial temporal lobe structures \n Output:\n " }, { "from": "agent", "value": "In the unconscious state , propofol sharply reduces the regional glucose metabolism rate ( rGMR ) and regional cerebral blood flow ( rCBF ) in all brain regions , particularly in the thalamus .\nHowever , GMR , such as in the occipital , temporal , and frontal lobes , was obviously decreased at a sedative dosage of propofol , whereas , changes in the thalamus were not obvious .\nUsing fMRI , several studies observed a decrease of connectivity of the thalamus versus an increase of connectivity within the pons of the brainstem during propofol-induced mild sedation .\nDuring deep sedation , propofol preserves cortical sensory reactivity , the specific thalamocortical network is moderately affected , whereas the nonspecific thalamocortical network is severely suppressed .\nIn contrast , several recent fMRI studies are consistent on the systemic decreased effects of propofol in the frontoparietal network .\nAccumulating evidence suggest that propofol-induced unconsciousness is associated with a global metabolic and vascular depression in the human brain and especially with a significant reduction in the thalamocortical network and the frontoparietal network" } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: BACKGROUND Trastuzumab plus chemotherapy has become the st and ard of care for women with human epidermal growth factor receptor 2 (HER2)-positive metastatic breast cancer . Trastuzumab-based pre-operative systemic ( neo-adjuvant ) therapy ( PST ) also appears promising , warranting further investigation . PATIENTS AND METHODS Patients with HER2-positive , stage II/III non-inflammatory , operable breast cancer requiring a mastectomy ( but who wished to conserve the breast ) received weekly trastuzumab and 3-weekly docetaxel for six cycles before surgery . The primary end point was pathological complete response ( pCR ) rate , determined from surgical specimens . RESULTS Thirty-three patients were enrolled . The majority ( 79 % ) had T2 tumors , with 42 % being N1/2 . Twenty-nine patients completed six cycles of therapy and one patient withdrew prematurely due to progressive disease . A complete or partial objective clinical response was seen in 96 % ( 73 % and 23 % , respectively ) of patients . Surgery was performed in 30 patients , breast conserving in 23 ( 77 % ) . In an intention-to-treat analysis , tumor and nodal pCR was seen in 14 ( 47 % ) patients . Treatment was generally well tolerated . Grade 3/4 neutropenia occurred in 85 % of patients while febrile neutropenia was encountered in 18 % . Only three patients withdrew prematurely due to toxicity . No symptomatic cardiac dysfunction was reported . CONCLUSIONS PST with trastuzumab plus docetaxel achieved promising efficacy , with a high pCR rate and good tolerability , in women with stage II or III HER2-positive breast cancer BACKGROUND Studies with pertuzumab , a novel anti-HER2 antibody , show improved efficacy when combined with the established HER2-directed antibody trastuzumab in breast cancer therapy . We investigated the combination of pertuzumab or trastuzumab , or both , with docetaxel and the combination of pertuzumab and trastuzumab without chemotherapy in the neoadjuvant setting . METHODS In this multicentre , open-label , phase 2 study , treatment-naive women with HER2-positive breast cancer were r and omly assigned ( 1:1:1:1 ) central ly and stratified by operable , locally advanced , and inflammatory breast cancer , and by hormone receptor expression to receive four neoadjuvant cycles of : trastuzumab ( 8 mg/kg loading dose , followed by 6 mg/kg every 3 weeks ) plus docetaxel ( 75 mg/m(2 ) , escalating , if tolerated , to 100 mg/m(2 ) every 3 weeks ; group A ) or pertuzumab ( loading dose 840 mg , followed by 420 mg every 3 weeks ) and trastuzumab plus docetaxel ( group B ) or pertuzumab and trastuzumab ( group C ) or pertuzumab plus docetaxel ( group D ) . The primary endpoint , examined in the intention-to-treat population , was pathological complete response in the breast . Neither patients nor investigators were masked to treatment . This study is registered with Clinical Trials.gov , number NCT00545688 . FINDINGS Of 417 eligible patients , 107 were r and omly assigned to group A , 107 to group B , 107 to group C , and 96 to group D. Patients given pertuzumab and trastuzumab plus docetaxel ( group B ) had a significantly improved pathological complete response rate ( 49 of 107 patients ; 45·8 % [ 95 % CI 36·1 - 55·7 ] ) compared with those given trastuzumab plus docetaxel ( group A ; 31 of 107 ; 29·0 % [ 20·6 - 38·5 ] ; p=0·0141 ) . 23 of 96 ( 24·0 % [ 15·8 - 33·7 ] ) women given pertuzumab plus docetaxel ( group D ) had a pathological complete response , as did 18 of 107 ( 16·8 % [ 10·3 - 25·3 ] ) given pertuzumab and trastuzumab ( group C ) . The most common adverse events of grade 3 or higher were neutropenia ( 61 of 107 women in group A , 48 of 107 in group B , one of 108 in group C , and 52 of 94 in group D ) , febrile neutropenia ( eight , nine , none , and seven , respectively ) , and leucopenia ( 13 , five , none , and seven , respectively ) . The number of serious adverse events was similar in groups A , B , and D ( 15 - 20 serious adverse events per group in 10 - 17 % of patients ) but lower in group C ( four serious adverse events in 4 % of patients ) . INTERPRETATION Patients given pertuzumab and trastuzumab plus docetaxel ( group B ) had a significantly improved pathological complete response rate compared with those given trastuzumab plus docetaxel , without substantial differences in tolerability . Pertuzumab and trastuzumab without chemotherapy eradicated tumours in a proportion of women and showed a favourable safety profile . These findings justify further exploration in adjuvant trials and support the neoadjuvant approach for accelerating drug assessment in early breast cancer . FUNDING F Hoffmann-La Roche BACKGROUND We compared the efficacy and safety of the addition of lapatinib versus trastuzumab to anthracycline-taxane-based neoadjuvant chemotherapy . METHODS In the GeparQuinto r and omised phase 3 trial , patients with untreated HER2-positive operable or locally advanced breast cancer were enrolled between Nov 7 , 2007 , and July 9 , 2010 . Patients were eligible if their tumours were classified as cT3/4a-d , or hormone receptor (HR)-negative , HR-positive with clinical ly node-positive and cT2 disease ( cT2 cN+ ) , or HR-positive and pathologically node-positive in the sentinel lymph node for those with cT1 disease ( cT1 pN(SLN+ ) ) . Patients were r and omly assigned in a 1:1 ratio to receive neoadjuvant treatment with four cycles of EC ( epirubicin [ 90 mg/m(2 ) intravenously ] plus cyclophosphamide [ 600 mg/m(2 ) intravenously ] , every 3 weeks ) , and four cycles of docetaxel ( 100 mg/m(2 ) intravenously every 3 weeks ) with either trastuzumab ( 6 mg/kg intravenously , with a starting loading dose of 8 mg/kg , for eight cycles , every 3 weeks ) or lapatinib ( 1000 - 1250 mg per day orally ) throughout all cycles before surgery . R and omisation was done by dynamic allocation with the minimisation method of Pocock and patients were stratified by participating site , HR status , and extent of disease ( cT1 - 3 cN0 - 2 vs T4 or N3 ) . The primary endpoint was pathological complete response ( defined as ypT0 and ypN0 ) and was analysed in all patients who received at least one cycle of EC . Participants and investigators were not masked to treatment assignment . Pathologists in centres assessing surgery outcomes were masked to group assignment . This trial is registered with Clinical Trials.gov , number NCT00567554 . FINDINGS Of 620 eligible patients , 309 were r and omly assigned to chemotherapy with trastuzumab ( ECH-TH group ) and 311 to chemotherapy with lapatinib ( ECL-TL group ) . Two patients in the ECH-TH group and three patients in the ECL-TL group did not start treatment because of withdrawal of consent or immediate surgery . 93 ( 30·3 % ) of 307 patients in the ECH-TH group and 70 ( 22·7 % ) of 308 patients in the ECL-TL group had a pathological complete response ( odds ratio [ OR ] 0·68 [ 95%CI 0·47 - 0·97 ] ; p=0·04 ) . Chemotherapy with trastuzumab was associated with more oedema ( 119 [ 39·1 % ] vs 88 [ 28·7 % ] ) and dyspnoea ( 90 [ 29·6 % ] vs 66 [ 21·4 % ] ) , and ECL-TL with more diarrhoea ( 231 [ 75·0 % ] vs 144 [ 47·4 % ] ) and skin rash ( 169 [ 54·9 % ] vs 97 [ 31·9 % ] ) . 43 ( 14·0 % ) patients discontinued in the ECH-TH group and 102 ( 33·1 % ) in the ECL-TL group . 70 serious adverse events were reported in the ECH-TH group and 87 in the ECL-TL group . INTERPRETATION This direct comparison of trastuzumab and lapatinib showed that pathological complete response rate with chemotherapy and lapatinib was significantly lower than that with chemotherapy and trastuzumab . Unless long-term outcome data show different results , lapatinib should not be used outside of clinical trials as single anti-HER2-treatment in combination with neoadjuvant chemotherapy . FUNDING GlaxoSmithKline , Roche , and Sanofi-Aventis The objective of this study is to evaluate the efficacy and safety profile of the doxorubicin followed by cisplatin/docetaxel as primary chemotherapy for patients with locally advanced breast cancer ( LABC ) . For this evaluation , 59 patients with LABC ( T2–T4 , N0–N2 , M0 ) received three cycles of doxorubicin , followed by three cycles of cisplatin/docetaxel and followed by definitive surgery and locoregional radiotherapy with or without tamoxifen . The primary end point was pathologic complete response ( pCR ) in breast and axilla . Fifty-nine patients were evaluable for analysis : median age : 41 years , premenopausal : 68 % , median tumor size : 6.0 cm ( 4–10 ) , Stage IIB : 32 % and IIIA/IIIB : 68 % , both ER/PR positive : 53 % , Her2/neu ( 3 + ) by IHC staining : 29 % . Clinical complete response was seen in 44 % , and clinical partial response was seen in 56 % . Breast conserving surgery was performed in 44 % , and MRM in 56 % . pCR in the breast was 30.5 % , in axilla was 37 % , and pCR in both breast and axilla was 24 % . Overall at follow-up of 60 months , the disease-free ( DFS ) and overall survival ( OS ) were 70 and 82 % , respectively . The DFS and OS of patients who achieved complete pathologic response in breast and axilla were 78 and 100 % , respectively , while 14 patients relapsed of which 46 % were Her2 positive . Sequential combination of doxorubicin followed by docetaxel/cisplatin is a safe , feasible , and active combination , which offers the possibility of conservative surgery and is associated with high clinical and pathologic response rates , with promising and encouraging survival outcomes BACKGROUND To evaluate capecitabine-docetaxel ( XT ) , with trastuzumab ( H ) in human epidermal growth factor receptor 2 (HER2)-positive disease , in inoperable locally advanced breast cancer ( LABC ) . PATIENTS AND METHODS Patients received up to six neoadjuvant 21-day cycles of capecitabine 900 mg/m(2 ) twice daily , days 1 - 14 , plus docetaxel 36 mg/m(2 ) , days 1 and 8 . Patients with HER2-positive disease also received trastuzumab 6 mg/kg every 3 weeks . The primary end point was pathologic complete response ( pCR ) rate , evaluated separately in HER2-negative and HER2-positive cohorts . Secondary end points included clinical response rates and tolerability . RESULTS The pCR rate was 15 % [ 95 % confidence interval ( CI ) 7 - 28 ] in 53 patients receiving XT and 40 % ( 95 % CI 26 - 55 ) in 50 patients receiving HXT . After neoadjuvant therapy , 50 patients receiving XT and 45 receiving HXT underwent surgery . No unexpected toxicity was observed : the most common grade ≥3 adverse events were diarrhea/mucositis ( 30 % and 20 % , respectively ) and grade 3 h and -foot syndrome ( 11 % and 6 % , respectively ) . Disease-free survival and overall survival were similar with XT and HXT after median follow-up of 22 months in the XT cohort and 21 months in the HXT cohort . CONCLUSION Neoadjuvant XT ( HXT in HER2-positive disease ) is highly effective in inoperable LABC , demonstrating pCR rates of 15 % and 40 % , respectively . This non-anthracycline-containing regimen offers obvious benefits in early disease , where avoidance of long-term cardiotoxicity is particularly important Background \n Output:\n " }, { "from": "agent", "value": "Significant advances have been made in HER2 targeting , result ing in a marked increase in the number of breast cancer patients experiencing tumour pCR ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: OBJECTIVE This pharmacologic protection trial was conducted to test the hypothesis that allopurinol , a scavenger and inhibitor of oxygen free radical production , could reduce death , seizures , coma , and cardiac events in infants who underwent heart surgery using deep hypothermic circulatory arrest ( DHCA ) . DESIGN This was a single center , r and omized , placebo-controlled , blinded trial of allopurinol in infant heart surgery using DHCA . Enrolled infants were stratified as having hypoplastic left heart syndrome ( HLHS ) and all other forms of congenital heart disease ( non-HLHS ) . Drug was administered before , during , and after surgery . Adverse events and the clinical efficacy endpoints death , seizures , coma , and cardiac events were monitored until infants were discharged from the intensive care unit or 6 weeks , whichever came first . RESULTS Between July 1992 and September 1997 , 350 infants were enrolled and 348 subsequently r and omized . A total of 318 infants ( 131 HLHS and 187 non-HLHS ) underwent heart surgery using DHCA . There was a nonsignificant treatment effect for the primary efficacy endpoint analysis ( death , seizures , and coma ) , which was consistent over the 2 strata . The addition of cardiac events to the primary endpoint result ed in a lack of consistency of treatment effect over strata , with the allopurinol treatment group experiencing fewer events ( 38 % vs 60 % ) in the entire HLHS stratum , compared with the non-HLHS stratum ( 30 % vs 27 % ) . In HLHS surgical survivors , 40 of 47 ( 85 % ) allopurinol-treated infants did not experience any endpoint event , compared with 27 of 49 ( 55 % ) controls . There were fewer seizures-only and cardiac-only events in the allopurinol versus placebo groups . Allopurinol did not reduce efficacy endpoint events in non-HLHS infants . Treated and control infants did not differ in adverse events . CONCLUSIONS Allopurinol provided significant neurocardiac protection in higher-risk HLHS infants who underwent cardiac surgery using DHCA . No benefits were demonstrated in lower risk , non-HLHS infants , and no significant adverse events were associated with allopurinol treatment.congenital heart defects , hypoplastic left heart syndrome , induced hypothermia , ischemia-reperfusion injury , neuroprotective agents , allopurinol , xanthine oxidase , free radicals , seizures , coma Background : It is unknown whether intraoperative hyperglycemia in infants is associated with worse neurodevelopmental outcomes after low-flow cardiopulmonary bypass ( LF ) , deep hypothermic circulatory arrest ( CA ) , or both . Methods : In a data base review of a prospect i ve trial of 171 infants undergoing arterial switch for D-transposition of the great arteries who were r and omly assigned to predominately LF or CA , glucose was measured after induction ( T1 ) , 5 min after cardiopulmonary bypass onset ( T2 ) , at the onset of CA or LF ( T3 ) , 5 min after CPB resumption ( T4 ) , at rewarming to 32 ° C ( T5 ) , 10 min after cardiopulmonary bypass weaning ( T6 ) , and 90 min after CA or LF ( T7 ) . Outcomes included seizures , electroencephalographic findings , and neurodevelopmental evaluation at 1 , 4 , and 8 yr . Results : Glucose concentrations were affected by support strategy and age at surgery . Lower glucose in the entire group at T6–T7 tended to predict electroencephalographic seizures ( P = 0.06 and P = 0.007 ) but was not related to clinical seizures . Within the predominantly CA group , higher glucose did not correlate with worse outcomes . Rather , it was associated with more rapid electroencephalographic normalization of “ close burst ” and “ relative continuous ” activity at all times except T2 ( P ≤ 0.03 ) , a finding more pronounced in infants aged 7 days old or younger . Intraoperative serum glucose concentrations were unrelated to neurodevelopmental outcomes at ages 1 , 4 , and 8 yr . Conclusions : Low glucose after cardiopulmonary bypass tended to relate to electroencephalographic seizures and slower electroencephalogram recovery , independent of CA duration . High glucose concentrations were not associated with worse neurodevelopmental outcomes . Avoiding hypoglycemia may be preferable to restricting glucose in infants undergoing heart surgery OBJECTIVE : The goal was to examine biochemical , neurophysiologic , anatomic , and clinical changes associated with erythropoietin administration to neonates with hypoxic-ischemic encephalopathy ( HIE ) . METHODS : We conducted a prospect i ve case-control study with 45 neonates in 3 groups , a normal healthy group ( N = 15 ) , a HIE-erythropoietin group ( N = 15 ; infants with mild/moderate HIE who received human recombinant erythropoietin , 2500 IU/kg , subcutaneously , daily for 5 days ) , and a HIE-control group ( N = 15 ; did not receive erythropoietin ) . Serum concentrations of nitric oxide ( NO ) were measured at enrollment for the normal healthy neonates and at enrollment and after 2 weeks for the 2 HIE groups . The 2 HIE groups underwent electroencephalography at enrollment and at 2 to 3 weeks . Brain MRI was performed at 3 weeks . Neurologic evaluations and Denver Developmental Screening Test II assessment s were performed at 6 months . RESULTS : Compared with normal healthy neonates , the 2 HIE groups had greater blood NO concentrations ( P < .001 ) . At enrollment , the 2 HIE groups did not differ in clinical severity , seizure incidence , NO concentrations , or electroencephalographic findings . At 2 weeks of age , electroencephalographic background s improved significantly ( P = .01 ) and NO concentrations decreased ( P < .001 ) in the HIE-erythropoietin group , compared with the HIE-control group ; MRI findings did not differ between groups . At 6 months of age , infants in the HIE-erythropoietin group had fewer neurologic ( P = .03 ) and developmental ( P = .03 ) abnormalities . CONCLUSION : This study demonstrates the feasibility of early administration of human recombinant erythropoietin to term neonates with HIE , to protect against encephalopathy Objectives To evaluate plasma brain specific proteins and cytokines as biomarkers of brain injury in newborns with hypoxic‐ischemic encephalopathy ( HIE ) and , secondarily , to assess the effect of erythropoietin ( Epo ) treatment on the relationship between biomarkers and outcomes . Study design A study of c and i date brain injury biomarkers was conducted in the context of a phase II multicenter r and omized trial evaluating Epo for neuroprotection in HIE . Plasma was collected at baseline ( < 24 hours ) and on day 5 . Brain injury was assessed by magnetic resonance imaging ( MRI ) and neurodevelopmental assessment s at 1 year . The relationships between Epo , brain‐specific proteins ( S100B , ubiquitin carboxy‐terminal hydrolase‐L1 [ UCH‐L1 ] , total Tau , neuron specific enolase ) , cytokines ( interleukin [IL]‐1&bgr ; , IL‐6 , IL‐8 , IL‐10 , IL‐12P70 , IL‐13 , interferon‐gamma [ IFN‐&ggr ; ] , tumor necrosis factor alpha [ TNF‐&agr ; ] , brain‐derived neurotrophic factor [ BDNF ] , monocyte chemoattractant protein‐1 ) , and brain injury were assessed . Results In 50 newborns with encephalopathy , elevated baseline S100B , Tau , UCH‐L1 , IL‐1&bgr ; , IL‐6 , IL‐8 , IL‐10 , IL‐13 , TNF‐&agr ; , and IFN‐&ggr ; levels were associated with increasing brain injury severity by MRI . Higher baseline Tau and lower day 5 BDNF were associated with worse 1 year outcomes . No statistically significant evidence of Epo treatment modification on biomarkers was detected in this small cohort . Conclusions Elevated plasma brain‐specific proteins and cytokine levels in the first 24 hours of life are associated with worse brain injury by MRI in newborns with HIE . Only Tau and BDNF levels were found to be related to neurodevelopmental outcomes . The effect of Epo treatment on the relationships between biomarkers and brain injury in HIE requires further study . Trial registration Clinical Trials.gov : 01913340 Objective : Infants are potentially more susceptible to cell death mediated via glutamate excitotoxicity attributed to cardiopulmonary bypass . We hypothesized that ketamine , via N-methyl D-aspartate receptor blockade and anti-inflammatory effects , would reduce central nervous system injury during cardiopulmonary bypass . Methods : We r and omized 24 infants , without chromosomal abnormalities , to receive ketamine ( 2 mg/kg , n = 13 ) or placebo ( saline , n = 11 ) before cardiopulmonary bypass for repair of ventricular septal defects . Plasma markers of inflammation and central nervous system injury were compared at the end of surgery , and 6 , 24 , and 48 hrs after surgery . Magnetic resonance imaging and spectroscopy before cardiopulmonary bypass and at the time of hospital discharge were performed in a subset of cases and controls ( n = 5 in each group ) . Cerebral hemodynamics were monitored postoperatively using near-infrared spectroscopy , and neurodevelopmental outcomes were assessed using Bayley Scales of Infant Development-II before and 2–3 wks after surgery . Results : Statistically significant differences were noted in preoperative inspired oxygen levels , intraoperative cooling and postoperative temperature , respiratory rate , platelet count , and bicarbonate levels . The peak concentration of C-reactive protein was lower in cases compared to controls at 24 hrs ( p = .048 ) and 48 hrs ( p = .001 ) . No significant differences were noted in the expression of various cytokines , chemokines , S100 , and neuron-specific enolase between the cases and controls . Magnetic resonance imaging with spectroscopy studies showed that ketamine administration led to a significant decrease in choline and glutamate plus glutamine/creatine in frontal white matter . No statistically significant differences occurred between pre- and postoperative Bayley Scales of Infant Development-II scores . Conclusions : We did not find any evidence for neuroprotection or neurotoxicity in our pilot study . A large , adequately powered r and omized control trial is needed to discern the central nervous system effect of ketamine on the developing brain . brain . Trial Registration : The trial is registered at www . Clinical Trials.gov , NCT00556361 Flaws in the design , conduct , analysis , and reporting of r and omised trials can cause the effect of an intervention to be underestimated or overestimated . The Cochrane Collaboration ’s tool for assessing risk of bias aims to make the process clearer and more OBJECTIVE : The purpose of this study was to evaluate the efficacy and safety of erythropoietin in neonatal hypoxic-ischemic encephalopathy ( HIE ) , by using a r and omized , prospect i ve study design . METHODS : A total of 167 term infants with moderate/severe HIE were assigned r and omly to receive either erythropoietin ( N = 83 ) or conventional treatment ( N = 84 ) . Recombinant human erythropoietin , at either 300 U/kg ( N = 52 ) or 500 U/kg ( N = 31 ) , was administered every other day for 2 weeks , starting < 48 hours after birth . The primary outcome was death or disability . Neurodevelopmental outcomes were assessed at 18 months of age . RESULTS : Complete outcome data were available for 153 infants . Nine patients dropped out during treatment , and 5 patients were lost to follow-up monitoring . Death or moderate/severe disability occurred for 35 ( 43.8 % ) of 80 infants in the control group and 18 ( 24.6 % ) of 73 infants in the erythropoietin group ( P = .017 ) at 18 months . The primary outcomes were not different between the 2 erythropoietin doses . Subgroup analyses indicated that erythropoietin improved long-term outcomes only for infants with moderate HIE ( P = .001 ) and not those with severe HIE ( P = .227 ) . No negative hematopoietic side effects were observed . CONCLUSION : Repeated , low-dose , recombinant human erythropoietin treatment reduced the risk of disability for infants with moderate HIE , without apparent side effects Background — Complex neonatal cardiac surgery is associated with cerebral injury . In particular , aortic arch repair , requiring either deep hypothermic circulatory arrest ( DHCA ) or ante grade cerebral perfusion ( ACP ) , entails a high risk of perioperative injury . It is unknown whether ACP results in less cerebral injury than D \n Output:\n " }, { "from": "agent", "value": "Erytropoietin , ketamine and dextromethorphan showed no neuroprotective effects .