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Clinical NLP Lab 29

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: The aim of this r and omized-controlled trial was to evaluate the effectiveness of an intensive intervention to reduce children 's environmental tobacco smoke ( ETS ) exposure at their home compared with a minimal intervention . The target population of the study was the mothers of children aged 1 - 5 who lived in the Cengizhan district of Izmir in Turkey , who smoked and /or whose spouses smoked . It was found that at least one parent of a total of 182 children smoked and 80 of these mothers were taken into stratified sampling based on the number of the smoking parents . Mothers were visited at their homes . During the initial visit , they were educated and urine sample s were taken from their children . Following this initial visit , mothers were r and omized to the intensive intervention ( n = 38 ) or the minimal intervention group ( n = 40 ) . The levels of cotinine in the intensive intervention ( P = 0.000 ) and minimal intervention ( P = 0.000 ) groups in the final follow-up were significantly lower than the initial levels . The proportion of mothers reporting a complete smoking ban at home in the final follow-up was higher in the intensive intervention group than the minimal intervention group ( P = 0.000 ) . The education provided during the home visits and the reporting of the urinary cotinine levels of the children were effective in lowering the children 's exposure to ETS at their home INTRODUCTION The objective of this study was to assess whether counseling both mothers and fathers reduces their infants ' exposure to secondh and smoke ( SHS ) . METHODS Participants were 130 nonsmoking children aged less than 1 year , exposed to their fathers ' or mothers ' smoking , and recruited from a health center in southern Tehran . Eligible families were r and omly assigned to intervention or control group . Infant urine sample s were collected , and parents were interviewed at baseline and at a 3-month follow-up in each of the 2 groups . Mothers of the intervention group were provided 3 counseling sessions , one of which was face to face and 2 of which were by telephone . Fathers were provided 3 counseling sessions by telephone . Parents were also given an educational pamphlet and a sticker depicting a smoke-free home . The control group received usual care . Changes in infant urinary cotinine levels , parental cigarette consumption in the presence of the child , and home- and car-smoking bans were assessed . RESULTS The intervention was effective in reducing infant urinary cotinine levels ( 1-tailed p = .029 ) . There was a greater decrease in the total daily cigarette consumption in the presence of the child in the intervention group compared with the control group , and the differences between the 2 groups were statistically significant ( 1-tailed p = .03 ) . While the differences between home-smoking bans in the 2 groups were statistically significant ( 1-tailed p = .049 ) , the differences between car-smoking bans did not reach significance . CONCLUSION Counseling similar to that employed in other countries can reduce infant exposure to SHS , suggesting generalizability Objective : To evaluate the effectiveness of a lay delivered intervention to reduce Latino children ’s exposure to environmental tobacco smoke ( ETS ) . The a priori hypothesis was that children living in households that were in the intervention group would have lower exposure over time than measurement only controls . Design : A two group , r and omised control trial was conducted . Setting : Areas of San Diego county with a large Latino population . Participants : 143 Latino parent – child pairs . Intervention : Trained bicultural and bilingual Latina lay community health advisors , or promotoras , conducted problem solving aim ed at lowering the target child ’s exposure to ETS in the household . Six home and telephone sessions were delivered by the promotoras over a four month period . Main outcome measures : Outcome measures were collected at baseline , immediately post-intervention , three months post-intervention , and 12 months post-intervention . Four outcomes were considered : ( 1 ) parent ’s paper- and -pencil reports of the child ’s past month exposure ; ( 2 ) hair sample s from the child analysed for past month nicotine ; ( 3 ) hair sample s from the child analysed for past month cotinine ; and ( 4 ) per cent confirmed reducers . Results : There were no significant condition-by-time interactions , the term indicative of a differential intervention effect . Significant or near significant time main effects were seen for children ’s hair cotinine , per cent confirmed reducers , and , in particular , parent reports of exposure . Conclusions : Applying a lay promotora model to deliver the behavioural problem solving intervention unfortunately was not effective . A likely explanation relates to the difficulty of delivering a relatively complex intervention by lay women untrained in behaviour change theory and research methods Objective : Approximately 40 % of women who smoke tobacco quit smoking during pregnancy , yet up to 85 % relapse after delivery . Those who resume smoking often do so by 2 to 8 weeks postpartum . Smoking mothers are more than twice as likely to quit breastfeeding by 10 weeks postpartum . The hospitalization of a newborn , while stressful , is an opportunity to emphasize the importance of a smoke-free environment for babies . Supporting maternal-infant bonding may reduce maternal stress and motivate mothers to remain smoke free and continue breastfeeding . The objective of this study was to reduce postpartum smoking relapse and prolong breastfeeding duration during the first 8 weeks postpartum in mothers who quit smoking just before or during pregnancy and have newborns admitted to the Neonatal Intensive Care Unit ( NICU ) . Study Design : This study was an Institutional Review Board-approved prospect i ve r and omized clinical trial . After informed consent , mothers of newborns admitted to the NICU were r and omized to a control or intervention group . Both groups received weekly encouragement to remain smoke free and routine breastfeeding support . Mothers in the intervention group were also given enhanced support for maternal-infant bonding including information about newborn behaviors , and were encouraged to frequently hold their babies skin-to-skin . Result : More mothers were smoke free ( 81 vs 46 % , P<0.001 ) and breastfeeding ( 86 vs 21 % , P<0.001 ) in the intervention than in the control group at 8 weeks postpartum . Conclusion : Interventions to support mother – infant bonding during a newborn 's hospitalization in the NICU are associated with reduced rates of smoking relapse and prolonged duration of breastfeeding during the first 8 weeks postpartum OBJECTIVE : To develop and test an intervention to reduce children ’s exposure to secondh and smoke ( SHS ) at homes in Yerevan , Armenia . METHODS : A single-blind , r and omized trial in 250 households with 2- to 6-year-old children tested an intensive intervention ( counseling sessions , distribution of tailored educational brochures , demonstration of home air pollution , and 2 follow-up counseling telephone calls ) against minimal intervention ( distribution of st and ard leaflets ) . At baseline and 4-month follow-up , research ers conducted biomonitoring ( children ’s hair ) and surveys . The study used paired t tests , McNemar ’s test , and linear and logistic regression analyses . RESULTS : After adjusting for baseline hair nicotine concentration , child ’s age and gender , the follow-up geometric mean ( GM ) of hair nicotine concentration in the intervention group was 17 % lower than in the control group ( P = .239 ) . The GM of hair nicotine in the intervention group significantly decreased from 0.30 ng/mg to 0.23 ng/mg ( P = .024 ) , unlike in the control group . The follow-up survey revealed an increased proportion of households with smoking restrictions and decreased exposure of children to SHS in both groups . The adjusted odds of children ’s less-than-daily exposure to SHS at follow-up was 1.87 times higher in the intervention group than in the control group ( P = .077 ) . The GM of mothers ’ knowledge scores at follow-up was 10 % higher in the intervention group than in the control group ( P = .006 ) . CONCLUSIONS : Intensive intervention is effective in decreasing children ’s exposure to SHS through educating mothers and promoting smoking restrictions at home . However , superiority over minimal intervention to decrease children ’s exposure was not statistically significant AIM To determine whether repeated infancy-onset lifestyle counselling alters parental smoking and children 's exposure to tobacco smoke . METHODS In 1990 , 1062 healthy infants were recruited to a r and omized , ongoing atherosclerosis prevention trial ( STRIP ) . Intervention families received at least twice a year individualized nutrition and lifestyle counselling . By 1999 , 652 8-y-old children continued participation . Exposure to tobacco smoke was evaluated using serum cotinine concentration . Parents ' smoking was also assessed using question naires and interviews . RESULTS Parents ' smoking decreased during the study similarly in the intervention and control groups . Of the 8-y-old children , 46 % had detectable serum cotinine concentration , suggesting exposure to tobacco smoke during the past few days . All children were non-smokers . Serum cotinine concentrations did not differ between the intervention and control children . Children 's cotinine values were highest in the families where either father or both parents were smokers . CONCLUSION Participation in the atherosclerosis prevention trial slightly decreased smoking among the intervention and control parents . However , counselling led to no differences in parental smoking between the two groups , or in exposure of the intervention and control children to tobacco smoke . This study suggests that more detailed and targeted intervention is required to achieve a significant effect on children 's tobacco smoke exposure INTRODUCTION We tested a combined intervention to reduce children 's secondh and smoke exposure ( SHSe ) and help parents quit smoking . METHODS After baseline , mothers who exposed their children younger than 4 years to 10 or more cigarettes/week were r and omized to the intervention ( n = 76 ) or usual care control condition ( n = 74 ) . Outcomes were assessed at 3 , 6 , 12 , and 18 months . Intervention families were offered 10 in-person at home and 4 telephone counseling sessions over 6 months , and additional pre- and postquit telephone sessions . Counseling procedures included behavioral contracting , self-monitoring , and problem solving . RESULTS Parents ' reports of their smoking and children 's exposure showed moderate and significant correlations with children 's urine cotinine levels and home air nicotine ( r = .40-.78 ) . Thirteen ( 17.1 % ) intervention group mothers and 4 ( 5.4 % ) controls reported that they quit smoking for 7 days prior to 1 or more study measurements , without biochemical contradiction ( p = .024 ) . Results of generalized estimating equations showed significantly greater decrease in reported SHSe and mothers ' smoking in the counseled group compared with controls . Reported indoor smoking and children 's urine cotinine decreased , yet group differences for changes were not significant . DISCUSSION Nicotine contamination of the home and result ing thirdh and exposure may have contributed to the failure to obtain a differential decrease in cotinine concentration . Partial exposure to counseling due to dropouts and lack of full participation from all family members and measurement reactivity in both conditions may have constrained intervention effects . Secondh and smoke exposure counseling may have been less powerful when combined with smoking cessation OBJECTIVES : Using longitudinal data from the multigenerational Youth Development Study ( YDS ) , this article documents how parents ’ long-term smoking trajectories are associated with adolescent children ’s likelihood of smoking . Prospect i ve data from the parents ( from age 14–38 years ) enable unique comparisons of the parents ’ and children ’s smoking behavior , as well as that of siblings . METHODS : Smoking trajectories are constructed using latent class analysis for the original YDS cohort ( n = 1010 ) . Multigenerational longitudinal data from 214 parents and 314 offspring ages 11 years and older are then analyzed by using logistic regression with cluster-corrected SEs . RESULTS : Four latent smoking trajectories emerged among the original cohort : stable nonsmokers ( 54 % ) , early-onset light smokers who quit/reduce ( 16 % ) , late-onset persistent smokers ( 14 % ) , and early-onset persistent heavy smokers ( 16 % ) . Although 8 % of children of stable nonsmokers smoked in the last year , the other groups ’ children had much higher percentages , ranging from 23 % to 29 % . Multivariate logistic regression models confirm that these significant differences were robust to the inclusion of myriad child- and parent-level measures ( for which child age and grade point average [ GPA ] are significant predictors ) . Older sibling smoking , however , mediated the link between parental heavy smoking and child smoking . CONCLUSIONS : Even in an era of declining rates of teenage cigarette use in the United States , children of current and former smokers face an elevated risk of smoking . Prevention efforts to weaken intergenerational associations should consider parents ’ long-term cigarette use , as well as the smoking behavior of older siblings in the household Background This study aim ed to evaluate the impact of a primary prevention intervention program on risk behavior for allergic diseases among children up to 2 years of age . The setting was in ordinary pre- and postnatal primary health care in Trondheim , Norway . Methods The Prevention of Allergy among Children in Trondheim , Norway ( PACT ) study invited all pregnant women and parents to children up to 2 years of age in the community to participate in a non-r and omized , controlled , multiple life-style intervention study . Interventional topics was increased dietary intake of cod liver oil and oily fish for women during pregnancy and for infants during the \n Output:\n " }, { "from": "agent", "value": "Results suggest that interventions for reduction in ETS may be more successful than for smoking cessation and relapse prevention in families of children aged less than 5 years ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: BACKGROUND Pulmonary rehabilitation programmes improve the health of patients disabled by lung disease but their cost effectiveness is unproved . We undertook a cost/utility analysis in conjunction with a r and omised controlled clinical trial of pulmonary rehabilitation versus st and ard care . METHODS Two hundred patients , mainly with chronic obstructive pulmonary disease , were r and omly assigned to either an 18 visit , 6 week rehabilitation programme or st and ard medical management . The difference between the mean cost of 12 months of care for patients in the rehabilitation and control groups ( incremental cost ) and the difference between the two groups in quality adjusted life years ( QALYs ) gained ( incremental utility ) were determined . The ratio between incremental cost and utility ( incremental cost/utility ratio ) was calculated . RESULTS Each rehabilitation programme for up to 20 patients cost £ 12 120 . The mean incremental cost of adding rehabilitation to st and ard care was £ –152 ( 95 % CI –881 to 577 ) per patient , p = NS . The incremental utility of adding rehabilitation was 0.030 ( 95 % CI 0.002 to 0.058 ) QALYs per patient , p=0.03 . The point estimate of the incremental cost/utility ratio was therefore negative . The bootstrapping technique was used to model the distribution of cost/utility estimates possible from the data . A high likelihood of generating QALYs at negative or relatively low cost was indicated . The probability of the cost per QALY generated being below £ 0 was 0.64 . CONCLUSIONS This outpatient pulmonary rehabilitation programme produces cost per QALY ratios within bounds considered to be cost effective and is likely to result in financial benefits to the health service Background : Although it has been repeatedly suggested that chronic obstructive pulmonary disease ( COPD ) is associated with depression , no conclusion has so far been reached . A study was undertaken to investigate whether depression occurs more often in patients with COPD than in controls . The demographic and clinical variables associated with depression were also determined . Methods : Patients with a registered diagnosis of obstructive airway disease in general practice , aged ≥40 years , forced expiratory volume in 1 second ( FEV1 ) < 80 % predicted , FEV1 reversibility ≤12 % , FEV1/VC ≤ predicted – 1.64 × SD , and a history of smoking were selected . A r and om sample of subjects without a registered diagnosis of asthma or COPD aged 40 years or older acted as controls . Depression was assessed using the Centers for Epidemiologic Studies Depression ( CES-D ) scale . Results : In patients with severe COPD ( FEV1 < 50 % predicted ) , the prevalence of depression was 25.0 % compared with 17.5 % in controls and 19.6 % in patients with mild to moderate COPD . When the results were adjusted for demographic variables and comorbidity , the risk for depression was 2.5 times greater for patients with severe COPD than for controls ( OR 2.5 , 95 % CI 1.2 to 5.4 ) . In patients with mild to moderate COPD this increased risk of depression was not seen . Living alone , reversibility of FEV1 % predicted , respiratory symptoms and physical impairment were significantly associated with the scores on the CES-D scale . Conclusion : Patients with severe COPD are at increased risk of developing depression . The results of this study underscore the importance of reducing symptoms and improving physical functioning in patients with COPD Background : Chronic obstructive pulmonary disease ( COPD ) is characterised by both an accelerated decline in lung function and periods of acute deterioration in symptoms termed exacerbations . The aim of this study was to investigate whether these are related . Methods : Over 4 years , peak expiratory flow ( PEF ) and symptoms were measured at home daily by 109 patients with COPD ( 81 men ; median ( IQR ) age 68.1 ( 63–74 ) years ; arterial oxygen tension ( Pao2 ) 9.00 ( 8.3–9.5 ) kPa , forced expiratory volume in 1 second ( FEV1 ) 1.00 ( 0.7–1.3 ) l , forced vital capacity ( FVC ) 2.51 ( 1.9–3.0 ) l ) ; of these , 32 ( 29 men ) recorded daily FEV1 . Exacerbations were identified from symptoms and the effect of frequent or infrequent exacerbations ( > or < 2.92 per year ) on lung function decline was examined using cross sectional , r and om effects models . Results : The 109 patients experienced 757 exacerbations . Patients with frequent exacerbations had a significantly faster decline in FEV1 and peak expiratory flow ( PEF ) of –40.1 ml/year ( n=16 ) and –2.9 l/min/year ( n=46 ) than infrequent exacerbators in whom FEV1 changed by –32.1 ml/year ( n=16 ) and PEF by –0.7 l/min/year ( n=63 ) . Frequent exacerbators also had a greater decline in FEV1 if allowance was made for smoking status . Patients with frequent exacerbations were more often admitted to hospital with longer length of stay . Frequent exacerbations were a consistent feature within a patient , with their number positively correlated ( between years 1 and 2 , 2 and 3 , 3 and 4 ) . Conclusions : These results suggest that the frequency of exacerbations contributes to long term decline in lung function of patients with moderate to severe COPD BACKGROUND In spite of the well-demonstrated benefits for patients with COPD , pulmonary rehabilitation programmes show considerable drop-out and suboptimal attendance rates . The purpose of this prospect i ve study is to examine causes for drop-out and non-attendance during a 12 week multidisciplinary pulmonary rehabilitation programme , and to investigate whether sociodemographic and medical factors as well as patients ' perception of their illness are related to drop-out and non-attendance . METHODS Two hundred and seventeen patients with COPD who were referred to a rehabilitation centre participated in this multicentre study . Prior to treatment , patients received a question naire , which included the Illness Perception Question naire-Revised . Clinical data were drawn from medical records . Drop-out and attendance were recorded during the programme . RESULTS Fifty patients ( 23 % ) did not complete the rehabilitation course , of which half was due to medical reasons ( e.g. exacerbations , hospitalisations ) . Non-completion could not be predicted by baseline sociodemographic , clinical or psychological variables . Patients who declined treatment did not differ from patients who dropped out due to medical reasons . On average , patients attended 92 % of all scheduled appointments . Of all missed appointments , approximately 20 % were accountable to factors beyond patients ' control ( e.g. absent therapists , hospitalisations ) . Smoking , living alone , a lower fat free mass and lower confidence in treatment increased the chance of patients not attending an appointment during rehabilitation . CONCLUSION In general , adherence in rehabilitation is high . However , paying attention to patients ' nutritional status and creating a positive expectation of treatment during referral and intake appear to be important if one aims to optimise patients ' attendance during rehabilitation The aim of this study was to evaluate a novel patient-held manual design ed to reduce the evidence – practice gap in chronic obstructive pulmonary disease ( COPD ) . The intervention manual contained summaries of research evidence . It was developed using current best practice for patient information material s and design ed to cause discussion of evidence between patient and doctor . A controlled before- and -after study was employed in two similar but geographically separate regions of metropolitan Adelaide , South Australia . Participants had moderate to severe COPD , with 249 included at baseline and 201 completing the study . Evidence -based COPD management was measured using an indicator with three components : rates of influenza vaccination , bone density testing , and pulmonary rehabilitation . A survey of behavioral steps leading to practice change was conducted with the trial . Analysis , by median split of socioeconomic disadvantage , showed significant difference between study arms for only one component of the indicator of evidence -based practice , enrolment in pulmonary rehabilitation and only for the most socioeconomically disadvantaged stratum . For both socioeconomic strata , more intervention participants than control participants reported remembering being given the information material , reading part or all , and finding it very or quite helpful . Other significant differences were restricted to the stratum of greatest socioeconomic disadvantage : reading all of the material , learning from it , referring back , and talking to a doctor about a topic from the material . Above 90 % of all participants who received the manual reported reading from it , 42 % reported discussing topics with a doctor , but only 10 % reported treatment change attributable to the manual . We have found that people with COPD will read an evidence manual developed using current best practice . However , the study demonstrated improvement for only one of the three components of an indicator of evidence -based disease management for only the most socioeconomically disadvantaged stratum of participants . Future interventions should be design ed to better translate reading uptake into evidence -based disease management This study reports the costs associated with rehabilitation among participants in the National Emphysema Treatment Trial ( NETT ) , and evaluates factors associated with adherence to rehabilitation . Pulmonary rehabilitation is recommended for moderate-to-severe COPD and required by the Centers for Medicare and Medicaid Services ( CMS ) prior to lung volume reduction surgery ( LVRS ) . Between January 1998 and July 2002 , 1,218 subjects with emphysema and severe airflow limitation ( FEV1 ≤ 45 % predicted ) were r and omized . Primary outcome measures were design ated as mortality and maximal exercise capacity 2 years after r and omization . Pre-r and omization , estimated mean total cost per patient of rehabilitation was $ 2,218 ( SD $ 314 ; 2006 dollars ) for the medical group and $ 2,187 ( SD $ 304 ) for the surgical group . Post-r and omization , mean cost per patient in the medical and surgical groups was $ 766 and $ 962 respectively . Among patients who attended ≥ 1 post-r and omization rehabilitation session , LVRS patients , patients with an FEV1 ≥ 20 % predicted , and higher education were significantly more likely to complete rehabilitation . Patients with depressive and anxiety symptoms , and those who live > 36 miles compared to < 6 miles away were less likely to be adherent . Patients who underwent LVRS completed more exercise sessions than those in the medical group and were more likely to be adherent with post-r and omization rehabilitation . A better underst and ing of patient factors such as socioeconomic status , depression , anxiety and transportation issues may improve adherence to pulmonary rehabilitation BACKGROUND The aim of this study was to determine whether cardiac patients ' perceptions of the barriers to and benefits of home exercise while in hospital and 6 weeks after discharge are predictive of nonadherence with regular home exercise 6 months after discharge from hospital . METHODS A prospect i ve longitudinal study of 459 patients age 75 years or less and discharged from any of six public hospitals in the Lower Hunter Region of New South Wales , Australia , with a diagnosis of acute myocardial infa rct ion or angina was conducted . RESULTS Multivariate logistic regression analysis , using data provided by 281 ( 61.2 % ) patients , showed that cardiac patients ' perceptions of the benefits of and the physical environment and time barriers to home exercise while in hospital were predictive of nonadherence with regular home exercise 6 months after discharge from hospital , after adjustment for potential confounders . Six weeks after discharge from hospital , patients ' perceptions of the enjoyment and time barriers to home exercise were predictive of nonadherence at follow-up , after adjustment for potential confounders . CONCLUSIONS Cardiac patients ' perceptions of the barriers to and benefits of home exercise may be modifiable sources of nonadherence . A r and omized controlled trial is required to confirm and extend upon these findings 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 \n Output:\n " }, { "from": "agent", "value": "Travel and transport were consistently identified as barriers to both uptake and completion .\nA lack of perceived benefit of pulmonary rehabilitation also influenced both uptake and completion .\nThe limited data available regarding barriers to uptake indicated that disruption to usual routine , influence of the referring doctor and program timing were important .\nIn conclusion poor access to transport and lack of perceived benefit affect uptake of pulmonary rehabilitation .\nCurrent smokers and patients who are depressed are at increased risk of non-completion ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: BACKGROUND Warfarin , which requires coagulation monitoring , is associated with relatively high rates of thromboembolism despite providing adequate prophylaxis . This study compared an oral direct thrombin inhibitor , ximelagatran , with warfarin in order to evaluate the safety and efficacy of the medication for the prevention of venous thromboembolism in patients undergoing total knee arthroplasty . METHODS Following surgery , patients were r and omly assigned to fixed-dose oral ximelagatran ( 36 mg twice daily ) or warfarin ( target international normalized ratio , 2.5 ) , both administered for seven to twelve days in a double-blind , double-dummy design . Warfarin was initiated on the evening of the day of surgery , and ximelagatran , on the morning after surgery . The primary efficacy end point was the incidence of asymptomatic deep-vein thrombosis determined by bilateral venography , objective ly confirmed symptomatic deep-vein thrombosis or pulmonary embolism , and death from all causes during treatment . RESULTS Adequate venograms or confirmed symptomatic events ( efficacy population ) were obtained for 1949 patients . Venous thromboembolism and death from all causes occurred in 22.5 % ( 221 ) of 982 ximelagatran-treated patients and in 31.9 % ( 308 ) of 967 warfarin-treated patients ( p < 0.001 ) . Proximal deep-vein thrombosis and pulmonary embolism were observed in 3.1 % ( thirty ) and 0.2 % , respectively , of the patients in the ximelagatran group and in 3.4 % ( thirty-three ) and 0.4 % , respectively , of the patients in the warfarin group . The six deaths from all causes included 0.3 % ( four ) of the ximelagatran-treated patients and 0.2 % ( two ) of the warfarin-treated patients . Major bleeding was noted in 1 % ( twelve ) of the ximelagatran-treated patients and in 0.4 % ( five ) of the warfarin-treated patients ( p = 0.09 ) . CONCLUSIONS Oral ximelagatran ( 36 mg twice daily ) , administered without coagulation monitoring or dose adjustment and started the day after total knee arthroplasty , demonstrates superior efficacy compared with warfarin prophylaxis , with no wound complications and no significant difference with respect to bleeding events , although the rate of major bleeding events was greater with ximelagatran than with warfarin . LEVEL OF EVIDENCE Therapeutic Level One hundred forty-nine consecutive patients requiring lower extremity total joint arthroplasty were r and omized to either coumadin ( 52 patients ) or intermittent pneumatic compression ( 48 patients ) as prophylaxis against deep vein thrombosis ( DVT ) . Forty-nine patients were excluded . When fully ambulatory , the presence or absence of DVT was diagnosed by ascending venography ( 90 % of patients ) , nuclear venography , venous dopplers , or impedence plethysmography . The two groups were similar in average age ( 64 years ) , indication for arthroplasty ( pain because of arthritis in 90 % ) , gender ( 98 % male ) , and average number of risk factors ( 2.4 ) . Twenty-five percent of patients on coumadin and 25 % of patients on intermittent pneumatic compression ( IPC ) developed DVT . IPC was more effective than coumadin following primary total hip arthroplasties ( THAs ) ( 16 % versus 24 % incidence DVT ) ; coumadin was more effective than IPC following primary total knee arthroplasties ( TKAs ) ( 19 % versus 32 % incidence of DVT ) . DVT developed in 36 % of patients following revision arthroplasty . Seventy-five percent of all thrombi were proximal . Both IPC and coumadin were found to be safe ; there was no increased perioperative bleeding in the coumadin group . Of three postoperative deaths , one was possibly due to pulmonary embolism ( PE ) The effect of the pneumatic tourniquet on the incidence of postoperative deep venous thrombosis is uncertain . We carried out a controlled study comparing the incidence of deep venous thrombosis when a tourniquet was used with the incidence when a tourniquet was not used . Thrombosis was detected by radioisotope venography . The results of the study showed no difference in incidence and we concluded that the pneumatic tourniquet has no influence on the formation of a thrombus in a deep vein In a r and omized , prospect i ve trial of 100 patients , we have studied the safety and efficacy of warfarin sodium in comparison with that of dextran 40 in the prevention of venous thrombosis in patients at high risk for deep vein thrombosis after elective total hip or knee replacement . Warfarin was given in a new two-step regimen design ed to avoid bleeding complications while still preventing venous thrombosis . A low dose of warfarin was started ten to 14 days preoperatively , and the prothrombin time was regulated to between 1.5 and 3 seconds longer than control at the time of surgery ; immediately after surgery , the dose was increased to prolong the prothrombin time to 1.5 times control . The overall incidence of venous thrombosis as documented by venography was less in the 53 patients treated with warfarin than in the 37 treated with dextran ( 21 % v 51 % ) , as was the incidence of thrombi in the femoral or popliteal veins ( 2 % v 16 % ) . Objective measures of blood loss showed no difference between patients treated with warfarin or dextran , and excessive postoperative bleeding was infrequent and similar in both treatment groups . This study demonstrates that two-step warfarin therapy provides highly effective prophylaxis of postoperative venous thrombosis after elective hip or knee prosthetic surgery without excessive risk of perioperative bleeding The authors undertook a r and omised prospect i ve study to investigate the contribution of thigh tourniquets to the formation of intra-operative venous emboli during lower limb surgery . Patients were r and omised to have a thigh tourniquet or no tourniquet and transoesophageal echocardiography was used to detect embolic signals in the right heart during and after knee arthroscopy . Three physicians blinded to patient demographics and tourniquet status separately assessed videotapes of the echocardiograms for evidence of emboli . Of the 32 patients r and omised , 18 underwent knee arthroscopy with and 14 without tourniquet . Emboli were seen in 72 % ( 95 % CI 55 to 84 ) of patients , in 14 patients with tourniquet and in 9 patients without tourniquet . There was an estimated 13 % greater incidence of emboli in the tourniquet group compared to the non-tourniquet group , a difference which was not statistically significant ( Fisher 's Exact Test , p = 0.45 ) . No patients suffered symptoms or signs attributable to a pulmonary embolus We assessed the safety and efficacy of the novel low molecular weight heparinoid Lomoparan ( Org 10172 ) for the prevention of deep-vein thrombosis in patients undergoing elective total hip replacement in a r and omized , placebo-controlled , double-blind trial in 197 consecutive patients . The heparinoid ( 750 anti-factor Xa-units , s.c . , b.i.d . ) was administered to 97 patients and 99 patients received placebo . Study medication was started preoperatively and continued for 10 days . Efficacy was assessed by bilateral phlebography at day 10 , postoperatively . The incidence of deep-vein thrombosis was 56.6 % and 15.5 % respectively in the placebo and heparinoid treated patients ( incidence reduction : 74 % ; P less than 0.001 ) . This reduction was observed both for proximal-vein thrombosis ( 25 % to 8 % ; P less than 0.005 ) and isolated calf-vein thrombosis ( 31 % to 7 % ; P less than 0.001 ) . No major hemorrhage was observed . The number of red-cell units transfused and drain-fluid loss were comparable for the two study groups . Six patients in the heparinoid group and none in the control group developed minor wound hematomas ( P less than 0.05 ) . During an 8-week post-discharge follow-up period three patients with a normal venogram at day 10 developed clinical ly apparent venous thromboembolism , which was confirmed by objective testing . All three patients belonged to the heparinoid-treated group . We conclude that 750 anti-factor Xa units Org 10172 s.c . twice daily starting preoperatively is safe and effectively reduces early deep-vein thrombosis following elective total hip replacement . Further studies on the incidence of post-discharge thromboembolism are required The scientific community 's quest for unbiased research received a strong boost from a recent policy amendment on r and omised controlled trials ( RCTs ) in this journal . Henceforth , the status of allocation concealment will be clearly indicated in the abstract s along with that of blinding . Thus , readers will have additional information by which to judge the internal validity of trials . In this editorial I