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MS22300	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: OBJECTIVE The relationship between cognition and outcome in people with schizophrenia has been established in studies that , for the most part , examined chronic patients and were cross-sectional in design . The purpose of this study was to analyze the relationships between neurocognitive variables assessed at illness onset and functional outcome in a longitudinal design . An additional area of interest was whether the severity of negative symptoms would predict outcome independently from neurocognitive variables or whether there would be an overlap in their predictive power . METHOD The authors administered a comprehensive cognitive battery and clinical assessment s to 99 subjects who were in their first episode of illness and analyzed the relationship of cognition and symptom severity at intake with community outcome after an average follow-up period of 7 years . RESULTS Verbal memory , processing speed and attention , and the severity of negative symptoms at intake were related to subsequent outcome . Global psychosocial functioning was predicted by negative symptoms and attention . Verbal memory was the significant predictor of the degree of impairment in recreational activities . Impairment in relationships was predicted by negative symptoms and memory , whereas attention and negative symptoms were predictive of work performance . There was an overlap in the variance in outcome explained by cognitive variables and negative symptoms . CONCLUSIONS Verbal memory and processing speed and attention are potential targets for psychosocial interventions to improve outcome . Results from cross-sectional or chronic patient studies do not necessarily correspond to the findings of this prospect i ve first-episode study in which cognition appears to explain less of the variance in outcome Neurocognitive deficits are believed to be important predictors of functional outcome in chronic psychotic disorders , but few supporting studies have utilized prospect i ve design s and adequate control . The aim of this study was to estimate the relative influence of symptoms and neurocognitive deficits on the development of social behavior skills in a cohort of individuals with schizophrenia or schizoaffective disorder recovering from acute symptom exacerbations . Forty-six individuals were recruited upon discharge from an inpatient unit and completed assessment s of symptoms , neurocognitive function , and social behavior at 3-month intervals for 1 year . Correlational analyses and r and om regression models were used to model social behavioral capacities longitudinally . Social behavior improved modestly ( 10 % improvements in ratings ) over the follow-up period for the group as a whole . Disorganized and negative symptoms , as well as neurocognitive deficits in short-term and working memory predicted changes in social behavior over time . Individuals with better working memory function showed significantly greater abilities to recover social behavior skills , whereas those with working memory deficits showed no functional improvement over time . Both symptoms and neurocognitive deficits are important determinants of functional outcome in schizophrenia . It is proposed that clinicians should consider neurocognitive thresholds for treatment response when developing rehabilitation plans Social functioning deficits ( e.g. , social skill , community functioning ) are a core feature of schizophrenia . These deficits are only minimally improved via the frontline treatments for schizophrenia ( e.g. medication , social skills training , cognitive-behavioral therapy ) . Social cognition is a promising treatment target in this regard as it may be more strongly related to social functioning outcomes than traditional neurocognitive domains [ Couture , S. , Penn , D.L. , Roberts , D.L. , 2006 . The functional significance of social cognition in schizophrenia : a review . Schizophrenia Bulletin ( Suppl . 1 ) , S-44 - 63 ] . Social cognition and interaction training ( SCIT ) is a 20-week , manualized , group treatment design ed to improve social functioning in schizophrenia by way of improved social cognition . This article reports preliminary data from a quasi-experimental study comparing SCIT + treatment as usual ( TAU ; n=20 ) to TAU alone ( n=11 ) among out patients . Results using analysis of variance ( ANOVA ) suggest SCIT-related improvements in emotion perception and social skill UNLABELLED Biosocial models are preeminent in the study of schizophrenia , yet there has been little empirical testing of these models . OBJECTIVE This study provided the first test of a biosocial causal model of functional outcome in schizophrenia , using neurocognition , social cognition , social competence and social support as predictors of both global and specific domains of functional outcome . METHOD The design used baseline variables to predict both concurrent functional status and prospect i ve 12-month functional outcome . Subjects were recruited upon admission to outpatient community-based psychosocial rehabilitation programs shown in previous studies to be effective in improving functional outcomes . 139 individuals diagnosed with schizophrenia or schizoaffective disorder participated in the study ; 100 participants completed the 12-month assessment s. Face-to-face interviews assessed neurocognitive functioning ( with five neuropsychological measures ) , social cognition ( as perception of emotion ) , social competence , social support , and functional outcome which consisted of items covering the domains of social , independent living , and work functioning . RESULTS Path analysis modeling showed that the proposed biosocial models had strong fit with the data , for both concurrent and 12-month global functional outcomes , with fit indices ranging from .95 to .98 . The model explained 21 % of the variance in concurrent global functional outcome , and 14 % of the variance in 12-month prospect i ve outcome . CONCLUSIONS The support for this model was strong , and it has implication s for underst and ing the causal factors related to functional outcome , as well as for intervention strategies for improving functional outcomes in schizophrenia Deficits in the ability to perceive facial and vocal emotion expression are common in schizophrenia . However , relatively little is known about how such deficits might affect functional outcomes . This prospect i ve study examined cross-sectional and longitudinal relationships between perception of emotion and aspects of psychosocial functioning , including family relationships , social relationships , work functioning , and independent living/self-care in 94 clinical ly stabilized schizophrenia out patients from five community-based rehabilitation programs . Emotion perception ( facial emotion , voice emotion , and affect perception ) and psychosocial outcome ( Strauss and Carpenter Outcome Scale and Role Functioning Scale ) were assessed at baseline and after 12 months of psychosocial rehabilitation . Significant associations were found between perception of emotion and work functioning/independent living both cross-sectionally and prospect ively over the 12 months . Causal explanatory models suggested that perception of emotion might cause work functioning/independent living outcome over 1 year . The results remained significant when conceptual disorganization was statistically controlled . We did not find differences between men and women in the correlations between emotion perception and work functioning/independent living . Associations between social functioning/family relationships and perception of emotion were not significant . These findings suggest that emotion processing is a key determinant of work functioning/independent living for individuals with serious mental illness The purpose of this study was to assess how neurocognition and social cognition were associated with initial functional level and with rates of functional change in intensive community-based psychosocial rehabilitation interventions that have been shown to yield significant functional change for individuals diagnosed with schizophrenia . We also examined how service intensity was associated with rates of change and whether it served as a moderator of the relationship between functional change and both neurocognition and social cognition . The sample consisted of 125 individuals diagnosed with schizophrenia or schizoaffective disorder who were recruited upon admission to 1 of 4 community-based psychosocial rehabilitation facilities and were followed prospect ively for 12 months . One hundred and two subjects completed the 12-month protocol . The findings suggested that ( i ) the initial level of psychosocial functioning was related to both social cognition and neurocognition at baseline , ( ii ) when significant rehabilitative change occurs , higher neurocognition and social cognition scores at baseline predicted higher rates of functional change over the subsequent 12 months , ( iii ) greater service intensity was related to higher rates of improvement in functional outcome over time , and ( iv ) service intensity moderated the relationship between neurocognition and initial functional level and moderated the relationship between social cognition and the rates of functional change at a trend level . These findings have relevance to our underst and ing of the heterogeneity in functional rehabilitative outcomes , to our underst and ing of the conditions of rehabilitative change and for the design of psychosocial interventions in the community This study examined whether frontal-system impairments in schizophrenia occur independently of one another and whether they have distinct implication s for information processing , symptom severity , and adaptive functioning . We assessed 26 medication-free schizophrenic out patients and 18 normal control subjects on eight frontally mediated tasks , semantic information processing , IQ , the BPRS , and long-term psychosocial adaptation . Schizophrenic subjects showed three types of deficits , which were uncorrelated with one another : ( 1 ) Executive dysfunction ( inflexible problem solving ) was related to decreased use of expectancy during controlled semantic priming , lower intelligence , more severe negative symptoms and stereotyped mannerisms . ( 2 ) Disinhibition of responses ( to irrelevant stimuli ) was associated with increased automatic priming , a trend for more severe hallucinations , and was unrelated to intelligence . ( 3 ) Motor dyscoordination ( inaccurate , dysfluent motor sequencing ) was not related to semantic processing , intelligence , or symptoms . Furthermore , all three impairments were unrelated to generalized slowness , age , sex , illness length , or pre-washout neuroleptic dose . Two deficits accounted for aspects of long-term psychosocial adaptation , even after statistical correction for IQ : Executive dysfunction was associated with younger illness onset , poor purpose fulness and planning , impaired social relations , and lower global functioning . Motor dyscoordination was associated with poor treatment outcome and restricted educational advancement . Furthermore , executive and motor deficits interacted significantly ; subjects who had both deficits showed the least favorable treatment outcome . These findings are neither consistent with generalized impairment nor with a unitary ' frontal syndrome ' in schizophrenia . They provide preliminary evidence for at least three frontal-system deficits ( dorsolateral , orbital , and premotor ) , which are dissociable from one another , can occur without general intellectual impairment , and have distinct implication s for long-term adaptive functioning The purpose of this cross-sectional study was to examine the relationships between neurocognitive deficits and quality of life for patient with schizophrenia . Fifty-seven schizophrenic out patients ( 38 men and 19 women ) were assessed for neurocognitive deficits using the Wisconsin Card Sorting Test ( WCST ) and all patients completed the PCASEE ( P = physical , C = cognitive , A = affective , S = social , E = economic-social , and E = ego functions ) question naire to assess their quality of life . We assessed psychiatric symptoms using the Schedule for the Assessment of Positive Symptoms ( SAPS ) and the Schedule for the Assessment of Negative Symptoms ( SANS ) . We rated the Abnormal Involuntary Movement Scale ( AIMS ) for extrapyramidal side effects . Pearson correlational analyses were conducted to assess the relationships among measures of quality of life , neurocognitive functioning , symptoms , and extrapyramidal side effects . There were significant relationships among the total score of the PCASEE question naire and the SANS total score and the AIMS total score ( P<.001 ) . Small but significant associations were found among the total score of the PCASEE question naire and the SAPS total score and a number of nonperseverative errors ( P<.05 ) . Negative symptoms and extrapyramidal side effects in schizophrenia appear to have direct impact on the patient 's perceived quality of life BACKGROUND Deficits in social cognition and neurocognition are believed to underlie schizophrenia disability . Attempts at rehabilitation have had circumscribed effects on cognition , without concurrent improvement in broad aspects of behavior and adjustment . OBJECTIVE To determine the differential effects of cognitive enhancement therapy ( a recovery-phase intervention ) on cognition and behavior compared with state-of-the-art enriched supportive therapy . DESIGN A 2-year , r and omized controlled trial with neuropsychological and behavioral assessment s completed at baseline and at 12 and 24 months . SETTING An outpatient research clinic housed in a medical center 's comprehensive care service for patients with severe mental illness . PATIENTS A total of 121 symptomatically stable , non-substance-abusing but cognitively disabled and chronically ill patients with schizophrenia or schizoaffective disorder . INTERVENTIONS Cognitive enhancement therapy is a multidimensional , developmental approach that integrates computer-assisted training in neurocognition with social cognitive group exercises . Enriched supportive therapy fosters illness management through applied coping strategies and education . MAIN OUTCOME MEASURES Six highly reliable summary measures --Processing Speed , Neurocognition , Cognitive Style , Social Cognition , Social Adjustment and Symptoms -- were tested using analysis of covariance and linear trend analysis . RESULTS At 12 months , robust cognitive enhancement therapy effects were observed on the Neurocognition and Processing Speed composites ( P<.003 ) , with marginal effects observed on the behavioral composites . By 24 months , differential cognitive enhancement therapy effects were again observed for the 2 neuropsychological composites and for Cognitive Style ( P=.001 ) , Social Cognition ( P=.001 ) , and Social Adjustment ( P=.01 ) . As expected , no differences were observed on the residual Symptoms composite . Effects were unrelated to the type of antipsychotic medication received . Enriched supportive therapy also demonstrated statistically significant within-group effect sizes , suggesting that supportive psychotherapy can also have positive , although more modest , effects on cognitive deficits . CONCLUSION Many cognitive deficits and related behav Output:	Overall , social cognition was more strongly associated with community functioning than neurocognition , with the strongest associations being between theory of mind and functional outcomes .
MS22301	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: The study evaluated the proportion of patients whose pituitary gl and s respond with a sharp decrease in luteinizing hormone ( LH ) levels when exposed to a conventional dose of 0.25 mg gonadotropin releasing hormone ( GnRH ) antagonist in a prospect i ve , single-center , non-r and omized , proof-of-concept study . Fifty women eligible for in vitro fertilization ( IVF ) received recFSH ( Gonal-F ) from day 2 or 3 of menstrual period . Basal estradiol , progesterone , and LH were measured on the same day and 4 - 5 days later–-immediately before GnRH antagonist 0.25 mg administration , and 24 hours after its administration . Responders were defined as “ normal ” if 24 hours after the first GnRH antagonist injection , LH level was ≥50 % of the pre-injection level and as “ over-suppressed ” if it was < 50 % of the pre-injection level . Twelve patients ( 26 % of the total ) were “ over-suppressed ” with a mean LH level of 37 % of the level 24 hours earlier . These patients also demonstrated a significant decrease in estradiol rise during the first 24 hours after initial antagonist administration . This effect was reversed for the rest of the stimulation period during which recLH ( Luveris , 150 IU/day ) was added to the “ over-suppressed . ” If proven advantageous in terms of pregnancy rate , this approach to individualized treatment would be easy to implement . Trial registration : Clinical Trials.gov Identifier : NCT01936077 BACKGROUND The role of LH in sensitizing antral follicles to FSH is unclear . LH is required for normal hormone production and normal oocyte and embryo development , but follicular responses to LH may depend upon the stage of development . Potential roles at the early follicular phase were explored in a clinical setting by employing a sequential approach to stimulation by recombinant human ( r-h ) LH followed by r-hFSH in women who were profoundly down-regulated by depo GnRH agonist . METHODS We employed a multi-centre , prospect i ve , r and omized approach . Women ( n = 146 ) were treated in a long course high-dose GnRH agonist ( Decapeptyl , 4.2 mg s.c . ) protocol and were r and omized to receive r-hLH ( Luveris , 300 IU/day ) for a fixed 7 days , or no r-hLH treatment . This was followed by a st and ard r-hFSH stimulation regime ( Gonal-F , 150 IU/day ) . Ultrasound and hormone assessment s of responses were measured at the start of r-hLH treatment , on FSH stimulation Days 0 and 8 and at the time of HCG administration . RESULTS The LH treatment was associated with increased small antral follicles prior to FSH stimulation ( P = 0.007 ) , and an increased yield of normally fertilized ( 2 PN ) embryos ( P = 0.03 ) . There was no influence of the r-hLH pretreatment upon hormone profiles or ultrasound assessment s during the FSH phase . Anti-mullerian hormone increased in both groups during the week prior to FSH stimulation ( P = 0.002 ) . CONCLUSIONS This sequential approach to the use of r-hLH in st and ard IVF showed a possible modest clinical benefit . The results support other recent work exploring up-regulated and rogen drive upon follicular metabolism indicating that clinical benefit may be obtainable after further practical explorations of the concept The impact of suppressed concentrations of circulating luteinizing hormone ( LH ) during ovarian stimulation on the outcome of in-vitro fertilization or intracytoplasmic sperm injection treatment in 200 consecutive , normogonadotrophic women ( couples ) was analysed retrospectively . A st and ard stimulation protocol with mid-luteal gonadotrophin-releasing hormone ( GnRH ) agonist down-regulation and ovarian stimulation with recombinant follicle stimulating hormone ( FSH ) was used in all cases . Blood was sample d from each woman on stimulation days 1 and 8 for analysis of oestradiol and LH in serum . A threshold value of serum LH of 0.5 IU/l on stimulation day 8 ( S8 ) was chosen to discriminate between women with low or ' normal ' LH concentrations . Low concentrations of LH on S8 ( < 0.5 IU/l ) were found in 49 % ( 98/200 ) of the women . This group of women was comparable with the normal LH group with regard to pre-treatment clinical parameters , and to the parameters characterizing the stimulation protocol with the exception of serum oestradiol concentration , which on S8 was significantly lower than in the normal LH group ( P < 0.001 ) . The proportion of positive pregnancy tests was similar in the two groups ( 30 % versus 34 % per started cycle ) , but the final clinical treatment outcome was significantly different , with a five-fold higher risk of early pregnancy loss ( 45 % versus 9 % ; P < 0.005 ) in the low LH group and consequently a significantly poorer chance of delivery than in the normal LH group . It is concluded that a substantial proportion of normogonadotrophic women treated with GnRH agonist down-regulation in combination with FSH , devoid of LH activity , experience LH suppression , which compromises the treatment outcome . Whether these women would benefit from supplementation with recombinant LH or human menopausal gonadotrophin during ovarian stimulation , remains to be proven in the future by prospect i ve r and omized trials A multicentre , open-label , r and omized study of the gonadotrophin-releasing hormone ( GnRH ) antagonist ganirelix ( Orgalutran((R))/Antagon((TM ) ) ) was performed in women undergoing ovarian stimulation with recombinant FSH ( rFSH : Puregon((R ) ) ) . The study was design ed as a non-inferiority study using a long protocol of buserelin ( intranasal ) and rFSH as a reference treatment . A total of 730 subjects was r and omized in a treatment ratio of 2:1 ( ganirelix : buserelin ) using an interactive voice response system which stratified for age , type of infertility and planned fertilization procedure [ IVF or intracytoplasmic sperm injection ( ICSI ) ] . The median duration of GnRH analogue treatment was 5 days in the ganirelix group and 26 days in the buserelin group , whereas the median total rFSH dose was 1500 IU and 1800 IU respectively . In addition , in the ganirelix group the mean duration of stimulation was 1 day shorter . During ganirelix treatment the incidence of LH rises ( LH > /=10 IU/l ) was 2.8 % versus 1.3 % during rFSH stimulation in the buserelin group . On the day of triggering ovulation by human chorionic gonadotrophin ( HCG ) , the mean number of follicles > /=11 mm diameter was 10.7 and 11.8 , and the median serum oestradiol concentrations were 1190 pg/ml and 1700 pg/ml in the ganirelix and buserelin groups respectively . The mean number of oocytes per retrieval was 9.1 and 10.4 respectively , whereas the mean number of good quality embryos was 3.3 and 3.5 respectively . The fertilization rate was equal in both groups ( 62.1 % ) , and the same mean number of embryos ( 2.2 ) was replaced . The mean implantation rates were 15.7 % and 21.8 % , and the ongoing pregnancy rates per attempt were 20.3 % and 25.7 % in the ganirelix and buserelin groups respectively . Evaluation of all safety data indicated that the ganirelix regimen was safe and well tolerated . The overall incidence of ovarian hyperstimulation syndrome was 2.4 % in the ganirelix group and 5.9 % in the reference group . The results of this study support a safe , short and convenient treatment regimen of ganirelix , result ing in a good clinical outcome for patients undergoing ovarian stimulation for IVF or ICSI Although the fundamental significance of both LH and FSH for adequate ovarian folliculogenesis and steroidogenesis has been extensively discussed , the clinical implication of recombinant ( r ) LH to rFSH for ovarian stimulation employing the GnRH antagonist protocol remains to be eluci date d. The aim of this prospect i ve r and omized controlled study was to explore whether rLH supplementation to rFSH following GnRH antagonist has an added value to the late follicular ovarian steroidogenesis in the advanced reproductive aged women OBJECTIVE To analyze the impact of LH administration on cycle outcome in ovarian stimulation with GnRH antagonists . DESIGN R and omized , open-label , controlled trial performed in two age subgroups . Recombinant ( r ) FSH versus rFSH + rLH administration was compared . SETTING University-affiliated private infertility clinic . PATIENT(S ) Up to 35 years old ( n = 380 ) and aged 36 to 39 years ( n = 340 ) , undergoing their first or second IVF cycle . INTERVENTION(S ) Recombinant LH administration since stimulation day 1 . MAIN OUTCOME MEASURE(S ) Implantation rate , ongoing pregnancy rate . RESULT ( S ) In the young population , implantation rates were similar : 27.8 % versus 28.6 % , odds ratio ( OR ) 1.03 ( 95 % confidence interval [ CI ] 0.73 - 1.47 ) , as was the ongoing pregnancy rate per started cycle : 37.4 % versus 37.4 % , OR 1.0 ( 95 % CI 0.66 - 1.52 ) . In older patients , the implantation rate was significantly higher in the rFSH + rLH group : 26.7 % versus 18.6 % , OR 1.56 ( 95 % CI 1.04 - 2.33 ) . Ongoing pregnancy rates per started cycle were 33.5 % versus 25.3 % , OR 1.49 ( 95 % CI 0.93 - 2.38 ) . CONCLUSION ( S ) Recombinant LH administration significantly increased the implantation rate in patients aged 36 to 39 years . A clinical ly relevant better ongoing pregnancy rate per started cycle was observed , although the difference was not statistically significant . Patients younger than 36 years do not obtain any benefit from rLH administration OBJECTIVE To evaluate clinical and endocrinological effects of intranasal ( IN ) vs. subcutaneous ( SC ) GnRH-a for pituitary down-regulation combined with hMG vs. rFSH . DESIGN Prospect i ve , r and omized study . SETTING University hospital , IVF unit . PATIENT(S ) Three hundred seventy-nine normogonadotropic women eligible for IVF or ICSI . INTERVENTION(S ) R and omization to intranasal ( IN ) or SC GnRH-a and to hMG or rFSH . MAIN OUTCOME MEASURE(S ) Oocytes retrieved , embryos developed , clinical pregnancy , and delivery rates . Serum hormone concentrations on stimulation days 1 ( S1 ) and 8 ( S8 ) , and oocyte pick-up ( OPU ) day . RESULT ( S ) After r and omization , four groups were formed : IN/hMG ( n = 100 ) , IN/FSH ( n = 98 ) , SC/hMG ( n = 89 ) , and SC/FSH ( n = 92 ) . Mean number of oocytes retrieved and of transferable and transferred embryos were similar in the four groups . Clinical pregnancy rate per started cycle was significantly higher in the IN/HMG group than in the SC/FSH group ( P<.05 ) and was intermediate in the two remaining groups . Se-LH on S8 in the two SC groups was significantly lower than in the two IN groups . Se-E2 on S8 in the SC/FSH group was significantly lower than in the other three groups . CONCLUSION ( S ) The clinical and endocrinological outcome in IVF and ICSI-treated normogonadotropic women is significantly influenced by mode of down-regulation as well as gonadotropin formulation OBJECTIVE To investigate the role of exogenous LH in controlled ovarian hyperstimulation for assisted reproductive technologies . DESIGN Prospect i ve r and omized study . SETTING SISMER fertility unit . PATIENT(S ) Women showing a hyporesponsiveness to FSH under GnRH agonist down-regulation were r and omized into three groups : group A ( n = 54 ) received an increased dosage of FSH ; group B ( n = 54 ) was administered recombinant LH in addition to the increased dose of FSH ; group C ( n = 22 ) was given additional FSH and LH using hMG as a combined drug . Fifty-four age-matched women with no need to increase the FSH dose were included as a control group ( D ) . INTERVENTION(S ) None . MAIN OUTCOME MEASURE(S ) Implantation and live birth rate per started cycles . RESULT ( S ) In group B , the pregnancy and implantation rates were statistically higher when compared with groups A and C and did not differ from the control group for normal response . The live birth rate Output:	RESULTS Evidence exists to show that rLH supplementation seems to have added value for pregnancy achievement in women with poor ovarian response and in women ≥35 years of age employing the GnRH agonist protocol , while the evidence is still debatable when the GnRH antagonist is administered . In the general infertile population , rLH supplementation does not have added value in the GnRH-antagonist cycles while the evidence is still controversial when the GnRH agonist is employed . An accurate definition of the LH threshold in GnRH analogue treated cycles may contribute to the discussion of which subgroups of women may benefit from adjuvant rLH therapy
MS22302	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: BACKGROUND Growth in normal and malignant tissues has been linked to hyperinsulinemia and insulin-like growth factors ( IGFs ) . We hypothesized that IGF and IGF-binding protein ( IGFBP ) responses may be acutely affected by differences in the glycemic index ( GI ) of foods . OBJECTIVE We compared the postpr and ial responses of IGFs and IGFBP to 2 foods of similar macronutrient composition but with greatly different GIs-pearled barley ( GI : 25 ) and instant mashed potato ( GI : 85 ) . DESIGN Ten young lean subjects consumed 50-g carbohydrate portions of the 2 foods or water ( extended fast ) in r and om order after an overnight fast . Capillary blood was collected at regular intervals over 4 h for measurement of blood glucose , insulin , and components of the IGF system . RESULTS Serum IGFBP-1 declined markedly after both meals , but the mean ( + /-SEM ) change at 4 h was significantly ( P < 0.01 ) more prolonged after the low-GI meal ( -55 + /- 20 ng/mL ) than after the high-GI meal ( -13 + /- 15 ng/mL ) . Conversely , the change in serum IGFBP-3 concentration at 4 h was significantly ( P < 0.05 ) higher after the low-GI meal ( 251 + /- 102 ng/mL ) than after the high-GI meal ( -110 + /- 96 ng/mL ) ; the same pattern was observed at 2 h. Changes in IGFBP-2 , free IGF-1 , and total IGF-1 responses were minimal and did not differ significantly from those during the 4-h fast . CONCLUSION Acute changes in IGFBP-3 after low-GI and high-GI foods may provide a biologic mechanism linking cell multiplication with greater consumption of high-GI carbohydrates Reliable tables of glycemic index ( GI ) compiled from the scientific literature are instrumental in improving the quality of research examining the relation between GI , glycemic load , and health . The GI has proven to be a more useful nutritional concept than is the chemical classification of carbohydrate ( as simple or complex , as sugars or starches , or as available or unavailable ) , permitting new insights into the relation between the physiologic effects of carbohydrate-rich foods and health . Several prospect i ve observational studies have shown that the chronic consumption of a diet with a high glycemic load ( GI x dietary carbohydrate content ) is independently associated with an increased risk of developing type 2 diabetes , cardiovascular disease , and certain cancers . This revised table contains almost 3 times the number of foods listed in the original table ( first published in this Journal in 1995 ) and contains nearly 1300 data entries derived from published and unpublished verified sources , representing > 750 different types of foods tested with the use of st and ard methods . The revised table also lists the glycemic load associated with the consumption of specified serving sizes of different foods The determine the effect of different foods on the blood glucose , 62 commonly eaten foods and sugars were fed individually to groups of 5 to 10 healthy fasting volunteers . Blood glucose levels were measured over 2 h , and expressed as a percentage of the area under the glucose response curve when the same amount of carbohydrate was taken as glucose . The largest rises were seen with vegetables ( 70 + /- 5 % ) , followed by breakfast cereals ( 65 + /- 5 % ) , cereals and biscuits ( 60 + /- 3 % ) , fruit ( 50 + /- 5 % ) , dairy products ( 35 + /- 1 % ) , and dried legumes ( 31 + /- 3 % ) . A significant negative relationship was seen between fat ( p less than 0.01 ) and protein ( p less than 0.001 ) and postpr and ial glucose rise but not with fiber or sugar content To evaluate the role of nutritional factors in the etiology of endometrial cancer , we performed a case-cohort analysis using data from women enrolled in the National Breast Screening Study in Canada from 1980 to 1985 . For this analysis , a subcohort was constructed by selecting a 10 % r and om sample from the 56,837 women in the dietary cohort . Cases were the 221 women diagnosed with incident adenocarcinoma of the endometrium during follow-up to December 31 , 1993 and ascertained by record linkage to the Canadian Cancer Data base . Information on usual diet at enrolment and other epidemiological variables was collected by means of self-administered question naires . Hazard ratios were obtained from proportional hazards regression models , with estimation of robust st and ard errors . We found a strong association of endometrial cancer with body mass index > 25 kg/m2 ( hazard ratio 2.72 , 95 % CI : 2.06–3.50 ) . Endometrial cancer risk was not associated significantly with intakes of total energy , carbohydrates , proteins , total fat and major fatty acids , total dietary fiber and various types of fibers , vitamin C , E and A , folic acid , β-carotene , lutein , or cryptoxanthin . Some decrease in risk was noted with relatively high intakes of saturated fat , animal fat or lycopene . The associations observed in the study were independent of total energy intake and most non-dietary risk factors . The study suggests that dietary intakes of energy and most major nutrients are not related to the risk of endometrial cancer among Canadian women The quantification of errors inherent in methods of measuring dietary intake has been h and icapped by the absence of independent markers for testing their validity . The doubly labeled water technique permits a precise measure of energy expenditure in free-living persons . Because energy expenditure must equal energy intake in population s in energy balance , this technique may be used to vali date the assessment of energy intake . A series of studies demonstrated good agreement between mean energy intake and mean energy expenditure when food intake was recorded by observers or when it was self-reported by normal-weight , self-selected , highly motivated volunteer subjects using weighed records . However , in r and omly recruited men and women , energy intake by weighed records was 82 % and 81 % , of energy expenditure , respectively , indicating underestimation of habitual intake . Men and women in the lowest third of reported intake recorded energy expenditure of only 69 % and 61 % , respectively . Reported intake of obese and previously obese women was only 73 % and 64 % of expenditure , whether measured by weighed record or by diet history , confirming suspicions that these subjects misrepresented their intake . Acceptable weighed records were obtained from 7- and 9-year-olds whereas 15- and 18-year-olds underestimated intake . Diet histories taken from the same children tended to overestimate intake . These studies suggest that , ideally , all dietary studies should include independent measures of validity Insulin-like growth factor (IGF)–related hormones and binding proteins ( IGFBP ) have been implicated in cancer risk . Specifically , two recent , small prospect i ve studies reported a significant positive association between IGF-I and ovarian cancer risk among women diagnosed before age 55 years . Therefore , we examined whether plasma concentrations of IGF-I , IGFBP-3 , and IGFBP-2 were associated with risk of epithelial ovarian cancer in a nested case-control study using data from three prospect i ve cohorts : the Nurses ' Health Study ( NHS ) , NHSII , and the Women 's Health Study ( WHS ) . The present study had 222 cases ( 159 from NHS/NHSII and 63 from WHS ) and 599 controls ( matching ratio , 1:3 for NHS/NHSII and 1:2 for WHS ) . Women ranged in age from 34 to 73 years ( mean , 56 years ) . The relative risk ( RR ) comparing the top versus bottom quartile of IGF-I was 0.56 ( 95 % confidence interval , 0.32 - 0.97 ; Ptrend = 0.14 ) . The risk did not differ by age at diagnosis ( comparable RR for age < 55 years at diagnosis , 0.70 ; RR for age ≥55 years at diagnosis , 0.52 ) . We did not observe any association between IGFBP-3 , IGFBP-2 , and the ratio of IGF-I to either binding protein and ovarian cancer risk . Overall , our results do not support a positive association between IGF-related proteins and ovarian cancer risk . ( Cancer Epidemiol Biomarkers Prev 2007;16(8):1691–5 We conducted a case‐control study nested within the European Prospect i ve Investigation into Cancer and Nutrition , to examine the associations between prediagnostic serum concentrations of C‐peptide , insulin‐like growth factor binding protein (IGFBP)‐1 and IGFBP‐2 , and endometrial cancer risk . Among pre‐ and post‐menopausal women , who were not currently using exogenous hormones , 286 women developed incident endometrial cancer during an average 5.1 years follow‐up . Using risk set sampling , 555 matched control subjects were selected . In conditional logistic regression models adjusted for matching factors only , endometrial cancer risk increased with increasing serum levels of C‐peptide ( relative risks ( RR ) for the top vs. bottom quartile = 2.13 [ 95 % confidence interval ( CI ) 1.33–3.41 ] , ptrend = 0.001 , and decreasing serum levels of IGFBP‐2 ( RR for the top vs. bottom quartile = 0.56 [ 95 % CI 0.35–0.90 ] , ptrend = 0.03 , but was not significantly associated with IGFBP‐1 levels ( RR for the top vs. bottom quartile = 0.76 [ 95 % CI 0.47–1.21 ] , ptrend = 0.25 ) . In BMI ‐adjusted models , only the C‐peptide association remained marginally statistically significant ( RR for the top vs. bottom quartile = 1.56 [ 95 % CI 0.94–2.57 ] , ptrend = 0.05 for C‐peptide ; 0.84 [ 95 % CI 0.50–1.40 ] , ptrend = 0.74 for IGFBP‐2 ; and 1.08 [ 95 % CI 0.65–1.78 ] , ptrend = 0.86 for IGFBP‐1 levels ) . These associations were stronger among nonfasting women ( ≤≤6 hr since last meal ; 63 % of subjects ) but were not evident among fasting women , although the interactions were not statistically significant . The C‐peptide‐risk association was substantially attenuated after adjustment for free estradiol in postmenopausal women ( RR for the top vs. bottom quartile = 1.28 [ 95 % CI 0.67–2.45 ] , ptrend = 0.42 . Our results provide modest support to the hypothesis that hyperinsulinaemia is a risk factor for endometrial cancer . © 2007 Wiley‐Liss , The applicability of the glycaemic index ( GI ) in the context of mixed meals and diets is still debatable . The objective of the present study was to investigate the predictability of measured GI in composite breakfast meals when calculated from table values , and to develop prediction equations using meal components . Furthermore , we aim ed to study the relationship between GI and insulinaemic index ( II ) . The study was a r and omised cross-over meal test including twenty-eight healthy young men . Thirteen breakfast meals and a reference meal were tested . All meals contained 50 g available carbohydrate , but differed considerably in energy and macronutrient composition . Venous blood was sample d for 2 h and analysed for glucose and insulin . Prediction equations were made by regression analysis . No association was found between predicted and measured GI . The meal content of energy and fat was inversely associated with GI ( R(2 ) 0.93 and 0.88 , respectively ; P<0.001 ) . Carbohydrate content ( expressed as percentage of energy ) was positively related to GI ( R(2 ) 0.80 ; P<0.001 ) . Using multivariate analysis the GI of meals was best predicted by fat and protein contents ( R(2 ) 0.93 ; P<0.001 ) . There was no association between GI and II . In conclusion , the present results show that the GI of mixed meals calculated by table values does not predict the measured GI and furthermore that carbohydrates do not play the most important role for GI in mixed breakfast meals . Our prediction models show that the GI of mixed meals is more strongly correlated either with fat and protein content , or with energy content , than with carbohydrate content alone . Furthermore , GI was not correlated with II BACKGROUND There is some evidence that plasma insulin levels might influence ovarian cancer risk . Glycaemic index ( GI ) and glycaemic load ( GL ) are measures that allow the carbohydrate content of individual foods to be classified according to their postpr and ial glycaemic effects and hence their effects on circulating insulin levels . Therefore , we examined ovarian cancer risk in association with GI and GL , and intake of dietary carbohydrate and sugar . METHODS The study was conducted in a prospect i ve cohort of Output:	A high GL , but not a high GI , diet is positively associated with the risk of endometrial cancer , particularly among obese women
MS22303	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: Background . The local anaesthetics used in day-case spinal anaesthesia should provide short recovery times . We aim ed to compare hyperbaric prilocaine and bupivacaine in terms of sensory block resolution and time to home readiness in day-case spinal anaesthesia . Methods . Fifty patients undergoing perianal surgery were r and omized into two groups . The bupivacaine-fentanyl group ( Group B ) received 7.5 mg , 0.5 % hyperbaric bupivacaine + 20 μg fentanyl in total 1.9 mL. The prilocaine-fentanyl group ( Group P ) received 30 mg , 0.5 % hyperbaric prilocaine + 20 μg fentanyl in the same volume . Results . Time to L1 block and maximum block was shorter in Group P than in Group B ( Group P 4.6 ± 1.3 min versus Group B 5.9 ± 01.9 min , P = 0.017 , and Group P 13.2 ± 7.5 min versus Group B 15.3 ± 6.6 min , P = 0.04 ) . The time to L1 regression and S3 regression of the sensorial block was significantly shorter in Group P than in Group B ( 45.7 ± 21.9 min versus 59.7 ± 20.9 min , P = 0.024 , and 133.8 ± 41.4 min versus 200.4 ± 64.8 min , P < 0.001 ) . The mean time to home readiness was shorter for Group P than for Group B ( 155 ± 100.2 min versus 207.2 ± 62.7 min ( P < 0.001 ) ) . Conclusion . Day-case spinal anaesthesia with hyperbaric prilocaine + fentanyl is superior to hyperbaric bupivacaine in terms of earlier sensory block resolution and home readiness and the surgical conditions are comparable for perianal surgery BACKGROUND : In this prospect i ve , r and omized , double-blind study , we evaluated whether a very low dose of spinal bupivacaine could be sufficient for safe performance of short perianal surgery . METHODS : Eighty patients were r and omly assigned to receive hyperbaric bupivacaine doses of either 1.5 mg ( n = 40 ) or 6.0 mg ( n = 40 ) . RESULTS : The lower dose produced satisfactory anesthesia with a more limited block ( median S4 ; P < 0.01 ) , earlier time to ambulation ( 98 vs 147 min ; P < 0.01 ) , and hospital discharge ( 126 vs 249 min ; P < 0.01 ) , compared with the higher spinal dose . CONCLUSIONS : The use of 1.5 mg spinal bupivacaine can be successful for short perianal surgery Background : Spinal anesthesia for knee arthroscopy can be produced with a low dose of bupivacaine , but additional intrathecal drugs are often required to lower the risk of failed blocks . We investigated the effect of the addition of clonidine ( 0 , 15 or 30 μg ) to 5 mg hyperbaric bupivacaine on the duration of the motor block , analgesic quality and ability to void after the surgery in a r and omized controlled trial Background Given the current practice environment , it is important to determine the anesthetic technique with the highest patient acceptance and lowest associated costs . The authors compared three commonly used anesthetic techniques for anorectal procedures in the ambulatory setting . Methods Ninety-three consenting adult out patients undergoing anorectal surgery were r and omly assigned to one of three anesthetic treatment groups : group 1 received local infiltration with a 30-ml mixture containing 15 ml lidocaine , 2 % , and 15 ml bupivacaine , 0.5 % , with epinephrine ( 1:200,000 ) in combination with intravenous sedation using a propofol infusion , 25–100 & mgr;g · kg−1 · min−1 ; group 2 received a spinal subarachnoid block with a combination of 30 mg lidocaine and 20 & mgr;g fentanyl with midazolam , 1–2-mg intravenous bolus doses ; and group 3 received general anesthesia with 2.5 mg/kg propofol administered intravenously and 0.5–2 % sevoflurane in combination with 65 % nitrous oxide . In groups 2 and 3 , the surgeon also administered 10 ml of the previously described local anesthetic mixture at the surgical site before the skin incision . Results The mean costs were significantly decreased in group 1 ( $ 69 ± 20 compared with $ 104 ± 18 and $ 145 ± 25 in groups 2 and 3 , respectively ) because both intraoperative and recovery costs were lowest ( P < 0.05 ) . Although the surgical time did not differ among the three groups , the anesthesia time and times to oral intake and home-readiness were significantly shorter in group 1 ( vs. groups 2 and 3 ) . There was no significant difference among the three groups with respect to the postoperative side effects or unanticipated hospitalizations . However , the need for pain medication was less in groups 1 and 2 ( 19 % and 19%vs . 45 % for group 3;P < 0.05 ) . Patients in group 1 had no complaints of nausea ( vs. 3 % and 26 % in groups 2 and 3 , respectively ) . More patients in group 1 ( 68 % ) were highly satisfied with the care they received than in groups 2 ( 58 % ) and 3 ( 39 % ) . Conclusions The use of local anesthesia with sedation is the most cost-effective technique for anorectal surgery in the ambulatory setting BACKGROUND The effects of volume and baricity of spinal bupivacaine on block onset , height , duration , and hemodynamics were studied . METHODS Ninety patients undergoing endoscopic urologic procedures were r and omized to receive 10 mg of intrathecal bupivacaine at L2-L3 level in sitting position . In the operating room , commercial products were diluted as needed with NaCl 0.9 % to obtain isobaric solutions ( density , 1.005 - 1.008 ) or with NaC 10.9 % and glucose 30 % to obtain hyperbaric solutions ( density , 1.031 - 1.037 ) of 2 , 5 , or 10 ml ( six groups of 15 patients each ) . Three minutes after spinal injection the patients were placed in lithotomy position . Sensory blockade was assessed using pinprick and cold sensation tests , and motor blockade was assessed using a four-point scale . RESULTS Onset times to maximal cephalad spread of spinal blockade were similar with isobaric and hyperbaric solutions . A greater maximal cephalad spread of anesthesia was obtained with diluted isobaric bupivacaine but was not associated with more hypotension . Volume had no effect on cephalad extent of anesthesia with hyperbaric bupivacaine . Times for regression of anesthesia to L2 and offset of motor block were longer with isobaric than with hyperbaric solutions of bupivacaine . The intensity of motor blockade was decreased with diluted hyperbaric bupivacaine . No patient reported back pain . CONCLUSION In this study , volume had no significant influence on either cephalad spread or duration of sensory blockade for either isobaric or hyperbaric bupivacaine . Time for offset of anesthesia was shorter with hyperbaric bupivacaine compared with isobaric solutions This study investigated whether the addition of 25 μg fentanyl to an ultra-low ( sub-anaesthetic ) dose of intrathecal bupivacaine provides adequate anaesthesia for out-patient anorectal surgery , without increasing side-effects or delaying hospital discharge . Patients were r and omly allocated to receive 2.5 mg 0.5 % bupivacaine plus 25 μg fentanyl ( group BF , n = 18 ) or 5 mg 0.5 % bupivacaine alone ( group B , n = 17 ) . There were no significant differences in intra-operative outcomes , but mean recovery and discharge times were significantly shorter in group BF . There were no between-group differences in hypotension , bradycardia or respiratory depression and post-operative complications were comparable , apart from pruritus which was significantly more frequent in group BF . Fewer patients requested analgesic medication in the early post-operative period in group BF than in group B. In conclusion , 25 μg intrathecal fentanyl added to ultra-low dose ( 2.5 mg ) bupivacaine provided good- quality spinal anaesthesia and reduced post-operative analgesic requirement in patients undergoing ambulatory anorectal surgery The effect of adding epinephrine to small doses of spinal bupivacaine on the duration of sensory motor block has not been carefully investigated . Twelve volunteers underwent hyperbaric bupivacaine spinal anesthesia ( 7.5 mg ) with and without epinephrine ( 0.2 mg ) in a r and omized , double-blind , cross-over fashion . Sensory block was assessed with pinprick , transcutaneous electrical stimulation ( TES ) equivalent to surgical stimulation ( at umbilicus , pubis , knee , and ankle ) , and tolerance of a pneumatic thigh tourniquet . Motor block was assessed with isometric force dynamometry . Discharge criteria were defined as return of pinprick sensation to dermatome S2 , ability to ambulate , and ability to urinate . Extent of sensory block to pinprick over time was unaffected by the addition of epinephrine . However , epinephrine prolonged tolerance of TES at the pubis , knee , and ankle ( 33 - 48 min , P < 0.05 ) and of thigh tourniquet ( 30 min , P < 0.01 ) . Motor block was prolonged by epinephrine at the quadriceps and gastrocnemius muscles ( by 23 and 51 min , respectively , P < 0.002 ) . Achievement of discharge criteria was prolonged by 48 min by the addition of epinephrine ( P < 0.01 ) . Thus , epinephrine may prolong surgical anesthesia for lower abdominal and lower extremity surgery and delay time until patients achieve discharge criteria . Implication s : Using a cross-over study design , 12 volunteers underwent bupivacaine spinal anesthesia with and without epinephrine . This study suggests that adding epinephrine to bupivacaine may prolong surgical anesthesia and also delay patients ' discharge . ( Anesth Analg 1998;86:973 - 7 In 60 patients undergoing inguinal hernia repair , we compared the clinical profile of unilateral spinal anesthesia produced with either 8 mg of hyperbaric bupivacaine 0.5 % ( n = 20 ) , 8 mg of hyperbaric levobupivacaine 0.5 % ( n = 20 ) , or 12 mg of hyperbaric ropivacaine 0.5 % ( n = 20 ) . The study drug was injected slowly through a 25-gauge Whitacre directional needle and patients maintained the lateral decubitus position for 15 min . The onset time and intraoperative efficacy were similar in the three groups . The maximal level of sensory block on the operative and nonoperative sides was T6 ( T12–5 ) and L3 ( /[no sensory level detectable]–T4 ) with bupivacaine , T8 ( T12–5 ) and L3 ( /–T3 ) with levobupivacaine , T5 ( T10–2 ) and T11 ( /–T3 ) with ropivacaine ( P = 0.11 , P = 0.23 , respectively ) . Complete regression of spinal anesthesia occurred after 166 ± 42 min with ropivacaine , 210 ± 63 min with levobupivacaine , and 190 ± 51 min with bupivacaine ( P = 0.03 and P = 0.04 , respectively ) ; however , no differences were observed in time for home discharge ( 329 ± 89 min with bupivacaine , 261 ± 112 min with levobupivacaine , and 332 ± 57 min with ropivacaine [ P = 0.28 ] ) . We conclude that 8 mg of levobupivacaine or 12 mg of ropivacaine are acceptable alternatives to 8 mg of bupivacaine when limiting spinal block at the operative side for inguinal hernia repair Background : Combination of local anesthetic and opioid enables the use of less spinal anesthetic and increases the success of anesthesia . Intrathecal opioid does not prolong motor recovery and thus should not delay discharge home . We hypothesized that 3 mg of hyperbaric bupivacaine with 10 µg of fentanyl permits fast‐tracking or shorter stay in post anesthesia care unit ( PACU ) , and earlier discharge home , compared with 4 mg of hyperbaric bupivacaine Background : We undertook this study to ascertain if a small dose of clonidine ( 30 μg Output:	CONCLUSION Ambulatory surgery is possible under spinal anaesthesia with bupivacaine although the dose range that ensures reliable anaesthesia with duration short enough to guarantee ambulatory management is narrow
MS22304	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: BACKGROUND In the presence of a thin and narrow zone of gingival tissue root recessions caused by trauma or inflammatory reactions seem to be a common feature of the buccal tissue morphology . The surgical coverage is mainly indicated for aesthetic reasons and may be accomplished with pedicled flaps in conjunction with or without the use of connective tissue grafts . AIM The purpose of the present study was to evaluate the degree of vascularization of connective tissue grafts by applying a microsurgical approach . In addition , the clinical outcome was followed for 1 year . MATERIAL AND METHODS The study population consisted of 10 patients with bilateral Class I and II recessions at maxillary canines . In split-mouth design , the defects were r and omly selected for recession coverage either by a microsurgical ( test ) or macrosurgical ( control ) approach . Immediately after the surgical procedures , and after 3 and 7 days of healing , fluorescent angiograms were performed to evaluate graft vascularization . In addition , the clinical parameters were assessed before the surgical intervention , and 1 , 3 , 6 and 12 months postoperatively . RESULTS The results of the angiographic evaluation at test sites revealed a vascularization of 8.9+/-1.9 % immediately after the procedure . After 3 days and after 7 days , the vascularization rose to 53.3+/-10.5 % and 84.8+/-13.5 % , respectively . The corresponding vascularization at control sites were 7.95+/-1.8%/44.5+/-5.7 % and 64.0+/-12.3 % , respectively . All the differences between test and control sites were statistically significant . The clinical measurements revealed a mean recession coverage of 99.4+/-1.7 % for the test and 90.8+/-12.1 % for the control sites after the first month of healing . Again , this difference was statistically significant . The percentage of root coverage both test and control sites remained stable during the first year at 98 % and 90 % , respectively . CONCLUSIONS The present controlled clinical study has demonstrated that in root surface coverage , a microsurgical approach substantially improved the vascularization of the grafts and the percentages of root coverage compared with applying a conventional macroscopic approach The etiologic factors associated with crestal bone loss have not been comprehensively clarified . Several theories exist as to the reason for the observed changes in crestal bone height following implant restoration . In the 1990s , the wide-diameter implants were commercially introduced . Initially , the implants were restored with st and ard-diameter abutments because of lack of matching prosthetic components . Long-term radiographic follow-up of these ' platform-switched ' restored wide-diameter dental implants has demonstrated a smaller-than-expected vertical change in the crestal bone height around these implants that is typically observed around implants restored conventionally with prosthetic components of matching diameters . The aim of this r and omised controlled study was to assess radiographically marginal bone level alterations in implants restored according to the platform-switching concept compared with traditionally restored implants . Fifty-four subjects to participate in this r and omised controlled study were selected . Two groups were assigned at r and om : control group ( 56 implants were restored with st and ard matching-diameter abutments ) and test group ( 58 implants were restored with medialised abutments ) . X-ray explorations were taken for peri-implant bone level at the minute the last cementing of the prosthesis and at 1-year follow-up . NHI Image was used to digitally process and manipulate the radiographic images and perform the measurements . Mean of bone loss with platform-switching implants was -0·01 mm , and the mean of bone loss with st and ard platform implant was 0·42 mm . Outcomes of this study indicated that the platform-switching design could preserve the crestal bone levels to 1-year follow-up . There was a statistically significant difference in marginal bone loss PURPOSE To evaluate the influence of macro- and microstructure of the implant surface at the marginal bone level after functional loading . MATERIAL S AND METHODS Sixty-eight patients were r and omly assigned to 1 of 3 groups . The first group received 35 implants with a machined neck ( Ankylos ) ; the second group , 34 implants with a rough-surfaced neck ( Stage 1 ) ; and the third , 38 implants with a rough-surfaced neck with microthreads ( Oneplant ) . Clinical and radiographic examinations were conducted at baseline ( implant loading ) and 3 , 6 , and 12 months postloading . Two-way repeated analysis of variance ( ANOVA ) was used to test the significance of marginal bone change of each tested group at baseline , 3 , 6 , and 12 month follow-ups and 1-way ANOVA was also used to compare the bone loss of each time interval within the same implant group ( P < .05 ) . RESULTS At 12 months , significant differences were noted in the amount of alveolar bone loss recorded for the 3 groups ( P < .05 ) . The group with the rough-surfaced microthreaded neck had a mean crestal bone loss of 0.18 + /- 0.16 mm ; the group with the rough-surfaced neck , 0.76 + /- 0.21 mm ; and the group with the machined neck , 1.32 + /- 0.27 mm . In the rough-surfaced group and the rough-surfaced microthreaded group , no statistically significant changes were observed after 3 months , whereas the machined-surface group showed significant bone loss for every interval ( P < .05 ) . DISCUSSION To minimize marginal bone loss , in addition to the use of a rough surface at the marginal bone level , a macroscopic modification such as the addition of microthreads could be recommended . A rough surface and microthreads at the implant neck not only reduce crestal bone loss but also help with early biomechanical adaptation against loading in comparison to the machined neck design . CONCLUSION A rough surface with microthreads at the implant neck was the most effective design to maintain the marginal bone level against functional loading 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 PURPOSE Several long-term clinical studies have shown a mean marginal bone loss around dental implants of 1.5 to 2 mm in the first year after prosthetic restoration . Currently , concepts to avoid bone remodeling around dental implants have been developed . The use of prosthetic abutments with reduced width in relation to the implant diameter ( platform switching ) seems to have the greatest potential to limit the crestal resorption . The purpose of this clinical trial was to show that crestal bone height around dental implants could be influenced using a platform switch protocol and that the bone level would remain stable within 1 year after final prosthetic reconstruction . MATERIAL S AND METHODS Fifteen patients were treated with fixed implant retained prosthesis ; 14 wide-diameter implants were supplied with platform-switched abutments and served as the test group . Eight implants with regular diameter were reconstructed with traditional abutments and served as the control group . St and ardized digital radiographs were obtained for evaluation of the peri-implant bone levels at the time of installation of the final restoration and at 1-year follow-up . Marginal peri-implant bone levels were measured at the mesial and distal surfaces of each implant using digital image analysis . RESULTS The mean values of crestal bone height at baseline were -0.09 mm + /- 0.65 mm for the platform-switched implants and -1.73 mm + /- 0.46 mm for the nonplatform-switched implants . One year after final restoration , the mean value of crestal bone height was -0.22 mm + /- 0.53 mm for the test group and -2.02 mm + /- 0.49 mm for the control group . When tested with statistical means , the differences were significant for baseline and for follow-up ( P < /= .0001 ) . Mean bone level change from baseline to 1-year follow-up was -0.12 mm + /- 0.40 mm for the test group and -0.29 mm + /- 0.34 mm , respectively , for the control group . On analysis using ANCOVA , this difference was shown to be significant ( P < /= .0132 ) . CONCLUSION The concept of platform switching appears to limit crestal resorption and seems to preserve peri-implant bone levels . A certain amount of bone remodeling 1 year after final reconstruction occurs , but significant differences concerning the peri-implant bone height compared with the nonplatform-switched abutments are still evident 1 year after final restoration . The reduction of the abutment of 0.45 mm on each side ( 5 mm implant/4.1 mm abutment ) seems sufficient to avoid peri-implant bone loss PURPOSE To evaluate whether platform switching could preserve marginal bone around implants up to 6 months after loading . MATERIAL S AND METHODS 15 patients were selected for a r and omised controlled trial . Each patient received one customised wide body implant , with the external hex connection located eccentrically , allowing an extra 1 mm switch on one side . The hex was positioned at r and om at the mesial or distal side and the implant was loaded after 6 months of non-submerged healing . Patients were examined at 3 , 6 and 12 months after surgery , during which a radiograph was taken to evaluate bone levels . At 12 months , the mucosal thickness was measured using a perio-probe . RESULTS All implants survived and the mean overall bone loss , calculated from both the switched and non-switched side , was 0.39 mm ( SD 0.33 , range 0.00 - 1.45 ) , 0.85 mm ( SD 0.59 , range 0.10 - 2.50 ) and 0.80 mm ( SD 0.46 , 0.26 - 1.89 ) after 3 , 6 and 12 months , respectively . The bone loss continued up to 6 months but stabilised thereafter ( P = 0.615 ) . Significantly more bone loss was observed at the non-switched side compared to the switched side at 3 months ( 0.51 mm versus 0.28 mm , P = 0.019 ) , 6 months ( 1.05 mm versus 0.64 mm , P = 0.002 ) and 12 months ( 0.94 mm versus 0.66 mm , P = 0.002 ) . The mean mucosal thickness was 4.22 mm ( SD 1.45 ; range 1.50 - 7.00 ) , and was not significantly different between the switched and non-switched sides ( P = 0.882 ) . However , using a post-hoc analysis with the mean thickness as a threshold , the mean bone loss was only significantly different between switched and non-switched sides when the mucosa was thicker than 4.22 mm ( P = 0.036 ) . CONCLUSIONS The outcome of this r and omised trial is in accordance with earlier studies suggesting that that platform switching decreases bone loss by 30 % . Although the sample size was limited , it seems that the creation of a biologic width affects peri-implant bone loss to a significant extent and that platform switching is only effective when the mucosal thickness allows the establishment of a biologic width The aim of this study was to evaluate the change of marginal bone level radiographically around three different implant systems after 3 years in function . Fifty-four patients were included and r and omly assigned to three treatment groups of rough-surface implants ( TiUnite , n = 37 ) , hybrid of smooth and rough-surface implants ( Restore , n = 38 ) and rough surface with microthread implants ( Hexplant , n = 45 ) . Clinical and radiographic examinations were conducted at the time of implant loading ( baseline ) , 1 and 3 years after loading . A three-level mixed-effect analysis of covariance ( ancova ) was used to test the significance of the mean marginal bone change of the three implant groups . A total 120 of 135 implants completed the study . None of the implants failed to integrate . Significant differences were noted in the marginal bone loss recorded for the three groups ( P < 0.0001 ) . At 3 years , the rough surface with microthread implants had a mean crestal bone loss of 0.59 + /- 0.30 mm ; the rough-surface implants , 0.95 + /- 0.27 mm ; and the hybrid surface implants , 1.05 + /- 0.34 mm . Within the limitations of this study , rough-surface implants with microthread at the coronal part might have a long-term positive effect in maintaining the marginal bone level against functional loading in comparison with implants without these two features PURPOSE The purpose of this study was to evaluate the effectiveness of the platform-switching technique to prevent crestal bone loss following the restoration of dental implants . MATERIAL S AND METHODS This r and omized prospect i ve multicenter trial analyzed 60 partially edentulous adults recruited at 12 professional dental centers . Subjects were r and omly selected to receive either platform-enlarged or control cylindric implants in three different surgical procedures : conventional nonsubmerged , submerged , and submerged with a reduced abutment . The primary outcome measure was the change in crestal bone level assessed radiographically 12 and 24 months following placement . Nonparametric analysis of variance for repeated measures ( the Friedman test ) was used to assess the overall significance over time of the differences among implants in changes Output:	Dental implants at bone level show significantly less crestal bone change after 1 year of loading than tissue-level implants
MS22305	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: Findings are presented from an Icel and ic r and omized control trial ( RCT ) evaluating parent management training - Oregon model ( PMTO ™ ) , a parent training intervention design ed to improve parenting practice s and reduce child behavior problems . In a prior report from this effectiveness study that focused on child outcomes , children in the PMTO condition showed greater reductions in reported child adjustment problems relative to the comparison group . The present report focuses on observed parenting practice s as the targeted outcome , with risk by treatment moderators also tested . It was hypothesized that mothers assigned to the PMTO condition would show greater gains in pre-post parenting practice s relative to controls . The sample was recruited from five municipalities throughout Icel and and included 102 participating families of children with behavior problems . Cases were referred by community professionals and r and omly assigned to either PMTO ( n = 51 ) or community services usually offered ( n = 51 ) . Child age ranged from 5 to 12 years ; 73 % were boys . Contrary to expectations , findings showed no main effects for changes in maternal parenting . However , evaluation of risk by treatment moderators showed greater gains in parenting practice s for mothers who increased in depressed mood within the PMTO group relative to their counterparts in the comparison group . This finding suggests that PMTO prevented the expected damaging effects of depression on maternal parenting . Failure to find hypothesized main effects may indicate that there were some unobserved factors regarding the measurement and a need to further adapt the global observational procedures to Icel and ic culture BACKGROUND There is a pressing need for cost-effective population -based interventions to tackle early-onset antisocial behaviour . As this is determined by many factors , it would seem logical to devise interventions that address several influences while using an efficient means of delivery . The aim of this trial was to change four risk factors that predict poor outcome : ineffective parenting , conduct problems , attention deficit/hyperactivity disorder ( ADHD ) symptoms , and low reading ability . METHODS A r and omised controlled trial was carried out in eight schools in London , Engl and . Nine hundred and thirty-six ( 936 ) 6-year-old children were screened for antisocial behaviour , then parents of 112 high scorers were r and omised to parenting groups held in schools or control ; 109 were followed up a year later . The intervention lasted 28 weeks and was novel as it had components to address both child behaviour ( through the Incredible Years programme ) and child literacy ( through a new ' SPOKES ' programme to help parents read with their children ) . Fidelity of implementation was emphasised by careful training of therapists and weekly supervision . Controls received an information helpline . Assessment of conduct problems was by parent interview , parenting by direct observation and child reading by psychometric testing . RESULTS At follow-up parents allocated to the intervention used play , praise and rewards , and time out more often than controls , and harsh discipline less ; effect sizes ranged from .31 to .59 sd ( p-values .046 to .005 ) . Compared to control children , whose behaviour did n't change , intervention children 's conduct problems reduced by .52sd , ( p < .001 ) , dropping from the 80th to the 61st percentile ; oppositional-defiant disorder ( ODD ) halved from 60 % to 31 % ( p = .003 ) . ADHD symptoms reduced by .44sd ( p = .002 ) , and reading age improved by six months ( .36sd , p = .027 ) . Teacher-rated behaviour did n't change . The programme cost pound2,380 ( $ 3,800 ) per child . CONCLUSIONS Effective population -based early intervention to improve the functioning of with antisocial behaviour is practically feasible by targeting multiple risk factors and emphasising implementation fidelity Structured parent training has been proven to be effective in reducing disruptive behavior problems ( DBP ) in children . Most of the programs that are used in Sweden have their origin in North America , and there is an ongoing debate over the transferability to Sweden of manual-based programs developed in other context s. The goal of the present study was to study effectiveness of the Incredible Years parent-training program ( IY ) , developed in the US , in regular clinical work in Sweden , using a r and omized controlled design . Parents of 62 four to eight-year-old children diagnosed with Oppositional Defiant Disorder participated in the study . Parents of 38 children were assigned to parent training ( PT ) and 24 to a waiting list ( WL ) . The results indicate that the IYS retains the positive effects on children 's disruptive behavior problems when translated and transferred to Swedish . There was a statistically significant difference in reduction of DBP in children between the groups in favor of the PT . The improvement in the PT group was sustained at the one-year follow-up . The improvement also , at least to some extent , generalized over time to the school context . There was also a statistically significant difference in mothers ' report of pre to post change in parenting alliance between the PT and WL groups . The IYS program was appreciated and well received by the participating mothers This study was a r and omized control trial ( RCT ) of Parent Management Training -- The Oregon Model ( PMTO ) in Norway . A sample representing all health regions of Norway and consisting of 112 children with conduct problems and their families participated in the study . Families were r and omly assigned to either PMTO or a regular services comparison group . PMTO was delivered via existing children 's services , and families were recruited using the agencies ' regular referral procedures , making this the first effectiveness study of PMTO and the first RCT of PMTO conducted outside of the United States . Using a multiagent-multi method approach , results showed that PMTO was effective in reducing parent-reported child externalizing problems , improving teacher-reported social competence , and enhancing parental discipline . Age level and gender modified the effects of PMTO treatment on other outcomes . In a path model , participation in PMTO was associated with improved parental discipline , and effective discipline predicted greater child compliance , fewer child-initiated negative chains , and lower levels of child externalizing problems . Findings are presented along with a discussion of the implication s for practice and research and the challenges accompanying effectiveness trials The present study evaluated the effectiveness of the Positive Parenting Program ( Triple P ) with a sample of Chinese parents of children with early onset conduct-related problems in Hong Kong . The participants consisted of 91 parents whose children attended maternal and child health centers and child assessment centers for service , and were between three to seven years old . Participants were r and omly assigned to the intervention ( TP ) and a waitlist control group ( WL ) . There was no significant difference in pre-intervention measures between the two groups . However , at post intervention , participants in the TP group reported significantly lower levels of child behavior problems , lower dysfunctional parenting styles , and higher parent sense of competence , compared to the WL group . Implication s of these findings for the use of Triple P with families of Chinese descent are discussed BACKGROUND To test effectiveness of a parenting intervention , delivered in a community-based voluntary-sector organisation , for reducing conduct problems in clinical ly-referred children . METHODS R and omised controlled trial , follow-up at 6 , 18 months , assessors blind to treatment status . Participants --76 children referred for conduct problems , aged 2 - 9 , primarily low-income families , r and omised to treatment vs. 6-month wait-list group . Retention was 93 % at 6 months , 90 % at 18 months . Interventions --Webster-Stratton Incredible Years video-based 14-week group programme , teaches cognitive-behavioural principles for managing behaviour , using a collaborative , practical , problem-solving approach . Primary outcomes --child problem behaviour by parent-report ( Eyberg ) and home-based direct observation ; secondary outcomes --observed positive and negative parenting ; parent-reported parenting skill , confidence and depression . RESULTS Post-treatment improvements were found in child problem behaviour , by parent-report ( effect size ( ES ) .48 , p = .05 ) and direct observation ( ES .78 , p = .02 ) ; child independent play ( ES .77 , p = .003 ) ; observed negative ( ES .74 , p = .003 ) and positive ( ES .38 , p = .04 ) parenting ; parent-reported confidence ( ES .40 , p = .03 ) and skill ( ES .65 , p = .01 ) , using ANCOVA to control for baseline scores . Maternal depression did not change . Consumer satisfaction was high . At 18-month follow-up , although no r and omised comparison was possible , changes appeared to maintain , with no significant change toward baseline level on any measure . Change in observed positive parenting appeared to mediate change in child problem behaviour ( p < .025 ) . CONCLUSIONS Findings suggest that a group-based cognitive-behavioural parenting programme , delivered by well-trained and supervised staff , can be effective in a community voluntary-sector setting , for reducing conduct problems and enhancing parenting skills . Change in parenting skill appears to be a key mechanism for change in child behaviour . Findings have implication s for feasibility of translating evidence -based programmes , even for clinical ly-referred conduct problems , into less specialised community setting s , likely to have lower costs and be more accessible for families Objective To evaluate the effectiveness of a parenting programme as a preventive intervention with parents of preschool children considered to be at risk of developing conduct disorder . Design Pragmatic r and omised controlled trial using a block design with allocation by area . Setting Eleven Sure Start areas in north and mid-Wales . Participants 153 parents from socially disadvantaged areas , with children aged 36 - 59 months at risk of conduct disorder defined by scoring over the clinical cut off on the Eyberg child behaviour inventory . Participants were r and omised on a 2:1 basis , 104 to intervention and 49 to remaining on the wait listing ( control ) . Twenty ( 13 % ) were lost to follow-up six months later , 18 from the intervention group . Intervention The Webster-Stratton Incredible Years basic parenting programme , a 12 week group based intervention . Main outcome measures Problem behaviour in children and parenting skills assessed by self reports from parents and by direct observation in the home . Parents ' self reported parenting competence , stress , and depression . St and ardised and well vali date d instruments were used throughout . Results At follow-up , most of the measures of parenting and problem behaviour in children showed significant improvement in the intervention group . The intention to treat analysis for the primary outcome measure , the Eyberg child behaviour inventory , showed a mean difference between groups of 4.4 points ( 95 % confidence interval 2.0 to 6.9 , P<0.001 ) on the problem scale with an effect size of 0.63 , and a mean difference of 25.1 ( 14.9 to 35.2 , P<0.001 ) on the intensity scale with an effect size of 0.89 . Conclusion This community based study showed the effectiveness of an evidence based parenting intervention delivered with fidelity by regular Sure Start staff . It has influenced policy within Wales and provides lessons for Engl and where , to date , Sure Start programmes have not been effective . Trial registration IS RCT This article reports the effectiveness of two universal prevention programs in reducing externalizing behavior in elementary school children . A sample of 1,675 first grade rs in 56 Swiss elementary schools was r and omly assigned to a school-based social competence intervention , a parental training intervention , both , or control . Externalizing psychopathology and social competence ratings were provided by the children , primary caregivers , and teachers at the beginning and end of the 2-year program , with a follow-up 2 years later . Intention-to-treat analyses revealed that long-term effects on teacher- and parent-rated externalizing behavior were greater for the social competence intervention than for the control . However , for most outcomes , no statistically significant positive effects were observed This r and omized clinical trial assessed the effectiveness of multisystemic therapy ( MST ) for 156 youths who met the diagnostic criteria for conduct disorder . Sweden 's 3 largest cities and 1 small town served as the recruiting area for the study . A mixed factorial design was used , with r and om allocation between MST and treatment as usual groups . Assessment s were conducted at intake and 7 months after referral . With an intention-to-treat approach , results from multiagent and multi method assessment batteries showed a general decrease in psychiatric problems and antisocial behaviors among participants across treatments . There were no significant differences in treatment effects between the 2 groups . The lack of treatment effect did not appear to be caused by site differences or variations in program maturity . MST treatment fidelity was lower than that of other studies , although not clearly related to treatment outcomes in this study . The results are discussed in terms of differences between Sweden and the United States . One difference is the way in which young offenders are processed ( a child welfare approach vs. a juvenile justice system approach ) . Sociodemographic differences ( e.g. , rates of poverty , crime , and substance abuse ) between the 2 countries may also have moderating effects on the rates of rehabilitation among young offenders . ( PsycINFO Data base Record ( c ) 2008 APA , all rights reserved ) This study evaluates the initial efficacy of the Parent-Child Interaction Therapy ( PCIT ) for Puerto Rican preschool children aged 4 - 6 years with a diagnosis of attention-deficit/hyperactivity disorder ( ADHD ) , combined or predominantly hyperactive type , and significant behavior problems . Thirty-two families were r and omly assigned to PCIT ( n = 20 ) or a 3.5-month waiting-list condition ( WL ; n = 12 ) . Participants from both groups completed pretreatment and posttreatment assessment s. Outcome measures included child 's ADHD symptoms and behavior problems , parent or family functioning , and parents ' satisfaction with treatment . ANCOVAs with pretreatment measures entered as covariates were significant for all posttreatment outcomes , except mother 's depression , and in the expected direction ( p < .01 ) . Mothers reported a highly significant reduction in pretreatment hyperactivity and inattention and less aggressive and oppositional-defiant behaviors Output:	Interventions transported to “ western ” countries showed comparable effects to trials in origin countries ; however , effects were stronger when interventions were transported to culturally more distant regions . Effects were higher in countries with survival-focused family/childrearing values than those ranked more individualistic . There were no differences in effects by country-level policy or re source factors . Contrary to common belief , parenting interventions appear to be at least as effective when transported to countries that are more different culturally , and in service provision , than those in which they were developed . Extensive adaptation did not appear necessary for successful transportation
MS22306	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: OBJECTIVE Determine whether Color Me Healthy ( CMH ) , an interactive nutrition and physical activity program for preschool children , increases fruit and vegetable consumption . DESIGN Intervention study . Data were collected at baseline , 1 week post-intervention , and 3 months post-intervention . SETTING Child care centers . PARTICIPANTS Preschool children ( n = 263 ) in 17 child care centers . INTERVENTION Child care centers were r and omly assigned to 1 of 2 conditions ; children ( n = 165 ) in 10 centers received the CMH curriculum , and children ( n = 98 ) in 7 centers acted as comparisons and did not receive the curriculum . MAIN OUTCOME MEASURES Process and outcome evaluation . Consumption of fruit and vegetable snacks . ANALYSIS Data were analyzed using repeated- measures analysis of variance and hierarchical linear modeling . RESULTS Children who received CMH significantly increased their consumption of fruit snacks by approximately 20.8 % and vegetable snacks by approximately 33.1 % between baseline assessment and the assessment conducted 3 months after the completion of the CMH program . Hierarchical linear modeling determined that group assignment ( ie , CMH or control ) was the only significant predictor of fruit and vegetable consumption . CONCLUSIONS AND IMPLICATION S Findings suggest that CMH may be used in child care setting s for developing healthful eating habits Background Governments worldwide recommend daily consumption of fruit and vegetables . We examine whether this benefits health in the general population of Engl and . Methods Cox regression was used to estimate HRs and 95 % CI for an association between fruit and vegetable consumption and all-cause , cancer and cardiovascular mortality , adjusting for age , sex , social class , education , BMI , alcohol consumption and physical activity , in 65 226 participants aged 35 + years in the 2001–2008 Health Surveys for Engl and , annual surveys of nationally representative r and om sample s of the non-institutionalised population of Engl and linked to mortality data ( median follow-up : 7.7 years ) . Results Fruit and vegetable consumption was associated with decreased all-cause mortality ( adjusted HR for 7 + portions 0.67 ( 95 % CI 0.58 to 0.78 ) , reference category < 1 portion ) . This association was more pronounced when excluding deaths within a year of baseline ( 0.58 ( 0.46 to 0.71 ) ) . Fruit and vegetable consumption was associated with reduced cancer ( 0.75 ( 0.59–0.96 ) ) and cardiovascular mortality ( 0.69 ( 0.53 to 0.88 ) ) . Vegetables may have a stronger association with mortality than fruit ( HR for 2 to 3 portions 0.81 ( 0.73 to 0.89 ) and 0.90 ( 0.82 to 0.98 ) , respectively ) . Consumption of vegetables ( 0.85 ( 0.81 to 0.89 ) per portion ) or salad ( 0.87 ( 0.82 to 0.92 ) per portion ) were most protective , while frozen/canned fruit consumption was apparently associated with increased mortality ( 1.17 ( 1.07 to 1.28 ) per portion ) . Conclusions A robust inverse association exists between fruit and vegetable consumption and mortality , with benefits seen in up to 7 + portions daily . Further investigations into the effects of different types of fruit and vegetables are warranted BACKGROUND The use of rewards to encourage children to eat healthily is controversial . However , research er-led interventions have shown that incentives combined with taste exposure can increase both intake and liking . To date , this has not been tested in the home setting . OBJECTIVES The objectives were to test the hypothesis that parent-administered repeated taste exposures to an initially disliked vegetable combined with reward will increase children 's liking and intake and to compare the effects of tangible and social rewards . DESIGN In this r and omized controlled trial , families with children aged 3 - 4 y ( n = 173 ) were r and omly assigned to exposure + tangible reward ( sticker ) , exposure + social reward ( praise ) , or no-treatment control conditions after a pretest assessment in which a target vegetable was selected for each child . In the intervention groups , parents offered their children 12 daily tastes of the vegetable , giving either praise or a sticker for tasting . No specific advice was given to the control group . Assessment s of intake and liking of the target vegetable were conducted by research ers immediately after the intervention period and 1 and 3 mo later . RESULTS Children who received exposure + tangible rewards increased their intake ( P = 0.001 ) and liking ( P = 0.001 ) of their target vegetable significantly more than did children in the control group . Differences were maintained at the 3-mo follow-up ( intake : P = 0.005 ; liking : P = 0.001 ) . Increases in intake and liking in the exposure + social reward group were not significantly different from the control group . CONCLUSION The findings of this home-based study support parental use of tangible rewards with repeated taste exposures to improve children 's diets . This trial is registered as IS RCT N42922680 Background Mexico has the highest adult overweight and obesity prevalence in the Americas ; 23.8 % of children < 5 years old are at risk for overweight and 9.7 % are already overweight or obese . Creciendo Sanos was a pilot intervention to prevent obesity among preschoolers in Instituto Mexicano del Seguro Social ( IMSS ) clinics . Methods We r and omized 4 IMSS primary care clinics to either 6 weekly educational sessions promoting healthful nutrition and physical activity or usual care . We recruited 306 parent-child pairs : 168 intervention , 138 usual care . Children were 2 - 5 years old with WHO body mass index ( BMI ) z-score 0 - 3 . We measured children ’s height and weight and parents reported children ’s diet and physical activity at baseline and 3 and 6-month follow-up . We analyzed behavioral and BMI outcomes with generalized mixed models incorporating multiple imputation for missing values . Results 93 ( 55 % ) intervention and 96 ( 70 % ) usual care families completed 3 and 6-month follow-up . At 3 months , intervention v. usual care children increased vegetables by 6.3 servings/week ( 95 % CI , 1.8 , 10.8 ) . In stratified analyses , intervention participants with high program adherence ( 5 - 6 sessions ) decreased snacks and screen time and increased vegetables v. usual care . No further effects on behavioral outcomes or BMI were observed . Transportation time and expenses were barriers to adherence . 90 % of parents who completed the post-intervention survey were satisfied with the program . Conclusions Although satisfaction was high among participants , barriers to participation and retention included transportation cost and time . In intention to treat analyses , we found intervention effects on vegetable intake , but not other behaviors or BMI .Trial registration Clinical Trials.gov NCT01539070.Comisión Nacional de Investigación Científica del IMSS : 2009 - 785 - 120 OBJECTIVE To measure the effects of two school-based interventions on children 's intake of fruit and vegetables ( F&V ) . DESIGN AND METHODS A total of six primary schools were r and omly assigned to ( 1 ) a free F&V distribution programme , or ( 2 ) a multicomponent programme , consisting of a classroom curriculum and parental involvement . The two interventions were evaluated on their effects and compared with six control schools in a pre-test-post-test design . Two methods were used for dietary assessment : a pre-structured food recall and a food-frequency question naire including only F&V. SUBJECTS A total of 939 parents of children aged 4 - 12 years filled out the question naire at both pre-test and post-test . The response rate was 54 % . RESULTS Multilevel analyses showed that both programmes were equally effective in increasing children 's fruit consumption by 0.2 portions per day . The free F&V distribution increased vegetable intake among non-native children and the oldest age group , and the multicomponent programme among the oldest children and girls . The distribution also caused an increased 24 h fruit , juice and vegetable intake among the youngest and the oldest age groups , and the multicomponent programme among all children . CONCLUSION The results of this study indicate that both interventions were shown to be effective for different subgroups regarding age , gender and ethnicity . When comparing both interventions , the distribution programme was shown to be more effective , especially in increasing vegetable consumption . An important next step will be to investigate which intervention has the greatest potential to be implemented in primary schools BACKGROUND Evidence -based strategies for promoting vegetable consumption among children are limited . OBJECTIVE To determine the effects of providing a palatable “ dip ” along with repeated exposure to a raw vegetable on preschoolers ' liking and intake . PARTICIPANTS One hundred fifty-two predominately Hispanic preschool-aged children studied in Head Start classrooms in 2008 . DESIGN A between-subjects , quasiexperimental design was used . A moderately-liked raw vegetable ( broccoli ) was offered twice weekly at afternoon snacks for 7 weeks . Classrooms were r and omized to receive broccoli in one of four conditions differing in the provision of dip . Bitter taste sensitivity was assessed using 6-n-propylthiouracil . INTERVENTION Broccoli was provided in four conditions : with regular salad dressing as a dip , with a light ( reduced energy/fat ) version of the dressing as a dip , mixed with the regular dressing as a sauce , or plain ( without dressing ) . MAIN OUTCOME MEASURES Mean broccoli intake during 7 weeks of exposure and broccoli liking following exposure . STATISTICAL ANALYSES Descriptive statistics were generated . Multilevel models for repeated measures tested effects of condition and bitter sensitivity on mean broccoli intake during exposure and on pre- and post-exposure liking while adjusting for classroom effects and potential covariates . RESULTS The majority of Hispanic preschoolers ( 70 % ) showed sensitivity to the bitter taste of 6-n-propylthiouracil . Children 's broccoli liking increased following exposure but did not vary by dip condition or bitter sensitivity . Bitter-sensitive children , however , ate 80 % more broccoli with dressing than when served plain ( P<0.001 ) ; effects did vary based on whether regular or light dressing was provided as a dip or sauce . Dip did not promote broccoli intake among bitter-insensitive children . CONCLUSIONS Providing dip — regular , light , or as a sauce — increased raw broccoli intake among bitter-sensitive Hispanic preschoolers . Findings suggest that offering low-fat dips can promote vegetable intake among some children who are sensitive to bitter tastes Children 's consumption of vegetables is still below recommendations . Since preference is the most important predictor of children 's intake and most children dislike vegetables , new strategies are needed to increase their preferences for vegetables . Flavour nutrient learning ( FNL ) could be an effective mechanism to change preferences . Forty healthy toddlers were included in a r and omized intervention study . During an intervention period of 7weeks , they consumed vegetable soups ( endive and spinach ) twice per week . Half of the group received a high-energy variant of one soup ( e.g. HE spinach ) and a low energy variant of the other ( LE endive ) , whereas for the other half the order was reversed ( HE endive , LE spinach ) . Primary outcome measures were preference and ad libitum consumption ( with a maximum of 200 g ) of both vegetable products ( LE ) , measured before , shortly after the intervention period , and 2 and 6months following conditioning to assess longer-term effects . After completion of the intervention period , 28 children ( 14 girls and 14 boys , age 35months ; SD±8.3 ) met criteria for FNL to occur , and were included in further data analysis . Results showed a significant increase ( ~58 g ) in ad libitum intake for both vegetable soups ( stable over time ) , but irrespective of the energy content . This indicates a robust effect of mere exposure on intake , but no FNL . For preference , however , results showed a significant shift in liking for the vegetable soup consistently paired with high energy , supporting FNL Children are not consuming sufficient amounts of fruits and vegetables in their habitual diet . Methods derived from associative learning theories could be effective at promoting vegetable intake in pre-school children . The objective of the present study was to compare the effectiveness of different learning strategies in promoting the intake of a novel vegetable . Children aged between 9 and 38 months were recruited from UK nurseries . The children ( n 72 ) were r and omly assigned to one of three conditions ( repeated exposure , flavour-flavour learning or flavour-nutrient learning ) . Each child was offered ten exposures to their respective version of a novel vegetable ( artichoke ) . Pre- and post-intervention measures of artichoke purée and carrot purée ( control vegetable ) intake were taken . At pre-intervention , carrot intake was significantly higher than artichoke intake ( P<0·05 ) . Intake of both vegetables increased over time ( P<0·001 ) ; however , when changes in intake were investigated , artichoke intake increased significantly more than carrot intake ( P<0·001 ) . Artichoke intake increased to the same extent in all three conditions , and this effect was persistent up to 5 weeks post-intervention . Five exposures were sufficient to increase intake compared to the first exposure ( P<0·001 ) . Output:	The meta- analysis revealed that interventions implementing repeated taste exposure had better pooled effects than those which did not . Intake increased with number of taste exposures and intake was greater when vegetables offered were in their plain form rather than paired with a flavor , dip or added energy ( e.g. oil ) . Moreover , intake of vegetables which were unfamiliar/disliked increased more than those which were familiar/liked . Repeated taste exposure is a simple technique that could be implemented in childcare setting s and at home by parents .
MS22307	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: STUDY OBJECTIVE We evaluate a computer-based intervention for screening and health promotion in the emergency department and determine its effect on patient recall of health advice . METHODS This controlled clinical trial , with alternating assignment of patients to a computer intervention ( prevention group ) or usual care , was conducted in a university hospital ED . The study group consisted of 542 adult patients with nonurgent conditions . The study intervention was a self-administered computer survey generating individualized health information . Outcome measures were ( 1 ) patient willingness to take a computerized health risk assessment , ( 2 ) disclosure of behavioral risk factors , ( 3 ) requests for health information , and ( 4 ) remembered health advice . RESULTS Eighty-nine percent ( 470/542 ) of eligible patients participated . Ninety percent were black . Eighty-five percent ( 210/248 ) of patients in the prevention group disclosed 1 or more major behavioral risk factors including current smoking ( 79/248 ; 32 % ) , untreated hypertension ( 28/248 ; 13 % ) , problem drinking ( 46/248 ; 19 % ) , use of street drugs ( 33/248 ; 13 % ) , major depression ( 87/248 ; 35 % ) , unsafe sexual behavior ( 84/248 ; 33 % ) , and several other injury-prone behaviors . Ninety-five percent of patients in the prevention group requested health information . On follow-up at 1 week , 62 % ( 133/216 ) of the prevention group patients compared with 27 % ( 48/180 ) of the control subjects remembered receiving advice on what they could do to improve their health ( relative risk 2.3 , 95 % confidence interval 1.77 to 3.01 ) . CONCLUSION Using a self-administered computer-based health risk assessment , the majority of patients in our urban ED disclosed important health risks and requested information . They were more likely than a control group to remember receiving advice on what they could do to improve their health . Computer methodology may enable physicians to use patient waiting time for health promotion and to target at-risk patients for specific interventions BACKGROUND Women experiencing domestic violence ( DV ) frequent health care setting s , but DV is rarely identified . METHODS We conducted a r and omized controlled trial to determine the effect of computer screening on health care provider-patient DV communication at 2 socioeconomically diverse emergency departments ( EDs ) . Consenting nonemergent female patients , aged 18 to 65 years , were r and omized to self-administered computer-based health risk assessment , with a prompt for the health care provider , or to " usual care " ; all visits were audiotaped . Outcome measures were rates of DV discussion , disclosure , and services . RESULTS Of 2169 eligible patients , 1281 ( 59 % ) consented ; 871 ( 68 % ) were successfully audiotaped , and 903 ( 71 % ) completed an exit question naire . Rates of current DV risk on exit question naire were 26 % in the urban ED and 21 % in the suburban ED . In the urban ED , the computer prompt increased rates of DV discussion ( 147/262 [ 56 % ] vs 123/275 [ 45 % ] ; P = .004 ) , disclosure ( 37/262 [ 14 % ] vs 23/275 [ 8 % ] ; P = .07 ) , and services provided ( 21 [ 8 % ] vs 10 [ 4 % ] ; P = .04 ) . Women at the suburban site and those with private insurance or higher education were much less likely to be asked about experiences with abuse . Only 48 % of encounters with a health care provider prompt regarding potential DV risk led to discussion s. Both inquiries about and disclosures of abuse were associated with higher patient satisfaction with care . CONCLUSIONS Computer screening for DV increased but did not guarantee that DV would be addressed during ED encounters . Nonetheless , it is likely that low-cost interventions that allow patients the opportunity to self-disclose can be used to improve detection of DV Background : A pregnant woman 's psychological health is a significant predictor of postpartum outcomes . The Antenatal Psychosocial Health Assessment ( ALPHA ) form incorporates 15 risk factors associated with poor postpartum outcomes of woman abuse , child abuse , postpartum depression and couple dysfunction . We sought to determine whether health care providers using the ALPHA form detected more antenatal psychosocial concerns among pregnant women than providers practising usual prenatal care . Methods : A r and omized controlled trial was conducted in 4 communities in Ontario . Family physicians , obstetricians and midwives who see at least 10 prenatal patients a year enrolled 5 eligible women each . Providers in the intervention group attended an educational workshop on using the ALPHA form and completed the form with enrolled women . The control group provided usual care . After the women delivered , both groups of providers identified concerns related to the 15 risk factors on the ALPHA form for each patient and rated the level of concern . The primary outcome was the number of psychosocial concerns identified . Results were controlled for clustering . Results : There were 21 ( 44 % ) providers r and omly assigned to the ALPHA group and 27 ( 56 % ) to the control group . A total of 227 patients participated : 98 ( 43 % ) in the ALPHA group and 129 ( 57 % ) in the control group . ALPHA group providers were more likely than control group providers to identify psychosocial concerns ( odds ratio [ OR ] 1.8 , 95 % confidence interval [ CI ] 1.1–3.0 ; p = 0.02 ) and to rate the level of concern as “ high ” ( OR 4.8 , 95 % CI 1.1–20.2 ; p = 0.03 ) . ALPHA group providers were also more likely to detect concerns related to family violence ( OR 4.8 , 95 % CI 1.9–12.3 ; p = 0.001 ) . Interpretation : Using the ALPHA form helped health care providers detect more psychosocial risk factors for poor postpartum outcomes , especially those related to family violence . It is a useful prenatal tool , identifying women who would benefit from additional support and interventions Objective To compare two different screening techniques for identifying women with a history of domestic violence or battering in the current pregnancy . Methods The five- question Abuse Assessment Screen was incorporated into routine social service interviews and applied prospect ively to all registrants for routine prenatal care at Women & Infants ' Hospital during an initial social service evaluation from September 7 through October 29 , 1993 . This group ( N = 143 ) was compared to a historical control group of all new registrants from July 12 through September 3 , 1993 ( N = 191 ) who had routine interviews by social services . Demographic and medical data were compared , as well as the specific information addressed by the screen , including history of domestic violence , physical or sexual violence within the last year , violence during the current pregnancy , recent sexual abuse , and fear of partner . Results The median age of the study population was 23 years old , 50 % were white , 63 % were single , and 42 % had no insurance . There was a higher detection of violence in all categories using the Abuse Assessment Screen compared with the st and ard interview — any history : 41 versus 14 % ( relative risk [ RR ] 3.0 , 95 % confidence interval [ CI ] 2.0–4.5 ) ; recent history : 15 versus 3 % ( RR 5.6 , CI 2.2–14.5 ) ; during pregnancy : 10 versus 1 % ( RR 9.3 , CI 2.2–40.5 ) ; recent sexual abuse : 4 versus 0 % ( P = .006 ) ; and fear of abuser : 6 versus 3 % ( RR 1.8 , CI 0.6–5.0 ) . Conclusion Use of a structured screen improves detection rates of battering both before and during pregnancy , enabling clinicians to have a greater opportunity to intervene Although violence against women is recognized as a major public health problem , few interventions have been developed to reduce abuse . In this study , 132 pregnant women received three counseling sessions that were design ed to reduce further abuse . A comparison group of 67 abused women were offered wallet-sized cards listing community re sources for abuse . Women in both groups were followed at 6 months and 12 months post-delivery . Using repeated measures MANCOVA with entry scores as a covariate , we found significantly less violence reported by women in the intervention group than by women in the comparison group Objective To evaluate the effectiveness of an empowerment intervention in reducing intimate partner violence ( IPV ) and improving health status OBJECTIVE To examine the relationship between intimate partner violence ( IPV ) type , severity , and duration and abused women 's use of medical and legal services . METHODS Participants were 1509 r and omly sample d women from a large health plan who were interviewed by telephone to assess ( 1 ) self-reported lifetime exposure to IPV type ( physical , sexual , and psychological ) , severity , and duration and ( 2 ) women 's use of medical and legal services ( civil protection orders ) . RESULTS Compared with women who experienced psychological abuse only , sexually abused women were 1.3 times as likely to seek medical care , and women exposed to physical IPV or sexual IPV were 3.2 times and 1.6 times as likely , respectively , to seek legal services . Rates of medical and legal help seeking increased with increasing abuse severity among physically abused women , and rates of legal help seeking increased with abuse severity among sexually and psychologically abused women . Longer duration of physical and sexual IPV was also found to be associated with increased legal help seeking . CONCLUSIONS Abused women who sought formal help were more likely to be exposed to physical or sexual IPV , severe psychological IPV , and severe and long-lasting physical and sexual IPV . Efforts should be considered to improve the healthcare and legal system 's response to IPV OBJECTIVE Our goal was to identify the prevalence , determinants of , and barriers to clinician-patient communication about intimate partner abuse . STUDY DESIGN We conducted telephone interviews with a r and om sample of ethnically diverse abused women . POPULATION We included a total of 375 African American , Latina , and non-Latina white women aged 18 to 46 years with histories of intimate partner abuse who attended 1 of 3 primary care clinics in San Francisco , California , in 1997 . OUTCOMES MEASURED We measured the relevance and determinants of past communication with clinicians about abuse and barriers to communication . RESULTS Forty-two percent ( 159 ) of the patients reported having communicated with a clinician about abuse . Significant independent predictors of communication were direct clinician question ing about abuse ( odds ratio [OR]=4.6 ; 95 % confidence interval [ CI ] 3.2 - 6.6 ) , and African American ethnicity ( OR=1.8 ; 95 % CI , 1.1 - 2.9 ) . Factors associated with lack of communication about abuse included immigrant status ( OR=0.6 ; 95 % CI , 0.3 - 1.0 ) and patient concerns about confidentiality ( OR=0.7 ; 95 % CI , 0.5 - 0.9 ) . Barriers significantly associated with lack of communication were patients ' perceptions that clinicians did not ask directly about abuse , beliefs that clinicians lack time and interest in discussing abuse , fears about involving police and courts , and concerns about confidentiality . CONCLUSIONS Clinician inquiry appears to be one of the strongest determinants of communication with patients about partner abuse . Other factors that need to be addressed include patient perceptions regarding clinicians ' time and interest in discussing abuse , fear of police or court involvement , and patient concerns about confidentiality OBJECTIVES National health care organizations recommend routinely screening patients for behavioral health risks , the effectiveness of which depends on patients ' willingness to disclose risky behaviors . This study aim ed to determine if primary care patients ' disclosures of potentially stigmatizing behaviors would be affected by ( 1 ) their expectation about whether or not their physician would see their disclosures and ( 2 ) the assessment method . METHODS One thous and nine hundred fifty-two primary care patients completed a question naire assessing human immunodeficiency virus ( HIV ) , alcohol , drug , domestic violence , tobacco , oral health , and seat belt risks ; half were told their responses would be seen by the research er and their physician and half were told that their responses would be seen by the research er only . Patients were r and omly assigned to one of five assessment methods : written , face-to-face , audio-based , computer-based , or video-based . RESULTS Across all risk areas , patients did not disclose differently whether or not they believed their physician would see their disclosures . Technologically advanced assessment methods ( audio , computer , and video ) produced greater risk disclosure ( 4%-8 % greater ) than traditional methods in three of seven risk areas . CONCLUSIONS These findings suggest patients are not less willing to disclose health risks to a research assistant knowing that this information would be shared with their physician and that a number of assessment methods can effectively elicit patient disclosure . Potentially small increases in risk disclosure must be weighed against other factors , such as cost and convenience , in determining which method ( s ) to use in different health care setting CONTEXT Screening for intimate partner violence ( IPV ) in health care setting s has been recommended by some professional organizations , although there is limited information regarding the accuracy , acceptability , and completeness of different screening methods and instruments . OBJECTIVE To determine the optimal method for IPV screening in health care setting s. DESIGN AND SETTING Cluster r and omized trial conducted from May 2004 to January 2005 at 2 each of emergency departments , family practice s , and women 's health clinics in Ontario Output:	Contribution This r and omized trial found that when a computer-generated report detailing patients ' responses to questions about intimate partner violence and control was attached to medical charts , family practitioners asked about it and detected it more often . Implication Computer-assisted screening for intimate partner violence and control led to improved detection in a busy ambulatory care setting . Computer screening may help to overcome some of the barriers to discussing risk for IPV .
MS22308	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: AIM To evaluate the effects of metformin on insulin resistance , and rogen concentration , ovulation rates and pregnancy rates in infertile women with polycystic ovary syndrome ( PCOS ) . METHODS Forty-two infertile women with PCOS were selected in this r and omized clinical study . Basal steroid and gonadotropin levels were measured , and oral glucose tolerance test ( OGTT ) was performed . The patients were r and omly divided into group 1 ( n = 21 ) and group 2 ( n = 21 ) . Group 1 patients were treated with laparoscopic ovarian drilling ( LOD ) . Group 2 patients underwent laparoscopic ovarian drilling ( LOD ) and received 1700 mg per day of metformin for 6 months . LOD was performed in women with PCOS using a unipolar electrode . Serum progesterone ( P ) level > 5 ng/mL was considered as a confirmation of ovulation . Ovulation and pregnancy rates were determined after six cycles . RESULTS Serum and rogens and insulin response to OGTT decreased significantly after metformin therapy . Mean serum P levels and endometrial thickness were significantly higher in cycles treated with metformin plus LOD ( 34.6 + /- 25.4 ng/mL , 8.4 + /- 1.1 mm ) than in those treated with LOD alone ( 26.2 + /- 24.7 ng/mL , 7.9 + /- 2.8 mm ) ( P < 0.05 ) . The ovulation ( 56 of 65 cycles , 86.1 % vs 29 of 65 cycles , 44.6 % ) and pregnancy rates ( nine of 21 women , 47.6 % vs four of 21 women , 19.1 % ) were significantly higher in group 2 than in group I. CONCLUSIONS Metformin improves insulin resistance , reduces and rogen levels and significantly increases the ovulation and pregnancy rates in infertile women , following LOD Laparoscopic Nd-YAG laser photocoagulation of the ovaries was performed in 40 anovulatory women with clomiphene citrate-resistant polycystic ovary disease . Following this procedure , the subjects were r and omly assigned to have either a second-look laparoscopy with lysis of adhesions within 3 - 4 weeks of the initial laparoscopy ( N=19 ) or expectant management ( N=20 ) . One patient assigned to the laparoscopy group refused the procedure . Minimal and mild adhesions that did not distort the normal tubo-ovarian relationship were encountered in 13 patients ( 68 % ) in the second-look laparoscopy group ; these adhesions were easily lysed using sharp or blunt dissection . The pregnancy rates over 6 months were similar in the two groups ( 47 % in the second-look group and 55 % in the expectant-management group ; P>.05 ) . These data suggest that early laparoscopic lysis of adhesions does not improve short-term conception rates following laparoscopic Nd-YAG laser photocoagulation of polycystic ovaries Objectives Laparoscopic ovarian drilling ( LOD ) has been put forward as the treatment of choice in women with clomiphene citrate (CC)-resistant polycystic ovary syndrome ( PCOS ) , with tubo-ovarian adhesion formation as the major disadvantage . Our study proposed to compare the efficacy of laparoscopic unilateral ovarian drilling with bilateral ovarian drilling in terms of ovulation and pregnancy rate with the expected advantage of decreasing postoperative adhesion rate and change in fimbiro ovarian relationship with unilateral drilling . Methods This prospect i ve r and omized study included 44 patients with anovulatory infertility due to PCOS . Twenty-two patients underwent unilateral ovarian drilling in group-I and 22 patients underwent bilateral ovarian drilling in group-II between June 2005 and June 2007 . The number of drilling site in each ovary was limited to five . The clinical and biochemical response , ovulation and pregnancy rates over a follow-up period of 1 year were compared . Tubo-ovarian adhesion rate was compared during cesarean section or during repeat laparoscopy . Results There was no statistical difference between the two groups in terms of clinical and biochemical response , ovulation rate and pregnancy rate . Postoperatively , tubo-ovarian adhesions could be assessed in 36.3 % of the patients and no adhesions were found in a single case in either group . Conclusion Unilateral drilling cauterization of ovary is equally efficacious as bilateral drilling in inducing ovulation and achieving pregnancy . Unilateral ovarian drilling may be a suitable option in clomiphene citrate resistant infertility patient of PCOS which can replace bilateral ovarian drilling with the potential advantage of decreasing the chances of adhesion formation Objective : We compared 12-month pregnancy and live birth rates in patients with polycystic ovarian disease undergoing 5- , 10- , and 15-point laparoscopic ovarian electrocauterization . Methods : This was a prospect i ve , r and omized study performed at the Dabirashrafi Fertility and Endoscopy Research Center , Tehran , Iran . The study included 187 patients with polycystic ovarian disease who were r and omly assigned to 3 groups . Group I comprised 67 patients whose ovaries received 5-point electrocauterization . Group II comprised 57 patients whose ovaries received 10-point electrocauterization . Group III comprised 63 patients whose ovaries received 15-point electocauterization . Laparoscopic ovarian electrocauterization with a unipolar current was used . The main outcome measures were 12-month pregnancy and live birth rates . Results : Patients were homogeneous for age , body mass index , and type and duration of infertility . Twenty pregnancies result ed in Group I , with a pregnancy rate of 29.9 % ( 20/67 ) and a live birth rate of 20.9 % ( 14/57 ) . Eighteen pregnancies result ed in Group II , with a pregnancy rate of 31.6 % ( 18/57 ) , and a live birth rate of 28.1 % (16/57).Thirty-three pregnancies result ed in group III , with a pregnancy rate of 52.4 % ( 33/63 ) , and a live birth rate of 47.6 % ( 30/63 ) . Comparison of Group III with Groups I and II revealed a statistically significant increase in pregnancies ( P=0.016 ) and live birth rates ( P=0.004 ) . Conclusion : We recommend 15-point electrocauterization of ovaries in patients with polycystic ovarian disease In this prospect i ve , r and omized , controlled clinical study , 21 women underwent a second-look laparoscopy 2 - 11 weeks after st and ardized laparoscopic electrosurgical treatment for polycystic ovarian syndrome ( PCOS ) . Following bilateral ovarian treatment , one ovary was r and omly chosen to have Interceed applied to its surface using a specially design ed applicator , with the other ovary serving as a control . Peri-adnexal adhesions of significant extent and severity developed in 57 % of the women and 38 % of the adnexa . The incidence of adhesions on the Interceed-treated side was 43 % , while on the control side it was 33 % . In addition , the extent and severity of the adhesions appeared to be similar on the Interceed-treated and control side . However , larger numbers would be required to determine statistically the effects of Interceed on de-novo adhesion formation after laparoscopic electrosurgical treatment of PCOS , as described here Objectives Rosiglitazone , an insulin sensitizing agent is used currently in women with clomiphene citrate ( CC ) resistant polycystic ovarian syndrome ( PCOS ) . Our study proposed to compare the efficacy of rosiglitazone and CC with laparoscopic ovarian drilling ( LOD ) and CC in terms of biochemical effects , ovulation rate and pregnancy rate in patients of PCOS resistant to CC . Methods This prospect i ve r and omised trial included 43 patients of PCOS resistant to CC . Twenty-two women were assigned to the rosiglitazone ( 4 mg twice daily ) and CC group and other 21 patients underwent unilateral LOD and then received CC and multivitamins . The treatment continued for six cycles in both the groups . The biochemical response , ovulation rate and pregnancy rate over a follow up period of 6 months were compared . Results Treatment with rosiglitazone and CC or LOD and CC result ed in increased ovulation ( 80.8 vs. 81.5 % ) and pregnancy ( 50 vs. 42.8 % ) , respectively . There was no statistical difference between the two groups in terms of biochemical response , ovulation rate and pregnancy rate . Conclusion To avoid the risk of adverse effects of LOD preference may be given to the use of rosiglitazone and CC therapy in patients of PCOS resistant to CC Fifty women with polycystic ovaries took part in a prospect i ve r and omized study . All women required treatment by in-vitro fertilization ( IVF ) for reasons other than anovulation . They had all previously undergone ovarian stimulation with gonadotrophin therapy which had failed to result in pregnancy or had been ab and oned due to high risk of developing ovarian hyperstimulation syndrome ( OHSS ) . Twenty-five women were treated by long-term pituitary desensitization followed by gonadotrophin therapy , oocyte retrieval and embryo transfer ( group 1 ) . Twenty-five women underwent laparoscopic ovarian electrocautery after pituitary desensitization followed by gonadotrophin therapy , oocyte retrieval and embryo transfer ( group 2 ) . A significantly higher number of women in group 1 had to have the treatment cycle ab and oned due to impending or actual OHSS , determined by endocrine and clinical findings . In addition , the development of moderate or severe OHSS in completed cycles was higher in group 1 . The pregnancy rate and miscarriage rates in the two treatment groups were similar . The authors propose that laparoscopic ovarian electrocautery is a potentially useful treatment for women who have previously had an IVF treatment cycle cancelled due to risk of OHSS or who have suffered OHSS in a previous treatment cycle BACKGROUND Laparoscopic ovarian diathermy ( LOD ) is currently accepted as a successful second-line treatment for ovulation induction ( OI ) in clomiphene citrate (CC)-resistant women with polycystic ovary syndrome ( PCOS ) . The aim of this study was to test the hypothesis that LOD may be superior to CC as a first-line treatment . METHODS The study included 72 anovulatory women with PCOS who were r and omized to LOD ( n = 36 ) or CC ( n = 36 ) . Women who remained anovulatory after LOD were offered CC . Similarly , women receiving CC who failed to ovulate or conceive were offered LOD . Pregnancy rates were compared between the two groups using chi(2 ) and odds ratio with 95 % confidence interval ( OR , 95 % CI ) . RESULTS After r and omization , six women conceived before starting treatment and another patient postponed treatment . The remaining 65 women received the treatment ( 33 underwent LOD and 32 received CC ) . After the primary treatment , more pregnancies ( 44 % ) occurred in women receiving CC than in those undergoing LOD ( 27 % ) , although the difference did not reach statistical significance [ P = 0.13 , OR 2.1 ( 0.7 - 5.8 ) ] . After adding the second treatment , the pregnancy rate was still higher , but to a less extent , in the CC group [ 63 % versus 52 % , P = 0.2 , OR 1.6 ( 0.6 - 4.2 ) ] . CONCLUSIONS LOD is not superior to CC as a first-line method of OI in women with PCOS . The trial is registered with Clinical Trials.gov with an identifier number NCT00220545 The diagnostic criteria used to identify patients suffering from polycystic ovary syndrome remain controversial . The present prospect i ve longitudinal follow-up study was design ed to identify whether certain criteria assessed during st and ardized initial screening could predict the response to ovulation induction with clomiphene citrate ( CC ) in 201 patients presenting with oligomenorrhea or amenorrhea and infertility . Serum FSH levels were within the normal range ( 1 - 10 IU/L ) , and all patients underwent spontaneous or progestin-induced withdrawal bleeding . Initial CC doses were 50 mg daily for 5 days starting on cycle day 3 . In the case of an absent response , doses were increased to 100 and 150 mg daily in subsequent cycles . First ovulation with CC was used as the end point . After a complete follow-up ( in the case of a nonresponse , at least 3 treatment cycles with daily CC doses up to 150 mg ) , 156 patients ( 78 % ) ovulated . The free and rogen index ( FAI = testosterone/sex hormone-binding globulin ratio ) , body mass index ( BMI ) , cycle history ( oligomenorrhea vs. amenorrhea ) , serum and rogen ( testosterone and /or and rostenedione ) levels , and mean ovarian volume assessed by transvaginal sonography were all significantly different ( P < 0.01 ) Output:	There was no evidence of a difference in the live birth rate and miscarriage rate in women with clomiphene-resistant PCOS undergoing LOD compared to gonadotrophin treatment . The reduction in multiple pregnancy rates in women undergoing LOD makes this option attractive .
MS22309	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: One hundred sixteen consecutive patients entered a functional restoration treatment program for chronic low back pain and were compared with 72 patients not treated . A two-year follow-up survey reached more than 85 % of both groups ; its findings were compared with earlier results of a five-month and one-year follow-up . Analysis demonstrated that 87 % of the treatment group was actively working after two years , as compared with only 41 % of the nontreatment comparison group . Moreover , about twice as many of the comparison group patients had additional spine surgery relative to the treatment group . The comparison group continued with an approximately five times higher rate of patient visits to health professionals in the second year as the treatment group . Also , treatment group reinjury rates were no higher than those expected in the general population , while nontreatment subjects had a higher incidence of reinjury . Finally , a small treatment " dropout " group did poorest of all , with results in almost all areas even worse than those of the comparison group patients The aim of this study was to evaluate an intensive , multidisciplinary functional restoration program for people with chronic low back pain . The program was compared to a non-treated control group in project A , and to less intensive treatment programs in project B. Both projects were r and omized and observer blinded . Two hundred and thirty-eight patients were included , 106 entering project A and 132 project B. All had had chronic low back disability of at least six months duration , with an average of one year 's sick leave due to low back pain over the last three years . Their average age was 41 years . The results at follow-up ( conducted four months after treatment , follow-up rate 90 % in project A and 86 % in project B ) showed that 67 % of the treated patients in project A were able to work compared to 28 % in the control group . In project B , 75 % of the patients treated in the functional restoration program were able to work , the corresponding numbers from the less intensive programs being 48 % and 40 % . Numbers of days of sick leave , contacts to the health-care system and pain- and disability-scores were significantly lower for the patients treated in the functional restoration program compared to the other groups in both projects . Functional restoration is more expensive to carry out , but the long-term benefits in form of reductions in pensions , sick leave and contacts to the health-care system , not to mention reduced pain for the patients , seems to justify this expenditure Study Design This was a study of a st and ardized functional restoration program that included 11 centers in saven states , involving 303 patients in the treatment group and 94 patients in the comparison group . Objective To illustrative the positive effect a functional restoration program has on return to work rates and work retention regardless of previous surgical intervention . Summary of Background Data Data were obtained from the initial and discharge evaluations as well as at 6− and 12-month follow-up . Methods Patients received a st and ardized work capacity assessment upon entrance and were recommended to the program if they adhered to specific entrance criteria . Treatment patients received the same evaluation at discharge . Results Significant improvement in functional abilities , actual return to work , and work retention were noted in the treatment group regardless of treatment intervention . Conclusions This study demonstrated improved return to work rates and work retention with surgical and nonsurgical patients after their participation in a functional restoration program & NA ; The effects of outpatient group cognitive therapy , relaxation training , and cognitive therapy in combination with relaxation training on chronic low back pain and associated physical and psychosocial disability were evaluated and compared . One‐hundred and two mildly disabled chronic low back pain patients were assigned r and omly to a waiting‐list ( WL ) control condition and the 3 treatments . Patient self‐report and observational measures were obtained pretreatment and post‐treatment for all conditions , and at 6‐ and 12‐month follow‐ups for the treatment conditions . Pain intensity decreased significantly pre‐ to post‐treatment for patients in all 3 treatment conditions , but not the WL condition . Depressive symptoms and disability improved significantly in all conditions ( including the waiting list ) from pretreatment to post‐treatment , with no statistically significant differences among treatments . At both follow‐ups , all 3 treatment groups remained significantly improved from pretreatment , with no statistically significant differences between treatments & NA ; This study reports a 9–18 month follow‐up of a r and omised controlled trial of pain management programmes for chronic , non‐malignant pain . Twenty‐two in patients , 18 out patients and 12 control subjects completed the follow‐up assessment s. Significant treatment effects were demonstrated by the inpatient group on pain ratings , the Pain Behaviour Checklist , and General Health Question naire , with similar effects demonstrated by the outpatient group on the former 2 measures . The findings were confounded by higher inpatient scores at pretreatment , in comparison with the 2 other conditions . There was a high drop‐out rate of subjects , particularly from the control condition which illustrates the limitations of controlled group design s in this area . Analgesic use , activity levels and pain ratings were also evaluated using the criteria for ‘ success ’ described by Malec et al. ( 1981 ) . Results indicated that 68 % of in patients , 61 % of out patients and 21 % of control subjects met all 3 criteria . Both treatment programmes were effective in returning patients to paid employment , whilst 3 control group patients gave up work . The cost‐benefit implication s of these changes are discussed . We conclude that pain management programmes contribute substantially to the rehabilitation of chronic pain sufferers OBJECTIVE To evaluate a progressive fitness programme for patients with chronic low back pain . DESIGN Single blind r and omised controlled trial . Assessment s were carried out before and after treatment by an observer blinded to the study and included a battery of vali date d measures . All patients were followed up by postal question naire six months after treatment . SETTING Physiotherapy department of orthopaedic hospital . SUBJECTS 81 patients with chronic low back pain referred from orthopaedic consultants for physiotherapy . The patients were r and omly allocated to a fitness programme or control group . INTERVENTION Both groups were taught specific exercises to carry out at home and referred to a back-school for education in back care . Patients allocated to the fitness class attended eight exercise classes over four weeks in addition to the home programme and backschool . RESULTS Significant differences between the groups were shown in the changes before and after treatment in scores on the Oswestry low back pain disability index ( P < 0.005 ) , pain reports ( sensory P < 0.05 and affective P < 0.005 ) , self efficacy reports ( P < 0.05 ) , and walking distance ( P < 0.005 ) . No significant differences between the groups were found by the general health question naire or question naire on pain locus of control . A benefit of about 6 percentage points on the disability index was maintained by patients in the fitness group at six months . CONCLUSION There is a role for supervised fitness programmes in the management of moderately disabled patients with chronic low back pain . Further clinical trials , however , need to be established in other centres to confirm these findings A prospect i ve r and omized study of 542 injured workers with continuing pain compared 271 workers who were treated at either one of two clinics that provided functional restoration with a control group of 271 subjects . Chronic pain was caused by low back injury in 78 % of patients ; 79 % of those treated were at work 12 months after completion of treatment compared with 78 % of the control subjects . When the patients were divided into subsets , based on the accident date and followed monthly , the duration of absence from work , the compensation costs , the disability award costs , and the total costs were less for those treated than the control subjects , but these were not statistically significant . Using the difference in total costs as a measure of relative success , back injuries had better results than other injuries in this study A group of 109 patients with unilateral low back pain for over three months were r and omised to receive one of three types of injection treatment : cortisone and local anaesthetic injected into two facet joints ( 28 ) , the same mixture around two facet joints ( 39 ) , or physiological saline into two facet joints ( 42 ) . The effect of the treatment was evaluated in relation to work attendance , pain , disability and movements of the lumbar spine . Patients were examined one hour and two and six weeks after treatment and also completed a question naire after three months . A significant improvement was observed in work attendance , pain and disability scores , but this was independent of the treatment given and movements of the lumbar spine were not improved . Of the 70 patients with initial pain relief after injection , 36 % reported persisting benefit at the three month follow-up , independent of the mode of treatment given . We conclude that facet joint injection is a non-specific method of treatment and the good results depend on a tendency to spontaneous regression and to the psychosocial aspects of back pain Chronic back/joint pain patients participated in a comparative study of relaxation and operant therapies for chronic pain . Patients were r and omly assigned to : ( 1 ) a waiting-list control , or to either ( 2 ) an applied relaxation , or ( 3 ) an applied relaxation plus operant conditioning treatment programme . Waiting patients were subsequently r and omly assigned to active treatment . The results indicated that the treatment groups tended to do significantly better than the waiting-list control group for pain , medicine use , activity , and depression , but there were few clear differences between the treatment groups . Applied relaxation plus the operant programme was significantly better than relaxation for medicine reduction , and applied relaxation was better than relaxation and operant conditioning for a patient evaluation of reaching treatment goals . Within-group and single-subject analyses indicated that there were significant improvements between pre- and post-tests for the treatment groups , but not for the waiting-list control group . Follow-up data indicated maintenance , and that applied relaxation had significantly lower pain ratings than applied relaxation plus operant conditioning . Taken as a whole , the results show that applied relaxation can produce significant decreases in pain , and that the addition of an operant programme does not improve pain reductions , but does tend to improve results with activity and especially medicine intake variables The results of a r and omized clinical trial can be reported using relative and /or absolute estimators of treatment effect . These various measures convey different information , and the choice can influence the physician 's appreciation of the size of treatment effect and , subsequently , treatment decisions . We compare the estimators with respect to the clinical ly relevant information conveyed to physicians , and identify which clinical questions can and can not be answered directly by each . We also identify opportunities for misinterpretation when one estimator is substituted for another , or when an estimator is mislabeled . Clinical ly important questions are addressed most directly by reporting both relative and absolute effects using relative risk and its complement , relative risk reduction , and risk difference and its reciprocal , number needed to treat . This is true of estimates of treatment effect derived from a single trial and also from meta- analysis of a group of trials . Because the control group 's risk affects the numerical value of the odds ratio , the odds ratio can not substitute for the risk ratio in conveying clinical ly important information to physicians . This is especially important when large treatment effects are shown in trials carried out in population s at high baseline risk Study Design The authors conducted a controlled clinical trial with 1-year follow-up to define the effectiveness of an intensive physical and psychosocial training program on patients with low back pain . Summary of Background Data The intervention group included 152 patients ( mean age 40.5 yr , Million index 45.1/100 ) , and the reference group included 141 patients ( mean age 40.4 yr , Million index 44.5/100 ) . Methods The progressive intervention program consisted of intensive physical training and psychosocial activation . The outcomes were physical and psychosocial measures , the pain and disability index ( Million ) , sick leaves , and occupational h and icap . Results The intervention was more efficient with respect to physical measures and pain and disability index . There were only mild or no differences in changes between the study groups in psychology variables , sick leaves , or retirement . Conclusions The intervention program could improve physical disability , but to improve occupational h and icap , activities of the whole society ( social legislation , labor market policy ) are needed Inpatient and outpatient treatments were compared with a control intervention in 288 men and 168 women , aged 35 - 54 , who were at work , but suffered from chronic or recurrent low back pain . Physical measurements and back pain assessment s were carried out before the intervention and at a 3-month follow-up . Physical fitness improved most in the in patients , but the out patients did not differ from the controls . Correlations between back pain and physical measurements indicated that increase of lumbar and hip mobility was more important than increase of trunk strength for subjective progress in these patients . Increased trunk extension strength correlated significantly with subjective progress in women , who also had higher correlations between improved physical fitness and progress than men In a r and omized , observer-blind trial , 150 men and women , aged 21 - 64 years , with chronic/subchronic low-back pain , followed one of these three treatment regimens : 1 ) intensive , dynamic back-muscle exercises ; 2 ) conventional physiotherapy , including isometric exercises for the trunk and leg muscles ; and 3 ) placebo-control treatment involving semihot packs and light traction . Eight treatment sessions were given during the course of 4 weeks , each session lasting 1 hour . The short-term effect was evaluated at the end of the treatment period and 1 month later , and the long-term effect at 6 and 12 months . The evaluations included recording of changes in pain level and assessment of overall treatment effect , which were indicated on visual interval scales . Subgroups of patients could be identified according to their treatment responses : physiotherapy was the superior treatment for the male participants , whereas the intensive back exercises appeared to be most efficient for the female participants . Patients with moderate or hard physical occupations tended toward a better response with physiotherapy , whereas intensive back exercises seemed most effective for those with sedentary/light job functions Patients with chronic disabling low-back pain have poor prospect s of returning to work . The authors tested a treatment program of functional restoration with behavioral support through 1 year prospect i ve observation of patients disabled for an average of 19 months without evidence of surgically correctable disease . Ninety patients were studied : 59 program graduates , five Output:	There was strong evidence that intensive multidisciplinary bio-psycho-social rehabilitation with a functional restoration approach improved function when compared with inpatient or outpatient non-multidisciplinary treatments . There was moderate evidence that intensive multidisciplinary bio-psycho-social rehabilitation with a functional restoration approach improved pain when compared with outpatient non-multidisciplinary rehabilitation or usual care . There was contradictory evidence regarding vocational outcomes of intensive multidisciplinary bio-psycho-social intervention . Some trials reported improvements in work readiness , but others showed no significant reduction in sickness leaves . Less intensive outpatient psycho-physical treatments did not improve pain , function or vocational outcomes when compared with non-multidisciplinary outpatient therapy or usual care . Few trials reported effects on quality of life or global assessment s. REVIEW ER 'S CONCLUSIONS The review ed trials provide evidence that intensive multidisciplinary bio-psycho-social rehabilitation with a functional restoration approach improves pain and function . Less intensive interventions did not show improvements in clinical ly relevant outcomes
MS22310	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: PURPOSE The purpose of this study was to compare the effects of enhanced milieu teaching ( EMT ) implemented by parents and therapists versus therapists only on the language skills of preschool children with intellectual disabilities ( IDs ) , including children with Down syndrome and children with autism spectrum disorders . METHOD Seventy-seven children were r and omly assigned to 2 treatments ( parent + therapist EMT or therapist-only EMT ) and received 36 intervention sessions . Children were assessed before , immediately after , 6 months after , and 12 months after intervention . Separate linear regressions were conducted for each st and ardized and observational measure at each time point . RESULTS Parents in the parent + therapist group demonstrated greater use of EMT strategies at home than untrained parents in the therapist-only group , and these effects maintained over time . Effect sizes for observational measures ranged from d = 0.10 to d = 1.32 favoring the parent + therapist group , with the largest effect sizes found 12 months after intervention . CONCLUSION Findings from this study indicate generally that there are benefits to training parents to implement naturalistic language intervention strategies with preschool children who have ID and significant language impairments The outcomes of a r and omized clinical trial of a new behavioral family intervention , Stepping Stones Triple P , for preschoolers with developmental and behavior problems are presented . Forty-eight children with developmental disabilities participated , 27 r and omly allocated to an intervention group and 20 to a wait-list control group . Parents completed measures of parenting style and stress , and independent observers assessed parent-child interactions . The intervention was associated with fewer child behavior problems reported by mothers and independent observers , improved maternal and paternal parenting style , and decreased maternal stress . All effects were maintained at 6-month follow-up OBJECTIVE : Early interventions for toddlers with expressive and receptive language delays have not result ed in positive expressive language outcomes . This r and omized controlled trial tested the effects on language outcomes of a caregiver-implemented communication intervention targeting toddlers at risk for persistent language delays . METHODS : Participants included 97 toddlers , who were between 24 and 42 months with language scores at least 1.33 SDs below the normative mean and no other developmental delays , and their caregivers . Toddlers were r and omly assigned to the caregiver-implemented intervention or a usual-care control group . Caregivers and children participated in 28 sessions in which caregivers were taught to implement the intervention . The primary outcome was the Preschool Language Scale , Fourth Edition , a broad-based measure of language . Outcome measurement was not blinded . RESULTS : Caregivers in the intervention improved their use of all language facilitation strategies , such as matched turns ( adjusted mean difference , intervention-control , 40 ; 95 % confidence interval 34 to 46 ; P < .01 ) . Children in the intervention group had significantly better receptive language skills ( 5.3 ; 95 % confidence interval 0.15 to 10.4 ) , but not broad-based expressive language skills ( 0.37 , 95 % confidence interval −4.5 to 5.3 ; P = .88 ) . CONCLUSIONS : This trial provides preliminary evidence of the short-term effects of systematic caregiver instruction on caregiver use of language facilitation strategies and subsequent changes in children ’s language skills . Future research should investigate the ideal dosage levels for optimizing child outcomes and determine which language facilitation strategies are associated with specific child outcomes . Research on adaptations for families from culturally and linguistically diverse background s is needed PURPOSE The authors examined ( a ) whether dose frequency of milieu communication teaching ( MCT ) affects children 's canonical syllabic communication and ( b ) whether the relation between early canonical syllabic communication and later spoken vocabulary is mediated by parental linguistic mapping in children with intellectual disabilities ( ID ) . METHOD The authors drew on extant data from a recent differential treatment intensity study in which 63 toddlers with ID were r and omly assigned to receive either five 1-hr MCT sessions per week ( i.e. , daily treatment ) or one 1-hr MCT session per week ( i.e. , weekly treatment ) for 9 months . Children 's early canonical syllabic communication was measured after 3 months of treatment , and later spoken vocabulary was measured at posttreatment . Midpoint parental linguistic mapping was measured after 6 months of treatment . RESULTS A moderate-sized effect in favor of daily treatment was observed on canonical syllabic communication . The significant relation between canonical syllabic communication and spoken vocabulary was partially mediated by linguistic mapping . CONCLUSIONS These results suggest that canonical syllabic communication may elicit parental linguistic mapping , which may in turn support spoken vocabulary development in children with ID . More frequent early intervention boosted canonical syllabic communication , which may jump-start this transactional language -learning mechanism . Implication s for theory , research , and practice are discussed Parents of children with a developmental disability require tailored parenting support , as their families have special needs and are at risk of increased burden . The aim of this study was to evaluate the efficacy of the Stepping Stones Triple P seminars , a brief group intervention for parents of a child with a disability . There were two seminars that presented parenting strategies to improve both child behavior and parenting variables implicated in the development and maintenance of child problem behavior . Fifty-three parents participated in this r and omized controlled trial . Each had a child , aged two to ten , with a disability . The results indicated significant reductions in child behavior problems , the use of dysfunctional parenting styles , and parental conflict reported by parents in the intervention group compared to a waitlist group . The results were maintained at 3-month follow-up and there was evidence of a sleeper effect for parenting confidence . This study demonstrated that the seminars provide a promising intervention for parents of children with a disability . Limitations and implication s for future research are also discussed Routines-based early intervention ( RBEI ) for children with or at risk for developmental delay encourages collaboration between professionals and families to enhance children 's participation in family routines with family-selected goals . We conducted the first single-blinded r and omized control trial to examine the effectiveness of a 6-month RBEI vs. traditional home visiting ( THV ) , which uses a curriculum focused on children 's developmental domains . Thirty-one families with children aged 5 - 30 months ( mean age 17.4 months ) with or at risk for developmental delay were r and omly assigned to an RBEI group ( n=15 ) or a THV group ( n=16 ) . The enrolled children were evaluated using the Chinese version of Pediatric Evaluation of Disability Inventory ( PEDI-C ) and the Comprehensive Development Inventory for Infants and Toddlers ( CDIIT ) at 5 time points . Two-way mixed analysis of variance ( ANOVA ) was used to examine the group by stage interactions . Goal Attainment Scaling ( GAS ) and the Canadian Occupational Performance Measure ( COPM ) were applied to explore between-group differences on individualized goal achievement . PEDI-C showed that the RBEI group had a faster progress rate in self-care functions and independence in social functions in the first 3 months of intervention and at the 6-month follow-up . The RBEI group also scored higher on the GAS in the first 3 months of intervention . However , between-group differences in changes in the developmental domains on the CDIIT were not significant . Thus , RBEI was more effective than THV in promoting functional outcomes and reaching family-selected goals , while both interventions allowed equal improvement in developmental domains The CONSORT ( Consoli date d St and ards of Reporting Trials ) statement is used worldwide to improve the reporting of r and omized , controlled trials . Schulz and colleagues describe the latest version , CONSORT 2010 , which up date s the reporting guideline based on new method ological evidence and accumulating experience . Family systems theory posits that the relative effectiveness of early interventions will vary depending on various aspects of the family . This study tested whether maternal responsivity would predict the extent to which Prelinguistic Milieu Teaching ( PMT ) facilitated generalized intentional communication better than a contrast treatment that was conducted in a small group by a responsive adult ( i.e. , Responsive Small Group , RSG ) . Fifty-eight children with developmental disabilities in the prelinguistic communication period of development were r and omly assigned to one of the two staff-implemented treatment groups . Thirty were assigned to RSG ; 28 were assigned to PMT . Mothers were kept naive to the intervention methods , hypotheses , and measures . In families with mothers who responded to a high percentage of the children 's communication acts at the pre-treatment period , the children in the PMT group used more frequent intentional communication in post-treatment generalization sessions with a trainer and mothers than did children in the RSG group . In the families with mothers who responded to fewer than 39 % of their children 's communication acts , children in the RSG intervention used more frequent intentional communication in post-treatment generalization sessions with the mothers than did children in the PMT intervention . Other family variables and no child variables that we measured could account for these findings AIM This study aim ed to evaluate the efficacy of a parent education program , the Happy Parenting program , for Chinese preschool children with developmental disabilities . METHODS This study adopted r and omized controlled trial design without blinding . Participants were r and omized into intervention group ( n=62 ) who were offered the Happy Parenting program delivered by educational psychologists and trainee educational psychologists , and a control group ( n=57 ) who were offered a parent talk after the intervention group had completed treatment . Parent participants were requested to complete question naires on their children 's behavior , their parenting stress , and discipline strategies . RESULTS Analysis was by intention-to-treat . The results indicated significant decrease in child problem behaviors , parenting stress and dysfunctional discipline strategies in the intervention group at post-intervention . CONCLUSION This study provided promising evidence on the effectiveness of a parent education program , the Happy Parenting program , for Chinese preschool children with developmental disabilities We design ed a parent-directed home-visiting intervention targeting socioeconomic status ( SES ) disparities in children 's early language environments . A r and omized controlled trial was used to evaluate whether the intervention improved parents ' knowledge of child language development and increased the amount and diversity of parent talk . Twenty-three mother-child dyads ( 12 experimental , 11 control , aged 1;5 - 3;0 ) participated in eight weekly hour-long home-visits . In the experimental group , but not the control group , parent knowledge of language development increased significantly one week and four months after the intervention . In lab-based observations , parent word types and tokens and child word types increased significantly one week , but not four months , post-intervention . In home-based observations , adult word tokens , conversational turn counts , and child vocalization counts increased significantly during the intervention , but not post-intervention . The results demonstrate the malleability of child-directed language behaviors and knowledge of child language development among low-SES parents PURPOSE To evaluate the longitudinal effects of a 6-month course of responsivity education (RE)/prelinguistic milieu teaching ( PMT ) for young children with developmental delay . METHOD Fifty-one children , age 24 - 33 months , with fewer than 10 expressive words were r and omly assigned to early-treatment/no-treatment groups . All treatment was added as a supplement to services that the children received in the community . Follow-up data were collected 6 and 12 months after the conclusion of the initial 6-month treatment/no-treatment conditions . RESULTS No effects of this treatment were detected 6 or 12 months after the conclusion of the initial treatment condition . CONCLUSIONS M. E. Fey et al. ( 2006 ) reported that 6 months of RE/PMT led to a significant treatment effect in the use of intentional communication in 1 of 2 communication sampling context s. This finding , combined with evidence from other studies , suggests that RE/PMT may be applied clinical ly at low intensity with the expectation of medium-sized effects on children 's rate of intentional communication acts over the short term . The results of the present study , however , provide no evidence for the anticipated longer term benefits of this intervention . Further investigation of the approach at higher intensity levels and for longer periods of time is warranted This article presents results of a r and omized controlled trial examining the efficacy of Parent – Child Interaction Therapy ( PCIT ) for treating disruptive behaviors of young children ( ages 3 to 6 ) with mental retardation ( MR ) and comorbid oppositional defiant disorder . Thirty families were r and omly assigned to an immediate treatment ( IT ) or waitlist ( WL ) control group . Results indicated that IT mothers interacted more positively with their children after treatment than WL mothers , and their children were more compliant after treatment . On parent-report measures , IT mothers reported fewer disruptive behaviors at home and lower parenting stress related to difficult child behavior than WL mothers after treatment . Whether evidence -based treatments for disruptive behavior require modification before application to children with MR is discussed This study assesses the longitudinal effects of an original early intervention programme on the adaptation of parents of children with a disability ( Down syndrome and cleft lip/palate , i.e. DS and CLP ) . Variations in the effects of the programme according to the time of measurement , the type of disability and parent 's gender are also examined . Globally , the results show a better adaptation among parents who participated in the intervention programme compared to those who did not participated in the programme . These parents had lower levels of parental stress , they had more positive perceptions and attitudes concerning their child 's disability and their parental situation , they were more confident in their own re sources and the help they could receive from others , they had lower levels of emotional distress , anxiety and depression and they perceived more emotional support from their spouse . In general , these gains were maintained throughout the year when the children were between six and 18 months of age , they were relatively similar for parents of children with DS and parents of children with CLP , as well as for mothers and fathers The interactive model of language intervention instructs parents to use techniques that promote reciprocal Output:	There is currently insufficient evidence to determine the effects of parent-mediated interventions for improving the language and communication of children with Down syndrome .