\nConclusions : Allopurinol seems promising for future trials in congenital heart disease infants to reduce brain injury given the early neuroprotective effects in hypoplastic left heart syndrome infants ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: Background Hitherto no study has been published on the effect of the adjunctive administration of essential oils following scaling and root planing ( SRP ) . This study describes the effect of a mouthrinse consisting of essential oils ( Cymbopogon flexuosus , Thymus zygis and Rosmarinus officinalis ) following SRP by clinical and microbiological variables in patients with generalized moderate chronic periodontitis . Methods Forty-six patients ( aged 40–65 years ) with moderate chronic periodontitis were r and omized in a double-blind study and rinsed their oral cavity following SRP with an essential oil mouthrinse ( n = 23 ) or placebo ( n = 23 ) for 14 days . Probing depth ( PD ) , attachment level ( AL ) , bleeding on probing ( BOP ) and modified sulcus bleeding index ( SBI ) were recorded at baseline and after 3 and 6 months . Subgingival plaque was taken for assessment of major bacteria associated with periodontitis . Results AL , PD , BOP and SBI were significantly improved in both groups after three ( p < 0.001 ) and 6 months ( p ≤ 0.015 ) . AL improved significantly better in the test than in the control group after 3 and 6 months ( p < 0.001 ) , so did PD after three months in the tendency ( p = 0.1 ) . BOP improved better in the test group after 3 months ( p = 0.065 ) . Numbers of Treponema denticola ( p = 0.044 ) and Fusobacterium nucleatum ( p = 0.029 ) decreased more in the test than in the control group after 3 months , those of Tannerella forsythia after 6 months ( p = 0.039 ) . Prevotella micra ( p < 0.001 , p = 0.035 ) and Campylobacter rectus ( p = 0.002 , p = 0.012 ) decreased significantly in both groups after 3 months . Conclusions The adjunctive use of a mouthrinse containing essential oils following SRP has a positive effect on clinical variables and on bacterial levels in the subgingival biofilm . Trial registration 332 - 12 - 24092012 , DRKS 00009387 , German Clinical Trials Register , Freiburg i. Br . , BACKGROUND Probiotics are living microorganisms that provide beneficial effects for the host when administered in proper quantities . The aim of this double-masked placebo-controlled parallel-arm r and omized clinical trial is to evaluate the clinical effects of a Lactobacillus rhamnosus SP1-containing probiotic sachet as an adjunct to non-surgical therapy . METHODS Twenty-eight systemically healthy volunteers with chronic periodontitis were recruited and monitored clinical ly at baseline and 3 , 6 , 9 , and 12 months after therapy . Clinical parameters measured included plaque accumulation , bleeding on probing , probing depths ( PDs ) , and clinical attachment loss . Patients received non-surgical therapy , including scaling and root planing ( SRP ) , and were assigned r and omly to a test ( SRP + probiotic , n = 14 ) or control ( SRP + placebo , n = 14 ) group . The intake , once a day for 3 months , of an L. rhamnosus SP1 probiotic sachet commenced after the last session of SRP . RESULTS Both test and control groups showed improvements in clinical parameters at all time points evaluated . However , the test group showed greater reductions in PD than the control . Also , at initial visits and after 1-year follow-up , the test group showed a statistically significant reduction in the number of participants with PD ≥6 mm , indicating a reduced need for surgery , in contrast to the placebo group . CONCLUSION The results of this trial indicate that oral administration of L. rhamnosus SP1 result ed in similar clinical improvements compared with SRP alone Summary Objectives The reason for the Study of Health in Pomerania ( SHIP ) is the lack of epidemiological studies with a broad range of health indicators . Furthermore , in Germany there is a need for studies that take into account the particular situation of life after the reunification . One objective of SHIP is to provide prevalence estimates on a broad range of diseases , risk and health factors for a defined region in the former GDR . Methods A sample of 7008 women and men aged 20 to 79 years in a north-east region of Germany , 4900 expected participants . The sample was drawn in two steps : First , 32 communities in the region were selected . Second , within the communities a simple r and om sample was drawn from residence registries , stratified by gender and age . The data collection and instruments include four parts : oral health examination , medical examination , health-related interview , and a health- and riskfactor-related question naire . The oral health examination includes the teeth , periodontium , oral mucosa , craniom and ibular system , and prosthodontics . The medical examination includes blood pressure measurements , electrocardiography , echocardiography , carotid , thyroid and liver ultrasounds , neurological screening , blood and urine sampling . The computer-aided health-related interview includes cardiovascular symptoms , utilisation of medical services , health-related behaviours , and socioeconomic variables . The self-administered question naire comprises housing conditions , social network , work conditions , subjective well-being and individual consequences from the German reunification . ZusammenfassungFragestellungGrundlage für die Study of Health in Pomerania ( SHIP ) ist der Mangel an epidemiologischen Studien mit einer hohen Zahl von Gesundheitsindikatoren . Darüber hinaus gibt es in Deutschl and Bedarf an Studien mit Berücksichtigung der besonderen Lebenssituation nach der Wiedervereinigung . Ziel der SHIP ist die Prävalenzschätzung eines breiten Spektrums an Erkrankungen , Risiko- und Gesundheitsfaktoren für eine Region in der früheren DDR . Method enDie Stichprobe umfasst 7008 Frauen und Männer i m Alter von 20 bis 79 Jahren in einer Region i m Nordosten Deutschl and s mit einer erwarteten Response von 4900 Teilnehmern . Die Ziehung der Zufallsstichprobe erfolgte in zwei Schritten : Zuerst wurden 32 Gemeinden in der Region ausgewählt . Danach wurde innerhalb der Gemeinden jeweils eine Stichprobe durch die Eiwohnermeldeämter gezogen , stratifiziert nach Geschlecht und Alter . Die Date nerhebung beinhaltet vier Teile : zahnmedizinische Untersuchung , medizinische Untersuchung , gesundheitsbezogenes Interview und gesundheits-und risikofaktoren-bezogener Fragebogen . Der zahnmedizinische Teil umfasst die Untersuchung von Zähnen , Zahnhalteapparat , Zahnfleisch , kraniom and ibulärem System und Prothetik . Die medizinische Untersuchung beinhaltet Blutdruckmessung , Elektrokardiographie , Echokardiographie , Sonographie der Arteria Carotis , der Schilddrüse und der Leber , ein neurologisches Screening sowie Blut- und Urinanalysen . Das computergestützte Interview beinhaltet kardiovaskuläre Symptome , Inanspruchnahme medizinischer Hilfen , gesundheitsbezogenes Verhalten und sozioökonomische Variablen . Der Fragebogen zum Selbstausfüllen betrifft die Wohnsituation , das soziale Netzwerk , Arbeitsbedingungen , subjektives Befinden und persönliche Bewertungen der Lebenssituation nach der deutschen Wiedervereinigung . RésuméObjectifsLa base de l'étude du santé en Poméranie ( Study of Health in Pomerania , SHIP ) , c'est le manque de l'études épidémiologiques avec beaucoup des facteurs de la santé . Au-delà , en Allemagne il y a besoin de l'études avec une considération de la situation de vie en les l and s nouveaux . L'objet de SHIP , c'est l'estimation des prévalences de beaucoup des maladies , facteurs risque et facteurs de la santé pour une région dans les l and s nouveaux . MéthodesL'épreuve contient 7008 femmes et hommes d'age 20 à 79 . On pouvait s'y attendre 4900 participants . L'épreuve a été tirée en deux pas : commencer 32 villes et villages dans la région ont été tirée , ensuite dans les communes chaque fois une épreuve a été tirée par les bureaux des déclarations de résidence , pour groupes de l'age et genre . Le lever des informations renferme quatre parts : l'examen dental , l'examen médical , l'interview et un question naire concernant la santé et les risques de la santé . Le part dental comprends les dents , les gencives , le système craniom and ibulaire et le dentier . L'examen médicale contient le mesurage de la tension artérielle , l'électrocardiographie , l'échocardiographie , l'ultrasonographie de l'artères carotides , de la gl and e thyroide et du foie , une diagnostique brève neurologique et des analyses du sang et d'urine . L'interview renferme des symptômes cardiovasculaires , l'utilisation des aides médicals , le comportement concernant la santé et facteurs économiques . Le question naire concerne la situation d'habitation , le panneau social , la condition du travail , l'état de santé subjectif et l'estimation du situation de vie après la réunification de l'Allemagne AIM The objective of this study was to evaluate the effects of lozenges containing L. reuteri as an adjuvant treatment to initial periodontal therapy for chronic periodontitis patients and to detect the level of L. reuteri colonization in the periodontal pockets of treated patients . MATERIAL AND METHODS A total of 40 patients were selected and r and omly divided into two groups . Each patient had at least two teeth with one approximal site each with a probing depth ( PD ) of 5 - 7 mm and gingival index ( GI ) of ≥2 in each quadrant . Group I received scaling and root planing ( SRP ) plus L. reuteri-containing lozenges , and Group II received SRP plus placebo . The plaque index ( PI ) , GI , bleeding on probing ( BoP ) , PD and relative attachment level were measured . Microbiological sampling was performed at baseline and on days 21 , 90 , 180 and 360 and were analysed by culturing . The Bonferroni-corrected paired sample t-test , Bonferroni-corrected Wilcoxon signed rank test and paired sample t-test were used to evaluate intra-group differences . The Bonferroni-corrected Student 's t-test and the Mann-Whitney U-tests were used to evaluate inter-group differences . RESULTS After treatment , the measured PI , GI , BoP and PD were significantly ( p < 0.05 ) lower in Group I compared with Group II at all time points . Similar observations were made for the total viable cell counts and the proportions of obligate anaerobes with the exception of day 360 . In Group I , significantly fewer patients required surgery on ≥3 sites . CONCLUSION L. reuteri-containing lozenges may be a useful adjuvant agent to slow re-colonization and improve clinical outcomes of chronic periodontitis . Further studies are required to clarify the optimal dose of the lozenges OBJECTIVE To explore associations between diabetes etiology ( type 1 diabetes mellitus [ T1DM ] vs. T2DM ) and glycemic control in the prediction of 5-year periodontal status change . RESEARCH DESIGN AND METHODS The Study of Health in Pomerania ( SHIP ) is a population -based stratified sample of German men and women . Healthy participants and those determined to have T2DM arose from the SHIP cohort , and T1DM participants were recruited from diabetes clinics in the catchment area that gave rise to SHIP . Dentate participants ( n = 2,626 ; 53 % women ; 20–81 years of age ) were included . Diabetes was determined via physician diagnosis and /or HbA1c ≥6.5 % ( uncontrolled diabetes > 7.0 % ) . Examiners blinded to diabetes status performed r and om half-mouth periodontal examinations , assessing probing depth ( PD ) and attachment loss ( AL ) ( four sites/tooth ) at baseline and follow-up . Participants were categorized into six groups as follows : 1 ) diabetes free ( n = 2,280 ) , 2 ) incident T2DM ( n = 79 ) , 3 ) controlled T2DM ( n = 80 ) , 4 ) uncontrolled T2DM ( n = 72 ) , 5 ) controlled T1DM ( n = 43 ) , and 6 ) uncontrolled T1DM ( n = 72 ) . In multivariable regressions , mean PD change ( ΔMPD ) , mean AL change ( ΔMAL ) , or incident tooth-loss values were regressed across the aforementioned diabetes categories . RESULTS Mean ( SD ) ΔMPD and ΔMAL values among all participants were −0.08 ± 0.5 mm and 0.08 ± 1.03 mm , respectively , and 34 % lost one or more teeth . Relative to diabetes-free participants , those with uncontrolled T2DM experienced greater ΔMPD ± SE ( P < 0.05 ) , whereas participants with either uncontrolled T1DM or uncontrolled T2DM realized greater ΔMAL ( P < 0.05 ) . Uncontrolled T1DM and T2DM were both associated with an increased risk of future tooth loss ( P < 0.05 ) . CONCLUSIONS Diabetes control , but not et \n Output:\n " }, { "from": "agent", "value": "Does short-term periodontal probing depth reduction and clinical attachment level gain after scaling and root planing depend on glycemic control in type 2 diabetes ?\nAre short-term scaling and root planing outcomes in people with hyperglycemia/diabetes inferior to those in people without diabetes ?\nDo periodontitis patients with diabetes benefit more from the use of adjuvant antibiotics with nonsurgical periodontal treatment than people without diabetes ?" } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: OBJECTIVE The purpose of this study was to estimate whether the efficacy of treatment with intravaginal misoprostol for first-trimester pregnancy failure is enhanced by the addition of saline solution . STUDY DESIGN Eighty women with embryonic/fetal death or anembryonic pregnancy were assigned r and omly to receive either 800 microg of misoprostol with saline solution ( group I , 41 women ) or without ( group II , 39 women ) . Treatment was repeated on day 3 if the gestational sac remained . Curettage was performed if the gestational sac remained on day 8 or as necessary during at least 30 days of follow-up . Data were analyzed with the Student t test and the chi(2 ) or Fisher exact test . RESULTS By the first follow-up visit , 73 % ( group I ) and 64 % ( group II ) of women passed the gestational sac ( P=.38 ) . By the second follow-up visit , expulsion rates were 83 % and 87 % , respectively ( P=.59 ) . Five subjects in each group underwent curettage . CONCLUSION Misoprostol is effective for the treatment of failed first-trimester pregnancy . The expulsion rate is not improved by adding saline solution BACKGROUND We aim ed to compare patients ' health-related quality of life after a misoprostol strategy to a curettage in women with early pregnancy failure after failed expectant management . METHODS A multicentre r and omized clinical trial was performed in The Netherl and s. In all , 154 women with early pregnancy failure confirmed at ultrasonography who had been managed expectantly unsuccessfully for > or = 1 week were r and omly assigned to undergo either treatment with misoprostol ( n=79 ) or curettage ( n=75 ) . The main outcome measures were health-related quality of life and satisfaction with treatment . RESULTS In the misoprostol strategy 47 % of the women needed additional curettage , as compared to 4 % after curettage . In both groups , health-related quality of life was impaired most severely 2 days after treatment . In the misoprostol group , health-related quality of life was more severely impaired ; after 2 days this was due to more pain and after 2 and 6 weeks this was due to a worse general health perception . Health-related quality of life was temporarily significantly more impaired in women in whom misoprostol failed as compared to women in whom misoprostol treatment was successful . In both treatment groups , an equal percentage of women ( 58 % ) would choose the same treatment in the future . In women treated with misoprostol , however , this choice depended on the initial success of misoprostol : in cases where misoprostol had caused complete evacuation , 76 % of the women would opt for the same treatment , whereas only 38 % of women who needed curettage after unsuccessful misoprostol would do so ( P<0.01 ) . CONCLUSION Our study shows that , although both the misoprostol strategy and the curettage strategy result ed in complete evacuation in the end , women are willing to accept some disadvantages of misoprostol to avoid curettage . A treatment inconvenience using misoprostol is accepted as long as initial evacuation rate is high . This finding should be an integral part of counselling women when deciding upon management of early pregnancy failure BACKGROUND Responses to miscarriage range from relief to devastation , yet there have been no r and omized controlled studies that demonstrate significant effects of counseling with women who miscarry . OBJECTIVE To test the effects of caring-based counseling , measurement , and time on the integration of loss ( miscarriage impact ) and women 's emotional well-being ( moods and self-esteem ) in the first year after miscarrying . METHOD ANCOVA was used in this r and omized , longitudinal Solomon four-group experimental investigation . Enrolled were 242 ; 185 completed . Outcomes included : self-esteem , overall emotional disturbance , anger , depression , anxiety , confusion , overall miscarriage impact , personal significance , devastating event , lost baby , and isolated . RESULTS During the first year after loss ( a ) caring was effective in reducing overall emotional disturbance , anger , and depression ; and ( b ) time passing led to increased self-esteem and decreased anxiety , depression , anger , confusion , and personal significance of loss . CONCLUSION Caring , measurement , and time had some positive and significant effects on the integration of loss and enhancement of well-being in the first year subsequent to miscarrying BACKGROUND Dilatation and curettage ( D&C ) has been the usual treatment for early pregnancy failure ( EPF ) . Medical management with misoprostol may be an effective alternative . Bleeding patterns during and after medical management of EPF are unknown . METHODS A prospect i ve cohort study was conducted at University-based clinics and physician offices . Eighty women < 11 weeks estimated gestational age with a diagnosis of missed abortion or fetal demise were enrolled . Treatment consisted of either 800 micro g of moistened ( 2 ml of saline ) or dry vaginal misoprostol . Self-reported bleeding and sanitary product usage were recorded in a daily 2 week diary . Haemoglobin was assessed at enrollment and 2 weeks later . RESULTS After misoprostol treatment , patients reported bleeding or spotting every day for the 14 days observed . Self-assessed heavy bleeding days were few ( median 3 ) and usually occurred immediately after treatment . Sanitary pad use was highly variable ( mean 30.5 , range 2 - 125 pads over the 2 week period ) and not related to changes in haemoglobin . The mean decrease in haemoglobin was 0.5 g/dl ( SD 1.2 ) . Complete expulsion without D&C occurred in 85 % of subjects . CONCLUSIONS Bleeding for at least 2 weeks after vaginal misoprostol for EPF is common . Heavy bleeding is usually limited to a few days after treatment . Clinical ly important changes in haemoglobin are rare OBJECTIVE The purpose of this study was to compare the psychologic impact and client satisfaction of routine surgical evacuation of the uterus with medical evacuation in cases of spontaneous abortion . STUDY DESIGN This was a prospect i ve , r and omized controlled trial . Two hundred eighteen women who were admitted to a university teaching hospital after spontaneous abortion and who consented to the study were r and omized to routine surgical evacuation or medical evacuation of the uterus with the use of misoprostol . General psychologic well-being , level of depression , fatigue symptoms , psychiatric morbidity , social functioning , client satisfaction , and acceptance were measured in the 2 groups . RESULTS The 2 groups did not differ in any of the measured psychological outcomes . Significantly more participants who experienced successful evacuation of the uterus with the misoprostol protocol would choose the same mode of treatment if they were able to choose again . However , participants for whom the medical treatment failed to evacuate the uterus and subsequent surgical evacuation was required are significantly less satisfied with the treatment . CONCLUSION Medical treatment of spontaneous abortion with misoprostol is psychologically safe and more compatible with the ethnomedical beliefs of our Chinese participants . Client satisfaction and acceptance should be taken into consideration in the evaluation of treatment outcomes OBJECTIVE To evaluate serial hormone concentrations in subjects treated with vaginally administered misoprostol for early pregnancy failure . DESIGN As part of a r and omized clinical trial , serum was collected on treatment days 1 , 3 , 8 , and 15 . SETTING Multicenter clinical trial . PATIENT(S ) Women with a nonviable first-trimester pregnancy . INTERVENTION(S ) Serum concentrations of human chorionic gonadotropin ( hCG ) , progesterone , and sex hormone binding globulin ( SHBG ) were evaluated . MAIN OUTCOME MEASURE(S ) A logistic regression model was constructed to assess the associations of percent and complete expulsion of the gestational sac and /or successful management . RESULT ( S ) The percent change from the day of treatment until the first follow-up visit was predictive for complete expulsion for progesterone ( P ) ( P<.005 ) and hCG ( P<.005 ) , but not for SHBG . The actual value was not significantly associated with complete expulsion or successful management . A decrease ( day 1 - 3 ) of 79 % for both hCG and P was associated with a 90 % probability of complete passage of the gestational sac . A 90 % probability of successful management was noted if P decreased by 78 % on day 3 or 59 % on day 7 , or hCG decreased by 74 % on day 3 or 78 % on day 7 compared with pretreatment values . CONCLUSION ( S ) Percent change , but not absolute change , in serial hormone values are strongly associated with both the complete expulsion of the gestational sac with one dose of misoprostol and ultimate success BACKGROUND The increased pressure on health care expenses implies that physicians should consider economic aspects as part of the clinical decision-making process . Direct and indirect costs of a strategy starting with misoprostol in treatment of early pregnancy failure as compared to curettage is therefore performed . METHODS We performed a cost-minimization analysis alongside a multicentre r and omized trial . Clinical data and data on the use of medical re sources were obtained from a r and omized trial comparing misoprostol and curettage , which had shown that misoprostol reduced the need for curettage in 53 % . In a sensitivity analysis the percentage of women who needed curettage after misoprostol varied between 25 and 90 % . RESULTS Direct costs per case were significantly lower in the misoprostol group ( mean 433 ) than in the curettage group ( mean 683 ) ( mean difference 250 , 95 % CI 184 to 316 , P < 0.001 ) . These significant differences existed under a wide range of alternative assumptions about unit costs . The differences in direct cost in favour of misoprostol were large for women who had complete evacuation after initial misoprostol treatment as compared to those who needed additional curettage after failed misoprostol . Mean indirect costs were equal for both groups ( misoprostol mean 486 ; curettage mean 428 ; mean difference 60 , 95 % CI -61 to 179 , P = 0.51 ) . The mean total costs for a strategy starting with misoprostol was 915 versus 1107 for curettage , with a mean difference between both groups of 192 ( 95 % CI 33 to 351 , P = 0.04 ) . An increase of the complete evacuation rates for initial misoprostol therapy to 90 % in the sensitivity analysis increased the cost difference between misoprostol and curettage to 550 . CONCLUSION The use of misoprostol for early pregnancy failure after failed expectant management is less costly than curettage Objectives To compare fertility rates after the three methods of managing early miscarriage in women recruited to the MIST ( miscarriage treatment ) r and omised controlled trial . Setting Early pregnancy clinics of acute hospitals in the south west region of Engl and . Participants 1199 women who had had an early miscarriage ( < 13 weeks ) confirmed by scan . Intervention Expectant , medical , or surgical management . Main outcome measures Self reported pregnancy rates and live birth rates . Results Of 1199 women recruited to the trial , 1128 consented to follow-up . Of these , 762 women replied giving pregnancy details ( 68 % response rate ) . Respondents were representative of the trial participants . The live birth rate five years after the index miscarriage was similar in the three management groups : 177/224 ( 79 % , 95 % confidence interval 73 % to 84 % ) in the expectant management group , 181/230 ( 79 % , 73 % to 84 % ) in the medical group , and 192/235 ( 82 % , 76 % to 86 % ) in the surgical group . There was also no significant difference according to previous birth history . Older women and those with previous miscarriages were significantly less likely to subsequently give birth . Conclusion Method of miscarriage management does not affect subsequent pregnancy rates with around four in five women giving birth within five years of the index miscarriage . Women can be reassured that long term fertility concerns need not affect their choice of miscarriage management . Trial registration National Research Register N0467011677/N0467073587 Objective To estimate and compare the costs of surgical and medical treatment of miscarriage to the National Health Service OBJECTIVES To assess if there was any potential relationship between endometrial thickness and final treatment outcome in women successfully treated with misoprostol for a first trimester anembryonic gestation , embryonic demise or fetal demise . METHODS Eighty women were treated with up to two doses of misoprostol 800 microg vaginally for early pregnancy failure . Subjects were scheduled to return 2 ( range 1 - 4 ) , 7 ( range 5 - 9 ) and 14 ( range 12 - 17 ) days after treatment . Transvaginal ultrasonography was performed at each follow-up visit . RESULTS The median endometrial thickness at each of the follow-up visits for women who had expelled the gestational sac was 14 mm , 10 mm , and 7 mm , respectively . The endometrial thickness at the first follow-up visit exceeded 15 mm in 20 subjects ( 36 % ) and 30 mm in four subjects ( 7 % ) . Only three women had a suction aspiration for bleeding after documented expulsion . The endometrial thickness for these women was 11 , 13 , and 14 mm at the first follow-up visit . CONCLUSIONS There is no obvious relationship between increasing endometrial thick \n Output:\n " }, { "from": "agent", "value": "Limited evidence suggests that women generally seem satisfied with their care .