address the background and rationale for these enhancements . R and om allocation to intervention groups remains the only method of ensuring that the groups being compared are on an equivalent footing at the outset of the study , thus eliminating selection and confounding biases . This has allowed RCTs to play a key part in advancing medical science . The success of r and omisation depends on 2 interrelated processes.1 , 2 The first entails generating a sequence by which the participants in a trial are allocated to intervention groups . To ensure unpredictability of that allocation sequence , investigators should generate it by a r and om process . The second process , allocation concealment , shields those involved in a trial from knowing upcoming assignments in advance.3 , 4 Without this protection , investigators and patients have been known to change who gets the next assignment , making the comparison groups less equivalent.5 , 6 For example , suppose that an investigator creates an adequate allocation sequence using a r and om number table . However , the investigator then affixes the list of that sequence to a bulletin board , with no allocation concealment . Those responsible for admitting participants could ascertain the upcoming treatment allocations and then route participants with better prognoses to the experimental group and those with poorer prognoses to the control group , or vice versa . Bias would result . Inadequate allocation concealment also Tourniquet time and its relationship to blood loss and deep vein thrombosis were studied in 80 cases of unilateral total knee arthroplasty . These data were part of a prospect i ve multicenter double-blind study on thromboprophylaxis for knee surgery . This study reports on the cases done at one institution in which the tourniquet was used in three different ways : group 1 , no tourniquet use ; group 2 , limited tourniquet use for cementing time only ; group 3 , tourniquet use throughout the whole case . Blood loss was significantly related to tourniquet time ( P = .0001 ) . The incidence of deep vein thrombosis was not related to the tourniquet group ( P = .9 ) We performed a prospect i ve r and omized clinical study to determine whether use of a thigh tourniquet influences the incidence of deep venous thrombosis . The lower limbs of patients who were scheduled for elective surgery on the fore part of the foot were r and omized and assigned to one of three treatment categories : Group I , no tourniquet ; Group II , exsanguination by an Esmarch b and age before tourniquet application ; and Group III , exsanguination by elevation of the extremity prior to application of a tourniquet . The 117 limbs of seventy-one patients included in this study were evaluated preoperatively and twenty-four and seventy-two hours postoperatively with 125I-labeled fibrinogen , and preoperatively and seventy-two hours postoperatively with Doppler ultrasound studies and phleborheography . The findings in all of the Doppler ultrasound studies and all of the phleborheograms were normal . Two of the 125I-fibrinogen studies were positive , but subsequent contrast venography revealed that these were false-positive findings . We therefore concluded that the use of a thigh tourniquet does not increase the risk of deep venous thrombosis in patients who have had an operation on the fore part of the foot The effects of using a tourniquet during total knee arthroplasty were studied in 80 patients r and omly allocated to two groups , either with or without a tourniquet . The groups were similar in mean age , gender , preoperative knee score and radiographic grading and the patients were all operated on by the same surgeon using one type of prosthesis . There was no significant difference between the two groups in operating time or total blood loss but postoperative pain was less in the patients in whom a tourniquet had not been used . They achieved straight-leg raising and knee flexion earlier and had fewer superficial wound infections and deep-vein thromboses . Total knee arthroplasty can be safely performed without the use of the tourniquet with the benefit that several adverse effects associated with its use can be avoided OBJECTIVE To compare efficacy , safety , and feasibility of adjusted-dose oral anticoagulants ( OAC ) versus fixed-dose subcutaneous low molecular weight heparin ( LMWH ) for the prevention of deep venous thrombosis ( DVT ) in \n Output:\n " }, { "from": "agent", "value": "The incidence of DVT in patients undergoing elective TKA appears to have declined in patients receiving warfarin thromboprophylaxis" } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: Objective Multiple studies have shown clear evidence of vitamin D ’s anti-tumor effects on prostate cancer cells in laboratory experiments , but the evidence has not been consistent in humans . We sought to examine the association between vitamin D and prostate cancer risk in a cohort of older men . Methods We conducted a prospect i ve case-cohort study nested within the multicenter Osteoporotic Fractures in Men ( MrOS ) study . Baseline serum 25-OH vitamin D was measured in a r and omly selected sub-cohort of 1,433 men ≥65 years old without a history of prostate cancer and from all participants with an incident diagnosis of prostate cancer ( n = 297 ) . Cox proportional hazards models were used to evaluate the associations between quartiles of total 25-OH vitamin D and incident prostate cancer , as well as Gleason score . Results In comparison with the lowest quartile of 25-OH vitamin D , the hazard ratio for the highest quartile of 25-OH vitamin D was 1.22 ( CI 0.50–1.72 , p = 0.25 ) , no trend across quartiles ( p = 0.94 ) or association with Gleason score was observed . Adjustment for covariates did not alter the results . Conclusions In this prospect i ve cohort of older men , we found no association between serum 25-OH vitamin D levels and subsequent risk of prostate cancer To lend clarity to inconsistent prior findings of an inverse association between ultraviolet radiation ( UVR ) exposure and risk of lymphoid malignancies , we examined the association of prospect ively ascertained residential ambient UVR exposure with risk of non-Hodgkin lymphomas ( NHLs ) , multiple myeloma ( MM ) , and classical Hodgkin lymphoma in the California Teachers Study cohort . Among 121 216 eligible women , 629 were diagnosed with NHL , 119 with MM , and 38 with Hodgkin lymphoma between 1995 - 1996 and 2007 . Cox proportional hazards regression was used to estimate incidence rate ratios ( RRs ) with 95 % confidence intervals ( CIs ) . Residential UVR levels within a 20-km radius were associated with reduced risk of overall NHL ( RR for highest vs lowest statewide quartile of minimum UVR [ ≥ 5100 vs < 4915 W-h/m(2 ) ] , 0.58 ; 95 % CI , 0.42 - 0.80 ) , especially diffuse large B-cell lymphoma ( RR , 0.36 ; 95 % CI , 0.17 - 0.78 ) and chronic lymphocytic leukemia/small lymphocytic lymphoma ( RR , 0.46 ; 95 % CI , 0.21 - 1.01 ) , and MM ( RR for maximum UVR , 0.57 ; 95 % CI , 0.36 - 0.90 ) . These associations were not modified by skin sensitivity to sunlight , race/ethnicity , body mass index , or neighborhood socioeconomic status . Dietary vitamin D also was not associated with risk of lymphoid malignancies . These results support a protective effect of routine residential UVR exposure against lymphomagenesis through mechanisms possibly independent of vitamin Several lines of evidence suggest that vitamin D may reduce incidence of breast cancer , but few epidemiologic studies have addressed the relation of plasma vitamin D metabolites to the risk of this disease . We prospect ively examined the relationship between plasma levels of 25-hydroxyvitamin D [ 25(OH)D ] and 1,25-dihydroxyvitamin D [ 1,25(OH)2D ] and risk of breast cancer in a case-control study nested within the Nurses ' Health Study cohort . Blood sample s were collected from study participants in 1989 - 1990 . Breast cancer cases developing between blood collection and June 1 , 1996 , were matched to cancer-free controls on the basis of age , menopausal status , and other factors . Stored plasma sample s from 701 cases and 724 controls were available for metabolite analysis . Cases had a lower mean 25(OH)D level than controls ( P = 0.01 ) , but mean 1,25(OH)2D levels were similar ( P = 0.49 ) . High levels of both metabolites were associated with a nonsignificant lower risk of breast cancer . Women in the highest quintile of 25(OH)D had a relative risk of 0.73 ( 95 % confidence interval = 0.49 - 1.07 ; Ptrend = 0.06 ) compared with those in the lowest quintile . For 1,25(OH)2D , the comparable relative risk was 0.76 ( 95 % confidence interval = 0.52 - 1.11 ; Ptrend = 0.39 ) . For both metabolites , the association was stronger in women ages 60 years and older , but results were not statistically significant . Our findings suggest that high levels of 25(OH)D , and perhaps 1,25(OH)2D , may be modestly associated with reduced risk of breast cancer Background : UV radiation and pigmentary characteristics may be associated with non – Hodgkin lymphoma ( NHL ) risk , but few prospect i ve studies exist . We investigated these associations in a Norwegian-Swedish cohort . Methods : The cohort included women ages 30 to 50 years at enrolment in 1991 to 1992 . Host factors , and exposure to sun and artificial tanning devices in life-decades 0 to 50 years were collected by question naire . Relative risks ( RR ) with 95 % confidence intervals ( CI ) were estimated by Poisson regression . Results : Among 104,953 women with complete follow-up through 2006 ( Sweden ) and 2007 ( Norway ) , 158 were diagnosed with NHL . Women with brown hair had an increased risk of NHL compared with dark brown – haired/black-haired women ( RR , 1.72 ; 95 % CI , 1.08 - 2.74 ) ; decreased risks were found among women with gray , green or mixed ( RR , 0.50 ; 95 % CI , 0.32 - 0.77 ) , or blue ( RR , 0.54 ; 95 % CI , 0.35 - 0.81 ) eyes compared with those with brown eyes , and among those with high propensity to burn compared with those with low propensity ( RR , 0.57 ; 95 % CI , 0.36 - 0.91 ) . Annual number of sunburns and bathing vacations in any age decade , or ever use of artificial tanning devices were not significantly associated with NHL risk . After exposure at ages 10 to 39 years , RRs for ever versus never exposed were 0.99 ( 95 % CI , 0.65 - 1.50 ) for sunburn , 1.00 ( 95 % CI , 0.64 - 1.54 ) for bathing vacations , and 0.99 ( 95 % CI , 0.67 - 1.46 ) for artificial tanning device use . Conclusion : Whereas several pigmentary characteristics were associated with NHL risk , our results do not support an association between UV radiation and NHL . Impact : Studies of UV radiation and NHL are warranted for etiologic underst and ing and public health recommendations . Cancer Epidemiol Biomarkers Prev ; 19(6 ) ; 1569–76 . © 2010 AACR Introduction Experimental evidence indicates vitamin D may play an important role in breast cancer etiology but epidemiologic evidence to date is inconsistent . Vitamin D comes from dietary intake and sun exposure and plasma levels of 25-hydroxyvitamin D ( 25(OH)D ) are considered the best measure of vitamin D status . Methods We conducted a prospect i ve nested case-control study within the Nurses ' Health Study II ( NHSII ) . Plasma sample s collected in 1996 to 1999 were assayed for 25(OH)D in 613 cases , diagnosed after blood collection and before 1 June 2007 , and in 1,218 matched controls . Multivariate relative risks ( RR ) and 95 % confidence intervals ( CI ) were calculated by conditional logistic regression , adjusting for several breast cancer risk factors . Results No significant association was observed between plasma 25(OH)D levels and breast cancer risk ( top vs. bottom quartile multivariate RR = 1.20 , 95 % CI ( 0.88 to 1.63 ) , P-value , test for trend = 0.32 ) . Results were similar when season-specific quartile cut points were used . Results did not change when restricted to women who were premenopausal at blood collection or premenopausal at diagnosis . Results were similar between estrogen receptor (ER)+/progesterone receptor (PR)+ and ER-/PR- tumors ( P-value , test for heterogeneity = 0.51 ) . The association did not vary by age at blood collection or season of blood collection , but did vary when stratified by body mass index ( P-value , test for heterogeneity = 0.01 ) . Conclusions Circulating 25(OH)D levels were not significantly associated with breast cancer risk in this predominantly premenopausal population We investigated the association between plasma 25(OH)D and the subsequent colorectal cancer incidence risk by a nested case – control study in The Japan Public Health Center-based Prospect i ve Study , covering 375 newly diagnosed cases of colorectal cancer from 38 373 study subjects during a 11.5-year follow-up after blood collection . Two controls were matched per case on sex , age , study area , date of blood draw , and fasting time . In a conditional logistic regression model with matched pairs adjusted for smoking , alcohol consumption , body mass index , physical exercise , vitamin supplement use , and family history of colorectal cancer , plasma 25(OH)D was not significantly associated with colorectal cancer in men or in women . However , the lowest category of plasma 25(OH)D was associated with an elevated risk of rectal cancer in both men ( odds ratio ( OR ) , 4.6 ; 95 % confidence interval ( CI ) , 1.0–20 ) and women ( OR , 2.7 , 95 % CI , 0.94–7.6 ) , compared with the combined category of the other quartiles . Our results suggest that a low level of plasma 25(OH)D may increase the risk of rectal cancer Objective To examine the association between pre-diagnostic circulating vitamin D concentration , dietary intake of vitamin D and calcium , and the risk of colorectal cancer in European population s. Design Nested case-control study . Setting The study was conducted within the EPIC study , a cohort of more than 520 000 participants from 10 western European countries . Participants 1248 cases of incident colorectal cancer , which developed after enrolment into the cohort , were matched to 1248 controls Main outcome measures Circulating vitamin D concentration ( 25-hydroxy-vitamin-D , 25-(OH)D ) was measured by enzyme immunoassay . Dietary and lifestyle data were obtained from question naires . Incidence rate ratios and 95 % confidence intervals for the risk of colorectal cancer by 25-(OH)D concentration and levels of dietary calcium and vitamin D intake were estimated from multivariate conditional logistic regression models , with adjustment for potential dietary and other confounders . Results 25-(OH)D concentration showed a strong inverse linear dose-response association with risk of colorectal cancer ( P for trend < 0.001 ) . Compared with a pre-defined mid-level concentration of 25-(OH)D ( 50.0 - 75.0 nmol/l ) , lower levels were associated with higher colorectal cancer risk ( < 25.0 nmol/l : incidence rate ratio 1.32 ( 95 % confidence interval 0.87 to 2.01 ) ; 25.0 - 49.9 nmol/l : 1.28 ( 1.05 to 1.56 ) , and higher concentrations associated with lower risk ( 75.0 - 99.9 nmol/l : 0.88 ( 0.68 to 1.13 ) ; ≥100.0 nmol/l : 0.77 ( 0.56 to 1.06 ) ) . In analyses by quintile of 25-(OH)D concentration , patients in the highest quintile had a 40 % lower risk of colorectal cancer than did those in the lowest quintile ( P<0.001 ) . Subgroup analyses showed a strong association for colon but not rectal cancer ( P for heterogeneity=0.048 ) . Greater dietary intake of calcium was associated with a lower colorectal cancer risk . Dietary vitamin D was not associated with disease risk . Findings did not vary by sex and were not altered by corrections for season or month of blood donation . Conclusions The results of this large observational study indicate a strong inverse association between levels of pre-diagnostic 25-(OH)D concentration and risk of colorectal cancer in western European population s. Further r and omised trials are needed to assess whether increases in circulating 25-(OH)D concentration can effectively decrease the risk of colorectal cancer Background : Ecological studies have suggested that vitamin D production through ultraviolet ( UV ) solar irradiance could reduce breast cancer ( BC ) risk . Although studies restricted to dietary vitamin \n Output:\n " }, { "from": "agent", "value": "We found that almost all epidemiological studies suggest that chronic ( not intermittent ) sun exposure is associated with a reduced risk of colorectal- , breast- , prostate cancer and NHL .\nIn colorectal- and to a lesser degree in breast cancer vitamin D levels were found to be inversely associated with cancer risk .\nIn prostate cancer and NHL , however , no associations were found .\nThese findings are discussed and it is concluded that the evidence that sunlight is a protective factor for colorectal- , prostate- , breast cancer and non-Hodgkin 's lymphoma is still accumulating .\nThe same conclusion can be drawn concerning high vitamin D levels and the risk of colorectal cancer and possibly breast cancer .