MS22311	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: BACKGROUND Pulmonary dysfunction is still a major problem in coronary artery bypass grafting ( CABG ) . The purpose of this r and omized study was to determine the effect of different CABG techniques on pulmonary function . METHODS Fifty eight patients with severe obstructive pulmonary disease had elective isolated coronary surgery . The surgical methods for the patients with chronic obstructive pulmonary disease ( COPD ) were st and ard CABG in 18 patients ( group 1 ) , beating heart surgery in 19 patients ( group 2 ) , and minimally invasive direct coronary artery bypass grafting ( MIDCABG ) in 21 patients ( group 3 ) . RESULTS The earliest extubation time was from group 3 ( p < 0.001 ) . The average stay in the intensive care unit was significantly longer in group 1 ( 2.6 + /- 1.5 days ) than in groups 2 ( 1.4 + /- 0.8 days ) and 3 ( 1.1 + /- 0.8 days ) ( p < 0.05 ) . The most prevalent respiratory morbidity was atelectasis that developed in 6 patients from group 1 , in 2 patients from group 2 , and in 3 patients from group 3 . Forced expiratory volumes in 1 second ( FEV1 ) obtained in the second postoperative month were significantly lower than preoperative values only in group 1 ( p < 0.05 ) . Forced vital capacity ( FVC ) values were significantly lower than the preoperative values in all three groups ( p < 0.05 ) . CONCLUSIONS Off-pump bypass surgical procedures are more advantageous than on-pump methods for patients with COPD . These patients can be operated on using the beating heart technique or by using MIDCABG to prevent side effects of CPB on pulmonary function and effects of sternotomy OBJECTIVE The authors performed a retrospective cost analysis for patients undergoing revascularization of their left anterior descending ( LAD ) coronary artery either by st and ard coronary artery bypass grafting ( CABG ) , percutaneous transluminal coronary angioplasty ( PTCA ) , or minimally invasive coronary artery bypass grafting ( MICABG ) . SUMMARY BACKGROUND DATA Minimally invasive CABG has become a safe and effective alternative treatment for single-vessel coronary artery disease . However , the acceptance of this procedure as a routine alternative for the treatment of coronary artery disease will depend on both long-term graft patency rates as well as a competitive market cost . METHODS The authors conducted a retrospective analysis of three patient groups undergoing LAD coronary revascularization from January 1995 to July 1996 . Ten patients were selected r and omly from this period after PTCA of an LAD lesion with or without stenting . Nine patients underwent st and ard CABG on cardiopulmonary bypass with a left internal mammary artery . Nine patients received MICABG via a limited left anterior thoracotomy and left internal mammary artery to LAD grafting without the use of cardiopulmonary bypass . RESULTS Percutaneous transluminal coronary angioplasty ( n = 10 ) was unsuccessful in two patients . One patient in the MICABG group ( n = 9 ) was converted successfully to conventional CABG because of an intramyocardial LAD and dilated left ventricle . There was no operative morbidity or mortality in any group . Average length of stay postprocedure was decreased significantly for both the MICABG and PTCA groups when compared with that of conventional CABG ( n = 9 ) ( 2.7 + 0.26 , p = 0.009 , and 2.6 + 0.54 , p = 0.006 , vs. 4.8 + 0.46 , respectively ) . Total hospital costs for the MICABG and PTCA groups were significantly less when compared with those of st and ard CABG ( $ 10,129 + 1104 , p = 0.0028 , and $ 9113 + 3,039 , p = 0.0001 , vs. $ 17,816 + 1043 , respectively ) . There were no statistically significant differences between the MICABG and PTCA groups . CONCLUSIONS The final role of minimally invasive CABG is unclear . This procedure is clearly cost effective when compared with that of PTCA and conventional CABG . The long-term patency rates for MICABG will determine its overall efficacy OBJECTIVE In order to evaluate the traumatic effects of median sternotomy and cardiopulmonary bypass ( CPB ) in conventional and minimally invasive coronary artery bypass grafting , inflammatory response was studied in a prospect i ve r and omized trial in patients referred to single-vessel coronary artery bypass grafting . METHODS Four surgical techniques were compared : group 1 , median sternotomy with CPB in ten patients ( eight male , two female ; aged 59.6+/-11.0 years ( mean+/-SD ) ) ; group 2 , median sternotomy and off-pump in ten patients ( seven male , three female ; aged 65.1+/-10.0 years ) ; group 3 , minithoracotomy with CPB in ten patients ( seven male , three female , aged 61.2+/-10.4 years ) ; group 4 , minithoracotomy and off-pump in ten patients ( nine male , one female , aged 62.9+/-9.8 years ) . All patients received a left internal mammary artery graft to the left anterior descending artery ( LAD ) . Clinical data , perioperative values of cytokines and cardiac enzymes were monitored . RESULTS There were no major complications . Troponin-T and creatine kinase isoenzyme MB ( CK-MB ) levels were significantly higher in CPB procedures ( P<0.0056 ; multivariate general linear model ) . Interleukin-6 ( IL-6 ) levels were significantly higher in minithoracotomy procedures . Interleukin-1 ( IL-1 ) was significantly increased in all patients compared with the preoperative values . CONCLUSIONS The use of CPB is combined with higher levels of troponin-T and CK-MB as signs of myocardial damage . Surgical access was identified as a trigger of inflammatory response , as minithoracotomy is related to higher levels of IL-6 . IL-1 increased in all procedures and this occurred independently of the surgical access or the use of CPB , which points out a potential relationship between inflammatory response and anesthesia . Neither CPB nor surgical access influenced the clinical outcome in the treatment of coronary artery single-vessel bypass grafting BACKGROUND This study compares conventional coronary artery bypass grafting ( CABG ) with port access CABG via a left anterior small thoracotomy in patients requiring surgical multivessel revascularization . Clinical , neuropsychological , and angiographic outcomes were studied , as well as parameters of myocardial and cerebral protection . Pathogenicity of cardiopulmonary bypass ( CPB ) was further evaluated by measuring parameters of peripheral limb ischemia and inflammatory whole-body response . METHODS In a prospect i ve r and omized study , 40 patients who required multivessel CABG were assigned to either conventional CABG via complete median sternotomy ( group A ) or port access CABG via minithoracotomy ( group B ) . Control angiograms were performed in group B only . In addition , patients underwent neuropsychological testing after the operation . CK , CK-MB , and Troponin T levels were documented . S-100B protein and neuron-specific enolase ( NSE ) served to quantify cerebral injury . The terminal complement complex ( C5b-9 ) and myeloperoxidase concentrations were determined to analyze inflammatory whole-body response after CPB . RESULTS There was no mortality . One patient suffered a retro grade aortic dissection immediately after onset of CPB , but had an uneventful postoperative course after surgical repair . Troponin T and CK-MB showed no difference between groups . CK and myoglobin were significantly higher in the minimally invasive cohort . Changes in complement activation ( C5b-9 ) and myeloperoxidase during CPB markers of the whole-body inflammatory response were similar in both groups . S-100B concentrations in the port access group were significantly higher , whereas NSE levels were similar in both groups . Both groups did not display any significant difference in neuropsychological testing . CONCLUSIONS Minimally invasive multivessel CABG via minithoracotomy using port access technology is feasible and safe . Though prolonged operating and CPB times with significantly higher S-100B concentrations were observed in group B , equivalent myocardial and cerebral protection and similar whole-body inflammatory response were documented OBJECTIVE Minimally invasive coronary artery bypass grafting is safe and widely applicable , and may be associated with fewer transfusions and infections , and better recovery than st and ard coronary artery bypass grafting . However , graft patency rates remain unknown . The Minimally Invasive Coronary Artery Bypass Grafting Patency Study prospect ively evaluated angiographic graft patency 6 months after minimally invasive coronary artery bypass grafting . METHODS In this dual-center study , 91 patients were prospect ively enrolled to undergo minimally invasive coronary artery bypass grafting via a 4- to 7-cm left thoracotomy approach . The left internal thoracic artery , the ascending aorta for proximal anastomoses , and all coronary targets were directly accessed without endoscopic or robotic assistance . The study primary outcome was graft patency at 6 months , using 64-slice computed tomography angiography . Secondary outcomes included conversions to sternotomy and major adverse cardiovascular events ( Clinical Trial Registration Unique identifier : NCT01334866 ) . RESULTS The mean age of patients was 64 ± 8 years , the mean ejection fraction was 51 % ± 11 % , and there were 10 female patients ( 11 % ) in the study . Surgeries were performed entirely off-pump in 68 patients ( 76 % ) . Complete revascularization was achieved in all patients , and the median number of grafts was 3 . There was no perioperative mortality , no conversion to sternotomy , and 2 reopenings for bleeding . Transfusion occurred in 24 patients ( 26 % ) . The median length of hospital stay was 4 days , and all patients were followed to 6 months , with no mortality or major adverse cardiovascular events . Six-month computed tomography angiographic graft patency was 92 % for all grafts and 100 % for left internal thoracic artery grafts . CONCLUSIONS Minimally invasive coronary artery bypass grafting is safe , feasible , and associated with excellent outcomes and graft patency at 6 months post-surgery OBJECTIVE The results of mitral repair for complex Barlow valves are adequate and support earlier intervention . It is unknown whether these results are reproducible in the context of minimally invasive surgery via right minithoracotomy . METHODS We r and omized patients with Barlow mitral disease ( bileaflet prolapse ) to have conventional open repair via median sternotomy ( MS group ) or minimally invasive ( MI group ) repair . Repair was done using polytetrafluoroethylene chordal reimplantation for both leaflets . In the MI group , we adopted right minithoracotomy , peripheral cannulation , external aortic clamping , and surgery under direct vision . RESULTS Both groups comprised 70 patients . The operative and the cardiopulmonary bypass times were significantly longer in the MI group ( P = .003 and P = .012 ) . Mitral repair was successful in 98.5 % MI patients and 100 % MS patients . Operative mortality was comparable . The mean mechanical ventilation time , intensive care unit stay , and hospital stay were lower in the MI group ( P = .014 , P = .02 , and P = .03 , ) . Mean pain score was lower in the MI group at postoperative days 2 and 4 . At follow-up , the freedom from moderate ( 2 + ) or severe ( 3 + or 4 + ) mitral regurgitation was 98 % versus 97 % ( P = .9 ) . Two patients underwent reoperation ( 1 in each group ) for late failure of repair . The Kaplan-Meier analysis confirmed these results . CONCLUSIONS Our data indicate that the optimal st and ard-of-care results of mitral repair for complex disease ( Barlow ) are reproducible in the minimally invasive setting s through right minithoracotomy and direct vision . The minimally invasive technique can be proposed for complex mitral disease and early referral of these patients can be encouraged BACKGROUND AND AIM OF THE STUDY A prospect i ve r and omized study was performed to compare conventional with minimally invasive aortic valve replacement ( AVR ) . METHODS Forty consecutive patients scheduled for elective aortic valve surgery were prospect ively r and omized either to the conventional group ( group A , complete median sternotomy ) or minimally invasive group ( group B , partial upper sternotomy ) . Intraoperative and postoperative clinical data , and markers of myocardial and cerebral protection were determined . Neuropsychological tests were carried out to quantify psychological disorders . RESULTS Operative time and cardiopulmonary bypass time were slightly longer in group B , but not significantly so . No significant inter-group differences were found for postoperative pain scores and respiratory function . Chest tube drainage was significantly less in group B ( 495 + /- 165 versus 240 + /- 69 ml , p = 0 Output:	Minimally invasive cardiac surgery is as safe as conventional surgery and could reduce costs due to a shorter period spent in ICU
MS22312	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: BACKGROUND Several studies have shown the efficacy , tolerability , and ease of administration of pemetrexed-an antifolate antineoplastic agent-in patients with advanced non-small-cell lung cancer . We assessed pemetrexed as maintenance therapy in patients with this disease . METHODS This r and omised double-blind study was undertaken in 83 centres in 20 countries . 663 patients with stage IIIB or IV disease who had not progressed on four cycles of platinum-based chemotherapy were r and omly assigned ( 2:1 ratio ) to receive pemetrexed ( 500 mg/m(2 ) , day 1 ) plus best supportive care ( n=441 ) or placebo plus best supportive care ( n=222 ) in 21-day cycles until disease progression . Treatment was r and omised with the Simon and Pocock minimisation method . Patients and investigators were masked to treatment . All patients received vitamin B(12 ) , folic acid , and dexamethasone . The primary endpoint of progression-free survival and the secondary endpoint of overall survival were analysed by intention to treat . This study is registered with Clinical Trials.gov , number NCT00102804 . FINDINGS All r and omly assigned participants were analysed . Pemetrexed significantly improved progression-free survival ( 4.3 months [ 95 % CI 4.1 - 4.7 ] vs 2.6 months [ 1.7 - 2.8 ] ; hazard ratio [ HR ] 0.50 , 95 % CI 0.42 - 0.61 , p<0.0001 ) and overall survival ( 13.4 months [ 11.9 - 15.9 ] vs 10.6 months [ 8.7 - 12.0 ] ; HR 0.79 , 0.65 - 0.95 , p=0.012 ) compared with placebo . Treatment discontinuations due to drug-related toxic effects were higher in the pemetrexed group than in the placebo group ( 21 [ 5 % ] vs three [ 1 % ] ) . Drug-related grade three or higher toxic effects were higher with pemetrexed than with placebo ( 70 [ 16 % ] vs nine [ 4 % ] ; p<0.0001 ) , specifically fatigue ( 22 [ 5 % ] vs one [ 1 % ] , p=0.001 ) and neutropenia ( 13 [ 3 % ] vs 0 , p=0.006 ) . No pemetrexed-related deaths occurred . Relatively fewer patients in the pemetrexed group than in the placebo group received systemic post-discontinuation therapy ( 227 [ 51 % ] vs 149 [ 67 % ] ; p=0.0001 ) . INTERPRETATION Maintenance therapy with pemetrexed is well tolerated and offers improved progression-free and overall survival compared with placebo in patients with advanced non-small-cell lung cancer . FUNDING Eli Lilly BACKGROUND A r and omized phase 3 trial of the treatment of squamous-cell carcinoma of the head and neck compared induction chemotherapy with docetaxel plus cisplatin and fluorouracil ( TPF ) with cisplatin and fluorouracil ( PF ) , followed by chemoradiotherapy . METHODS We r and omly assigned 501 patients ( all of whom had stage III or IV disease with no distant metastases and tumors considered to be unresectable or were c and i date s for organ preservation ) to receive either TPF or PF induction chemotherapy , followed by chemoradiotherapy with weekly carboplatin therapy and radiotherapy for 5 days per week . The primary end point was overall survival . RESULTS With a minimum of 2 years of follow-up ( > or =3 years for 69 % of patients ) , significantly more patients survived in the TPF group than in the PF group ( hazard ratio for death , 0.70 ; P=0.006 ) . Estimates of overall survival at 3 years were 62 % in the TPF group and 48 % in the PF group ; the median overall survival was 71 months and 30 months , respectively ( P=0.006 ) . There was better locoregional control in the TPF group than in the PF group ( P=0.04 ) , but the incidence of distant metastases in the two groups did not differ significantly ( P=0.14 ) . Rates of neutropenia and febrile neutropenia were higher in the TPF group ; chemotherapy was more frequently delayed because of hematologic adverse events in the PF group . CONCLUSIONS Patients with squamous-cell carcinoma of the head and neck who received docetaxel plus cisplatin and fluorouracil induction chemotherapy plus chemoradiotherapy had a significantly longer survival than did patients who received cisplatin and fluorouracil induction chemotherapy plus chemoradiotherapy . ( Clinical Trials.gov number , NCT00273546 [ Clinical Trials.gov ] . ) BACKGROUND We studied the combination of pemetrexed , a multi-targeted antifolate , and cetuximab , an mAb against the epidermal growth factor receptor , with radiotherapy in poor prognosis head and neck cancer . PATIENTS AND METHODS Patients received pemetrexed on days 1 , 22 , and 43 on a dose-escalation scheme with starting level ( 0 ) 350 mg/m(2 ) ( level -1 , 200 mg/m(2 ) ; level + 1 , 500 mg/m(2 ) ) with concurrent radiotherapy ( 2 Gy/day ) and cetuximab in two separate cohorts , not previously irradiated ( A ) and previously irradiated ( B ) , who received 70 and 60 - 66 Gy , respectively . Genetic polymorphisms of thymidylate synthase and methylenetetrahydrofolate reductase were evaluated . RESULTS Thirty-two patients were enrolled . The maximum tolerated dose of pemetrexed was 500 mg/m(2 ) in cohort A and 350 mg/m(2 ) in cohort B. Prophylactic antibiotics were required . In cohort A , two dose-limiting toxicities ( DLTs ) occurred ( febrile neutropenia ) , one each at levels 0 and + 1 . In cohort B , two DLTs occurred at level + 1 ( febrile neutropenia ; death from perforated duodenal ulcer and sepsis ) . Grade 3 mucositis was common . No association of gene polymorphisms with toxicity or efficacy was evident . CONCLUSION The addition of pemetrexed 500 mg/m(2 ) to cetuximab and radiotherapy is recommended for further study in not previously irradiated patients Purpose This phase I study characterized the pharmacokinetics of free and total platinum derived from cisplatin administered alone and in combination with pemetrexed . Secondary objectives were to assess the pharmacokinetics of pemetrexed when it is combined with cisplatin as well as to evaluate the safety profile and document antitumor activity associated with this combination . Methods An open-label , two-arm , cross-over phase 1 study was performed in patients with squamous cell carcinoma of the head and neck , age ≥18 years , an Eastern Cooperative Oncology Group performance status of 0–2 , and adequate organ function . Blood sample s were taken and pharmacokinetics evaluated for the first two cycles using noncompartmental analysis . Patients received either pemetrexed ( 500 mg m−2 ) plus cisplatin ( 75 mg m−2 ) administered in cycle 1 followed by cisplatin alone in cycle 2 ; or in the reverse order ( i.e. , cisplatin alone in cycle 1 followed by pemetrexed plus cisplatin in cycle 2 ) . Each treatment cycle was 21 days and patients received folic acid , vitamin B12 supplementation , and dexamethasone prophylaxis . After the first two cycles , patients continued study treatment with pemetrexed plus cisplatin every 3 weeks up to a maximum of six total treatment cycles . Toxicities were grade d by the investigators according to the National Cancer Institute Common Toxicity Criteria for Adverse Events ( CTCAE ) , version 3.0 . Results A total of 13 patients were treated ; one patient was discontinued from the study after cycle 1 for failure to meet baseline eligibility criteria for renal function . The ratios and 90 % confidence intervals ( CI ) comparing the pharmacokinetics for cisplatin administered with pemetrexed to those for cisplatin administered alone for free platinum were : Cmax = 1.08 ( CI : 0.92 , 1.27 ) and AUC = 0.93 ( CI : 0.82 , 1.06 ) ; and , total platinum were : Cmax = 0.97 ( CI : 0.88 , 1.06 ) and AUC = 0.87 ( CI : 0.81 , 0.93 ) . These results indicate that platinum pharmacokinetics ( free and total ) are similar , whether cisplatin is administered alone or combined with pemetrexed . The pemetrexed pharmacokinetic results were consistent with those from previous single-agent pemetrexed studies and a previous study of pemetrexed in combination with cisplatin . The combination of pemetrexed and cisplatin did not show any unexpected toxicities . Consistent with the platinum pharmacokinetic results , co-administration with pemetrexed did not appear to enhance cisplatin-related toxicities . Of the 13 treated patients , 11 had stable disease as the best overall response and 2 had progressive disease . Conclusions The pharmacokinetics of free platinum derived from cisplatin were not altered by co-administration with pemetrexed , and in agreement with this , no unexpected cisplatin-induced toxicities were observed when these drugs were combined PURPOSE Patients with malignant pleural mesothelioma , a rapidly progressing malignancy with a median survival time of 6 to 9 months , have previously responded poorly to chemotherapy . We conducted a phase III trial to determine whether treatment with pemetrexed and cisplatin results in survival time superior to that achieved with cisplatin alone . PATIENTS AND METHODS Chemotherapy-naive patients who were not eligible for curative surgery were r and omly assigned to receive pemetrexed 500 mg/m2 and cisplatin 75 mg/m2 on day 1 , or cisplatin 75 mg/m2 on day 1 . Both regimens were given intravenously every 21 days . RESULTS A total of 456 patients were assigned : 226 received pemetrexed and cisplatin , 222 received cisplatin alone , and eight never received therapy . Median survival time in the pemetrexed/cisplatin arm was 12.1 months versus 9.3 months in the control arm ( P = .020 , two-sided log-rank test ) . The hazard ratio for death of patients in the pemetrexed/cisplatin arm versus those in the control arm was 0.77 . Median time to progression was significantly longer in the pemetrexed/cisplatin arm : 5.7 months versus 3.9 months ( P = .001 ) . Response rates were 41.3 % in the pemetrexed/cisplatin arm versus 16.7 % in the control arm ( P < .0001 ) . After 117 patients had enrolled , folic acid and vitamin B12 were added to reduce toxicity , result ing in a significant reduction in toxicities in the pemetrexed/cisplatin arm . CONCLUSION Treatment with pemetrexed plus cisplatin and vitamin supplementation result ed in superior survival time , time to progression , and response rates compared with treatment with cisplatin alone in patients with malignant pleural mesothelioma . Addition of folic acid and vitamin B12 significantly reduced toxicity without adversely affecting survival time BACKGROUND Concurrent chemoreirradiation therapy ( CRRT ) offers a therapeutic option for patients with locoregionally recurrent squamous cell carcinoma of the head and neck ( SCCHN ) . We hypothesized that response to induction chemotherapy ( IC ) would improve outcome and predict increased survival . PATIENTS AND METHODS Subjects with recurrent SCCHN not amenable to st and ard therapy were eligible . IC consisted of two 28-day cycles of gemcitabine and pemetrexed on days 1 and 14 , followed by surgical resection , if appropriate , and /or CRRT consisting of carboplatin , pemetrexed , and single daily fractionated radiotherapy . RESULTS Thirty-five subjects were enrolled , 31 were assessable for response , with 11 responders [ response rate = 35 % ; 95 % confidence interval ( CI ) 19.2 - 54.6 ] . Among 24 subjects who started CRRT , 11 were assessable for radiographic response , 4 complete response , 2 partial response , and 5 progressive disease . Median progression-free survival and overall survival ( OS ) were 5.5 months ( 95 % CI 3.6 - 8.3 ) and 9.5 months ( 95 % CI 7.2 - 15.4 ) , respectively . One-year OS was 43 % ( 95 % CI 26 % to 58 % ) . Subjects who responded to IC had improved survival ( Output:	Results for ORR , PFS , and /or OS in patients receiving pemetrexed in combination with other chemotherapeutic agents and /or radiotherapy were promising in the first-line treatment setting . Pemetrexed was associated with acceptable grade 3 - 4 hematologic toxicities ; it did not result in nonhematologic toxicities commonly seen with cisplatin , such as nephrotoxicity , ototoxicity , and neuropathy . Results of this review suggest that pemetrexed is an active chemotherapeutic in combination with other agents or radiotherapy in patients with HNC .
MS22313	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: PURPOSE The role of vascular endothelial growth factor ( VEGF ) in diabetic macular edema ( DME ) was tested with ranibizumab , a specific antagonist of VEGF . DESIGN A nonr and omized clinical trial . METHODS Ten patients with chronic DME received intraocular injections of 0.5 mg of ranibizumab at baseline and at one , two , four , and six months . The primary outcome was change in foveal thickness between baseline and seven months , and the secondary outcome measures were changes from baseline in visual acuity and macular volume . RESULTS Mean values at baseline were 503 microm for foveal thickness , 9.22 mm3 for macular volume , and 28.1 letters ( 20/80 ) read on an Early Treatment Diabetic Retinopathy Study ( ETDRS ) visual acuity chart . At seven months ( one month after the fifth injection ) , the mean foveal thickness was 257 microm , which was a reduction of 246 microm ( 85 % of the excess foveal thickness present at baseline ; P = .005 by Wilcoxon signed-rank test for likelihood that this change is due to ranibizumab rather than chance ) . The macular volume was 7.47 mm3 , which was a reduction of 1.75 mm3 ( 77 % of the excess macular volume at baseline ; P = .009 ) . Mean visual acuity was 40.4 letters ( 20/40 ) , which was an improvement of 12.3 letters ( P = .005 ) . The injections were well-tolerated with no ocular or systemic adverse events . CONCLUSION Intraocular injections of ranibizumab significantly reduced foveal thickness and improved visual acuity in 10 patients with DME , which demonstrated that VEGF is an important therapeutic target for DME . A r and omized , controlled , double-masked trial is needed to test whether intraocular injections of ranibizumab provide long-term benefit to patients with DME Purpose To report 1-year visual and anatomic outcomes of a prospect i ve , double-masked r and omised clinical trial comparing bevacizumab with ranibizumab for the treatment of age-related macular degeneration ( AMD ) . Methods Patients who met inclusion criteria were r and omised 2 : 1 to bevacizumab or ranibizumab . All subjects and investigators ( except for the pharmacist responsible for study assignments ) were masked to treatment arms . Visual acuity was taken on Early Treatment Diabetic Retinopathy Study chart . Patients were given either bevacizumab or ranibizumab every month for the first 3 months , followed by an optical coherence tomography-guided , variable-dosing treatment schedule . Main outcomes measured included visual acuity , foveal thickness , and total number of injections over the 1-year treatment period . Results In total , 15 patients received bevacizumab and 7 patients received ranibizumab . The average pre-operative visual acuity was 34.9 letters in the bevacizumab group , and 32.7 letters in the ranibizumab group . At 1-year follow-up , mean vision was 42.5 letters in the bevacizumab group , and 39.0 letters in the ranibizumab group . Two-tailed t-test failed to showed statistical significance between the two groups ( P=0.5 ) . Patients in the bevacizumab group underwent an average of eight injections , whereas patients in the ranibizumab group underwent a mean of four injections ( P=0.001 ) . Conclusion The 1-year outcomes of a prospect i ve , double-masked , r and omised clinical trial comparing bevacizumab with ranibizumab failed to show a difference in visual and anatomic outcomes between the two treatments for choroidal neovascularisation in AMD . Total injections given over the treatment period were significantly different between the two groups . Further studies with larger sample sizes are warranted OBJECTIVE To describe effects of ranibizumab and bevacizumab when administered monthly or as needed for 2 years and to describe the impact of switching to as-needed treatment after 1 year of monthly treatment . DESIGN Multicenter , r and omized clinical trial . PARTICIPANTS Patients ( n = 1107 ) who were followed up during year 2 among 1185 patients with neovascular age-related macular degeneration who were enrolled in the clinical trial . INTERVENTIONS At enrollment , patients were assigned to 4 treatment groups defined by drug ( ranibizumab or bevacizumab ) and dosing regimen ( monthly or as needed ) . At 1 year , patients initially assigned to monthly treatment were reassigned r and omly to monthly or as-needed treatment , without changing the drug assignment . MAIN OUTCOME MEASURES Mean change in visual acuity . RESULTS Among patients following the same regimen for 2 years , mean gain in visual acuity was similar for both drugs ( bevacizumab-ranibizumab difference , -1.4 letters ; 95 % confidence interval [ CI ] , -3.7 to 0.8 ; P = 0.21 ) . Mean gain was greater for monthly than for as-needed treatment ( difference , -2.4 letters ; 95 % CI , -4.8 to -0.1 ; P = 0.046 ) . The proportion without fluid ranged from 13.9 % in the bevacizumab-as-needed group to 45.5 % in the ranibizumab monthly group ( drug , P = 0.0003 ; regimen , P < 0.0001 ) . Switching from monthly to as-needed treatment result ed in greater mean decrease in vision during year 2 ( -2.2 letters ; P = 0.03 ) and a lower proportion without fluid ( -19 % ; P < 0.0001 ) . Rates of death and arteriothrombotic events were similar for both drugs ( P > 0.60 ) . The proportion of patients with 1 or more systemic serious adverse events was higher with bevacizumab than ranibizumab ( 39.9 % vs. 31.7 % ; adjusted risk ratio , 1.30 ; 95 % CI , 1.07 - 1.57 ; P = 0.009 ) . Most of the excess events have not been associated previously with systemic therapy targeting vascular endothelial growth factor ( VEGF ) . CONCLUSIONS Ranibizumab and bevacizumab had similar effects on visual acuity over a 2-year period . Treatment as needed result ed in less gain in visual acuity , whether instituted at enrollment or after 1 year of monthly treatment . There were no differences between drugs in rates of death or arteriothrombotic events . The interpretation of the persistence of higher rates of serious adverse events with bevacizumab is uncertain because of the lack of specificity to conditions associated with inhibition of VEGF PURPOSE To report the findings at 1 year of a study comparing repeated intravitreal bevacizumab ( ivB ) and modified Early Treatment of Diabetic Retinopathy Study ( ETDRS ) macular laser therapy ( MLT ) in patients with persistent clinical ly significant diabetic macular edema ( CSME ) . DESIGN Prospect i ve , r and omized , masked , single-center , 2-year , 2-arm clinical trial . PARTICIPANTS A total of 80 eyes of 80 patients with center-involving CSME and at least 1 prior MLT . METHODS Subjects were r and omized to either ivB ( 6 weekly ; minimum of 3 injections and maximum of 9 injections in the first 12 months ) or MLT ( 4 monthly ; minimum of 1 treatment and maximum of 4 treatments in the first 12 months ) . MAIN OUTCOME MEASURES The primary end point was the difference in ETDRS best-corrected visual acuity ( BCVA ) at 12 months between the bevacizumab and laser arms . RESULTS The baseline mean ETDRS BCVA was 55.7+/-9.7 ( range 34 - 69 ) in the bevacizumab group and 54.6+/-8.6 ( range 36 - 68 ) in the laser arm . The mean ETDRS BCVA at 12 months was 61.3+/-10.4 ( range 34 - 79 ) in the bevacizumab group and 50.0+/-16.6 ( range 8 - 76 ) in the laser arm ( P = 0.0006 ) . Furthermore , the bevacizumab group gained a median of 8 ETDRS letters , whereas the laser group lost a median of 0.5 ETDRS letters ( P = 0.0002 ) . The odds of gaining > or = 10 ETDRS letters over 12 months were 5.1 times greater in the bevacizumab group than in the laser group ( adjusted odds ratio , 5.1 ; 95 % confidence interval , 1.3 - 19.7 ; P = 0.019 ) . At 12 months , central macular thickness decreased from 507+/-145 microm ( range 281 - 900 microm ) at baseline to 378+/-134 microm ( range 167 - 699 microm ) ( P<0.001 ) in the ivB group , whereas it decreased to a lesser extent in the laser group , from 481+/-121 microm ( range 279 - 844 microm ) to 413+/-135 microm ( range 170 - 708 microm ) ( P = 0.02 ) . The median number of injections was 9 ( interquartile range [ IQR ] 8 - 9 ) in the ivB group , and the median number of laser treatments was 3 ( IQR 2 - 4 ) in the MLT group . CONCLUSIONS The study provides evidence to support the use of bevacizumab in patients with center-involving CSME without advanced macular ischemia OBJECTIVES To compare ranibizumab with focal/grid laser or a combination of both in diabetic macular edema ( DME ) . DESIGN Prospect i ve , r and omized , interventional , multicenter clinical trial . PARTICIPANTS A total of 126 patients with DME . METHODS Subjects were r and omized 1:1:1 to receive 0.5 mg of ranibizumab at baseline and months 1 , 3 , and 5 ( group 1 , 42 patients ) , focal/grid laser photocoagulation at baseline and month 3 if needed ( group 2 , 42 patients ) , or a combination of 0.5 mg of ranibizumab and focal/grid laser at baseline and month 3 ( group 3 , 42 patients ) . MAIN OUTCOME MEASURES The primary end point was the change from baseline in best-corrected visual acuity ( BCVA ) at month 6 . RESULTS At month 6 , the mean gain in BCVA was significantly greater in group 1 ( + 7.24 letters , P = 0.01 , analysis of variance ) compared with group 2 ( -0.43 letters ) , and group 3 ( + 3.80 letters ) was not statistically different from groups 1 or 2 . For patients with data available at 6 months , improvement of 3 lines or more occurred in 8 of 37 ( 22 % ) in group 1 compared with 0 of 38 ( 0 % ) in group 2 ( P = 0.002 , Fisher exact test ) and 3 of 40 ( 8 % ) in group 3 . Excess foveal thickness was reduced by 50 % , 33 % , and 45 % in groups 1 , 2 , and 3 , respectively . CONCLUSIONS During a span of 6 months , ranibizumab injections by the current protocol had a significantly better visual outcome than focal/grid laser treatment in patients with DME PURPOSE To evaluate the efficacy and safety of ranibizumab administered monthly for three months and then quarterly in patients with subfoveal choroidal neovascularization ( CNV ) secondary to age-related macular degeneration ( AMD ) . DESIGN Phase IIIb , multicenter , r and omized , double-masked , sham injection-controlled trial in patients with predominantly or minimally classic or occult with no classic CNV lesions . METHODS Patients were r and omized 1:1:1 to 0.3 mg ranibizumab ( n = 60 ) , 0.5 mg ranibizumab ( n = 61 ) , or sham ( n = 63 ) treatment groups . The primary efficacy endpoint was mean change from baseline visual acuity ( VA ) at month 12 . RESULTS Mean changes from baseline VA at 12 months were -16.3 , -1.6 , and -0.2 letters for the sham , 0.3 mg , and 0.5 mg groups , respectively ( P < or = .0001 , each ranibizumab dose vs sham ) . Ranibizumab arrested CNV growth and reduced leakage from CNV . However , the treatment effect declined in the ranibizumab groups during quarterly dosing ( e.g. , at three months the mean changes from baseline VA had been gains of 2.9 and 4.3 letters for the 0.3 mg and 0.5 mg doses , respectively ) . Results of subgroups analyses of mean change from baseline VA at 1 Output:	Anti-VEGF mAbs did not significantly increase overall mortality , cardiovascular mortality , stroke , myocardial infa rct ion , VTEs , or hypertension .
MS22314	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: We illustrate Fairweather 's approach to Experimental Social Innovation and Dissemination with two experimental studies of programs to reduce homelessness for 168 and 225 people with mental illness and often substance abuse . Literally homeless participants were r and omly assigned to programs that emphasized consumer choice or to the usual continuum of care , in which housing and services are contingent on sobriety and progress in treatment . A drop-in center that eliminated barriers to access to services was more successful than control programs in reducing homelessness , but after 24 months only 38 % of participants had moved to community housing . A subsequent apartment program , in which individuals in the experimental condition moved to subsidized apartments directly from the street , with services under their control , had 79 % in stable housing ( compared to 27 % in the control group ) at the end of 6 months . Groups in this study did not differ on substance abuse or psychosocial outcomes Investigators examined the 6-month impact of three cognitive-behavioral HIV risk-reduction programs on behavioral factors ( substance use and sexual risk behaviors ) and cognitive and psychological re sources of 325 women who resided in emergency or sober-living shelters and their 308 intimate sexual partners . Participants were r and omized by shelter to a peer-mentored , a nurse case-managed , or a st and ard care HIV risk-reduction program . Significant improvements were observed in all groups in all behavioral factors and cognitive and psychological re sources except for self-esteem . Participants in the peer-mentored and nurse case-managed groups did not differ significantly from the st and ard group in self-esteem , life satisfaction , psychological well-being , use of noninjection drugs , sex with multiple partners , and unprotected sex at 6 months ( n = 633 ) . It was concluded that a st and ard approach by health care professionals appears to effectively modify HIV risk behaviors for a majority of homeless participants and may have important economic and policy implication s. Further , the impact of short-term programs that address psychological vulnerabilities of impoverished population s needs to be studied further PURPOSE This exploratory study examined the feasibility of homeless parents ' participation in an intervention to increase use of facilitating language strategies during interactions with their preschool children while residing in family homeless shelters . This study also examined the intervention 's impact on the parents ' use of facilitating language strategies , regardless of parent performance on a single-word receptive vocabulary test . METHOD Using a prospect i ve , pretest/posttest comparison group design , 12 parents were r and omly assigned to a 4-session experimental group training emphasizing use of facilitating language utterances with children following vocabulary testing . Four parents were r and omly assigned to a control group intervention . RESULTS It was feasible for parents to participate in the intervention . Before the intervention , individual experimental group parents with poor test performance demonstrated relatively high use of facilitating language utterances . After the intervention , the experimental group increased use of facilitating language utterances during interactions with their children . CONCLUSIONS This exploratory study provides initial evidence that it is feasible for parents to participate in , and benefit from , a brief language -based group intervention while residing in family homeless shelters . Further study of language -based interventions for these at-risk families and of the possible impact of parent language functioning on intervention benefit is needed A women 's therapeutic community ( TC ) design ed to prevent homelessness was evaluated using a quasi-experimental process . Propensity analysis selected comparable experimental ( E ) and comparison ( C ) participants . Significant improvements were found for the E group at the domain level , both in “ psychological ” dysfunction on symptoms ( e.g. , depression ) , and in “ health , ” including ratings of health and adherence to medication regimens . No significant difference was found at the domain level for “ parenting ” or “ housing stabilization , ” but specific outcomes did differ . For example , a greater number of children resided with the E group mothers who also assumed financial responsibility for more of their children OBJECTIVES This study tested a psychiatric rehabilitation approach for organizing and delivering services to street-dwelling persons with severe mental illness . METHODS Street-dwelling persons with severe mental illness were r and omly assigned to the experimental program ( called Choices ) or to st and ard treatment in New York City . We assessed study participants at baseline and at 6-month intervals over 24 months , using measures of service use , quality of life , health , mental health , and social psychological status . The average deviation from baseline summary statistic was employed to assess change . RESULTS Compared with persons in st and ard treatment ( n = 77 ) , members of the experimental group ( n = 91 ) were more likely to attend a day program ( 53 % vs 27 % ) , had less difficulty in meeting their basic needs , spent less time on the streets ( 55 % vs 28 % reduction ) , and spent more time in community housing ( 21 % vs 9 % increase ) . They showed greater improvement in life satisfaction and experienced a greater reduction in psychiatric symptoms . CONCLUSIONS With an appropriate service model , it is possible to engage disaffiliated population s , exp and their use of human services , and improve their housing conditions , quality of life , and mental health status Housing First is an effective intervention that ends and prevents homelessness for individuals with severe mental illness and co-occurring addictions . By providing permanent , independent housing without prerequisites for sobriety and treatment , and by offering support services through consumer-driven Assertive Community Treatment teams , Housing First removes some of the major obstacles to obtaining and maintaining housing for consumers who are chronically homeless . In this study , consumers diagnosed with severe mental illness and who had the longest histories of shelter use in a suburban county were r and omly assigned to either one of two Housing First programs or to a treatment-as-usual control group . Participants assigned to Housing First were placed in permanent housing at higher rates than the treatment-as-usual group and , over the course of four years , the majority of consumers placed by both Housing First agencies were able to maintain permanent , independent housing . Results also highlight that providers new to Housing First must be aware of ways in which their practice s may deviate from the essential features of Housing First , particularly with respect to enrolling eligible consumers on a first-come , first-served basis and separating clinical issues from tenant or housing responsibilities . Finally , other aspects of successfully implementing a Housing First program are discussed BACKGROUND Supported housing , integrating clinical and housing services , is a widely advocated intervention for homeless people with mental illness . In 1992 , the US Department of Housing and Urban Development ( HUD ) and the US Department of Veterans Affairs ( VA ) established the HUD-VA Supported Housing ( HUD-VASH ) program . METHODS Homeless veterans with psychiatric and /or substance abuse disorders or both ( N = 460 ) were r and omly assigned to 1 of 3 groups : ( 1 ) HUD-VASH , with Section 8 vouchers ( rent subsidies ) and intensive case management ( n = 182 ) ; ( 2 ) case management only , without special access to Section 8 vouchers ( n = 90 ) ; and ( 3 ) st and ard VA care ( n = 188 ) Primary outcomes were days housed and days homeless . Secondary outcomes were mental health status , community adjustment , and costs from 4 perspectives . RESULTS During a 3-year follow-up , HUD-VASH veterans had 16 % more days housed than the case management-only group and 25 % more days housed than the st and ard care group ( P<.001 for both ) . The case management-only group had only 7 % more days housed than the st and ard care group ( P = .29 ) . The HUD-VASH group also experienced 35 % and 36 % fewer days homeless than each of the control groups ( P<.005 for both ) . There were no significant differences on any measures of psychiatric or substance abuse status or community adjustment , although HUD-VASH clients had larger social networks . From the societal perspective , HUD-VASH was 6200 US dollars ( 15 % ) more costly than st and ard care . Incremental cost-effectiveness ratios suggest that HUD-VASH cost 45 US dollars more than st and ard care for each additional day housed ( 95 % confidence interval , -19 US dollars to 108 US dollars ) . CONCLUSIONS Supported housing for homeless people with mental illness results in superior housing outcomes than intensive case management alone or st and ard care and modestly increases societal costs Homelessness and unstable housing have been associated with HIV risk behavior and poorer health among persons living with HIV/AIDS ( PLWHA ) , yet prior research has not tested causal associations . This paper describes the challenges , methods , and baseline sample of the Housing and Health Study , a longitudinal , multi-site , r and omized controlled trial investigating the effects of providing immediate rental housing assistance to PLWHA who were homeless or at severe risk of homelessness . Primary outcomes included HIV disease progression , medical care access and utilization , treatment adherence , mental and physical health , and risks of transmitting HIV . Across three study sites , 630 participants completed baseline sessions and were r and omized to receive either immediate rental housing assistance ( treatment group ) or assistance finding housing according to local st and ard practice ( comparison group ) . Baseline sessions included a question naire , a two-session HIV risk-reduction counseling intervention , and blood sample collection to measure CD4 counts and viral load levels . Three follow-up visits occurred at 6 , 12 , and 18 months after baseline . Participants were mostly male , Black , unmarried , low-income , and nearly half were between 40 and 49 years old . At 18 months , 84 % of the baseline sample was retained . The retention rates demonstrate the feasibility of conducting scientifically rigorous housing research , and the baseline results provide important information regarding characteristics of this understudied population that can inform future HIV prevention and treatment efforts OBJECTIVE Reductions in runaways ' sexual risk behaviors were evaluated in response to an intensive program to prevent human immunodeficiency virus ( HIV ) infection and the acquired immunodeficiency syndrome ( AIDS ) . DESIGN In a nonr and omized control trial , sexual risk behaviors among 78 runaways at one residential shelter who received up to 30 HIV/AIDS intervention sessions were compared with 67 runaways at a nonintervention shelter with sexual behaviors assessed at baseline and 3 and 6 months . SETTING Runaways were recruited from the only two publicly funded shelters in New York , NY . PARTICIPANTS The runaways were aged 11 to 18 years , 64 % female , and predominantly black or Hispanic . INTERVENTION The intervention addressed general knowledge about HIV/AIDS , coping skills , access to health care and other re sources , and individual barriers to safer sex . MAIN OUTCOME MEASURES Consistent condom use , a high-risk pattern of sexual behavior , and sexual abstinence over a 3-month time frame were assessed . MAIN RESULTS As the number of intervention sessions increased , runaways ' reports of consistent condom use increased significantly ( at 3 months , unique R2 = .06 , P less than .05 ; at 6 months , unique R2 = .09 , P less than .05 ) , and their reports of engaging in a high-risk pattern of sexual behavior decreased significantly ( at 3 months , unique R2 = .03 , P = .06 ; at 6 months , unique R2 = .04 , P less than .05 ) . Abstinence did not change . CONCLUSIONS The demonstrated effectiveness of the intensive HIV/AIDS program highlights the importance of enlarging the scope of most current HIV/AIDS prevention programs Background : People who are homeless and chronically alcoholic have increased health problems , use of emergency services and police contact , with a low likelihood of rehabilitation . Harm reduction is a policy to decrease the adverse consequences of substance use without requiring abstinence . The shelter-based Managed Alcohol Project ( MAP ) was created to deliver health care to homeless adults with alcoholism and to minimize harm ; its effect upon consumption of alcohol and use of crisis services is described as proof of principle . Methods : Subjects enrolled in MAP were dispensed alcohol on an hourly basis . Hospital charts were review ed for all emergency department ( ED ) visits and admissions during the 3 years before and up to 2 years after program enrolment , and the police data base was accessed for all encounters during the same periods . The results of blood tests were analyzed for trends . A question naire was administered to MAP participants and staff about alcohol use , health and activities of daily living before and during the program . Direct program costs were also recorded . Results : Seventeen adults with an average age of 51 years and a mean duration of alcoholism of 35 years were enrolled in MAP for an average of 16 months . Their monthly mean group total of ED visits decreased from 13.5 to 8 ( p = 0.004 ) ; police encounters , from 18.1 to 8.8 ( p = 0.018 ) . Changes in blood test findings were nonsignificant . All program participants reported less alcohol consumption during MAP , and subjects and staff alike reported improved hygiene , compliance with medical care and health . Interpretation : A managed alcohol program for homeless people with chronic alcoholism can stabilize alcohol intake and significantly decrease ED visits and police encounters This study tests components of Wong and Solomon ’s ( 2002 , Mental Health Services Research , 4(2 ) , 13–28 ) model of community integration , identifying both the dimensions and predictors of integration . It evaluates community integration among adults with psychiatric disabilities assigned r and omly to receive either independent scatter-site apartments with the Housing First approach ( experimental ) or services as usual ( control ) . Factor analysis supported a definition of community integration that includes psychological , physical , and social domains , but Output:	For homeless people with mental illness , provision of housing upon hospital discharge was effective in improving sustained housing . For homeless people with substance abuse issues or concurrent disorders , provision of housing was associated with decreased substance use , relapses from periods of substance abstinence , and health services utilization , and increased housing tenure . Abstinent dependent housing was more effective in supporting housing status , substance abstinence , and improved psychiatric outcomes than non-abstinence dependent housing or no housing . Provision of housing also improved health outcomes among homeless population s with HIV . Health promotion programs can decrease risk behaviours among homeless population s. Conclusions These studies provide important new evidence regarding interventions to improve health , housing status , and access to healthcare for homeless population s. The additional studies included in this current review provide further support for earlier evidence which found that coordinated treatment programs for homeless persons with concurrent mental illness and substance misuse issues usually result in better health and access to healthcare than usual care . This review also provides a synthesis of existing evidence regarding interventions that specifically support homeless population s with HIV
MS22315	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: Context How often does colonoscopy miss adenomas ? Contribution During a multicenter screening trial , experienced colonoscopists performed same-day optical ( OC ) and virtual colonoscopy ( VC ) on 1233 asymptomatic adults . Optical colonoscopy performed without knowledge of the VC findings missed 55 of 511 polyps ; 21 of these polyps were adenomas measuring 6 mm or greater . Adenomas missed by OC were usually on the proximal side of a fold or near the anal verge . Virtual colonoscopy missed 14 % of the adenomas that measured 6 mm or greater that were de-tected by OC . Implication s Neither OC nor VC is a perfect test : Each misses 10 % to 14 % of adenomas that measure 6 mm or greater . The Editors Optical colonoscopy ( OC ) is widely accepted as the gold st and ard for detecting colorectal neoplasia ( 1 , 2 ) . However , even in the most experienced h and s , this skilled examination is underst and ably not infallible . Retrospective analysis has suggested that the OC miss rate for adenomas 10 mm or greater is approximately 10 % ( 3 ) . More recently , prospect i ve back-to-back or t and em colonoscopy studies have reported miss rates for 10-mm adenomas ranging from 0 % to 6 % ( 4 , 5 ) . However , in addition to evaluating relatively small population s of patients with a high prevalence of polyps , a notable weakness common to these studies was that they used OC as its own reference st and ard . In a large , prospect i ve , multicenter trial that was primarily intended to evaluate the performance of virtual colonoscopy ( VC ) in asymptomatic adults ( 6 ) , we also had a unique opportunity to evaluate the adenoma miss rate on OC by segmentally unblinding the results from same-day VC . By using a reference st and ard other than OC itself for comparison , we could uncover lesions that may be systematic ally missed on repeated colonoscopies . These data not only provide novel insight into OC miss rates but also indicate the relative blind spots where more attention could be focused . Methods Study Design The institutional review boards at all 3 participating medical centers approved the study protocol for same-day VC and OC , and all patients provided written informed consent . We recruited asymptomatic adults who were referred for colorectal cancer screening . Exclusion criteria were a positive stool guiaic test result or iron deficiency anemia within the past 6 months ; rectal bleeding , hematochezia , or unintentional weight loss of more than 10 pounds within the past 12 months ; OC within the past 10 years or barium enema within the past 5 years ; personal history of adenomatous polyps , colorectal cancer , or inflammatory bowel disease ; and family history of familial adenomatous polyposis or nonpolyposis cancer syndromes . Between May 2002 and June 2003 , 1253 asymptomatic adults enrolled in the study . Eight patients were excluded because of failure to reach the cecum at OC , 6 patients were excluded because of inadequate colonic preparation , and another 6 patients were excluded because of computed tomography ( CT ) system failure . The final study group comprised 1233 asymptomatic adults ( 728 men and 505 women ; mean age , 57.8 years ) who successfully completed same-day VC and OC . Study participants underwent colonic preparation with oral intake of 90 mL of phospho-soda and 10 mg of bisacodyl . To opacify residual colonic fluid and stool for VC examination , patients also consumed dilute oral contrast as previously described ( 7 ) . Our CT protocol and VC technique have also been detailed previously ( 6 ) . To briefly summarize , we obtained supine and prone CT acquisitions on multidetector scanners after patient-controlled rectal insufflation of room air . One of 6 trained radiologists interpreted VC studies by using a commercially available CT colonography system ( Viatronix V3D-Colon , version 1.2 , Viatronix , Inc. , Stony Brook , New York ) . We used the 3-dimensional endoluminal fly-through view primarily for detecting polyps and 2-dimensional images for confirmation and problem solving . We measured polyps on the 3-dimensional view and recorded them by segment ( cecum , ascending colon , hepatic flexure , transverse colon , splenic flexure , descending colon , sigmoid colon , or rectum ) . We defined the proximal colon as including the cecum to the splenic flexure . We prospect ively rated diagnostic confidence for each detected lesion on a 3-point scale ( most certain , intermediate , and least certain ) . One of 17 experienced colonoscopists performed OC immediately after VC interpretation by using st and ard commercial video colonoscopes ( Olympus , Inc. , Melville , New York ) . The colonoscope was advanced to the cecum and then sequentially withdrawn into more distal segments for polyp detection . The colonoscopist measured polyps by using a calibrated linear probe , which is more accurate than either visual or biopsy forceps estimation ( 8) . Our polyp-matching algorithm requires VC and OC agreement according to size ( within a 50 % margin of error ) and location ( within the same or adjacent segment ) . After the colonoscopist evaluated a given segment , a study nurse unblinded the VC results for the previous segment . For any suspected polyp seen on VC that measured 5 mm or greater but was not seen on the initial blinded OC , the colonoscopist closely reexamined that segment and could review the VC images for guidance . We sent all retrieved polyps for histologic examination . For all cases in which a colorectal neoplasm measuring 6 mm or greater was found on second-look OC , we retrospectively review ed both the VC and OC images . We recorded polyp characteristics , such as size , morphologic characteristic ( sessile , pedunculated , or flat ) , and location on VC . If the polyp was situated on a colonic fold on VC , we further subcategorized it as being located on the back ( proximal ) side , front ( distal ) side , or edge of the fold . We analyzed both supine and prone VC sets for all cases . The primary reason that diminutive polyps measuring 5 mm at VC were included for potential unblinding at OC was that , given the relative error in polyp measurement , such polyps found on second-look OC might , in fact , measure 6 mm or greater . This allows for more accurate assessment of the OC miss rate at the 6-mm threshold . We did not include unblinded polyps that measured 5 mm or less on both VC and OC examinations in the final analysis . All study participants completed a detailed question naire on their personal and family medical history . For the purpose s of this study , particular attention was given to the question about previous abdominal or pelvic surgery , since adhesions could conceivably result in a more difficult colonoscopic examination . Statistical Analysis Prospect i ve OC performance was compared against the enhanced reference st and ard of second-look OC after segmental unblinding of VC results . We estimated exact binomial 95 % CIs for OC miss rates . We used the chi-square test to compare the frequency of previous abdominal surgery among patients with and without polyps missed at OC and also to compare the OC miss rates among the 3 medical centers . We calculated the 95 % CIs by using Stata software , version 7.0 for Windows ( Stata Corp. , College Station , Texas ) , and performed the chi-square tests by using SAS software , version 8.0 for Windows ( SAS Institute , Inc. , Cary , North Carolina ) . Role of the Funding Source The funding source had no role in the collection , analysis , or interpretation of the data or in the decision to su bmi t the manuscript for publication . Results The performance characteristics of VC from this prospect i ve , multicenter screening trial , using OC as the reference st and ard , have been previously reported ( 6 ) . Our technique of segmental unblinding also allows for a separate assessment of OC by using the blinded VC results for comparison , which is the focus of this study . We identified 1310 polyps at OC in the 1233 asymptomatic adults ; 511 ( 39.0 % ) of these polyps measured 5 mm or greater ( Figure 1).Of these 511 polyps , 55 ( 10.8 % ) were found only on second-look OC after segmental unblinding of VC results . Twenty-four ( 43.6 % ) of the 55 unblinded lesions were nonadenomatous , including 16 hyperplastic polyps . Of the 31 missed neoplasms , 10 adenomas that measured only 5 mm were excluded from further analysis because of their diminutive size ( 9 ) . Including unblinded lesions , 554 adenomas were detected on OC in this screening sample ; 210 of these measured 6 mm or greater and 51 measured 10 mm or greater . Figure 1 . Polyp flowchart . In 20 patients ( 17 men and 3 women ; mean age , 58.2 years ) , 21 adenomas measuring 6 mm or greater ( range , 6 mm to 17 mm ; mean , 8.1 mm ) were found on OC only after the VC results were unblinded , which represent the lesions of primary interest for this study ( Table ) . The corresponding adenoma miss rate on prospect i ve OC examination was 10.0 % ( 95 % CI , 6.3 % to 14.9 % ) ( 21 of 210 adenomas ) at a 6-mm cutoff . The 20 patients with missed adenomas that measured 6 mm or greater represented only 1.6 % of the study sample ( 20 of 1233 patients ) but 11.9 % of patients with adenomas 6 mm or greater ( 20 of 168 patients ) . At 8-mm and 10-mm thresholds , the OC adenoma miss rates by polyp were 10.5 % ( CI , 5.2 % to 18.5 % ) ( 10 of 95 adenomas ) and 11.8 % ( CI , 4.4 % to 23.9 % ) ( 6 of 51 adenomas ) , respectively . The 10 patients with missed adenomas 8 mm or greater represented 12.2 % ( 10 of 82 patients ) of all patients with neoplasms of this size or greater ; the 6 patients with missed adenomas 8 mm or greater represented 12.5 % of all patients with neoplasms 10 mm or greater . Table . Characteristics of Neoplasms Missed at Prospect i ve Colonoscopic Evaluation Seventeen ( 81.0 % ) of the 21 unblinded neoplasms 6 mm or greater were tubular adenomas , 3 ( 14.3 % ) were tubulovillous adenomas , and 1 ( 4.8 % ) was an adenocarcinoma . Seven ( 33.3 % ) of the 21 unblinded polyps were classified as advanced lesions ( that is , size 10 mm or high- grade dysplasia , prominent villous component , or focus of malignancy ) . There were 15 sessile lesions , 4 pedunculated lesions , and 2 flat BACKGROUND & AIMS Colonoscopic polypectomy is considered effective for preventing colorectal cancer ( CRC ) , but the incidence of cancer in patients under colonoscopic surveillance has rarely been investigated . We determined the incidence of CRC in patients under colonoscopic surveillance and examined the circumstances and risk factors for CRC and adenoma with high- grade dysplasia . METHODS Patients were drawn from 3 adenoma chemoprevention trials . All underwent baseline colonoscopy with removal of at least one adenoma and were deemed free of remaining lesions . We identified patients subsequently diagnosed with invasive cancer or adenoma with high- grade dysplasia . The timing , location , and outcome of all cases of cancer and high- grade dysplasia identified are described and risks associated with their development explored . RESULTS CRC was diagnosed in 19 of the 2915 patients over a mean follow-up of 3.7 years ( incidence , 1.74 cancers/1000 person-years ) . The cancers were located in all regions of the colon ; 10 were at or proximal to the hepatic flexure . Although most of the cancers ( 84 % ) were of early stage , 2 participants died of CRC . Seven patients were diagnosed with adenoma with high- grade dysplasia during follow-up . Older patients and those with a history of more adenomas were at higher risk of being diagnosed with invasive cancer or adenoma with high- grade dysplasia . CONCLUSIONS CRC is diagnosed in a clinical ly important proportion of patients following complete colonoscopy and polypectomy . More precise and representative estimates of CRC incidence and death among patients undergoing surveillance examinations are needed Background and aims : Colonoscopy is an established method of colorectal cancer screening , but has an adenoma miss rate of 10–20 % . Detection rates are expected to improve with optimised visualisation methods . This prospect i ve r and omised study evaluated narrow-b and imaging ( NBI ) , a new technique that may enhance image contrast in colon adenoma detection . Methods : Eligible patients presenting for diagnostic colonoscopy were r and omly assigned to undergo wide-angle colonoscopy using either conventional high-resolution imaging or NBI during instrument withdrawal . The primary outcome parameter was the difference in the adenoma detection rate between the two techniques . Results : A total of 401 patients were included ( mean age 59.4 years , 52.6 % men ) . Adenomas were detected more frequently in the NBI group ( 23 % ) than in the control group ( 17 % ) with Output:	Conclusion NBI does not improve detection of colorectal polyps when compared to conventional colonoscopy ( Australian New Zeal and Clinical Trials Registry ACTRN12610000456055 )
MS22316	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: AIM Transcatheter arterial chemoembolization ( TACE ) is an established treatment for unresectable hepatocellular carcinoma ( HCC ) . However , it is unclear which chemotherapeutic agent should be selected for TACE . The aim of this study was to compare the efficacy of cisplatin ( CDDP ) with that of epirubicin ( EPI ) in TACE for patients with unresectable or relapsed HCC . METHODS We performed a historical cohort study involving 131 patients treated with a first TACE , defined as either an initial treatment for previously untreated HCC or a first treatment for relapsed HCC after curative resections or ablations . Efficacy was estimated as the response rate ( RR ) and it was adjusted for the confounding factors that were defined in this study . RESULTS The RR were 62.5 % ( 20/32 ) for the first TACE with CDDP and 51.5 % ( 51/99 ) for that with EPI . In the adjusted analysis for a history of hepatectomy , percutaneous treatment combined with TACE and tumor factors , the odds ratio was 1.72 ( 95 % confidence interval [ CI ] = 0.70 - 4.48 ) . However , a test for interaction between the number of tumors and the chemotherapeutic agent was statistically significant ( P = 0.016 ) . In multiple HCC , the RR were 66.7 % ( 10/17 ) for CDDP and 39.6 % ( 30/46 ) for EPI . The odds ratio was 4.11 ( 95 % CI = 1.14 - 17.2 ) . CONCLUSION CDDP may be more effective than EPI in TACE for multiple HCC . A r and omized controlled study is needed to clarify the efficacy of CDDP in TACE in patients with multiple HCC The prognosis of patients with hepatocellular carcinoma ( HCC ) with portal vein tumor thrombosis ( PVTT ) is extremely poor . The aim of this study was to eluci date the efficacy of hepatic arterial infusion chemotherapy ( HAIC ) for patients with advanced HCCs Sorafenib targets the Raf/mitogen-activated protein kinase , VEGF , and platelet-derived growth factor pathways and prolongs survival patients in advanced hepatocellular carcinoma ( HCC ) . Everolimus inhibits the mammalian target of rapamycin , a kinase overactive in HCC . To investigate whether the antitumor effects of these agents are additive , we compared a combined and sequential treatment regimen of everolimus and sorafenib with monotherapy . After hepatic implantation of Morris Hepatoma ( MH ) cells , rats were r and omly allocated to everolimus ( 5 mg/kg , 2 × /week ) , sorafenib ( 7.5 mg/kg/d ) , combined everolimus and sorafenib , sequential sorafenib ( 2 weeks ) then everolimus ( 3 weeks ) , or control groups . MRI quantified tumor volumes . Erk1/2 , 4E-BP1 , and their phosphorylated forms were quantified by immunoblotting . Angiogenesis was assessed in vitro by aortic ring and tube formation assays , and in vivo with Vegf-a mRNA and vascular casts . After 35 days , tumor volumes were reduced by 60 % , 85 % , and 55 % , relative to controls , in everolimus , the combination , and sequential groups , respectively ( P < 0.01 ) . Survival was longest in the combination group ( P < 0.001 ) . Phosphorylation of 4E-BP1 and Erk1/2 decreased after everolimus and sorafenib , respectively . Angiogenesis decreased after all treatments ( P < 0.05 ) , although sorafenib increased Vegf-a mRNA in liver tumors . Vessel sprouting was abundant in control tumors , lower after sorafenib , and absent after the combination . Intussusceptive angiogenic transluminal pillars failed to coalesce after the combination . Combined treatment with everolimus and sorafenib exerts a stronger antitumoral effect on MH tumors than monotherapy . Everolimus retains antitumoral properties when administered sequentially after sorafenib . This supports the clinical use of everolimus in HCC , both in combination with sorafenib or after sorafenib . Mol Cancer Ther ; 10(6 ) ; 1007–17 . © 2011 AACR In a prospect i ve , multicenter , open‐label study , de novo liver transplant patients were r and omized at day 30±5 to ( i ) everolimus initiation with tacrolimus elimination ( TAC Elimination ) ( ii ) everolimus initiation with reduced‐exposure tacrolimus ( EVR+Reduced TAC ) or ( iii ) st and ard‐exposure tacrolimus ( TAC Control ) . R and omization to TAC Elimination was terminated prematurely due to a higher rate of treated biopsy‐proven acute rejection ( tBPAR ) . EVR+Reduced TAC was noninferior to TAC Control for the primary efficacy endpoint ( tBPAR , graft loss or death at 12 months posttransplantation ) : 6.7 % versus 9.7 % ( −3.0 % ; 95 % CI −8.7 , 2.6 % ; p<0.001 for noninferiority [ 12 % margin ] ) . tBPAR occurred in 2.9 % of EVR+Reduced TAC patients versus 7.0 % of TAC Controls ( p = 0.035 ) . The change in adjusted estimated GFR from r and omization to month 12 was superior with EVR+Reduced TAC versus TAC Control ( difference 8.50 mL/min/1.73 m2 , 97.5 % CI 3.74 , 13.27 mL/min/1.73 m2 , p<0.001 for superiority ) . Drug discontinuation for adverse events occurred in 25.7 % of EVR+Reduced TAC and 14.1 % of TAC Controls ( relative risk 1.82 , 95 % CI 1.25 , 2.66 ) . Relative risk of serious infections between the EVR+Reduced TAC group versus TAC Controls was 1.76 ( 95 % CI 1.03 , 3.00 ) . Everolimus facilitates early tacrolimus minimization with comparable efficacy and superior renal function , compared to a st and ard tacrolimus exposure regimen 12 months after liver transplantation Hepatocellular carcinoma ( HCC ) st and s as a major health problem worldwide . The management of advanced HCC , limited for a longtime by the disappointing results of conventional cytotoxic chemotherapies , has recently changed with the publication of the results of the Sorafenib Hepatocellular Carcinoma Assessment R and omized Protocol ( SHARP ) trial , which demonstrated an overall survival benefit over placebo in patients with advanced HCC . This study was further confirmed by the Asian-Pacific trial using sorafenib in Eastern patients . Those trials demonstrated that therapeutic benefits may derive from improving our knowledge of deregulated signaling pathways involved in HCC carcinogenesis . This review summarizes the results of clinical trials in which targeted therapies are currently evaluated aim ing to enlarge the therapeutic armamentarium for HCC in a near future We present the 12-month results of a prospect i ve trial of conversion from calcineurin inhibitors ( CNI ) to everolimus ( EVL ) in maintenance liver transplant ( LT ) recipients . Forty ( M : F = 28:12 ; 54.9 + /- 11 years ) patients were enrolled at a mean interval of 45.5 + /- 31.2 months from transplantation . Conversion was with EVL at a dosage of 0.75 mg b.i.d . , withdrawal of antimetabolites , and a 50%-per-week reduction of CNI to a complete stop within 4 weeks . The treatment success was conversion to EVL monotherapy at 12 months while failure was presence of CNI , death , and graft loss . Indication to conversion was deteriorating renal function in 36 ( 90 % ) . At 12 months , patient- and graft survival were 100 % and the success rate was 75 % ( 30/40 ) . Ten patients ( 25 % ) were failures : four ( 10 % ) for acute rejection ; three hepatitis C virus-RNA positive patients ( 7.5 % ) for hypertransaminasemia ; one ( 2.5 % ) for acute cholangitis ; and two ( 5 % ) due to persistent pruritus and oral ulcers . In patients on EVL monotherapy , at 12 months the mean change of calculated creatinine clearance ( cCrCl ) was 4.03 + /- 12.6 mL/min and the only variable correlated with the probability of improvement was baseline cCrCl ( P < 0.0001 ) . Conversion from CNI to EVL is feasible in 75 % of the cases and associated with improvement in renal function for patients with higher baseline cCrCl Data on the conversion of patients to everolimus after liver transplantation are sparse . A multicenter , retrospective study followed 240 maintenance liver transplant patients to analyze the current indications for everolimus conversion , the employed regimens and exposure levels , and the impact on efficacy and safety . The mean time from transplantation to the introduction of everolimus was 4.9 ± 5.2 years . The mean everolimus trough level was 7.3 ± 4.1 ng/mL at month 1 and 8.1 ± 4.7 ng/mL at month 12 . At 12 months , 61.6 % of the patients were no longer receiving calcineurin inhibitor ( CNI ) therapy . The mean estimated glomerular filtration rate ( eGFR ) according to the Cockcroft-Gault formula was 64.2 ± 30.0 mL/minute on day 0 and 68.4 ± 32.5 mL/minute at month 12 ( P = 0.007 ) . Among patients with baseline serum creatinine levels ≥ 130 μmol/L , the eGFR values were 44.3 ± 15.7 mL/minute on day 0 and 53.7 ± 26.0 mL/minute at month 12 ( P = 0.003 ) . Four patients ( 1.6 % ) developed mild or moderate biopsy-proven acute rejection . Adverse events led to everolimus discontinuation in 12.9 % of the patients . After the initiation of everolimus , the mean white blood cell count decreased significantly , and the total cholesterol and triglyceride levels increased significantly . In this retrospective analysis of the largest cohort of maintenance liver transplant patients analyzed after their conversion to everolimus , more than 60 % of the patients were kept free of CNIs with a very low risk of acute rejection and with an acceptable safety profile . R and omized trials in which maintenance liver transplant patients are switched to everolimus in response to clinical indications or preemptively are warranted BACKGROUND Resistance to endocrine therapy in breast cancer is associated with activation of the mammalian target of rapamycin ( mTOR ) intracellular signaling pathway . In early studies , the mTOR inhibitor everolimus added to endocrine therapy showed antitumor activity . METHODS In this phase 3 , r and omized trial , we compared everolimus and exemestane versus exemestane and placebo ( r and omly assigned in a 2:1 ratio ) in 724 patients with hormone-receptor-positive advanced breast cancer who had recurrence or progression while receiving previous therapy with a nonsteroidal aromatase inhibitor in the adjuvant setting or to treat advanced disease ( or both ) . The primary end point was progression-free survival . Secondary end points included survival , response rate , and safety . A preplanned interim analysis was performed by an independent data and safety monitoring committee after 359 progression-free survival events were observed . RESULTS Baseline characteristics were well balanced between the two study groups . The median age was 62 years , 56 % had visceral involvement , and 84 % had hormone-sensitive disease . Previous therapy included letrozole or anastrozole ( 100 % ) , tamoxifen ( 48 % ) , fulvestrant ( 16 % ) , and chemotherapy ( 68 % ) . The most common grade 3 or 4 adverse events were stomatitis ( 8 % in the everolimus-plus-exemestane group vs. 1 % in the placebo-plus-exemestane group ) , anemia ( 6 % vs. < 1 % ) , dyspnea ( 4 % vs. 1 % ) , hyperglycemia ( 4 % vs. < 1 % ) , fatigue ( 4 % vs. 1 % ) , and pneumonitis ( 3 % vs. 0 % ) . At the interim analysis , median progression-free survival was 6.9 months with everolimus plus exemestane and 2.8 months with placebo plus exemestane , according to assessment s by local investigators ( hazard ratio for progression or death , 0.43 ; 95 % confidence interval [ CI ] , 0.35 to 0.54 ; P<0.001 ) . Median progression-free survival was 10.6 months and 4.1 months , Output:	Manypre clinical studies demonstrated that everolimus had antitumor effects such as antiproliferation and antiangiogenesis . However , some differences in the effects were observed among in vivo animal studies for HCC treatment . Meanwhile , clinical studies demonstrated that the response rate of single-agent everolimus was low , though survival benefits could be expected . Everolimus at the dose of 10 mg/day significantly increased the risk of the adverse events .
MS22317	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: BACKGROUND Sublingual immunotherapy with liquid extracts provides an appealing alternative to subcutaneous immunotherapy for the treatment of allergic rhinoconjunctivitis ( ARC ) , but a lack of robust evidence has deterred its use in North America . OBJECTIVE To determine the efficacy and tolerability of st and ardized glycerinated short ragweed sublingual allergen immunotherapy liquid ( RW-SAIL ) extract in subjects with ragweed-related ARC . METHODS This phase 3 , r and omized , placebo-controlled trial was conducted in North America . Subjects ( age range , 18 - 55 years ) with or without asthma were selected based on ARC symptom severity and erythema skin prick reaction to short ragweed . Subjects self-administered the maximum tolerated dose of RW-SAIL ( n = 218 ) or placebo ( n = 211 ) daily beginning approximately 8 to 16 weeks before and through the end of the ragweed pollen season . The primary end point was subject-assessed total combined daily rhinoconjunctivitis symptom and medication scores ( TCS ) . RESULTS During the entire season , there was a 43 % decrease in TCS in subjects treated with RW-SAIL compared with placebo . Similar decreases were observed in TCS between the 2 groups during peak season ( 42 % ) and in daily symptom scores during the entire ( 42 % ) and peak ( 41 % ) seasons . The occurrence of adverse events was similar between the treatment groups ; most were mild in severity . Treatment-related oromucosal local application site reactions occurred early and were transient and self-limited . No anaphylaxis occurred . CONCLUSIONS This is the first successful North American confirmatory phase 3 clinical trial to demonstrate the safety and efficacy of a sublingual st and ardized ragweed allergen immunotherapy liquid extract for the treatment of ARC BACKGROUND Data on the long-term effects of sublingual immunotherapy ( SLIT ) are sparse , and the optimal duration of treatment is a matter of debate . OBJECTIVE We sought to prospect ively evaluate the long-term effect of SLIT given for 3 , 4 , or 5 years and to compare the effect of those different duration s. METHODS In this prospect i ve open controlled study we followed up patients with respiratory allergy who were monosensitized to mites for 15 years . The subjects were divided in 4 groups receiving drug therapy alone or SLIT for 3 , 4 , or 5 years . Clinical scores , skin sensitizations , methacholine reactivity , and nasal eosinophil counts were evaluated every year during the winter months . The clinical effect was considered to persist until clinical scores remained at less than 50 % of the baseline value , and then patients underwent another course of SLIT . RESULTS Seventy-eight patients were enrolled , and 59 completed the study . In the 12 control subjects no relevant change in clinical scores was seen throughout the study . In the patients receiving SLIT for 3 years , the clinical benefit persisted for 7 years . In those receiving immunotherapy for 4 or 5 years , the clinical benefit persisted for 8 years . New sensitizations occurred in all the control subjects over 15 years and in less than a quarter of the patients receiving SLIT ( 21 % , 12 % , and 11 % , respectively ) . The second course of vaccination induced a benefit more rapidly than the first course . The behavior of bronchial hyperreactivity and nasal eosinophils paralleled the clinical score . CONCLUSION Under the present conditions , it can be suggested that a 4-year duration of SLIT is the optimal choice because it induces a long-lasting clinical improvement similar to that seen with a 5-year course and greater than that of a 3-year vaccination ABSTRACT Background : Concomitant allergic rhinitis ( AR ) adds to the symptomatic burden of asthma . Scope : To determine the proportion of adults with concomitant asthma and AR whose AR is diagnosed and /or treated , data were derived from a cross-sectional , stratified , r and om sample of 26,468 adults from France , Germany and the UK , participants in the 2004 web-based National Health and Wellness Survey . Patients were drawn from the data base if they reported ( 1 ) experiencing asthma in the prior 12 months , ( 2 ) a physician diagnosis of asthma , and ( 3 ) ever experiencing ‘ nasal allergies/hay fever ’ ( physician diagnosed or self-reported symptoms ) . Findings : Of 1139 patients with asthma who reported AR , 203 ( 18 % ) did not have a diagnosis of AR . Of these , 86 ( 42 % ) pursued over-the-counter self-treatment for AR , and 117 ( 58 % ) remained untreated . Of 936 patients who reported diagnosed AR , 471 ( 50 % ) received AR prescriptions , 200 ( 21 % ) pursued over-the-counter self-treatment , and 265 ( 28 % ) remained untreated . Overall , 34 % of patients with asthma and diagnosed or self-reported AR were not treated for AR . There were no significant differences in QoL over the prior 4 weeks , nor healthcare re source use over the prior 6 months between patients treated and those not treated for AR . Conclusion : Based on self-reported data , despite global treatment guidelines recommending evaluation and treatment of AR among patients with asthma , AR was not diagnosed for 1 in 5 patients , and AR was not treated for 1 in 3 patients with asthma OBJECTIVES To determine whether long-term , continuous use of inhaled anti-inflammatory medications affects asthma outcomes in children with mild to moderate asthma after use is discontinued . STUDY DESIGN Of the 1041 participants in the Childhood Asthma Management Program r and omized clinical trial , 941 ( 90 % ) were followed to determine whether 4.3 years of twice-daily budesonide or nedocromil administration ( each compared with placebo ) affected subsequent asthma outcomes during a 4.8-year posttrial period in which treatment was managed by the participants ' physicians . RESULTS The groups treated continuously during the trial with either budesonide or nedocromil did not differ from the group given placebo in terms of lung function , control of asthma , or psychological status at the end of 4.8 years of posttrial follow-up . However , the decreased mean height in the budesonide group relative to the placebo group at the end of the trial ( 1.1 cm ; P = .005 ) remained statistically significant ( 0.9 cm ; P = .01 ) after an additional 4.8 years and was more pronounced in girls ( 1.7 cm ; P = .001 ) than in boys ( 0.3 cm ; P = .49 ) . Participants in all groups used inhaled corticosteroids during 30 % of the posttrial period . CONCLUSIONS Clinical ly meaningful improvements in the control of asthma and in airway responsiveness achieved during continuous treatment with inhaled corticosteroids do not persist after continuous treatment is discontinued BACKGROUND Allergic rhinoconjunctivitis is a global health problem . Around 14 million people in Spain , France , Italy , and Austria suffer from grass pollen induced allergic rhinitis . St and ard care only provides symptoms relief , while allergen specific immunotherapy ( SIT ) treats the underlying cause of the disease . Grazax from ALK-Abelló is a new , tablet-based , effective route of SIT for home treatment . The objective was to assess the cost-effectiveness of Grazax in four Southern European countries . METHODS A prospect i ve pharmacoeconomic analyses was carried out alongside a multinational , clinical trial measuring the efficacy of Grazax . Pooled data on re source use and health outcomes were collected . A societal perspective was adopted , and the analysis had a nine-year time horizon . The primary outcome measure was quality adjusted life years ( QALYs ) . RESULTS Grazax was superior to st and ard care for all efficacy endpoints , including QALYs gained , and result ed in significantly less use of rescue medication and fewer hours missed from work . Grazax was cost-effective for all countries for an annual price in the range of 1500 euros - 1900 euros . The result was improved by inclusion of future costs of asthma and exclusion of Spanish trial centers which experienced an exceptionally low pollen season . CONCLUSION The analysis illustrates that allergen SIT with Grazax for grass pollen induced rhinoconjunctivitis is a cost-effective intervention in Southern Europe OBJECTIVE To investigate the health and monetary consequences of treating allergy with specific immunotherapy ( SIT ) compared with symptomatic treatment/st and ard care among patients with grass pollen or mite allergy . METHODS We performed an economic analysis based on 253 grass- and /or mite allergic patients who started SIT from 1.1.1996 to 1.1.2002 at the Allergy Unit , Aarhus University Hospital and at a specialist practice in Aarhus . Relevant data were collected before , during and after SIT treatment from the national health service based on each patient 's personal identification number and medical records and from a specifically design ed question naire . A cost-benefit analysis including direct and indirect costs before , during and after SIT was performed . In addition direct costs were related to the clinical effect ( improvement in well-being ) in the form of a cost-effectiveness analysis . RESULTS The direct cost per patient/year before SIT ( equivalent to st and ard care ) was DKK 2,580 . The investment in SIT was DKK 27,545 ( in present values ) per patient over a 4-year period . After SIT the cost was reduced to DKK 1,072 per patient/year . In the long term , prospect i ve introduction of SIT incurred additional present-value direct costs of DKK 13,676 per patient treated and DKK 2,784 per patient/year of improved well-being . However , when indirect costs were included in the economic evaluation SIT was shown to be net beneficial . CONCLUSION This study reveals that SIT is associated with initial re source investments and subsequent re source savings in the long term compared with st and ard care . When all consequences are measured in monetary terms , and assuming that sick days are associated with a loss of productivity , this analysis suggests that SIT increases societal welfare . This conclusion also holds if there is no loss of productivity BACKGROUND It is unknown whether inhaled corticosteroids can modify the subsequent development of asthma in preschool children at high risk for asthma . METHODS We r and omly assigned 285 participants two or three years of age with a positive asthma predictive index to treatment with fluticasone propionate ( at a dose of 88 mug twice daily ) or masked placebo for two years , followed by a one-year period without study medication . The primary outcome was the proportion of episode-free days during the observation year . RESULTS During the observation year , no significant differences were seen between the two groups in the proportion of episode-free days , the number of exacerbations , or lung function . During the treatment period , as compared with placebo use , use of the inhaled corticosteroid was associated with a greater proportion of episode-free days ( P=0.006 ) and a lower rate of exacerbations ( P<0.001 ) and of supplementary use of controller medication ( P<0.001 ) . In the inhaled-corticosteroid group , as compared with the placebo group , the mean increase in height was 1.1 cm less at 24 months ( P<0.001 ) , but by the end of the trial , the height increase was 0.7 cm less ( P=0.008 ) . During treatment , the inhaled corticosteroid reduced symptoms and exacerbations but slowed growth , albeit temporarily and not progressively . CONCLUSIONS In preschool children at high risk for asthma , two years of inhaled-corticosteroid therapy did not change the development of asthma symptoms or lung function during a third , treatment-free year . These findings do not provide support for a subsequent disease-modifying effect of inhaled corticosteroids after the treatment is discontinued . ( Clinical Trials.gov number , NCT00272441 . ) BACKGROUND The main aim of specific immunotherapy is sustained effect due to changes in the immune system that can be demonstrated only in long-term trials . OBJECTIVE To investigate sustained efficacy and disease modification in a 5-year double-blind , placebo-controlled trial , including 2 years of blinded follow-up after completion of a 3-year period of treatment , with the SQ-st and ardized grass allergy immunotherapy tablet , Grazax ( Phleum pratense 75,000 SQ-T/2,800 BAU,(∗ ) ALK , Denmark ) or placebo . METHODS A r and omized , double-blind , placebo-controlled , multinational , phase III trial included adults with a history of moderate-to-severe grass pollen-induced allergic rhinoconjunctivitis , with or without asthma , inadequately controlled by symptomatic medications . Two hundred thirty-eight participants completed the trial . End points included rhinoconjunctivitis symptom and medication scores , combined scores , asthma symptom and medication scores , quality of life , days with severe symptoms , immunologic end points , and safety parameters . RESULTS The mean rhinoconjunctivitis daily symptom score was reduced by 25 % to 36 % ( P ≤ .004 ) in the grass allergy immunotherapy tablet group compared with the placebo group over the 5 grass pollen seasons covered by the trial . The rhinoconjunctivitis DMS was reduced by 20 % to 45 Output:	Although some economic modeling studies included the costs of ' asthma prevented ' , the collective literature of AIT economics provides very little to no information about the cost benefits of the preventive aspect of AIT . SUMMARY Overall , individual studies and systematic review s provide strong evidence for the cost-effectiveness of AIT over SDT . The magnitude of cost-efficacy is likely underestimated in that few studies consider the cost-savings due to AIT 's long-term benefits or preventive effect
MS22318	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: OBJECTIVE This additional analysis of data from a previously reported prospect i ve trial comparing the effect of intraoperative alcohol or saline placebo neurolytic block in patients with pancreatic cancer was conducted in response to the development of a new theory , which explores the relationship of negative mood states to pain , pain-related behavior , and ultimately , longevity . METHODS The original study used a double-blind procedure to r and omly assign 139 patients with histologically proven , unresectable pancreatic cancer to receive either an alcohol or a saline block . Data on visual analog pain , mood , and interference with activity were collected preoperatively and every 2 months postoperatively until death . The current analysis was conducted on the complete data sets received from 130 patients . Demographic data were su bmi tted to chi-square analysis and to univariate and multivariate analysis of variance . Univariate and multivariate analyses of variance also compared 1 ) the effect of alcohol versus saline on pain , mood , interference of pain with activities , and longevity and 2 ) the impact of mood on pain with longevity as the dependent variable . Correlation and regression analyses examined the impact of mood on life expectancy . RESULTS The alcohol intervention had a significant positive effect on life duration and mood scores . High negative mood states correlated significantly with an increase in visual analog pain , the rating of pain intensity at its worse , and pain interference with patients ' activities . CONCLUSION In these subjects , the neurolytic block , as compared with medical management alone , improved pain , elevated mood , reduced pain interference with activity , and was associated with an increase in life expectancy Twenty-one patients with pancreatic cancer pain were studied to evaluate the effectiveness of celiac plexus block ( CPB ) on pain relief and quality of life ( QOL ) , compared to the traditional NSAID-morphine treatment . The criteria were morphine consumption , visual analogue pain scale ( VAS ) , performance status ( PS ) determined by medical and nursing staffs , and answers to QOL question naires . Morphine consumption , VAS , PS , and self-assessed QOL scores were taken when the administration of morphine was necessary for pain relief and those scores were used as control . Morphine consumption and the VAS score were recorded at regular weekly intervals and the PS and QOL scores were measured every 2 weeks thereafter . CPB was performed within 2 - 3 days after the control measurement . The VAS scores of the patients receiving CPB ( n = 10 ) were statistically lower for the first 4 weeks after the procedure than those of the patients receiving the st and ard NSAID-morphine treatment ( n = 11 ) during the same time period after the control measurement . Morphine consumption was significantly lower in weeks 4 - 7 ( inclusive ) following the procedure in the CPB group and continued to be lower thereafter , though not significantly so . Although the PS score slightly improved at the 2nd week after CPB , it was not improved by the start of the NSAID-morphine treatment . Self-assessed QOL scores did not ameliorate statistically after CPB ; however , they did deteriorate remarkably in the patients treated only with morphine-NSAID during their survival periods , while they deteriorated only slightly in the CPB group . There were fewer side effects after CPB . These results indicate CPB does not directly improve QOL in patients with pancreatic cancer pain , but it may prevent deterioration in QOL by the long-lasting analgesic effect , limitation of side effects and the reduction of morphine consumption , compared to treatment only with NSAID-morphine CONTEXT Pancreatic cancer is an aggressive tumor associated with high mortality . Optimal pain control may improve quality of life ( QOL ) for these patients . OBJECTIVE To test the hypothesis that neurolytic celiac plexus block ( NCPB ) vs opioids alone improves pain relief , QOL , and survival in patients with unresectable pancreatic cancer . DESIGN , SETTING , AND PATIENTS Double-blind , r and omized clinical trial conducted at Mayo Clinic , Rochester , Minn. Enrolled ( October 1997 and January 2001 ) were 100 eligible patients with unresectable pancreatic cancer experiencing pain . Patients were followed up for at least 1 year or until death . INTERVENTION Patients were r and omly assigned to receive either NCPB or systemic analgesic therapy alone with a sham injection . All patients could receive additional opioids managed by a clinician blinded to the treatment assignment . MAIN OUTCOME MEASURES Pain intensity ( 0 - 10 numerical rating scale ) , QOL , opioid consumption and related adverse effects , and survival time were assessed weekly by a blinded observer . RESULTS Mean ( SD ) baseline pain was 4.4 ( 1.7 ) for NCPB vs 4.1 ( 1.8 ) for opioids alone . The first week after r and omization , pain intensity and QOL scores were improved ( pain intensity , P < or = .01 for both groups ; QOL , P<.001 for both groups ) , with a larger decrease in pain for the NCPB group ( P = .005 ) . From repeated measures analysis , pain was also lower for NCPB over time ( P = .01 ) . However , opioid consumption ( P = .93 ) , frequency of opioid adverse effects ( all P>.10 ) , and QOL ( P = .46 ) were not significantly different between groups . In the first 6 weeks , fewer NCPB patients reported moderate or severe pain ( pain intensity rating of > or = 5/10 ) vs opioid-only patients ( 14 % vs 40 % , P = .005 ) . At 1 year , 16 % of NCPB patients and 6 % of opioid-only patients were alive . However , survival did not differ significantly between groups ( P = .26 , proportional hazards regression ) . CONCLUSION Although NCPB improves pain relief in patients with pancreatic cancer vs optimized systemic analgesic therapy alone , it does not affect QOL or survival OBJECTIVE : Computed tomography (CT)-guided celiac plexus neurolysis has been used for controlling the chronic abdominal pain associated with intra-abdominal malignancy and chronic pancreatitis . Endoscopic ultrasound (EUS)-guided celiac plexus neurolysis has been reported to have some success in controlling pain from pancreatic cancer . The aim of this study is to assess the efficacy of EUS-guided celiac plexus block versus CT-guided celiac plexus block for controlling the chronic abdominal pain associated with chronic pancreatitis . METHODS : Patients enrolled were r and omly assigned to EUS-guided or CT-guided celiac plexus block . Pain scores were determined pre- and postceliac block for both techniques . Follow-up was obtained by a nurse at 1 day postblock , then weekly thereafter for 24 wk . Patients also rated overall experience with these procedures . The EUS celiac block was performed with a 22-gauge sterile needle inserted into the celiac region with guidance of real-time linear array endosonography followed by injection of 10 ml of bupivacaine ( 0.75 % ) and 3 ml ( 40 mg ) of triamcinolone on both sides of the celiac area . RESULTS : Twenty-two consecutive patients ( 10 men , 12 women ) , were ultimately enrolled in this study between 7/1/95 and 12/30/95 ; four patients were excluded for protocol violations . We performed EUS-guided celiac block in 10 patients and CT-guided celiac block in eight . A significant improvement in pain scores with reduction in pain medication usage occurred in 50 % ( five of 10 ) of patients having the EUS block . The mean postprocedure follow-up was 15 weeks ( range : 8–24 wk ) . Persistent benefit was experienced by 40 % of patients at 8 wk and by 30 % at 24 wk . In the patients with CT block , however , only 25 % ( two of eight ) had relief . The mean follow-up was 4 wk ( range : 2–6 wk ) . Only 12 % ( one of eight ) had some relief at 12 wk of follow-up . There were no complications . EUS-guided celiac block was the preferred technique among patients who experienced both techniques . A cost comparison between both celiac block techniques shows EUS to be less costly than CT . CONCLUSIONS : EUS-guided celiac block provided more persistent pain relief than CT-guided block and was the preferred technique among the subjects studied . EUS-guided celiac block appears to be a safe , effective , and less costly method for controlling the abdominal pain that can accompany chronic pancreatitis in some patients This large-volume , single-institution review examines factors influencing long-term survival after resection in patients with adenocarcinoma of the head , neck , uncinate process , body , or tail of the pancreas . Between January 1984 and July 1999 inclusive , 616 patients with adenocarcinoma of the pancreas underwent surgical resection . A retrospective analysis of a prospect ively collected data base was performed . Both univariate and multivariate models were used to determine the factors influencing survival . Of the 616 patients , 526 ( 85 % ) underwent pancreaticoduodenectomy for adenocarcinoma of the head , neck , or uncinate process of the pancreas , 52 ( 9 % ) underwent distal pancreatectomy for adenocarcinoma of the body or tail , and 38 ( 6 % ) underwent total pancreatectomy for adenocarcinoma extensively involving the gl and . The mean age of the patients was 64.3 years , with 54 % being male and 91 % being white . The overall perioperative mortality rate was 2.3 % , whereas the incidence of postoperative complications was 30 % . The median postoperative length of stay was 11 days . The mean tumor diameter was 3.2 cm , with 72 % of patients having positive lymph nodes , 30 % having positive resection margins , and 36 % having poorly differentiated tumors . Patients undergoing distal pancreatectomy for left-sided lesions had larger tumors ( 4.7 vs. 3.1 cm , P < 0.0001 ) , but fewer node-positive resections ( 59 % vs. 73 % , P = 0.03 ) and fewer poorly differentiated tumors ( 29 % vs. 36 % , P<0.001 ) , as compared to those undergoing pancreaticoduodenectomy for right-sided lesions . The overall survival of the entire cohort was 63 % at 1 year and 17 % at 5 years , with a median survival of 17 months . For right-sided lesions the 1- and 5-year survival rates were 64 % and 17 % , respectively , compared to 50 % and 15 % for left-sided lesions . Factors shown to have favorable independent prognostic significance by multivariate analysis were negative resection margins ( hazard ratio [ HR ] = 0.64 , confidence interval [ CI ] = 0.50 to 0.82 , P = 0.0004 ) , tumor diameter less than 3 cm ( HR = 0.72 , CI = 0.57 to 0.90 , P = 0.004 ) , estimated blood loss less than 750 ml ( HR = 0.75 , CI = 0.58 to 0.96 , P = 0.02 ) , well/moderate tumor differentiation ( HR = 0.71 , CI = 0.56 to 0.90 , P = 0.005 ) , and postoperative chemoradiation ( HR = 0.50 , CI = 0.39 to 0.64 , P } < 0.0001 ) . Tumor location in head , neck , or uncinate process approached significance in the final multivariate model ( HR = 0.60 , CI = 0.35 to 1.0 , P = 0.06 ) . Pancreatic resection remains the only hope for long-term survival in patients with adenocarcinoma of the pancreas . Completeness of resection and tumor characteristics including tumor size and degree of differentiation are important independent prognostic indicators . Adjuvant chemoradiation is a strong predictor of outcome and likely decreases the independent significance of tumor location and nodal status The purpose of this study was to evaluate the technical possibilities of placing a catheter near the celiac plexus for performance of a celiac plexus block , and to study the efficacy of repeated neurolytic celiac plexus blocks with alcohol in patients with advanced pancreatic cancer pain resistant to opioid treatment . In 12 patients , a neurolytic celiac plexus block with alcohol , administered via an indwelling celiac catheter , was performed . To evaluate the efficacy , visual analog scale scores were recorded every day . Quality of life scores were registered before and 4 weeks following the procedure . Alterations in opioid consumption , and the time between the diagnosis of pancreatic cancer and the performance of the block , were registered . All patients were followed until they died . Two patients remained without pain after the first neurolytic celiac plexus block . In all other patients a second block was administered which provided only temporary relief . Additional intermittent administration of bupivacaine through the catheter was necessary to provide adequate pain relief in these patients . Quality of life increased significantly during the treatment . Opioid consumption decreased significantly in all patients . Our study indicates that a neurolytic celiac plexus blockade with alcohol results in a significant but short-lasting analgesic effect . The use of a celiac catheter improves the long-term management of pancreatic cancer pain OBJECTIVE A prospect i ve , r and omized , double-blind study was completed comparing intraoperative chemical splanchnicectomy with 50 % alcohol versus a placebo Output:	No differences in survival were observed . : In patients with unresectable pancreatic cancer , NCPB is associated with improved pain control , and reduced narcotic usage and constipation compared with st and ard treatment , albeit with minimal clinical significance
MS22319	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: The development of stimulus selectivity in the primary sensory cortex of higher vertebrates is considered in a general mathematical framework . A synaptic evolution scheme of a new kind is proposed in which incoming patterns rather than converging afferents compete . The change in the efficacy of a given synapse depends not only on instantaneous pre- and postsynaptic activities but also on a slowly varying time-averaged value of the postsynaptic activity . Assuming an appropriate nonlinear form for this dependence , development of selectivity is obtained under quite general conditions on the sensory environment . One does not require nonlinearity of the neuron 's integrative power nor does one need to assume any particular form for intracortical circuitry . This is first illustrated in simple cases , e.g. , when the environment consists of only two different stimuli presented alternately in a r and om manner . The following formal statement then holds : the state of the system converges with probability 1 to points of maximum selectivity in the state space . We next consider the problem of early development of orientation selectivity and binocular interaction in primary visual cortex . Giving the environment an appropriate form , we obtain orientation tuning curves and ocular dominance comparable to what is observed in normally reared adult cats or monkeys . Simulations with binocular input and various types of normal or altered environments show good agreement with the relevant experimental data . Experiments are suggested that could test our theory further Young ( ages 18 - 22 years ) and older ( ages 61 - 87 years ) adults ( N = 106 ) played the Virtual Week board game , which involves simulating common prospect i ve memory ( PM ) tasks of everyday life ( e.g. , taking medication ) , and performed working memory ( WM ) and vigilance tasks . The Virtual Week game includes regular ( repeated ) and irregular ( nonrepeated ) PM tasks with cues that are either more or less focal to other ongoing activities . Age differences in PM were reduced for repeated tasks , and performance improved over the course of the week , suggesting retrieval was more spontaneous or habitual . Correlations with WM within each age group were reduced for PM tasks that had more regular or focal cues . WM ( but not vigilance ) ability was a strong predictor of irregular PM tasks with less focal cues . Taken together , these results support the hypothesis that habitual and focally cued PM tasks are less dem and ing of attentional re sources ( specifically , WM ) , whereas tasks that are more dem and ing of controlled attentional processes produce larger age differences , which may be attributable to individual differences in WM Background : Repetitive transcranial magnetic stimulation over the left dorsolateral prefrontal cortex ( DLPFC ) has been documented to influence striatal and orbitofrontal dopaminergic activity implicated in reward processing . However , the exact neuropsychological mechanisms of how DLPFC stimulation may affect the reward system and how trait hedonic capacity may interact with the effects remains to be eluci date d. Objective : In this sham-controlled study in healthy individuals , we investigated the effects of a single session of neuronavigated intermittent theta burst stimulation ( iTBS ) on reward responsiveness , as well as the influence of trait hedonic capacity . Methods : We used a r and omized crossover single session iTBS design with an interval of 1 week . We assessed reward responsiveness using a rewarded probabilistic learning task and measured individual trait hedonic capacity ( the ability to experience pleasure ) with the temporal experience of pleasure scale question naire . Results : As expected , the participants developed a response bias toward the most rewarded stimulus ( rich stimulus ) . Reaction time and accuracy for the rich stimulus were respectively shorter and higher as compared to the less rewarded stimulus ( lean stimulus ) . Active or sham stimulation did not seem to influence the outcome . However , when taking into account individual trait hedonic capacity , we found an early significant increase in the response bias only after active iTBS . The higher the individual 's trait hedonic capacity , the more the response bias toward the rich stimulus increased after the active stimulation . Conclusion : When taking into account trait hedonic capacity , one active iTBS session over the left DLPFC improved reward responsiveness in healthy male participants with higher hedonic capacity . This suggests that individual differences in hedonic capacity may influence the effects of iTBS on the reward system This individual differences study examined the separability of three often postulated executive functions-mental set shifting ( " Shifting " ) , information updating and monitoring ( " Updating " ) , and inhibition of prepotent responses ("Inhibition")- and their roles in complex " frontal lobe " or " executive " tasks . One hundred thirty-seven college students performed a set of relatively simple experimental tasks that are considered to predominantly tap each target executive function as well as a set of frequently used executive tasks : the Wisconsin Card Sorting Test ( WCST ) , Tower of Hanoi ( TOH ) , r and om number generation ( RNG ) , operation span , and dual tasking . Confirmatory factor analysis indicated that the three target executive functions are moderately correlated with one another , but are clearly separable . Moreover , structural equation modeling suggested that the three functions contribute differentially to performance on complex executive tasks . Specifically , WCST performance was related most strongly to Shifting , TOH to Inhibition , RNG to Inhibition and Updating , and operation span to Updating . Dual task performance was not related to any of the three target functions . These results suggest that it is important to recognize both the unity and diversity of executive functions and that latent variable analysis is a useful approach to study ing the organization and roles of executive functions Prospect i ve memory ( PM ) refers to a complex cognitive ability that underpins the delayed execution of previously formulated intentions . PM performance declines early in normal aging and this process is accentuated in Alzheimer 's disease . The left frontopolar cortex ( BA10 ) has been consistently assigned a major role in PM functioning , but whether it can be noninvasively modulated to enhance PM performance in aged people has not been addressed so far . Here , we investigated the effects of modulating left BA10 by means of theta burst stimulation ( TBS ) , using either excitatory ( intermittent TBS ) , inhibitory ( continuous TBS ) or control ( vertex ) TBS in healthy aged subjects . The behavioral effects were assessed using a reliable and ecological virtual reality PM task that included both event- and time-based retrievals . As compared with vertex stimulation , event-based PM performance significantly improved after excitatory stimulation , whereas inhibitory stimulation had no significant effect . Additionally , and across the different types of stimulation , performance for congruent links between the event-based PM cue and the action to be performed was significantly better as compared with incongruent links . In conclusion , intermittent TBS might provide a relevant interventional strategy to counteract the decline of cognitive functions and memory abilities in normal aging Dopamine is implicated in movement , learning , and motivation , and in illnesses such as Parkinson 's disease , schizophrenia , and drug addiction . Little is known about the control of dopamine release in humans , but research in experimental animals suggests that the prefrontal cortex plays an important role in regulating the release of dopamine in subcortical structures . Here we used [(11)C]raclopride and positron emission tomography to measure changes in extracellular dopamine concentration in vivo after repetitive transcranial magnetic stimulation ( rTMS ) of the dorsolateral prefrontal cortex in healthy human subjects . Repetitive TMS of the left dorsolateral prefrontal cortex caused a reduction in [(11)C]raclopride binding in the left dorsal cau date nucleus compared with rTMS of the left occipital cortex . There were no changes in binding in the putamen , nucleus accumbens , or right cau date . This shows that rTMS of the prefrontal cortex induces the release of endogenous dopamine in the ipsilateral cau date nucleus . This finding has implication s for the therapeutic and research use of rTMS in neurological and psychiatric disorders 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 The present study aim ed to investigate the role of frontopolar cortex in prospect i ve memory ( PM ) by means of inhibitory theta-burst stimulation ( cTBS ) . " Experiment 1"-8 volunteers were evaluated after inhibitory cTBS over left Brodmann area ( BA ) 10 , right BA10 , and Cz . In the PM procedure , sequences of 4 words each were presented . During the intersequence delay , subjects had to repeat the sequence in the observed order ( ongoing task forward ) or in the reverse order ( backward ) . At the occurrence of a target word , subjects had to press a key on the keyboard ( PM task ) . Recall and recognition of the target words were also tested . PM accuracy was lower after cTBS over left BA10 compared with Cz ( P = 0.012 ) , whereas it was comparable in right BA10 and Cz conditions . No other significant differences between the 3 conditions were found . " Experiment 2"-8 subjects were administered the same experimental PM procedure as above after inhibitory cTBS over left BA46 and Cz . In this case , none of the tested effects were significant . Our findings corroborate the hypothesis that within the prefrontal cortex , the left BA10 is specifically involved in the mediation of processes related to the execution of delayed intentions The involvement of frontopolar cortex in mediating prospect i ve memory processes has been evidence d by various studies , mainly by means of neuroimaging techniques . Recently , one transcranial magnetic stimulation study documented that transient inhibition of left Brodmann Area ( BA ) 10 impaired verbal prospect i ve memory . This result raises the issue of whether the BA 10 involvement in prospect i ve memory functioning may be modulated by the physical characteristics of the stimuli used . The present study aim ed to investigate the role of the frontopolar cortex in visual-spatial PM by means of the application of inhibitory theta-burst stimulation . Twelve volunteers were evaluated after inhibitory theta-burst stimulation over left BA 10 , right BA10 and CZ ( control condition ) . In the prospect i ve memory procedure , sequences of four spatial positions ( black squares ) each were presented . During the inter-sequence delay , subjects had to reproduce the sequence in the observed order ( ongoing task forward ) or the reverse order ( backward ) . At the occurrence of a target position , subjects had to press a key on the keyboard ( prospect i ve memory score ) . Recall and recognition of the target positions were also tested . We found that prospect i ve memory accuracy was lower after theta-burst stimulation over right BA10 than CZ ( p<0.01 ) , whereas it was comparable in left BA10 and CZ conditions . No significant difference was found among the three conditions on recall and recognition of target positions and on ongoing task performance . Our findings provide a novel strong evidence for a specific involvement of right frontopolar cortex in visual-spatial prospect i ve memory . In the context of previous data providing evidence for left BA 10 involvement in verbal prospect i ve memory , our results also suggest material -specific lateralization of prospect i ve memory processes in BA 10 Although previous studies have shown that the rostral prefrontal cortex ( rPFC ) plays a crucial role in executive tasks , the various functions of the rPFC in the humans are still understudied . Here we used transcranial magnetic stimulation ( TMS ) with continuous theta burst stimulation ( cTBS ) to interfere with the executive control functions of the right rostrolateral PFC ( RLPFC ) or the right rostromedial PFC ( RMPFC ) . Subjects performed a task-switching paradigm , which included spatial detection ( SD ) , prospect i ve memory ( PM ) and working memory ( WM ) tasks , after cTBS . The performance of 18 healthy volunteers was evaluated on different days after cTBS over the right RLPFC , the right RMPFC , and the vertex ( serving as a control site ) . The application of cTBS over the RLPFC significantly increased the switching costs ( SCs ) of the error rates ( ERs ) when switching to the PM task , while RMPFC-cTBS decreased SCs of ERs when switching to the WM task , compared with the control vertex site . These findings provide evidence for a differential role of the RLPFC and the RMPFC in executive functions , with a specific involvement of the RLPFC and the RMPFC in PM , and WM , respectively The brain-derived neurotrophic factor gene ( BDNF ) is one of many genes thought to influence synaptic plasticity in the adult brain and shows a common single nucleotide polymorphism ( BDNF Val66Met ) in the normal population that is associated with differences in hippocampal volume and episodic memory . It is also thought to influence possible synaptic changes in motor cortex following a simple motor learning task . Here we extend these studies by using new non-invasive transcranial magnetic stimulation ( TMS ) and transcranial direct current stimulation ( TDCS ) techniques that directly test the excitability and plasticity of neuronal circuits in human motor cortex in subjects at rest . We investigated whether the susceptibility to TMS probes of plasticity is significantly influenced by the BDNF polymorphism . Val66Met carriers were matched with Val66Val individuals and tested on the following protocol s : continuous and intermittent theta burst TMS ; median nerve paired associative stimulation ; and homeostatic plasticity in the TDCS/1 Hz rTMS model . The response of Met allele carriers differed significantly in all protocol s compared with the response of Val66Val individuals . We suggest that this is due to the effect of BNDF on the susceptibility of synapses to undergo LTP/LTD . The circuits tested here are implicated in the pathophysiology of movement disorders such as dystonia and are Output:	A systematic review of iTBS studies revealed variability in reliability of effects though most were in the theorized direction . TBS protocol s appear to be effective in modulating prefrontal cortical excitability in previously theorized directions . HIGHLIGHTSPrefrontal cTBS has a significant attenuating effect on executive functions . The cognitive effects of prefrontal iTBS are mostly in the theorized direction . These data suggest that TBS is a reliable means of modulating prefrontal activity
MS22320	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: This pilot aims to better underst and the market for childcare in Saudi Arabia – both the supply and dem and sides – and to design a r and omized controlled experiment to test whether access to affordable day care ( in the form of subsidies , for example ) would incentivize Saudi mothers to search actively for employment and to remain employed once they are hired . In addition , the study seeks to underst and the degree to which employment early on in one ’s life impacts employment in later stages . The pilot will provide information on the groups of women the experiment should target , appropriate levels for the childcare subsidy , and the quality and current geographic locations of daycare sites . Expected Impact Determine the effects of facilitating childcare access on Saudi women ’s employment . PRINCIPAL INVESTIGATORS  Boston University Patricia Cortes  Harvard University Claudia Goldin  Swarthmore College Jennifer Objective To find out whether changes within the hemostatic system are related to the severity of illness and organ failure in patients at the onset of clinical ly defined sepsis and to find some indications for the contribution of endothelial cell activation or perturbation to the patient 's status . The following measurements were undertaken : Acute Physiology and Chronic Health Evaluation ( APACHE ) II score , multiple organ failure ( MOF ) score , plasma levels of thrombin — antithrombin III complexes ( TAT ) , antithrombin III ( AT III ) , protein C antigen , factor XII , and plasminogen activator inhibitor type 1 antigen ( PAI-1 ) , neopterin , and interleukin 6 ( IL-6 ) . Design A prospect i ve case series study . Setting Intensive care unit ( ICU ) of the Department of Internal Medicine , Justus Liebig University , Giessen , Germany . Patients 28 consecutive patients ( 11 females , 17 males ; mean age 58 years ) with clinical ly defined sepsis . Eleven patients were admitted from the surgical ICU ( 9 after elective surgery , 2 after trauma surgery ) . The operations were done 1–26 days ( mean 14 days ) prior to the onset of sepsis . Main results At the onset of sepsis we found elevated plasma levels of TAT , PAI-1 , neopterin , and IL-6 , and lowered plasma levels of AT III , factor XII , and protein Cantigen . Neopterin , PAI-1 , IL-6 , and factor XII showed a statistically significant correlation with the APACHE II score . The MOF score is significantly correlated with IL-6 and neopterin . The extent of hemostatic abnormalities was related to increasing levels of IL-6 . Conclusions Clinical evidence of a septic process is most likely to be preceded by activation of the hemostatic system , the vascular endothelium , and the monocyte/macrophage system . IL-6 may have a regulatory function for hemostasis in inflammation . Laboratory monitoring could be helpful in deciding whether to start early intensive therapy in patients at risk for sepsis Variables of the fibrinolytic system were prospect ively studied in patients with haematologic malignancies in chemotherapy-induced leukocytopenia at onset and during the course of septicemia to evaluate their prognostic value . This group of patients was chosen because of their high risk of developing severe septic complications , thus allowing serial prospect i ve testing of fibrinolytic variables prior to and during evolving sepsis or septic shock . 62 patients with febrile infectious events were accrued to the study . Of these , 13 patients progressed to severe sepsis and an additional 13 patients to septic shock as defined according to st and ard diagnostic criteria . At onset of fever , plasminogen activator inhibitor ( PAI ) activity and PAI-1 antigen levels increased from normal baseline levels and were significantly higher in the group of patients who developed septic shock compared to those with severe sepsis ( medians : 10.6 versus 1.3 U/ml , p = 0.0001 ; 50.0 versus 5.0 ng/ml , p = 0.0002 ) . The increase in PAI activity and antigen in septic shock was accompanied by an increase in tissue-type plasminogen activator antigen and total fibrin(ogen ) degradation products and a decrease in alpha(2)-antiplasmin activity ( p < 0.006 ) . In contrast , in the group of patients that developed severe sepsis the variables of the fibrinolytic system remained unchanged at onset of fever . These differences between septic shock and severe sepsis were sustained throughout the septic episode for all variables ( p < 0.0001 ) . PAI activity of > 5 U/ml at onset of fever predicted a lethal outcome with a sensitivity of 92 % and a specificity of 100 % . Thus , septic shock in leukocytopenia is associated with significant activation of the fibrinolytic system presumably as a response of the vascular endothelium to inflammatory injury . Furthermore , PAI activity measurements are sensitive markers of an unfavourable prognosis Circulating levels of thrombin-antithrombin III complex ( TAT ) and plasmin-α2 plasmin inhibitor complex ( PIC ) in 49 septic patients ( 23 patients with organ dysfunction ( OD ) , 26 without OD ) and 11 postgastrectomy patients were measured to determine the significance of the coagulation-fibrinolytic systems in the development of OD . Tissue plasminogen activator ( t-PA ) , plasminogen activator inhibitor 1 ( PAI-1 ) , and thrombomodulin were also measured . The mean level of TAT on the day when OD occurred was significantly higher compared with the maximum level of TAT in septic patients without OD ( P < .01 ) or postoperative patients ( P < .01 ) . There was no difference in PIC levels between the three groups . The TAT/PIC ratio was significantly higher in septic patients with OD compared with the other groups ( P < .001 ) . Septic patients with OD showed higher levels of PAI-1 ( P < .001 ) but not of t-PA . Thrombomodulin levels were significantly higher in the septic patients with OD compared with the others ( P < .001 ) . We conclude that suppression of the fibrinolytic system contributes to the imbalance between coagulation and fibrinolysis , and that this hypercoagulabe millieu on the endothelial surface leads to the onset of OD Introduction Impairment of fibrinolysis during sepsis is associated with worse outcome . Early identification of this condition could be of interest . The aim of this study was to evaluate whether a modified point-of-care viscoelastic hemostatic assay can detect sepsis-induced impairment of fibrinolysis and to correlate impaired fibrinolysis with morbidity and mortality . Methods This single center observational prospect i ve pilot study was performed in an adult Intensive Care Unit ( ICU ) of a tertiary academic hospital . Forty consecutive patients admitted to the ICU with severe sepsis or septic shock were included . Forty healthy individuals served as controls . We modified conventional kaolin activated thromboelastography ( TEG ) adding urokinase to improve assessment of fibrinolysis in real time ( UK-TEG ) . TEG , UK-TEG , plasminogen activator inhibitor (PAI)-1 , thrombin-activatable fibrinolysis inhibitor ( TAFI ) , d-dimer , DIC scores and morbidity ( rated with the SOFA score ) were measured upon ICU admission . Logistic regression was used to calculate odds ratios ( ORs ) and 95 % confidence intervals ( 95 % CIs ) of mortality at ICU discharge . Results UK-TEG revealed a greater impairment of fibrinolysis in sepsis patients compared to healthy individuals confirmed by PAI-1 . TAFI was not different between sepsis patients and healthy individuals . 18/40 sepsis patients had fibrinolysis impaired according to UK-TEG and showed higher SOFA score ( 8 ( 6–13 ) vs 5 ( 4–7 ) , p = 0.03 ) , higher mortality ( 39 % vs 5 % , p = 0.01 ) and greater markers of cellular damage ( lactate levels , LDH and bilirubin ) . Mortality at ICU discharge was predicted by the degree of fibrinolysis impairment measured by UK-TEG Ly30 ( % ) parameter ( OR 0.95 , 95 % CI 0.93–0.98 , p = 0.003 ) . Conclusions Sepsis-induced impairment of fibrinolysis detected at UK-TEG was associated with increased markers of cellular damage , morbidity and mortality Introduction Current criteria for early diagnosis of coagulopathy in sepsis are limited . We postulated that coagulopathy is already complicated with sepsis in the initial phase , and severe coagulopathy or disseminated intravascular coagulation ( DIC ) becomes overt after progressive consumption of platelet and coagulation factors . To determine early diagnostic markers for severe coagulopathy , we evaluated plasma biomarkers for association with subsequent development of overt DIC in patients with sepsis . Methods A single-center , prospect i ve observational study was conducted in an adult ICU at a university hospital . Plasma sample s were obtained from patients with sepsis at ICU admission . Fourteen biomarkers including global markers ( platelet count , prothrombin time , activated partial thromboplastin time , fibrinogen and fibrin degradation product ( FDP ) ) ; markers of thrombin generation ( thrombin-antithrombin complex ( TAT ) and soluble fibrin ) ; markers of anticoagulants ( protein C ( PC ) and antithrombin ) ; markers of fibrinolysis ( plasminogen , α2-plasmin inhibitor ( PI ) , plasmin-α2-PI complex , and plasminogen activator inhibitor (PAI)-1 ) ; and a marker of endothelial activation ( soluble E-selectin ) were assayed . Patients who had overt DIC at baseline were excluded , and the remaining patients were followed for development of overt DIC in 5 days , and for mortality in 28 days . Results A total of 77 patients were enrolled , and 37 developed overt DIC within the following 5 days . Most patients demonstrated hemostatic abnormalities at baseline with 98.7 % TAT , 97.4 % FDP and 88.3 % PC . Most hemostatic biomarkers at baseline were significantly associated with subsequent development of overt DIC . Notably , TAT , PAI-1 and PC discriminated well between patients with and without developing overt DIC ( area under the receiver operating characteristic curve ( AUROC ) , 0.77 ( 95 % confidence interval , 0.64 to 0.86 ) ; 0.87 ( 0.78 to 0.92 ) ; 0.85 ( 0.76 to 0.91 ) , respectively ) , and using the three together , significantly improved the AUROC up to 0.95 ( vs. TAT , PAI-1 , and PC ) . Among the significant diagnostic markers for overt DIC , TAT and PAI-1 were also good predictors of 28-day mortality ( AUROC , 0.77 and 0.81 , respectively ) . Conclusions Severe coagulation and fibrinolytic abnormalities on ICU admission were associated with subsequent development of overt DIC . A single measurement of TAT , PAI-1 , and PC activity could identify patients with ongoing severe coagulopathy , early in the course of sepsis Introduction Previous reports suggest that endothelial activation is an important process in sepsis pathogenesis . We investigated the association between biomarkers of endothelial cell activation and sepsis severity , organ dysfunction sequential organ failure assessment ( SOFA ) score , and death . Methods This is a prospect i ve , observational study including adult patients ( age 18 years or older ) presenting with clinical suspicion of infection to the emergency department ( ED ) of an urban , academic medical center between February 2005 and November 2008 . Blood was sample d during the ED visit and biomarkers of endothelial cell activation , namely soluble fms-like tyrosine kinase-1 ( sFlt-1 ) , plasminogen activator inhibitors -1 ( PAI-1 ) , sE-selectin , soluble intercellular adhesion molecule ( sICAM-1 ) , and soluble vascular cell adhesion molecule ( sVCAM-1 ) , were assayed . The association between biomarkers and the outcomes of sepsis severity , organ dysfunction , and in-hospital mortality were analyzed . Results A total of 221 patients were included : sepsis without organ dysfunction was present in 32 % , severe sepsis without shock in 30 % , septic shock in 32 % , and 6 % were non-infected control ED patients . There was a relationship between all target biomarkers ( sFlt-1 , PAI-1 , sE-selectin , sICAM-1 , and sVCAM-1 ) and sepsis severity , P < 0.05 . We found a significant inter-correlation between all biomarkers , including the strongest correlations between sFlt-1 and sE-selectin ( r = 0.55 , P < 0.001 ) , and between sFlt-1 and PAI-1 ( 0.56 , P < 0.001 ) . Among the endothelial cell activation biomarkers , sFlt-1 had the strongest association with SOFA score ( r = 0.66 , P < 0.001 ) , the highest area under the receiver operator characteristic curve for severe sepsis of 0.82 , and for mortality of 0.91 . Conclusions Markers of endothel Output:	Conclusion PAI-1 is a significant predictor of disease severity and all-cause mortality in sepsis .
MS22321	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: Objectives Possible association between diabetes mellitus ( DM ) and Alzheimer ’s disease ( AD ) has been controversial . This study used a nationwide population -based data set to investigate the relationship between DM and subsequent AD incidence . Methods Data were collected from Taiwan ’s National Health Insurance Research Data base , which released a cohort data set of 1,000,000 r and omly sample d people and confirmed it to be representative of the Taiwanese population . We identified 71,433 patients newly diagnosed with diabetes ( age 58.74±14.02 years ) since January 1997 . Using propensity score , we matched them with 71,311 non-diabetic subjects by time of enrollment , age , gender , hypertension , hyperlipidemia , and previous stroke history . All the patients were followed up to December 31 , 2007 . The endpoint of the study was occurrence of AD . Results Over a maximum 11 years of follow-up , diabetic patients experienced a higher incidence of AD than non-diabetic subjects ( 0.48 % vs. 0.37 % , p<0.001 ) . After Cox proportional hazard regression model analysis , DM ( hazard ratio [ HR ] , 1.76 ; 95 % confidence interval [ CI ] , 1.50–2.07 , p<0.001 ) , age ( HR , 1.11 ; 95 % CI , 1.10–1.12 , p<0.001 ) , female gender ( HR , 1.24 ; 95 % CI , 1.06–1.46 , p = 0.008 ) , hypertension ( HR , 1.30 ; 95 % CI , 1.07–1.59 , p = 0.01 ) , previous stroke history ( HR , 1.79 ; 95 % CI , 1.28–2.50 , p<0.001 ) , and urbanization status ( metropolis , HR , 1.32 ; 95 % CI , 1.07–1.63 , p = 0.009 ) were independently associated with the increased risk of AD . Neither monotherapy nor combination therapy with oral antidiabetic medications were associated with the risk of AD after adjusting for underlying risk factors and the duration of DM since diagnosis . However , combination therapy with insulin was found to be associated with greater risk of AD ( HR , 2.17 ; 95 % CI , 1.04–4.52 , p = 0.039 ) . Conclusion Newly diagnosed DM was associated with increased risk of AD . Use of hypoglycemic agents did not ameliorate the risk OBJECTIVE To investigate the associations of metformin , serum vitamin B12 , calcium supplements , and cognitive impairment in patients with diabetes . RESEARCH DESIGN AND METHODS Participants were recruited from the Primary Research in Memory ( PRIME ) clinics study , the Australian Imaging , Biomarkers and Lifestyle ( AIBL ) study of aging , and the Barwon region of southeastern Australia . Patients with Alzheimer disease ( AD ) ( n = 480 ) or mild cognitive impairment ( n = 187 ) and those who were cognitively intact ( n = 687 ) were included ; patients with stroke or with neurodegenerative diseases other than AD were excluded . Subgroup analyses were performed for participants who had either type 2 diabetes ( n = 104 ) or impaired glucose tolerance ( n = 22 ) . RESULTS Participants with diabetes ( n = 126 ) had worse cognitive performance than participants who did not have diabetes ( n = 1,228 ; adjusted odds ratio 1.51 [ 95 % CI 1.03–2.21 ] ) . Among participants with diabetes , worse cognitive performance was associated with metformin use ( 2.23 [ 1.05–4.75 ] ) . After adjusting for age , sex , level of education , history of depression , serum vitamin B12 , and metformin use , participants with diabetes who were taking calcium supplements had better cognitive performance ( 0.41 [ 0.19–0.92 ] ) . CONCLUSIONS Metformin use was associated with impaired cognitive performance . Vitamin B12 and calcium supplements may alleviate metformin-induced vitamin B12 deficiency and were associated with better cognitive outcomes . Prospect i ve trials are warranted to assess the beneficial effects of vitamin B12 and calcium use on cognition in older people with diabetes who are taking metformin Background : Long acting insulin detemir administered intranasally for three weeks enhanced memory for adults with Alzheimer ’s disease dementia ( AD ) or amnestic mild cognitive impairment ( MCI ) . The investigation of longer-term administration is necessary to determine whether benefits persist , whether they are similar to benefits provided by regular insulin , and whether either form of insulin therapy affects AD biomarkers . Objective : The present study aim ed to determine whether four months of treatment with intranasal insulin detemir or regular insulin improves cognition , daily functioning , and AD biomarkers for adults with MCI or AD . Methods : This r and omized , double-blind , placebo-controlled trial included an intent-to-treat sample consisting of 36 adults diagnosed with MCI or mild to moderate AD . Participants received placebo ( n = 12 ) , 40 IU of insulin detemir ( n = 12 ) , or 40 IU of regular insulin ( n = 12 ) daily for four months , administered with a nasal delivery device . A cognitive battery was administered at baseline and after two and four months of treatment . MRI was administered for all participants and lumbar puncture for a subset ( n = 20 ) at baseline and four months . The primary outcome was change from baseline to four months on a memory composite ( sum of Z scores for delayed list and story recall ) . Secondary outcomes included : global cognition ( Alzheimer ’s Disease Assessment Scale-Cognition ) , daily functioning ( Dementia Severity Rating Scale ) , MRI volume changes in AD-related regions of interest , and cerebrospinal fluid AD markers . Results : The regular insulin treated group had better memory after two and four months compared with placebo ( p < 0.03 ) . No significant effects were observed for the detemir-assigned group compared with the placebo group , or for daily functioning for either group . Regular insulin treatment was associated with preserved volume on MRI . Regular insulin treatment was also associated with reduction in the tau-P181/Aβ42 ratio . Conclusion : Future research is warranted to examine the mechanistic basis of treatment differences , and to further assess the efficacy and safety of intranasal insulin Diabetes mellitus is a leading cause of death in the United States and is associated with microvascular and macrovascular complications . Approximately 29.1 million persons , or 9.3 % of the U.S. population , have type 2 diabetes ( 1 ) . In 2012 , the total direct and indirect costs associated with diabetes in the United States were $ 245 billion ( 1 ) . Markedly elevated glucose levels can result in subacute symptoms , such as polyuria , polydipsia , weight loss , and dehydration . Over time , the metabolic derangements associated with diabetes may lead to vision loss , painful neuropathy or sensory loss , foot ulcers , amputations , myocardial infa rct ions , strokes , and end-stage renal disease . Lowering blood glucose may decrease risk for complications , but lowering strategies come with harms , patient burden , and costs . Blood glucose can be measured in various ways , including the hemoglobin A1c ( HbA1c ; also called glycosylated or glycated hemoglobin ) level , which approximates average blood glucose control over about 3 months . As with all laboratory tests , HbA1c measurements are associated with variability ( 2 ) and can vary further with race and ethnicity ( 35 ) . Guidelines have historically recommended initiation or intensification of pharmacologic therapy to achieve specific HbA1c targets , depending on the population in question . The ideal target that optimally balances benefits and harms remains uncertain . Guidance Statement Focus and Target Population The purpose of this American College of Physicians ( ACP ) guidance statement is to critically review the available guidelines from various organizations and the evidence included therein to assist clinicians in making decisions about targets when using pharmacologic therapy in adults with type 2 diabetes . Recent data suggesting that newer agents reduce cardiovascular morbidity and mortality in high-risk patients with type 2 diabetes have prompted calls for a fundamental shift in diabetes management . Some anticipate that treatment decisions will eventually be based more on cardiovascular risk than achievement of specific HbA1c targets , analogous to recent changes in lipid management . However , for the foreseeable future , glycemic targets will continue to influence management decisions by front-line clinicians ( 6 ) . This statement focuses on the benefits and harms of targeting lower versus higher HbA1c levels and does not cover use of specific medications outside of their use to achieve HbA1c targets . The intended audience is all clinicians , and the target population is nonpregnant adults with type 2 diabetes . Methods The Clinical Guidelines Committee ( CGC ) of ACP develops guidance statements on topics where several conflicting guidelines are available . We provide clinicians with a rigorous review of the guidelines and the evidence they include . We then adopt the clinical recommendations if we agree with their evaluation of benefits and harms or adapt them if changes are needed based on our assessment of the recommendations and evidence . Data Sources and Guideline Selection We search ed the National Guideline Clearinghouse and the Guidelines International Network library ( May 2017 ) for guidelines on recommended HbA1c targets in the treatment of type 2 diabetes in nonpregnant outpatient adults . We included guidelines that were developed by national organizations , were published in English , and targeted the correct population . We review ed titles and abstract s and excluded guidelines that were modified or adapted from other organizations or addressed specific population s ( such as pregnant women or patients with kidney disease ) . Our search yielded guidelines from the National Institute for Health and Care Excellence ( NICE ) ( 7 ) and the Institute for Clinical Systems Improvement ( ICSI ) ( 8) . On the basis of the knowledge and expertise of ACP CGC members , we also selected the following 4 guidelines not identified in either data base at the time of the search but commonly used in clinical practice : the American Association of Clinical Endocrinologists and American College of Endocrinology ( AACE/ACE ) guideline ( 9 ) , the American Diabetes Association ( ADA ) guideline ( 10 ) , the Scottish Intercollegiate Guidelines Network ( SIGN ) guideline ( 11 ) , and the U.S. Department of Veterans Affairs and Department of Defense ( VA/DoD ) guideline ( 12 ) . Quality Assessment Six co authors independently review ed and assessed each guideline using the AGREE II ( Appraisal of Guidelines for Research and Evaluation II ) instrument ( 13 ) . This instrument asks 23 questions in the following 6 domains : scope and purpose , stakeholder involvement , rigor of development , clarity of presentation , applicability , and editorial independence . The authors scored each guideline independently , and the scores were compared ( Appendix Figure and Appendix Table 1 ) . Authors then provided a summary determination of whether they would recommend this guideline for use by recording yes , no , or yes with modifications . Appendix Figure . Mean AGREE II scores for items in each domain across the 6 review ers . Each question was rated on a Likert scale with a minimum of 1 point and a maximum of 7 points . The scores were averaged for each of the 6 review ers . Error bars represent calculated st and ard deviation . AACE/ACE = American Association of Clinical Endocrinologists and American College of Endocrinology ; ADA = American Diabetes Association ; AGREE II = Appraisal of Guidelines for Research and Evaluation II ; GDG = guideline development group ; ICSI = Institute for Clinical Systems Improvement ; NICE = National Institute for Health and Care Excellence ; SIGN = Scottish Intercollegiate Guidelines Network ; VA/DoD = U.S. Department of Veterans Affairs and Department of Defense . Appendix Table 1 . Scaled AGREE II Domain Scores for Each Guideline and Overall Assessment Peer Review The draft guidance statement was peer- review ed through Annals of Internal Medicine and was posted online for comments from ACP Regents and Governors , who represent ACP members at the regional level . The final guidance statement incorporated comments from peer review ers and ACP Regents and Governors . Public Panel Review The development of this guidance statement also included perspectives , values , and preferences of 2 CGC members who represent the public and a 7-member public panel . Summary of Evaluated Guidelines Using the AGREE II Instrument We review ed and rated 6 guidelines ( AACE/ACE [ 9 ] , ADA [ 10 ] , ICSI [ 8 ] , NICE [ 7 ] , SIGN [ 11 ] , and VA/DoD [ 12 ] ) , focusing solely on sections addressing HbA1c targets in patients with type 2 diabetes . Appendix Table 1 shows the detailed scaled domain scores and average quality ratings for each guideline , and the Appendix Figure shows average AGREE II scores for each item in each of the 6 domains . The fundamental difference between high- and low-scoring guidelines was methodology . The 2 lowest-scoring guidelines , AACE/ACE and ADA , scored lowest on stakeholder involvement , applicability , editorial independence , and scientific rigor . A systematic review is the backbone for any trustworthy guideline , but some guidelines might not be based on a systematic review or may not Output:	Conclusions and limitations The association between treatment for diabetes and dementia is differential according to drug class , which is potentially mediated by hypoglycemic risk .
MS22322	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: BACKGROUND AND AIM We tested the hypothesis that an intervention with a Mediterranean diet ( MeDiet ) could mitigate the well-known harmful effects of abdominal obesity on cardiovascular health . METHODS AND RESULTS We assessed the relationship between baseline waist-to-height ratio ( WHtR ) and major cardiovascular events during a median follow-up of 4.8 years in the Prevention with Mediterranean Diet ( PREDIMED ) r and omized primary prevention trial , which tested a MeDiet against a control diet ( advice on a low-fat diet ) . We also examined whether the MeDiet intervention was able to counteract the detrimental cardiovascular effects of an increased WHtR. The trial included 7447 participants ( 55 - 80 years old , 57 % women ) at high cardiovascular risk but free of cardiovascular disease ( CVD ) at enrollment . An increased risk of CVD events ( myocardial infa rct ion , stroke , or cardiovascular death ) was apparent for the highest versus the lowest quartile of WHtR ( multivariable-adjusted hazard ratio : 1.98 ) ( 95 % confidence interval : 1.10 - 3.57 ; linear trend : p = 0.019 ) only in the control-diet group , but not in the two groups allocated to intervention with MeDiet ( p for interaction = 0.034 ) . This apparent interaction suggesting that the intervention counterbalanced the detrimental cardiovascular effects of adiposity was also significant for body mass index ( BMI ) ( p = 0.01 ) and waist circumference ( p = 0.043 ) . CONCLUSIONS The MeDiet may counteract the harmful effects of increased adiposity on the risk of CVD OBJECTIVE To test the effects of two Mediterranean diet ( MedDiet ) interventions versus a low-fat diet on incidence of diabetes . RESEARCH DESIGN AND METHODS This was a three-arm r and omized trial in 418 nondiabetic subjects aged 55–80 years recruited in one center ( PREDIMED-Reus , northeastern Spain ) of the Prevención con Dieta Mediterránea [ PREDIMED ] study , a large nutrition intervention trial for primary cardiovascular prevention in individuals at high cardiovascular risk . Participants were r and omly assigned to education on a low-fat diet ( control group ) or to one of two MedDiets , supplemented with either free virgin olive oil ( 1 liter/week ) or nuts ( 30 g/day ) . Diets were ad libitum , and no advice on physical activity was given . The main outcome was diabetes incidence diagnosed by the 2009 American Diabetes Association criteria . RESULTS After a median follow-up of 4.0 years , diabetes incidence was 10.1 % ( 95 % CI 5.1–15.1 ) , 11.0 % ( 5.9–16.1 ) , and 17.9 % ( 11.4–24.4 ) in the MedDiet with olive oil group , the MedDiet with nuts group , and the control group , respectively . Multivariable adjusted hazard ratios of diabetes were 0.49 ( 0.25–0.97 ) and 0.48 ( 0.24–0.96 ) in the MedDiet supplemented with olive oil and nuts groups , respectively , compared with the control group . When the two MedDiet groups were pooled and compared with the control group , diabetes incidence was reduced by 52 % ( 27–86 ) . In all study arms , increased adherence to the MedDiet was inversely associated with diabetes incidence . Diabetes risk reduction occurred in the absence of significant changes in body weight or physical activity . CONCLUSIONS MedDiets without calorie restriction seem to be effective in the prevention of diabetes in subjects at high cardiovascular risk BACKGROUND Adherence to a Mediterranean diet may improve longevity , but relevant data are limited . METHODS We conducted a population -based , prospect i ve investigation involving 22,043 adults in Greece who completed an extensive , vali date d , food-frequency question naire at base line . Adherence to the traditional Mediterranean diet was assessed by a 10-point Mediterranean-diet scale that incorporated the salient characteristics of this diet ( range of scores , 0 to 9 , with higher scores indicating greater adherence ) . We used proportional-hazards regression to assess the relation between adherence to the Mediterranean diet and total mortality , as well as mortality due to coronary heart disease and mortality due to cancer , with adjustment for age , sex , body-mass index , physical-activity level , and other potential confounders . RESULTS During a median of 44 months of follow-up , there were 275 deaths . A higher degree of adherence to the Mediterranean diet was associated with a reduction in total mortality ( adjusted hazard ratio for death associated with a two-point increment in the Mediterranean-diet score , 0.75 [ 95 percent confidence interval , 0.64 to 0.87 ] ) . An inverse association with greater adherence to this diet was evident for both death due to coronary heart disease ( adjusted hazard ratio , 0.67 [ 95 percent confidence interval , 0.47 to 0.94 ] ) and death due to cancer ( adjusted hazard ratio , 0.76 [ 95 percent confidence interval , 0.59 to 0.98 ] ) . Associations between individual food groups contributing to the Mediterranean-diet score and total mortality were generally not significant . CONCLUSIONS Greater adherence to the traditional Mediterranean diet is associated with a significant reduction in total mortality BACKGROUND The Lyon Diet Heart Study is a r and omized secondary prevention trial aim ed at testing whether a Mediterranean-type diet may reduce the rate of recurrence after a first myocardial infa rct ion . An intermediate analysis showed a striking protective effect after 27 months of follow-up . This report presents results of an extended follow-up ( with a mean of 46 months per patient ) and deals with the relationships of dietary patterns and traditional risk factors with recurrence . METHODS AND RESULTS Three composite outcomes ( COs ) combining either cardiac death and nonfatal myocardial infa rct ion ( CO 1 ) , or the preceding plus major secondary end points ( unstable angina , stroke , heart failure , pulmonary or peripheral embolism ) ( CO 2 ) , or the preceding plus minor events requiring hospital admission ( CO 3 ) were studied . In the Mediterranean diet group , CO 1 was reduced ( 14 events versus 44 in the prudent Western-type diet group , P=0.0001 ) , as were CO 2 ( 27 events versus 90 , P=0.0001 ) and CO 3 ( 95 events versus 180 , P=0 . 0002 ) . Adjusted risk ratios ranged from 0.28 to 0.53 . Among the traditional risk factors , total cholesterol ( 1 mmol/L being associated with an increased risk of 18 % to 28 % ) , systolic blood pressure ( 1 mm Hg being associated with an increased risk of 1 % to 2 % ) , leukocyte count ( adjusted risk ratios ranging from 1.64 to 2.86 with count > 9x10(9)/L ) , female sex ( adjusted risk ratios , 0.27 to 0 . 46 ) , and aspirin use ( adjusted risk ratios , 0.59 to 0.82 ) were each significantly and independently associated with recurrence . CONCLUSIONS The protective effect of the Mediterranean dietary pattern was maintained up to 4 years after the first infa rct ion , confirming previous intermediate analyses . Major traditional risk factors , such as high blood cholesterol and blood pressure , were shown to be independent and joint predictors of recurrence , indicating that the Mediterranean dietary pattern did not alter , at least qualitatively , the usual relationships between major risk factors and recurrence . Thus , a comprehensive strategy to decrease cardiovascular morbidity and mortality should include primarily a cardioprotective diet . It should be associated with other ( pharmacological ? ) means aim ed at reducing modifiable risk factors . Further trials combining the 2 approaches are warranted Objective To assess the relation between adherence to a Mediterranean diet and the incidence of diabetes among initially healthy participants . Design Prospect i ve cohort study with estimates of relative risk adjusted for sex , age , years of university education , total energy intake , body mass index , physical activity , sedentary habits , smoking , family history of diabetes , and personal history of hypertension . Setting Spanish university department . Participants 13 380 Spanish university graduates without diabetes at baseline followed up for a median of 4.4 years . Main outcome measures Dietary habits assessed at baseline with a vali date d 136 item food frequency question naire and scored on a nine point index . New cases of diabetes confirmed through medical reports and an additional detailed question naire posted to those who self reported a new diagnosis of diabetes by a doctor during follow-up . Confirmed cases of type 2 diabetes . Results Participants who adhered closely to a Mediterranean diet had a lower risk of diabetes . The incidence rate ratios adjusted for sex and age were 0.41 ( 95 % confidence interval 0.19 to 0.87 ) for those with moderate adherence ( score 3 - 6 ) and 0.17 ( 0.04 to 0.75 ) for those with the highest adherence ( score 7 - 9 ) compared with those with low adherence ( score < 3 ) . In the fully adjusted analyses the results were similar . A two point increase in the score was associated with a 35 % relative reduction in the risk of diabetes ( incidence rate ratio 0.65 , 0.44 to 0.95 ) , with a significant inverse linear trend ( P=0.04 ) in the multivariate analysis . Conclusion Adherence to a Mediterranean diet is associated with a reduced risk of diabetes BACKGROUND The accumulation of abdominal fat increases risk of metabolic disorders and premature death . There is a dearth of prospect i ve data on the association between caloric beverage consumption and surrogate markers of abdominal adiposity . OBJECTIVE The aim of this study was to assess the relation between consumption of nonalcoholic caloric beverages , including soft drinks , fruit juice , whole milk , and skim and low-fat milk , and changes in waist circumference ( WC ) and odds of 10-y incidence of abdominal obesity . METHODS We conducted a prospect i ve , population -based study of 2181 Spanish men and women aged 25 - 74 y who were followed from 2000 to 2009 . We measured weight , height , and WC , and recorded data on diet and leisure-time physical activity ( LTPA ) with the use of vali date d question naires . We fit multivariable linear and logistic regression models . RESULTS A 100 kcal increase in soft drink consumption was associated with a 1.1 cm increase in WC ( P = 0.018 ) after 10 y of follow-up . Substitution of 100 kcal of soft drinks with 100 kcal of whole milk or 100 kcal of juice was associated with a 1.3 cm ( 95 % CI : 0.3 , 2.4 ) and 1.1 cm ( 95 % CI : 0.03 , 2.2 ) decrease in WC , respectively . Increasing consumption of soft drinks from baseline to follow-up led to WC gain compared with maintaining nonconsumption . Greater soft drink consumption was positively associated ( P = 0.029 ) with increased odds of 10-y incidence of abdominal obesity . CONCLUSION Adults ' consumption of soft drinks was associated with increased WC and odds of 10-y incidence of abdominal obesity . This association was moderate but consistent in all statistical models Objective : The aim of this work was to evaluate the combined effect of physical activity and 1 and 12 months ’ adherence to Mediterranean diet ( MD ) on serum total antioxidant capacity ( TAC ) in obese patients , as well as factors contributing to TAC . Methods : One hundred twenty-four patients were r and omly assigned to either MD combined with physical activity or st and ard hypolypemic diet ( SHD ) with physical activity . Both groups received counseling and education during the initial week and were invited for the follow-up visits , where data on body weight and blood sample s were collected . TAC was determined by Trolox equivalent antioxidant capacity and urate was determined using a uricase spectrophotometric method at the initial visit and after 1 and 12 months . Results : Eighty-four patients finished the 12-month program and were analyzed . The baseline and 1- and 12-month mean ( ±SD ) TAC values in the MD group ( n = 40 ) were 2.38 ± 0.48 , 2.51 ± 0.47 , and 2.47 ± 0.45 mmol Trolox equivalent (TE)/L , respectively . In the SHD group ( n = 44 ) , TAC values were 2.37 ± 0.49 , 2.48 ± 0.49 , and 2.31 ± 0.51 mmol TE/L , respectively . There was a statistically significant main effect for time ( p < 0.001 ) , as well as statistically significant time – diet interaction effect ( p = 0.009 ) . There was no statistically significant correlation between TAC and uric acid Output:	There is a high level of evidence showing that MedDiet adherence plays a role in the primary and secondary prevention of cardiovascular disease ( CVD ) and improves health in overweight and obese patients . There is moderate-to-high evidence that the MedDiet prevents increases in weight and waist circumference in non-obese individuals , and improves metabolic syndrome ( MetS ) and reduces its incidence . Finally , there is moderate evidence that the MedDiet plays primary and secondary roles in the prevention of type 2 diabetes mellitus ( T2DM ) . The MedDiet is effective in preventing obesity and MetS in healthy and at-risk individuals , in reducing mortality risk in overweight or obese individuals , in decreasing the incidence of T2DM and CVD in healthy individuals , and in reducing symptom severity in individuals with T2DM or CVD
MS22323	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: OBJECTIVE : To vali date a range of dietary assessment instruments in general practice . METHODS : Using a r and omised block design , brief assessment instruments and more complex conventional dietary assessment tools were compared with an accepted " relative " st and ard -- a seven day weighed dietary record . The st and ard was checked using biomarkers , and by performing test-retest reliability in additional subjects ( n = 29 ) . OUTCOMES : Agreement with weighed record . Percentage agreement with weighed record , rank correlation from scatter plot , rank correlation from Bl and -Altman plot . Reliability of the weighed record . SETTING : Practice nurse treatment room in a single suburban general practice . SUBJECTS : Patients with risk factors for cardiovascular disease ( n = 61 ) or age/sex stratified general population group ( n = 50 ) . RESULTS : Brief self completion dietary assessment tools based on food groups caten during a week show reasonable agreement with the relative st and ard . For % energy from fat and saturated fat , non-starch polysaccharide , grams of fruit and vegetables and starchy foods consumed the range of agreement with the st and ard was : median % difference -6 % to 12 % , rank correlation 0.5 to 0.6 . This agreement is of a similar order to the reliability of the weighed record , as good as or better than test st and ard agreement for more time consuming instruments , and compares favourably with research instruments vali date d in other setting s. Under-reporting of energy intake was common ( 40 % ) and more likely if subjects were obese ( body mass idex ( BMI ) > or = 30 60 % under-reported ; BMI < 30 29 % , p < 0.001 ) . CONCLUSION : Under-reporting of absolute energy intake is common , particularly among obese patients . Simple self assessment tools based on food groups , design ed for practice nurse dietary assessment , show acceptable agreement with a st and ard , and suggest such tools are sufficiently accurate for clinical work , research , and possibly population dietary monitoring OBJECTIVE The validity of the 24-hour recall , 3-day food record , and 5-day food frequency was assessed to decide on a dietary assessment method for the National Heart , Lung , and Blood Institute ( NHLBI ) Growth and Health Study . DESIGN All subjects were assigned to one of three dietary assessment methods . Unobtrusive observers recorded types and amounts of foods eaten during lunch , and these were compared with the foods reported by the girls in the study . SETTING School lunchrooms in California and Ohio . SUBJECTS 58 girls , aged 9 and 10 years . MAIN OUTCOME MEASURES Reporting errors for dietary assessment methods . STATISTICAL ANALYSES PERFORMED Descriptive statistics , matched pair t tests , and Spearman correlation coefficients . RESULTS Comparison of the intakes of energy and selected macronutrients showed different ranges of , and median percentage absolute errors for , each dietary assessment method . Percentage absolute errors ranged between 20 and 33 for the 5-day food frequency method ; 19 and 39 for the 24-hour recall ; and 12 and 22 for the 3-day food record . The proportion of missing foods ( ie , observed food items not reported ) and phantom foods ( ie , reported food items not observed ) by each method were 46 % and 40 % , respectively , for the 5-day food frequency ; 30 % and 33 % , respectively , for the 24-hour recall ; and 25 % and 10 % , respectively , for the 3-day food record . APPLICATIONS/ CONCLUSIONS Errors in food reporting and quantification can vary with the type of dietary methodology . Agreement between observed and reported intakes from 3-day food records made it the best overall choice . On this basis , it was selected as the method of assessment for the NHLBI Growth and Health Study Output:	Interventions did not appear to increase health inequalities although this was examined in fewer studies . We found strong evidence to support beneficial effects of child obesity prevention programmes on BMI , particularly for programmes targeted to children aged six to 12 years .