\nThe available evidence suggests that medical treatment , with misoprostol , and expectant care are both acceptable alternatives to routine surgical evacuation given the availability of health service re sources to support all three approaches ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: OBJECTIVE To study the possible relationship between the C677 T mutation in the methylenetetrahydrofolate reductase ( MTHFR ) gene and the toxicity and efficacy of treatment with methotrexate ( MTX ) in patients with rheumatoid arthritis ( RA ) . METHODS Genotype analysis of the MTHFR gene was done in 236 patients who started MTX treatment with ( n = 157 ) or without ( n = 79 ) folic or folinic acid supplementation . Outcomes were parameters of efficacy of MTX treatment , patient withdrawal due to adverse events , discontinuation of MTX treatment because of elevated liver enzyme levels , and the total occurrence of elevated liver enzyme levels during the study . Multivariate logistic regression analysis was used to study the relationship between the presence of the MTHFR C677 T mutation and toxicity outcomes of MTX treatment . RESULTS Forty-eight percent of the patients showed the homozygous ( T/T ) or heterozygous ( T/C ) mutation . The presence of the C677CT or C677TT genotypes was associated with an increased risk of discontinuing MTX treatment because of adverse events ( relative risk 2.01 ; 95 % confidence interval 1.09 , 3.70 ) , mainly due to an increased risk of elevated liver enzyme levels ( relative risk 2.38 ; 95 % confidence interval 1.06 , 5.34 ) . Efficacy parameters were not significantly different between the patients with and those without the mutation . CONCLUSION The C677 T mutation is the first identified genetic risk factor for elevated alanine aminotransferase values during MTX treatment in patients with RA . We postulate that the incidence of clinical ly important elevation of liver enzyme levels during MTX treatment is mediated by homocysteine metabolism . Supplementation with folic or folinic acid reduced the risk of toxicity-related discontinuation of MTX treatment both in patients with and in patients without the mutation Background . Hemostatic events in patients undergoing allogeneic hematopoietic stem-cell transplantation ( HSCT ) increase the morbidity and mortality in this cohort . Little is known about the impact of graft-versus-host disease ( GvHD ) or of thrombophilic gene mutations/polymorphisms on these complications . Study Design . Eighty-nine allogeneic stem-cell recipients and their donors were evaluated prospect ively for the presence of the factor V G1691A mutation , the prothrombin G20210A mutation , the 5,10-methylenetetrahydrofolate-reductase ( MTHFR ) C677 T mutation , the glycoprotein IIIa PIa1/a2 polymorphism , the fibrinogen-β-chain 455G/A polymorphism , the plasminogen activator inhibitor-1 −675 4G/5 G polymorphism , and the angiotensin-converting enzyme intron 16 I/D polymorphism . These mutations/polymorphisms and GvHD parameters were correlated to hemostatic and toxic complications after transplantation . The data were compared with those of 128 healthy controls . Results . The PAI-1 4G/4 G polymorphism increases the risk for catheter thrombosis after HSCT 5.7-fold ( 32.2 % vs. 71.4 % , P<0.05 ) . In patients with hepatic veno-occlusive disease , the frequency of the PAI-1 4 G allele is also increased ( 83.3 % vs. 55.1 % , NS ) . Thrombophilic mutations/polymorphisms in donors do not influence complications in the corresponding recipients . The MTHFR TT genotype does not modify severity and duration of mucositis and aplasia in patients receiving methotrexate prophylaxis . Patients with chronic GvHD have a higher risk of thromboembolism ( 12.9 % vs. 1.7 % , P<0.05 ) . Conclusion . Thrombophilic gene mutations have only a moderate influence on hemostatic complications in patients undergoing HSCT . This may be because of the overwhelming immunologic impact of GvHD on hemostasis in the allogeneic transplantation setting BACKGROUND The anti-folate drug methotrexate ( MTX ) is commonly used to treat rheumatoid arthritis . OBJECTIVE To determine the allele frequencies of five common coding single-nucleotide polymorphisms ( SNPs ) in the methylenetetrahydrofolate reductase ( MTHFR ) gene in African-Americans and Caucasians with rheumatoid arthritis and controls to assess whether there are differences in allele frequencies among these ethnic or racial groups and whether these SNPs differentially affect the efficacy or toxicity of MTX . METHODS Allele frequencies in the 677 , 1298 and 3 additional SNPs in the MTHFR coding region in 223 ( 193 Caucasians and 30 African-Americans ) patients with rheumatoid arthritis who previously participated in one of two prospect i ve clinical trials were characterised , and genotypes were correlated with the efficacy and toxicity of MTX . Another 308 subjects with rheumatoid arthritis who participated in observational studies , one group predominantly Caucasian and the other African-American , as well as 103 normal controls ( 53 African-Americans and 50 Caucasians ) were used to characterise allele frequencies of these SNPs and their associated haplotypes . RESULTS Significantly different allele frequencies were seen in three of the five SNPs and haplotype frequencies between Caucasians and African-Americans . Allele frequencies were similar between patients with rheumatoid arthritis and controls of the same racial or ethnic group . Frequencies of the rs4846051C , 677 T and 1298C alleles were 0.33 , 0.11 and 0.13 , respectively , among African-Americans with rheumatoid arthritis . Among Caucasians with rheumatoid arthritis , these allele frequencies were 0.08 ( p<0.001 compared with African-Americans with rheumatoid arthritis ) , 0.30 ( p = 0.002 ) and 0.34 ( p<0.001 ) , respectively . There was no association between SNP alleles or haplotypes and response to MTX as measured by the mean change in the 28-joint Disease Activity Score from baseline values . In Caucasians , the 1298 A ( major ) allele was associated with a significant increase in MTX-related adverse events characteristic of a recessive genetic effect ( odds ratio 15.86 , 95 % confidence interval 1.51 to 167.01 ; p = 0.021 ) , confirming previous reports . There was an association between scores of MTX toxicity and the rs4846051 C allele , and haplotypes containing this allele , in African-Americans , but not in Caucasians . CONCLUSIONS : These results , although preliminary , highlight racial or ethnic differences in frequencies of common MTHFR SNPs . The MTHFR 1298 A and the rs4846051 C alleles were associated with MTX-related adverse events in Caucasians and African-Americans , respectively , but these findings should be replicated in larger studies . The rs4846051 SNP , which is far more common in African-Americans than in Caucasians , can also be proved to be a useful ancestry informative marker in future studies on genetic admixture We analyzed the relationship of genetic variation within the methylenetetrahydrofolate reductase gene ( MTHFR 677 C→T ) with clinical characteristics , outcome , and therapy-related toxicity in pediatric non-Hodgkin ’s lymphoma ( NHL ) in our multicenter trial NHL-BFM 95 . In this trial , high-dose methotrexate ( MTX ) infusion regimens were r and omized ( 4- vs 24-h infusion ) in patients with B-cell lymphoma ; MTX was applied as 24-h infusion in all patients with lymphoblastic lymphoma and anaplastic large cell lymphoma . Toxicity data were collected per patient and therapy course according to National Cancer Institute Common Toxicity Criteria ( NCI-CTC ) . The genotypes in 484 pediatric patients were distributed as follows : MTHFR 677 CC , 206 patients ( 42.6 % ) ; MTHFR 677 CT , 214 patients ( 44.2 % ) ; and MTHFR 677 TT , 64 patients ( 13.2 % ) . Lymphoblastic lymphoma was significantly associated with homozygosity for the MTHFR 677 T allele . No association of MTHFR 677 genotype with clinical characteristics ( sex , age , and tumor stage ) , outcome , or therapy-related toxicity could be detected . Therefore , we conclude that the MTHFR 677 C→T polymorphism does not appear to influence outcome or therapy-associated toxicity in pediatric patients with NHL treated on BFM protocol \n Output:\n " }, { "from": "agent", "value": "RESULTS The analysis highlighted a significant association of C677 T polymorphism with overall MTX toxicity , hepatotoxicity , hematological toxicity , and neurotoxicity .\nIt also revealed an association with MTX toxicity in patients with rheumatoid arthritis .\nIn contrast , a protective effect of C677 T MTHFR polymorphism on acute graft-versus-host disease and on patients treated with hematopoietic cell transplantation was found .\nAs for the A1298C polymorphism , a statistically significant association with overall MTX toxicity and a protective role of the polymorphism in rheumatoid arthritis patients was detected .\nThese results indicate the association of MTHFR polymorphisms with MTX toxicity ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: In addition to modern medicinal therapy , many cancer patients in Taiwan are treated regularly with herbal medicines or prescribed a traditional herbal diet . In this paper , the effect of a Taiwanese traditional herbal diet ( TTHD ) on pain in terminal cancer patients was investigated . A total of 2,466 patients diagnosed with a variety of cancers were included . The most common patient-reported symptoms included troublesome pain ( 79.2 % ) , weakness ( 69.0 % ) , anorexia ( 46.4 % ) , fever ( 36.5 % ) , dyspnea ( 31.1 % ) , and leg edema ( 30.9 % ) . The 2,466 terminal cancer patients included in the study were r and omly divided into three groups . The TTHD group ( n=1044 ; 42.3 % ) were given the TTHD consisting of analgesic herbs ( paeony root : licorice root=1:1 ) and a Taiwanese tonic vegetable soup ( Lilii bulbus , Nelumbo seed , and Jujube fruit ) . The remaining patients were divided into a reference group , given the regular hospital diet , ( n=909 , 36.9 % ) and a control group , given the Taiwanese tonic vegetable soup without analgesic herbs , ( n=513 , 20.8 % ) . All patients maintained their assigned diets for one week . A verbal numerical scale was used to assess pain . Results revealed that the patients given TTHD reported enhanced pain relief ( p<0.05 ) compared to the reference and control groups . We found that TTHD could alleviate the pain among terminal cancer patients thereby supporting the supposition that Eastern and Western medicines can be effectively co-administered to enhance terminal patient 's quality of life . Further research is warranted BACKGROUND This study aim ed to evaluate traditional Chinese medicine ( TCM ) in improving quality of life ( QOL ) , reducing chemotoxicity and modulating immune function in patients undergoing chemotherapy . PATIENTS AND METHODS Patients with ovarian cancer were r and omized to receive either TCM or placebo in addition to st and ard chemotherapy . The primary outcome was global health status ( GHS ) score , assessed by European Organization for Research and Treatment of Cancer question naire , while the secondary outcomes were other QOL items , chemotoxicity according to World Health Organization criteria and alterations in immune function as measured by immune cells count and the numbers of cytokines-secreting cells . RESULTS There was no significant difference in the GHS between the two groups . With adjustment for stage , chemotherapy type , disease status , age and baseline value , emotional function , cognitive function and nausea and vomiting were found to be worse or less improved in the TCM group compared with placebo group after six cycles of chemotherapy . The TCM group had less neutropenia after three cycles ( 0 % grade 4 neutropenia versus 28.6 % ) . There were no other significant differences in terms of chemotoxicity . Lymphocyte counts and cytokine activities decreased less in the TCM group . CONCLUSIONS TCM did not improve QOL but did have some effects in terms of maintaining immune function CONTEXT A prior national survey documented the high prevalence and costs of alternative medicine use in the United States in 1990 . OBJECTIVE To document trends in alternative medicine use in the United States between 1990 and 1997 . DESIGN Nationally representative r and om household telephone surveys using comparable key questions were conducted in 1991 and 1997 measuring utilization in 1990 and 1997 , respectively . PARTICIPANTS A total of 1539 adults in 1991 and 2055 in 1997 . MAIN OUTCOMES MEASURES Prevalence , estimated costs , and disclosure of alternative therapies to physicians . RESULTS Use of at least 1 of 16 alternative therapies during the previous year increased from 33.8 % in 1990 to 42.1 % in 1997 ( P < or = .001 ) . The therapies increasing the most included herbal medicine , massage , megavitamins , self-help groups , folk remedies , energy healing , and homeopathy . The probability of users visiting an alternative medicine practitioner increased from 36.3 % to 46.3 % ( P = .002 ) . In both surveys alternative therapies were used most frequently for chronic conditions , including back problems , anxiety , depression , and headaches . There was no significant change in disclosure rates between the 2 survey years ; 39.8 % of alternative therapies were disclosed to physicians in 1990 vs 38.5 % in 1997 . The percentage of users paying entirely out-of-pocket for services provided by alternative medicine practitioners did not change significantly between 1990 ( 64.0 % ) and 1997 ( 58.3 % ) ( P=.36 ) . Extrapolations to the US population suggest a 47.3 % increase in total visits to alternative medicine practitioners , from 427 million in 1990 to 629 million in 1997 , thereby exceeding total visits to all US primary care physicians . An estimated 15 million adults in 1997 took prescription medications concurrently with herbal remedies and /or high-dose vitamins ( 18.4 % of all prescription users ) . Estimated expenditures for alternative medicine professional services increased 45.2 % between 1990 and 1997 and were conservatively estimated at $ 21.2 billion in 1997 , with at least $ 12.2 billion paid out-of-pocket . This exceeds the 1997 out-of-pocket expenditures for all US hospitalizations . Total 1997 out-of-pocket expenditures relating to alternative therapies were conservatively estimated at $ 27.0 billion , which is comparable with the projected 1997 out-of-pocket expenditures for all US physician services . CONCLUSIONS Alternative medicine use and expenditures increased substantially between 1990 and 1997 , attributable primarily to an increase in the proportion of the population seeking alternative therapies , rather than increased visits per patient OBJECTIVE To observe the effect and safety of Zhiling Capsule ( ZC ) in treating lung cancer of middle/advanced stage . METHODS With the multi-center , r and omized , double-blinded and parallel controlled method , the patients were divided into 4 groups , the 104 patients in the group A were treated with the whole recipe of ZC , the 52 in the group B with the disassembled recipe 1 ( Western medicines ) of ZC , the 46 in the group C with the disassembled recipe 2 ( Chinese medicines ) of ZC , and the 48 in the control group with Pingxiao Capsule , all the drugs were administered orally for 2 weeks . The changes of syndrome of qi-yin deficiency , symptoms , quality of life ( QOL ) , body weight and adverse reactions occurred in patients were observed . RESULTS The effective rate in alleviating syndrome in the groups A-D was 91.3 % , 80.8 % , 37.0 % and 14.6 % respectively ; in remitting stuffiness and chest pain 86.9 % , 60.5 % , 20.0 % and 10.0 % ; in improving appetite was 80.4 % , 47.9 % , 23.7 % and 10.3 % . QOL in the groups A-C was significantly elevated after treatment ( P < 0.05 or P < 0.01 ) , the improvement of group A was superior to that of other treatments ( P < 0.01 ) . Body weight in the group A was significantly increased and superior to that of others ( P < 0.05 ) . The whole recipe of ZC showed the therapeutic effect superior to that of the other treatments ( P < 0.05 ) . No obvious adverse reaction was found in all the 4 groups . CONCLUSION ZC can improve the symptoms and QOL in patients with lung cancer of middle/advanced stage OBJECTIVE To observe the effects ot Guben Yiliu II ( GY II ) combined with arterial perfusion with chemotherapeutic agent on advanced pancreatic cancer ( APC ) . METHODS Sixty-five APC patients were r and omly assigned to the treated group ( 35 cases ) given GY II and arterial perfusion with chemotherapeutic agent and the control group ( 30 cases ) with chemotherapeutic agent alone . RESULTS The clinical beneficial rate was 54.2 % in the treated group and 40.0 % in the control group , with significant difference between them ( P < 0.05 ) , the overall effective rate being 17.1 % and 13.3 % , and the effective rate in relieving pain being 64.5 % and 59.2 % in the treated and the control group respectively , all showed insignificant difference between groups ( P > 0.05 ) . Furthermore , in the treated group after treatment , the blood hypercoagulation state ameliorated , cellular immunity elevated , the toxic and side- effects of chemical medicine relieved , and the quality of life improved . CONCLUSION GY II is effective in enhancing clinical effects and relieving toxic and side-effects of chemotherapy , and so , better efficacy could be obtained by therapy of GY II and arterial perfusion with chemotherapeutic agent for treatment of APC Objective To observe the efficacy of Chinese medicine comprehensive therapeutic project in treating the middle/late stage primary hepatic carcinoma ( PHC ) . Methods With prospect i ve r and omized controlled design , 97 patients with PHC were assigned to the test group ( 49 cases ) treated with Chinese medicine comprehensive therapy using Oleum fructus bruceas intervention combining oral intake of Ganji Decoction ( 肝积方 ) and external application of Ailitong ( 癌理通 ) , and the control group ( 48 cases ) treated with chemotherapeutic agents combining iodized oil chemo-embolization and analgesics . The immediate and long-term efficacy , adverse reaction , pain-relieving initial time ( PRIT ) and pain-relieving sustained time ( PRST ) of the treatment , as well as the change in relieving patients ’ quality of life ( QOL ) were observed . Results The difference between the two groups in illness control rate was statistically insignificant ( P>0.05 ) , but the adverse reaction occurence rate in the test group was lesser than that in the control group ( P<0.05 ) . PRIT was insignificantly different in the two groups ( P>0.05 ) , but the PRST was significantly superior in the test group than that in the control group ( 10.37±2.18 h vs 7.78±1.95 h , P<0.01 ) . After treatment , the increased Karnofsky scores in the test group indicated that the patients ’ somatic activity , symptoms and QOL were improved significantly , which were significantly superior to those in the control group ( P<0.05 ) . The survival rate in the two groups was similar at the 3rd month after treatment , but the test group did show superiority in terms of half- and 1-year survival rate ( 65.9 % vs 42.5 % and 38.6 % vs 18.1 % , respectively , P<0.05 ) . The median survival time in the test group was 8.9 months and that in the control group was 5.3 months . Conclusion Chinese medicine comprehensive therapy is an effective treatment for the middle/late stage patients of PHC , and it could extend the PRST , improve the patients ’ QOL and long-term survival with less adverse reaction Objective To observe the clinical effectiveness of a topical application of Xiaozheng Zhitong : Paste ( 消癥止痛方 , XZP ) in alleviating the cancerous pain of patients with middle/late stage cancer Methods By : adopting a r and om number table , 124 patients enrolled were r and omized into the treatment group ( 64 patients ) and the control group ( 60 patients ) . In addition to the basic therapy [ including the three-ladder ( 3L ) analgesia ] used in both groups , topical application of XZP was given to patients in the treatment group for pain alleviation . The analgesic efficacy was recorded in terms of pain intensity , analgesia initiating time and sustaining time , and the optimal analgesic effect revealing time . Meanwhile , the quality of life ( QOL ) and adverse reactions that occurred in patients were recorded as well . Results The total effective rate in the treatment group was : 84.38 % ( 54/64 ) , and in the control group it was 88.33 % ( 53/60 ) , showing no significant difference between them ( P>0.05 ) , but the analgesia initiating time and the optimal analgesia effect revealing time in the treatment group were significantly shorter ( both P<0.01 ) . Moreover , XZP was better in improving patients ’ QOL , showing more significant improvements in the treatment group than those in the control group in aspects of mental condition , walking capacity , working capacity , social acceptability , sleep and joy of living ( P<0.05 or P<0.01 ) . Lower incidence of adverse reactions , such as nausea , vomiting , mouth dryness , dizziness , etc . , especially constipation , was noted in the treatment group ( P<0.05 or P<0.01 ) . Conclusion Applying an external compress : of XZP showed a synergistic action with 3L analgesia for shortening the initiating time and the optimal effect revealing time , and could evidently enhance patients ’ QOL with fewer adverse reactions OBJECTIVE To observe the effects of ginsenosides ( GS ) and low dose glucocorticoid for preventing and treating the post-transcatheter arterial chemoembolization ( TACE ) syndrome . METHODS Adopting r \n Output:\n " }, { "from": "agent", "value": "The results of these studies suggest that THM combined with conventional therapy is efficacious as an adjunctive therapy for patients with cancer pain ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: BACKGROUND AND OBJECTIVE To develop a checklist of items measuring the quality of reports of r and omized clinical trials ( RCTs ) assessing nonpharmacological treatments ( NPTs ) . STUDY DESIGN AND SETTING The Delphi consensus method was used to select and reduce the number of items in the checklist . A total of 154 individuals were invited to participate : epidemiologists and statisticians involved in the field of methodology of RCTs ( n = 55 ) , members of the Cochrane Collaboration ( n = 41 ) , and clinicians involved in planning NPT clinical trials ( n = 58 ) . Participants ranked on a 10-point Likert scale whether an item should be included in the checklist . RESULTS Fifty-five experts ( 36 % ) participated in the survey . They were experienced in systematic review s ( 68 % were involved in the Cochrane Collaboration ) and in planning RCTs ( 76 % ) . Three rounds of the Delphi method were conducted to achieve consensus . The final checklist contains 10 items and 5 subitems , with items related to the st and ardization of the intervention , care provider influence , and additional measures to minimize the potential bias from lack of blinding of participants , care providers , and outcome assessors . CONCLUSIONS This tool can be used to critically appraise the medical literature , design NPT studies , and assess the quality of trial reports included in systematic review Study Design . A prospect i ve , r and omized , multicenter , Food and Drug Administration-regulated Investigational Device Exemption clinical trial . Objective . To evaluate the safety and effectiveness of the ProDisc ® -L ( Synthes Spine , West Chester , PA ) lumbar total disc replacement compared to circumferential spinal fusion for the treatment of discogenic pain at 1 vertebral level between L3 and S1 . Summary of Background Data . As part of the Investigational Device Exemption clinical trial , favorable single center results of lumbar total disc replacement with the ProDisc ® -L have been reported previously . Methods . Two hundred eighty-six ( 286 ) patients were treated on protocol . Patients were evaluated before and after surgery , at 6 weeks , 3 , 6 , 12 , 18 , and 24 months . Evaluation at each visit included patient self- assessment s , physical and neurologic examinations , and radiographic evaluation . Results . Safety of ProDisc ® -L implantation was demonstrated with 0 % major complications . At 24 months , 91.8 % of investigational and 84.5 % of control patients reported improvement in the Oswestry Low Back Pain Disability Question naire ( Oswestry Disability Index [ ODI ] ) from preoperative levels , and 77.2 % of investigational and 64.8 % of control patients met the ≥15 % Oswestry Disability Index improvement criteria . Overall neurologic success in the investigational group was superior to the control group ( 91.2 % investigational and 81.4 % control ; P = 0.0341 ) . At 6 weeks and 3 months follow-up time points , the ProDisc ® -L patients recorded SF-36 Health Survey scores significantly higher than the control group ( P = 0.018 , P = 0.0036 , respectively ) . The visual analog scale pain assessment showed statistically significant improvement from preoperative levels regardless of treatment ( P < 0.0001 ) . Visual analog scale patient satisfaction at 24 months showed a statistically significant difference favoring investigational patients over the control group ( P = 0.015 ) . Radiographic range of motion was maintained within a normal functional range in 93.7 % of investigational patients and averaged 7.7 ° . Conclusions . ProDisc ® -L has been found to be safe and efficacious . In properly chosen patients , ProDisc ® -L has been shown to be superior to circumferential fusion by multiple clinical criteria Background The objective of this clinical study is to evaluate the safety and effectiveness of the Activ-L Artificial Disc for treatment of single-level degenerative disc disease of the lumbar spine in patients who have been unresponsive to at least six months of prior conservative care . The hypothesis of the study is that the Activ-L Disc is non-inferior to the control ( the Charité ® Artificial Disc [ DePuy Spine ] or ProDisc-L ® Total Disc Replacement [ Synthes Spine ] ) with respect to the rate of individual subject success at 24 months . Individual subject success is a composite of effectiveness and safety . Methods / Design The study proposed is a prospect i ve , r and omized , single-masked , controlled , multi-center clinical trial consisting of an estimated 414 subjects with single-level DDD of the lumbar spine ( L4/L5 , or L5/S1 ) who have failed to improve with conservative treatment for at least six months prior to enrollment . After enrollment , subjects will be r and omized in a 2:1 ratio to either the Activ-L Disc ( investigational device ) or the control ( Charité or ProDisc-L ) . Radiographic endpoints will be evaluated by an independent review er at an imaging core laboratory . Each subject will be followed for 5 years post-treatment . Discussion The safety and effectiveness of the Activ-L Artificial Disc for treatment of single-level degenerative disc disease of the lumbar spine will be equivalent to Charité ® Artificial Disc [ DePuy Spine ] or ProDisc-L ® Total Disc Replacement [ Synthes Spine ] at 24 months . Trial Registration Current Controlled Trials NCT00589797 Study Design . Prospect i ve study analyzing midterm clinical results of total lumbar disc replacement ( ProDisc II ) for different indications . Objectives . To assess functional outcome after total lumbar disc replacement ( TDR ) treated for varying indications . Summary of Background Data . Despite its frequent use and increasing popularity , indications and contraindications for TDR have not been defined precisely at this stage and remain a matter of debate , leading to disc replacement procedures in a variety of pathologies that have not yet been evaluated and compared separately . Methods . Patients meeting inclusion criteria were evaluated prospect ively according to Visual Analogue Scale ( VAS ) , Oswestry Question naire , SF-36 , and numerous clinical parameters . Indications included degenerative disc disease ( DDD ) , DDD with accompanying soft disc herniation ( nucleus pulposus prolapse , NPP ) , osteochondrosis following previous discectomy , and DDD with presence of Modic changes . Postoperative improvement was recorded and analyzed for influence of preoperative diagnosis . Results . Overall , 92 patients from four groups with a mean follow-up of 34.2 months ( minimum , 24 months ) achieved significant and maintained improvement from preoperative levels ( P < 0001 ) . Patients with DDD + NPP achieved results significantly better than patients from the other groups ( P < 0.05 ) . Presence of Modic changes or previous discectomy did not influence outcome negatively . Improvement was achieved for both monosegmental and bisegmental disc replacements ( P < 0.05 ) , nevertheless with significantly inferior results for bisegmental interventions at 12- and 24-month follow-up and considerably higher complication rate . While older patients were still highly satisfied with postoperative outcome , better functional outcome was observed in younger patients . Conclusion . Present data suggest beneficial clinical results of TDR for treatment of DDD in a highly selected group of patients . Better functional outcome was obtained in younger patients under 40 years of age and patients with degenerative disc disease in association with disc herniation . Multilevel disc replacement had significantly higher complication rate and inferior outcome . Results are significantly dependent on preoperative diagnosis and patient selection , number of replaced segments , and age of the patient at the time of operation . Because of significantly varying outcomes , indications for disc replacement must be defined precisely Background Difficulties in performing r and omized controlled trials ( RCTs ) to evaluate new treatment options are increasing . Higher costs and patient unwillingness are the main obstacles . A spinal surgery register has been in use in Sweden for 11 years . Our aim was to determine whether this register can provide the same information as an RCT and whether register data compare favorably with RCT data , making RCTs unnecessary . If not the case , was patient selection or follow-up frequency the cause of any differences ? Material s and methods We compared baseline data and outcome , retrieved from our register , between 2 surgical groups , total disc replacement ( TDR ) and fusion at 1 or 2 levels , performed for degenerative disc disease . One hundred fifty-two patients were part of an RCT , whereas four hundred fifty-five patients had been treated according to an active decision . These 2 subgroups were the subjects for comparison . Results The 2 subgroups were not similar at baseline . Patients who were fused in the non- RCT subgroup were older , had a higher Oswestry Disability Index , and were more frequently smokers than the other patients . The outcome for the non- RCT group showed larger differences in favor of TDR than the RCT did . The nonresponders in the non- RCT group showed worse life quality and disability at baseline , and patients who answered the 1-year follow-up question naire but not the 2-year follow-up question naire had an inferior clinical result compared with the other patients at 1 year . Conclusion Data from our register showed results similar to the RCT , but a register can not fully replace an RCT study when evaluating a new treatment option if the RCT has narrower selection than just the diagnosis . In this RCT comparing TDR with posterior fusion , the normal exclusion criteria for TDR were used . These were not registered , so the register could not prevent a possible selection bias , which might also be caused by the nonresponders Study Design . Radiographic results from a prospect i ve , r and omized , multicenter trial assessing patients who underwent lumbar total disc replacement ( TDR ) or circumferential arthrodesis for 1-level degenerative disc disease . Objective . To quantify the relative segmental contribution to total lumbar range of motion ( ROM ) at the operative level at each adjacent level in lumbar TDR and arthrodesis . Summary of Background Data . Although previous studies have evaluated ROM in TDR and fusion , no study has quantified or compared the relative segmental contribution to total lumbar ROM . Further , no study to the best of our knowledge has evaluated the kinematic profile of the more cranial adjacent segments ( i.e. , the second or third adjacent levels ) following implantation of either TDR or fusion . Methods . Radiographic data collected from all r and omized 1-level degenerative disc disease patients operated at L4/5 or L5/S1 that participated in the multicenter , prospect i ve , r and omized IDE study comparing ProDisc-L with circumferential lumbar arthrodesis were evaluated before surgery and at 24 months . Radiographic measurements were performed independently using custom digitized image stabilization software to generate ROM at the operative level , and at each cranial and caudal adjacent level . Results . There were 200 total patients included ( 155 ProDisc-L , average age 39 years ; 45 arthrodesis , average age 40 years ) . At 24 months , the L4/5 TDR group experienced a significant improvement in total lumbar ROM from baseline ( + 6.3 ° ) , whereas there was no change seen with L5/S1 TDR or any fusion group . Between-group comparisons from baseline to 24 months postoperatively revealed : ( 1 ) significantly more contribution from the operative level towards total lumbar range in TDR at operative level L4/5 ( TDR : −2.5 % , fusion : −16.8 % , P = 0.006 ) , and operative level L5/S1 ( TDR : −5.1 % , fusion : −15.9 % , P < 0.001 ) , and ( 2 ) the relative contribution towards total lumbar range of motion from the first cranial adjacent segment to fusion at L5/S1 increased by 12.1 % , compared with −1.2 % seen in TDR ( P = 0.03 ) . There were elevated contributions from the more cranial adjacent levels to a fusion when compared with TDR , however , these differences were not statistically significant . At operative level L4/5 , there was significantly increased ROM from the first caudal segment below TDR ( 6 % , P = 0.03 ) , but not below fusion ( 3.1 % , P = 0.59 ) . Conclusion . In conclusion , patients with TDR lost slight relative contribution to total lumbar motion from the operative level which was mostly compensated for by the caudal adjacent level ( if operated at L4/5 ) . In contrast , the significant loss of relative range of motion contribution from the operative level in fusions was redistributed among multiple cranial adjacent levels , most notably at the first cranial adjacent level Sixty patients with one-level discogenic pain confirmed by plain radiography , magnetic resonance imaging , and provocative discography for degenerative disc disease were r and omized : one-third BAK anterior interbody fusion and two-thirds anterior SB Charité artificial disc replacement . The mean age was 40.3 years ( range 21 - 56 years ) . Nineteen cases were at L4-L5 and 41 cases were at L5-S1 . Nineteen cases had BAK anterior interbody fusion and 41 cases were r and omized as SB Charité disc replacement . The length of surgery was mean 88.4 minutes ( range 54 - 137 minutes ) for both groups . The estimated blood loss was mean 289.5 mL ( range 50 - 1800 mL ) . The length of hospital stay was a mean of 3.03 days ( range 2 - 6 days ) . Oswestry Disability Index scores for the SB Charité disc ( aggregate study group ) were 50.0 + /- 14.3 preoperatively and 25.0 + /- 20.1 at 1 - 3 years ' follow-up ( P < 0.001 ) . This is the first study that shows improvement of functional outcome measures in a prospect i ve r and omized design with disc arthroplasty treating primarily mechanical back pain and achieving comparable successful results to lumbar fusion-interbody fusion cage and BMP or interbody autograft and pedicle screw instrumentation OBJECT A secondary lumbar \n Output:\n " }, { "from": "agent", "value": "Choice of control group ( circumferential or anterior fusion ) did not appear to result in different outcomes .\nAUTHORS ' CONCLUSIONS Although statistically significant , the differences between disc replacement and conventional fusion surgery for degenerative disc disease were not beyond the generally accepted clinical important differences with respect to short-term pain relief , disability and Quality of Life .\nTherefore , because we believe that harm and complications may occur after years , we believe that the spine surgery community should be prudent about adopting this technology on a large scale , despite the fact that total disc replacement seems to be effective in treating low-back pain in selected patients , and in the short term is at least equivalent to fusion surgery" } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: Nursing students ' disinterest in caring for elders presents health care challenges . As the aged population increases , nursing faculty are challenged to improve students ' attitudes toward elder care . Reed 's self-transcendence theory guided this pilot study with nursing students ( n=22 ) who implemented either a Creative-Bonding Intervention ( CBI ) or a Friendly Visit ( FV ) at senior citizen centers to test the effect of creative approaches on student self-transcendence and attitudes toward elders . Demographic data , a revised Kogan 's Attitudes toward Old People statements , and Reed 's Self-transcendence Scale were analyzed with descriptive , paired t test , ANCOVA , and Pearson correlation statistics . Results demonstrated significant differences in attitudes in the FV and changes in the expected directions in the CBI group . Self-transcendence had no significant changes . Valuable information was provided by students ' comments about the interventions . Reed 's belief that self-transcendence is present regardless of age was supported . Future studies are suggested with an increased sample size , a combined CBI/FV intervention , and supportive help during students ' intervention delivery Recent studies encourage educators in nursing to use innovative and non-traditional teaching methods , such as using popular movies , posters , portfolios and surfing the internet , to stimulate students ' interest , participation and interaction to enhance academic performance as well as knowledge retention . In this , descriptive cross-sectional study , we used self-administered question naires with statements grade d on 5-points Likert scale ( quantitative measures ) and open-ended questions ( qualitative measures ) , to assess the feasibility and students ' perceptions regarding the use of Lance Armstrong 's autobiography of surviving against cancer as a teaching tool . At the beginning of the lecture copies of selected chapters from : \" It 's Not About the Bike ; My Journey Back to Life \" [ Armstrong , L. , Jenkins , S. 2001 . It 's Not About The Bike : My Journey Back To Life . Yellow Jersey Press , R and om House ( Pty ) Limited , Great Britain ] , were given to students . Willing students were requested to read for the whole class while the lecturer interjected periodically to explain and expound on certain pharmacological concepts . Eighty percent ( 80 % ) of participants felt that the use of an autobiography stimulated their interesting in cancer drugs and 84 % agreed/strongly agreed that it contributed to their knowledge of pharmacology . Using Lance Armstrong 's autobiography of survival to teach cytotoxic drugs is a worthwhile and rewarding exercise from the student nurses ' perspective In the GRADE approach , r and omized trials start as high- quality evidence and observational studies as low- quality evidence , but both can be rated down if most of the relevant evidence comes from studies that suffer from a high risk of bias . Well-established limitations of r and omized trials include failure to conceal allocation , failure to blind , loss to follow-up , and failure to appropriately consider the intention-to-treat principle . More recently recognized limitations include stopping early for apparent benefit and selective reporting of outcomes according to the results . Key limitations of observational studies include use of inappropriate controls and failure to adequately adjust for prognostic imbalance . Risk of bias may vary across outcomes ( e.g. , loss to follow-up may be far less for all-cause mortality than for quality of life ) , a consideration that many systematic review s ignore . In deciding whether to rate down for risk of bias -- whether for r and omized trials or observational studies -- authors should not take an approach that averages across studies . Rather , for any individual outcome , when there are some studies with a high risk , and some with a low risk of bias , they should consider including only the studies with a lower risk of bias The challenges of providing exemplary undergraduate nursing education can not be underestimated in an era when burnout and negative mood states predictably lead to alarming rates of academic as well as career attrition . While the multi-dimensional nature of this complex issue has been extensively eluci date d , few rational strategies exist to reverse a disheartening trend recognizable early in the educational process that subsequently threatens to undermine the future viability of quality healthcare . This controlled prospect i ve crossover study examined the impact of a 6-session Recreational Music-making ( RMM ) protocol on burnout and mood dimensions as well as Total Mood Disturbance ( TMD ) in first year associate level nursing students . A total of 75 first year associate degree nursing students from Allegany College of Maryl and ( ACM ) participated in a 6-session RMM protocol focusing on group support and stress reduction utilizing a specific group drumming protocol . Burnout and mood dimensions were assessed with the Maslach Burnout Inventory and the Profile of Mood States respectively . Statistically significant reductions of multiple burnout and mood dimensions as well as TMD scores were noted . Potential annual cost savings for the typical associate degree nursing program ( $ 16,800 ) and acute care hospital ( $ 322,000 ) were projected by an independent economic analysis firm . A cost-effective 6-session RMM protocol reduces burnout and mood dimensions as well as TMD in associate degree nursing students Undergraduate students often request \" h and s-on \" research experience but seldom have the time and opportunity during a one-semester introductory course to participate in such a project . The purpose s of this educational approach , implemented during a beginning research class for baccalaureate nursing students , were to provide an opportunity for students to participate in an experimental research study , and test the effect of a creative arts intervention on students ' stress , anxiety , and emotions . Students design ed , participated in , and analyzed the results of the project . The intervention significantly reduced stress and anxiety and increased positive emotions in this student population , while providing a creative research experience . For future use , the intervention may be helpful with a variety of vulnerable groups The effects of a creative reflective clinical experience on psychiatric nursing students ' empathy was examined using a mixed- method approach . The Interpersonal Reactivity Index ( IRI ) was used to measure empathy in students ( N = 73 ) in a baccalaureate nursing program . The control group ( n = 44 ) completed a conventional 14-week clinical experience , whereas the comparison group ( n = 29 ) experienced a community psychosocial program for 4 of the weeks . Comparison group participants completed a creative reflective assignment to represent the life experience of a client with mental illness . To further underst and empathy , a constructivist approach with purposive sampling was used to examine students ' perceptions . Four themes emerged : having expectations , building relationships , changing perceptions , and gaining underst and ing through creative expression . Trends were noted , although no statistically significant differences in IRI scores were found for either group . However , this article argues that the use of a creative reflective assignment reduces stigma and promotes empathy The purpose of this project was to examine the effect of Narrative Pedagogy in nursing education on students ' ability to move toward cognitive and ethical maturity and thereby increase their autonomy in nursing practice . Students taking a class using Narrative Pedagogy demonstrated \" entry \" and \" exit \" mean scores that showed marginal and statistically significant ( p < 0.05 ) improvement on the Measure of Intellectual Development and the California Critical Thinking Disposition Inventory . Using nonparametric and parametric analyses of variance , there was minor improvement on both scales in cognitive and ethical maturity and the disposition to think critically in the intervention group . For all variables , there were no significant differences between the control group and the intervention group , with or without adjustment for age , the only significant covariate . The cognitive and ethical growth documented by either instrument is probably not large enough to be considered practically significant in terms of movement toward autonomous practice This article introduces the approach of GRADE to rating quality of evidence . GRADE specifies four categories-high , moderate , low , and very low-that are applied to a body of evidence , not to individual studies . In the context of a systematic review , quality reflects our confidence that the estimates of the effect are correct . In the context of recommendations , quality reflects our confidence that the effect estimates are adequate to support a particular recommendation . R and omized trials begin as high- quality evidence , observational studies as low quality . \" Quality \" as used in GRADE means more than risk of bias and so may also be compromised by imprecision , inconsistency , indirectness of study results , and publication bias . In addition , several factors can increase our confidence in an estimate of effect . GRADE provides a systematic approach for considering and reporting each of these factors . GRADE separates the process of assessing quality of evidence from the process of making recommendations . Judgments about the strength of a recommendation depend on more than just the quality of evidence The aim of the study was to develop an educational tool consisting of selection s of paintings in order to complement theoretical knowledge regarding non-verbal communication . Another aim was to investigate students ' opinions of the educational tool . A visual art programme which introduced student nurses to varying facial expressions in art reproductions was developed as a complement to textbooks on nonverbal communication . Participants were student nurses from two nursing schools in Sweden . Data were collected over a period of two years ( 1998 - 2000 ) in the second year of the 3-year undergraduate programme . Participants were able to infer whether a positive or negative message had been given to the depicted person . Participants ' evaluations of the programme were expressed in positive terms In an effort to bridge the gap in learning in the affective domain , nurse educators must underst and and develop meaningful teaching strategies . Specific strategies design ed to facilitate cognitive underst and ing of the affective response can be found in entertainment films . The findings of this study suggest that the use of entertainment films with guidance is effective in teaching empathetic responses . The continued study of the complex phenomenon in developing an underst and ing of the many variables that comprise not only the experience of empathy , but also the transference of the experience into helping interventions A r and omized study was performed to investigate whether a teaching intervention program using a reproduction of Edvard Munch 's painting , \" The Sick Girl , \" stimulated student nurses to engage in learning about empathy . A control group was used to control for effects of the visual art dialogues in the intervention group . The study was undertaken at a university college of health science in Sweden . Data were collected from student nurses ( n = 144 ) during their first study year . The result showed a significant improvement in the visual art group compared with the matched control group . Students in the visual art group were more engaged in learning about empathy when measured with the Wheel Question naire parameters of structure , motivation , and emotional investment . The present study supported the idea that Edvard Munch 's painting could be used in nurse education complementary to theoretical knowledge on empathy to stimulate student nurses to engage in empathy learning Visual art dialogues were used in student nurses ' education as a teaching and learning complement to theoretical knowledge of nursing care . An intervention group as well as a control group discussed what was characteristic of good nursing care . The control group was used to control for the effects of visual art dialogues in the intervention group . The study was undertaken at two university colleges of health sciences in Sweden . Data were collected from student nurses ( n = 267 ) during their first year of study . The Wheel Question naire was used in the intervention group and control group . It measured three aspects of student nurses ' perception of nursing situations : structure , the extent of emotional involvement , and motivation . The results showed statistical differences ( one way ANOVA ) between the intervention group in which visual art dialogues were implemented and the control group . Students in the intervention group , compared to the control group , were more structured , motivated and emotionally balanced when they expressed the elements most typical of good nursing care . They showed personal readiness in caring situations \n Output:\n " }, { "from": "agent", "value": "The two synthesized findings revealed that art forms could create meaning and inspire learning in undergraduate nursing education and that ABP can develop important learner outcomes /competencies for professional nursing .\nThe narrative synthesis suggested that ABP improved nursing students ' knowledge acquisition , level of empathy , attitude toward others , emotional states , level of reflective practice , learning behaviors and aspects of cognitive/ethical maturity .\nWhen the QL and QN findings were interpreted as a whole , ABP appeared to facilitate learning in the cognitive and affective domains and may be especially useful in addressing the affective domain .\nNurse educators should consider using ABP as students found that this approach offered a meaningful way of learning and result ed in the development of important competencies for professional nursing .\nThe QN studies provide a very low level of evidence that ABP improved students ' knowledge acquisition , level of empathy , attitude toward others , emotional states , level of reflective practice , learning behaviors and aspects of cognitive/ethical maturity .