\nParticularly in prostate cancer and NHL other sunlight potentiated and vitamin D independent pathways , such as modulation of the immune system and the circadian rhythm , and the degradation of folic acid might play a role in reduced cancer risk as well" } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: BACKGROUND Ischemia-reperfusion injury during open heart surgery related to unsuccessful myocardial protection may increase morbidity or mortality . We analyze the clinical outcome after cardiac surgery with a cardioplegic solution based on intracellular components added with histidine-ketoglutarate-tryptophan . METHODS Thirty patients programmed for elective open heart surgery were r and omized into two groups . In group I ( n = 15 ) , myocardial protection was carried out with Bretschenider solution ( HTK ) , and in group II ( n = 15 ) with conventional crystalloid cardioplegia . The incidence of arrhythmias , inotropic support requirement , and length-of-stay in the intensive care unit were evaluated . RESULTS During reperfusion , there was no difference in incidence of arrhythmias ; however , in the postoperative period group I had a lower incidence of arrhythmias ( p = 0.001 ) . Inotropic support ( p = 0.003 ) and length-of-stay in the intensive care unit ( p = 0.037 ) were lower in group I. There were no deaths in either group . CONCLUSIONS It was concluded that myocardial protection with Bretschneider solution effectively decreases incidence of arrhythmias , inotropic support , and length-of-stay in the intensive care unit BACKGROUND We hypothesized that blood cardioplegia preserves myocardial metabolism and function more effectively than St Thomas ' crystalloid cardioplegia in infant cardiac surgery . METHODS Thirty infants with atrioventricular septal defects were r and omly allocated to either blood or crystalloid intermittent cold ( 4 degrees C ) cardioplegia . Arterial and coronary sinus blood was analyzed for lactate and oxygen . Cardiac output ( thermodilution ) and left ventricular function ( echocardiography ) were evaluated . RESULTS The lactate concentration in coronary sinus blood early after bypass was significantly higher after crystalloid cardioplegia than after blood cardioplegia ( 2.1 + /- 0.3 vs 1.3 + /- 0.1 mmol/L , p = 0.006 ) , with a significant myocardial release of lactate after crystalloid but not after blood cardioplegia . Oxygen extraction ( arterial-coronary sinus O2 content ) was higher early after crystalloid cardioplegia ( 3.02 + /- 0.13 vs 2.35 + /- 0.22 mmol/L , p = 0.01 ) , possibly reflecting a difference in oxygen debt . The cardiac index was higher after blood cardioplegia ( 4.9 + /- 0.3 vs 4.0 + /- 0.3 L/min(-1)/m(-2 ) , p = 0.04 ) and echocardiographic grading of left ventricular function was better ( 4.1 + /- 0.17 vs 3.5 + /- 0.22 arbitrary units , p = 0.046 ) . CONCLUSIONS This study indicates that blood cardioplegia preserves myocardial metabolism and function more effectively than crystalloid cardioplegia in infant cardiac surgery . The clinical significance of this finding is uncertain , but the more than 20 % increase in cardiac index in the critical phase during weaning from bypass may be advantageous OBJECTIVES A single or dual-dose strategy for myocardial protection is attractive in long operations , in avoiding the need to interrupt the procedure to re-administer cardioplegia . We hypothesized that a single administration of Bretschneider histidine-tryptophan-ketoglutarate ( HTK ) crystalloid solution ( Custodiol ) offers myocardial protection comparable with repeated tepid blood cardioplegia . METHODS We review ed a prospect ively compiled single-centre data base containing all adult cardiac procedures performed from January 2005 to January 2011 . Preoperative demographic and investigative data , operative variables and postoperative ( 30-day ) mortality and morbidity were compared between the Custodiol and blood cardioplegia groups . The study primary endpoints were 30-day mortality , return to the operating theatre , myocardial infa rct ion , stroke , postoperative requirement for an intra-aortic balloon pump , new renal failure , prolonged ventilation and re-admission to hospital within 30 days . Propensity score matching was performed to correct for any bias that may have been associated with the usage of Custodiol . RESULTS A total of 1900 cardiac surgical procedures were identified of which 126 ( 7 % ) utilized Custodiol and 1774 ( 93 % ) used blood cardioplegia as the primary cardioplegic agent . After propensity-score matching , we were able to match 71 Custodiol cases one-to-one to those receiving blood cardioplegia . There were no statistically significant differences noted for any of the endpoints studied after propensity-score matching . In particular , the proportion of mortality ( blood cardioplegia : 1 vs Custodiol 4 % , P = 0.63 ) any mortality/morbidity ( blood cardioplegia : 35 vs Custodiol : 39 % P = 0.46 ) was similar between the groups . CONCLUSIONS The use of Custodiol is convenient , simple and at least as safe as tepid blood cardioplegia for myocardial protection in complex cardiac operations . A r and omized prospect i ve comparison of myocardial protection strategies is warranted Background —The advantages of blood cardioplegia include the oxygen-carrying capacity , superior oncotic and buffering properties , and endogenous antioxidants contained in blood . However , the partial dilution of blood in 4:1 ( blood : crystalloid ) cardioplegic solutions may nullify these advantages and progressively dilute blood during continuous retro grade delivery . This study tested the hypothesis that all-blood ( 66:1 ) cardioplegia provides superior myocardial protection compared with dilute ( 4:1 ) cardioplegia delivered in a continuous retro grade modality during surgical reperfusion of evolving myocardial infa rct ion . Methods and Results —After 60 minutes of left anterior descending coronary artery ( LAD ) occlusion , anesthetized canines were placed on cardiopulmonary bypass and r and omized to either all-blood cardioplegia ( AB group ) or dilute blood cardioplegia ( Dil group ) . After cross clamping , arrest was induced with 5 minutes of tepid ( 30 ° C ) ante grade potassium all-blood or dilute blood cardioplegia and maintained with tepid retro grade coronary sinus cardioplegia for a total of 1 hour . The LAD was released after 30 minutes of arrest , simulating revascularization . The cardioplegia hematocrit for the Dil group was lower than that for the AB group ( 7±1 % versus 12±2 % , P < 0.05 ) ; at the end of bypass , systemic hematocrit was lower in the Dil group than in the Ab group ( 15±1 % versus 20±1 % , P < 0.05 ) . Infa rct size ( triphenyltetrazolium chloride staining ) was comparable between the AB and Dil groups ( 29.6±2.9 % versus 30.3±3.9 % of area at risk ) , and there was no difference in area-at-risk myocardium systolic shortening ( by sonomicrometry , −0.3±1 % versus −0.4±1 % ) . Tissue edema after bypass tended to be greater in the Dil group compared with the AB group in the heart ( 82±0 % versus 81±1 % ) , lung ( 79±1 % versus 78±1 % ) , liver ( 75±1 % versus 74±0 % ) , and skeletal muscle ( 76±1 % versus 73±2 % ) and was significantly greater in the duodenum ( 80±1 % versus 79±1 % , P < 0.05 ) and kidney ( 82±1 % versus 79±1 % , P < 0.05 ) . Postexperimental endothelial function ( relaxation of acetylcholine ) was impaired in LADs of the AB group versus the Dil group ( 59±6 % versus 77±5 % , P < 0.05 ) . Conclusions —Both all-blood cardioplegia and dilute cardioplegia have disadvantages , but these do not have an impact on the pathogenesis of infa rct size or recovery of regional contractile function While blood : crystalloid cardioplegia is the clinical st and ard for patients undergoing cardiopulmonary bypass ( CPB ) , it has been postulated that whole blood minicardioplegia may benefit the severely injured heart by reducing cardioplegic volume , thereby reducing myocardial edema . To test this hypothesis , we compared the cardioprotection of a popular 4:1 blood : crystalloid cardioplegia to whole blood minicardioplegia ( WB ) in a porcine model of acute myocardial ischemia . Yorkshire pigs ( n = 20 ) were placed on atriofemoral bypass and subjected to 30 minutes of global normothermic ischemia . Animals were r and omized to receive either 4:1 cold cardioplegia ( n = 10 ) or WB cold cardioplegia ( n = 10 ) delivered ante grade continuously for 90 minutes . Baseline ( BL ) echocardiographic determination of left ventricular mass ( LVM ) was compared within groups for cardiac edema ( % ) measured by histologic morphometrics . All ( 100 % ) animals receiving WB were successfully weaned off CPB , whereas only 40 % of animals receiving 4:1 were successfully weaned off CPB . Cardiac edema percentage ( p < .004 ) and LVM ( p < .05 ) were significantly decreased in the WB group compared with 4:1 . WB cardioplegia increases the number of hearts successfully weaned from CPB and decreases cardiac edema in our porcine model of acute myocardial ischemia . This finding implies whole blood cardioplegia may be more protective in a select group of patients undergoing extended CPB time by decreasing myocardial edema BACKGROUND Blood cardioplegia has been widely accepted in clinical cardiac surgery based on its excellent oxygen delivery and pH buffering capacity . To further conserve blood during clinical cardiac surgery , we formulated a new crystalloid cardioplegic solution containing histidine ( 100 mol/L ) as the pH buffering agent . METHODS Sixty patients being applied Histidine Buffered Solution ( HBS ) ( n = 27 ) or Cold Blood Cardioplegic solution ( CBC ) ( n = 33 ) , both at 4 degrees C , were studied prospect ively . Pre- and post-bypass left-ventricular ( LV ) volume was measured by echocardiography . With a ventricular pressure catheter , LV pressure-volume loops were constructed to determine the slope of the end-systolic pressure-volume relationship ( Emax ) without inotropes . RESULTS There were no postoperative deaths in either group . Thirty minutes after reperfusion Emax was significantly better in the HBS group than in the CBC group ( 6.0 + /- 1.0 mmHg/cm3 vs 3.7 + /- 0.8 mmHg/cm3 ) . Cardiac Index was also significantly higher in HBS group than in CBC group with lower inotropic requirement . Homologous blood transfusion was avoided in 64 % of the patients receiving HBS versus 48 % of the patients with CBC . CONCLUSIONS We conclude that the new histidine-buffered cardioplegic solution provides effective protection with excellent recovery of pump performance in clinical open heart surgery OBJECTIVE Although experimental studies have indicated that blood cardioplegia may be superior to crystalloid cardioplegia for myocardial protection , clinical data still remain uncertain . In a previous r and omised study from our institution , including 1440 patients undergoing coronary artery bypass grafting ( CABG ) , no beneficial effects of blood cardioplegia were seen in any relevant outcome variables . The investigation was therefore extended to a patient population having longer pump times and ischaemic periods . METHODS Over a 48-month period , all patients undergoing aortic valve replacement with or without CABG performed by two surgeons , were prospect ively r and omised to receive either intermittent cold retro grade blood cardioplegia ( group B ) or intermittent cold retro grade crystalloid cardioplegia ( group C ) during aortic cross-clamping . RESULTS A total of 345 patients aged 28 - 90 years ( median , 72 years ) entered the study ( group B , n=172 , group C , n=173 ) . All relevant demographic and operative variables were similar for both groups . As for the clinical course , no statistically significant differences were seen concerning spontaneous sinus rhythm after aortic declamping , use of inotropic drugs , duration of ventilatory support , bleeding and rate of allogeneic blood transfusions , perioperative myocardial infa rct ion , episodes of atrial fibrillation , stroke or minor neurological dysfunction , renal function , infections , physical rehabilitation or mortality . Further , in the patients with the longest ischaemic times , no statistically significant differences between the groups could be demonstrated . CONCLUSIONS There were no indications that retro grade cold blood cardioplegia was superior to retro grade cold crystalloid cardioplegia patients undergoing aortic valve replacement , with or without CABG OBJECTIVES Histidine-tryptophan-ketoglutarate ( HTK-Custodiol ) cardioplegic solution is administered as one single dose for more than 2 \n Output:\n " }, { "from": "agent", "value": "Some solutions , del Nido cardioplegia in particular , were found to have few or no significant human trials to back the rigor required in such a highly specialized field as cardiovascular surgery .\nWithout this research , surgeon preference remains the primary determining factor for deciding which cardioplegic solution to use ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: The topiramate study was a 12-month r and omized placebo-controlled trial in patients with ALS . Follow-up evaluation of the placebo group ( n = 97 ) constituted a well-described cohort of patients with ALS , in whom multiple outcome measures were assessed at 3-month intervals . During the 12-month study period , the decline of forced vital capacity ( FVC% ) and ALS functional rating scale ( ALSFRS ) was linear , whereas the decline of maximum voluntary isometric contraction – arm ( MVIC-arm ) and MVIC-grip Z scores was curvilinear . Rates of FVC% and ALFRS decline , but not of MVIC-arm or MVIC-grip , were independent predictors of survival Our objective was to determine the effect of creatine monohydrate on disease progression in patients with amyotrophic lateral sclerosis ( ALS ) . One hundred and seven patients with the diagnosis of probable or definite ALS , of less than five years duration from symptom onset , were r and omized to either treatment with daily creatine monohydrate ( 5 g/d ) or placebo . In this multicenter , double-blinded study we followed changes in disease progression : using quantitative measures of strength via maximal isometric voluntary contraction , forced vital capacity , ALSFRS , quality of life , fatigue and survival . Patients were followed for nine months . The results showed that creatine monohydrate did not significantly improve motor , respiratory or functional capacity in this patient population . The drug was well tolerated and the study groups well balanced , especially considering the absence of forced vital capacity criteria for entrance into the study . There was a trend toward improved survival in patients taking daily creatine monohydrate and this was identical to the trend seen in another recently published report of creatine in ALS patients 1 . In conclusion , creatine monohydrate ( 5 g/d ) did not have an obvious benefit on the multiple markers of disease progression measured over nine months . We measured fatigue during isometric contraction and found no significant improvement despite anecdotal patient reports prior to and during the study . The trend toward improved survival was also found in another recently completed blinded trial using creatine monohydrate . Further investigation on the possible survival benefit of creatine in this patient population is ongoing The ALS Functional Rating Scale ( ALSFRS ) is a vali date d rating instrument for monitoring the progression of disability in patients with amyotrophic lateral sclerosis ( ALS ) . One weakness of the ALSFRS as originally design ed was that it granted disproportionate weighting to limb and bulbar , as compared to respiratory , dysfunction . We have now vali date d a revised version of the ALSFRS , which incorporates additional assessment s of dyspnea , orthopnea , and the need for ventilatory support . The Revised ALSFRS ( ALSFRS-R ) retains the properties of the original scale and shows strong internal consistency and construct validity . ALSFRS-R scores correlate significantly with quality of life as measured by the Sickness Impact Profile , indicating that the quality of function is a strong determinant of quality of life in ALS The Scottish Motor Neuron Disease Register ( SMNDR ) is a prospect i ve , collaborative , population -based project which has been collecting data on incident patients since 1989 . In this report we present the clinical features of 229 patients with motor neuron disease ( 218 sporadic and 11 familial ) diagnosed in 1989 and 1990 and compare their prognosis with previous studies of survival . The overall 50 % survival from symptom onset was 2.5 years ( 95 % CI , 2.2–3.0 ) and 5-year survival 28 % ( 95 % Cl , 20–36 % ) . The presence of progressive bulbar palsy ( PBP ) , either at presentation or developing during the course of the illness , significantly reduced survival and was the most important prognostic indicator . Patients who survived longer than 5 years from symptom onset did not have BP as part of their presenting illness . The prognosis was worse for women , and this was in part related to the higher frequency of PBP in older women , but age was also an independent adverse risk factor . Differences in survival between this and previous series can probably be explained on the basis of variation in case definition and ascertainment methods Background : In recent years , there has been a paradigm shift in the method of healthcare delivery to amyotrophic lateral sclerosis ( ALS ) patients with the emergence of multidisciplinary ALS clinics that cater exclusively for patients with this condition . The impact of multidisciplinary management has not been previously evaluated . Methods : Using data from the Irish ALS Register , we conducted a prospect i ve , population based study of all ALS cases diagnosed in Irel and over a five year period to evaluate the effectiveness of a multidisciplinary clinic on ALS survival . Results : Eighty two ( 24 % ) patients attended the multidisciplinary ALS clinic , with the remaining 262 ( 76 % ) cases followed in a general neurology clinic . The ALS clinic cohort was an average of five years younger ( 60.1 v 65.6 years ) and were more likely to receive riluzole than the general neurology cohort ( 99 % v 61 % ) . The median survival of the ALS clinic cohort was 7.5 months longer than for patients in the general neurology cohort ( logrank = 15.4 , p < 0.0001 ) . Overall , one year mortality was decreased by 29.7 % . Prognosis of bulbar onset patients was extended by 9.6 months if they attended the ALS clinic . Using multivariate analysis , attendance at the ALS clinic was an independent covariate of survival ( HR = 1.47 , p = 0.02 ) . Conclusions : ALS patients who received their care at a multidisciplinary clinic had a better prognosis than patients attending a general neurology clinic . The data suggest that active and aggressive management enhances survival , particularly among ALS patients with bulbar dysfunction . The effect of clinic type must be considered in future clinical trials design Objective : To determine the incidence , prevalence , and mortality rates of ALS in the province of Modena , Northern Italy , from 1990 through 1999 . Methods : A retrospective epidemiologic study was conducted , ascertaining cases from all neurologic centers and hospitals of the