MS22324	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: In a prospect i ve r and omized trial , 73 patients received prednisolone , 7.5 mg daily , for one cycle in addition to Clomid and /or gonadotrophins , while another 73 patients were not given the corticosteroid . In-vitro fertilization ( IVF ) result ed in 16 versus six clinical pregnancies in the prednisolone and the non-prednisolone group , respectively ( P less than 0.05 ) . Oestrogen was significantly higher under prednisolone during the ovulatory phase , while LH was significantly lower . The adrenal and rogen dehydroepi and rosterone sulphate was markedly depressed by prednisolone and testosterone was also markedly lower in the prednisolone group . A stress-related and rogen excess might occur in some patients undergoing IVF with consequent cystic degeneration of some follicles as in polycystic ovarian disease . Prednisolone might counteract this detrimental effect by depressing adrenal and ovarian and rogens OBJECTIVE To verify whether advantages can derive from the implementation of preimplantation genetic diagnosis for aneuploidy in patients with a poor prognosis of full-term pregnancy , compared with conventional treatment procedures . DESIGN A r and omized , controlled study . SETTING Reproductive Medicine Unit of the Società Italiana Studi Medicina della Riproduzione , Bologna , Italy . PATIENT(S ) In a total of 262 stimulated cycles , women presented with the following poor-prognosis indications : maternal age of > or = 36 years ( n = 157 ) , > or =3 previous IVF failures ( n = 54 ) , and an altered karyotype ( n = 51 ) . After giving consent , 127 patients underwent preimplantation genetic diagnosis for aneuploidy , whereas 135 controls underwent assisted zona hatching . INTERVENTION(S ) Analysis of chromosomes XY , 13 , 14 , 15 , 16 , 18 , 21 , and 22 was carried out with the fluorescence in situ hybridization technique in a blastomere biopsied from day 3 embryos . Assisted zona hatching was performed on day 3 embryos from the control group . MAIN OUTCOME MEASURE(S ) Embryo morphology and chromosomal status , number of transferred embryos , clinical pregnancies , implantation rates , and abortions . RESULT ( S ) In the study group , 717 embryos were analyzed by fluorescence in situ hybridization , and 60 % were chromosomally abnormal . A mean of 2.3+/-0.9 euploid embryos were transferred in 99 cycles , result ing in 37 clinical pregnancies ( 37 % ) and a 22.5 % ongoing implantation rate . In the control group , 126 cycles were performed with 3.2+/-1.3 embryos transferred , yielding 34 clinical pregnancies ( 27 % ) and a 10.2 % ongoing implantation rate . CONCLUSION ( S ) The advantage of selecting embryos with a normal chromosome complement has an immediate impact on the ongoing implantation rate , especially in patients aged > or = 38 years and carriers of an altered karyotype BACKGROUND Cancellation of assisted conception cycles because of poor ovarian response to gonadotrophins is a significant problem in assisted reproduction . Various adjuvant treatments have been suggested to improve responsiveness . This study reports on the potential benefits of low dose dexamethasone . METHODS Patients < 40 years of age were invited to participate in a twin centre prospect i ve double blind r and omized placebo controlled study . A total of 290 patients were recruited and computer r and omized using sealed envelopes to receive either 1 mg dexamethasone ( n = 145 ) or placebo tablets ( n = 145 ) in addition to a st and ard long protocol gonadotrophin-releasing hormone analogue with gonadotrophin stimulation regime . RESULTS A significantly lower cancellation rate for poor ovarian response was observed in the dexamethasone group compared with controls ( 2.8 versus 12.4 % respectively , P < 0.002 ) . Further comparisons between the dexamethasone group and controls were made of median fertilization rates ( 60 versus 61 % respectively , NS ) , implantation rates ( 16.3 versus 11.6 % respectively , NS ) and pregnancy rate per cycle started ( 26.9 versus 17.2 % , NS ) . The benefit was apparent in patients both with polycystic and normal ovaries . CONCLUSION Low dose dexamethasone co-treatment reduces the incidence of poor ovarian response . It may increase clinical pregnancy rates and should be considered for inclusion in stimulation regimes to optimize ovarian response Immunosuppression by exogenous corticosteroids has been used to improve the rates of embryo implantation and pregnancy in in-vitro fertilization ( IVF ) patients who have micromanipulated embryos replaced . The present study was conducted , in a prospect i ve design , to evaluate effects of corticosteroid on the pregnancy rate in IVF/embryo transfer patients who have non-micromanipulated embryos replaced . Infertile women < 40 years old with tubal factor were included in this study . Patients were grouped according to the different follicle stimulation protocol s , and received various doses of 16 beta-methylprednisolone ( 0 , 16 or 60 mg/day ) for 4 days from the day of oocyte retrieval . The mean age , duration of infertility , length of folliculogenesis and serum oestradiol concentrations at the time of human chorionic gonadotrophin ( HCG ) injection were not significantly different between control and corticosteroid-treated groups of patients . Short-term immunosuppression by 16 beta-methylprednisolone administration did not show any effects on the pregnancy and miscarriage rates in IVF/embryo transfer patients . Also , immunosuppression showed no dose effects in any groups . There was no relationship between the types of follicle stimulation protocol s and the effect of 16 beta-methylprednisolone . Therefore , we concluded that short-term immunosuppression by exogenous corticosteroids in IVF/embryo transfer patients who have embryos with intact zona pellucida replaced has neither positive nor negative effects on pregnancy rates OBJECTIVE To determine if the administration of glucocorticoids reduced the rate of ovarian hyperstimulation syndrome ( OHSS ) in high-risk patients after ovarian stimulation for in vitro fertilization ( IVF ) . DESIGN Prospect i ve r and omized study . PATIENTS Thirty-one patients who were stimulated with human menopausal gonadotropin ( hMG ) after pituitary desensitization by gonadotropin-releasing hormone agonist and who developed greater than 20 follicles greater than 12 mm and /or had a serum estradiol ( E2 ) level of greater than 10,000 pmol/L on the day of administration of human chorionic gonadotropin ( hCG ) . INTERVENTIONS Patients were r and omly divided into two groups . Those who were r and omized to receive glucocorticoids ( group A ) ( n = 17 ) were administered intravenous hydrocortisone , 100 mg , immediately after ultrasound (US)-directed oocyte recovery . Prednisolone , 10 mg three times per day , was given for 5 days starting on the day of oocyte recovery followed by prednisolone 10 mg two times a day for 3 days and 10 mg/d for 2 days . Those in group B ( n = 14 ) did not receive any glucocorticoid treatment . In both groups , luteal support was provided by intramuscular injections of gestone 100 mg/d . RESULTS The two groups of patients were comparable in terms of age , duration of infertility , and total dose of hMG used . All had polycystic ovaries on US examination . On the day of hCG administration , the mean number of follicles in the two groups were 26.76 + /- 2.49 and 25.93 + /- 1.44 and the serum E2 concentration 13,404 + /- 710 and 13,915 + /- 901 pmol/L , respectively . There were no significant differences in the number of oocytes collected or in the fertilization , cleavage , and implantation rates in the two groups . The pregnancy rates per initiated cycle were 41.18 % and 35.71 % , respectively . Seven of the 17 patients ( 41.2 % ) who received glucocorticoids developed ovarian hyperstimulation syndrome compared with 6 of the 14 patients ( 42.9 % ) who did not receive glucocorticoids . CONCLUSIONS Administrations of glucocorticoids to high risk patients did not reduce the rate of OHSS after ovarian stimulation for IVF The effect of low dose immunosuppression with methylprednisolone during the first 4 days after oocyte retrieval on potential immune cell invasion of partially zona dissected embryos in utero was investigated in alternate in vitro fertilization patients ( n = 32 ) . The incidence of pregnancy was significantly higher in patients receiving methylprednisolone ( 7 of 18 , 39 % ) than in control patients ( 1 of 14 , 7 % ) . Twenty-eight percent ( 11 of 39 ) of the embryos replaced in the corticosteroid treated patients implanted , whereas only 7 % ( 2 of 31 ) of embryos in control patients had a fetal heart beat . There were no side effects reported in any of the patients receiving corticosteroids . It can be concluded that methylprednisolone supports implantation of embryos with small holes in their zonae . However , the actual mechanisms of corticosteroid support on the interaction between immune cells and micromanipulated embryos are not well understood Background Anti-thyroid antibodies ( ATA ) , even if not associated with thyroid dysfunction , are suspected to cause poorer outcome of in vitro fertilization ( IVF ) . Methods We retrospectively analyzed : ( a ) the prevalence of ATA in euthyroid infertile women , ( b ) IVF outcome in euthyroid , ATA+ patients , and ( c ) the effect of adjuvant treatments ( levothyroxine alone or associated with acetylsalicylic acid and prednisolone ) on IVF results in ATA+ patients . One hundred twenty-nine euthyroid , ATA+ women undergoing IVF were compared with 200 matched , ATA-controls . During IVF cycle , 38 ATA+ patients did not take any adjuvant treatment , 55 received levothyroxin ( LT ) , and 38 received LT + acetylsalicylic acid (ASA)+prednisolone ( P ) . Results The prevalence of ATA among euthyroid , infertile patients was 10.5 % , similar to the one reported in euthyroid women between 18 and 45 years . ATA+ patients who did not receive any adjuvant treatment showed significantly poorer ovarian responsiveness to stimulation and IVF results than controls . ATA+ patients receiving LT responded better to ovarian stimulation , but had IVF results as poor as untreated ATA+ women . Patients receiving LT+ASA+P had significantly higher pregnancy and implantation rates than untreated ATA+ patients ( PR/ET 25.6 % and IR 17.7 % vs. PR/ET 7.5 % and IR 4.7 % , respectively ) , and overall IVF results comparable to patients without ATA ( PR/ET 32.8 % and IR 19 % ) . Conclusion These observations suggest that euthyroid ATA+ patients undergoing IVF could have better outcome if given LT+ASA+P as adjuvant treatment . This hypothesis must be verified in further r and omized , prospect i ve studies A group of 78 infertile women , diagnosed as having tubal factor infertility only , was enrolled in a prospect i ve , r and omized study conducted to determine whether the addition of different doses of glucocorticoids to the protocol of ovulation induction for in-vitro fertilization ( IVF ) would be beneficial . Oocyte numbers , percentage of fertilization , oestradiol , luteinizing hormone and follicle stimulating hormone serum concentrations , number of embryo transfers and pregnancy rate were evaluated . Compared to control cycles ( group A ; n = 24 ) , the addition of 0.5 mg ( group B ; n = 27 ) of 1 mg dexamethasone ( group C ; n = 27 ) , combined with the protocol of programmed oocyte retrieval for IVF patients in the study , demonstrated equivalent results . The mean numbers of oocytes retrieved were 10.8 + /- 3.9 in the control group , compared to 11.2 + /- 4.0 in group B and 10.5 + /- 3.6 in group C. The fertilization rates were 69 + /- 21 , 66 + /- 18 and 70 + /- 15 % respectively . The pregnancy rates were 20 , 16 and 20.8 % respectively . The addition of up to 1 mg dexamethasone daily to the protocol of ovulation induction for oocyte retrieval did not improve the overall IVF-embryo transfer outcome in patients with tubal factor infertility BACKGROUND Glucocorticoids have been used in conjunction with zona dissection to improve pregn Output:	There were no significant differences in adverse events , but these were poorly and inconsistently reported . Overall , there was no clear evidence that administration of peri-implantation glucocorticoids in ART cycles significantly improved the clinical outcome . These findings were limited to the routine use of glucocorticoids and can not be extrapolated to women with autoantibodies , unexplained infertility or recurrent implantation failure .
MS22325	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: Study objective : To determine the association between a clinician assessment of temperament in early adulthood and cause specific mortality . Design : Prospect i ve observational study . Setting : Glasgow University . Participants : 9239 male former students aged 16–30 ( mean 20.5 ) years who participated in an ongoing health survey from 1948–68 . A physician recorded free text assessment of temperament , which seemed to capture aspects of personality ( trait ) and mental health ( state ) , was coded into : stable , anxious , schizoid , hypomanic , odd , depressed , immature , hypochondriacal , unstable , and obsessive . Associations between temperament and mortality were investigated using Cox proportional hazards models . Main results : There were 878 deaths . Most students—8342 (90.3%)—were assessed as stable , the remaining 897 ( 9.7 % ) having at least one , and 103 ( 1.1 % ) having more than one , temperament type . The second most common temperament was anxiety , recorded in 520 ( 5.6 % ) students . In multivariable analyses , having at least one temperament type was associated with increased all cause and stroke mortality , hazard ratios ( 95 % confidence intervals ) : 1.23 ( 1.01 to 1.50 ) and 1.95 ( 1.06 to 3.59 ) respectively , compared with stable students . Students with more than one temperament type had higher risk of death from : all causes , 2.05 ( 1.36 to 3.09 ) ; stroke , 3.26 ( 1.01 to 10.56 ) ; and cancer , 2.90 ( 1.62 to 5.20 ) . Anxiety was positively associated with all cause and cancer mortality , respective hazard ratios : 1.36 ( 1.07 to 1.72 ) and 1.51 ( 1.04 to 2.20 ) . Men labelled hypomanic had increased cardiovascular mortality risk , 1.90 ( 1.05 to 3.44 ) . Conclusions : Markers of early adult psychological distress are associated with increased mortality . Mechanisms underlying these associations require investigation Background : Social anxiety disorder ( SAD ) is characterized by distorted self-views . The goal of this study was to examine whether mindfulness-based stress reduction ( MBSR ) alters behavioral and brain measures of negative and positive self-views . Methods : Fifty-six adult patients with generalized SAD were r and omly assigned to MBSR or a comparison aerobic exercise ( AE ) program . A self-referential encoding task was administered at baseline and post-intervention to examine changes in behavioral and neural responses in the self-referential brain network during functional magnetic resonance imaging . Patients were cued to decide whether positive and negative social trait adjectives were self-descriptive or in upper case font . Results : Behaviorally , compared to AE , MBSR produced greater decreases in negative self-views , and equivalent increases in positive self-views . Neurally , during negative self versus case , compared to AE , MBSR led to increased brain responses in the posterior cingulate cortex ( PCC ) . There were no differential changes for positive self versus case . Secondary analyses showed that changes in endorsement of negative and positive self-views were associated with decreased social anxiety symptom severity for MBSR , but not AE . Additionally , MBSR-related increases in dorsomedial prefrontal cortex ( DMPFC ) activity during negative self-view versus case were associated with decreased social anxiety related disability and increased mindfulness . Analysis of neural temporal dynamics revealed MBSR-related changes in the timing of neural responses in the DMPFC and PCC for negative self-view versus case . Conclusion : These findings suggest that MBSR attenuates maladaptive habitual self-views by facilitating automatic ( i.e. , uninstructed ) recruitment of cognitive and attention regulation neural networks . This highlights potentially important links between self-referential and cognitive-attention regulation systems and suggests that MBSR may enhance more adaptive social self-referential processes in patients with SAD BACKGROUND Escitalopram , the therapeutically active isomer of the racemic selective serotonin reuptake inhibitor antidepressant citalopram , has shown significant anxiolytic effects in placebo-controlled clinical trials of social anxiety disorder , generalized anxiety disorder , and anxiety symptoms associated with major depression . This study evaluated the safety and efficacy of escitalopram in out patients diagnosed with panic disorder . METHOD Male and female out patients between 18 and 80 years of age meeting DSM-IV criteria for panic disorder , with or without agoraphobia , were r and omly assigned to 10 weeks of double-blind treatment with escitalopram , citalopram , or placebo in a study conducted from September 1999 to July 2001 . The primary measure of efficacy was panic attack frequency at week 10 relative to baseline , as assessed by the Modified Sheehan Panic and Anticipatory Anxiety Scale . RESULTS A total of 366 subjects ( 128 escitalopram patients , 119 citalopram patients , and 119 placebo patients ) received at least 1 dose of double-blind treatment . The frequency of panic attacks was statistically significantly improved ( p = .04 ) , and the increase in percentage of patients with zero panic attacks reached borderline significance ( p = .051 ) , in the escitalopram-treated group relative to the placebo-treated group . Both escitalopram and citalopram statistically significantly reduced panic disorder symptoms and severity versus placebo at endpoint ( p < /=.05 ) , as measured by the Panic and Agoraphobia Scale total score , the Clinical Global Impressions scale , the Patient Global Evaluation , and the Quality of Life Enjoyment and Satisfaction Question naire . Treatment with escitalopram was safe and well tolerated , with a similar incidence of the most common adverse events for the escitalopram and placebo groups . The rate of discontinuation for adverse events was 6.3 % for escitalopram , 8.4 % for citalopram , and 7.6 % for placebo . CONCLUSION Escitalopram is efficacious , safe , and well tolerated in the treatment of panic disorder OBJECTIVES The aim of the study was to determine the status of the autonomic nervous system ( ANS ) in anxiety disorder patients and to evaluate possible exercise intervention in order to improve the ANS and overall psychiatric status of patients . PATIENTS AND METHODS The ANS function was monitored via means of heart rate variability ( HRV ) changes during a 6-week hospitalization at the Psychiatric Clinic of University Hospital in Olomouc . The status of ANS was monitored by the new evaluation method of spectral analysis ( SA ) of HRV . The research involved 43 anxiety patients ( 29 women and 14 men ) who underwent six weeks of intensive psychotherapy ; part of the test group also participated in regular aerobic exercise . RESULTS In the sense of autonomic dysfunction we can not give clear-cut answers to the question whether the autonomic dysfunction could be one of the predictors of anxiety disorder , although our results suggest lower vagal representation in the spectra . Unlike in the healthy population the exercise had a positive impact only on a limited number of patients . Regular endurance exercise on a stationary bicycle had a positive impact on the ANS efficiency only in patients with primary ANS activity reduction . In patients with normal ANS efficiency the exercise intervention had no effect ; in some cases we even found activity reduction during the hospitalization period . However , the exercise had a positive effect on the course and outcome of the applied therapy in all patients . CONCLUSIONS ANS disturbances have not been exhibited in some patients suffering from anxiety disorder . Due to the positive impact of regular physical activity on cardiovascular , metabolic , neural , and psychological changes in organism , monitored exercise should be implemented into therapeutic programs for patients with anxiety disorders Background : Interrelations of exercise , mood , and weight reduction are unclear in the behavioral treatment of obesity . Methods : Obese women volunteers with high tension ( anxiety ) ( T ) , depression ( D ) , or total mood disturbance ( TMD ) scores , who were previously r and omized into conditions of ( 1 ) exercise supported by The Coach Approach : a protocol based on social cognitive and self-efficacy theory ( CA ; n = 53 , 66 , and 60 , respectively ) , ( 2 ) personal demonstration and follow up of exercise methods ( EX ; n = 27 , 27 , and 21 , respectively ) , and ( 3 ) exercise suggested through written information only ( INFO ; n = 24 , 28 , and 20 , respectively ) , were subjects . Identical nutrition information was provided to all subjects in a small group format . Results : Minutes of exercise over the 6-month study were greatest in the CA condition , with minutes in the EX condition greater than the INFO condition . T , D , and TMD scores were reduced to normal levels mostly in the CA condition , with the EX condition having significantly more normalized D scores than the INFO . Across conditions , normalized mood scores generally predicted a greater reduction in waist circumference , with CA associated with additional benefits when D scores were considered . Conclusion : Properly accounting for exercise-induced mood change may be important in the behavioral treatment of obesity Background : Exercise training may be especially helpful for patients with generalized anxiety disorder ( GAD ) . We conducted a r and omized controlled trial to quantify the effects of 6 weeks of resistance ( RET ) or aerobic exercise training ( AET ) on remission and worry symptoms among sedentary patients with GAD . Methods : Thirty sedentary women aged 18–37 years , diagnosed by clinicians blinded to treatment allocation with a primary DSM-IV diagnosis of GAD and not engaged in any treatment other than pharmacotherapy , were r and omly allocated to RET , AET , or a wait list ( WL ) . RET involved 2 weekly sessions of lower-body weightlifting . AET involved 2 weekly sessions of leg cycling matched with RET for body region , positive work , time actively engaged in exercise , and load progression . Remission was measured by the number needed to treat ( NNT ) . Worry symptoms were measured by the Penn State Worry Question naire . Results : There were no adverse events . Remission rates were 60 % , 40 % , and 30 % for RET , AET , and WL , respectively . The NNT was 3 ( 95 % CI 2 to 56 ) for RET and 10 ( 95 % CI –7 to 3 ) for AET . A significant condition-by-time interaction was found for worry symptoms . A follow-up contrast showed significant reductions in worry symptoms for combined exercise conditions versus the WL . Conclusions : Exercise training , including RET , is a feasible , low-risk treatment that can potentially reduce worry symptoms among GAD patients and may be an effective adjuvant , short-term treatment or augmentation for GAD . Preliminary findings warrant further investigation BACKGROUND Several studies have suggested an increased risk of fatal coronary heart disease ( CHD ) among patients with panic disorder , phobic anxiety , and other anxiety disorders . We prospect ively examined this association in the Normative Aging Study . METHODS AND RESULTS An anxiety symptoms scale was constructed out of five items from the Cornell Medical Index , which was administered to the cohort at baseline . During 32 years of follow-up , we observed 402 cases of incident coronary heart disease ( 137 cases of nonfatal myocardial infa rct ion , 134 cases of angina pectoris , and 131 cases of fatal CHD : made up of 26 cases of sudden cardiac death and 105 cases of nonsudden death ) . A nested case-control design ( involving 1869 control subjects who remained free of diagnosed CHD ) was used to assess the association between anxiety and risk of CHD . Compared with men reporting no symptoms of anxiety , men reporting two or more anxiety symptoms had elevated risks of fatal CHD ( age-adjusted odds ratio [ OR ] = 3.20 , 95 % confidence interval [ CI ] : 1.27 to 8.09 ) , and sudden death ( age-adjusted OR = 5.73 , 95 % CI : 1.26 to 26.1 ) . The multivariate OR after adjusting for a range of potential confounding variables was 1.94 ( 95 % CI : 0.70 - 5.41 ) for fatal CHD and 4.46 ( 95 % CI : 0.92 - 21.6 ) for sudden death . No excess risks were found for nonfatal myocardial infa rct ion or angina . CONCLUSIONS These data suggest an association between anxiety and fatal coronary heart disease , in particular , sudden cardiac death Background : Previous studies have suggested that physical exercise can reduce symptoms for subjects suffering from panic disorder ( PD ) . The efficacy of this intervention has so far not been compared to an established psychotherapy , such as cognitive behaviour therapy ( CBT ) . Assessment of controlled long-term effects and the clinical significance of the treatment are also lacking . Aim : To compare physical exercise to CBT as treatment for PD , and assess controlled long-term and clinical ly significant effects . Method : PD- patients were r and omized to either three weekly sessions of physical exercise ( n = 17 ) , or one weekly session of CBT ( n = 19 ) . Both treatments ran for 12 weeks , were manualized and administered in groups . Patients were assessed twice before the start of treatment , at post-treatment and at 6 and 12 months thereafter . Primary outcome - measures consisted of the Mobility Inventory ( MI ) , the Agoraphobia Cognitions Question naire ( ACQ ) and the Body Sensations Question naire ( BSQ ) . Results : A two-way repeated measures MANOVA of these measures demonstrated a significant effect of time , F(16 , Output:	Conclusions Exercise may be a useful treatment for anxiety , but lack of data from rigorous , method ologically sound RCTs precludes any definitive conclusions about its effectiveness
MS22326	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: Background Preterm-born or asphyxiated term-born children who received neonatal intensive care show more emotional and behavioral problems than term-born children without a medical condition . It is uncertain whether regular parenting intervention programs to which the parents of these children are usually referred , are effective in reducing child problem behavior in this specific population . Our objective was to investigate whether a regular , brief parenting intervention , Primary Care Triple P , is effective in decreasing emotional and behavioral problems in preterm-born or asphyxiated term-born preschoolers . Methods For this pragmatic , open r and omized clinical trial , participants were recruited from a cohort of infants admitted to the neonatal intensive care units ( NICU ) of two Dutch hospitals . Children born with a gestational age < 32 weeks or birth weight < 1500 g and children born at a gestational age 37–42 weeks with perinatal asphyxia were included . After screening for a t-score ≥60 on the Child Behavior Checklist ( CBCL ) , children were r and omly assigned to Primary Care Triple P ( n = 34 ) or a wait-list control group ( n = 33 ) . The primary outcome was child emotional and behavioral problems reported by parents on the CBCL , 6 months after the start of the trial . Results There was no effect of the intervention on the CBCL at the trial endpoint ( t64 = 0.54 , P = .30 ) . On secondary measurements of child problem behavior , parenting style , parenting stress , and parent perceived child vulnerability , groups either did not differ significantly or the intervention group showed more problems . In both the intervention and control group there was a significant decrease in emotional and behavioral problems during the trial . Conclusions Primary Care Triple P , a brief parenting intervention , is not effective in reducing child emotional and behavioral problems in preterm-born children or term-born children with perinatal asphyxia . Trial registration Netherl and s National Trial Register ( NTR ) : 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 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 examine the language development at corrected age 4 years of a regionally representative cohort of children born very preterm ( VPT ) . Of particular interest was the identification of biological and socioenvironmental risk and protective factors that influence VPT children 's early language development . Method : Data were collected as part of a prospect i ve longitudinal study of 110 VPT ( VPT : ≤33 weeks gestation ) and 113 full-term children ( full term : 37–41 weeks gestation ) born in Canterbury , New Zeal and from 1998 to 2000 . At corrected age 4 years , all children were assessed with the preschool version of the Clinical Evaluation of Language Fundamentals . Extensive information was also collected about children 's family social background , perinatal health , childrearing environment , education/intervention exposures , and neurodevelopmental progress from birth to age 4 . Results : At the age of 4 years , VPT children were characterized by poorer receptive and expressive language development than full-term children . These differences persisted after exclusion of children with neurosensory impairment as well as statistical adjustment for the effects of social risk . Within the VPT group , the key predictors of children 's overall language development were family social risk at birth ( p = .05 ) , severity of white matter abnormalities on neonatal magnetic resonance imaging ( p = .49 ) , observed parent-child synchrony ( p = .001 ) , and concurrent child cognitive ability ( p = .001 ) . Together , these factors accounted for 45 % of the variance in children 's total Clinical Evaluation of Language Fundamentals — Preschool scores . Conclusion : By preschool age , children born VPT show early emerging mild to moderate language delays that are likely to affect their school success and longer-term developmental progress . Findings highlight the importance of potentially modifiable factors such as early brain injury and parenting quality in predicting the language outcomes of children born VPT This study reports on child welfare outcomes of a community based , r and omized control trial of Promoting First Relationships ® ( PFR ; Kelly , S and oval , Zuckerman , & Buehlman , 2008 ) , a 10-week relationship-based home visiting program , on stability of children 's placements and permanency status two years after enrollment into the study . Toddlers 10 - 24 months ( N = 210 ) with a recent placement disruption were r and omized , along with their birth or foster/kin parents , to PFR ( n = 105 ) or a comparison condition ( n = 105 ) . A stable placement had no interruptions or disruptions . A permanent placement was a stable placement ending with a legal discharge to the study caregiver . Logistic regression models predicting the dichotomous stability and permanency variables , controlling for caregiver type , child welfare variables , and caregiver commitment , were conducted . There was no difference by intervention group on stability or permanency , but there was a significant interaction between caregiver type ( birth parent vs. foster/kin ) and intervention group . More foster/kin caregivers who received the PFR intervention provided stable , uninterrupted care and eventually adopted or became the legal guardians of the toddlers in their care , compared to foster/kin caregivers r and omized to the comparison condition The differential susceptibility to parenting model was examined in relation to toddler self-regulation in a prospect i ve longitudinal study of infants born preterm or low birth weight . We followed 153 mother-infant dyads across five time points between the infant 's Neonatal Intensive Care Unit stay and 24 months postterm . Assessment s of infant temperament , quality of early parenting interactions , context ual variables , and toddler effortful control and behavior problems were conducted . Results supported differential susceptibility and dual risk models in addition to documenting main effects of early parenting on children 's emerging self-regulation . Our data suggested that preterm or low birth weight infants who were prone to distress or rated by mothers as more difficult were particularly susceptible to the effects of early negative parenting OBJECTIVE . Although low birth weight premature infants and parents are at high risk for adverse health outcomes , there is a paucity of studies that test early NICU interventions with parents to prevent the development of negative parent-infant interaction trajectories and to reduce hospital length of stay . Our objective was to evaluate the efficacy of an educational-behavioral intervention program ( ie , Creating Opportunities for Parent Empowerment ) that was design ed to enhance parent-infant interactions and parent mental health outcomes for the ultimate purpose of improving child developmental and behavior outcomes . DESIGN , SETTING , AND PARTICIPANTS . A r and omized , controlled trial was conducted with 260 families with preterm infants from 2001 to 2004 in 2 NICUs in the northeast United States . Parents completed self-administered instruments during hospitalization , within 7 days after infant discharge , and at 2 months ' corrected age . Blinded observers rated parent-infant interactions in the NICU . INTERVENTION . All participants received 4 intervention sessions of audiotaped and written material s. Parents in the Creating Opportunities for Parent Empowerment program received information and behavioral activities about the appearance and behavioral characteristics of preterm infants and how best to parent them . The comparison intervention contained information regarding hospital services and policies . MAIN OUTCOME MEASURES . Parental stress , depression , anxiety , and beliefs ; parent-infant interaction during the NICU stay ; NICU length of stay ; and total hospitalization were measured . RESULTS . Mothers in the Creating Opportunities for Parent Empowerment program reported significantly less stress in the NICU and less depression and anxiety at 2 months ' corrected infant age than did comparison mothers . Blinded observers rated mothers and fathers in the Creating Opportunities for Parent Empowerment program as more positive in interactions with their infants . Mothers and fathers also reported stronger beliefs about their parental role and what behaviors and characteristics to expect of their infants during hospitalization . Infants in the Creating Opportunities for Parent Empowerment program had a 3.8-day shorter NICU length of stay ( mean : 31.86 vs 35.63 days ) and 3.9-day shorter total hospital length of stay ( mean : 35.29 vs 39.19 days ) than did comparison infants . CONCLUSIONS . A reproducible educational-behavioral intervention program for parents that commences early in the NICU can improve parent mental health outcomes , enhance parent-infant interaction , and reduce hospital length of stay ABSTRACT . We investigated the effects of a 1 -year home intervention on premature infants with low ( < 1500 g ) and higher ( 1500–2000 g ) birth weights . Infants from each weight condition were block r and omly assigned to a control or to one of two treatment groups . One treatment group focused on the development of the infant ; the other treatment group focused on the parent-infant interaction . The low birth weight infants obtained significantly lower Bayley mental and motor scores , and were more passive and less intense than the higher birth weight infants . However , the low birth weight infants and their parents were more responsive to the home intervention than were the higher birth weight infants , as demonstrated by changes in the Bayley mental scores and the Home Observation for Measurement of the Environment ( HOME ) inventory . These findings exemplify the reciprocal relationship between the child 's characteristics and parental responding . The importance of selecting the most high-risk premature infants for early home intervention is outlined The purpose of this pilot study was to evaluate the effectiveness of a parent-focused intervention program ( COPE ) on infant cognitive development and maternal coping . A r and omized clinical trial was conducted with 42 mothers of low-birth-weight ( LBW ) premature infants hospitalized in a neonatal intensive care unit ( NICU ) , with follow-up at 3 months ' and 6 months ' corrected ages . COPE mothers received the four-phase educational-behavioral program that began 2 - 4 days postbirth and continued through 1 week following discharge from the NICU . Comparison mothers received audiotaped information during the same four time frames . Results indicated that COPE infants had significantly higher mental development scores at a 3 months ' corrected age ( M = 100.3 ) than did the comparison infants ( M = 93.9 ) , and this difference widened at 6 months ' corrected age , with COPE infants scoring 14 points higher . COPE mothers were significantly less stressed by the NICU sights and sounds and had significantly stronger beliefs about what behaviors and characteristics to expect from their premature infants . Findings from this study support the need for further testing of early NICU interventions with parents to determine their effectiveness on parental coping and infant developmental outcomes OBJECTIVE Few studies exist that examine continuities between child and adult psychopathology in unselected sample s. This study prospect ively examined the adult outcomes of psychopathology in an epidemiological sample of children and adolescents across a 14-year period . METHOD In 1983 , parent ratings of behavioral and emotional problems were obtained for 1,578 children and adolescents aged 4 through 16 years from the Dutch general population . At follow-up , 14 years later , subjects were reassessed with a st and ardized DSM-IV interview . RESULTS High levels of childhood problems predicted an approximate 2- to 6-fold increased risk for adulthood DSM-IV diagnoses . The associations between specific childhood problems and adulthood diagnoses were complex . Social Problems in girls predicted later DSM-IV disorder . Rule-breaking behavior in boys predicted both mood disorders and disruptive disorders in adulthood . CONCLUSIONS High levels of childhood behavioral and emotional problems are related to DSM-IV diagnoses in adulthood . The strongest predictor of disorders in adulthood was childhood rule-breaking behavior . Attention Problems did not predict any Output:	Parental responsivity is the only parenting axis strongly associated with both improved child cognition and behaviour . Parental dem and ingness is associated only with improved child cognition , and parental warmth and rejection are associated only with child behaviour . Parental coercion is not associated with subsequent child outcomes . Parental responsivity may be essential in optimizing neurodevelopment in former preterm infants .
MS22327	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: PURPOSE To compare the usefulness of gadolinium ethoxybenzyl diethylenetriaminepentaacetic acid ( Gd-EOB-DTPA ) and gadolinium diethylenetriaminepentaacetic acid ( Gd-DTPA ) in the diagnosis of focal liver lesions . MATERIAL S AND METHODS Thirty-one patients with focal liver lesions underwent T2- and T1-weighted spin-echo magnetic resonance ( MR ) imaging and fast low-angle shot two-dimensional MR imaging before , during , and after intravenous administration of three different doses of Gd-EOB-DTPA ( 12.5 , 25 , and 50 mumol per kilogram body weight ) . Gd-DTPA-enhanced imaging ( dose , 0.1 mmol per kilogram body weight ) was performed in the same patients within 1 week of Gd-EOB-DTPA imaging . RESULTS During the perfusion phase ( the 3 minutes after injection of contrast material ) , the dynamic enhancement characteristics seen after injection of 25 and 50 mumol of Gd-EOB-DTPA were similar to those seen with Gd-DTPA . At the lowest dose of Gd-EOB-DTPA ( 12.5 mumol ) , the dynamic enhancement characteristics were not comparable to those seen with Gd-DTPA . During the hepatobiliary phase ( 1.5 minutes to 4 hours after injection ) , Gd-EOB-DTPA-enhanced images yielded a dose-independent , statistically significant improvement in the detection rate of additional metastases , hepatocellular carcinomas , and hemangiomas compared with unenhanced and Gd-DTPA-enhanced images ( P < .05 ) . CONCLUSION Gd-EOB-DTPA-enhanced MR imaging enables improved detection of hepatic lesions over Gd-DTPA-enhanced MR imaging while providing comparable differential diagnostic information OBJECTIVE The purpose of this article is to prospect ively determine the sensitivity of hepatobiliary phase gadoxetate disodium-enhanced MRI combined with st and ard MRI in differentiating focal nodular hyperplasia ( FNH ) from hepatocellular adenoma ( HCA ) . SUBJECTS AND METHODS Patients suspected of having FNH or HCA larger than 2 cm underwent gadoxetate disodium-enhanced MRI . St and ard MRI was evaluated separately from the additional hepatobiliary phase by two blinded radiologists . For the largest lesion in each patient , findings were compared with histologic diagnosis . Sensitivity , positive predictive value ( PPV ) , and distinctive features were analyzed using McNemar and analysis of variance tests . RESULTS Fifty-two patients completed the study . Histologic diagnosis revealed 24 HCAs and 28 FNHs . Characterization on st and ard MRI was inconclusive in 40 % ( 21/52 ) and conclusive in 60 % ( 31/52 ) of lesions . The sensitivity of st and ard MRI for HCA was 50 % ( 12/24 ) with a PPV of 100 % ( 12/12 ) . The sensitivity for FNH was 68 % ( 19/28 ) with a PPV of 95 % ( 18/19 ) . After review of hepatobiliary phase , the sensitivity for HCA improved to 96 % ( 23/24 ) with a PPV of 96 % ( 23/24 ) . The sensitivity for FNH improved to 96 % ( 27/28 ) with a PPV of 96 % ( 27/28 ) . Features with significant predictive value for diagnosis in HCA included bleeding ( p < 0.001 ) , fat ( p = 0.010 ) , and glycogen ( p = 0.024 ) . The presence of a central scar was predictive for FNH ( p < 0.001 ) . CONCLUSION This study shows high sensitivity of gadoxetate disodium-enhanced MRI when st and ard series are combined with the hepatobiliary phase for differentiation of FNH and HCA in lesions larger than 2 cm PURPOSE To assess prospect ively the efficacy and safety of postcontrast magnetic resonance ( MR ) imaging with gadolinium ethoxybenzyl diethylenetriamine pentaacetic acid ( Gd-EOB-DTPA ) compared with that of precontrast MR imaging in patients who are known to have or are suspected of having liver lesions and who are scheduled for hepatic surgery . MATERIAL S AND METHODS Investigational review board approval and written informed consent were obtained . HIPAA went into effect after data collection . A total of 172 patients were enrolled . After precontrast MR imaging , 169 patients ( 94 men , 75 women ; mean age , 61 years ; age range , 19 - 84 years ) received an intravenous bolus of 25 micromol/kg Gd-EOB-DTPA and underwent dynamic gradient-recalled-echo and delayed MR imaging 20 minutes after injection . Arterial and portal phase computed tomography ( CT ) were performed within 6 weeks of MR imaging . The st and ard of reference was surgery with intraoperative ultrasonography ( US ) and biopsy and /or pathologic evaluation of resected liver segments and /or 3-month follow-up of nonresected segments if intraoperative US was not available . Three blinded review ers and unblinded site investigators identified liver lesions on segment maps . The Wilcoxon signed rank test was used to compare differences in per-patient sensitivity of precontrast and postcontrast MR images . Adverse events were recorded , and patient monitoring and laboratory assay were performed at time of injection and up to 24 hours after contrast material administration . RESULTS At MR imaging , 316 lesions were identified in 131 patients . In 77 % ( P = .012 ) , 72 % ( P = .15 ) , and 71 % ( P = .027 ) of patients for readers 1 , 2 , and 3 , respectively , more lesions were seen at precontrast and postcontrast MR imaging combined than at precontrast MR imaging alone . Sensitivity values for blinded readings were significantly greater at postcontrast MR imaging than at precontrast MR imaging for two of three blinded readers . For all blinded readers , combined precontrast and postcontrast MR images showed no difference in sensitivity compared with helical CT scans . The use of MR imaging , however , yielded fewer patients with at least one false-positive lesion ( 37 % , 31 % , and 34 % of patients for readers 1 , 2 , and 3 , respectively ) than did helical CT ( 45 % , 36 % , and 43 % of patients for readers 1 , 2 , and 3 , respectively ) . CONCLUSION Compared with precontrast MR imaging , postcontrast MR imaging with Gd-EOB-DTPA demonstrated improved sensitivity for lesion detection in the majority of blinded readers , with no substantial adverse events Aim : To evaluate diffusion-weighted MR imaging ( DWI ) , gadoxetic acid-enhanced MR imaging and the combination of both methods in the detection , classification , and characterization of focal liver lesions ( FLL ) . Methods : A total of 119 FLL ( 28 HCCs , 39 metastases , 15 FNHs , 11 adenomas , 13 hemangiomas , 13 cysts ) were retrospectively analyzed in 36 patients . In those patients MR imaging of the liver comprising respiratory-triggered DWI ( b values of 50 , 300 , and 600 s/mm2 ) and gadoxetic acid-enhanced MR imaging including image acquisition in the hepatocyte-selective phase ( 20 min post injection ) had been performed . Three image sets were assigned and compared : DWI only ( set A ) , gadoxetic acid-enhanced MR imaging only ( set B ) , and both modalities in combination ( set C ) . Two readers independently interpreted the images in r and om order . For each reader and image set , the area under the receiver operating characteristic curve ( Az ) and sensitivity in the detection of FLL was determined as well as the accuracy in the classification and characterization of FLL . Results : There was no significant difference between the three image sets in the detection of FLL with regards to Az . However , when only lesions with a diameter of 10 mm or less were analyzed , the Az values of set C were significantly higher than those of sets A and B for both readers . For classifying and characterizing FLL both set B and C were significantly superior to set A. Conclusion : Adding DWI to gadoxetic acid-enhanced MR imaging significantly increases the accuracy in the detection of small FLL Objectives : The aim of this prospect i ve study was to evaluate the diagnostic performance of magnetic resonance imaging ( MRI ) of the liver with the hepatocellular-specific contrast agent gadolinium-ethoxybenzyl-diethylenetriamine pentaacetic acid ( Gd-EOB-DTPA ) in comparison to precontrast MRI and spiral computed tomography ( CT ) in the specific diagnosis of focal nodular hyperplasia ( FNH ) and to describe morphologic features and enhancement pattern of FNH . Material s and Methods : In 176 patients from a phase III multicenter trial , 59 confirmed FNHs were present ( 13 = histopathology ; 46 = imaging follow-up within 12 months before or 3 months after the MRI study ) . MR examination consisted of precontrast T1- and T2-w sequences , T1-weighted ( w ) dynamic sequences after bolus-injection of 0.025 mmol Gd-EOB-DTPA ( Primovist ; Bayer Schering Pharma)/kg bodyweight and T1-w sequences with fat saturation in the hepatocyte-phase after 20 minutes . The number of correctly characterized FNHs was evaluated and compared with that determined on spiral CT in an on-site reading ( clinical study ) and an off-site reading ( 3 blinded readers ) . The morphologic appearance and enhancement patterns of the FNHs were evaluated . Results : Characterization with combined pre- and post-MRI ( 88.1 % ) was superior to that achieved with biphasic-enhanced spiral CT ( 84.7 % , not significant ) and precontrast MRI ( 67.8 % , P < 0.05 ) in the clinical study and significantly superior to both precontrast MRI and spiral CT for 2 of 3 blinded readers . Complete or partial enhancement of the lesions was present in the early dynamic phase ( arterial and portovenous dynamic phase ) in 94 % and 85 % , respectively . The pattern of lesion enhancement in the early dynamic phase was mainly homogenous ( 78%–80 % ) ; the median contrast-to-noise ratio was −5.9 in T1-w precontrast images , 14.0 in the arterial phase , 2.4 in the portovenous phase , and 2.9 in the equilibrium phase . Enhancement in the hepatocyte-phase after 10 and 20 minutes was observed in 88 % and 90 % of lesions , respectively . Conclusions : Characterization of FNH provided by Gd-EOB-DTPA-enhanced MRI is superior to that provided by precontrast MRI alone or spiral CT . FNHs show very similar enhancement characteristics to those of other extracellular contrast agents in the early dynamic phase after bolus injection of Gd-EOB-DTPA , after 20 minutes in the liver-specific phase enhancement is regularly seen PURPOSE To determine whether a multiphase method with high spatiotemporal resolution ( STR ) by means of a combination of parallel imaging , pseudor and om sampling and temporal view sharing improves the capture and intensity of gadoxetate arterial phase images as well as lesion enhancement . MATERIAL S AND METHODS Thirty-seven patients were imaged with a conventional spoiled gradient echo acquisition and 48 with a high STR multiphase acquisition after the administration of gadoxetate . Arterial phase capture , image quality , and quality of fat suppression were qualitatively grade d. Fourteen lesions in the conventional group and 28 in the high STR multiphase group were imaged , including 34 focal nodular hyperplasias . The ratio of lesion to parenchyma enhancement as well as relative hepatic artery enhancement were calculated . Chi-squared , Mann-Whitney U and student t-tests were used to compare differences . RESULTS The high STR multiphase acquisition included the arterial phase more frequently than conventional acquisitions ( P < 0.001 ) , with the arterial phase missed in 17 % ( 95 % CI of 4 - 28 % ) of patients with conventional acquisition compared with 2 % ( 95 % CI of 0 - 6 % ) with the high STR multiphase acquisition . There was no loss of image quality or degree of fat saturation . Additionally , there was increased relative intensity of the hepatic arteries ( P < 0.001 ) as well as lesion enhancement ( P = 0.01 ) . CONCLUSION The high STR multiphase acquisition result ed in more reliable gadoxetate arterial phase capture compared with a conventional acquisition while preserving image quality with robust fat saturation You are back where we put you in the previous article1 on diagnostic tests in this series on how to use the medical literature : in the library study ing an article that will guide you in interpreting ventilation-perfusion ( V/Q ) lung scans . Using the criteria in Table 1 , you have decided that the Prospect i ve Investigation of Pulmonary Diagnosis ( PIOPED ) study 2 will provide you with valid information . Just then , another OBJECTIVES The clinical management of hepatocellular adenoma ( HCA ) and focal nodular hyperplasia ( FNH ) is still Output:	Conclusions High/iso SI on the HBP of Gd-EOB-DTPA-MRI is characteristic and a prevalent finding of FNHs and can be helpful in the management of patients with FNH.Key Points• The vast majority ( 94–97 % ) of FNHs show high/iso SI on HBP . • High/iso SI on HBP was accurate for distinguishing FNH from hepatocellular adenoma . • HBP of Gd-EOB-DTPA-MRI can reduce unnecessary biopsies for the diagnosis of FNHs
MS22328	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: Few r and omized controlled trials have examined the effects of combined aerobic and resistance training in breast cancer survivors soon after completing adjuvant therapy . Breast cancer survivors ( N = 58 ) within 2 years of completing adjuvant therapy were r and omly assigned to an immediate exercise group ( IEG ; n = 29 ) or a delayed exercise group ( DEG ; n = 29 ) . The IEG completed 12 weeks of supervised aerobic and resistance exercise , three times per week . The DEG completed the program during the next 12 weeks . Participants completed patient-rated outcomes at baseline , 6 , 12 , 18 and 24 weeks . The primary endpoint was overall quality of life ( QoL ) measured by the Functional Assessment of Cancer Therapy-Breast scale . Secondary endpoints were fatigue , social physique anxiety , and physical fitness . Follow-up data was obtained on 97 % of participants and exercise adherence was 61.3 % . Repeated measures analyses of variance revealed a significant group by time interaction for overall QoL ( P < 0.001 ) . Specifically , QoL increased in the IEG from baseline to 12 weeks by 20.8 points compared to a decrease in the DEG of 5.3 points ( mean group difference = 26.1 ; 95 % CI = 18.3–32.7 ; P < 0.001 ) . From 12 to 24 weeks , QoL increased in the DEG by 29.5 points compared to an increase of 6.5 points in the IEG ( mean group difference = 23.0 ; 95 % CI = 16.3–29.1 ; P < 0.001 ) . Similar results were obtained for the secondary endpoints . Combined aerobic and resistance exercise soon after the completion of breast cancer therapy produces large and rapid improvements in health-related outcomes BACKGROUND During the last decade , survival rates for breast cancer have increased as a result of earlier detection and increased use of adjuvant therapy . Limited data exist on the psychosocial aspects of the transitional period between the end of primary treatment and survivorship . We investigated the baseline psychosocial status of women enrolled in a r and omized trial testing two psychosocial interventions for women at the end of primary treatment . METHODS Participants , identified within 1 month after surgery ( registration ) , provided demographic information and limited measures of quality of life . They were followed until they finished primary treatment ( enrollment ) , at which time they completed a mailed baseline survey that included st and ardized measures of quality of life ( including st and ardized scales of physical and emotional functioning ) , mood , symptoms , and sexual functioning . A total of 558 patients ( mean age = 56.9 years ) were enrolled in the study between July 1 , 1999 , and June 30 , 2002 . Health outcomes were examined according to treatment received : mastectomy with and without chemotherapy , and lumpectomy with and without chemotherapy . All statistical tests were two-sided . RESULTS Among all treatment groups , patients who had a mastectomy had the poorest physical functioning at registration ( P<.001 ) and at enrollment ( P=.05 ) . At enrollment , mood and emotional functioning were similar among all patients , with no differences by type of treatment received . At enrollment , symptoms , including muscle stiffness , breast sensitivity , aches and pains , tendency to take naps , and difficulty concentrating , were common among patients in all groups and were statistically significantly associated with poor physical functioning and emotional well-being . Sexual functioning was worse for women who received chemotherapy than for those who did not , regardless of type of surgery ( P<.001 ) . CONCLUSIONS At the end of primary treatment for breast cancer , women in all treatment groups report good emotional functioning but report decreased physical functioning , particularly among women who have a mastectomy or receive chemotherapy . Clinical interventions to address common symptoms associated with treatment should be considered to improve physical and emotional functioning at the end of primary treatment for breast cancer The question of whether stress poses a risk for cancer progression has been difficult to answer . A r and omized clinical trial tested the hypothesis that cancer patients coping with their recent diagnosis but receiving a psychologic intervention would have improved survival compared with patients who were only assessed Background Current frequent follow-up after treatment for breast cancer does not meet its intended aims , but does depend on expensive and scarce specialized knowledge for routine history taking and physical examinations . The study described in this paper compared patient satisfaction with a reduced follow-up strategy , i.e. nurse-led telephone follow-up , to satisfaction with traditional hospital follow-up . Methods Patient satisfaction was assessed among patients ( n = 299 ) who were participants of a r and omized controlled trial investigating the cost-effectiveness of several follow-up strategies in the first year after treatment for breast cancer . Data on patient satisfaction were collected at baseline , three , six and 12 months after treatment , using the Dutch version of Ware 's Patient Satisfaction Question naire III ( PSQ III ) . In addition to general satisfaction , the PSQ III reports on satisfaction scores for technical competence , interpersonal aspects , and access of care . Regression analysis was used to predict satisfaction scores from whether or not nurse-led telephone follow-up was received . Results Nurse-led telephone follow-up had no statistically significant influence on general patient satisfaction ( p = 0.379 ) , satisfaction with technical competence ( p = 0.249 ) , and satisfaction with interpersonal aspects ( p = 0.662 ) . Regarding access of care , patient satisfaction scores were significantly higher for patients receiving telephone follow-up ( p = 0.015 ) . However , a mean difference at 12 months of 3.1 points was judged to be not clinical ly relevant . Conclusions No meaningful differences were found in satisfaction scores between nurse-led telephone and hospital follow-up in the first year after breast cancer treatment . With high satisfaction scores and the potential to substantially reduce clinic visits , nurse-led telephone follow-up may be an acceptable alternative to traditional hospital follow-up . Trial registration numberIS RCT N 74071417 Background After curative treatment for breast cancer women frequently attend scheduled follow-up examinations . Usually the follow-up is most frequent in the first 2–3 years ( 2–4 times a year ) ; thereafter the frequency is reduced to once a year in most countries . Its main aim is to detect local disease recurrence , or a second primary breast cancer , but also to provide information and psychosocial support . However , the cost-effectiveness of these frequent visits is under much debate , leading to a search for less intensive and more cost-effective follow-up strategies . In this paper the design of the MaCare trial is described . This trial compares the cost-effectiveness of four follow-up strategies for curatively treated breast cancer patients . We investigate the costs and effects of nurse-led telephone follow-up and a short educational group programme . Methods / design The MaCare trial is a multi centre r and omised clinical trial in which 320 breast cancer patients are r and omised into four follow-up strategies , focussed on the first 18 months after treatment : 1 ) st and ard follow-up ; 2 ) nurse-led telephone follow-up ; 3 ) arm 1 with the educational group programme ; 4 ) arm 2 with the educational group programme . Data is collected at baseline and 3 , 6 , 12 and 18 months after treatment . The primary endpoint of the trial is cancer-specific quality of life as measured by the global health/QoL scale of the EORTC QLQ-C30 . Secondary outcomes are perceived feelings of control , anxiety , patients ' satisfaction with follow-up and costs . A cost-effectiveness analysis will be performed from a societal perspective . Discussion Reduced follow-up strategies for breast cancer have not yet been widely applied in clinical practice . Improvement of psychosocial support and information to patients could lead to a better acceptance of reduced follow-up . The MaCare trial combines a reduced follow-up strategy with additional psychosocial support . Less frequent follow-up can reduce the burden on medical specialists and costs . The educational group programme can improve QoL of patients , but also less frequent follow-up can improve QoL by reducing the anxiety experienced for each follow-up visit . Results of the trial will provide knowledge on both costs and psychosocial aspects regarding follow-up and are expected in 2009 AIMS As a result of the rising prevalence of breast cancer and improved adjuvant treatment strategies , oncologists are faced with an ever-increasing workload of providing long-term follow-up care for early-stage breast cancer patients . In order to cope with these growing dem and s , innovative follow-up strategies are urgently required . MATERIAL S AND METHODS To explore if patient transfer back to the family physician for follow-up was a potential option , a prospect i ve programme of planned discharge was established for all patients who had completed adjuvant chemo/radiotherapy or had started adjuvant endocrine therapy . Patient and family physician information packages were also provided . RESULTS Between April and August 2005 , of the 193 patients assessed for transfer back to the family physician for follow-up care , transfer was possible in 43 % . Fifty-seven per cent ( or 110 patients ) were unsuitable for transfer back to the family physician . The reasons cited among those deemed unsuitable for transfer were as follows : clinical trial enrollment ( 50.9 % ) , ongoing endocrine treatment ( 31.8 % ) , new symptoms ( 6.3 % ) , and patient refusal ( 0.9 % ) . In both discharged and non-discharged groups , patients were also frequently being followed by other oncologists ( surgical and /or radiation ) . CONCLUSION Transfer of care back to family physicians for follow-up may offer a strategy to control workload volumes , and thus enable oncologists to focus their efforts on newly diagnosed and advanced-stage patients with more complex patient care needs BACKGROUND Routine follow-up of breast cancer patients in specialist clinics is st and ard practice in most countries . Follow-up involves regularly scheduled breast cancer check-ups during the disease-free period . The aims of follow-up are to detect breast cancer recurrence and to provide psychosocial support to the patient ; however , little is known about patients ' views on breast cancer follow-up . AIM To assess the effect on patient satisfaction of transferring primary responsibility for follow-up of women with breast cancer in remission from hospital outpatient clinics to general practice . METHOD R and omized controlled trial with 18 months ' follow-up in which women received routine follow-up either in hospital outpatient clinics or from their own general practitioner . Two hundred and ninety-six women with breast cancer in remission receiving regular follow-up care at two district general hospitals in Engl and were included in the study . Patient satisfaction was measured by means of a self-administered question naire supplied three times during the 18-month study period . RESULTS The general practice group selected responses indicating greater satisfaction than did the hospital group on virtually every question . Furthermore , in the general practice group there was a significant increase in satisfaction over baseline ; a similar significant increase in satisfaction over baseline was not found in the hospital group . CONCLUSION Patients with breast cancer were more satisfied with follow-up in general practice than in hospital outpatient departments . When discussing follow-up with breast cancer patients , they should be provided with complete and accurate information about the goals , expectations , and limitations of the follow-up programme so that they can make an informed choice PURPOSE To up date the 1999 American Society of Clinical Oncology ( ASCO ) guideline on breast cancer follow-up and management in the adjuvant setting . METHODS An ASCO Expert Panel review ed pertinent information from the literature through March 2006 . More weight was given to studies that tested a hypothesis directly relating testing to one of the primary outcomes in a r and omized design . RESULTS The evidence supports regular history , physical examination , and mammography as the cornerstone of appropriate breast cancer follow-up . All patients should have a careful history and physical examination performed by a physician experienced in the surveillance of cancer patients and in breast examination . Examinations should be performed every 3 to 6 months for the first 3 years , every 6 to 12 months for years 4 and 5 , and annually thereafter . For those who have undergone breast-conserving surgery , a post-treatment mammogram should be obtained 1 year after the initial mammogram and at least 6 months after completion of radiation therapy . Thereafter , unless otherwise indicated , a yearly mammographic evaluation should be performed . Patients at high risk for familial breast cancer syndromes should be referred for genetic counseling . The use of CBCs , chemistry panels , bone scans , chest radiographs , liver ultrasounds , computed tomography scans , [18F]fluorodeoxyglucose-positron emission tomography scanning , magnetic resonance imaging , or tumor markers ( carcinoembryonic antigen , CA 15 - 3 , and CA 27.29 ) is not recommended for routine breast cancer follow-up in an otherwise asymptomatic patient with no specific findings on clinical examination . CONCLUSION Careful history taking , physical examination , and regular mammography are recommended for appropriate detection of breast cancer recurrence PURPOSE Women with breast cancer were provided with an audiotape of their primary adjuvant treatment consultation , and the following patient outcomes were measured at 12 weeks postconsultation : perceived degree of information provision , audiotape satisfaction and use , communication satisfaction with oncologist , mood state , and cancer-specific quality of life . PATIENTS AND METHODS Participants included 628 women newly diagnosed with breast cancer and 40 oncologists from six cancer centers in Canada . The patients were block r and omized to one of four consultation groups : st and ard care control , not audiotaped ; audiotaped , no audiotape given ; audiotaped , patient given audiotape ; and audiotaped , patient offered choice of receiving audiotape or not . RESULTS Patients receiving the consultation audiotape had significantly better recall of having discussed side effects of treatment than patients who did not receive the audiotape . Audiotape benefit was not significantly related to patient satisfaction with communication , mood state , or quality of life at 12 weeks Output:	Mammographically detected local recurrences or those detected by women themselves gave better survival than those detected by clinical examination . Follow up in alternative setting s to the specialist clinic is acceptable to women but trials are underpowered for survival .
MS22329	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: The effects of oral environment stabilization procedures on counts of C and ida spp . have rarely been discussed , and no conclusive results are found in the literature . The aim of this study was thus to ascertain the effects of oral environment stabilization procedures with glass ionomer and zinc oxide-eugenol cements on counts of C and ida spp . in the oral cavity of children . For this purpose , oral rinses of sterile phosphate-buffered saline were initially collected from 30 boys and 30 girls , positive for C and ida in the saliva and aged from 4 to 10 years . Data on the initial quantity of CFU/ml of C and ida were obtained . Then , the children were r and omly divided into two groups and oral environment stabilization procedures were performed using zinc oxide-eugenol cement or glass ionomer cement . One week after the procedures were performed , oral rinses were collected again and final C and ida counts were obtained . An expressive reduction in C and ida counts was observed in both groups . The zinc oxide-eugenol and glass ionomer cements were efficient in the reduction of C and ida counts and statistically significant differences were observed between initial and final counts in both groups . Considering the percentage of reduction , the zinc oxide-eugenol cement presented more favorable results , with a reduction of 70 % . A reduction of 46 % was observed with the use of the glass ionomer cement . According to the obtained results , we concluded that oral environment stabilization procedures were efficient in reducing C and ida spp . counts , especially when the zinc oxide-eugenol cement was employed OBJECTIVE The aim of this r and omized clinical trial was to evaluate the frequency of bacteriemia during endodontic treatment , with comparison between two techniques for biomechanical preparation of the root canal system . MATERIAL S AND METHODS The sample comprised 50 patients aged 16 to 52 years , of both genders , which were divided into 2 groups with 25 patients each . Group I underwent biomechanical preparation by the step-back technique , and Group II was treated by the rotary technique with nickel-titanium instruments ( K3 ) . Patients were su bmi tted to antisepsis of the oral cavity with chlorhexidine digluconate and three sample s of blood were collected for blood culture : preoperatively , immediately after the biomechanical preparation and 10 minutes later . The significance level adopted was 5.0 % , and analysis was performed by descriptive and inferential statistics by means of the Fisher 's exact test , Fisher-Freeman-Halton test and Student 's t test . Data were analyzed on the Statexact and SPSS softwares . RESULTS All blood cultures achieved before and immediately after preparation were negative . On the other h and , with regard to the blood cultures collected 10 minutes after preparation , one ( 4 % ) positive case was found for Group I. However , this difference was not statistically significant ( p = 0.50 ) . CONCLUSION The frequency of bacteriemia was low and observed just for Group Objective : The objective of this study was to evaluate the incidence of adverse effects reported by adolescents following 14 days of use of a mouthrinse containing 0.05 % NaF+0.12 % chlorhexidine . Methods : This double-blind study was developed as part of a r and omized clinical trial . The adolescents enrolled to the study were r and omly divided into two groups to use either : 0.05 % NaF+0.12 % chlorhexidine ( G1 , n=85 ) or 0.05 % NaF ( G2 , n=85 ) . Both groups used a 10mL solution of the mouthwash during 1 minute daily for 2 weeks under supervision . After that period , the subject 's acceptance of taste was measured using a verbal descriptive scale ( Labeled Magnitude Scale - LMS)11 . Participants were also interviewed regarding the occurrence of possible adverse effects during treatment ( temporary palate disorders , tooth staining or unpleasant taste ) . The proportional differences between the groups were tested using the chi-square test . Results : Palate changes were reported by 26 % of participants of each group ; 17.7 % of G1 and 32 % of G2 reported an unpleasant taste ( p = 0.062 ) , while staining was reported by 55 % of G1 and 68.9 % of G2 ( p = 0.117 ) . Absenteeism rates were similar in both groups ( G1= 2.58 ± 2.69 ; G2=2.81 ± 2.39 ) , p=0.362 . Conclusion : adherence was high in both groups and side effects reported by subjects were not perceived by them as being important . Since subjects ' acceptance and compliance is fundamental to the success of an oral health program , chlorhexidine-fluoride could be a useful re source in a program of plaque control Different dental procedures in children undergoing treatment can induce changes in blood pressure . These changes will be minimized if psychological treatment is applied prior to any procedure . The objective of this study was to determine changes in blood pressure ( systolic-diastolic ) in children undergoing psychological treatment before dental procedures . The population studied consisted of 100 children and adolescents , ages 6 to 15 years . The patients were assigned to two groups at r and om , i.e. with or without psychological treatment before dental procedures . Behavior management was carried out applying the tell-show-do technique of conduct h and ling . The systolic and diastolic blood pressures were measured prior to the initiation of the treatment , during drilling , restoring , and before dismissing the patient . The no-psychological treatment group exhibited significant differences in diastolic and systolic blood pressures during the dental procedure whereas the psychological treatment group evidence d no significant differences in blood pressure . No correlation was found between the alterations of blood pressure and the type of dental treatment performed . The application of the tell-show-do method would have an effect on the blood pressure in patients undergoing dental procedures Abstract Objective To examine the extent and nature of outcome reporting bias in a broad cohort of published r and omised trials . Design Retrospective review of publications and follow up survey of authors . Cohort All journal articles of r and omised trials indexed in PubMed whose primary publication appeared in December 2000 . Main outcome measures Prevalence of incompletely reported outcomes per trial ; reasons for not reporting outcomes ; association between completeness of reporting and statistical significance . Results 519 trials with 553 publications and 10 557 outcomes were identified . Survey responders ( response rate 69 % ) provided information on unreported outcomes but were often unreliable — for 32 % of those who denied the existence of such outcomes there was evidence to the contrary in their publications . On average , over 20 % of the outcomes measured in a parallel group trial were incompletely reported . Within a trial , such outcomes had a higher odds of being statistically non-significant compared with fully reported outcomes ( odds ratio 2.0 ( 95 % confidence interval 1.6 to 2.7 ) for efficacy outcomes ; 1.9 ( 1.1 to 3.5 ) for harm outcomes ) . The most commonly reported reasons for omitting efficacy outcomes included space constraints , lack of clinical importance , and lack of statistical significance . Conclusions Incomplete reporting of outcomes within published articles of r and omised trials is common and is associated with statistical non- significance . The medical literature therefore represents a selective and biased subset of study outcomes , and trial protocol s should be made publicly available Chloral hydrate and hydroxyzine are a drug combination frequently used by practitioners to se date pediatric dental patients , but their effectiveness has not been compared to a negative control group in humans . The aim of this crossover , double-blinded study was to evaluate the effect of these drugs compared to a placebo , administered to young children for dental treatment . Thirty-five dental sedation sessions were carried out on 12 uncooperative ASA I children aged less than 5 years old . In each session patients were r and omly assigned to groups P ( placebo ) , CH ( chloral hydrate 75 mg/kg ) and CHH ( chloral hydrate 50 mg/kg plus hydroxyzine 2.0 mg/kg ) . Vital signs and behavioral variables were evaluated every 15 min . Comparisons were statistically analyzed using Friedman and Wilcoxon tests . P , CH and CHH had no differences concerning vital signs , except for breathing rate . All vital signs were in the normal range . CH and CHH promoted more sleep in the first 30 min of treatment . Overall behavior was better in CH and CHH than in P. CH , CHH and P were effective in 62.5 % , 61.5 % and 11.1 % of the cases , respectively . Chloral hydrate was safe and relatively effective , causing more satisfactory behavioral and physiological outcomes than a placebo The aim of this double-blind , controlled , split-mouth design ed clinical trial was to assess the effect of a single application of Gluma Desensitizer on alleviating dentin hypersensitivity . Twelve subjects entered the study and ten completed the protocol . Each subject had two teeth treated : one with Gluma Desensitizer according to the manufacturer 's instructions and one with water . The assessment of pain was performed with the VAS ( Visual Analogue Scale ) , after tactile ( probe ) , thermal ( cold blast of water ) and thermal/evaporative ( cold blast of air ) stimuli at baseline , immediately after treatment , after 1 week and after 4 weeks . The mean VAS values for the test and control teeth were compared by the paired t test ( alpha = 0.05 ) . Repeated measurements ANOVA was used to compare the different experimental times . The results showed that for test teeth , at baseline , mean VAS values were 1.76 ( + /- 2.82 ) , 7.10 ( + /- 2.10 ) and 4.75 ( + /- 2.65 ) , and , after 4 weeks , the mean values were 1.70 ( + /- 2.31 ) , 5.50 ( + /- 3.30 ) and 4.61 ( + /- 3.14 ) , respectively for probe , water and air stimuli . For the control teeth , at baseline , the mean VAS values were 1.86 ( + /- 2.92 ) , 6.61 ( + /- 2.31 ) and 4.08 ( + /- 2.91 ) and , after 4 weeks , 2.66 ( + /- 3.07 ) , 6.32 ( + /- 2.94 ) e 4.76 ( + /- 3.26 ) . There were no statistically significant differences between test and control teeth at any time . No intra-group differences were demonstrated either . It was concluded that Gluma Desensitizer had no effect on hypersensitive teeth from periodontally treated patients for a period up to 4 weeks The aim of this r and omised , double blind controlled trial was to verify the efficacy of a herbal dentifrice on the reduction of plaque and gingivitis . Forty eight volunteers with established gingivitis were r and omly assigned to either a test group ( herbal dentifrice ) or positive control group ( dentifrice with triclosan and fluoride ) . The dentifrices were distributed in plain white tubes by an independent pharmacy , which revealed the contents of each tube only after the experimental period . Plaque and gingivitis assessment s were carried out on baseline and after 28 days of product use . All examinations were conducted by the same calibrated investigator . Subjects were instructed to brush their teeth three times daily using their assigned dentifrice for 28 days . There was a significant reduction in plaque levels in both the test and control groups . However , there was no significant difference between the groups . A significant reduction in gingivitis was observed in both groups , although there was no significant difference between them . No adverse reactions were reported . The authors concluded that both dentifrices were effective in reducing plaque and gingivitis in subjects with established gingivitis The aim of the present study was to evaluate the efficacy of manual and electric toothbrushes in plaque control in periodontal patients after proper instructions . Thirty six periodontal patients ( mean age of 49 years , 21 females and 15 males ) were included and completed the study ( 100 % compliance ) . A single-blinded , r and omized , controlled , cross-over clinical design was adopted , with the patients using during 2 periods of 14 days each the manual and /or electric toothbrush . Four subgroups of 9 individuals were studied : A1 - -used manual toothbrush in both experimental periods ; A2 - -used the manual toothbrush during the first period and the electrical toothbrush during the second period ; B1 - -used electrical toothbrush during both periods ; B2 - -used the electrical toothbrush in the first period and the manual one in the second period . Brushing was performed during 14 days and at day 14 and 28 it was performed in the clinic , and timing of brushing was recorded without patients being aware . The Plaque Index ( Silness , Löe , 1964 ) was used . Intra-group comparisons were performed by paired t-test and inter-group comparisons by independent sample t-test , with an alpha level of 0.05 . The results showed no difference between the tested brushes neither for plaque nor for timing . However , re-instruction was detected as an important factor , since for all groups the second period , after reinstruction , showed lower plaque scores . It is concluded that professional advice and instruction and re-instruction seem more important in order to obtain good plaque control than the choice of toothbrush in subjects with periodontal disease UNLABELLED The dentin hypersensitivity is a painful condition rather prevalent in the general population . There are several ways of treatment for such condition , including the low intensity lasers . The proposal of this study was to verify the effectiveness of the Gallium-Aluminum-Arsenide diode laser in the treatment of this painful condition , using a placebo as control . MATERIAL S AND METHODS Thirty-two patients were selected , 22 females and 10 males , with ages ranging from 20 to 52 years old . The 32 patients were r and Output:	CONCLUSION The effective presence of bias seriously weakened the reliability of the results from the dental studies evaluated , such that they would be of little use for clinicians and administrators as support for decision-making processes
MS22330	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: PURPOSE Transanal endorectal pull-through ( TEPT ) has drastically changed the treatment of Hirschsprung 's disease ( HD ) . A short follow-up of children su bmi tted to TEPT reveals results that are similar to the classic transabdominal pull-through procedures . However , few reports compare the late results of TEPT with transabdominal pull-through procedures with respect to complication rates and the fecal continence . The aims of the present work are to describe some technical refinements that we introduced in the procedure and to compare the short and long-term outcome of TEPT with the outcomes of a group of patients with HD who previously underwent the Duhamel procedure . METHODS Thirty-five patients who underwent TEPT were prospect ively studied and compared to a group of 29 patients who were treated with colostomy followed by a classical Duhamel pull-through . The main modifications introduced in the TEPT group were no preoperative colon preparation , operation conducted under general anesthesia in addition to regional sacral anesthesia , use of only one purse-string suture in the rectal mucosa before transanal submucosal dissection , and no use of retractors and electrocautery during the submucosal dissection . RESULTS The most frequent early complications of TEPT group were perineal dermatitis ( 22.8 % ) and anastomotic strictures ( 8.6 % ) . The comparison with patients who underwent Duhamel procedure revealed no difference in the incidence of preoperative enterocolitis , the patients of the TEPT group were younger at the time of diagnosis and of surgery , they had shorter operating times , and they began oral feeding more quickly after the operation . The incidence of wound infection was lower in the TEPT group . Moreover , the TEPT and Duhamel groups showed no difference in the incidences of mortality , postoperative partial continence , and total incontinence . Although the incidences of complete continence and postoperative enterocolitis were not different , a tendency to the increased incidence in the TEPT group was observed . CONCLUSIONS This study further supports the technical advantages , the simplicity , and the decreased incidence of complications of a primary TEPT procedure when compared to a classical form of pull-through . Some technical refinements are described , and no preoperative colon preparation was necessary for the patients studied here . The results show that the long-term outcomes of the modified TEPT procedure are generally better than those obtained with classical approaches Transanal one-stage endorectal pull-through ( TOSEPT ) has been presented as the most recent progression in treatment of Hirschsprung ’s disease ( HD ) , which may be able to replace various previous techniques . This prospect i ve study was design ed to compare the efficacy and probable complications of the commonly used open surgery with those of TOSEPT technique in management of HD . Forty-two children ( 35 boys and 7 girls ) between 3 days and 12 years of age underwent surgical treatment for HD — all after being diagnosed by barium enema over an 18-month period . In a manner of systematic r and om selection , 21 patients were operated by TOSEPT and the other 21 by Swenson procedures . All patients were followed-up at least for 12 months after hospital discharge . The necessary data containing age , sex , length of the resected aganglionic segment , intraoperative details , duration of hospital stay and postoperative functional results or complications were collected during hospitalization and follow-up period . There was no significant difference in age at the first operation , sex distribution and length of resected bowel between the two groups . Rate of postoperative complications were significantly higher in Swenson procedure group ( P < 0.01 ) . Narcotics were needed in all patients of Swenson procedure group but only in two patients operated by TOSEPT also required laparotomy ( P < 0.001 ) . The hospitalization period of TOSEPT group was also less than that of Swenson group ( P < 0.001 ) . The total cost of treatment by Swenson procedure is considerably higher than by TOSEPT . TOSEPT can significantly diminish postoperative pain , surgical complications , hospital stay and cost burden caused by Hirschsprung ’s disease . Besides , this procedure is cosmetically preferable because no visible scar remains AIM Our aim was to examine the long-term bowel dysfunction that followed surgery for Hirschsprung 's disease . METHODS Of 414 patients diagnosed with Hirschsprung 's disease between 1974 and 2002 , 98 were interviewed using a structured question naire to provide an assessment of bowel function , medication , diet , physical and social limitations . Forty-two completed a prospect i ve 4-week toileting diary and 16 underwent anorectal manometry . RESULTS Four of the 98 patients had permanent stomas and 10 had Down 's syndrome . Of the remaining 84 patients ( mean age 12 + /- 8 years , range 1.9 - 41.9 years ) , 13 % ( 11/84 ) had heavy soiling by day and 17 % ( 14/84 ) by night . Fifty percent reported episodic urgency , but 36 % also reported episodic constipation . Stool consistency was looser in patients with a history of long segment disease . Some aspects of bowel function improved with age . Enuresis was much more frequent than expected . Sixty-four percent reported adverse reactions to foods , particularly to fruit , vegetables , fats and diary products , and 15 % limited their social activities because of fecal incontinence . There were no significant differences in manometric parameters between those patients who soiled and those who did not . CONCLUSIONS Fecal incontinence is common after surgery for Hirschsprung 's disease and has a significant impact on social activities . Some aspects of bowel function did improve with age . Adverse reactions to food were unexpectedly frequent and need to be further studied PURPOSE The reported incidence of Hirschsprung's-associated enterocolitis ( HAEC ) is extremely variable . A st and ardized definition would permit comparison of different studies and provide an interpretable outcome measure for future prospect i ve studies in patients with Hirschsprung 's disease . METHODS The Delphi method is a technique for achieving consensus among a panel of experts . A list of 38 potential criteria from the history , physical examination , radiologic studies , and pathologic specimens was made available to pediatric surgeons and gastroenterologists who have contributed to the literature on Hirschsprung 's disease . Each expert ranked the diagnostic importance of each item using a Likert scale . In subsequent surveys , the same process was used , but the means and SDs from previous rounds were included as a way of influencing the experts toward consensus . Cronbach 's alpha was used after each round to measure variability among the experts . Once consensus was reached , an overall " HAEC score " was developed by assigning a value of 1 or 2 to each item that was considered important by the expert panel . The score was then vali date d by circulating 10 clinical cases to the panel and asking if each represented HAEC or not . RESULTS Twenty-seven experts completed the survey . Cronbach 's alpha increased from 0.93 after the first round to 0.97 after the second . Criteria receiving the highest scores were diarrhea , explosive stools , abdominal distension , and radiologic evidence of bowel obstruction or mucosal edema . Eighteen items were included in the score . During the validation process , the score agreed with the experts in 9 of the 10 case scenarios . CONCLUSION The most important clinical diagnostic criteria for HAEC were identified from a larger pool of potential diagnostic items through a consensus approach using the Delphi method . A score was developed and vali date d and can now be used as a st and ardized and reproducible outcome measure for future studies in children with Hirschsprung 's disease PURPOSE A new endorectal pull-through technique using a transanal approach is presented in this report . METHODS Mucosectomy , colectomy , and pull-through are performed transanally , and neither laparotomy or laparoscopy are required . Five patients affected with Hirschsprung 's disease have been operated on with this technique . CONCLUSION During the 6- to 15-month follow-up period , all of them have had postoperative normal bowel movements AIM To evaluate the indications , results , and complications of Transanal Endorectal Pull-Through ( TEPT ) in the management of rectosigmoid Hirschsprung 's disease ( HD ) compared with the open technique . PATIENTS AND METHODS Between November 1998 and March 2002 , 68 Transanal Endorectal Pull-Through ( TEPT ) procedures were performed in infants and children . The patients ' ages ranged from 6 days to 13 years . The primary diagnosis in all 68 patients was Hirschsprung 's disease confined to the rectosigmoid region . All children were operated without construction of a pre-operative colostomy except for one patient . Follow-up period ranged from 6 - 46 months ( mean 32 months ) . These patients were compared with fifty patients who had undergone open pull-through for HD during the period from November 1995 to October 1998 . RESULTS AND COMPLICATIONS For the TEPT group , the mean operating time was 90 min and the average length of resected bowel was 25 cm . Sixty-two patients had satisfactory results without complications . Blood transfusion was needed in eleven patients only . Recovery was very fast and patients were often hungry within 24 hours . Feeding was resumed within 48 hours . One patient required laparotomy during the procedure due to injury to the urethra . Two patients required colostomy 3 and 5 days after surgery because of delayed leakage . Three patients suffered from attacks of enterocolitis 6 - 9 months postoperatively . There was increased frequency of defecation ( 5 - 15 times daily ) for 4 - 6 weeks after surgery in all patients . There was no constipation , no incontinence , no cuff abscess and no mortality in any of the patients . Average frequency of defecation was 1 - 3 times daily after 3 months postoperatively . For the open technique group , mean operating time was 150 min , the length of the average resected segment was 29 cm . Forty-one patients had satisfactory results without complications . The cost of the open technique was almost double that of the TEPT ( 6300 vs. 3200 pounds ) . CONCLUSIONS Transanal Endorectal Pull-Through ( TEPT ) is characterized by a shorter operating time , less bleeding , shorter hospital stay , less morbidity and earlier recovery than similar open pull-through procedures . The hazards and morbidities associated with laparotomy and colostomy may be avoided with a one-stage technique in Hirschsprung 's disease confined to the rectosigmoid area ( 70 - 80 % ) . Careful long-term follow-up is required to assess continence and sexual function BACKGROUND The transanal one-stage endorectal pull-through operation for Hirschsprung 's disease is relatively new and makes assessment of the functional outcome and colonic motility difficult . The aim of this study was to evaluate the stooling patterns and colonic motility after a one-stage transanal pull-through operation for Hirschsprung 's disease in children . METHODS Twenty-two children who underwent a one-stage transanal pull-through operation for Hirschsprung 's disease were followed up for at least 6 months . The children ( 17 boys and 5 girls ) were from 12 months to 13 years of age ( mean age , 4 years ) . All patients had an aganglionic segment confined to the rectosigmoid area ( confirmed by preoperative barium enema and postoperative histology ) . Clinical outcome was assessed by interviews and question naires , and children were divided into symptomatic and nonsymptomatic groups . Contrast barium enema and defecography and determination of total and segmental colonic transit time ( using radio-opaque markers ) were performed on all 22 children . RESULTS The stooling patterns were considered satisfactory in 17 children . Of all the children , the mean stool times were 1 to 2 per day and only 2 were 8 to 10 per day ; postoperative soiling was found in 4 , constipation was observed in 2 , and Hirschsprung-associated enterocolitis in 1 . There was no incontinence , cuff infection , anastomotic leak , or mortality noted . Barium enema showed that the dilated and spastic colonic segment disappeared in all 22 children . The dilated sigmoid loops decreased in 17 ( 2 symptomatic , 15 nonsymptomatic ) and disappeared in 5 ( 4 symptomatic , 1 nonsymptomatic ) . There was a significant difference between the decreasing and disappearing loop group in regard to stooling disorders ( P < .05 ) . Postoperative defecography showed that the anorectal angle of all children was open , fixed , and significantly larger than that of the preoperative and control groups ( 123.3 degrees + /- 15.1 degrees vs 84.7 degrees + /- 8.3 degrees vs 79.0 degrees + /- 11.6 degrees , P < .01 ) and larger in the symptomatic group when compared with the nonsymptomatic group ( 135.6 degrees + /- 15.9 degrees vs 111.0 degrees + /- 14.3 degrees , P < .05 ) . Postoperatively , the total gastrointestinal transit time , left colonic transit time , and rectosigmoid colonic transit time of all the children were shorter than preoperatively ( 26.8 + /- 8.2 vs > 188 hours , P < .01 ; 6.3 + /- 4.1 vs > 60 hours , P < .01 ; 11.8 + /- 4.4 vs > 120 hours , P < .01 ) and similar to controls . The total gastrointestinal transit time and rectosigmoid colonic transit time of the symptomatic group were significantly shorter than the nonsymptomatic group ( 25.2 + Output:	We could show a significant advantage of L-TERPT/TERPT over OPEN surgery regarding the incidence of soiling/incontinence and constipation . No differences were seen for enterocolitis and anastomotic stricture . We conclude from our data that L-TERPT/TERPT represents a valid option in the treatment of HD and might have some advantages over the OPEN techniques .
MS22331	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: The study of Cu metabolism is hampered by a lack of sensitive and specific biomarkers of status and suitable isotopic labels , but limited information suggests that Cu homeostasis is maintained through changes in absorption and endogenous loss . The aim of the present study was to employ stable-isotope techniques to measure Cu absorption and endogenous losses in adult men adapted to low , moderate and high Cu-supplemented diets . Twelve healthy men , aged 20 - 59 years , were given diets containing 0.7 , 1.6 and 6.0 mg Cu/d for 8 weeks , with at least 4 weeks intervening washout periods . After 6 weeks adaptation , apparent and true absorption of Cu were determined by measuring luminal loss and endogenous excretion of Cu following oral administration of 3 mg highly enriched (65)Cu stable-isotope label . Apparent and true absorption ( 41 and 48 % respectively ) on the low-Cu diet were not significantly different from the high-Cu diet ( 45 and 48 % respectively ) . Endogenous losses were significantly reduced on the low- ( 0.45 mg/d ; P<0.001 ) and medium- ( 0.81 mg/d ; P=0.001 ) compared with the high-Cu diet ( 2.46 mg/d ) . No biochemical changes result ing from the dietary intervention were observed . Cu homeostasis was maintained over a wide range of intake and more rapidly at the lower intake , mainly through changes in endogenous excretion A double-blind study was done giving 10 mg of copper/day as copper gluconate or placebo capsules for 12 wk . The seven subjects receiving copper gluconate had no change in the level of copper in the serum , urine , or hair . There was also no change in the levels of zinc or magnesium . There was also no significant change in levels of hematocrit , triglyceride , SGOT , GGT , LDH , cholesterol , or alkaline phosphatase . The side effects of nausea , diarrhea , and heartburn were the same in the subjects receiving copper gluconate and subjects receiving placebo capsules We examined the effects of low-copper diets on indexes of immune response of 11 healthy men ( aged 21 - 32 y ) during a 90-d metabolic suite study . Daily copper intake for the first 24 d , next 42 d , and the last 24 d of the study was 0.66 , 0.38 , and 2.49 mg , respectively . Feeding the diet with 0.38 mg Cu/d was associated with a significant ( P < or = 0.05 ) decrease in the proliferation of peripheral blood mononuclear cells cultured with phytohemagglutinin , Concanavalin A , or pokeweed , and an increase in the percentage of circulating B cells ( CD 19 + ) , but had no effect on the concentration of serum interleukin 2 receptor , the percentage of peripheral monocytes , neutrophils , CD3 + , CD4 + , or CD8 + T cells ; or on the neutrophil phagocytic activity . Feeding 2.49 mg Cu/d for 24 d prevented further decreases in the indexes affected by the low-copper diet but did not restore them to the pre study concentrations , even though plasma copper and ceruloplasmin concentrations were restored to normal The effects of calcium supplementation ( as calcium citrate malate , 1000 mg elemental Ca/d ) with and without the addition of zinc ( 15.0 mg/d ) , manganese ( 5.0 mg/d ) and copper ( 2.5 mg/d ) on spinal bone loss ( L2-L4 vertebrae ) was evaluated in healthy older postmenopausal women ( n = 59 , mean age 66 y ) in a 2-y , double-blind , placebo-controlled trial . Changes ( mean + /- SEM ) in bone density were -3.53 + /- 1.24 % ( placebo ) , -1.89 + /- 1.40 % ( trace minerals only ) , -1.25 + /- 1.46 % ( calcium only ) and 1.48 + /- 1.40 % ( calcium plus trace minerals ) . Bone loss relative to base-line value was significant ( P = 0.0061 ) in the placebo group but not in the groups receiving trace minerals alone , calcium alone , or calcium plus trace minerals . The only significant group difference occurred between the placebo group and the group receiving calcium plus trace minerals ( P = 0.0099 ) . These data suggest that bone loss in calcium-supplemented , older postmenopausal women can be further arrested by concomitant increases in trace mineral intake A study was conducted in young men to evaluate the effect of a low-copper diet on copper absorption , excretion , and retention . Eleven young men were confined to a metabolic research unit for 90 d. The study was divided into three periods , with dietary copper as the only variable . Dietary copper intake was 0.66 mg/d for 24 d , 0.38 mg/d for 42 d , and 2.49 mg/d for 24 d. The stable isotope 65Cu was fed to five of the subjects once during the first and last dietary period and twice , early and late , in the second period to determine copper absorption . 65Cu was infused into an arm vein of the other six subjects once during each dietary period to estimate excretion of endogenous copper . Total copper and 65Cu were determined by isotope dilution with thermal-ionization mass spectrometry . Fractional absorption was significantly higher during the low-copper period than in either period with higher dietary copper and excretion of the infused isotope was significantly lower in the low-copper period . Subjects were in negative balance early in the first two periods but achieved balance by the end of those periods . They retained copper during the highest dietary copper period ( third period ) . The results suggest that endogenous copper excretion is a major point of regulation of the body 's copper stores . Regulation of absorption and of endogenous excretion in response to dietary copper intake helps to protect against deficiency and toxicity . However , this regulation was not sufficient to maintain copper status at the lowest intake of dietary copper , 0.38 mg/d Red cell superoxide dismutase ( SOD ) activity was evaluated as a biochemical index of copper nutrition in a double-blind study of 17 infants recovering from malnutrition and receiving marginal copper intakes . Children were paired on admission by sex , birth weight , nutritional status and antecedents of diarrhea and breast feeding . Nine served as controls receiving a copper sulfate supplement ( 80 micrograms/kg daily for 120 d ; eight received a placebo and were supplemented only if plasma copper levels dropped below 90 micrograms/dl or on d 90 for at least 30 d. After copper supplementation there was a significant rise ( paired t-test ; P less than 0.05 ) in plasma copper ( 96 vs. 165 micrograms/dl ) ; ceruloplasmin ( 33 vs. 50 mg/dl ) and SOD ( 1073 vs. 1371 U/g Hb ) . After supplementation these values were similar to those of the controls . SOD was correlated with plasma copper ( r = 0.78 ; P less than 0.001 ) and not with weight-for-age or weight-for-length . Addition of copper in vitro did not modify the SOD activity . Red cell SOD is a good marker of copper nutrition in humans and correlates well with plasma copper BACKGROUND Numerous studies have examined the effect of low and adequate intakes of copper on absorption and retention , but little information is available on the regulation of absorption and retention of copper when intake is high . OBJECTIVE A study was conducted in men to determine the effect of long-term high copper intake on copper absorption , retention , and homeostasis . DESIGN Nine men were confined to a metabolic research unit ( MRU ) for 18 d and were fed a 3-d rotating menu containing an average of 1.6 mg Cu/d . They continued the study under free-living conditions for 129 d , supplementing their usual diets with 7 mg Cu/d . They then returned to the MRU for 18 d and consumed the same diet as during the first period , except that copper intake was 7.8 mg/d . The stable isotope (63)Cu was fed to 3 subjects and infused into the other 6 on day 7 of each MRU period , and complete urine and stool collection s were made throughout the study . Total copper and (63)Cu were determined by inductively coupled plasma mass spectrometry . Copper absorption , excretion , and retention were calculated on the basis of dietary , urinary , and fecal copper and (63)Cu . RESULTS Results were as follows when comparing the high copper intake with the usual intake : fractional copper absorption was significantly lower , but the amount absorbed was significantly higher ; excretion of the infused (63)Cu was significantly faster ; and total retention was significantly higher . CONCLUSIONS Homeostatic regulation of copper absorption and retention helped to minimize the amount of copper retained with high copper intake but was not sufficient to prevent retention of > 0.6 mg Cu/d Western diets containing suboptimal Cu concentrations could be widespread . A link between marginal Cu deficiency and CVD has been suggested . The objective of the present study was to investigate the effect of Cu supplementation on both Cu status and CVD risk factors in healthy young women . Sixteen women with a mean age of 24 ( sd 2 ) years participated in a r and omised crossover study of three 4-week periods with 3-week washouts between periods . During each intervention period , subjects received 0 , 3 or 6 mg elemental Cu/d as CuSO4 in addition to their habitual diet . Blood sample s were taken to assess the effect of supplementation on putative markers of Cu status . The content of plasma lipids , lipoprotein ( a ) , apo and certain haemostatic factors , as putative indices of CVD , was also analysed . Daily supplementation with 3 mg Cu significantly increased ( P < 0.05 ) serum Cu concentration and the activity of erythrocyte superoxide dismutase , although there was no further significant increase after an intake of 6 mg Cu/d . The concentration of the fibrinolytic factor plasminogen activator inhibitor type 1 was significantly reduced ( P < 0.05 ) by about 30 % after supplementation with 6 mg Cu/d . No other marker of Cu status or CVD risk factor was affected by Cu supplementation . The results indicate that supplementation with 3 or 6 mg Cu/d may improve Cu status in these healthy young women . Increased Cu intake could reduce the risk of CVD and atherosclerosis in man by promoting improved fibrinolytic capacity In rats , copper deficiency leads to low copper metalloenzyme activity , high serum cholesterol , and cardiovascular lesions . In humans , moderately low copper intake may be common , but the consequences remain largely uncertain . The present study examined the effects of copper supplementation ( 2 mg/d for 4 weeks in a copper/placebo crossover design ) in 20 adult men with moderately high plasma cholesterol . End-point measurements were three copper enzyme activities , erythrocyte superoxide dismutase ( SOD ) , plasma ceruloplasmin ( Cp ) , and plasma diamine oxidase ( DAO ) , and three parameters related to the risk of cardiovascular disease ( CVD ) , plasma cholesterol , plasma lipoprotein ( a ) [ Lp(a ) ] , and lag times for very-low-density lipoprotein ( VLDL ) and low-density lipoprotein ( LDL ) oxidation in vitro . Although copper had no significant effects on any parameter for the entire study group , it did significantly increase two enzyme activities ( SOD and DAO ) , as well as lipoprotein oxidation lag times , in 10 subjects in the lower half of a median split for precopper values . Thus , copper supplementation appeared to influence some types of measurements in subjects beginning with less than median values No sensitive functional index is currently available to assess Cu status in healthy human population s. This study evaluated the effect of Cu supplementation on putative indices of Cu status in twelve women and twelve men , aged between 22 and 45 years , who participated in a double-blind placebo controlled crossover study . The study consisted of three 6-week supplementation regimens of 3 mg CuSO4 , 3 mg Cu-glycine chelate and 6 mg Cu-glycine chelate , each separated by placebo periods of equal length . Women had significantly higher caeruloplasmin oxidase activity ( P < 0.001 ) , caeruloplasmin protein concentration ( P < 0.05 ) , and serum diamine oxidase activity ( P < 0.01 ) at baseline than men . Erythrocyte and leucocyte superoxide dismutase activity , leucocyte cytochrome c oxidase activity , and erythrocyte glutathione peroxidase activity did not respond to Cu supplementation . Platelet cytochrome c oxidase activity was significantly higher ( P < 0.01 ) , after supplementation with 6 mg Cu-glycine chelate in the total group and in women but did not change in men . Caeruloplasmin Output:	Data for serum copper suggested its value as a biomarker , reflecting changes in status in both depleted and replete individuals , although these changes were smaller in the latter . Total ceruloplasmin protein is related to copper status but reflects changes in highly depleted individuals only . Erythrocyte superoxide dismutase and urinary deoxypyridinoline are not useful biomarkers , but there were insufficient data to draw firm conclusions about plasma , erythrocyte , and platelet copper ; leukocyte superoxide dismutase ; erythrocyte , platelet , and plasma glutathione peroxidase ; platelet and leukocyte cytochrome-c oxidase ; total glutathione ; diamine oxidase ; and urinary pyridinoline . Despite limited data , serum copper appears to be a useful biomarker of copper status at the population level .
MS22332	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: BACKGROUND Extended- duration low-molecular-weight heparin has been shown to prevent venous thromboembolism ( VTE ) in high-risk surgical patients . OBJECTIVE To evaluate the efficacy and safety of extended- duration enoxaparin thromboprophylaxis in acutely ill medical patients . DESIGN R and omized , parallel , placebo-controlled trial . R and omization was computer-generated . Allocation was central ized . Patients , caregivers , and outcome assessors were blinded to group assignment . ( Clinical Trials.gov registration number : NCT00077753 ) SETTING : 370 sites in 20 countries across North and South America , Europe , and Asia . PATIENTS Acutely ill medical patients 40 years or older with recently reduced mobility ( bed rest or sedentary without [ level 1 ] or with [ level 2 ] bathroom privileges ) . Eligibility criteria for patients with level 2 immobility were amended to include only those who had additional VTE risk factors ( age > 75 years , history of VTE , or active or previous cancer ) after interim analyses suggested lower-than-expected VTE rates . INTERVENTION Enoxaparin , 40 mg/d subcutaneously ( 2975 patients ) , or placebo ( 2988 patients ) , for 28 + /- 4 days after receiving open-label enoxaparin for an initial 10 + /- 4 days . MEASUREMENTS Incidence of VTE up to day 28 and of major bleeding events up to 48 hours after the last study treatment dose . RESULTS Extended- duration enoxaparin reduced VTE incidence compared with placebo ( 2.5 % vs. 4 % ; absolute risk difference favoring enoxaparin , -1.53 % [ 95.8 % CI , -2.54 % to -0.52 % ] ) . Enoxaparin increased major bleeding events ( 0.8 % vs. 0.3 % ; absolute risk difference favoring placebo , 0.51 % [ 95 % CI , 0.12 % to 0.89 % ] ) . The benefits of extended- duration enoxaparin seemed to be restricted to women , patients older than 75 years , and those with level 1 immobility . LIMITATION Estimates of efficacy and safety for the overall trial population are difficult to interpret because of the change in eligibility criteria during the trial . CONCLUSION Use of extended- duration enoxaparin reduces VTE more than it increases major bleeding events in acutely ill medical patients with level 1 immobility , those older than 75 years , and women . PRIMARY FUNDING SOURCE Sanofi-aventis Betrixaban is an oral direct inhibitor of factor Xa ( FXa ) being developed for the prevention of venous thromboembolism ( VTE ) . Its antithrombotic effects had not been previously tested in patients . This exploratory clinical trial in the US and Canada r and omized 215 patients undergoing elective total knee replacement ( TKR ) in a 2:2:1 ratio to receive post-operative betrixaban 15 mg or 40 mg p.o . bid or enoxaparin 30 mg s.c . q12h , respectively , for 10 - 14 days . The betrixaban dosage was blinded , but enoxaparin was not . Primary efficacy outcome was the incidence of VTE , consisting of deep-vein thrombosis ( DVT ) on m and atory unilateral ( operated leg ) venography , symptomatic proximal DVT , or pulmonary embolism ( PE ) through Day 10 - 14 . Safety outcomes included major and clinical ly significant non-major bleeds through 48 h after treatment . All efficacy and bleeding outcomes were adjudicated by a blinded independent central adjudication committee . Of 214 treated patients , 175 ( 82 % ) were evaluable for primary efficacy . VTE incidence was 14/70 ( 20 % ; 95 % CI : 11 , 31 ) for betrixaban 15 mg , 10/65 ( 15 % ; 95 % CI : 8 , 27 ) for betrixaban 40 mg , and 4/40 ( 10 % ; 95 % CI : 3 , 24 ) for enoxaparin . No bleeds were reported for betrixaban 15 mg , 2 ( 2.4 % ) clinical ly significant non-major bleeds with betrixaban 40 mg , and one ( 2.3 % ) major and two ( 4.6 % ) clinical ly significant non-major bleeds with enoxaparin . A dose- and concentration-dependent effect of betrixaban on inhibition of thrombin generation and anti-Xa levels was observed . Betrixaban demonstrated antithrombotic activity and appeared well tolerated in knee replacement patients at the doses studied BACKGROUND The efficacy and safety of prolonging prophylaxis for venous thromboembolism in medically ill patients beyond hospital discharge remain uncertain . We hypothesized that extended prophylaxis with apixaban would be safe and more effective than short-term prophylaxis with enoxaparin . METHODS In this double-blind , double-dummy , placebo-controlled trial , we r and omly assigned acutely ill patients who had congestive heart failure or respiratory failure or other medical disorders and at least one additional risk factor for venous thromboembolism and who were hospitalized with an expected stay of at least 3 days to receive apixaban , administered orally at a dose of 2.5 mg twice daily for 30 days , or enoxaparin , administered subcutaneously at a dose of 40 mg once daily for 6 to 14 days . The primary efficacy outcome was the 30-day composite of death related to venous thromboembolism , pulmonary embolism , symptomatic deep-vein thrombosis , or asymptomatic proximal-leg deep-vein thrombosis , as detected with the use of systematic bilateral compression ultrasonography on day 30 . The primary safety outcome was bleeding . All efficacy and safety outcomes were independently adjudicated . RESULTS A total of 6528 subjects underwent r and omization , 4495 of whom could be evaluated for the primary efficacy outcome --2211 in the apixaban group and 2284 in the enoxaparin group . Among the patients who could be evaluated , 2.71 % in the apixaban group ( 60 patients ) and 3.06 % in the enoxaparin group ( 70 patients ) met the criteria for the primary efficacy outcome ( relative risk with apixaban , 0.87 ; 95 % confidence interval [ CI ] , 0.62 to 1.23 ; P=0.44 ) . By day 30 , major bleeding had occurred in 0.47 % of the patients in the apixaban group ( 15 of 3184 patients ) and in 0.19 % of the patients in the enoxaparin group ( 6 of 3217 patients ) ( relative risk , 2.58 ; 95 % CI , 1.02 to 7.24 ; P=0.04 ) . CONCLUSIONS In medically ill patients , an extended course of thromboprophylaxis with apixaban was not superior to a shorter course with enoxaparin . Apixaban was associated with significantly more major bleeding events than was enoxaparin . ( Funded by Bristol-Myers Squibb and Pfizer ; Clinical Trials.gov number , NCT00457002 . ) This study aim ed to determine the frequency of fatal pulmonary emboli in hospitalised medical patients by a retrospective necropsy review and prospect i ve non-interventional patient follow up study . The main outcome measure , necropsy proven fatal pulmonary embolism , was determined from 400 consecutive necropsy records and 200 consecutive medical inpatient episodes . Fatal pulmonary embolism was recorded in 29 of 400 necropsies ; 17 were medical patients . Thirty one of 200 consecutive medical patients died . Fourteen necropsies were performed and revealed pulmonary embolism as the cause of death in five patients . The incidence of necropsy proven fatal pulmonary embolism was therefore 2.5 % ( 95 % confidence intervals 0.8 % to 5.7 % ) . Therefore , one in 40 medical patients had pulmonary embolism recorded as the cause of death at necropsy . As the necropsy rate was only 45 % the incidence of fatal pulmonary embolism may be greater . There is , therefore , a need to perform more large prospect i ve studies to confirm the incidence of fatal pulmonary embolism in medical patients and to identify risk factors and effective antithrombotic prophylaxis BACKGROUND Hospitalized patients with medical illness are especially susceptible to the development of venous thromboembolism ( VTE ) . METHODS To improve our underst and ing of the demographics , comorbidities , risk factors , clinical presentation , prophylaxis , and treatment of hospitalized medical patients with deep vein thrombosis ( DVT ) , we evaluated hospitalized medical patients in a prospect i ve registry of 5,451 consecutive ultrasound-confirmed DVT patients at 183 institutions in the United States . RESULTS Of those patients who participated in the registry , 2,609 ( 48 % ) were hospitalized medical patients . Compared with 1,953 hospitalized nonmedical patients with DVT , medical patients with DVT experienced pulmonary embolism ( PE ) more often ( 22.2 % vs 15.5 % , respectively ; p < 0.0001 ) . However , medical patients in whom DVT developed had received VTE prophylaxis far less frequently than nonmedical patients ( 25.4 % vs 53.8 % , respectively ; p < 0.0001 ) . The underutilization of VTE prophylaxis among hospitalized medical patients extended to both pharmacologic and mechanical modalities . In a multivariable logistic regression analysis of all hospitalized VTE patients , status as a medical patient was negatively associated with receiving prophylaxis ( adjusted odds ratio , 0.47 ; 95 % confidence interval , 0.28 to 0.78 ) . CONCLUSIONS Hospitalized medical patients face " double trouble . " First , during hospitalization for a reason other than VTE , VTE prophylaxis is omitted in medical patients more often than in nonmedical patients . Second , when VTE develops as a complication of hospitalization , hospitalized medical patients experience PE more often . Further studies should focus on underst and ing why prophylaxis is often omitted in hospitalized medical patients and on improving its implementation in this vulnerable population PURPOSE The purpose of this investigation is to estimate the prevalence of acute pulmonary embolism ( PE ) in a general hospital , its frequency among patients who died , and the ability of physicians to diagnose PE antemortem . METHODS The prevalence of acute PE among 51,645 patients hospitalized over a 21-month period was assessed in 1 of the 6 clinical centers ( Henry Ford Hospital ) that participated in the collaborative study , prospect i ve investigation of pulmonary embolism diagnosis ( PIOPED ) . The diagnosis of PE was made by pulmonary angiography , or in those who did not undergo pulmonary angiography because they declined or were ineligible for r and omization to angiography in PIOPED , the diagnosis was based on the ventilation/perfusion ( V/Q ) lung scan . Based on data in PIOPED , PE was considered to be present in 87 % of patients with high probability V/Q scam interpretations , 30 % with intermediate probability interpretations , 14 % with low probability interpretations , and 4 % with nearly normal V/Q scans . RESULTS The estimated prevalence of acute PE in hospitalized patients was 526 of 51,645 ( 1.0 % ; 95 % confidence interval [ CI ] , 0.9 to 1.1 % ) . Based on extrapolated data from autopsy , PE was estimated to have caused or contributed to death in 122 of 51,645 ( 0.2 % ; 95 % CI , 0.19 to 0.29 % ) . Pulmonary embolism was observed at autopsy in 59 of 404 ( 14.6 % ; 95 % CI , 11.3 to 18.4 % ) . Among patients with PE at autopsy , the PE caused or contributed to death in 22 of 59 ( 37.3 % ; 95 % CI , 25.0 to 50.9 % ) and PE was incidental in 37 of 59 ( 62.7 % ; 95 % CI , 49.1 to 75.0 % ) . Among patients at autopsy who died from PE , the diagnosis was unsuspected in 14 of 20 ( 70.0 % ; 95 % CI , 45.7 to 88.1 % ) . Most of these patients had advanced associated disease . In these patients , death from PE occurred within 2.5 h in 13 of 14 ( 92.9 % ; 95 % CI , 66.1 to 99.8 % ) . CONCLUSION Pulmonary embolism is common in a general hospital . The prevalence of PE at autopsy has not changed over 3 decades . The frequency of unsuspected PE in patients at autopsy has not diminished . Even among patients who die from PE , the PE is usually unsuspected . Such patients , however , typically have advanced disease . Among moribund patients , incidental PE is rarely diagnosed . Patients who suffer sudden unexplained catastrophic events in the hospital are a group in whom the diagnosis might be suspected more frequently if physicians maintain a high index of suspicion Output:	Conclusion : In acute medically ill patients , prolonged thromboprophylaxis with an oral FXa inhibitor is more protective than regular short-term treatment with enoxaparin . However , treatment with FXa inhibitors is significantly associated with major bleeding , both in long- and short-term treatment compared with enoxaparin
MS22333	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: BACKGROUND : There is evidence that administration of higher doses of aminoglycosides given less frequently improves the bactericidal effect and reduces the potential to cause side effects . To investigate this , a prospect ively r and omised open label therapeutic trial was undertaken in stratified groups of patients with cystic fibrosis to examine the efficacy and toxic potential of an aminoglycoside dosing regimen design ed to generate high peak drug concentrations at 12 hourly intervals compared with conventional dosing at eight hourly intervals . METHODS : Patients in group A received tobramycin eight hourly using a dose aim ed at generating a peak concentration of 10 mg/l with trough concentrations below 2 mg/l , and those in group B received the total daily dose required to achieve eight hourly target concentrations administered as two equal 12 hourly doses . Clinical outcomes measured and assessed included vestibular symptoms , hearing and renal function , length of hospital stay , readmission rate , and mortality . RESULTS : Twenty nine patients were recruited during a six month period , 20 to group A and nine to group B. The average peak tobramycin level was higher in group B ( 12.5 ( 2.2 ) mg/l ) than in group A ( 7.9 ( 1.9 ) mg/l ) , whilst the average trough level was higher in group A ( 0.8 ( 0.3 ) mg/l ) than in group B ( 0.5 ( 0.2 ) mg/l ) . There was a difference in the number of ototoxic events between patients in group A ( seven of 18 , 38.9 % ) and group B ( none of eight ) , but no difference was found in other outcome measures assessed . CONCLUSIONS : These results suggest that 12 hourly high peak aminoglycoside dosing may be less toxic than equivalent eight hourly dosing , without any apparent difference in efficacy OBJECTIVES Once-daily administration of aminoglycosides in cystic fibrosis ( CF ) patients is considered equally efficacious and potentially less nephrotoxic than dosing three times a day . However , the choice of the most suitable PK/PD index ( C(max)/MIC versus AUC(24)/MIC ) to ensure optimum clinical outcome in this patient population is not clear . PATIENTS AND METHODS In a single-centre , open , r and omized , controlled , non-blinded study 33 adult CF patients ( 20 females , 19 - 37 years ) were treated with intravenous tobramycin ( 10 mg/kg/day ) for 14 days given either as single dose once a day ( Q24 ; 17 patients ) or divided into three equal doses every 8 h ( Q8 ; 16 patients ) . Tobramycin serum concentrations and MICs for Pseudomonas aeruginosa were determined on days 1 and 14 . The clinical outcome parameter , correlated to PK/PD indices , was the percentage predicted forced expiratory volume in 1 s ( FEV(1)% pred . ) . RESULTS FEV(1)% pred . improved significantly for both treatments . There was a log-linear relationship between C(max)/MIC and FEV(1)% pred . and AUC/MIC and FEV(1)% pred . for both treatments . For equal values of AUC24/MIC , however , Q24 treatment provided better improvement in lung function than Q8 dosing , whereas C(max)/MIC did not show any dosing interval dependence . A statistically significant increase was observed for MIC ( day 1 ) versus MIC ( day 14 ) for Q24 treatment , however , no such difference was observed for Q8 treatment . CONCLUSIONS The most important PK/PD parameter for clinical outcome in CF patients was C(max)/MIC . Outcome prediction of AUC(24)/MIC was dependent on the regimen . The increase of P. aeruginosa resistance after once-daily administration is linked to a long dosing interval . More and larger studies are needed to optimize the dosing regimen for maximum clinical outcome with minimum resistance development Twenty-six patients with cystic fibrosis and pulmonary exacerbations were enrolled in a prospect i ve r and omized study to compare the efficacy of aminoglycosides ( tobramycin or netilmicin ) administered once daily ( 21 episodes , 5 with netilmicin , 16 with tobramycin ) and thrice daily ( 23 episodes , 2 with netilmicin , 21 with tobramycin ) , respectively . In addition , the patients received an anti-pseudomonal beta-lactam antibiotic . In the single-dose group the total daily dosage was 4.97 + /- 1.12 mg/kg ( total dosage per exacerbation : 74.55 mg/kg ) , compared to 9.60 + /- 2.70 mg/kg in the triple-dose group ( total dosage per exacerbation : 165.12 mg/kg ) . The mean peak and trough serum levels of the aminoglycoside were 8.31 + /- 1.76 mg/l and 0.18 + /- 0.10 mg/l , respectively in the single dose group compared to 6.12 + /- 1.30 mg/l and 0.58 + /- 0.31 mg/l in the triple dose group . Success of treatment , defined as decrease in leucocyte counts , normalization of elevated CRP-values , number of days in hospital and interval until next admission to hospital , was not different between both groups . We conclude that single daily dose of aminoglycosides was as efficacious as triple dose in our patients Aminoglycosides are often prescribed as part of the treatment regimen for acute pulmonary exacerbations due to their potent activity and low potential for development of resistance . Preliminary evidence from r and omized controlled trials in patients with cystic fibrosis ( CF ) suggests that once-daily administration of aminoglycosides results in similar efficacy and a low risk for toxicity compared with traditional dosing . The pharmacokinetics of aminoglycosides administered once daily in CF patients are currently not well described . In this study we compare the distribution and elimination patterns of traditional dosing ( 3.3 mg/kg q8h ) versus once-daily dosing ( 10 mg/kg q24h ) of tobramycin in six adult patients with CF . The pharmacokinetics of tobramycin administered either once daily or every 8 h were best described by a two-compartment model . No statistically significant differences in any of the pharmacokinetic parameter values between regimens were noted . The distribution phase half-lives of 32 and 24 min following the q8h and q24h regimens were longer than expected . The use of a one-compartment model requires clinical peak levels to be drawn 2 h after initiation of either a 30 min infusion for multiple daily dosing or a 60 min infusion with once-daily dosing , to ensure completion of the distribution phase . Our data indicate that a dose of 10 mg/kg/day provides post-distributional phase peak concentrations that achieve the desired goal for susceptible organisms ( > 20 mg/L ) and AUC(24 ) values at the upper end of the desired range ( 70 - 100 mg.h/L ) ABSTRACT We undertook assessment of hearing in patients with cystic fibrosis who were taking part in a large r and omized controlled trial of once- versus three-times-daily tobramycin for pulmonary exacerbations of cystic fibrosis ( the TOPIC study ) . All patients were eligible to have st and ard pure tone audiometry performed across the frequency range of 0.25 to 8 kHz . High-frequency pure tone audiometry over 10 to 16 kHz was also performed with a subset of patients . Audiometry was undertaken at the start of tobramycin treatment , at the end of a 14-day course of treatment , and at follow-up 6 to 8 weeks later . We enrolled 244 patients , of whom 219 ( 125 children and 94 adults ) completed treatment . Nineteen patients were excluded from analysis due to abnormal baseline audiometry . Complete pre- and posttreatment st and ard audiological data were obtained for 168/219 patients . We found no significant differences in hearing thresholds when they were assessed at the baseline , at the end of treatment , and at follow-up 6 to 8 weeks later were compared . In addition , no significant differences in hearing thresholds were detected between treatment regimens . Similar results were obtained for the subset of 63/168 patients who underwent high-frequency audiometry . We conclude that for a single 14-day course of tobramycin treatment in patients with cystic fibrosis with no preexisiting auditory deficit , no measurable effect on hearing was apparent with either once- or three-times-daily treatment . Estimation of the cumulative cochleotoxic risk in cystic fibrosis patients due to repeated aminoglycoside therapy , as evidence d by the patients excluded from this study due to hearing loss , also requires further characterization Our objective was to compare the efficacy , safety , and microbiology of once-daily intravenous ( IV ) tobramycin with conventional 8-hourly tobramycin/ceftazidime IV therapy for acute Pseudomonas aeruginosa ( PA ) pulmonary exacerbations in cystic fibrosis ( CF ) . CF patients with PA-induced pulmonary exacerbations were allocated to receive either once-daily tobramycin ( Mono ) or conventional therapy with tobramycin/ceftazidime given 8-hourly ( Conv ) . The two longitudinal groups received therapy in a double-blind , r and omized manner over a period of 2 years . Tobramycin doses were adjusted to achieve a daily area under the time-concentration curve of 100 mg x hr/L in both groups . Results were assessed for both short-term changes ( efficacy and safety after 10 days of IV antibiotics during acute exacerbations ) and long-term changes ( efficacy , safety , and sputum microbiology between study entry and exit ) . Pulmonary function tests ( PFTs ) on admission were similar in both groups . After 10 days of IV antibiotics , absolute mean improvements in percent of predicted PFTs were 12.8 , 12.1 , and 13.7 for forced expiratory volume in 1 sec ( FEV(1 ) ) , forced vital capacity ( FVC ) , and forced expired flow between 25 - -75 % of FVC ( FEF(25 - -75 % ) ) in the Conv group ( n = 51 admissions ) compared to 10.6 , 9.9 , and 10.6 in the Mono group ( n = 47)(P<0.05 for all ) . Sixteen percent in the Conv group and 15 % of patients in the Mono group did not respond to therapy by day 10 . Long-term PFT patterns were similar for the Conv and Mono groups . The time between admissions did not differ . The Mono group showed a significant increase in tobramycin minimum inhibitory concentrations ( MICs ) against PA from study entry to study exit ( P = 0.02 , n = 27 strains ) ; this failed to reach significance in the Conv group ( P = 0.08 , n = 25 ) . There was no significant increase in the number of isolates , with MIC > or = 8 mg/L in both groups . No short- or long-term changes in audiology or serum creatinine were found in either group . After 10 days of IV therapy , the urinary enzyme N-acetyl-beta-d-glucosaminidase/creatinine ratios increased in both groups ( P0.05 ) . This increase was greater in the Conv compared to the Mono group ( P < 0.05 ) . We conclude that this pilot study indicates once-daily tobramycin therapy to be as effective and safe as conventional 8-hourly tobramycin/ceftazidime therapy . Combination antibacterial therapy appears to offer no clinical advantage over once-daily tobramycin monotherapy . Tobramycin once-daily monotherapy is a potential alternative to conventional IV antibacterial therapy which deserves further investigation , including the impact on susceptibility of PA to tobramycin The efficacy and toxicity of a shortened tobramycin dosing interval in the treatment of exacerbations of Pseudomonas aeruginosa pulmonary infection in cystic fibrosis patients were evaluated prospect ively . Patients ages 13 to 30 years received 34 treatment courses and were r and omized by pairs to receive tobramycin administered either every 6 or 8 hours . Peak serum concentrations were adjusted to 8 to 10 micrograms/ml ; thus a larger total daily dosage was administered to patients receiving tobramycin every 6 hours . The shorter dosing interval was associated with better pulmonary function at follow-up and significantly longer time before next hospital admission for a pulmonary exacerbation . During the study hospitalization there were no differences in pulmonary function tests , clinical score , sputum carriage of P. aeruginosa , toxicity or necessary length of hospitalization . A 6-hour tobramycin dosing interval was more efficacious than an 8-hour dosing interval in the treatment of cystic fibrosis patients Although there are reports of cases of acute renal failure occurring in cystic fibrosis ( CF ) patients , usually in association with the use of nephrotoxic antibiotic therapy , there have been no studies of renal function in this patient group . We hypothesized that long-term use of intravenous ( IV ) nephrotoxic antibiotics ( aminoglycosides and colistin sulphomethate ) may contribute to renal disease in CF patients . In a prospect i ve study , we assessed creatinine clearance as an index Output:	Once- and three-times daily aminoglycoside antibiotics appear to be equally effective in the treatment of pulmonary exacerbations of cystic fibrosis . There is evidence of less nephrotoxicity in children
MS22334	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: Anemia , one of the most common complications of cancer chemotherapy , has been managed with red blood cell ( RBC ) transfusions . As an alternative , the agent epoetin alfa has the potential to reduce the transfusion requirements of patients receiving cancer chemotherapy . To estimate the value that cancer patients place on the drug , an economic analysis using the concept of willingness to pay ( WTP ) was conducted ABSTRACT Objective : To compare the cost-effectiveness of epoetin alfa ( EPO ) and darbepoetin alfa ( DARB ) for the treatment of chemotherapy-induced anemia ( CIA ) , using dosing regimens approved by the FDA ( EPO 40 000 U once weekly and DARB 2.25 mcg/kg once weekly ) . Methods : The study compared published results of two double-blind , r and omized , phase III trials one utilizing EPO ( N = 166 ) and the other , DARB ( N = 367 ) . Patients in both trials had similar baseline characteristics . Effectiveness was measured as the proportion of EPO or DARB patients who were successfully treated ( i.e. , did not require blood transfusion ) during weeks 0–16 and 5–16 , respectively . Estimated drug costs were presented in 2005 USD based on wholesale acquisition cost ( WAC ) and average drug utilization over 16 weeks . Cost-effectiveness was calculated as the estimated drug costs divided by transfusion effectiveness . Threshold analysis was used to determine the break-even point at which EPO and DARB had the same drug costs . Results : Estimated drug costs over 16 weeks were $ 9039 for EPO and $ 13 555 for DARB . During weeks 5–16 , 85 % of EPO patients and 73 % of DARB patients were successfully treated , result ing in average cost-effectiveness ratios of $ 106 for EPO and $ 186 for DARB per one per cent of successfully treated patients . A 33 % reduction in DARB WAC was required to achieve the same drug costs as for EPO . Conclusions : Utilizing FDA -approved doses , EPO was found to result in lower drug costs and better treatment success when compared to DARB . Hence , EPO is a dominant alternative compared to DARB for the treatment of CIA . The analyses presented here are not without limitations . Specifically , although the studies were comparable , patients were ultimately drawn from different population Previous phase I-II clinical trials have shown that recombinant human erythropoietin ( rHuEpo ) can ameliorate anemia in a portion of patients with multiple myeloma ( MM ) and non-Hodgkin 's lymphoma ( NHL ) . Therefore , we performed a r and omized controlled multicenter study to define the optimal initial dosage and to identify predictors of response to rHuEpo . A total of 146 patients who had hemoglobin ( Hb ) levels < or = 11 g/dL and who had no need for transfusion at the time of enrollment entered this trial . Patients were r and omized to receive 1,000 U ( n = 31 ) , 2,000 U ( n = 29 ) , 5,000 U ( n = 31 ) , or 10,000 U ( n = 26 ) of rHuEpo daily subcutaneously for 8 weeks or to receive no therapy ( n = 29 ) . Of the patients , 84 suffered from MM and 62 from low- to intermediate- grade NHL , including chronic lymphocytic leukemia ; 116 of 146 ( 79 % ) received chemotherapy during the study . The mean baseline Hb level was 9.4 + /- 1.0 g/dL. The median serum Epo level was 32 mU/mL , and endogenous Epo production was found to be defective in 77 % of the patients , as judged by a value for the ratio of observed-to-predicted serum Epo levels ( O/P ratio ) of < or = 0.9 . An intention-to-treat analysis was performed to evaluate treatment efficacy . The median average increase in Hb levels per week was 0.04 g/dL in the control group and -0.04 ( P = .57 ) , 0.22 ( P = .05 ) , 0.43 ( P = .01 ) , and 0.58 ( P = .0001 ) g/dL in the 1,000 U , 2,000 U , 5,000 U , and 10,000 U groups , respectively ( P values versus control ) . The probability of response ( delta Hb > or = 2 g/dL ) increased steadily and , after 8 weeks , reached 31 % ( 2,000 U ) , 61 % ( 5,000 U ) , and 62 % ( 10,000 U ) , respectively . Regression analysis using Cox 's proportional hazard model and classification and regression tree analysis showed that serum Epo levels and the O/P ratio were the most important factors predicting response in patients receiving 5,000 or 10,000 U. Approximately three quarters of patients presenting with Epo levels inappropriately low for the degree of anemia responded to rHuEpo , whereas only one quarter of those with adequate Epo levels did so . Classification and regression tree analysis also showed that doses of 2,000 U daily were effective in patients with an average platelet count greater than 150 x 10(9)/L. About 50 % of these patients are expected to respond to rHuEpo . Thus , rHuEpo was safe and effective in ameliorating the anemia of MM and NHL patients who showed defective endogenous Epo production . From a practical point of view , we conclude that the decision to use rHuEpo in an individual anemic patient with MM or NHL should be based on serum Epo levels , whereas the choice of the initial dosage should be based on residual marrow function OBJECTIVE To compare the steady-state pharmacokinetics and pharmacodynamics following multiple subcutaneous administration of a new erythropoiesis stimulating agent ( HX575 , Binocrit , S and oz GmbH , Holzkirchen , Germany ) with that of epoetin beta ( NeoRecormon , Roche Ltd. , Welwyn Garden City , UK ) . METHODS An open , r and omized , parallel group study was conducted in 80 healthy adult males . Subjects were r and omized to multiple subcutaneous doses of 100 IU/kg body weight of HX575 or epoetin beta three-times-weekly for 4 weeks . Serum epoetin concentrations were measured using an enzyme-linked immunosorbent assay ( ELISA ) and pharmacokinetic parameters for the two treatments were compared . The time course and area under the effect curve ratios of hematological characteristics were used as surrogate parameters for efficacy evaluation . RESULTS The pharmacokinetic profiles after multiple doses were similar for both treatments . HX575 was bioequivalent to epoetin beta with respect to the rate and extent of exposure of exogenous epoetin , as indicated by the ratios ( 90 % confidence intervals ) of AUC(tau ) ( 96.1 ( 86.4 - 106.9 ) ) and C(max , ss ) ( 98.5 ( 85.2 - 113.9 ) ) . The hematological profiles of both treatments were similar as determined from the population mean curves and the AUEC(Hb ) ratio ( 90 % confidence interval ] ( 99.2 ( 97.7 - 100.7 ) ) , the primary endpoint of this study . Study medication was well tolerated with no clinical ly relevant differences between safety profiles of the treatments . Anti-epoetin antibodies were not detected at any time . CONCLUSIONS HX575 and epoetin beta were bioequivalent with respect to their steady-state pharmacokinetic profile and pharmacodynamic action . These results support the conclusion that HX575 and epoetin beta will be equally efficacious and may be interchangeable as therapy Patients with breast cancer treated with adjuvant chemotherapy experience not only fatigue and menopausal symptoms but also documented cognitive dysfunction and reduced capacity to carry out activities of daily living . The role of epoetin alfa in improving cognition and functional capacity was assessed in a large r and omized trial through patient self-reported outcomes . Patients with breast cancer ( N = 354 , adjuvant and metastatic ) undergoing chemotherapy were r and omized in a 1:1 ratio to receive epoetin alfa ( 40,000 IU once weekly ) or the st and ard of care ( SOC ) . Change in patient-reported Health Utilities Index Mark 3 ( HUI3 ) from baseline to week 12 was compared between the epoetin alfa and SOC groups . In addition , correlations between the disease-nonspecific HUI3 utility scale and the cancer-specific quality of life instrument Functional Assessment of Cancer Therapy-Anemia ( FACT-An ) and Fatigue subscales were assessed . Epoetin alfa treatment significantly improved HUI3 scores compared with patients receiving SOC ( P = 0.036 ) . Three subscales within HUI3 were also significantly better for epoetin alfa-treated patients ( emotion , P = 0.048 ; ambulation , P = 0.048 ; and cognition , P = 0.02 ) . Moreover , a strong correlation ( P = 0.0001 ) exists between the disease-nonspecific utility scale HUI3 and the disease-specific FACT-An and FACT-Fatigue scales in terms of overall scores and score changes . The findings of the study demonstrate for the first time in patients with breast cancer that epoetin alfa significantly enhances functional well-being , which translates into significantly better utility scores . In addition , epoetin alfa also significantly improved cognitive function of women undergoing chemotherapy , and this could have an important impact on their lives from a societal perspective Health-related quality of life ( HrQOL ) assessment s are gaining importance as outcome measures in cancer clinical trials . A recently published clinical trial reported statistically significant ( P<0.001 ) increases in haemoglobin ( Hb ) levels and significantly ( P<0.01 ) increased HrQOL scores following the administration of recombinant human erythropoietin ( r-HuEPO , epoetin alfa ) versus placebo to anaemic cancer patients who received non-platinum chemotherapy . This study employed five cancer-specific HrQOL instruments . Hb and HrQOL data from this trial were analysed to estimate the minimally important difference ( MID ) in HrQOL measures that could be interpreted as clinical ly meaningful , with Hb level selected as the best external st and ard . Patients were assigned to two groups : improved ( Hb increases of > /=1 g/dL ) or stable ( change in Hb of-1 g/dL to < 1 g/dL ) . The MID was first determined as the difference between the mean changes in HrQOL in the improved group versus the stable group . By this analysis , the differences in HrQOL scores between the epoetin alfa group and the placebo group were clinical ly important for all Hb-sensitive , cancer-specific HrQOL evaluations . Linear regression analyses performed to provide estimates of the MID for specific values of Hb change confirmed that the differences in HrQOL scores between patient groups were clinical ly significant . These analyses were repeated using a data set from a separate clinical trial , which further supported the conclusion that observed HrQOL changes demonstrated in the multicentre , double-blind study were clinical ly important . These methods provide one means for interpreting the clinical relevance of changes in HrQOL evaluated in clinical trials Background HX575 is a human recombinant epoetin alfa that was approved for use in Europe in 2007 under the European Medicines Agency biosimilar approval pathway . Therefore , in order to demonstrate the bioequivalence of HX575 to an existing epoetin alfa , the pharmacokinetic and pharmacodynamic response to steady state circulating concentrations of HX575 and a comparator epoetin alfa were compared following multiple intravenous administrations . Methods An open , r and omised , parallel group study was conducted in 80 healthy adult males . Subjects were r and omised to multiple intravenous doses of 100 IU/kg body weight of HX575 or of the comparator epoetin alfa three-times-weekly for four weeks . Serum epoetin concentrations were measured using an enzyme-linked immunosorbent assay and pharmacokinetic parameters for the two treatments were compared . The time course and area under the effect curve ratio of haematological characteristics were used as surrogate parameters for efficacy evaluation . Results The haematological profiles of both treatments were similar , as determined from their population mean curves and the AUECHb ratio and 90 % confidence interval ( 99.9 % [ 98.5–101.2 % ] ) , the primary pharmacodynamic endpoint of this study . The pharmacokinetic parameters after the treatments showed minor differences after single dosing , but not at steady state doses . After multiple doses , HX575 was bioequivalent to the comparator with respect to the rate and extent of exposure of exogenous epoetin ( AUCτ ratio and 90 % confidence interval : 89.2 % [ 82.5–96.2 % ] ) . Study medication was well tolerated with no clinical ly relevant differences between safety profiles of the treatments . Anti-epoetin antibodies were not detected . Conclusion HX575 and the comparator epoetin alfa were bioequivalent at steady state circulating drug concentrations with respect to their pharmacokinetic profile and pharmacodynamic action . This supports the conclusion that HX575 and the comparator epoetin alfa , when administered intraveneously , will be equally efficacious and may be interchangeable as therapy PURPOSE Erythropoietin , an oxygen-regulated Output:	The results suggest a clinical benefit from ESAs for anaemia-related outcomes and an improvement in HRQoL scores . The impact of ESAs on AEs and survival remains highly uncertain , although point estimates are lower , confidence intervals are wide and not statistically significant . Base-case incremental cost-effectiveness ratios ( ICERs ) for ESA treatment compared with no ESA treatment ranged from £ 19,429 to £ 35,018 per QALY gained , but sensitivity and scenario analyses demonstrate considerable uncertainty in these ICERs , including the possibility of overall health disbenefit . ESAs could be cost-effective when used closer to licence , but there is considerable uncertainty , mainly because of unknown impacts on overall survival .
MS22335	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: Objective To evaluate the effects of short-term , high-volume hemofiltration ( STHVH ) on hemodynamic and metabolic status and 28-day survival in patients with refractory septic shock . Design Prospect i ve , interventional . Setting Intensive care unit ( ICU ) , tertiary institution . Patients Twenty patients with intractable cardiocirculatory failure complicating septic shock , who had failed to respond to conventional therapy . Interventions STHVH , followed by conventional continuous venovenous hemofiltration . STHVH consisted of a 4-hr period during which 35 L of ultrafiltrate is removed and neutral fluid balance is maintained . Subsequent conventional continuous venovenous hemofiltration continued for at least 4 days . Measurements and Main Results Cardiac index , systemic vascular resistance , pulmonary vascular resistance , oxygen delivery , mixed venous oxygen saturation , arterial pH , and lactate were measured serially . Fluid and inotropic support were managed by protocol . Therapeutic endpoints were as follows during STHVH : a ) by 2 hrs , a ≥50 % increase in cardiac index ; b ) by 2 hrs , a ≥25 % increase in mixed venous saturation ; c ) by 4 hrs , an increase in arterial pH to > 7.3 ; d ) by 4 hrs , a ≥50 % reduction in epinephrine dose . Patients who attained all four goals ( 11 of 20 ) were considered hemodynamic “ responders ” ; patients who did not ( 9 of 20 ) were considered hemodynamic “ nonresponders . ” There were no differences in baseline hemodynamic , metabolic , and Acute Physiology and Chronic Health Evaluation and Simplified Acute Physiology Scores between responders and nonresponders . Survival to 28 days was better among responders ( 9 of 11 patients ) than among nonresponders ( 0 of 9 ) . Factors associated with survival were hemodynamic-metabolic response status , time interval from ICU admission to initiation of STHVH , and body weight . Conclusions These data suggest that STHVH may be of major therapeutic value in the treatment of intractable cardiocirculatory failure complicating septic shock . Early initiation of therapy and adequate dose may improve hemodynamic and metabolic responses and 28-day survival STUDY OBJECTIVE To determine whether correction of acidemia using bicarbonate improves hemodynamics in patients who have lactic acidosis . DESIGN Prospect i ve , r and omized , blinded , crossover study . Each patient sequentially received sodium bicarbonate and equimolar sodium chloride . The order of the infusions was r and omized . SETTING Intensive care unit of a tertiary care hospital . PATIENTS Fourteen patients who had metabolic acidosis ( bicarbonate less than 17 mmol/L and base excess less than -10 ) and increased arterial lactate ( mean , 7.8 mmol/L ) . All had pulmonary artery catheters and 13 were receiving catecholamines . MEASUREMENTS AND MAIN RESULTS Sodium bicarbonate ( 2 mmol/kg body weight over 15 minutes ) increased arterial pH ( 7.22 to 7.36 , P less than 0.001 ) , serum bicarbonate ( 12 to 18 mmol/L , P less than 0.001 ) , and partial pressure of CO2 in arterial blood ( PaCO2 ) ( 35 to 40 mm Hg , P less than 0.001 ) and decreased plasma ionized calcium ( 0.95 to 0.87 mmol/L , P less than 0.001 ) . Sodium bicarbonate and sodium chloride both transiently increased pulmonary capillary wedge pressure ( 15 to 17 mm Hg , and 14 to 17 mm Hg , P less than 0.001 ) and cardiac output ( 18 % and 16 % , P less than 0.01 ) . The mean arterial pressure was unchanged . Hemodynamic responses to sodium bicarbonate and sodium chloride were the same . These data have more than 90 % power of detecting a 0.5 L/min ( 7 % ) change in mean cardiac output after administration of sodium bicarbonate compared with that after sodium chloride . Even the 7 most acidemic patients ( mean pH , 7.13 ; range , 6.90 to 7.20 ) had no significant hemodynamic changes after either infusion . CONCLUSIONS Correction of acidemia using sodium bicarbonate does not improve hemodynamics in critically ill patients who have metabolic acidosis and increased blood lactate or the cardiovascular response to infused catecholamines in these patients . Sodium bicarbonate decreases plasma ionized calcium and increases PaCO2 BACKGROUND Acute renal failure ( ARF ) requiring dialysis in critically ill patients is associated with an in-hospital mortality rate of 50 to 80 % . The worldwide st and ard for renal replacement therapy is intermittent hemodialysis ( IHD ) . Continuous hemodialysis and hemofiltration techniques have recently emerged as alternative modalities . These two therapies have not been directly compared . METHODS A multicenter , r and omized , controlled trial was conducted comparing two dialysis modalities ( IHD vs. continuous hemodiafiltration ) for the treatment of ARF in the intensive care unit ( ICU ) . One hundred sixty-six patients were r and omized . Principal outcome measures were ICU and hospital mortality , length of stay , and recovery of renal function . RESULTS Using intention-to-treat analysis , the overall ICU and in-hospital mortalities were 50.6 and 56.6 % , respectively . Continuous therapy was associated with an increase in ICU ( 59.5 vs. 41.5 % , P < 0.02 ) and in-hospital ( 65.5 vs. 47.6 % , P < 0.02 ) mortality relative to intermittent dialysis . Median ICU length of stay from the time of nephrology consultation was 16.5 days , and complete recovery of renal function was observed in 34.9 % of patients , with no significant group differences . Despite r and omization , there were significant differences between the groups in several covariates independently associated with mortality , including gender , hepatic failure , APACHE II and III scores , and the number of failed organ systems , in each instance biased in favor of the intermittent dialysis group . Using logistic regression to adjust for the imbalances in group assignment , the odds of death associated with continuous therapy was 1.3 ( 95 % CI , 0.6 to 2.7 , P = NS ) . A detailed investigation of the r and omization process failed to explain the marked differences in patient assignment . CONCLUSIONS A r and omized controlled trial of alternative dialysis modalities in ARF is feasible . Despite the potential advantages of continuous techniques , this study provides no evidence of a survival benefit of continuous hemodiafiltration compared with IHD . This study did not control for other major clinical decisions or other supportive management strategies that are widely variable ( for example , nutrition support , hemodynamic support , timing of initiation , and dose of dialysis ) and might material ly influence outcomes in ARF . St and ardization of several aspects of care or extremely large sample sizes will be required to answer optimally the questions originally posed by this investigation Objectives Maintenance of normoglycemia with insulin reduces mortality and morbidity of critically ill patients . Here we report the factors determining insulin requirements and the impact of insulin dose vs. blood glucose control on the observed outcome benefits . Design A prospect i ve , r and omized , controlled trial . Setting A 56-bed predominantly surgical intensive care unit in a tertiary teaching hospital Patients and InterventionA total of 1,548 patients were r and omly assigned to either strict normalization of blood glucose ( 80–110 mg/dL ) with insulin infusion or the conventional approach , in which insulin is only given to maintain blood glucose levels at 180–200 mg/dL. Measurements and Main Results It was feasible and safe to achieve and maintain blood glucose levels at < 110 mg/dL by using a titration algorithm . Stepwise linear regression analysis identified body mass index , history of diabetes , reason for intensive care unit admission , at-admission hyperglycemia , caloric intake , and time in intensive care unit as independent determinants of insulin requirements , together explaining 36 % of its variation . With nutritional intake increasing from a mean of 550 to 1600 calories/day during the first 7 days of intensive care , normoglycemia was reached within 24 hrs , with a mean daily insulin dose of 77 IU and maintained with 94 IU on day 7 . Insulin requirements were highest and most variable during the first 6 hrs of intensive care ( mean , 7 IU/hr ; 10 % of patients required > 20 IU/hr ) . Between day 7 and 12 , insulin requirements decreased by 40 % on stable caloric intake . Brief , clinical ly harmless hypoglycemia occurred in 5.2 % of intensive insulin-treated patients on median day 6 ( 2–14 ) vs. 0.8 % of conventionally treated patients on day 11 ( 2–10 ) . The outcome benefits of intensive insulin therapy were equally present regardless of whether patients received enteral feeding . Multivariate logistic regression analysis indicated that the lowered blood glucose level rather than the insulin dose was related to reduced mortality ( p < .0001 ) , critical illness polyneuropathy ( p < .0001 ) , bacteremia ( p = .02 ) , and inflammation ( p = .0006 ) but not to prevention of acute renal failure , for which the insulin dose was an independent determinant ( p = .03 ) . As compared with normoglycemia , an intermediate blood glucose level ( 110–150 mg/dL ) was associated with worse outcome . Conclusion Normoglycemia was safely reached within 24 hrs and maintained during intensive care by using insulin titration guidelines . Metabolic control , as reflected by normoglycemia , rather than the infused insulin dose per se , was related to the beneficial effects of intensive insulin therapy BACKGROUND This study was design ed to determine the consequences of acute hyperglycemia on the immune function of peripheral neutrophils , peritoneal macrophages , and alveolar macrophages in nondiabetic rats . METHODS The animals were r and omly divided into nonsurgical ( normal ) and surgical groups . The postoperative rats were further divided into normoglycemic ( control ) and hyperglycemic ( glucose ) groups . The hyperglycemic condition was maintained by constant infusion of glucose to raise plasma glucose concentration to 300 mg/dL for 3 hours . The immune cells were then harvested to determine their phagocytic and oxidative capacities via flow cytometry . RESULTS The results showed that hyperglycemia significantly decreased the respiratory burst of alveolar macrophages ( p < .05 ) . In contrast , hyperglycemia enhanced phagocytosis in these cells ( p < .002 ) . There was a significant activation of the respiratory burst in peripheral neutrophils by surgery ( p < .002 ) , but no effect of hyperglycemia . CONCLUSIONS We conclude that hyperglycemia itself can influence immune function in some phagocytic cells , which may be an important factor in postsurgical infection Objective To study the effect of early and continuous venovenous hemofiltration ( CVVH ) on the plasma concentrations of several humoral mediators of inflammation and subsequent organ dysfunction in septic patients . Design R and omized , controlled trial . Setting Intensive care unit of a tertiary hospital . Patients Twenty-four patients with early septic shock or septic organ dysfunction . Interventions R and om allocation to receive 48 hrs of isovolemic CVVH at 2 L/hr of fluid exchange or no hemofiltration . Measurements and Main Results We measured the plasma concentrations of complement fractions C3a and C5a , interleukins 6 , 8 , and 10 , and tumor necrosis factor & agr ; at baseline and 2 , 24 , 26 , 48 , and 72 hrs . A multiple organ dysfunction score ( MODS ) was calculated daily for each patient until death or discharge from the intensive care unit . The concentrations of most mediators decreased between baseline and 72 hrs . Some significant falls in concentration could be identified between specific time points , but CVVH was not associated with an overall reduction in any plasma cytokine concentrations . There was also no difference between the mean cumulative MODS for control survivors ( 43.3 ± 19.7 ) and CVVH survivors ( 33.2 ± 19.0;p = .30 ) , and no difference between the average MODS calculated for all controls ( 4.1 ± 1.9 ) and all CVVH subjects ( 3.3 ± 1.7;p = .26 ) . CVVH did not improve oxygenation , lower the platelet count , or reduce the duration of vasopressor support and mechanical ventilation . Conclusions Early use of CVVH at 2 L/hr did not reduce the circulating concentrations of several cytokines and anaphylatoxins associated with septic shock , or the organ dysfunction that followed severe sepsis . CVVH using current technology can not be recommended as an adjunct to the treatment of sept Output:	Glycemic control ( maintenance of glucose < 150 mg/dL ) is recommended . The beneficial effect of glycemic control appears to be related control of glucose and not the administration of insulin . Continuous hemofiltration offers easier management of fluid balance in hemodynamically unstable septic patients but in the absence of hemodynamic instability is equivalent to intermittent hemodialysis . It is uncertain whether high-volume hemofiltration improves prognosis in sepsis .