\nAlthough the QN findings can inform future research , the evidence is not robust enough to demonstrate improved outcomes" } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: Introduction This study hypothesised that a reduction of sound during the night using earplugs could be beneficial in the prevention of intensive care delirium . Two research questions were formulated . First , does the use of earplugs during the night reduce the onset of delirium or confusion in the ICU ? Second , does the use of earplugs during the night improve the quality of sleep in the ICU ? Methods A r and omized clinical trial included adult intensive care patients in an intervention group of 69 patients sleeping with earplugs during the night and a control group of 67 patients sleeping without earplugs during the night . The research ers were blinded during data collection . Assignment was performed by an independent nurse research er using a computer program . Eligible patients had an expected length of stay in the ICU of more than 24 hours , were Dutch- or English-speaking and scored a minimum Glasgow Coma Scale of 10 . Delirium was assessed using the vali date d NEECHAM scale , sleep perception was reported by the patient in response to five questions . Results The use of earplugs during the night lowered the incidence of confusion in the studied intensive care patients . A vast improvement was shown by a Hazard Ratio of 0.47 ( 95 % confidence interval ( CI ) 0.27 to 0.82 ) . Also , patients sleeping with earplugs developed confusion later than the patients sleeping without earplugs . After the first night in the ICU , patients sleeping with earplugs reported a better sleep perception . Conclusions Earplugs may be a useful instrument in the prevention of confusion or delirium . The beneficial effects seem to be strongest within 48 hours after admission . The relation between sleep , sound and delirium , however , needs further research .Trial registration Current Controlled Trials IS RCT OBJECTIVE To develop and vali date a new st and ardized confusion assessment method ( CAM ) that enables nonpsychiatric clinicians to detect delirium quickly in high-risk setting s. DESIGN Prospect i ve validation study . SETTING Conducted in general medicine wards and in an outpatient geriatric assessment center at Yale University ( site 1 ) and in general medicine wards at the University of Chicago ( site 2 ) . PATIENTS The study included 56 subjects , ranging in age from 65 to 98 years . At site 1 , 10 patients with and 20 without delirium participated ; at site 2 , 16 patients with and 10 without delirium participated . MEASUREMENTS AND MAIN RESULTS An expert panel developed the CAM through a consensus building process . The CAM instrument , which can be completed in less than 5 minutes , consists of nine operationalized criteria from the Diagnostic and Statistical Manual of Mental Disorders ( DSM-III-R ) . An a priori hypothesis was established for the diagnostic value of four criteria : acute onset and fluctuating course , inattention , disorganized thinking , and altered level of consciousness . The CAM algorithm for diagnosis of delirium required the presence of both the first and the second criteria and of either the third or the fourth criterion . At both sites , the diagnoses made by the CAM were concurrently vali date d against the diagnoses made by psychiatrists . At sites 1 and 2 values for sensitivity were 100 % and 94 % , respectively ; values for specificity were 95 % and 90 % ; values for positive predictive accuracy were 91 % and 94 % ; and values for negative predictive accuracy were 100 % and 90 % . The CAM algorithm had the highest predictive accuracy for all possible combinations of the nine features of delirium . The CAM was shown to have convergent agreement with four other mental status tests , including the Mini-Mental State Examination . The interobserver reliability of the CAM was high ( kappa = 0.81 - 1.0 ) . CONCLUSIONS The CAM is sensitive , specific , reliable , and easy to use for identification of delirium Background : Major depression is a frequent and serious disorder in older medical in patients . Because the condition goes undetected and untreated in most of these patients , we conducted a r and omized clinical trial to evaluate the effectiveness of a strategy of systematic detection and multidisciplinary treatment of depression in this population . Methods : Consecutive patients aged 65 years or more admitted to general medical services in a primary care hospital between October 1999 and November 2002 were screened for depression with the Diagnostic Interview Schedule ( DIS ) within 48 hours after admission . Patients found to have major depression were r and omly allocated to receive the intervention or usual care . The intervention involved consultation and treatment by a psychiatrist and follow-up by a research nurse and the patient 's family physician . Research assistants , blind to group allocation , collected data from the patients at enrolment and at 3 and 6 months later using the Hamilton Depression Rating Scale ( HAMD ) , the Medical Outcomes 36-item Short Form ( SF-36 ) , the DIS , the Mini-Mental State Examination ( MMSE ) , the Older Americans Re sources and Services ( OARS ) question naire to assess basic and instrumental activities of daily living ( OARS-ADL and OARS-IADL ) and the Rating Scale for Side Effects . Data on the severity of illness , length of hospital stay , health services and medication use , mortality and process of care were also collected . The primary outcome measures were the HAMD and SF-36 . Results : Of 1500 eligible patients who were screened , 157 were found to have major depression and consented to participate ( 78 in the intervention group and 79 in the usual care group ) . At r and omization , there were no clinical ly or statistically significant differences between the 2 groups . Sixty-four patients completed follow-up to 6 months , 57 withdrew , and 36 died . At 6 months , there were no clinical ly or statistically significant differences the 2 groups in HAMD or SF-36 scores or any of the secondary outcome measures . Interpretation : We were unable to demonstrate that systematic detection and multidisciplinary care of depression was more beneficial than usual care for elderly medical in patients BACKGROUND delirium is a frequent adverse consequence of hospitalisation for older patients , but there has been little research into its prevention . A recent study of Hospital in the Home ( admission substitution ) noted less delirium in the home-treated group . SETTING a tertiary referral teaching hospital in Sydney , Australia . METHODS we r and omised 104 consecutive patients referred for geriatric rehabilitation to be treated in one of two ways , either in Hospital in the Home ( early discharge ) or in hospital , in a rehabilitation ward . We compared the occurrence of delirium measured by the confusion assessment method . Secondary outcome measures were length of stay , hospital bed days , cost of acute care and rehabilitation , functional independence measure ( FIM ) , Mini-Mental State Examination ( MMSE ) and geriatric depression score ( GDS ) assessed on discharge and at 1- and 6-month follow-up and patient satisfaction . RESULTS the home group had lower odds of developing delirium during rehabilitation [ odds ratio ( OR ) = 0.17 ; 95 % confidence interval 0.03 - 0.65 ] , shorter duration of rehabilitation ( 15.97 versus 23.09 days ; P = 0.0164 ) and used less hospital bed days ( 20.31 versus 40.09 , P < or = 0.0001 ) . The cost was lower for the acute plus rehabilitation phases ( 7,680 pounds versus 10,598 pounds ; P = 0.0109 ) and the rehabilitation phase alone ( 2,523 pounds versus 6,100 pounds ; P < or = 0.0001 ) . There was no difference in FIM , MMSE or GDS scores . the home group was more satisfied ( P = 0.0057 ) . CONCLUSIONS home rehabilitation for frail elderly after acute hospitalisation is a viable option for selected patients and is associated with a lower risk of delirium , greater patient satisfaction , lower cost and more efficient hospital bed use The purpose of this r and omized controlled study was to determine the effects of music listening on acute confusion that is common in older adults after hip or knee surgery . A control group demonstrated greater decreases in cognition on the first postoperative day compared to a music-listening group ( F = 8.448 , p = .009 ) . In the 3-day postoperative period , the cognitive status of the control group improved ; on the third postoperative day , there was no significant difference between the two groups ( F = 3.52 , p = .075 ) . The music-listening group had higher scores on the NEECHAM Acute Confusion Scale across the 3-day postoperative period ( F = 7.28 , p = .014 ) OBJECTIVES Delirium ( or acute confusional state ) affects 35 % to 65 % of patients after hip-fracture repair , and has been independently associated with poor functional recovery . We performed a r and omized trial in an orthopedic surgery service at an academic hospital to determine whether proactive geriatrics consultation can reduce delirium after hip fracture . DESIGN Prospect i ve , r and omized , blinded . SETTING Inpatient academic tertiary medical center . PARTICIPANTS 126 consenting patients 65 and older ( mean age 79 + /- 8 years , 79 % women ) admitted emergently for surgical repair of hip fracture . MEASUREMENTS Detailed assessment through interviews with patients and design ated proxies and review of medical records was performed at enrollment to ascertain prefracture status . Subjects were then r and omized to proactive geriatrics consultation , which began preoperatively or within 24 hours of surgery , or \" usual care . \" A geriatrician made daily visits for the duration of the hospitalization and made targeted recommendations based on a structured protocol . To ascertain study outcomes , all subjects underwent daily , blinded interviews for the duration of their hospitalization , including the Mini-Mental State Examination ( MMSE ) , the Delirium Symptom Interview ( DSI ) , and the Memorial Delirium Assessment Scale ( MDAS ) . Delirium was diagnosed using the Confusion Assessment Method ( CAM ) algorithm . RESULTS The 62 patients r and omized to geriatrics consultation were not significantly different ( P>.1 ) from the 64 usual-care patients in terms of age , gender , prefracture dementia , comorbidity , type of hip fracture , or type of surgical repair . Sixty-one percent of geriatrics consultation patients were seen preoperatively and all were seen within 24 hours postoperatively . A mean of 10 recommendations were made throughout the duration of the hospitalization , with 77 % adherence by the orthopedics team . Delirium occurred in 20 /62 ( 32 % ) intervention patients , versus 32 / 64 ( 50 % ) usual-care patients ( P = .04 ) , representing a relative risk of 0.64 ( 95 % confidence interval ( CI ) = 0.37 - 0.98 ) for the consultation group . One case of delirium was prevented for every 5.6 patients in the geriatrics consultation group . There was an even greater reduction in cases of severe delirium , occurring in 7/ 60 ( 12 % ) of intervention patients and 18 / 62 ( 29 % ) of usual-care patients , with a relative risk of 0.40 ( 95 % CI = 0.18 - 0.89 ) . Despite this reduction in delirium , length of stay did not significantly differ between intervention and usual-care groups ( median + /- interquartile range = 5 + /- 2 days in both groups ) , likely because protocol s and pathways predetermined length of stay . In subgroup analyses , geriatrics consultation was most effective in reducing delirium in patients without prefracture dementia or activities of daily living ( ADL ) functional impairment . CONCLUSIONS Proactive geriatrics consultation was successfully implemented with good adherence after hip-fracture repair . Geriatrics consultation reduced delirium by over one-third , and reduced severe delirium by over one-half . Our trial provides strong preliminary evidence that proactive geriatrics consultation may play an important role in the acute hospital management of hip-fracture patients BACKGROUND delirium is a clinical syndrome associated with multiple short and long-term complications and therefore prevention is an essential part of its management . This study was design ed to assess the efficacy of multicomponent intervention in delirium prevention . METHODS a total of 287 hospitalised patients at intermediate or high risk of developing delirium were r and omised to receive a non-pharmacological intervention delivered by family members ( 144 patients ) or st and ard management ( 143 patients ) . The primary efficacy outcome was the occurrence of delirium at any time during the course of hospitalisation . Three vali date d observers performed the event adjudication by using the confusion assessment method screening instrument . RESULTS there were no significant differences in the baseline characteristics between the two groups . The primary outcome occurred in 5.6 % of the patients in the intervention group and in 13.3 % of the patients in the control group ( relative risk : 0.41 ; confidence interval : 0.19 - 0.92 ; P = 0.027 ) . CONCLUSION the results of this study show that there is a benefit in the non-pharmacological prevention of delirium using family members , when compared with st and ard management of patients at risk of developing this condition BACKGROUND Delirium is a common syndrome with poor prognosis affecting elderly in patients . Treatment is mainly based on common sense with wide variations in practice . We investigated whether intensified , multicomponent geriatric treatment could improve the prognosis of delirious patients . METHODS We performed a r and omized , controlled trial of 174 patients with delirium in six general medicine units from an acute hospital \n Output:\n " }, { "from": "agent", "value": "Strong recommendations in favor of multicomponent interventions to prevent delirium , in surgical or medicals wards , were formulated .\nIn the latter case the evidence applied to older patients at intermediate - high risk of developing delirium .\nWeak recommendations , to prevent delirium , were formulated for multicomponent interventions provided by family members ( medical ward ) , staff education ( medical ward ) , ear plugs ( intensive care unit ) , reorientation protocol ( intensive care unit ) , and the use of a software to perform drug review .\nWeak recommendations were provided for the use of multicomponent interventions to prevent delirium in medical wards in patients not selected according to the risk of delirium .\nStrong recommendations not to use bright light therapy to prevent delirium in intensive care unit setting s were articulated .\nMoreover , weak recommendations were provided for the use of multicomponent interventions to treat delirium of older patients ( medical wards ) .\nConclusions Overall , the panel developed 12 recommendations for the delivery of non-pharmacological interventions to older patients at risk of developing or , with delirium" } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: Purpose We design ed American College of Surgeons Oncology Group ( ACOSOG ) Z6041 , a prospect i ve , multicenter , single-arm , phase II trial to assess the efficacy and safety of neoadjuvant chemoradiation ( CRT ) and local excision ( LE ) for T2N0 rectal cancer . Here , we report tumor response , CRT-related toxicity , and perioperative complications ( PCs ) . Methods Clinical ly staged T2N0 rectal cancer patients were treated with capecitabine and oxaliplatin during radiation followed by LE . Because of toxicity , capecitabine and radiation doses were reduced . LE was performed 6 weeks after CRT . Patients were evaluated for clinical and pathologic response . CRT-related complications and PCs were recorded . Results Ninety patients were accrued ; 6 received non protocol treatment . The remaining 84 were 65 % male ; median age 63 years ; 83 % Eastern Cooperative Oncology Group performance score 0 ; 92 % white ; mean tumor size 2.9 cm ; and average distance from anal verge 5.1 cm . Five patients were considered ineligible . Therapy was completed per protocol in 79 patients , but two patients did not undergo LE . Among 77 eligible patients who underwent LE , 34 patients achieved a pathologic complete response ( 44 % ) and 49 ( 64 % ) tumors were downstaged ( ypT0–1 ) , but 4 patients ( 5 % ) had ypT3 tumors . Five LE specimens contained lymph nodes ; one T3 tumor had a positive node . All but one patient had negative margins . Thirty-three ( 39 % ) of 84 patients developed CRT-related grade ≥3 complications . Rectal pain was the most common PC . Conclusions CRT before LE for T2N0 tumors results in a high pathologic complete response rate and negative resection margins . However , complications during CRT and after LE are high . The true efficacy of this approach will ultimately be assessed by the long-term oncologic outcomes Background : Retrospective single-center studies have shown that diffusion-weighted magnetic resonance imaging ( DWI ) is promising for identification of patients with rectal cancer with a complete tumor response after neoadjuvant chemoradiotherapy ( CRT ) , using certain volumetric thresholds . Objective : This study aims to vali date the diagnostic value of these volume thresholds in a larger , independent , and bi-institutional patient cohort . Methods : A total of 112 patients with locally advanced rectal cancer ( 2 centers ) treated with a long course of CRT were enrolled . Patients underwent st and ard T2W-magnetic resonance imaging and DWI , both pre- and post-CRT . Two experienced readers independently determined pre-CRT and post-CRT tumor volumes ( cm3 ) on T2W-magnetic resonance image and diffusion-weighted magnetic resonance image by means of freeh and tumor delineation . Tumor volume reduction rates ( & Dgr;volume ) were calculated . Previously determined T2W and DWI threshold values for prevolume , postvolume , and & Dgr;volume were tested to “ prospect ively ” assess their respective diagnostic value in discriminating patients with a complete tumor response from patients with residual tumor . Results : Twenty patients had a complete response . Using the average measurements between the 2 readers , areas under the curve for the pre-/post-/&Dgr;volumes was 0.73/0.82/0.78 for T2W-magnetic resonance imaging and 0.77/0.92/0.86 for DWI , respectively . For T2W-volumetry , sensitivity and specificity using the predefined volume thresholds were 55 % and 74 % for pre- , 60 % and 89 % for post- , and 60 % and 86 % for & Dgr;volume . For DWI volumetry , sensitivity and specificity were 65 % and 76 % for pre- , 70 % and 98 % for post- , and 70 % and 93 % for & Dgr;volume . Conclusions : Previously established DWI volume thresholds can be reproduced with good results . Post-CRT DWI volumetry offers the best results for the detection of patients with a complete response after CRT with an area under the curve of 0.92 , sensitivity of 70 % , and specificity of 98 % BACKGROUND AND STUDY AIMS The aim of this study was to assess whether preoperative endorectal ultrasound ( ERUS ) is able to predict histological infiltration of the external anal sphincter or the levator ani muscle in patients with a lower-third rectal neoplasm and so the possibility of treatment by sphincter-saving surgery . PATIENTS AND METHODS Between May 1996 and May 2003 , 66 patients with a lower-third rectal neoplasm that was staged as uT2 or greater were entered into a prospect i ve evaluation of ERUS . All patients underwent neoadjuvant treatment before surgery . RESULTS The first ERUS ( ERUS 1 ) was performed before neoadjuvant treatment ; the second ERUS ( ERUS 2 ) was performed between the end of the radiotherapy and the surgery . An abdominoperineal resection was performed mainly when the lower extent of the tumor was within 3.5 cm from the anal verge ( P = 0.011 ) , but no correlation was observed between the lateral clearance determined by ERUS 1 and the histological clearance ( P = 0.091 ) . After neoadjuvant treatment , the ERUS 2 lateral clearance was significantly correlated with the type of surgery ( P = 0.003 ) and the histological clearance ( P < 0.001 ) . With regard to the performance of ERUS 2 for predicting histological infiltration of the external anal sphincter or the levator ani muscle , the sensitivity was 100 % , the negative predictive value was 100 % , the specificity was 87 % , and the positive predictive value was 53 % . In a multivariate analysis , the histological clearance and tumor T stage were statistically correlated with disease-free survival ( P = 0.035 and P = 0.05 , respectively ) . CONCLUSIONS ERUS could help oncologists and surgeons in the management of patients with lower rectal carcinomas . Moreover , ERUS is able to predict lateral histological clearance after neoadjuvant treatment BACKGROUND To date , the role of endoscopic ultrasound ( EUS ) in restaging locally advanced rectal cancer ( LARC ) after neoadjuvant chemoradiotherapy ( NAT ) have not been thoroughly investigated . AIM To evaluate accuracy and clinical usefulness of EUS for both staging and restaging LARC . METHODS According to EUS staging , patients with LARC were enrolled in the study . Those who underwent surgery directly represented a control group useful for evaluating the accuracy of EUS in staging LARC . In the study group , EUS was repeated seven weeks after NAT , before surgery . The results of EUS were compared with the corresponding pTN stages . RESULTS From 2000 to 2006 , 212 consecutive patients with RC underwent EUS staging . Among them EUS diagnosed 162 LARC ( M/F = 93/69 ; mean age : 60 years [ range 40 - 80 ] ) . The final study group included 85 patients with LARC . EUS restaging had an overall accuracy of 61 % and 59 % for T and N-stage , respectively . In the control group , the accuracy of EUS in staging LARC was 86 % and 58 % for T and N-stage , respectively . CONCLUSION EUS accurately stages LARC and enables appropriate decision-making , with selection of those patients who need NAT . On the other h and , EUS restaging of LARC after NAT has low accuracy and should not be used in clinical practice BACKGROUND Postoperative chemoradiotherapy is the recommended st and ard therapy for patients with locally advanced rectal cancer . In recent years , encouraging results with preoperative radiotherapy have been reported . We compared preoperative chemoradiotherapy with postoperative chemoradiotherapy for locally advanced rectal cancer . METHODS We r and omly assigned patients with clinical stage T3 or T4 or node-positive disease to receive either preoperative or postoperative chemoradiotherapy . The preoperative treatment consisted of 5040 cGy delivered in fractions of 180 cGy per day , five days per week , and fluorouracil , given in a 120-hour continuous intravenous infusion at a dose of 1000 mg per square meter of body-surface area per day during the first and fifth weeks of radiotherapy . Surgery was performed six weeks after the completion of chemoradiotherapy . One month after surgery , four five-day cycles of fluorouracil ( 500 mg per square meter per day ) were given . Chemoradiotherapy was identical in the postoperative-treatment group , except for the delivery of a boost of 540 cGy . The primary end point was overall survival . RESULTS Four hundred twenty-one patients were r and omly assigned to receive preoperative chemoradiotherapy and 402 patients to receive postoperative chemoradiotherapy . The overall five-year survival rates were 76 percent and 74 percent , respectively ( P=0.80 ) . The five-year cumulative incidence of local relapse was 6 percent for patients assigned to preoperative chemoradiotherapy and 13 percent in the postoperative-treatment group ( P=0.006 ) . Grade 3 or 4 acute toxic effects occurred in 27 percent of the patients in the preoperative-treatment group , as compared with 40 percent of the patients in the postoperative-treatment group ( P=0.001 ) ; the corresponding rates of long-term toxic effects were 14 percent and 24 percent , respectively ( P=0.01 ) . CONCLUSIONS Preoperative chemoradiotherapy , as compared with postoperative chemoradiotherapy , improved local control and was associated with reduced toxicity but did not improve overall survival Objectives To evaluate the performance of diffusion-weighted MRI ( DWI ) in addition to T2-weighted ( T2W ) MRI for nodal restaging after chemoradiation in rectal cancer . Methods Thirty patients underwent chemoradiation followed by MRI ( 1.5 T ) and surgery . Imaging consisted of T2W-MRI and DWI ( b0 , 500 , 1000 ) . On T2W-MRI , nodes were scored as benign/malignant by two independent readers ( R1 , R2 ) . Mean apparent diffusion coefficient ( ADC ) was measured for each node . Diagnostic performance was compared for T2W-MRI , ADC and T2W+ADC , using a per lesion histological validation . Results ADC was higher for the malignant nodes ( 1.43 ± 0.38 vs 1.19 ± 0.27 * 10−3 mm2/s , p < 0.001 ) . Area under the ROC curve/sensitivity/specificity were 0.88/65%/93 % ( R1 ) and 0.95/71%/91 % ( R2 ) using T2W-MRI ; 0.66/53%/82 % using ADC ( mean of two readers ) ; and 0.91/56%/98 % ( R1 ) and 0.96/56%/99 % ( R2 ) using T2W+ADC . There was no significant difference between T2W-MRI and T2W+ADC . Interobserver reproducibility was good for T2W-MRI ( κ0.73 ) and ADC ( intraclass correlation coefficient 0.77 ) . Conclusions After chemoradiation , ADC measurements may have potential for nodal characterisation , but DWI on its own is not reliable . Addition of DWI to T2W-MRI does not improve accuracy and T2W-MRI is already sufficiently accurate PURPOSE This study was design ed to evaluate prospect ively magnetic resonance imaging for the prediction of the circumferential resection margin in rectal cancer to identify in which patient magnetic resonance imaging could accurately assess the circumferential resection margin before surgery and in which patients it could not . METHODS During a 17-month period , a preoperative magnetic resonance imaging for the assessment of circumferential resection margin was obtained prospect ively in 38 patients with mid or low rectal cancer . The agreement of magnetic resonance imaging and pathologic examination for assessment of circumferential resection margin was analyzed . RESULTS Overall , magnetic resonance imaging agreed with histologic examination of the circumferential resection margin assessment in 28 patients ( 73 percent ; κ = 0.47 ) . In all cases of disagreement between magnetic resonance imaging and pathology , magnetic resonance imaging overestimated the circumferential resection margin involvement . For the 11 patients with mid rectal cancer , circumferential resection margin was well predicted by magnetic resonance imaging in all cases ( κ = 1 ) . For 27 patients with low rectal tumor , overall agreement between magnetic resonance imaging and histologic assessment was 63 percent ( κ = 0.35 ) . Agreement was 22 percent ( κ = 0.03 ) for the 9 patients with low anterior and 83 percent ( κ = 0.67 ) for the 18 patients with low posterior rectal tumor . Univariate analysis revealed that only low and anterior rectal tumor was risk factor of overestimation of the circumferential resection margin by magnetic resonance imaging . CONCLUSIONS Although magnetic resonance imaging remains the best imaging tool for the preoperative assessment of the circumferential resection margin in patients with rectal cancer , it can overestimate the circumferential resection margin involvement in low and anterior tumor with \n Output:\n " }, { "from": "agent", "value": "Restaging MRI is accurate at excluding circumferential resection margin involvement .\nThe heterogeneity amongst restaging studies is high , limiting conclusive findings regarding their accuracies .\nThe accuracy of restaging imaging is different for different pathological T stages and highest for T3 tumours .\nMorphological assessment of T- or N-stage by MRI or ERUS is currently not accurate or consistent enough for clinical application .