province , death certificates , and the Italian ALS Association , section of Modena . All clinical records were review ed , and only patients fulfilling the El Escorial revised diagnostic criteria were included . Results : During the period considered ( 1990 to 1999 ) , 143 residents ( 67 men and 76 women ) entered the study . The average annual incidence was 2.16 per 100,000 , with a peak in the age class of 75 to 79 years . Mean prevalence rate was 4.02 per 100,000 , and mean mortality rate was 1.69 per 100,000 . The incidence rate remained constant over time , whereas the prevalence and mortality rates increased owing to a rise in survival time ( ALS mean duration was 17.38 months in 1990 , 43.18 months in 1999 ) . In the mountainous areas , where agricultural work is more common , the incidence , prevalence , and mortality rates were higher than in urban areas and the disease onset occurred 10 years later . Of the risk factors examined , only agricultural work and rural residence were significant . Conclusions : The incidence , prevalence , and mortality rates agree with those in recent Italian surveys and with most international studies , but the distribution of cases varied with higher rates in mountainous areas . Further prospect i ve studies are required ALS is a progressive motor neuron disease with no effective treatment . The anti-excitotoxic drug riluzole ( 100 mg/day ) has been shown to decrease mortality and muscular deterioration in ALS patients . To confirm and extend the therapeutic effect of riluzole , we performed a double-blind , placebo-controlled , multicenter , international , dose-ranging ( 50 , 100 , 200 mg/day ) , stratified study in 959 ALS out patients treated for up to 18 months . Primary efficacy criterion was survival and the effect of treatment was analyzed before ( Wilcoxon and log rank tests ) and after adjustment on prognostic factors ( Cox model ) . Secondary efficacy criterion was disease progression assessed through change in functional measures . Tracheostomy-free survival rates were : 50.4 % ( placebo ) , 55.3 % ( 50 mg riluzole ) ( p = 0.23 , Wilcoxon test ; p = 0.25 , log-rank test ) , 56.8 % ( 100 mg riluzole ) ( p = 0.05 , Wilcoxon test ; p = 0.076 , log-rank test ) , and 57.8 % ( 200 mg riluzole ) ( p = 0.061 , Wilcoxon test ; p = 0.075 , log-rank test ) . At the end of the 18-month study , there was a significant dose-related decrease in risk of death or tracheostomy ( p = 0.04 ) . Adjustment for baseline prognostic factors showed a 35 % decreased risk of death with the 100-mg dose compared with placebo ( p = 0.002 ) . No significant treatment effects were detected for the functional assessment s. The most frequent dose-related adverse events included nausea , asthenia , and elevated liver enzyme levels . This study confirms the therapeutic effect of riluzole in a large representative ALS sample , over an 18-month period . Riluzole is well tolerated and decreases the risk of death or tracheostomy in ALS patients . NEUROLOGY 1996;47(Suppl 4 ) : Creatine supplementation in humans has been reported to enhance power and strength both in normal subjects and in patients with various neuromuscular diseases . The purpose of this study was to examine the effects of supplementation on exercise performance and maximal voluntary isometric muscular contraction ( MVIC ) in Amyotrophic Lateral Sclerosis ( ALS ) patients . We report the results obtained in 28 patients with probable/definite ALS . In each patient we acquired the dynamometric measurement of MVIC in 10 muscle groups of upper and lower limbs and a measure of fatigue by means of an high-intensity intermittent protocol in elbow flexors and knee extensors muscles . All patients completed the protocol s at the baseline and after supplementation of 20 g per day for 7 days and after supplementation of 3 g per day for 3 and 6 months . MVIC increased after 7 days of supplementation in 20 patients ( 70 % ) in knee extensors and in 15 ( 53 % ) of them also in elbow flexors . A statistically significant difference between pre and post-treatment mean values of MVIC was found both in elbow flexors ( P<0.05 ) and knee extensors ( p<0.04 ) . The analysis of the slopes of fatigue test showed a statistically significant improvement after 7 days of supplementation in 11 patients ( 39 % ) in elbow flexors and in 9 patients ( 32 % ) also in knee extensors muscles . During the 6-month follow-up period all the examined parameters showed a linear progressive decline . In conclusion , our preliminary results have demonstrated that supplementation temporary increases maximal isometric power in ALS patients so it may be of potential benefit in situations such as high intensity activity and it can be proposed as a symptomatic treatment Amyotrophic lateral sclerosis ( ALS ) is a fatal disease with no cure . In a transgenic mouse model of ALS , creatine monohydrate showed a promising increase in survival . We performed a double‐blind , placebo‐controlled , sequential clinical trial to assess the effect of creatine monohydrate on survival and disease progression in patients with ALS . Between June 2000 and December 2001 , 175 patients with probable , probable‐laboratory supported , or definite ALS were r and omly assigned to receive either creatine monohydrate or placebo 10gm daily . A sequential trial design was used with death , persistent assisted ventilation , or tracheostomy as primary end points . Secondary outcome measurements were rate of decline of isometric arm muscle strength , forced vital capacity , functional status , and quality of life . The trial was stopped when the null hypothesis of indifference was accepted . Creatine did not affect survival ( cumulative survival probability of 0.70 in the creatine group vs 0.68 in the placebo group at 12 months , and 0.52 in the creatine group vs 0.47 in the placebo group at 16 months ) , or the rate of decline of functional measurements . Creatine intake did not cause important adverse reactions . This placebo‐controlled trial did not find evidence of a beneficial effect of creatine monohydrate on survival or disease progression in patients with ALS . Ann Neurol Amyotrophic lateral sclerosis is a rapidly progressive disease of unknown etiology result ing in tetraparalysis , dysarthria , dysphagia , and ultimately death from respiratory insufficiency . In the course of the disease , recurrent episodes of aspiration , pneumonia , dehydration , and malnutrition may necessitate nasoenteral tube placement , an inconvenient and unattractive arrangement in patients with dribbling and impaired swallowing . A percutaneous endoscopic gastrostomy seemed a better , though potentially hazardous , alternative in view of the often severely restricted pulmonary function of these patients . Therefore , we prospect ively investigated the use of percutaneous endoscopic g \n Output:\n " }, { "from": "agent", "value": "Creatine was reportedly well-tolerated in all three included studies , with no evidence of renal failure or serious adverse events specifically attributable to creatine .\nIn patients already diagnosed with clinical ly probable or definite amyotrophic lateral sclerosis ( ALS ) , creatine at doses ranging from 5 to 10 g per day did not have a statistically significant effect on survival , ALS functional rating revised scores ( ALSFRS-R ) progression or percent predicted forced vital capacity ( FVC ) progression" } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: Aims /hypothesis . The amount and quality of fat in the diet could be of importance for development of insulin resistance and related metabolic disorders . Our aim was to determine whether a change in dietary fat quality alone could alter insulin action in humans . Methods . The KANWU study included 162 healthy subjects chosen at r and om to receive a controlled , isoenergetic diet for 3 months containing either a high proportion of saturated ( SAFA diet ) or monounsaturated ( MUFA diet ) fatty acids . Within each group there was a second assignment at r and om to supplements with fish oil ( 3.6 g n-3 fatty acids/d ) or placebo . Results . Insulin sensitivity was significantly impaired on the saturated fatty acid diet ( -10 % , p = 0.03 ) but did not change on the monounsaturated fatty acid diet ( + 2 % , NS ) ( p = 0.05 for difference between diets ) . Insulin secretion was not affected . The addition of n-3 fatty acids influenced neither insulin sensitivity nor insulin secretion . The favourable effects of substituting a monounsaturated fatty acid diet for a saturated fatty acid diet on insulin sensitivity were only seen at a total fat intake below median ( 37E % ) . Here , insulin sensitivity was 12.5 % lower and 8.8 % higher on the saturated fatty acid diet and monounsaturated fatty acid diet respectively ( p = 0.03 ) . Low density lipoprotein cholesterol ( LDL ) increased on the saturated fatty acid diet ( + 4.1 % , p < 0.01 ) but decreased on the monounsaturated fatty acid diet ( MUFA ) ( –5.2 , p < 0.001 ) , whereas lipoprotein ( a ) [ Lp(a ) ] increased on a monounsaturated fatty acid diet by 12 % ( p < 0.001 ) . Conclusions /interpretation . A change of the proportions of dietary fatty acids , decreasing saturated fatty acid and increasing monounsaturated fatty acid , improves insulin sensitivity but has no effect on insulin secretion . A beneficial impact of the fat quality on insulin sensitivity is not seen in individuals with a high fat intake ( > 37E % ) . [ Diabetologia ( 2001 ) 44 : 312–319 Meat contains numerous carcinogens , such as heterocyclic amines , polycyclic aromatic hydrocarbons , and N‐nitroso compounds , which can be derived either from natural food or during the process of food preparation . These carcinogens may increase pancreatic cancer risk . Furthermore , studies in animals showed that polyunsaturated fatty acids , especially linoleic acid , increase pancreatic cancer risk . We examined prospect ively the relation between pancreatic cancer risk and intake of fresh meat , processed meat , fish , eggs , total fat , and different types of fat . The Netherl and s Cohort Study consisted of 120,852 men and women who completed a baseline question naire in 1986 . After 13.3 years of follow‐up , 350 pancreatic cancer cases ( 66 % microscopically confirmed ) were available for analysis . A vali date d 150‐item food‐frequency question naire was used to calculate intake of fresh meat , processed meat , fish , eggs , fat and different types of fat . No association was found when examining the association between intake of fresh meat , other types of meat , fish , eggs , dietary intake of total fat and different types of fat and risk of pancreatic cancer . It is important for future studies to investigate the relation between different meat‐cooking methods and pancreatic cancer . © 2009 Case-control studies suggest that meat and cholesterol intakes may be related to elevated risks of pancreatic cancer . Few prospect i ve studies have examined associations between diet and pancreatic cancer , although in one recent study saturated fat consumption was related to higher risk . In a cohort of US women , the authors confirmed 178 pancreatic cancer cases over 18 years of follow-up . A mailed 61-item food frequency question naire was self-administered at baseline , and health and lifestyle variables were up date d biennially . Analyses were performed using Cox proportional hazards models to adjust for potential confounders . Intakes of total fat , different types of fats , and cholesterol were not associated with pancreatic cancer risk . Similarly , total meat , red meat , and dairy products were not related to risk . Individual food items contributing to intakes of total meat and dairy products , as well as fish and eggs , did not reveal any specific association . Updating dietary exposures by using question naires from 1980 , 1984 , 1986 , and 1990 produced similar findings . The authors ' data do not support previous findings that meat or saturated fat intakes are related to pancreatic cancer risk . Future prospect i ve studies should examine the influence of cooking practice s as well as other dietary habits on the risk of pancreatic cancer BACKGROUND Previous research relating dietary fat , a modifiable risk factor , to pancreatic cancer has been inconclusive . METHODS We prospect ively analyzed the association between intakes of fat , fat subtypes , and fat food sources and exocrine pancreatic cancer in the National Institutes of Health-AARP Diet and Health Study , a US cohort of 308 736 men and 216 737 women who completed a 124-item food frequency question naire in 1995 - 1996 . Hazard ratios ( HRs ) and 95 % confidence intervals ( CIs ) were calculated using Cox proportional hazards regression models , with adjustment for energy intake , smoking history , body mass index , and diabetes . Statistical tests were two-sided . RESULTS Over an average follow-up of 6.3 years , 865 men and 472 women were diagnosed with exocrine pancreatic cancer ( 45.0 and 34.5 cases per 100 000 person-years , respectively ) . After multivariable adjustment and combination of data for men and women , pancreatic cancer risk was directly related to the intakes of total fat ( highest vs lowest quintile , 46.8 vs 33.2 cases per 100 000 person-years , HR = 1.23 , 95 % CI = 1.03 to 1.46 ; P(trend ) = .03 ) , saturated fat ( 51.5 vs 33.1 cases per 100 000 person-years , HR = 1.36 , 95 % CI = 1.14 to 1.62 ; P(trend ) < .001 ) , and monounsaturated fat ( 46.2 vs 32.9 cases per 100 000 person-years , HR = 1.22 , 95 % CI = 1.02 to 1.46 ; P(trend ) = .05 ) but not polyunsaturated fat . The associations were strongest for saturated fat from animal food sources ( 52.0 vs 32.2 cases per 100 000 person-years , HR = 1.43 , 95 % CI = 1.20 to 1.70 ; P(trend ) < .001 ) ; specifically , intakes from red meat and dairy products were both statistically significantly associated with increased pancreatic cancer risk ( HR = 1.27 and 1.19 , respectively ) . CONCLUSION In this large prospect i ve cohort with a wide range of intakes , dietary fat of animal origin was associated with increased pancreatic cancer risk A case-control study was conducted in the Minneapolis-St Paul ( Minnesota , United States ) area to assess the role of dietary factors in the etiology of pancreatic cancer . Cases were White males aged 40 to 84 whose death certificate listed pancreatic cancer ( exocrine only ) . White male controls were ascertained through r and om-digit dialing . Family members were interviewed about the subject 's dietary usage in the two years prior to death ( cases , n=212 ) or prior to interview ( controls , n=220 ) . Energy-adjusted , nutrient-intake , risk estimates were calculated . Among all respondents , negative trends were observed for polyunsaturated fat , linoleic acid , vitamin C , and β-carotene . Positive trends were observed for riboflavin and retinol . Point estimates were , in general , comparable between the analyses of all respondents and spouse-only respondents . The nutrients associated with a decreased risk for pancreatic cancer occur primarily in vegetables and fruits , of which the consumption of cruciferous and β-carotene-rich vegetables and citrus fruits provided the greatest reduction in risk To examine the relation between diet and pancreatic cancer , we conducted a population -based case-control study in western Washington . Cases ( n = 148 ) were married men , aged 20 - 74 years , who were diagnosed with pancreatic cancer from July 1982 to June 1986 . Controls ( n = 188 ) , identified by r and om digit dialing , were frequency matched to the cases by 5-year age groups . Wives responded as surrogates for both cases and controls . Wives were interviewed by telephone , and they completed a mailed , self-administered food frequency question naire . Results indicated that pancreatic cancer risk increased with increasing protein intake . The increased risk for heavy consumers of protein was largely confined to individuals aged 65 years and above . In that group , the odds ratio for those in the highest quartile of protein intake , relative to the lowest , was 6.0 ( 95 % confidence interval 1.7 - 20.6 ) . No association was found between pancreatic cancer risk and the intake of total fat , saturated fat , cholesterol , omega-3 fatty acids , or vitamins A and C. There was an unexpected inverse association between calcium intake and pancreatic cancer risk in these data . These findings are discussed in relation to possible etiologic mechanisms that they suggest Background Few epidemiologic studies have examined the role of nutrient intake in the development of pancreatic cancer in Japan . We addressed this association in a population -based case-control study . Methods The cases were 109 patients who were newly diagnosed with pancreatic cancer between January 2000 and March 2002 , and controls were selected by a r and om procedure from the general population . Data on dietary intake were collected by in-person interview , with the use of a food-frequency question naire . The risk of pancreatic cancer associated with nutrient intake was estimated by using the odds ratios ( ORs ) and 95 % confidence intervals ( CIs ) derived from a conditional logistic model . Results A statistically positive trend in risk was observed with increasing cholesterol intake , with subjects in the highest tertile experiencing a two fold increased risk ( OR , 2.06 ; 95 % CI , 1.11–3.85 ; Ptrend = 0.02 ) . Vitamin C intake was negatively associated with risk of pancreatic cancer . The OR was 0.45 ( 95 % CI , 0.22–0.94 ) for subjects in the highest tertile compared to the lowest tertile ( Ptrend = 0.04 ) . Conclusions Our study indicates that high cholesterol intake is significantly associated with an increased risk of pancreatic cancer and that high vitamin C intake decreases the risk of pancreatic cancer BACKGROUND Meat intake has been associated with risk of exocrine pancreatic cancer , but previous findings have been inconsistent . This association has been attributed to both the fat and cholesterol content of meats and to food preparation methods . We analyzed data from the prospect i ve Multiethnic Cohort Study to investigate associations between intake of meat , other animal products , fat , and cholesterol and pancreatic cancer risk . METHODS During 7 years of follow-up , 482 incident pancreatic cancers occurred in 190,545 cohort members . Dietary intake was assessed using a quantitative food frequency question naire . Associations for foods and nutrients relative to total energy intake were determined by Cox proportional hazards models stratified by gender and time on study and adjusted for age , smoking status , history of diabetes mellitus and familial pancreatic cancer , ethnicity , and energy intake . Statistical tests were two-sided . RESULTS The strongest association was with processed meat ; those in the fifth quintile of daily intake ( g/1000 kcal ) had a 68 % increased risk compared with those in the lowest quintile ( relative risk = 1.68 , 95 % confidence interval = 1.35 to 2.07 ; Ptrend < .01 ) . The age-adjusted yearly incidence rates per 100,000 persons for the respective quintiles were 41.3 and 20.2 . Intakes of pork and of total red meat were both associated with 50 % increases in risk , comparing the highest with the lowest quintiles ( both Ptrend < .01 ) . There were no associations of pancreatic cancer risk with intake of poultry , fish , dairy products , eggs , total fat , saturated fat , or cholesterol . Intake of total and saturated fat from meat was associated with statistically significant increases in pancreatic cancer risk but that from dairy products was not . CONCLUSION Red and processed meat intakes were associated with an increased risk of pancreatic cancer . Fat and saturated fat are not likely to contribute to the underlying carcinogenic mechanism because the findings for fat from meat and dairy products differed . Carcinogenic substances related to meat preparation methods might be responsible for the positive association Although mounting evidence suggests that insulin resistance is involved in pancreatic carcinogenesis \n Output:\n " }, { "from": "agent", "value": "There was no evidence of publication bias or significant heterogeneity between subgroups on meta-regression analyses .