MS22336	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: Increased fat mass , particularly abdominal fat mass , is associated with poor metabolic profiles and an increase in cardiovascular risk factors . The purpose of this study was to evaluate the effect of a 1-year combined aerobic and strength training regimen , compared to aerobic training only , on body composition in patients with coronary artery disease ( CAD ) . Thirty-six males with CAD were assigned to 3 groups : 13 to weight training plus aerobic training ( combined training group [ CT ] ) , 13 to aerobic training only ( aerobic training group [ AT ] ) , and 10 to a control group ( no exercise [ CG ] ) . Body composition was determined by dual-energy x-ray absorptiometry ( DEXA ) . Differences were observed between groups at the end of the study , controlling for prevalues . The total and trunk percent fat mass ( % FM ) were lower in CT compared with AT and CG ( P<.05 ) . The total % FM in AT was significantly ( P<.05 ) lower than in CG , but the % FM of the trunk did not differ between the 2 groups . Fat-free mass ( FFM ) was significantly higher in CT than in AT and CG ( P<.05 ) . The results suggest that a long-term CT program is more effective than an AT program alone in producing changes in body composition . The percentage changes in total and trunk fat mass were higher in CT ( -11 % and -12 % , respectively ) than in AT ( -2.4 % and -0.7 % , respectively ) . Future studies need to investigate the specific health effects of trunkal fat mass loss in patients with CAD A prospect i ve , r and omized study evaluated the feasibility , safety , and efficacy of upper body circuit weight training ( CWT ) in 25 stable male cardiac patients entering the initial out-of-hospital phase of cardiac rehabilitation . Both groups performed 30 minutes of aerobic exercise only for 6 weeks . The aerobic exercise group ( N = 13 ) continued this regimen for 6 more weeks , during which time the CWT group ( N = 12 ) performed 15 minutes of aerobic exercise followed by CWT ( two loops , eight upper body exercises ) . The only adverse response was in one CWT patient in whom restenosis developed . Peak heart rate during aerobic exercise and CWT was similar , but peak systolic blood pressure during aerobic exercise was significantly greater than during CWT . Peak rate pressure product during aerobic exercise and CWT was similar . Treadmill time increased significantly in both groups . Upper body strength ( cumulative pounds lifted ) increased significantly only in the CWT group . A coordinated program of CWT and aerobic exercise can be performed safely in stable cardiac patients during phase 2 cardiac rehabilitation , result ing in improved upper body strength and aerobic capacity PURPOSE We evaluated the value of resistance training on measures of physical performance in disabled older women with coronary heart disease ( CHD ) . METHODS The study intervention consisted of a 6-month program of resistance training in a r and omized controlled trial format . Training intensity was at 80 % of the single-repetition maximal lift . Control patients performed light yoga and breathing exercises . Study participants included 42 women with CHD , all > or= 65 yr of age and community dwelling . Subjects were screened by question naire to have low self-reported physical function . The primary study measurements related to the performance of 16 household activities of the Continuous Scale Physical Functional Performance test ( CSPFP ) . These ranged from dressing , to kitchen and cleaning activities , to carrying groceries and walking onto a bus with luggage , and a 6-min walk . Activities were measured in time to complete a task , weight carried during a task , or distance walked . Other measures included body composition , measures of aerobic fitness and strength , and question naire-based measures of physical function and depression score . RESULTS Study groups were similar at baseline by age , aerobic capacity , strength , body composition , and in performing the CSPFP . After conditioning , 13 of 16 measured activities were performed more rapidly , or with increased weight carried , compared with the control group ( all P < 0.05 ) . Maximal power for activities that involved weight-bearing over a distance , increased by 40 % ( P < 0.05 ) . CONCLUSIONS Disabled older women with CHD who participate in an intense resistance-training program improve physical capacity over a wide range of household physical activities . Benefits extend beyond strength-related activities , as endurance , balance , coordination , and flexibility all improved . Strength training should be considered an important component in the rehabilitation of older women with CHD In the context of sedentary middle-aged adults , the present study examined the relationships among domain-specific and global levels of self-esteem over the course of a 20-week exercise program . Additionally , the roles played by physical fitness , body composition , self-efficacy , and exercise participation as possible contributors to changes in physical self-worth were examined . Significant improvements in self-esteem at all levels were discovered with global esteem , physical self-worth , and perceptions of physical condition and attractive body increasing . Tests of the hierarchical structure of self-esteem showed greater improvements in physical condition and physical self-worth than global esteem and the relationships between global esteem and subdomain levels were shown to be mediated by physical self-worth . Hierarchical regression analyses showed changes in ratings of importance to have little impact on changes in physical self-worth . Both changes in efficacy and aerobic capacity were demonstrated to account for modest but significant variation in physical self-esteem . Results are discussed in terms of contemporary models of self-esteem , potential mediators of exercise effects on esteem , and the need to measure the constructs of interest appropriately BACKGROUND Many activities of daily living require significant amounts of muscular strength . Time lines for current strength training guidelines preclude many myocardial infa rct ion patients from receiving strength training as part of their cardiac rehabilitation program . This study was design ed to examine the effectiveness and safety of low-to-moderate level strength training in patients early after myocardial infa rct ion . METHODS Fifty-seven low-risk men ( < 61 years of age , 6 - 16 weeks post-infa rct ion ) were r and omly assigned to a control group or one of three treatment groups . All groups trained aerobically , three times per week for 12 weeks . The three treatment groups performed additional strength exercises on each training day of the last 10 weeks . These groups differed in their strength training stimulus with Group 20 performing 20 reps of 20 % of 1 repetition maximum ( 1 RM ) , Group 40 performing 10 repetitions of 40 % of 1 RM , and Group 60 performing 7 repetitions of 60 % of 1 RM . RESULTS Maximal strength remained unchanged in the control group ( + 0.5 % ) , but increased in Groups 20 , 40 , and 60 by + 10.5 % , + 11.9 % , and + 13.5 % , respectively . The increases in strength in the treatment groups were all significantly different ( P < .001 ) from the results of the control group , but were not significantly different from each other . For the three treatment groups , 30 of 42 subjects had one or more cardiovascular complication ( arrhythmias , angina , ischemia , hypertension , hypotension ) during the aerobic exercises as compared to only 1 subject with complications during the resistive exercises ( P < .01 ) . CONCLUSIONS In selected patients , low-to-moderate intensity strength training performed early after infa rct ion is effective and may have lower rates of cardiovascular problems than aerobic exercise BACKGROUND Muscle power ( force x velocity ) recedes at a faster rate than strength with age and may also be a stronger predictor of fall risk and functional decline . The optimal training paradigm for improving muscle power in older adults is not known , although some literature suggests high velocity , low load training is optimal in young adults . METHODS One hundred twelve healthy older adults ( 69 + /- 6 years ) were r and omly assigned to either explosive resistance training at 20 % ( G20 ) , 50 % ( G50 ) , or 80 % ( G80 ) one repetition maximum ( 1RM ) for 8 - 12 weeks or to a nontraining control group ( CON ) . Participants trained twice per week ( five exercises ; three sets of eight rapidly concentric and slow eccentric repetitions ) using pneumatic resistance machines . Repeated- measures analysis of variance and covariance ( ANOVA and ANCOVA ) were used to determine the effects of training . RESULTS Average peak power increased significantly and similarly in G80 ( 14 + /- 8 % ) , G50 ( 15 + /- 9 % ) , and G20 ( 14 + /- 6 % ) compared to CON ( 3 + /- 6 % ) ( p < .0001 ) . By contrast , a positive dose-response relationship with training intensity was observed for relative changes in average strength ( r = .40 , p = .0009 ) and endurance ( r = .43 , p = .0005 ) . Average strength increased in G80 ( 20 + /- 7 % ) , G50 ( 16 + /- 7 % ) , and G20 ( 13 + /- 7 % ) compared to CON ( 4 + /- 4 % ) ( p < .0001 ) . Average muscle endurance increased in G80 ( 185 + /- 126 % , p < .0001 ) , G50 ( 103 + /- 75 % , p = .0004 ) , and G20 ( 82 + /- 57 % , p = .0078 ) compared to CON ( 28 + /- 29 % ) . CONCLUSION Peak muscle power may be improved similarly using light , moderate , or heavy resistances , whereas there is a dose-response relationship between training intensity and muscle strength and endurance changes . Therefore , using heavy loads during explosive resistance training may be the most effective strategy to achieve simultaneous improvements in muscle strength , power , and endurance in older adults PURPOSE The purpose of this study was to examine the impact of moderate-intensity , progressive , upper-body resistance training ( RT ) on muscle strength and perceived performance of household physical activities ( HPA ) among women in cardiac rehabilitation . METHODS The 10-week , pretest-posttest , experiment r and omized women to either usual care ( UC ) aerobic exercise or RT . Muscle strength for 5 upper-body RT exercises ( chest press , shoulder press , biceps curl , lateral row , and triceps extension ) was measured using the 1-Repetition Maximum Assessment . The RT group progressively increased weight lifted using 40 % , 50 % , and 60 % of obtained 1-Repetition Maximum Assessment at 3-week intervals . Perceived performance of HPA was measured with the Kimble Household Activities Scale . RESULTS The RT group ( n = 16 , mean age 64 ± 11 ) significantly increased muscle strength in all 5 exercises in comparison with the UC group ( n = 14 , mean age 65 ± 10 ) ( chest press , 18 % vs 11 % ; shoulder press , 24 % vs 14 % ; biceps curl , 21 % vs 12 % ; lateral row , 32 % vs 9 % ; and triceps extension , 28 % vs 20 % , respectively ) . By study end , Household Activities Scale scores significantly increased ( F = 13.878 , P = .001 ) in the RT group ( 8.75 ± 3.19 vs 11.25 ± 2.14 ) , whereas scores in the UC group decreased ( 8.60 ± 3.11 vs 6.86 ± 4.13 ) . CONCLUSION Progressive upper-body RT in women shows promise as an effective tool to increase muscle strength and improve the ability to perform HPA after a cardiac event . Beginning RT early after a cardiac event in a monitored cardiac rehabilitation environment can maximize the strengthening benefit PURPOSE This study examined the effects of performing combined resistance and aerobic training , versus aerobic training alone , in patients with coronary artery disease . METHODS Thirty-six patients with coronary artery disease were r and omized to either an aerobic-only training group ( AE ) or a combined aerobic and resistance training group ( AE + R ) . Both groups performed 30 minutes of aerobic exercise 3 days/week for 6 months . In addition , AE + R group performed two sets of resistance exercise on seven different Nautilus machines after completion of aerobic training each day . Twenty patients ( AE : n = 10 ; AE + R : n = 10 ) completed the training protocol with > 70 % attendance . RESULTS Strength gains for AE + R group were greater than for AE group on six of seven resistance machines ( P < 0.05 ) . VO2peak increased after training for both AE and AE + R ( P < 0.01 ) with no difference in improvement between the groups . Resting and submaximal exercise heart rates and rate-pressure product were lower after training in the AE + R group ( P < 0.01 ) , but not in the AE group . AE + R increased lean mass in arm , trunk , and total body regions ( P < 0.01 ) , while AE increased lean mass in trunk region only ( P < 0.01 ) . Percent body fat was reduced for AE + R after training ( P < 0.05 ) with a between group trend toward reduced body fat ( P = 0.09 ) . Lean mass gain significantly correlated with strength increase in five of seven resistance exercises for AE + R. CONCLUSIONS Resistance training adds to the effects of aerobic training in cardiac rehabilitation patients by improving muscular strength , increasing lean body mass , and reducing body fat Background Resistance training ( RT ) is safe and practicable in low-risk population s with coronary artery disease . In patients with left ventricular ( LV ) dysfunction after Output:	There was no evidence of a difference in effect when comparing RT and AT . Shorter duration CT was superior to shorter duration AT for improving peak oxygen uptake and muscular strength ( low quality evidence ) while longer duration CT was only superior to longer duration AT in improving muscular strength ( moderate quality evidence ) . CT is more beneficial than AT alone for improving physical function . Shorter duration interventions that include resistance training might allow patients to return to their normal activities of daily living earlier
MS22337	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: BACKGROUND Information regarding the safety and efficacy of artemisinin combination treatments for malaria in pregnant women is limited , particularly among women who live in sub-Saharan Africa . METHODS We conducted a multicenter , r and omized , open-label trial of treatments for malaria in pregnant women in four African countries . A total of 3428 pregnant women in the second or third trimester who had falciparum malaria ( at any parasite density and regardless of symptoms ) were treated with artemether-lumefantrine , amodiaquine-artesunate , mefloquine-artesunate , or dihydroartemisinin-piperaquine . The primary end points were the polymerase-chain-reaction (PCR)-adjusted cure rates ( i.e. , cure of the original infection ; new infections during follow-up were not considered to be treatment failures ) at day 63 and safety outcomes . RESULTS The PCR-adjusted cure rates in the per- protocol analysis were 94.8 % in the artemether-lumefantrine group , 98.5 % in the amodiaquine-artesunate group , 99.2 % in the dihydroartemisinin-piperaquine group , and 96.8 % in the mefloquine-artesunate group ; the PCR-adjusted cure rates in the intention-to-treat analysis were 94.2 % , 96.9 % , 98.0 % , and 95.5 % , respectively . There was no significant difference among the amodiaquine-artesunate group , dihydroartemisinin-piperaquine group , and the mefloquine-artesunate group . The cure rate in the artemether-lumefantrine group was significantly lower than that in the other three groups , although the absolute difference was within the 5-percentage-point margin for equivalence . The unadjusted cure rates , used as a measure of the post-treatment prophylactic effect , were significantly lower in the artemether-lumefantrine group ( 52.5 % ) than in groups that received amodiaquine-artesunate ( 82.3 % ) , dihydroartemisinin-piperaquine ( 86.9 % ) , or mefloquine-artesunate ( 73.8 % ) . No significant difference in the rate of serious adverse events and in birth outcomes was found among the treatment groups . Drug-related adverse events such as asthenia , poor appetite , dizziness , nausea , and vomiting occurred significantly more frequently in the mefloquine-artesunate group ( 50.6 % ) and the amodiaquine-artesunate group ( 48.5 % ) than in the dihydroartemisinin-piperaquine group ( 20.6 % ) and the artemether-lumefantrine group ( 11.5 % ) ( P<0.001 for comparison among the four groups ) . CONCLUSIONS Artemether-lumefantrine was associated with the fewest adverse effects and with acceptable cure rates but provided the shortest posttreatment prophylaxis , whereas dihydroartemisinin-piperaquine had the best efficacy and an acceptable safety profile . ( Funded by the European and Developing Countries Clinical Trials Partnership and others ; Clinical Trials.gov number , NCT00852423 . ) BACKGROUND Intermittent treatment with sulfadoxine-pyrimethamine is widely recommended for the prevention of malaria in pregnant women in Africa . However , with the spread of resistance to sulfadoxine-pyrimethamine , new interventions are needed . METHODS We conducted a double-blind , r and omized , controlled trial involving 300 human immunodeficiency virus (HIV)-uninfected pregnant adolescents or women in Ug and a , where sulfadoxine-pyrimethamine resistance is widespread . We r and omly assigned participants to a sulfadoxine-pyrimethamine regimen ( 106 participants ) , a three-dose dihydroartemisinin-piperaquine regimen ( 94 participants ) , or a monthly dihydroartemisinin-piperaquine regimen ( 100 participants ) . The primary outcome was the prevalence of histopathologically confirmed placental malaria . RESULTS The prevalence of histopathologically confirmed placental malaria was significantly higher in the sulfadoxine-pyrimethamine group ( 50.0 % ) than in the three-dose dihydroartemisinin-piperaquine group ( 34.1 % , P=0.03 ) or the monthly dihydroartemisinin-piperaquine group ( 27.1 % , P=0.001 ) . The prevalence of a composite adverse birth outcome was lower in the monthly dihydroartemisinin-piperaquine group ( 9.2 % ) than in the sulfadoxine-pyrimethamine group ( 18.6 % , P=0.05 ) or the three-dose dihydroartemisinin-piperaquine group ( 21.3 % , P=0.02 ) . During pregnancy , the incidence of symptomatic malaria was significantly higher in the sulfadoxine-pyrimethamine group ( 41 episodes over 43.0 person-years at risk ) than in the three-dose dihydroartemisinin-piperaquine group ( 12 episodes over 38.2 person-years at risk , P=0.001 ) or the monthly dihydroartemisinin-piperaquine group ( 0 episodes over 42.3 person-years at risk , P<0.001 ) , as was the prevalence of parasitemia ( 40.5 % in the sulfadoxine-pyrimethamine group vs. 16.6 % in the three-dose dihydroartemisinin-piperaquine group [ P<0.001 ] and 5.2 % in the monthly dihydroartemisinin-piperaquine group [ P<0.001 ] ) . In each treatment group , the risk of vomiting after administration of any dose of the study agents was less than 0.4 % , and there were no significant differences among the groups in the risk of adverse events . CONCLUSIONS The burden of malaria in pregnancy was significantly lower among adolescent girls or women who received intermittent preventive treatment with dihydroartemisinin-piperaquine than among those who received sulfadoxine-pyrimethamine , and monthly treatment with dihydroartemisinin-piperaquine was superior to three-dose dihydroartemisinin-piperaquine with regard to several outcomes . ( Funded by the Eunice Kennedy Shriver National Institute of Child Health and Human Development ; Clinical Trials.gov number , NCT02163447 . ) Background Artemisinin combination therapies ( ACTs ) are currently the preferred option for treating uncomplicated malaria . Dihydroartemisinin-piperaquine ( DHA-PQP ) is a promising fixed-dose ACT with limited information on its safety and efficacy in African children . Methodology /Principal Findings The non-inferiority of DHA-PQP versus artemether-lumefantrine ( AL ) in children 6–59 months old with uncomplicated P. falciparum malaria was tested in five African countries ( Burkina Faso , Kenya , Mozambique , Ug and a and Zambia ) . Patients were r and omised ( 2∶1 ) to receive either DHA-PQP or AL . Non-inferiority was assessed using a margin of −5 % for the lower limit of the one-sided 97.5 % confidence interval on the treatment difference ( DHA-PQP vs. AL ) of the day 28 polymerase chain reaction ( PCR ) corrected cure rate . Efficacy analysis was performed in several population s , and two of them are presented here : intention-to-treat ( ITT ) and enlarged per- protocol ( ePP ) . 1553 children were r and omised , 1039 receiving DHA-PQP and 514 AL . The PCR-corrected day 28 cure rate was 90.4 % ( ITT ) and 94.7 % ( ePP ) in the DHA-PQP group , and 90.0 % ( ITT ) and 95.3 % ( ePP ) in the AL group . The lower limits of the one-sided 97.5 % CI of the difference between the two treatments were −2.80 % and −2.96 % , in the ITT and ePP population s , respectively . In the ITT population , the Kaplan-Meier estimate of the proportion of new infections up to Day 42 was 13.55 % ( 95 % CI : 11.35%–15.76 % ) for DHA-PQP vs 24.00 % ( 95 % CI : 20.11%–27.88 % ) for AL ( p<0.0001 ) . Conclusions / Significance DHA-PQP is as efficacious as AL in treating uncomplicated malaria in African children from different endemicity setting s , and shows a comparable safety profile . The occurrence of new infections within the 42-day follow up was significantly lower in the DHA-PQP group , indicating a longer post-treatment prophylactic effect . Trial Registration Controlled-trials.com IS RCT BACKGROUND Artemisinin-based combinations are judged the best treatments for multidrug-resistant Plasmodium falciparum malaria . Artesunate-mefloquine is widely recommended in southeast Asia , but its high cost and tolerability profile remain obstacles to widespread deployment . To assess whether dihydroartemisinin-piperaquine is a suitable alternative to artesunate-mefloquine , we compared the safety , tolerability , efficacy , and effectiveness of the two regimens for the treatment of uncomplicated falciparum in western Myanmar ( Burma ) . METHODS We did an open r and omised comparison of 3-day regimens of artesunate-mefloquine ( 12/25 mg/kg ) versus dihydroartemisinin-piperaquine ( 6.3/50 mg/kg ) for the treatment of children aged 1 year or older and in adults with uncomplicated falciparum malaria in Rakhine State , western Myanmar . Within each group , patients were r and omly assigned supervised or non-supervised treatment . The primary endpoint was the PCR-confirmed parasitological failure rate by day 42 . Failure rates at day 42 were estimated by Kaplan-Meier survival analysis . This study is registered as an International St and ard R and omised Controlled Trial , number IS RCT N27914471 . FINDINGS Of 652 patients enrolled , 327 were assigned dihydroartemisinin-piperaquine ( 156 supervised and 171 not supervised ) , and 325 artesunate-mefloquine ( 162 and 163 , respectively ) . 16 patients were lost to follow-up , and one patient died 22 days after receiving dihydroartemisinin-piperaquine . Recrudescent parasitaemias were confirmed in only two patients ; the day 42 failure rate was 0.6 % ( 95 % CI 0.2 - 2.5 ) for dihydroartemisinin-piperaquine and 0 ( 0 - 1.2 ) for artesunate-mefloquine . Whole-blood piperaquine concentrations at day 7 were similar for patients with observed and non-observed dihydroartemisinin-piperaquine treatment . Gametocytaemia developed more frequently in patients who had received dihydroartemisinin-piperaquine than in those on artesunate-mefloquine : day 7 , 18 ( 10 % ) of 188 versus five ( 2 % ) of 218 ; relative risk 4.2 ( 1.6 - 11.0 ) p=0.011 . INTERPRETATION Dihydroartemisinin-piperaquine is a highly efficacious and inexpensive treatment of multidrug-resistant falciparum malaria and is well tolerated by all age groups . The effectiveness of the unsupervised treatment , as in the usual context of use , equalled its supervised efficacy , indicating good adherence without supervision . Dihydroartemisinin-piperaquine is a good alternative to artesunate-mefloquine Background In Africa , most plasmodium infections during pregnancy remain asymptomatic , yet are associated with maternal anemia and low birthweight . WHO recommends intermittent preventive therapy in pregnancy with sulfadoxine-pyrimethamine ( IPTp-SP ) . However , sulfadoxine-pyrimethamine ( SP ) efficacy is threatened by high-level parasite resistance . We conducted a trial to evaluate the efficacy and safety of scheduled intermittent screening with malaria rapid diagnostic tests ( RDTs ) and treatment of RDT-positive women with dihydroartemisinin-piperaquine ( DP ) as an alternative strategy to IPTp-SP . Methods and Findings This was an open-label , two-arm individually r and omized superiority trial among HIV-seronegative women at three sites in Malawi with high SP resistance . The intervention consisted of three or four scheduled visits in the second and third trimester , 4 to 6 wk apart . Women in the IPTp-SP arm received SP at each visit . Women in the intermittent Output:	Compared with IPT-SP , moderate certainty evidence indicated that women who received IPT-DP had significantly lower risks of clinical malaria during pregnancy . High certainty evidence showed intermittent screening and treatment with DP did not reduce placental malaria or maternal parasitemia at delivery . Effect of DP on low birth weight and adverse birth outcomes was minimal . Moderate certainty evidence suggests that IPT-DP may reduce maternal and placental malaria compared with IPT-SP , and monthly DP is more effective than SP in reducing placental malaria .
MS22338	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: OBJECTIVE Antipsychotics , such as aripiprazole and risperidone , are often used to treat individuals with schizophrenia . The efficacy as well as safety of aripiprazole in Western population s has been described . The objective of this study is to investigate the efficacy , safety , and tolerability of aripiprazole and risperidone in Chinese Han schizophrenia subjects in mainl and China . METHOD The 6-week , double-blind , r and omized , parallel study was conducted in 5 medical centers in mainl and China from November 2007 to March 2011 . A total of 279 subjects with a primary DSM-IV diagnosis of schizophrenia were r and omly assigned ( with a r and omization ratio of 1:1 ) to aripiprazole ( n=139 ) or risperidone ( n=140 ) . Efficacy measurements included the Positive and Negative Syndrome Scale ( PANSS ) total , positive , negative and general psychopathology subscale scores , and Clinical Global Impressions-Severity of Illness ( CGI-S ) , and Improvement scale scores . Extrapyramidal symptoms ( EPS ) , weight gain , serum prolactin level , QTc interval , and self-reported adverse events were also assessed as measures of safety and tolerability . RESULTS Both the aripiprazole and risperidone groups showed statistically significant improvement of PANSS total , positive , negative , general psychopathology subscale scores , and CGI-S scores from baseline to the endpoint ( all p<0.01 ) . Significant improvement was noted in the first week for both treatment groups . There were no significant differences in efficacy measurements between the two treatment groups . Mean change of PANSS total scores from baseline to the endpoint was -26.8±18.1 for aripiprazole and -30.0±17.7 for risperidone , ( p=0.1475 ) . The responder rate was 71 % ( n=99 ) and 76 % ( n=107 ) for aripiprazole and risperidone , respectively , ( p=0.323 ) . The incidences of EPS were similar in the aripiprazole ( 25 % , n=35 ) and risperidone groups ( 24 % , n=34 ) , respectively ( p=0.757 ) . No clinical ly meaningful effects on QTc interval , QRS duration , or PR interval were observed in either treatment groups . However , the incidence of clinical ly significant weight gain ( p=0.0118 ) and hyperprolactinemia ( p<0.001 ) in the aripiprazole group was significantly lower than in the risperidone group . CONCLUSION The study demonstrated that aripiprazole , as well as risperidone , had rapid and persistent efficacy for psychotic symptoms from the first week of therapy . There may be poor efficacy for aripiprazole compared with risperidone for overall improvement , but there were no significant differences in this study . Aripiprazole showed good tolerability with less weight gain and hyperprolactinemia compared with risperidone . The overall efficacy and safety of aripiprazole in Chinese Han schizophrenia subjects were similar to that reported in Western population OBJECTIVE The objective of this multicenter , international study was to evaluate safety and tolerability of paliperidone extended-release ( ER ) tablets in elderly ( age > or = 65 years ) patients with schizophrenia . The authors conducted a 6-week , double-blind , r and omized , placebo-controlled , optional 24-week open-label extension study . Interventions consisted of flexible , once-daily doses of paliperidone ER ( 3 - 12 mg/day ; 6-mg starting dose , adjusted in 3-mg dose increments ) or placebo ( 2:1 ) during double-blind treatment and paliperidone ER only during open-label treatment . Measurements included adverse events , laboratory tests , physical examinations , 12-lead electrocardiograms , movement disorder rating scales , Positive and Negative Syndrome Scale , and Clinical Global Impression scale . The study was not powered to show statistical differences . RESULTS Patients ( N = 114 ) were predominantly female ( 73 % ) ; mean age was 70 years ( double-blind phase ) . Concomitant disease presence was consistent with that of an older population . During the double-blind phase , discontinuation rates result ing from adverse events were similar between groups ( paliperidone ER : 7 % , placebo : 8 % ) as were incidences of treatment-emergent adverse events ( paliperidone ER : 67 % , placebo : 71 % ) . Serious adverse events occurred in 3 % of the paliperidone ER- and 8 % of the placebo-treated patients . Elevated prolactin levels occurred in approximately one half of patients . No prolactin- or glucose treatment-related adverse events or noteworthy mean changes in body weight ( 0 kg [ st and ard deviation : 2.1 ] and 0 kg [ st and ard deviation : 2.3 ] for paliperidone ER and placebo , respectively ) were observed . Safety and tolerability results in the extension were consistent with the shorter-term results . Efficacy measures did not show consistent statistical improvement between treatment groups . CONCLUSION Paliperidone ER ( 3 - 12 mg/day ) treatment over a 30-week period was generally well-tolerated and may improve symptom severity in elderly patients with schizophrenia OBJECTIVE To evaluate aripiprazole once-monthly ( AOM ) , a long-acting injectable suspension of aripiprazole , as acute treatment in patients with schizophrenia ( DSM-IV-TR ) . METHOD Adults experiencing an acute psychotic episode were r and omized to 12 weeks of double-blind treatment with AOM 400 mg or placebo ( October 2012-August 2013 ) . The primary efficacy outcome was change from baseline to endpoint ( week 10 ) in Positive and Negative Syndrome Scale ( PANSS ) total score . The key secondary efficacy outcome was change from baseline in Clinical Global Impressions-Severity of Illness scale ( CGI-S ) score . Secondary efficacy outcomes included change from baseline in PANSS positive and negative subscale and Personal and Social Performance Scale ( PSP ) scores . The study took place from October 2012 through August 2013 . RESULTS Patients ( N = 340 ; 79 % male , 66 % black ) were r and omized to AOM ( n = 168 ) or placebo ( n = 172 ) . Least squares ( LS ) mean change from baseline to endpoint ( week 10 ) favored AOM versus placebo in PANSS total ( treatment difference , -15.1 [ 95 % CI , -19.4 to -10.8 ] ; P < .0001 ) and CGI-S ( treatment difference , -0.8 [ 95 % CI , -1.1 to -0.6 ] ; P < .0001 ) scores , as it did at all other timepoints through 12 weeks ( all P ≤ .0005 ) . LS mean change from baseline in PANSS positive and negative subscale and PSP scores favored AOM versus placebo ( P < .0001 ) . Common ( > 10 % ) treatment-emergent adverse events ( AOM vs. placebo ) were increased weight ( 16.8 % vs 7.0 % ) , headache ( 14.4 % vs. 16.3 % ) , and akathisia ( 11.4 % vs 3.5 % ) . CONCLUSIONS Symptoms and functioning improved with AOM 400 mg versus placebo in patients with acute schizophrenia , with acceptable safety and tolerability . These data suggest that AOM 400 mg is a viable treatment option for patients experiencing an acute schizophrenia episode . TRIAL REGISTRATION Clinical Trials.gov identifier : NCT01663532 OBJECTIVE The efficacy , safety , and tolerability of brexpiprazole and placebo were compared in adults with acute schizophrenia . METHOD This was a multicenter , r and omized , double-blind , placebo-controlled study . Patients with schizophrenia experiencing an acute exacerbation were r and omly assigned to daily brexpiprazole at a dosage of 0.25 , 2 , or 4 mg or placebo ( 1:2:2:2 ) for 6 weeks . Outcomes included change from baseline to week 6 in Positive and Negative Syndrome Scale ( PANSS ) total score ( primary endpoint measure ) , Clinical Global Impressions Scale ( CGI ) severity score ( key secondary endpoint measure ) , and other efficacy and tolerability measures . RESULTS The baseline overall mean PANSS total score was 95.2 , and the CGI severity score was 4.9 . Study completion rates were 62.2 % , 68.1 % , and 67.2 % for patients in the 0.25- , 2- , and 4-mg brexpiprazole groups , respectively , versus 59.2 % in the placebo group . At week 6 , compared with placebo , brexpiprazole dosages of 2 and 4 mg produced statistically significantly greater reductions in PANSS total score ( treatment differences : -8.72 and -7.64 , respectively ) and CGI severity score ( treatment differences : -0.33 and -0.38 ) . The most common treatment-emergent adverse event for brexpiprazole was akathisia ( 2 mg : 4.4 % ; 4 mg : 7.2 % ; placebo : 2.2 % ) . Weight gain with brexpiprazole was moderate ( 1.45 and 1.28 kg for 2 and 4 mg , respectively , versus 0.42 kg for placebo at week 6 ) . There were no clinical ly or statistically significant changes from baseline in lipid and glucose levels and extrapyramidal symptom ratings . CONCLUSIONS Brexpiprazole at dosages of 2 and 4 mg/day demonstrated statistically significant efficacy compared with placebo and good tolerability for patients with an acute schizophrenia exacerbation Objective : The objective of this study was to evaluate the short-term efficacy and safety of the atypical antipsychotic agent lurasidone in the treatment of schizophrenia . Methods : In this phase II , r and omized , double-blind , placebo-controlled study , hospitalized adult patients diagnosed with schizophrenia and experiencing an acute exacerbation of psychotic symptoms were r and omly assigned to 6 weeks of fixed-dose lurasidone 20 mg/day ( n = 71 ) , lurasidone 40 mg/day ( n = 67 ) , lurasidone 80 mg/day ( n = 71 ) , haloperidol 10 mg/day ( n = 72 , included to test for assay sensitivity ) , or placebo ( n = 72 ) . Efficacy was assessed using the brief psychiatric rating scale , positive and negative syndrome scale , and clinical global impression-severity . Safety assessment s included incidence of adverse events and clinical laboratory measures . Results : Numerical improvement was observed from baseline to week 6 ( last observation carried forward ) on all efficacy measures in all treatment groups ; however , no statistically significant differences were noted between any lurasidone group and placebo , or between haloperidol and placebo . The most common adverse events in lurasidone-treated patients , with an incidence of at least 10 % ( dose groups combined ) and greater than placebo , were sedation ( 15.3 % ) , dyspepsia ( 13.4 % ) , nausea ( 13.4 % ) , akathisia ( 12.4 % ) , and vomiting ( 10.5 % ) ; for haloperidol , the most common adverse events ( incidence ⩾ 10 % and greater than placebo ) were extrapyramidal disorder ( 20.8 % ) , sedation ( 19.4 % ) , akathisia ( 19.4 % ) , dystonia ( 15.3 % ) , insomnia ( 13.9 % ) , and somnolence ( 12.5 % ) . Lurasidone was associated with minimal changes in weight , metabolic parameters , and prolactin levels . Conclusions : None of the lurasidone groups separated from placebo in this clinical study of patients with acute schizophrenia . In addition , haloperidol , which was included for assay sensitivity , did not separate from placebo , result ing in a failed study . Possible reasons for the lack of assay sensitivity in this study include the use of multiple active treatment arms and the relatively large placebo response . Consistent with other studies , lurasidone was generally safe and well tolerated , with minimal effects on weight or metabolic parameters Paliperidone palmitate is a long-acting injectable antipsychotic agent . This 13-week , multicenter , r and omized ( 1 : 1 : 1 : 1 ) , double-blind , parallel-group study evaluated the efficacy , safety , and tolerability of fixed 25 , 50 , and 100 milligram equivalent ( mg equiv . ) doses of paliperidone palmitate vs placebo administered as gluteal injections on days 1 and 8 , then every 4 weeks ( days 36 and 64 ) in 518 adult patients with schizophrenia . The intent-to-treat analysis set ( N=514 ) was 67 % men and 67 % White , with a mean age of 41 years . All paliperidone palmitate dose groups showed significant improvement vs placebo in the Positive and Negative Syndrome Sc Output:	Interpretation Marked differences exist between antipsychotics in terms of metabolic side-effects , with olanzapine and clozapine exhibiting the worst profiles and aripiprazole , brexpiprazole , cariprazine , lurasidone , and ziprasidone the most benign profiles . Increased baseline weight , male sex , and non-white ethnicity are predictors of susceptibility to antipsychotic-induced metabolic change , and improvements in psychopathology are associated with metabolic disturbance .
MS22339	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: CONTEXT Medical errors are associated with feelings of distress in physicians , but little is known about the magnitude and direction of these associations . OBJECTIVE To assess the frequency of self-perceived medical errors among resident physicians and to determine the association of self-perceived medical errors with resident quality of life , burnout , depression , and empathy using vali date d metrics . DESIGN , SETTING , AND PARTICIPANTS Prospect i ve longitudinal cohort study of categorical and preliminary internal medicine residents at Mayo Clinic Rochester . Data were provided by 184 ( 84 % ) of 219 eligible residents . Participants began training in the 2003 - 2004 , 2004 - 2005 , and 2005 - 2006 academic years and completed surveys quarterly through May 2006 . Surveys included self- assessment of medical errors and linear analog scale assessment of quality of life every 3 months , and the Maslach Burnout Inventory ( depersonalization , emotional exhaustion , and personal accomplishment ) , Interpersonal Reactivity Index , and a vali date d depression screening tool every 6 months . MAIN OUTCOME MEASURES Frequency of self-perceived medical errors was recorded . Associations of an error with quality of life , burnout , empathy , and symptoms of depression were determined using generalized estimating equations for repeated measures . RESULTS Thirty-four percent of participants reported making at least 1 major medical error during the study period . Making a medical error in the previous 3 months was reported by a mean of 14.7 % of participants at each quarter . Self-perceived medical errors were associated with a subsequent decrease in quality of life ( P = .02 ) and worsened measures in all domains of burnout ( P = .002 for each ) . Self-perceived errors were associated with an odds ratio of screening positive for depression at the subsequent time point of 3.29 ( 95 % confidence interval , 1.90 - 5.64 ) . In addition , increased burnout in all domains and reduced empathy were associated with increased odds of self-perceived error in the following 3 months ( P=.001 , P<.001 , and P=.02 for depersonalization , emotional exhaustion , and lower personal accomplishment , respectively ; P=.02 and P=.01 for emotive and cognitive empathy , respectively ) . CONCLUSIONS Self-perceived medical errors are common among internal medicine residents and are associated with substantial subsequent personal distress . Personal distress and decreased empathy are also associated with increased odds of future self-perceived errors , suggesting that perceived errors and distress may be related in a reciprocal cycle 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 CONTEXT It has been reported that medical students become more cynical as they progress through medical school . This can lead to a decline in empathy . Empirical research to address this issue is scarce because the definition of empathy lacks clarity , and a tool to measure empathy specifically in medical students and doctors has been unavailable . OBJECTIVE To examine changes in empathy among medical students as they progress through medical school . MATERIAL S AND SUBJECTS A newly developed scale ( Jefferson Scale of Physician Empathy [ JSPE ] , with 20 Likert-type items ) was administered to 125 medical students at the beginning ( pretest ) and end ( post-test ) of Year 3 of medical school . This scale was specifically developed for measuring empathy in patient care situations and has acceptable psychometric properties . METHODS In this prospect i ve longitudinal study , the changes in pretest/post-test empathy scores were examined by using t-test for repeated measure design ; the effect size estimates were also calculated . RESULTS Statistically significant declines were observed in 5 items ( P < 0.01 ) and the total sores of the JSPE ( P < 0.05 ) between the 2 test administrations . CONCLUSIONS Although the decline in empathy was not clinical ly important for all of the statistically significant findings , the downward trend suggests that empathy could be amenable to change during medical school . Further research is needed to identify factors that contribute to changes in empathy and to examine whether targeted educational programmes can help to retain , reinforce and cultivate empathy among medical students for improving clinical outcomes BACKGROUND Empathy is critical to the development of professionalism in medical students , and the humanities-particularly literature -have been touted as an effective tool for increasing student empathy . This quantitative/qualitative study was undertaken to assess whether reading and discussing poetry and prose related to patients and doctors could significantly increase medical student empathy and appreciation of the relevance of the humanities for their own professional development . METHOD In 2000 - 2001 , first year students ( n=22 ) volunteered for an eight-session literature and medicine elective and were r and omly assigned to either immediate participation in the class or a wait-list group , who participated in the same class 6 months later . Complete pre- and post-intervention data for 16 students from both groups were obtained for two quantitative measures of empathy and an attitudes-toward-the-humanities scale . Students also participated in a qualitative group interview pre- and post-intervention . RESULTS Empathy and attitudes toward the humanities improved significantly ( p<0.01 ) after participation in the class when both groups of students were combined . The scaled treatment effect size was in the moderate range ( > or = 0.60 st and ard deviation units ) for both measures that had statistically significant pre-to-post changes . Furthermore , student underst and ing of the patient 's perspective became more detailed and complex after the intervention . Students were also more likely post-intervention to note ways reading literature could help them cope with training-related stress . CONCLUSION A brief literature -based course can contribute to greater student empathy and appreciation for the value of humanities in medical education BACKGROUND Doctors ' communication with patients is commonly hampered by lack of training in this core skill . This study aim ed to assess the efficacy of an intensive 3-day training course on communication skills in a r and omised controlled trial with a two-by-two factorial design and several outcomes . METHODS 160 oncologists from 34 UK cancer centres were r and omly allocated to four groups : written feedback followed by course ; course alone ; written feedback alone ; and control . At each of two assessment periods , consultations with six to ten consecutive , consenting patients per doctor were videotaped . 2407 patients participated . Outcome measures included objective and subjective ratings made by research ers , doctors , and patients . The primary outcomes were objective improvements after the intervention in key communication skills . Course content included structured feedback , videotape review of consultations , role-play with simulated patients , interactive group demonstrations , and discussion led by a trained facilitator . FINDINGS In Poisson regression analysis of counts of communication behaviours , course attendance significantly improved key outcomes . The estimated effect sizes corresponded to higher rates of use of focused questions ( difference between course attenders [ n=80 ] and non-attenders [ n=80 ] 34 % , p=0.003 ) , focused and open questions ( 27 % , p=0.005 ) , expressions of empathy ( 69 % , p=0.003 ) , and appropriate responses to patients ' cues ( 38 % , p=0.026 ) , and a 24 % lower rate of use of leading questions ( p=0.11 ) . There was little evidence for the effectiveness of written feedback . INTERPRETATION The communication problems of senior doctors working in cancer medicine are not resolved by time and clinical experience . This trial shows that training courses significantly improve key communication skills . More re sources should be allocated to address doctors ' training needs in this vital area Medical education faces increasing criticism because of the perception that it is difficult to produce physicians who are both technically competent and compassionate . One approach to addressing this problem is to train physicians to address the emotional concerns that patients experience as a result of their medical problems . Results of the authors ' r and omized , controlled experiment in training medical students to respond to patients ' emotional concerns provide evidence of the efficacy and feasibility of such training . Only students who received small-group instruction in addition to large-group lectures exhibited statistically significant ( p less than .001 ) improvement in their ability to respond to the emotional concerns of patients in hypothetical cases . The students who received only the lectures exhibited significant improvement ( p less than .001 ) in their preference for responses that addressed patients ' emotional concerns but not in their responses to written , hypothetical patient cases . Even though these students ' preferences for responses to emotional concerns on the average did increase significantly , the preferences were significantly ( p less than .001 ) less favorable than the preferences of the students who received small-group instruction . The small group instruction consisted of both interviews with elderly nursing home residents , who served as simulated patients , and structured practice and review sessions Summary Practitioner empathy and patient enablement at a " contact " consultation were retrospectively associated with changes in main complaint and well-being , in a cross-sectional study of out- patients attending the Glasgow Homoeopathic Hospital . Patient expectation , relational continuity , and duration of attendance at the hospital were also correlated with perceived change in health outcome in univariate analysis . However , multi-regression analysis suggested three major independent variables associated with health outcome – empathy , enablement , and duration of attendance . Health outcomes were then measured in the same cohort 12 months after " contact " consultation . Both univariate and multivariate analysis indicated that the only significant predictive factor in health change over the 12-month period was patient enablement score at contact consultation . This study demonstrates the importance of prospect i ve studies in assessing potentially causal relationships between consultation quality and health outcomes and suggests a key role for patient enablement . ZusammenfassungIn einer Querschnittsstudie wurden ärztliche Empathie und Patienten-"Enablement " bei ambulanter Erstkonsultation am Glasgow Homeopathic Hospital retrospektiv auf ihre Auswirkung auf Hauptbeschwerden und Wohlbefinden untersucht . Die Erwartung der Patienten , Kontinuität der Betreuung und Dauer der Betreuung wurden ebenso mit Änderungen i m Befinden korreliert . In der Multiregressionsanalyse sind 3 wesentliche unabhängige Faktoren mit dem Outcome assoziiert – Empathie , Enablement und Betreuungsdauer . Outcome -Parameter wurden anschließend in der gleichen Kohorte 12 Monate nach Erstkonsultation untersucht . Sowohl in der univariaten als auch der multivariaten Analyse war der einzige Faktor mit signifikanter Auswirkung auf das Outcome nach 12 Monaten der Patienten-"Enablement"-Score bei Erstkonsultation . Die Studie zeigt die Wichtigkeit prospektiver Untersuchungen , um kausale Zusammenhänge zwischen der Qualität einer Konsultation und dem Outcome zu erfassen , und legt eine Schlüsselrolle für den Faktor Patienten-"Enablement " nahe OBJECTIVE To relate prospect ively initial consultation characteristics-length , empathy , and patient enablement- with perceived health changes in patients going to the Glasgow Homoeopathic Hospital ( GHH ) . METHODS Consecutive out patients completed the Consultation and Relational Empathy ( CARE ) measure and the Patient Enablement Instrument ( PEI ) immediately after their first consultations , again at 3 months , and the PEI also at 12 months . The Short Form-12 was completed immediately before and the Measure Yourself Medical Outcome ( MYMOP ) Profile during the first consultation , and both were repeated at 3 and 12 months . Perceived changes in main complaint and well-being were assessed using the Glasgow Homoeopathic Outcome Scale ( GHHOS ) . RESULTS Empathy score at first consultation was highly predictive of ongoing empathy score at 3 months ( Spearman 's rho , 0.572 , p < 0.0001 ) . Empathy scores at first consultation also correlated significantly with enablement score at first consultation ( rho , 0.325 , p < 0.0001 ) and overall enablement at 12 months ( rho , 0.281 ; p < 0.05 ) . Controlling for the number of subsequent consultations , initial empathy scores were also predictive of change in main complaint , and general well-being , at 3 months ( rho , 0.225 , 0.213 respectively ; p < 0.05 ) . Enablement score at first consultation also predicted overall enablement at 3 months ( rho , 0.255 ; p < 0.05 ) and 12 months ( rho , 0.282 ; p < 0.05 ) . Initial enablement predicted GHOSS well-being score at 3 months after controlling for number of consultations ( rho , 0.279 ; p < 0.05 ) . Both empathy and enablement at 3 months predicted overall enablement at 12 months ( rho , 0.327 ; p < 0.01 and rho , 0.577 ; p < 0.0001 , respectively ) . Empathy at 3 months was not significantly related to GHHOS scores at 12 months , whereas enablement scores at 3 months were highly predictive of both GHHOS main complaint and well-being scores at 12 months ( rho , 0.459 and 0.50 Output:	Conclusion A number of empathy measures available have been psychometrically assessed for research use among medical students and practising medical doctors . No empathy measures were found with sufficient evidence of predictive validity for use as selection measures for medical school .
MS22340	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: W.H.O. and U.S. Dept . of Health and Human Services advocate a fat-modified , fruits and vegetable-enriched diet in conjunction with mode-rate physical activity for fitness and health . The Diet and Moderate Exercise Trial ( DAMET ) is a r and omized and controlled study and has provided scientific proof , possibly for the first time , to the above hypothesis ( based on epidemiologic studies , short clinical trials and experimental studies ) that the new approach can cause modulation of risk factors of coronary heart disease ( CHD ) as well as improve fitness . In the DAMET , 231 group A and 232 group B patients with risk factors of CHD were administered a prudent diet for 4 weeks , group A patients in addition were also given at least 400 g/day of fruits and vegetables that are rich in dietary fibre and antioxidants such as vitamins A , C , E , carotene and copper , selenium and magnesium . Fruits and vegetables were administered in a foods-to-eat approach by asking the patients to eat these foods before meals when they were hungry to allow better nutrient adequacy . After 4 weeks , group A patients also did moderate exercise such as brisk walking and spot running compared to no such advice to group B for another 20 weeks . After a follow-up period of 24 weeks , adding exercise to diet was associated with a significant decrease in blood total cholesterol ( 8.9 % ) and LDL-cholesterol ( 6.7 % ) and triglycerides ( 11.9 % ) and a marked increase in HDL-cholesterol ( 16.5 % ) . Mean blood pressures , fasting blood glucose , body weight , body mass index , waist-to-hip ratio and subcutaneous fat also showed a significant decrease in group A , leading to a significant decrease in 12-year CHD risk . A long-term follow-up may be necessary to demonstrate the role of this new approach in decreasing cardiovascular morbidity and mortality AIMS Western Europeans have low blood levels of selenium ( BSe ) , an antioxidant trace element . In a Flemish population , we investigated the cross-sectional and longitudinal association of blood pressure ( BP ) with BSe . METHODS AND RESULTS We r and omly recruited 710 subjects ( mean age 48.8 years ; 51.8 % women ) . We measured BP and BSe and kept participants in follow-up for BP . At baseline , systolic/diastolic BP averaged ( SD ) 130/77 ( 17.3/9.2 ) mmHg . BSe was 97.0 ( 19.0 ) microg/L. Of 385 participants with normal baseline BP ( < 130 and < 85 mmHg ) , over 5.2 years ( range 3.4 - 8.4 years ) , 139 developed high-normal BP ( 130 - 139/85 - 90 mmHg ) or hypertension ( > or=140/90 mmHg ) . In multivariate-adjusted cross-sectional analyses of men , a 20 microg/L ( approximately 1 SD ) higher BSe was associated with lower BP with effect sizes of 2.2 mmHg systolic ( 95 % CI -0.57 to -5.05 ; P = 0.009 ) and 1.5 mmHg diastolic ( 95 % CI -0.56 to -2.44 ; P = 0.017 ) . In prospect i ve analyses of men , a 20 microg/L higher baseline BSe was associated with a 37 % ( 95 % CI -52 to -17 ; P = 0.001 ) lower risk of developing high-normal BP or hypertension . None of these associations was significant in women . CONCLUSION Deficiency of selenium might be an underestimated risk factor for the development of high BP in European men Background Antioxidant supplementations have the potential to alleviate the atherosclerotic damage caused by excessive production of reactive oxygen species ( ROS ) . The present study evaluated the effects of prolonged antioxidant treatment on arterial elasticity , inflammatory and metabolic measures in patients with multiple cardiovascular risk factors . Methods Study participants were r and omly assigned to two groups . Group 1 received oral supplementation with 2 capsules per day of Mid Life Guard , SupHerb , Israel . In each capsule vitamin C ( 500 mg ) vitamin E ( 200 iu ) , co-enzyme Q10 ( 60 mg ) and selenium ( 100 mcg ) , Group 2 received matching placebo(SupHerb ) for 6 months . Patients were evaluated for lipid profile , HbA1C , insulin , C-peptide , hs-CRP , endothelin , aldosterone , plasma renin activity and Homeostasis model assessment -insulin resistance ( HOMA-IR ) . Arterial elasticity was evaluated using pulse wave contour analysis ( HDI CR 2000 , Eagan , Minnesota ) . Results Antioxidant-treated patients exhibited significant increases in large arterial elasticity index ( LAEI ) as well as small arterial elasticity index ( SAEI ) . A significant decline HbA1C and a significant increase in HDL-cholesterol were also observed . In the placebo group , significant changes in LAEI , SAEI or metabolic measures were not observed . Conclusions Antioxidant supplementation significantly increased large and small artery elasticity in patients with multiple cardiovascular risk factors . This beneficial vascular effect was associated with an improvement in glucose and lipid metabolism as well as decrease in blood pressure Blood selenium ( Se ) concentrations and glutathione peroxidase ( GSHPX ) activities were measured in 118 men ( 39 + /- SD 15 yr ) and 112 women ( 42 + /- 16 yr ) r and omly selected from the total respondents ( 1192 ) to health survey in Milton , a low soil-selenium area in Otago . GSHPx activities were marginally lower for men ( 11.9 + /- 3.2 units/g Hb ) than for women ( 12.9 + /- 3.8 units/g Hb ) . Blood , erythrocyte and plasma selenium concentrations were about the same for both sexes and means for all subjects ( 61 + /- 15 ; 73 + /- 19 ; 49 + /- 12 ng Se/ml ) were almost identical with a control group of Otago blood donors . No differences in blood levels could be associated with smoking , use of oral contraceptives , arthritis and /or rheumatism , or anti-hypertensive drugs . No relationship was found for the men or women between any of the parameters of selenium status and any of the parameters of risk factors for cardiovascular disease measured in the health survey : age , Quetelet 's index , total skinfolds , systolic and diastolic pressure , pulse rate , plasma lipids and lipoprotein lipid concentrations . Moreover no relationship was found for the subgroups ( 36 % group ) of men and of women with plasma selenium below 45 ng Se/ml . This study indicates that if selenium is important it does not operate through the risk factors of cardiovascular disease as presently understood This study is aim ed at examining whether essential arterial hypertension ( HTN ) or ACE inhibitors have any effect on erythrocyte selenium (Se)-dependent and Se-non-dependent glutathione peroxidase ( GSH-Px ) and superoxide dismutase ( SOD ) activity . Eleven patients with HTN ( 2 men and 9 women ) and 9 healthy volunteers were included in this study after clinical examination and laboratory investigation . The activities of all three enzymes were determined and then the patients were assigned to receive ACE inhibitor therapy consisting of captopril , 25 to 50 mg daily , or enalapril , 10 to 40 mg daily . After 1 year , the determination of antioxidant enzymes was repeated . Our results showed that the initial values of Se-dependent GSH-Px in patients treated with ACE inhibitors were significantly lower ( 19.60 + /- 3.50 microM NADPH/min(-1)/mgHb(-1 ) ) compared with the controls ( 28.64 + /- 4.93 microM NADPH/min(-1)/mgHb(-1 ) ; p < 0.001 ) , whereas the activity of Se-non-dependent GSH-Px was significantly enhanced ( 13.55 + /- 1.46 microM NADPH/min(-1)/mgHb(-1 ) ; p < 0.001 ) compared with the control group ( 9.44 + /- 0.81 microM NADPH/min(-1)/mgHb(-1 ) ; p < 0.001 ) . ACE inhibitors did not significantly change the activity of Se-dependent GSH-Px or Se-non-dependent GSH-Px . No significant alteration was observed in SOD activity The independent association of serum concentrations of saturated and polyunsaturated fatty acids , apolipoproteins AI and B , selenium and vitamins A and E with the risk of death from coronary artery disease ( CAD ) was studied in 92 persons with no previous myocardial infa rct ion , who died from CAD during a 5-year follow-up , and their 92 1-to-1 matched controls . Case-control pairs came from a r and omly drawn population sample of approximately 12,000 persons aged 30 to 64 years from 2 provinces of eastern Finl and , an area with exceptionally high CAD mortality . Control subjects were matched for sex , age , serum cholesterol , mean arterial pressure , tobacco consumption and history of cardiovascular diseases . The persons who died of CAD had lower serum esterified arachidonic acid concentrations before follow-up than the control subjects ( 41 vs 48 mg/liter , p = 0.05 ) , and this difference was greater for pairs with no chest pain on effort ( 36 vs 50 mg/liter , p less than 0.05 ) . The adjusted risk of CAD death in persons with a serum polyunsaturated to saturated ( P/S ) fatty acid ratio of 0.28 or less ( in the lowest tertile ) was 3.5-fold ( 95 % confidence interval [ CI ] , 1.5 to 8.2 ) compared with those with higher serum P/s ratios in a multivariate logistic model and 5.6-fold ( 95 % CI 1.6 to 19.8 ) for pairs with no chest pain on effort . A low serum apolipoprotein AI concentration ( 1.25 g/liter or less , in the lowest tertile ) was associated with a 2.5-fold ( 95 % CI 1.1 to 5.7 ) adjusted risk of CAD death among the chest pain-free persons . ( ABSTRACT TRUNCATED AT 250 WORDS Output:	Based on the present systematic review , there is no conclusive evidence supporting an association between Se and hypertension .
MS22341	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: The contribution of emphysema to lung cancer risk has been recognized , but the effect size needs to be further defined . In this study , 565 primary lung cancer cases were enrolled though a prospect i ve lung cancer cohort at Mayo Clinic , and 450 controls were smokers participating in a lung cancer screening study in the same institution using spiral computed tomography ( CT ) . Cases and controls were frequency matched on age , gender , race , smoking status , and residential region . CT imaging using st and ard protocol at the time of lung cancer diagnosis ( case ) or during the study ( control ) was assessed for emphysema by visual scoring CT analysis as a percentage of lung tissue destroyed . The clinical definition of emphysema was the diagnosis recorded in the medical documentation . Using multiple logistic regression models , emphysema ( ≥5 % on CT ) was found to be associated with a 3.8-fold increased lung cancer risk in Caucasians , with higher risk in subgroups of younger ( < 65 years old , OR = 4.64 ) , heavy smokers ( ≥40 pack-years , OR = 4.46 ) , and small-cell lung cancer ( OR = 5.62 ) . When using > 0 % or ≥10 % emphysema on CT , lung cancer risk was 2.79-fold or 3.33-fold higher than controls . Compared with CT evaluation ( using criterion ≥5 % ) , the sensitivity , specificity , positive and negative predictive values , and the accuracy of the clinical diagnosis for emphysema in controls were 19 % , 98 % , 73 % , 84 % , and 83 % , respectively . These results imply that an accurate evaluation of emphysema could help reliably identify individuals at greater risk of lung cancer among smokers . Cancer Prev Res ; 4(1 ) ; 43–50 . © 2010 AACR Prolonged cigarette smoking causes even more deaths from other diseases than from lung cancer . In developed countries , the absolute age-sex-specific lung cancer rates can be used to indicate the approximate proportions due to tobacco of deaths not only from lung cancer itself but also , indirectly , from vascular disease and from various other categories of disease . Even in the absence of direct information on smoking histories , therefore , national mortality from tobacco can be estimated approximately just from the disease mortality statistics that are available from all major developed countries for about 1985 ( and for 1975 and so , by extrapolation , for 1995 ) . The relation between the absolute excess of lung cancer and the proportional excess of other diseases can only be approximate , and so as not to overestimate the effects of tobacco it has been taken to be only half that suggested by a recent large prospect i ve study of smoking and death among one million Americans . Application of such methods indicates that , in developed countries alone , annual deaths from smoking number about 0.9 million in 1965 , 1.3 million in 1975 , 1.7 million in 1985 , and 2.1 million in 1995 ( and hence about 21 million in the decade 1990 - 99 : 5 - 6 million European Community , 5 - 6 million USA , 5 million former USSR , 3 million Eastern and other Europe , and 2 million elsewhere , [ ie , Australia , Canada , Japan , and New Zeal and ] ) . More than half these deaths will be at 35 - 69 years of age : during the 1990s tobacco will in developed countries cause about 30 % of all deaths at 35 - 69 ( making it the largest single cause of premature death ) plus about 14 % of all at older ages . Those killed at older ages are on average already almost 80 years old , however , and might have died soon anyway , but those killed by tobacco at 35 - 69 lose an average of about 23 years of life . At present just under 20 % of all deaths in developed countries are attributed to tobacco , but this percentage is still rising , suggesting that on current smoking patterns just over 20 % of those now living in developed countries will eventually be killed by tobacco ( ie , about a quarter of a billion , out of a current total population of just under one and a quarter billion ) Chronic obstructive pulmonary disease ( COPD ) is a common comorbid disease in lung cancer , estimated to affect 40–70 % of lung cancer patients , depending on diagnostic criteria . As smoking exposure is found in 85–90 % of those diagnosed with either COPD or lung cancer , coexisting disease could merely reflect a shared smoking exposure . Potential confounding by age , sex and pack-yr smoking history , and /or by the possible effects of lung cancer on spirometry , may result in over-diagnosis of COPD prevalence . In the present study , the prevalence of COPD ( pre-bronchodilator Global Initiative for Chronic Obstructive Lung Disease 2 + criteria ) in patients diagnosed with lung cancer was 50 % compared with 8 % in a r and omly recruited community control group , matched for age , sex and pack-yr smoking exposure ( n = 602 , odds ratio 11.6 ; p<0.0001 ) . In a subgroup analysis of those with lung cancer and lung function measured prior to the diagnosis of lung cancer ( n = 127 ) , we found a nonsignificant increase in COPD prevalence following diagnosis ( 56–61 % ; p = 0.45 ) . After controlling for important variables , the prevalence of COPD in newly diagnosed lung cancer cases was six-fold greater than in matched smokers ; this is much greater than previously reported . We conclude that COPD is both a common and important independent risk factor for lung cancer RATIONALE Identification of risk factors for lung cancer can help in selecting patients who may benefit the most from smoking cessation interventions , early detection , or chemoprevention . OBJECTIVE To evaluate whether the presence of emphysema on low-radiation-dose CT ( LDCT ) of the chest is an independent risk factor for lung cancer . METHODS The study used data from a prospect i ve cohort of 1,166 former and current smokers participating in a lung cancer screening study . All individuals underwent a baseline LDCT and spirometry followed by yearly repeat LDCT studies . The incidence density of lung cancer among patients with and without emphysema on LDCT was estimated . Stratified and multiple regression analyses were used to assess whether emphysema is an independent risk factor for lung cancer after adjusting for age , gender , smoking history , and the presence of airway obstruction on spirometry . RESULTS On univariate analysis , the incidence density of lung cancer among individuals with and without emphysema on LDCT was 25.0 per 1,000 person-years and 7.5 per 1,000 person-years , respectively ( risk ratio [ RR ] , 3.33 ; 95 % confidence interval [ CI ] , 1.41 to 7.85 ) . Emphysema was also associated with increased risk of lung cancer when the analysis was limited to individuals without airway obstruction on spirometry ( RR , 4.33 ; 95 % CI , 1.04 to 18.16 ) . Multivariate analysis showed that the presence of emphysema ( RR , 2.51 ; 95 % CI , 1.01 to 6.23 ) on LDCT but not airway obstruction ( RR , 2.10 ; 95 % CI , 0.79 to 5.58 ) was associated with increased risk of lung cancer after adjusting for potential cofounders . CONCLUSIONS Results suggest that the presence of emphysema on LDCT is an independent risk factor for lung cancer BACKGROUND COPD is an independent risk factor for lung cancer , especially in patients with mild to moderate disease . OBJECTIVE To determine if performing lung cancer screening in GOLD 1 and 2 COPD patients , results in reduced lung cancer mortality . METHODS This study compared patients with mild to moderate COPD from 2 cohorts matched for age , gender , BMI , FEV1 % , pack-yrs history and smoking status . The screening group ( SG ) had an annual low dose computed tomography ( LDCT ) . The control group ( CG ) was prospect ively followed with usual care . Lung cancer incidence and mortality densities were compared between groups . RESULTS From an initial sample of 410 ( SG ) and 735 ( CG ) patients we were able to match 333 patients from each group . At the same follow-up time lung cancer incidence density was 1.79/100 person-years in the SG and 4.14/100 person-years in the CG ( p = 0.004 ) . The most frequent histological type was adenocarcinoma in both SG and CG ( 65 % and 46 % , respectively ) , followed by squamous cell carcinoma ( 25 % and 37 % , respectively ) . Eighty percent of lung cancers in the SG ( 16/20 ) were diagnosed in stage I , and all of CG cancers ( 35/35 ) were in stage III or IV . Mortality incidence density from lung cancer ( 0.08 vs. 2.48/100 person-years , p < 0.001 ) was lower in the SG . CONCLUSIONS This pilot study in patients with mild to moderate COPD suggests that screening with LDCT detects lung cancer in early stages , and could decrease lung cancer mortality in that high risk group . Appropriately design ed studies should confirm these important findings Breathlessness is a common symptom in patients with primary bronchial carcinoma and is often not well-controlled . Most patients are ex- or current smokers , and therefore are at high risk for co-existing chronic obstructive pulmonary disease ( COPD ) . The incidence of airflow obstruction in patients with bronchial carcinoma , its relation to breathlessness , and response to bronchodilator therapy was examined prospect ively . Fifty-seven consecutive patients attending our outpatient clinic with bronchial carcinoma diagnosed in the preceding 12 months were studied ( 22 female , 35 male , mean age 68.4 years ) . Spirometry was performed and breathlessness rated . Those with airflow obstruction ( FEV1:FVC < 65 % and FEV1 < 70 % predicted ) and who judged themselves to have moderate or severe breathlessness , were offered a trial of bronchodilator therapy . The response to regular inhaled fenoterol and ipratropium bromide by metered dose inhaler ( MDI ) and large volume spacer , and to regular nebulized salbutamol and ipratropium bromide was assessed by home peak flow recordings , spirometry and two subjective scores : ( a ) rating of breathlessness on a simple four-point scale , and ( b ) activity score of the St George 's Respiratory Question naire . There was very strong association between airflow obstruction and breathlessness . Twenty-eight patients ( 49 % ) had airflow obstruction , and we had breathlessness ratings on 26 of these patients of whom 18 ( 69 % ) had rated it as moderate or severe . Only four of the patients with airflow obstruction and breathlessness were using bronchodilator therapy . There was no significant difference in the mean age , time from diagnosis , tumour site , or smoking history between the groups with , and without , airflow obstruction . There was no association between cell type and the presence of airflow obstruction . ( ABSTRACT TRUNCATED AT 250 WORDS Our aim was to describe the characteristics of a case-series of never-smoker small cell lung cancer ( SCLC ) cases . Cases of SCLC were selected from a prospect i ve , multicenter , hospital-based case – control study performed in Spain . Participants were never-smokers older than 30 years with an anatomo-pathological confirmation of primary lung cancer . We collected clinical and epidemiological variables according to the study 's protocol . We included 19 SCLC cases , 18 females ( 94.7 % ) , median age 75 years ( interquartile range ( IQR ) 70–80 years ) . Median residential radon concentration was 195 Bq·m−3 ( IQR 130–229 Bq·m−3 ) . 10 patients had limited disease and nine had extended disease . Median survival was 242 days ( IQR 94–496 days ) ; 1- and 2-year survival were 36.8 % and 17.6 % , respectively . Survival was much higher for individuals with limited disease than for those with extended disease ( median 336 versus 235 days ; 1-year survival 50 % versus 22.2 % and 2-year survival 27 % versus 0 % , respectively ) . Performance status at diagnosis was closely related to survival . SCLC is an infrequent , highly aggressive disease in never-smokers . Survival is poor , even for limited disease . Age at diagnosis in SCLC is higher than that observed for never-smokers with adenocarcinoma . Residential radon exposure is higher than the action levels recommended by the World Health Organization . Small cell lung cancer in never-smokers has a poor survival and is diagnosed at older ages than other lung cancers OBJECTIVES Several studies have identified airflow obstruction as a risk factor for lung cancer independent of smoking history , but the risk associated with the presence of radiographic evidence of emphysema has not been extensively studied . We proposed to assess this risk using a quantitative volumetric CT scan analysis . METHODS Sixty-four cases of lung cancer were identified from a prospect i ve cohort of 1,520 participants enrolled in a spiral CT scan lung cancer screening trial . Each case was matched to six control subjects for age , sex , and smoking history . Quantitative CT scan analysis of emphysema was performed . Spirometric measures were also conducted . Data were analyzed using conditional logistic regression making use of the 1:6 set groups of 64 cases and 377 matched control subjects . RESULTS Decreased FEV(1 ) and FEV(1)/FVC were Output:	Both COPD and emphysema seem to increase the risk of developing lung cancer , being this risk higher for smokers with heavier tobacco consumption .
MS22342	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* 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 Output:	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 . There is mixed evidence on the benefit of using zinc supplementation in people with sickle cell disease .
MS22343	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: BACKGROUND Women have higher rates of knee ligament injury than men . Co-contraction of knee muscles is proposed to be an important mechanism to protect the joint from injuries . HYPOTHESIS Females have lower co-contraction levels when compared to males . STUDY DESIGN Exploratory , cross-sectional design . METHODS Thirty-six men and women equally divided into four groups according to gender and activity level ( sedentary and athletic ) were compared in relation to vastus lateralis and biceps femoris co-contraction before heel strike during level walking and before floor contact during l and ing from a jump . Muscular co-contraction was assessed by surface electromyography . Correlations between co-contraction and ligament laxity , extensor and flexor work , and flexion/extension torque ratio were also analyzed . RESULTS No differences between genders were found in the studied situations ( p0.381 ) . During walking , co-contraction was greater in sedentary women compared to athletic women ( p=0.002 ) . A moderate inverse correlation was found between co-contraction during walking and women extensor ( r=-0.613 ; p=0.007 ) and flexor ( r=-0.575 ; p=0.012 ) work . During l and ing from a jump , no variables correlated to co-contraction in any of the groups tested ( r0.477 ; p0.061 ) . CONCLUSION Co-contraction levels were not different between genders . Results suggest that women compensate strength deficits by means of increasing activation levels , possibly to generate adequate joint stiffness to meet stabilization dem and s. However , this is not evident in a more stressful activity like l and ing from a jump . CLINICAL RELEVANCE This study contributes to a better underst and ing of the factors related to joint protection in females , who are at a greater risk of ligament injuries Background and Purpose — The purpose of this study was to compare treadmill and electromechanical gait trainer therapy in subacute , nonambulatory stroke survivors . The gait trainer was design ed to provide nonambulatory subjects the repetitive practice of a gait-like movement without overexerting therapists . Methods — This was a r and omized , controlled study with a crossover design following an A-B-A versus a B-A-B pattern . A consisted of 2 weeks of gait trainer therapy , and B consisted of 2 weeks of treadmill therapy . Thirty nonambulatory hemiparetic patients , 4 to 12 weeks after stroke , were r and omly assigned to 1 of the 2 groups receiving locomotor therapy every workday for 15 to 20 minutes for 6 weeks . Weekly gait ability ( functional ambulation category [ FAC ] ) , gait velocity , and the required physical assistance during both kinds of locomotor therapy were the primary outcome measures , and other motor functions ( Rivermead motor assessment score ) and ankle spasticity ( modified Ashworth score ) were the secondary outcome measures . Follow-up occurred 6 months later . Results — The groups did not differ at study onset with respect to the clinical characteristics and effector variables . During treatment , the FAC , gait velocity , and Rivermead scores improved in both groups , and ankle spasticity did not change . Median FAC level was 4 ( 3 to 4 ) in group A compared with 3 ( 2 to 3 ) in group B at the end of treatment ( P = 0.018 ) , but the difference at 6-month follow up was not significant . The therapeutic effort was less on the gait trainer , with 1 instead of 2 therapists assisting the patient at study onset . All but seven patients preferred the gait trainer . Conclusions — The newly developed gait trainer was at least as effective as treadmill therapy with partial body weight support while requiring less input from the therapist . Further studies are warranted OBJECTIVE To establish whether functional recovery of gait in patients with post-stroke hemiparesis coincides with changes in the temporal patterning of lower extremity muscle activity and coactivity during treadmill walking . METHODS Electromyographic ( EMG ) data from both legs , maximum walking speed , the amount of swing phase asymmetry and clinical measures were obtained from a group of post-acute patients with hemiparesis , as early as possible after admission in a rehabilitation centre ( mean time post-stroke 35 days ) and 1 , 3 , 6 , and 10 weeks later , while all patients participated in a regular rehabilitation program . EMG data from the first assessment were compared to those obtained from a group of healthy controls to identify abnormalities in the temporal patterning of muscle activity . Within subject comparisons of patient data were made over time to investigate whether functional gait recovery was accompanied by changes in the temporal patterns muscle (co-)activity . RESULTS EMG patterns during the first assessment showed a number of abnormalities on the paretic side , namely abnormally long duration s of activity in biceps femoris ( BF ) during the single support ( SS ) phase and in gastrocnemius medialis ( GM ) during the first double support phase ( DS1 ) . Furthermore , in both legs a prolongation of the activity was seen in the rectus femoris ( RF ) during the SS phase . In addition , the duration of BF-RF coactivation was longer on the paretic side than it was in controls . Over time , the level of ambulatory independence , body mobility , and maximum walking speed increased significantly , indicating that substantial improvements in gait ability occurred . Despite these improvements , duration s of muscle ( co- ) activity and the level of swing phase asymmetry did not change during rehabilitation . More specifically , timing abnormalities in muscle (co-)activity that were found during the first assessment did not change significantly , indicating that these aberrations were not an impediment for functional gait improvements . CONCLUSIONS Normalization of the temporal patterning of gait related muscle activity in the lower extremities is not a prerequisite for functional recovery of gait in patients with post-stroke hemiparesis . Apparently , physiological processes other than improved temporal muscular coordination must be important determinants of the restoration of ambulatory capacity after stroke . SIGNIFICANCE Recovery of walking ability in post-stroke hemiparesis is not necessarily associated with , or dependent on , reorganization in the temporal control of gait related muscle activity . Normalization of the temporal coordination of muscle activity during gait may not be an important clinical goal during post-acute rehabilitation OBJECTIVE The purpose of this study was to compare the kinematics , muscle activation , and force production between Parkinson 's patients and healthy , age-matched participants during sit-to-st and transfers . DESIGN This cross-sectional study employed a 2x2x3 multivariate analysis of variance to test for significant differences between and within groups . BACKGROUND The underlying mechanisms that predispose an individual to lose strength during the clinical progression of Parkinson 's disease have proved to be elusive , especially during performance of functional tasks such as the sit to st and transfer . METHODS Twenty-four men ( mean age : 71.5 years ) categorized as Parkinson 's patients ( n = 13 ) and healthy adults ( n = 11 ) participated in this study . Two force platforms measured antero-posterior and vertical force components as well as peak torque . Muscle activation was measured by a six channel , bilateral electromyography system . A lower-body kinematic assessment was conducted utilizing a high-speed motion analysis system . RESULTS No statistically significant differences were found between groups for the outcome variables measured . However , Parkinson 's patients did exhibit significant within-group bilateral differences for the variables of knee angle at seat-off , peak vertical force and peak torque . CONCLUSION Data from this study reveal that persons with mild to moderate Parkinson 's disease exhibit moderately altered bilateral mechanics when performing a sit to st and transfer compared to their healthy peers . RELEVANCE The inability to produce constant equilateral force when performing functional tasks could be an indicator for the increased propensity of falls or other instabilities in this population OBJECTIVE To compare the gait of hemiparetic subjects walking on a treadmill with various body weight supports and walking on the floor . DESIGN Hemiparetic subjects walked on a treadmill , secured in a harness , with no body weight support and with 15 % and 30 % body weight relief , and walked on a floor . SETTING Kinematic laboratory of a department of rehabilitation . SUBJECTS Eighteen hemiparetic stroke patients . MAIN OUTCOME MEASURES Gait cycle parameters and kinesiologic electromyogram of six muscles of the affected side and of two muscles of the nonaffected side . RESULTS On the treadmill , patients walked more slowly because of a reduced cadence , with a longer single stance period of the paretic limb , more symmetrically , and with a larger hip extension ( multivariate profile analysis , p<.05 ) . The mean functional activities of the gastrocnemius muscle and of the first crest of the erector spinae of the paretic side were smaller on the treadmill ( univariate test , p<.05 ) . Further , the premature activity of the gastrocnemius muscle , indicating spasticity , was less on the treadmill ( univariate test , p<.05 ) ; correspondingly the qualitative muscle pattern analysis revealed less co-contraction between the gastrocnemius and tibialis anterior muscles in 11 of the 18 subjects . CONCLUSIONS Treadmill training with partial body weight support in hemiparetic subjects allows them to practice a favorable gait characterized by a greater stimulus for balance training because of the prolonged single stance period of the affected limb , a higher symmetry , less plantar flexor spasticity , and a more regular activation pattern of the shank muscles as compared with floor walking Information on the dynamic properties ( joint stiffness , viscosity and limb inertia ) of the human knee joint is scarce in the literature , especially for actively contracting knee musculature . A joint driving device was developed to apply small-amplitude r and om perturbations to the human knee at several flexion angles with the subject maintaining various levels of muscle contraction . It was found that joint stiffness and viscosity increased with muscle contraction substantially , while limb inertia was constant . Stiffness produced by the quadriceps was highest at 30 degrees flexion and decreased with increasing or decreasing flexion angle , while knee flexors produced highest stiffness at 90 degree flexion . When knee flexion was < 60 degrees , stiffness produced by the quadriceps was higher than that of the hamstrings and gastrocnemius at the same level of background muscle torque , while knee flexor muscles produced higher stiffnesses than the quadriceps at 90 degree flexion . Similar but less obvious trends were observed for joint viscosity . Passive joint stiffness at full knee extension was significantly higher than in more flexed positions . Surprisingly , as the knee joint musculature changed from relaxed to contracting at 50 % MVC , system damping ratio remained at about 0.2 . This outcome potentially simplifies neuromuscular control of the knee joint . In contrast , the natural undamped frequency increased more than twofold , potentially making the knee joint respond more quickly to the central nervous system comm and s. The approach described here provides us with a potentially valuable tool to quantify in vivo dynamic properties of normal and pathological human knee joints Background . Little is known about whether changes in coordination patterns of muscle activation after stroke are related to functional recovery of walking . Objective . The present study investigated the longitudinal relationship between changes in neuromuscular activation patterns of paretic muscles in hemiplegic gait and improvement in walking ability after stroke . Methods . Thirteen patients diagnosed with a first unilateral ischemic stroke had their recovery of walking measured by the Rivermead Mobility Index , Functional Ambulation Categories , Barthel Index , Trunk Control Test , Motricity Index , and comfortable walking speed . Surface electromyography ( SEMG ) of the erector spinae , gluteus maximus , gluteus medius , rectus femoris , vastus lateralis , semitendinosus , gastrocnemius , and tibialis anterior muscles of both legs was used to quantify coordination patterns in comfortable walking mode . All clinical and electromyography-related measurements were taken at 3 , 6 , 9 , 12 , and 24 weeks poststroke . Timing parameters of the SEMG patterns were calculated , using an objective burst detection algorithm , and analyzed with the measures of functional recovery . Results . All functional measures , except Trunk Control Test , showed statistically significant improvement over time , whereas SEMG patterns did not change significantly over time . Conclusion . The lack of significant change in SEMG patterns over time suggests that functional gait improvements may be more related to compensatory strategies in muscle activation of the unaffected leg and biomechanical changes than by restitution of muscle coordination patterns in the affected leg Output:	There is some controversy in MCo results , however subjects with stroke tended towards longer MCo in both lower limbs in both the acute and chronic stages , when compared with healthy controls . A higher level of post-stroke walking ability ( speed ; level of independence ) was correlated with longer thigh MCo in the non-affected limb . CONCLUSIONS Subjects with stroke commonly present longer MCo during walking , probably in an attempt to improve walking ability .
MS22344	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: Summary A controlled clinical study on the outcome of family intervention in chronic schizophrenics is being carried out in Athens . All subjects participating in the study reside with their families and attend a vocational rehabilitation unit . Those belonging to families characterized by high “ Expressed Emotion ” ( EE ) are r and omly assigned to either the experimental or the control condition . The former receive family intervention combined with individual treatment , the latter individual treatment alone . 75 subjects have entered the study , and 121 relatives were interviewed with the Camberwell Family Interview . 40 patients ( 53.3 % ) were found to belong to high EE families . The present article presents the results of the baseline assessment . It was found that the EE status of the family was significantly associated with measures of psychopathology and social functioning ( BPRS , GAS , DAS , number of residual symptoms ) . Further analyses revealed that these associations exist only when all key relatives express high EE . The implication s of these findings are discussed Purpose To evaluate the contribution of positive affect in the family environment to relapse in first episode psychosis . Method 65 service users with a first episode of psychosis were recruited into the current study along with their key relatives . Relatives were interviewed and rated using the Expressed Emotion ( EE ) measure of warmth , whilst service users completed question naires about the positive and negative affects that they perceived from the family environment . Associations between these measures and relapse were examined in a one-year prospect i ve design . Results Service users were less likely to relapse within 6 and 12-month follow-up periods when their relatives were rated high on EE warmth , or when they perceived more positive affect from the family . The relationships between service users ’ perceived positive affect and relapse were preserved after controlling for baseline symptoms , substance use and employment status . Service users ’ perceptions of positive affect and EE ratings of warmth appeared to be stronger predictors of relapse outcome than criticism and other EE variables . Conclusions Positive family environments may protect against relapse in first episode psychosis . Psychosocial interventions should aim to foster and maintain positive affect in families during the early stages of illness . Further research is needed to underst and the mechanisms linking positive affect and outcomes for people recovering from psychosis This article explores family burden in relation to relatives ' coping strategies and social networks , as well as in relation to the patients ' severity of positive and negative symptoms . Data on the severity of symptoms ( Positive and Negative Syndrome Scale for Schizophrenia [ PANSS ] ) , social functioning ( Social Functioning Scale [ SFS ] ) , caregivers burden ( Interview on Objective and Subjective Family Burden or Entrevista de Carga Familiar Objetiva y Subjetiva [ ECFOS ] ) , coping skills ( Family Coping Question naire [ FCQ ] ) , and social support ( Social Network Question naire [ SNQ ] ) were gathered from a r and omized sample of 101 Chilean out patients and their primary caregivers , mostly mothers . Low levels of burden were typically found , with the exception of moderate levels on general concerns for the ill relative . A hierarchical regression analysis with four blocks showed that clinical characteristics , such as higher frequency of relapses , more positive symptoms and lower independence-performance , together with lower self-control attributed to the patient , decrease in social interests , and less affective support , predict burden . The results support the relevance of psychoeducational interventions where families ' needs are addressed As part of a controlled study of the effectiveness of a counseling program for family caregivers of patients with schizophrenia , we conducted a comprehensive examination of the process . The particular foci were on themes that arose during sessions , principal therapeutic interventions offered , and caveats for counselors working in the field . The most striking finding was the diverse range of themes , covering personal , coping , family , and social aspects of the caregiving experience . This required a correspondingly broad array of interventions . The implication s are clear : confining counseling for caregivers to such traditional dimensions as education or attempts to reduce emotional expressiveness denies them the opportunity to deal with other equally relevant concerns BACKGROUND Poorly defined cohorts and weak study design s have hampered cross-cultural comparisons of course and outcome in schizophrenia . AIMS To describe long-term outcome in 18 diverse treated incidence and prevalence cohorts . To compare mortality , 15- and 25-year illness trajectory and the predictive strength of selected baseline and short-term course variables . METHODS Historic prospect i ve study . St and ardised assessment s of course and outcome . RESULTS About 75 % traced . About 50 % of surviving cases had favourable outcomes , but there was marked heterogeneity across geographic centres . In regression models , early ( 2-year ) course patterns were the strongest predictor of 15-year outcome , but recovery varied by location ; 16 % of early unremitting cases achieved late-phase recovery . CONCLUSIONS A significant proportion of treated incident cases of schizophrenia achieve favourable long-term outcome . Sociocultural conditions appear to modify long-term course . Early intervention programmes focused on social as well as pharmacological treatments may realise longer-term gains Output:	Results Similar to chronic patients , a high prevalence of high-EE in carers of FEP patients was reported . High-EE status appears to be independent of the patient ’s illness-related characteristics , but dependent of relatives ’ attributions . In contrast to chronic patients , low levels of FB and psychological distress among family members of FEP patients were observed indicating that in the early stages of the illness family involvement is not yet associated with significant disruption in their lives . Studies assessing FB in chronic patients have found a well-established link of FB with patient ’s illness-related factors , but in FEP patients the families ’ appraisal of FB is more closely associated with their coping mechanisms .
MS22345	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: 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 Abstract Objective To examine the extent and nature of outcome reporting bias in a broad cohort of published r and omised trials . Design Retrospective review of publications and follow up survey of authors . Cohort All journal articles of r and omised trials indexed in PubMed whose primary publication appeared in December 2000 . Main outcome measures Prevalence of incompletely reported outcomes per trial ; reasons for not reporting outcomes ; association between completeness of reporting and statistical significance . Results 519 trials with 553 publications and 10 557 outcomes were identified . Survey responders ( response rate 69 % ) provided information on unreported outcomes but were often unreliable — for 32 % of those who denied the existence of such outcomes there was evidence to the contrary in their publications . On average , over 20 % of the outcomes measured in a parallel group trial were incompletely reported . Within a trial , such outcomes had a higher odds of being statistically non-significant compared with fully reported outcomes ( odds ratio 2.0 ( 95 % confidence interval 1.6 to 2.7 ) for efficacy outcomes ; 1.9 ( 1.1 to 3.5 ) for harm outcomes ) . The most commonly reported reasons for omitting efficacy outcomes included space constraints , lack of clinical importance , and lack of statistical significance . Conclusions Incomplete reporting of outcomes within published articles of r and omised trials is common and is associated with statistical non- significance . The medical literature therefore represents a selective and biased subset of study outcomes , and trial protocol s should be made publicly available OBJECTIVE : This study was design ed to develop and to test a home-based , guided imagery treatment protocol , using audio and video recordings , that is easy for health care professionals and patients to use , is inexpensive , and is applicable to a wide range of health care setting s. METHODS : Thirty-four children , 6 to 15 years of age , with a physician diagnosis of functional abdominal pain were assigned r and omly to receive 2 months of st and ard medical care with or without home-based , guided imagery treatment . Children who received only st and ard medical care initially received guided imagery treatment after 2 months . Children were monitored for 6 months after completion of guided imagery treatment . RESULTS : All treatment material s were reported to be self-explanatory , enjoyable , and easy to underst and and to use . The compliance rate was 98.5 % . In an intention-to-treat analysis , 63.1 % of children in the guided imagery treatment group were treatment responders , compared with 26.7 % in the st and ard medical care – only group ( P = .03 ; number needed to treat : 3 ) . Per- protocol analysis showed similar results ( 73.3 % vs 28.6 % responders ) . When the children in the st and ard medical care group also received guided imagery treatment , 61.5 % became treatment responders . Treatment effects were maintained for 6 months ( 62.5 % responders ) . CONCLUSION : Guided imagery treatment plus medical care was superior to st and ard medical care only for the treatment of abdominal pain , and treatment effects were sustained over a long period Forty-eight adolescents suffering from recurrent tension headache participated in a controlled trial conducted in a high school setting . During the first treatment phase self-help relaxation training was compared with a waiting-list group . Following this phase a pharmacological regimen consisting of a muscle relaxant ( chlormezanone ) and placebo was superimposed on relaxation therapy in a double-blind crossover design . Each treatment phase encompassed a 5-week period . In addition to the evaluation of headache complaints , psychological distress among students was measured with respect to their experience of somatic complaints , depressive , anxiety and stress symptoms . Although self-help relaxation training significantly decreased the severity and annoyance of adolescents ' headache besides their somatic complaints , the clinical improvement of headache was modest . The addition of chlormezanone did not help those who were nonresponders to self-help relaxation training . Finally , a set of pretreatment variables consisting of baseline headache severity and annoyance , experience of anxiety and daily life stress among adolescents could predict outcome of self-help relaxation therapy A comparison was carried out of the efficacy of psychological and drug treatments for children with migraine . Forty-three children aged between 8 and 16 years ( mean age : 11.3 years ) who suffered from migraine received either progressive relaxation or cephalic vasomotor feedback , both with stress management training , or metoprolol , a beta-blocker . Psychological treatment was administered in ten sessions lasting six weeks and the drug treatment lasted ten weeks . Relaxation and stress management training reduced the headache index ( frequency x intensity of headache episodes ) , more effectively than metoprolol with cephalic vasomotor feedback and stress management training in between . An overall improvement over time was found with regard to frequency and intensity of headache episodes and analgesics intake . When comparing pre- to post-treatment data , children treated with relaxation training improved significantly in headache frequency and intensity , whereas those treated with cephalic vasomotor feedback improved significantly in headache frequency and duration as well as mood . The clinical improvement was stable at an 8-months follow-up This study describes the results of a controlled clinical trial involving 44 7- to 14-year-old children with recurrent abdominal pain who were r and omly allocated to either cognitive-behavioral family intervention ( CBFI ) or st and ard pediatric care ( SPC ) . Both treatment conditions result ed in significant improvements on measures of pain intensity and pain behavior . However , the children receiving CBFI had a higher rate of complete elimination of pain , lower levels of relapse at 6- and 12-month follow-up , and lower levels of interference with their activities as a result of pain and parents reported a higher level of satisfaction with the treatment than children receiving SPC . After controlling for pretreatment levels of pain , children 's active self-coping and mothers ' caregiving strategies were significant independent predictors of pain behavior at posttreatment 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 Objectives : We evaluated the efficacy of cognitive-behavioral family intervention in the treatment of crises of pain in children with nonorganic recurrent abdominal pain ( RAP ) and the thresholds of pain for 17 body surface areas in these children . Methods : A r and omized clinical trial was undertaken with 32 children between the ages of 5.1 and 13.9 years with nonorganic RAP . A group of 15 patients , aged 9.9 ± 2.2 years ( 11 girls ) , received st and ard pediatric care and cognitive-behavioral family intervention for treatment of pain crises . The control group of 17 children , aged 8.4 ± 2.0 years ( 11 girls ) , received only st and ard pediatric care . These procedures were undertaken by general pediatricians over 4 monthly sessions . An analog visual scale was used to measure the frequency and intensity of the pain crises per month and a mechanical pressure algometer for the measurement of pain threshold . Results : The median frequency of pain crises per month reported by patients at the 3 monthly cognitive-behavioral family intervention sessions was 15 , 5 , 2 and 2 , respectively . In contrast , the median frequency for pain crises per month reported by the control group was 12 , 8 , 10 and 8 , respectively . The difference between the intervention group and the controls was statistically significant for frequency of pain at the second , third and fourth visits . There was no statistical difference for intensity of pain or for measured pain thresholds between the control and the intervention group . Conclusions : The cognitive-behavioral family intervention reduced the frequency of pain crises of children with nonorganic RAP . This successful intervention was carried out by the intervention of general pediatricians OBJECTIVE Juvenile fibromyalgia syndrome ( FMS ) is a chronic musculoskeletal pain disorder in children and adolescents for which there are no evidence -based treatments . The objective of this multisite , single-blind , r and omized clinical trial was to test whether cognitive-behavioral therapy ( CBT ) was superior to fibromyalgia ( FM ) education in reducing functional disability , pain , and symptoms of depression in juvenile FMS . METHODS Participants were 114 adolescents ( ages 11 - 18 years ) with juvenile FMS . After receiving stable medications for 8 weeks , patients were r and omized to either CBT or FM education and received 8 weekly individual sessions with a therapist and 2 booster sessions . Assessment s were conducted at baseline , immediately following the 8-week treatment phase , and at 6-month followup . RESULTS The majority of patients ( 87.7 % ) completed the trial per protocol . Intent-to-treat analyses showed that patients in both groups had significant reductions in functional disability , pain , and symptoms of depression at the end of the study , and CBT was significantly superior to FM education in reducing the primary outcome of functional disability ( mean baseline to end-of-treatment difference between groups 5.39 [ 95 % confidence interval 1.57 , 9.22 ] ) . Reduction in symptoms of depression was clinical ly significant for both groups , with mean scores in the range of normal/nondepressed by the end of the study . Reduction in pain was not clinical ly significant for either group ( < 30 % decrease in pain ) . There were no study -related adverse events . CONCLUSION In this controlled trial , CBT was found to be a safe and effective treatment for reducing functional disability and symptoms of depression in adolescents with juvenile FMS & NA ; Little is known about the epidemiology of pain in children . We studied the prevalence of pain in Dutch children aged from 0 to 18 years in the open population , and the relationship with age , gender and pain parameters . A r and om sample of 1300 children aged 0–3 years was taken from the register of population in Rotterdam , The Netherl and s. In the Rotterdam area , 27 primary schools and 14 secondary schools were selected to obtain a representative sample of 5336 children aged 4–18 years . Depending on the age of the child , a question naire was either mailed to the parents ( 0–3 years ) or distributed at school ( 4–18 years ) . Of 6636 children surveyed , 5424 ( 82 % ) responded ; response rates ranged from 64 to 92 % , depending on the subject age and who completed the question naire . Of the respondents , 54 % had experienced pain within the previous 3 months . Overall , a quarter of the respondents reported chronic pain ( recurrent or continuous pain for more than 3 months ) . The prevalence of chronic pain increased with age , and was significantly higher for girls ( P<0.001 ) . In girls , a marked increase Output:	RESULTS 35 included studies revealed that across all chronic pain conditions , psychological interventions reduced pain symptoms and disability posttreatment . For headache pain , higher treatment dose led to greater reductions in pain . No effect of dosage was found for other chronic pain conditions .
MS22346	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: Background With the burden of mental illness estimated to be costing the English economy alone around £ 22.5 billion a year [ 1 ] , coupled with growing evidence that many mental disorders have their origins in adolescence , there is increasing pressure for schools to address the emotional well-being of their students , alongside the stigma and discrimination of mental illness . A number of prior educational interventions have been developed and evaluated for this purpose , but inconsistency of findings , reporting st and ards , and method ologies have led the majority of review ers to conclude that the evidence for the efficacy of these programmes remains inconclusive . Methods / Design A cluster r and omised controlled trial design has been employed to enable a feasibility study of ' SchoolSpace ' , an intervention in 7 UK secondary schools addressing stigma of mental illness , mental health literacy , and promotion of mental health . A central aspect of the intervention involves students in the experimental condition interacting with a young person with lived experience of mental illness , a stigma reducing technique design ed to facilitate students ' engagement in the project . The primary outcome is the level of stigma related to mental illness . Secondary outcomes include mental health literacy , resilience to mental illness , and emotional well-being . Outcomes will be measured pre and post intervention , as well as at 6 month follow-up . Discussion The proposed intervention presents the potential for increased engagement due to its combination of education and contact with a young person with lived experience of mental illness . Contact as a technique to reduce discrimination has been evaluated previously in research with adults , but has been employed in only a minority of research trials investigating the impact on youth . Prior to this study , the effect of contact on mental health literacy , resilience , and emotional well-being has not been evaluated to the authors ' knowledge . If efficacious the intervention could provide a reliable and cost-effective method to reduce stigma in young people , whilst increasing mental health literacy , and emotional well-being . Trial registration IS RCT N : IS RCT Stigmatizing , or discriminatory , perspectives and behaviour , which target individuals on the basis of their mental health , are observed in even the youngest school children . We conducted a systematic review of the published and unpublished , scientific literature concerning the benefits and harms of school-based interventions , which were directed at students 18 years of age or younger to prevent or eliminate such stigmatization . Forty relevant studies were identified , yet only a qualitative synthesis was deemed appropriate . Five limitations within the evidence base constituted barriers to drawing conclusive inferences about the effectiveness and harms of school-based interventions : poor reporting quality , a dearth of r and omized controlled trial evidence , poor methods quality for all research design s , considerable clinical heterogeneity , and inconsistent or null results . Nevertheless , certain suggestive evidence derived both from within and beyond our evidence base has allowed us to recommend the development , implementation and evaluation of a curriculum , which fosters the development of empathy and , in turn , an orientation toward social inclusion and inclusiveness . These effects may be achieved largely by bringing especially but not exclusively the youngest children into direct , structured contact with an infant , and likely only the oldest children and youth into direct contact with individuals experiencing mental health difficulties . The possible value of using educational activities , material s and contents to enhance hypothesized benefits accruing to direct contact also requires investigation . Overall , the curriculum might serve as primary prevention for some students and as secondary prevention for others PURPOSE This study examined the effectiveness of an intervention to reduce explicit and implicit stigma-relevant attitudes toward mental illness and treatment-seeking and behavioural indicators of willingness to seek treatment . METHODS Adolescents were r and omly assigned to the experimental ( education about mental illness and treatment involving psychoeducation and contact ( via DVD ) with an affected individual ) or control intervention ( education about tobacco ) . RESULTS Findings suggest the stigma intervention was effective at reducing explicit but not implicit stigma-relevant attitudes . As hypothesized , participants receiving the experimental intervention reported less explicit stigma toward treatment and greater openness to personally seek treatment if they had also reported prior mental health treatment . CONCLUSIONS AND IMPLICATION S These findings support the potential for a brief educational intervention among adolescents to reduce negative attitudes toward mental health treatment , but raise questions about how to effectively address implicit stigma as well as the importance of translating stigma reduction into behavior changes The purpose of this school-based cluster-r and omized trial was to determine the initial acceptability , feasibility , and efficacy of an existing community-based intervention , In Our Own Voice , in a sample of US adolescent girls aged 13 - 17 years ( n = 156 ) . In Our Own Voice is a knowledge-contact intervention that provides knowledge about mental illness to improve mental health literacy and facilitates intergroup contact with persons with mental illness as a means to reduce mental illness stigma . This longitudinal study was set in two public high schools located in a southern urban community of the U.S. Outcomes included measures of mental illness stigma and mental health literacy . Findings support the acceptability and feasibility of the intervention for adolescents who enrolled in the study . Findings to support the efficacy of In Our Own Voice to reduce stigma and improve mental health literacy are mixed . The intervention did not reduce mental illness stigma or improve mental health literacy at one week follow up . The intervention did not reduce mental illness stigma at 4 and 8 weeks follow up . The intervention did improve mental health literacy at 4 and 8 weeks follow up . Previous studies have assessed the preliminary efficacy In Our Own Voice among young adults ; rarely has In Our Own Voice been investigated longitudinally and with adolescents in the United States . This study provides initial data on the effects of In Our Own Voice for this population and can be used to further adapt the intervention for adolescents BACKGROUND A school mental-health programme has been developed as a component of the community mental-health programme in Rawalpindi , Pakistan . It has the objective of improving the underst and ing of disorders of mental health in the rural community . We aim ed to assess the impact of a school mental-health programme on the awareness of schoolchildren , their parents , friends who were not attending school , and neighbours . METHODS We chose two secondary schools for boys and two for girls that were similar in terms of size , staff-pupil ratio , and drop-out rates . 100 children aged 12 - 16 years ( 25 girls and 25 boys in each of the study and control groups ) , 100 parents ( one for each child ) , 100 friends who did not attend school ( one for each child ) , and 100 neighbours ( one for each child ) were given a 19-item question naire before and after the study group had had a 4-month programme of mental-health education . The maximum score for the question naire was 16 points . FINDINGS Before the school mental-health programme the awareness of mental-health issues was poor ( mean score 5.7 - 7.6 ) in the four groups of participants . In the study group there was a significant improvement in the mean scores after the school programme in the schoolchildren ( mean improvement 7.6 [ 95 % CI 6.7 - 8.5 ] , p<0.01 ) , their parents ( 5.3 [ 4.5 - 6.1 ] , p<0.01 ) , friends ( 5.1 [ 4.1 - 6.1 ] , p<0.01 ) , and neighbours ( 3.4 [ 2.6 - 4.2 ] , p<0.01 ) . In the control group the difference in awareness was significant only in schoolchildren ( 1.5 [ 0.5 - 2.3 ] , p=0.01 ) and their friends ( 0.8 [ 0.3 - 1.3 ] , p<0.01 ) . INTERPRETATION The school programme succeeded in improving awareness of mental health in schoolchildren and the community . The schoolchildren were receptive to the programme , and shared their new underst and ing with family , friends , and neighbours . Mental-health planners who wish to improve community awareness of mental health , particularly in areas with low literacy rates , should consider setting up school mental-health programmes This study evaluated the effectiveness of a cognitive behaviour therapy Internet program ( MoodGYM ) for depressive symptoms , attributional style , self‐esteem and beliefs about depression , and on depression and depression‐vulnerable status in male youth . A total of 78 boys age 15 and 16 years were allocated to either undertake MoodGYM or to st and ard personal development activities . Outcomes were measured before commencement , post‐program and 16 weeks post‐program . There were no significant between‐group differences in change scores pre‐ to post‐ or pre‐ to follow‐up using the intention to treat sample or for participants with post‐ and /or follow‐up data . For boys completing 3 or more modules there were small relative benefits of MoodGYM for depressive symptoms ( Effect Size , ES = 0.34 ) , attributional style ( ES = 0.17 ) and self‐esteem ( ES = 0.16 ) at post‐program , although only the effect for self‐esteem was sustained at follow‐up . Both groups showed improvement in their beliefs about depression at follow‐up , with the control group showing a moderate relative benefit ( ES = 0.40 ) . While the numbers are small , there was a reduction in the risk of being depressed in the MoodGYM group of 9 % at post‐treatment compared with a slightly increased risk for the control group . The risk of being classified as vulnerable to depression reduced by 17 % in the MoodGYM group at post‐treatment compared with no change in risk for the control group . These reductions in risk for the MoodGYM group were not sustained at follow‐up . The limitations of the study highlight several important challenges for MoodGYM and other self‐directed Internet cognitive behaviour therapy programs . These include how to ensure enough of the program is received and that people who could potentially benefit access the program and continue to remain engaged with it , and how to enhance the sustainability of any benefits BACKGROUND This study evaluates the benefits of a self-directed Internet intervention for depression ( MoodGYM ) delivered as a part of the high school curriculum . METHOD One hundred and fifty-seven girls , aged 15 and 16 years , were allocated to undertake either MoodGYM or their usual curriculum . MoodGYM 's impact on depressive symptoms , risk of depression , attributional style , depression literacy and attitudes toward depression was examined using r and om effect regression . RESULTS MoodGYM produced a significantly faster rate of decline in depressive symptoms over the trial period than the control condition . The effect size for MoodGYM was not significant immediately after the intervention ( Cohen 's d=.19 , 95 % CI -.18-.56 ) but was moderate and significant 20 weeks after the intervention ( d=.46 , 95 % CI .10-.82 ) . Girls with high depression scores before intervention showed the strongest benefits on self-reported depression at follow-up ( d=.92 , 95 % CI .10 - 1.38 ) . There were no significant intervention effects on depression status , attributional style , depression literacy , and attitudes . Approximately 70 % of girls in the MoodGYM group completed less than three of its modules and completion of fewer modules was related to high depression score before intervention . CONCLUSIONS The findings suggest that there are benefits from MoodGYM on self-reported depressive symptoms but has low rates of completion highlight problems in ensuring adherence to Internet programs for depression Output:	There is currently no strong evidence to support previous conclusions that these types of intervention work for children and adolescents .
MS22347	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: BACKGROUND Research has demonstrated the effectiveness of computerized cognitive behaviour therapy ( cCBT ) for depression and anxiety in adults , but there has been little work with children and adolescents . AIMS To describe the development of a cCBT intervention ( Think , Feel , Do ) for young people , and preliminary outcomes and feedback from a pilot r and omized controlled trial . METHOD Twenty participants aged 11 to 16 with depression or anxiety were r and omized to receive cCBT immediately or after a delay . St and ardized measures were used to assess self-reported anxiety , depression , self-esteem and cognitions , as well as parent rated strengths and difficulties . A feedback form was also completed to assess young people 's views of the programme . RESULTS A total of 15 participants completed the pre and post assessment s in the trial , and 17 provided feedback on the intervention . Paired sample s t-tests demonstrated significant improvements on 3 subscales in the control condition , compared to 7 subscales in the cCBT condition . Feedback showed moderate to high satisfaction for participants . CONCLUSIONS This study provides encouraging preliminary results for the effectiveness and acceptability of cCBT with this age group OBJECTIVE To evaluate the efficacy of an Internet-based cognitive-behavioral therapy ( CBT ) approach to the treatment of child anxiety disorders . METHODS Seventy-three children with anxiety disorders , aged 7 - 12 years , and their parents were r and omly assigned to either an Internet-based CBT ( NET ) or wait-list ( WL ) condition . Clinical diagnostic assessment and parent and child question naires were completed before and after treatment . The NET condition was reassessed at 6-month follow-up . RESULTS At posttreatment assessment , children in the NET condition showed small but significantly greater reductions in anxiety symptoms and increases in functioning than WL participants . These improvements were enhanced during the 6-month follow-up period , with 75 % of NET children free of their primary diagnosis . CONCLUSIONS Internet delivery of CBT for child anxiety offers promise as a way of increasing access to treatment for this population . Future research is needed to examine ways to increase treatment compliance and further enhance the impact of treatment Background Guided internet-delivered cognitive behavior therapy ( ICBT ) has been tested in several trials on social anxiety disorder ( SAD ) with moderate to large effects . The aims of this study were threefold . First , to compare the effects of ICBT including online discussion forum with a moderated online discussion forum only . Second , to investigate if knowledge about SAD increased following treatment and third to compare the effects of inexperienced versus experienced therapists on patient outcomes . Methods A total of 204 participants with a primary diagnosis of SAD were included and r and omized to either guided ICBT or the control condition . ICBT consisted of a 9-week treatment program which was guided by either psychology students at MSc level ( n = 6 ) or by licensed psychologists with previous experience of ICBT ( n = 7 ) . A knowledge test dealing with social anxiety was administered before and after treatment . Measures of social anxiety and secondary outcomes dealing with general anxiety , depression , and quality of life were administered before and after treatment . In addition , a 1-year follow-up was conducted on the treated individuals . Results Immediately following treatment , the ICBT group showed superior outcome on the Liebowitz Social Anxiety Scale self-report version with a between group posttreatment Hedges g effect size of g = 0.75 . In addition , significant differences on all the secondary outcomes were observed . Gains were well maintained one year later . Knowledge , as assessed by the knowledge test , increased following treatment with little gain in the control group . Therapist experience did not result in different outcomes , but experienced therapists logged in less frequently compared to the inexperienced therapists , suggesting that they needed less time to support patients . Discussion We conclude that guided ICBT reduce symptoms of SAD , increase knowledge about SAD and that therapist experience does not make a difference apart from the finding that experienced therapist may require less time to guide patients . Trial Registration UMIN.ac.jp OBJECTIVE This study examined the feasibility , acceptability , and effects of Camp Cope-A-Lot ( CCAL ) , a computer-assisted cognitive behavioral therapy ( CBT ) for anxiety in youth . METHOD Children ( 49 ; 33 males ) ages 7 - 13 ( M = 10.1 ± 1.6 ; 83.7 % Caucasian , 14.2 % African American , 2 % Hispanic ) with a principal anxiety disorder were r and omly assigned to ( a ) CCAL , ( b ) individual CBT ( ICBT ) , or ( c ) a computer-assisted education , support , and attention ( CESA ) condition . All therapists were from the community ( school or counseling psychologists , clinical psychologist ) or were PsyD or PhD trainees with no experience or training in CBT for child anxiety . Independent diagnostic interviews and self-report measures were completed at pre- and posttreatment and 3-month follow-up . RESULTS At posttreatment , ICBT or CCAL children showed significantly better gains than CESA children ; 70 % , 81 % , and 19 % , respectively , no longer met criteria for their principal anxiety diagnosis . Gains were maintained at follow-up , with no significant differences between ICBT and CCAL . Parents and children rated all treatments acceptable , with CCAL and ICBT children rating higher satisfaction than CESA children . CONCLUSIONS Findings support the feasibility , acceptability and beneficial effects of CCAL for anxious youth . Discussion considers the potential of computer-assisted treatments in the dissemination of empirically supported treatments BACKGROUND Cognitive Behaviour Therapy self-help has been recommended in the NICE guidelines for the treatment of anxiety and depression . However , little is known about who benefits from self-help and the potential drawbacks and problems of using this approach . AIMS To address the current gap in knowledge , we contacted accredited BABCP practitioners to examine practitioner use and attitudes to self-help , current trends of use , and to identify possible problems with this therapy . METHOD A 50 % r and om sample of all accredited BABCP practitioners was approached , and the overall response rate for the survey was 57.6 % . RESULTS Self-help material s were seen positively by therapists and were used by 99.6 % , mainly as an adjunct to individual therapy . Only 38.2 % had been trained in the use of self-help , with those trained being more likely to recommend self-help . Higher levels of patient motivation , credibility , likely adherence , self-efficacy and a lower degree of hopelessness were the five factors identified by more than 70 % of respondents as predicting successful patient outcome with self-help . Non-compliance and a lack of detection of a worsening of the patient 's clinical state due to reduced therapist contact were viewed as being the most important problems with self-help by more than 70 % of respondents . CONCLUSIONS Preferable patient characteristics for self-help have been identified , as have potential problems and adverse consequences Background Little is known about the factors that influence acceptability of and adherence to online psychological interventions . Evidence is needed to guide further development of promising programs . Objective Our goal was to investigate users ’ views of two online approaches to self-help for depression : computerized cognitive behavior therapy ( cCBT ) and informational websites , in a workplace context . Computerized CBT offers an inexpensive and accessible alternative to face-to-face therapy , and employers have an interest in reducing the working time lost to depression or stress . Yet little is known about how employees , who have actual experience of using online approaches , judge the intervention as a process . Methods The qualitative data reported here were collected within an online r and omized controlled trial whose participants had diagnosable depression . The experimental intervention was a 5-week cCBT program called MoodGYM , and the control condition was five informational websites about mental health . Data were collected via online question naires . There was no evidence of the superiority of either in terms of treatment outcomes . In parallel , using brief rating scales and open-ended questions design ed for this purpose , we examined the relative acceptability of each approach over time , including perceptions of cCBT compared to seeing a health care professional . Results At least 60 % of participants held online therapy to be at least as acceptable as seeing a professional about mental health issues , and they were more likely to retain this opinion over time if they used the interactive program , MoodGYM , rather than informational websites alone . Barriers to cCBT use fell into four categories : intrinsic , intrapersonal problems ; extrinsic technical problems ; generic issues mostly pertaining to perceptions of cCBT ; and specific issues about the intervention or control condition . These indicate strategies for improving engagement . Conclusions As first-aid for mild to moderate mental health problems , evidence -based computerized approaches have broad acceptability . This could be increased by attending to the barriers noted here and by proactively managing users ’ expectations at individual and organizational levels . The findings have implication s for occupational health providers and others addressing the needs of working-age adults with depression . They also raise method ological issues for online research . Trial Registration International St and ard R and omized Controlled Trial Number ( IS RCT N ) : 24529487 ; http://www.controlled-trials.com/IS RCT N24529487 ( Archived by Webcite at http://www.webcitation.org/6O8cCL4mh ) Research suggests that the sequelae of childhood anxiety disorders , if left untreated , can include chronic anxiety , depression , and substance abuse . The current study evaluated the maintenance of outcomes of children who received a 16-week cognitive-behavioral treatment for primary anxiety disorders ( generalized , separation , and social anxiety disorders ) an average of 7.4 years earlier . The 86 participants ( ages 15 to 22 years ; 91 % of the original sample ) and their parents completed diagnostic interviews and self- and parent-report measures . According to the diagnostic interviews , a meaningful percentage of participants maintained significant improvements in anxiety at long-term follow-up . With regard to sequelae , positive responders to anxiety treatment , as compared with less positive responders , had a reduced amount of substance use involvement and related problems at long-term follow-up . The findings are discussed with regard to child anxiety and some of its sequelae Seventy-two clinical ly anxious children , aged 7 to 14 years , were r and omly allocated to clinic-based , cognitive-behavior therapy , the same treatment partially delivered via the Internet , or a wait-list control ( WL ) . Children in the clinic and clinic-plus-Internet conditions showed significantly greater reductions in anxiety from pre- to posttreatment and were more likely to be free of their anxiety diagnoses , compared with the WL group . Improvements were maintained at 12-month follow-up for both therapy conditions , with minimal difference in outcomes between interventions . The Internet treatment content was highly acceptable to families , with minimal dropout and a high level of therapy compliance Output:	RESULTS The findings together suggested that CBT programmes involving computerised elements were well received by children and their families , and its efficacy was almost as favourable as clinic-based CBT .
MS22348	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: PURPOSE Cancers rely on angiogenesis for their growth and dissemination . We hypothesized that thalidomide , an oral antiangiogenic agent , when combined with chemotherapy , and as maintenance treatment , would improve survival in patients with advanced non-small-cell lung cancer ( NSCLC ) . PATIENTS AND METHODS Seven hundred twenty-two patients were r and omly assigned to receive placebo or thalidomide capsules 100 to 200 mg daily for up to 2 years . All patients received gemcitabine and carboplatin every 3 weeks for up to four cycles . End points were overall survival ( OS ) , progression-free survival ( PFS ) , response rate , grade 3/4 toxicity , and quality of life ( QoL ) . RESULTS The median OS rates were 8.9 months ( placebo ) and 8.5 months ( thalidomide ) . The hazard ratio ( HR ) was 1.13 ( 95 % CI , 0.97 to 1.32 ; P = .12 ) . The 2-year survival rate was 16 % and 12 % in the placebo and thalidomide arms , respectively . The PFS results were consistent with those for OS . The risk of having a thrombotic event was increased by 74 % in the thalidomide group : HR of 1.74 ( 95 % CI , 1.20 to 2.52 ; P = .003 ) . There were no differences in hematologic toxicities , but a slight excess of rash and neuropathy in the thalidomide group . QoL scores were similar but thalidomide was associated with less insomnia , and more constipation and peripheral neuropathy . In a retrospective analysis , patients with nonsquamous histology in the thalidomide group had a poorer survival : 2-year risk difference of 10 % ( 95 % CI , 4 % to 16 % ; P < .001 ) . CONCLUSION In this large trial of patients with NSCLC , thalidomide in combination with chemotherapy did not improve survival overall , but increased the risk of thrombotic events . Unexpectedly , survival was significantly worse in patients with nonsquamous histology We present experience from a phase II r and omized clinical trial , comparing st and ard gemcitabine as monotherapy with low-dose gemcitabine in long infusion in a doublet with cisplatin at reduced dose for patients with non-small cell lung cancer ( NSCLC ) and who are unfit for st and ard platin-based chemotherapy . Eligible patients had microscopically confirmed NSCLC in stage IIIB ( wet ) or IV , were chemo-naive , and were in poor performance status or presented with significant comorbidity . St and ard treatment with gemcitabine , 1250 mg/m2 in 20–30 min on days 1 and 8 as monotherapy ( arm A ) was compared with low-dose gemcitabine in long infusion ( 200 mg/m2 in 6 h on day 1 ) and cisplatin at 60 mg/m2 on day 2 ( arm B ) . Both treatment schedules were repeated every 3 weeks until disease progression , unacceptable toxicity , or to a maximum of six cycles . A total of 112 patients ( 83 male , 29 female , median age 66 years ) were r and omized between arm A ( 57 patients ) and B ( 55 patients ) . The two groups were balanced for prognostic factors . Fifty-three patients in arm A and 52 in arm B received at least one application of chemotherapy and were evaluable for toxicity and response . The median number of cycles was four and five for arms A and B , respectively . Except for grade 3 anemia ( one patient in arm A and two in arm B ) , no other major toxicity was seen . Regarding response to treatment , arm B was superior : 1 complete response and 13 partial remissions ( response rate 26.9 % ) as compared with five partial remissions ( response rate 9.4 % ) in arm A ( P<0.01 ) . The median time to progression was 3.8 and 5.6 months , and the median survival was 4.3 and 6.8 months for arms A and B , respectively ( P<0.05 ) . Treatment with low-dose gemcitabine in long infusion and cisplatin at reduced dose has very low toxicity , is effective , was found to be superior to monotherapy with gemcitabine in st and ard doses , and is suitable for patients with NSCLC who can not tolerate a st and ard platin-based doublet PURPOSE To determine the radiosensitizing effect of prolonged exposure of carboplatin in patients with locally unresectable non-small-cell lung cancer ( NSCLC ) . PATIENTS AND METHODS Patients with histologically proven NSCLC , performance score < 2 , weight loss < 10 % , and normal organ functions were r and omized between carboplatin 840 mg/m2 administered continuously during 6 weeks of radiotherapy or thoracic radiotherapy alone ( both 60 Gy ) . Toxicity was evaluated with National Cancer Institute Common Toxicity Criteria ( NCI CTC ) and the Radiation Therapy Oncology Group ( RTOG ) criteria . Quality of life was measured with European Organization for Research and Treatment of Cancer ( EORTC ) QLQ-C30/LC13 question naires . RESULTS One-hundred and sixty patients were included . Pathologically confirmed persistent tumor was present in 53 % of patients in the combination arm versus 58 % in the radiotherapy alone arm ( P=0.5 ) . Median survival in the combination arm was 11.8 [ 95 % confidence interval ( CI ) 9.3 - 14.2 ] months and in the radiotherapy alone arm 11.7 ( 95 % CI 8.1 - 15.5 ) months ; progression-free survival was not different between arms [ 6.8 and 7.5 months , respectively ( P=0.28 ) ] . Acute toxicity was mild , late toxicity was radiation-induced cardiomyopathy ( three patients ) and pulmonary fibrosis ( five patients ) . Quality of life was not different between arms , but in all measured patients cough and dyspnea improved , pain became less , and slight paresthesia developed 3 months after treatment . CONCLUSION Addition of continuously administered carboplatin as radiosensitizer for locally unresectable NSCLC does not improve local tumor control or overall survival BACKGROUND AND PURPOSE To compare the course of symptoms and health-related quality -of-life ( HRQOL ) after immediate thoracic radiotherapy ( TRT ) between symptomatic ( S ) and non-symptomatic ( NS ) patients with advanced NSCLC . PATIENTS AND METHODS 407 stage III/IV patients were initially treated with immediate TRT within a r and omised phase III trial comparing different fractionation schedules . At inclusion , patients were prospect ively stratified according to presence ( S ) or absence ( NS ) of tumour-related chest/airway symptoms to facilitate comparison between these groups . The EORTC QLQ-C30 and LC-13 were used for symptom and HRQOL assessment s at baseline and at regular intervals up to 1 year ( N=395 ) . RESULTS NS patients had significantly more favourable baseline characteristics when compared to S patients with a median survival of 11.8 versus 6.0 months ( P<0.0001 ) , respectively . At baseline , S patients demonstrated HRQOL scores inferior to those of NS patients ( P<0.01 ) for most scales . Until week 14 , NS patients developed more symptoms while S patients experienced symptom relief in most scales . After week 14 , no significant differences could be observed between the groups . CONCLUSION This study indicates that immediate TRT , given to patients with minimal/none chest symptoms , does not prevent development of disease-related symptoms and diminished HRQOL . A wait- and -see policy appears to be acceptable PURPOSE Gemcitabine plus carboplatin ( GC ) is active as front-line treatment for advanced non-small-cell lung cancer ( NSCLC ) . For patients without progression , timing of second-line chemotherapy for optimum clinical benefit remains uncertain . This phase III , r and omized trial assessed the efficacy and safety of docetaxel administered either immediately after GC or at disease progression . PATIENTS AND METHODS The chemotherapy-naïve patients enrolled had either stage IIIB NSCLC with pleural effusion or stage IV NSCLC . Gemcitabine ( 1,000 mg/m(2 ) ) was administered on days 1 and 8 followed by carboplatin ( area under the curve = 5 ) on day 1 . After four 21-day cycles , patients who did not have progression were r and omly assigned either to an immediate docetaxel group ( docetaxel 75 mg/m(2 ) on day 1 every 21 days , with maximum of six cycles ) or to a delayed docetaxel group . The primary end point was overall survival ( OS ) measured from r and om assignment . Additional analyses included tumor response , toxicity , progression-free survival ( PFS ) , and quality of life ( QOL ) . RESULTS Enrollment totaled 566 patients ; 398 patients completed GC ; 309 patients were r and omly assigned equally to the two docetaxel treatment groups . Toxicity profiles were generally comparable for the docetaxel groups . Median PFS for immediate docetaxel ( 5.7 months ) was significantly greater ( P = .0001 ) than for delayed docetaxel ( 2.7 months ) . Median OS for immediate docetaxel ( 12.3 months ) was greater than for delayed docetaxel ( 9.7 months ) , but the difference was not statistically significant ( P = .0853 ) . QOL results were not statistically different ( P = .76 ) between docetaxel groups . CONCLUSION We observed a statistically significant improvement in PFS and a nonstatistically significant increase in OS when docetaxel was administered immediately after front-line GC , without increasing toxicity or decreasing QOL The purpose of our study was to compare progression-free survival and quality of life ( QOL ) after cisplatin – gemcitabine ( CG ) or epirubicin – gemcitabine ( EG ) in chemotherapy-naive patients with unresectable non-small-cell lung cancer . Patients ( n=240 ) were r and omised to receive gemcitabine 1125 mg m−2 ( days 1 and 8) plus either cisplatin 80 mg m−2 ( day 2 ) or epirubicin 100 mg m−2 ( day 1 ) every 3 weeks for a maximum of five cycles . Eligible patients had normal organ functions and Eastern Cooperative Oncology Group performance status ⩽2 . QOL was measured with European Organisation for Research and Treatment of Cancer QLQ-C30 and LC13 question naires . There were no significant differences in median progression-free survival ( CG 26 weeks , EG 23 weeks ) , median overall survival ( CG 43 weeks , EG 36 weeks ) , or tumour response rates ( CG 46 % , EG 36 % ) . Toxicity was mainly haematologic . In the EG arm granulocytopenia occurred more frequently , leading to more febrile neutropenia . Also , elevation of serum transaminases , mucositis , fever , and decline in LVEF were more common in the EG arm . In the CG arm , more patients experienced elevated serum creatinine levels , sensory neuropathy , nausea , and vomiting . Global QOL was not different in both arms . Progression-free survival , overall survival , response rate , and QOL were not different between both arms ; however , overall toxicity was more severe in the EG arm Objective : Gemcitabine in low dose in prolonged infusion is a treatment with documented activity against a variety of tumors . We here report the first r and omized trial to compare st and ard brief and low-dose prolonged infusion of gemcitabine . Patients and Methods : Eligible patients had non-small cell lung cancer in stage IIIB ( wet ) or IV , Karnofsky performance status 100 to 70 ( Eastern Cooperative Oncology Group 0–2 ) , measurable disease , were chemonaïve and fulfilled the st and ard criteria for chemotherapy . In arm A ( st and ard treatment ) , gemcitabine was given at 1250 mg/m2 in 20 to 30 minutes and in arm B ( prolonged infusion ) at 250 mg/m2 in 6 hours infusion . All patients received gemcitabine on days 1 and 8 and cisplatin at 75 mg/m2 on day 2 of a 3-week cycle for four cycles , followed by two cycles of gemcitabine as monotherapy . Results : A total of 249 patients ( 188 men and 61 women , median age 58 years ) were r and omized between arm A ( 125 patients ) and arm B ( 124 patients ) . Adenocarcinoma ( 53.9 % ) was the predominant histologic type ; 92 % of patients were in stage IV . The two groups were balanced for prognostic factors ; however , group A had fewer patients with significant weight loss and no patient with lung cancer as a second malignancy or after radiotherapy for brain metastases . Grade 3 or greater toxicity was rare : anemia in 0.8 and 3.2 % , neutropenia in 21.6 and 22.6 % , thrombocytopenia in 0 and 1.6 % , and nausea/vomiting in 4 and 8.1 % for arms A and B , respectively . Alopecia was seen in 54.5 % of patients in arm B , as compared with 9. Output:	The quality of HRQOL reporting has improved ; both reporting of clinical ly significant differences and statistical testing of HRQOL have improved . The number of NSCLC RCTs incorporating HRQOL assessment s has considerably increased . HRQOL continues to demonstrate its importance in RCTs , especially in those studies in which no OS difference is found .