\nRestaging MRI appears to have a role in excluding circumferential resection margin involvement" } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: Prophylaxis reduces cytomegalovirus ( CMV ) disease , but is associated with increased costs and risks for side effects , viral resistance and late onset CMV disease . Preemptive therapy avoids drug costs but requires frequent monitoring and may not prevent complications of asymptomatic CMV replication . Kidney transplant recipients at risk for CMV ( D+/R− , D+/R+ , D−/R+ ) were r and omized to prophylaxis ( valganciclovir 900 mg q.d . for 100 days , n = 49 ) or preemptive therapy ( 900 mg b.i.d . for 21 days , n = 49 ) for CMV DNAemia ( CMV DNA level > 2000 copies/mL in ≥ 1 whole blood specimens by quantitative PCR ) assessed weekly for 16 weeks and at 5 , 6 , 9 and 12 months . More patients in the preemptive group , 29 ( 59 % ) than in the prophylaxis group , 14 ( 29 % ) developed CMV DNAemia , p = 0.004 . Late onset of CMV DNAemia ( > 100 days after transplant ) occurred in 11 ( 24 % ) r and omized to prophylaxis , and none r and omized to preemptive therapy . Symptomatic infection occurred in five patients , four ( 3 D+/R− and 1 D+/R+ ) in the prophylactic group and one ( D+/R− ) in the preemptive group . Peak CMV levels were highest in the D+/R− patients . Both strategies were effective in preventing symptomatic CMV . Overall costs were similar and insensitive to wide fluctuations in costs of either monitoring or drug Both preemptive therapy and universal prophylaxis are used to prevent cytomegalovirus ( CMV ) disease after transplantation . R and omized trials comparing both strategies are sparse . Renal transplant recipients at risk for CMV ( D+/R− , D+/R+ , D−/R+ ) were r and omized to 3‐month prophylaxis with valacyclovir ( 2 g q.i.d . , n = 34 ) or preemptive therapy with valganciclovir ( 900 mg b.i.d . for a minimum of 14 days , n = 36 ) for significant CMV DNAemia ( ≥2000 copies/mL by quantitative PCR in whole blood ) assessed weekly for 16 weeks and at 5 , 6 , 9 and 12 months . The 12‐month incidence of CMV DNAemia was higher in the preemptive group ( 92 % vs. 59 % , p < 0.001 ) while the incidence of CMV disease was not different ( 6 % vs. 9 % , p = 0.567 ) . The onset of CMV DNAemia was delayed in the valacyclovir group ( 37 ± 22 vs. 187 ± 110 days , p < 0.001 ) . Significantly higher rate of biopsy‐proven acute rejection during 12 months was observed in the preemptive group ( 36 % vs. 15 % , p = 0.034 ) . The average CMV‐associated costs per patient were $ 5525 and $ 2629 in preemptive therapy and valacyclovir , respectively ( p < 0.001 ) . However , assuming the cost of $ 60 per PCR test , there was no difference in overall costs . In conclusion , preemptive valganciclovir therapy and valacyclovir prophylaxis are equally effective in the prevention of CMV disease after renal transplantation Oral ganciclovir prophylaxis and intravenous preemptive therapy are competitive approaches to prevent cytomegalovirus ( CMV ) disease after renal transplantation . This trial compared efficacy , safety and long-term graft outcome in 148 renal graft recipients r and omized to ganciclovir prophylaxis ( N = 74 ) or preemptive therapy ( N = 74 ) . Hierarchical testing revealed ( i ) patients with CMV infection had more severe periods of impaired graft function ( creatinine clearance(max-min ) 25.0 + /- 14.2 mL/min vs. 18.1 + /- 12.5 mL/min for patients without CMV infection ; p = 0.02),(ii ) prophylaxis reduced CMV infection by 65 % ( 13 vs. 33 patients ; p < 0.0001 ) but ( iii ) creatinine clearance at 12 months was comparable for both regimes ( 54.0 + /- 24.9 vs. 53.1 + /- 23.7 mL/min ; p = 0.92 ) . No major safety issues were observed , and patient survival at 12 months was similar in both groups ( 5 deaths [ 6.8 % ] vs. 4 [ 5.4 % ] , p = 1.0000 ) . Prophylaxis significantly increased long-term graft survival 4 years posttransplant ( 92.2 % vs. 78.3 % ; p = 0.0425 ) with a number needed to treat of 7.19 . Patients with donor + /recipient + CMV serostatus had the lowest rate of graft loss following prophylaxis ( 0.0 % vs. 26.8 % ; p = 0.0035 ) . In conclusion , it appears that routine oral prophylaxis may improve long-term graft survival for most renal transplant patients . Preemptive therapy can be considered in low risk patients in combination with adequate CMV monitoring BACKGROUND The impact of cytomegalovirus ( CMV ) infection and disease on long-term outcome after kidney transplantation is still unsettled . METHODS Between 1994 and 1997 , 397 consecutive first kidney graft recipients and 74 retransplants were included in the study and followed prospect ively until December 31 , 2001 . CMV infection ( CMV pp65 antigenemia ) and CMV disease were recorded once weekly during the first 100 days after transplantation . No CMV prophylaxis or preemptive therapy was given . In a multiple Cox proportional hazard model allowing time-dependent covariates , the effects of asymptomatic CMV infection and CMV disease , recipient age and gender , retransplantation , living donor , panel-reactive cytotoxid antibodies , acute rejection , and graft loss were tested on overall mortality beyond 100 days post-transplantation . In a similar analysis , the effect of asymptomatic CMV infection and CMV disease plus other factors were tested on death censored graft loss beyond 100 days . RESULTS Median ( range ) follow up time was 66.6 ( < 1 - 86.9 ) months . The incidence of CMV infection and disease during the first 100 days was 62.8 % and 23.4 % , respectively . The number of total deaths was 96 ( 20 % ) , 82 occurred after the first 100 days . Independent risk factors for overall mortality beyond 100 days were asymptomatic CMV infection , RR = 2.90 ( 95 % CI 1.61 - 5.22 ) ( P= 0.001 ) , CMV disease , RR = 2.50 ( 95 % CI 1.31 - 4.79 ) ( P= 0.006 ) , both compared to no infection or disease , recipient age , RR = 1.066 per year ( 95 % CI 1.048 - 1.084 ) ( P < 0.001 ) , and graft loss in the whole study period RR = 7.88 ( 95 % CI 4.75 - 13.08 ) ( P < 0.001 ) . Asymptomatic CMV infection and CMV disease were not independent risk factors for death censored graft loss , but they significantly reduced graft survival uncensored for death , ( log rank P= 0.001 , respectively ) . CONCLUSION Asymptomatic CMV infection and overt CMV disease during the first 100 days increase the risk of recipient mortality beyond 100 days . This raises the question whether CMV prophylaxis should be given routinely after kidney transplantation \n Output:\n " }, { "from": "agent", "value": "The results of the meta- analysis were as follows : the prophylactic protocol was significantly more effective than the preemptive protocol in reducing CMV infections and the recurrence rates of CMV infection ; both the preemptive protocol and the prophylactic protocol reduced the risk of CMV disease , with no significant differences ; no significant differences were observed in the risks of mortality , acute rejection , graft loss , other infections , or neutropenia between preemptive therapy and prophylaxis .\nPreemptive protocol s are as effective as prophylaxis in reducing the risk of CMV disease in renal transplant recipients , whereas the prophylactic protocol s could more effectively reduce the CMV recurrence rates ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: PURPOSE To compare directly the effect of intensity-modulated radiotherapy ( IMRT ) vs. conventional radiotherapy ( CRT ) on salivary flow and quality of life ( QoL ) in patients with early-stage nasopharyngeal carcinoma ( NPC ) . METHODS AND MATERIAL S Fifty-one patients with T2 , N0/N1 , M0 NPC took part in a r and omized controlled clinical study and received IMRT or CRT . Stimulated whole ( SWS ) and parotid ( SPS ) saliva flow were measured and Medical Outcomes Short Form 36 ( SF-36 ) , European Organization for Research and Treatment of Cancer ( EORTC ) core quetionnaire , and EORTC head- and -neck module ( QLQ-H&N35 ) were completed at baseline and 2 , 6 , and 12 months after radiotherapy . RESULTS Forty-six patients ( 88 % ) were in disease remission 12 months after radiotherapy . At 12 months postradiotherapy , 12 ( 50.0 % ) and 20 patients ( 83.3 % ) in the IMRT group had recovered at least 25 % of preradiotherapy SWS and SPS flow respectively , compared with 1 ( 4.8 % ) and 2 patients ( 9.5 % ) , respectively , in the CRT group . Global health scores showed continuous improvement in QoL after both treatments ( p < 0.001 ) . However , after 12 months subscale scores for role-physical , bodily pain , and physical function were significantly higher in the IMRT group , indicating a better condition ( p < 0.05 ) . Dry mouth and sticky saliva were problems in both groups 2 months after treatment . In the IMRT group , there was consistent improvement over time with xerostomia-related symptoms significantly less common than in the CRT group at 12 months postradiotherapy . CONCLUSIONS IMRT was significantly better than CRT in terms of parotid sparing and improved QoL for early-stage disease . The findings support the case for assessment of health-related QoL in relation to head- and -neck cancer using a site-specific approach PURPOSE Many cancer patients take antioxidant vitamin supplements with the hope of improving the outcome of conventional therapies and of reducing the adverse effects of these treatments . A r and omized trial was conducted to determine whether supplementation with antioxidant vitamins could reduce the occurrence and severity of acute adverse effects of radiation therapy and improve quality of life without compromising treatment efficacy . PATIENTS AND METHODS We conducted a r and omized , double-blind , placebo-controlled trial among 540 head and neck cancer patients treated with radiation therapy . Patients were r and omly assigned into two arms . The supplementation with alpha-tocopherol ( 400 IU/d ) and beta-carotene ( 30 mg/d ) or placebos was administered during radiation therapy and for 3 years thereafter . During the course of the trial , supplementation with beta-carotene was discontinued because of ethical concerns . RESULTS Patients r and omly assigned in the supplement arm tended to have less severe acute adverse effects during radiation therapy ( odds ratio [ OR ] , 0.72 ; 95 % CI , 0.52 to 1.02 ) . The reduction was statistically significant when the supplementation combined alpha-tocopherol and beta-carotene for adverse effects to the larynx ( OR , 0.38 ; 95 % CI , 0.21 to 0.71 ) and overall at any site ( OR , 0.38 ; 95 % CI , 0.20 to 0.74 ) . Quality of life was not improved by the supplementation . The rate of local recurrence of the head and neck tumor tended to be higher in the supplement arm of the trial ( hazard ratio , 1.37 ; 95 % CI , 0.93 to 2.02 ) . CONCLUSION Supplementation with high doses of alpha-tocopherol and beta-carotene during radiation therapy could reduce the severity of treatment adverse effects . However , this trial suggests that use of high doses of antioxidants as adjuvant therapy might compromise radiation treatment efficacy The current Phase I/II study assessed induction docetaxel/carboplatin given weekly for 4 weeks , followed by weekly docetaxel/carboplatin and concomitant boost radiotherapy ( CB‐XRT ) for locally advanced head and neck squamous cell carcinoma PURPOSE This study was design ed to investigate the quality of life ( QOL ) of patients enrolled onto the High-Dose Chemotherapy for Breast Cancer Study Group trial ( PEGASE 02 ) , a French pilot multicenter trial of the treatment of inflammatory breast cancer ( IBC ) aim ed at evaluating ( 1 ) toxicity and feasibility of sequential high-dose chemotherapy ( HDC ) with recombinant human granulocyte colony-stimulating factor ( filgrastim ) and stem-cell support and ( 2 ) response to HDC in terms of pathologic response and survival . PATIENTS AND METHODS QOL measures were performed at inclusion and four times subsequently up to 1 year using an ad hoc side-effect question naire ( 19 physical symptoms ) and the European Organization for Research and Treatment of Cancer Quality -of-Life Question naire ( EORTC QLQ-C30 ) . RESULTS Of the 95 patients entered , the overall QOL question naire completion compliance was 75.6 % . During cycle 3 of HDC , the number of symptoms was high ( mean + /- SD QOL score , 10 + /- 3 ) , with fatigue , hair loss , appetite loss , nausea , change in taste , vomiting , fever , and weight loss reported by more than 60 % of patients . Toxicity and distress associated with HDC were reflected in the decline of four EORTC QLQ-C30 scores : global QOL ( P = .001 ) , and physical , role , and social functioning ( P < .001 for all statistics ) . However , QOL deterioration disappeared after treatment completion , except for physical functioning ( P = .025 ) . One year after inclusion , most QOL scores returned to baseline , and both emotional functioning and global QOL scores were even higher than baseline ( P = .030 and P = .009 , respectively ) . CONCLUSION If it is confirmed that improvements in pathologic response rates with HDC effectively translate into increased probabilities of survival for IBC patients , adoption of such treatment as PEGASE 02 will not involve crucial choices between length of life and QOL and should not be delayed for QOL arguments PURPOSE This open-label , multicenter trial evaluated the efficacy of a mucoadherent , anesthetic medication ( MGI 209 ) for relief from painful oral ulcers associated with cytotoxic chemotherapy . PATIENTS AND METHODS Twenty-eight eligible cancer patients who had up to five discrete oral ulcers ( total area < or = 5 cm2 ) completed this study . Mean age was 53.5 years ( range , 21 to 81 ) . Subjective assessment s of oral discomfort before and after an orange juice pain challenge ( OJPC ) , which was measured using a visual analog scale ( VAS ) , and visual estimates of the amount of MGI 209 that remained on treated ulcers were collected at ( 1 ) baseline ( before MGI 209 treatment ) ; and ( 2 ) 30 , 60 , 120 , and 180 minutes posttreatment . RESULTS Most subjects had low VAS scores ( 4 or less ) , which was indicative of oral discomfort , at baseline before and after the OJPC . At 30 , 60 , 120 , and 180 minutes after MGI 209 treatment , most subjects had high VAS scores before and after an OJPC compared with baseline scores , which was indicative of a substantial increase in oral comfort ; these differences were statistically significant ( P < .0001 ) . Mean percent of MGI 209 estimated to remain on ulcers at the previously mentioned times was 93.7 % , 90.3 % , 79.6 % , and 71.3 % of the total amount applied , respectively . CONCLUSION Benzocaine hydrochloride in combination with the protective , mucoadherent film-coating relieved discomfort for at least 3 hours even with exposure to an irritating beverage . MGI 209 treatment should allow patients with chemotherapy-induced oral ulcers to drink and eat with significantly diminished pain or no pain PURPOSE The purpose of this study was to evaluate the feasibility , toxicity , and efficacy of a novel combined-modality treatment for patients with locally advanced squamous carcinoma of the head and neck . PATIENTS AND METHODS In this multicenter , community-based phase II study , 123 previously untreated patients with locally advanced squamous carcinoma of the head and neck received 6 weeks of induction chemotherapy followed by concurrent high-dose radiation therapy and weekly chemotherapy . Induction chemotherapy included paclitaxel ( 200 mg/m2 , 1-hour i.v . infusion ) on days 1 and 22 , carboplatin ( AUC 6.0 i.v . ) on days 1 and 22 , and 5-fluorouracil ( 225 mg/m2 per day , 24-hour continuous i.v . infusion ) on days 1–43 . After 1 week without therapy , radiation therapy , 1.8 Gy/day , 5 days weekly , to a total dose of 68.4 Gy , was administered to the primary site and the bilateral cervical lymph nodes . During radiation therapy , patients also received six weekly doses of paclitaxel ( 50 mg/m2 , 1-hour i.v . infusion ) and carboplatin ( AUC 1.0 i.v ) . After completion of therapy , patients were restaged with computed tomographic and endoscopic examination ; patients in complete remission were followed up without further treatment . RESULTS One hundred twenty-three patients ( 74 % with stage IV disease ) entered this trial , and 111 patients ( 90 % ) completed the entire treatment course . Seventy of 116 evaluable patients ( 60 % ; 95 % CI , 51%-69 % ) had a clinical complete response to treatment . After a median follow-up of 24 months , the 2- and 3-year actuarial survivals were 66 % and 51 % , respectively . Local toxicity was moderately severe during combined-modality therapy ; however , xerostomia has been the only frequent chronic toxicity of this program . CONCLUSIONS This novel combined-modality treatment program , containing paclitaxel and avoiding the use of cisplatin , is feasible , is highly active , and can be administered with acceptable toxicity in a community-based setting . Aggressive nutritional support should be considered in patients receiving this regimen , to improve acute palliation and to maximize the delivery of combined-modality therapy . Further evaluation of this treatment program is warranted . Incorporation of various novel biologic agents , particularly the epidermal growth factor receptor antagonists , may further improve efficacy Goal of the workOral mucositis ( OM ) is a functionally destructive complication of aggressive head and neck cancer therapy , often result ing in intense pain , an inability to eat and drink and secondary malnutrition and dehydration . The barrier-forming properties of Gelclair have shown promise in relieving such symptoms . The aim of this r and omised-controlled trial was to evaluate the efficacy of Gelclair , as compared to st and ard therapy , as a means of short-term symptom control for patients suffering from radiotherapy-induced OM . Material s and methods Twenty patients , with radiotherapy-induced OM seen in two oncology centres in Devon , were r and omised to either st and ard therapy ( Sucralfate and Mucaine ) or Gelclair and assessed over 24 h. Both treatments were taken four times during the 24-h period , 30 min before meals . Main results No significant difference was found between the Gelclair and st and ard therapy arms in terms of general pain ( F = 1.512 , df = 1 , 17 , ns ) . There did appear to be a trend towards pain improvement initially after the use of Gelclair , but this did not last for the full 24-h assessment period . There was no significant reduction in pain on speaking ( F = 0.261 , df = 1 , 17 , ns ) nor an improvement in capacity to eat and drink , although the effects of st and ard therapy did appear to last longer than the Gelclair . Conclusion This study indicates that Gelclair is no more effective than current st and ard practice in relieving the pain associated with radiotherapy-induced OM . Nevertheless , observations from this preliminary study warrant further investigation , with a view to shaping the way forward for head and neck cancer practice on a national level The National Institutes of Health recently recommended research initiatives to investigate oral complications of cancer chemotherapy . This prospect i ve cohort study investigated orofacial complications of combination chemotherapy ( cyclophosphamide , methotrexate , fluorouracil , vincristine , and prednisone ) in women with breast cancer . Thirty-four patients were given baseline interviews and examinations . Each patient was given weekly orofacial examinations and biweekly interviews for the first seven cycles of cytotoxic treatment . The orofacial complications included neurotoxicity caused by vincristine , mucositis , and c and idiasis . Neurotoxicity affected 22 of 34 ( 65 % ) patients , was significantly associated with age less than 50 years ( p less than 0.05 ) , and manifested as pain \n Output:\n " }, { "from": "agent", "value": "Conclusions This systematic review identified the presence of pain before cancer therapy , likely attributable to the cancer ; an increase in pain during therapy and the common persistence of pain following cancer treatment ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: BACKGROUND AND AIMS Endothelial dysfunction , insulin resistance and oxidative stress are believed to be central and associated mechanisms in atherogenesis . We aim ed to determine the effect of the antioxidant vitamin E on endothelial function , insulin action and cardiovascular risk markers in young healthy adult offspring of parents with Type 2 diabetes . METHODS Healthy , glucose-tolerant adults ( 18 - 38 years ) , 14 ( 12 male/2 female ) with at least one parent with Type 2 diabetes , and 14 ( 12 male/2 female ) subjects with no family history of diabetes ( controls ) were studied . Insulin action was assessed by euglycaemic hyperinsulinaemic clamp ( 1 mU/kg/min ) . Endothelial function was assessed by forearm blood flow ( FBF ) responses to intra-brachial artery infusions of acetylcholine ( ACh ) ( endothelium-dependent vasodilation ) , sodium nitroprusside ( SNP ) ( endothelium-independent vasodilation ) and N(G)-monomethyl L-arginine ( LNMMA ) ( nitric oxide synthase inhibition ) . Thirteen offspring ( 18 - 38 years , 11 male/2 female , BMI < 30 kg/m2 ) completed a r and omized , double-blind , crossover trial ( 12 weeks vitamin E 800 IU/day or placebo , 6-week washout ) . RESULTS Exogenous glucose infusion rates to maintain euglycaemia were positively associated with response to acetylcholine in offspring ( r = 0.61 , P < 0.05 ) , and were linked with triglycerides . Vitamin E had no effect on endothelial function , insulin action or cardiovascular risk markers in healthy adult offspring of parents with Type 2 diabetes . CONCLUSIONS Our results support a positive association between insulin action and endothelial-dependent vasodilation in young healthy adult offspring of parents with Type 2 diabetes , but indicate no effect of vitamin E on these parameters Non-alcoholic fatty liver disease ( NAFLD ) has been suggested to be well correlated with altered blood pressure . This study was conducted to determine the effects of symbiotic and vitamin E supplementation on blood pressure and inflammatory indices of patients with NAFLD . This r and omized , double-blind , placebo-controlled trial was performed among 60 NAFLD patients aged 25 to 64 years old . Participants were r and omly divided into four groups to receive a 400 IU alpha-tocopherol and 2 × 108 CFU/g symbiotic supplement for 8 weeks . The anthropometric parameters , systolic blood pressure ( SBP ) and diastolic blood pressure ( DBP ) , serum malondialdehyde ( MDA ) , nitric oxide ( NO ) and tumor necrosis factor α ( TNFα ) were assessed at baseline and after 8 weeks of intervention . After 8 weeks of intervention , combined symbiotic and alpha-tocopherol , symbiotic and alpha-tocopherol alone administration , compared with the placebo , result ed in significant decreases in SBP ( -17.07±2.1 , -16.07±3.56 , -1.73±2.25 and -1.55±3.01 mmHg , P=0.01 ) , serum MDA ( -1.19±0.5 , -0.12±0.65 , 0.14 ± 0.64 and 0.16±0.34 nmol/mL , P<0.001 ) , serum TNFα ( -15.62±13.93 , -9.24±7.12 , -11.44 ± 15.47 and 3.01±1.71 pg/ml , P<0.001 ) concentrations . A significant decrease in serum AST ( -11.36±4.52 , -7.43±8.58 , -5.93±6.61 and 2.5±5.75 μmol/L , P < 0.001 ) , ALT ( -12.79±3.65 , -3.66±6.81 , -6.54±7.66 and 4.16±3.43 μmol/L , P < 0.001 ) and ALP ( -26.8±11.1 , -4.56±9.22 , -14.48±12.22 and 5.19±2.64 μmol/L , P < 0.001 ) was seen . Variations in DBP and serum NO concentration were not significant . Alpha-tocopherol and symbiotic supplementation among patients with NAFLD result ed in decreased SBP , serum MDA , TNFα levels and enzymes liver ; however , they did not affect DBP and serum NO concentration Exercise increases oxygen consumption and causes a disturbance of intracellular pro-oxidant-antioxidant homeostasis . Athletes are exposed to acute and chronic stress that may lead to increased generation of oxidative species . Hence oxidative stress increases in athletes . Administration of antioxidant like alpha-tocopherol as supplementation may reduce the cell damage caused due to oxidative stress . In the present study , our aim was to study the effects of alpha-tocopherol supplementation on the cardiopulmonary fitness in endurance athletes ( cyclists ) and non-athletes . Our study included 40 cyclists who were trained under District Youth Service & Sports Office . 