\nThe results of this meta- analysis do not support an independent association between diets high in total fat and pancreatic cancer risk" } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: Abstract Objective To evaluate whether routine administration of sublingual misoprostol 600 μg after delivery reduces postpartum haemorrhage . Design R and omised double blind placebo controlled trial . Setting Primary health centre in Bissau , Guinea-Bissau , West Africa . Participants 661 women undergoing vaginal delivery . Intervention Misoprostol 600 μg or placebo administered sublingually immediately after delivery . Main outcome measures Postpartum haemorrhage , defined as a loss of ≥ 500 ml and decrease in haemoglobin concentration after delivery . Results The incidence of postpartum haemorrhage was not significantly different between the two groups , the relative risk being 0.89 ( 95 % confidence interval 0.76 to 1.04 ) in the misoprostol group compared with the placebo group . Mean blood loss was 10.5 % ( −0.5 % to 20.4 % ) lower in the misoprostol group than in the control group . Severe postpartum haemorrhage of ≥ 1000 ml or ≥1500 ml occurred in 17 % ( 56 ) and 8 % ( 25 ) in the placebo group and 11 % ( 37 ) and 2 % ( 7 ) in the misoprostol group . Significantly fewer women in the misoprostol group experienced a loss of ≥1000 ml ( 0.66 , 0.45 to 0.98 ) or ≥ 1500 ml ( 0.28 , 0.12 to 0.64 ) . The decrease in haemoglobin concentration tended to be less in the misoprostol group , the mean difference between the two groups being 0.16 mmol/l ( −0.01 mmol/l to 0.32 mmol/l ) . Conclusion Sublingual misoprostol reduces the frequency of severe postpartum haemorrhage Purpose In India , two third of maternal deaths occur in rural areas where there is lack of transportation facilities , lack of refrigeration to store the injectable uterotonic drug such as oxytocin , lack of skilled personnel to administer them and lack of sterile syringes and needles . Hence , this study was conceived to evaluate misoprostol as a safe , effective , easily administered non-parenteral drug in the prevention of postpartum hemorrhage . Methods This study was conducted during the period from August 2012 to July 2014 . Low risk women with singleton pregnancy at term admitted for vaginal delivery were eligible for the study . A total of 500 women were r and omized to two groups , 250 in each group , either to receive 400 mcg misoprostol sublingually or 10 units oxytocin intramuscularly at the delivery of anterior shoulder . Patient factors , labor parameters , blood loss and side effects were noted . Results The women in both the groups were well matched with respect to age , parity , gestational age and labor parameters . There was statistical significance in the blood loss ( p = 0.04 ) between the two groups . The average blood loss was 70 ml in misoprostol group and 75 ml in oxytocin group . Shivering was the statistically significant side effect ( p = 0.004 ) in the misoprostol group and nausea was the statistically significant side effect ( p = 0.003 ) in the oxytocin group . Conclusions Sublingual misoprostol is as effective as intramuscular oxytocin as a prophylactic oxytocic in the active management of third stage of labor for prevention of postpartum hemorrhage OBJECTIVE In the poor underdeveloped countries , anaemia is very common in pregnant women . Maternal mortality is four times higher in severely anaemic women than non-anaemic ones and postpartum haemorrhage ( PPH ) is the most common cause of death . Its main cause is uterine atony , which accounts for more than 70 % . The objective of this study is to evaluate the use of sublingual misoprostol in different doses of 600 , 800 and 1000μg in management of the third stage of labor , with regards to blood loss and incidence of atonic postpartum haemorrhag ( APPH ) . STUDY DESIGN Double blind r and omized controlled study METHODS One thous and and two hundred parturient were studied in a control and three study groups , each composed of 300 women . Methylergometrine 0.2 mg IM injection and sublingual misoprostol 600 , 800 and 1000 μg tablets were given to women in control and the three study groups respectively , immediately after delivery . OUTCOME MEASURES Duration of the third stage of labour , Blood loss in the third stage of labour , Outcomes in anaemic compared to non-anaemic women , Incidance of atonic postpartum haemorrhage in different groups , Haemoglobin deficit after 24 hrs of delivery , Changes in the women 's blood pressure during the study , Side effects of the drug , and , Women 's acceptability of sublingual misoprostol administration . RESULTS Only significant reduction in blood loss and haemoglobin deficits were seen in the third stage of labour and after delivery in women used misoprostol doses of 800 μg and 1000 μg . The incidences of PPH in studied women and controls were almost similar , ranging between 2 and 3 % . Similar results were seen in anaemic and non-anaemic women with a higher incidence of APPH in the non-misoprostol user anaemic women . Side effects of the drug were dose related . CONCLUSION Misoprostol in high dose may be used for managing third stage of labour to reduce maternal morbidity and mortality due to APPH particularly , in the poor underdeveloped countries where , facilities to deliver in health centers , purchase and store the oxytocic ampoules or medically trained persons are not readily available in all places . Benefits of large dose misoprostol outweigh its side effects The haemodynamic effects of oxytocin receive scant attention in pharmacology texts , but may be clinical ly significant in vulnerable patients . Despite prescriber information recommending a dose of 5 international units by slow i.v . injection , it is the authors ' experience that it is very common practice in the UK to give 10 units as a rapid injection . We therefore conducted a r and omised , double-blind study of the haemodynamic changes induced by rapid bolus of 5 or 10 units of oxytocin in 34 healthy term parturients at caesarean section under spinal anaesthesia . There was a small but statistically significant ( P < 0.05 ) reduction in mean arterial pressure from baseline 30 s after a 10-unit bolus . However , large , statistically significant increases in heart rate and cardiac output occurred 1 min after 5 units and 2 min after 10 units . These changes peaked 1 min after oxytocin administration and were greater in the 10-unit group ( P < 0.05 ) . The importance of these findings is that some women with hypovolaemia or cardiac disease may be unable to mount these compensatory responses and are therefore at risk of haemodynamic collapse after oxytocin boluses . This has been illustrated by a maternal death reported to the Confidential Enquiries into Maternal Deaths in the United Kingdom . The need to adhere to a dose regimen of 5 units by slow injection needs re-emphasis , but no evidence exists to cl aim that even this will be haemodynamically inert . We therefore recommend that oxytocin boluses be avoided in women with hypovolaemia or cardiac disease INTRODUCTION Although the third stage of labour is usually uneventful , several significant complications may be encountered that may lead to maternal morbidity and mortality , especially primary postpartum haemorrhage . The objective of this study was to compare 400 ug oral misoprostol with 10 IU intramuscular oxytocin in the active management of the third stage of labour . METHODS This was a prospect i ve r and omised controlled clinical trial in which 200 parturients at term who had vaginal delivery were r and omly assigned into two groups : oral misoprostol and intramuscular oxytocin , after the delivery of the baby and the clamping of the umbilical cord . The primary outcome was the incidence of primary postpartum haemorrhage . Secondary outcomes included a drop in haemoglobin concentration 48 hours after delivery , the need for extra oxytocics , duration of the third stage of labour and side effects of the oxytocics . These results were subjected to statistical analysis using chi-square test or student 's t-test . RESULTS No occurrence of primary postpartum haemorrhage or significant difference in the drop in haemoglobin concentration levels was reported after delivery ( p-value is 0.49 ) , and no significant differences were observed in other secondary outcome measures with the exception of nausea , which occurred solely in the misoprostol group ( 4 percent , p-value is 0.04 ) . CONCLUSION Oral misoprostol appeared to be as effective and as safe as intramuscular oxytocin in the active management of the third stage of labour OBJECTIVE To compare the effects of oral misoprostol 800 mug with intramuscular oxytocin 10 IU in routine management of the third stage of labour . METHODS This r and omized controlled trial was performed in a rural district hospital in Ghana , West Africa , and enrolled women in labour with anticipated vaginal delivery and no known medical contraindication to prostagl and in administration . Women were r and omized to receive oral misoprostol 800 mug or intramuscular oxytocin 10 IU . Blood sample s were taken to determine hemoglobin concentration before delivery and at 12 hours post partum . Treatment was administered at delivery of the anterior shoulder . The primary outcome was the change in hemoglobin concentration from before to after delivery . Secondary outcomes included other measures of blood loss and presumed medication side effects . RESULTS In total , 450 women were enrolled in the study . Their baseline characteristics were similar . There was no significant difference between the groups in the change in hemoglobin concentration ( misoprostol 1.07 g/dL and oxytocin 1.00 g/dL ) . The only significant secondary outcomes were shivering ( 80.7 % with misoprostol vs. 3.6 % with oxytocin ) and pyrexia ( 11.4 % with misoprostol , none with oxytocin ) . CONCLUSION Routine use of oral misoprostol 800 microg appears to be as effective as 10 IU parenteral oxytocin in minimizing blood loss during the third stage of labour , as determined by change in hemoglobin concentration . Misoprostol appears to be a safe , inexpensive , and effective uterotonic for use in rural and remote areas , where intravenous oxytocin may be unavailable Summary In this study , 100 singleton pregnant women underwent a caesarean delivery under general anaesthesia and were studied in terms of postpartum bleeding using oxytocin or misoprostol . Patients were r and omly divided into two equal groups . One group received two tabs of misoprostol 200 μg sublingually and the second group took intravenous infusion of 20 units of oxytocin at the rate of 10 cc/min immediately after delivery until full contraction of the uterine . The amount of blood loss was lower in misoprostol group comparing with oxytocin group ( 608.91 ml vs 673.9 ml ) ( p = 0.048 ) and this difference was statistically significant . The need to give additional oxytocin therapy in oxytocin group ( 36 % ) was significantly higher than misoprostol group ( 14 % ) ( p = 0.032 ) . It seems that the efficacy of sublingual misoprostol is equivalent to that of low dose intravenous oxytocin in reducing postpartum haemorrhage at caesarean section . Misoprostol has some other advantages like long shelf -life , stability at room temperature and oral use International research partnerships bring together some of the best and the brightest in an effort to tackle global health problems . Such collaborations also pose complex challenges , such as maintaining ethical principles in the conduct of research in developing nations . In implementing a r and omized clinical trial to reduce postpartum hemorrhage ( PPH ) during childbirth in rural India , U.S. and Indian collaborators addressed three such issues : the appropriateness of an ethical r and omized controlled trial in the developing world , the inclusion of a placebo arm , and the relevance of informed consent in a semiliterate rural population Background The two most commonly used uterotonic drugs in caesarean section are oxytocin and carbetocin , a synthetic oxytocin analogue . Carbetocin has a longer half-life when compared to oxytocin , result ing in a reduced use of additional uterotonics . Oxytocin is known to cause fewer cardiovascular side effects when administered as a short-infusion compared to as an intravenous bolus . Based on these findings , we aim at comparing carbetocin 100 mcg given as a slow intravenous bolus with carbetocin 100 mcg applied as a short-infusion in 100 ml 0.9 % sodium chloride in women undergoing a planned or unplanned caesarean delivery . We hypothesise uterine contraction not to be inferior to a bolus application ( primary efficacy endpoint ) and greater haemodynamic stability to be achieved after a short-infusion than after a bolus administration , as measured by heart rate and mean arterial blood pressure ( primary safety endpoint ) . Methods / Design This is a prospect i ve , double-blind , r and omised controlled , investigator-initiated , non-inferiority trial taking place at the University Hospital Basel , Switzerl and .Uterine tone is quantified by manual palpation by the obstetrician using \n Output:\n " }, { "from": "agent", "value": "Two combination regimens had the poorest rankings for side-effects .\nCarbetocin had similar risk for side-effects compared with oxytocin although the quality evidence was very low for vomiting and for fever , and was low for hypertension .\nErgometrine plus oxytocin combination , carbetocin , and misoprostol plus oxytocin combination were more effective for preventing PPH ≥ 500 mL than the current st and ard oxytocin .\nErgometrine plus oxytocin combination was more effective for preventing PPH ≥ 1000 mL than oxytocin .