MS22349	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: UNLABELLED Both nadolol and ligation have proved to be effective in the prophylaxis of first variceal bleeding . This study was conducted to evaluate the effects and safety of combining nadolol with ligation . Cirrhotic patients with high-risk esophageal varices but without a bleeding history were considered for enrolment . Eligible patients were r and omized to receive b and ligation plus nadolol ( Combined group , 70 patients ) or nadolol alone ( Nadolol group , 70 patients ) . In the Combined group multiligators were applied . Patients received regular ligation treatment at an interval of 4 weeks until variceal obliteration . Nadolol was administered at a dose to reduce 25 % of the pulse rate in both the Combined group and the Nadolol group . Both groups were comparable in baseline data . In the Combined group 50 patients ( 71 % ) achieved variceal obliteration . The mean dose of nadolol was 52 + /- 16 mg in the Combined group and 56 + /- 19 mg in the Nadolol group . During a median follow-up of 26 months , 18 patients ( 26 % ) in the Combined group and 13 patients ( 18 % ) in the Nadolol group experienced upper gastrointestinal bleeding ( P = NS ) . Esophageal variceal bleeding occurred in 10 patients ( 14 % ) in the Combined group and nine patients ( 13 % ) in the Nadolol group ( P = NS ) . Adverse events were noted in 48 patients ( 68 % ) in the Combined group and 28 patients ( 40 % ) in the Nadolol group ( P = 0.06 ) . Sixteen patients in each group died . CONCLUSION The addition of ligation to nadolol may increase adverse events and did not enhance effectiveness in the prophylaxis of first variceal bleeding OBJECTIVES We sought to evaluate the effects of carvedilol on mortality and morbidity in dialysis patients with dilated cardiomyopathy . BACKGROUND Several lines of evidence support the concept that therapy with beta-blocking agents reduces morbidity and mortality in patients with congestive heart failure ( HF ) , but the demonstration of such a survival benefit in dialysis patients with dilated cardiomyopathy is still lacking . METHODS A total of 114 dialysis patients with dilated cardiomyopathy were r and omized to receive either carvedilol or placebo in addition to st and ard therapy . A first analysis was performed at one year and was followed by an additional follow-up period of 12 months . RESULTS Two-year echocardiographic data revealed a significant attenuation of pathologic remodeling , with smaller cavity diameters and higher ejection fractions in the active treatment group than in the placebo group . At two years , 51.7 % of the patients died in the carvedilol group , compared with 73.2 % in the placebo group ( p < 0.01 ) . Furthermore , there were significantly fewer cardiovascular deaths ( 29.3 % ) and hospital admissions ( 34.5 % ) among patients receiving carvedilol than among those receiving a placebo ( 67.9 % and 58.9 % , respectively ; p < 0.00001 ) . The exploratory analyses revealed that fatal myocardial infa rct ions , fatal strokes , and hospital admissions for worsening HF were lower in the carvedilol group than in the placebo group . A reduction in sudden deaths and pump-failure deaths was also observed , though it did not reach statistical significance . CONCLUSIONS Carvedilol reduced morbidity and mortality in dialysis patients with dilated cardiomyopathy . These data suggest the use of carvedilol in all dialysis patients with chronic HF Factors determining in-hospital mortality and long-term survival of patients hospitalised with acute exacerbations of chronic obstructive pulmonary disease ( AE COPD ) are not precisely understood . The aim of the present study was to assess the parameters related to in-hospital mortality and long-term survival after hospitalisation of patients with AE COPD . Clinical and epidemiological parameters on admission in 205 consecutive patients hospitalised with AE COPD were prospect ively assessed . Patients were followed-up for 3 yrs . Factors determining short- and long-term mortality were analysed . In total , 17 patients ( 8.3 % ) died in hospital . In-hospital mortality was significantly associated with lower arterial oxygen tension ( Pa , O2 ) , higher carbon dioxide arterial tension , lower arterial oxygen saturation and longer hospital stay . The overall 6-month mortality rate was 24 % , with 1- , 2- and 3-yr mortality rates of 33 % , 39 % and 49 % , respectively . Cox regression analysis revealed that long-term mortality was associated with longer disease duration ( relative risk ( RR ) = 1.158 ) , lower albumin ( RR = 0.411 ) , lower Pa , O2 ( RR = 0.871 ) and lower body mass index ( RR = 0.830 ) . When the model was run for the time elapsed since first hospitalisation , it also appeared as statistically significant ( RR = 1.195 ) . These findings show that patients hospitalised with acute exacerbations of chronic obstructive pulmonary disease have poor short- and long-term survival . Prediction of survival status may be enhanced by considering arterial oxygen tension , albumin , body mass index , disease duration and time elapsed since the first hospitalisation CONTEXT Estimating life expectancy is challenging in advanced dementia , potentially limiting the use of hospice care in these patients . OBJECTIVE To prospect ively vali date and compare the performance of the Advanced Dementia Prognostic Tool ( ADEPT ) and hospice eligibility guidelines to estimate 6-month survival in nursing home residents with advanced dementia . DESIGN , SETTING , AND PARTICIPANTS A prospect i ve cohort study conducted in 21 nursing homes in Boston , Massachusetts , of 606 residents with advanced dementia who were recruited between November 1 , 2007 , and July 30 , 2009 . Data were ascertained at baseline to determine the residents ' ADEPT score ( range , 1.0 - 32.5 ; higher scores indicate worse prognosis ) and whether they met Medicare hospice eligibility guidelines . Survival was followed up to 6 months . MAIN OUTCOME MEASURES Assessment and comparison of the performance of the ADEPT score and hospice guidelines to predict 6-month survival using sensitivity , specificity , and the area under the receiver operating characteristic ( AUROC ) curve . RESULTS At baseline , the residents ' mean ( SD ) ADEPT score was 10.1 ( 3.1 ) points and 65 residents ( 10.7 % ) met hospice eligibility guidelines . Over 6 months , 111 residents ( 18.3 % ) died . The AUROC for the ADEPT score 's prediction of 6-month mortality as a continuous variable was 0.67 ( 95 % confidence interval [ CI ] , 0.62 - 0.72 ) . The AUROC for Medicare hospice eligibility guidelines was 0.55 ( 95 % CI , 0.51 - 0.59 ) , the specificity was 0.89 ( 95 % CI , 0.86 - 0.92 ) , and the sensitivity was 0.20 ( 95 % CI , 0.13 - 0.28 ) . Using a cutoff of 13.5 on the ADEPT score , which also had specificity of 0.89 , the AUROC was 0.58 ( 95 % CI , 0.54 - 0.63 ) and the sensitivity was 0.27 ( 95 % CI , 0.19 - 0.36 ) . CONCLUSIONS When prospect ively vali date d at the bedside and used as a continuous measure , the ability of the ADEPT score to identify nursing home residents with advanced dementia at high risk of death within 6 months was modest , albeit better than hospice eligibility guidelines . Care provided to these residents should be guided by their goals of care rather than estimated life expectancy BACKGROUND Malnutrition is prevalent in elderly population s. Recommended methods of nutritional screening are often too complicated and time-consuming for routine application in frail , very old , hospitalized patients . OBJECTIVE Our aims were to identify risk factors for development of malnutrition in very old hospitalized patients and to evaluate the total Mini Nutritional Assessment ( MNA ) score and MNA subscores as predictors of in-hospital and long-term mortality . DESIGN A prospect i ve cohort study of patients aged > or = 75 y was conducted in a geriatric hospital . Assessment included demographic , clinical , and laboratory data and cognitive , functional , and nutritional status . Follow-up was conducted for < or = 2.7 y. RESULTS Of the 414 patients studied , only 73 ( 17.6 % ) were well-nourished . Low serum albumin and phosphorus concentrations , dementia , and cerebrovascular accident ( CVA ) were significant risk factors for malnutrition . Survival was significantly lower in malnourished patients and patients at risk of malnutrition than in well-nourished patients ( P < 0.0001 ) . Low MNA-3 subscores ( dietary habits ) were significantly correlated with laboratory indexes of malnutrition and were significantly lower in patients with infections , malignancy , pressure ulcers , dementia , recent orthopedic surgery , and CVA . Multivariate analysis showed that a low MNA-3 score was an independent predictor of mortality ; scores < 7.5 increased the risk of death 2.05-fold . CONCLUSIONS The prevalence of malnutrition was high in elderly hospitalized patients . Dietary habits were significant predictors of poor hospitalization outcome . A question naire on dietary habits can serve as a useful tool in assessing nutritional status and prognosis in elderly patients BACKGROUND / AIM Hepatorenal syndrome ( HRS ) is associated with a poor prognosis . The incidence and prognostic impact of kidney dysfunction due to other causes in cirrhotic patients are less well known . The current study prospect ively evaluated the incidence and the prognostic relevance of different etiologies of kidney failure in cirrhotic patients . METHODS Eighty-eight consecutive patients with cirrhosis and serum creatinine > or = 1.5 mg/dl were enrolled . The etiologies of kidney dysfunction were analyzed , and prognostic factors including Model for End-Stage Liver Disease ( MELD ) score were evaluated in a multivariate Cox model . RESULTS HRS was present in 35 ( 40 % ) patients ( 15 HRS 1 , 20 HRS 2 ) , followed by renal parenchymal disease ( 23 % ) , drug-induced kidney dysfunction ( 19 % ) and prerenal failure due to bleeding or infections ( 15 % ) . HRS patients had a significantly higher MELD score and shorter survival . In addition to the MELD score , only HRS 1 was independently predictive for survival . HRS 2 patients had a similar outcome as patients with non-HRS kidney dysfunction . CONCLUSIONS In patients with cirrhosis and renal failure , hepatorenal syndrome is associated with a worse prognosis than kidney dysfunction due to other conditions but only HRS type 1 has independent prognostic relevance in addition to the MELD score in these patients BACKGROUND A supplemented very-low-protein diet ( sVLPD ) seems to be safe when postponing dialysis therapy . STUDY DESIGN Prospect i ve multicenter r and omized controlled study design ed to assess the noninferiority of diet versus dialysis in 1-year mortality assessed by using intention-to-treat and per- protocol analysis . SETTING & PARTICIPANTS Italian uremic patients without diabetes older than 70 years with glomerular filtration rate of 5 to 7 mL/min ( 0.08 to 0.12 mL/s ) . INTERVENTION R and omization to an sVLPD ( diet group ) or dialysis . The sVLPD is a vegan diet ( 35 kcal ; proteins , 0.3 g/kg body weight daily ) supplemented with keto-analogues , amino acids , and vitamins . Patients following an sVLPD started dialysis therapy in the case of malnutrition , intractable fluid overload , hyperkalemia , or appearance of uremic symptoms . OUTCOMES & MEASUREMENTS Mortality , hospitalization , and metabolic markers . RESULTS 56 patients were r and omly assigned to each group , median follow-up was 26.5 months ( interquartile range , 40 ) , and patients in the diet group spent a median of 10.7 months ( interquartile range , 11 ) following an sVLPD . Forty patients in the diet group started dialysis treatment because of either fluid overload or hyperkalemia . There were 31 deaths ( 55 % ) in the dialysis group and 28 deaths ( 50 % ) in the diet group . One-year observed survival rates at intention to treat were 83.7 % ( 95 % confidence interval [ CI ] , 74.5 to 94.0 ) in the dialysis group versus 87.3 % ( 95 % CI , 78.9 to 96.5 ) in the diet group ( log-rank test for noninferior Output:	Even though advanced noncancer syndromes differ clinical ly , a universal set of prognostic factors signals progression to terminal disease , including poor performance status , advanced age , malnutrition , comorbid illness , organ dysfunction , and hospitalization for acute decompensation . Generally , a 6-month median survival is associated with the presence of 2 - 4 of these factors . With few exceptions , these terminal presentations are quite refractory to treatment . There is little evidence at present that treatment prolongs survival at these terminal stages
MS22350	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: A prospect i ve study of patients with chronic low-back pain was made to determine the significance of the patient 's own prediction of the outcome of a vocational rehabilitation program . Fifty-two patients were screened , and their work situation determined one and 4 years after the rehabilitation program was started . The patients predicted the outcome correctly in 69 % , with a sensitivity of 68 % and a specificity of 71 % . A statistically significant correlation was found between the patient 's prediction and the recommendations given by the rehabilitation unit OBJECTIVE There is accumulating evidence to indicate that the illness representations of significant others are important for underst and ing patients ' responses to chronic disease . The aims of the present study were to ( a ) assess the illness representations of patients with type 2 diabetes and their partners , ( b ) determine the extent of agreement between patient and partner representations , and ( c ) examine whether partners ' representations mediate the relationships between patients ' representations and their prospect i ve self-management behaviors . METHODS Patients ' and partners ' representations of diabetes were assessed with the Revised Illness Perception Question naire [ Moss-Morris R , Weinman J , Petrie K , Horne R , Cameron LD , Buick , D. The revised illness perception question naire ( IPQ-R ) . Psychol Health 2002;17:116 ] at baseline ( n=164 ) . Self-management behaviors were assessed 12 months later with self-report measures of physical activity , medication , and a food frequency question naire . RESULTS Patients scored lower on the illness coherence dimension , indicating that they reported a poorer underst and ing of the condition ( t=-2.66 , df=163 , P=.009 ) relative to their partners . Patients demonstrated higher scores for personal control than their partners ( t=2.01 , df=163 , P=.046 ) . Mediational analyses indicated that partners ' perceived timeline of diabetes partially mediated the relationship between patients ' representations and their self-management behaviors including physical activity and dietary intake . In addition , partners ' personal control representations partially mediated the relationship between patients ' representations and physical activity . CONCLUSION It was demonstrated that patient-partner dyads generally share similar representations of type 2 diabetes and perceived control over the condition . Furthermore , there was evidence that partners ' representations partially mediated the relationships between patients ' representations and their prospect i ve self-management behaviors Dysfunctional beliefs and attitudes about sleep are presumed to play an important mediating role in perpetuating insomnia . The present study evaluated the impact of cognitive-behavioral and pharmacological treatments for insomnia on sleep-related beliefs and attitudes and the relationship between those changes and sleep improvements . The participants were older adults with chronic and primary insomnia . They received cognitive-behavior therapy ( CBT ) , pharmacotherapy ( PCT ) , combined CBT+PCT ( COMB ) , or a medication placebo ( PLA ) . In addition to daily sleep diaries and sleep laboratory measures , the participants completed the dysfunctional beliefs and attitudes about sleep scale ( DBAS ) at baseline and posttreatment , and at 3- , 12- and 24-month follow-up assessment s. The results showed that CBT and COMB treatments produced greater improvements of beliefs and attitudes about sleep at posttreatment than PCT and PLA . Reductions of DBAS scores were significantly correlated with improvements of sleep efficiency as measured by daily sleep diaries and by polysomnography . In addition , more adaptive beliefs and attitudes about sleep at posttreatment were associated with better maintenance of sleep improvements at follow-ups . These findings highlight the importance of targeting sleep-related beliefs and attitudes in the treatment of insomnia Medication noncompliance occurs among as many as one-third to one-half of all medical and psychiatric out patients . Noncompliance has serious consequences for individuals diagnosed with schizophrenia , often result ing in higher rates of relapse and rehospitalization , and poorer community adjustment . Health education interventions have been shown to be effective in promoting compliance among patients with chronic medical illnesses such as hypertension or diabetes , but there have been few r and omized trials of this approach among patients with chronic psychiatric disorders . This paper presents the results of an application of health education among a group of male psychiatric out patients . Two interventions were developed which used health education techniques to 1 ) engage families or significant others as active participants in the aftercare process , and 2 ) train patients to become effective health care consumers . A total of 418 individuals participated in a six-month trial over a four-year study . Both interventions significantly improved medication compliance among those who received them . The results show that comparatively brief interventions can significantly alter medication compliance behavior and improve the quality of life for patients with chronic psychiatric disorders Although alcohol use disorders ( AUDs ) adversely affect women , research on efficacious treatments for women is limited . In this r and omized efficacy trial of 102 heterosexual women with AUDs , the authors compared alcohol behavioral couple therapy ( ABCT ) and alcohol behavioral individual therapy ( ABIT ) on percentage of days abstinent ( PDA ) and percentage of days of heavy drinking ( PDH ) over 6 months of treatment and 12 months of posttreatment follow-up . Baseline relationship functioning and comorbid disorders were tested as moderators of outcome . Piecewise linear growth models were used to model outcomes . During treatment , women increased their PDA and decreased their PDH , with significantly greater improvements in ABCT than in ABIT ( d = 0.59 for PDA ; d = 0.79 for PDH ) . Differences favoring ABCT were maintained during follow-up . Women with poorer baseline relationship functioning improved more on PDA during treatment with ABCT than with ABIT . For PDH , results during treatment and follow-up favored ABCT for women with better baseline relationship functioning . ABCT result ed in better outcomes than ABIT for women with Axis I disorders at the end of follow-up ( PDA ) , and for women with Axis II disorders at the end of treatment ( PDA ) and at the end of follow-up ( PDH ) Output:	Consistent evidence was found that SOs ’ positive and encouraging attitudes regarding work participation , encouragement and motivating behaviour and open communication with patients are facilitators for work participation . Consistently reported barriers were SOs ’ positive attitudes towards sickness absence and advise , encouragement or pressure to refrain from work . Conclusions Our findings show that several cognitions and behaviours of SOs can facilitate or hinder work participation of individuals with a chronic disease . Intervening on these factors by involving SOs in disability prevention and return to work intervention strategies may be beneficial .
MS22351	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: Background : Bacterial sepsis is one of the major causes of mortality in newborn infants . Mortality increases when sepsis is associated with neutropenia . Material s and Methods : We conducted a prospect i ve , r and omized , double-blind , placebo-controlled trial of recombinant human granulocyte colony-stimulating factor on preterm neonates ( gestational age ( GA ) < 34 weeks ) with sepsis and absolute neutrophil count ( ANC ) of < 1500 cells/mm3 . Mortality , duration of Neonatal Intensive Care Unit ( NICU ) stay , hematological parameters ( ANC , platelet count , and total leukocyte count ) were compared between the two groups . The GCSF group ( n=39 ) received GCSF intravenously in a single daily dose of 10 μg/kg/day in a 5 % dextrose solution over 20 - 40 min for three consecutive days , while the control group ( n=39 ) received placebo of an equivalent volume of 5 % dextrose . Results : Baseline demographic profile among the two groups was comparable . Mortality rate in the GCSF group was significantly lower than in the control group ( 10 % vs. 35 % ; P<0.05 ) . By day 3 of treatment , ANC in the GCSF group was significantly higher ( 3521±327 ) compared to 2094±460 in the control group , with P value being < 0.05 . Duration of NICU stay also decreased significantly in the GCSF group . Conclusion : The administration of GCSF in preterms with septicemia and neutropenia result ed in lower mortality rates . Further studies are required to confirm our results and establish this adjunctive therapy in neonatal sepsis Neonates are susceptible to septicemia secondary to quantitative and qualitative neutrophilic defects . Granulocyte colony-stimulating factor ( G-CSF ) stimulates myeloid progenitor cell proliferation and induces selective neutrophil functions . The authors aim ed to evaluate the effect of G-CSF administration in septic neonates on neutrophil production and CD11b expression . Sixty septic neonates were r and omized to receive intravenous G-CSF 10 μg/kg/day for 3 days ( G-CSF group , n = 30 ) , or not to receive G-CSF ( non – G-CSF group , n = 30 ) . Thirty healthy newborns were included as controls . Laboratory investigations included complete blood count , C-reactive protein , blood culture , renal and liver function tests , and assessment of neutrophilic expression of CD11b . Total leukocytes count ( TLC ) , absolute neutrophil count ( ANC ) , and immature myeloid cell count in G-CSF group showed significant difference between post– and pre – G-CSF levels . TLC , ANC , immature myeloid cell count and immature/total myeloid cells ratio were higher in G-CSF group compared to non – G-CSF group on days 1 and 3 . Higher neutrophilic expression of CD11b was reported in both septic groups on day 0 compared to control group . On day 5 , CD11b was higher in G-CSF group than non – G-CSF group . G-CSF improved CD11b% in neutropenic and non-neutropenic septic neonates . No significant difference was found between pre- and posttreatment renal and liver function tests . Lower duration of antibiotic intake and hospitalization was observed in G-CSF group compared to non – G-CSF group . G-CSF administration as an adjuvant therapy for neonatal septicemia , whether neutropenic or not , improves neutrophilic count and function and contributed to early healing from sepsis BACKGROUND To investigate the efficacy and safety of recombinant human granulocyte colony-stimulating factor , recombinant human granulocyte-macrophage colony-stimulating factor ( rhG-CSF ) to treat sepsis in neutropenic preterm infants . METHODS Fifty-six neutropenic preterm infants with suspected or culture-proven sepsis hospitalized in Zeynep Kamil Maternity and Children 's Educational and Training Hospital , Kozyatağı/Istanbul , Turkey between January 2008 and January 2010 were enrolled . Patients were r and omized either to receive rhG-CSF plus empirical antibiotics ( Group I ) or empirical antibiotics alone ( Group II ) . Clinical features were recorded . Daily complete blood count was performed until neutropenia subsided . Data were analyzed using SPSS version 11.5 . RESULTS Thirty-three infants received rhG-CSF plus antibiotic treatment and 23 infants received antibiotic treatment . No drug-related adverse event was recorded . Absolute neutrophil count values were significantly higher on the 2(nd ) study day and 3(rd ) study day in Group I. Short-term mortality did not differ between the groups . CONCLUSION Treatment with rhG-CSF result ed in a more rapid recovery of ANC in neutropenic preterm infants . However , no reduction in short-term mortality was documented In a prospect i ve double‐blind study , st and ard intravenous immunoglobulin ( IVIG ) was compared with an IgM‐enriched IVIG in the treatment of neonatal sepsis . The two treatment groups were also compared with matched controls . One hundred and thirty babies ( 65 in each group ) ranging from 0 to 24 days old , 480 to 4200 g in weight and born between 24 and 42 weeks of gestation who had , or were suspected of having , sepsis were given either st and ard IVIG or IgM‐enriched IVIG ( 250 mg/kg per day ) for 4 days in addition to supportive and antibiotic therapy . A further 65 babies who received similar supportive , antibiotic and fluids but not IVIG were used as matched controls . Mortality from infection in ‘ culture proven sepsis ’ was 3/44 ( 6·8 % ) in the IgM‐enriched IVIG group , 6/42 ( 14·2 % ) in the st and ard IVIG group , and 11/43 ( 25·5 % ) in the control group ( P = 0·017 , IgM versus control , P = 019 st and ard IVIG versus control ) . There was no statistical difference in the outcome between the two immunoglobulin therapy groups ( P = 0·25 ) . The study indicates that IVIG improves outcome in neonatal sepsis when used as an adjunct to supportive and antibiotic therapy , but larger studies are required to confirm this OBJECTIVES The primary objective was to investigate the safety of recombinant human granulocyte colony stimulating factor ( rhG-CSF ) for the treatment of very low birthweight infants ( VLBW ) with sepsis and relative neutropenia , specifically with regard to worsening of respiratory distress and thrombocytopenia and all cause mortality . Secondary objectives were to evaluate duration of ventilation , intensive care , and antibiotic use as markers of efficacy . DESIGN Neonates ( ⩽ 28 days ) in intensive care , with birth weights of 500–1500 g , absolute neutrophil count ( ANC ) of ⩽ 5 × 109/l , and clinical evidence of sepsis , were r and omly assigned to receive either rhG-CSF ( 10 μg/kg/day ) administered intravenously ( n = 13 ) , or placebo ( n = 15 ) for a maximum of 14 days , in addition to st and ard treatment and antibiotics . All adverse events , oxygenation index , incidence of thrombocytopenia , all cause mortality , duration of ventilation , intensive care and antibiotic treatment , and ANC recovery were compared between the two groups . RESULTS Adverse events and oxygenation index were not increased by , and thrombocytopenia was not attributable to , treatment with rhG-CSF . At 6 and 12 months postmenstrual age , there were significantly fewer deaths in the group receiving rhG-CSF ( 1/13 v 7/15 ; p ⩽ 0.038 ) . There was a non-significant trend towards a reduction in duration of ventilation , intensive care , and antibiotic use in the rhG-CSF group . There was a significantly more rapid increase in ANC in the rhG-CSF treated babies ( p < 0.001 ) . CONCLUSIONS In a small r and omised placebo controlled trial in a highly selected group of neonates , adjuvant treatment with rhG-CSF increased ANC rapidly , and no treatment related adverse events were identified . Mortality at 6 and 12 months postmenstrual age was significantly lower in the treatment group . A large trial investigating efficacy in a similar group of neonates is warranted . Key messages rhG-CSF increases the absolute neutrophil count in very low birthweight infants with neutropenia and sepsis Thrombocytopenia is not an effect of rhG-CSF treatment Potential beneficial effects on long term survival require further In a double blind controlled study antilipopolysaccharide gammaglobulin given intramuscularly did not reduce mortality in low birthweight babies suffering from septicaemia . It did , however , reduce the recovery period of survivors from 310 to 120 hours Thirty-seven neonates with confirmed septicemia through hemoculture were studied . Of them , 18 were treated with antibiotic and the other 19 were given 500 mg/kg of intravenous immunoglobin with a pH of 4.25 ( IGIV ) . The greater part of the neonates in this study were full-term or near full-term . There were no differences in age , gestational age and weight , nor in mortality , the bacterias found and the clinical manifestations which were seen in both groups . Yet , the hospitalary stay was shorter for those in the group treated with IGIV ( 13.9 + /- 5.7 days ) than in the trial group ( 24.4 + /- 10.3 days ) ; as well as some clinical manifestations like diarrhea and splenomegalia ( P < 0.05 ) . The serum of the neonates from the IGIV group showed a greater capacity of opsonization and inhibition of bacterial growth than those in the trial group ( P < 0.001 ) , coinciding with an increase of 300 mg/dL in the serum levels of IgG of the group treated with IGIV from the 3rd day of the study and the C4 and B-Properdine factor serum levels from the 7th day of the study , while in the trial group , there were no changes in these factors ( P < 0.001 ) . Even though no differences were seen in the mortality rate due to septicemia , the results suggest a much shorter evolution of the illness in patients treated with IGIV . In addition , the serum of those patients treated with IGIV showed in in vitro studies , a better bacteriostatic activity and a better capacity to opsonize the bacterias isolated in the hemocultures . ( ABSTRACT TRUNCATED AT 250 WORDS Objective . Preterm neonates undergoing intensive care have high morbidity from sepsis . These infants also frequently develop neutropenia , and when this is associated with sepsis , mortality is high . This study investigates the potential for granulocyte-macrophage colony-stimulating factor ( GM-CSF ) to effect a clinical ly relevant increase in neutrophil number when used prophylactically in high-risk preterm neonates , and assesses its safety in this population . Design . In an open , r and omized , controlled study , 75 neonates ( 25 small for gestational age ) < 32 weeks gestation were r and omized to receive GM-CSF ( 10 μg/kg/d ) by subcutaneous injection for 5 days from < 72 hours after birth , or to a control group . The primary outcome measure was the neutrophil count during 14 days from study entry . The infants were monitored for potential toxicity . Clinical outcomes , sepsis , and mortality , were recorded , but this initial study was not design ed to address clinical benefit . Results . Prophylactic GM-CSF therapy completely abolished neutropenia in treated infants , when both well and septic , throughout the period of study . Neutropenia ( ≤1.7 × 109/L ) developed in 16 of 39 control infants . Five control infants experienced an acute decrease in neutrophil count coincident with the onset of sepsis . There was no evidence of hematologic , respiratory , or gastrointestinal toxicity in treated infants . Treated infants had a trend to fewer symptomatic , blood culture positive septic episodes than controls during 2 weeks from study entry ( 11/36 vs 18/39 ) . Conclusion . Five-day prophylactic GM-CSF completely abolishes postnatal neutropenia and sepsis-induced neutropenia in preterm neonates at high risk of sepsis , and so removes an important risk factor for sepsis and sepsis-related mortality . GM-CSF , preterm neonates , neutropenia , sepsis Abstract The objective of this study was to investigate the effect of treatment with recombinant human granulocyte-colony stimulating factor ( rhG-CSF ) on the neutrophil count and function of preterm neonates with documented sepsis . For this purpose 62 preterm neonates with proven sepsis and 19 healthy preterm ones were studied . Of the 62 patients , 27 septic neonates had an absolute neutrophil count ( ANC ) > 5000/mm3 ( group A ) and were scheduled not to receive rhG-CSF and 35/62 Output:	Conclusions No significant differences in all-cause mortality or the duration of hospital stay were found in neonates with suspected or proven sepsis treated with the four types of immunotherapies and those treated with placebo
MS22352	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: PURPOSE Evaluation of night glare after excimer laser in situ keratomileusis ( LASIK ) using two different ablation zone diameters . METHODS One hundred and twenty eyes of 60 consecutive myopic patients received LASIK with the Nidek EC-5000 excimer laser . Eyes were r and omized so that every patient had a single ablation zone of 5.5 mm on one eye and an ablation zone of 5.5 mm with a transition zone of 1.0 mm diameter larger on the other eye . Night glare was measured by two methods ; a spot light test and a subjective question naire . RESULTS At 6 months , 54 patients ( 90 % ) were examined ; results of the spot light test showed that 40 patients ( 74.1 % ) perceived more glare with the eye with the single ablation zone ; the subjective question naire indicated that 22 patients ( 40.7 % ) had more night glare with the eye with a single ablation zone compared to the other eye . The use of the transition zone increased the required total ablation depth by 20 % . CONCLUSION The use of a peripheral transition 1.0 mm diameter larger than the ablation zone significantly decreased night glare after LASIK with slight increase in the required central ablation depth OBJECTIVE To compare refractive performance and safety of laser in situ keratomileusis ( LASIK ) and Artisan phakic intraocular lens ( PIOL ) for moderately high myopia . DESIGN A prospect i ve , r and omized trial with paired eye control . PARTICIPANTS Twenty-five patients with myopia ranging from -8.00 to -12.00 diopters ( D ) . INTERVENTION For each patient , one eye received LASIK and the other one was implanted with an Artisan phakic intraocular lens . The treated eye and the surgical technique were r and omized . MAIN OUTCOME MEASURES Primary outcome measure was spherical equivalent refraction . Main secondary outcome measures were the change of two or more lines and safety index ( ratio postoperative to preoperative best-corrected visual acuity ) . RESULTS One year after surgery , the mean spherical equivalent refraction was -0.74 + /- 0.67 D for LASIK-treated eyes and -0.95 + /- 0.45 D for Artisan-treated eyes , and the majority of LASIK-treated eyes ( 64 % ) and Artisan-treated eyes ( 60 % ) were within + /-1.00 D of the intended result . At 1 month , the mean spherical equivalent refraction was -0.28 + /- 0.71 D for LASIK and -1.07 + /- 0.59 D for Artisan ( P < 0.01 ) . The changes of two or more lines were in favor of Artisan ( P < 0.05 ) . The safety index was significantly better for Artisan ( 1.12 + /- 0.21 ) than for LASIK ( 0.99 + /- 0.17 ) at 1 year ( P < 0.02 ) . CONCLUSIONS In cases of moderately high myopia , LASIK and Artisan phakic intraocular lenses seemed to produce a similar predictability . The best-corrected visual acuity and subjective evaluation of quality of vision were better for Artisan Purpose . To compare the results of laser assisted in situ keratomileusis ( LASIK ) and implantable contact lenses ( ICL ) in the correction of moderate/high myopia . Methods . Five hundred fifty-nine LASIK eyes from the Davis Duehr Eye Center , Madison , WI , and 210 ICL eyes from the 14-site U.S. FDA Clinical Trial for ICL for Myopia were compared . These series were concurrently operated on with 8 to 12 D of preoperative myopia and were examined at 1 day , 1 week , 1 month , 6 months , and 1 year postoperatively . The mean baseline myopia was slightly higher in the ICL group , ( ICL : −9.8 ± 1.7 D ; LASIK : −9.1 ± 0.97 D ) . BSCVA , UCVA , and refractions were collected prospect ively in both series . Results . Every index of BSCVA , UCVA , predictability of refraction , and stability of refraction studied favored the ICL over the LASIK procedure . All but one of the indices ( UCVA % 20/40 or better ) were statistically significant in at least half of the time periods studied . At 6-month follow-up , both the loss of two or more lines ( ICL : 0 % ; LASIK : 2%;p = 0.05 ) and gain of two or more lines ( ICL : 7 % ; LASIK : 3%;p = 0.04 ) of BSCVA were better with the ICL . Similarly , efficacy outcomes with the ICL were better with predictability ( attempted versus achieved ±1.0 D ) of the ICL at 90 % ; 76 % with LASIK ( p < 0.001 ) . In this highly myopic series , UCVA 20/20 or better was 50 % with ICL compared with 35 % with LASIK ( p < 0.001 ) . No serious complications occurred in either series of cases . Conclusions . The ICL was safer and more effective than LASIK and appears to be a viable alternative to corneal refractive excimer surgery in the treatment of moderate to high myopia OBJECTIVE To determine the incidence and severity of complications from laser in situ keratomileusis ( LASIK ) for the correction of myopia by experienced and inexperienced surgeons . DESIGN Prospect i ve , observational clinical study . PARTICIPANTS Fourteen surgeons and 1062 eyes of 574 myopic patients who desired surgical correction of myopia ranging from -2.00 to -22.50 diopters ( D ; mean , -7.57 D ) and astigmatism no greater than 4.00 D participated in this study . INTERVENTION Myopia was corrected with LASIK . Astigmatism was corrected with arcuate keratotomy at the same time as the initial procedure or subsequently . MAIN OUTCOME MEASURES Primary outcome measures were change in best spectacle-corrected visual acuity ( BSCVA ) and the incidence of complications . RESULTS Eyes were followed for a mean of 9.5 months after their last surgical procedure ( range , 2 weeks-21 months ) . Three hundred eighty-one eyes ( 36 % ) underwent 468 enhancement procedures 3 months or more after the initial treatment . There were 27 ( 2.1 % ) intraoperative and 40 ( 3.1 % ) postoperative complications . Laser ablation was not performed during the initial treatment of 17 ( 1.6 % ) eyes because of intraoperative complications . Seventy-four eyes gained 2 or more lines of BSCVA , while 50 eyes lost 2 or more lines of BSCVA . Only three eyes lost two or more lines of BSCVA to a level worse than 20/40 . One eye with a flap buttonhole ( BSCVA 20/50 ) also had an epiretinal membrane . The second eye ( BSCVA 20/60 ) had a flap buttonhole that may have been related to a previous corneal transplant . The third eye ( -22.50 D before surgery ) had a rhegmatogenous retinal detachment develop , reducing BSCVA from 20/60 to 20/200 . The incidence of intraoperative complications decreased from 3.1 % during the first 3 months to 0.7 % during the last 9 months of the study ( P = 0.02 ) . CONCLUSIONS LASIK is acceptably safe for the correction of myopia . Although complications occur in approximately 5 % of cases , these rarely lead to visual loss of more than two Snellen lines and postoperative acuity below 20/40 . Flap buttonholes were more likely to cause loss of BSCVA than free or incomplete flaps ( P = 0.02 ) ; flap buttonholes may be more likely in eyes that have undergone previous surgery . Complication rates can be reduced as the surgical team gains experience OBJECTIVE This study evaluated the predictability , stability , and safety of laser in situ keratomileusis ( LASIK ) in myopia and myopic astigmatism . DESIGN The study design was a prospect i ve , unmasked , nonr and omized clinical trial . PARTICIPANTS Participating were 25 patients with myopia ( 37 eyes ) with astigmatism of less than 1.00 diopter ( D ) , divided into 3 subgroups ( -5.00 to -9.90 D , 8 eyes ; -10.00 to -14.90 D , 10 eyes ; -15.00 to -29.00 D , 19 eyes ) , and 37 patients with myopia ( 56 eyes ) with corneal astigmatism of 1.00 to 4.50 D , divided into 3 subgroups ( -5.00 to -9.90 D , 12 eyes ; -10.00 to -14.90 D , 24 eyes ; -15.00 to -29.00 D , 20 eyes ) . INTERVENTION LASIK was performed using the Automatic Corneal Shaper and the Keracor 116 excimer laser . MAIN OUTCOME MEASURES Visual acuity , manifest refraction , central corneal isl and s , ablation decentration , and patient satisfaction were measured . RESULTS At 12 months , predictability , regression between 1 and 12 months , uncorrected visual acuity ( UCVA ) , loss of two or more lines of corrected visual acuity , and patient satisfaction of the spherical ( toric ) groups are reported . Subgroups -5.00 to -9.90 D : 100 % ( 75 % ) + 1.00 D ; regression less than or equal to 1.00 D in 100 % ( 91.7 % ) ; UCVA greater than or equal to 20/40 in 87.5 % ( 70 % ) ; none lost two or more lines ; 100 % ( 84 % ) highly satisfied . Subgroups -10.00 to -14.90 D : 60 % ( 78.3 % ) + /-1.00 D ; regression less than or equal to 1.00 D in 100 % ( 87 % ) ; UCVA greater than or equal to 20/40 in 77.8 % ( 86.4 % ) ; 10 % ( 4.3 % ) lost two lines ; 90 % ( 91 % ) highly satisfied . Subgroups -15.00 to -29.00 D : 38.9 % ( 21.4 % ) + /-1.00 D ; regression less than or equal to 1.00 D in 72.2 % ( 64.3 % ) ; UCVA greater than or equal to 20/40 in 33.3 % ( 40 % ) ; 5.6 % ( 7.1 % ) lost two lines ; 78 % ( 50 % ) highly satisfied . Differences of predictability and change of manifest refraction between subgroups of -5.00 to -9.90 D and -15.00 to -29.00 D were statistically significant . Central isl and s ( decentrations ) were observed in 17 % ( 5.6 % ) of eyes of the spherical and in 16 % ( 4.1 % ) of the toric group . Overall , the corneal interface was visible in 8.2 % . CONCLUSIONS The LASIK method used in this study showed stability of manifest refraction and adequate uncorrected central visual acuity in a large percentage of patients with myopia up to -15.00 D. Corneal stability was not as uniform . Central corneal isl and s were observed in a sizable minority of patients despite pretreatment . For myopia greater than 15.00 D , accuracy and patient satisfaction were sufficiently poor to advise against using the authors ' treatment technique in these groups . Visually significant microkeratome and laser-related problems were noted in a smaller percentage of patients . Patients with astigmatism correction were less pleased with results than were patients who received spherical corrections PURPOSE To compare visual , refractive , and clinical outcomes of foldable iris-fixated phakic intraocular lens ( PIOL ) implantation versus femtosecond laser-assisted LASIK for myopia between -6.00 and -9.00 diopters ( D ) . METHODS Forty-six myopic patients were r and omized to undergo bilateral Artiflex ( Ophtec BV ) PIOL implantation or bilateral femtosecond laser-assisted conventional LASIK with the VISX S2 ( Abbott Medical Optics ) . Refraction , uncorrected ( UDVA ) and corrected ( CDVA ) distance visual acuity , contrast sensitivity , corneal endothelial cell count , rate of retreatment , and complications were compared . RESULTS Twelve months after surgery , no statistically significant differences were noted in spherical equivalent refraction ( P=.19 ) or UDVA ( P=.28 ) , whereas CDVA was better in the PIOL group ( P<.001 ) . Spherical equivalent refraction was within ±0.50 D in 42 ( 91.3 % ) LASIK eyes and 41 ( 89.1 % ) PIOL eyes ( P>.99 ) . The percentage of eyes gaining lines of CDVA was significantly higher in the PIOL group ( 50.0 % vs 8.7 % ; P<.001 ) . Contrast sensitivity was better for PIOL eyes at 1.5 cycles per degree Output:	Phakic IOL surgery was safer than excimer laser surgical correction for moderate to high myopia as it results in significantly less loss of best spectacle corrected visual acuity ( BSCVA ) at 12 months postoperatively . However there is a low risk of developing early cataract with phakic IOLs . Phakic IOL surgery appears to result in better contrast sensitivity than excimer laser correction for moderate to high myopia . Phakic IOL surgery also scored more highly on patient satisfaction/preference question naires . The results of this review suggest that , at one year post surgery , phakic IOLs are safer than excimer laser surgical correction for moderate to high myopia in the range of -6.0 to -20.0 D and phakic IOLs are preferred by patients . While phakic IOLs might be accepted clinical practice for higher levels of myopia ( greater than or equal to 7.0 D of myopic spherical equivalent with or without astigmatism ) , it may be worth considering phakic IOL treatment over excimer laser correction for more moderate levels of myopia ( less than or equal to 7.0 D of myopic spherical equivalent with or without astigmatism ) .
MS22353	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: We examined gender differences in growth hormone ( GH ) secretion during rest and exercise . Eighteen subjects ( 9 women and 9 men ) were tested on two occasions each [ resting condition ( R ) and exercise condition ( Ex ) ] . Blood was sample d at 10-min intervals from 0600 to 1200 and was assayed for GH by chemiluminescence . At R , women had a 3.69-fold greater mean calculated mass of GH secreted per burst compared with men ( 5.4 + /- 1.0 vs. 1.7 + /- 0.4 microg/l , respectively ) and higher basal ( interpulse ) GH secretion rates , which result ed in greater GH production rates and serum GH area under the curve ( AUC ; 1,107 + /- 194 vs. 595 + /- 146 microg x l(-1 ) x min , women vs. men ; P = 0.04 ) . Compared with R , Ex result ed in greater mean mass of GH secreted per burst , greater mean GH secretory burst amplitude , and greater GH AUC ( 1,196 + /- 211 vs. 506 + /- 90 microg x l(-1 ) x min , Ex vs. R , respectively ; P < 0.001 ) . During Ex , women attained maximal serum GH concentrations significantly earlier than men ( 24 vs. 32 min after initiation of Ex , respectively ; P = 0.004 ) . Despite this temporal disparity , both genders had similar maximal serum GH concentrations . The change in AUC ( adjusted for unequal baselines ) was similar for men and women ( 593 + /- 201 vs. 811 + /- 268 microg x l(-1 ) x min ) , but there were significant gender-by-condition interactive effects on GH secretory burst mass , pulsatile GH production rate , and maximal serum GH concentration . We conclude that , although women exhibit greater absolute GH secretion rates than men both at rest and during exercise , exercise evokes a similar incremental GH response in men and women . Thus the magnitude of the incremental secretory GH response is not gender dependent INTRODUCTION This study examined the effects of short-term physical training on the acute hormonal response ( i.e. , growth hormone , total and free insulin-like growth factor I [ IGF-I ] , and IGF binding proteins [IGFBP]-1 , IGFBP-2 , and IGFBP-3 ) to resistance exercise ( RE ) in women . METHODS Forty-six women ( 20.3 ± 0.3 yr , mass = 64.1 ± 7.3 kg , height = 165.7 ± 1.0 cm ) were r and omly assigned to an endurance training ( E ) , resistance training ( R ) , combined training ( R + E ) , or control ( C ) group for 8wk . Subjects completed a st and ardized bout of RE ( six sets of back squats at 10 repetition maximum ) before and after training . Blood sample s were obtained at rest ( PRE ) , after the third set , immediately postexercise ( POST ) , and at 15 min and 30 min after exercise . RESULTS Acute RE significantly increased ( P < 0.05 ) serum growth hormone ( mean ± SD ; change from PRE to POST = + 10.9 ± 7.5 μg·L-1 ) , total IGF-I ( + 66.1 ± 25.4 μg·L-1 ) , IGFBP-1 ( + 2.5 ± 3.1 μg·L-1 ) , IGFBP-2 ( + 86.0 ± 86.8 μg·L-1 ) , and IGFBP-3 ( + 0.69 ± 0.25 mg·L-1 ) concentrations and decreased free IGF-I concentrations ( -0.14 ± 0.21 μg·L-1 ) . After 8 wk of training , total IGF-I concentrations were significantly increased ( change in POST concentrations from week 0 to week 8 = + 82.5 ± 120.8 μg·L-1 ) , and IGFBP-1 concentrations were significantly decreased ( -6.7 ± 13.6 μg·L-1 ) during exercise in groups that participated in resistance training ( R and R + E ) ; no significant changes were seen after E or C. CONCLUSIONS Participation in resistance training increased total IGF-I and reduced IGFBP-1 concentrations during acute RE , indicating exercise mode-specific adaptations in the circulating IGF-I system We examined the relationship between physical fitness and circulating components of the GH-insulin-like growth factor I ( IGF-I ) system [ i.e. GH , GH-binding protein ( GHBP ) , IGF-I , and IGF-binding proteins 1 - 5 ( IGFBP-1 through-5 ) ] in adolescent females ( age range , 15 - 17 yr ) . The study consisted of 1 ) a cross-sectional protocol ( n = 23 ) in which GH-IGF-I components were correlated with fitness , as estimated by thigh muscle volume and maximal O2 uptake ; and 2 ) a prospect i ve study in which fitness , GH-IGF-I system components , and osteocalcin were examined before and after a 5-week period of endurance-type training ( control , n = 6 ; trained , n = 10 ) . The cross-sectional analysis revealed significant ( P < 0.05 ) positive correlations between fitness and 1 ) mean 12-h overnight GH levels , 2 ) GHBP , and 3 ) IGF-I. Muscle volume was negatively correlated with both IGFBP-2 and -4 . The prospect i ve training study was associated with 1 ) increases in circulating osteocalcin ( 39 + /- 14 % ; P < 0.007 ) , and 2 ) decreases in IGF-I ( -14 + /- 5 % ; P < 0.05 ) and IGFBP-5 ( -10 + /- 4 % ; P < 0.04 ) . Unexpectedly , IGFBP-3 fell in both control (-8 + /- 2 % ; P < 0.01 ) and trained subjects ( -5 + /- 3 % ; P < 0.05 ) , and GHBP was reduced only among control subjects ( -10 + /- 7 % ; P < 0.04 ) . In summary , fitter adolescent girls tended to have increased mean serum GH , GHBP , and IGF-I. In contrast , brief endurance training led to increases in muscle mass and serum osteocalcin that were not accompanied by increases in GH or IGF-I. In fact , training may , in the short term , have led to a catabolic state hormonally expressed by reductions in IGF-I and IGFBP-5 The purpose of this study was to determine the impact of dietary factors and exercise-associated factors on the response of IGF-I and its binding proteins ( IGFBPs ) during a period of increased physical activity . Twenty-nine men completed a 4-day ( days 1 - 4 ) baseline period of a controlled energy balanced diet while maintaining their normal physical activity level followed by 7 days ( days 5 - 11 ) of a 1,000 kcal/day increase in physical activity above their normal activity levels . Two subject groups , one sedentary ( Sed , mean Vo(2peak ) : 39 mlxkg(-1)xmin(-1 ) , n = 7 ) and one fit ( FIT1 , mean Vo(2peak ) : 56 ml.kg(-1)xmin(-1 ) , n = 8) increased energy intake to maintain energy balance throughout the 7-day intervention . In two other fit subject groups ( FIT2 , n = 7 and FIT3 , n = 7 ) , energy intake remained at baseline result ing in a 1,000 kcal/day exercise-induced energy deficit . Of these , FIT2 received an adequate protein diet ( 0.9 g/kg ) , and FIT3 received a high-protein diet ( 1.8 g/kg ) . For all four groups , IGF-I , IGFBP-3 , and the acid labile subunit ( ALS ) were significantly decreased by day 11 ( 27 + /- 4 % , 10 + /- 2 % , and 19 + /- 4 % , respectively ) and IGFBP-2 significantly increased by 49 + /- 21 % following day 3 . IGFBP-1 significantly increased only in the two negative energy balance groups , FIT2 ( 38 + /- 6 % ) and FIT3 ( 46 + /- 8 % ) . Differences in initial fitness level and dietary protein intake did not alter the IGF-I system response to an acute increase in physical activity . Decreases in IGF-I were observed during a moderate increase in physical activity despite maintaining energy balance , suggesting that currently unexplained exercise-associated mechanisms , such as increased energy flux , regulate IGF-I independent of energy deficit OBJECTIVE To study interstitial IGF-I concentrations in resting and exercising skeletal muscle in relation to the circulating components of the IGF-IGF binding protein ( IGFBP ) system . DESIGN AND METHODS Seven women performed endurance exercise with 1 leg ( Ex-leg ) for 1 h. The resting leg ( Rest-leg ) served as a control . IGF-I was determined in microdialysate ( MD ) and was compared with veno-arterial ( v-a ) concentrations of circulating IGF-IGFBP components . RESULTS Median ( range ) basal MD-IGF-I was 0.87 ( 0.4 - 1.5 ) microg/l or 0.4 (0.2)% of total-IGF-I ( t-IGF-I ) determined in arterial serum and in the same concentration range as free dissociable IGF-I ( f-IGF-I ) . Rest-leg MD-IGF-I decreased , reaching significance after exercise . Ex-leg MD-IGF-I was unchanged during exercise and declined after exercise at the level of significance ( P = 0.05 ) . There was a release of f-IGF-I from the Ex-leg into the circulation at the end of and shortly after exercise . A small but significant increase in circulating IGFBP-1 was detected at the end of exercise and IGFBP-1 increased further after exercise . Although interleukin-6 ( IL-6 ) has been associated with IGFBP-3 proteolysis , the circulating molecular forms of IGFBP-3 remained unchanged in spite of an IL-6 release from the muscle compartment . CONCLUSIONS Circulating IGFBP-1 is related to interstitial IGF-I in resting muscle although the temporal relationship may not be simple . Further studies should explore the role of local release of IGF-I and its impact on IGF-I activity during contraction Acute resistance exercise and L-arginine have both been shown to independently elevate plasma growth hormone ( GH ) concentrations ; however , their combined effect is controversial . The purpose was to investigate the combined effects of resistance exercise and L-arginine supplementation on plasma L-arginine , GH , GH secretagogues , and IGF-1 in strength trained participants . Fourteen strength trained males ( age : 25 ± 4 y ; body mass : 81.4 ± 9.0 kg ; height : 179.4 ± 6.9 cm ; and training experience : 6.3 ± 3.4 y ) participated in a r and omized double-blind crossover design ( separated by ~7 days ) . Subjects reported to the laboratory at 08:00 in a fasted state , consumed L-arginine ( ARG ; 0.075 g·kg-1 body mass ) or a placebo ( PLA ) before performing an acute bout of resistance exercise ( 3 sets of 8 exercises , 10 repetitions at ~75 % 1RM ) . Blood sample s were collected at rest , before exercise , and at 0 , 15 , 30 , and 60 min of rest-recovery . The ARG condition significantly increased plasma L-arginine concentrations ( ~120 % ) while no change was detected in the PLA condition . There were no differences between conditions for GH , GH-releasing hormone , ghrelin , or IGF-1 at any time point . GH-inhibiting hormone was significantly lower in the ARG condition . However , integrated area under the curve for GH was blunted in the ARG condition ( L-arginine = 288.4 ± 368.7 vs. placebo = 487.9± 482.0 min·ng·mL1 , p < .05 ) . L-arginine ingested before resistance exercise significantly elevated plasma L-arginine concentration but attenuated plasma GH in strength trained individuals despite a lower GHIH . Furthermore our data shows that the GH suppression was not due to a GH or IGF-1 induced autonegative feedback loop Taylor , LW , Wilborn , CD , Kreider , RB , and Willoughby , DS . Effects of resistance exercise intensity on extracellular signal-regulated kinase 1/2 mitogen-activated protein kinase activation in men . J Strength Cond Res 26(3 ) : 599–607 , 2012—Extracellular signal-regulated kinase ( ERK ) 1/2 signaling has been shown to be increased after heavy resistance exercise and suggested to play a role in the hypertrophic adaptations that are known to occur with training . However , the role that ERK1/2 may play in response to lower intensities of resistance exercise is unknown . Therefore , the purpose of this study was to determine the effects of resistance exercise intensity on ER Output:	The present study showed that IGF-1 serum concentrations are altered by exercise type , but in conditions which are not well-defined . The systematic review and meta- analysis suggest that there is no determinant in serum IGF-1 changes for the exercise load characteristic . Therefore , physical exercise may be an alternative treatment to control changes in IGF-1 metabolism and blood concentration
MS22354	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: Background Depression is a disabling , prevalent condition . Physical activity programs may assist depression management in older people , ameliorate co-morbid conditions and reduce the need for antidepressants . The UPLIFT pilot study assessed the feasibility of older depressed people attending a community-based progressive resistance training ( PRT ) program . The study also aim ed to determine whether PRT improves depressive status in older depressed patients . Methods A r and omised controlled trial was conducted . People aged ≥ 65 years with depressive symptoms were recruited via general practice s. Following baseline assessment , subjects were r and omly allocated to attend a local PRT program three times per week for 10 weeks or a brief advice control group . Follow-up assessment of depressive status , physical and psychological health , functional and quality of life status occurred post intervention and at six months . Results Three hundred and forty six people responded to the study invitation , of whom 22 % had depressive symptoms ( Geriatric Depression Scale , GDS-30 score ≥ 11 ) . Thirty two people entered the trial . There were no significant group differences on the GDS at follow-up . At six months there was a trend for the PRT intervention group to have lower GDS scores than the comparison group , but this finding did not reach significance ( p = 0.08 ) . More of the PRT group ( 57 % ) had a reduction in depressive symptoms post program , compared to 44 % of the control group . It was not possible to discern which specific components of the program influenced its impact , but in post hoc analyses , improvement in depressive status appeared to be associated with the number of exercise sessions completed ( r = -0.8 , p < 0.01 ) . Conclusion The UPLIFT pilot study confirmed that older people with depression can be successfully recruited to a community based PRT program . The program can be offered by existing community-based facilities , enabling its ongoing implementation for the potential benefit of other older people BACKGROUND Although exercise has been shown to relieve depression , little is known about its mechanism or dose-response characteristics . We hypothesized that high intensity progressive resistance training ( PRT ) would be more effective than either low intensity PRT or st and ard care by a general practitioner ( GP ) in depressed elderly persons , and that high intensity PRT would provide superior benefits in quality of life , sleep quality , and self-efficacy . METHODS Sixty community-dwelling adults > 60 years with major or minor depression were r and omized to supervised high intensity PRT ( 80 % maximum load ) or low intensity PRT ( 20 % maximum load ) 3 days per week for 8 weeks , or GP care . RESULTS A 50 % reduction in the Hamilton Rating Scale of Depression score was achieved in 61 % of the high intensity , 29 % of the low intensity , and 21 % of the GP care group ( p = .03 ) . Strength gain was directly associated with reduction in depressive symptoms ( r = 0.40 , p = .004 ) , as was baseline social support network type ( F = 3.52 , p = .015 ) , whereas personality type , self-efficacy , and locus of control were unrelated to the antidepressant effect . Vitality quality -of-life scale improved more in the high intensity group than in the others ( p = .04 ) . Sleep quality improved significantly in all participants ( p < .0001 ) , with the greatest relative change in high intensity PRT ( p = .05 ) . CONCLUSIONS High intensity PRT is more effective than is low intensity PRT or GP care for the treatment of older depressed patients BACKGROUND Serum anticholinergic activity ( SAA ) , as measured by a radioreceptor assay , quantifies a person 's overall anticholinergic burden caused by all drugs and their metabolites . In several small geriatric patient groups , SAA has been associated with cognitive impairment or frank delirium . To our knowledge , there has not yet been any systematic study of the prevalence of SAA and its effect on cognition in a community-based population . METHODS Serum anticholinergic activity was measured in 201 subjects who were r and omly selected among the participants in an epidemiological community study , based on their age and sex . Cognitive performance was assessed with use of the Mini-Mental State Examination . The association between SAA and cognitive performance was examined using a univariate analysis and a multiple logistic regression model , adjusting for age , sex , educational level , and number of medications . RESULTS Serum anticholinergic activity was detectable in 180 ( 89.6 % ) participants ( range , 0.50 - 5.70 pmol/mL ) . Univariate testing showed a significant association between SAA and Mini-Mental State Examination scores . Logistic regression analysis indicated that subjects with SAA at or above the sample 's 90th percentile ( ie , SAA > /=2.80 pmol/mL ) were 13 times ( odds ratio , 1.08 - 152.39 ) more likely than subjects with undetectable SAA to have a Mini-Mental State Examination score of 24 ( the sample 's 10th percentile ) or below . CONCLUSIONS To our knowledge , this is the largest analysis of SAA and the first to examine its extent and relationship with cognitive performance in a community sample . Its results suggest that SAA can be detected in most older persons in the community and confirm that even low SAA is associated with cognitive impairment BACKGROUND Depression is a major health problem for community-dwelling elderly adults . Since limited re sources are available to decrease the high prevalence of depressive symptoms among the elderly adults , improved support for them can be provided if we can determine which intervention is superior in ridding depressive symptoms . OBJECTIVE To compare the effectiveness of the physical fitness exercise program and the cognitive behavior therapy program on primary ( depressive symptoms ) and secondary outcomes ( 6-min walk distance , quality of life , and social support ) for community-dwelling elderly adults with depressive symptoms . DESIGN AND SETTING S A prospect i ve r and omized control trial was conducted in three communities in northern Taiwan . PARTICIPANTS The elderly adults in the three communities were invited to participate by mail , phone calls , and posters . There were a total of 57 participants who had depressive symptoms and all without impaired cognition that participated in this trial . None of the participants withdrew during the 9 months of follow-up for this study . METHODS Fifty-seven participants were r and omly assigned to one of the three groups : the physical fitness exercise program group , the cognitive behavior therapy ( CBT ) group , or the control group . The primary ( Geriatric Depression Scale-15 , GDS-15 ) , and secondary outcomes ( 6-min walk distance , SF-36 , and Inventory of Socially Supportive Behaviors scales , ISSB ) were collected immediately ( T2 ) , at 3 months ( T3 ) , and at 6 months after the interventions ( T4 ) . RESULTS After the interventions , the CBT group participants demonstrated significantly lower symptoms of depression ( p=0.009 ) at T2 and perceived more social support from those around them ( p<0.001 , < 0.001 and = 0.004 , respectively ) at three time-point comparisons than the control group . Moreover , after intervention , participants in the physical fitness exercise program group had decreased GDS-15 scores at three time-point comparisons ( p=0.003 , 0.012 and 0.037 , respectively ) , had a substantially greater 6-min walk distance ( p=0.023 ) , a better quality of life ( p<0.001 ) , and a better perceived social support at T2 ( p<0.001 ) . CONCLUSIONS Immediately after a 12-week intervention , there were significant decreases in depressive symptoms and more perceived social support amongst those in the CBT group . When considering the effectiveness in the decrease of depressive symptoms longer term , the increase in the 6-min walk distance and raising the patients ' quality of life , physical fitness exercise program may be a better intervention for elderly adults with depressive symptoms Objectives We pilot tested a one-visit behavioral intervention with telephone follow-up for older primary care patients with mild to moderate depressive symptoms . Methods A total of 16 English-speaking primary care patients aged 60 years and older who scored 5 to 14 on the Patient Health Question naire-9 ( PHQ-9 ) engaged in the intervention visit . Outcomes were assessed at baseline and 4 weeks : activity goals , readiness to change ( University of Rhode Isl and Change Assessment ) , PHQ-9 , Generalized Anxiety Disorder-7 , World Health Organization Disability Assessment Schedule 2.0 , and satisfaction . Results The 14 participants who completed the study met or exceeded 73 % of activity goals on average . They also improved on all outcomes ( P < 0.05 ) with medium ( University of Rhode Isl and Change Assessment , GAD-7 ) to large effect sizes ( PHQ-9 , World Health Organization Disability Assessment Schedule 2.0 ) , and they were satisfied . Conclusions This pilot study provided preliminary evidence that a one-visit behavioral activation intervention is acceptable and feasible and improves outcomes . If findings are confirmed , then this intervention could be integrated into existing collaborative care programs OBJECTIVES This study provides an empirical evaluation of Cognitive Behaviour Therapy ( CBT ) alone vs Treatment as usual ( TAU ) alone ( generally pharmacotherapy ) for late life depression in a UK primary care setting . METHOD General Practitioners in Fife and Glasgow referred 114 Participants to the study with 44 meeting inclusion criteria and 40 participants providing data that permitted analysis . All participants had a diagnosis of mild to moderate Major Depressive Episode . Participants were r and omly allocated to receive either TAU alone or CBT alone . RESULTS Participants in both treatment conditions benefited from treatment with reduced scores on primary measures of mood at end of treatment and at 6 months follow-up from the end of treatment . When adjusting for differences in baseline scores , gender and living arrangements , CBT may be beneficial in levels of hopelessness at 6 months follow-up . When evaluating outcome in terms of numbers of participants meeting Research Diagnostic Criteria for depression , there were significant differences favouring the CBT condition at the end of treatment and at 3 months follow-up after treatment . CONCLUSIONS CBT alone and TAU alone produced significant reductions in depressive symptoms at the end of treatment and at 6 months follow-up . CBT on its own is shown to be an effective treatment procedure for mild to moderate late life depression and has utility as a treatment alternative for older people who can not or will not tolerate physical treatment approaches for depression Anxiety and depression are commonly comorbid in older adults and are associated with worse physical and mental health outcomes and poorer response to psychological and pharmacological treatments . However , little research has examined the effectiveness of psychological programs to treat comorbid anxiety and depression in older adults . Sixty-two community dwelling adults aged over 60 years with comorbid anxiety and depression were r and omly allocated to group cognitive behavioural therapy or a waitlist condition and were assessed immediately following and three months after treatment . After controlling for cognitive ability at pre-treatment , cognitive behaviour therapy result ed in significantly greater reductions , than waitlist , on symptoms of anxiety and depression based on a semi-structured diagnostic interview rated by clinicians unaware of treatment condition . Significant time by treatment interactions were also found for self-report measures of anxiety and depression and these gains were maintained at the three month follow up period . In contrast no significant differences were found between groups on measures of worry and well-being . In conclusion , group cognitive behavioural therapy is efficacious in reducing comorbid anxiety and depression in geriatric population s and gains maintain for at least three months CONTEXT In older people , depressive symptoms are common , psychological adjustment to aging is complex , and associated chronic physical illness limits the use of antidepressants . Despite this , older people are rarely offered psychological interventions , and only 3 r and omized controlled trials of individual cognitive behavioral therapy ( CBT ) in a primary care setting have been published . OBJECTIVE To determine the clinical effectiveness of CBT delivered in primary care for older people with depression . DESIGN A single-blind , r and omized , controlled trial with 4- and 10-month follow-up visits . PATIENTS A total of 204 people aged 65 years or older ( mean [ SD ] age , 74.1 [ 7.0 ] years ; 79.4 % female ; 20.6 % male ) with a Geriatric Mental State diagnosis of depression were recruited from primary care . INTERVENTIONS Treatment as usual ( TAU ) , TAU plus a talking control ( TC ) , or TAU plus CBT . The TC and CBT were offered over 4 months . OUTCOME MEASURES Beck Depression Inventory-II ( BDI-II ) scores collected at baseline , end of therapy ( 4 months ) , and 10 months after the baseline visit . Subsidiary measures were the Beck Anxiety Inventory , Social Functioning Question naire , and Euroqol . Intent to treat using Generalized Estimating Equation and Compliance Average Causal Effect analyses were used . RESULTS Eighty percent of participants were followed up . The mean number of sessions of TC or CBT was just greater than 7 . Intent-to-treat analysis found improvements of -3.07 ( 95 % confidence interval [ CI ] , -5.73 to -0.42 ) and -3.65 ( 95 % CI , -6.18 to -1.12 ) in BDI-II scores in favor of CBT vs TAU and TC , respectively . Compliance Average Causal Effect analysis compared CBT with TC . A significant benefit of CBT of 0.4 points ( 95 % CI , 0. Output:	DISCUSSION We conclude that the effects of several treatments are promising , but need to be replicated before they can be implemented more widely in primary care .
MS22355	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: A group of 200 patients who presented in general practice with symptoms but no abnormal physical signs and in whom no definite diagnosis was made were r and omly selected for one of four consultations : a consultation conducted in a " positive manner , " with and without treatment , and a consultation conducted in a " non-positive manner , " called a negative consultation , with and without treatment . Two weeks after consultation there was a significant difference in patient satisfaction between the positive and negative groups but not between the treated and untreated groups . Similarly , 64 % of those receiving a positive consultation got better , compared with 39 % of those who received a negative consultation ( p = 0.001 ) and 53 % of those treated got better compared with 50 % of those not treated ( p = 0.5 ) Summary This multifactorial mixed‐ methods r and omized controlled trial quantified the specific and nonspecific factors of acupuncture , and found that the practitioner , not the treatment , has the strongest effect on outcome . Abstract The nonspecific effects of acupuncture are well documented ; we wished to quantify these factors in osteoarthritic ( OA ) pain , examining needling , the consultation , and the practitioner . In a prospect i ve r and omised , single‐blind , placebo‐controlled , multifactorial , mixed‐ methods trial , 221 patients with OA awaiting joint replacement surgery were recruited . Interventions were acupuncture , Streitberger placebo acupuncture , and mock electrical stimulation , each with empathic or nonempathic consultations . Interventions involved eight 30‐minute treatments over 4 weeks . The primary outcome was pain ( VAS ) at 1 week posttreatment . Face‐to‐face qualitative interviews were conducted ( purposive sample , 27 participants ) . Improvements occurred from baseline for all interventions with no significant differences between real and placebo acupuncture ( mean difference −2.7 mm , 95 % confidence intervals −9.0 to 3.6 ; P = .40 ) or mock stimulation ( −3.9 , −10.4 to 2.7 ; P = .25 ) . Empathic consultations did not affect pain ( 3.0 mm , −2.2 to 8.2 ; P = .26 ) but practitioner 3 achieved greater analgesia than practitioner 2 ( 10.9 , 3.9 to 18.0 ; P = .002 ) . Qualitative analysis indicated that patients ’ beliefs about treatment veracity and confidence in outcomes were reciprocally linked . The supportive nature of the trial attenuated differences between the different consultation styles . Improvements occurred from baseline , but acupuncture has no specific efficacy over either placebo . The individual practitioner and the patient ’s belief had a significant effect on outcome . The 2 placebos were equally as effective and credible as acupuncture . Needle and nonneedle placebos are equivalent . An unknown characteristic of the treating practitioner predicts outcome , as does the patient ’s belief ( independently ) . Beliefs about treatment veracity shape how patients self‐report outcome , complicating and confounding study interpretation OBJECTIVE To examine the causal effects of doctor-patient relations and the severity of a medical outcome on medical patient perceptions and mal practice intentions in the event of an adverse medical outcome . DESIGN R and omized between-subjects experimental design . Patients were given scenarios depicting interactions between an obstetric patient and her physician throughout the patient 's pregnancy , labor , and delivery . PARTICIPANTS One hundred twenty-eight postpartum obstetric patients were approached for participation , of whom 104 completed the study . Main outcome measures Patients ' perceptions of physician competence and intentions to file a mal practice cl aim . RESULTS Positive physician communication behaviors increased patients ' perceptions of physician competence and decreased mal practice cl aim intentions toward both the physician and the hospital . A more severe outcome increased only patients ' intentions to sue the hospital . CONCLUSION These results provide empiric evidence for a direct , causal effect of the doctor-patient relationship on medical patients ' treatment perceptions and mal practice cl aim intentions in the event of an adverse medical outcome Background Placebo effects contribute substantially to outcome in most fields of medicine . While clinical trials typically try to control or minimize these effects , the potential of placebo mechanisms to improve outcome is rarely used . Patient expectations about treatment efficacy and outcome are major mechanisms that contribute to these placebo effects . We aim ed to optimize these expectations to improve outcome in patients undergoing coronary artery bypass graft ( CABG ) surgery . Methods In a prospect i ve three-arm r and omized clinical trial with a 6 month follow-up , 124 patients scheduled for CABG surgery were r and omized to either a brief psychological pre-surgery intervention to optimize outcome expectations ( EXPECT ) ; or a psychological control intervention focusing on emotional support and general advice , but not on expectations ( SUPPORT ) ; or to st and ard medical care ( SMC ) . Interventions were kept brief to be feasible with a heart surgery environment ; “ dose ” of therapy was identical for both pre-surgery interventions . Primary outcome was disability 6 months after surgery . Secondary outcomes comprised further clinical and immunological variables . Results Patients in the EXPECT group showed significantly larger improvements in disability ( −12.6 ; −17.6 to −7.5 ) than the SMC group ( −1.9 ; −6.6 to + 2.7 ) ; patients in the SUPPORT group ( −6.7 ; −11.8 to 1.7 ) did not differ from the SMC group . Comparing follow-up scores and controlling for baseline scores of EXPECT versus SUPPORT on the variable disability only revealed a trend in favor of the EXPECT group ( P = 0.09 ) . Specific advantages for EXPECT compared to SUPPORT were found for mental quality of life and fitness for work ( hours per week ) . Both psychological pre-surgery interventions induced less pronounced increases in pro-inflammatory cytokine concentrations reflected by decreased interleukin-8 levels post-surgery compared to changes in SMC patients and lower interleukin-6 levels in patients of the EXPECT group at follow-up . Both pre-surgery interventions were characterized by great patient acceptability and no adverse effects were attributed to them . Considering the innovative nature of this approach , replication in larger , multicenter trials is needed . Conclusions Optimizing patients ’ expectations pre-surgery helps to improve outcome 6 months after treatment . This implies that making use of placebo mechanisms has the potential to improve long-term outcome of highly invasive medical interventions . Further studies are warranted to generalize this approach to other fields of medicine . Trial registration Ethical approval for the study was obtained from the IRB of the Medical School , University of Marburg , and the trial was registered at ( NCT01407055 ) on July 25 , 2011 Variations in treatment effects between drug trials are usually attributed to different patient characteristics , variations in outcome assessment , and r and om error . We have previously hypothesized that part of the variation in treatment effects between drug trials might be caused by differences in nonspecific factors . In a r and omized clinical trial , we aim ed to investigate whether experimentally induced expectancy can modify the analgesic effect of tramadol relative to placebo in chronic pain patients . In a 2 x 2 factorial , r and omized , placebo-controlled , double-blind trial , chronic pain patients attending a chronic pain outpatient clinic were r and omized to receive a single oral dose of 50 mg tramadol or placebo , and they were further r and omized to receive positive or neutral information , verbally expressed by the physician , regarding the expected analgesic effect of the drug . Pain intensity was measured using a 10 centimeter visual analogue scale at baseline , and 0.5 , 1 , 2 , 4 , 6 , and 8 hours after baseline . The one-hour pain intensity difference , calculated as the sum of pain intensity differences between baseline and 0.5 and 1 hour , was taken as main outcome measure . The one-hour sum of pain intensity differences of 28 patients treated after positive expectation and r and omized to tramadol was 1.4 cm , while in 27 patients r and omized to placebo , it was 0.8 cm . This corresponds with an analgesic effect of tramadol relative to placebo of 0.6 cm ( 95 % confidence interval [ CI ] , -0.5 cm to 1.8 cm ) . The 28 patients in the neutral expectancy group who were r and omized to tramadol reported a 1.4 cm decrease on the sum of pain intensity differences , while 28 patients in the placebo group reported a 0.9 cm decrease . This corresponds with an analgesic effect of tramadol relative to placebo of 0.5 cm ( 95 % CI , -0.9 cm to 1.8 cm ) . The 0.1 cm difference ( 0.6 cm - 0.5 cm ) in analgesic effect between positive and neutral expectancy group was not statistically significant ( 95 % CI , -0.7 cm to 1.0 cm ) . This trial did not discern a significant difference in the analgesic effect of tramadol between a positive and neutral expectancy group . This means that the phenomenon either does not exist , or we had an inappropriate model to demonstrate it . Regardless , this study demonstrates the type of quality trial that should be done to find out which non-specific factors , such as information regarding the expected effect , can modify treatment effects BACKGROUND Clinicians frequently warn patients of discomfort before potentially painful procedures , despite the lack of evidence that such communications are helpful . We aim ed to compare two communications ( one with , and the other without , a warning of a ' sting ' ) immediately before i.v . cannulation in order to measure differences in perceived pain by patients during the procedure . METHODS R and omly assigned patients awaiting elective surgery received a communication immediately before i.v . cannulation consisting of either ' I am going to apply the tourniquet and insert the needle in a few moments . It 's a sharp scratch and it may sting a little ' ( Group S ) or ' I am going to apply the tourniquet on the arm . As I do this many people find the arm becomes heavy , numb and tingly . This allows the drip to be placed more comfortably ' ( Group NS ) . Cannulation pain was measured by a 0 - 10 verbal numerical rating score ( VNRS ) and five-point Likert scale . RESULTS Of 101 participants , 49 were allocated to Group S and 52 to Group NS . Median VNRS pain scores with inter-quartile ranges ( IQR ) were 1 and 2 , respectively , for both groups . Median Likert scores were 3 in Group S and 2 in Group NS with an IQR of 1 for both groups ( P = 0.13 ) . Six participants vocalized pain in Group S and none in Group NS ( P = 0.01 ) . Three participants withdrew their arm spontaneously in Group S and none in Group NS ( P = 0.11 ) . CONCLUSIONS Warning patients of a ' sting ' before i.v . cannulation may not be helpful BACKGROUND The impact of changing non-verbal consultation behaviours is unknown . AIM To assess brief physician training on improving predominantly non-verbal communication . DESIGN AND SETTING Cluster r and omised parallel group trial among adults aged ≥16 years attending general practice s close to the study coordinating centres in Southampton . METHOD Sixteen GPs were r and omised to no training , or training consisting of a brief presentation of behaviours identified from a prior study ( acronym KEPe Warm : demonstrating Knowledge of the patient ; Encouraging [ back-channelling by saying ' hmm ' , for example ] ; Physically engaging [ touch , gestures , slight lean ] ; Warm-up : cool/professional initially , warming up , avoiding distancing or non-verbal cut-offs at the end of the consultation ) ; and encouragement to reflect on videos of their consultation . Outcomes were the Medical Interview Satisfaction Scale ( MISS ) mean item score ( 1 - 7 ) and patients ' perceptions of other domains of communication . RESULTS Intervention participants scored higher MISS overall ( 0.23 , 95 % confidence interval [ CI ] = 0.06 to 0.41 ) , with the largest changes in the distress-relief and perceived relationship subscales . Significant improvement occurred in perceived communication/partnership ( 0.29 , 95 % CI = 0.09 to 0.49 ) and health promotion ( 0.26 , 95 % CI = 0.05 to 0.46 ) . Non-significant improvements occurred in perceptions of a personal relationship , a positive approach , and underst and ing the effects of the illness on life . CONCLUSION Brief training of GPs in predominantly non-verbal communication in the consultation and reflection on consultation videotapes improves patients ' perceptions of satisfaction , distress , a partnership approach , and health promotion BACKGROUND Placebos are hypothesized to exert positive effects on medical conditions by enhancing patient expectancies . Recent review s suggest that placebo benefits are restricted to subjective responses , like pain , but might be ineffective for objective physiologic outcomes . Nevertheless , mind-body links and placebo responsivity in asthma are widely believed to exist . OBJECTIVE We carried out a r and omized , double-blind investigation to ( 1 ) determine whether placebo can suppress airway hyperreactivity in asthmatic subjects , ( 2 ) quantify the placebo effect , ( 3 ) identify predictors of the placebo response , and ( 4 ) determine whether physician interventions modify the placebo response . METHODS In a double-blind , crossover design investigation , 55 subjects with mild intermittent and persistent asthma with stable airway hyperreactivity were r and omized to placebo or salmeterol before serial methacholine challenges . Subjects were additionally r and omized to physician interactions that communicated either positive or neutral expectancies regarding drug effect . RESULTS Placebo bronchodilator administration significantly reduced bronchial hyperreactivity compared with baseline ( the calculated concentration of methacholine required to induce a Output:	Conclusions Greater practitioner empathy or communication of positive messages can have small patient benefits for a range of clinical conditions , especially pain .
MS22356	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: Surplus embryos available for cryopreservation in fresh cycles are considered as having good potential for future use . However , the optimal stage of embryo cryopreservation remains unclear . In this study , 1190 patients with surplus embryos on day 3 were divided into two groups : cleavage-stage embryo cryopreservation ( control group ) and blastocyst cryopreservation ( blastocyst group ) . The clinical outcomes of the subsequent warming cycles were evaluated . The proportion of cycles with blastocyst formation was 73.8 % in the blastocyst group . Although in the blastocyst group , the cancellation rate of blastocyst transfer was increased due to lack of blastocysts available for cryopreservation , the blastocyst group achieved significantly higher rates of clinical pregnancy/cycle ( 43.2 % versus 34.9 % ; P=0.003 ) , pregnancy/transfer ( 59.5 % versus 35.4 % ; P<0.001 ) and implantation ( 46.5 % versus 22.2 % ; P<0.001 ) from the first warming cycle compared with the control group . In an embryo-number classified analysis , the clinical pregnancy rate was also higher in the blastocyst group . However , the cumulative pregnancy was similar between the two groups . Blastocyst culture as an embryo selection tool will not improve embryo viability but it will help patients to achieve pregnancy more quickly . Extended culture of surplus embryos to the blastocyst stage for cryopreservation optimizes the clinical outcomes Objective It is well known that fresh blastocyst transfer results in better pregnancy outcomes with a smaller number of transferred embryos compared with cleavage stage embryo transfer . However , in terms of frozen-thawed blastocyst transfer , only a few studies are available . We aim ed to evaluate clinical outcomes of frozen-thawed embryo transfer ( FET ) with blastocysts . Methods Retrospective analysis of FET cycles with blastocysts ( B-FET ) between Jan 2007 and June 2009 was performed . Age-matched FET cycles with cleavage stage embryos ( C-FET ) during the same period were collected as controls . A total of 58 B-FET cycles were compared with 172 C-FET cycles and also compared with those of post-thaw extended culture blastocysts from frozen pronuclear stage embryos ( 22 cycles ) . Results There was no difference in the patient characteristics of each group . The embryos ' survival rates after thawing were comparable ( > 90 % ) and there was no difference in the implantation rate or clinical and ongoing pregnancy rate among the three groups . Conclusion In FET , blastocyst transfers may not present better pregnancy outcomes than cleavage stage embryo transfers . A further large-scale prospect i ve study is needed Conventionally , most in vitro fertilization ( IVF ) embryos are transferred in fresh treatment cycles with freezing reserved for spare ones . Improvement in cryopreservation facilities over time has encouraged the greater use of this technology with the success rate of frozen replacement cycles approaching that associated with fresh embryo transfer . Data from observational studies suggest that obstetric and perinatal outcomes are better in pregnancies result ing from frozen replacement cycles . In the interests of promoting feto-maternal safety is it therefore time to avoid fresh embryo transfers in IVF , freeze all available embryos and replace them in subsequent cycles ? In this article we explore the biological plausibility of this concept , appraise the evidence underpinning it and consider the implication s of adopting such a strategy in routine clinical practice . The outcomes of existing r and omized trials appear to favour a strategy of frozen embryo transfer , but larger trials are needed before a major change in clinical practice can be considered High-frequency uterine contractions at the time of non-cavitating embryo transfer influence adversely IVF-embryo transfer outcome . This prompted us to quantify prospect ively the possible decline in uterine contraction frequency occurring during later stages of the luteal phase of ovarian stimulation , up to the time of blastocyst transfers , in 43 IVF-embryo transfer c and i date s. Contractility was assessed on the day of human chorionic gonadotrophin ( HCG ) administration , 4 days after HCG ( non-cavitating embryo transfer ; HCG + 4 ) , and 7 days after HCG ( blastocyst transfers ; HCG + 7 ) . For this , 2 min sagittal uterine scans were obtained by ultrasound and digitized with a computerized system for the assessment of uterine contraction frequency . Our results indicated that a slight , yet significant , decrease in uterine contraction frequency , observed from the day of HCG ( 4.4 + /- 0.2 contractions/min ) to HCG + 4 ( 3.5 + 0.2 contractions/min ) , was followed by a more pronounced , additional decrease between HCG + 4 and HCG + 7 ( 1.5 + /- 0.2 contractions/min ; P < 0.001 ) . In conclusion , during the luteal phase of ovarian stimulation , uterine contractility decreases progressively , and reaches a nearly quiescent status 7 days after HCG administration , at the time of blastocyst transfers . It is possible that such a uterine relaxation assists blastocyst implantation BACKGROUND Single-embryo transfer has been recommended to reduce the incidence of multiple gestations when in vitro fertilization is performed in women under 36 years of age . We design ed a prospect i ve , r and omized , controlled trial to determine whether there were any differences in the rates of pregnancy and delivery between women undergoing transfer of a single cleavage-stage ( day 3 ) embryo and those undergoing transfer of a single blastocyst-stage ( day 5 ) embryo . METHODS We studied 351 infertile women under 36 years of age who were r and omly assigned to undergo transfer of either a single cleavage-stage embryo ( 176 patients ) or a single blastocyst-stage embryo ( 175 patients ) . Multifollicular ovarian stimulation was performed with a gonadotropin-releasing hormone antagonist and recombinant follicle-stimulating hormone . RESULTS The study was terminated early after a prespecified interim analysis ( which included 50 percent of the planned number of patients ) found a higher rate of pregnancy among women undergoing transfer of a single blastocyst-stage embryo ( P=0.02 ) . The rate of delivery was also significantly higher in this group than in the group undergoing transfer of a single cleavage-stage embryo ( 32.0 percent vs. 21.6 percent ; relative risk , 1.48 ; 95 percent confidence interval , 1.04 to 2.11 ) . Two multiple births occurred , both of monozygotic twins , both of which were in the group undergoing transfer of a single cleavage-stage embryo . CONCLUSIONS These findings support the transfer of a single blastocyst-stage ( day 5 ) embryo in infertile women under 36 years of age Purpose To determine if blastocyst transfer increases the ongoing and cumulative pregnancy rates , compared with day 3 embryo transfer , in women of all ages when at least 4 zygotes are obtained . Methods Prospect i ve study including patients undergoing a first IVF/ICSI treatment and assigned to cleavage stage ( n = 46 ) or blastocyst ( n = 58 ) embryo transfer . Supernumerary embryos were vitrified and patients failing to achieve an ongoing pregnancy after fresh embryo transfer would go through cryopreserved cycles . The main outcome measure was the ongoing pregnancy rate after the fresh IVF/ICSI transfer and the cumulative ongoing pregnancy rate . Results were also analyzed according to age ( under 35 and 35 or older ) . Results A majority of patients ( 96.6 % ) had a blastocyst transfer when at least 4 zygotes were obtained . The ongoing pregnancy rate was significantly higher in the day-5 group compared with the day-3 group ( 43.1 % vs. 24 % , p = 0.041 ) . The cumulative ongoing pregnancy rate was higher ( but not significantly ) with blastocyst than with cleavage stage embryos ( 56.8 % vs. 43.4 % , p = 0.174 ) . When analysed by age , patients 35 or older showed significantly higher ongoing pregnancy rate ( 48.4 % vs. 19.3 % , p = 0.016 ) and cumulative ongoing pregnancy rate ( 58 % vs. 25.8 % , p = 0.01 ) in the day-5 group compared to the day-3 group , while no such differences were observed in women under 35 . Conclusions Blastocyst transfer can be suggested whenever there are at least 4 zygotes . While there are no differences in women under 35 , the benefit of this option over cleavage stage transfer could be significant in women 35 or older OBJECTIVE To compare the implantation and pregnancy rates after cleavage stage embryo transfer ( ET ) with transfer of blastocyst-stage ( days 5 - 6 ) embryos . STUDY DESIGN Prospect i ve r and omized trial at an assisted reproduction unit in a university hospital . Women with six or more follicles at the last ultrasound scan before oocyte aspiration were r and omized for transfer of a maximum of two embryos after 2 - 3 days ( n = 80 ) or after 5 - 6 days ( n = 64 ) of culture . Embryo quality , implantation and pregnancy rates were evaluated . Statistical significance was tested with the Chi-square test and Fisher 's exact test . RESULT ( S ) No significant difference was observed in implantation rates ( 21.1 % versus 20.9 % , respectively ) and clinical pregnancy rates ( 36.7 % versus 32.5 % respectively ) after blastocyst and cleavage stage transfers for the two groups . The pregnancy rate among subjects who had at least one good quality embryo transferred was 37.5 % per day 2 - 3 ET and 60 % per day 5 - 6 ET . CONCLUSION ( S ) The overall implantation and pregnancy rates after embryo transfer at cleavage stage and at blastocyst stage transfer were not statistically different . Women who had at least one good quality blastocyst ( n = 25 ) had a high pregnancy rate ( 60 % per ET ) . Blastocyst transfer is a good alternative for couples with many good quality embryos on day 2 after insemination Output:	Conclusion In summary , this meta- analysis shows that vitrification at any stage has no detrimental effect on clinical outcome . Blastocyst transfer will still remain a favorable and promising option in ART .
MS22357	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: 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 BACKGROUND Clear , transparent , and sufficiently detailed abstract s of conferences and journal articles related to r and omized controlled trials ( RCTs ) are important , because readers often base their assessment of a trial solely on information in the abstract . Here , we extend the CONSORT ( Consoli date d St and ards of Reporting Trials ) Statement to develop a minimum list of essential items , which authors should consider when reporting the results of a RCT in any journal or conference abstract . METHODS AND FINDINGS We generated a list of items from existing quality assessment tools and empirical evidence . A three-round , modified-Delphi process was used to select items . In all , 109 participants were invited to participate in an electronic survey ; the response rate was 61 % . Survey results were presented at a meeting of the CONSORT Group in Montebello , Canada , January 2007 , involving 26 participants , including clinical trialists , statisticians , epidemiologists , and biomedical editors . Checklist items were discussed for eligibility into the final checklist . The checklist was then revised to ensure that it reflected discussion s held during and subsequent to the meeting . CONSORT for Abstract s recommends that abstract s relating to RCTs have a structured format . Items should include details of trial objectives ; trial design ( e.g. , method of allocation , blinding/masking ) ; trial participants ( i.e. , description , numbers r and omized , and number analyzed ) ; interventions intended for each r and omized group and their impact on primary efficacy outcomes and harms ; trial conclusions ; trial registration name and number ; and source of funding . We recommend the checklist be used in conjunction with this explanatory document , which includes examples of good reporting , rationale , and evidence , when available , for the inclusion of each item . CONCLUSIONS CONSORT for Abstract s aims to improve reporting of abstract s of RCTs published in journal articles and conference proceedings . It will help authors of abstract s of these trials provide the detail and clarity needed by readers wishing to assess a trial 's validity and the applicability of its results Abstract Background . Cancer survivors are at increased risk for second malignancies , cardiovascular disease , diabetes , and functional decline . Evidence suggests that a healthful diet and physical activity may reduce the risk of chronic disease and improve health in this population . Methods . We conducted a feasibility study to evaluate a vegetable gardening intervention that paired 12 adult and child cancer survivors with Master Gardeners to explore effects on fruit and vegetable intake , physical activity , quality -of-life , and physical function . Throughout the year-long study period , the survivor-Master Gardener dyads worked together to plan/plant three gardens , harvest/rotate plantings , and troubleshoot/correct problems . Data on diet , physical activity , and quality -of-life were collected via surveys ; anthropometrics and physical function were objective ly measured . Acceptability of the intervention was assessed with a structured debriefing survey . Results . The gardening intervention was feasible ( robust enrollment ; minimal attrition ) and well-received by cancer survivors and Master Gardeners . Improvement in three of four objective measures of strength , agility , and endurance was observed in 90 % of survivors , with the following change scores [ median ( interquartile range ) ] noted between baseline and one-year follow-up : h and grip test [ + 4.8 ( 3.0 , 6.7 ) kg ] , 2.44 meter Get-Up- and -Go [ + 1.0 ( + 1.8 , + 0.2 ) seconds ] , 30-second chair st and [ + 3.0 ( + 1.0 , 5.0 ) st and s ] , and six-minute walk [ + 11.6 ( 6.1 , 48.8 ) meters ] . Increases of ≥ 1 fruit and vegetable serving/day and ≥ 30 minutes/week of physical activity were observed in 40 % and 60 % , respectively . Conclusion . These preliminary results support the feasibility and acceptability of a mentored gardening intervention and suggest that it may offer a novel and promising strategy to improve fruit and vegetable consumption , physical activity , and physical function in cancer survivors . A larger r and omized controlled trial is needed to confirm our results 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 PURPOSE To assess the effects of horticultural therapy ( HT ) on mood state and heart rate ( HR ) in patients participating in an inpatient cardiac rehabilitation program . METHODS Cardiac rehabilitation in patients ( n = 107 ) participated in the study . The HT group consisted of 59 subjects ( 34 males , 25 females ) . The control group , which participated in patient education classes ( PECs ) , consisted of 48 subjects ( 31 males , 17 females ) . Both HT sessions and PEC are components of the inpatient rehabilitation program . Each group was evaluated before and after a class in their respective modality . Evaluation consisted of the completion of a Profile of Mood States ( POMS ) inventory , and an HR obtained by pulse oximetry . RESULTS Changes in the POMS total mood disturbance ( TMD ) score and HR between preintervention and postintervention were compared between groups . There was no presession difference in either TMD score ( 16 + /- 3.6 and 19.0 + /- 3.2 , PEC and HT , respectively ) or HR ( 73.5 + /- 2.5 and 79 + /- 1.8 , PEC and HT , respectively ) . Immediately following the intervention , the HT TMD was significantly reduced ( post-TMD = 1.6 + /- 3.2 , P < .001 ) , while PEC TMD was not significantly changed ( TMD = 17.0 + /- 28.5 ) . After intervention , HR fell in HT by 4 + /- 9.6 bpm ( P < .001 ) but was unchanged in PEC . CONCLUSION These findings indicate that HT improves mood state , suggesting that it may be a useful tool in reducing stress . Therefore , to the extent that stress contributes to coronary heart disease , these findings support the role of HT as an effective component of cardiac rehabilitation CONTEXT Therapists can use horticultural therapy as an adjuvant therapy in a non threatening context , with the intent of bringing about positive effects in physical health , mental health , and social interaction . Very few experimental studies exist that test its clinical effectiveness . OBJECTIVE To determine whether the addition of horticultural therapy to a pain-management program improved physical function , mental health , and ability to cope with pain . DESIGN The research team design ed a prospect i ve , nonr and omized , controlled cohort study , enrolling all patients consecutively referred to the Zurzach Interdisciplinary Pain Program ( ZISP ) who met the study s criteria . The team divided them into two cohorts based on when medical professionals referred them : before ( control group ) or after ( intervention group ) introduction of a horticultural therapy program . SETTING The setting was the rehabilitation clinic ( RehaClinic ) in Bad Zurzach , Switzerl and . PARTICIPANTS Seventy-nine patients with chronic musculoskeletal pain ( fibromyalgia or chronic , nonspecific back pain ) participated in the study . INTERVENTIONS The research team compared a 4-week , inpatient , interdisciplinary pain-management program with horticultural therapy ( intervention , n = 37 ) with a pain-management program without horticultural therapy ( control , n = 42 ) . The horticultural therapy program consisted of seven sessions of group therapy , each of 1-hour duration . OUTCOME MEASURES The research team assessed the outcome using the Medical Outcome Study Short Form-36 ( SF-36 ) , the West Haven-Yale Multidimensional Pain Inventory ( MPI ) , the Hospital Anxiety and Depression Scale ( HADS ) , the Coping Strategies Question naire ( CSQ ) , and two functional performance tests . The team tested participants on entry to and discharge from the 4-week pain-management program . RESULTS Between-group differences in sociodemographic and outcome variables were not significant on participants entry to the pain-management program . On discharge , the research team measured small to moderate outcome effects ( effect size [ ES ] up to 0.71 ) within both groups . The study found significantly larger improvements for the horticultural therapy group vs the control group in SF-36 role physical ( ES = 0.71 vs 0.22 ; P = .018 ) ; SF-36 mental health ( ES = 0.46 vs 0.16 ; P = .027 ) ; HADS anxiety ( ES = 0.26 vs 0.03 ; P = .043 ) ; and CSQ pain behavior ( ES = 0.30 vs -0.05 ; P = .032 ) . CONCLUSION The addition of horticultural therapy to a pain management program improved participants ' physical and mental health and their coping ability with respect to chronic musculoskeletal pain PURPOSE We examined the effects of communication skills training and the use of memory books by certified nursing assistants ( CNAs ) on verbal interactions between CNAs ( n = 64 ) and nursing home residents ( n = 67 ) during care routines . DESIGN AND METHODS CNAs were taught to use communication skills and memory books during their interactions with residents with moderate cognitive impairments and intact communication abilities . A staff motivational system was used to encourage performance and maintenance of these skills . Formal measures of treatment implementation were included . RESULTS Results were compared with those for participants on no-treatment control units . Trained CNAs talked more , used positive statements more frequently , and tended to increase the number of specific instructions given to residents . Changes in staff behavior did not result in an increase in total time giving care to residents . Maintenance of CNA behavior change was Output:	These studies showed significant effectiveness in one or more outcomes for mental health and behavior . Although there was insufficient evidence in the studies of HT due to poor method ological and reporting quality and heterogeneity , HT may be an effective treatment for mental and behavioral disorders such as dementia , schizophrenia , depression , and terminal-care for cancer
MS22358	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: OBJECTIVES To determine the effect of acupuncture on hot flash frequency and intensity , quality of life , and sleep quality in patients undergoing hormonal therapy for prostate cancer . Hot flashes are a common adverse effect of hormonal therapy for prostate cancer . METHODS Men who had a hot flash score > 4 who were receiving and rogen deprivation therapy for prostate cancer underwent acupuncture with electrostimulation biweekly for 4 weeks , then weekly for 6 weeks , using a predefined treatment plan . The primary endpoint was a 50 % reduction in the hot flash score after 4 weeks of therapy , calculated from the patients ' daily hot flash diaries . The hot flash-related quality of life and sleep quality and biomarkers potentially related to hot flashes , including serotonin , calcitonin gene-related peptide , and urinary 5-hydroxyindoleacetic acid , were examined . RESULTS A total of 25 men were enrolled from September 2003 to April 2007 . Of these , 22 were eligible and evaluable . After 4 weeks , 9 ( 41 % , 95 % confidence interval 21%-64 % ) of 22 patients had had a > 50 % reduction in the hot flash score . Of the 22 patients , 12 ( 55 % , 95 % confidence interval 32%-76 % ) met this response definition at any point during the therapy course . No patient had a significant increase in hot flash score during therapy . A reduced hot flash score was associated with improvement in the hot flash-related quality of life and sleep quality . CONCLUSIONS Multiple placebo-controlled trials have demonstrated a 25 % response rate to placebo treatment for hot flashes . Of the 22 patients , 41 % had responded by week 4 and 55 % overall in the present pilot study , providing evidence of a potentially meaningful benefit . Additional studies of acupuncture for hot flashes in this population are warranted PURPOSE Most men who undergo castration therapy for prostatic carcinoma will have vasomotor symptoms that usually persist for years . Vasomotor symptoms are elicited from the thermoregulatory center , possibly due to a decrease in hypothalamic opioid activity induced by low sex steroid concentrations . Acupuncture treatment in women , which stimulates hypothalamic opioid activity , alleviates vasomotor symptoms . We report on men treated with acupuncture for relief of vasomotor symptoms after castration therapy . MATERIAL S AND METHODS We asked 7 men with vasomotor symptoms due to castration therapy to receive acupuncture treatment 30 minutes twice weekly for 2 weeks and once a week for 10 weeks . Effects on flushes were recorded in logbooks . RESULTS Of the 7 men 6 completed at least 10 weeks of acupuncture therapy and all had a substantial decrease in the number of hot flushes ( average 70 % after 10 weeks ) . At 3 months after the last treatment the number of flushes was 50 % lower than before therapy . Therapy was discontinued after 10 weeks because of a femoral neck fracture in 1 man and after 3 weeks due to severe back pain in 1 . CONCLUSIONS Acupuncture may be a therapeutic alternative in men with hot flushes after castration therapy and merits further evaluation Recommendations for treatment are commonly based on results evaluating variation in systematic effects ( group responses ) from r and omised controlled trials without taking the individual patient 's variation into account . In the evaluation of acupuncture-related treatment effects , the trial design and statistical analysis used are a challenge since the assessed variables commonly have subjective properties and are based on the person 's own self-report . Thus , the results that are seen are often varied , most likely due to inter-individual variation in rating of the actual variable such that the treatment effects are expressed more ( or less ) in some individuals than in others . The basis for the individual variation is probably multi-modal and could be related to the individuals ’ expectation , gender , genetic polymorphisms and the aetiology of the condition . The assessment methods used should preferably have proven useful in controlled trials , and the methods for statistical analysis should consider the non-metric properties of the variable and the contribution of the individuals ’ variation in the results . In order to evaluate the treatment effects more properly and increase the possibility of detecting any effectiveness , it is therefore important to assess the level of perceived dysfunction or symptom , taking into account the individual variation as well as the systematic effects ( the effects of the group ) . In the evaluation of acupuncture effects , both systematic and individual variation should be reported allowing for the detection of subgroup effects and thereby leading to treatment recommendations that are more likely to be based on each individual 's specific needs BACKGROUND Radiation treatment of head and neck cancer can cause chronic xerostomia which impairs patients ' quality of life . The study reported here examined the efficacy of acupuncture in alleviating xerostomia symptoms especially dry mouth . PATIENTS AND METHODS A total of 145 patients with chronic radiation-induced xerostomia > 18 months after treatments were recruited from seven UK cancer centres . The study employed a r and omised crossover design with participants receiving two group sessions of oral care education and eight of acupuncture using st and ardised methods . Patient-reported outcome ( PROs ) measures were completed at baseline and weeks 5 , 9 , 13 , 17 , and 21 . The primary outcome was improvement in dry mouth . OBJECTIVE saliva measurements were also carried out . RESULTS Acupuncture compared with oral care , produced significant reductions in patient reports of severe dry mouth ( OR = 2.01 , P = 0.031 ) sticky saliva ( OR = 1.67 , P = 0.048 ) , needing to sip fluids to swallow food ( OR = 2.08 , P = 0.011 ) and in waking up at night to drink ( OR = 1.71 , P = 0.013 ) . There were no significant changes in either stimulated or unstimulated saliva measurements over time . CONCLUSION Eight sessions of weekly group acupuncture compared with group oral care education provide significantly better relief of symptoms in patients suffering from chronic radiation-induced xerostomia More than 70 % of seriously ill patients with cancer suffer from xerostomia and the associated problems of swallowing , chewing and speaking . This study aims to investigate whether treatment with acupuncture is a viable option for hospice patients with xerostomia . During a 2-year period , 117 patients were assessed for xerostomia . Eighty-two patients were found to have moderate xerostomia . Sixty-seven fulfilled the criteria for inclusion . Of these , 14 were included but only eight completed the study . Ten acupuncture treatments were given during a 5-week period . The effect of acupuncture was measured using a visual analogue scale , and by measuring the saliva production before and after the series of treatment . The results show that all the patients experienced alleviation of dryness of the mouth and the associated symptoms , and thus benefited from the acupuncture treatment . However , conducting a 5-week acupuncture intervention study is not feasible at an inpatient hospice due to the patients being too close to death Purpose / Objective : Patients with cancer or symptoms referable to cancer therapy were offered acupuncture as potential palliation of their symptoms . This paper describes the physical integration of the discipline into the Oncology Clinic , and patient perspectives on its availability and efficacy . Patients and methods : Between August 1999 and May 2000 , 123 patients with varying symptoms received acupuncture in our Center 's Radiation and Medical Oncology Clinics and Breast Health Center . These patients had 823 visits during this time period . A practice outcome analysis was performed on patients receiving therapy between 1 January 2000 and 30 April 2000 . The 89 patients treated during this interval had 444 total visits . In June and July 2000 , a question naire was administered by phone to 79 of these patients ( 89 % ) . St and ard allopathic care continued while patients were receiving acupuncture . Results : Major reasons for referral included pain ( 53 % ) , xerostomia ( 32 % ) , hot flashes ( 6 % ) and nausea/loss of appetite ( 6 % ) . Patients had a mean of five acupuncture visits ( range 1– 9 ) . Most patients ( 60 % ) showed at least 30 % improvement in their symptoms . About one-third of patients had no change in severity of symptoms . There were no untoward effects reported related to the acupuncture . When analysed by diagnosis , these values persist . Irrespective of response to therapy , 86 % of respondents considered it ‘ very important ' that we continue to provide acupuncture services . Conclusion : Acupuncture may contribute to control of symptoms for cancer patients . Expansion of providers , continued patient follow-up , optimization of techniques and prospect i ve objective measurement of response continue in our clinic Of 21 patients with severe xerostomia , 11 were treated with acupuncture and 10 patients received placebo acupuncture . Those patients who received acupuncture treatment showed increased salivary flow rates during and after the acupuncture treatment . The improved salivary values persisted during the observation year , whereas the patients who received placebo acupuncture showed some improvement of salivary flow rates only during the actual treatment . The results of the present study indicate that acupuncture may be a useful adjunct for the stimulation of salivary flow in some patients with xerostomia PURPOSE We aim ed to assess the effectiveness of acupuncture for cancer-related fatigue ( CRF ) in patients with breast cancer . PATIENTS AND METHODS We conducted a pragmatic , r and omized controlled trial comparing acupuncture with enhanced usual care . Three hundred two out patients with breast cancer participated . We r and omly assigned 75 patients to usual care and 227 patients to acupuncture plus usual care ( r and om assignment of 1:3 respectively ) with minimization controlling for baseline general fatigue and maintenance treatment . Treatment was delivered by acupuncturists once a week for 6 weeks through needling three pairs of acupoints . The usual care group received a booklet with information about fatigue and its management . Primary outcome was general fatigue at 6 weeks , measured with the Multidimensional Fatigue Inventory ( MFI ) . Other measurements included the Hospital Anxiety and Depression Scale , Functional Assessment of Cancer Therapy-General quality -of-life scale , and expectation of acupuncture effect . Analyses were by intention to treat . RESULTS Two hundred forty-six of 302 patients r and omly assigned provided complete data at 6 weeks . The difference in the mean General Fatigue score , between those who received the intervention and those who did not , was -3.11 ( 95 % CI , -3.97 to -2.25 ; P < .001 ) . The intervention also improved all other fatigue aspects measured by MFI , including Physical Fatigue and Mental Fatigue ( acupuncture effect , -2.36 and -1.94 , respectively ; both at P < .001 ) , anxiety and depression ( acupuncture effect , -1.83 and -2.13 , respectively ; both at P < .001 ) , and quality of life ( Physical Well-Being effect , 3.30 ; Functional Well-Being effect , 3.57 ; both at P < .001 ; Emotional Well-Being effect , 1.93 ; P = .001 ; and Social Functioning Well-Being effect , 1.05 ; P < .05 ) . CONCLUSION Acupuncture is an effective intervention for managing the symptom of CRF and improving patients ' quality of life The m and ate of Human Reproduction Up date involves several roles : ( i ) to provide a synthesis of evidence that can aid scientists and clinicians in their daily work ; ( ii ) to help reproductive specialists underst and concepts from related disciplines ; and ( iii ) to summarize current knowledge generated by basic science as the foundation of future scientific and clinical advancement . Given that review and synthesis are central to good scientific and clinical practice , and that a grasp of the current state of knowledge is a prerequisite to design ing new studies , it is pertinent to ask which review s are most likely to fulfil the needs of readers . A related question concerns whether systematic review s meet the needs of all review topics and all readers . Summarizing evidence or knowledge is a difficult problem in reproductive medicine , as in other branches of science and medical care ( Eddy et al. , 1992 ) . For each question there may be multiple studies that use different design s and inclusion criteria . For clinical questions , the interventions , outcomes and measures of effect may vary : the effect measures in treatment studies include odds ratios , relative risks and absolute differences . For scientific questions , the experimental species , models and design s may differ . Moreover , it is always uncertain whether all of the relevant evidence has been evaluated . Even when the search has been exhaustive , there are no simple guides on how to interpret conflicting results and whether to accept apparently outlying studies . The choices that the review er makes to address the variable conditions and uncertainties may be conservative , strict and exclusive , or liberal , open and inclusive . The decisions made by the review er may not be consistent throughout and these choices may or may not satisfy the reader who seeks out the review to address a clinical or research question . Faced with uncertainty and doubt , readers nonetheless must form an impression of the evidence and synthesize the state of knowledge in order to address the clinical or research question that stimulated their interest in the review . We argue that the reader is better served when the choices made in the review , regardless of whether they are strict or open , should be explicit , transparent , clearly stated and reproducible by interested readers . This list of objectives for review s is more easily satisfied by systematic review s , which use explicit methods to method ically search , critically appraise and synthesize the available literature on a specific issue . The question or issue need not be clinical : indeed , the concept evolved primarily in psychology studies ( Light and Pillemer , 1984 ) . The systematic review attempts to reduce Output:	Benefit was reported for other cancer-related symptoms , including pain , fatigue , hot flushes , xerostomia , dyspnoea and anxiety . Much of the primary research reported in review s is innovative and indicates potential benefit for people with cancer-related symptoms .
MS22359	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: Background Schools are the most frequent target for intervention programs aim ed at preventing child obesity ; however , the overall effectiveness of these programs has been limited . It has therefore been recommended that interventions target multiple ecological levels ( community , family , school and individual ) to have greater success in changing risk behaviors for obesity . This study examined the immediate and short-term , sustained effects of the Switch program , which targeted three behaviors ( decreasing children 's screen time , increasing fruit and vegetable consumption , and increasing physical activity ) at three ecological levels ( the family , school , and community ) . Methods Participants were 1,323 children and their parents from 10 schools in two states . Schools were matched and r and omly assigned to treatment and control . Measures of the key behaviors and body mass index were collected at baseline , immediately post-intervention , and 6 months post-intervention . Results The effect sizes of the differences between treatment and control groups ranged between small ( Cohen 's d = 0.15 for body mass index at 6 months post-intervention ) to large ( 1.38 ; parent report of screen time at 6 months post-intervention ) , controlling for baseline levels . There was a significant difference in parent-reported screen time at post-intervention in the experimental group , and this effect was maintained at 6 months post-intervention ( a difference of about 2 hours/week ) . The experimental group also showed a significant increase in parent-reported fruit and vegetable consumption while child-reported fruit and vegetable consumption was marginally significant . At the 6-month follow-up , parent-reported screen time was significantly lower , and parent and child-reported fruit and vegetable consumption was significantly increased . There were no significant effects on pedometer measures of physical activity or body mass index in the experimental group . The intervention effects were moderated by child sex ( for fruit and vegetable consumption , physical activity , and weight status ) , family involvement ( for fruit and vegetable consumption ) , and child body mass index ( for screen time ) . The perception of change among the experimental group was generally positive with 23 % to 62 % indicating positive changes in behaviors . Conclusion The results indicate that the Switch program yielded small-to-modest treatment effects for promoting children 's fruit and vegetable consumption and minimizing screen time . The Switch program offers promise for use in youth obesity prevention Objective To evaluate the effectiveness of a school-based intervention involving the families and teachers that aim ed to promote healthy eating habits in adolescents ; the ultimate aim of the intervention was to reduce the increase in body mass index ( BMI ) of the students . Design Paired cluster r and omized school-based trial conducted with a sample of fifth grade rs . Setting Twenty classes were r and omly assigned into either an intervention group or a control group . Participants From a total of 574 eligible students , 559 students participated in the study ( intervention : 10 classes with 277 participants ; control : 10 classes with 282 participants ) . The mean age of students was 11 years . Intervention Students attended 9 nutritional education sessions during the 2010 academic year . Parents/guardians and teachers received information on the same subjects . Main Outcome Measurement Changes in BMI and percentage of body fat . Results Intention-to-treat analysis showed that changes in BMI were not significantly different between the 2 groups ( β = 0.003 ; p = 0.75 ) . There was a major reduction in the consumption of sugar-sweetened beverages and cookies in the intervention group ; students in this group also consumed more fruits . Conclusion Encouraging the adoption of healthy eating habits promoted important changes in the adolescent diet , but this did not lead to a reduction in BMI gain . Strategies based exclusively on the quality of diet may not reduce weight gain among adolescents . Trial Registration Clinical trials.gov NCT01046474 The purpose of this study was to assess the effects of a six-months ’ nutrition program , delivered and taught by classroom teachers with in-service nutrition training , on the prevention of overweight and obesity among children in grade s 1 to 4 . In this r and omized trial , four hundred and sixty four children from seven elementary schools were allocated to a nutrition educational program delivered by their own teachers . Intervened teachers had 12 sessions of three hours each with the research ers throughout six months , according to the topics nutrition and healthy eating , the importance of drinking water and healthy cooking activities . After each session , teachers were encouraged to develop activities in class focused on the learned topics . Sociodemographic , anthropometric , dietary , and physical activity assessment s were performed at baseline and at the end of the intervention . In the intervention group the increase in Body Mass Index ( BMI ) z-score was significantly lower than in the control group ( p = 0.009 ) ; fewer proportion of children became overweight in the intervened group compared with the control ( 5.6 % vs. 18.4 % ; p = 0.037 ) . Our study provides further support to decrease the overweight epidemic , involving classroom teachers in a training program and making them dedicated interventionists Objectives To assess the behavioural and weight status outcomes in English children in a feasibility study of a novel primary school-based obesity prevention programme . Design Exploratory cluster r and omised controlled trial of the Healthy Lifestyles Programme . Setting Four city primary schools ( two control and two intervention ) in the South West of Engl and . Participants 202 children aged 9–10 years , of whom 193 and 188 were followed up at 18 and 24 months , respectively . No child was excluded from the study ; however , to be eligible , schools were required to have at least one single Year 5 class . Intervention Four-phase multicomponent programme using a range of school-based activities including lessons , assemblies , parents ' evenings , interactive drama workshops and goal setting to engage and support schools , children and their families in healthy lifestyle behaviours . It runs over the spring and summer term of Year 5 and the autumn term of Year 6 . Primary and secondary outcomes Weight status outcomes were body mass index , waist circumference and body fat st and ard deviation scores ( SDS ) at 18 and 24 months , and behavioural outcomes were physical activity , television ( TV ) viewing/screen time and food intake at 18 months . Results At 18 months of follow-up , intervention children consumed less energy-dense snacks and more healthy snacks ; had less ‘ negative food markers ’ , more ‘ positive food markers ’ , lower mean TV/screen time and spent more time doing moderate-vigorous physical activity each day than those in the control schools . Intervention children had lower anthropometric measures at 18 and 24 months than control children , with larger differences at 24 months than at 18 months for nearly all measures . Conclusions Results from this exploratory trial show consistent positive changes in favour of the intervention across all targeted behaviours , which , in turn , appear to affect weight status and body shape . A definitive trial is now justified OBJECTIVE To determine whether an educational programme aim ed at discouraging students from drinking sugar-sweetened beverages could prevent excessive weight gain . DESIGN Forty-seven classes in twenty-two schools were r and omised as intervention or control . SUBJECTS Participants were 1140 , 9 - 12-year-old fourth grade rs ( 435 in the intervention group and 608 in the control group ) . Sugar-sweetened beverages and juice intake were measured through one 24 h recall at baseline and another at the end of the trial . The main outcome was the change in BMI ( BMI = weight (kg)/height ( m2 ) ) , measured at the beginning and at the end of the school year . Intention-to-treat analysis was performed taking into account the cluster ( classes ) effect . RESULTS A statistically significant decrease in the daily consumption of carbonated drinks in the intervention compared to control ( mean difference = -56 ml ; 95 % CI -119 , -7 ml ) was followed by a non-significant overall reduction in BMI , P = 0.33 . However , among those students overweight at baseline , the intervention group showed greater BMI reduction ( -0.4 kg/m2 compared with -0.2 kg/m2 in the control group ( P = 0.11 ) ) , and this difference was statistically significant among girls ( P = 0.009 ) . Fruit juice consumption was slightly increased in the intervention group ( P = 0.08 ) , but not among girls . CONCLUSION Decreasing sugar-sweetened beverages intake significantly reduced BMI among overweight children , and mainly among girls . Efforts to reduce energy intake through liquids need to emphasise overall sweetened beverages and addition of sugar on juices Objectives To examine the prospect i ve associations between body mass index ( BMI ) , waist circumference , and fat mass in childhood and cardiovascular risk factors at age 15 - 16 . Design Prospect i ve cohort study . Setting Avon Longitudinal Study of Parents and Children . Participants 5235 children aged 9 - 12 at start of study . Main exposures BMI , waist circumference , and fat mass determined by dual energy x ray absorptiometry , assessed at age 9 - 12 and at age 15 - 16 . Main outcome measures Systolic and diastolic blood pressure and concentrations of fasting glucose , insulin , triglycerides , low density lipoprotein cholesterol , and high density lipoprotein cholesterol assessed at age 15 - 16 . Results In girls a 1 SD greater BMI at age 9 - 12 was associated with cardiovascular risk factors at age 15 - 16 in fully adjusted models : odds ratio 1.23 ( 95 % confidence interval 1.10 to 1.38 ) for high systolic blood pressure ( ≥130 mm Hg ) ; 1.19 ( 1.03 to 1.38 ) for high concentration of low density lipoprotein cholesterol ( ≥2.79 mmol/l ) ; 1.43 ( 1.06 to 1.92 ) for high concentration of triglycerides ( ≥1.7 mmol/l ) ; 1.25 ( 1.08 to 1.46 ) for low concentration of high density lipoprotein cholesterol ( < 1.03 mmol/l ) ; and 1.45 ( 1.22 to 1.73 ) for high concentration of insulin ( ≥16.95 IU/l ) . Equivalent results in boys were 1.24 ( 1.13 to 1.37 ) for systolic blood pressure ; 1.30 ( 1.07 to 1.59 ) for low density lipoprotein cholesterol ; 1.96 ( 1.51 to 2.55 ) for triglycerides ; 1.39 ( 1.22 to 1.57 ) for high density lipoprotein cholesterol , and 1.84 ( 1.56 to 2.17 ) for insulin . BMI was associated with high fasting glucose ( ≥5.6 mmol/l ) only in boys ( 1.18 , 1.03 to 1.36 ) . With these binary outcomes there was statistical evidence that associations differed between girls and boys for fasting glucose ( P=0.03 ) and insulin ( P<0.001 ) . When risk factors were examined as continuous outcomes there was evidence for stronger associations of BMI with more adverse levels in boys than girls for fasting insulin , glucose , and triglyceride concentrations ( all interaction P≤0.03 ) . BMI , waist circumference , and fat mass were all strongly correlated with each other ( r=0.89 - 0.94 ) , and associations of the three with cardiovascular outcomes were of similar magnitude with statistical evidence of consistency in associations ( all P>0.2 for heterogeneity ) . When waist circumference or fat mass or both were added to models including BMI they did not increase the variation in cardiovascular risk factors already explained by BMI and confounders alone . Girls who were overweight/obese at age 9 - 12 but were normal weight by 15 - 16 had similar odds of adverse levels of risk factors to those who were normal weight at both ages . In boys odds of high systolic blood pressure , high concentrations of triglycerides and insulin , and low concentrations of high density lipoprotein cholesterol remained higher in this group compared with those who were normal weight at both ages but were lower than in those who remained overweight/obese at both ages . Conclusions Measurements of waist circumference or directly assessed fat mass in childhood do not seem to be associated with cardiovascular risk factors in adolescence any more strongly than BMI . Girls who favourably alter their overweight status between childhood and adolescence have cardiovascular risk profiles broadly similar to those who were normal weight at both time points , but boys who change from overweight to normal show risk factor profiles intermediate between those seen in boys who are normal weight at both ages or overweight at both ages OBJECTIVES : The objective of this study was to evaluate a 12-session home/community-based health promotion/obesity prevention program ( Challenge ! ) on changes in BMI status , body composition , physical activity , and diet . METHODS : A total of 235 black adolescents ( aged 11–16 years ; 38 % overweight/obese ) were recruited from low-income urban communities . Baseline measures included weight , height , body composition , physical activity ( PA ) , and diet . PA was measured by 7-day play-equivalent physical activity ( ≥1800 activity counts per minute ) . Participants were r and omly assigned to health promotion/obesity prevention that is anchored in social cognitive theory and motivational interviewing and was delivered by college-aged black mentors or to control . Postintervention ( 11 months ) and delayed follow-up ( 24 months ) evaluations were conducted . Longitudinal analyses used multilevel models with r and om intercepts and generalized estimating equations , controlling for baseline age/gender . Stratified analyses exam Output:	RESULTS We found that interventions based only on advice had modest results in identifying changes in the anthropometric indicators of children and adolescents over time , although they appear to be effective in promoting positive changes in the eating habits of this population . CONCLUSION Intervention programs based only on counseling are effective in promoting changes in dietary patterns , but show poor results in the changes of anthropometric parameters of children and adolescents
MS22360	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: BACKGROUND Because smoking has a profound impact on socioeconomic disparities in illness and death , it is crucial that vulnerable population s of smokers be targeted with treatment . The U.S. Public Health Service recommends that all patients be asked about their smoking at every visit and that smokers be given brief advice to quit and referred to treatment . PURPOSE Initiatives to facilitate these practice s include the 5A 's ( ask , advise , assess , assist , arrange ) and Ask-Advise-Refer ( AAR ) . Unfortunately , primary care referrals are low , and most smokers referred fail to enroll . This study evaluated the efficacy of the Ask-Advise-Connect ( AAC ) approach to linking smokers with treatment in a large , safety net public healthcare system . DESIGN The study design was a pair-matched group-r and omized trial with two treatment arms . SETTING / PARTICIPANTS Ten safety net clinics in Houston TX . INTERVENTION Clinics were r and omized to AAC ( n=5 ; intervention ) or AAR ( n=5 ; control ) . Licensed vocational nurses ( LVNs ) were trained to assess and record the smoking status of all patients at all visits in the electronic health record . Smokers were given brief advice to quit . In AAC , the names and phone numbers of smokers who agreed to be connected were sent electronically to the Texas quitline daily , and patients were proactively called by the quitline within 48 hours . In AAR , smokers were offered a quitline referral card and encouraged to call on their own . Data were collected between June 2010 and March 2012 and analyzed in 2012 . MAIN OUTCOME MEASURES The primary outcome was impact , defined here as the proportion of identified smokers that enrolled in treatment . RESULTS The impact ( proportion of identified smokers who enrolled in treatment ) of AAC ( 14.7 % ) was significantly greater than the impact of AAR ( 0.5 % ) , t(4)=14.61 , p=0.0001 , OR=32.10 ( 95 % CI=16.60 , 62.06 ) . CONCLUSIONS The AAC approach to aiding smoking cessation has tremendous potential to reduce tobacco-related health disparities Background To determine the effectiveness of a single checklist reminder form to improve the delivery of preventive health services at adult health check-ups in a family practice setting . Methods A prospect i ve cluster r and omized controlled trial was conducted at four urban family practice clinics among 38 primary care physicians affiliated with the University of Toronto . Preventive Care Checklist Forms © were created to be used by family physicians at adult health check-ups over a five-month period . The sex-specific forms incorporate evidence -based recommendations on preventive health services and documentation space for routine procedures such as physical examination . The forms were used in two intervention clinics and two control clinics . Rates and relative risks ( RR ) of the performance of 13 preventive health maneuvers at baseline and post-intervention and the percentage of up-to- date preventive health services delivered per patient were compared between the two groups . Results R and omly-selected charts were review ed at baseline ( n = 509 ) and post-intervention ( n = 608 ) . Baseline rates for provision of preventive health services ranged from 3 % ( fecal occult blood testing ) to 93 % ( blood pressure measurement ) , similar to other setting s. The percentage of up-to- date preventive health services delivered per patient at the end of the intervention was 48.9 % in the control group and 71.7 % in the intervention group . This is an overall 22.8 % absolute increase ( p = 0.0001 ) , and 46.6 % relative increase in the delivery of preventive health services per patient in the intervention group compared to controls . Eight of thirteen preventive health services showed a statistically significant change ( p < 0.05 ) in favor of the intervention ( adjusted RR ( 95 % C.I. ) ) : counseling on brushing/flossing teeth ( 9.2 ( 4.3–19.6 ) ) , folic acid counseling ( 7.5 ( 2.7–20.8 ) ) , fecal occult blood testing ( 6.7 ( 1.9–24.1 ) ) , smoking cessation counseling ( 3.9 ( 2.2–7.2 ) ) , tetanus immunization ( 3.0 ( 1.7–5.2 ) ) , history of alcohol intake ( 1.33 ( 1.2–1.5 ) ) , history of smoking habits ( 1.28 ( 1.2–1.4 ) ) and blood pressure measurement ( 1.05 ( 1.00–1.10 ) ) . Conclusion This simple , low cost , clinical ly relevant intervention improves the delivery of preventive health services by prompting physicians of evidence -based recommendations in a checklist format that incorporates existing practice patterns . Periodic up date s of the Preventive Care Checklist Forms © will allow a feasible and easy-to-use tool for primary care physicians to provide evidence -based preventive health services to adults at routine health check-ups . The forms can also be incorporated into an electronic health record . The Preventive Care Checklist Forms © are accessible in English and French at the College of Family Physicians of Canada web site OBJECTIVE To test the effectiveness of a care coordination program for telephone counseling in raising referral and treatment rates for smoking cessation . STUDY DESIGN A demonstration project implementing a smoking cessation care coordination program offering telephone counseling and medication management to patients referred from primary care . METHODS The study was performed at 18 Veterans Health Administration ( VA ) sites in California . Participants were VA patients receiving primary care . We r and omly allocated 10 of 18 sites to receive the Telephone Care Coordination Program , which included simple 2-click referral , proactive care coordination , medication management , and 5 follow-up telephone calls . Each patient received a 30- to 45-minute counseling session from the California Smokers ' Helpline . Patients at control sites received usual care . RESULTS During 10 months , we received 2965 referrals . We were unable to reach 1156 patients ( 39 % ) , despite at least 3 attempts . We excluded 73 patients ( 3 % ) , and 391 patients ( 13 % ) were not interested . We connected the remaining 1345 patients ( 45 % ) to the Helpline . At 6-month followup , 335 patients ( 11 % of all referrals and 25 % of participating patients ) were abstinent . Providers at intervention sites reported referring many more patients to telephone counseling than providers at control sites ( 15.6 vs 0.7 in the prior month ) . CONCLUSIONS The program generated a large number of referrals ; almost half of the patients referred were connected with the Helpline . Long-term abstinence was excellent . These results suggest that managed care organizations may be able to improve tobacco control by implementing a similar system of care coordination Background : Strategies to improve smoking cessation counseling in clinical setting s are critical to supporting smokers ’ attempts to quit . This study evaluates the impact of adding 2 smoking-related vital sign questions in an electronic medical records system on identification , assessment , and counseling for patients who smoke : “ Current smoker ? ” and “ Plan to quit ? ” Methods : Baseline data and data after intervention were collected through record review of 899 r and omly selected patient visits across 3 outpatient clinics . Results : From before to after intervention , identification of smokers increased 18 % ( from 71 % to 84 % ; P < .001 ) , and assessment for a plan to quit increased 100 % ( from 25.5 % to 51 % ; P < .005 ) . Among all smokers , cessation counseling increased 26 % ( from 23.6 % to 29.8 % ; P = .41 ) . Significantly more smokers who received the assessment for a plan to quit received cessation counseling ( 46 % vs. 14 % , P < .001 ) . Regression analysis showed that patients receiving an assessment for plan to quit were 80 % more likely to receive cessation counseling ( OR 0.209 ; 95 % CI , 0.095–0.456 ) . Conclusions : Physician-documented counseling rates are significantly higher when patients are asked about smoking and assessed for a plan to quit . Two questions that ask about smoking status and assess plans to quit may provide prompts to increase the likelihood that patients who smoke receive cessation counseling OBJECTIVE To evaluate the impact of a locally adapted evidence -based quality improvement ( EBQI ) approach to implementation of smoking cessation guidelines into routine practice . DATA SOURCES / STUDY SETTING We used patient question naires , practice surveys , and administrative data in Veterans Health Administration ( VA ) primary care practice s across five southwestern states . STUDY DESIGN In a group-r and omized trial of 18 VA facilities , matched on size and academic affiliation , we evaluated intervention practice s ' abilities to implement evidence -based smoking cessation care following structured evidence review , local priority setting , quality improvement plan development , practice facilitation , expert feedback , and monitoring . Control practice s received mailed guidelines and VA audit-feedback reports as usual care . DATA COLLECTION To represent the population of primary care-based smokers , we r and omly sample d and screened 36,445 patients to identify and enroll eligible smokers at baseline ( n=1,941 ) and follow-up at 12 months ( n=1,080 ) . We used computer-assisted telephone interviewing to collect smoking behavior , nicotine dependence , readiness to change , health status , and patient sociodemographics . We used practice surveys to measure structure and process changes , and administrative data to assess population utilization patterns . PRINCIPAL FINDINGS Intervention practice s adopted multifaceted EBQI plans , but had difficulty implementing them , ultimately focusing on smoking cessation clinic referral strategies . While attendance rates increased ( p<.0001 ) , we found no intervention effect on smoking cessation . CONCLUSIONS EBQI stimulated practice s to increase smoking cessation clinic referrals and try other less evidence -based interventions that did not translate into improved quit rates at a population level Cluster r and omized trials are increasingly common in general practice ( family medicine ) . This paper will consider the design and analysis of such trials and emphasize the similarities and differences with trials in education , heath promotion and public health . Issues discussed are the estimation and range of values of the intra-cluster correlation coefficient found in general practice , and the associated sample size problems . There are problems with widely varying numbers of subjects per cluster , which leads to planning and analysis difficulties . Ethical issues in these trials , and considerations such as the principle of intention to treat are also considered . An example of the type of analysis available for a continuous outcome variable is given , and the available software is summarized briefly IMPORTANCE Several national health care-based smoking cessation initiatives have been recommended to facilitate the delivery of evidence -based treatments , such as quitline ( telephone-based tobacco cessation services ) assistance . The most notable examples are the 5 As ( Ask , Advise , Assess , Assist , Arrange ) and Ask . Advise . Refer . ( AAR ) programs . Unfortunately , rates of primary care referrals to quitlines are low , and most referred smokers fail to call for assistance . OBJECTIVE To evaluate a new approach -- Ask-Advise-Connect (AAC)-- design ed to address barriers to linking smokers with treatment . DESIGN A pair-matched , 2-treatment-arm , group-r and omized design in 10 family practice clinics in a single metropolitan area . Five clinics were r and omized to the AAC ( intervention ) and 5 to the AAR ( control ) conditions . In both conditions , clinic staff were trained to assess and record the smoking status of all patients at all visits in the electronic health record , and smokers were given brief advice to quit . In the AAC clinics , the names and telephone numbers of smokers who agreed to be connected were sent electronically to the quitline daily , and patients were called proactively by the quitline within 48 hours . In the AAR clinics , smokers were offered a quitline referral card and encouraged to call on their own . All data were collected from February 8 through December 27 , 2011 . SETTING Ten clinics in Houston , Texas . PARTICIPANTS Smoking status assessment s were completed for 42,277 patients ; 2052 unique smokers were identified at AAC clinics , and 1611 smokers were identified at AAR clinics . INTERVENTIONS Linking smokers with quitline-delivered treatment . MAIN OUTCOME MEASURE Impact was based on the RE- AIM ( Reach , Efficacy , Adoption , Implementation , and Maintenance ) conceptual framework and defined as the proportion of all identified smokers who enrolled in treatment . RESULTS In the AAC clinics , 7.8 % of all identified smokers enrolled in treatment vs 0.6 % in the AAR clinics ( t4 = 9.19 [ P < .001 ] ; odds ratio , 11.60 [ 95 % CI , 5.53 - 24.32 ] ) , a 13-fold increase in the proportion of smokers enrolling in treatment . CONCLUSIONS AND RELEVANCE The system changes implemented in the AAC approach could be adopted broadly by other health care systems and have tremendous potential to reduce tobacco-related morbidity and mortality BACKGROUND Preventive care is an important role for general practitioners , yet opportunities for prevention are often missed . METHOD We provided an automatic electronic record preventive care reminder system for 12 preventive care activities for one 10 doctor practice . All patients who attended were r and omised by Output:	Overall , these studies found only modest improvements in some of the recommended clinician actions on tobacco use . AUTHORS ' CONCLUSIONS Documentation of tobacco status and referral to cessation counselling appears to increase following EHR modifications design ed to prompt the recording and treating of tobacco use at healthcare visits .
MS22361	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: Abstract OBJECTIVE : There is a well-documented gap between diabetes care guidelines and the services received by patients in almost all health care setting s. This project reports initial results from a computer-assisted , patient-centered intervention to improve the level of recommended services received by patients from a wide variety of primary care providers . DESIGN AND SETTING S : Eight hundred eighty-six patients with type 2 diabetes under the care of 52 primary care physicians participated in the Diabetes Priority Program . Physicians were stratified and r and omized to intervention or control conditions and evaluated on 2 primary outcomes : number of recommended laboratory screenings and recommended patient-centered care activities completed . Secondary outcomes were evaluated using the Problem Areas in Diabetes scale and the Patient Health Question naire (PHQ)-9 depression scale , and the RE- AIM framework was used to evaluate potential for dissemination . RESULTS : The program was well-implemented and significantly improved both number of recommended laboratory assays ( 3.4 vs 3.1 ; P<.001 ) and patient-centered aspects of diabetes care patients received ( 3.6 vs 3.2 ; P<.001 ) compared to those in r and omized control practice s. Activities that were increased most were foot exams ( follow-up rates of 80 % vs 52 % ; P<.003 ) and nutrition counseling ( 76 % vs 52 % ; P<.001 ) . CONCLUSIONS : Patients are very willing to participate in a brief computer-assisted intervention that is effective in enhancing quality of diabetes care . Staff in primary care offices can consistently deliver an intervention of this nature , but most physicians were unwilling to participate in this translation research study Background Evidence -based practice s design ed for large urban clinics are not necessarily portable into smaller isolated clinics . Implementing practice -based collaborative care for depression in smaller primary care clinics presents unique challenges because it is often not feasible to employ on-site psychiatrists . Objective The purpose of the Telemedicine Enhanced Antidepressant Management ( TEAM ) study was to evaluate a telemedicine-based collaborative care model adapted for small clinics without on-site psychiatrists . Design Matched sites were r and omized to the intervention or usual care . Participants Small VA Community-based outpatient clinics with no on-site psychiatrists , but access to telepsychiatrists . In 2003–2004 , 395 primary care patients with PHQ9 depression severity scores ≥12 were enrolled , and followed for 12 months . Patients with serious mental illness and current substance dependence were excluded . Measures Medication adherence , treatment response , remission , health status , health-related quality of life , and treatment satisfaction . Results The sample comprised mostly elderly , white , males with substantial physical and behavioral health comorbidity . At baseline , subjects had moderate depression severity ( Hopkins Symptom Checklist , SCL-20 = 1.8 ) , 3.7 prior depression episodes , and 67 % had received prior depression treatment . Multivariate analyses indicated that intervention patients were more likely to be adherent at both 6 ( odds ratio [ OR ] = 2.1 , p = .04 ) and 12 months ( OR = 2.7 , p = .01 ) . Intervention patients were more likely to respond by 6 months ( OR = 2.0 , p = .02 ) , and remit by 12 months ( OR = 2.4 , p = .02 ) . Intervention patients reported larger gains in mental health status and health-related quality of life , and reported higher satisfaction . Conclusions Collaborative care can be successfully adapted for primary care clinics without on-site psychiatrists using telemedicine technologies BACKGROUND The eight-item Patient Health Question naire depression scale ( PHQ-8 ) is established as a valid diagnostic and severity measure for depressive disorders in large clinical studies . Our objectives were to assess the PHQ-8 as a depression measure in a large , epidemiological population -based study , and to determine the comparability of depression as defined by the PHQ-8 diagnostic algorithm vs. a PHQ-8 cutpoint > or = 10 . METHODS R and om-digit-dialed telephone survey of 198,678 participants in the 2006 Behavioral Risk Factor Surveillance Survey ( BRFSS ) , a population -based survey in the United States . Current depression as defined by either the DSM-IV based diagnostic algorithm ( i.e. , major depressive or other depressive disorder ) of the PHQ-8 or a PHQ-8 score > or = 10 ; respondent sociodemographic characteristics ; number of days of impairment in the past 30 days in multiple domains of health-related quality of life ( HRQoL ) . RESULTS The prevalence of current depression was similar whether defined by the diagnostic algorithm or a PHQ-8 score > or = 10 ( 9.1 % vs. 8.6 % ) . Depressed patients had substantially more days of impairment across multiple domains of HRQoL , and the impairment was nearly identical in depressed groups defined by either method . Of the 17,040 respondents with a PHQ-8 score > or = 10 , major depressive disorder was present in 49.7 % , other depressive disorder in 23.9 % , depressed mood or anhedonia in another 22.8 % , and no evidence of depressive disorder or depressive symptoms in only 3.5 % . LIMITATIONS The PHQ-8 diagnostic algorithm rather than an independent structured psychiatric interview was used as the criterion st and ard . CONCLUSIONS The PHQ-8 is a useful depression measure for population -based studies , and either its diagnostic algorithm or a cutpoint > or = 10 can be used for defining current depression CONTEXT Depressive symptoms predict adverse cardiovascular outcomes in patients with coronary heart disease , but the mechanisms responsible for this association are unknown . OBJECTIVE To determine why depressive symptoms are associated with an increased risk of cardiovascular events . DESIGN AND PARTICIPANTS The Heart and Soul Study is a prospect i ve cohort study of 1017 out patients with stable coronary heart disease followed up for a mean ( SD ) of 4.8 ( 1.4 ) years . SETTING Participants were recruited between September 11 , 2000 , and December 20 , 2002 , from 12 outpatient clinics in the San Francisco Bay Area and were followed up to January 12 , 2008 . MAIN OUTCOME MEASURES Baseline depressive symptoms were assessed using the Patient Health Question naire ( PHQ ) . We used proportional hazards models to evaluate the extent to which the association of depressive symptoms with subsequent cardiovascular events ( heart failure , myocardial infa rct ion , stroke , transient ischemic attack , or death ) was explained by baseline disease severity and potential biological or behavioral mediators . RESULTS A total of 341 cardiovascular events occurred during 4876 person-years of follow-up . The age-adjusted annual rate of cardiovascular events was 10.0 % among the 199 participants with depressive symptoms ( PHQ score > or = 10 ) and 6.7 % among the 818 participants without depressive symptoms ( hazard ratio [ HR ] , 1.50 ; 95 % confidence interval , [ CI ] , 1.16 - 1.95 ; P = .002 ) . After adjustment for comorbid conditions and disease severity , depressive symptoms were associated with a 31 % higher rate of cardiovascular events ( HR , 1.31 ; 95 % CI , 1.00 - 1.71 ; P = .04 ) . Additional adjustment for potential biological mediators attenuated this association ( HR , 1.24 ; 95 % CI , 0.94 - 1.63 ; P = .12 ) . After further adjustment for potential behavioral mediators , including physical inactivity , there was no significant association ( HR , 1.05 ; 95 % CI , 0.79 - 1.40 ; P = .75 ) . CONCLUSION In this sample of out patients with coronary heart disease , the association between depressive symptoms and adverse cardiovascular events was largely explained by behavioral factors , particularly physical inactivity CONTEXT Chronic pain is common in primary care patients and is associated with distress , disability , and increased health care use . OBJECTIVE To assess whether a collaborative intervention can improve chronic pain-related outcomes , including comorbid depression severity , in a Department of Veterans Affairs primary care setting . DESIGN , SETTING , AND PARTICIPANTS Cluster r and omized controlled trial of a collaborative care assistance with pain treatment intervention vs treatment as usual at 5 primary care clinics of 1 Department of Veterans Affairs Medical Center . Forty-two primary care clinicians were r and omized to the assistance with pain treatment intervention group or the treatment as usual group . The 401 patients had musculoskeletal pain diagnoses , moderate or greater pain intensity , and disability lasting 12 weeks or longer and were assigned to the same treatment groups as their clinicians . Recruitment occurred from January 2006 to January 2007 and follow-up concluded in January 2008 . INTERVENTION Assistance with pain treatment included a 2-session clinician education program , patient assessment , education and activation , symptom monitoring , feedback and recommendations to clinicians , and facilitation of specialty care . MAIN OUTCOME MEASURES Changes over 12 months in pain-related disability ( Rol and -Morris Disability Question naire , range of 0 - 24 ) , pain intensity ( Chronic Pain Grade [ CPG ] Pain Intensity subscale , range of 0 - 100 ) , and depression ( Patient Health Question naire 9 [ PHQ-9 ] , range of 0 - 27 ) , measured as beta coefficients ( difference in slopes in points per month ) . RESULTS Intervention patients had a mean ( SD ) of 10.6 ( 4.5 ) contacts with the assistance with pain treatment team . Compared with the patients receiving treatment as usual , intervention patients showed greater improvements in pain-related disability ( Rol and -Morris Disability Question naire beta , -0.101 [ 95 % confidence interval { CI } , -0.163 to -0.040 ] ; P = .004 and CPG Pain Intensity subscale beta , -0.270 [ 95 % CI , -0.480 to -0.061 ] ; P = .01 ) . Among patients with baseline depression ( PHQ-9 score > or = 10 ) , there was greater improvement in depression severity in patients receiving the intervention compared with patients receiving treatment as usual ( PHQ-9 beta , -0.177 [ 95 % CI , -0.295 to -0.060 ] ; P = .003 ) . The differences in scores between baseline and 12 months for the assistance with pain treatment intervention group and the treatment as usual group , respectively , were -1.4 vs -0.2 for the Rol and -Morris Disability Question naire , -4.7 vs -0.6 for the CPG Pain Intensity subscale , and -3.7 vs -1.2 for PHQ-9 . CONCLUSION The assistance with pain treatment collaborative intervention result ed in modest but statistically significant improvement in a variety of outcome measures . TRIAL REGISTRATION clinical trials.gov Identifier : NCT00129480 OBJECTIVE To evaluate the psychometric properties of a single-item depression screen against vali date d scoring algorithms for the Patient Health Question naire ( PHQ ) and the utility of these algorithms in screening for depression and suicidality in a Department of Veterans Affairs ( VA ) primary care setting . STUDY DESIGN Recruitment phase of a r and omized trial . METHODS A total of 1211 Portl and VA patients with upcoming primary care clinic appointments were administered by telephone a single item assessing depressed mood over the past year and the PHQ . The PHQ-9 ( 9 items ) encompasses DSM-IV criteria for major depression , the PHQ-8 ( 8 items ) excludes the thoughts of death or suicide item , and the PHQ-2 ( 2 items ) assesses depressed mood and anhedonia . Patients whose responses suggested potential suicidality were administered 2 additional items assessing suicidal ideation . Patients receiving mental health specialty care were excluded . RESULTS Using the PHQ-9 algorithm for major depression as the reference st and ard , the VA single-item screen was specific ( 88 % ) but less sensitive ( 78 % ) . A PHQ-2 score of > or =3 demonstrated similar specificity ( 91 % ) with high sensitivity ( 97 % ) . For case finding , the PHQ-8 was similar to the PHQ-9 . Approximately 20 % of patients screened positive for moderate depression , 7 % reported thoughts of death or suicide , 2 % reported thoughts of harming themselves , and 1 % had specific plans . CONCLUSIONS The PHQ-2 offers brevity and better psychometric properties for depression screening than the single-item screen . The PHQ-9 item assessing thoughts of death or suicide does not improve depression case finding ; however , one third of patients endorsing this item reported recent active suicidal ideation PURPOSE Patients seeking care for medically unexplained physical symptoms pose a major challenge at primary care sites , and there are very few well-accepted and properly evaluated interventions to manage such patients . METHODS We tested the effectiveness of a cognitive behavior therapy (CBT)-type intervention delivered in primary care for patients with medically unexplained physical symptoms . Patients were r and omly assigned to receive either the intervention plus a consultation letter or usual clinical care plus a consultation letter . Physical and psych Output:	RESULTS The PHQ-9 and its abbreviated eight-item ( PHQ-8 ) and two-item ( PHQ-2 ) versions have good sensitivity and specificity for detecting depressive disorders . Likewise , the GAD-7 and its abbreviated two-item ( GAD-2 ) version have good operating characteristics for detecting generalized anxiety , panic , social anxiety and post-traumatic stress disorder . The optimal cutpoint is > or = 10 on the parent scales ( PHQ-9 and GAD-7 ) and > or = 3 on the ultra-brief versions ( PHQ-2 and GAD-2 ) . The PHQ-15 is equal or superior to other brief measures for assessing somatic symptoms and screening for somatoform disorders . Cutpoints of 5 , 10 and 15 represent mild , moderate and severe symptom levels on all three scales . Sensitivity to change is well-established for the PHQ-9 and emerging albeit not yet definitive for the GAD-7 and PHQ-15 . CONCLUSIONS The PHQ-9 , GAD-7 and PHQ-15 are brief well-vali date d measures for detecting and monitoring depression , anxiety and somatization
MS22362	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: Contingency management ( CM ) rapidly reduces cocaine use , but its effects subside after treatment . Cognitive-behavioral therapy ( CBT ) produces reductions months after treatment . Combined , the 2 might be complementary . One hundred ninety-three cocaine-using methadone-maintained out patients were r and omly assigned to 12 weeks of group therapy ( CBT or a control condition ) and voucher availability ( CM contingent on cocaine-negative urine or noncontingent ) . Follow-ups occurred 3 , 6 , and 12 months posttreatment . Primary outcome was cocaine-negative urine ( urinalysis 3 times/week during treatment and once at each follow-up ) . During treatment , initial effects of CM were dampened by CBT . Posttreatment , there were signs of additive benefits , significant in 3- versus 12-month contrasts . Former CBT participants were also more likely to acknowledge cocaine use and its effects and to report employment BACKGROUND Injection drug use directly or indirectly accounts for nearly half the annual human immunodeficiency virus ( HIV ) infections in the United States . Prospect i ve studies that investigate both sexual and parenteral HIV risks among injection drug users ( IDUs ) are needed . We studied factors for HIV seroconversion among male and female IDUs in Baltimore , Md. METHODS The HIV-negative IDUs ( 1447 male and 427 female ) were recruited into a prospect i ve study from 1988 to 1989 or in 1994 . Participants underwent semiannual HIV tests and surveys through December 1998 . Poisson regression was used to identify risk factors for HIV seroconversion , stratified by sex . Behaviors were treated as time-dependent covariates that varied at each semiannual period . RESULTS Subjects were primarily African American ( 91 % ) , and median age at enrollment was 35 years . Incidence of HIV was 3.14 per 100 person years ( 95 % confidence interval , 2.78 - 3.53 ) and did not significantly differ by sex . Younger age independently predicted HIV seroconversion for both men and women . Among men , factors that independently predicted HIV seroconversion were the following : less than a high school education , recent needle sharing with multiple partners , daily injection , and shooting-gallery attendance . The incidence of HIV was double for men recently engaging in homosexual activity and cocaine injection . Among women , the incidence of HIV was more than double for those recently reporting sexually transmitted diseases . CONCLUSIONS The incidence of HIV remained high among IDUs in Baltimore over the past decade . Risk factors for HIV seroconversion differed markedly by sex . Predominant risks among men included needle sharing and homosexual activity ; among women , factors consistent with high-risk heterosexual activity were more significant than drug-related risks . Human immunodeficiency virus interventions aim ed at IDUs should be sex-specific and incorporate sexual risks A r and omized trial was conducted to test the effectiveness of couple-based HIV counseling and testing ( CB-HIV-CT ) and women-only relationship-focused HIV counseling and testing ( WRF-HIV-CT ) in reducing HIV risk compared to the National Institute on Drug Abuse HIV-CT st and ard intervention . Substance using HIV-negative women and their primary heterosexual partner ( N = 330 couples ) were r and omized to 1 of the 3 interventions . Follow-up assessment s measuring HIV risk behaviors and other relevant variables were conducted at 3- and 9-months postintervention . Repeated measures generalized linear mixed model analysis was used to assess treatment effects . A significant reduction in HIV risk was observed over the 9-month assessment in the CB-HIV-CT group compared to that of the control group ( b = −0.51 , t[527 ] = −3.20 , P = 0.002 ) and compared to that of the WRF-HIV-CT group ( b = −0.34 , t[527 ] = −2.07 , P = 0.04 ) , but no significant difference was observed between WRF-HIV-CT and controls ( b = −0.17 , t[527 ] = −1.09 , P = 0.28 ) . A brief couple-based HIV counseling and testing intervention design ed to address both drug-related and sexual risk behaviors among substance using women and their primary male partners was shown to be more effective at reducing overall HIV risk compared to a st and ard HIV-CT intervention in an urban setting Background : There is a lack of effective behavioral interventions for HIV-positive injection drug users ( IDUs ) . We sought to evaluate the efficacy of an intervention to reduce sexual and injection transmission risk behaviors and to increase utilization of medical care and adherence to HIV medications among this population . Methods : HIV-positive IDUs ( n = 966 ) recruited in 4 US cities were r and omly assigned to a 10-session peer mentoring intervention or to an 8-session video discussion intervention ( control condition ) . Participants completed audio computer-assisted self-interviews and had their blood drawn to measure CD4 cell count and viral load at baseline and at 3-month ( no blood ) , 6-month , and 12-month follow-ups . Results : Overall retention rates for r and omized participants were 87 % , 83 % , and 85 % at 3 , 6 , and 12 months , respectively . Participants in both conditions reported significant reductions from baseline in injection and sexual transmission risk behaviors , but there were no significant differences between conditions . Participants in both conditions reported no change in medical care and adherence , and there were no significant differences between conditions . Conclusions : Both interventions led to decreases in risk behaviors but no changes in medical outcomes . The characteristics of the trial that may have contributed to these results are examined , and directions for future research are identified OBJECTIVES We evaluated the efficacy of a peer-mentoring behavioral intervention design ed to reduce risky distributive injection practice s ( e.g. , syringe lending , unsafe drug preparation ) among injection drug users with hepatitis C virus ( HCV ) infection . METHODS A r and omized trial with a time-equivalent attention-control group was conducted among 418 HCV-positive injection drug users aged 18 to 35 years in 3 US cities . Participants reported their injection-related behaviors at baseline and at 3- and 6-month follow-ups . RESULTS Compared with the control group , intervention-group participants were less likely to report distributive risk behaviors at 3 months ( odds ratio [OR]=0.46 ; 95 % confidence interval [CI]=0.27 , 0.79 ) and 6 months ( OR=0.51 ; 95 % CI=0.31 , 0.83 ) , a 26 % relative risk reduction , but were no more likely to cite their HCV-positive status as a reason for refraining from syringe lending . Effects were strongest among intervention-group participants who had known their HCV-positive status for at least 6 months . Peer mentoring and self-efficacy were significantly increased among intervention-group participants , and intervention effects were mediated through improved self-efficacy . CONCLUSIONS This behavioral intervention reduced unsafe injection practice s that may propagate HCV among injection drug users Background We evaluated brief combination interventions to simultaneously reduce sexual and injection risks among female sex workers who inject drugs ( FSW-IDUs ) in Tijuana and Ciudad Juarez , Mexico during 2008–2010 , when harm reduction coverage was exp and ing rapidly in Tijuana , but less so in Juarez . Methods FSW-IDUs ≥18 years reporting sharing injection equipment and unprotected sex with clients within the last month participated in a r and omized factorial trial comparing four brief , single-session conditions combining either an interactive or didactic version of a sexual risk intervention to promote safer sex in the context of drug use , and an injection risk intervention to reduce sharing of needles/injection paraphernalia . Women underwent quarterly interviews and testing for HIV , syphilis , gonorrhea , Chlamydia and Trichomonas , blinding interviewers and assessors to assignment . Poisson regression with robust variance estimation and repeated measures ordinal logistic regression examined effects on combined HIV/STI incidence and receptive needle sharing frequency . Findings Of 584 initially HIV-negative FSW-IDUs , retention was ≥90 % . After 12 months , HIV/STI incidence decreased > 50 % in the interactive vs. didactic sex intervention ( Tijuana : AdjRR:0.38,95 % CI:0.16–0.89 ; Juarez : AdjRR:0.44,95 % CI:0.19–0.99 ) . In Juarez , women receiving interactive vs. didactic injection risk interventions decreased receptive needle-sharing by 85 % vs. 71 % , respectively ( p = 0.04 ) ; in Tijuana , receptive needle sharing declined by 95 % , but was similar in active versus didactic groups . Tijuana women reported significant increases in access to syringes and condoms , but Juarez women did not . Interpretation After 12 months in both cities , the interactive sexual risk intervention significantly reduced HIV/STI incidence . Exp and ing free access to sterile syringes coupled with brief , didactic education on safer injection was necessary and sufficient for achieving robust , sustained injection risk reductions in Tijuana . In the absence of exp and ing syringe access in Juarez , the injection risk intervention achieved significant , albeit more modest reductions , suggesting that community-level interventions incorporating harm reduction are more powerful than individual-level interventions . Trial Registration clinical trials.gov Active injection drug users ( IDUs ) who are also hazardous alcohol users are at particularly high risk for HIV transmission due to sharing of injection equipment . We recruited AUDIT-positive injectors from the Providence , RI needle exchange program for a r and omized clinical trial testing the effect of a brief motivational intervention ( MI ) on frequency of injection-related HIV risk behavior ( IRRB ) . HIV drug risk behavior was measured as the number of days on which subjects reported sharing works using the 30-day Timeline Followback Method . Overall , 109 subjects reported a mean reduction of IRRB days of 9.1 days from baseline to 6-month follow-up ( p < .001 ) . When compared to controls , there was a trend in reduction of IRRB days to zero at follow-up for MI subject ( OR = 2.1 ; 95 % CI = 0.9 - 4.5 ) , and strongly significant reductions in IRRB days across a range of alternative improvement thresholds . Results from this study demonstrate that MI reduces drug-related HIV risk behaviors among active IDUs . As a brief intervention , MI may be a useful adjunct to existing services intended to reduce harm AIM Contingency management ( CM ) is efficacious in reducing drug use . This study examined whether CM also reduces human immunodeficiency virus ( HIV ) risk behaviors and if these effects are mediated by longest duration of abstinence achieved during treatment . DESIGN Data were analyzed from a subset of participants in a combined data set of three published r and omized controlled trials of CM treatments . SETTING A community-based methadone maintenance clinic . PARTICIPANTS One-hundred and sixty-five cocaine-abusing methadone maintenance patients . INTERVENTION Participants received either st and ard methadone treatment or st and ard methadone treatment with CM for 3 months . MEASUREMENTS The HIV Risk Behavior Scale ( HRBS ) was administered prior to r and omization to a study condition and 3 months after the study treatments ended . The primary objective indicator of drug use was longest duration of cocaine and opioid abstinence achieved during treatment . FINDINGS Relative to those assigned to st and ard care , participants receiving CM significantly decreased overall HIV risk behaviors and injection drug use risk behaviors . CM participants also achieved longer duration s of consecutive cocaine and opioid abstinence during treatment . Duration of abstinence achieved mediated the relationship between treatment condition and HRBS difference scores . CONCLUSIONS These results suggest that CM treatment reduces HIV drug use risk behaviors in cocaine-abusing methadone maintenance patients The authors conducted a preliminary study of the 4-session Holistic Health for HIV ( 3H+ ) , which was adapted from a 12-session evidence -based risk reduction and antiretroviral adherence intervention . Improvements were found in the behavioral skills required to properly adhere to HIV medication regimens . Enhancements were found in all measured aspects of sex-risk reduction outcomes , including HIV knowledge , motivation to reduce sex-risk behavior , behavioral skills related to engaging in reduced sexual risk , and reduced risk behavior . Improvements in drug use outcomes included enhancements in risk reduction skills as well as reduced heroin and cocaine use . Intervention effects also showed durability from post-intervention to the follow-up assessment point . Females responded particularly well in terms of improvements in risk reduction skills and risk behavior . This study suggests that an evidence -based behavioral intervention may be successfully adapted for use in community-based clinical setting s where HIV-infected drug users can be more efficiently reached Injection drug use is a leading transmission route of HIV and STDs , and disease prevention among drug users is an important public health concern . This study assesses cost-effectiveness of behavioral interventions for reducing HIV and STDs infections among injection drug-using women . Cost-effectiveness analysis was conducted from societal and provider perspectives for r and omized trial data and Bernoullian model estimates of infections averted for three increasingly intensive interventions : ( 1 ) NIDA ’s st and ard intervention ( SI ) ; ( 2 ) SI plus a well woman exam ( WWE ) ; and ( 3 ) SI , WWE , plus four educational sessions ( 4ES ) . Trial results indicate that Output:	Exposure to information on improving injecting techniques did not encourage riskier injecting practice s or injecting frequency , and benefits were reported among attendees . The intervention has the potential to positively influence BBV prevention . FUTURE WORK The intervention did not meet the complex needs of some PWID , more tailoring may be needed to reach PWID who are more frequent injectors , who are homeless and female . LIMITATIONS Intervention delivery proved more feasible in London than other locations . Non-attendance at the York trial site substantially influenced the results .