40 controls were r and omly selected from student group of B.L.D.E.A 's Medical College . Alpha-tocopherol ( Vitamin E ) 200 mg/day for 21 days wasgiven to study group and placebo was given to placebo group . Various physiological parameters like heart rate , blood pressure , respiratory rate were recorded , for assessing cardiopulmonary fitness : Physical Fitness Index ( PFI ) and VO2 max ml/min/kg were recorded before and after supplementation of vitamin E in athletes , and were compared with placebo group before and after supplementation of placebo and also with non-athletes . The results obtained from present study indicate that antioxidant like alpha-tocopherol supplementation did not contribute significantly to improve the cardiopulmonary fitness of endurance athletes There is considerable evidence that chronic moderate-to-high alcohol consumption increases blood pressure . The mechanisms by which this occurs are not clear . Alcohol consumption can induce oxidative stress and cytochrome P450 ( CYP450 ) isoforms that are associated with oxidative stress and may influence vascular tone . To study the role of such mechanisms we examined whether reducing alcohol intake in moderate-to-heavy drinkers ( 40 - 110 g/day ) result ed in changes in urinary excretion of 20-HETE , a CYP450 metabolite of arachidonic acid , and plasma and urinary F(2)-isoprostanes as markers of lipid peroxidation . After a 4-week run-in period during which healthy men maintained their usual drinking pattern they were r and omized to a two-way crossover intervention study . In each of the 4-week treatment periods subjects either substituted their usual alcohol intake with a 0.9 % alcohol beer or maintained their usual alcohol intake . Plasma and urinary F(2)-isoprostanes and urinary 20-HETE were measured by gas chromatography mass spectrometry , and serum gamma-glutamyl transpeptidase ( gamma-GT ) was measured as a biomarker of alcohol consumption , at the end of each study period . Sixteen healthy men age 51.0+/-2.7 years and with a BMI of 26.4+/-0.61 kg/m(2 ) completed the study . The reductions in alcohol intake ( 72.4+/-5.0 vs 7.9+/-1.6 g/day , p<0.001 ) and serum gamma-GT ( geometric mean 24.4 U/L ( 95 % CI 19.7 , 30.2 ) vs 18.6 U/L ( 95 % CI 15.5 , 22.2 , p<0.01 ) were accompanied by a significant fall in blood pressure as well as urinary 20-HETE excretion ( 158+/-23 vs 109+/-19 pmol/mmol creatinine , p<0.001 ) and plasma F(2)-isoprostanes ( 3438+/-158 vs 2929+/-145 pmol/L , p=0.01 ) . A substantial reduction in alcohol consumption in healthy men lowered plasma F(2)-isoprostanes and urinary 20-HETE . Increased oxidative stress and 20-HETE production may be linked , at least in part , to the pathogenesis of alcohol-related hypertension The aim of this study was to assess the impact of conjugated linoleic acids ( CLAs ) , vitamin E , and combination of these nutrients on serum lipid profiles and blood pressure ( BP ) in patients with active rheumatoid arthritis ( RA ) . In a r and omized , double-blind , placebo-controlled trial , 87 patients with active RA were divided into four groups receiving one of the following daily supplements for three months : Group C : CLAs 2.5 g equivalent to 2 g mixture of cis 9-trans 11 and trans 10-cis12 CLAs in a rate of 50/50 ; Group E : vitamin E : 400 mg ; Group CE : CLAs and vitamin E at above doses : Group P : placebo . After supplementation , SBP levels decreased significantly in the group C in comparison with groups E and P and mean arterial pressure reduced significantly in groups C and CE . There were n’t significant differences in the levels of prostagl and in E2 ( PGE2 ) , triglycerides , cholesterol , low-density lipoprotein cholesterol ( LDL-C ) , high-density lipoprotein cholesterol ( HDL-C ) , LDL/HDL , cholesterol/HDL , fasting blood sugar , C-reactive protein ( CRP ) , arylestrase activity , platelet count and body mass index between groups . CRP dropped nonsignificantly in groups P , C , E and CE ( 19 % , 24 % , 55 % , and 39 % , respectively ) . Erythrocytes sedimentation rate levels decreased in groups C , E and CE ( P ≤ 0.05 , P ≤ 0.05 , P ≤ 0.001 , respectively ) . It is concluded that supplementation of CLAs decreased BP and vitamin E decreased CRP . Therefore cosupplementation of CLAs and vitamin E might be profitable for heart disease prevention in RA patients We examined the effects of high-dosage vitamin E treatment over a 12-month period on the vascular reactivity of micro- and macrocirculation and left ventricular function in diabetic patients . Subjects ( n = 89 ) were r and omized to vitamin E ( 1,800 IU daily ) or placebo and were followed for 12 months . High-resolution ultrasound images were used to measure the flow-mediated dilation ( FMD ; endothelium dependent ) and nitroglycerin-induced dilation ( NID ; endothelium independent ) of the brachial artery . Laser Doppler perfusion imaging was used to measure vascular reactivity in the forearm skin . Left ventricular function was evaluated using transthoracic echocardiogram . At the end of the 6-month period , a worsening in endothelium-dependent skin vasodilation ( P = 0.02 ) and rise in endothelin levels ( P = 0.01 ) were found in the vitamin E compared with the placebo group . At the end of the 12-month period , a worsening was observed in NID ( P = 0.02 ) and a marginal worsening was seen in systolic blood pressure ( P = 0.04 ) and FMD ( P = 0.04 ) in the vitamin E compared with the placebo group . In addition C-reactive protein levels decreased marginally in the vitamin E compared with the placebo group ( P = 0.05 ) . No changes were observed in left ventricular function . We concluded that long-term treatment with 1,800 IU of vitamin E has no beneficial effects on endothelial or left ventricular function in diabetic patients . Because vitamin E-treated patients had a worsening in some vascular reactivity measurements when compared with control subjects , the use of high dosages of vitamin E can not be recommended OBJECTIVES We examined the effects of oral administration of vitamin E , an antioxidant , on endothelium-dependent vasodilation in patients with coronary spastic angina . BACKGROUND We have recently reported that endothelium-dependent vasodilation is impaired in patients with coronary spastic angina ( CSA ) . Furthermore , it is known that oxidative stress may play an important role in the impairment of endothelium-dependent vasodilation in cardiovascular diseases . METHODS With the ultrasound technique , flow-dependent vasodilation of the brachial arteries during reactive hyperemia was examined before and after treatment for a month with either oral administration of vitamin E ( alpha-tocopherol acetate , 300 mg/day ) or placebo , which is r and omly assigned , in patients with CSA ( n=60 ) . RESULTS Before treatment , \n Output:\n " }, { "from": "agent", "value": "Overall , there were no significant effects on DBP and MAP .\nThis meta- analysis suggested that vitamin E supplements decreased only SBP and had no favorable effect on DBP and MAP" } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: & NA ; Given the lack of objective physical measures for assessing fibromyalgia syndrome ( FS ) , the role of pain assessment is particularly important . The role of psychological factors is controversial among FS patients . This study was design ed to better underst and the relationship between pain behaviors and psychological variables . Specifically , this study ( 1 ) refined a pain behavior observation ( PBO ) methodology for use with FS patients , ( 2 ) determined whether stretching is a valid pain behavior,(3 ) assessed whether psychological variables including self‐efficacy and /or depression can predict pain behaviors after controlling for disease severity and age . The 73 FS subjects meeting the American College of Rheumatology classification system completed question naires measuring self‐efficacy , depression , and pain . Trained physicians conducted tender‐point examinations . Subjects were videotaped using a st and ardized procedure . Two trained raters independently coded all pain behaviors . Kappa coefficients and correlations among pain behaviors and self‐reported pain indicated that the PBO method was both reliable and valid . However , the newly defined pain behavior ‘ stretching ’ was found to be negatively associated with self‐reported pain . Hierarchical multiple regression ( MR ) analyses revealed that depression did not predict pain behavior over and above myalgic scores and age ; however , in 3 separate MR analyses , self‐efficacy for function , pain , and other symptoms each predicted pain behavior over and above myalgic scores and age . This study indicated that the original pain behavior scoring methodology is appropriate for use with the FS population and should not be modified to include the pain behavior ‘ stretching ’ . Self‐efficacy was related to pain behavior while depression was not among this FS sample & NA ; It has been shown that a person 's mood can influence pain tolerance . Films have been used as a means of inducing a desired mood . The effect on pain perception of film type and film length to induce mood was investigated . Previous research with brief humorous films had not indicated any unique advantage of humor over distraction approaches . Other recent research had indicated that after exposure to film stimulation there is a need to wait approximately 40 min before physiological changes can be obtained . Thus , the present study varied both film type and length and introduced a 30‐min waiting period following the mood induction via film prior to exposure to cold‐pressor pain . Two hundred subjects in nine different groups participated in the study . Three types of films were used : ( 1 ) humorous , ( 2 ) holocaust , ( 3 ) neutral . Three lengths of each type were also used : 15 min , 30 min , and 45 min . In addition , a tenth no‐film group served as a control for the effects of a film . Each subject was given a baseline trial of cold‐pressor pain , a trial immediately following the film and a trial 30 min later . Results indicated an advantage in increased pain tolerance for the humorous film and an increased pain tolerance for the longer film regardless of type only after the 30‐min waiting period . Results were discussed from a pain theoretical perspective with emphasis placed on returning to psychological manipulations of the sensory aspects of pain and not just the cognitive/emotional/motivational dimensions OBJECTIVE To evaluate the Stress Process Model proposed by Pearlin and colleagues by examining the role of personal and social re sources in mediating the relationship between the rheumatoid arthritis ( RA ) related stressors of functional disability , pain , and flares , and the outcome of depressive symptoms . METHODS Data are from 285 patients who participated in a study of the natural history of RA , comorbidity and depression . Measures include the Center for Epidemiologic Studies -Depression ( CES-D ) scale , the Arthritis Impact Measurement Scale Functioning and Pain scales , the Lubben Social Network scale , and items indicating sociodemographic status , health status and personal re sources . A series of hierarchical regression analyses with multiplicative interaction terms were conducted . RESULTS Substantial consistency between the Stress Process Model and relationships observed in the data was demonstrated . CONCLUSION Although no cl aim is made to having demonstrated that the observed relationships are causal , the fact that the data are consistent with the model invites a prospect i ve analysis in which the ordering of the variables over time can be established unambiguously . Because of the implication s of the Stress Process Model for the design of psychosocial interventions , such a test is especially important Although patients with chronic pain are often psychologically distressed , it has been difficult to determine whether this distress is an antecedent of chronic pain or whether it is caused by the experience of living with chronic pain . The aim of this investigation was to develop a method that would allow individuals who are at risk for the development of chronic pain to be studied before their pain has become chronic . Patients with acute herpes zoster were assessed with demographic , medical , pain , and psychosocial measures . Pain was assessed in follow-up interviews at 6 weeks and 3 , 5 , 8 , and 12 months after these initial assessment s. There were no significant differences between patients who developed short-term herpes zoster pain and patients who did not develop short-term pain for any of the measures at the initial assessment , except for one measure of pain intensity . Patients who developed chronic herpes zoster pain , however , had significantly greater pain intensity , higher state and trait anxiety , greater depression , lower life satisfaction , and greater disease conviction at the initial assessment than patients who did not develop chronic pain . In discriminant analyses , disease conviction , pain intensity , and state anxiety each made a unique contribution to discriminating patients who did and who did not develop chronic pain . This study demonstrates the feasibility of investigating psychosocial antecedents of the development of chronic pain by prospect ively examining the longitudinal course of herpes zoster & NA ; This report examined first onset rates of 5 common pain symptoms and assessed , on a prospect i ve basis , whether depressive symptoms at baseline were associated with onset risks . Adult Health Maintenance Organization ( HMO ) enrollees ( n = 1016 ) were interviewed in 1986 about their history of each of 5 pain conditions ( back pain , severe headache , chest pain , abdominal pain and temporom and ibular disorder ( TMD ) pain ) . Three years later , this sample was re‐interviewed ( n = 803 ) to measure site‐specific first onset rates . The Symptom Checklist 90‐Revised ( SCL‐90‐R ) Depression scale was administered at baseline and at 3 year follow‐up . Over the three year follow‐up interval , rates of first onset were : 17.7 % for back pain ; 4.2 % for severe headache ; 3.0 % for chest pain ; 3.1 % for abdominal pain ; and 6.5 % for TMD pain . Onset rates of persistent pain and of chronic pain dysfunction were substantially lower , but over 1 % experienced onset of chronic pain dysfunction for back pain and for headache . There were not significant differences in onset rates of back pain , abdominal pain or TMD pain by severity or chronicity of depressive symptoms . Relative to the non‐depressed , persons with moderate‐to‐severe depressive symptoms were more likely to develop headache and chest pain ( adjusted odds ratios of 1.7 to 5.0 ) . For headache and chest pain , onset risks were highest among the chronically depressed . After adjusting for age , gender , education and depression severity , persons with a pain condition at baseline were more likely to report first onset of a new pain condition over the follow‐up period ( adjusted odds ratios of 2.1 for back pain , 4.3 for headache , 1.4 for chest pain , 6.3 for abdominal pain and 3.7 for TMD pain ) . Thus , presence of a pain condition was a more consistent predictor of subsequent risks of developing a new pain condition than was the severity or chronicity of depressive symptoms . Possible explanations for this relationship are considered The relationship between pain perception and emotional states is well known . However , the nature of this relationship and how different emotional states affect sensory and cognitive dimensions of pain remains uncertain . Results from experimental investigations are often contradictory , which may be due to method ological difficulties in inducing pain and monitoring physiological responses . In addition , most studies have focused on a single emotion , and data on the relative effects of different emotional states are lacking . In the present study we attempted to eliminate some of these method ological problems . Laser evoked potentials were used as a quantitative correlate to pain perception and were measured in 12 highly hypnotically susceptible subjects during seven conditions : ( a ) a prehypnotic baseline condition ; ( b ) a neutral hypnotic control condition ; ( c-e ) hypnotically recalled anger , fear , and depression in r and omized order ; ( f ) a hypnotically recalled happy condition , and ( g ) a posthypnotic awake control condition . The pain evoked potentials were significantly decreased in the angry condition and significantly increased in the depressed condition compared with baseline . No differences could be detected for either the happy or the fear-related condition compared with the baseline or neutral hypnotic condition . A significant positive correlation between the subjective intensity of depression and the increase in evoked potentials was found , but none for the other three emotions . The results support earlier findings that clinical depression is related to increased pain perception , and findings that the expression of anger can inhibit the experience of pain . ( ABSTRACT TRUNCATED AT 250 WORDS & NA ; In a homogeneous sample of 20 healthy male students , the analgesic effects of the tricyclic antidepressant imipramine ( 100 mg ) were compared to those of the narcotic meperidine ( 150 mg ) and a further tricyclic compound with assumed analgesic properties ( fluradoline , 450 mg ) . Drugs were orally administered , using a placebo controlled , double‐blind repeated measures Latin Square design . Phasic pain was induced by intracutaneous electrical shocks with r and om intensities and interstimulus intervals . Each stimulus block consisted of 80 stimuli and lasted for 20 min . Pain estimates , somatosensory evoked cerebral potentials ( SSEPs ) and power spectral density of the electroencephalogram ( EEG ) were measured under each drug condition . Under placebo , pain ratings and SSEP amplitudes were constant within the entire session lasting for approximately 4 h. Meperidine analgesia was evident within 30 min of drug application , reaching a maximum after about 90 min . Imipramine produced a comparable degree of pain reduction , however , with a delay of 2 h. Under both drugs , the decrease in pain ratings was accompanied by decreased amplitudes of the late components of the SSEP , as well as by a reduction in alpha activity and an enhancement of slow EEG waves . Effects of fluradoline on experimental pain could not be affirmed . These findings are discussed in terms of pain relief and decrease in vigilance \n Output:\n " }, { "from": "agent", "value": "Depressed subjects are less likely to perceive a sensory stimulus as being painful compared with nondepressed controls .\nThe influence of depression on attention to the pain stimulus may account for this effect ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: Background No quantitative data on glenohumeral translation exist allowing one to distinguish insufficiency of the active or passive stabilizers in different forms of shoulder instability . Hypothesis To determine whether 1 ) in traumatic or atraumatic shoulder instability an increase of glenohumeral translation can be observed in specific relevant arm positions , 2 ) muscle activity leads to recentering of the humeral head , and 3 ) there exist differences between traumatic and atraumatic instability . Study Design Prospect i ve clinical trial . Methods In 12 patients with traumatic and 10 patients with atraumatic instability , both shoulders were examined in different arm positions — with and without muscle activity — by using open magnetic resonance imaging and a three-dimensional postprocessing technique . Results At 90 ° of abduction and external rotation , translation ( anterior-inferior ) was significantly higher in patients with traumatic unstable shoulders compared with their contralateral side ( 3.6 ± 1.5 versus 0.7 ± 1.6 mm ) . In patients with atraumatic instability , significantly increased translation ( 4.7 ± 2.0 mm ) was observed , with the direction being nonuniform . Muscle activity led to significant recentering in traumatic but not in atraumatic instability . Conclusions In traumatic instability , increased translation was observed only in functionally important arm positions , whereas intact active stabilizers demonstrate sufficient recentering . In atraumatic instability , a de central ized head position was recorded also during muscle activity , suggesting alterations of the active stabilizers . Clinical Relevance Clinical Relevance : These data are relevant for optimizing diagnostics and therapeutic strategies Most systematic review s rely substantially on the assessment of the method ological quality of the individual trials . The aim of this study was to obtain consensus among experts about a set of generic core items for quality assessment of r and omized clinical trials ( RCTs ) . The invited participants were experts in the field of quality assessment of RCTs . The initial item pool contained all items from existing criteria lists . Subsequently , we reduced the number of items by using the Delphi consensus technique . Each Delphi round comprised a question naire , an analysis , and a feedback report . The feedback report included staff team decisions made on the basis of the analysis and their justification . A total of 33 international experts agreed to participate , of whom 21 completed all question naires . The initial item pool of 206 items was reduced to 9 items in three Delphi rounds . The final criteria list ( the Delphi list ) was satisfactory to all participants . It is a starting point on the way to a minimum reference st and ard for RCTs on many different research topics . This list is not intended to replace , but rather to be used alongside , existing criteria lists BACKGROUND AND PURPOSE Assessment of the quality of r and omized controlled trials ( RCTs ) is common practice in systematic review s. However , the reliability of data obtained with most quality assessment scales has not been established . This report describes 2 studies design ed to investigate the reliability of data obtained with the Physiotherapy Evidence Data base ( PEDro ) scale developed to rate the quality of RCTs evaluating physical therapist interventions . METHOD In the first study , 11 raters independently rated 25 RCTs r and omly selected from the PEDro data base . In the second study , 2 raters rated 120 RCTs r and omly selected from the PEDro data base , and disagreements were resolved by a third rater ; this generated a set of individual rater and consensus ratings . The process was repeated by independent raters to create a second set of individual and consensus ratings . Reliability of ratings of PEDro scale items was calculated using multirater kappas , and reliability of the total ( summed ) score was calculated using intraclass correlation coefficients ( ICC [ 1,1 ] ) . RESULTS The kappa value for each of the 11 items ranged from.36 to.80 for individual assessors and from.50 to.79 for consensus ratings generated by groups of 2 or 3 raters . The ICC for the total score was.56 ( 95 % confidence interval=.47-.65 ) for ratings by individuals , and the ICC for consensus ratings was.68 ( 95 % confidence interval=.57-.76 ) . DISCUSSION AND CONCLUSION The reliability of ratings of PEDro scale items varied from \" fair \" to \" substantial , \" and the reliability of the total PEDro score was \" fair \" to \" good . Descriptive studies have shown that shoulder complaints can be persistent and recurrent , requiring long term evaluation of treatment.1 Unfortunately , in most r and omised studies comparing treatments for shoulder complaints the study period varies from a few weeks ( trials of non-steroidal anti-inflammatory drugs ) to 3 - 6 months ( injection therapy and physiotherapy trials).2–4 ) In a trial in 1994 - 5 of treatment of shoulder complaints in general practice we showed that in a study period of 11 weeks , injection therapy with a corticosteroid was superior to physiotherapy and manipulative therapy in the patients whose complaints originated from the structures of the glenohumeral joint , the subacromial space , or the acromioclavicular joint ( synovial group).5 In the patients whose complaints related to functional disorders of the cervical spine , the upper thoracic spine , or the adjoining ribs ( shoulder girdle group ) , manipulation was superior to physiotherapy . To assess the various treatments in A method for directly measuring the position of the humeral head on the face of the glenoid in different positions of abduction of the arm was developed . We studied three subject groups : 12 patients with normal shoulders ( group 1 ) , 15 patients with stage II impingement syndrome ( group 2 ) , and 20 patients with rotator cuff tears or stage III impingement ( group 3 ) . The study consisted of a series of anteroposterior roentgenograms in the plane of the scapula with the arm in neutral rotation . Roentgenograms were obtained at 20 degrees intervals as the arm was elevated in the plane of the scapula from 0 degree to 120 degrees . Patients held a weight equal to 2 1/2 % of body weight in the h and . The parameters measured were excursion of the humeral head on the glenoid face , expressed as the distance that the center of the head lies above or below the center of the glenoid , arm angle , scapulothoracic angle , and glenohumeral angle . For patients with normal shoulders ( group 1 ) , there was no significant change in position of the humeral head with arm elevation . In contrast , those with stage II impingement ( group 2 ) had significant ( p < 0.05 ) superior displacement of the center of the humeral head with arm elevation . Patients with rotator cuff tears ( group 3 ) demonstrated a significant rise ( p < 0.05 ) during the first 40 degrees of abduction . The average position of the humeral head in the two pathologic patient groups was superior ( p < 0.05 ) to the average head position in the normal patient group . There was no significant difference in head position between patients with stage II impingement and patients with rotator cuff tear . The ratio of the glenohumeral angle to the scapulothoracic angle during abduction was calculated for our patient groups . In both patient groups , arm abduction had a larger scapulothoracic component than for normal shoulders . The superior migration of the humeral head is a probable result of cuff failure , either partial or complete \n Output:\n " }, { "from": "agent", "value": "Evidence , however , indicated that not only the passive , but also the active and control subsystems of the shoulder may need to be considered when determining the direction of the translational gliding of the HOH ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: I SHALL discuss the combination of estimates of relative prevalence or incidence , commonly referred to as relative risk , obtained from retrospective 2 X 2 tables . Barnet Woolf ' described the method in 1954 and J. B. S. Haldane2 introduced some modifications shortly afterward in the Annals of Human Genetics . Figure 1 shows how retrospective case and control data may be classified . There are usually some background classes based on age , sex , race , occupation , and the like . Within each such class , individuals are further classified into a 2 X 2 table according to the presence or absence of the disease being studied and the presence or absence of a defined characteristic of focal interest . For any single 2 X 2 table , Cornfield3 has shown a simple way to estimate the risk of disease among those wvith the characteristic , relative to the risk of disease among those without the characteristic . This is done , as illustrated below Figure 1 , by taking the ratio of diagonal products of the cell frequencies . This is a maximum likelihood estimate of the relative risk of disease in the parent population , provided that it is assumed that the cases and controls have been selected at r and om and that cases comprise a negligible portion of the population . It is also possible to obtain a combined , unconditioned , maximum likelihood estimate of relative risk based on all of the 2 X 2 tables . However , the method is time-consuming , involving the iterative solution of sets of quadratic equations . Unless such a method is programed for the computer , I feel that the less tedious procedure to be described is adequate for most practical purpose s. Strictly speaking , the maximum likelihood estimate just described has infinite bias and it is positively skewed . To help remedy these defects , the number , 1/2 , is