\nMisoprostol plus oxytocin combination evidence is less consistent and may relate to different routes and doses of misoprostol used in the studies ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: Background : Management of MRSA infection includes immediate isolation of the patient . Long periods of isolation are considered to be psychologically detrimental , though little information is available about the impact of isolation as an infection control procedure . The purpose of this study is to examine the psychological well-being of spinal cord injured patients who are isolated as a result of being MRSA positive . Methods : A cross-sectional matched-control study of MRSA positive patients with MRSA negative patients was carried out at the National Spinal Injuries Centre , Stoke M and eville Hospital , Bucks , Engl and . Sixteen MRSA positive patients , aged 18 to 65 , and their matched controls completed a series of question naires to measure aspects of psychological impact . The measures used were functional independence , depression , anxiety , and the affective states of anger , vigour , fatigue and confusion . Findings : The MRSA positive spinal cord injured patients were only significantly more angry than the control group , although these isolated patients scored higher in all measures . Interpretations : In this spinal cord injured group the difference between the psychological well-being of isolated MRSA positive patients and non-isolated MRSA negative patients is not as great as might have been expected . Patients feel that rehabilitation is affected , but the situation may be improved by providing more space and a better view onto the ward BACKGROUND Contact isolation is a method used for limiting the spread of antimicrobial-resistant organisms when caring for patients . This policy has been linked to several adverse outcomes and less patient satisfaction . We assessed patient and caregiver underst and ing and satisfaction with the use of contact isolation . METHODS A prospect i ve survey of > 500 patients in contact isolation at our institution was performed during 2014 . Participants responded to a series of statements relating to contact isolation , using a 5-point Likert scale . Responses were assessed for overall positivity or negativity and further compared according to floor type or design ation . RESULTS Of the patients , 48.7 % responded to the survey ; 70 caregivers also responded . Patient and caregiver responses were similar and were positive overall . Most respondents felt safer because of the use of contact isolation and because it prevented infections . A smaller majority of respondents also thought the policy was adequately explained to them and adhered to by staff . CONCLUSIONS In the largest collection of respondents surveyed to date about contact isolation and its impact on them , the policy was viewed positively , both by patients and caregivers . There is still room for improvement in the area of patient education regarding the use of contact isolation OBJECTIVES Concerns have been raised that isolation pre caution s may have unintended consequences . The relationship between patient isolation and the 30-day risk of readmission or death among patients discharged from a general medicine ward was examined . METHODS A prospect i ve cohort study of adult patients discharged to the community from seven general internal medicine wards in Edmonton , Alberta , Canada , from October 2013 to November 2014 , was performed . Patients under contact , respiratory , or droplet pre caution s were considered isolated . Covariates measured at discharge included the Charlson comorbidity score , LACE index , clinical frailty , depression , anxiety , health-related quality of life , and patient satisfaction . Outcomes were measured at 30 days by telephone follow-up and provincial electronic health record query . RESULTS Of 495 patients ( mean age 62 years , 51 % female ) , 75 ( 18 % ) were isolated during their admission . Isolated and non-isolated patients had similar lengths of stay ( 6.2 vs. 6.2 days ) , depression , anxiety , health-related quality of life , and satisfaction scores at discharge ( all p-values non-significant ) . At 30 days , 85 ( 17.2 % ) patients had been readmitted or had died ( 20.0 % of isolated patients vs. 16.7 % of non-isolated patients ; adjusted odds ratio 1.11 , 95 % confidence interval 0.57 - 2.18 ) . CONCLUSIONS In-hospital isolation does not appear to have an adverse impact on outcomes once patients are discharged from hospital Risk assessment is used to determine the need for isolation in single rooms . Limited availability of isolation rooms and /or operational needs may compromise this process . This article reports the results of a 12-month prospect i ve observational study of every infection control request for isolation in a 1100-bed teaching hospital . In addition , four point-prevalence surveys of the usage of single rooms were carried out . Data were collected on the incidence of new clinical meticillin-resistant Staphylococcus aureus ( MRSA ) isolates per ward and these were correlated with rates of isolation failures for MRSA cases . There were 845 requirements for patient isolation , of which 185 ( 22 % ) could not be met ( isolation failures ) . Three-quarters of the requirements for isolation were due to MRSA or Clostridium difficile . The proportion of isolation failures was consistent for most organisms and conditions but varied markedly between clinical specialities ( 0 - 57 % ) . Reasons for failure to isolate included no single rooms available , all single/isolation rooms occupied ( for both isolation and non-infection-control reasons ) , limitations on the use of single rooms in mixed-sex wards and patient-specific reasons . Only a minority of the available single rooms were occupied for infection control reasons ( 12 - 19 % ) . There was a statistically significant correlation between isolation failures and MRSA incidence ( Spearman 's rho 0.596 , P<0.001 ) . In only one case where a ward had > or=30 % of its beds provided in single rooms was there an instance of failure to isolate . In conclusion , insufficient capacity to isolate patients with potentially transmissible pathogens is common and may compromise infection control requirements . Either isolation capacity must be increased or evidence -based risk assessment must be applied to situations where dem and for isolation exceeds availability . Further information is needed on the consequences of isolation failure BACKGROUND Patients who are hospitalized and infected with multidrug-resistant bacteria are usually placed in contact isolation , which requires hospital personnel to gown and glove before patient examination . Contact isolation with active culture surveillance appears beneficial in preventing the spread of drug-resistant infections ; however , contact isolation may impede the ability to examine patients as a result of the additional effort required to gown and glove . We assessed whether patients who are hospitalized and placed under contact pre caution s are examined less often by second- and third-year medical residents ( ie , senior medical residents ) , and attending physicians during morning rounds . METHOD We conducted a prospect i ve cohort study on the inpatient medical services at 2 university-affiliated medical centers . We directly observed senior medical residents and attending physicians during morning rounds , and recorded the contact pre caution status of the patient and whether they were examined by either physician . RESULTS Of a total of 139 patients , 31 ( 22 % ) were in contact isolation . Senior medical residents examined 26 of 31 patients ( 84 % ) in contact isolation versus 94 of 108 patients ( 87 % ) not in contact isolation ( relative risk , 0.96 ; 95 % confidence interval , 0.81 - 1.14 ; P = .58 ) . In comparison , attending physicians examined 11 of 31 patients ( 35 % ) in contact isolation versus 79 of 108 patients ( 73 % ) not in contact isolation ( relative risk , 0.49 ; 95 % confidence interval , 0.30 - 0.79 ; P < .001 ) . DISCUSSION Attending physicians are about half as likely to examine patients in contact isolation compared with patients not in contact isolation Isolation pre caution s in patients with multi-drug resistant bacteria or other communicable infectious agents can be associated with adverse effects . The aim of this study was to assess satisfaction and psychological impact of patients hospitalized with isolation pre caution s in comparison with controls . An observational prospect i ve cohort study was performed in five different medical and surgical departments in a 3,000-bed university hospital in Western France between March and July 2012 . Different scales were used to assess patient satisfaction ( qualitative scale ) and anxiety ( Spielberger scale ) , including 30 patients with isolation pre caution s and 60 matched patients without isolation pre caution s over 45-hour interviews . Cases were significantly less satisfied than controls for healthcare workers ( HCW ) assistance in activities of daily life ( p < 0.001 ) , availability and relationships ( 17 % vs 5 % , p = 0.05 and 10 % vs 0 % , p = 0.02 , respectively ) . Sixty-seven percent of patients with isolation pre caution s were not satisfied about the quality of the information related to their infectious status control measures . The median score [ range ] of anxiety significantly was higher in patients with isolation pre caution s ( 52 [ 20–56 ] vs 31 [ 23–73 ] , p < 0.001 ) . Isolation pre caution s may have negative psychological effects , leading to anxiety , and may compromise patient satisfaction according to the availability and relationship with HCW . Professionals should be aware of adverse effects of isolation and inform patients more actively with regard to their infectious status and pre caution OBJECTIVE To determine the association between contact pre caution s and depression or anxiety as well as feelings of anger , sadness , worry , happiness , or confusion . DESIGN Prospect i ve frequency-matched cohort study . SETTING The University of Maryl and Medical Center , a 662-bed tertiary care hospital in Baltimore , Maryl and . PARTICIPANTS A total of 1,876 medical and surgical patients over the age of 18 years were approached ; 528 patients were enrolled from January through November 2010 , and 296 patients , frequency matched by hospital unit , completed follow-up on hospital day 3 . RESULTS The primary outcome was Hospital Anxiety and Depression Scale ( HADS ) scores on hospital day 3 , controlling for baseline HADS scores . Secondary moods were measured with visual analog mood scale diaries . Patients under contact pre caution s had baseline symptoms of depression 1.3 points higher ( P<.01 ) and anxiety 0.8 points higher ( P=.08 ) at hospital admission using HADS . Exposure to contact pre caution s was not associated with increased depression ( P=.42 ) or anxiety ( P=.25 ) on hospital day 3 . On hospital day 3 , patients under contact pre caution s were no more likely than unexposed patients to be angry ( 20 % vs 20 % ; P=.99 ) , sad ( 33 % vs 38 % ; P=.45 ) , worried ( 51 % vs 46 % ; P=.41 ) , happy ( 58 % vs 67 % ; P=.14 ) , or confused ( 23 % vs 24 % ; P=.95 ) . CONCLUSIONS Patients under contact pre caution s have more symptoms of depression and anxiety at hospital admission but do not appear to be more likely to develop depression , anxiety , or negative moods while under contact pre caution s. The use of contact pre caution s should not be restricted by the belief that contact pre caution s will produce more depression or anxiety This study was aim ed to assess the effects of contact isolation application on anxiety and depression levels of the patients , the effects of certain sociodemographics and patient characteristics on anxiety and depression levels , and the thoughts of the isolated patients about contact isolation . This non-r and omized quasi-experimental study was carried out with 60 isolated and 57 non-isolated patients with hospital infection . The data were acquired from Hospital Anxiety and Depression Scale ( HADS-A ( anxiety ) and HADS-D ( depression ) ) and patient information form . There was no statistically significant difference between the anxiety and depression levels of the isolated and non-isolated patients . In the isolated patients , the depression points were higher in patients who were , women , received primary education and had lower income levels . Of the patients , 86.4 % of them told that they were happy to be in the isolation room . Contact isolation application did not affect anxiety and depression levels of the patients . However , personal attributes increased the development of depression . In contact isolated patients , personal attributes should be taken into consideration in nursing care planning to prevent development of depression OBJECTIVE Contact pre caution s decrease healthcare worker-patient contact and may impact patient satisfaction . To determine the association between contact pre caution s and patient satisfaction , we used a st and ardized interview for perceived issues with care . DESIGN Prospect i ve cohort study of in patients , evaluated at admission and on hospital days 3 , 7 , and 14 ( until discharged ) . At each point , patients underwent a st and ardized interview to identify perceived problems with care . After discharge , the st and ardized interview and Hospital Consumer Assessment of Healthcare Providers and Systems ( HCAHPS ) survey were administered by telephone . Responses were recorded , transcribed , and coded by 2 physician review ers . PARTICIPANTS A total of 528 medical or surgical patients not admitted to the intensive care unit . RESULTS A total of 528 patients were included in the primary analysis , of whom 104 ( 20 % ) perceived some issue with their care . On multivariable logistic regression , contact pre caution s were independently associated with a greater number of perceived concerns with care ( odds ratio , 2.05 [ 95 % confidence interval , 1.31 - 3.21 ] ; P < .01 ) , including poor coordination of care ( P = .02 ) and a lack of respect for patient needs and preferences ( P = .001 ) . Eighty-eight patients were included in the secondary analysis of HCAHPS . Patients under contact pre caution s did not have different HCAHPS scores than those not under contact pre caution s ( odds ratio , 1.79 \n Output:\n " }, { "from": "agent", "value": "The review indicates that isolation to contain the risk of infection has negative consequences for segregated patients ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: In a prospect i ve study of 321 consecutive cases of dislocation ankle fractures , operatively treated according to the AO ( ASIF ) principles , 306 cases ( 95 % ) were followed up two to six years after surgery . The infection rate was 1.8 % with no septic arthritis . The clinical results were \" excellent and good \" in 82 % , \" acceptable \" in 8 % , and \" poor \" in 10 % . Posttraumatic arthritis occurred in 14 % and was significantly more common among middle-aged women . There was a strong correlation between the degree of arthritis and the clinical result . A computer analysis ( AID ) revealed that the most decisive factors influencing the clinical result were the type of fracture , the accuracy of the reduction , and the sex of the patient . Exact reduction , rigid internal fixation , early postoperative joint exercises , and subsequent full weight-bearing in a below-the-knee walking plaster are essential for a good end result of fracture-dislocations of the ankle joint Objectives : To compare radiographic and clinical midterm outcomes of posterior malleolar fractures treated with posterior buttress plating versus anterior to posterior lag screw fixation . Design : Retrospective case series . Setting : Level I trauma center . Patients / Participants : Between January 2002 and December 2010 , patients with posterior malleolar fractures were identified by Current Procedural Terminology code and their charts review ed for eligibility . Intervention : Posterior malleolar fixation using either anterior to posterior ( AP ) lag screws or posterior buttress plating . Main Outcome Measurements : Demographic data , length of follow-up , range of motion , and postoperative Short Musculoskeletal Function Assessment ( SMFA ) scores were the main outcome measurements . Immediate postoperative radiographs for residual gap/step-off and final follow-up radiographs for the degree of arthritis that developed were evaluated . Results : Thirty-seven patients were eligible for the study , and 27 chose to participate . Sixteen patients underwent posterior buttress plating , and 11 underwent AP screw fixation with mean follow-up times of 54.9 and 32 months , respectively . Demographic data were similar between groups . The posterolateral plating group demonstrated superior postoperative SMFA scores compared with the AP screw group with statistically significant differences in the SMFA bother index ( 26.7 vs. 9.2 , P = 0.03 ) and trends toward improvement in the mobility ( 28.3 vs. 12.9 , P = 0.08 ) and functional indices ( 20.2 vs. 9.4 , P = 0.08 ) . There were no significant differences in the range of motion or the development of ankle arthritis over time . Conclusions : Patients with trimalleolar ankle fractures in whom the posterior malleolus was treated with posterolateral buttress plating had superior clinical outcomes at follow-up compared with those treated with AP screws . Level of Evidence : Therapeutic Level III . See Instructions for Authors for a complete description of levels of evidence Purpose In this retrospective study , we evaluated the treatment effect of ankle joint fracture surgery involving the posterior malleolus , and discuss relevant factors influencing the occurrence of traumatic arthritis of the ankle joint . Methods A total of 102 cases of ankle joint fractures involving the posterior malleolus in five large-scale skeletal trauma centres in China , from January 2000 to July 2009 , were retrospectively analysed in terms of surgical treatment and complete follow-up . Ankle joint mobility , posterior malleolus fragment size , articular surface evenness , Ankle-Hindfoot Scale of the American Orthopedic Foot and Ankle Society ( AOFAS ) score , and imaging scale score for arthritis were recorded . The degree of fracture pain during rest , active movement , and weight-bearing walking , and satisfaction with treatment were evaluated using a visual analogue scale ( VAS ) . Results The average AOFAS score was 95.9 , excellence rate was 92.2 % , and average VAS scores for degree of fracture pain during rest , active movement , and weight-bearing walking were 0.15 , 0.31 , and 0.68 , respectively . Thirty-six cases showed arthritic manifestations . Ankle joint mobility along all directions on the injured side was lower than that on the unaffected side . There was no obvious difference in treatment effect between the fixed and unfixed posterior malleolus fragment groups for all and for fragment size of < 25 % ; between fixing the posterior malleolus fragment from front to back or from back to front ; or between elderly patients ( ≥60 years old ) and young patients ( < 60 years old ) . There was a distinct difference in the treatment effect between articular surface evenness and unevenness for all and for fragment size of ≥25 % . Conclusions For all 102 cases of ankle joint fracture involving the posterior malleolus , the treatment effect was satisfactory . Restoration of an even articular surface , especially when fragment size ≥25 % , should be attempted during treatment Background : The goal of this study was to report the results of selective open reduction and internal fixation of fractures of the posterior malleolus with a posterolateral approach and to compare the results of the 2 techniques . Methods : We prospect ively evaluated 40 patients who underwent posterior malleolar fracture fixation between 2008 and 2012 . The patients were treated with a posterolateral approach . We assigned alternating patients to receive plate fixation and the next screw fixation , consecutively , based on the order in which they presented to our institution . Fixation of the posterior malleolus was made with lag screws in 20 patients and a buttress plate in 20 patients . We used American Orthopaedic Foot and Ankle Society ( AOFAS ) scores , range of motion ( ROM ) of the ankle , and radiographic evaluations as the main outcome measurements . The mean follow-up was 38.2 ( range , 24 - 51 ) months . Results : Full union without any loss of reduction was obtained in 38 of the 40 patients . We detected a union with a step-off of 3 mm in 1 patient in the screw group and a step-off of 2 mm in 1 patient in the plate group . At the final follow-up , the mean AOFAS score of the patients regardless of fixation type was 94.1 ( range , 85 - 100 ) . The statistical results showed no significant difference between the patients regardless of the fixation type of the posterior malleolus in terms of AOFAS scores and ROM of the ankle ( P > .05 ) . Conclusions : Good ( AOFAS score of 94/100 ) and equivalent ( within 3 points ) results were obtained using the 2 techniques ( screws or plate ) for fixation after open reduction of posterior malleolar fragments . Level of Evidence : Level II , prospect i ve case series Objectives : To evaluate the lateral transmalleolar ( LTM ) approach for a displaced posterolateral fragments of a posterior malleolus fracture . Design : Prospect i ve , consecutive . Setting : Level 1 trauma center . Patients : Thirty-six patients . Outcome Measures : The x-rays , evaluation of arthritic changes of the ankle joint , range of motion , and Short Musculoskeletal Function Assessment question naire ( SMFA ) . Intervention : The LTM approach followed by multiple interfragmentary miniscrew-only fixation . Results : No patients experienced intraoperative or postoperative complications that required a revision operation . All fractures healed . There were no infections , and no patient required implant removal . The median range of motion showed no significant difference as compared with the uninjured side . Patients achieved a mean SMFA dysfunction index of 8.2 ± 2.4 points and a mean SMFA bother index of 3.2 ± 1.2 points . All patients performed normal daily life activities at averagely 3 ( range , 2–5 ) months postoperatively . Conclusions : Direct visualization with the LTM approach followed by fixation with multiple miniscrews may be an alternative option for the treatment of ankle fractures with a posterolateral fragment associated with a posterior malleolar fracture . Level of Evidence : Therapeutic Level IV . See Instructions for Authors for a complete description of levels of evidence \n Output:\n " }, { "from": "agent", "value": "There was no clear association between posterior fragment size and functional outcome or development of osteoarthritis .