MS22363	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: BACKGROUND It is unclear from prior reports whether the relationships between self-ratings of anxiety or emotional stress and parasympathetic nervous system components of heart rate variability are independent of personality and cardiorespiratory fitness . We examined those relationships in a clinical setting prior to a st and ardized exercise test . METHODS AND RESULTS Heart rate variability ( HRV ) was measured during 5 min of supine rest among 92 healthy men ( N=52 ) and women ( N=40 ) who had above-average cardiorespiratory fitness as indicated by peak oxygen uptake measured during grade -incremented treadmill exercise . HRV data sets were decomposed into low-frequency ( LF ; 0.05 - 0.15 Hz ) and high-frequency ( HF ; 0.15 - 0.5 Hz ) components using spectral analysis . Self-ratings of trait anxiety and perceived emotional stress during the past week were also assessed . CONCLUSIONS There was an inverse relationship between perceived emotional stress during the past week and the normalized HF component of HRV ( P=0.038 ) . This indicates a lower cardiac vagal component of HRV among men and women who perceived more stress . That relationship was independent of age , gender , trait anxiety , and cardiorespiratory fitness . It was also independent of heart rate ; mean arterial blood pressure ; and respiration rate , factors which can influence HRV and might be elevated among people reporting anxiety and perceived stress . We conclude that vagal modulation of heart period appears to be sensitive to the recent experience of persistent emotional stress , regardless of a person 's level of physical fitness and disposition toward experiencing anxiety In a study of the effectiveness of systematic relaxation training alone or combined with biofeedback in the treatment of hypertension in pregnancy , 60 women were seen weekly for 6 weeks . 18 were given relaxation therapy alone ( group A ) , 18 relaxation plus biofeedback ( group B ) , and there were 24 controls . Whereas two-thirds of the control group had to be admitted to hospital during their pregnancies , less than a third of each experimental group had to be admitted . The experimental groups also had significantly lower systolic and diastolic blood pressure than the control group . There were no significant differences between groups A and B in hospital admission rates or blood-pressure measurements Matched groups of primigravid women received one of three antenatal training programmes : normal antenatal classes , normal classes plus electromyography biofeedback relaxation training , or normal classes plus skin-conductance biofeedback relaxation training . Myographic training was found to be effective within conventional antenatal constraints , whereas skin-conductance training was not . The women reported use of biofeedback training and related skills to be of some benefit during early labour . However , no difference between effectively trained electromyographic , ineffectively trained skin-conductance and control groups was found on labour and delivery performance measures OBJECTIVE Prenatal distress has been linked to pregnancy complications and poor offspring 's health , despite the fact that longitudinal assessment s of various stress dimensions are still lacking . Hence , we aim ed to assess perceived stress over the course of pregnancy . Moreover , we examined whether social support and coping styles are linked to prenatal stress trajectories . METHODS Data from 543 women participating in the PRINCE ( Prenatal Identification of Children Health ) study , a prospect i ve population -based cohort study , was used for the present analyses . Once per trimester the women completed question naires regarding different psychometric measures , including the Perceived Stress Scale ( PSS ) . Linear mixed regression models were used to examine perceived stress development longitudinally and to relate social support and coping styles to stress trajectories during pregnancy . RESULTS A significant decrease of perceived stress was observed over the course of pregnancy . Stratifying the study sample according to parity , women delivering their first child had continuously lower perceived stress scores compared to women having already one or more children , and a significant decrease during pregnancy was exclusively observed in primiparous women . Both , positive coping strategies and higher perceived and received social support were independently associated with lower perceived stress , while evasive coping strategies were associated with higher levels of perceived stress . CONCLUSION Our study reveals stress perception trajectories during pregnancies in primi- and multiparous women . Our findings underscore the need for intervention strategies aim ing to improve social support and positive coping strategies especially in multiparous women in order to reduce the risks for adverse pregnancy outcomes Acute psychosocial stress is typically investigated in laboratory setting s using protocol s with distinctive characteristics . For example , some tasks involve the action of speaking , which seems to alter Heart Rate Variability ( HRV ) through acute changes in respiration patterns . However , it is still unknown which task induces the strongest subjective and autonomic stress response . The present cross-over r and omized trial sought to investigate the differences in perceived stress and in linear and non-linear analyses of HRV between three different verbal ( Speech and Stroop ) and non-verbal ( Montreal Imaging Stress Task ; MIST ) stress tasks , in a sample of 60 healthy adults ( 51.7 % females ; mean age = 25.6 ± 3.83 years ) . Analyses were run controlling for respiration rates . Participants reported similar levels of perceived stress across the three tasks . However , MIST induced a stronger cardiovascular response than Speech and Stroop tasks , even after controlling for respiration rates . Finally , women reported higher levels of perceived stress and lower HRV both at rest and in response to acute psychosocial stressors , compared to men . Taken together , our results suggest the presence of gender-related differences during psychophysiological experiments on stress . They also suggest that verbal activity masked the vagal withdrawal through altered respiration patterns imposed by speaking . Therefore , our findings support the use of highly-st and ardized math task , such as MIST , as a valid and reliable alternative to verbal protocol s during laboratory studies on stress A study of the effects of biofeedback on the pain of childbirth was conducted . Forty primigravidae were r and omly assigned to either an experimental group or a control group . The experimental group was given a series of training sessions in biofeedback and used biofeedback equipment during labor . All subjects were monitored during the labor and delivery period for their reports of pain using a visual analogue scale ( VAS ) and a verbal descriptor scale ( VDS ) . Results showed that women using biofeedback during childbirth reported significantly lower pain : from admission to labor and delivery ( p less than 0.05:VDS ; p less than 0.01:VAS ) , at delivery ( p less than 0.005:VDS ) , and 24-hr postpartum ( p less than 0.01:VDS ) . Also , women in the biofeedback group labored an average of 2 hr less and used 30 % fewer medications . The results of this study suggest that EMG biofeedback may be effective in reducing levels of acute pain experienced by childbearing women The aim of this study was to investigate cardiac functional status in pregnancy using a comprehensive approach taking into account the simultaneous changes in loading and geometry , as well as maternal age and anthropometric indices . This was a prospect i ve cross-sectional study of 559 nulliparous pregnant women assessed at 4 time points during pregnancy and at 1 year postpartum . All women underwent conventional echocardiography and tissue Doppler velocities and strain rate analysis at multiple cardiac sites . Mean arterial pressure and total vascular resistance index significantly decreased ( both P<0.001 ) during the first 2 trimesters of pregnancy and increased thereafter . Stroke volume index and cardiac index showed the opposite trend compared with mean arterial pressure and total vascular resistance index ( both P<0.05 ) . Myocardial and ventricular function were significantly enhanced in the first 2 trimesters but progressively declined thereafter . By the end of pregnancy , significant chamber diastolic dysfunction and impaired myocardial relaxation was evident in 17.9 % and 28.4 % of women , respectively , whereas myocardial contractility was preserved . There was full recovery of cardiac function at 1 year postpartum . Cardiovascular changes during pregnancy are thought to represent a physiological adaptation to volume overload . The findings of a drop in stroke volume index , impaired myocardial relaxation with diastolic dysfunction , and a tendency toward eccentric remodeling in a significant proportion of cases at term are suggestive of cardiovascular maladaptation to the volume-overloaded state in some apparently normal pregnancies . These unexpected cardiovascular findings have important implication s for the management of both normal and pathological pregnancy states 1 . The effect of a variation in inspiration and expiration times on heart rate variability was studied in 12 healthy subjects ( mean age 30±6 years ; five females ) This investigation assessed the efficacy of a biobehavioral intervention in the adjunctive treatment of mild pregnancy-induced hypertension ( PIH ) , a potentially serious complication of pregnancy in which normotensive women develop hypertension , proteinuria , and edema of unknown etiology late in gestation . Forty-five women with symptoms of PIH were r and omly assigned to one of three treatment conditions : bed rest alone ( the most common obstetrical treatment ) , bed rest with individualized compliance enhancement training , or a four-session biobehavioral treatment consisting of bed rest , compliance enhancement training , and individualized thermal biofeedback-assisted relaxation training . Results indicated that while blood pressure for the bed rest and compliance enhancement groups continued to rise and pose an increasing health risk to maternal and fetal well-being , subjects in the biobehavioral group maintained their blood pressure at a significantly lower , and presumably safer , level . The biobehavioral treatment is hypothesized to affect blood pressure levels in subjects with mild PIH through the mediation of the sympathetic nervous system , decreasing peripheral vascular resistance and cardiac output . The results of this investigation suggest that the biobehavioral intervention may be an effective adjunct to bed rest in the treatment of mild PIH remote from term PURPOSE This study was conducted to investigate the effectiveness of pelvic floor muscle exercise using biofeedback and electrical stimulation after normal delivery . METHODS The subjects of this study were 49 ( experimental group : 25 , control group : 24 ) postpartum women who passed 6 weeks after normal delivery without complication of pregnancy , delivery and postpartum . The experimental group was applied to the pelvic muscle enforcement program by biofeedback and electrical stimulation for 30 minutes per session , twice a week for 6 weeks , after then self-exercise of pelvic floor muscle was done 50 - 60 repetition per session , 3 times a day for 6 weeks . Maximum pressure of pelvic floor muscle contraction ( MPPFMC ) , average pressure of pelvic floor muscle contraction ( APPFMC ) , duration time of pelvic floor muscle contraction ( DTPFMC ) and the subjective lower urinary symptoms were measured by digital perineometer and Bristol Female Urinary Symptom Question naire and compared between two groups prior to trial , at the end of treatment and 6 weeks after treatment . RESULTS The results of this study indicated that MPPFMC , APPFMC , DTPFMC were significantly increased and subjective lower urinary symptoms were significantly decreased after treatment in the experimental group than in the control group . CONCLUSIONS This study suggested that the pelvic floor muscle exercise using biofeedback and electrical stimulation might be a safer and more effective program for reinforcing pelvic floor muscle after normal delivery BACKGROUND Several parameters of heart rate variability ( HRV ) have been shown to predict the risk of sudden cardiac death ( SCD ) in cardiac patients . There is consensus that risk prediction is increased when measuring HRV during specific provocations such as orthostatic challenge . For the first time , we provide data on reproducibility of such a test in patients with a history of acute coronary syndrome . METHODS Sixty male patients ( 65 ± 8 years ) with a history of acute coronary syndrome on stable medication were included . HRV was measured in supine ( 5 min ) and st and ing ( 5 min ) position on 2 occasions separated by two weeks . For risk assessment relevant time-domain [ st and ard deviation of all R-R intervals ( SDNN ) and root mean squared st and ard differences between adjacent R-R intervals ( RMSSD ) ] , frequency domain [ low-frequency power ( LF ) , high-frequency power ( HF ) and LF/HF power ratio ] and short-term fractal scaling component ( DF1 ) were computed . Absolute reproducibility was assessed with the st and ard errors of the mean ( SEM ) and 95 % limits of r and om variation , and relative reproducibility by the intraclass correlation coefficient ( ICC ) . RESULTS We found comparable SEMs and ICCs in supine position and after an orthostatic challenge test . All ICCs were good to excellent ( ICCs between 0.636 and 0.869 ) . CONCLUSIONS Reproducibility of HRV parameters during orthostatic challenge is good and comparable with supine position Abstract Objective : We sought to characterise the influence of an antenatal exercise programme on ECG-derived cardiac variables . Methods : Fifity-one healthy pregnant women were recruited and r and omly assigned ( 2 × 2 × 2 design ) to an exercise group or a control group . Exercising groups attended weekly classes from the 20th week of pregnancy onwards . Cardiovascular assessment s ( heart rate variabiliy ( HRV ) , QT , and the QT variability index ( QTVI ) ) were performed at 12–16 , 26–28 , 34–36 weeks and 12 weeks following birth , during supine rest and exercise conditions . Results : Advancing gestation was associated with an increased maternal heart rate ( p = 0.001 ) , shorter QT interval ( p = 0.003 ) , diminished HRV ( p = 0.002 ) and increased QTVI ( p = 0.002 ) . Each of these changes was reversed within 12 weeks postpartum ( p < 0.004 ) . The Output:	The major findings of this review can be described as follows : ( a ) HRVBF and psychological stress in peripartum women are related concepts , ( b ) peripartum women who completed HRVBF report a reduction in stress compared with participants who did not receive HRVBF , and ( c ) there is currently no information on the effectiveness of HRVBF on psychological stress in the first and early second trimester of pregnancy . Overall , this systematic review of the literature provides objective evidence that HRVBF may be a potential beneficial adjuvant treatment for stress management in peripartum women
MS22364	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: Therapeutic trials often attempt to “ blind ” patient and investigator to the true nature of treatments received , reducing the influences of conscious or subconscious prejudices . In drug trials , this is accomplished with placebo tablets , but blinding in trials of physical treatments is more problematic . This issue arose in a clinical trial of transcutaneous electrical nerve stimulation ( TENS ) for patients with chronic low back pain . Several study design features were incorporated to promote blinding : use of sham TENS units visually identical with real units , exclusion of potential subjects with previous TENS experience , avoidance of a crossover design and use of identical visit frequency , instructions and modifications in electrode placement . Subjects were asked not to discuss treatments with the clinicians who performed outcome assessment s. Both patients and clinicians were asked to guess actual treatment assignments at the trial 's end . Every patient in the true TENS group believed the unit was functioning properly , but the degree of certainty varied . In the sham TENS group , 84 % also believed they had functioning units , but their certainty was significantly less than in the active treatment group . Differences in patient perceptions did not affect compliance , as the two groups had similar dropout rates , appointment compliance , days of TENS use and daily duration of TENS use . Clinicians guessed treatments correctly 61 % of the time ( as opposed to 50 % expected by chance ) , again suggesting partial success in blinding . These efforts at blinding may partly explain the negative trial results for TENS efficacy . We conclude that complete blinding is difficult to achieve because of sensory difference in treatment and unintended communication between patient and examiner . Nonetheless , trials of physical treatments can achieve partial blinding with the techniques described here , and the success of blinding can be assessed with simple questions at study completion 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 BACKGROUND Fibromyalgia is a chronic pain syndrome associated with sleep disorders , fatigue and psychological symptoms . Combinations therapies , such as electrotherapy and therapeutic exercises have been used in the clinical practice . AIM To assess the efficacy of high-frequency transcutaneous electrical nerve stimulation ( TENS ) as an adjuvant therapy to aerobic and stretching exercises , for the treatment of fibromyalgia . DESIGN Controlled clinical trial . SETTING Unit of rehabilitation of a public hospital . POPULATION Twenty-eight women aged 52.4±7.5 years , with fibromyalgia . METHODS A visual analogue scale measured pain intensity ; tender points pain threshold , by dolorimetry ; and quality of life , by the Fibromyalgia Impact Question naire . All subjects participated in an eight-week program consisting of aerobic exercises , followed by static stretching of muscle chains . In TENS group , high-frequency ( 150 Hz ) was applied on bilateral tender points of trapezium and supraspinatus . RESULTS TENS group had a greater pain reduction ( mean change score=-2.0±2.9 cm ) compared to Without TENS group ( -0.7±3.7 cm ) . There was a difference between mean change scores of each group for pain threshold ( right trapezium : 0.2±1 kg/cm² in TENS group and -0.2±1.2 kg/cm² in Without TENS group ) . In the evaluation of clinical ly important changes , patients receiving TENS had relevant improvement of pain , work performance , fatigue , stiffness , anxiety and depression compared to those not receiving TENS . CONCLUSION It has suggested that high-frequency TENS as an adjuvant therapy is effective in relieving pain , anxiety , fatigue , stiffness , and in improving ability to work of patients with fibromyalgia . CLINICAL REHABILITATION IMPACT High-frequency TENS may be used as a short-term complementary treatment of fibromyalgia UNLABELLED Transcutaneous electrical nerve stimulation ( TENS ) is an electrophysical modality used for pain management . This study investigated the dose response of different TENS intensities on experimentally induced pressure pain . One hundred and thirty TENS naïve healthy individuals ( 18 - 64 years old ; 65 males , 65 females ) were r and omly allocated to 5 groups ( n = 26 per group ) : Strong Non Painful TENS ; Sensory Threshold TENS ; Below Sensory Threshold TENS ; No Current Placebo TENS ; and Transient Placebo TENS . Active TENS ( 80 Hz ) was applied to the forearm for 30 minutes . Transient Placebo TENS was applied for 42 seconds after which the current amplitude automatically reset to 0 mA. Pressure pain thresholds ( PPT ) were recorded from 2 points on the h and and forearm before and after TENS to measure hypoalgesia . There were significant differences between groups at both the h and and forearm ( ANOVA ; P = .005 and .002 ) . At 30 minutes , there was a significant hypoalgesic effect in the Strong Non Painful TENS group compared to : Below Sensory Threshold TENS , No Current Placebo TENS and Transient Placebo TENS groups ( P < .0001 ) at the forearm ; Transient Placebo TENS and No Current Placebo TENS groups at the h and ( P = .001 ) . There was no significant difference between Strong Non Painful TENS and Sensory Threshold TENS groups . The area under the curve for the changes in PPT significantly correlated with the current amplitude ( r(2 ) = .33 , P = .003 ) . These data therefore show that there is a dose-response effect of TENS with the largest effect occurring with the highest current amplitudes . PERSPECTIVE This study shows a dose response for the intensity of TENS for pain relief with the strongest intensities showing the greatest effect ; thus , we suggest that TENS intensity should be titrated to achieve the strongest possible intensity to achieve maximum pain relief Summary Pain and fatigue during movement , but not at rest , are reduced by a onetime 30‐m treatment with active transcutaneous electrical nerve stimulation ( TENS ) in individuals with fibromyalgia . Abstract Because transcutaneous electrical nerve stimulation ( TENS ) works by reducing central excitability and activating central inhibition pathways , we tested the hypothesis that TENS would reduce pain and fatigue and improve function and hyperalgesia in people with fibromyalgia who have enhanced central excitability and reduced inhibition . The current study used a double‐blinded r and omized , placebo‐controlled cross‐over design to test the effects of a single treatment of TENS with people with fibromyalgia . Three treatments were assessed in r and om order : active TENS , placebo TENS and no TENS . The following measures were assessed before and after each TENS treatment : pain and fatigue at rest and in movement ; pressure pain thresholds , 6‐m walk test , range of motion ; 5‐time sit‐to‐st and test , and single‐leg stance . Conditioned pain modulation was completed at the end of testing . There was a significant decrease in pain and fatigue with movement for active TENS compared to placebo and no TENS . Pressure pain thresholds increased at the site of TENS ( spine ) and outside the site of TENS ( leg ) when compared to placebo TENS or no TENS . During active TENS , conditioned pain modulation was significantly stronger compared to placebo TENS and no TENS . No changes in functional tasks were observed with TENS . Thus , the current study suggests TENS has short‐term efficacy in relieving symptoms of fibromyalgia while the stimulator is active . Future clinical trials should examine the effects of repeated daily delivery of TENS , similar to the way in which TENS is used clinical ly on pain , fatigue , function , and quality of life in individuals with fibromyalgia Adequate reporting of r and omized , controlled trials ( RCTs ) is necessary to allow accurate critical appraisal of the validity and applicability of the results . The CONSORT ( Consoli date d St and ards of Reporting Trials ) Statement , a 22-item checklist and flow diagram , is intended to address this problem by improving the reporting of RCTs . However , some specific issues that apply to trials of nonpharmacologic treatments ( for example , surgery , technical interventions , devices , rehabilitation , psychotherapy , and behavioral intervention ) are not specifically addressed in the CONSORT Statement . Furthermore , considerable evidence suggests that the reporting of nonpharmacologic trials still needs improvement . Therefore , the CONSORT group developed an extension of the CONSORT Statement for trials assessing nonpharmacologic treatments . A consensus meeting of 33 experts was organized in Paris , France , in February 2006 , to develop an extension of the CONSORT Statement for trials of nonpharmacologic treatments . The participants extended 11 items from the CONSORT Statement , added 1 item , and developed a modified flow diagram . To allow adequate underst and ing and implementation of the CONSORT extension , the CONSORT group developed this elaboration and explanation document from a review of the literature to provide examples of adequate reporting . This extension , in conjunction with the main CONSORT Statement and other CONSORT extensions , should help to improve the reporting of RCTs performed in this field Fibromyalgia is characterized by a range of symptoms that include muscle pain , fatigue and sleep disorders . Transcutaneous electrical nerve stimulation ( TENS ) is an established method for pain relief . The purpose of the study was to evaluate the effectiveness and safety of the use of two simultaneously new TENS devices for fibromyalgia pain . After Ethics approval and informed consent , 39 patients were prospect ively divided into three groups to evaluate TENS device , applied simultaneously in each patient : ( 1 ) at the lower back ( perpendicular to the vertebrae canal , at the level of the 5th lumbar vertebrae ) and ( 2 ) central ly above and below the space between the C7 and T1 spinous processes . The devices were applied for 20 min at 12-h interval during 7 consecutive days . For the placebo group ( PG ) , the devices did not transmitted electrical stimulus . The single-TENS group ( STG ) ( n = 13 ) had one active and one placebo TENS . The DTG applied both active TENS devices at the low back and cervical areas . Diclofenac was used as rescue analgesic . The efficacy measures were pain relief , reduction in use of daily analgesic tablets , quality of sleep and fatigue . The evaluation within groups revealed that patients from DPG refereed no pain relief when compared to their previous VAS pain score ( 8 cm , p > 0.05 ) , while patients from the STG refereed improvement of 2.5 cm in the pain VAS ( previous 8.5 cm compared to 6 cm after treatment ) ( p < 0.05 ) , and the DPG refereed daily maintained reduction of 4 cm in the VAS pain ( previous 8.5–4.3 cm ) ( p < 0.02 ) . Concurrent daily consumption of analgesic tablets was reduced in both STG ( p < 0.05 ) and DTG ( p < 0.02 ) . Comparison among groups revealed that analgesia , as well as quality of sleep and disposition , was DTG > STG > PG ( p < 0.05 ) . Participants subjectively found the active device useful . While the application of a single active TENS improved pain relief in fibromyalgia pain , pain and fatigue were further improved when two active devices were simultaneously applied at the low back and cervical area , with no side effects The aim of this study was to investigate the results of a supervised exercise with transcutaneous electrical nerve stimulation ( TENS ) in an exercise controlled study in women with fibromyalgia . Sixty-six women with fibromyalgia who admitted to the outpatient clinic of our hospital were r and omized into two treatment groups . The patients in both groups participated in a supervised combined exercise program for 12 weeks . The women in first group had additional TENS in the first 3 weeks of the study . All subjects were analyzed at the baseline , at the end of the 3rd and 12th Output:	There were no significant differences between TENS and placebo for pain at rest . There was insufficient high- quality evidence to support or refute the use of TENS for fibromyalgia .
MS22365	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: PURPOSE The role of thyroxine replacement in sub clinical hypothyroidism remains unclear . We performed a 6-month r and omized , double-blind , placebo-controlled trial to evaluate the effects of thyroxine treatment for mild sub clinical hypothyroidism , defined as a serum thyroid-stimulating hormone level between 5 to 10 microU/mL with a normal serum free thyroxine level ( 0.8 - 16 ng/dL ) . SUBJECTS AND METHODS We r and omly assigned 40 women with mild sub clinical hypothyroidism who had presented to their family practitioners to either thyroxine treatment ( n = 23 ; 50 to 100 microg daily ) or placebo ( n = 17 ) . Health-related quality of life ( Hospital Anxiety and Depression scale , 30-item General Health Question naire ) , fasting lipid profiles , body weight , and resting energy expenditure were measured at baseline and 6 months . RESULTS The most common presenting symptoms were fatigue ( n = 33 [ 83 % ] ) and weight gain ( n = 32 [ 80 % ] ) . At presentation , 20 women ( 50 % ) had elevated anxiety scores and 22 ( 56 % ) had elevated scores on the General Health Question naire . Thirty-five women completed the study . There were no significant differences in the changes from baseline to 6 months between women in the thyroxine group and the placebo group for any of the metabolic , lipid , or anthropometric variables measured , expressed as the mean change in the thyroxine group minus the mean change in the placebo group : body mass index , -0.3 kg/m(2 ) ( 95 % confidence interval [ CI ] : -0.9 to 0.4 kg/m(2 ) ) ; resting energy expenditure , -0.2 kcal/kg/24 h ( 95 % CI : -1.3 to 1.0 kcal/kg/24 h ) ; and low-density lipoprotein cholesterol , -4 mg/dL ( 95 % CI : -23 to 15 mg/dL ) . There was a significant worsening in anxiety scores in the thyroxine group ( scores increased in 8 of 20 women and were unchanged in 2 of 20 ) compared with the placebo group ( scores increased in 1 of 14 women and were unchanged in 6 of 14 ; P = 0.03 ) . CONCLUSIONS ; We observed no clinical ly relevant benefits from 6 months of thyroxine treatment in women with mild sub clinical hypothyroidism Sub clinical hypothyroidism ( sHT ) affects 5 - 15 % of the general population ; however , the need of lifelong L-T(4 ) therapy is still controversial . As myocardium is a main target of thyroid hormone action , we investigated whether sHT induces cardiovascular alterations . Twenty sHT patients were r and omly assigned to receive placebo or L-T(4 ) therapy and were followed for 1 yr . Twenty sex- and age-matched normal subjects served as controls . Doppler echocardiography and videodensitometric analysis were performed in all subjects . Myocardium textural parameters were obtained as mean gray levels , which were then used to calculate the cyclic variation index ( CVI ; percent systolic/diastolic change in mean gray levels ) . Patients had a significantly higher isovolumic relaxation time ( 3.1 + /- 0.5 vs. 2.6 + /- 0.6 ; P < 0.03 ) , peak A ( 0.77 + /- 0.16 vs. 0.56 + /- 0.13 m/s ; P < 0.01 ) , and preejection/ejection time ( PEP/ET ) ratio ( 0.72 + /- 0.05 vs. 0.57 + /- 0.06 ; P < 0.03 ) and a lower CVI ( P < 0.0001 ) than controls . CVI was inversely related to TSH level ( P < 0.0001 ) and PEP/ET ratio ( P < 0.01 ) . L-T(4)-treated patients showed a significant reduction of the PEP/ET ratio ( P < 0.05 ) , peak A ( P < 0.05 ) , and isovolumic relaxation time ( P < 0.05 ) along with a normalization of CVI . Conversely , no changes were observed in the placebo-treated group . In conclusion , sHT affects both myocardial structure and contractility . These alterations may be reversed by L-T(4 ) therapy Sub clinical hypothyroidism ( sHT ) is associated with dyslipidemia and enhanced cardiovascular risk . We assessed carotid artery intima-media thickness ( IMT , high-resolution ultrasonography ) and lipoprotein profile in 45 sHT patients ( aged 37 + /- 11 yr ) at baseline and after 6 months of r and omized , placebo-controlled L-T(4 ) replacement . In comparison with 32 age- and sex-matched controls , sHT patients had elevated total and low-density lipoprotein ( LDL ) cholesterol and ApoB levels ( P = 0.002 , P = 0.0007 , and P = 0.01 , respectively ) and higher mean-IMT values ( P < 0.0001 ) . In stepwise regression analysis , mean-IMT was positively related ( r(2 ) = 0.71 , P < 0.0001 ) to age , TSH , and LDL cholesterol . L-T(4 ) replacement significantly reduced both total and LDL cholesterol ( P < 0.0001 for both ) and mean-IMT ( by 11 % , P < 0.0001 ) . The decrement in IMT was directly related to the decrements of both total cholesterol and TSH ( P = 0.02 and P = 0.0001 , respectively ) . We conclude that early carotid artery wall alterations are present in sHT patients . Whether such IMT increase is related to an early atherosclerotic involvement of the arterial wall can not be clearly decided on the basis of the present results . However , the fact that L-T(4 ) replacement therapy was able to improve both the atherogenic lipoprotein profile and intima-media thickening suggests that lipid infiltration of arterial wall may represent a major mechanism underlying IMT increase in sub clinical hypothyroidism OBJECTIVE To evaluate the effects of physiologic doses of levothyroxine replacement on the lipoprotein profile in patients with sub clinical hypothyroidism ( SCH ) . METHODS In a prospect i ve , double-blind , placebo-controlled study , we enrolled 120 patients --mostly , but not exclusively , premenopausal women -- with SCH . Patients were r and omly assigned to either a levothyroxine-treated group ( n = 60 ) or a placebo ( control ) group ( n = 60 ) . Total cholesterol ( TC ) , low-density lipoprotein cholesterol ( LDL-C ) , high-density lipoprotein cholesterol ( HDL-C ) , and triglycerides ( TG ) were measured before and 52 weeks after assignment to either group . RESULTS In the levothyroxine-treated group , the lipoprotein mean values before and after the 52-week study were as follows : TC , 5.05 + /- 0.98 mmol/L versus 4.74 + /- 0.87 mmol/L ( P<.0001 ) ; LDL-C , 3.30 + /- 0.90 mmol/L versus 2.89 + /- 0.59 mmol/L ( P<.01 ) ; TG , 1.18 + /- 0.71 mmol/L versus 0.95 + /- 0.53 mmol/L ( P<.002 ) ; and HDL-C , 1.20 + /- 0.33 mmol/L versus 1.19 + /- 0.32 mmol/L ( P = .29 ) . In the control group , TC , HDL-C , and TG values remained unchanged after 52 weeks in comparison with baseline , but LDL-C mean values increased from 2.79 + /- 0.60 mmol/L to 3.11 + /- 0.77 mmol/L , a change that was statistically significant ( P<.001 ) . At the end of the study , the lipid profile changes between levothyroxine-treated and control groups were compared . Total cholesterol and LDL-C were significantly lower in the levothyroxine-receiving group ( P<.029 and P<.0001 , respectively ) in comparison with the control group . The difference did not reach statistical significance for TG and HDL-C values . CONCLUSION In premenopausal women , SCH has a negative effect on the lipoprotein profile and may translate into a sizable cardiovascular risk if left untreated BACKGROUND : Previous studies have suggested an association between sub clinical hypothyroidism and coronary artery disease that could be related to changes in serum lipids or endothelial dysfunction . METHODS : Thirty-two female sub clinical hypothyroidism patients were r and omly assigned to 12 months of L-thyroxine replacement or no treatment . Endothelial function was measured by the flow-mediated vasodilatation of the brachial artery , as well as mean carotid artery intima-media thickness , and lipid profiles were studied at baseline and after 12 months of follow-up . RESULTS : The mean ( ±SD ) serum thyroid-stimulating hormone levels in the L-thyroxine replacement and control groups were 6.09±1.32 and 6.27±1.39 µUI/ml , respectively . No relationship between carotid artery intima-media thickness or brachial flow-mediated vasodilatation and free T4 and serum thyroid-stimulating hormone was found . The median L-T4 dose was 44.23±18.13 µg/day . After 12 months , there was a significant decrease in the flow-mediated vasodilatation in the sub clinical hypothyroidism control group ( before : 17.33±7.88 to after : 13.1±4.75 % , p = 0.03 ) , but there were no significant differences in flow-mediated vasodilatation in the L-thyroxine treated group ( before : 16.81±7.0 to after : 18.52±7.44 % , p = 0.39 ) . We did not find any significant change in mean carotid intima-media thickness after 12 months of L-thyroxine treatment . CONCLUSION : Replacement therapy prevents a decline in flow-mediated vasodilatation with continuation of the sub clinical hypothyroidism state . Large prospect i ve multicenter placebo-controlled trials are necessary to investigate endothelial physiology further in sub clinical hypothyroidism patients and to define the role of L-thyroxine therapy in improving endothelial function in these patients BACKGROUND Mild sub clinical hypothyroidism ( SCH ) affects a large number of people and is known to be a risk factor for dyslipidemia . However , whether mild SCH patients should be treated with L-thyroxine to improve lipid profiles remains controversial . In addition , it is also unclear whether all mild SCH patients can benefit from L-thyroxine treatment , regardless of basal thyrotropin or lipid levels . This study aim ed to assess the effects of L-thyroxine replacement therapy on the lipid profiles of mild SCH patients . METHODS This open-label r and omized controlled trial was performed in Ningyang County , Sh and ong Province , China . A total of 378 mild SCH patients with diagnoses confirmed by two thyroid function tests were r and omly assigned to either the intervention group ( L-thyroxine replacement therapy ) or the control group ( no treatment ) . The primary outcome was a change in serum total cholesterol ( TC ) concentration . RESULTS In all , 369 participants completed the 15-month follow-up period . Reduced TC concentrations were more prominent in the intervention group than they were in the control group ( -0.41 mmol/L vs. -0.17 mmol/L ; p = 0.012 ) , and changes in low-density lipoprotein cholesterol levels exhibited the same trend . Subgroup analyses were performed to assess the effects of L-thyroxine in patients with different thyrotropin or TC levels . When the study population was stratified according to basal thyrotropin concentration , all patients who had received L-thyroxine showed reduced TC levels ( p < 0.001 ) . The treatment was similarly beneficial for all patients , regardless of basal TC level . Even for subjects with TC levels < 5.18 mmol/L , serum TC concentrations remained unchanged in the intervention group ( p = 0.936 ) but increased by 0.35 mmol/L in the control group ( p = 0.004 ) . CONCLUSIONS The findings suggest that mild SCH patients could benefit from L-thyroxine treatment to improve lipid profiles , regardless of basal thyrotropin or TC concentrations Although muscle metabolism and exercise capacity seem to be affected in patients with sub clinical hypothyroidism , there is little evidence indicating improvement of the exercise tolerance due to levothyroxine ( L-T(4 ) ) replacement . The aim of the present study was to verify possible cardiopulmonary changes during exercise in patients with sub clinical hypothyroid Output:	Results from the included r and omized controlled trials suggested no benefit of treatment for sub clinical hypothyroidism for the large majority of outcomes . This review found moderate to very low- quality evidence on the benefits and harms of treatment for sub clinical hypothyroidism , with most of the evidence showing no benefit of treatment
MS22366	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: Objective Early detection and early treatment are of vital importance to the successful treatment of various cancers . The development of a novel screening method that is as economical and non-invasive as the faecal occult blood test ( FOBT ) for early detection of colorectal cancer ( CRC ) is needed . A study was undertaken using canine scent detection to determine whether odour material can become an effective tool in CRC screening . Design Exhaled breath and watery stool sample s were obtained from patients with CRC and from healthy controls prior to colonoscopy . Each test group consisted of one sample from a patient with CRC and four control sample s from volunteers without cancer . These five sample s were r and omly and separately placed into five boxes . A Labrador retriever specially trained in scent detection of cancer and a h and ler cooperated in the tests . The dog first smelled a st and ard breath sample from a patient with CRC , then smelled each sample station and sat down in front of the station in which a cancer scent was detected . Results 33 and 37 groups of breath and watery stool sample s , respectively , were tested . Among patients with CRC and controls , the sensitivity of canine scent detection of breath sample s compared with conventional diagnosis by colonoscopy was 0.91 and the specificity was 0.99 . The sensitivity of canine scent detection of stool sample s was 0.97 and the specificity was 0.99 . The accuracy of canine scent detection was high even for early cancer . Canine scent detection was not confounded by current smoking , benign colorectal disease or inflammatory disease . Conclusions This study shows that a specific cancer scent does indeed exist and that cancer-specific chemical compounds may be circulating throughout the body . These odour material s may become effective tools in CRC screening . In the future , studies design ed to identify cancer-specific volatile organic compounds will be important for the development of new methods for early detection of CRC BACKGROUND Sensitive , specific blood-based tests are difficult to develop unless steps are taken to maximize performance characteristics at every stage of marker discovery and development . We describe a sieving strategy for identifying high-performing marker assays that detect colorectal cancer (CRC)-specific methylated DNA in plasma . METHODS We first used restriction enzyme-based discovery methods to identify marker c and i date s with obviously different methylation patterns in CRC tissue and nonpathologic tissue . We then used a selection process incorporating microarrays and /or real-time PCR analysis of tissue sample s to further test marker c and i date s for maximum methylation in CRC tissue and minimum amplification in tissues from both healthy individuals and patients with other diseases . Real-time assays of 3 selected markers were vali date d with plasma sample s from 133 CRC patients and 179 healthy control individuals in the same age range . RESULTS Restriction enzyme-based testing identified 56 c and i date markers . This group was reduced to 6 with microarray and real-time PCR testing . Three markers , TMEFF2 , NGFR , and SEPT9 , were tested with plasma sample s. TMEFF2 methylation was detected in 65 % [ 95 % confidence interval , 56%-73 % ] of plasma sample s from CRC patients and not detected in 69 % ( 62%-76 % ) of the controls . The corresponding results for NGFR were 51 % ( 42%-60 % ) and 84 % ( 77%-89 % ) ; for SEPT9 , the values were 69 % ( 60%-77 % ) and 86 % ( 80%-91 % ) . CONCLUSIONS The stringent criteria applied at all steps of the selection and validation process enabled successful identification and ranking of blood-based marker c and i date Background About half of Americans 50 to 75 years old do not follow recommended colorectal cancer ( CRC ) screening guidelines , leaving 40 million individuals unscreened . A simple blood test would increase screening compliance , promoting early detection and better patient outcomes . The objective of this study is to demonstrate the performance of an improved sensitivity blood-based Septin 9 ( SEPT9 ) methylated DNA test for colorectal cancer . Study variables include clinical stage , tumor location and histologic grade . Methods Plasma sample s were collected from 50 untreated CRC patients at 3 institutions ; 94 control sample s were collected at 4 US institutions ; sample s were collected from 300 colonoscopy patients at 1 US clinic prior to endoscopy . SEPT9 methylated DNA concentration was tested in analytical specimens , plasma of known CRC cases , healthy control subjects , and plasma collected from colonoscopy patients . Results The improved SEPT9 methylated DNA test was more sensitive than previously described methods ; the test had an overall sensitivity for CRC of 90 % ( 95 % CI , 77.4 % to 96.3 % ) and specificity of 88 % ( 95 % CI , 79.6 % to 93.7 % ) , detecting CRC in patients of all stages . For early stage cancer ( I and II ) the test was 87 % ( 95 % CI , 71.1 % to 95.1 % ) sensitive . The test identified CRC from all regions , including proximal colon ( for example , the cecum ) and had a 12 % false-positive rate . In a small prospect i ve study , the SEPT9 test detected 12 % of adenomas with a false-positive rate of 3 % . Conclusions A sensitive blood-based CRC screening test using the SEPT9 biomarker specifically detects a majority of CRCs of all stages and colorectal locations . The test could be offered to individuals of average risk for CRC who are unwilling or unable to undergo colonscopy OBJECTIVES : The immunological fecal occult blood test ( IFOBT ) has established itself as a more precise marker for colorectal cancer ( CRC ) screening than traditional guaiac-based FOBT . The simpler , cheaper , and more convenient newer office-based IFOBTs have been vali date d for diagnosing CRC . Dimeric isoenzyme of pyruvate kinase , M2-PK , expressed by tumor cells , has as well been proposed as a screening tool for CRC . This is the first study comparing fecal M2-PK as a screening biomarker for CRC against previously evaluated office-based IFOBT and colonoscopy . METHODS : Six hundred forty consecutive subjects ( symptomatic , as well as for CRC screening ) referred for colonoscopy for various indications across five centers in Germany provided the stool sample s for performing M2-PK and an immunochemical FOB strip test . The IFOBT used was a rapid immunochromatographic assay for detection of fecal hemoglobin . For M2-PK , a commercially available s and wich enzyme-linked immunosorbent assay ( ELISA ) was used . The M2-PK test needs 6 h , while the office-based test can be read in just 10 min and is five times cheaper . RESULTS : Office-based IFOBT had sensitivity , specificity , positive predictive value ( PPV ) , negative predictive value ( NPV ) , and positive and negative likelihood ratios ( LR ) of 64.5 , 96.3 , 72.0 , 94.9 , 17.5 , and 0.4 for diagnosing colorectal neoplasia ( CRN ) , while the above performance characteristics for M2-PK at a cutoff value of 4U/mL were 72.4 , 73.8 , 29.0 , 94.8 , 2.8 , and 0.8 respectively . CONCLUSIONS : This office-based IFOBT was found to have significantly higher specificity , PPV , and positive LR as compared with M2-PK . IFOBT proved to be a convenient , noncumbersome , quick , and cheap tool in patients with above-average risk for detection of CRN Purpose Neoplasia cells exfoliated from colorectal epithelium have dysfunctional apoptotic mechanisms , thus it is possible to identify high-molecular weight DNA fragments in feces . This prospect i ve single-center study was performed to evaluate the sensitivity and specificity of fecal-based DNA integrity versus immunological fecal occult blood test ( iFOBT ) and calprotectin for colorectal cancer ( CRC ) and adenoma detection . Methods Feces were collected from 204 subjects and DNA integrity was quantified by quantitative-denaturing high performance liquid chromatography ( QdHPLC ) . Calprotectin and iFOBT were assessed using commercial kits . The diagnostic performance was calculated by receiver operating characteristic ( ROC ) curves analysis . Results A total of 192 fecal specimens were analyzed and 12 sample s were excluded due to DNA degradation . We found long DNA ( L-DNA ) occurrence in feces with a sensitivity of 86 % ( n = 24/28 ) and a specificity of 81 % for CRC detection . To minimize false-positive cases of the developed test , area under the curve of ROC was evaluated such that the specificity was increased to 92 % with decreased sensitivity to 79 % , p = 0.0001 for CRC detection . iFOBT was positive in 51 % ( n = 14/27 ) while calprotectin was positive in 75 % ( n = 18/27 ) . The combination of iFOBT and L-DNA identified a greater number of CRC cases with a sensitivity of 89 % and a specificity of 95 % , p < 0.001 . The combination also improved the sensitivity of polyps , particularly high- grade dysplasia and advanced adenoma ( 33 % , p = 0.0015 ) as opposed to a single evaluation assay ( 17–21 % ) . Conclusions This study illustrates the usefulness of fecal DNA integrity assay by QdHPLC as a non-invasive , easy-to-perform , and reproducible method with a high level of sensitivity in detecting individuals with colorectal neoplasia . Combination of iFOBT and L-DNA improves the sensitivity for CRC and adenoma detection BACKGROUND & AIMS Screening colonoscopy examinations for colorectal cancer are offered in the United States and some European countries . Data on results and adverse effects of screening colonoscopy are limited . In autumn 2002 , colonoscopy was introduced as part of a nationwide cancer screening program in Germany ; it was offered to the general population for individuals 55 years of age or older . We collected and analyzed data from this program . METHODS We performed a prospect i ve cross-sectional study , collecting results from 2,821,392 screening colonoscopies performed at more than 2100 practice s by highly qualified endoscopists in Germany from January 2003 to December 2008 . Data on participation , colorectal adenoma and cancer detection , and complications were collected using st and ardized documentation forms . The data generated were central ly processed and evaluated . RESULTS The cumulative participation rate was 17.2 % of eligible women and 15.5 % of eligible men 55 - 74 years old . The adenoma detection rate ( ADR ) was 19.4 % , with a higher rate in men ( 25.8 % vs 16.7 % in women ) . Advanced adenomas were found in 6.4 % of patients . Carcinomas were detected in 25,893 subjects ( 0.9 % ) ; most were of an early UICC stage ( I , 47.3 % ; II , 22.3 % ; III , 20.7 % ; IV , 9.6 % ) . The ADRs for gastroenterologists and nongastroenterologists were 25.1 % and 22.3 % , respectively ( adjusted odds ratio , 1.18 ; 95 % confidence interval , 1.16 - 1.21 ) . The overall complication rate was 2.8/1000 colonoscopies , and the rate of serious complications was 0.58/1000 colonoscopies . CONCLUSIONS A nationwide colonoscopy screening program that uses highly qualified endoscopists can detect a significant number of adenomas and early-stage carcinomas . The ADR for gastroenterologists was higher than for nongastroenterologists Proliferating cells , particularly the tumor cells , express a dimeric isoenzyme of pyruvate kinase , termed M2‐PK . It 's a direct target of several oncoproteins ; the determination of fecal tumor pyruvate kinase type M2 ( M2‐PK ) might be another promising tool for colorectal cancer ( CRC ) screening . In this study , we have evaluated fecal M2‐PK as a screening biomarker for colorectal neoplasia . It was compared against fecal occult blood ( FOB ) and colonoscopy . Three hundred and seventeen consecutive subjects from 4 different centers were included . Stool specimens were collected before purgation , processed appropriately and were tested for FOB and quantitatively analyzed for M2‐PK . Colonoscopies were performed by experienced endoscopists who were unaware of fecal assay results . At cutoff value of 4 U/ml , fecal M2‐PK assay had a sensitivity , specificity , PPV and NPV of 81.1 , 86.7 , 71.1 and 61.9 % respectively for diagnosing CRC whereas FOBT showed a sensitivity of 36.5 % , specificity of 92.2 % , PPV of 72.9 % and NPV of 71.5 % for CRC . Such low specificity of fecal M2‐PK will lead to unacceptably high number of false positives if it is used for mass CRC screening , leading to unindicated colonoscopies with its associated inconveniences , risks and costs . CRC screening test must have high specificity ; Output:	Combining fecal DNA markers increased the sensitivity of colorectal cancer and adenoma detection . Combinations of fecal and serum biomarkers produce higher sensitivities , specificities , and PPVs for early detection of colorectal cancer and adenomas .
MS22367	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: Background The North-Eastern part of Sri Lanka had already been affected by civil war when the 2004 Tsunami wave hit the region , leading to high rates of posttraumatic stress disorder ( PTSD ) in children . In the acute aftermath of the Tsunami we tested the efficacy of two pragmatic short-term interventions when applied by trained local counselors . Methods A r and omized treatment comparison was implemented in a refugee camp in a severely affected community . 31 children who presented with a preliminary diagnosis of PTSD were r and omly assigned either to six sessions Narrative Exposure Therapy for children ( KIDNET ) or six sessions of meditation-relaxation ( MED-RELAX ) . Outcome measures included severity of PTSD symptoms , level of functioning and physical health . Results In both treatment conditions , PTSD symptoms and impairment in functioning were significantly reduced at one month post-test and remained stable over time . At 6 months follow-up , recovery rates were 81 % for the children in the KIDNET group and 71 % for those in the MED-RELAX group . There was no significant difference between the two therapy groups in any outcome measure . Conclusion As recovery rates in the treatment groups exceeded the expected rates of natural recovery , the study provides preliminary evidence for the effectiveness of NET as well as meditation-relaxation techniques when carried out by trained local counselors for the treatment of PTSD in children in the direct aftermath of mass disasters . Trial registration Clinical Trials.gov Identifier : CONTEXT Despite the importance of mental illness in Africa , few controlled intervention trials related to this problem have been published . OBJECTIVES To test the efficacy of group interpersonal psychotherapy in alleviating depression and dysfunction and to evaluate the feasibility of conducting controlled trials in Africa . DESIGN , SETTING , AND PARTICIPANTS For this cluster r and omized , controlled clinical trial ( February-June 2002 ) , 30 villages in the Masaka and Rakai districts of rural Ug and a were selected using a r and om procedure ; 15 were then r and omly assigned for study ing men and 15 for women . In each village , adult men or women believed by themselves and other villagers to have depressionlike illness were interviewed using a locally adapted Hopkins Symptom Checklist and an instrument assessing function . Based on these interviews , lists were created for each village totaling 341 men and women who met Diagnostic and Statistical Manual of Mental Disorders , Fourth Edition ( DSM-IV ) criteria for major depression or subsyndromal depression . Interviewers revisited them in order of decreasing symptom severity until they had 8 to 12 persons per village , totaling 284 . Of these , 248 agreed to be in the trial and 9 refused ; the remainder died or relocated . A total of 108 men and 116 women completed the study and were reinterviewed . INTERVENTION Eight of the 15 male villages and 7 of the 15 female villages were r and omly assigned to the intervention arm and the remainder to the control arm . The intervention villages received group interpersonal psychotherapy for depression as weekly 90-minute sessions for 16 weeks . MAIN OUTCOME MEASURES Depression and dysfunction severity scores on scales adapted and vali date d for local use ; proportion of persons meeting DSM-IV major depression diagnostic criteria . RESULTS Mean reduction in depression severity was 17.47 points for intervention groups and 3.55 points for controls ( P<.001 ) . Mean reduction in dysfunction was 8.08 and 3.76 points , respectively ( P<.001 ) . After intervention , 6.5 % and 54.7 % of the intervention and control groups , respectively , met the criteria for major depression ( P<.001 ) compared with 86 % and 94 % , respectively , prior to intervention ( P = .04 ) . The odds of postintervention depression among controls was 17.31 ( 95 % confidence interval , 7.63 - 39.27 ) compared with the odds among intervention groups . Results from intention-to-treat analyses remained statistically significant . CONCLUSIONS Group interpersonal psychotherapy was highly efficacious in reducing depression and dysfunction . A clinical trial proved feasible in the local setting . Both findings should encourage similar trials in similar setting s in Africa and beyond Background Infection with severe malaria in African children is associated with not only a high mortality but also a high risk of cognitive deficits . There is evidence that interventions done a few years after the illness are effective but nothing is known about those done immediately after the illness . We design ed a study in which children who had suffered from severe malaria three months earlier were enrolled into a cognitive intervention program and assessed for the immediate benefit in cognitive , academic and behavioral outcomes . Methods This parallel group r and omised study was carried out in Kampala City , Ug and a between February 2008 and October 2010 . Sixty-one Ug and an children aged 5 to 12 years with severe malaria were assessed for cognition ( using the Kaufman Assessment Battery for Children , second edition and the Test of Variables of Attention ) , academic skills ( Wide Range Achievement Test , third edition ) and psychopathologic behaviour ( Child Behaviour Checklist ) three months after an episode of severe malaria . Twenty-eight were r and omised to sixteen sessions of computerised cognitive rehabilitation training lasting eight weeks and 33 to a non-treatment group . Post-intervention assessment s were done a month after conclusion of the intervention . Analysis of covariance was used to detect any differences between the two groups after post-intervention assessment , adjusting for age , sex , weight for age z score , quality of the home environment , time between admission and post-intervention testing and pre-intervention score . The primary outcome was improvement in attention scores for the intervention group . This trial is registered with Current Controlled Trials , number IS RCT N53183087 . Results Significant intervention effects were observed in the intervention group for learning mean score ( SE ) , [ 93.89 ( 4.00 ) vs 106.38 ( 4.32 ) , P = 0.04 ] but for working memory the intervention group performed poorly [ 27.42 ( 0.66 ) vs 25.34 ( 0.73 ) , P = 0.04 ] . No effect was observed in the other cognitive outcomes or in any of the academic or behavioural measures . Conclusions In this pilot study , our computerised cognitive training program three months after severe malaria had an immediate effect on cognitive outcomes but did not affect academic skills or behaviour . Larger trials with follow-up after a few years are needed to investigate whether the observed benefits are sustained . Trial registration IS RCT N : IS RCT BACKGROUND The ability of specific behaviour-change interventions to reduce HIV infection in young people remains question able . Since January 1999 , an adolescent sexual and reproductive health ( SRH ) intervention has been implemented in ten r and omly chosen intervention communities in rural Tanzania , within a community r and omised trial ( see below ; NCT00248469 ) . The intervention consisted of teacher-led , peer-assisted in-school education , youth-friendly health services , community activities , and youth condom promotion and distribution . Process evaluation in 1999 - 2002 showed high intervention quality and coverage . A 2001/2 intervention impact evaluation showed no impact on the primary outcomes of HIV seroincidence and herpes simplex virus type 2 ( HSV-2 ) seroprevalence but found substantial improvements in SRH knowledge , reported attitudes , and some reported sexual behaviours . It was postulated that the impact on " upstream " knowledge , attitude , and reported behaviour outcomes seen at the 3-year follow-up would , in the longer term , lead to a reduction in HIV and HSV-2 infection rates and other biological outcomes . A further impact evaluation survey in 2007/8 ( approximately 9 years post-intervention ) tested this hypothesis . METHODS AND FINDINGS This is a cross-sectional survey ( June 2007 through July 2008 ) of 13,814 young people aged 15 - 30 y who had attended trial schools during the first phase of the MEMA kwa Vijana intervention trial ( 1999 - 2002 ) . Prevalences of the primary outcomes HIV and HSV-2 were 1.8 % and 25.9 % in males and 4.0 % and 41.4 % in females , respectively . The intervention did not significantly reduce risk of HIV ( males adjusted prevalence ratio [ aPR ] 0.91 , 95%CI 0.50 - 1.65 ; females aPR 1.07 , 95%CI 0.68 - 1.67 ) or HSV-2 ( males aPR 0.94 , 95%CI 0.77 - 1.15 ; females aPR 0.96 , 95%CI 0.87 - 1.06 ) . The intervention was associated with a reduction in the proportion of males reporting more than four sexual partners in their lifetime ( aPR 0.87 , 95%CI 0.78 - 0.97 ) and an increase in reported condom use at last sex with a non-regular partner among females ( aPR 1.34 , 95%CI 1.07 - 1.69 ) . There was a clear and consistent beneficial impact on knowledge , but no significant impact on reported attitudes to sexual risk , reported pregnancies , or other reported sexual behaviours . The study population was likely to have been , on average , at lower risk of HIV and other sexually transmitted infections compared to other rural population s , as only youth who had reached year five of primary school were eligible . CONCLUSIONS SRH knowledge can be improved and retained long-term , but this intervention had only a limited effect on reported behaviour and no significant effect on HIV/STI prevalence . Youth interventions integrated within intensive , community-wide risk reduction programmes may be more successful and should be evaluated . TRIAL REGISTRATION Clinical Trials.gov BACKGROUND In situations of ongoing violence , childhood psychosocial and mental health problems require care . However , re sources and evidence for adequate interventions are scarce for children in low- and middle-income countries . This study evaluated a school-based psychosocial intervention in conflict-affected , rural Nepal . METHODS A cluster r and omized controlled trial was used to evaluate changes on a range of indicators , including psychiatric symptoms ( depression , anxiety , posttraumatic stress disorder ) , psychological difficulties , resilience indicators ( hope , prosocial behavior ) and function impairment . Children ( n = 325 ) ( mean age = 12.7 , SD = 1.04 , range 11 - 14 years ) with elevated psychosocial distress were allocated to a treatment or waitlist group . RESULTS Comparisons of crude change scores showed significant between-group differences on several outcome indicators , with moderate effect sizes ( Cohen d = .41 to .58 ) . After correcting for nested variance within schools , no evidence for treatment effects was found on any outcome variable . Additional analyses showed gender effects for treatment on prosocial behavior ( mean change difference : 2.70 ; 95 % CI , .97 to 4.44 ) , psychological difficulties ( -2.19 ; 95 % CI , -3.82 to -.56 ) , and aggression ( -4.42 ; 95 % CI , -6.16 to -2.67 ) . An age effect for treatment was found for hope ( .90 ; 95 % CI , -1.54 to -.26 ) . CONCLUSIONS A school-based psychosocial intervention demonstrated moderate short-term beneficial effects for improving social-behavioral and resilience indicators among subgroups of children exposed to armed conflict . The intervention reduced psychological difficulties and aggression among boys , increased prosocial behavior among girls , and increased hope for older children . The intervention did not result in reduction of psychiatric symptoms BACKGROUND Depression in women is one of the commonest problems encountered in primary care . We aim ed to compare the effectiveness of a stepped-care programme with usual care in primary -care management of depression in low-income women in Santiago , Chile . METHODS In a r and omised controlled trial , in three primary -care clinics in Chile , 240 adult female primary -care patients with major depression were allocated stepped care or usual care . Stepped care was a 3-month , multicomponent intervention led by a non-medical health worker , which included a psychoeducational group intervention , structured and systematic follow-up , and drug treatment for patients with severe depression . Data were analysed on an intention-to-treat basis . The primary outcome measure was the Hamilton depression rating scale ( HDRS ) administered at baseline and at 3 and 6 months after r and omisation . FINDINGS About 90 % of r and omised patients completed outcome assessment s. There was a substantial between-group difference in all outcome measures in favour of the stepped-care programme . The adjusted difference in mean HDRS score between the groups was -8.89 ( 95 % CI -11.15 to -6.76 ; p<0.0001 ) . At 6-months ' follow-up , 70 % ( 60 - 79 ) of the stepped-care compared with 30 % ( 21 - 40 ) of the usual-care group had recovered ( HDRS score < 8) . INTERPRETATION Despite few re sources and marked deprivation , women with major depression responded well to a structured , stepped-care treatment programme , which is being introduced across Chile . Socially disadvantaged patients might gain the most from systematic improvements in treatment of depression OBJECTIVE To compare the efficacy of an outreach program for young children with cerebral palsy with center-based and " minimal intervention " control groups . DESIGN R and omized controlled trial conducted in a group of 85 children between the ages of 1.5 and 5 years . Urban children were allocated to Output:	Results In behavioural disorders parent training is a highly promising intervention , which can successfully improve children ’s compliance and bring down rates of conduct problems significantly . In young children cognitive , emotional and behavioural development can be enhanced through nutritional supplements and by stimulation through play , praise and reading . Trauma treatments can bring positive results even in severely traumatised children , who remain in unstable living conditions . In developmental disorders , there are successful prevention strategies as well as programmes that bring children out of isolation and improve their independence . Some classroom-based interventions for adolescents have reduced symptoms of common mental disorders as well as risk taking behaviours . Conclusions While many results are still tentative the evidence suggests that it is possible to develop affordable and feasible interventions that significantly improve the lives of affected children , their families and their communities around the world
MS22368	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: Background and Purpose — The aim of this study was to evaluate the effects of hypertonic saline in stroke patients with increased intracranial pressure ( ICP ) after conventional therapy with mannitol had failed . Methods — Twenty-two episodes of ICP crisis occurred in 8 patients in whom the st and ard treatment of 200 mL of 20 % mannitol was not effective . ICP crisis was defined as an increase in ICP of 20 mm Hg ( n=18 ) , pupillary abnormality ( n=3 ) , or a combination of both ( n=1 ) . The patients were treated with 75 mL of 10 % saline over the course of 15 minutes . ICP , mean arterial blood pressure , and cerebral perfusion pressure were monitored for 4 hours . Blood gases , hematocrit , hemoglobin , pH , osmolarity , and electrolytes levels were measured before and 15 and 60 minutes after the start of infusion . Treatment was regarded as effective if ICP decreased > 10 % or the pupillary reaction had normalized . Results — Treatment was effective in all 22 episodes . The maximum ICP decrease was 9.9 mm Hg 35 minutes after the start of infusion . Thereafter , ICP began to rise again . There was no constant effect on mean arterial blood pressure , whereas cerebral perfusion pressure was consistently increased . Blood osmolarity rose by 9 mmol/L and serum sodium by 5.6 mmol/L. Potassium levels , hemoglobin , hematocrit , and pH were slightly decreased . No unexpected side effects were noted . Conclusions — Infusion of 75 mL hypertonic ( 10 % ) saline decreases elevated ICP and increases cerebral perfusion pressure in stroke patients in whom mannitol had failed . The effect on the ICP and cerebral perfusion pressure reaches its maximum after the end of infusion and is seen for 4 hours 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 ( BACKGROUND In sub-Saharan Africa , bacterial meningitis is common and is associated with a high mortality . Adjuvant therapy with corticosteroids reduces mortality among adults in the developed world , but it has not been adequately tested in developing countries or in the context of advanced human immunodeficiency virus ( HIV ) infection . METHODS We conducted a r and omized , double-blind , placebo-controlled trial of dexamethasone ( 16 mg twice daily for 4 days ) and an open-label trial of intramuscular versus intravenous ceftriaxone ( 2 g twice daily for 10 days ) in adults with an admission diagnosis of bacterial meningitis in Blantyre , Malawi . The primary outcome was death at 40 days after r and omization . RESULTS A total of 465 patients , 90 % of whom were HIV-positive , were r and omly assigned to receive dexamethasone ( 233 patients ) or placebo ( 232 patients ) plus intramuscular ceftriaxone ( 230 patients ) or intravenous ceftriaxone ( 235 patients ) . There was no significant difference in mortality at 40 days in the corticosteroid group ( 129 of 231 patients ) as compared with the placebo group ( 120 of 228 patients ) by intention-to-treat analysis ( odds ratio , 1.14 ; 95 % confidence interval [ CI ] , 0.79 to 1.64 ) or when the analysis was restricted to patients with proven pneumococcal meningitis ( 68 of 129 patients receiving corticosteroids vs. 72 of 143 patients receiving placebo ) ( odds ratio , 1.10 ; 95 % CI , 0.68 to 1.77 ) . There were no significant differences between groups in the outcomes of disability and death combined , hearing impairment , and adverse events . There was no difference in mortality with intravenous ceftriaxone ( 121 of 230 patients ) as compared with intramuscular ceftriaxone ( 128 of 229 patients ) ( odds ratio , 0.88 ; 95 % CI , 0.61 to 1.27 ) . CONCLUSIONS Adjuvant therapy with dexamethasone for bacterial meningitis in adults from an area with a high prevalence of HIV did not reduce mortality or morbidity . In this setting , intramuscular administration was not inferior to intravenous administration of ceftriaxone for bacterial meningitis . ( Current Controlled Trials number , IS RCT N31371499 [ controlled-trials.com ] . ) Background Several reports have suggested that raised intracranial pressure ( ICP ) is a major contributor to death among children with cerebral malaria . Mannitol , an osmotic diuretic , effectively lowers ICP and is used to treat post-traumatic raised ICP . It is not clear whether intravenous mannitol given to children with cerebral malaria improves clinical outcome . The objective of this study was to determine the effect of mannitol as adjunct therapy on the clinical outcome of children with cerebral malaria . Methods This r and omized double-blind placebo controlled clinical trial was carried out at the Emergency Paediatric ward of Mulago Hospital , Ug and a 's national referral and teaching hospital . One hundred and fifty six children aged 6 to 60 months with cerebral malaria were r and omized to either one dose of mannitol 1 g/kg or placebo , in addition to intravenous quinine . Main outcome measures included coma recovery time ; time to sit unsupported , begin oral intake ; duration of hospitalization ; death and adverse effects . Results Time to regain consciousness ( p = 0.11 ) , sit unsupported ( p = 0.81 ) , time to start oral intake ( p = 0.13 ) and total coma duration ( p = 0.07 ) were similar in both groups . There was no significant difference in the mortality between the placebo ( 13/80 or 16.3 % ) and mannitol ( 10/76 or 13.2 % ) groups : RR = 1.2 ( CI 0.5–2.7 ) . No adverse effects were observed after administration of mannitol . Conclusion Mannitol had no significant impact on clinical outcome of cerebral malaria . It is difficult to recommend intravenous mannitol as adjunct therapy for childhood cerebral malaria . Clinical registration number Clinical Trials.gov ID : Background : The burden that spontaneous bacterial meningitis ( SBM ) currently represents among HIV-1-infected patients is poorly known . Methods : We prospect ively evaluated 32 episodes of SBM in HIV-1-infected patients from the VACH ( VIH-Aplicación de Control Hospitalario ) Cohort and compared findings with those of 267 episodes in uninfected persons , matched by age and year of infection . A group of 13,187 HIV-1-infected patients from the VACH Cohort were used to identify predictors for acquiring SBM . Results : Between 1997 and 2006 , we found 32 episodes of SBM among HIV-1-infected patients for an annual incidence rate of 62.0 cases per 100,000 population compared with 3.2 ( 3.0 to 3.4 ) per 100,000 population for uninfected patients ( P < 0.001 ) . The last CD4 ≥200/mm3 count was the only predictor for developing SBM . Compared with uninfected , HIV-1-infected patients with SBM had a greater prevalence of primary extrameningeal infection , especially pneumonia ( P = 0.02 ) , bacteremia ( P = 0.02 ) , focal neurologic signs ( P = 0.005 ) , seizures ( P = 0.06 ) , a lower cerebrospinal fluid to blood glucose ratio ( P = 0.02 ) , and a lower prevalence of nuchal rigidity ( P = 0.005 ) . Streptococcus pneumoniae was the most frequent etiologic agent among HIV-1-infected patients . HIV-1-infected patients had neurologic complications more frequently ( P = 0.02 ) , a higher overall case fatality rate ( P = 0.004 ) , and greater incidence of neurologic sequelae ( P = 0.001 ) . Conclusions : Even in the highly active antiretroviral therapy era , the risk of developing SBM is 19 times higher among HIV-1-infected patients than among uninfected ones . It tends to present in severely immunosuppressed patients not previously vaccinated and off antiretroviral therapy , with a concomitant extrameningeal infection , bacteremia , and focal neurologic signs , and is caused by S. pneumoniae . SBM in HIV-1-infected patients carries a worse prognosis than in uninfected ones both in terms of lethality and sequelae 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 Objectives Traumatic brain injury ( TBI ) is still a major cause of mortality and morbidity . Recent trials have failed to demonstrate a beneficial outcome from therapeutic treatments such as corticosteroids , hypothermia and hypertonic saline . We investigated the effect of a new hyperosmolar solution based on sodium lactate in controlling raised intracranial pressure ( ICP ) . Design and setting Prospect i ve open r and omized study in an adult ICU . Patients Thirty-four patients with isolated severe TBI ( Glasgow Coma Scale ≤ 8) and intracranial hypertension were allocated to receive equally hyperosmolar and isovolumic therapy , consisting of either mannitol or sodium lactate . Rescue therapy by crossover to the alternative treatment was indicated when ICP could not be controlled . The primary endpoint was efficacy in lowering ICP after 4 h , with a secondary endpoint of the percentage of successfully treated episodes of intracranial hypertension . The analysis was performed with both intention-to-treat and actual treatments provided . Measurements and results Compared to mannitol , the effect of the lactate solution on ICP was significantly more pronounced ( 7 vs. 4 mmHg , P = 0.016 ) , more prolonged ( fourth-hour-ICP decrease : −5.9 ± 1 vs. −3.2 ± 0.9 mmHg , P = 0.009 ) and more frequently successful ( 90.4 vs. 70.4 % , P = 0.053 ) . Conclusion Acute infusion of a sodium lactate-based hyperosmolar solution is effective in treating intracranial hypertension following traumatic brain injury . This effect is significantly more pronounced than that of an equivalent osmotic load of mannitol . Additionally , in this specific group of patients , long-term outcome was better in terms of GOS in those receiving as compared to mannitol . Larger trials are warranted to confirm our findings BACKGROUND Steroids are used as adjuvant treatment in childhood pyogenic meningitis to attenuate host inflammatory responses to bacterial invasion . We aim ed to assess the effectiveness of dexamethasone in management of acute bacterial meningitis in a developing country . METHODS In a double-blind , placebo controlled trial , we included 598 children with pyogenic meningitis who had been admitted to the children 's wards of the Queen Elizabeth Central Hospital , Blantyre , Malaw Output:	Stratified analysis shows no effect modification with steroids ; we present aggregate effect estimates . Authors ' conclusions Glycerol was the only osmotic therapy evaluated , and data from trials to date have not demonstrated an effect on death . Glycerol may reduce neurological deficiency and deafness
MS22369	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: BACKGROUND Heparin and direct thrombin inhibitors , such as hirudin , have limitations in the treatment of acute coronary syndromes . Heparin does not inactivate fibrin-bound thrombin , whereas hirudin fails to block thrombin generation . In contrast , Vasoflux is a novel anticoagulant that inactivates fibrin-bound thrombin and attenuates factor Xa generation . METHODS AND RESULTS Vasoflux is prepared by depolymerization of heparin , restricting molecular size to between 3000 and 8000 Da , and reducing antithrombin affinity by perio date oxidation . Vasoflux catalyzes fibrin-bound thrombin inactivation by heparin cofactor II ( HCII ) and inhibits factor IXa activation of factor X independently of antithrombin and HCII . Compared with other anticoagulants in a thrombogenic extracorporeal circuit , Vasoflux maintains filter patency at concentrations that produce an activated clotting time ( ACT ) of 220 seconds . In contrast , to maintain filter patency , heparin , low-molecular-weight heparin ( LMWH ) , and hirudin require concentrations that produced an ACT of 720 , 415 , and > 1500 seconds , respectively , whereas dermatan sulfate was ineffective at concentrations that produced an ACT of 360 seconds . CONCLUSIONS Vasoflux is more effective than heparin and LMWH because it inactivates fibrin-bound thrombin and is superior to hirudin and dermatan sulfate because it also blocks factor Xa generation Output:	Heparin was reported to have a beneficial impact on mortality , graft and wound healing , and pain control . Given poor study quality , there is no strong evidence to indicate that heparin can improve clinical outcomes in the treatment of burn injury .
MS22370	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: OBJECTIVES To assess general practitioners ' and practice nurses ' self reported behaviour , attitudes , and knowledge in relation to smoking cessation . DESIGN AND SETTING Two postal surveys of r and om national sample s of 303 GPs ( survey 1 ) and 459 practice nurses ( survey 2 ) covering Engl and and Wales ; effective response rates were 75 % and 96 % , respectively . RESULTS Survey 1 found that 96 % of GPs accepted that intervening against smoking was part of their role and almost all ( 99 % ) said that they recorded smoking status when patients registered ; 57 % reported that they routinely up date d their records on smoking status , 50 % said they advised smokers to stop during most or all consultations , and 76 % said they advised smokers to cut down if they can not stop . A large majority ( 83 % ) said they either recommended or prescribed nicotine replacement therapy ( NRT ) . Although most GPs ( 86 % ) thought that NRTs were effective , only a minority thought they were worth the cost ( 47 % ) or should be on National Health Service ( NHS ) prescription ( 32 % ) . There was little evidence that previous training in smoking cessation was associated with more activity , more positive attitudes , or greater knowledge . Survey 2 found that almost all practice nurses ( 99 % ) agreed that intervening against smoking was part of their role and 95 % said they advised patients to stop at least occasionally ; 71 % said they advised smokers to stop at most or all consultations . A majority ( 74 % ) said that they recommended NRT to their patients . As with the GPs most practice nurses thought that nicotine replacement was effective ( 79 % ) , but fewer ( 42 % ) thought the cost was justified , and only about half ( 53 % ) thought it should be available on NHS prescription . Nurses who said they had been trained in smoking cessation engaged in more activity relating to smoking cessation , had more positive attitudes , and were more knowledgeable . CONCLUSION GPs and practice nurses accepted that intervening with smoking was an important part of their role and a large majority reported that they intervened at least with some smokers . This represents a promising baseline from which to proceed in terms of implementation of the new smoking cessation guidelines , but it is hoped that improvements can be made in terms of the frequency of updating records and intervening , and acceptance of the cost-effectiveness of NRT as a life preserving intervention The efficacy of physician anti-smoking intervention with 289 patients in a family practice setting was assessed . The design included two treatment conditions , physician advice and physician advice plus the offer of nicotine chewing gum ( NCG ) prescription . A no-advice group permitted assessment of the effects of repeated testing . The NCG group had higher rates of abstinence at all follow-up points , but the difference approached statistical significance at 3 months only ( p less than .10 ) . Comparison of those who actually used NCG to all other groups revealed significantly more users were abstinent at 1- and 3-month follow-up . A similar pattern occurred for proportion attempting cessation and smoking reduction . A dose-response relationship of gum use to outcome was identified . Long-term users ( greater than 20 days ) had 86 % abstinence at 3 months versus 18 % for short-term users . Thus , NCG does appear to have a role in family practice for promoting short-term cessation Smoking cessation treatment is now integrated into many health-care systems and a major research effort is under way to improve current success rates . Until now results from r and omized clinical trials have been reported in many different ways , leading to problems of interpretation . We propose six st and ard criteria comprising the ' Russell St and ard ' ( RS ) . These criteria are applicable to trials of cessation aids where participants have a defined target quit date and there is face-to-face contact with research ers or clinic staff , as follows . ( 1 ) Follow-up for 6 months ( RS6 ) or 12 months ( RS12 ) from the target quit date or the end of a predefined ' grace period ' ; ( 2 ) self-report of smoking abstinence over the whole follow-up period allowing up to five cigarettes in total ; ( 3 ) biochemical verification of abstinence at least at the 6-month or 12-month follow-up point ; ( 4 ) use of an ' intention-to-treat ' approach in which data from all r and omized smokers are included in the analysis unless they have died or moved to an untraceable address ( participants who are included in the analysis are counted as smokers if their smoking status at the final follow-up can not be determined ) ; ( 5 ) following-up ' protocol violators ' and using their true smoking status in the analysis ; and ( 6 ) collecting follow-up data blind to smokers ' allocation to trial group . We believe that these criteria provide the best compromise between practicability and surrogacy for long-term cessation and will enable meaningful comparison between studies . There may be good reasons why other outcome criteria would also be reported , and studies that involve interventions with special groups or where there is no design ated target quit date or face to face contact would need to adapt these criteria accordingly PURPOSE Guidelines encourage primary care clinicians to document smoking status when obtaining patients ’ blood pressure , temperature , and pulse rate ( vital signs ) , but whether this practice promotes cessation counseling is unclear . We examined whether the vital sign intervention influences patient-reported frequency and intensity of tobacco cessation counseling . METHODS This study was a cluster-r and omized , controlled trial conducted in the Virginia Ambulatory Care Outcomes Research Network ( ACORN ) . At intervention practice s , nurses and medical assistants were instructed to assess the tobacco use status of every adult patient and record it with the traditional vital signs . Control practice s did not use any systematic tobacco screening or identification system . Outcomes were the proportion of smokers reporting clinician counseling of any kind and the frequency of 2 counseling subcomponents : simple quit advice and more intensive discussion . RESULTS A total of 6,729 adult patients ( 1,149 smokers ) at 18 primary care practice s completed exit question naires during a 6-month comparison period . Among 561 smokers at intervention practice s , 61.9 % reported receiving any counseling , compared with 53.4 % of the 588 smokers at control practice s , for a difference of 8.6 % ( P = .04 ) . The effect was largely restricted to simple advice , which was reported by 59.9 % of intervention patients and 51.5 % of control patients ( P=.04 ) . There was no significant increase in more extensive discussion , with 32.5 % and 29.3 % of patients at intervention and control practice s , respectively , reporting this type of counseling ( P=.18 ) . CONCLUSIONS The vital sign intervention promotes tobacco counseling at primary care practice s through a modest increase in simple advice to quit . When implemented as a st and -alone intervention , it does not appear to increase intensive counseling BACKGROUND AND OBJECTIVE GPs are an important source of smoking cessation advice . This research examined whether a model encouraging GP referral of patients who smoke to a specialist service would be acceptable and effective for increased smoking cessation when compared with a model of in- practice management . METHODS The study design was cluster r and omized controlled trial . Practice s were r and omized to one of two interventions , at a rate of 1:2 : ( i ) st and ard in- practice GP management or ( ii ) referral to a quitline service . The main outcome measures were sustained abstinence of > or=1 month duration at 3-month follow-up and > or=10 months duration at 12 months , using intention to treat analysis . RESULTS At 3-month follow-up , patients in the referral condition were twice as likely to report sustained abstinence than those in the in- practice condition [ 12.3 % compared with 6.9 % ; odds ratio ( OR ) = 1.92 ( 95 % confidence interval ( CI ) 1.17 - 3.13 ] . At 12-month follow-up , patients in the referral condition had nearly three times the odds of sustained abstinence [ 6.5 % compared with 2.6 % ; OR = 2.86 ( 95 % CI 0.94 - 8.71 ) ] . The intervention effect was mediated by the amount of help received outside the practice . CONCLUSIONS This research provided evidence that GPs referring smokers to an evidence -based quitline service results in increased cessation . The benefit is largely due to patients in the referral condition receiving more external help than patients in the in- practice condition , as they received equivalent practice -based help . Where suitable services exist , we recommend that referral become the normative strategy for management of smoking cessation in general practice to complement any practice -based help provided The results are reported from a multicentered , r and omized clinical trial of a physician-delivered smoking cessation intervention package . All physicians attended a four-hour training session during which the rationale s for the different aspects of the intervention were discussed , including a detailed description of the proper use of nicotine-bearing chewing gum . Patients were r and omized to receive an offer of a prescription of 2 mg of nicotine chewing gum in addition to the basic intervention ( n = 111 ) or the basic intervention alone ( n = 112 ) . The basic intervention included advice , setting a date for quitting , self-help material s , and the offer of supportive follow-up visits . Receptionists were instructed to recruit the first two smokers attending the practice each day . One-year smoking cessation was vali date d by cotinine saliva analysis . The vali date d three-month sustained abstinence rates at one year were 8.1 percent and 9.8 percent in the gum and no-gum groups , respectively . The 95 percent confidence interval about this difference was -9.3 percent to 6.4 percent . There is no evidence from this study that the offer of 2 mg of nicotine-bearing gum enhances smoking cessation rates when added to a comprehensive intervention offered to all smokers in primary care . Until larger trials are completed , however , the possibility that this dose of nicotine gum may produce small beneficial effects can not be excluded BACKGROUND This project examined tobacco policies and delivery of cessation services in nonprofit HMOs that collectively provide comprehensive medical care to more than 8 million members . METHODS Three annual surveys with health plan managers showed that all of these health plans had written tobacco control guidelines that became more comprehensive over the span of this study . We also surveyed a r and om sample of 4207 current smokers who had attended a primary care visit in the past year ( 399 - 528 at each of nine health plans ) . RESULTS Of these smokers , 71 % reported advice to quit , 56 % were asked about their willingness to quit , 49 % were provided some assistance in quitting ( mostly self-help material or information about classes or counseling ) , and 9 % were offered some kind of follow-up . Smokers receiving assistance in quitting reported higher satisfaction with their care . CONCLUSIONS In general , health plans with the most comprehensive policies also showed higher rates of implementing tobacco treatment programs in primary care . Compared with tobacco control efforts of a decade or more ago , considerable progress has been made . However , there is still room for improvement in the proportion of smokers who receive the most effective forms of assistance in quitting The purpose of this study was to examine the effectiveness of different practice -based approaches to assist patients of primary care physicians to quit smoking and sustain cessation . Forty-four nonsmoking general practitioners volunteered for the study . After a period of training , they r and omized 923 smoking clients , unselected for motivation toward quitting , to four different intervention groups : ( i ) minimal intervention , consisting of one single counselling session and a brief h and out on quitting techniques ; ( ii ) repeated counselling including reinforcing sessions at Months 1 , 3 , 6 , and 9 ; ( iii ) repeated counselling and use of nicotine gum ; and ( iv ) repeated counselling and spirometry . Biochemically vali date d smoking status was assessed at six and 12 months after recruitment . The proportion of verified quitters at 12 months was 4.8 percent among subjects r and omized to the minimal intervention group , compared to 5.5 percent , 7.5 percent , and 6.5 percent among those r and omized to the three repeated-counselling groups . In no treatment group was the outcome significantly different from that for one-time counselling at the ( P<0.05 ) level . Lack of power , contamination , and low attendance at reinforcing sessions should be taken into account in interpreting the results Objective : To compare the characteristics of smokers who do and do not receive smoking cessation treatment in primary care . Design : Prospect i ve cohort study using practice s registered with the pilot Q RESEARCH data base . Setting : 156 550 patients aged 18 years and over from 39 general practice s located within four strategic health authorities , representing the former Trent Region , UK . Subjects : Patients registered with practice s between 1 April 2001 and 31 March 2003 aged 18 years and over who were identified as smokers before the two year study period . Outcome : Prescription for smoking cessation treatment ( nicotine replacement therapy ( NRT ) or bupropion ) in the two year study period . Variables : Age , sex , deprivation score , co-morbidity . Results : Of the 29 492 patients recorded as current smokers at the start of the study period 1892 ( 6.4 % ) were given prescriptions for smoking cessation treatment during the subsequent two years . Of these , 1378 ( 72.8 % ) were given NRT alone , 406 ( 21.5 % ) bupropion alone , and 108 ( 5.7 Output:	There was evidence that medical advice increased the success of quit attempts and inconclusive evidence that offering assistance increased their success . CONCLUSIONS Physicians may be more effective in promoting attempts to stop smoking by offering assistance to all smokers than by advising smokers to quit and offering assistance only to those who express an interest in doing so
MS22371	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: CONTEXT Illness and hospitalization often trigger functional decline among older persons . Home care services implemented for functional decline provide an opportunity to intervene to improve outcomes . OBJECTIVE To compare functional status and the likelihood of remaining at home for persons receiving restorative care vs usual home care . DESIGN AND SETTING Intervention using prospect i ve individual matching conducted between November 1 , 1998 , and April 30 , 2000 . Six offices of a home care agency in Connecticut were used . One branch office served as the restorative care unit and the other 5 served as usual care offices . PARTICIPANTS Patients receiving home care through the restorative care office who were 65 years or older ; in receipt of Medicare-covered home care lasting at least 7 days ; with absence of severe cognitive impairment ; and not terminal , bedridden , or requiring total care were matched with patients from 1 of the usual care offices . The matching factors included age , sex , race , baseline self-care function , cognitive status , whether hospitalization preceded the home care episode , and date of the home care episode . Of the 712 eligible restorative care patients , 691 ( 97 % ) were matched with a usual care patient . INTERVENTION Restorative care , provided by the home care agency nursing , therapy , and home health aide staff , was based on principles from geriatric medicine , nursing , rehabilitation , and goal attainment . MAIN OUTCOME MEASURES Remaining at home , functional status at completion of the home care episode , and duration and intensity of home care episode . RESULTS Compared with usual care , and after adjusting for baseline characteristics and other factors , restorative care was associated with a greater likelihood of remaining at home ( 82 % vs 71 % ; odds ratio [ OR ] , 1.99 ; 95 % confidence interval [ CI ] , 1.47 - 2.69 ) and a reduced likelihood of visiting an emergency department ( 10 % vs 20 % ; OR , 0.44 ; 95 % CI , 0.32 - 0.61 ) . Home care episodes were shorter ( mean [ SD ] , 24.8 [ 26.8 ] days vs 34.3 [ 44.2 ] days ; S = -17 821 ; P<.001 ) . Restorative care patients had better mean ( SD ) scores than usual care patients in self-care ( 11.0 [ 2.1 ] vs 10.7 [ 2.5 ] ; P = .07 after adjustment ) , home management ( 9.5 [ 2.9 ] vs 9.2 [ 3.0 ] ; P = .05 after adjustment ) , and mobility ( 3.3 [ 0.8 ] vs 3.2 [ 0.9 ] ; P = .02 after adjustment ) . CONCLUSIONS This trial suggests that reorganizing the structure and goals of home care can enhance health outcomes of older patients without increasing health care utilization STUDY QUESTION Did the Medicare Alzheimer 's Disease Demonstration , with its goal of improving caregiver outcomes through case management and subsidized community services , affect the nursing home entry rate of treatments with dementia compared to controls ? DATA SOURCES Interviews conducted at baseline and six months thereafter . Measures include date of nursing home entry , client and caregiver health , and income . STUDY DESIGN The demonstration r and omly assigned voluntary applicants into treatment and control groups . Treatment group cases were eligible for case management and for an 80 percent discount on community care benefits , up to about $ 600 per month . DATA COLLECTION All cases received baseline and semi-annual assessment interviews for up to three years after enrollment . Analyses are among cases that remained in the demonstration for more than 30 days after enrollment ( n = 8,095 ) . PRINCIPAL FINDINGS The intervention of case management and subsidized community service had no effect on nursing home entry rates for treatments overall , compared to those of controls , and few effects on treatment subgroups , with the exception of one site where it may have increased nursing home entry rates . CONCLUSIONS Providing case management and subsidized community services with the goal of improving caregiver outcomes may have little effect on nursing home entry rates for people with dementia Objectives The aim was to evaluate the effects of integrated home care and discharge practice on the functional ability ( FA ) and health-related quality of life ( HRQoL ) of home care patients . Methods A cluster r and omised trial ( CRT ) with Finnish municipalities ( n=22 ) as the units of r and omisation . At baseline the sample included 669 patients aged 65 years or over . Data consisted of interviews ( at discharge , and at 3-week and 6-month follow-up ) , medical records and care registers . The intervention was a generic prototype of care/case management- practice ( IHCaD- practice ) that was tailored to municipalities needs . The aim of the intervention was to st and ardize practice s and make written agreements between hospitals and home care administrations , and also within home care and to name a care/case manager pair for each home care patient . The main outcomes were HRQoL — as measured by a combination of the Nottingham Health Profile ( NHP ) and the EQ-5D instrument for measuring health status— and also Activities of Daily Living ( ADL ) . All analyses were based on intention-to-treat . Results At baseline over half of the patient population perceived their FA and HRQoL as poor . At the 6-month follow-up there were no improvements in FA or in EQ-5D scores , and no differences between groups . In energy , sleep , and pain the NHP improved significantly in both groups at the 3-week and at 6-month follow-up with no differences between groups . In the 3-week follow-up , physical mobility was higher in the trial group . Conclusions Although the effects of the new practice did not improve the patients ' FA and HRQoL , except for physical mobility at the 3-week follow-up , the workers thought that the intervention worked in practice . The intervention st and ardised practice s and helped to integrate services . The intervention was focused on staff activities and through the changed activities also had an effect on patients . It takes many years to achieve permanent changes in every worker 's individual practice and it is also likely that changes in working practice s would be visible before effects on patients . The use of other outcome measures , such as the use of services , may be clearer in showing a positive impact of the intervention rather than FA or STUDY QUESTION Did the Medicare Alzheimer 's Disease Demonstration with its case management and community service waivers affect the use of community-based long-term care services among people with dementia and their primary caregivers ? DATA SOURCES Baseline and periodic caregiver interviews . Measures include client and caregiver attributes and self-reported service use . STUDY DESIGN The demonstration r and omly assigned voluntary applicants into treatment and control groups . Treatment group cases were eligible for case management and for up to $ 699 per month in community care benefits . The actual monthly entitlement varied among the eight demonstration communities due to regional cost and inflation adjustments over time . Analyses are for the year after enrollment . DATA COLLECTION Analyses are of cases surviving six months or more in the community after enrollment ( n = 5,209 ) . Cases received baseline and semi-annual assessment s. PRINCIPAL FINDINGS The intervention of case management and community service reimbursement had a strong , consistent , and positive effect on the likelihood of using home care ( including homemaker/chore services , personal care services , companion services ) and adult day care . Treatment group clients were at least twice as likely as control group clients to be using any of the four community-based services . A similar , but less pervasive effect was achieved with caregiver training and support group participation . Reimbursement provided by the demonstration 's Medicare waiver was generally not sufficient to exceed the level of control group service acquired through private payment . CONCLUSIONS Reimbursement levels within the demonstration may have enabled more individuals to purchase some services , but they were not sufficient to increase the average level of use over those in the control group . No consistent differences between demonstration models were found in service use likelihood or average use among users Abstract Objective : To evaluate the impact of a programme of integrated social and medical care among frail elderly people living in the community . Design : R and omised study with 1 year follow up . Setting : Town in northern Italy ( Rovereto ) . Subjects : 200 older people already receiving conventional community care services . Intervention : R and om allocation to an intervention group receiving integrated social and medical care and case management or to a control group receiving conventional care . Main outcome measures : Admission to an institution , use and costs of health services , variations in functional status . Results : Survival analysis showed that admission to hospital or nursing home in the intervention group occurred later and was less common than in controls ( hazard ratio 0.69 ; 95 % confidence interval 0.53 to 0.91 ) . Health services were used to the same extent , but control subjects received more frequent home visits by general practitioners . In the intervention group the estimated financial savings were in the order of £ 1125 ( $ 1800 ) per year of follow up . The intervention group had improved physical function ( activities of daily living score improved by 5.1 % v 13.0 % loss in controls ; P<0.001 ) . Decline of cognitive status ( measured by the short portable mental status question naire ) was also reduced ( 3.8 % v 9.4 % ; P<0.05 ) . Conclusion : Integrated social and medical care with case management programmes may provide a cost effective approach to reduce admission to institutions and functional decline in older people living in the community . Key messages Responsibility for management of care of elderly people living in the community is poorly defined Integration of medical and social services together with care management programmes would improve such care in the community In a comparison of this option with a traditional and fragmented model of community care the integrated care approach reduced admission to institutions and functional decline in frail elderly people living in the community and also reduced OBJECTIVE To examine how a new model of consumer-directed care changes the way that consumers with disabilities meet their personal care needs and , in turn , affects their well-being . STUDY SETTING Eligible Medicaid beneficiaries in Arkansas , Florida , and New Jersey volunteered to participate in the demonstration and were r and omly assigned to receive an allowance and direct their own Medicaid supportive services as Cash and Counseling consumers ( the treatment group ) or to rely on Medicaid services as usual ( the control group ) . The demonstration included elderly and non-elderly adults in all three states and children in Florida . DATA SOURCES Telephone interviews administered 9 months after r and om assignment . METHODS Outcomes for the treatment and control group were compared , using regression analysis to control for consumers ' baseline characteristics . PRINCIPAL FINDINGS Treatment group members were more likely to receive paid care , had greater satisfaction with their care , and had fewer unmet needs than control group members in nearly every state and age group . However , among the elderly in Florida , Cash and Counseling had little effect on these outcomes because so few treatment group members actually received the allowance . Within each state and age group , consumers were not more susceptible to adverse health outcomes or injuries under Cash and Counseling . CONCLUSIONS Cash and Counseling substantially improves the lives of Medicaid beneficiaries of all ages if consumers actually receive the allowance that the program offers OBJECTIVES To compare the effects of nurse case management with usual care provided to community-dwelling frail older people in regard to quality of life , satisfaction with care , functional status , admission to hospital , length of hospital stay , and readmission to emergency department . DESIGN R and omized controlled trial . SETTING University hospital and two proximal community health centers . PARTICIPANTS 427 frail older people ( > or = 70 years of age and at risk for repeated hospital admissions ) discharged home from the emergency department . INTERVENTIONS EXPERIMENTAL Nurse case management , which consisted of coordination and provision of healthcare services by nurses , both in and out of hospital , for a 10-month period . CONTROL Usual care , which varied by healthcare provider and community health center . MEASUREMENTS Outcomes were assessed 10 months post-r and omization by telephone and /or home interview and by medical record review . Question naires included the SF-36 , CSQ-8 , and OARS . RESULTS No significant differences were found in quality of life , satisfaction with care , functional status , admission to hospital , or length of hospital stay . Nurse-case-managed older adults were readmitted to the emergency department significantly more often than their usual care counterparts . CONCLUSIONS Frail older people receiving nurse case management are more likely to use emergency health services without a concomitant increase in health benefits Context Dementia is an incurable chronic disease , but assistance to caregivers can reduce the severity of patients ' symptoms and delay institutionalization . Because this assistance requires provision of multiple health care and social services , patients and caregivers might benefit from a coordinated system of care . Contribution The investigators r and omly assigned patients with dementia and their caregivers to usual care or to a coordinated system of care . In the coordinated system , care managers regularly assessed patient and caregiver pairs and coordinated guideline -recommended provision of services by health care providers and community agencies using computerized information systems . The study found that pairs cared for in the coordinated system received higher- quality health care and more needed assistance than those who received usual care . Caution s The study focused on a relatively homogeneous population of white , well-educated , otherwise healthy , noninstitutionalized patients with health insurance . The findings might not apply to other population s. Implication s The quality of care for patients with dementia and their caregivers can be improved with a model of care in which services provided by the health system and community agencies are coordinated by a care manager . The Editors Dementia has enormous health and financial consequences for affected individuals , their family caregivers , and society ( 15 ) . Although most dementia is currently neither preventable nor reversible , existing practice guidelines reflect evidence from r and omized , controlled trials that caregiver assistance Output:	Evidence from r and omized controlled trials showed that case management improves function and appropriate use of medications , increases use of community services and reduces nursing home admission . Evidence , mostly from non-r and omized trials , showed that integrated care increases service use ; r and omized trials reported that integrated care does not improve clinical outcomes . The lowest quality evidence was for consumer directed care which appears to increase satisfaction with care and community service use but has little effect on clinical outcomes . Conclusions The outcomes of each model of care differ and correspond to the model 's focus . Combining key elements of all three models may maximize outcomes
MS22372	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: ABSTRACT Background Patients infected with HIV-1 initiating antiretroviral therapy ( ART ) containing a non-nucleoside reverse transcriptase inhibitor ( NNRTI ) show presumably fewer atherogenic lipid changes than those initiating most ARTs containing a protease inhibitor . We analysed whether lipid changes differed between the two most commonly used NNRTIs , nevirapine ( NVP ) and efavirenz ( EFV ) . Methods and Findings Prospect i ve analysis of lipids and lipoproteins was performed in patients enrolled in the NVP and EFV treatment groups of the 2NN study who remained on allocated treatment during 48 wk of follow-up . Patients were allocated to NVP ( n = 417 ) , or EFV ( n = 289 ) in combination with stavudine and lamivudine . The primary endpoint was percentage change over 48 wk in high-density lipoprotein cholesterol ( HDL-c ) , total cholesterol ( TC ) , TC : HDL-c ratio , non-HDL-c , low-density lipoprotein cholesterol , and triglycerides . The increase of HDL-c was significantly larger for patients receiving NVP ( 42.5 % ) than for patients receiving EFV ( 33.7 % ; p = 0.036 ) , while the increase in TC was lower ( 26.9 % and 31.1 % , respectively ; p = 0.073 ) , result ing in a decrease of the TC : HDL-c ratio for patients receiving NVP ( −4.1 % ) and an increase for patients receiving EFV ( + 5.9 % ; p < 0.001 ) . The increase of non-HDL-c was smaller for patients receiving NVP ( 24.7 % ) than for patients receiving EFV ( 33.6 % ; p = 0.007 ) , as were the increases of triglycerides ( 20.1 % and 49.0 % , respectively ; p < 0.001 ) and low-density lipoprotein cholesterol ( 35.0 % and 40.0 % , respectively ; p = 0.378 ) . These differences remained , or even increased , after adjusting for changes in HIV-1 RNA and CD4 + cell levels , indicating an effect of the drugs on lipids over and above that which may be explained by suppression of HIV-1 infection . The increases in HDL-c were of the same order of magnitude as those seen with the use of the investigational HDL-c-increasing drugs . Conclusion NVP-containing ART shows larger increases in HDL-c and decreases in TC : HDL-c ratio than an EFV-containing regimen . Based on these findings , protease-inhibitor-sparing regimens based on non-nucleoside reverse transcriptase inhibitor , particularly those containing NVP , may be expected to result in a reduced risk of coronary heart disease OBJECTIVE This prospect i ve , observational , study evaluates the clinical outcomes , drug utilization patterns , and adherence to treatment of patients on highly active anti retroviral therapy ( HAART ) at a government institution in Kerala , India . METHODS Patients who met criteria for treatment of HIV/AIDS were enrolled into the study , given free NNRTI-based combination therapy , and were followed for a period of 6 months . Data regarding demographics , clinical outcome , laboratory results , drug utilization , adherence and adverse effects were collected . Analysis was conducted utilizing descriptive statistics , anova , Fisher-exact , and t-test . RESULTS One hundred and forty-two patients with HIV-1 were enrolled in the study into three treatment groups . The mean age was 37.88 years , 64 % of the patients were male , and 92 % were married . Group 1 was given zidovudine , lamivudine , and nevirapine [ n = 52 ( 37 % ) ] , group 2 was given lamivudine , stavudine , and nevirapine [ n = 51 ( 36 % ) ] , and group 3 was given lamivudine , stavudine , and efavirenz [ n = 39 ( 27 % ) ] . The increase in CD4 was 107.46 ( SD : 106.25 ) . Mean medication adherence for the 104 patients who completed the study , was 90.7 % ; for group 1 : 92.06 % , group 2 : 93.37%1 , and group 3 : 85.71 % ( P > 0.05 ) . Forty ( 38 % ) patients have at least one adverse event to HARRT , with headache being the most common side effect ( 11.5 % ) . Mortality rate was 3.5 % during the course of the study . CONCLUSION Provision of free NNRTI-based combination therapy to patients in Kerala , India , result ed in greater than 90 % adherence leading to better clinical outcomes in terms of increasing CD4 counts and low mortality , for patients consistently attending a treatment clinic Objectives : We wished to determine the efficacy of nonnucleoside reverse transcriptase inhibitor (NNRTI)-based regimens in antiretroviral-naive patients commencing highly active antiretroviral therapy ( HAART ) and to evaluate the effect of calendar year , nucleoside analogue reverse transcriptase inhibitor ( NRTI ) backbone , sex , and ethnicity on treatment outcome . Methods : Antiretroviral-naive individuals commencing efavirenz or nevirapine with dual-nucleoside analogue backbones were identified from a prospect i ve data base . Virological success was defined as HIV viral load < 500 copies per milliliter . Treatment failure was defined as a switch or discontinuation of NNRTI or documented virological failure ( 2 measurements with viral load > 500 copies/mL ) . Results : From a cohort of 994 individuals , 73 % commenced efavirenz- and 27 % nevirapine-containing regimens . We found no differences between the 2 treatment groups for the time to virological success ( proportion with virological success : efavirenz 71 % , nevirapine 72 % , P = 0.77 ) or treatment failure ( proportion failing treatment : efavirenz 23 % , nevirapine 26 % , P = 0.58 ) . There was a significant difference in the calendar year for commencing HAART for the time to virological success and treatment failure ( P < 0.001 ) . In the multivariable model , the likelihood of virological success for stavudine/lamivudine was 52 % [ relative hazard ( RH ) 1.52 , 95 % confidence interval ( CI ) 1.17 to 1.97 , P = 0.002 ] . The nonthymidine analogue backbones as a group seemed to be least likely associated with virological success ( RH 0.62 , 95 % CI 0.48 to 0.80 , P < 0.001 ) . This was however largely driven by tenofovir/didanosine being significantly associated with treatment failure ( RH 6.48 , 95 % CI 3.81 to 11.0 , P < 0.001 ) . Sex and ethnicity were not associated with treatment outcome . Conclusions : We found no significant differences between nevirapine and efavirenz for the time to virological success or treatment failure . Calendar year of commencing HAART and NRTI backbones were significant predictors of virological success and treatment failure , explaining differences in data to the 2NN study . The weaker the NNRTI ( or the weaker the protease inhibitor ) the more important the NRTI backbone becomes Objectives and Design We used data from a r and omized trial of HIV-tuberculosis co-infected patients in Mozambique to determine the incidence and predictors of paradoxical tuberculosis-associated immune reconstitution inflammatory syndrome ( IRIS ) occurring within 12 weeks of starting antiretroviral therapy , and to evaluate its association with patient outcome at 48 weeks . Methods HIV-tuberculosis co-infected and antiretroviral therapy-naïve adults with less than 250 CD4/mm3 were r and omized to a nevirapine or efavirenz-based antiretroviral therapy initiated 4 to 6 weeks after starting tuberculosis treatment , and were then followed for 48 weeks . Tuberculosis cases were diagnosed using WHO guidelines , and tuberculosis-IRIS by case definitions of the International Network for the Study of HIV-associated IRIS . Results The 573 HIV-tuberculosis co-infected patients who initiated antiretroviral therapy had a median CD4 count of 92 cells/mm3 and HIV-1 RNA of 5.6 log10 copies/mL. Mortality at week 48 was 6.1 % ( 35/573 ) . Fifty-three ( 9.2 % ) patients presented a tuberculosis-IRIS within 12 weeks of starting antiretroviral therapy . Being female and having a low CD4 count , high HIV-1 RNA load , low body mass index and smear-positive pulmonary tuberculosis were independently associated with tuberculosis-IRIS . After adjustment for baseline body mass index , CD4 count and hemoglobin , occurrence of tuberculosis-IRIS was independently associated with 48-week mortality ( aOR 2.72 95%CI 1.14 - 6.54 ) . Immunological and HIV-1 virological responses and tuberculosis treatment outcomes were not different between patients with and without tuberculosis-IRIS . Conclusion In this large prospect i ve cohort , tuberculosis-IRIS occurrence within 12 weeks of starting antiretroviral therapy was independently associated with the mortality of HIV-tuberculosis co-infected patients at 48 weeks post antiretroviral therapy initiation OBJECTIVE The relationships between adverse events ( AEs ) and plasma concentrations of nevirapine ( NVP ) and efavirenz ( EFV ) were investigated as part of the large , international , r and omized 2NN study . METHODS Treatment-naive , HIV-1-infected patients received NVP ( once or twice daily ) , EFV or their combination , each in combination with lamivudine and stavudine . Blood sample s were collected on day 3 and weeks 1 , 2 , 4 , 24 and 48 . Concentrations of NVP and EFV were quantitatively assessed by a vali date d HPLC assay . Individual Bayesian estimates of the area under the plasma concentration-time curve over 24 h ( AUC24h ) , and minimum and maximum plasma concentrations ( Cmin and Cmax ) as measures for drug exposure of NVP and EFV , were generated using a previously developed population pharmacokinetic model . Pharmacokinetic parameters were compared for patients with and without central nervous system ( CNS ) and psychiatric AEs , hepatic events , liver enzyme elevations ( LEEs ) and rash . Furthermore , it was investigated whether a clear cut-off for a pharmacokinetic parameter could be identified above which the incidence of AEs was clearly increased . AEs were also related to demographic parameters and baseline characteristics . RESULTS In total , from 1077 patients , NVP ( 3024 sample s ) and EFV ( 1694 sample s ) plasma concentrations and AE data ( 825 observations ) were available . For all patients Cmin , Cmax and AUC24h were determined . When corrected for known covariates of gender , CD4 cell count at baseline , region , hepatitis coinfection and possible interactions between these factors , no significant associations between AEs and any tested exposure parameter of NVP was observed . Also , no target Cmin value , above which patients were at increased risk for AEs , could be established . On the other h and , geographical region , hepatitis coinfection , CD4 cell count and gender were found to be significantly related with the incidence of CNS and psychiatric AEs , hepatic events , LEEs and rash during the treatment with NVP . The occurrence of elevated liver enzymes during the first 6 weeks in the EFV-containing arm was significantly ( P = 0.036 ) correlated to the exposure of EFV ( Cmin ) . Only hepatitis coinfection impacted on LEEs during the first 6 weeks of treatment . With an EFV Cmin above 2.18 mg/l during the induction phase , patients were 4.4 ( range 1.3 - 15.5 ) times more at risk for elevated liver enzymes . No other correlations between AEs and EFV pharmacokinetics or patient characteristics could be identified . CONCLUSIONS Pharmacokinetic parameters of NVP did not have a relationship to AEs in the 2NN trial when corrected for known covariates . The value of periodical drug monitoring of NVP as a way to prevent toxicity is therefore limited . Treating physicians should instead focus on factors that are more predictive of AEs ( gender , CD4 count and hepatitis coinfection ) . High EFV Cmin levels result ed in elevated liver enzyme values during the first 6 weeks of treatment . Regular measurement of EFV levels and liver enzymes at the start of therapy may therefore be advised CONTEXT Rifampicin-based antitubercular therapy reduces the plasma concentrations of nevirapine and efavirenz . The virological consequences of these interactions are not well described . OBJECTIVE To assess the effectiveness and tolerability of concomitant efavirenz- or nevirapine-based combination antiretroviral therapy and rifampicin-based antitubercular therapy . DESIGN , SETTING , AND PARTICIPANTS C Output:	There were little or no differences in the primary outcomes for patients who were concurrently receiving treatment for tuberculosis . Authors ' conclusions Both drugs have similar benefits in initial treatment of HIV infection when combined with two NRTIs . The adverse events encountered affect different systems , with EFV more likely to cause central nervous system adverse events and NVP more likely to raise transaminases , cause neutropenia and rash .
MS22373	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: BACKGROUND The inconsistent effect of hypothermia treatment on severe brain injury in previous trials might be because hypothermia was induced too late after injury . We aim ed to assess whether very early induction of hypothermia improves outcome in patients with severe brain injury . METHODS The National Acute Brain Injury Study : Hypothermia II ( NABIS : H II ) was a r and omised , multicentre clinical trial of patients with severe brain injury who were enrolled within 2·5 h of injury at six sites in the USA and Canada . Patients with non-penetrating brain injury who were 16 - 45 years old and were not responsive to instructions were r and omly assigned ( 1:1 ) by a r and om number generator to hypothermia or normothermia . Patients r and omly assigned to hypothermia were cooled to 35 ° C until their trauma assessment was completed . Patients who had none of a second set of exclusion criteria were either cooled to 33 ° C for 48 h and then gradually rewarmed or treated at normothermia , depending upon their initial treatment assignment . Investigators who assessed the outcome measures were masked to treatment allocation . The primary outcome was the Glasgow outcome scale score at 6 months . Analysis was by modified intention to treat . This trial is registered with Clinical Trials.gov , NCT00178711 . FINDINGS Enrolment occurred from December , 2005 , to June , 2009 , when the trial was terminated for futility . Follow-up was from June , 2006 , to December , 2009 . 232 patients were initially r and omised a mean of 1·6 h ( SD 0·5 ) after injury : 119 to hypothermia and 113 to normothermia . 97 patients ( 52 in the hypothermia group and 45 in the normothermia group ) did not meet any of the second set of exclusion criteria . The mean time to 35 ° C for the 52 patients in the hypothermia group was 2·6 h ( SD 1·2 ) and to 33 ° C was 4·4 h ( 1·5 ) . Outcome was poor ( severe disability , vegetative state , or death ) in 31 of 52 patients in the hypothermia group and 25 of 56 in the normothermia group ( relative risk [ RR ] 1·08 , 95 % CI 0·76 - 1·53 ; p=0·67 ) . 12 patients in the hypothermia group died compared with eight in the normothermia group ( RR 1·30 , 95 % CI 0·58 - 2·52 ; p=0·52 ) . INTERPRETATION This trial did not confirm the utility of hypothermia as a primary neuroprotective strategy in patients with severe traumatic brain injury BACKGROUND Induction of hypothermia in patients with brain injury was shown to improve outcomes in small clinical studies , but the results were not definitive . To study this issue , we conducted a multicenter trial comparing the effects of hypothermia with those of normothermia in patients with acute brain injury . METHODS The study subjects were 392 patients 16 to 65 years of age with coma after sustaining closed head injuries who were r and omly assigned to be treated with hypothermia ( body temperature , 33 degrees C ) , which was initiated within 6 hours after injury and maintained for 48 hours by means of surface cooling , or normothermia . All patients otherwise received st and ard treatment . The primary outcome measure was functional status six months after the injury . RESULTS The mean age of the patients and the type and severity of injury in the two treatment groups were similar . The mean ( + /-SD ) time from injury to r and omization was 4.3+/-1.1 hours in the hypothermia group and 4.1+/-1.2 hours in the normothermia group , and the mean time from injury to the achievement of the target temperature of 33 degrees C in the hypothermia group was 8.4+/-3.0 hours . The outcome was poor ( defined as severe disability , a vegetative state , or death ) in 57 percent of the patients in both groups . Mortality was 28 percent in the hypothermia group and 27 percent in the normothermia group ( P=0.79 ) . The patients in the hypothermia group had more hospital days with complications than the patients in the normothermia group . Fewer patients in the hypothermia group had high intracranial pressure than in the normothermia group . CONCLUSIONS Treatment with hypothermia , with the body temperature reaching 33 degrees C within eight hours after injury , is not effective in improving outcomes in patients with severe brain injury OBJECTIVE To observe the changes of evoked potentials after severe brain injury and the effect of mild hypothermia on acute severe brain injury . METHODS A total of 44 patients with severe closed head injury ( GCS 3 - 8 , admitted within 10 hours from injury ) admitted from May 1998 to March 1999 were selected for this study . All patients were admitted into the intensive care unit and divided into 2 groups , Group A ( GCS 3 - 5 ) and Group B ( GCS 6 - 8 ) . Patients were also r and omly assigned to either normothermia or hypothermia subgroups . Patients in the hypothermia group were cooled to 32 - 34 degrees C. Median nerve short-latency somatosensory evoked potentials ( SLSEP ) and brain stem auditory evoked potentials ( BAEP ) were recorded before cooling and 4 , 24 , 48 , 72 , 96 and 120 hours , respectively after cooling and temperature resuming . SLSEP and BAEP were measured at the same time in the normothermia group ( control group ) . The changes of evoked potentials ( EP ) were analyzed by statistical methods . RESULTS In the Group B , N(20 ) amplitudes in SLSEP and I/V amplitudes in BAEP after mild hypothermia treatment in the hypothermia group differed significantly from those in the control group ( P<0.05 ) . However , in the Group A , no significant difference in all parameters was found . CONCLUSIONS These results demonstrate that mild hypothermia treatment ( 32 - 34 degrees C ) in the Group B has a significant neuroelectrophysiological effect on severe brain injury . Nevertheless , the effect of mild hypothermia in the Group A is not apparent and needs further study ing Background Traumatic brain injury is a major cause of death and severe disability worldwide with 1,000,000 hospital admissions per annum throughout the European Union . Therapeutic hypothermia to reduce intracranial hypertension may improve patient outcome but key issues are length of hypothermia treatment and speed of re-warming . A recent meta- analysis showed improved outcome when hypothermia was continued for between 48 hours and 5 days and patients were re-warmed slowly ( 1 ° C/4 hours ) . Previous experience with cooling also appears to be important if complications , which may outweigh the benefits of hypothermia , are to be avoided . Methods / design This is a pragmatic , multi-centre r and omised controlled trial examining the effects of hypothermia 32 - 35 ° C , titrated to reduce intracranial pressure < 20 mmHg , on morbidity and mortality 6 months after traumatic brain injury . The study aims to recruit 1800 patients over 41 months . Enrolment started in April 2010 . Participants are r and omised to either st and ard care or st and ard care with titrated therapeutic hypothermia . Hypothermia is initiated with 20 - 30 ml/kg of intravenous , refrigerated 0.9 % saline and maintained using each centre 's usual cooling technique . There is a guideline for detection and treatment of shivering in the intervention group . Hypothermia is maintained for at least 48 hours in the treatment group and continued for as long as is necessary to maintain intracranial pressure < 20 mmHg . Intracranial hypertension is defined as an intracranial pressure > 20 mmHg in accordance with the Brain Trauma Foundation Guidelines , 2007 . Discussion The Eurotherm3235Trial is the most important clinical trial in critical care ever conceived by European intensive care medicine , because it was launched and funded by the European Society of Intensive Care Medicine and will be the largest non-commercial r and omised controlled trial due to the substantial number of centres required to deliver the target number of patients . It represents a new and fundamental step for intensive care medicine in Europe . Recruitment will continue until January 2013 and interested clinicians from intensive care units worldwide can still join this important collaboration by contacting the Trial Coordinating Team via the trial website http://www.eurotherm3235trial.eu . Trial registration Current Controlled Trials IS RCT Recent experimental studies have demonstrated that mild hypothermia at about 34 degrees C can be effective in the control of intracranial hypertension . A r and omized controlled study of mild hypothermia was carried out in 33 severely head-injured patients . All patients fulfilled the following criteria : 1 ) persistent intracranial pressure ( ICP ) greater than 20 mm Hg despite fluid restriction , hyperventilation , and high-dose barbiturate therapy ; 2 ) an ICP lower than the mean arterial blood pressure ; and 3 ) a Glasgow Coma Scale score of 8 or less . The patients were divided into two groups : one received mild hypothermia ( 16 patients ) and one served as a control group ( 17 patients ) . Mild hypothermia significantly reduced the ICP and increased the cerebral perfusion pressure . Eight patients ( 50 % ) in the hypothermia group and three ( 18 % ) in the control group survived ( p < 0.05 ) , while five ( 31 % ) in the hypothermia group and 12 ( 71 % ) in the control group died of uncontrollable intracranial hypertension ( p < 0.05 ) . In five patients in the hypothermia group , cerebral blood flow was measured by the hydrogen clearance method and arteriojugular venous oxygen difference was evaluated before and during mild hypothermia . Mild hypothermia significantly decreased the cerebral blood flow , arteriojugular venous oxygen difference , and cerebral metabolic rate of oxygen ( p < 0.01 ) . The results of this preliminary investigation suggest that mild hypothermia is a safe and effective method to control traumatic intracranial hypertension and to improve mortality and morbidity rates PURPOSE We investigated the effects of therapeutic mild hypothermia on patients with severe traumatic brain injury after craniotomy ( TBI ) . METHODS Eighty patients with severe TBI after unilateral craniotomy were r and omized into a therapeutic hypothermia group with the brain temperature maintained at 33 degrees C to 35 degrees C for 4 days , and a normothermia control group in the intensive care unit . Vital signs , intracranial pressure , serum superoxide dismutase level , Glasgow Outcome Scale scores , and complications were prospect ively analyzed . RESULTS The mean intracranial pressure values of the therapeutic hypothermia group at 24 , 48 , and 72 hours after injury were much lower than those of the control group ( 23.49 + /- 2.38 , 24.68 + /- 1.71 , and 22.51 + /- 2.44 vs 25.87 + /- 2.18 , 25.90 + /- 1.86 , and 24.57 + /- 3.95 mm Hg ; P = .000 , .000 , and .003 , respectively ) . The mean serum superoxide dismutase levels of the therapeutic hypothermia group at days 3 and 7 were much higher than those of the control group at the same time point ( 533.0 + /- 103.4 and 600.5 + /- 82.9 vs 458.7 + /- 68.1 and 497.0 + /- 57.3 mug/L , respectively ; P = .000 ) . The percentage of favorable neurologic outcome 1 year after injury was 70.0 % and 47.5 % , respectively ( P = .041 ) . Complications , including pulmonary infections ( 57.5 % in the therapeutic hypothermia group vs 32.5 % in the control group ; P = .025 ) were managed without severe sequelae . CONCLUSIONS Therapeutic mild hypothermia provides a promising way in the intensive care unit for patients with severe TBI after craniotomy Studies in adults have demonstrated improved outcomes using moderate hypothermia in the management of acute traumatic brain injury ( 1–6 ) . Moderate hypothermia may reduce secondary brain injury by reducing cerebral ischemia , edema , and tissue injury and by attenuating the production of excitatory amino acids ( 7–10 ) . A rat model utilizing mechanical traumatic brain injury and transient forebrain ischemia demonstrated that the peak time of vulnerability for posttraumatic secondary brain ischemia occurs within the first 24 hrs ( 11 ) . Another model demonstrated that apoptotic cells were detectable for up to 72 hrs after the initial brain injury , reaching a peak at approximately 24 to 48 hrs . In the animals treated with moderate hypothermia ( 32 ° C ) , the numbers of apoptotic cells were reduced , and DNA fragmentation was inhibited ( 12 ) . Studies evaluating the efficacy of moderate hypothermia in the management of acute traumatic brain injury have had variable entry criteria , time to entry , and duration of hypothermia . Shiozaki et al. ( 1 ) utilized hypothermia of 33.5–34.5 ° C for a minimum of 48 hrs after failure of conventional Output:	Hypothermia was associated with cerebrovascular disturbances on rewarming and possibly with pneumonia in adult patients . Given the quality of the data currently available , no benefit of PTH on mortality or neurological morbidity could be identified .
MS22374	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: AIMS This study tested the hypothesis that patients with more severe substance use disorders ( SUDs ) at intake respond better when treated in more structured and intensive setting s ( i.e. in-patient/residential versus out-patient ) , whereas patients with less severe SUD problems have similar outcomes regardless of treatment setting . DESIGN , SETTING AND PARTICIPANTS Up to 50 new patients were selected r and omly from each of a r and om and representative sample of 50 Department of Veterans Affairs ( VA ) SUD treatment programs ( total n = 1917 patients ) , and were followed-up an average of 6.7 months later ( n = 1277 ) . MEASURES Patients completed a brief self-report version of the Addiction Severity Index ( ASI ) at baseline and at follow-up . FINDINGS In mixed-model regression analyses , baseline substance use severity predicted follow-up substance use severity and there were no main effects of treatment setting . However , interaction effects were found , such that more severe patients experienced better alcohol and drug outcomes following in-patient/residential treatment versus out-patient treatment ; on the other h and , patients with lower baseline ASI drug severity had better drug outcomes following out-patient treatment than in-patient treatment . Treatment setting was unrelated to alcohol outcomes in patients with less severe ASI alcohol scores . CONCLUSIONS Results provide some support to the matching hypothesis that for patients who have higher levels of substance use severity at intake , treatment in in-patient/residential treatment setting s is associated with better outcomes than out-patient treatment . More research needs to be conducted before in-patient/residential setting s are further reduced as a part of the SUD continuum of care in the United States Objective : To determine the prevalence of concurrent personality disorders ( PDs ) among alcoholic men and women seeking outpatient treatment , and to examine their effect on the course of alcohol treatment . Method : Patients with alcohol use disorders ( n = 165 ) were assessed by clinical and semi-structured interviews , as well as self-report scales , to measure levels of psychological distress , impulsivity , social functioning , and addiction severity at treatment intake . PD diagnoses were assessed using the Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders , Fourth Edition , Personality Disorder ( SCID-II ) . Course in treatment was monitored prospect ively for 12 weeks . Results : Using the results of the SCID-II ( n = 138 ) , the sample was divided into 3 groups — that is , no PD 41 % ( n = 57 ) , Cluster B PD 32 % ( n = 44 ) , and other PD 27 % ( n = 37 ) . The 3 groups did not differ in their alcohol use severity at intake . However , the Cluster B PD group achieved alcohol milestones at a younger age . Subjects with a PD had more severe psychological and social problems at intake . The Cluster B PD group showed significantly higher levels of impulsivity at intake , greater likelihood of early treatment dropout , and quicker times to first slip and to relapse . Conclusions : This study supports the high prevalence of concurrent PDs , particularly Cluster B PDs , among treatment-seeking alcoholics . The relation between observed high levels of impulsivity and worse course in early alcohol treatment among people with a Cluster B PD merits further investigation BACKGROUND Our initial attempts to " match " substance-abuse patients from an employee assistance program to an optimal setting or program failed . Scientifically , we found no differential predictors of better outcomes by setting or program . From a practical perspective , it was impossible to place patients in the intended programs . This led to a second study , design ed to identify specific patient problems and match professional services to those problems within each of the 4 programs . METHODS Ninety-four new patients admitted to 4 substance-abuse treatment programs were r and omly assigned to st and ard treatment and treated in the usual manner or were assigned to " matched " services , in which patients received at least 3 professional sessions directed at their important employment , family , or psychiatric problems . RESULTS Matched patients stayed in treatment longer , were more likely to complete treatment , and had better posttreatment outcomes than did the st and ard patients treated in the same programs . CONCLUSIONS For logistical , financial , and clinical reasons , it is improbable that patients will be matched to specific types of programs . However , within any program , it is possible and practical to match appropriate services to patients ' specific treatment problems . This strategy was clinical ly and administratively practical , attractive to patients , and responsible for a 20 % to 30 % increase in the effectiveness of this substance-abuse treatment system To investigate the impact of counselor style , a 2-session motivational checkup was offered to 42 problem drinkers ( 18 women and 24 men ) who were r and omly assigned to 3 groups : ( a ) immediate checkup with directive-confrontational counseling , ( b ) immediate checkup with client-centered counseling , or ( c ) delayed checkup ( waiting-list control ) . Overall , the intervention result ed in a 57 % reduction in drinking within 6 weeks , which was maintained at 1 year . Clients receiving immediate checkup showed significant reduction in drinking relative to controls . The 2 counseling styles were discriminable on therapist behaviors coded from audiotapes . The directive-confrontational style yielded significantly more resistance from clients , which in turn predicted poorer outcomes at 1 year . Therapist styles did not differ in overall impact on drinking , but a single therapist behavior was predictive ( r = .65 ) of 1-year outcome such that the more the therapist confronted , the more the client drank AIMS Post-discharge monitoring and early reintervention have become st and ard practice when managing numerous chronic conditions . These two experiments tested the effectiveness of recovery management checkup ( RMC ) protocol s for adult chronic substance users . INTERVENTION RMC included quarterly monitoring ; motivational interviewing to provide personalized feedback and to resolve ambivalence about substance use ; treatment linkage , engagement and retention protocol s to increase the amount of treatment received . PARTICIPANTS AND SETTING Recruited from sequential addiction treatment admissions , participants in the two experiments were , on average , 36 and 38 years of age , mainly female ( 59 % versus 46 % ) , African American ( 85 % versus 80 % ) and met past-year criteria for dependence ( 87 % versus 76 % ) . DESIGN Participants in both experiments were assigned r and omly to the RMC or control condition and interviewed quarterly for 2 years . MEASUREMENT The Global Appraisal of Individual Needs ( GAIN ) was the main assessment instrument . FINDINGS RMC participant outcomes were better than control participants in both experiments . Effect sizes were larger in the second experiment in terms of reducing days to readmission ( Cohen 's d = 0.41 versus d = 0.22 ) , successive quarters in the community using substances ( d = -0.32 versus -0.19 ) , past-month symptoms of abuse/dependence ( d = -0.23 versus -0.02 ) and increasing the days of abstinence over 2 years ( d = + 0.29 versus 0.04 ) . CONCLUSION RMC , which provided ongoing monitoring and linkage , is feasible to conduct and is effective for adults with chronic substance dependence This study reports 3-year outcomes for clients who had been treated in the five outpatient sites of Project MATCH , a multisite clinical trial design ed to test a priori client treatment matching hypotheses . The main purpose of this study was to characterize the status of the matching hypotheses at the 3-year follow-up . This entailed investigating which matching findings were sustained or even strengthened across the 3-year study period , and whether any hypotheses that were not supported earlier eventually emerged at 3 years , or conversely , whether matching findings discerned earlier dissipated at this later time . This research also examines the prognostic effects of the client matching attributes , characterizes the overall outcomes at 37 to 39 months , and explores differential effects of the three treatments at extended follow-up . With regard to the matching effects , client anger demonstrated the most consistent interaction in the trial , with significant matching effects evident at both the 1-year and 3-year follow-ups . As predicted , clients high in anger fared better in Motivational Enhancement Therapy ( MET ) than in the other two MATCH treatments : Cognitive-Behavioral Therapy ( CBT ) and Twelve-Step Facilitation ( TSF ) . Among subjects in the highest third of the anger variable , clients treated in MET had on average 76.4 % abstinent days , whereas their counterparts in the other two treatments ( CBT and TSF ) had on average 66 % abstinent days . Conversely , clients low in anger performed better after treatment in CBT and TSF than in MET . Significant matching effects for the support for drinking variable emerged in the 3-year outcome analysis , such that clients whose social networks were more supportive of drinking derived greater benefit from TSF treatment than from MET . Among subjects in the highest third of the support for drinking variable , TSF participants were abstinent 16.1 % more days than MET participants . At the lower end of this variable , difference in percent days abstinent between MET and TSF was 3 % , with MET clients having more abstinent days . A significant matching effect for psychiatric severity that appeared in the first year posttreatment was not observed after 3 years . Of the 21 client attributes used in testing the matching hypotheses , 11 had prognostic value at 3 years . Among these , readiness-to-change and self-efficacy emerged as the strongest predictors of long-term drinking outcome . With regard to the overall outcomes , the reductions in drinking that were observed in the first year after treatment were sustained over the 3-year follow-up period : almost 30 % of the subjects were totally abstinent in months 37 to 39 , whereas those who did report drinking nevertheless remained abstinent an average of two-thirds of the time . As in the 1-year follow-up , there were few differences among the three treatments , although TSF continued to show a possible slight advantage BACKGROUND In 2001 , the Canadian Psychiatric Association and the Canadian Network for Mood and Anxiety Treatments ( CANMAT ) partnered to produce evidence -based clinical guidelines for the treatment of depressive disorders . A revision of these guidelines was undertaken by CANMAT in 2008 - 2009 to reflect advances in the field . This article , one of five in the series , review s new studies of psychotherapy in the acute and maintenance phase of MDD , including computer-based and telephone-delivered psychotherapy . METHODS The CANMAT guidelines are based on a question -answer format to enhance accessibility to clinicians . Evidence -based responses are based on up date d systematic review s of the literature and recommendations are grade d according to the Level of Evidence , using pre-defined criteria . Lines of Treatment are identified based on criteria that included evidence and expert clinical support . RESULTS Cognitive-Behavioural Therapy ( CBT ) and Interpersonal Therapy ( IPT ) continue to have the most evidence for efficacy , both in acute and maintenance phases of MDD , and have been studied in combination with antidepressants . CBT is well studied in conjunction with computer-delivered methods and bibliotherapy . Behavioural Activation and Cognitive-Behavioural Analysis System of Psychotherapy have significant evidence , but need replication . Newer psychotherapies including Acceptance and Commitment Therapy , Motivational Interviewing , and Mindfulness-Based Cognitive Therapy do not yet have significant evidence as acute treatments ; nor does psychodynamic therapy . LIMITATIONS Although many forms of psychotherapy have been studied , relatively few types have been evaluated for MDD in r and omized controlled trials . Evidence about the combination of different types of psychotherapy and antidepressant medication is also limited despite widespread use of these therapies concomitantly . CONCLUSIONS CBT and IPT are the only first-line treatment recommendations for acute MDD and remain highly recommended for maintenance . Both computer-based and telephone-delivered psychotherapy -- primarily studied with CBT and IPT -- are useful second-line recommendations . Where feasible , combined antidepressant and CBT or IPT are recommended as first-line treatments for acute MDD Over 50 % of people with a severe mental illness also use illicit drugs and /or alcohol at hazardous levels . This review is based on the findings of 25 r and omized controlled trials which assessed the effectiveness of psychosocial interventions , offered either as one-off treatments or as an integrated or nonintegrated program , to reduce substance use by people with a severe mental illness . The findings showed that there was no consistent evidence to support any one psychosocial treatment over another . Differences across trials with regard to outcome measures , sample characteristics , type of mental illness and substance used , setting s , levels of adherence to treatment guidelines , and st and ard care all made pooling results difficult . More quality trials are required that adhere to proper r and omization methods ; use clinical ly valuable , reliable , and vali date d measurement scales ; and clearly report data , including retention in treatment , relapse , and abstinence rates . Future trials of this quality will allow a more thorough assessment of the efficacy of psychosocial interventions for reducing substance use in this challenging population This study examines the linkages in the treatment process chains that are thought to underlie two prevalent approaches to substance abuse treatment , traditional 12-Step treatment and cognitive-behavioral treatment . The focus is on the " proximal outcomes " specified by the two treatment approaches and their relation to " ultimate " substance use outcomes assessed at a 1-year follow-up . A total of 2687 men who received treatment in 15 Department of Veterans Affairs substance abuse treatment programs were assessed at treatment entry , at or near discharge , and at a 1-year follow-up . Based on the results of factor analyses , composite proximal outcomes variables were constructed to assess 1 Output:	There is strong evidence that some , but not all , psychosocial treatments are effective in treating alcohol problems . Those with the strongest empirical support are motivational enhancement therapy , various cognitive-behavioural interventions , and brief interventions . When these modalities have been compared with one another in well- design ed clinical trials , they have been shown to be of comparable effectiveness .