added to each cell frequency before obtaining the ratio of diagonal products ; furthermore , the natural logarithm of this ratio is taken . The result ing value is an estimate of natural log relative risk . Woolf pointed out that the logarithmic transformation tends to remove skew and Haldane showed that of all possible numbers which might be added to or subtracted from the cell frequencies , 1/2 is the number which reduces the bias of the estimate to a minimum . This estimate of log relative risk is shown in the first column of Figure 2 . The estimated Background The approximately 1100 medical journals now active in China are publishing a rapidly increasing number of research reports , including many studies identified by their authors as r and omized controlled trials . It has been noticed that these reports mostly present positive results , and their quality and authenticity have consequently been called into question . We investigated the adequacy of r and omization of clinical trials published in recent years in China to determine how many of them met acceptable st and ards for allocating participants to treatment groups . Methods The China National Knowledge Infrastructure electronic data base was search ed for reports of r and omized controlled trials on 20 common diseases published from January 1994 to June 2005 . From this sample , a subset of trials that appeared to have used r and omization methods was selected . Twenty-one investigators trained in the relevant knowledge , communication skills and quality control issues interviewed the original authors of these trials about the participant r and omization methods and related quality -control features of their trials . Results From an initial sample of 37,313 articles identified in the China National Knowledge Infrastructure data base , we found 3137 apparent r and omized controlled trials . Of these , 1452 were studies of conventional medicine ( published in 411 journals ) and 1685 were studies of traditional Chinese medicine ( published in 352 journals ) . Interviews with the authors of 2235 of these reports revealed that only 207 studies adhered to accepted methodology for r and omization and could on those grounds be deemed authentic r and omized controlled trials ( 6.8 % , 95 % confidence interval 5.9–7.7 ) . There was no statistically significant difference in the rate of authenticity between r and omized controlled trials of traditional interventions and those of conventional interventions . R and omized controlled trials conducted at hospitals affiliated to medical universities were more likely to be authentic than trials conducted at level 3 and level 2 hospitals ( relative risk 1.58 , 95 % confidence interval 1.18–2.13 , and relative risk 14.42 , 95 % confidence interval 9.40–22.10 , respectively ) . The likelihood of authenticity was higher in level 3 hospitals than in level 2 hospitals ( relative risk 9.32 , 95 % confidence interval 5.83–14.89 ) . All r and omized controlled trials of pre-market drug clinical trial were authentic by our criteria . Of the trials conducted at university-affiliated hospitals , 56.3 % were authentic ( 95 % confidence interval 32.0–81.0 ) . Conclusion Most reports of r and omized controlled trials published in some Chinese journals lacked an adequate description of r and omization . Similarly , most so called ' r and omized controlled trials ' were not real r and omized controlled trials owing toa lack of adequate underst and ing on the part of the authors of rigorous clinical trial design . All r and omized controlled trials of pre-market drug clinical trial included in this research were authentic . R and omized controlled trials conducted by authors in high level hospitals , especially in hospitals affiliated to medical universities had a higher rate of authenticity . That so many non-r and omized controlled trials were published as r and omized controlled trials reflected the fact that peer review needs to be improved and a good practice guide for peer review including how to identify the authenticity of the study urgently needs to be developed OBJECTIVE To determine whether clinical trials originating in certain countries always have positive results . DATA SOURCES Abstract s of trials from Medline ( January 1966-June 1995 ) . STUDY SELECTION Two separate studies were conducted . The first included trials in which the clinical outcome of a group of subjects receiving acupuncture was compared to that of a group receiving placebo , no treatment , or a nonacupuncture intervention . In the second study , r and omized or controlled trials of interventions other than acupuncture that were published in China , Japan , Russia/USSR , or Taiwan were compared to those published in Engl and . DATA EXTRACTION Blinded review ers determined inclusion and outcome and separately classified each trial by country of origin . DATA SYNTHESIS In the study of acupuncture trials , 252 of 1085 abstract s met the inclusion criteria . Research conducted in certain countries was uniformly favorable to acupuncture ; all trials originating in China , Japan , Hong Kong , and Taiwan were positive , as were 10 out of 11 of those published in Russia/USSR . In studies that examined interventions other than acupuncture , 405 of 1100 abstract s met the inclusion criteria . Of trials published in Engl and , 75 % gave the test treatment as superior to control . The results for China , Japan , Russia/USSR , and Taiwan were 99 % , 89 % , 97 % , and 95 % , respectively . No trial published in China or Russia/USSR found a test treatment to be ineffective . CONCLUSIONS Some countries publish unusually high proportions of positive results . Publication bias is a possible explanation . Research ers undertaking systematic review s should consider carefully how to manage data from these countries BACKGROUND We conducted a r and omized study to determine whether any of three chemotherapy regimens was superior to cisplatin and paclitaxel in patients with advanced non-small-cell lung cancer . METHODS A total of 1207 patients with advanced non-small-cell lung cancer were r and omly assigned to a reference regimen of cisplatin and paclitaxel or to one of three experimental regimens : cisplatin and gemcitabine , cisplatin and docetaxel , or carboplatin and paclitaxel . RESULTS The response rate for all 1155 eligible patients was 19 percent , with a median survival of 7.9 months ( 95 percent confidence interval , 7.3 to 8.5 ) , a 1-year survival rate of 33 percent ( 95 percent confidence interval , 30 to 36 percent ) , and a 2-year survival rate of 11 percent ( 95 percent confidence interval , 8 to 12 percent ) . The response rate and survival did not differ significantly between patients assigned to receive cisplatin and paclitaxel and those assigned to receive any of the three experimental regimens . Treatment with cisplatin and gemcitabine was associated with a significantly longer time to the progression of disease than was treatment with cisplatin and paclitaxel but was more likely to cause grade 3 , 4 , or 5 renal toxicity ( in 9 percent of patients , vs. 3 percent of those treated with cisplatin plus paclitaxel ) . Patients with a performance status of 2 had a significantly lower rate of survival than did those with a performance status of 0 or 1 . CONCLUSIONS None of four chemotherapy regimens offered a significant advantage over the others in the treatment of advanced non-small-cell lung cancer PURPOSE This r and omized trial was design ed to determine whether paclitaxel plus carboplatin ( PC ) offered a survival advantage over vinorelbine plus cisplatin ( VC ) for patients with advanced non -- small-cell lung cancer . Secondary objectives were to compare toxicity , tolerability , quality of life ( QOL ) , and re source utilization . PATIENTS AND METHODS Two hundred two patients received VC ( vinorelbine 25 mg/m(2)/wk and cisplatin 100 mg/m(2)/d , day 1 every 28 days ) and 206 patients received PC ( paclitaxel 225 mg/m(2 ) over 3 hours with carboplatin area under the curve of 6 , day 1 every 21 days ) . Patients completed QOL question naires at baseline , 13 weeks , and 25 weeks . Re source utilization forms were completed at five time points through 24 months . RESULTS Patient characteristics were similar between the groups . The objective response rate was 28 % in the VC arm and 25 % in the PC arm . Median survival was 8 months in both arms , with 1-year survival rates of 36 % and 38 % , respectively . Grade 3 and 4 leukopenia ( P = .002 ) and neutropenia ( P = .008 ) occurred more frequently on the VC arm . Grade 3 nausea and vomiting were higher on the VC arm ( P = .001 , P = .007 ) , and grade 3 peripheral neuropathy was higher on the PC arm ( P < .001 ) . More patients on the VC arm discontinued therapy because of toxicity ( P = .001 ) . No difference in QOL was observed . Overall costs on the PC arm were higher than on the VC arm because of drug costs . CONCLUSION PC is equally efficacious as VC for the treatment of advanced non -- small-cell lung cancer . PC is less toxic and better tolerated but more expensive than VC . New treatment strategies should be pursued OBJECTIVE To observe the clinical therapeutic effect and mechanism of Yiqi Yangyin Jiedu Decoction ( YYJD , a Chinese herbal recipe for strengthening qi , nourishing yin and removing toxic substance , consisting of milkvetch root 30 g , glehnia root 30 g , asparagus root 15 g , lilyturf root 15 g , grossy privet fruit 12 g , spikemoss herb 30 g , Chinese sage herb 30 g , manyleaf paris rhizome 30 g , etc . ) in treating patients with advanced nonsmall cell lung cancer ( NSCLC ) . METHODS Sixty patients with advanced lung cancer of qi-yin deficiency syndrome were r and omized into three groups : the TCM group ( A ) treated with YYJD , the chemotherapy group ( B ) treated by chemotherapy with NP or GP protocol , and the combined treated group ( C ) treated with YYJD and chemotherapy in combination . The efficacy was evaluated after two cycles of treatment . RESULTS The total effective rate for alleviating qi-yin deficiency syndrome in group A was 80 % , significantly higher than that in Group C and B ( 35 % and 20 % , P < 0.01 ) respectively . The KPS increasing and stabilizing rate in Group A and C was 90 % and 85 % respectively , significantly higher than that in Group B ( 75 % ) , and difference between A and B was significant ( P < 0.05 ) . In Group C after treatment , CD(3)+ showed a rising trend ( P = 0.05 ) , different to that in Group A and B ( P < 0.05 and P < 0.01 ) ; CD(4)+ significantly increased ( P < 0.05 ) and CD(4)+/CD(8)+ ratio showed increasing trend ( P = 0.06 ) , while in Group B both were decreased significantly , showed significantly difference ( P < 0.05 ) . CD(8)+ CD(28)+ significantly increased after treatment in Group A and C ( P < 0.01 and P < 0.05 ) , but showed decreasing trend ( P = 0.06 ) in Group B , significant difference was shown between B and C ( P < 0.05 ) . CONCLUSION YYJD can ameliorate the qi-yin deficiency syndrome evidently in advance lung cancer patients ; improve their quality of life , the mechanism might be by way of enhancing T-lymphocyte activity and killer T-cell function , to elevate the T-cell mediated immunity in a round way OBJECTIVE To observe the regulatory effect of Jianpi Wenshen Recipe ( JPWS ) , a Chinese herbal preparation for strengthening Pi and warming Shen , combined with chemotherapy on the level of estradiol ( E2 ) in patients with mid-late non-small cell lung cancer ( NSCLC ) , and to analyse the relationship between the changes of estradiol and tumor size . METHODS Fifty-one NSCLC patients were r and omized into three groups : 1 \n Output:\n " }, { "from": "agent", "value": "We found a large treatment effect of adding astragalus-based herbal treatment to st and ard chemotherapy regimens ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: Exposure to unhealthy food marketing stimulates children 's food consumption . A child 's responsiveness is influenced by individual factors , result ing in an increased vulnerability to advertising effects among some children . Whether these differential responses may be altered by different parental feeding behaviours is unclear . The purpose of this study was to determine the relationship between parental feeding practice s and children 's food intake responses to food advertising exposure . A r and omised , crossover , counterbalanced , within subject trial was conducted across four , six-day holiday camps in New South Wales , Australia between April 2016 and January 2017 with 160 children ( 7 - 12 years , n = 40/camp ) . Children were r and omised to either a multiple media ( TV and Internet ) or single media ( TV ) condition and exposed to food ( 3 days ) and non-food ( 3 days ) advertising in an online game and /or a cartoon . Children 's food consumption ( kilojoules ( kJ ) ) was measured at a snack immediately after advertising exposure and then at lunch later in the day . Parents completed the Child Feeding Question naire , and ' restriction ' and ' pressure to eat ' subscale scores were calculated . While food advertising affected all children in the multiple media condition , there was an increased effect on snack intake among children whose parents reported pressuring them to eat , with children consuming an additional 356 kJ after food advertising compared with non-food advertising . This was 209 kJ more than children whose parents did not pressure them to eat . In the single media condition , only children whose parents reported restrictive feeding practice s ate more at lunch on food advertising days than non-food advertising days ( 240 kJ ) . These data highlight an increased susceptibility to food advertising among children whose parents report controlling feeding practice The weight of evidence points to the advertising of food affecting food consumption , especially among children . Such advertising often promotes unhealthy foods . Current policy deliberations focus on developing effective ' protective ' messages to increase advertising literacy and consequent scepticism about advertising targeting children . This study examined whether incorporating a ' protective ' message in an advergame promoting energy-dense snacks would reduce children 's snack intake . A r and omized between-subject design was conducted in the Netherl and s ( N = 215 ) and Spain ( N = 382 ) with an advergame promoting either energy-dense snacks or nonfood products . The results showed that playing an advergame promoting energy-dense snacks increased caloric intake in both countries , irrespective of whether the ' protective ' message was present or not . These results point to the limitations of ' protective ' messages and advertising literacy and provide policy makers with a rationale for extending the current prohibition of food advertising to young children in the terrestrial media to online environments Background / Objective : Exposure to food advertisements may cue overeating among children , especially among those genetically predisposed to respond to food cues . We aim ed to assess how television food advertisements affect eating in the absence of hunger among children in a r and omized trial . We hypothesized that the fat mass and obesity-associated gene ( FTO ) rs9939609 single-nucleotide polymorphism would modify the effect of food advertisements . Subjects/ Methods : In this r and omized experiment , 200 children aged 9–10 years were served a st and ardized lunch and then shown a 34-min television show embedded with either food or toy advertisements . Children were provided with snack food to consume ad libitum while watching the show and we measured caloric intake . Children were genotyped for rs9939609 and analyses were conducted in the overall sample and stratified by genotype . A formal test for interaction of the food advertisement effect on consumption by rs9939609 was conducted . Results : About 172 unrelated participants were included in this analysis . Children consumed on average 453 ( s.d.=185 ) kcals during lunch and 482 ( s.d.=274 ) kcals during the experimental exposure . Children who viewed food advertisements consumed an average of 48 kcals ( 95 % confidence interval : 10 , 85 ; P=0.01 ) more of a recently advertised food than those who viewed toy advertisements . There was a statistically significant interaction between genotype and food advertisement condition ( P for interaction=0.02 ) , where the difference in consumption of a recently advertised food related to food advertisement exposure increased linearly with each additional FTO risk allele , even after controlling for body mass index percentile . Conclusions : Food advertisement exposure was associated with greater caloric consumption of a recently advertised food , and this effect was modified by an FTO genotype . Future research is needed to underst and the neurological mechanism underlying these associations Background Policies restricting children ’s exposure to unhealthy food marketing have been impeded by the lack of evidence showing a direct link between food advertising exposure and children ’s energy intake and body weight . Food advertising exposure increases children ’s immediate food consumption , but whether this increased intake is compensated for at later eating occasions is not known ; consequently the sustained effect on diets remains unclear . Methods We conducted a within-subject , r and omised , crossover , counterbalanced study across four , six-day holiday camps in New South Wales , Australia between April 2016 and January 2017 . Children ( 7–12 years , n = 160 ) were recruited via local schools , email networks and social media . Two gender- and age-balanced groups were formed for each camp ( n = 20 ) , r and omised to either a multiple- or single- media condition and exposed to food and non-food advertising in an online game and /or a television cartoon . Children ’s food consumption ( kilojoules ) was measured at a snack immediately after exposure and then at lunch later in the day . Linear mixed models were conducted to examine relationships between food advertising exposure and dietary intake , taking into account gender , age and weight status . Results All children in the multiple-media condition ate more at a snack after exposure to food advertising compared with non-food advertising ; this was not compensated for at lunch , leading to additional daily food intake of 194 kJ ( 95 % CI 80–308 , p = 0.001 , d = 0.2 ) . Exposure to multiple-media food advertising compared with a single-media source increased the effect on snack intake by a difference of 182 kJ ( 95 % CI 46–317 , p = 0.009 , d = 0.4 ) . Food advertising had an increased effect among children with heavier weight status in both media groups . Conclusion Online ( ‘ advergame ’ ) advertising combined with TV advertising exerted a stronger influence on children ’s food consumption than TV advertising alone . The lack of compensation at lunch for children ’s increased snack intake after food advertising exposure suggests that unhealthy food advertising exposure contributes to a positive energy-gap , which could cumulatively lead to the development of overweight . Trial registration Australian New Zeal and Clinical Trials Registry , number ACTRN12617001230347 ( Retrospectively registered ) OBJECTIVE To assess the effects of reducing television viewing and computer use on children 's body mass index ( BMI ) as a risk factor for the development of overweight in young children . DESIGN R and omized controlled clinical trial . SETTING University children 's hospital . PARTICIPANTS Seventy children aged 4 to 7 years whose BMI was at or above the 75th BMI percentile for age and sex . INTERVENTIONS Children were r and omized to an intervention to reduce their television viewing and computer use by 50 % vs a monitoring control group that did not reduce television viewing or computer use . MAIN OUTCOME MEASURES Age- and sex-st and ardized BMI ( z BMI ) , television viewing , energy intake , and physical activity were monitored every 6 months during 2 years . RESULTS Children r and omized to the intervention group showed greater reductions in targeted sedentary behavior ( P < .001 ) , z BMI ( P < .05 ) , and energy intake ( P < .05 ) compared with the monitoring control group . Socioeconomic status moderated z BMI change ( P = .01 ) , with the experimental intervention working better among families of low socioeconomic status . Changes in targeted sedentary behavior mediated changes in z BMI ( P < .05 ) . The change in television viewing was related to the change in energy intake ( P < .001 ) but not to the change in physical activity ( P = .37 ) . CONCLUSIONS Reducing television viewing and computer use may have an important role in preventing obesity and in lowering BMI in young children , and these changes may be related more to changes in energy intake than to changes in physical activity BACKGROUND : Preschoolers in the United States are heavily exposed to unhealthy food advertisements . Whether such exposure promotes cued eating has not been documented in this age group . METHODS : R and omized experiment among 60 children , aged 2 to 5 years , recruited in 2015–2016 from New Hampshire and Vermont . Children completed the experiment at a behavioral laboratory . Children were provided with a healthy snack to consume upon arrival then r and omized to view a 14-minute TV program embedded with advertisements for either a food or a department store . Children were provided 2 snack foods to consume ad libitum while viewing the TV program ; 1 of those snacks was the food advertised . Eating in the absence of hunger ( EAH ) was operationalized as the kilocalories of snack foods consumed . t tests were used to compare EAH by advertisement condition ; linear regression models assessed effect modification by the child ’s age , sex , BMI percentile , and parental feeding restriction . RESULTS : Mean age was 4.1 ( SD 0.9 ) years , 55 % of children were male , 80 % were non-Hispanic white , and 20 % were overweight or obese . There were no differences in child or socioeconomic characteristics by advertisement condition . Child BMI was not related to EAH . Mean kilocalories consumed during the EAH phase was greater among children exposed to the food advertisements ( 126.8 , SD : 58.5 ) versus those exposed to the nonfood advertisements ( 97.3 , SD : 52.3 ; P = .04 ) , an effect driven by greater consumption of the advertised food ( P < .01 ) . There was no evidence of effect modification . CONCLUSIONS : Findings suggest that food advertisement exposure may encourage obesogenic-eating behaviors among the very young BACKGROUND Previous studies have focused on the effects of television advertising on the energy intake of children . However , the rapidly changing food-marketing l and scape requires research to measure the effects of nontraditional forms of marketing on the health-related behaviors of children . OBJECTIVES The main aim of this study was to examine the effect of advergames that promote energy-dense snacks or fruit on children 's ad libitum snack and fruit consumption and to examine whether this consumption differed according to br and and product type ( energy-dense snacks and fruit ) . The second aim was to examine whether advergames can stimulate fruit intake . DESIGN We used a r and omized between-subject design with 270 children ( age : 8 - 10 y ) who played an advergame that promoted energy-dense snacks ( n = 69 ) , fruit ( n = 67 ) , or nonfood products ( n = 65 ) or were in the control condition ( n = 69 ) . Subsequently , we measured the free intake of energy-dense snacks and fruit . The children then completed question naire measures , and we weighed and measured them . RESULTS The main finding was that playing an advergame containing food cues increased general energy intake , regardless of the advertised br and or product type ( energy-dense snacks or fruit ) , and this activity particularly increased the intake of energy-dense snack foods . Children who played the fruit version of the advergame did not eat significantly more fruit than did those in the other groups . CONCLUSION The findings suggest that playing advergames that promote food , including either energy-dense snacks or fruit , increases energy intake in children OBJECTIVE Recent research offers conflicting views of whether women high in dietary restraint are inspired or demoralized after viewing thin-ideal images . We conducted two studies to explore the impact of diet commercials featuring the thin-ideal image on snack food consumption . METHOD In Study 1 , 91 high school women watched a sad movie interrupted with diet or neutral commercials . In Study 2 , 102 college women saw diet commercials early or midway through a sad movie . RESULTS In Study 1 , high restraint participants consumed more snacks after exposure to diet commercials than to neutral commercials . In Study 2 , early commercials reduced snacking in low restraint women but not in high restraint women . DISCUSSION Thin-ideal images embedded in diet commercials do not inspire high restraint women but can modify the eating of low restraint women BACKGROUND AND OBJECTIVES : Previous studies have focused on the effect of food advertisements on the caloric intake of children . However , the role of individual susceptibility in this effect is unclear . The aim of this study was to examine the role of impulsivity in the effect of advergames that promote energy-dense snacks on children ’s snack intake . METHODS : First , impulsivity scores were assessed with a computer task . Then a r and omized between-subject design was conducted with 261 children aged 7 to 10 years who played an advergame promoting either energy-dense snacks or nonfood products . As an extra manipulation , half of the children in each condition were rewarded for refraining from eating , the other half were not . Children could eat freely while playing the game . Food intake was measured . The children then \n Output:\n " }, { "from": "agent", "value": "Findings from nonexperimental studies revealed that exposure to TV food advertising was positively associated with and predictive of dietary intake in children .\nShort-term exposure to unhealthy food advertising on TV and advergames increases immediate calorie consumption in children" } ]