MS22375	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: In a pediatric intensive care unit we conducted a 1-year prospect i ve study of 454 patients to determine whether wearing a gown decreased the overall nosocomial infection rate , incidence of intravascular catheter colonization , breaks in h and washing technique , and traffic . The overall infection rate was 26 ( 13 % ) of 198 admissions during the gown-wearing periods v 23 ( 9 % ) of 256 admissions for the periods when gowns were not worn ( P less than .25 ) . Of 348 intravascular catheter tips cultured 16 ( 4.6 % ) were colonized during gown-wearing periods compared with 21 ( 6.3 % ) of 330 when no gowns were worn ( P less than .25 ) . Of 78 patient contacts 54 ( 69 % ) were followed by no h and washing during gown-wearing periods and 59 ( 70 % ) of 84 contacts were followed by no h and washing during periods when no gowns were worn . The mean occurrence of visits per patient per hour and total visits per hour differed between gown-wearing and no-gown-wearing periods by analysis of variance , P less than .01 and P less than .005 , respectively . Although traffic was decreased during periods of gown use , overgowns are an expensive , ineffective method of decreasing nosocomial infection rates , vascular catheter colonization rates , and breaks in h and washing technique OBJECTIVE To assess the efficacy of a multimodal , central ly coordinated , multisite h and hygiene culture-change program ( HHCCP ) for reducing rates of methicillin-resistant Staphylococcus aureus ( MRSA ) bacteraemia and disease in Victorian hospitals . DESIGN , PARTICIPANTS AND SETTING A pilot HHCCP was conducted over a 24-month period ( October 2004 to September 2006 ) in six Victorian health care institutions ( 4 urban , 2 rural ; total beds , 2379 ) . Subsequently , we assessed the efficacy of an identical program implemented throughout Victorian public hospitals over a 12-month period ( beginning between March 2006 and July 2006 ) . MAIN OUTCOME MEASURES Rates of h and hygiene ( HH ) compliance ; rates of MRSA disease ( patients with bacteraemia and number of clinical isolates per 100 patient discharges [ PD ] ) . RESULTS Mean HH compliance improved significantly at all pilot program sites , from 21 % ( 95 % CI , 20%-22 % ) at baseline to 48 % ( 95 % CI , 47%-49 % ) at 12 months and 47 % ( 95 % CI , 46%-48 % ; range , 31%-75 % ) at 24 months . Mean baseline rates for the number of patients with MRSA bacteraemia and the number of clinical MRSA isolates were 0.05/100 PD per month ( range , 0.00 - 0.13 ) and 1.39/100 PD per month ( range , 0.16 - 2.39 ) , respectively . These were significantly reduced after 24 months to 0.02/100 PD per month for bacteraemia ( P = 0.035 for trend ; 65 fewer patients with bacteraemia ) and 0.73/100 PD per month for MRSA isolates ( P = 0.003 ; 716 fewer isolates ) . Similar findings were noted 12 months after the statewide roll-out , with an increase in mean HH compliance ( from 20 % to 53 % ; P < 0.001 ) and reductions in the rates of MRSA isolates ( P = 0.043 ) and bacteraemias ( P = 0.09 ) . CONCLUSIONS Pilot and subsequent statewide implementation of a multimodal HHCCP was effective in significantly improving HH compliance and reducing rates of MRSA infection Abstract H and washing practice s are persistently suboptimal among healthcare professionals and are also stubbornly resistant to change . The purpose of this quasi-experimental intervention trial was to assess the impact of an intervention to change organizational culture on frequency of staff h and washing ( as measured by counting devices inserted into soap dispensers on four critical care units ) and nosocomial infections associated with methicillin-resistant Staphylococcus aureus ( MRSA ) and vancomycin-resistant enterococci ( VRE ) . All staff in one of two hospitals in the mid-Atlantic region received an intervention with multiple components design ed to change organizational culture ; the second hospital served as a comparison . Over a period of 8 months , 860 567 soap dispensings were recorded , with significant improvements in the study hospital after 6 months of follow-up . Rates of MRSA were not significantly different between the two hospitals , but rates of VRE were significantly reduced in the intervention hospital during implementation Background Limited data describe the sustained impact of h and hygiene programs ( HHPs ) implemented in teaching hospitals , where the burden of healthcare-associated infections ( HAIs ) is high . We use a quasi-experimental , before and after , study design with prospect i ve hospital-wide surveillance of HAIs to assess the cost effectiveness of HHPs . Methods and Findings A 4-year hospital-wide HHP , with particular emphasis on using an alcohol-based h and rub , was implemented in April 2004 at a 2,200-bed teaching hospital in Taiwan . Compliance was measured by direct observation and the use of h and rub products . Poisson regression analyses were employed to evaluate the densities and trends of HAIs during the preintervention ( January 1999 to March 2004 ) and intervention ( April 2004 to December 2007 ) periods . The economic impact was estimated based on a case-control study in Taiwan . We observed 8,420 opportunities for h and hygiene during the study period . Compliance improved from 43.3 % in April 2004 to 95.6 % in 2007 ( p<.001 ) , and was closely correlated with increased consumption of the alcohol-based h and rub ( r = 0.9399 ) . The disease severity score ( Charlson comorbidity index ) increased ( p = .002 ) during the intervention period . Nevertheless , we observed an 8.9 % decrease in HAIs and a decline in the occurrence of bloodstream , methicillin-resistant Staphylococcus aureus , extensively drug-resistant Acinetobacter baumannii , and intensive care unit infections . The intervention had no discernable impact on HAI rates in the hematology/oncology wards . The net benefit of the HHP was US$ 5,289,364 , and the benefit-cost ratio was 23.7 with a 3 % discount rate . Conclusions Implementation of a HHP reduces preventable HAIs and is cost effective OBJECTIVE To evaluate the effectiveness of a positive deviance strategy for the improvement of h and hygiene compliance in 2 adult step-down units . DESIGN A 9-month , controlled trial comparing the effect of positive deviance on compliance with h and hygiene . SETTING Two 20-bed step-down units at a tertiary care private hospital . METHODS The first phase of our study was a 3-month baseline period ( from April to June 2008 ) in which h and hygiene episodes were counted by use of electronic h and washing counters . From July to September 2008 ( ie , the second phase ) , a positive deviance strategy was implemented in the east unit ; the west unit was the control unit . During the period from October to December 2008 ( ie , the third phase ) , positive deviance was applied in both units . RESULTS During the first phase , there was no statistically significant difference between the 2 step-down units in the number of episodes of h and hygiene per 1,000 patient-days or in the incidence density of healthcare-associated infections ( HAIs ) per 1,000 patient-days . During the second phase , there were 62,000 h and hygiene episodes per 1,000 patient-days in the east unit and 33,570 h and hygiene episodes per 1,000 patient-days in the west unit ( P < .01 ) . The incidence density of HAIs per 1,000 patient-days was 6.5 in the east unit and 12.7 in the west unit ( p = .04 ) . During the third phase , there was no statistically significant difference in h and hygiene episodes per 1,000 patient-days ( P = .16 ) or in incidence density of HAIs per 1,000 patient-days . CONCLUSION A positive deviance strategy yielded a significant improvement in h and hygiene , which was associated with a decrease in the overall incidence of HAIs It is now well known that st and ard statistical procedures become invali date d when applied to cluster r and omized trials in which the unit of inference is the individual . A result ing consequence is that research ers conducting such trials are faced with a multitude of design choices , including selection of the primary unit of inference , the degree to which clusters should be matched or stratified by prognostic factors at baseline , and decisions related to cluster subsampling . Moreover , application of ethical principles developed for individually r and omized trials may also require modification . We discuss several topics related to these issues , with emphasis on the choices that must be made in the planning stages of a trial and on some potential pitfalls to be avoided OBJECTIVES . H and hygiene promotion interventions rarely result in sustained improvement , and an assessment of their impact on individual infection risk has been lacking . We sought to measure the impact of h and hygiene promotion on health care worker compliance and health care – associated infection risk among neonates . METHODS . We conducted an intervention study with a 9-month follow-up among all of the health care workers at the neonatal unit of the Children 's Hospital , University of Geneva Hospitals , between March 2001 and February 2004 . A multifaceted h and hygiene education program was introduced with compliance assessed during successive observational surveys . Health care – associated infections were prospect ively monitored , and genotypic relatedness of bloodstream pathogens was assessed by pulsed-field gel electrophoresis . A comparison of observed h and hygiene compliance and infection rates before , during , and after the intervention was conducted . RESULTS . A total of 5325 opportunities for h and hygiene were observed . Overall compliance improved gradually from 42 % to 55 % across study phases . This trend remained significant after adjustment for possible confounders and paralleled the measured increase in h and -rub consumption ( from 66.6 to 89.2 L per 1000 patient-days ) . A 9-month follow-up survey showed sustained improvement in compliance ( 54 % ) , notably with direct patient contact ( 49 % at baseline vs 64 % at follow-up ) . Improved compliance was independently associated with infection risk reduction among very low birth weight neonates . Bacteremia caused by clonally related pathogens markedly decreased after the intervention . CONCLUSIONS . H and hygiene promotion , guided by health care workers ' perceptions , identification of the dynamics of bacterial contamination of health care workers ' h and s , and performance feedback , is effective in sustaining compliance improvement and is independently associated with infection risk reduction among high-risk neonates OBJECTIVES To assess h and washing frequency according to CDC recommendations ; and to test a simple intervention to increase h and washing compliance , design ed for the unique setting of the ED . METHODS A prospect i ve , observational , before- and -after study design with a convenience sampling technique was used to assess h and washing compliance in the ED of a 742-bed urban , university-affiliated medical center with 65,000 visits annually . Emergency physicians ( EPs ) , registered nurses ( RNs ) , and nurse practitioners ( NPs ) were informed that their patient encounters were being monitored , but the nature of the study was kept confidential . A single observer evaluated individual EPs , RNs , and NPs in one- , two- , or three-hour blocks , recording compliance with CDC h and washing recommendations . After two weeks , brightly colored signs with CDC recommendations for h and washing were posted at all sinks and a copy of a related publication on h and washing by medical personnel was distributed to all staff . H and washing behaviors were again observed . RESULTS A total of 252 situations requiring h and washing were observed , 132 pre-intervention and 120 post-intervention . Total h and washing , h and washing by each staff design ation , and h and washing in each CDC recommendation category -- except h and washing between contacts with different patients --all showed tendencies toward improvement , though none was significant ( p > 0.05 ) . Both the NPs and RNs demonstrated significantly higher adherence to recommended h and washing between patients after the intervention than did the EPs ( 85 % vs 71 % vs 31 % , p < 0.01 and p < 0.05 , respectively ) . CONCLUSION Despite a trend in improvement of compliance with CDC recommendations , h and washing among ED personnel remained unacceptably low Introduction Achieving a sustained improvement in h and -hygiene compliance is the WHO ’s first global patient safety challenge . There is no RCT evidence showing how to do this . Systematic review s suggest feedback is most effective and call for long term well design ed RCTs , applying behavioural theory to intervention design to optimise effectiveness . Methods Three year stepped wedge cluster RCT of a feedback intervention testing hypothesis that the intervention was more effective than routine practice in 16 English/Welsh Hospitals ( 16 Intensive Therapy Units [ IT Output:	The quality of intervention studies intended to increase h and hygiene compliance remains disappointing . Although multifaceted campaigns with social marketing or staff involvement appear to have an effect , there is insufficient evidence to draw a firm conclusion .
MS22376	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: 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 determine whether aspirin and antioxidant therapy , combined or alone , are more effective than placebo in reducing the development of cardiovascular events in patients with diabetes mellitus and asymptomatic peripheral arterial disease . Design Multicentre , r and omised , double blind , 2 × 2 factorial , placebo controlled trial . Setting 16 hospital centres in Scotl and , supported by 188 primary care groups . Participants 1276 adults aged 40 or more with type 1 or type 2 diabetes and an ankle brachial pressure index of 0.99 or less but no symptomatic cardiovascular disease . Interventions Daily , 100 mg aspirin tablet plus antioxidant capsule ( n=320 ) , aspirin tablet plus placebo capsule ( n=318 ) , placebo tablet plus antioxidant capsule ( n=320 ) , or placebo tablet plus placebo capsule ( n=318 ) . Main outcome measures Two hierarchical composite primary end points of death from coronary heart disease or stroke , non-fatal myocardial infa rct ion or stroke , or amputation above the ankle for critical limb ischaemia ; and death from coronary heart disease or stroke . Results No evidence was found of any interaction between aspirin and antioxidant . Overall , 116 of 638 primary events occurred in the aspirin groups compared with 117 of 638 in the no aspirin groups ( 18.2 % v 18.3 % ) : hazard ratio 0.98 ( 95 % confidence interval 0.76 to 1.26 ) . Forty three deaths from coronary heart disease or stroke occurred in the aspirin groups compared with 35 in the no aspirin groups ( 6.7 % v 5.5 % ) : 1.23 ( 0.79 to 1.93 ) . Among the antioxidant groups 117 of 640 ( 18.3 % ) primary events occurred compared with 116 of 636 ( 18.2 % ) in the no antioxidant groups ( 1.03 , 0.79 to 1.33 ) . Forty two ( 6.6 % ) deaths from coronary heart disease or stroke occurred in the antioxidant groups compared with 36 ( 5.7 % ) in the no antioxidant groups ( 1.21 , 0.78 to 1.89 ) . Conclusion This trial does not provide evidence to support the use of aspirin or antioxidants in primary prevention of cardiovascular events and mortality in the population with diabetes studied . Trial registration Current Controlled Trials IS RCT N53295293 A r and omized , double-blind clinical trial was design ed to assess the effect of aspirin ( ASA ) alone or in combination with dipyridamole ( DIP ) on the patency rates of exp and ed PTFE grafts placed in the infrainguinal position . Forty-nine patients were r and omized into three groups who received three times daily either two placebos ( 17 patients ) , 325 mg ASA and placebo ( 16 patients ) , or 325 mg ASA and 75 mg DIP ( 16 patients ) . The patients were seen at 3-month intervals for 1 year , and coded medication bottles were dispensed and returned pills counted to assess patient compliance . Treatment failure was defined as the first graft occlusion . The data were analyzed using the Breslow statistic for progressively censored survival type data . The 1-year cumulative patency rate for the entire series was 59 % . The rates for above-knee grafts in the ASA group ( 100 % ) and the ASA/DIP group ( 100 % ) were significantly higher than the rates for the placebo group ( 50 % ) ( P = 0.05 ) . The 1-year cumulative patency rates for patients with below-knee grafts were not statistically different among the groups , although the patients who received ASA alone had a higher rate than did the other two groups ( 65 % versus 21 % for placebo and 19 % for ASA/DIP ) . There were fewer occlusions in the above-knee grafts as compared to below-knee grafts in all groups , but the differences were statistically significant only in the ASA/DIP group . There were no statistical differences between the two active treatment groups The effect of 7-mono-hydroxyethylrutoside and its combination with acetylsalicylic acid was evaluated in a controlled clinical trial , performed in 105 patients with obliterative atherosclerosis of the lower limbs , and using non-invasive measurement of peripheral haemodynamic parameters -- blood flow during reactive hyperaemia and ankle systolic blood pressure . Patients , r and omized into three groups , received either placebo or 7-mono-hydroxyethylrutoside alone or in combination with acetylsalicylic acid for 12 months . The placebo group showed a decrease in maximum calf blood flow and a decrease in ankle systolic pressure . Administration of 7-mono-hydroxyethylrutoside did not lead to any significant changes in systolic pressure but there was a decrease in the maximum calf blood flow . There were no statistically significant changes in patients receiving the 7-mono-hydroxyethylrutoside and acetylsalicylic acid combination who , by contrast , showed a tendency to increased values of the parameters measured Thirty one r and omised trials of antiplatelet treatment for patients with a history of transient ischaemic attack , occlusive stroke , unstable angina , or myocardial infa rct ion were identified . Six were still in progress , and the results of the remaining 25 were review ed . They included a total of some 29 000 patients , 3000 of whom had died . Overall , allocation to antiplatelet treatment had no apparent effect on non-vascular mortality but reduced vascular mortality by 15 % ( SD 4 % ) and non-fatal vascular events ( stroke or myocardial infa rct ion ) by 30 % ( 4 % ) . This suggested that with good compliance these treatments might reduce vascular mortality by about one sixth , other vascular events by about a third , and total vascular events by about a quarter . There was no significant difference between the effects of the different types of antiplatelet treatment tested ( 300 - 325 mg aspirin daily , higher aspirin doses , sulphinpyrazone , or high dose aspirin with dipyridamole ) , nor between the effects in patients with histories of cerebral or cardiac disease . Thus antiplatelet treatment can reduce the incidence of serious vascular events by about a quarter among a wide range of patients at particular risk of occlusive vascular disease . The balance of risk and benefit , however , might be different for “ primary ” prevention among people at low absolute risk of occlusive disease if antiplatelet treatment produced even a small increase in the incidence of cerebral haemorrhage Background : In patients with symptomatic peripheral artery disease with a history of limb revascularization , the optimal antithrombotic regimen for long-term management is unknown . Methods : The EUCLID trial ( Examining Use of Ticagrelor In PAD ) r and omized 13 885 patients with peripheral artery disease to treatment with ticagrelor 90 mg twice daily or clopidogrel 75 mg daily . Patients were enrolled based on an abnormal ankle-brachial index ⩽0.80 or a previous lower extremity revascularization . This analysis focuses on the 7875 ( 57 % ) patients enrolled based on the previous lower extremity revascularization criterion . Patients could not be enrolled within 30 days of most recent revascularization , and patients with an indication for dual antiplatelet therapy were excluded . The primary efficacy end point was a composite of cardiovascular death , myocardial infa rct ion , or ischemic stroke . The primary safety end point was major bleeding . Results : Patients with a previous revascularization had a mean age of 66 years , 73 % were male , and the median baseline ankle-brachial index was 0.78 . After adjustment for baseline characteristics , patients enrolled based on previous revascularization had similar rates of the primary composite end point ( hazard ratio [ HR ] 1.10 , 95 % confidence interval [ CI ] 0.98–1.23 , P=0.12 ) and statistically significantly higher rates of myocardial infa rct ion ( HR 1.29 , 95 % CI 1.08–1.55 , P=0.005 ) and acute limb ischemia ( HR 4.23 , 95 % CI 2.86–6.25 , P<0.001 ) when compared with patients enrolled based on ankle-brachial index criteria . No differences in ticagrelor- versus clopidogrel-treated patients were found for the primary efficacy end point ( 11.4 % vs 11.3 % ; HR 1.01 , 95 % CI 0.88–1.15 ; P=0.90 ) , all-cause mortality ( 9.2 % vs 9.2 % ; HR 0.99 , 95 % CI 0.86–1.15 ; P=0.93 ) , acute limb ischemia ( 2.5 % vs 2.5 % ; HR 1.03 , 95 % CI 0.78–1.36 ; P=0.84 ) , or major bleeding ( 1.9 % vs 1.8 % ; HR 1.15 , 95 % CI 0.83–1.59 ; P=0.41 ) . The median duration of follow-up was ≈30 months . Conclusions : After adjustment for baseline characteristics , patients enrolled based on previous revascularization for peripheral artery disease had higher rates of myocardial infa rct ion and acute limb ischemia , with similar composite rates of cardiovascular death , myocardial infa rct ion , and stroke when compared with patients enrolled based on the ankle-brachial index criterion . No significant differences were found between ticagrelor and clopidogrel for reduction of cardiovascular or acute limb events . Clinical Trial Registration : URL : http://www . clinical trials.gov . Unique identifier : NCT01732822 In this prospect i ve study 364 patients were subjected to different types of arterial reconstructive surgery . The patients were r and omly divided into four groups according to the type of antithrombotic medication given . During the hospitalization period there were no reocclusions in the dipyridamole/ASA group of 93 patients compared with 12 reocclusions in the control group of 86 patients . The difference was statistically highly significant . The difference between the control group and the given dipyridamole or ASA was not statistically significant . Dipyridamole and ASA were tolerated well by the patients in this clinical trial . This was the first clinical investigation to prove the effectiveness of dipyridamole and ASA medication in the prevention of reocclusions in arterial reconstructive bypass surgery 240 patients were admitted to a double-blind study to determine the effect of long-term treatment with platelet-function inhibiting agents on occlusive arterial disease in the lower extremities . Patients were r and omised into 1 of 3 treatment groups : aspirin 330 mg ; dipyridamole 75 mg and aspirin 330 mg ; or matching placebo 3 times daily . The duration of treatment was 2 years . Arteriography was carried out at the beginning of the study and 2 years later or before if deterioration was observed . 199 patients completed the study according to the trial protocol . The serial arteriograms were assessed in pairs qualitatively , by means of simple comparative viewing , and semiquantitatively with Bollinger 's score system . Progression of the disease was most pronounced in the placebo-treated group , less so in the aspirin-treated group , and least of all in the dipyridamole- and -aspirin group . Patients who smoke and those with hypertension may benefit most from treatment with the 2 preparations under investigation CONTEXT A low ankle brachial index ( ABI ) indicates atherosclerosis and an increased risk of cardiovascular and cerebrovascular events . Screening for a low ABI can identify an asymptomatic higher risk group potentially amenable to preventive treatments . OBJECTIVE To determine the effectiveness of aspirin in preventing events in people with a low ABI identified on screening the general population . DESIGN , SETTING , AND PARTICIPANTS The Aspirin for Asymptomatic Atherosclerosis trial was an intention-to-treat double-blind r and omized controlled trial conducted from April 1998 to October 2008 , involving 28,980 men and women aged 50 to 75 years living in central Scotl and , free of clinical cardiovascular disease , recruited from a community health registry , and had an ABI screening test . Of those , 3350 with a low ABI ( < or = 0.95 ) were entered into the trial , which was powered to detect a 25 % proportional risk reduction in events . INTERVENTIONS Once daily 100 mg aspirin ( enteric coated ) or placebo . MAIN OUTCOME MEASURES The primary end point was a composite of initial fatal or nonfatal coronary event or Output:	CONCLUSIONS Aspirin use in PVD might not be associated with improved cardiovascular outcomes or worse bleeding outcomes .
MS22377	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: Introduction Return to work ( RTW ) of employees on sick leave for common mental disorders may require a multidisciplinary approach . This article aims to assess time to RTW after a psychiatric consultation providing treatment advice to the occupational physician ( OP ) for employees on sick leave for common mental disorders in the occupational health ( OH ) setting , compared to care as usual ( CAU ) . Methods Cluster r and omized clinical trial evaluating patients of 12 OPs receiving consultation by a psychiatrist , compared to CAU delivered by 12 OPs in the control group . 60 patients suffering from common mental disorders and ≥ six weeks sicklisted were included . Follow up three and six months after inclusion . Primary outcome measure was time to RTW . Intention- to-treat multilevel analysis and a survival analysis were performed to evaluate time to RTW in both groups . Results In CAU , referral was the main intervention . Both groups improved in terms of symptom severity and quality of life , but time to RTW was significantly shorter in the psychiatric consultation group . At three months follow up , 58 % of the psychiatric consultation group had full RTW versus 44 % of the control group , a significant finding ( P = 0.0093 ) . Survival analysis showed 68 days earlier RTW after intervention in the psychiatric consultation group ( P = 0.078 ) compared to CAU . Conclusion Psychiatric consultation for employees on sick leave in the OH setting improves time to RTW in patients with common mental disorders as compared to CAU . In further research , focus should be on early intervention in patients with common mental disorders on short sick leave duration . Psychiatric consultation might be particularly promising for improvement of RTW in those patients . Trial registration number IS RCT N : Background To reduce the duration of sick leave and loss of productivity due to common mental disorders ( CMDs ) , we developed a return-to-work programme to be provided by occupational physicians ( OPs ) based on the principles of exposure in vivo ( RTW-E programme ) . This study evaluates this programme 's effectiveness and cost-effectiveness by comparing it with care as usual ( CAU ) . The three research questions we have are : 1 ) Is an RTW-E programme more effective in reducing the sick leave of employees with common mental disorders , compared with care as usual ? 2 ) Is an RTW-E programme more effective in reducing sick leave for employees with anxiety disorders compared with employees with other common mental disorders ? 3 ) From a societal perspective , is an RTW-E programme cost-effective compared with care as usual ? Methods / design This study was design ed as a pragmatic cluster-r and omized controlled trial with a one-year follow-up and r and omization on the level of OPs . We aim ed for 60 OPs in order to include 200 patients . Patients in the intervention group received the RTW-E programme . Patients in the control group received care as usual . Eligible patients had been on sick leave due to common mental disorders for at least two weeks and no longer than eight weeks . As primary outcome measures , we calculated the time until full return to work and the duration of sick leave . Secondary outcome measures were time until partial return to work , prevalence rate of sick leave at 3 , 6 , 9 , and 12 months ' follow-up , and scores of symptoms of distress , anxiety , depression , somatization , and fatigue ; work capacity ; perceived working conditions ; self-efficacy for return to work ; coping behaviour ; avoidance behaviour ; patient satisfaction ; and work adaptations . As process measures , we used indices of compliance with the intervention in the intervention group and employee-supervisor communication in both groups . Economic costs were calculated from a societal perspective . The total costs consisted of the costs of consuming health care , costs of production loss due to sick leave and reduced productivity , and out-of-pocket costs of patients for travelling to their OP . Discussion The results will be published in 2009 . The strengths and weaknesses of the study protocol are discussed . Trial registration IS RCT OBJECTIVE High levels of work-related stress are associated with increased absenteeism from work and reduced work ability . In this study , we investigated the effects of a stress management intervention on absenteeism and return to work . METHODS We r and omized 102 participants into either the intervention or wait-list control ( WLC ) group . The intervention group received the intervention in weeks 1 - 16 from baseline , and the WLC group received the intervention in weeks 17 - 32 . Self-reported data on absenteeism ( number of days full- or part-time absent from work within the previous three months ) were obtained at 16 , 32 , and 48 weeks follow-up . Register-based data on long-term absence from work were drawn from the Danish public transfer payments ( DREAM ) data base from baseline and 48 weeks onwards . The DREAM data base contains weekly information on long-term sickness absence compensation . The threshold to enter DREAM is sick leave for two consecutive weeks . RESULTS At follow-up in week 16 , self-reported absenteeism in the intervention group [ median 11 days ( range 3 - 25 ) ] was lower ( P=0.02 ) than in the WLC group [ median 45 days ( range 19 - 60 ) ] , corresponding to a 29 % [ 95 % confidence interval ( 95 % CI ) 5 - 52 ] reduction . On register-based data ( cumulated weeks in DREAM , weeks 1 - 16 ) , the intervention group median [ 6 weeks ( range 0 - 11 ) ] was lower than that of the WLC group [ median 12 weeks ( range 8 - 16 ) ] , though not significantly ( P=0.06 ) , corresponding to a 21 % ( 95 % CI 0 - 42 ) reduction . For return to work , a hazard ratio of 1.58 ( 95 % CI 0.89 - 2.81 ) favoring the intervention group was found ( P=0.12 ) . CONCLUSIONS The intervention reduces self-reported absenteeism from work . A similar trend was found from register-based records . No conclusive evidence was found for return to work Background Considering the high costs of sick leave and the consequences of sick leave for employees , an early return-to-work of employees with mental disorders is very important . Therefore , a workplace intervention is developed based on a successful return-to-work intervention for employees with low back pain . The objective of this paper is to present the design of a r and omized controlled trial evaluating the cost-effectiveness of the workplace intervention compared with usual care for sick-listed employees with common mental disorders . Methods The study is design ed as a r and omized controlled trial with a follow-up of one year . Employees eligible for this study are on sick leave for 2 to 8 weeks with common mental disorders . The workplace intervention will be compared with usual care . The workplace intervention is a stepwise approach that aims to reach consensus about a return-to-work plan by active participation and strong commitment of both the sick-listed employee and the supervisor . Outcomes will be assessed at baseline , 3 , 6 , 9 and 12 months . The primary outcome of this study is lasting return-to-work , which will be acquired from continuous registration systems of the companies after the follow-up . Secondary outcomes are total number of days of sick leave during the follow-up , severity of common mental disorders , coping style , job content , and attitude , social influence , and self-efficacy determinants . Cost-effectiveness will be evaluated from the societal perspective . A process evaluation will also be conducted . Discussion Return-to-work is difficult to discuss in the workplace for sick-listed employees with mental disorders and their supervisors . Therefore , this intervention offers a unique opportunity for the sick-listed employee and the supervisor to discuss barriers for return-to-work . Results of this study will possibly contribute to improvement of disability management for sick-listed employees with common mental disorders . Results will become available in 2009.Trial registration IS RCT Background Workplace mental health promotion ( WMHP ) aims to prevent and effectively manage the social and economic costs of common mental illnesses such as depression . The mental health of managers and employees within small-medium enterprises ( SMEs ) is a neglected sector in occupational health research and practice , despite the fact that this sector is the most common work setting in most economies . The availability and propensity of SME staff to attend face-to-face training/therapy or workshop style interventions often seen in corporate or public sector work setting s is a widely recognised problem . The ' Business in Mind ' program employs a DVD mode of delivery that is convenient for SME managers , particularly those operating in regional and remote areas where internet delivery may not be optimal . The objective of the intervention program is to improve the mental health of SME managers , and examine whether employees of managers ' whose mental health improves , report positive change in their psychosocial work environment . The mechanisms via which we aim to improve managers ' mental health are through the development of their psychological capital ( a higher order construct comprised of hope , self efficacy , resilience and optimism ) and their skills and capacities for coping with work stress . Methods / Design The effectiveness of two versions of the program ( self administered and telephone facilitated ) will be assessed using a r and omised trial with an active control condition ( psychoeducation only ) . We aim to recruit a minimum of 249 managers and a sample of their employees . This design allows for 83 managers per group , as power analyses showed that this number would allow for attrition of 20 % and still enable detection of an effect size of 0.5 . The intervention will be implemented over a three month period and postal surveys will assess managers and employees in each group at baseline , intervention completion , and at 6 month follow up . The intervention groups ( managers only ) will also be assessed at 12 and 24 month follow-up to examine maintenance of effects . Primary outcomes are managers ' levels of psychological capital ( hope , resilience , self-efficacy and optimism ) , coping strategies , anxiety and depression symptoms , self-reported health , job satisfaction and job tension . Secondary outcomes are participating managers subordinates ' perceptions of manager support , relational justice , emotional climate and job tension . In order to provide an economic evaluation of the intervention , both employees and manager rates of absenteeism and presenteeism will also be assessed . Discussion The intervention being trialled is expected to improve both primary and secondary outcomes . If proven efficacious , the intervention could be disseminated to reach a much larger proportion of the business community . Trial registration Current controlled trials IS RCT N Background Major depressive disorder is among the medical conditions with the highest negative impact on work outcome . However , little is known regarding evidence -based interventions targeting the improvement of work outcomes in depressed employees . In this paper , the design of a r and omized controlled trial is presented in order to evaluate the effectiveness of adjuvant occupational therapy in employees with depression . This occupational intervention is based on an earlier intervention , which was design ed and proven effective by our research group , and is the only intervention to date that specifically targets work outcome in depressed employees . Methods / Design In a two-arm r and omized controlled trial , a total of 117 participants are r and omized to either ' care as usual ' or ' care as usual ' with the addition of occupational therapy . Patients included in the study are employees who are absent from work due to depression for at least 25 % of their contract hours , and who have a possibility of returning to their own or a new job . The occupational intervention consists of six individual sessions , eight group sessions and a work-place visit over a 16-week period . By increasing exposure to the working environment , and by stimulating communication between employer and employee , the occupational intervention aims to enhance self-efficacy and the acquisition of more adaptive coping strategies . Assessment s take place at baseline , and at 6 , 12 , and 18-month follow-ups . Primary outcome measure is work participation ( hours of absenteeism and time until work resumption ) . Secondary outcome measures are work functioning , symptomatology , health-related quality of life , and neurocognitive functioning . In addition , cost-effectiveness is evaluated from a societal perspective . Finally , mechanisms of change ( intermediate outcomes ) and potential patient-treatment matching variables are investigated . Discussion This study hopes to provide valuable knowledge regarding an intervention to treat depression , one of the most common and debilitating diseases of our time . If our intervention is proven ( cost- ) effective , the personal , economic , and health benefits for both patients and employers are far-reaching . Trial registration Background Common mental disorders , such as depression , anxiety disorder , and adjustment disorder , have emerged as a major public and occupational health problem in many countries . These disorders can have severe consequences such as absenteeism and work disability . Different interventions have been developed to improve the return-to-work of employees with common mental disorders , but still a large proportion of employees experiences health and work problems after their return-to-work . For this reason , the SHARP-at work intervention is developed to prevent a relapse of sickness absence among employees who have returned to work after a period of sickness absence because of common mental disorders . We aim to evaluate the effectiveness , cost-benefit and process of the intervention compared to care as usual . Methods / Design The study is design ed as a cluster-r and omised controlled trial with r and omisation at the level of the occupational physician . Employees who have returned to work after a period of sickness absence because of a common mental disorder are included in the study . Employees in the intervention group will receive the SHARP-at work intervention . The intervention focusses on active guidance of employees by occupational physicians during the first weeks of work after sickness absence . Employees in the control group will receive care as usual . Outcomes will be assessed at baseline and at 3 , 6 , and 12 months follow-up . The primary outcome is cumulative recurrent sickness absence days . Secondary outcome measures are mental health , work functioning , and coping . Adherence to the protocol , communication between stakeholders , and satisfaction with the treatment are the process measures assessed in both study groups . Cost-benefit is calculated from a societal perspective . Finally , prognostic factors for a relapse of sickness absence are investigated . Discussion This study goes beyond return-to-work by focussing Output:	We found moderate- quality evidence that CBT did not significantly reduce time until partial RTW and low- quality evidence that it did not significantly reduce time to full RTW compared with no treatment . Moderate- quality evidence showed that PST significantly enhanced partial RTW at one-year follow-up compared to non- guideline based care but did not significantly enhance time to full RTW at one-year follow-up .
MS22378	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: Psychological theories of categorization generally focus on either rule- or exemplar-based explanations . We present 2 experiments that show evidence of both rule induction and exemplar encoding as well as a connectionist model , ATRIUM , that specifies a mechanism for combining rule- and exemplar-based representation . In 2 experiments participants learned to classify items , most of which followed a simple rule , although there were a few frequently occurring exceptions . Experiment 1 examined how people extrapolate beyond the range of training . Experiment 2 examined the effect of instance frequency on generalization . Categorization behavior was well described by the model , in which exemplar representation is used for both rule and exception processing . A key element in correctly modeling these results was capturing the interaction between the rule- and exemplar-based representations by using shifts of attention between rules and exemplars Counseling women about breast cancer risks has been found to decrease screening compliance . We investigated whether women 's reactions to risk information are an artifact of requiring women to estimate the risk of breast cancer prior to receiving risk information . Three hundred and fifty-six women were r and omized to either make or not make a risk estimate prior to receiving risk information . Outcome measures were participants ' estimates of the average woman 's breast cancer risk and their emotional response to the risk information . Women overestimated the lifetime risk of breast cancer ( M = 46 % ) . Women who made risk estimates felt more relieved about the risk and perceived the risk as being lower than women who did not make estimates ( p 's < 0.001 ) . Asking people to estimate risks influenced their subsequent perceptions of the risk of breast cancer In the present study , the authors investigated the effects of framing of options on risky decision making in groups of younger adults ( M = 23.8 years , n = 192 ) and older adults ( M = 69.1 years , n = 192 ) . The participants were assigned to one of three scenarios varying in the goods at stake ( human lives , paintings , money ) . The authors observed a majority preference in favor of the risky options after negative , but not positive framing . They also found , as they had predicted , that the type of framing effect varied across scenarios , with a bidirectional framing effect for the life-death scenario and unidirectional ( risk averse ) framing effects when public property ( paintings ) or personal property ( money ) were at stake . It is important to note that these choice preference patterns were highly similar across the age groups , which reinforced the conclusion that younger and older adults are equally susceptible to framing effects Output:	The model is also shown to be scientifically parsimonious using st and ard measures .
MS22379	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: Background Given that relatively little is known about the development of resilience in early childhood , this longitudinal study aim ed to identify preschool re source factors associated with young children ’s mental health resilience to family adversity . Methods A community sample of 474 young Australian children was assessed in preschool ( mean age 4.59 years , 49 % male ) , and again two years later after their transition into formal schooling . At each assessment , st and ard question naires were used to obtain ratings from both parents and teachers about the quality of children ’s relationships with parents and teachers , children ’s self-concept and self-control , mental health ( Strengths and Difficulties Question naire ) , and family adversities ( including stressful life events and socioeconomic disadvantage ) . Results Greater exposure to cumulative family adversities was associated with both greater teacher- and parent-reported child mental health difficulties two years later . Multiple method ologies for operationalizing resilience were used to identify re sources associated with resilient mental health outcomes . Higher quality child – parent and child-teacher relationships , and greater child self-concept and self-control were associated with resilient mental health outcomes . With the exception of child-teacher relationships , these re sources were also prospect i ve antecedents of subsequent resilient mental health outcomes in children with no pre-existing mental health difficulties . Child – parent relationships and child self-concept generally had promotive effects , being equally beneficial for children facing both low- and high-adversity . Child self-control demonstrated a small protective effect on teacher-reported outcomes , with greater self-control conferring greater protection to children under conditions of high-adversity . Conclusions Findings suggest that early intervention and prevention strategies that focus on fostering child-adult relationship quality , self-concept , and self-control in young children may help build children ’s mental health and their resilience to family adversities OBJECTIVE : To evaluate the impact of an early childhood , family-centered , school-based intervention on children ’s kindergarten academic achievement . METHODS : This was a cluster ( school ) r and omized controlled trial with assessment s from pre-kindergarten ( pre-k ) entry through the end of kindergarten . The setting was 10 public elementary schools with 26 pre-k classes in 2 school districts in urban disadvantaged neighborhoods serving a largely black , low-income population . Participants were 1050 black and Latino , low-income children ( age 4 ; 88 % of pre-k population ) enrolled in 10 schools over 4 years . Universal intervention aim ed to promote self-regulation and early learning by strengthening positive behavior support and effective behavior management at home and school , and increasing parent involvement in education . Intervention included after-school group sessions for families of pre-k students ( 13 2-hour sessions ; co-led by pre-k teachers ) and professional development for pre-k and kindergarten teachers . The outcome measures were st and ardized test scores of kindergarten reading , writing , and math achievement by independent evaluators masked to intervention condition ( primary outcome ) ; developmental trajectories of teacher-rated academic performance from pre-k through kindergarten ( secondary outcome ) . RESULTS : Relative to children in control schools , children in intervention schools had higher kindergarten achievement test scores ( Cohen ’s d = 0.18 , mean difference = 2.64 , SE = 0.90 , P = .03 ) and higher teacher-rated academic performance ( Cohen ’s d = 0.25 , mean difference = 5.65 , SE = 2.34 , P = .01 ) . CONCLUSIONS : Early childhood population -level intervention that enhances both home and school environments shows promise to advance academic achievement among minority children from disadvantaged , urban neighborhoods Correctable weaknesses in the design , conduct , and analysis of biomedical and public health research studies can produce misleading results and waste valuable re sources . Small effects can be difficult to distinguish from bias introduced by study design and analyses . An absence of detailed written protocol s and poor documentation of research is common . Information obtained might not be useful or important , and statistical precision or power is often too low or used in a misleading way . Insufficient consideration might be given to both previous and continuing studies . Arbitrary choice of analyses and an overemphasis on r and om extremes might affect the reported findings . Several problems relate to the research workforce , including failure to involve experienced statisticians and method ologists , failure to train clinical research ers and laboratory scientists in research methods and design , and the involvement of stakeholders with conflicts of interest . Inadequate emphasis is placed on recording of research decisions and on reproducibility of research . Finally , reward systems incentivise quantity more than quality , and novelty more than reliability . We propose potential solutions for these problems , including improvements in protocol s and documentation , consideration of evidence from studies in progress , st and ardisation of research efforts , optimisation and training of an experienced and non-conflicted scientific workforce , and reconsideration of scientific reward systems Self-regulatory abilities are robust predictors of important outcomes across the life span , yet they are rarely taught explicitly in school . Using a r and omized controlled design , the present study investigated the effects of a 12-week mindfulness-based Kindness Curriculum ( KC ) delivered in a public school setting on executive function , self-regulation , and prosocial behavior in a sample of 68 preschool children . The KC intervention group showed greater improvements in social competence and earned higher report card grade s in domains of learning , health , and social-emotional development , whereas the control group exhibited more selfish behavior over time . Interpretation of effect sizes overall indicate small to medium effects favoring the KC group on measures of cognitive flexibility and delay of gratification . Baseline functioning was found to moderate treatment effects with KC children initially lower in social competence and executive functioning demonstrating larger gains in social competence relative to the control group . These findings , observed over a relatively short intervention period , support the promise of this program for promoting self-regulation and prosocial behavior in young children . They also support the need for future investigation of program implementation across diverse setting Background : Childhood is important and critical period in human life . The foundation of ego is shaped in childhood . Play therapy is one of the successful strategies to help children with inner conflicts problems . This method of psychotherapy is base on the normal learning processes of children , provides solutions to relieve feelings of stress , and exp and s self-expression . Group play therapy can enhance the self-awareness , self- regulation , social communication , empathy and adoptability in children . Methods : Present study investigated the effects of play therapy on relational and emotional skills of pre-school children . For this purpose , the total numbers of 372 pre-school children were r and omly selected , and divided into two equal groups ( case and control ) . In next step , the BUSSE-SR methodology was used for evaluation and comparison of self-awareness , self-regulation , social interaction , empathy , adoptability , and control groups . Pre-test were performed for both groups and case group was involved in-group play therapy . According to the results of post-test , correlation of variables between case-control groups was examined by multivariate analysis of covariance . Results : Frequency of boys and girls in our sample were 51.3 and 48.7 percent , respectively . The mean age of children was 5.1±0.6 year . According to the results of present study , play therapy significantly enhanced the social-emotional skills ( P < 0.001 ) . Our findings are consistent with the results of previous studies in other nations with different environmental and cultural properties . In conclusion , it seems that play therapy can be used in pre-school centers to help children learn problem-solving skills and communicate with others Background Little is known about how contributing factors of development change during early childhood in Japan . The aim of this study was to investigate the factors that contributed to the developmental attainment of children between 9 and 18 months of age using prospect i ve longitudinal data from a developmental cohort study . Methods We used data from observations at 3 time points ( at infant age of 4 , 9 and 18 months ) in the Japan Children ’s Study . Mothers were administered question naires that requested information about their child ’s perinatal outcomes , temperament , family structure , family income , parental education , parenting stress , and child-rearing environment at home . At 9 and 18 months , mothers completed the Kinder Infant Development Scale to evaluate their child ’s development . Results A total of 284 children were available for analysis . Female children and children having siblings had higher probability of attaining developmental norms at 18 months than male and only children . Birth weight , gestational age , and temperament were associated with development at 9 months , but the effects of gestational age and temperament on development disappeared at 18 months . Stimulation from the mother at 9 months was not only related to development at that age but also promoted development at 18 months . Conclusions Our findings suggest that the role of family environmental factors such as early mother ’s stimulation and sibling ’s existence in development during early childhood might become more important as the child gets older Research Findings : The purpose of this study was to test the premise that children 's effortful control ( EC ) is prospect ively related to their academic achievement and to specify mechanisms through which EC is related to academic success . We used data from 214 children ( M age at Time 1 [ T1 ] = 73 months ) to test whether social functioning ( e.g. , social competence and externalizing problems ) mediated the relations between EC and academic achievement . Children 's adult-reported and observed EC were assessed at T1 . Parents ' and teachers ' reports of social functioning were obtained 2 years later ( T2 ) , whereas teachers ' and children 's reports of academic achievement were obtained 4 years after T2 ( T3 ) . Children 's T2 social functioning fully mediated the relation between T1 EC and T3 academic achievement in a structural equation model . Practice or Policy : Findings highlight the importance of considering social and emotional processes when attempting to improve academic achievement and have implication s for curriculum developers and professionals working in preschool programs and elementary schools Social experiments are powerful sources of information about the effectiveness of interventions . In practice , initial r and omization plans are almost always compromised . Multiple hypotheses are frequently tested . " Significant " effects are often reported with p-values that do not account for preliminary screening from a large c and i date pool of possible effects . This paper develops tools for analyzing data from experiments as they are actually implemented . We apply these tools to analyze the influential HighScope Perry Preschool Program . The Perry program was a social experiment that provided preschool education and home visits to disadvantaged children during their preschool years . It was evaluated by the method of r and om assignment . Both treatments and controls have been followed from age 3 through age 40 . Previous analyses of the Perry data assume that the planned r and omization protocol was implemented . In fact , as in many social experiments , the intended r and omization protocol was compromised . Accounting for compromised r and omization , multiple-hypothesis testing , and small sample sizes , we find statistically significant and economically important program effects for both males and females . We also examine the representativeness of the Perry study This study examines the role of one component of emotion regulation , behavioral control , in the growth of children 's early behavior problems by examining whether increases in parental positive behavior support brought about by a family-centered intervention were associated with greater child behavioral control , and whether greater behavioral control at age 3 mediated the association between improvements in aspects of positive behavior support from ages 2 to 3 and decreases in growth of behavior problems from ages 2 to 4 . The sample included 713 at-risk children ( 50 % female ) and their primary caregivers ( 50 % European American , 28 % African American , 13 % biracial , 9 % other ) who were r and omly assigned to the intervention or control group . Children had a mean age of 29.91 months at the initial assessment . Data were collected through home visits at child ages 2 to 4 , which involved question naires for primary caregivers and structured and unstructured play activities for children with primary and alternative caregivers and siblings . Results indicated that the intervention improved parental positive behavior support and reduced growth of child behavior problems . One dimension of positive behavior support , proactive parenting , was modestly associated with behavioral control at age 3 , which in turn was significantly associated with growth in behavior problems from ages 2 to 4 , with greater behavioral control related to lower levels of growth in behavior problems . Results provide support for the notion that proactive parenting is an important factor in the development of children 's behavioral control and that behavioral control plays an important role in the growth of behavior problems Based on theoretically driven models , the Chicago School Readiness Project ( CSRP ) targeted low-income children 's school readiness through the mediating mechanism of self-regulation . The CSRP is a multicomponent , cluster-r and omized efficacy trial implemented in 35 Head Start-funded classrooms ( N = 602 children ) . The analyses confirm that the CSRP improved low-income children 's self-regulation skills ( as indexed by attention/impulse control and executive function ) from fall to spring of the Head Start year . Analyses also suggest significant benefits of CSRP for children 's preacademic skills , as measured by vocabulary , letter-naming , and math skills . Partial support was found for improvement in children 's self-regulation as a hypothesized mediator for children 's gains in academic readiness . Implication s for programs and policies that support young children 's behavioral health and academic success are discussed Research Findings : This study examined processes of change associated with the positive preschool and kindergarten outcomes of children who received the Head Start REDI ( REsearch -based , Developmentally Informed ) intervention compared to usual practice Head Start . Using data from a large-scale r and omized controlled trial ( N = 356 children , 42 % African American or Latino , all from low-income families ) , this study tests the logic model that improving preschool social-emotional skills ( e.g. , emotion underst and ing , social problem solving , and positive social behavior ) as well as language /emergent literacy skills will promote cross-domain academic and behavioral adjustment after children transition into kindergarten . Validating this logic model , the present study finds that intervention effects on 3 important kindergarten outcomes ( e.g. , reading achievement , learning engagement , and positive social behavior ) were mediated by preschool gains in the proximal social-emot Output:	Funnel plots of EQIs and observational studies showed asymmetric distributions and potential for small study bias . There is some evidence that non-cognitive skills associate with improved outcomes . Interventions design ed to develop children ’s non-cognitive skills could potentially improve outcomes .
MS22380	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: The functional differences between persons with amputation who are classified as Medicare Functional Classification Level (MFCL)-2 and -3 include the abilities to walk at various cadences and to negotiate environmental barriers outside the home . This study compared the effect of active microprocessor control and passive mechanical control of the prosthetic knee on function and safety in 17 subjects with transfemoral amputation ( 8 MFCL-2 and 9 MFCL-3 ) . Assessed functional tasks included hill and stair descent , an attentional dem and task , and an obstacle course . Self-reported measures included concentration , multitasking ability , and numbers of stumbles and falls . Active knee control was associated with significant improvements ( p < 0.05 ) in hill and stair gait , speed ( hills , obstacle course , and attentional dem and task ) , and ability to multitask while walking for both cohorts . MFCL-2 subjects also reported a significant reduction ( p < 0.01 ) in uncontrolled falls . Over the study , 50 % of MFCL-2 subjects and 33 % of MFCL-3 subjects transitioned to a higher MFCL . Results suggest that active knee control improves function and reduces the frequency of adverse events in a population that is at risk for falls . Use of active knee control may allow persons with amputation to exp and their functional domain , transition to a higher MFCL , and access additional prosthetic options Microprocessor-controlled prosthetic knees are cl aim ed to improve gait efficiency in transfemoral ( TF ) amputees . This hypothesis was tested in a prospect i ve r and omized crossover trial that compared the Mauch SNS knee and the C-Leg microprocessor-controlled knee in eight TF amputees . The subjects were given a 3-month acclimation period in each knee . Then , their net oxygen cost ( mL/kg/m ) was measured while they walked overground at four speeds in r and om order : 0.8 m/s , 1.0 m/s , 1.3 m/s , and self-selected walking speed ( SSWS ) . The C-Leg caused small reductions in net oxygen cost that were not statistically significant compared with the Mauch SNS at any of the walking speeds ( p > 0.190 ) . Subjects chose higher SSWSs with the C-Leg compared with the Mauch SNS ( mean + /- st and ard deviation = 1.31 + /- 0.12 m/s vs 1.21 + /- 0.10 m/s , respectively , p = 0.046 ) but did not incur higher oxygen costs ( p = 0.270 ) , which suggests greater efficiency only at their SSWS OBJECTIVE To evaluate the gait of transfemoral amputee patients using a prosthesis with a 4-bar linkage knee joint with either a mechanical swing phase control ( Otto Bock 3R20 ) or a pneumatic swing phase control ( Tehlin knee ) . DESIGN R and omized cross-over trial . SETTING Rehabilitation Department of a university hospital in The Netherl and s. PATIENTS Twenty-eight subjects with unilateral transfemoral amputation for reasons other than chronic vascular disease ; ages between 16 and 65 years and familiar with the use of the Otto Bock 3R20 knee . SELECTION PROCEDURE a consecutive sample . INTERVENTION The Otto Bock 3R20 was used by the subjects before they entered the study . The patients changed to the Tehlin knee at r and om either after 1 or 2 assessment s with the Otto Bock 3R20 . MAIN OUTCOME MEASURES Temporal and kinematic variables in gait analysis ( speed recordings were taken before and after the equipment for the measurements of the other parameters was placed on the patients ) . Subjective scores for comfortable and fast ambulation were obtained by means of 2 question naires . Question naire A consisted of multiple choice questions ( maximum score : 5 ) and questions using an 8-point rating scale ( maximum score : 7 ) . In question naire B , the patient was asked to compare the present prosthesis with the previous one . RESULTS Fast walking speed in gait analysis was higher with the Tehlin knee than with the 3R20 ( without equipment 95 % confidence interval ( CI ) .02-.09 m/sec , with equipment CI .04-.11 ) , while comfortable walking speed was not higher with the Tehlin knee ( without equipment CI -.20-.20 m/sec , with equipment CI .00-.05 ) . Symmetry of walking as regards swing phase duration was closer to 100 % with the Tehlin knee than with the 3R20 ( comf . walking CI 4 % to 19 % , fast walking CI 7 % to 17 % ) . Knee joint range of motion during swing phase was smaller with the Tehlin knee than with the 3R20 ( comf . walking CI 1.8 degrees-8.7 degrees , fast walking CI 2.0 degrees-9.5 degrees ) . Knee flexion duration during swing phase was shorter for the Tehlin knee than for the 3R20 at fast walking speed ( CI 6 - 46msec ) , while knee flexion duration from and to 10 degrees flexion was shorter for the Tehlin knee at comfortable speed ( CI 18 - 67msec ) and fast speed ( CI 20 - 64msec ) . In question naire A the amputees reported the Tehlin knee to be better for fast walking ( part A1 CI .01-.52 , part A2 CI .13-.98 ) and in question naire B for both comfortable and fast walking The C-Leg ( Otto Bock , Duderstadt , Germany ) is a microprocessor-controlled prosthetic knee that may enhance amputee gait . This intrasubject r and omized study compared the gait biomechanics of transfemoral amputees wearing the C-Leg with those wearing a common noncomputerized prosthesis , the Mauch SNS ( Ossur , Reykjavik , Icel and ) . After subjects had a 3-month acclimation period with each prosthetic knee , typical gait biomechanical data were collected in a gait laboratory . At a controlled walking speed ( CWS ) , peak swing phase knee-flexion angle decreased for the C-Leg group compared with the Mauch SNS group ( 55.2 degrees + /- 6.5 degrees vs 64.41 degrees + /- 5.8 degrees , respectively ; p = 0.005 ) ; the C-Leg group was similar to control subjects ' peak swing knee-flexion angle ( 56.0 degrees + /- 3.4 degrees ) . Stance knee-flexion moment increased for the C-Leg group compared with the Mauch SNS group ( 0.142 + /- 0.05 vs 0.067 + /- 0.07 N"m , respectively ; p = 0.01 ) , but remained significantly reduced compared with control subjects ( 0.477 + /- 0.1 N"m ) . Prosthetic limb step length at CWS was less for the C-Leg group compared with the Mauch SNS group ( 0.66 + /- 0.04 vs 0.70 + /- 0.06 m , respectively ; p = 0.005 ) , which result ed in increased symmetry between limbs for the C-Leg group . Subjects also walked faster with the C-Leg versus the Mauch SNS ( 1.30 + /- 0.1 vs 1.21 + /- 0.1 m/s , respectively ; p = 0.004 ) . The C-Leg prosthetic limb vertical ground reaction force decreased compared with the Mauch SNS ( 96.3 + /- 4.7 vs 100.3 + /- 7.5 % body weight , respectively ; p = 0.0092 ) Johansson JL , Sherrill DM , Riley PO , Bonato P , Herr H : A clinical comparison of variable-damping and mechanically passive prosthetic knee devices . Am J Phys Med Rehabil 2005;84:563–575 . Objective : Although variable-damping knee prostheses offer some improvements over mechanically passive prostheses to transfemoral amputees , there is insufficient evidence that such prostheses provide advantages at self-selected walking speeds . In this investigation , we address this question by comparing two variable-damping knees , the hydraulic-based Otto Bock C-leg and the magnetorheological-based Össur Rheo , with the mechanically passive , hydraulic-based Mauch SNS . Design : For each prosthesis , metabolic data were collected on eight unilateral amputees walking at self-selected speeds across an indoor track . Furthermore , kinetic , kinematic , and electromyographic data were collected while walking at self-selected speeds across a 10-m walkway in a laboratory . Results : When using the Rheo , metabolic rate decreases by 5 % compared with the Mauch and by 3 % compared with the C-leg . Furthermore , for the C-leg and Rheo knee devices , we observe biomechanical advantages over the mechanically passive Mauch . These advantages include an enhanced smoothness of gait , a decrease in hip work production , a lower peak hip flexion moment at terminal stance , and a reduction in peak hip power generation at toe-off . Conclusion : The results of this study indicate that variable-damping knee prostheses offer advantages over mechanically passive design s for unilateral transfemoral amputees walking at self-selected ambulatory speeds , and the results further suggest that a magnetorheological-based system may have advantages over hydraulic-based design OBJECTIVE To evaluate differences in function , performance , and preference between mechanical and microprocessor prosthetic knee control technologies . DESIGN A-B-A-B reversal design . SETTING Home , community , and laboratory environments . PARTICIPANTS Twenty-one unilateral , transfemoral amputees . INTERVENTION Mechanical control prosthetic knee versus microprocessor control prosthetic knee ( Otto Bock C-Leg ) . MAIN OUTCOME MEASURES Stair rating , hill rating and time , obstacle course time , divided attention task accuracy and time , Amputee Mobility Predictor score , step activity , Prosthesis Evaluation Question naire score , Medical Outcomes Study 36-Item Short-Form Health Survey score , self-reported frequency of stumbles and falls , and self-reported concentration required for ambulation . RESULTS Stair descent score , hill descent time , and hill sound-side step length showed significant ( P<.01 ) improvement with the C-Leg . Users reported a significant ( P<.05 ) decrease in frequency of stumbles and falls , frustration with falling , and difficulty in multitasking while using the microprocessor knee . Subject satisfaction with the C-Leg was significantly ( P<.001 ) greater than the mechanical control prosthesis . CONCLUSIONS The study population showed improved performance when negotiating stairs and hills , reduced frequency of stumbling and falling , and a preference for the microprocessor control C-Leg as compared with the mechanical control prosthetic knee This study investigated energy expenditure and obstacle course negotiation between the C-leg ® and various non-microprocessor control ( NMC ) prosthetic knees and compared a quality of life survey ( SF-36v2 ™ ) of use of the C-leg ® to national norms . Thirteen subjects with unilateral limb loss ( 12 with trans-femoral and one with a knee disarticulation amputation ) participated in the study . The mean age was 46 years , range 30 – 75 . Energy expenditure using both the NMC and C-leg ® prostheses was measured at self-selected typical and fast walking paces on a motorized treadmill . Subjects were also asked to walk through a st and ardized walking obstacle course carrying a 4.5 kg ( 10 lb ) basket and with h and s free . Finally , the SF-36v2 ™ was completed for subjects while using the C-leg ® . Statistically significant differences were found in oxygen consumption between prostheses at both typical and fast paces with the C-leg ® showing decreased values . Use of the C-leg ® result ed in a statistically significant decrease in the number of steps and time to complete the obstacle course . Scores on a quality of life index for subjects using the C-leg ® were above the mean for norms for limitation in the use of an arm or leg , equal to the mean for the general United States population for the physical component score and were above this mean for the mental component score . Based on oxygen consumption and obstacle course findings , the C-leg ® when compared to the NMC prostheses may provide increased functional mobility and ease of performance in the home and community environment . Question naire results suggest a minimal quality of life impairment when using a C-leg ® for this cohort of individuals with amputation Objective : To compare the gait of amputees wearing conventionally damped pneumatic swing-phase control knees and microchip-controlled Intelligent Prostheses . Design : Crossover trial . Setting : An amputee rehabilitation centre in a teaching hospital . Participants : Ten established unilateral transfemoral prosthetic users were asked to participate in the trial ; all agreed . Interventions : The amputees were assessed wearing pneumatic swing-phase control knees and then with the Intelligent Prosthesis . Main outcome measures : Oxygen consumption while walking at different speeds on a treadmill , video-recording of gait assessed by a panel and temporal – spatial parameters of gait whilst walking at slow , fast or normal speeds in a gait laboratory . Results : Mean oxygen cost for all subjects at 0.69 m/s was 0.33 ml/kg.m with the conventional limb and 0.30 ml/kg.m with the Intelligent Prosthesis ( p–0.01 ) . At 1.25 m/s the mean oxygen cost for the conventional limb was 0.24 ml/kg.m and for the Intelligent Prosthesis was 0.22 ml/kg.m ( not significant ) . The ANOVA analysis showed that oxygen cost was similar at normal walking speeds but increased more Output:	Fluid knee benefits and indications : Knees with hydraulic or pneumatic swing resistance are indicated for active walkers , permitting increased walking comfort , speed , and symmetry . Microprocessor knee benefits : Compared with nonmicroprocessor knees : a ) With respect to self-report indices and measures , microprocessor knees are indicated to reduce stumbles , falls , and associated frustrations as well as the cognitive dem and s of ambulation . b ) With respect to self-report indices and measures , microprocessor knees are indicated to increase confidence while walking , self-reported mobility , satisfaction , well-being , and quality of life . c ) With respect to physical performance indices and measures , microprocessor knees are indicated to increase self-selected walking speed , walking speed on uneven terrain , and metabolic efficiency during gait . Microprocessor knees for limited community ambulators : Among limited community ambulators , microprocessor knees are indicated to enable increases in level ground walking speed and walking speed on uneven terrain while substantially reducing uncontrolled falls and increasing both measured and perceived balance .
MS22381	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: Background Joint pain is thought to be an early sign of injury to a pitcher . Objective To evaluate the association between pitch counts , pitch types , and pitching mechanics and shoulder and elbow pain in young pitchers . Study Design Prospect i ve cohort study . Methods Four hundred and seventy-six young ( ages 9 to 14 years ) baseball pitchers were followed for one season . Data were collected from pre- and postseason question naires , injury and performance interviews after each game , pitch count logs , and video analysis of pitching mechanics . Generalized estimating equations and logistic regression analysis were used . Results Half of the subjects experienced elbow or shoulder pain during the season . The curveball was associated with a 52 % increased risk of shoulder pain and the slider was associated with an 86 % increased risk of elbow pain . There was a significant association between the number of pitches thrown in a game and during the season and the rate of elbow pain and shoulder pain . Conclusions Pitchers in this age group should be caution ed about throwing breaking pitches ( curveballs and sliders ) because of the increased risk of elbow and shoulder pain . Limitations on pitches thrown in a game and in a season can also reduce the risk of pain . Further evaluation of pain and pitching mechanics is necessary INTRODUCTION A recent US Major League Baseball ( MLB ) rule change requires baseball pitchers to deliver pitches within 12 s. PURPOSE S To examine the effect of three between-pitch rest intervals on throwing performance during a simulated seven-inning game and muscle damage during postgame recovery . DESIGN A r and omized counterbalanced study . METHODS Seven intercollegiate pitchers threw 15 pitches per inning for seven innings with rest interval trials of 8 , 12 , and 20 s between pitches and 5 min between innings . Pitchers threw aim ed fastballs at their best effort . Trials were separated by ≥2 wk . RESULTS Progressive decreases in pitching speed and accuracy below baseline ( first inning of 20-s trial ) occurred after fourth inning during the 8-s and 12-s trials , but not the 20-s trial . Plasma creatine kinase elevated 48 h later for the 8-s and 12-s trials ( + 105 % and + 75 % , P < 0.01 ) , but not the 20-s trial ( + 26 % , no significance ) . A transient interleukin (IL)-6 surges immediately after the game for the 8- and 12-s trials ( + 265 % , + 128 % , P < 0.01 ) above baseline . IL-6 reversed below the level of 20-s trial at 48 h after game , whereas IL-10 increased significantly above the level of 20-s trial . CONCLUSIONS Under the same pitching load , decreasing rest interval from 20 to 12 s or less results in an early-onset performance loss during a game and increases in muscle damage and inflammation for more than 2 d after a game . Our data do not favor the current rule change in concern of keeping musculoskeletal health of pitchers OBJECTIVE : To test the feasibility of creating a valid and reliable checklist with the following features : appropriate for assessing both r and omised and non-r and omised studies ; provision of both an overall score for study quality and a profile of scores not only for the quality of reporting , internal validity ( bias and confounding ) and power , but also for external validity . DESIGN : A pilot version was first developed , based on epidemiological principles , review s , and existing checklists for r and omised studies . Face and content validity were assessed by three experienced review ers and reliability was determined using two raters assessing 10 r and omised and 10 non-r and omised studies . Using different raters , the checklist was revised and tested for internal consistency ( Kuder-Richardson 20 ) , test-retest and inter-rater reliability ( Spearman correlation coefficient and sign rank test ; kappa statistics ) , criterion validity , and respondent burden . MAIN RESULTS : The performance of the checklist improved considerably after revision of a pilot version . The Quality Index had high internal consistency ( KR-20 : 0.89 ) as did the subscales apart from external validity ( KR-20 : 0.54 ) . Test-retest ( r 0.88 ) and inter-rater ( r 0.75 ) reliability of the Quality Index were good . Reliability of the subscales varied from good ( bias ) to poor ( external validity ) . The Quality Index correlated highly with an existing , established instrument for assessing r and omised studies ( r 0.90 ) . There was little difference between its performance with non-r and omised and with r and omised studies . Raters took about 20 minutes to assess each paper ( range 10 to 45 minutes ) . CONCLUSIONS : This study has shown that it is feasible to develop a checklist that can be used to assess the method ological quality not only of r and omised controlled trials but also non-r and omised studies . It has also shown that it is possible to produce a checklist that provides a profile of the paper , alerting review ers to its particular method ological strengths and weaknesses . Further work is required to improve the checklist and the training of raters in the assessment of external validity CONTEXT Fatigue could contribute to ankle-sprain injuries during sport , particularly for individuals with chronic ankle instability ( CAI ) . OBJECTIVE To examine whether adults with or without CAI develop fatigue at similar rates when performing ankle exercises at the same relative effort level and whether these groups differ in their subjective perceptions of fatigue . DESIGN Controlled laboratory study . SETTING Biomechanics research laboratory . PATIENTS OR OTHER PARTICIPANTS A total of 11 volunteers with CAI ( 1 man , 10 women ; age = 23.5 ± 3.0 years , height = 168.0 ± 11.2 cm , mass = 64.3 ± 13.5 kg ) were recruited for the unstable-ankle group , and 11 volunteers matched for age , height , mass , and sex ( 1 man , 10 women ; age = 24.1 ± 2.1 years , height = 169.5 ± 9.7 cm , mass = 62.3 ± 9.7 kg ) were recruited as control participants . INTERVENTION(S ) Localized muscle fatigue ( LMF ) was induced in the ankle of the dominant limb using a custom fatigue protocol . Plantar-flexion and dorsiflexion exertions were completed at a rate of 12 cycles per minute at isotonic loads equal to 70 % and 30 % , respectively , of individual maximal voluntary isometric strength . Intermittent measures of maximal voluntary isometric strength and ratings of perceived exertion ( RPEs ) were obtained . MAIN OUTCOME MEASURE(S ) We compared isometric-strength measures and RPE scores at each observation time ( prefatigue and at 4 , 8 , 12 , and 16 minutes into the fatigue protocol ) and the group correlations between changes in strength and changes in RPE scores . RESULTS Based on ankle-strength measures , the 2 test groups developed LMF at similar rates when exercising at equivalent levels of relative effort . The 2 groups also reported similar levels of discomfort as fatigue progressed . CONCLUSIONS The rate of LMF development at the ankle and the associated perception of fatigue did not differ between adults with or without CAI Abstract Freeston , J , Adams , R , Ferdin and s , RED , and Rooney , K. Indicators of throwing arm fatigue in elite adolescent male baseball players : A r and omized crossover trial . J Strength Cond Res 28(8 ) : 2115–2120 , 2014—Throwing carries an inherent risk of injury that worsens in the presence of arm fatigue . The purpose of this study was to identify markers that could facilitate the early detection of this type of fatigue , by comparing the response to bouts of throwing-specific and running-based exercise . Thirteen elite junior male baseball players were tested twice , 7 days apart with a r and omized crossover design . They were assessed for shoulder proprioception , maximal throwing velocity , and throwing accuracy before and after a 10-minute bout of either throwing-specific ( THROW ) or general ( RUN ) exercise . Maximal throwing velocity was reduced similarly after both THROW and RUN bouts ( −1.0 ± 0.4 vs. −0.6 ± 0.2 m·s−1 , respectively ; p ⩽ 0.05 ) ; however , accuracy was only reduced after THROW ( 7.6 ± 3.4 cm ; p ⩽ 0.05 ) . Arm soreness increased significantly more after THROW than RUN ( 3.5 ± 0.7 vs. 1.4 ± 0.5 km·h−1 , respectively ; p ⩽ 0.05 ) . Shoulder proprioception did not change after either exercise bout . The results suggest that throwing velocity is an indicator of general fatigue , whereas throwing accuracy and arm soreness are markers of arm fatigue . Shoulder proprioception does not seem to be a sensitive marker of either type of fatigue . Throwing velocity should be monitored to gauge overall fatigue levels , whereas accuracy and arm soreness should be closely monitored to gauge arm fatigue and throwing-induced injury risk Abstract Oliver , GD , Weimar , WH , and Henning , LE . Effects of a simulated game on muscle activation in youth baseball pitchers . J Strength Cond Res 30(2 ) : 415–420 , 2016—It is generally accepted that playing with fatigue is a primary predictor of injury in youth baseball because muscular fatigue is believed to alter mechanics during the arm cocking and acceleration phases . Therefore , the purpose of this study was to quantitatively describe gluteal and upper extremity muscle activations in youth baseball pitchers during a simulated game . Twenty-three youth baseball players ( 11.2 ± 0.8 years ; 151.4 ± 8.7 cm ; 47.5 ± 10.8 kg ) participated . Data were collected through a Delsys Bagnoli–8-channel electromyography system . Single differential electrodes ( interelectrode distance : 10 mm ) were attached to the bilateral gluteus maximus and medius and throwing side latissimus dorsi , lower trapezius , and serratus anterior and upper trapezius . After warm-up , participants were instructed to throw r and omly provided game situations over a regulation distance ( 46 feet ; 14.02 meters ) to a catcher . Three , 4-seam fastballs for strikes , thrown in the first and last innings of the simulated game were selected for analysis . A multivariate analysis of variance revealed no statistically significant differences in muscle activity at the 3 phases of the throw , between first and last innings of the simulated game with an observed power of 0.274 ( phase 1 : foot contact to maximum shoulder external rotation ) , 0.297 ( phase 2 : maximum shoulder external rotation to ball release ) , and 0.226 ( phase 3 : ball release to maximum shoulder internal rotation ) . Examining muscle activations as a pitcher approaches fatigue provides information on how long a pitcher can perform before mechanical alterations occur . Although this study did not reveal significant changes , it did reiterate the fact that pitch counts may be working in possibly preventing a youth pitcher throwing to fatigue BACKGROUND Overexertion caused by increased pitch counts can evoke protective biomechanical responses signified by decreased ball velocity , such as reduced throwing arm kinematics and kinetics . Among skilled pitchers , overexertion may not always present ball velocity decrements , because compensatory throwing biomechanics aid in maintaining peak ball velocity although lowering physiologic stress . METHODS Nineteen pitchers ( collegiate and elite high school ) , r and omly crossed over to pitch two simulated games at ± 25 % of their desired stride length , were recorded by an eight-camera motion capture system ( 240 Hz ) integrated with two piezoelectric force plates ( 960 Hz ) and a professional model radar gun . HR , self-reported exertion scores , blood glucose and lactate , salivary biomarkers , peak linear h and and fastball velocities were examined . Repeated- measures ANOVA as well as independent and pairwise t-tests examined significant differences ( P ≤ 0.05 ) . RESULTS Shortened strides reduced mean pitching HR by 11.1 bpm ( P < 0.001 ) , improved recovery capacity by 5.76 % ( P = 0.012 ) , and lowered salivary cortisol from baseline ( P = 0.001 ) . Physiologic stress elevated with greater strides , because salivary alpha amylase was significantly elevated from baseline ( P = 0.011 ) with no improvements evidence d in pitching HR or recovery capacity . Linear h and and ball velocities remained equivalent between stride conditions . CONCLUSION Stride length can affect physical exertion without disrupting ball velocity , where shortening strides can plausibly respond to competitive exertion in baseball pitchers . Current pitch count st and ards and radar velocity accounts have not been proven efficacious in predicting exertion in professional and collegiate baseball , where biomechanical compensations arise to maintain ball velocity . In some instances , compensatory adaptations may be pathomechanic where future research identifying injurious movement patterns can advance injury prevention in professional baseball Output:	Conclusions Findings show that a co-dependence between changes in kinematics and a decrease in performance , which stems from central and peripheral fatigue , is a contributing factor of injury in baseball pitchers . A large percentage of baseball pitchers exhibit pain or soreness in either their elbow or shoulder , or both at some point in a season . Initially , kinematic changes occur that could maintain performance , but may increase joint and tissue loading . Performance decreased with elevated pitch counts and innings thrown , and pitching further into games or the season .
MS22382	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: This study employed a self-report question naire in a Solomon four-groups design to assess the efficacy of suicide intervention classes in achieving their instructional objectives . Because adolescents are often the first to know of a peer 's suicidal thoughts or plans , the goal of the classes was to increase the likelihood that students who come into contact with potentially suicidal peers can more readily identify them and will be consistently inclined to take responsible action on their behalf . Students who participated in the classes as compared to controls showed significant gains in relevant knowledge about suicidal peers and significantly more positive attitudes toward help seeking and intervening with troubled peers . Results of this study will be used to strengthen components of the lessons aim ed at enhancing the likelihood of performance of responsible interventions The effectiveness of a school-based primary prevention psychological program is assessed in the present study . The program was design ed to ( a ) improve students ' distress-coping , ( b ) prepare them as " gatekeepers " with regard to self-destructive behavior of peers and ( c ) assess the program 's face validity and social validity . The program was primarily based on cognitive-behavioral modification principles , procedures and techniques . Two hundred and thirty-seven students , drawn from six homeroom grade eight classes were r and omly assigned to experimental and control ( no intervention ) conditions . The program consisted of seven units passed during twelve weekly one-hour sessions . Overall , the program had a positive effect on attitudes , emotions , knowledge and awareness of distress coping skills . In addition , it had some degree of face validity and social validity from the students ' vantage point . These results lend support to the feasibility of a cognitive-behavioral , school-based prevention program for students ' distress-coping enhancement OBJECTIVES We examined the effectiveness of the Signs of Suicide ( SOS ) prevention program in reducing suicidal behavior . METHODS Twenty-one hundred students in 5 high schools in Columbus , Ga , and Hartford , Conn , were r and omly assigned to intervention and control groups . Self-administered question naires were completed by students in both groups approximately 3 months after program implementation . RESULTS Significantly lower rates of suicide attempts and greater knowledge and more adaptive attitudes about depression and suicide were observed among students in the intervention group . The modest changes in knowledge and attitudes partially explained the beneficial effects of the program . CONCLUSIONS SOS is the first school-based suicide prevention program to demonstrate significant reductions in self-reported suicide attempts BACKGROUND Psycho-educational programs are among the most commonly applied suicide prevention approaches for young people . This study examined the effectiveness of these programs in a controlled study by assessing the effect on knowledge , attitudes , coping and hopelessness . METHOD Fourteen- to 18-year-old students were administered structured question naires before and after the program to assess the effect on knowledge , attitudes , coping and hopelessness . RESULTS The program had no effect on coping styles and levels of hopelessness . However , a positive effect on knowledge could be identified and an interaction effect of the program with gender on attitudes was also found . A negative impact of the program could not be found . Results indicated effects of gender and pre-test on knowledge , attitudes and coping . CONCLUSIONS The findings from this study suggest that psycho-educational programs in schools may influence knowledge about suicide and attitudes towards suicidal persons but may not affect the use of coping styles or levels of hopelessness OBJECTIVE : To test the feasibility of creating a valid and reliable checklist with the following features : appropriate for assessing both r and omised and non-r and omised studies ; provision of both an overall score for study quality and a profile of scores not only for the quality of reporting , internal validity ( bias and confounding ) and power , but also for external validity . DESIGN : A pilot version was first developed , based on epidemiological principles , review s , and existing checklists for r and omised studies . Face and content validity were assessed by three experienced review ers and reliability was determined using two raters assessing 10 r and omised and 10 non-r and omised studies . Using different raters , the checklist was revised and tested for internal consistency ( Kuder-Richardson 20 ) , test-retest and inter-rater reliability ( Spearman correlation coefficient and sign rank test ; kappa statistics ) , criterion validity , and respondent burden . MAIN RESULTS : The performance of the checklist improved considerably after revision of a pilot version . The Quality Index had high internal consistency ( KR-20 : 0.89 ) as did the subscales apart from external validity ( KR-20 : 0.54 ) . Test-retest ( r 0.88 ) and inter-rater ( r 0.75 ) reliability of the Quality Index were good . Reliability of the subscales varied from good ( bias ) to poor ( external validity ) . The Quality Index correlated highly with an existing , established instrument for assessing r and omised studies ( r 0.90 ) . There was little difference between its performance with non-r and omised and with r and omised studies . Raters took about 20 minutes to assess each paper ( range 10 to 45 minutes ) . CONCLUSIONS : This study has shown that it is feasible to develop a checklist that can be used to assess the method ological quality not only of r and omised controlled trials but also non-r and omised studies . It has also shown that it is possible to produce a checklist that provides a profile of the paper , alerting review ers to its particular method ological strengths and weaknesses . Further work is required to improve the checklist and the training of raters in the assessment of external validity This study employed simulations of encounters with suicidal peers to assess the impact of classroom suicide response lessons . Students were asked to anonymously write how they would respond , and how concerned they would be in regard to two vignettes of troubled peers . On the posttest , students who had participated in the classes provided significantly more " tell an adult " responses than those in the control group , whereas no differences existed between the groups on the pretest . On both the pretest and posttest , all students expressed greater concern on the unambiguous vignette ( student said that he has been thinking about killing himself ) than on the ambiguous vignette ( student wrote an essay about final decisions ) ; and , overall , females expressed greater concern than males . These results provide evidence for the efficacy of the classes and the utility of the simulations for assessing their impact Output:	Overall , statistically significant improvements were noted in knowledge , attitude , and help-seeking behaviour . CONCLUSION Although evidence exists that school-based programmes to prevent suicide among adolescents improve knowledge , attitudes , and help-seeking behaviours , no evidence yet exists that these prevention programmes reduce suicide rates .
MS22383	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: There is limited evidence on the association between adherence to guidelines for cancer survivors and health-related quality of life ( HRQoL ) . In a cross-sectional study of Korean breast cancer survivors , we examined whether adherence to the guidelines of the American Cancer Society ( ACS ) and World Cancer Research Fund/American Institute for Cancer Research ( WCRF/AICR ) for cancer survivors was related to levels of HRQoL , assessed by the Korean version of Core 30 ( C30 ) and Breast cancer module 23 ( BR23 ) of the European Organization for Research and Treatment of Cancer- Quality of Life Question naire ( EORTC-QLQ ) . We included a total of 160 women aged 21 to 79 years who had been diagnosed with breast cancer according to American Joint Committee on Cancer ( AJCC ) stages I to III and had breast cancer surgery at least six months before the interview . Increasing adherence to ACS guidelines was associated with higher scores of social functioning ( p for trend = 0.05 ) , whereas increasing adherence to WCRF/AICR recommendations was associated with higher scores of arm symptoms ( p for trend = 0.01 ) . These associations were limited to those with stage II or III cancer . Diet may be an important factor in relation to quality of life among Korean breast cancer survivors , however our findings warrant further prospect i ve studies to evaluate whether healthy diet improves survivors ’ quality of life PURPOSE To determine the effects of breast cancer-specific print material s and step pedometers on physical activity ( PA ) and quality of life ( QoL ) in breast cancer survivors . PATIENTS AND METHODS Breast cancer survivors ( N = 377 ) were r and omly assigned to receive one of the following : a st and ard public health recommendation for PA , previously developed breast cancer-specific PA print material s , a step pedometer , or a combination of breast cancer-specific print material s and step pedometers . The primary outcome was self-reported moderate/vigorous PA minutes per week . Secondary outcomes were QoL ( Functional Assessment of Cancer Therapy-Breast ) , fatigue , self-reported brisk walking , and objective step counts . Assessment s were conducted at baseline and postintervention ( 12 weeks ) . RESULTS Attrition was 10.3 % ( 39 of 377 ) . On the basis of linear mixed-model analyses , PA increased by 30 minutes/week in the st and ard recommendation group compared with 70 minutes/week in the print material group ( mean difference , 39 minutes/week ; 95 % CI = -10 to 89 ; d = 0.25 ; P = .117 ) , 89 minutes/week in the pedometer group ( mean difference , 59 minutes/week ; 95 % CI , 11 to 108 ; d = 0.38 ; P = .017 ) , and 87 minutes/week in the combined group ( mean difference , 57 minutes/week ; 95 % CI , 8 to 106 ; d = 0.37 ; P = .022 ) . For brisk walking minutes/week , all three intervention groups reported significantly greater increases than the st and ard recommendation group . The combined group also reported significantly improved QoL ( mean difference , 5.8 ; 95 % CI , 2.0 to 9.6 ; d = 0.33 ; P = .003 ) and reduced fatigue ( mean difference , 2.3 ; 95 % CI , 0.0 to 4.7 ; d = 0.25 ; P = .052 ) compared with the st and ard recommendation group . CONCLUSION Breast cancer-specific PA print material s and pedometers may be effective strategies for increasing PA and QoL in breast cancer survivors . A combined approach appears to be optimal . CLINICAL TRIAL REGISTRATION Clinical Trials.gov Identifier BACKGROUND Modifiable lifestyle factors , such as diet quality , could reduce inflammation and improve quality of life ( QOL ) in breast cancer survivors , but data are inconclusive . OBJECTIVE To determine whether diet quality , as measured by Healthy Eating Index-2010 ( HEI-2010 ) score , is associated with inflammation , health status , or functional outcomes affecting QOL in survivors of early-stage breast cancer . DESIGN This is a cross-sectional , secondary analysis of baseline data collected from breast cancer survivors after completion of primary therapy and before r and om assignment to a pilot nutritional intervention aim ed at reducing side effects of aromatase inhibitor treatment . PARTICIPANTS / SETTING Participants were 44 postmenopausal women with stage I to III endocrine receptor-positive breast cancer receiving outpatient care at a midwestern cancer center between November 2011 and October 2013 . MAIN OUTCOME MEASURES Primary outcomes were serum proinflammatory cytokines ( interleukin-6 [ IL-6 ] , IL-17 , and tumor necrosis factor-α receptor 2 [ TNFR-2 ] ) . Secondary outcomes included QOL measured by the Stanford Health and Disability Question naire and the Functional Assessment of Cancer Therapy-Breast with Endocrine Subscale . STATISTICAL ANALYSES PERFORMED Pearson correlation coefficients ( r ) and linear regression models were used to evaluate the relationship of dietary variables with inflammatory cytokines and QOL measures . RESULTS A higher overall HEI-2010 score ( healthier diet ) was associated with lower IL-6 ( r=-0.46 ; P=0.002 ) and TNFR-2 ( r=-0.41 ; P=0.006 ) ; however , associations were attenuated by body mass index ( BMI ) ( IL=6 [ r=-0.26 ; P=0.10 ] ; TNFR-2 [ r=-0.30 ; P=0.06 ] ) . In women with prior chemotherapy , a higher HEI-2010 score was strongly associated with lower IL-6 ( r=-0.67 ; P=0.009 ) and TNFR-2 ( r=-0.59 ; P=0.03 ) after BMI adjustment . There were no significant correlations between HEI-2010 score and QOL measures after adjustment for BMI . CONCLUSIONS These data suggest the need for more rigorous investigation into the relationship of diet quality , BMI , and inflammation in breast cancer survivors Obese breast cancer survivors have increased risk of recurrence and death compared to their normal weight counterparts . Rural women have significantly higher obesity rates , thus weight control intervention may be a key strategy for prevention of breast cancer recurrence in this population . This one-arm treatment study examined the impact of a group-based weight control intervention delivered through conference call technology to obese breast cancer survivors living in remote rural locations . The intervention included a reduced calorie diet incorporating prepackaged entrees and shakes , physical activity gradually increased to 225 min/week of moderate intensity exercise , and weekly group phone sessions . Outcomes included anthropomorphic , diet , physical activity , serum biomarker , and quality of life changes . Ninety-one percent of participants ( 31 of 34 ) attended > 75 % of intervention sessions and completed post-treatment data collection visits . At 6 months , significant changes were observed for weight ( −12.5 ± 5.8 kg , 13.9 % of baseline weight ) , waist circumference ( −9.4 ± 6.3 cm ) , daily energy intake ( −349 ± 550 kcal/day ) , fruits , and vegetables ( + 3.7 ± 4.3 servings/day ) , percent kcal from fat ( −12.6 ± 8.6 % ) , physical activity ( + 1235 ± 832 kcal/week ; all P values < 0.001 ) , as well as significant reductions in fasting insulin ( 16.7 % reduction , P = 0.006 ) , and leptin ( 37.1 % reduction , P < 0.001 ) . Significant improvements were also seen for quality of life domains including mood , body image , and sexuality . In conclusion , the intervention produced > 10 % weight loss as well as significant improvements across multiple endpoints . The group phone-based treatment delivery approach may help disseminate effective weight control intervention to hard-to-reach breast cancer survivors Objectives To support return to work ( RTW ) among cancer patients , a multidisciplinary rehabilitation programme was developed which combined occupational counselling with a supervised physical exercise programme during chemotherapy . The aim was to investigate RTW rates of cancer patients and to evaluate changes in work-related quality of life and physical outcomes . Design Longitudinal prospect i ve intervention study using a one-group design . Setting Two hospitals in the Netherl and s. Participants Of the eligible patients , 56 % participated ; 93 patients with a primary diagnosis of cancer receiving chemotherapy and on sick leave were included . Patients completed question naires on RTW , the importance of work , work ability ( WAI ) , RTW self-efficacy , fatigue ( MFI ) , and quality of life ( EORTC QLQ C-30 ) at baseline and 6 , 12 and 18 months follow-up . Before and after the exercise programme 1-repetition maximum ( 1RM ) muscle strength and cardiorespiratory fitness ( VO2 peak ) were assessed . Results Six months after the start of a multidisciplinary rehabilitation programme that combined occupational counselling with a supervised physical exercise programme , 59 % of the cancer patients returned to work , 86 % at 12 months and 83 % at 18 months . In addition , significant improvements ( p<0.05 ) in the importance of work , work ability , RTW self-efficacy , and quality of life were observed , whereas fatigue levels were significantly reduced . After completing the exercise programme , 1RM muscle strength was significantly increased but there was no improvement in VO2 peak level . Conclusions RTW rates of cancer patients were high after completion of the multidisciplinary rehabilitation programme . A multidisciplinary rehabilitation programme which combines occupational counselling with a supervised physical exercise programme is likely to result in RTW , reduced fatigue and increased importance of work , work ability , and quality of life Objective With increases in cancer survival , promotion of healthy lifestyle behaviors among survivors is receiving considerable attention . This study compared health behaviors among a large sample of Australian adult cancer survivors with an age- and sex-matched cohort of people with no cancer history . Methods Using the Australian National Health Survey , 968 cancer survivors were identified , and r and omly matched by age and sex to 5,808 respondents without a history of cancer . Six health behaviors were compared ( smoking , physical activity , servings of vegetables , servings of fruit , alcohol use , skin checks ) , along with overweight and obesity , using polytomous logistic regression analyses controlling for selected chronic conditions . Models were applied across both groups and by tumor site . Results Compared to the non-cancer comparison group , cancer survivors were significantly more likely to be current ( OR = 1.35 ) smokers , particularly those under 40 years ( OR = 1.69 ) , and more likely to have regular skin checks ( OR = 1.76 ) . Although not significant , there was consistent evidence that cancer survivors were slightly more likely to be overweight or obese ( p = 0.065 ) and have higher levels of alcohol consumption ( p = 0.088 ) . There was no evidence of differences between survivors and controls for levels of physical inactivity , vegetable consumption or fruit consumption . Women with a history of gynecological cancers were much more likely to be current smokers ( OR = 2.37 ) , while other differences by sex and cancer site were consistent with overall patterns . Cancer survivors were also significantly more likely to report having a range of co-morbid chronic medical conditions . Conclusion Given their increased risk of second cancers and co-morbid chronic conditions , the lack of difference in behavioral risk factors confirms the need for a focus on improving the health behaviors of cancer survivors . Collaborative chronic disease management models may be particularly appropriate in this regard Context Some experts attribute a low incidence of heart disease in Mediterranean countries to dietary habits . Contribution In this multicenter , 3-group trial , investigators r and omly assigned 772 adults at high risk for cardiovascular disease to a low-fat diet or to a Mediterranean diet supplemented with either virgin olive oil ( 1 L per week ) or nuts ( 30 g per day ) . After 3 months , the Mediterranean diet groups had lower mean plasma glucose level , systolic blood pressure , and total cholesterolhigh-density lipoprotein cholesterol ratio than the low-fat diet group . Caution s The Mediterranean diet groups received more nutritional education than the low-fat diet group . Implication s Mediterranean diets supplemented with olive oil or nuts may improve cardiovascular risk factors . The Editors Cardiovascular disease is the main cause of death in industrialized countries , but incidence rates have marked geographic differences . The low incidence of coronary heart disease ( CHD ) in Mediterranean countries has been partly ascribed to dietary habits ( 1 - 3 ) . Recent findings from large European cohort studies ( 4 - 6 ) suggest that a high degree of adherence to the Mediterranean diet is associated with a reduction in mortality . In small clinical studies , the Mediterranean diet or some of its components have reduced blood pressure ( 7 ) and have improved lipid profiles ( 8 , 9 ) and endothelial function ( 10 ) . Moreover , a recent cross-sectional study ( 11 ) and a 2-year feeding trial ( 12 ) have shown that adherence to the Mediterranean diet is associated with reduced markers of vascular inflammation . These beneficial effects on surrogate markers of cardiovascular risk add biological plausibility to the epidemiologic evidence Output:	We showed that low consumption of red meat and carbonated beverages , daily consumption of wine and high consumption of dishes seasoned with sofrito had beneficial effects on several QoL subscales . By contrast , using olive oil as the main culinary fat , low consumption of commercial sweets and high consumption of nuts were associated with negative effects . All the studies demonstrated significant improvements in overall QoL and /or its subscales after the interventions .
MS22384	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: BACKGROUND Trastuzumab , a monoclonal antibody against human epidermal growth factor receptor 2 ( HER2 ; also known as ERBB2 ) , was investigated in combination with chemotherapy for first-line treatment of HER2-positive advanced gastric or gastro-oesophageal junction cancer . METHODS ToGA ( Trastuzumab for Gastric Cancer ) was an open-label , international , phase 3 , r and omised controlled trial undertaken in 122 centres in 24 countries . Patients with gastric or gastro-oesophageal junction cancer were eligible for inclusion if their tumours showed overexpression of HER2 protein by immunohistochemistry or gene amplification by fluorescence in-situ hybridisation . Participants were r and omly assigned in a 1:1 ratio to receive a chemotherapy regimen consisting of capecitabine plus cisplatin or fluorouracil plus cisplatin given every 3 weeks for six cycles or chemotherapy in combination with intravenous trastuzumab . Allocation was by block r and omisation stratified by Eastern Cooperative Oncology Group performance status , chemotherapy regimen , extent of disease , primary cancer site , and measurability of disease , implemented with a central interactive voice recognition system . The primary endpoint was overall survival in all r and omised patients who received study medication at least once . This trial is registered with Clinical Trials.gov , number NCT01041404 . FINDINGS 594 patients were r and omly assigned to study treatment ( trastuzumab plus chemotherapy , n=298 ; chemotherapy alone , n=296 ) , of whom 584 were included in the primary analysis ( n=294 ; n=290 ) . Median follow-up was 18.6 months ( IQR 11 - 25 ) in the trastuzumab plus chemotherapy group and 17.1 months ( 9 - 25 ) in the chemotherapy alone group . Median overall survival was 13.8 months ( 95 % CI 12 - 16 ) in those assigned to trastuzumab plus chemotherapy compared with 11.1 months ( 10 - 13 ) in those assigned to chemotherapy alone ( hazard ratio 0.74 ; 95 % CI 0.60 - 0.91 ; p=0.0046 ) . The most common adverse events in both groups were nausea ( trastuzumab plus chemotherapy , 197 [ 67 % ] vs chemotherapy alone , 184 [ 63 % ] ) , vomiting ( 147 [ 50 % ] vs 134 [ 46 % ] ) , and neutropenia ( 157 [ 53 % ] vs 165 [ 57 % ] ) . Rates of overall grade 3 or 4 adverse events ( 201 [ 68 % ] vs 198 [ 68 % ] ) and cardiac adverse events ( 17 [ 6 % ] vs 18 [ 6 % ] ) did not differ between groups . INTERPRETATION Trastuzumab in combination with chemotherapy can be considered as a new st and ard option for patients with HER2-positive advanced gastric or gastro-oesophageal junction cancer . FUNDING F Hoffmann-La Roche Resected specimens of 288 primary stomach cancers ( 175 early cases and 113 advanced cases ) and recurrent tumors or biopsy specimens of 21 recurrent or inoperable metastatic stomach cancers were examined immunohistochemically for expression of c-erbB-2 oncogene product . c-erbB-2 protein-positive staining was detected in 6.9 , 15.9 and 28.6 % of early , advanced and recurrent or inoperable metastatic stomach cancers , respectively , the difference being significant ( p < 0.005 ) . Four patients with advanced cancer showed positive staining in metastatic lymph nodes but not in the primary tumors . The results of tissue immunostaining were compared with c-erbB-2 protein levels in sera of the patients measured by an enzyme-linked immunosorbent assay . The levels of this oncogene product were consistently low in the sera of most of the patients with primary stomach cancers , regardless of whether or not c-erbB-2 protein was expressed in the tumor . However , in the recurrent or inoperable metastatic stomach cancers , 5 of 6 patients with c-erbB-2 protein-positive tumors showed elevated levels of c-erbB-2 protein in the serum . After following up c-erbB-2 protein levels in the sera of 3 patients during the period of chemotherapy against recurrent or inoperable metastatic disease , we found that the levels increased only in the late stage . These results suggest that , in stomach cancer , c-erbB-2 protein is likely to be excreted into the serum at a relatively late stage , reflecting systemic spread of the disease PURPOSE The c-erbB-2 gene ( encoding the protein p185 ) is overexpressed in diverse human cancers and has been implicated to be of prognostic value in gastric cancer . Recent studies suggest a role of p185 in tumor progression by specifically promoting the invasive capacity of tumor cells . Therefore , the present study was conducted with the following three objectives : ( 1 ) to support the prognostic value of c-erbB-2 in gastric cancer in a large prospect i ve series using a monoclonal antibody and a highly sensitive immunohistochemical method ; ( 2 ) to determine the association of c-erbB-2 expression with the expression of invasion-related genes ; and ( 3 ) to perform the first overall multivariate analysis including c-erbB-2 and the invasion-related tumor-associated protease systems . PATIENTS AND METHODS In a consecutive prospect i ve series of 203 gastric cancer patients ( median follow-up , 42 months ) , expression of c-erbB-2 and a panel of tumor-associated proteases and inhibitors by tumor cells were evaluated semiquantitatively ( score 0 to 3 ) and analyzed for correlation ( chi(2 ) test , Bonferroni-corrected ) . Kaplan-Meier survival analysis and multivariate Cox analysis were performed to determine the relative prognostic impact of c-erbB-2 and the invasion-related parameters . RESULTS Kaplan-Meier analysis ( log-rank statistics ) revealed a significant association of increasing expression of c-erbB-2 with shorter disease-free ( P = . 0023 ) and overall survival ( P = .0160 ) . High amounts of p185 were significantly associated with a high expression of urokinase-type plasminogen activator ( uPA ) ( P < .010 ) , uPA-receptor ( P = .030 ) , type-1 plasminogen activator inhibitor ( PAI ) ( P < .010 ) , type-2 PAI ( P = .021 ) , cathepsin D ( P = .036 ) , matrix metalloproteinase-2 ( P = . 024 ) , alpha-1-antichymotrypsin ( P = .025 ) , and alpha-2-macroglobulin ( P = .017 ) . Multivariate analysis considering these proteases/protease inhibitors , in addition to alpha-1-antitrypsin , tissue plasminogen activator , plasminogen , alpha-2-antiplasmin , and antithrombin III , and established prognostic parameters revealed that , in addition to surgical curability , pT stage , pN stage , and PAI-1 , c-erbB-2 is an independent prognostic factor for overall survival of curatively resected patients ( n = 139 ; P = .049 ; relative risk , 1.54 ; 95 % confidence interval , 1.08 to 1.67 ) and all patients ( P = .028 ; relative risk 1.33 ; 95 % CI , 1.28 to 1.38 ) . CONCLUSION c-erbB-2 is confirmed as a new independent , functional prognostic parameter for overall survival in gastric cancer , even when a panel of invasion-related factors , including the strong prognostic parameter PAI-1 , are considered . The significant correlation of p185 with several tumor-associated proteases supports the hypothesis that c-erbB-2 is a promoter of invasion and metastasis . This strongly suggests that c-erbB-2 may be a promising target for anti-invasive therapy in gastric cancer Amplification of the HER2 gene and over-expression of the HER2 protein in gastric cancer have been shown in a large number of studies . HER2 positivity can be detected in approximately 20 % of patients , which is a characteristic associated with poor prognosis . Pre clinical in vitro and in vivo studies have demonstrated that both trastuzumab and lapatinib are effective in different gastric cancer models and have thus lead to the initiation of clinical studies . In the first phase III study , the ToGA trial , HER2-positive patients with advanced gastroesophageal and gastric adenocarcinoma were r and omized to receive 5-fluorouracil/capecitabine and cisplatin either alone or in combination with trastuzumab . A statically significant gain in overall survival was seen in the patients who received the combined treatment of trastuzumab and chemotherapy . It is expected that the encouraging results from the ToGA trial will have an immediate impact on the management of patients and that routine HER2 testing of patients with advanced gastric cancer will be initiated within a relatively short period of time Using a prospect ively acquired data base of 290 patients with advanced gastric adenocarcinoma , the prognostic significance of serum levels of carcinoembryonic antigen ( CEA ) ( 237 patients ) , alphafeto protein ( AFP ) ( 164 patients ) , beta-human chorionic gonadotrophin ( beta HCG ) ( 165 patients ) , CA19 - 9 ( 64 patients ) and CA125 ( 104 patients ) and tissue staining for C-erb B-2 ( 160 patients ) and beta HCG ( 160 patients ) was investigated . Serum was taken prior to 5-fluorouracil (5FU)-based chemotherapy and immunohistochemistry was performed on diagnostic specimens . In the univariate analysis , tumour markers of poor prognosis were CEA > or = 5 micrograms/l ( P = 0.01 ; median survival ( MS ) 42 versus 35 weeks ) , serum beta HCG > or = 4 U/l ( P = 0.02 ; MS 42 versus 25 weeks ) , CA125 > or = 35 U/ml ( P = 0.03 ; MS 43 versus 31 weeks ) and CA125 > or = 350 U/ml ( P = 0.001 ; MS 42 versus 17 weeks ) . Other significant factors were poor performance status , the presence of metastases and poorly differentiated tumour histology . Tumours markers of poor prognosis in the multivariate analysis were serum beta HCG > or = 4 IU/l [ hazard ratio ( HR ) 1.7 ; 95 % confidence interval ( CI ) 2.8 - 1.1 ] and CA125 > or = 350 U/ml ( HR 2.2 ; CI 4.2 - 1.2 ) . There was a degree of subgroup variability in this model but , in general , other factors correlating with a poor survival were poor performance status , metastases and poorly differentiated tumour histology . This is the largest prognostic study of each tumour marker in advanced disease and demonstrates that serum beta HCG and CA125 in gastric cancer prior to chemotherapy do convey an independent poor prognosis which may reflect not just tumour burden but aggressive biology Output:	Based on the current analysis a clear trend towards a potential role for HER2 as a negative prognostics factor in gastric cancer was shown , suggesting that HER2 overexpression and /or amplification is a molecular abnormality that might be linked to the development of gastric cancer
MS22385	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: The efficacy of oral ketorolac 5 mg and 10 mg taken qid was compared in a r and omized double-blind study with that of oral diflunisal 500 mg bid ( interleaved with placebo twice daily ) and of placebo , in 120 patients suffering at least moderate pain following meniscectomy . The trial comprised two phases : ( 1 ) an acute phase ( the first postoperative day ) and ( 2 ) a chronic phase ( days 2 - 5 postoperatively ) . Acutely , pain was assessed before drug administration , and then 0.5 , 1.0 , 2.0 , 3.0 , 4.0 , 6.0 , 8.0 , and 9.0 hours after the first dose . The second of the four daily doses was administered at four hours after the first dose . During the chronic phase , pain was assessed using visual analogue scales at 8 AM and 4 PM daily . The acute phase results show that all the active treatments were statistically significantly superior to placebo but were not distinguished from each other . Over the chronic phase , ketorolac 5 mg and placebo showed similar results , with diflunisal showing the least pain relief and ketorolac 10 mg the most . All the active treatments showed a low incidence of side effects and , in an overall evaluation , no one treatment was distinguishable . Ketorolac would seem to be an acceptable therapy for acute postoperative pain 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 This multicenter study compared the analgesic efficacy and side effects of ketorolac and hydrocodone-acetaminophen when administered orally after ambulatory arthroscopic or laparoscopic tubal ligation procedures . After awakening from general anesthesia , 252 patients experiencing moderate or severe postoperative pain were r and omly assigned to receive one of three analgesic treatments according to a placebocontrolled , double-blind protocol . Group 1 ( n = 83 ) received oral ketorolac 10 mg every 6 h for up to 3 days , Group 2 ( n = 82 ) received hydrocodone 7.5 mg plus acetaminophen 750 mg every 6 h for up to 3 days , and Group 3 ( n = 87 ) received placebo capsules followed by ketorolac 10 mg every 6 h for up to 3 days . Severity of pain was recorded using a 4-point categorical score and visual analog scale ( VAS ) at 0.5 h and subsequently at hourly intervals for 6 h , as well as daily for up to 3 days . Pain relief was recorded using a 5-point categorical scale at the same time points . In the patients undergoing arthroscopic surgery , both ketorolac and hydromorphone-acetaminophen provided superior pain relief compared with the placebo . Although the categorical summed pain intensity difference ( SPID ) , VASSPID , and total pain relief scores were higher in the ketorolac group compared with the hydrocodone-acetaminophen group , the differences were not statistically significant . In the patients undergoing laparoscopic tubal ligation surgery , the three treatment groups displayed similar responses to the study medications . However , the ketorolac group scored higher in terms of overall tolerability than the hydrocodone-acetaminophen group . In conclusion , there was no difference in the efficacy between oral ketorolac and hydrocodone-acetaminophen combination in controlling pain after outpatient arthroscopic surgery procedures . Neither oral analgesic proved to be very effective after laparoscopic tubal ligation . ( Anesth Analg 1997;85:37 - 43 The analgesic efficacy and side-effects of a single parenteral dose of metkephamid acetate 70 mg were compared with those of pethidine ( meperidine ) hydrochloride 100 mg and placebo in a double-blind , r and omised , controlled clinical trial . 30 out of 32 postoperative patients completed the study --10 in the metkephamid group , 11 in the pethidine group , and 9 in the placebo group . The time-effect curves of summated pain measures and analyses of derived measures all indicated that the analgesic activity of metkephamid 70 mg was significantly greater than that of placebo and not less than that of pethidine 100 mg . The metkephamid group had a greater incidence of side-effects than the other two treatment groups . Some side-effects , such as sensations of heaviness of the extremities and nasal congestion , were peculiar to metkephamid but not distressing Overemphasis on hypothesis testing-- and the use of P values to dichotomise significant or non-significant results --has detracted from more useful approaches to interpreting study results , such as estimation and confidence intervals . In medical studies investigators are usually interested in determining the size of difference of a measured outcome between groups , rather than a simple indication of whether or not it is statistically significant . Confidence intervals present a range of values , on the basis of the sample data , in which the population value for such a difference may lie . Some methods of calculating confidence intervals for means and differences between means are given , with similar information for proportions . The paper also gives suggestions for graphical display . Confidence intervals , if appropriate to the type of study , should be used for major findings in both the main text of a paper and its abstract In a double-blind , placebo-controlled study , 207 patients with moderate pain after surgical removal of impacted third molars were r and omly assigned to receive a single oral dose of 10 mg of ketorolac tromethamine , 10 mg of hydrocodone plus 1000 mg of acetaminophen , or placebo . Analgesic effect as assessed by summed pain intensity difference at 3 and 6 hours was significantly ( P < or = 0.01 ) greater after ketorolac than after hydrocodone/acetaminophen . Total pain relief at 3 and 6 hours was significantly ( P < 0.026 ) greater after ketorolac than after hydrocodone/acetaminophen or placebo . Patients taking hydrocodone/acetaminophen remedicated significantly ( P = 0.027 ) sooner than those taking ketorolac . In this single-dose study , adverse events were reported more frequently by patients taking hydrocodone/acetaminophen than with ketorolac or placebo . It is concluded that , in this pain model , 10 mg of ketorolac affords better pain relief with fewer side effects than hydrocodone/acetaminophen Abstract A previously established relationship for deriving dichotomous from continuous information in r and omised controlled trials ( RCTs ) of analgesics has been tested using an independent data set . Individual patient information from 18 RCTs of parallel‐group design in acute postoperative pain ( after abdominal , gynaecological and oral surgery ) was used to calculate the percentage of the maximum possible pain relief score ( % maxTOTPAR ) and the proportion of patients with > 50%maxTOTPAR for the different treatments . The relationship between the measures was investigated in 85 treatments with over 3400 patients . In 80 of 85 treatments ( 94 % ) agreement between calculated and actual number of patients with > 50%maxTOTPAR was within four patients per treatment and in 72 ( 85 % ) was within three ( average of 40 patients per treatment , range 21–58 patients ) . Summing the positive and negative differences between actual and calculated numbers of patients with > 50%maxTOTPAR gave an average difference of 0.30 patients per treatment arm . Reports of RCTs of analgesics frequently describe results of studies in the form of mean derived indices , rather than using discontinuous events , such as number or proportion of patients with 50 % pain relief . Because mean data inadequately describe information with a non‐normal distribution , combining mean data in systematic review s may compromise the results . Showing that dichotomous data can reliably be derived from mean data in acute pain studies enables data published as means to be used for quantitative systematic review s which require data in dichotomous form The aim of the present study was to investigate the dose-effect relationship of single doses of 4 to 32 mg of lornoxicam ( LNX ) , a new nonsteroidal antiinflammatory drug belonging to the oxicam group , compared with placebo and 10 mg ketorolac ( KET ) in the treatment of pain after oral surgery . Also , it was the aim of the study to evaluate the relationship between adverse events and different doses of LNX . After the surgical removal of a m and ibular third molar , test medication was taken when the patients experienced at least moderate pain . After medication , pain relief , pain intensity , and any discomfort from the medication were noted in a question naire . Paracetamol was used as rescue medication . A total of 278 patients completed the study according to the protocol . The primary efficacy parameter was total pain relief after 6 hours , and all active treatments showed significantly better effect than placebo , with LNX 16 and 32 mg being significantly superior to LNX 4 mg . All other efficacy parameters showed the same dose-effect relationship . A total of 37 adverse events were reported evenly distributed in the 6 treatment groups ; only 3 of these were considered severe , and all disappeared without treatment . In conclusion , the study showed a dose-effect relationship of LNX without a rise in adverse events . The effect of 10 mg KET seemed to be at the level of 8 to 16 mg LNX Two-hundred six out patients with postoperative pain after the surgical removal of impacted third molars were r and omly assigned on a double-blind basis to receive oral doses of ketorolac tromethamine 10 and 20 mg , ibuprofen 400 mg , acetaminophen 600 mg , a combination of acetaminophen 600 mg plus codeine 60 mg , or placebo . Using a self-rating record , subjects rated their pain and its relief hourly for 6 hours after medicating . All active medications were significantly superior to placebo . Analgesia was similar for ketorolac 10 and 20 mg and ibuprofen 400 mg ; however , these treatments were superior to acetaminophen alone and the acetaminophen-codeine combination . The analgesic effect of each active medication was significant by hour 1 and persisted for 5 - 6 hours . The data suggest a plateau in ketorolac 's analgesic efficacy at the 10-mg level . Repeat-dose data indicated that on the day of surgery ketorolac 10 and 20 mg and ibuprofen 400 mg were superior to acetaminophen 600 mg ; ketorolac 20 mg was also superior to acetaminophen-codeine . Differences among active medications were not significant when data for the entire postoperative period ( days 0 - 6 ) were evaluated . The frequency of adverse effects was similar for the active medications The analgesic efficacy and safety of single doses of 10 mg and 30 mg ketorolac tromethamine and 100 mg pethidine were evaluated in a double-blind , parallel-group study . The drugs were administered intramuscularly to patients experiencing moderate , severe or very severe pain immediately following major abdominal surgery . A total of 129 patients were r and omly assigned to receive either active drug ( n = 32 for each treatment group ) or placebo ( n = 33 ) , and the patients assessed pain intensity and pain relief on a visual analogue scale at regular intervals over the following 8 h. During the first 2 h , pethidine had a more rapid onset of action than ketorolac or placebo , and thereafter 100 mg pethidine and 30 mg ketorolac were equally effective . Ketorolac , at a dose of Output:	Oral ketorolac 10 mg was consistently at least as effective as ketorolac 30 mg i.m .
MS22386	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: An investigation was carried out on six hospitalized elderly male urinary incontinent patients for 21 days to test three urinary sheath systems by means of a quasi-experimental trial , incorporating crossover . Observations were made , and recorded , of detachment or leakage in systems and of skin condition round the shaft of the penis . Results suggest that two of the systems differ significantly in their performance and that performance of the urinary sheath was probably the limiting factor in overall performance . Incidence of skin problems , and other problems within systems , were minimal . It was also observed that patients differ significantly in their suitability for the application of sheath systems . This observation was made at two time intervals . A further line of investigation is suggested to test the effect of components , other than sheaths , on performance of systems A new system of urine collection to be used with indwelling catheters or condom drainage was developed and evaluated in the laboratory , and clinical ly . The aims included prevention of twisting of the tubes , non-leakage , comfortable body bags and ease of use of drainage taps . The new system was highly acceptable to patient and attendant alike A newly marketed vaginal sponge intended to support the urethra was tested during aerobic exercise in a group of 6 women suffering from stress urinary incontinence . The patients performed half an hour of aerobic exercises on 2 consecutive days , with and without the vaginal sponge . A pad was worn during exercise and weighed before and after . Without the vaginal sponge the patients had a mean loss of 7 g ( range 2–18 g ) during exercise . With the vaginal sponge in situ there was no leakage . The sponge can be recommended for use during sports in patients with mild to moderate incontinence Urethral devices are one conservative management option for stress and mixed urinary incontinence , but there is little published data about their use . The aims of this study were to assess the safety and efficacy of a new urethral device ( NEAT ) and compare it with the Reliance Insert . The ease of use of both devices was then evaluated . Twenty-four women with mixed or stress urinary incontinence , patients at our tertiary care urogynecology unit and who met the inclusion and exclusion criteria , were enrolled in the study . Study subjects were blinded and r and omly assigned to a device group . Device efficacy was assessed by pad weighing at 0 and 4 months . Success was defined as a 50 % or greater reduction in urine loss using the formula 100[(pad weight without device −pad weight with device)/pad weight with device ] . Safety was evaluated using urinalysis and urine cultures . Ease of use assessment scales were also completed . Eleven patients were r and omized to the Reliance Insert and 13 to the NEAT device . There were no significant differences between the two groups in age , height , weight , duration of incontinence , pad weight , leakage score , parity or quality of life score . Based on the pad weight success formula , there was no significant difference in device success between the two groups at 4 months . Women who were postmenopausal had a trend towards a higher level of success in reduction of their pad weight . Previous treatment , diagnosis and hormone replacement therapy all had no relationship to device success . Leakage score data showed that subjects had a significant decrease in urine leakage when using either device . There was no statistically significant difference in ease of use between the two devices . Adverse symptoms most commonly noted were awareness of the device ( 62.5 % ) , urgency ( 29.2 % ) , and urethral discomfort or pain ( 20.8 % ) . One urinary tract infection ( UTI ) was observed . The most common finding on urinalysis was trace hematuria ( 15.8 % ) . Our conclusions are that the NEAT device appears to be at least as effective and safe as the Reliance Insert . Both devices are effective at decreasing urine leakage in patients with stress or mixed urinary incontinence . The risk of UTI is low , but these devices may cause trace hematuria Objective The objective of this study was to determine if differences exist in pelvic symptom distress and impact on women r and omized to pessary versus behavioral therapy for treatment of stress urinary incontinence ( SUI ) . Methods Change in symptom and condition-specific health-related quality -of-life ( HRQOL ) measures were compared between pessary and behavioral groups 3 months after r and omization in the Ambulatory Treatments for Leakage Associated With Stress Incontinence trial . Four hundred forty-six women with symptoms of SUI were r and omized to continence pessary , behavioral therapy ( pelvic floor muscle training and continence strategies ) or combination therapy . Vali date d measures utilized included urinary , prolapse , and colorectal scales of the Pelvic Floor Distress Inventory ; urinary , prolapse , and colorectal scales of the Pelvic Floor Impact Question naire ; and Stress and Urge scales of the Question naire for Urinary Incontinence Diagnosis . Student t test and analysis of variance were used to compare scores within and between groups . Results Mean age of participants was 49.8 ( SD , 11.9 ) years ; 84 % were white , and 10 % were African American . One hundred forty-nine were r and omized to pessary , and 146 to behavioral therapy . Baseline symptoms and HRQOL scores were significantly reduced within treatment arms at 3 months after r and omization , but there was no statistically significant difference between groups . Conclusions There was no difference in pelvic floor symptom bother and HRQOL between the pessary and behavioral therapy arms in women undergoing conservative treatment for SUI . Individualized preference issues should be considered in the approach to the nonsurgical treatment of SUI A developed urethral plug was evaluated for the treatment of women with genuine urinary stress incontinence . The plug consists of an oval meatal plate , a soft stalk and one or two spheres along the stalk with fixed distances between the meatal plate and the spheres . Inside the stalk is a removable semi-rigid guide pin to ease insertion . Forty women were r and omly allocated to treatment with either the two-sphere or the one-sphere plug during period one ( two weeks ) . In period two ( two weeks ) the patients used the other plug . They then continued with what they judged to be the better plug in period three ( two months ) . Eighteen patients ( 45 % ) completed period three with the " preference " plug and 17 were subjectively and objective ly continent or improved . Fourteen of these women preferred the two-sphere device . The plugs were equally effective in patients with mild or severe incontinence . Six women developed urinary tract infections and two of these had a plug in the bladder . The urethral plug is an effective treatment in a group of women with stress incontinence . Removal by h and is advisable in order to avoid retention of plugs in the bladder Introduction and hypothesisManagement of stress urinary incontinence ( SUI ) with intravaginal devices is an alternative to surgical management , but data of a high level of evidence remain scarce . Our goal was to assess efficacy , tolerance , and acceptability of the 75NC007 intravaginal device for SUI management . Methods A phase III , multicenter r and omized controlled trial was conducted . After an initial washout period with no treatment , allowing baseline evaluation , women with SUI were r and omly assigned to a treatment or control group ( no treatment ) . The primary endpoint was the reduction of incontinence episode frequency ( IEF ) , according to bladder diaries , as compared to baseline . Secondary endpoints were variation of the Urinary Symptom Profile ( USP ) score , of 24-h pad test , and of CONTILIFE question naire scores as compared to baseline . Intent-to-treat and per- protocol analyses were conducted . Results Fifty-five patients were enrolled and analyzed ( 26 controls and 29 treated ) . The mean relative variations of IEF , SUI USP subscore , and overactive bladder ( OAB ) USP subscore were more significant in the treatment group than in the control group ( −31.7 ± 65.1 % vs −7.6 ± 24.5 % , p = 0.002 , −2.4 ± 2.6 vs 0.2 ± 2.2 , p = 0.004 , and −1.5 ± 2.8 vs 0.2 ± 1.8 , p = 0.016 , respectively ) . The dysuria USP subscore was slightly decreased in the treatment group . CONTILIFE scores were slightly improved in the treatment group . Pad test variations were not different between groups . No serious adverse event was noted throughout the entire study . Conclusions The 75NC007 intravaginal device is a safe and effective noninvasive treatment of SUI in women PURPOSE We evaluated the usefulness and safety of a bladder neck support prosthesis in patients with stress or mixed incontinence . MATERIAL S AND METHODS A total of 57 women with stress and 20 with mixed incontinence completed a 12-week prospect i ve clinical trial of a bladder neck support prosthesis . While indexes of incontinence episodes , leakage amounts and urgency along with a bothersome index were subjectively evaluated , a 60-minute pad test and urinary flow parameters were objective ly evaluated . Three patients scheduled to undergo surgery for stress incontinence voluntarily used the device , and provided urodynamic data and cystourethrograms . Two prongs at 1 end of the ring , a type of elastic vaginal pessary , elevate the bladder neck against the pubic bone and facilitate pressure transmission around the bladder neck , result ing in urinary continence . RESULTS Four subjective indexes significantly improved . There was no urinary flow obstruction . Urine loss decreased from 20.6 to 4.8 gm . per hour ( p < 0.001 ) on the 60-minute pad test . Of the patients 22 ( 29 % ) reported complete continence and 39 ( 51 % ) had decreased severity of incontinence by more than 50 % . Minor adverse effects occurred in 26 % of the patients . Taking subjective evaluation , changes in objective parameters and adverse effects into consideration , 62 patients ( 81 % ) had some or maximum benefit according to the global usefulness rating . CONCLUSIONS The bladder neck support prosthesis is safe , well tolerated and clinical ly effective for the treatment of stress or mixed incontinence OBJECTIVE : To identify factors that may predict success and satisfaction in women undergoing nonsurgical therapy for stress urinary incontinence . METHODS : Baseline demographic and clinical characteristics of women participating in a multicenter r and omized trial of pessary , behavioral , or combined therapy for stress urinary incontinence were evaluated for potential predictors of success and satisfaction . Success and satisfaction outcomes were assessed at 3 months and included the Patient Global Impression of Improvement , stress incontinence subscale of the Pelvic Floor Distress Inventory , and Patient Satisfaction Question naire . Logistic regression was performed to identify predictors , adjusting for treatment and other important clinical covariates . Adjusted odds ratios ( ORs ) , 95 % confidence intervals ( CIs ) , and associated P values are presented . RESULTS : Four hundred forty-six women were r and omized . College education or more and no previous urinary incontinence surgery predicted success based on the stress subscale of the Pelvic Floor Distress Inventory ( adjusted OR 1.61 , 95 % CI 1.01–2.55 , P=.04 and adjusted OR 3.15 , 95 % CI 1.04- 9.53 , P=.04 , respectively ) . Menopausal status predicted success using the Patient Global Impression of Improvement ( adjusted OR 2.52 postmenopausal compared with premenopausal , 95 % CI 1.29–4.95 ; adjusted OR 1.32 unsure menopausal status compared with premenopausal , 95 % CI 0.65–2.66 ; P=.03 across all three groups ) . Fewer than 14 incontinence episodes per week predicted satisfaction with the Patient Satisfaction Question naire ( adjusted OR 1.97 , 95 % CI 1.21–3.19 ; P=.01 ) . These predictors did not differ across the three treatment groups . CONCLUSION : Menopause , higher education , no previous urinary incontinence surgery , and lower incontinence frequency were found to be predictors of success and satisfaction with nonsurgical therapy for stress urinary incontinence . This information may help better-align provider and patient expectations with nonsurgical treatment outcomes . CLINICAL TRIAL REGISTRATION : Clinical Trials.gov , www . clinical trials.gov , NCT00270998 . LEVEL OF EVIDENCE : OBJECTIVES The purpose of this study was to test the safety and effectiveness of a urethral insert for managing stress or mixed urinary incontinence . METHODS We performed a prospect i ve , multicenter study of 135 female patients who were treated for 4 months with the Reliance Urinary Control Insert . The effectiveness of the insert was measured objective ly at the time of first use and after 4 months ' use by st and ardized pad weight studies . Insert effectiveness was also measured by reports of symptom improvement during patient interviews and on patient diaries . Urine microscopy and culture were obtained monthly ; cystoscopy and urodynamics were conducted at study entry and at 4 months . RESULTS Significant improvement in involuntary urine loss was observed . Objective measurement of urine loss revealed that 80 % of the patients were completely dry , and 95 % of the patients achieved greater than an 80 % decrease in urine loss . In addition , patients ' perceptions of acceptability , incontinence symptom improvement , ease of learning , comfort , and time to habituation also showed improvements . Untoward events reported during the study included hematuria , bacteriuria , and bladder irritation . These events did not require significant medical intervention and did not result in any long-term clinical sequelae . CONCLUSIONS These preliminary results indicate that Output:	Three small trials compared a mechanical device with no treatment and although they suggested that use of a mechanical device might be better than no treatment , the evidence for this was inconclusive . While at three months there were more withdrawals from the device-only group , at 12 months differences between the groups were not sustained on any measure . The place of mechanical devices in the management of urinary incontinence remains in question . There was also insufficient evidence in favour of one device over another and little evidence to compare mechanical devices with other forms of treatment
MS22387	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: Purpose This study aim ed to assess the effectiveness of functional electrical stimulation on the swallowing function of irradiated nasopharyngeal carcinoma patients with dysphagia . Material s and methods Twenty nasopharyngeal carcinoma subjects with dysphagia were divided into a functional electrical stimulation ( FES ) and a home rehabilitation program ( HRP ) group . Each subject completed a quality of life question naire on swallowing and a videofluoroscopic study at the commencement and the end of the procedures . The FES group received functional electrical stimulation of the supra-hyoid muscles over 15 sessions . The HRP group performed self-swallowing exercises at home . The evaluation parameters included the quality of life question naire scores , the penetration – aspiration scale ( PAS ) , the movement of the hyoid bone , and the amount of pyriform sinuses stasis . Results Most swallowing outcomes of the FES group improved after FES . The quality of life score ( p = 0.003 ) , the duration of the movement of thin barium through the hyoid ( p = 0.001 ) , the moving speed of paste barium through the hyoid ( p = 0.028 ) , and the pyriform sinus stasis area of the paste barium ( p = 0.026 ) reached significant difference in the FES group . Most swallowing outcomes did not improve in the HRP group . The degree of improvement in the movement speed of the hyoid bone in the thin barium ( p = 0.018 ) and the PAS of the paste barium ( p = 0.016 ) were statistically significantly greater in the FES group than in the HRP group . Conclusion FES will improve the swallowing function of NPC patients with dysphagia and bring about better quality of life OBJECTIVES Dysphagia is a common and debilitating side effect of chemoradiotherapy . Assessment is difficult ; swallowing is multifactorial and studies choose from a range of dysphagia assessment s. This study intended to investigate the relationship between swallowing assessment s of dysphagia in a cohort of patients and to evaluate whether clinical swallowing measures can predict patient reported swallowing outcomes . MATERIAL S AND METHODS One hundred and seventy-three head and neck cancer patients from two teaching hospitals were recruited prospect ively over 25 months . At three months follow-up patients were assessed using Rosenbeck 's Penetration-Aspiration Scale ( PAS ) , The 100 ml Water Swallow Test ( WST ) , The Performance Status Scale : Normalcy of Diet and the MD And erson Dysphagia Inventory ( MDADI ) . RESULTS The highest correlation was observed between the MDADI and Normalcy of Diet ( rho 0.68 ) and the lowest between the MDADI and the PAS ( rho 0.34 ) . Using multiple regression the PAS and WST accounted for 44 % of the variance in the MDADI scores ( R2 = 0.44 , F = 37.8 , p < 0.001 ) . On stepwise regression , the model only retained the Normalcy of Diet scores ( R2 = 0.42 , F=107.9 , p < 0.001 ) . Separating the PAS into subgroups , those with no penetration or aspiration on the PAS scored significantly higher on the MDADI ( p = < 0.001 ) . CONCLUSION Patient reported swallowing outcomes were strongly aligned with diet restrictions but poorly aligned with clinical assessment . The WST , however , was more correlated than the PAS score , representing a more functional assessment . Clinical dysphagia , associated with significant morbidity , and patient reported dysphagia related to quality of life are not interchangeable and must be measured separately OBJECTIVE To design a reliable and vali date d self-administered question naire whose purpose is to assess dysphagia 's effects on the quality of life ( QOL ) of patients with head and neck cancer . DESIGN Cross-sectional survey study . METHODS Focus groups were convened for question naire development and design . The M. D. And erson Dysphagia Inventory ( MDADI ) included global , emotional , functional , and physical subscales . One hundred consecutive adult patients with a neoplasm of the upper aerodigestive tract who underwent evaluation by our Speech Pathology team completed the MDADI and the Medical Outcomes Study 36-Item Short Form Health Survey ( SF-36 ) . Speech pathologists completed the Performance Status Scale for each patient . Validity and reliability properties were calculated . Analysis of variance was used to assess how well the MDADI discriminated between groups of patients . RESULTS The internal consistency reliability of the MDADI was calculated using the Cronbach alpha coefficient . The Cronbach alpha coefficients of the MDADI subscales ranged from 0.85 to 0.93 . Test-retest reliability coefficients of the subscales ranged from 0.69 to 0.88 . Spearman correlation coefficients between the MDADI subscales and the SF-36 subscales demonstrated construct validity . Patients with primary tumors of the oral cavity and oropharynx had significantly greater swallowing disability with an adverse impact on their QOL compared with patients with primary tumors of the larynx and hypopharynx ( P<.001 ) . Patients with a malignant lesion also had significantly greater disability than patients with a benign lesion ( P<.001 ) . CONCLUSIONS The MDADI is the first vali date d and reliable self-administered question naire design ed specifically for evaluating the impact of dysphagia on the QOL of patients with head and neck cancer . St and ardized question naires that measure patients ' QOL offer a means for demonstrating treatment impact and improving medical care . The development and validation of the MDADI and its use in prospect i ve clinical trials allow for better underst and ing of the impact of treatment of head and neck cancer on swallowing and of swallowing difficulty on patients ' QOL UNLABELLED Dysphagia can be a consequence of total laryngectomy even in the absence of symptoms and it could indeed directly or indirectly compromise quality of life . AIM To evaluate the characteristics of swallowing after total laryngectomy and pharyngolaryngectomy with pharyngeal T closure , correlating them with the Quality of Life in Swallowing Disorders question naire . METHODS A prospect i ve evaluation was performed in 28 patients ; fifteen undergoing total laryngectomy and thirteen undergoing total pharyngolaryngectomy . Swallowing was evaluated through videofluoroscopy regarding the preparatory , oral and pharyngeal phases of swallowing , and the quality of life related to swallowing question naire was employed to measure quality of life . RESULTS Anatomical and functional changes were observed under videofluoroscopic evaluation . Dysphagia was diagnosed in 18 patients ( 64.3 % ) , being mild in 66.6 % and moderate/severe in 33.3 % . The question naire indicated good quality of life in almost all scales . Complaints of dysphagia were associated to the burden ( p=0.036 ) and mental health scale ( p=0.031 ) . The question naire indicated impact on the mental health scale for patients with severe dysphagia ( p=0.012 ) . CONCLUSIONS High incidence of dysphagia was observed in some quality of life assessment s , especially of mild degree Aims : To evaluate the patient-to-patient model and swallowing problems in Chinese patients with supraglottic laryngeal cancer ( SLC ) , and to find a solution to help SLC patients with swallowing problems . Methods : Eighty-nine patients who had undergone operation for horizontal partial laryngectomy were chosen and divided r and omly into two groups . The European Organization for Research and Treatment of Cancer ( EORTC ) , Swallow Quality -of-Life ( SWAL-QOL ) and Visual Analogue Scale ( VAS ) question naires were used to measure the quality of life and swallowing situation of those patients . Results : At 0.5 and 1 months after eating , the scores of the EORTC QLQ-C30 and SWAL-QOL of the participant group were significantly higher than those of the nonparticipant group ( p < 0.05 ) . One week after eating , the VAS score for swallowing improved significantly from 4.9 to 7.9 in the participant group . However , in the nonparticipant group , the VAS score showed no obvious change ( from 4.5 to 4.1 ) . Conclusions : We concluded that the patient-to-patient model may be utilized in clinical cases to solve swallowing problems of SLC patients , and infered that swallowing problems mainly appeared in 60 to 70-year-olds , and 1 week after eating was a critical time point of communication Recent and specific data on the prevalence and /or incidence of oropharyngeal dysphagia in the general population are scarce . This study focuses on obtaining this data by means of a literature review and telephone survey . A literature review was performed to obtain data on the prevalence of dysphagia in the general population . Secondly , a quasi-r and om telephone survey using the functional health status question naire EAT-10 was conducted with the aim of establishing prevalence data on oropharyngeal dysphagia in the Netherl and s. The literature review revealed six articles which met the inclusion criteria . The prevalence data on oropharyngeal dysphagia in the general population varied between 2.3 and 16 % . For the telephone survey , a total of 6,700 individuals were contacted by telephone , of which , 2,600 ( 39 % ) participated in the study . Of the 2,600 participants , as many as 315 ( 12.1 % ) were identified as having swallowing abnormalities and showed increased risk of oropharyngeal dysphagia with age . Prevalence data on oropharyngeal dysphagia in the Dutch general population were as high as 12.1 % . This data are in line with the retrieved prevalence data from the literature This study compares the effects of traditional logopedic dysphagia treatment with those of neuromuscular electrical stimulation ( NMES ) as adjunct to therapy on the quality of life in patients with Parkinson ’s disease and oropharyngeal dysphagia . Eighty-eight patients were r and omized over three treatment groups . Traditional logopedic dysphagia treatment and traditional logopedic dysphagia treatment combined with NMES at sensor or motor level stimulation were compared . At three times ( pretreatment , post-treatment , and 3 months following treatment ) , two quality -of-life question naires ( SWAL-QOL and MD And erson Dysphagia Inventory ) and a single-item Dysphagia Severity Scale were scored . The Functional Oral Intake Scale was used to assess the dietary intake . After therapy , all groups showed significant improvement on the Dysphagia Severity Scale and restricted positive effects on quality of life . Minimal group differences were found . These effects remained unchanged 3 months following treatment . No significant correlations were found between dietary intake and quality of life . Logopedic dysphagia treatment results in a restricted increased quality of life in patients with Parkinson ’s disease . In this r and omized controlled trial , all groups showed significant therapy effects on the Dysphagia Severity Scale and restricted improvements on the SWAL-QOL and the MDADI . However , only slight nonsignificant differences between groups were found The aim of this work was to translate the 44-item SWAL-QoL into Dutch ( SWAL-QoL-NL ) and compare the validity of this question naire against Euroqol in a Dutch population with dysphagia . SWAL-QoL was translated according to international guidelines . SWAL-QoL-NL and Euroqol were completed by 152 patients in seven diagnosis groups . Internal consistency and correlations were calculated . Scores for nine subscales ( General burden , Food selection , Eating duration , Fear of eating , Sleep , Fatigue , Mental health , Social functioning and a symptom score ) ranged between 0.80 and 0.92 ( Cronbach ’s α ) . Two subscales ( Eating desire and Communication scored 0.67 and 0.60 , respectively , and were removed from the question naire . The 14-item battery on clinical symptoms showed an internal consistency of 0.80 , allowing the use of a sum score on group level in clinical research . Correlation of SWAL-QoL-NL subscales with the Euroqol was negligible to low ( Pearson ’s correlations range = 0.09–0.36 ) . The 39-item SWAL-QoL-NL proved to be a reliable tool to examine the impact of dysphagia on quality of life in a Dutch population . Internal consistency allows the use of nine subscales of SWAL-QoL-NL for comparisons on a group level ( 0.80 < α < 0.92 ) only . Also a Symptom score can be derived from the raw data This prospect i ve , cross-sectional study evaluated the impact of dysphagia on quality of life in healthy ageing and in subjects with Parkinson ’s disease ( PD ) using the Swallowing Quality of Life ( SWAL-QOL ) question naire . Sixteen healthy young adults ( 8 males , mean age = 25.1 years ) and 16 healthy elders ( 8 males , mean age = 72.8 years ) were recruited . Thirty-two subjects with idiopathic PD ( mean age = 68.5 years ) were recruited from a movement disorders clinic . The severity of PD was staged using the Hoehn and Yahr scale . Results revealed that elders experienced symptoms of dysphagia more frequently than young adults but the overall SWAL-QOL scores were not significantly different . Sub Output:	Inverse bidirectional relationships were found between decreased HRQoL and increased OD severity . Following intervention , changes were evident through improved HRQoL with decreased OD severity . The findings of this paper highlight the importance of targeting HRQoL in patients with OD .
MS22388	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: Background and Objective : Transradial access is an attractive approach for angiography or percutaneous coronary intervention . Different devices have been used to apply pressure locally at the site of arterial entry for achieving hemostasis . The aim of this study was to evaluate the effect of 2 different hemostatic devices on radial artery outcomes after transradial coronary intervention . Subjects and Methods : This study included 600 patients who had undergone transradial coronary intervention who were r and omized into 2 groups after the procedure : 300 were treated with a radial compression device ( TR B and , Terumo Medical , Tokyo , Japan ) ( CD group ) and the other 300 patients were treated using a chitosan-based pad ( Anscare , Daxon , Taoyuan , Taiwan ) ( CS group ) . Compression time , major and minor access site bleeding complications , and incidence of radial artery occlusion were recorded . Results : There were no statistical differences in the baseline clinical characteristics of the patients between the 2 groups . Compression time in the CS group was significantly shorter than that in the CD group ( P < .001 ) . Although no major access site bleeding complications were observed in either group , 6 patients in each group experienced minor access site bleeding complications . At the same time , 61 patients in the CD group and 21 patients in the CS group experienced errhysis ( 20 % vs 7 % , respectively ; P < .001 ) . Early radial artery occlusion ( 24 hours ) occurred in 11.7 % of the patients in the CD group and 5.4 % of the patients in the CS group ( P < .05 ) . Chronic radial artery occlusion ( 30 days ) occurred in 10 % of the patients in the CD group and 5 % of the patients in the CS group ( P < .05 ) . Conclusion : The application of the chitosan-based pad showed better hemostatic efficacy and a lower incidence of radial artery occlusion after transradial coronary intervention compared with the compression device Here , we evaluate the efficacy of the Clo-Sur PAD nonwoven hydrophilic wound dressing ( HWD ) on hemostasis in an arterial-access site after transradial percutaneous coronary angiography compared with the RadiStop compression device ( CD ) . Eighty patients who had undergone transradial coronary angiography with or without intravascular ultrasound were r and omly assigned to the HWD or CD group . The time required to achieve hemostasis was measured , and the incidence of vascular complications was assessed . No significant differences in clinical and procedural characteristics were observed between the HWD group ( n = 40 ) and the CD group ( n = 40 ) . A significant reduction in the time required to achieve hemostasis ( 58.7 + /- 32.6 minutes versus 131.3 + /- 59.1 minutes ; p < 0.001 ) was associated with the use of HWD . The incidence of vascular complications was similar in both groups ( 5 % for HWD versus 2.5 % for CD ; p = 0.500 ) . No major complications , such as large hematoma or acute radial occlusion , occurred in the HWD group . In conclusion , HWD represents a safe alternative to the compression method . Hemostasis can be achieved more quickly using HWD , with no increase in access site complications , as compared to CD Objective : The objective of this study was to evaluate the efficacy of hemostasis with patency in avoiding radial artery occlusion after transradial catheterization . Background : Radial artery occlusion is an infrequent but discouraging complication of transradial access . It is related to factors such as sheath to artery ratio and is less common in patients receiving heparin . Despite being clinical ly silent in most cases , it limits future transradial access . Patients and Methods : Four hundred thirty‐six consecutive patients undergoing transradial catheterization were prospect ively enrolled in the study . Two hundred nineteen patients were r and omized to group I , and underwent conventional pressure application for hemostasis . Two hundred seventeen patients were r and omized to group II and underwent pressure application confirming radial artery patency using Barbeau 's test . Radial artery patency was studied at 24 hr and 30 days using Barbeau 's test . Results : Thirty‐eight patients had evidence of radial artery occlusion at 24 hr . Twenty patients had persistent evidence of radial artery occlusion at 1 month . Group II , with documented patency during hemostatic compression , had a statistically and clinical ly lower incidence of radial artery occlusion ( 59 % decrease at 24 hr and 75 % decrease at 30 days , P < 0.05 ) , compared with patients in group I. Low body weight patients were at significantly higher risk of radial artery occlusion . No procedural variables were found to be associated with radial artery occlusion . Conclusion : Patent hemostasis is highly effective in reducing radial artery occlusion after radial access and guided compression should be performed to maintain radial artery patency at the time of hemostasis , to prevent future radial artery occlusion . © 2008 Wiley‐Liss , Background : Transradial access is the approach of choice in many laboratories for diagnostic coronariography or percutaneous coronary interventions ( PCI ) because of its lower vascular complication rate than the femoral approach . However , this approach has a higher rate ( 5–10 % ) of asymptomatic radial artery ( RA ) occlusion . Methods : We conducted a prospect i ve , controlled , single‐centre trial study . We investigated whether the pneumatic compression ( using “ TR B and of Terumo ® ” ) of the radial artery guided by the mean artery pressure ( MAP ) after the procedure ( group A ) is efficient in reducing radial occlusion in patients under a coronary angiography by transradial access for diagnostic coronariography or PCI compared to use of st and ard procedure ( group B , 15 cm3 of air in the device ) . Results : The study was suspended after analyzing the results of 50 % of the scheduled patients . An analysis of the results of 351 consecutive r and om patients in Group A showed significantly ( P = 0.0001 ) lower rate ( 1.1 % ) of occlusion than Group B ( 12.0 % ) without significant differences in the rate of other complications . Other variables associated with RA occlusion in univariate analysis were previous or active smoker ( P < 0.04 ) , absence of anti‐aggregant treatment ( P < 0.04 ) , and the presence of RA flow postprocedure ( PFP , P < 0.001 ) . Independent predictors with logistic regression analysis were PFP ( HR = 0.06 , 95 % CI 0.01–0.2 ) , presence of hematoma ( HR = 3.7 , 95 % CI 1.2–11.0 ) , and st and ard pneumatic compression in group B patients ( HR = 18.8 , 95 % CI 3.8–92.2 ) . Conclusions : Use of pneumatic compression guided by MAP is safe and efficient , and it can significantly lower the incidence of radial artery occlusion . © 2009 Wiley‐Liss , Background —Compared with transfemoral access , transradial access ( TRA ) for percutaneous coronary intervention is associated with reduced risk of bleeding and vascular complications . Studies suggest that TRA may reduce mortality in patients with ST-segment – elevation myocardial infa rct ion . However , there are few data on the effect of TRA on mortality , specifically , in patients with non – ST-segment – elevation myocardial infa rct ion . Methods and Results —We analyzed 10 095 consecutive patients with non – ST-segment – elevation myocardial infa rct ion treated with percutaneous coronary intervention between 2005 and 2011 in all 8 tertiary cardiac centers in London , United Kingdom . TRA was a predictor for reduced bleeding ( odds ratio=0.21 ; 95 % confidence interval [ CI ] : 0.08–0.57 ; P=0.002 ) , access-site complications ( odds ratio=0.47 ; 95 % CI : 0.23–0.95 ; P=0.034 ) , and 1-year mortality ( hazard ratio [HR]=0.72 ; 95 % CI : 0.54–0.94 ; P=0.017 ) . Between 2005 and 2007 , TRA did not appear to reduce mortality at 1 year ( HR=0.81 ; 95 % CI : 0.51–1.28 ; P=0.376 ) , whereas between 2008 and 2011 , TRA conferred survival benefit at 1 year ( HR=0.65 ; 95 % CI : 0.46–0.92 ; P=0.015 ) . The mortality benefit with TRA at 1 year was not seen at the low-volume centers ( HR=0.80 ; 95 % CI : 0.47–1.38 ; P=0.428 ) but specifically seen in the high volume radial centers ( HR=0.70 ; 95 % CI : 0.51–0.97 ; P=0.031 ) . In propensity-matched analyses , TRA remained a predictor for survival at 1 year ( HR=0.60 ; 95 % CI : 0.42–0.85 ; P=0.005 ) . Instrumental variable analysis demonstrated that TRA conferred mortality benefit at 1-year with an absolute mortality reduction of 5.8 % ( P=0.039 ) . Conclusions —In this analysis of patients with non – ST-segment – elevation myocardial infa rct ion , TRA appears to be a predictor for survival . Furthermore , the evolving learning curve , experience , and expertise may be important factors contributing to the prognostic benefit conferred with TRA Background : The transradial route for coronary intervention has proven to be safe , effective , and widely applicable in different clinical situations . Several compressive hemostatic devices have been introduced that have shown to be safe and are effective in achieving hemostasis . Methods : Seven hundred ninety patients were r and omly assigned to receive either TR b and or Radistop hemostatic compression devices after transradial coronary procedure . The outcome measures were patient tolerance of the device , local vascular complications , and the time taken to achieve hemostasis . Results : The mean age was 62.88 years , and 74.2 % of the patients were men . Patient age , height , weight , wrist circumference , body mass index , male sex , hypertension , diabetes , hypercholesterolemia , and smoking incidences were similar in both groups . There were significantly more patients reporting no discomfort in the TR b and group compared to the Radistop group ( 77 % vs. 61 % ; P = 0.0001 ) . Patients in the Radistop group reported significantly more pain across all categories of severity and three patients in the Radistop group were crossed over to TR b and because of severe discomfort . Oozing and ecchymosis were seen in about 16 % of the patients . Local small hematoma and large hematoma were seen in 5.4 % and 2.2 % patients respectively , and similar in both groups . Radial artery occlusion at the time of discharge was seen in 9.2 % of the patients though only 6.8 % showed persistent occlusion at the time of follow‐up . The time taken to achieve hemostasis was significantly longer in the TR B and group ( 5.32 ± 2.29 vs. 4.83 ± 2.23 hr ; P = 0.004 ) . There was significantly higher incidence of radial artery occlusion in patients with smaller wrist circumference , the patients who experienced radial artery spasm during the procedure , and patients with no heparin administration during the procedure . Conclusions : We have shown in a r and omized comparison of Radistop and TR b and that both devices are safe and effective as hemostatic compression devices following transradial procedures . However , more patients felt discomfort with the Radistop device and the time taken to achieve hemostasis was longer with TR b and . © 2010 Wiley‐Liss , A novel hemostatic device , Adapty ( Medikit , Tokyo , Japan ) , was developed to achieve effective and comfortable hemostasis following transradial procedures . The device consists of a pad fixed to a transparent plastic plate and a self-adhesive strap . The catheter sheath is removed from the radial artery after the pad has been positioned precisely over the puncture site , with the strap attached to the plate . Compression pressure then is adjusted with the self-adhesive strap , as is required with occlusive clamps . Patients do not need to maintain hyperextension of the wrist after the procedure . The wrist can be mobilized immediately after application . The efficacy of Adapty was evaluated in prospect i ve observations of 200 patients . The device was successfully applied in all patients immediately after sheath removal . No patient required interruption of compression because of pain , congestion or ischemia . Complete hemostasis was obtained in 199 patients ( 99.5 % ) , and the device caused no vascular complications . This study demonstrates that Adapty is highly effective for achieving hemostasis after transradial procedures OBJECTIVE Our objective was to evaluate the effectof two different hemostatic devices on radial artery outcomes after transradial catheterization . BACKGROUND Radial artery occlusion is an infrequent but discouraging complication of transradial access . It is related to factors such as sheath-to-artery ratio and its incidence is decreased by the administration of heparin . It usually does not lead to ischemic complications , but precludes future transradial access . PATIENTS AND METHODS 500 consecutive patients undergoing transradial catheterization were prospect ively enrolled in the study . 250 consecutive patients received hemostasis by application of the HemoB and ( Group I ) , and the next 250 patients received hemostasis using the Output:	Conclusion There is limited evidence to support the use of any single hemostatic method to prevent RAO rates after percutaneous coronary procedures . Although used extensively , there is evidence of no effect of the pneumatic compression method using the TR b and on the incidence of RAO at discharge or follow-up , the time taken to obtain hemostasis and the incidence of hematoma . The MAP-guided compression method and the Biopolymer dressing ( Chitosen ) were superior to the TR b and compression method , and patent hemostasis was superior to hemob and in the prevention of RAO .
MS22389	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: Nonsteroidal antiinflammatory drugs have been used to obtain preemptive analgesia . We investigated , in this r and omized , double-blind study , whether sublingual ( s.l . ) piroxicam given before was more effective than that given after surgery . Fifty-two patients scheduled for laparoscopic bilateral inguinal hernia repair under general anesthesia were enrolled . Group PRE ( 25 patients ) received 40 mg of piroxicam s.l . 2 h before surgery and a placebo 10 min after surgery . Group POST ( 27 patients ) were treated with a placebo 2 h before surgery and received 40 mg of piroxicam s.l . 10 min after surgery . After an initial dose of 100 mg tramadol IV , patient-controlled analgesia with tramadol was started and recorded . Visual analog scores were assessed in the recovery and at 6 , 20 , and 30 h postoperatively . Significantly lower visual analog scores were found in group PRE at 6 and 20 h. Significantly smaller cumulative tramadol consumption was observed after 30 h in group PRE . In summary , our findings suggest that preoperative s.l . piroxicam is more effective than the postoperative administration . Because of the low pain scores in both groups , the clinical relevance of these findings is not clear from this study The purpose of this prospect i ve clinical trial was to investigate the analgesic efficacy of three oral medication groups on postoperative endodontic pain in male and female dental patients , with an emphasis on analgesic differences between the sexes . Forty-three patients were administered ibuprofen 600 mg , placebo , or pentazocine 50 mg/0.5 mg naloxone in a r and omized , double-blinded manner . Beginning immediately after endodontic treatment , patients took the assigned medication every 6 hours for 24 hours and recorded their degree of discomfort on a 100-mm visual analog scale . Statistical analysis of the data showed that ibuprofen 600 mg provided statistically significantly greater analgesia than placebo at 6 and 12 hours ( P = 0.0014 and 0.0024 ) , and pentazocine/naloxone provided statistically significantly greater analgesia than placebo at 12 hours ( P = 0.0084 ) . Sex-dependent differences were noted within the pentazocine/naloxone group , which showed significantly greater analgesia in females compared with males ( P = 0.007 ) Successful management of endodontic pain represents a continuing challenge . The purpose of this r and omized , double-blind , placebo-controlled , parallel-group trial was to compare the pain reducing effect of oral preparations of meloxicam , piroxicam , and placebo in endodontic emergency patients . A total of 51 patients who presented to the Tehran University endodontic clinic and one private dental clinic were invited to participate . Patients were asked to evaluate their pretreatment pain with a visual-analog scale . After root canal therapy they were r and omly assigned to one of three groups : meloxicam , piroxicam , or placebo . Each patient was sent home with a visual-analog scale to fill out at 8 and 24 h after completion of therapy . The results of this study showed no significant differences between efficacy of meloxicam , piroxicam , and placebo , but a significant effect of the time factor in reducing postoperative pain in all treatment groups was observed STUDY OBJECTIVE To determine whether intravenous injection of lornoxicam 30 minutes before skin incision provides better pain relief after varicocelectomy than postoperative administration of lornoxicam . DESIGN Prospect i ve , double-blind , r and omized clinical investigation . SETTING Operating room and postoperative recovery area . PATIENTS 44 ASA physical status I and II adult male patients undergoing varicocelectomy . INTERVENTIONS Patients were r and omized either to receive 8 mg lornoxicam infusion 30 minutes before skin incision , followed by saline infusion immediately after skin closure ( group 1 ) , or to receive the identical injections but in reverse order ( group 2 ) . All patients received local anesthesia with bupivacaine . MEASUREMENTS Postoperative pain scores were evaluated hourly for the first 8 hours after surgery , then at 12 , 16 , 20 , and 24 hours after surgery , using a 10-cm visual analog scale . Time to first analgesic request and patients ' global assessment s also were recorded . MAIN RESULTS Patients in group 1 reported significantly lower pain scores ( P < 0.05 ) at all time intervals except at 24 hours and better global assessment ( P = 0.001 ) than did group 2 . There were significantly fewer patients in the preemptive group than group 2 who required rescue analgesic within the first 24 hours ( 0 % vs 22.7 % ; P = 0.024 ) . Mean time to first analgesic request was also significantly longer in the preemptive group ( P = 0.001 ) . CONCLUSION Intravenous lornoxicam administered before surgery has a better analgesic effect for varicocelectomy than when administered postoperatively Background : Postendodontic pain ( PEP ) has always been a major problem for patients and dentists and NSAIDs are being used to relieve PEP and it is supposed that some benzodiazepines may potentiate facilitate the analgesic effects of the NSAIDs . This study was conducted to evaluate the effect of alprazolam on the analgesic effect of ibuprofen in PEP treatment . Methods : This r and omized double-blind clinical trial was conducted on 45 patients aged 20 - 45 years who were subjected of root canal treatment . A written informed consent was obtained from each patient . The subjects were r and omly divided into three groups ; placebo , ibuprofen ( 400 mg ) and alprazolam ( 0.5 ) mg + ibuprofen ( 400 mg ) . The intensity of pain was recorded using visual analog scale ( VAS ) at 4 , 6 , 12 , 24 , 48 and 72 hours after drug administration . Results : Of the participants , twenty six ( 57.8 % ) were males and 19 patients ( 42.2 % ) were females . Four hours after starting treatment , the VAS scores in the placebo and ibuprofen -treated groups were significantly higher than ibuprofen and alprazolam+ibuprofen groups ( 4.93±1.16 , 3.67±1.88 and 2.67±1.11 , respectively , p<0.0001 ) . The VAS scores in alprazolam + ibuprofen group ( 2.33±1.05 ) were significantly lower at 6 hours after treatment when compared to the other groups ( Ibuprofen : 3.00±1.36 and placebo : 3.08±1.74 , P=0.002 ) . This decrease in VAS score sustained to 12 hours after the start of alprazolam + ibuprofen treatment when compared to ibuprofen or placebo receiving group alone ( p<0.003 ) . The average pain score in female patients who received alprazolam + ibuprofen was significantly lower than males at 12 hours ( 1.3±0.6 v.s 2.14±0.9 , P=0.002 ) and 24 hours after treatment ( 0.88±0.6 v.s 1.86±0.9 , P=0.003 ) . Conclusion : According to the results , it can conclude that alprazolam may enhance the analgesic efficacy of ibuprofen in postendodontic pain To determine if prophylactic etodolac would significantly reduce postendodontic pain , when compared with ibuprofen or placebo , 36 patients consented to single blind oral administration of either 400 mg of etodolac , 600 mg of ibuprofen , or a placebo , before conventional one-appointment root canal therapy . Patient-reported visual analog scale ratings of pain intensity were conducted upon initial clinical presentation , immediately postoperative , 4 , 8 , 12 , 24 , 48 , and 72 h after initiation of root canal therapy . Results showed that prophylactic ibuprofen administration significantly reduced postendodontic pain at 4 and 8 h after initiation of root canal therapy , when compared with etodolac and a placebo . Patients with a periapical diagnosis of acute apical periodontitis or with a Phoenix abscess showed a significant increased need for additional medication after completion of root canal therapy , compared with all other periapical diagnoses Background Periapical lesions are inflammatory diseases that result in periapical bone destruction because of host defensive – microbial disturbances . Objective To evaluate the role of prophylactic ibuprofen and N-acetylcysteine ( NAC ) on the levels of tumor necrosis factor alpha ( TNF- α ) , interleukin- 6(IL-6 ) and IL-17 and post-treatment pain level in chronic periapical lesions . Material s and methods Eighty patients with chronic apical lesions less than 1 cm were r and omly assigned to receive NAC tablets ( 400 mg ) , ibuprofen tablets ( 400 mg ) , NAC ( 400 mg)/ibuprofen ( 200 mg ) combination and placebo 90 minutes prior to sampling . Periapical exu date s were collected from root canals . TNF- α , IL-6 and IL-17 levels were determined by ELISA and post-treatment pain was assessed using a visual analog scale ( VAS ) . Results There was a significant difference in IL-6 level between ibuprofen group and placebo ( p = 0.019 ) . Significant difference in IL-17 level was observed between NAC/ibuprofen combination group and placebo ( p = 0.043 ) . Four hours after treatment , a significant difference was observed in VAS pain score between ibuprofen group and placebo ( p = 0.017 ) . Eight hours post-treatment , VAS pain score for NAC group was statistically lower than placebo group ( p = 0.033 ) . After 12 hours VAS pain score showed a significant decrease in NAC group compared to placebo ( p = 0.049 ) . Conclusion The prophylactic ibuprofen and NAC failed to clearly reflect their effect on cytokines levels in exu date s of chronic periapical lesions . On the other h and it seems that NAC can be a substitute for ibuprofen in the management of post endodontic pain Achieving successful anesthesia and pain control in a predictable , efficient manner is a challenge in the endodontic treatment of vital inflamed lower molars . The aim of this study was to evaluate the effect of oral ketamine on the dosage of local anesthetics required and postoperative pain management for irreversibly inflamed m and ibular molars . In this r and omized double-blind placebo-controlled clinical trial , 36 patients with irreversibly inflamed m and ibular molars were r and omly divided into two groups of 18 . Ten mg of ketamine dissolved in 20 ml of fruit juice was administered orally to patients in the experimental group . The control group was given 20 ml of fruit juice alone as a placebo . After 30 min , inferior alveolar nerve block ( IANB ) anesthesia was induced using one cartridge of 2 % lidocaine and 1:100000 epinephrine . Teeth were tested after 5 to 10 min using an electrical pulp tester . In patients showing a positive response , another IANB injection was applied , and the total number of anesthetic cartridges used was recorded . Postoperative pain was evaluated using a visual analogue scale ( VAS ) . In addition , use of analgesic in the first 24 h after treatment was monitored using a question naire . Data were analyzed by t test using SPSS software . There were no significant differences in age or gender between the two groups . The number of anesthetic cartridges used in the ketamine group was significantly less than that in the control group ( P = 0.003 ) . Furthermore , postoperative pain in the ketamine group was significantly lower ( P = 0.019 ) . Also the number of analgesic tablets taken in the ketamine group was significantly lower ( P = 0.011 ) . It can be concluded that a low dose of ketamine might be beneficial for enhancing the effect of local anesthetics STUDY OBJECTIVE To determine the optimum time of administration of diclofenac in patients undergoing ambulatory knee arthroscopy : either preoperatively or postoperatively . DESIGN R and omized , double-blind study . SETTING Ambulatory surgical unit in a tertiary referral hospital . PATIENTS 127 ASA physical status I and II patients undergoing ambulatory knee arthroscopy . INTERVENTIONS Patients were r and omized into three groups . The Preop group received 50 mg of potassium diclofenac orally 1 hour preoperatively and a placebo 30 minutes postoperatively . The Pre+postop group received 25 mg of potassium diclofenac 1 hour preoperatively and 25 mg diclofenac 30 minutes postoperatively . The Postop group received a placebo 1 hour before surgery and 50 mg of potassium diclofenac 30 minutes postoperatively . MEASUREMENTS AND MAIN RESULTS The Postop group received a placebo 1 hour preoperatively and 50 mg of potassium diclofenac 30 min postoperatively . Postoperatively , patients used intravenous patient-controlled analgesia ( PCA ) with fentanyl Output:	Our meta-regression analysis provided the evidence for association between some study covariates with treatment effect , each at different follow-ups . We concluded that the clinicians can manage post-operative endodontic pain by administration of NSAIDs and /or paracetamol .
MS22390	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: BACKGROUND Membranous nephropathy is a common cause of nephrotic syndrome ( NS ) in adults . Its treatment is still under debate . METHODS We report our experience in a pilot study using initially low doses of steroids and tacrolimus ( Tac ) . After 3 months of treatment , mycophenolate mofetil ( MMF ) was added if the proteinuria was higher than 1 g/day . RESULTS In accordance with this st and ard , 21 patients entered the study . A proteinuria level lower than 1 g/day was reached at month 3 of therapy with steroids and Tac in 11 patients . These patients continued this treatment for 12 months . MMF was added in nine cases after the third month and triple therapy was maintained for 12 more months . Two patients were withdrawn because of side effects . At the end of the treatment , remission of the NS was present in 15 out of all the patients ( 71.4 % ) . Remission of the NS was complete in eight ( 53.3 % ) patients and partial in seven ( 46.7 % ) others . The remaining four patients did not respond . There were no significant changes in renal function . At a mean time of 23.1 months after treatment was discontinued , 11 ( 73.3 % ) patients had relapsed . CONCLUSIONS In this trial , treatment with tacrolimus showed a good efficacy but a high relapse rate when it was discontinued BACKGROUND Because humoral immunity is believed to play a pivotal role in the pathogenesis of IgA nephropathy ( IgAN ) , a prospect i ve placebo-controlled r and omized study was started in patients with IgAN using mycophenolate mofetil ( MMF ) . METHODS A total of 34 patients with IgAN were treated with salt intake restriction , angiotensin-converting enzyme ( ACE ) inhibition and MMF 2 g per day ( N= 21 ) or placebo ( N= 13 ) . After 36 months of follow-up clinical , biochemical , and radiologic data were analyzed using linear mixed models for longitudinal data and Kaplan-Meier survival analysis . RESULTS Therapy had to be stopped prematurely in five patients . Two patients ( MMF group ) evolved to end-stage renal disease ( ESRD ) . There was no difference between groups in the percentage of patients with a decrease of 25 % or more in the inulin clearance or with a serum creatinine increase of 50 % or more over 3 years . There was also no significant difference between groups in annualized rate of change of serum creatinine , computed by linear regression analysis . No significant difference was noted between groups for inulin clearance , serum creatinine , proteinuria , blood pressure , or other parameters of renal function . Hemoglobin and C-reactive protein were significantly lower in the MMF group compared with the placebo group . As a function of time , a significant decline in both groups was noted of proteinuria , parenchymal thickness of the kidneys and C3d . CONCLUSION In patients with IgAN at risk for progressive disease , no beneficial effect of 3-year treatment with MMF 2 g per day could be demonstrated on renal function/ outcome or proteinuria . However , larger r and omized studies are needed to confirm or reject these results BACKGROUND The n-3 fatty acids in fish oil affect eicosanoid and cytokine production and therefore have the potential to alter renal hemodynamics and inflammation . The effects of fish oil could prevent immunologic renal injury in patients with IgA nephropathy . METHODS In a multicenter , placebo-controlled , r and omized trial we tested the efficacy of fish oil in patients with IgA nephropathy who had persistent proteinuria . The daily dose of fish oil was 12 g ; the placebo was a similar dose of olive oil . Serum creatinine concentrations , elevated in 68 percent of the patients at base line , and creatinine clearance were measured for two years . The primary end point was an increase of 50 percent or more in the serum creatinine concentration at the end of the study . RESULTS Fifty-five patients were assigned to receive fish oil , and 51 to receive placebo . According to Kaplan-Meier estimation , 3 patients ( 6 percent ) in the fish-oil group and 14 ( 33 percent ) in the placebo group had increases of 50 percent or more in their serum creatinine concentrations during treatment ( P = 0.002 ) . The annual median changes in the serum creatinine concentrations were 0.03 mg per deciliter ( 2.7 mumol per liter ) in the fish-oil group and 0.14 mg per deciliter ( 12.4 mumol per liter ) in the placebo group . Proteinuria was slightly reduced and hypertension was controlled to a comparable degree in both groups . The cumulative percentage of patients who died or had end-stage renal disease was 40 percent in the placebo group after four years and 10 percent in the fish-oil group ( P = 0.006 ) . No patient discontinued fish-oil treatment because of adverse effects . CONCLUSIONS In patients with IgA nephropathy , treatment with fish oil for two years retards the rate at which renal function is lost In several studies diets supplemented with fish oil containing a high proportion of omega-3-polyunsaturated fatty acids ( w-3-PUFA ) have been shown to produce beneficial effects , such as a reduction in blood pressure , lipid levels and inflammation , all of which may affect the course of IgA nephropathy . However , the results of hitherto published studies concerning IgA nephropathy have been inconclusive . We therefore carried out a prospect i ve , r and omized , placebo-controlled six-month study with a higher daily dose of w-3-PUFA than used in previous studies . Thirty-two adult patients with biopsy-proven IgA nephropathy and proteinuria completed the study : 15 were assigned to a fish-oil product with a high percentage of w-3-PUFA ( K 85 , with 55 % eicosapentenoic and 30 % docosahexenoic acid ) and 17 to corn oil , 6 g daily of either oil . At the start , no significant differences were found between the two groups ( K85 : 3 females/12 males , mean age 39 years ( range 22 - 64 ) , corn oil : 4 females/13 males , age 42 years ( range 26 - 68 ) . By six months , supplements of K85 result ed in a slight but significant reduction in glomerular filtration rate ( GFR ) compared to the start : 51Cr-EDTA : 63 + /- 22 to 59 + /- 21 ml/min/1.73 m2 ( p < 0.05 ) , creatinine clearance : 91 + /- 31 to 79 + /- 25 ml/min ( p < 0.01 ) , s-creatinine : 131 + /- 39 to 139 + /- 39 mumol/l , whereas no change in GFR was observed in the corn oil group . The urinary total protein and red blood cell excretions were not affected in any of the groups . ( ABSTRACT TRUNCATED AT 250 WORDS A multicentre , r and omized , placebo-controlled study was performed in 39 adult patients with biopsy-proven IgA nephropathy with the aim of comparing the effects of the ACE inhibitor fosinopril and placebo on proteinuria . All patients had normal blood pressure and normal renal function . Proteinuria ranged from 1.0 to 2.5 g/24 h. After a 3-month run-in period , fosinopril and placebo were r and omly administered in two 4-month sequences separated from cross-over treatment by a 1-month interval . The mean values of creatinine clearance did not change during either the placebo or the treatment sequences . The mean values of mean arterial pressure ( MAP ) were significantly lower during the fosinopril sequence ( 90.4 + /- 9.0 mmHg ) than in basal conditions ( 92.8 + /- 9.1 mmHg ) ( P = 0.034 ) . The mean basal values of proteinuria were 1.74 + /- 0.84 g/24 h. They were unchanged during the placebo sequence ( 1.79 + /- 1.20 ) and fell to 1.37 + /- 0.98 g/24 h after 4 months of fosinopril treatment . Using a multivariate statistical analysis , the treatment effect by time on proteinuria was significantly evident only in the fosinopril sequence ( Wilks test , P = 0.033 ) . Changes in protein excretion were not correlated with changes in MAP , baseline plasma renin activity , and urinary sodium excretion . This controlled study shows that fosinopril can significantly reduce proteinuria even in normotensive patients with IgA nephropathy . Obviously , the results of treatment with ACE inhibitors on long-term renal prognosis remain to be eluci date BACKGROUND Treatment of primary glomerular diseases may be unsuccessful or have potential toxicities . Therefore , we evaluated the use of mycophenolate mofetil ( MMF ) for empirical treatment of primary glomerulopathies . METHODS Forty-six patients with biopsy-proven primary glomerulopathies received MMF for > or =3 months as adjunctive or primary treatment . Median ( range ) 24-hour urine protein to creatinine ratio ( Up/c ) and serum creatinine at the start and end of MMF therapy were compared using the Wilcoxon signed-ranks test . RESULTS Overall , the median Up/c decreased from 4.7 ( range < 0.1 , 20.3 ) to 1.1 ( < 0.1 , 14.3 ; P < 0.001 ) at the end of MMF treatment with no significant change in median serum creatinine 1.3 ( 0.6 to 6.1 ) to 1.2 ( 0.5 to 6.5 ) mg/dL. Median serum albumin increased from 3.4 ( 1.4 , 4.6 ) to 4.1 ( 1.7 , 48 ) g/dL ( P < 0.001 ) and the median serum cholesterol decreased from 270 ( 148 , 795 ) to 220 ( 140 , 309 ) mg/dL ( P < 0.001 ) post-treatment . For those with minimal change disease , a complete steroid withdrawal was accomplished in 5/6 steroid dependent patients . Focal segmental glomerulosclerosis ( FSGS ) patients had a median Up/c that decreased from 2.7 ( 0.1 , 20.3 ) to 0.8 ( < 0.1 , 8.2 ; P = 0.001 ) in 18 patients . In membranous nephropathy ( MN ) patients , the median Up/c decreased from 7.3 ( 0.1 , 18.5 ) to 1.5 ( < 0.1 , 14.3 ) ( P = 0.001 ) in 17 patients . No significant change in median serum creatinine was detected in FSGS or MN patient groups during treatment . CONCLUSIONS Empirical MMF therapy in the majority of patients with primary glomerulopathies was well tolerated and achieved the goals of steroid withdrawal , improvement of nephrotic syndrome , and stabilization of renal function BACKGROUND The therapy of nephrotic syndrome in focal segmental glomerulosclerosis ( FSGS ) is still a matter of controversy . METHODS We performed a prospect i ve r and omized study of the treatment of nephrotic syndrome due to FSGS . We compared 2 specific treatment protocol s to assess the effect of treatment on proteinuria and renal function . Fifty-seven patients were r and omly assigned to 2 groups : group 1 ( n = 34 ) received steroids and cyclosporine , and group 2 ( n = 23 ) received steroids and chlorambucil for 6 months . When treatment was refractory to chlorambucil , the patients in this group were treated with cyclosporine . Creatinine , blood urea nitrogen , proteinuria , lipids , and arterial hypertension were monitored at regular intervals . RESULTS Patients showed a mean serum creatinine of 1.5 + /- 0.2 mg/dL ( 132.6 + /- 17.7 micromol/L ) and proteinuria of 4.8 + /- 2.8 g/24 h with no differences between the groups . At the end of the chlorambucil therapy , patients in group 2 had creatinine levels of 1.8 + /- 0.6 mg/dL ( 159.1 + /- 53 micromol/L ) and proteinuria levels of 3.4 + /- 1 g/24 h. All patients in this group were given cyclosporine . After 4 years the mean creatinine level in group 1 was 1.7 + /- 0.4 mg/dL ( 150.3 + /- 35.4 micromol/L ) and the proteinuria level was 2.5 + /- 1 g/24 h. In group 2 , the mean creatinine level was 1.9 + /- 0.6 mg/dL ( 168 + /- 53 micromol/L ) ( not significant [ NS ] ) and the mean proteinuria level was 2.3 + /- 1.1 g/24 h ( NS ) . Full remission occurred in 23 % of the patients in group 1 ( n = 8) and 17 % of the patients in group 2 ( n = 4 ; NS ) . Partial rem Output:	In the two trials with subjects having moderate to high risk for progressive disease , MMF did not demonstrate any significant difference in retarding the decline in renal function and proteinuria reduction . CONCLUSION No benefit was seen in moderately-advanced IgAN treated with MMF . In a selected group of patients with less advanced disease , MMF was effective in proteinuria reduction .
MS22391	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: OBJECTIVE To assess the effect of a plaster cast socket on the healing of open wounds and on temporary prosthesis fitting after below-knee amputation because of arterial occlusive disease . DESIGN R and omized controlled trial . SETTING Rehabilitation center , university hospital . PATIENTS All included patients had undergone recent ( in the previous 3 months ) below-knee amputation because of arterial disease and initially had an open stump . Patients were r and omly assigned to two groups of 28 subjects each . The sizes of the amputation scars were 8 to 24 cm2 . Ischemia of the stump was eliminated as a probable cause of delayed wound healing by the inclusion criterion of transcutaneous oxygen tension ( TcPO2 ) of > 35 mmHg . The average age in group I ( the experimental group ) was 65.2 + /- 12.4 ( SD ) years and in group II ( the control group ) 66.8 + /- 10.8 years ( not significant ) . INTERVENTION A plaster cast ( supracondylar-type ) socket was fitted on the stumps of group I patients , interposed with a silicone sleeve . The patients were gradually trained to wear this cast for up to 5 hours a day . They were provided with elastic compression b and ages for the remainder of the time . Patients in group II wore elastic compression b and ages , which were only removed for dressing changes . MAIN OUTCOME MEASURES Time required for stump healing , length of time between amputation and ability to walk wearing a contact socket , and length of hospital stay . RESULTS Group I had a quicker average healing time ( 71.2 + /- 31.7 [ SD ] days compared to the control group 's 96.8 + /- 54.9 days ) and a shorter average length of hospital stay ( 99.8 + /- 22.4 days compared to the control group 's 129.9 + /- 48.3 days ) . CONCLUSION Use of a plaster cast socket leads to more rapid healing of the open stump and to a shorter hospitalization . If there is no stump ischemia , this plaster cast technique is safe To evaluate the use of an immediate postoperative prosthesis ( IPOP ) for transtibial amputees , we compared patient outcomes from a prospect i ve clinical study of 19 patients managed with an IPOP with those of a retrospective review of a matched historic control group of 23 patients managed with st and ard soft dressings . Data were analyzed with the Student 's t-test , and significance was set at P=0.05 . The IPOP patients had no surgical revisions , whereas the patients with st and ard soft dressings had 11 . This was a significant difference . IPOP patients also had significantly fewer postoperative complications and shorter times to custom prosthesis than did controls The purpose of this study was to determine if the removable rigid dressing is more effective in preprosthetic management than the conventional support dressing with elastic b and ages . Residual limb circumference , independent application of the dressing , tendency of the dressing to remain secure , development of pressure areas , and presence of pain were evaluated in two groups of below-knee amputees . Subjects were r and omly assigned to use either removable rigid dressings or conventional elastic b and ages . Residual limb circumference was measured three times a week , and the other variables were measured weekly . The results indicated that the removable rigid dressing is more effective in preprosthetic management than the elastic b and age A study of 182 diabetic , largely geriatric , amputees has been presented to compare three different methods of postoperative care . In r and om selected groups , a st and ard soft dressing was compared with a rigid plaster dressing and both were then compared with plaster rigid dressing with an ambulatory pylon attached . The patient population was relatively homogeneous in that they all bore the diagnosis of diabetes . When rigid dressings were applied , they were provided by prosthetists trained specifically for this method of care . The results of this study support the view that the rigid dressing and ambulation do not deter wound healing and probably are a positive factor in achieving a healed wound and a physical and mental attitude able to accept the prosthetic use . However , additional evidence supports the idea that immediate ambulation may be an early deterrent factor to healing and should be delayed for several weeks . The rate of prosthetic use in this study has been greatly improved when compared with previous experience with essentially the same type of patient population ten years ago . Two major reasons for this improvement are the more frequent use of the below-the-knee amputation and the early use of temporary , total-contact prosthetic devices In order to reduce the need for repeated changes of socket due to postoperative atrophy and resorption of oedema simple temporary limbs are required to delay the casting of individual sockets until the stump is more mature . A r and omized study of 95 below-knee amputees was performed with a re-usable temporary one-size prosthesis of endoskeletal type with adjustable tube length . Total contact was obtained by moulding a thin plastic pillow containing small plastic pellets around the stump in parallel connected sections . As air was evacuated the pillow became rigid . The pillow was kept in place about the stump by Velcro b and s. Physiotherapists were able to make all adjustments and ambulate the patient 1–2 hours a day . The training started 2–4 weeks after amputation and lasted for 1–4 weeks . Healing problems due to training did not occur in well healed stumps where training started 3 weeks or more after amputation . No negative influence on maturing of stump , hospital stay and walking ability three months after amputation was found The most popular early walking aid ( EWA ) in the United Kingdom ( UK ) is the Pneumatic PostAmputation Mobility aid or PPAM aid . A disadvantage of this device is that it does not allow a transtibial amputee to flex or extend the knee during walking . The Amputee Mobility Aid ( AMA ) was developed to allow knee movement , enabling transtibial amputees to practise a more natural gait . The benefits of using EWAs include early walking , reduction in postoperative oedema and improvement in patient morale . This pilot study investigated the pneumatic bag/stump interface pressures of the PPAM aid and the AMA . In addition , the range of motion of the knee on the amputated side and the mechanical knee of the AMA were compared . The AMA was found to have higher interface pressures than the PPAM aid during st and ing and similar pressures during supported walking . Subjects using the AMA did flex and extend their knee during walking but through a reduced range of motion . There were no significant differences between the angular movements of the AMA 's mechanical knee and the patient 's knee within it OBJECTIVES To compare the functional outcome associated with the use of Unna semirigid dressings ( SRD ) and elastic b and age soft dressings ( ED ) for adults with lower limb amputation . DESIGN Experimental design . SETTING Inpatient rehabilitation unit of an urban academic medical center . PARTICIPANTS A successive series of adults with vascular disease who had lower limb amputation surgery . Subjects were r and omly assigned to the SRD ( 12 patients with 12 recent amputations ) or the ED ( 9 patients with 10 recent amputations ) group . Subjects in each group were not significantly different except for age ; those in the SRD group were somewhat older . INTERVENTION Subjects in the SRD group had Unna dressings applied to the amputation limb by physical therapists trained in the technique . Those in the ED group had elastic b and aging by therapists , nurses , family , and themselves , all of whom were trained in the technique . RESULTS Sixty-seven percent of the SRD group and 20 % of those in the ED group were discharged from the rehabilitation unit ambulating with prostheses . Of those who received prostheses , time from admission to the rehabilitation unit to readiness for fitting averaged 20.8 days for the SRD group and 28.7 days for the ED group . Comparison of survival curves shows that the time from surgery to fitting in the SRD group was almost half that of the ED group ; 30 % of the SRD group was fitted within 34 days , whereas it took 64 days for the same percentage of the ED group to be fitted . CONCLUSIONS Unna semirigid dressings are more effective in fostering amputation limb wound healing and preparing the amputation limb for prosthetic fitting . Subjects treated with SRDs were more likely to be fitted with prostheses and to return home walking with a prosthesis To evaluate the effect of wound dressing upon wound healing , fifty-one patients undergoing below-knee amputation using a long posterior myocutaneous flap technic were r and omly allocated into a soft or plaster dressing group . Neither wound dressing technic proved superior , as wounds healed in 85.2 per cent of the plaster dressing group and 83.3 per cent of the soft dressing group Output:	Despite the large variability of included studies , this review reveals a trend in favour of rigid and semi-rigid dressings for achieving stump healing and reduction of stump volume . No conclusions can be drawn with regard to the effect on functional outcome . The literature is not conclusive on the effects of early weight bearing on stump healing , volume reduction , and functional outcome .
MS22392	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: Tobacco use is the single most important preventable cause of death in military personnel . The purpose of this r and omized clinical trial was to evaluate the effectiveness of two behavioral interventions when added to nicotine-replacement therapy on smoking cessation . The sample of 512 included 52 % active duty military , 29 % family , 11 % retirees , and 8 % Department of Defense civilians . There was a main effect of compliance at the end of the program ( EOP ) ; 69 % of those who attended 75 % of the classes were abstinent from tobacco ; regression analysis found the more intensive program to be twice as effective at EOP and at 3 months , an outcome not continued at 6 months . The longer , more intensive V and erbilt University Medical Center program was significantly more effective at helping the civilian portion of the population ( 85 % versus 60 % in the American Cancer Society program ) but not the active duty participants Residential treatment for substance use disorders ( SUD ) provides opportunity for smoking intervention . A r and omized controlled trial compared : ( 1 ) motivational interviewing ( MI ) to brief advice ( BA ) , ( 2 ) in one session or with two booster sessions , for 165 alcoholics in SUD treatment . All received nicotine replacement ( NRT ) . MI and BA produced equivalent confirmed abstinence , averaging 10 % at 1 month , and 2 % at 3 , 6 and 12 months . However , patients with more drug use pretreatment ( > 22 days in 6 months ) given BA had more abstinence at 12 months ( 7 % ) than patients in MI or with less drug use ( all 0 % ) . Boosters produced 16 - 31 % fewer cigarettes per day after BA than MI . Substance use was unaffected by treatment condition or smoking cessation . Motivation to quit was higher after BA than MI . Thus , BA plus NRT may be a cost-effective way to reduce smoking for alcoholics with comorbid substance use who are not seeking smoking cessation Background There is no more effective intervention for secondary prevention of coronary heart disease than smoking cessation . Yet , evidence about the (cost-)effectiveness of smoking cessation treatment methods for cardiac in patients that also suit nursing practice is scarce . This protocol describes the design of a study on the (cost-)effectiveness of two intensive smoking cessation interventions for hospitalised cardiac patients as well as first results on the inclusion rates and the characteristics of the study population . Methods / design An experimental study design is used in eight cardiac wards of hospitals throughout the Netherl and s to assess the (cost-)effectiveness of two intensive smoking cessation counselling methods both combined with nicotine replacement therapy . R and omization is conducted at the ward level ( cross-over ) . Baseline and follow-up measurements after six and 12 months are obtained . Upon admission to the cardiac ward , nurses assess patients ’ smoking behaviour , ensure a quit advice and subsequently refer patients for either telephone counselling or face-to-face counselling . The counselling interventions have a comparable structure and content but differ in provider and delivery method , and in duration . Both counselling interventions are compared with a control group receiving no additional treatment beyond the usual care . Between December 2009 and June 2011 , 245 cardiac patients who smoked prior to hospitalisation were included in the usual care group , 223 in the telephone counselling group and 157 in the face-to-face counselling group . Patients are predominantly male and have a mean age of 57 years . Acute coronary syndrome is the most frequently reported admission diagnosis . The ultimate goal of the study is to assess the effects of the interventions on smoking abstinence and their cost-effectiveness . Telephone counselling is expected to be more (cost-)effective in highly motivated patients and patients with high SES , whereas face-to-face counselling is expected to be more (cost-)effective in less motivated patients and patients with low SES . Discussion This study examines two intensive smoking cessation interventions for cardiac patients using a multi-centre trial with eight cardiac wards . Although not all eligible patients could be included and the distribution of patients is skewed in the different groups , the results will be able to provide valuable insight into effects and costs of counselling interventions varying in delivery mode and intensity , also concerning subgroups . Trial registration Dutch Trial Register Subjects ( N = 139 ) were assigned to intensive behavioral or to low-contact smoking treatment and to 2-mg nicotine gum or to placebo gum in a 2 X 2 factorial design . The 2-mg gum produced higher abstinence rates than did the placebo . Subjects receiving the low-contact condition plus the 2-mg nicotine gum had excellent abstinence rates at both 26 weeks ( 56 % abstainers ) and 52 weeks ( 50 % abstainers ) . Smokers who scored at the median on a measure of physical dependence to nicotine were more likely to benefit by nicotine gum treatment than subjects who scored either higher or lower , but this relation was nonsignificant . The results of this study are compared with an earlier nonblind trial PURPOSE / OBJECTIVES To determine the predictors of participation in a smoking-cessation program among patients with head and neck cancer . DESIGN This cross-sectional study is a sub study of a larger , r and omized trial of patients with head and neck cancer that determined the predictors of smokers ' participation in a cessation intervention . SETTING Otolaryngology clinics at three Veterans Affairs medical centers ( Ann Arbor , MI , Gainesville , FL , and Dallas , TX ) , and the University of Michigan Hospital in Ann Arbor . SAMPLE 286 patients who had smoked within six months of the screening survey were eligible for a smoking-cessation intervention . METHODS Descriptive statistics and bivariate and multivariate logistic regression were used to determine the independent predictors of smokers ' participation in an intervention study . MAIN RESEARCH VARIABLES Perceived difficulty quitting ( as a construct of self-efficacy ) , health behaviors ( i.e. , smoking and problem drinking ) , clinical characteristics ( i.e. , depression and cancer site and stage ) , and demographic variables . FINDINGS Forty-eight percent of those eligible participated . High perceived difficulty quitting was the only statistically significant predictor of participation , whereas problem drinking , lower depressive symptoms , and laryngeal cancer site approached significance . CONCLUSIONS Special outreach may be needed to reach patients with head and neck cancer who are overly confident in quitting , problem drinkers , and patients with laryngeal cancer . IMPLICATION S FOR NURSING Oncology nurses are in an opportune position to assess patients ' perceived difficulty quitting smoking and motivate them to enroll in cessation programs , ultimately improving quality of life , reducing risk of recurrence , and increasing survival for this population OBJECTIVES To investigate the effects on serum lipids , plasma fibrinogen , plasma insulin , plasma C-peptide and blood glucose , of smoking cessation after 4 months . To develop a group-based smoking intervention programme in primary health care . SETTING Twenty health centres in primary health care in southern Sweden . SUBJECTS Four hundred habitual smokers ( > 10 cigarettes per day-1 , > 10 years ) , recruited by advertisement in local papers . INTERVENTION The smokers were r and omized , after stratification for age and sex , to one intervention group ( n = 200 ) and one control group ( n = 200 ) . The intervention group was offered supportive group sessions and free nicotine supplementation ( patches , chewing gum ) . MAIN OUTCOME MEASURES All participants were investigated at the start and after 4 months ( medical history , physical examination , laboratory evaluation ) . Blood sample s were drawn for determination of glucose , insulin and C-peptide , both in the fasting state and during an oral glucose tolerance test ( OGTT ) , and for measurement of lipoproteins , fibrinogen , nicotine and cotinine . RESULTS In the intervention group 98 of the subjects ( 48 % ) had quit smoking after 4 months . They were compared with the 156 subjects in the control group ( 91 % ) who were still daily smokers during the whole period . There were no significant differences in any variable between the two ( total ) experimental groups at baseline . Plasma nicotine and cotinine decreased ( P < 0.001 ) in the intervention group following smoking cessation , and weight increased by 2.7 kg . In the intervention group HDL-cholesterol increased by 11 % ( P < 0.001 ) , whereas HbA1c increased by 2 % ( P < 0.05 ) only in the control group . No changes occurred in levels of glucose , insulin , C-peptide and fibrinogen . CONCLUSION The smoking cessation programme had a success rate of almost 50 % over 4 months . Smoking cessation was associated with a marked increase in HDL-cholesterol levels but did not affect glucose tolerance . A concomitant weight increase may have blunted any independent beneficial effect of smoking cessation on glucose metabolism Tobacco Dependence among smokers with psychiatric disorders has been under-addressed by the mental health , addictions , and tobacco control communities . This study examined depressed smokers ' readiness to quit and the applicability of the Stages of Change framework to a psychiatric sample . Currently depressed smokers ( N=322 ) were recruited from four outpatient psychiatric clinics . Participants averaged 16 cigarettes per day ( S.D.=10 ) and 24 years ( S.D.=13 ) of smoking . The majority ( 79 % ) reported intention to quit smoking with 24 % ready to take action in the next 30 days . Individuals in the preparation stage reported more prior quit attempts , a greater commitment to abstinence , increased recognition of the cons of smoking , and greater use of the processes of change . Precontemplators were least likely to identify a goal related to their smoking behavior . Depressive symptom severity and history of recurrent depressive episodes were unrelated to readiness to quit . This study is one of the first to examine the smoking behaviors of currently depressed psychiatric out patients . The level and longevity of their tobacco use underscore the need for cessation interventions . The consistency in hypothesized patterns among theoretical constructs of the Stages of Change model supports the transfer of stage-tailored interventions to this clinical population Smoking exerts detrimental effects on dental treatment and oral health . Our goal was to evaluate effectiveness in terms of the abstinence rate in smoking-cessation intervention delivered by dental professionals . Individuals who were willing to quit smoking were r and omly assigned to either an intervention or a non-intervention group . Intensive intervention was provided , consisting of 5 counseling sessions , including an additional nicotine replacement regimen . Reported abstinence was verified by the salivary cotinine level . Thirty-three persons in the intervention and 23 in the non-intervention group started the trial . On an intent-to-treat basis , 3- , 6- and 12-month continuous abstinence rates in the intervention group were 51.5 % , 39.4 % , and 36.4 % , respectively , while the rates in the non-intervention group were consistent at 13.0 % . Adjusted odds ratios ( 95 % confidence interval ) by logistic stepwise regression analyses were 7.1 ( 1.8 , 28.5 ) , 8.9 ( 1.7 , 47.2 ) , and 6.4 ( 1.3 , 30.7 ) , respectively . Intensive smoking-cessation intervention in the dental setting was therefore effective INTRODUCTION Identifying successful smoking treatment interventions and methods of delivery is critical given the smoking rates among HIV-positive population s and the medical implication s of smoking in this population . This study compared the efficacy of 3 smoking cessation interventions provided in HIV clinical treatment setting s. METHODS Following a baseline assessment , 209 HIV-positive smokers were r and omly assigned to 1 of 3 conditions in a parallel group design . Treatment conditions were individual counseling plus nicotine replacement treatment ( NRT ) , a computer-based Internet smoking treatment plus NRT , and self-help plus NRT . Smoking status was determined at follow-up assessment s completed at 12 , 24 , 36 , and 52 weeks following treatment initiation . RESULTS Cessation rates ranged from 15 % to 29 % ; however , no statistically significant differences in abstinence were found among the treatment conditions over time . Those employed , those who reported a greater desire to quit , or those with lower mood disturbance scores were more likely to achieve abstinence ( p < .01 ) . The number of cigarettes participants reported smoking in the 24hr prior to each assessment significantly declined over time ( p < .001 ) . CONCLUSIONS Although we found no differences in abstinence rates across groups , the results indicate that integration of smoking cessation interventions is feasible in HIV clinical treatment setting s , and cessation results are promising . The overall abstinence rates we report are comparable to those found in similar treatment studies across multiple population s. Further research is warranted Background Tobacco use continues to be a global public health problem . Helping patients to quit is part of the preventive role of all health professionals . There is now increasing interest in the role that the dental team can play in helping their patients to quit smoking . The aim of this study was to determine the feasibility of undertaking a r and omised controlled smoking cessation intervention , utilising dental hygienists to deliver tobacco cessation advice to a cohort of periodontal patients . Methods One hundred and eighteen patients who attended Output:	Interventions that combine pharmacotherapy and behavioural support increase smoking cessation success compared to a minimal intervention or usual care . Although trials differed in the details of their population s and interventions , we did not detect any factors that modified treatment effects apart from the recruitment setting . We did not find evidence from indirect comparisons that offering more intensive behavioural support was associated with larger treatment effects
MS22393	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: PURPOSE To compare complication rates for distal radius fractures treated operatively versus nonsurgical in patients older than 65 years . We hypothesized that surgical intervention would improve fracture alignment , but it would be associated with more complications and equivalent functional outcomes when compared with the nonsurgical group . METHODS Patients ( operative , n = 129 ) and controls ( nonsurgical , n = 129 ) were identified from a prospect i ve clinical and operating room data base . They were matched on fracture severity ( AO-A/B/C1 vs AO-C2/C3 ) , sex , age , and energy of injury . Data on complications were extracted from medical charts using a vali date d complications checklist , and radiologic data were collected for all patients . Functional outcomes ( Patient-Related Wrist Evaluation ) at 1 year were available in only a subset of patients . We determined differences in complication and reoperation rates using a chi-square test . RESULTS A significant number of patients experienced complications in the operative group ( operative = 37 of 129 ; nonsurgical = 22 of 129 ) . The most common complication was median neuropathy ( n = 8 operative ; n = 14 nonsurgical ) , followed by surgical site infections ( n = 16 operative ; 12 of 16 were pin site infections ) and complex regional pain syndrome ( n = 4 operative ; 3 nonsurgical ) . The complication rate in patients treated with volar plate was 22 % ( 16 of 74 ) , for dorsal plate it was 50 % ( 2 of 4 ) , for external fixation it was 42 % ( 16 of 38 ) , and for percutaneous pinning it was 23 % ( 3 of 13 ) . The number of patients requiring reoperations was similar in both groups ( 11 [ 9 % ] operative ; 7 [ 5 % ] nonsurgical ) . Our secondary radiologic and functional outcomes demonstrate that despite a higher incidence of malunion in nonsurgical patients ( nonsurgical : 69 % vs operative : 29 % ) , a subset of patients from both groups ( n = 140 ) had minimal pain and disability at 1 year ( Patient-Related Wrist Evaluation operative : 16.9 ± 23.2 ; nonsurgical : 15.7 ± 17.5 ) . CONCLUSIONS In a study matching fracture severity , sex , age , and energy of injury , we found that elderly patients with distal radius fractures who underwent surgery had higher complication rates than those treated nonsurgically . TYPE OF STUDY /LEVEL OF EVIDENCE Therapeutic III We carried out a prospect i ve r and omised controlled clinical trial to compare the functional and radiological outcomes of casting with percutaneous pinning in treating extra-articular distal radial fracture in an elderly Chinese population . Sixty patients were r and omly allocated by sealed envelopes to either a ‘ Cast ’ group ( n = 30 ) or a ‘ K-wire ’ group ( n = 30 ) . All patients were available for final follow-up assessment . The radiological outcomes in terms of dorsal angulation , radial inclination and radial length were statistically significantly better in the K-wire group , whereas the Mayo wrist score and quality of life , healing rate , healing time , and complications were similar . The functional outcomes and quality of life were not affected by the treatments . Both treatments had a very low rate of complication and high healing rates PURPOSE The aim of this study was to compare the functional and radiographic outcomes of dorsally displaced distal radius fractures treated by closed reduction plaster cast fixation ( CRPCF ) and external fixation ( EF ) in patients 65 years and older . METHODS This retrospective and nonr and omized study comprised 46 consecutive patients older than 65 years who had distal radial fractures . Patients were divided into 2 groups according to treatment : a CRPCF group and an EF group . All the fractures were dorsally displaced and AO/ASIF type A or C , without articular stepoff or gap . Cases were evaluated based on the criteria of Disabilities of the Arm , Shoulder , and H and ( DASH ) question naire score , wrist range of motion , and radiologic results . RESULTS The mean follow-up period was 25.1 months . Union was achieved in all cases . Although it was not a statistically significant difference , posttreatment complications were more common in the CRPCF group ( 10 patients ) than in the EF group ( 7 patients ) . In the CRPCF group , most complications were discomfort from the cast , whereas in the EF group , most were pin site infections . The average wrist extension and ulnar deviation ( clinical ly ) and palmar tilt and radial height ( radiologically ) were statistically better in the EF group at the final follow-up . The mean DASH scores were 20.3 in the CRPCF group and 21.9 in the EF group . There was no statistically significant difference in the DASH scores ; in wrist flexion , radial deviation , pronation , supination , grip strength , or pinch strength ( clinical ly ) ; or in ulnar variance or radial inclination ( radiologically ) . There was no correlation between the DASH scores and palmar tilt and ulnar variance . CONCLUSIONS We concluded that both CRPCF and EF are useful methods for distal radius fractures in elderly patients . The results showed significant differences in wrist extension and ulnar deviation BACKGROUND Despite the recent trend toward the internal fixation of distal radial fractures in older patients , the currently available literature lacks adequate r and omized trials examining whether open reduction and internal fixation ( ORIF ) with a volar locking plate is superior to nonoperative ( cast ) treatment . The purpose of the present r and omized clinical trial was to compare the outcomes of two methods that were used for the treatment of displaced and unstable distal radial fractures in patients sixty-five years of age or older : ( 1 ) ORIF with use of a volar locking plate and ( 2 ) closed reduction and plaster immobilization ( casting ) . METHODS A prospect i ve r and omized study was performed . Seventy-three patients with a displaced and unstable distal radial fracture were r and omized to ORIF with a volar locking plate ( n = 36 ) or closed reduction and cast immobilization ( n = 37 ) . The outcome was measured on the basis of the Patient-Rated Wrist Evaluation ( PRWE ) score ; the Disabilities of the Arm , Shoulder and H and ( DASH ) score ; the pain level ; the range of wrist motion ; the rate of complications ; and radiographic measurements including dorsal radial tilt , radial inclination , and ulnar variance . RESULTS There were no significant differences between the groups in terms of the range of motion or the level of pain during the entire follow-up period ( p > 0.05 ) . Patients in the operative treatment group had lower DASH and PRWE scores , indicating better wrist function , in the early postoperative time period ( p < 0.05 ) , but there were no significant differences between the groups at six and twelve months . Grip strength was significantly better at all times in the operative treatment group ( p < 0.05 ) . Dorsal radial tilt , radial inclination , and radial shortening were significantly better in the operative treatment group than in the nonoperative treatment group at the time of the latest follow-up ( p < 0.05 ) . The number of complications was significantly higher in the operative treatment group ( thirteen compared with five , p < 0.05 ) . CONCLUSIONS At the twelve-month follow-up examination , the range of motion , the level of pain , and the PRWE and DASH scores were not different between the operative and nonoperative treatment groups . Patients in the operative treatment group had better grip strength through the entire time period . Achieving anatomical reconstruction did not convey any improvement in terms of the range of motion or the ability to perform daily living activities in our cohorts OBJECTIVE To compare the differences of the efficacy between the conservative treatment and surgical treatment for unstable distal radius fractures with surgical indications . METHODS From March 2008 to July 2011 , the patients with unstable distal radius fractures were devided into the surgical treatment group and the conservative treatment group in a non r and omized manner . In the surgical group , there were 16 males and 32 females with an average age of 50.26 years old ranging from 22 to 76 years ; in the conservative treatment group there were 10 males and 27 females with an average age of 51.12 years old ranging from 42 to 79 years . The patients of two groups were almost all with falling damage trauma , which accounting for 92.94 % ( 79/85 ) , all the patients were closed injury , 41 cases were in the left side , and 44 cases in the right . Fracture in accordance with AO classification : C1 in 12 cases , C2 in 32 cases , C3 in 38 cases , B3 in 3 cases . Patients in the surgical treatment group were treated with volar locking compression plate ( LCP ) fixation and patients in the conservative were treated with manual reduction and plaster external fixation . The active wrist range of motion , pain assessment , subjective evaluation , Gartl and and Werley score , Batra radiology score and complications were observed in the last follow-up . RESULTS Forty-three patients in the surgical treatment group were followed up for an average time of 8.03 months ( 4 to 15 months ) ; 33 paitents in the conservative group were followed up for an average time of 6.54 months ( 2 to 9 months ) . The difference of the wrist joint active dorsiflexion and supination rotation range in the two groups were statistically significant ( t = 2.212 , P < 0.05 ; t = 2.392 , P < 0.05 ) ; the difference of the proportion of patients with ulnar wrist pain in the two groups was statistically significant ( chi2 = 5.71 , P < 0.05 ) ; the difference of patients ' subjective evaluation score of two groups was statistically significant ( Z = 2.13 , P < 0.05 ) ; the difference of Gartl and and Werley score between the two groups was statistically significant ( Z = 2.36 , P < 0.05 ) ; the difference of Batra radiology score in the two groups was statistically significant ( Z = 2.58 , P < 0.05 ) ; the differences in the X-ray measurement of the proportion of distal radial shortening > or = 5 mm , the radial height ( shortening ) was statistically significant ( for the correction chi2 = 7.57 , P < 0.05 ; t = 2.016 , P < 0.05 ) ; the differences of malunion rate , ulnar impaction syndrome , the incidence rate of ulnar styloid fracture nonunion of two groups was statistically significant ( adjusted chi2 = 10.05 , P < 0.05 ; chi2 = 8.39 , P < 0.05 ; chi2 = 5.51 , P < 0.05 ) . CONCLUSION For patients with surgical indications for unstable distal radius fractures , every indicator of the outcome after surgery in the treatment is better than that of the manipulative reduction and plaster fixation BACKGROUND From 2000 to 2012 , the annual incidence of inpatient treatment for distal radius fracture in Germany rose from 65 to 86 per 100 000 persons . It is unclear whether open reduction and volar angle-stable plate osteo synthesis ( ORIF ) , a currently advocated treatment , yields a better functional outcome or quality of life than closed reposition and casting . METHODS In the ORCHID multi-center trial , 185 patients aged 65 and older with an AO type C distal radial fracture were r and omly assigned to ORIF or closed reposition and casting . Their health-related quality of life and h and /arm function were assessed 3 and 12 months afterward with the Short Form 36 ( SF-36 ) question naire and the Disability of the Arm , Shoulder and H and ( DASH ) question naire . The radiological findings , range of movement of the wrist , and EuroQol-5D ( EQ-5D ) scores were documented as well . RESULTS Among the 149 patients in the intention-to-treat- analysis , there was no significant difference in SF-36 scores between the two treatment groups at one year ( mean difference , 3.3 points in favor of ORIF ; 95 % confidence interval , -0.2 + 6.8 points ; p = 0.058 ) . The DASH scores showed moderately strong , but clinical ly unimportant effects in favor of ORIF , and there was no difference in EQ-5D scores . ORIF led to better radiological results and wrist mobility at 3 months , with comparable results at 12 months . 37 of the patients initially allotted to nonsurgical treatment underwent secondary surgery due to significant loss of reduction . CONCLUSION The findings with respect to mobility , functionality , and quality of life at 12 months provide marginal and inconsistent evidence for the superiority of volar angle-stable plate osteo synthesis over closed reduction and casting in the treatment of intra-articular distal radius fractures . Primary nonsurgical management is also effective in suitable patients OBJECTIVE To examine the incidence and predictors of complex regional pain syndrome type I ( CRPS I ) after fracture of the distal radius . DESIGN Prospect i ve study . SETTING University hospital . PARTICIPANTS A consecutive sample of patients ( N=90 ) with fracture of the distal radius treated by closed reduction and casting . INTERVENTIONS Not applicable . MAIN OUTCOME MEASURES Occurrence of CRPS I , occurrence of pain , wrist and h and range of motion , radiographic measures , Patient-Rated Wrist Evaluation , Hospital Anxiety and Depression Scale , and Medical Outcomes Study Output:	The nonsurgical group had significantly greater wrist flexion , radial deviation , and ulnar variance and less radial inclination than the surgical group . Conclusions Surgical and nonsurgical methods produce similar results in the treatment of DRFS in the elderly , and minor objective functional differences did not result an impact on subjective function outcome and quality of life
MS22394	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: OBJECTIVES ( 1 ) To conduct a contemporary analysis of historical data on short-term efficacy of a 3-year hearing conservation program conducted from 1992 to 1996 in Wisconsin , USA , with 753 high school students actively involved in farm work ; ( 2 ) to establish procedures for assessment of hearing loss for use in a recently funded follow-up of this same hearing conservation program cohort . METHODS We analyzed a pragmatic cluster-r and omized controlled trial , with schools as the unit of r and omization . Thirty-four rural schools were recruited and r and omized to intervention or control . The intervention included classroom instruction , distribution of hearing protection devices , direct mailings , noise level assessment s , and yearly audiometric testing . The control group received the audiometric testing . RESULTS Students exposed to the hearing conservation program reported more frequent use of hearing protection devices , but there was no evidence of reduced levels of noise-induced hearing loss ( NIHL ) . CONCLUSION Our analysis suggests that , since NIHL is cumulative , a 3-year study was likely not long enough to evaluate the efficacy of this intervention . While improvements in reported use of hearing protection devices were noted , the lasting impact of these behaviors is unknown and the finding merits corroboration by longer term objective hearing tests . A follow-up study of the cohort has recently been started OBJECTIVES : Concerts have long periods of intense sound with short break intervals . Hearing concerns are well known to performers ; concertgoers largely ignore them . Preperformance and postperformance audiograms were compared to assess hearing threshold shifts with and without earplugs . METHODS : A prospect i ve , r and omized study in which 29 volunteers attended 3 concerts , encompassing 3 music genres . Audiograms , seating location , sound intensity , and earplug-use data were collected . Data were analyzed to determine frequency test-retest variability . RESULTS : Sound levels averaged 99.8 dBA , and the maximum was 125.6 dBA . Sixty-four percent ( 9/14 ) of participants without earplugs showed significant threshold shifts compared with 27 % ( 4/15 ) of those using earplugs . No significant differences existed between music genres or seating location . CONCLUSIONS : This study showed a high incidence of threshold shifts in unprotected concertgoers . Sound levels exceeded all Occupational Safety and Health Act rules despite st and ardized sound systems . A significant reduction in threshold shifts was seen with the use of earplugs This experiment investigated the effect of small-group versus individual hearing loss prevention ( HLP ) training on the attenuation performance of passive insert-type hearing protection devices ( HPDs ) . A subject-fit ( SF ) methodology , which gave naive listeners access only to the instructions printed on the HPD product label , was used to determine real-ear attenuation at threshold ( REAT ) at third-octave noise b and s between 125–8000 Hz . REAT measurements were augmented by use of the Hearing Loss Prevention Attitude-Belief ( HLPAB ) survey , a field-tested self- assessment tool developed by the National Institute for Occupational Safety and Health ( NIOSH ) . Participants were r and omly assigned to one of four experimental groups , consisting of 25 listeners each , in a controlled behavioral-intervention trial . There were two types of HPDs ( formable and premolded ) and two training formats ( individual and small group ) . A short multimedia program , including a practice session , was presented to all 100 listeners . Results showed training to have a significant effect , for both HPDs on real-ear attenuation and attitude , but , importantly , there was no difference between small-group and individual training Background About 15 % of adolescents in the Netherl and s have mental health problems and many also have health risk behaviours such as excessive alcohol consumption , cigarette smoking , use of drugs , and having unsafe sex . Mental health problems and health risk behaviours may have adverse effects on the short and longer term . Therefore , in the Netherl and s there is a considerable support for an additional public health examination at age 15–16 years . The study evaluates the effect of two options for such an additional examination . Adolescents in the ‘ E-health4Uth ’ group receive internet-based tailored health messages on their health behaviour and well-being . Adolescents in the ‘ E-health4Uth + counselling ’ group receive the computer-tailored messages combined with personal counselling for adolescents at risk of mental health problems . Methods and design A three-arm cluster r and omised controlled trial will be conducted in the Netherl and s among fourth- grade secondary school students . School classes are the unit of r and omisation . Both intervention groups complete the computer-tailored program during one class session ; the program focuses on nine topics related on health behaviour and well-being . For each topic a score is computed that can be compared with the Dutch health norms for adolescents . Based on the score , a message is presented that reflects the person ’s current behaviour or well-being , the Dutch health norm , and offers advise to change unhealthy behaviour or to talk to a person they trust . Adolescents in the ‘ E-health4Uth + counselling ’ group are also invited for an appointment to see the nurse when they are at risk of mental health problems . The control group receives ‘ care as usual’.The primary outcome measures are health behaviour ( alcohol , drugs , smoking , safe sex ) and mental health status . The secondary outcome measure is health-related quality of life . Data will be collected with a question naire at baseline and at 4-months follow-up . A process evaluation will also be conducted . Discussion It is hypothesized that at follow-up adolescents in the ‘ E-health4Uth ’ group and adolescents in the ‘ E-health4Uth + counselling ’ group will show fewer mental health problems and less risky behaviour compared to the control group . Trial registration Current Controlled Trials OBJECTIVE To assess the impact of a web-based intervention supplemented with text messages to reduce cancer risk linked with smoking , unhealthy diet , alcohol consumption , obesity , sedentary lifestyle and sun exposure . METHODS A total of 2001 voluntary adolescents from Spain and Mexico were recruited between 2009 and 2012 and r and omly assigned to : one control group and two experimental groups , which received exclusively the online intervention ( experimental group 1 ) or the intervention supplemented with encouraging text messages ( experimental group 2 ) . The educational intervention was based on both : successful psychosocial models ( i.e. A.S.E. and Transtheoretical model ) and the school curriculum . RESULTS After a 9-month follow-up , the prevalence of students who did not eat fruit was reduced significantly in all groups : experimental group 1 ( -62.6 % ) , experimental group 2 ( -71.5 % ) and even the control group ( -66.8 % ) . Being overweight was only reduced in the experimental group 2 ( -19.6 % ) . The total cancer behavioral risk score , which ranged from 0 to 100 points ( highest risk ) , was significantly reduced in the experimental group 1 ( -3.5 points ) and in the experimental group 2 ( -5.3 points ) . The text-supplemented online intervention increased the probability of improving the post-test total cancer behavioral risk ( OR=1.62 ) . CONCLUSION The web-based intervention supplemented with text messages had a positive global impact , but it lead to only minimal changes in risky behaviors . This intervention appears useful in controlling overweight adolescents . CLINICAL TRIAL REGISTRATION NUMBER IS RCT N27988779 OBJECTIVE To assess the efficacy of a hearing conservation program in changing acoustic risk-taking and hearing conservation behaviors in elementary school children . STUDY DESIGN Prospect i ve , r and omized , mixed design controlled study . METHODS Participants were grade -six students from 16 Vancouver School Board schools . Differences between the intervention and control group responses on a behavioral question naire were measured at baseline , and then at 2 weeks and 6 months after administration of a hearing conservation program ( Sound Sense ™ ) . RESULTS The intervention result ed in significant interactions for improved earplug use at dances ( P = .019 ) , rock concerts ( P = .001 ) , with percussion musical instruments ( P = .002 ) , and electric guitars ( P = .028 ) at 2 weeks postintervention relative to baseline . Improvements in children 's earplug use at dances ( P = .041 ) , rock concerts ( P = .0024 ) , and with power lawn mowers ( P = .043 ) at 6 months postintervention relative to baseline were also observed . Behavior in the intervention group compared to control group improved in earplug use with any " other noises " at 2 weeks ( P = .001 ) , and 6 months ( P = .022 ) relative to baseline . There was a tendency in the intervention group to reduce the duration of use of personal music devices at 2 weeks and 6 months after the hearing conservation program , which was nonsignificant . CONCLUSION The Sound Sense ™ hearing conservation program improved earplug use practice s in elementary school children in the short and long term . The development , implementation and evaluation of a community-based health promotion project around hearing loss can serve as a tremendous opportunity for students to develop their knowledge and skills in health advocacy Adolescents working in agricultural setting s may be exposed to noise levels that result in hearing loss . The article describes the design , implementation , and results of a four-year , hearing conservation program ( HCP ) conducted at school . Thirty-four schools ( 753 students ) were r and omly assigned to either an intervention or control group . The intervention included multicomponent educational strategies and employed features of an industrial HCP . Final compliance surveys indicated 87.5 % of intervention students reported using hearing protection devices ( HPD ) at least some of the time , compared to 45 % of control students . The HCP components with the greatest reported influence were distribution of HPDs for use on the farm and yearly hearing tests . Eighty percent of intervention students reported intention to use HPDs in the future . It is feasible to conduct a hearing conservation program with junior high school and senior high school students , and it appears possible to persuade teen-agers to protect themselves from exposure to loud noise while working on a farm Abstract Objective : Adolescent farmworkers are exposed to loud noise during farm activities . We present a prospect i ve study that evaluated the efficacy of low-cost , technology-based intervention approaches in high schools to enhance the use of hearing protection among adolescent farmworkers . Design : Six high schools in Iowa that agreed to participate in the study were divided into three equal groups through cluster-r and omisation with each group receiving one of the three formats of hearing protection intervention : ( a ) classroom training , ( b ) classroom training coupled with smartphone app training and ( c ) computer training . Participants completed baseline ( pre-training ) and six-week post-intervention surveys for assessing hearing protection knowledge , attitudes and behaviour . Study Sample : Seventy participants from six schools were initially enrolled but 50 completed both pre- and post-intervention surveys . Results : In most cases , all three groups showed significant improvement in hearing protection knowledge , attitude and frequency of use from pre- to post-intervention . However , changes between groups were statistically non-significant . Conclusions : Although all three formats led to improvements on hearing protection knowledge , attitude and behaviour , the findings of the study , perhaps due to the small sample size , did not allow us to detect whether technology-based hearing protection interventions were more effective than the traditional face-to-face training for adolescent farmworkers OBJECTIVES : We had the rare opportunity to conduct a cluster-r and omized controlled trial to observe the long-term ( 16-year ) effects of a well- design ed hearing conservation intervention for rural high school students . This trial assessed whether the intervention result ed in ( 1 ) reduced prevalence of noise-induced hearing loss ( NIHL ) assessed clinical ly and /or ( 2 ) sustained use of hearing protection devices . METHODS : In 1992–1996 , 34 rural Wisconsin schools were recruited and 17 were assigned r and omly to receive a comprehensive , 3-year , hearing conservation intervention . In 2009–2010 , extensive efforts were made to find and contact all students who completed the original trial . Participants in the 16-year follow-up study completed an exposure history question naire and a clinical audiometric examination . Rates of NIHL and use of hearing protection were compared . RESULTS : We recruited 392 participants from the original trial , 200 ( 53 % ) from the intervention group and 192 ( 51 % ) from the control group . Among participants with exposure to agricultural noise , the intervention group reported significantly greater use of hearing protection compared with the control group ( 25.9 % vs 19.6 % ; P = .015 ) . The intervention group also reported significantly greater use of hearing protection for shooting guns ( 56.2 % vs 41.6 % ; P = .029 ) , but the groups reported similar uses of protection in other context s. There was no significant difference between groups with respect to objective measures of NIHL . CONCLUSION : This novel trial provides objective evidence that a comprehensive educational intervention by itself may be of limited effectiveness in preventing NIHL in a young rural population PURPOSE Few computer-based HIV , sexually transmitted infection ( STI ) , and pregnancy prevention programs are available , and even fewer target early adolescents . In this study , we tested the efficacy of It 's Your Game (IYG)-Tech , a completely computer-based , middle school sexual health education program . The primary hypothesis was that students who received IYG-Tech would significantly delay sexual initiation by ninth grade . METHODS We evaluated IYG-Tech using a r and omized , two-arm nested design among 19 schools in a large , urban school district in southeast Texas ( 20 schools were originally r and omized ) . The target population was English-speaking eighth- grade students who were followed into the ninth grade . The final analytic sample included 1,374 students . Multilevel logistic regression models were used to test for differences Output:	While use of technology in hearing conservation educational programs offers promise , its effectiveness has not been studied
MS22395	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: Background and Purpose — Among patients with acute stroke , high blood pressure is often associated with poor outcome , although the reason is unclear . We analyzed data from the International Stroke Trial ( IST ) to explore the relationship between systolic blood pressure ( SBP ) , subsequent clinical events over the next 2 weeks , and functional outcome at 6 months in patients with acute stroke . Methods — We included in the analysis 17 398 patients from IST with confirmed ischemic stroke . A single measurement of SBP was made immediately before r and omization . Clinical events within 14 days of r and omization were recorded : recurrent ischemic stroke , symptomatic intracranial hemorrhage , death result ing from presumed cerebral edema , fatal coronary heart disease , and death . Survival and dependency were assessed at 6 months . Outcomes were adjusted for age , sex , clinical stroke syndrome , time to r and omization , consciousness level , atrial fibrillation , and treatment allocation ( aspirin , unfractionated heparin , both , or neither ) . Results — A U-shaped relationship was found between baseline SBP and both early death and late death or dependency : early death increased by 17.9 % for every 10 mm Hg below 150 mm Hg ( P < 0.0001 ) and by 3.8 % for every 10 mm Hg above 150 mm Hg ( P = 0.016 ) . The rate of recurrent ischemic stroke within 14 days increased by 4.2 % for every 10–mm Hg increase in SBP ( P = 0.023 ) ; this association was present in both fatal and nonfatal recurrence . Death result ing from presumed cerebral edema was independently associated with high SBP ( P = 0.004 ) . No relationship between symptomatic intracranial hemorrhage and SBP was seen . Low SBP was associated with a severe clinical stroke ( total anterior circulation syndrome ) and an excess of deaths from coronary heart disease ( P = 0.002 ) . Conclusions — Both high blood pressure and low blood pressure were independent prognostic factors for poor outcome , relationships that appear to be mediated in part by increased rates of early recurrence and death result ing from presumed cerebral edema in patients with high blood pressure and increased coronary heart disease events in those with low blood pressure . The occurrence of symptomatic intracranial hemorrhage within 14 days was independent of SBP BACKGROUND We assessed patient outcomes 90 days after hospital admission for stroke following a multidisciplinary intervention targeting evidence -based management of fever , hyperglycaemia , and swallowing dysfunction in acute stroke units ( ASUs ) . METHODS In the Quality in Acute Stroke Care ( QASC ) study , a single-blind cluster r and omised controlled trial , we r and omised ASUs ( clusters ) in New South Wales , Australia , with immediate access to CT and on-site high dependency units , to intervention or control group . Patients were eligible if they spoke English , were aged 18 years or older , had had an ischaemic stroke or intracerebral haemorrhage , and presented within 48 h of onset of symptoms . Intervention ASUs received treatment protocol s to manage fever , hyperglycaemia , and swallowing dysfunction with multidisciplinary team building workshops to address implementation barriers . Control ASUs received only an abridged version of existing guidelines . We recruited pre-intervention and post-intervention patient cohorts to compare 90-day death or dependency ( modified Rankin scale [ mRS ] ≥2 ) , functional dependency ( Barthel index ) , and SF-36 physical and mental component summary scores . Research assistants , the statistician , and patients were masked to trial groups . All analyses were done by intention to treat . This trial is registered at the Australia New Zeal and Clinical Trial Registry ( ANZCTR ) , number ACTRN12608000563369 . FINDINGS 19 ASUs were r and omly assigned to intervention ( n=10 ) or control ( n=9 ) . Of 6564 assessed for eligibility , 1696 patients ' data were obtained ( 687 pre-intervention ; 1009 post-intervention ) . Results showed that , irrespective of stroke severity , intervention ASU patients were significantly less likely to be dead or dependent ( mRS ≥2 ) at 90 days than control ASU patients ( 236 [ 42 % ] of 558 patients in the intervention group vs 259 [ 58 % ] of 449 in the control group , p=0·002 ; number needed to treat 6·4 ; adjusted absolute difference 15·7 % [ 95 % CI 5·8 - 25·4 ] ) . They also had a better SF-36 mean physical component summary score ( 45·6 [ SD 10·2 ] in the intervention group vs 42·5 [ 10·5 ] in the control group , p=0·002 ; adjusted absolute difference 3·4 [ 95 % CI 1·2 - 5·5 ] ) but no improvement was recorded in mortality ( 21 [ 4 % ] of 558 in intervention group and 24 [ 5 % ] of 451 in the control group , p=0·36 ) , SF-36 mean mental component summary score ( 49·5 [ 10·9 ] in the intervention group vs 49·4 [ 10·6 ] in the control group , p=0·69 ) or functional dependency ( Barthel Index ≥60 : 487 [ 92 % ] of 532 patients vs 380 [ 90 % ] of 423 patients ; p=0·44 ) . INTERPRETATION Implementation of multidisciplinary supported evidence -based protocol s initiated by nurses for the management of fever , hyperglycaemia , and swallowing dysfunction delivers better patient outcomes after discharge from stroke units . Our findings show the possibility to augment stroke unit care . FUNDING National Health & Medical Research Council ID 353803 , St Vincent 's Clinic Foundation , the Curran Foundation , Australian Diabetes Society-Servier , the College of Nursing , and Australian Catholic University BACKGROUND AND PURPOSE The efficacy of stroke units has been extensively examined . It is unknown , however , whether the superiority of the stroke unit will remain after the increased focus on stroke treatment in general medicine . This study of patients admitted to the hospital early and with a short length of stay determines the effect and identifies certain important components of a stroke unit . METHODS Five hundred fifty patients aged 60 years or older with acute stroke were allocated by a quasi-r and omized design to a stroke unit or a general medical ward based on date of birth in the month . Patients admitted within 24 hours of onset were enrolled . Outcomes after 7 months were death , proportion needing long-term care , and change in neurological and functional state assessed by the Sc and inavian Stroke Scale and Barthel Index . RESULTS Seven months after admission there was a trend in favor of the stroke unit in all outcome measures , but no significant differences in clinical outcomes were found except for change in the Sc and inavian Stroke Scale score . Recurrent stroke during hospitalization occurred more often in the general medical ward ( P = .03 ) . The stroke unit was significantly more aggressive in mobilization out of bed ( P<.01 ) and use of parenteral fluid ( P<.0001 ) , aspirin ( P<.0001 ) , antipyretics ( P<.0001 ) , and antibiotics ( P<.0001 ) . CONCLUSIONS Our study confirms the benefit of the stroke unit , but the effects on the most reliable clinical outcomes were modest and insignificant . Treatment in this stroke unit hastened recovery . More aggressive rehabilitation and use of parenteral fluid , aspirin , antipyretics , and antibiotics appeared in the stroke unit Background : Stroke patients are more likely to make a good recovery if they receive care in a well-organised stroke unit . However , there are uncertainties about how best to provide such care . We studied 2 key aspects of early stroke unit care : early active mobilisation ( EM ) and automated monitoring ( AM ) for physiological complications such as hypoxia . Methods : This was an observer-blinded , factorial ( 2 × 2 ) pilot r and omised controlled trial recruiting stroke patients within 36 h of symptom onset . The patients were r and omised to 1 of 4 nurse-led treatment protocol s : ( a ) st and ard stroke unit care , ( b ) EM , ( c ) AM or ( d ) combined EM and AM . The primary outcome was the Rankin score at 3 months . We also report the data on feasibility and safety . Results : We r and omised 32 patients ( mean age = 65 years ; mean baseline modified NIH score = 6 ) . On unadjusted comparisons , the EM patients were significantly ( p < 0.05 ) more likely to mobilise very early ( within 1 h of r and omisation ) and to achieve walking by day 5 and were less likely to develop complications of immobility . The AM group was significantly ( p < 0.05 ) more likely to have pre-defined physiological complication events detected . All these associations remained , but were less statistically significant , after correcting for age , baseline NIH score and co- interventions . There were no significant safety concerns . Discussion : We have demonstrated the feasibility of implementing EM and AM for physiological complications in a r and omised controlled trial . Larger trials are warranted to determine whether these interventions have clinical benefits BACKGROUND In laboratory animals , cerebral ischaemia is worsened by hyperthermia and improved by hypothermia . Whether these observations apply to human beings with stroke is unknown . We therefore examined the relation between body temperature on admission with acute stroke and various indices of stroke severity and outcome . METHODS In a prospect i ve and consecutive study 390 stroke patients were admitted to hospital within 6 h after stroke ( median 2.4 h ) . We determined body temperature on admission , initial stroke severity , infa rct size , mortality , and outcome in survivors . Stroke severity was measured on admission , weekly , and at discharge on the Sc and inavian Stroke Scale ( SSS ) . Infa rct size was determined by computed tomography . Multiple logistic and linear regression outcome analyses included relevant confounders and potential predictors such as age , gender , stroke severity on admission , body temperature , infections , leucocytosis , diabetes , hypertension , atrial fibrillation , ischaemic heart disease , smoking previous stroke , and comorbidity . FINDINGS Mortality was lower and outcome better in patients with mild hypothermia on admission ; both were worse in patients with hyperthermia . Body temperature was independently related to initial stroke severity ( p < 0.009 ) , infa rct size ( p < 0.0001 ) , mortality ( p < 0.02 ) , and outcome in survivors ( SSS at discharge ) ( p < 0.003 ) . For each 1 degrees C increase in body temperature the relative risk of poor outcome ( death or SSS score on discharge < 30 points ) rose by 2.2 ( 95 % CI 1.4 - 3.5 ) ( p < 0.002 ) . INTERPRETATION We have shown that , in acute human stroke , an association exists between body temperature and initial stroke severity , infa rct size , mortality , and outcome . Only intervention trials of hypothermic treatment can prove whether this relation is causal Background and Purpose — Although several studies have demonstrated the effectiveness of specialist Stroke Unit ( SU ) care of stroke patients , there is still disagreement over how these units are best organized . We sought to clarify the role of continuous monitoring of physiological parameters in acute ischemic stroke . Methods — We conducted a prospect i ve study of 268 first-ever ischemic stroke patients admitted to our Cerebrovascular Department and allocated , according to the availability of beds , to the SU or Cerebrovascular Unit ( CU ) . Statistical analysis compared mortality and outcome at discharge , medical and neurological complications , and length of hospitalization in the 2 care setting s. Results — Two hundred sixty-eight patients were enrolled . A good outcome at discharge , observed in 114 SU patients ( 85 % ) and 78 CU patients ( 58 % ) ( odds ratio , 2.63 ; 95 % CI , 1.4 to 4.8 ; P < 0.02 ) , was found , on multivariate analysis , to be significantly related to type of care ( SU versus CU ) . A significantly greater proportion of SU patients showed adverse changes in monitored parameters , which required acute medical treatment ( SU : 64 % ; CU : 19 % ; P < 0.0001 ) . The mean duration of these complications was significantly shorter in the SU patients ( SU : 1.0 day ; CU : 2.4 days ; P < 0.02 ) , and the outcome in patients experiencing complications covered by the monitoring protocol was significantly better in the SU ( 66 % ) than in the CU ( 35 % ) group ( P < 0.0001 ) . Conclusions — Admission of acute stroke patients to a monitoring SU may positively influence their outcome at discharge . Confirmation of our findings in larger trials will indicate the need for a revision of the minimum requirements of SUs , with the addition of monitoring as a new requirement BACKGROUND AND PURPOSE We have previously shown that treatment of acute stroke patients in our stroke unit ( SU ) compared with treatment in general ward ( GWs ) improves short- and long-term survival and functional outcome and increases the possibility of earlier discharge to home . The aim of the present study was to identify the differences in treatment between the SU and the GW and to assess which aspects of the SU care which were most responsible for the better outcome . METHODS Of the 220 patients included in our trial , only 206 were actually treated ( SU , 102 patients ; GW , 104 patients ) . For these patients , we Output:	Continuous monitoring of physiological variables for the first two to three days may improve outcomes and prevent complications .
MS22396	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: The clinical implication s of sensitization to the fragrance material isoeugenol were studied in 19 subjects . Patch testing with serial dilutions of isoeugenol and a repeated open application test ( ROAT ) were performed The minimum effect level under patch test conditions was below 0.01 % isoeugenol in 4/19 ( 20 % ) of the test subjects . The ROAT was performed with a test solution of 0.2 % isoeugenol in ethanol . which is the recommended maximum concentration used in perfumes , ethanol being applied as vehicle control . 4 weeks was the maximum exposure period . The upper arm was used as test site the 1st 14 days and the upper arm as well as the neck for the next 14 days , 12/19 ( 63 % ) of test subjects had a positive ROAT . 4 of the responders ( 33 % ) reacted beyond day 7 , but none alter day 14 . Use testing on the neck for 14 days did not add any further ROAT‐positive cases , compared with testing on the upper arm . The sensitivity found on patch testing may be a guidance for the outcome of use tests with the same compound . In this study , all subjects with a positive use test to isoeugenol ( 0.2 % ) in ethanol also demonstrated on patch testing a minimum effect level of 0.2 % or lower . Data from serial dilution patch and use IC‐N may contribute significant information to assessment of the relationship between patch test responses and clinical contact hypersensitivity , and thus the safety of allergens used in cosmetics OBJECTIVES To assess the effect of incentive size on response rates , data quality , and cost in a digestive health status mail survey of a community sample of health plan enrollees . DATA SOURCES / SETTING The study population was selected from a data base of enrollees in various health plans obligated to receive care at Park Nicollet Clinic-HealthSystem Minnesota , a large , multispecialty group in Minneapolis , Minnesota , and the nearby suburbs . STUDY DESIGN A total of 1,800 HealthSystem Minnesota enrollees were r and omly assigned to receive a survey with an incentive of $ 5 or $ 2 . The response rates for each incentive level were determined . Data quality , as indicated by item nonresponse and scale scores , was measured . Total cost and cost per completed survey were calculated . PRINCIPAL FINDINGS The response rate among enrollees receiving $ 5 ( 74.3 percent ) was significantly higher than among those receiving $ 2 ( 67.4 percent ) ; differences were more pronounced in the first wave of data collection . Data quality did not differ between the two incentive groups . The total cost per completed survey was higher in the $ 5 condition than in the $ 2 condition . CONCLUSIONS A $ 5 incentive result ed in a higher response rate among a community patient sample with one mailing than did a $ 2 incentive . However , the response rates in the $ 2 condition approached the level of the $ 5 incentive , and costs were significantly lower when the full follow-up protocol was completed . Response rates were marginally increased by follow-up phone calls . The incentive level did not influence data quality . The results suggest if a survey budget is limited and a timeline is not critical , a $ 2 incentive provides an affordable means of increasing participation The pattern of patch test reactivity to nickel sulfate and fragrance mix was studied with respect to patch test performance , reproducibility and clinical relevance in a population of unselected infants followed prospect ively from birth to 18 months of age . TRUE Test ™ patches with nickel sulfate in 3 concentrations , 200 , 66 and 22 µg/cm2 , and fragrance mix 430 µg/cm2 were used . A likely case of nickel sensitivity was defined as a reproducible positive reaction with at least homogeneous erythema and palpable infiltration occurring at least 2 × and present at both the 12 and 18 months follow‐up . 543 infants ( 268 girls and 275 boys ) were tested at least 1 × , 304 were tested at both 12 and 18 months . The prevalence of a reproducible positive reaction to nickel was 8.6 % ( 20 girls and 6 boys ) . A transient positive reaction was observed in 111 children . Clinical relevance of nickel sensitivity was found in only 1 child . No reproducible positive reaction to fragrance mix was found . The high proportion of transient patch test reactivity to nickel sulfate 200 µg/cm2 indicates that this st and ard concentration used for adults can not be applied to infants . The interpretation of a single positive nickel patch test in infants must be assessed with caution and it is probably of non‐specific or irritant nature BACKGROUND There is a big contradiction in the medical literature regarding the relationship between atopy and contact hypersensitivity . Some research ers believe that atopy would prevent , whereas others believe that it would promote , the development of contact allergy . Possible causes of this confusion range from different study population s to different definitions of atopy . OBJECTIVE To evaluate the relationship between atopy and contact hypersensitivity in a well-defined general population sample using objective ly measurable markers . METHODS I studied 135 r and omly selected students from 5 vocational schools : 73 women and 62 men aged 18 to 19 years . The following atopy markers were tested : positive skin prick test results , positive Phadiatop test results , and total IgE levels greater than 120 kU/L. Contact hypersensitivity was detected by using patch tests . Statistical analyses included the Fisher exact test , the Mann-Whitney U test , and calculation of odds ratios . RESULTS At least 1 positive skin prick test result was found in 23.7 % ( 95 % confidence interval [ CI ] , 16.5%-30.9 % ) of study participants , positive Phadiatop test results were found in 20.0 % ( 95 % CI , 13.3%-26.7 % ) , and total IgE levels greater than 120 kU/L were found in 23.7 % ( 95 % CI , 16.5%-30.9 % ) . Positive patch test reactions were found in 28.1 % ( 95 % CI , 20.6%-35.7 % ) of participants , most frequently to thimerosal ( 18.5 % ; 95 % CI , 12.0%-25.1 % ) and nickel ( 9.6 % ; 95 % CI , 4.6%-14.6 % ) . For persons with atopy markers , odds ratios for contact hypersensitivity ranged from 1.0 to 3.2 , the highest being for nickel hypersensitivity among those with total IgE levels greater than 120 kU/L. None of these relationships were statistically significant . CONCLUSION Atopy and contact hypersensitivity are independent phenomena Few studies have so far addressed the prevalence and risk factors for contact sensitization in the general adult population ; however , many such studies have been conducted in hospitals . We present the prevalence of contact sensitization in a general adult population and its relationship to potential risk factors like smoking , ear piercing and atopic diseases . 1236 adults ( 44.2 % men and 55.8 % women ) were r and omly selected from a cross‐section of the population in Sør‐Varanger municipality , Norway , and patch tested with TRUE Test ( Pharmacia , Hillerød , Denmark ) . Contact sensitivity to at least 1 out of 24 allergens was found in 35.4 % of the women and in 14.8 % of the men . The most common allergens were nickel ( 17.6 % ) , cobalt ( 2.8 % ) , thiomersal ( 1.9 % ) , fragrance mix ( 1.8 % ) and colophony ( 1.2 % ) . All other allergens were observed in 1.0 % or less . In women , ear piercing was an important risk factor for nickel sensitization . No such significant correlation was seen in men [ in women relative risk ( RR ) = 3.30 , 95 % confidence interval ( CI ) = 2.01–5.43 , and in men RR = 1.82 , 95 % CI = 0.66–5.00 ] , and contact sensitivity was associated with atopic dermatitis ( AD ) [ adjusted odds ratio ( OR ) = 1.58 , 95 % CI = 1.04–2.40 ] and smoking ( adjusted OR = 1.42 , 95 % CI = 1.01–1.99 ) in women but not in men . The prevalence of contact sensitivity was common in this general population , especially in women . Smoking and AD might be a risk factor for contact sensitization This is a report on a comparative study of the reactivity of TRUE test and Finn Chamber patch test techniques . 413 patients attending a contact dermatitis clinic in Singapore were simultaneously patch tested with panels 1 and 2 of the TRUE test st and ard series and with corresponding allergens ( Hermal . Hamburg ) using Finn Chambers . The left/right application of the TRUE test and Finn Chambers was r and omized . The concordance of positive patch test reactions to the 2 test techniques was studied The number of patient with positive ructions was 38 % and 42 % for TRUE Test and Finn Chamber techniques , respectively ( n.s . ) . The overall concordance of positive patch test reactions was 64 % , ( 209/328 ) 13 % ( 42/128 ) of positive reactions appeared on TRUE Test only and 24 % ( 77 % 328 ) on Finn Chamber only . When only relevant positive reactions were considered , the concordance fate was 67 % ; 11 6 % Of positive reactions appeared on TRUE Test only and 21 % on Finn Chamber only . Positive reactions to p‐phenylenediamine ( PPD ) and neomycin were more frequent with the Finn Chamber technique than with TRUE Test , i e. , false negative reactions to PPD and neomyein were more likely to occur with TRUE Test . It appeared that the TRUE Test and Finn Chamber techniques were comparable when used for patch testing However false negative and false positive patch test reactions can occur when using either technique In 1990 and 1998 15 - 41-year-old people were patch-tested in 2 cross-sectional studies of r and om sample s of the population in the western part of Copenhagen County , Denmark . In 1990 , 290 subjects and in 1998 , 469 subjects were patch-tested . The participation rates were 69 % and 51 % , respectively . Contact sensitivity to one or more haptens was found in 15.9 % and 18.6 % in 1990 and 1998 , respectively . Nickel sensitivity is still the most common contact sensitivity . The risk of contact sensitivity to the cosmetic-related haptens included in the series ( formaldehyde was not included ) increased significantly from 2.4 % in 1990 to 5.8 % in 1998 ( odds ratio 2.44 , 95 % confidence interval 1.04 - 5.73 ) . The prevalence of contact sensitivity to cosmetic-related allergens has been doubled between 1990 and 1998 The aim of the present study was to investigate the relationship between patients ' own recognition of skin problems using consumer products and the results of patch testing with markers of fragrance sensitization . Eight hundred and eighty-four consecutive eczema patients , 18 - 69 years of age , filled in a question naire prior to patch testing with the European st and ard series . The question naire contained questions about skin symptoms from the use of scented and unscented products as well as skin reactions from contact with spices , flowers and citrus fruits that could indicate fragrance sensitivity . A highly significant association was found between reporting a history of visible skin symptoms from using scented products and a positive patch test to the fragrance mix , whereas no such relationship could be established to the Peru balsam in univariate or multivariate analysis . Our results suggest that the role of Peru balsam in detecting relevant fragrance contact allergy is limited , while most fragrance mix-positive patients are aware that the use of scented products may cause skin problems BACKGROUND Fragrances are the first or second most common cause of contact allergy in dermatitis patients . OBJECTIVE The aim of this study was to identify risk products for fragrance contact allergy . METHODS The design was a case-control study with a case group of 78 fragrance-mix-positive eczema patients and two control groups , one consisting of 1,279 subjects selected as a r and om sample of the general population and the other consisting of 806 fragrance-mix-negative eczema patients . The identification of risk products was based on the patients ' histories of rash to scented products . Analysis of the associations between first-time rash caused by different specified product categories and fragrance mix sensitivity was performed using logistic regression . RESULTS It was found that first-time rash caused by deodorant sprays and /or perfumes were related to fragrance contact allergy in a comparison with both control groups . The risk ( odds ratio ) of being diagnosed as fragrance allergic was 2.3 to 2.9 greater in cases of a history of first-time rash to deodorant sprays and 3.3 to 3.4 greater in cases of a history of rash to perfumes than if no such history were present . First-time rash to cleansing agents , deodorant sticks , or h and lotions was also statistically significant but only in comparison with one of the control groups . CONCLUSION Safety evaluation of fragrance material s used in perfumes and deodorant sprays should be performed with special attention Output:	Based on the reliability of patch test data from the general population and exposure data obtained from patients with dermatitis , the prevalence and burden of fragrance sensitization in the general population is significant
MS22397	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: Introduction : Care home residents are at particular risk from medication errors , and our objective was to determine the prevalence and potential harm of prescribing , monitoring , dispensing and administration errors in UK care homes , and to identify their causes . Methods : A prospect i ve study of a r and om sample of residents within a purposive sample of homes in three areas . Errors were identified by patient interview , note review , observation of practice and examination of dispensed items . Causes were understood by observation and from theoretically framed interviews with home staff , doctors and pharmacists . Potential harm from errors was assessed by expert judgement . Results : The 256 residents recruited in 55 homes were taking a mean of 8.0 medicines . One hundred and seventy-eight ( 69.5 % ) of residents had one or more errors . The mean number per resident was 1.9 errors . The mean potential harm from prescribing , monitoring , administration and dispensing errors was 2.6 , 3.7 , 2.1 and 2.0 ( 0 = no harm , 10 = death ) , respectively . Contributing factors from the 89 interviews included doctors who were not accessible , did not know the residents and lacked information in homes when prescribing ; home staff ’s high workload , lack of medicines training and drug round interruptions ; lack of team work among home , practice and pharmacy ; inefficient ordering systems ; inaccurate medicine records and prevalence of verbal communication ; and difficult to fill ( and check ) medication administration systems . Conclusions : That two thirds of residents were exposed to one or more medication errors is of concern . The will to improve exists , but there is a lack of overall responsibility . Action is required from all concerned Objectives To compare the effectiveness of pharmacist medication review , with or without pharmacist prescribing , with st and ard care , for patients with chronic pain . Design An exploratory r and omised controlled trial . Setting Six general practice s with prescribing pharmacists in Grampian ( 3 ) and East Anglia ( 3 ) . Participants Patients on repeat prescribed pain medication ( 4815 ) were screened by general practitioners ( GPs ) , and mailed invitations ( 1397 ) . 196 were r and omised and 180 ( 92 % ) completed . Exclusion criteria included : severe mental illness , terminally ill , cancer related pain , history of addiction . R and omisation and intervention Patients were r and omised using a remote telephone service to : ( 1 ) pharmacist medication review with face-to-face pharmacist prescribing ; ( 2 ) pharmacist medication review with feedback to GP and no planned patient contact or ( 3 ) treatment as usual ( TAU ) . Blinding was not possible . Outcome measures Outcomes were the SF-12v2 , the Chronic Pain Grade ( CPG ) , the Health Utilities Index 3 and the Hospital Anxiety and Depression Scale ( HADS ) . Outcomes were collected at 0 , 3 and 6 months . Results In the prescribing arm ( n=70 ) two patients were excluded/nine withdrew . In the review arm ( n=63 ) one was excluded/three withdrew . In the TAU arm ( n=63 ) four withdrew . Compared with baseline , patients had an improved CPG in the prescribing arm , 47.7 % ( 21/44 ; p=0.003 ) and in the review arm , 38.6 % ( 17/44 ; p=0.001 ) , but not the TAU group , 31.3 % ( 15/48 ; ns ) . The SF-12 Physical Component Score showed no effect in the prescribing or review arms but improvement in TAU ( p=0.02 ) . The SF-12 Mental Component Score showed no effect for the prescribing or review arms and deterioration in the TAU arm ( p=0.002 ) . HADS scores improved within the prescribing arm for depression ( p=0.022 ) and anxiety ( p=0.007 ) , between groups ( p=0.022 and p=0.045 , respectively ) . Conclusions This is the first r and omised controlled trial of pharmacist prescribing in the UK , and suggests that there may be a benefit for patients with chronic pain . A larger trial is required . Trial registration : www.is rct n.org/IS RCT N06131530 . Medical Research Council funding OBJECTIVES To assess the effect of a Screening Tool of Older Persons potentially inappropriate Prescriptions/Screening Tool to Alert doctors to Right Treatment ( STOPP/START ) medication intervention on clinical and economic outcomes . DESIGN Parallel-group r and omized trial . SETTING Chronic care geriatric facility . PARTICIPANTS Residents aged 65 and older prescribed with at least one medication ( N = 359 ) were r and omized to receive usual pharmaceutical care or undergo medication intervention . INTERVENTION Screening medications with STOPP/START criteria followed up with recommendations to the chief physician . MEASUREMENTS The outcome measures assessed at the initiation of the intervention and 1 year later were number of hospitalizations and falls , Functional Independence Measure ( FIM ) , quality of life ( measured using the Medical Outcomes Study 12-item Short-Form Health Survey ) , and costs of medications . RESULTS The average number of drugs prescribed was significantly lower in the intervention than in the control group after 1 year ( P < .001 ) . The average drug costs in the intervention group decreased by 103 shekels ( US$ 29 ) per participant per month ( P < .001 ) . The average number of falls in the intervention group dropped significantly ( P = .006 ) . Rates of hospitalization , FIM scores , and quality of life measurements were similar for both groups . CONCLUSION Implementation of STOPP/START criteria reduced the number of medications , falls , and costs in a geriatric facility . Their incorporation in those and similar setting s is recommended OBJECTIVES Evaluate whether implementing of pharmacy-led psychopharmacology rounds in a nursing facility will improve the rate of antipsychotic use . DESIGN Single-center , prospect i ve ; medication use evaluation ( MUE ) . SETTING Rutl and Nursing Home , Brooklyn , New York . PARTICIPANTS Nursing facility residents , excluding the pediatric unit . INTERVENTIONS Weekly interdisciplinary psychopharmacology rounds that include : clinical pharmacists , nurse managers , medical director , social workers , and administration . Antipsychotics were analyzed for all residents for appropriateness of use , proper documentation , and adequate monitoring . MAIN OUTCOME MEASURE Assess the overall rate of reduction of antipsychotic use after implementation of psychopharmacology rounds . Secondary outcomes assessed improvements in monitoring and documentation for residents on antipsychotics . RESULTS A total of 81 residents were evaluated over the six-month MUE . Of those residents , 20 had their antipsychotics discontinued , and 11 had their antipsychotics tapered . The overall use of antipsychotics decreased from 14.6 % ( 62/422 ) to 12.2 % ( 50/411 ) ( P = 0.285 ) . Compliance with indications generally approved by the Centers for Medicare & Medicaid Services improved from 65 % ( 37/57 ) to 85 % ( 46/54 ) ( P = 0.008 ) . Matching indications on the psychiatry consult and the medication order improved from 58 % ( 33/57 ) to 80 % ( 43/54 ) ( P = 0.015 ) . Metabolic laboratory monitoring improved from 58 % ( 33/57 ) to 83 % ( 45/54 ) ( P = 0.003 ) . Improvements in timeliness of psychiatry and ophthalmology consults were not statistically significant . CONCLUSION Implementing interdisciplinary psycho-pharmacology rounds in a nursing facility result ed in a reduction of inappropriate antipsychotic use and improved monitoring and documentation AIMS To evaluate whether a year long clinical pharmacy program involving development of professional relationships , nurse education on medication issues , and individualized medication review s could change drug use , mortality and morbidity in nursing home residents . METHODS A cluster r and omised controlled trial , where an intervention home was matched to three control homes , was used to examine the effect of the clinical pharmacy intervention on resident outcomes . The study involved 905 residents in 13 intervention nursing homes and 2325 residents in 39 control nursing homes in south-east Queensl and and north-east New South Wales , Australia . The outcome measures were : continuous drug use data from government prescription subsidy cl aims , cross-sectional drug use data on prescribed and administered medications , deaths and morbidity indices ( hospitalization rates , adverse events and disability indices ) . RESULTS This intervention result ed in a reduction in drug use with no change in morbidity indices or survival . Differences in nursing home characteristics , as defined by cluster analysis with SUDAAN , negated intervention-related apparent significant improvements in survival . The use of benzodiazepines , nonsteroidal anti-inflammatory drugs , laxatives , histamine H2-receptor antagonists and antacids was significantly reduced in the intervention group , whereas the use of digoxin and diuretics remained similar to controls . Overall , drug use in the intervention group was reduced by 14.8 % relative to the controls , equivalent to an annual prescription saving of A64 dollars per resident ( approximately 25 pound sterling ) . CONCLUSIONS This intervention improved nursing home resident outcomes related to changes in drug use and drug-related expenditure . The continuing divergence in both drug use and survival at the end of the study suggests that the difference would have been more significant in a larger and longer study , and even more so using additional instruments specific for measuring outcomes related to changes in drug use OBJECTIVE to measure the impact of pharmacist-conducted clinical medication review with elderly care home residents . DESIGN r and omised controlled trial of clinical medication review by a pharmacist against usual care . SETTING sixty-five care homes for the elderly in Leeds , UK . PARTICIPANTS a total of 661 residents aged 65 + years on one or more medicines . INTERVENTION clinical medication review by a pharmacist with patient and clinical records . Recommendations to general practitioner for approval and implementation . Control patients received usual general practitioner care . MAIN OUTCOME MEASURES primary : number of changes in medication per participant . Secondary : number and cost of repeat medicines per participant ; medication review rate ; mortality , falls , hospital admissions , general practitioner consultations , Barthel index , St and ardised Mini-Mental State Examination ( SMMSE ) . RESULTS the pharmacist review ed 315/331 ( 95.2 % ) patients in 6 months . A total of 62/330 ( 18.8 % ) control patients were review ed by their general practitioner . The mean number of drug changes per patient were 3.1 for intervention and 2.4 for control group ( P < 0.0001 ) . There were respectively 0.8 and 1.3 falls per patient ( P < 0.0001 ) . There was no significant difference for GP consultations per patient ( means 2.9 and 2.8 in 6 months , P = 0.5 ) , hospitalisations ( means 0.2 and 0.3 , P = 0.11 ) , deaths ( 51/331 and 48/330 , P = 0.81 ) , Barthel score ( 9.8 and 9.3 , P = 0.06 ) , SMMSE score ( 13.9 and 13.8 , P = 0.62 ) , number and cost of drugs per patient ( 6.7 and 6.9 , P = 0.5 ) ( pounds sterling 42.24 and pounds sterling 42.94 per 28 days ) . A total of 75.6 % ( 565/747 ) of pharmacist recommendations were accepted by the general practitioner ; and 76.6 % ( 433/565 ) of accepted recommendations were implemented . CONCLUSIONS general practitioners do not review most care home patients ' medication . A clinical pharmacist can review them and make recommendations that are usually accepted . This leads to substantial change in patients ' medication regimens without change in drug costs . There is a reduction in the number of falls . There is no significant change in consultations , hospitalisation , mortality , SMMSE or Barthel scores Aim of study : This study sought to determine whether multidisciplinary case conference review s improved outcomes for nursing home residents , and the effects of this team approach to resident care on carers , including the h and s-on carers employed by the nursing home , and health professionals . Method : 245 residents of three Canberra nursing homes were enrolled in this non-r and omised controlled trial . The intervention consisted of sessions of three case conference review s held between 10/4sol;96 and 4sol;12sol;96 . These sessions were attended by the General Practitioners ( GPs ) of the residents discussed , the GP project officer from the ACT Division of General Practice , a clinical pharmacist , senior nursing staff , other health professionals eg physiotherapist , and occasionally the resident concerned or their representative . At each review , a case presentation by the resident 's GP was followed by a multidisciplinary discussion of all aspects , medical and non-medical , of the resident 's care . The review concluded with a management plan for the resident . In total 75 residents were review ed . Main outcome measures : Medication use and cost , and mortality . Results : One month after the review s were completed comparisons between those who were review ed and those who were not showed Output:	Provision of pharmaceutical care , effective multidisciplinary working and care home staff training represented the main areas of practical knowledge . This study provides insight into potential codified and practical knowledge requirements for pharmacists assuming responsibility for the provision of pharmaceutical care within care homes .
MS22398	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: Treatment with heparin or streptokinase was allocated r and omly to 30 patients with life-threatening pulmonary embolism verified by angiography . Treatment was given for 72 hours and pulmonary angiography was repeated . There was significantly greater ( P < 0·001 ) evidence of thrombolysis in those patients treated with streptokinase compared with those treated with heparin . The reduction of systolic and mean pulmonary arterial pressures was also significantly greater ( P < 0·05 and P < 0·02 respectively ) in the streptokinase group . Seven patients failed to complete 72 hours of the trial treatment : five successfully underwent pulmonary embolectomy . Six of these “ failures ” had initial pulmonary angiographic scores of 24 or more and systemic systolic blood pressure recordings of 100 mm Hg or less . Patients with these features should probably be considered for pulmonary embolectomy as the initial treatment . A febrile reaction commonly occurred in the streptokinase group ; otherwise side effects were no more common than in the heparin group Dissolution of pulmonary emboli with heparin and urokinase is ascribed , respectively , to anticoagulation and fibrinolysis . Since truly independent assessment of these effects in man is lacking , we administered each drug alone . Fibrinogen and plasminogen plasma levels and the resolution of pulmonary emboli were measured in three r and omized groups of 10 patients each : groups A and C infused with small repeated doses of urokinase and a large single dose of urokinase , respectively , and group B who received heparin . After 6 h of treatment , fibrinogen fell in all the groups , while , after 12 h , remained equally reduced in groups A and B and declined further in group C. Plasminogen behaved similarly . Up to 60 h , statistical analysis showed that these effects were related to timing and amounts of urokinase and heparin infusion . These observations suggest that heparin may induce a lytic state . As to signs of pulmonary emboli resolution , no differences between groups were found in lung perfusion and gas exchange recovery at any time ( from 1 day to 1 year ) and in pulmonary artery pressure reduction at 1 week . The greater angiographic and scintigraphic recovery observed with urokinase , versus heparin alone , after 1 day of treatment in the Urokinase Pulmonary Embolism Trial may be ascribed to a synergistic effect with urokinase of heparin administered during the diagnostic work-out . The indications of heparin and urokinase should be evaluated in the light of these results BACKGROUND Acute pulmonary embolism ( PE ) can worsen quality of life due to persistent dyspnea or exercise intolerance . OBJECTIVE Test if tenecteplase increases the probability of a favorable composite patient-oriented outcome after submassive PE . METHODS Normotensive patients with PE and right ventricular ( RV ) strain ( by echocardiography or biomarkers ) were enrolled from eight hospitals . All patients received low-molecular-weight heparin followed by r and om assignment to either a single weight-based bolus of tenecteplase or placebo , administered in a double-blinded fashion . The primary composite outcome included : ( i ) death , circulatory shock , intubation or major bleeding within 5 days or ( ii ) recurrent PE , poor functional capacity ( RV dysfunction with either dyspnea at rest or exercise intolerance ) or an SF36 ( ® ) Physical Component Summary ( PCS ) score < 30 at 90-day follow-up . RESULTS Eighty-three patients were r and omized ; 40 to tenecteplase and 43 to placebo . The trial was terminated prematurely . Within 5 days , adverse outcomes occurred in three placebo-treated patients ( death in one and intubation in two ) and one tenecteplase-treated patient ( fatal intracranial hemorrhage ) . At 90 days , adverse outcomes occurred in 13 unique placebo-treated patients and five unique tenecteplase-treated patients Thus , 16 ( 37 % ) placebo-treated and six ( 15 % ) tenecteplase-treated patients had at least one adverse outcome ( exact two-sided P = 0.017 ) . CONCLUSIONS Treatment of patients with submassive pulmonary embolism with tenecteplase was associated with increased probability of a favorable composite outcome BACKGROUND The role of fibrinolytic therapy in patients with intermediate-risk pulmonary embolism is controversial . METHODS In a r and omized , double-blind trial , we compared tenecteplase plus heparin with placebo plus heparin in normotensive patients with intermediate-risk pulmonary embolism . Eligible patients had right ventricular dysfunction on echocardiography or computed tomography , as well as myocardial injury as indicated by a positive test for cardiac troponin I or troponin T. The primary outcome was death or hemodynamic decompensation ( or collapse ) within 7 days after r and omization . The main safety outcomes were major extracranial bleeding and ischemic or hemorrhagic stroke within 7 days after r and omization . RESULTS Of 1006 patients who underwent r and omization , 1005 were included in the intention-to-treat analysis . Death or hemodynamic decompensation occurred in 13 of 506 patients ( 2.6 % ) in the tenecteplase group as compared with 28 of 499 ( 5.6 % ) in the placebo group ( odds ratio , 0.44 ; 95 % confidence interval , 0.23 to 0.87 ; P=0.02 ) . Between r and omization and day 7 , a total of 6 patients ( 1.2 % ) in the tenecteplase group and 9 ( 1.8 % ) in the placebo group died ( P=0.42 ) . Extracranial bleeding occurred in 32 patients ( 6.3 % ) in the tenecteplase group and 6 patients ( 1.2 % ) in the placebo group ( P<0.001 ) . Stroke occurred in 12 patients ( 2.4 % ) in the tenecteplase group and was hemorrhagic in 10 patients ; 1 patient ( 0.2 % ) in the placebo group had a stroke , which was hemorrhagic ( P=0.003 ) . By day 30 , a total of 12 patients ( 2.4 % ) in the tenecteplase group and 16 patients ( 3.2 % ) in the placebo group had died ( P=0.42 ) . CONCLUSIONS In patients with intermediate-risk pulmonary embolism , fibrinolytic therapy prevented hemodynamic decompensation but increased the risk of major hemorrhage and stroke . ( Funded by the Programme Hospitalier de Recherche Clinique in France and others ; PEITHO EudraCT number , 2006 - 005328 - 18 ; Clinical Trials.gov number , NCT00639743 . ) OBJECTIVE To test the reliability and validity of specific instructions to classify blinding , when unclearly reported in r and omized trials , as " probably done " or " probably not done . " STUDY DESIGN AND SETTING We assessed blinding of patients , health care providers , data collectors , outcome adjudicators , and data analysts in 233 r and omized trials in duplicate and independently using detailed instructions . The response options were " definitely yes , " " probably yes , " " probably no , " and " definitely no. " We contacted authors for data verification ( 46 % response ) . For each of the five questions , we assessed reliability by calculating the agreement between the two review ers and validity by calculating the agreement between review ers ' consensus and verified data . RESULTS The percentage with unclear blinding status varied between 48.5 % ( patients ) and 84.1 % ( data analysts ) . Reliability was moderate for blinding of outcome adjudicators ( κ=0.52 ) and data analysts ( κ=0.42 ) and substantial for blinding of patients ( κ=0.71 ) , providers ( κ=0.68 ) , and data collectors ( κ=0.65 ) . The raw agreement between the consensus record and the author-verified record varied from 84.1 % ( blinding of data analysts ) to 100 % ( blinding of health care providers ) . CONCLUSION With the possible exception of blinding of data analysts , use of " probably yes " and " probably no " instead of " unclear " may enhance the assessment of blinding in trials Abstract Background : The use of thrombolytic agents in the treatment of hemodynamically stable patients with acute submassive pulmonary embolism ( PTE ) remains controversial . We , therefore , conducted this study to compare the effect of thrombolytic plus anticoagulation versus anticoagulation alone on early death and adverse outcome following submassive PTE . Methods : We conducted a study of patients with acute pulmonary embolism and pulmonary hypertension or right ventricular dilatation/dysfunction but without arterial hypotension or shock . The patients were r and omly assigned in a single-blind fashion to receive an anticoagulant [ Enoxaparin ( 1 mg/kg twice a day ) ] plus a thrombolytic [ Alteplase ( 100 mg ) or Streptokinase ( 1500000 u/2 hours ) ] or an anticoagulant [ Enoxaparin ( 1 mg/kg twice a day ) ] alone . The primary endpoint was in-hospital death or clinical deterioration requiring an escalation of treatment . The secondary endpoints of the study were major bleeding , pulmonary hypertension , right ventricular dilatation at the end of the first week , and exertional dyspnea at the end of the first month . Results : Of 50 patients enrolled , 25 patients were r and omly assigned to receive an anticoagulant plus a thrombolytic and the other 25 patients were given an anticoagulant alone . The incidence of the primary endpoints was significantly higher in the anticoagulant-alone group than in the thrombolytic-plus-anticoagulant group ( p value = 0.022 ) . At the time of discharge , pulmonary artery pressure was significantly higher in the anticoagulant-alone group than in the thrombolytic-plus-anticoagulant group ( p value = 0.018 ) ; however , reduction in the right ventricular size or normalization of the right ventricle showed non-significant differences between the two groups . There was no significant difference regarding the New York Heat Association ( NYHA ) functional class between the two groups at the end of the first month ( p value = 0.213 ) . No fatal bleeding or cerebral bleeding occurred in the patients receiving an anticoagulant plus a thrombolytic . Conclusion : When given in conjunction with anticoagulants , thrombolytics may improve the clinical course of stable patients who have acute submassive pulmonary embolism and prevent clinical deterioration The role of low-dose thrombolysis in the reduction of pulmonary artery pressure in moderate pulmonary embolism ( PE ) has not been investigated . Because the lungs are very sensitive to thrombolysis , we postulated that effective and safe thrombolysis might be achieved by a lower dose of tissue plasminogen activator . The purpose of the present study was to evaluate the role of this " safe dose " thrombolysis in the reduction of pulmonary artery pressure in moderate PE . During a 22-month period , 121 patients with moderate PE were r and omized to receive a " safe dose " of tissue plasminogen activator plus anticoagulation ( thrombolysis group [ TG ] , n = 61 patients ) or anticoagulation alone ( control group [ CG ] , n = 60 ) . The primary end points consisted of pulmonary hypertension and the composite end point of pulmonary hypertension and recurrent PE at 28 months . Pulmonary hypertension and the composite end point developed in 9 of 58 patients ( 16 % ) in the TG and 32 of 56 patients ( 57 % ) in the CG ( p < 0.001 ) and 9 of 58 patients ( 16 % ) in the TG and 35 of 56 patients ( 63 % ) in the CG ( p < 0.001 ) , respectively . The secondary end points were total mortality , the duration of hospital stay , bleeding at the index hospitalization , recurrent PE , and the combination of mortality and recurrent PE . The duration of hospitalization was 2.2 ± 0.5 days in the TG and 4.9 ± 0.8 days in the CG ( p < 0.001 ) . The combination of death plus recurrent PE was 1 ( 1.6 % ) in TG and 6 ( 10 % ) in the CG ( p = 0.0489 ) . No bleeding occurred in any group , and despite a positive trend in favor of a " safe dose " thrombolysis , no significant difference was noted in the rate of individual outcomes of death and recurrent PE when assessed independently . In conclusion , the results from the present prospect i ve r and omized trial suggests that " safe dose " thrombolysis is safe and effective in the treatment of moderate PE , with a significant immediate reduction in the pulmonary artery pressure that was maintained at 28 months BACKGROUND The influence of the duration of anticoagulant therapy after venous thromboembolism ( VTE ) on the long-term morbidity and mortality is unclear . AIM To investigate the long-term sequelae of VTE in patients r and omized to different duration of secondary prophylaxis . METHODS In a mult Output:	Our findings indicate that thrombolytics probably reduce mortality in patients with submassive- or intermediate-risk PE and may reduce PTS in patients with proximal DVT at the expense of a significant increase in major bleeding .
MS22399	*TASK* the task is to summarize an input biomedical literature in six sentences *INPUT* the input is a biomedical literature *OUTPUT* the output is the summary of an input biomedical literature in six sentences *DOCUMENTATION* *EXAMPLES* Input: Background Psychological theories of behaviour may provide a framework to guide the design of interventions to change professional behaviour . Behaviour change interventions , design ed using psychological theory and targeting important motivational beliefs , were experimentally evaluated for effects on the behavioural intention and simulated behaviour of GPs in the management of uncomplicated upper respiratory tract infection ( URTI ) . Methods The design was a 2 × 2 factorial r and omised controlled trial . A postal question naire was developed based on three theories of human behaviour : Theory of Planned Behaviour ; Social Cognitive Theory and Operant Learning Theory . The beliefs and attitudes of GPs regarding the management of URTI without antibiotics and rates of prescribing on eight patient scenarios were measured at baseline and post-intervention . Two theory-based interventions , a " grade d task " with " action planning " and a " persuasive communication " , were incorporated into the post-intervention question naire . Trial groups were compared using co-variate analyses . Results Post-intervention question naires were returned for 340/397 ( 86 % ) GPs who responded to the baseline survey . Each intervention had a significant effect on its targeted behavioural belief : compared to those not receiving the intervention GPs completing Intervention 1 reported stronger self-efficacy scores ( Beta = 1.41 , 95 % CI : 0.64 to 2.25 ) and GPs completing Intervention 2 had more positive anticipated consequences scores ( Beta = 0.98 , 95 % CI = 0.46 to 1.98 ) . Intervention 2 had a significant effect on intention ( Beta = 0.90 , 95 % CI = 0.41 to 1.38 ) and simulated behaviour ( Beta = 0.47 , 95 % CI = 0.19 to 0.74 ) . Conclusion GPs ' intended management of URTI was significantly influenced by their confidence in their ability to manage URTI without antibiotics and the consequences they anticipated as a result of doing so . Two targeted behaviour change interventions differentially affected these beliefs . One intervention also significantly enhanced GPs ' intentions not to prescribe antibiotics for URTI and result ed in lower rates of prescribing on patient scenarios compared to a control group . The theoretical frameworks utilised provide a scientific rationale for underst and ing how and why the interventions had these effects , improving the reproducibility and generalisability of these findings and offering a sound basis for an intervention in a " real world " trial . Trial registration Clinical trials.gov BACKGROUND Suspected acute viral upper respiratory tract infection ( SAVURTI ) is the commonest acute reason why children consult in general practice . The clinical course varies widely and about one in five children re-consult for the same SAVURTI episode . If clinicians had feasible tools for predicting which children are likely to suffer a prolonged course , then additional explanations and possibly treatments could be provided at the initial consultation that might enable carers to manage the condition without re-consulting . OBJECTIVE To identify features available on the day of consulting that might predict a prolonged clinical course among children with SAVURTI . METHOD Regression analysis using Canadian Respiratory Illness and Flu Scale ( CARIFS ) data from a r and omized controlled trial cohort of children aged from 6 months to 12 years consulting in general practice with SAVURTI . RESULTS Two variables from the clinician 's records ( ' age ' and ' cough ' ) and two variables from the CARIFS completed by carers on the day of consulting ( ' fever ' and ' low energy , tired ' ) explained approximately 15 % of the variation present in CARIFS scores on day seven . CONCLUSION Children and carers may benefit from a clear account of the evidence that the clinical course of RTIs in children varies widely and may be longer that expected , and that prediction for individuals is difficult Background Biomedical research constantly produces new findings , but these are not routinely incorporated into health care practice . Currently , a range of interventions to promote the uptake of emerging evidence are available . While their effectiveness has been tested in pragmatic trials , these do not form a basis from which to generalise to routine care setting s. Implementation research is the scientific study of methods to promote the uptake of research findings , and hence to reduce inappropriate care . As clinical practice is a form of human behaviour , theories of human behaviour that have proved to be useful in other setting s offer a basis for developing a scientific rationale for the choice of interventions . Aims The aims of this protocol are 1 ) to develop interventions to change beliefs that have already been identified as antecedents to antibiotic prescribing for sore throats , and 2 ) to experimentally evaluate these interventions to identify those that have the largest impact on behavioural intention and behavioural simulation . Design The clinical focus for this work will be the management of uncomplicated sore throat in general practice . Symptoms of upper respiratory tract infections are common presenting features in primary care . They are frequently treated with antibiotics , and research evidence is clear that antibiotic treatment offers little or no benefit to otherwise healthy adult patients .Reducing antibiotic prescribing in the community by the " prudent " use of antibiotics is seen as one way to slow the rise in antibiotic resistance , and appears safe , at least in children . However , our underst and ing of how to do this is limited . Participants will be general medical practitioners . Two theory-based interventions will be design ed to address the discriminant beliefs in the prescribing of antibiotics for sore throat , using empirically derived re sources . The interventions will be evaluated in a 2 × 2 factorial r and omised controlled trial delivered in a postal question naire survey . Two outcome measures will be assessed : behavioural intention and behavioural simulation Little is known about incorporation of new knowledge from r and omised clinical trials into clinical practice . Thrombolytic therapy was shown to reduce the mortality of acute myocardial infa rct ion in several large trials published during 1986 - 88 . To examine the effect of these data on clinical practice , we analysed the supply of thrombolytic drugs in a representative English region ( population 4.7 million ) in 1987 - 92 . During the study period there were over 10,000 hospital admissions per year in the region for acute myocardial infa rct ion . From a very low initial level , thrombolytic drug use rose slowly for several years after publication of the trial results and reached a plateau in 1991 - 92 . Rates of use per 1000 patients admitted with myocardial infa rct ion varied almost six-fold between districts in 1989 - 90 and over two-fold in 1991 - 92 . Level of use attained by districts in the latter period was strongly associated with the extent of their previous participation in multicentre trials of thrombolysis ( p = 0.003 ) ; we estimate that 35 - 50 % of patients admitted with acute myocardial infa rct ion were receiving thrombolytics . The full potential of thrombolytic treatment has still not been achieved in routine care and the limiting factors need to be defined Background Psychological models can be used to underst and and predict behaviour in a wide range of setting s. However , they have not been consistently applied to health professional behaviours , and the contribution of differing theories is not clear . The aim of this study was to explore the usefulness of a range of psychological theories to predict health professional behaviour relating to management of upper respiratory tract infections ( URTIs ) without antibiotics . Methods Psychological measures were collected by postal question naire survey from a r and om sample of general practitioners ( GPs ) in Scotl and . The outcome measures were clinical behaviour ( using antibiotic prescription rates as a proxy indicator ) , behavioural simulation ( scenario-based decisions to managing URTI with or without antibiotics ) and behavioural intention ( general intention to managing URTI without antibiotics ) . Explanatory variables were the constructs within the following theories : Theory of Planned Behaviour ( TPB ) , Social Cognitive Theory ( SCT ) , Common Sense Self-Regulation Model ( CS-SRM ) , Operant Learning Theory ( OLT ) , Implementation Intention ( II ) , Stage Model ( SM ) , and knowledge ( a non-theoretical construct ) . For each outcome measure , multiple regression analysis was used to examine the predictive value of each theoretical model individually . Following this ' theory level ' analysis , a ' cross theory ' analysis was conducted to investigate the combined predictive value of all significant individual constructs across theories . Results All theories were tested , but only significant results are presented . When predicting behaviour , at the theory level , OLT explained 6 % of the variance and , in a cross theory analysis , OLT ' evidence of habitual behaviour ' also explained 6 % . When predicting behavioural simulation , at the theory level , the proportion of variance explained was : TPB , 31 % ; SCT , 26 % ; II , 6 % ; OLT , 24 % . GPs who reported having already decided to change their management to try to avoid the use of antibiotics made significantly fewer scenario-based decisions to prescribe . In the cross theory analysis , perceived behavioural control ( TPB ) , evidence of habitual behaviour ( OLT ) , CS-SRM cause ( chance/bad luck ) , and intention entered the equation , together explaining 36 % of the variance . When predicting intention , at the theory level , the proportion of variance explained was : TPB , 30 % ; SCT , 29 % ; CS-SRM 27 % ; OLT , 43 % . GPs who reported that they had already decided to change their management to try to avoid the use of antibiotics had a significantly higher intention to manage URTIs without prescribing antibiotics . In the cross theory analysis , OLT evidence of habitual behaviour , TPB attitudes , risk perception , CS-SRM control by doctor , TPB perceived behavioural control and CS-SRM control by treatment entered the equation , together explaining 49 % of the variance in intention . Conclusion The study provides evidence that psychological models can be useful in underst and ing and predicting clinical behaviour . Taking a theory-based approach enables the creation of a replicable methodology for identifying factors that predict clinical behaviour . However , a number of conceptual and method ological challenges remain OBJECTIVES : General practitioners ( GPs ) in the UK continue to prescribe antibiotics for patients with sore throats despite evidence that they are ineffective and can contribute to the growth of antibiotic resistance in the population . This study uses the theory of planned behaviour ( TPB ) to investigate the strength of intention to prescribe antibiotics , and to identify the salient beliefs associated with this intention . DESIGN : Cross-sectional study testing hypotheses derived from the TPB . METHOD : A 66-item postal question naire was distributed to a r and om sample of GPs in one NHS region ( N = 185 ) . The question naire included measures of intention to prescribe antibiotics , attitude , behavioural beliefs and evaluations , normative beliefs and evaluations , perceived behavioural control , control beliefs , and past prescribing . RESULTS : Two-thirds of the GPs returned complete question naires ( N = 126 , 68 % ) . The majority intended to prescribe antibiotics for less than half of their patients with sore throats ( N = 69 , 55 % ) . The variables specified in TPB predicted 48 % of the variance in intention , with past behaviour adding a further 15 % . Seven salient beliefs distinguished between doctors who intend to prescribe antibiotics and those who do not . CONCLUSIONS : Attitudes towards antibiotics and control beliefs are important predictors of intention to prescribe , as predicted by TPB . Interventions could target salient beliefs associated with motivation to prescribe A consistent finding in health services research is the report of uneven uptake of research findings . Implementation trials have a variable record of success in effectively influencing clinicians ' behaviour . A more systematic approach may be to conduct Intervention Modelling Experiments before service-level trials , examining intervention effects on ' interim endpoints ' representing clinical behaviour , derived from empirically supported psychological theories . The objectives were to : ( 1 ) Design Intervention Modelling Experiments by backward engineering a ' real-world ' r and omised controlled trial ( NEXUS ) ; ( 2 ) examine the applicability of psychological theories to clinical decision-making ; ( 3 ) explore whether psychological theories can illuminate how interventions achieve their effects . A 2 x 2 factorial r and omised controlled trial was design ed with pre- and post-intervention data collection by postal question naire surveys . The first survey was used to generate feedback data and the interventions were delivered in the second survey . General medical practitioners ( GPs ) in Engl and and Scotl and participated . First survey respondents were r and omised twice to receive or not audit and feedback and educational reminder messages . The main outcome measures included behavioural intention ( general plan to refer for lumbar X-rays ) and simulated behaviour ( specific , scenario-based , decisions to refer for lumbar X-ray ) . Predictors were attitude , subjective norm , perceived behavioural control ( theory of planned behaviour ) , self-efficacy ( social cognitive theory ) and decision difficulty . Both interventions significantly influenced simulated behaviour , but neither influenced behavioural intention . There were no interaction effects . All theoretically derived cognitions significantly predicted simulated behaviour . Only subjective norm was not predictive of behavioural intention . The effect of audit and feedback on simulated behaviour was mediated through perceived behavioural control . The results of this study suggest that Intervention Modelling Experiments , using psychological models to help isolate mediators of clinical decision-making , may be a means of developing more potent interventions , and selecting implementation interventions with a greater likelihood of success in a service-level r and omised controlled trial Objective The lag between publication of evidence for clinical practice and implementation by clinicians may be decades . Research using psychological models demonstrates that changing intention is very important in changing behaviour . This study examined an intervention ( rehearsing alternative actions ) to change dentists ' intention to implement evidence -based practice ( EBP ) for third molar ( TM ) management . Design R and omised controlled trial / postal . Setting Primary care . Subjects and methods Dentists were r and omly selected from the Scottish Dental Practice Output:	Conclusion It is feasible to systematic ally develop theoretically-based interventions to change professional practice .

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