\nThe non-anatomical reduction of the fragment was of more influence on outcome .\nRadiological and functional outcome was better after open reduction and internal fixation via the posterolateral approach than after percutaneous anterior-to-posterior screw fixation .\nConclusion The posterior fragment size is not a clear indication for its fixation .\nA step-off , however , seems an important indicator for developing posttraumatic osteoarthritis and worse functional outcome .\nPosterior fragments involving the intra-articular surface need to be reduced and fixated to prevent postoperative persisting step-off .\nFurthermore , fixation of the posterior malleolus via an open posterolateral approach seems superior to percutaneous anterior-to-posterior fixation ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: Background There are very few studies on the frequency of breakfast and snack consumption and its relation to fruit and vegetable intake . This study aims to fill that gap by exploring the relation between irregular breakfast habits and snack consumption and fruit and vegetable intake in Tuscan adolescents . Separate analyses were conducted with an emphasis on the potentially modifying factors of sex and age . Methods Data was obtained from the 2010 Tuscan sample of the Health Behaviour in School-aged Children ( HBSC ) study . The HBSC study is a cross-sectional survey of 11- , 13- and 15-year-old students ( n = 3291 ) , selected from a r and om sample of schools . Multivariate logistic regression was used for analyzing the food-frequency question naire . Results A significant relation was found between low fruit and vegetable intake and irregular breakfast habits . Similarly , low fruit intake was associated with irregular snack consumption , whereas vegetable intake did not prove to be directly related to irregular snack consumption . Different patterns emerged when gender and age were considered as modifying factors in the analyses . A statistically significant relation emerged only among female students for irregular breakfast habits and fruit and vegetable intake . Generally , older female participants with irregular breakfast habits demonstrated a higher risk of low fruit and vegetable intake . Age pattern varied between genders , and between fruit and vegetable consumption . Conclusions Results suggest that for those adolescents who have an irregular consumption of breakfast and snacks , fruit intake occurs with a lower frequency . Lower vegetable consumption was associated with irregular breakfast consumption . Gender and age were shown to be moderators and this indicated the importance of analyzing fruit and vegetable intake and meal types separately . This study also confirmed that health-promotion campaigns that aim to promote regular meal consumption and consumption of fruits and vegetables need to take into account gender and age differences in design ing promotional strategies . Future research should identify evidence -based interventions to facilitate the achievement of the Italian guidelines for a healthy diet for fruit , vegetables and meals intake Twenty-nine schoolchildren were tested throughout the morning on 4 successive days , having a different breakfast each day ( either of the cereals Cheerios or Shreddies , glucose drink or No breakfast ) . A series of computerised tests of attention , working memory and episodic secondary memory was conducted prior to breakfast and again 30 , 90 , 150 and 210 min later . The glucose drink and No breakfast conditions were followed by declines in attention and memory , but the declines were significantly reduced in the two cereal conditions . This study provides objective evidence that a typical breakfast of cereal rich in complex carbohydrates can help maintain mental performance over the morning BACKGROUND / OBJECTIVES Aside from the health consequences , observational studies indicate that being overweight may also negatively affect cognitive function . However , existing evidence has to a large extent not controlled for the possible confounding effect of having different lifestyles . Therefore , the objective was to examine the independent associations between weight status and lifestyle indicators with cognitive performance in 8 - 11year old Danish children . SUBJECTS/ METHODS The analyses included 828 children ( measured in 2011 - 2012 ) each having one to three measurement occasions separated by approximately 100days . Dietary intake , physical activity , sedentary time , and sleep duration were measured using dietary records and accelerometers . The Children 's Sleep Habits Question naire was used to access sleep problems and the And ersen test was carried out to estimate cardio-respiratory fitness ( CRF ) . Weight status ( underweight , normal weight , and overweight/obese ) was defined according to body mass index and cognitive performance was assessed using the d2-test of attention , a reading test , and a math test . A linear mixed model including a number of fixed and r and om effects was used to test associations between lifestyle indicators as well as BMI category and cognitive performance . RESULTS After adjustment for demographics , socioeconomics , and multiple lifestyle indicators , normal weight children had higher cognitive test scores than overweight/obese and underweight children of up to 89 % and 48 % of expected learning within one school year ( P<0.05 ) . Daily breakfast consumption , fewer sleep problems , higher CRF , less total physical activity , more sedentary time , and less light physical activity were associated with higher cognitive performance independently of each other in at least one of the three cognitive tests ( P<0.05 ) . CONCLUSIONS Normal weight children had higher cognitive performance compared to overweight/obese as well as underweight children , independent of multiple lifestyle indicators OBJECTIVE . The goal was to determine whether breakfast had effects on the cognitive performance and mood of high school students . METHODS . A crossover trial was performed in boarding schools , involving 104 students between 13 and 20 years of age . The participants were r and omly assigned to 2 equal-size groups on the morning of the first testing day . One half of the total sample received a st and ardized breakfast , whereas the other half received no breakfast . Seven days later , the treatment order was reversed . Measurements of cognitive function included st and ardized tests of attention and concentration , as well as tests of verbal and spatial memory . In addition , mood was rated with a self-administered question naire covering the dimensions of positive and negative affect , information uptake , arousal , and alertness . Statistical analysis consisted of repeated- measures analysis of variance . RESULTS . Breakfast had no effect on sustained attention among high school students . Visuospatial memory was improved in male students . Self-reported alertness improved significantly in the entire study population . Male students reported feeling more positive after consuming breakfast , compared with the fasting condition . CONCLUSIONS . This crossover trial demonstrated positive short-term effects of breakfast on cognitive functioning and self-reported alertness in high school students This study examined the effects of breakfast consumption on cognitive function , mood and blood glucose concentration in adolescent schoolchildren . With the institution 's ethical advisory committee approval , 96 adolescents ( 12 to 15 years old ) completed two r and omly assigned trials ( one following breakfast consumption and one following breakfast omission ) , scheduled 7 days apart . Cognitive function tests ( visual search test , Stroop test and Sternberg paradigm ) , a mood question naire and a finger prick blood sample ( in a subgroup of 60 participants ) were completed immediately following breakfast and 120 min after the baseline measures . Following breakfast consumption , accuracy on the more complex level of the visual search test was higher than following breakfast omission ( p=0.021 ) . Similarly , accuracy on the Stroop test was better maintained across the morning following breakfast consumption when compared to breakfast omission ( p=0.022 ) . Furthermore , responses on the Sternberg paradigm were quicker later in the morning following breakfast consumption , particularly on the more complex levels ( p=0.012 ) . Breakfast consumption also produced higher self-report energy and fullness , lower self-report tiredness and hunger and higher blood glucose concentrations ( all p<0.0005 ) . Overall , the findings of the present study suggest that breakfast consumption enhances cognitive function in an adolescent population when compared to breakfast omission \n Output:\n " }, { "from": "agent", "value": "The results of the review of eating breakfast studies showed positive and conclusive effects on cognitive performance , academic achievement , quality of life , well-being and on morbidity risk factors .\nConclusions The overall assessment of the studies indicated positive effects of eating breakfast ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: BACKGROUND It is generally accepted that the age-related increased aneuploidy rate is correlated with reduced implantation and a higher abortion rate . Therefore , advanced maternal age ( AMA ) couples are a good target group to assess the possible benefit of preimplantation genetic diagnosis for aneuploidy screening ( PGD-AS ) on the outcome after assisted reproductive technology ( ART ) . METHODS A prospect i ve r and omized controlled clinical trial ( RCT ) was carried out comparing the outcome after blastocyst transfer combined with PGD-AS using fluorescence in situ hybridization ( FISH ) for the chromosomes X , Y , 13 , 16 , 18 , 21 and 22 in AMA couples ( aged > or = 37 years ) with a control group without PGD-AS . From the 400 ( 200 for PGD-AS and 200 controls ) couples that were allocated to the trial , an oocyte pick-up was performed effectively in 289 cycles ( 148 PGD-AS cycles and 141 control cycles ) . RESULTS Positive serum HCG rates per transfer and per cycle were the same for PGD-AS and controls : 35.8 % ( 19.6 % ) [ % /per embryo transfer ( per cycle ) ] and 32.2 % ( 27.7 % ) , respectively ( NS ) . Significantly fewer embryos were transferred in the PGD-AS group than in the control group ( P<0.001 ) . The implantation rate ( with fetal heart beat ) was 17.1 % in the PGD-AS group versus 11.5 % in the control group ( not significant ; P=0.09 ) . We observed a normal diploid status in 36.8 % of the embryos . CONCLUSIONS This RCT provides no arguments in favour of PGD-AS for improving clinical outcome per initiated cycle in patients with AMA when there are no restrictions in the number of embryos to be transferred OBJECTIVE The purpose of this study was to determine the positive predictive value ( PPV ) and negative predictive value ( NPV ) of FISH analysis and to determine which chromosomal abnormalities are most frequently confirmed . DESIGN Prospect i ve observational . SETTING IVF laboratory . PATIENT(S ) Two hundred forty-one embryos were analyzed from 98 patients . INTERVENTION(S ) FISH re analysis . MAIN OUTCOME MEASURE(S ) Embryos that would have been discarded in patients undergoing preimplantation genetic diagnosis ( PGD ) were fixed and FISH re analysis was performed . Results of re analysis were compared with the day 3 diagnosis while PPV and NPV were calculated . RESULT ( S ) Among the 241 embryos , 198 embryos were abnormal and 43 were normal by day 3 FISH analysis . The PPV was 83 % and the NPV was 81 % . PPV was also determined for specific categories of aneuploidy , and certain abnormalities such as monosomies , trisomies , tetrasomies , and polyploidies were frequently confirmed on re analysis ( PPV > 80 % ) , whereas Turner syndrome diagnosis was not ( PPV = 17 % ) . CONCLUSION ( S ) FISH analysis offers a PPV of 83 % and NPV of 81 % when evaluating a single blastomere in conjunction with PGD . FISH errors and mosaicism are primarily responsible for the errors associated with FISH analysis in PGD 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 OBJECTIVE To apply preimplantation genetic diagnosis ( PGD ) for the treatment of patients with a history of failed IVF-ET or habitual aborters . DESIGN Prospect i ve clinical study . SETTING Tertiary center for assisted reproduction . PATIENT(S ) Ninety-four couples with failed IVF-ET after > 2 IVF cycles and 64 couples with > 2 spontaneous abortions . INTERVENTION(S ) Patients were prepared for oocyte retrieval using st and ard controlled ovarian hyperstimulation protocol s after st and ard laboratory techniques . Blastomeres from 6- to 8-cell embryos were analysed using fluorescence in situ hybridization with commercial chromosomal probes , and normoploid embryos were transferred on day 3 after fertilization . MAIN OUTCOME MEASURE(S ) Pregnancy and implantation rates and live births . RESULT ( S ) Both 3- and 5-probe PGD result ed in a significantly higher outcome than controls for failed IVF-ET . Five-probe PGD appeared to be more suitable for habitual aborters . CONCLUSION ( S ) This pilot study suggests that 3-probe PGD is a valid option for failed IVF-ET patients . The use of five or more probes is indicated for habitual aborters BACKGROUND The use of ICSI has been a major breakthrough in the treatment of male infertility . Even azoospermic patients with focal spermatogenesis in the testis ( not sufficient to spill over into the ejaculate ) may benefit from the technique . Previous reports suggest a higher pregnancy rate after ICSI treatment in patients with obstructive azoospermia ( OA ) compared to their non-obstructive azoospermia ( NOA ) counterparts , which could be due to a higher aneuploidy frequency in the embryos of the latter group . We therefore conducted a prospect i ve cohort study to compare the aneuploidy frequency of the screened embryos between the two groups . METHODS From May 2001 until September 2003 , we offered couples with an OA or NOA partner ICSI in combination with preimplantation genetic diagnosis for aneuploidy screening . RESULTS No difference in age ( 30.6 and 33.5 years ) or stimulation parameters was observed between the two groups ; 53 and 60 % of the embryos were abnormal in the NOA and OA groups respectively ( P = not significant ) . CONCLUSIONS The aneuploidy frequency in embryos obtained from NOA as well as OA men is similar and very high , despite the young age of their female partners OBJECTIVE To determine aneuploidy for chromosome 16 by recycling nuclei of cells already analyzed for chromosomes X , Y , 18 , 13 , and 21 using multiple fluorescence in situ hybridization in preimplantation human embryos in a time frame compatible with clinical IVF and to asssess the incidence of chromosome 16 aneuploidy in embryos related to maternal age . DESIGN Prospect i ve experimental study . SETTING In vitro fertilization program in a tertiary center . PATIENTS One hundred four consenting patients undergoing IVF . MAIN OUTCOME MEASURES Chromosome 16 ploidy was analyzed in a total of 195 embryos . In 89 embryos , a st and ard multiple-probe fluorescence in situ hybridization was used for chromosomes X , Y , 18 and 16 ( series 1 ) . The remaining 106 embryos ( series 2 ) were reanalyzed with a new procedure for chromosome 16 , which involves rehybridization with a digoxigenin-labeled alpha satellite probe after the st and ard analysis for chromosomes X , Y , 18 , 13 , and 21 was completed . The embryos were assigned to one of three groups according to the women 's age ; group 1 : < /= 34 years ( n = 34 ) , group 2 : 35 to 39 years ( n = 47 ) ; group 3 : > /= 40 years ( n = 23 ) . RESULTS Successful analysis , including biopsy , fixation , and fluorescence in situ hybridization was achieved in 86 % of the blastomeres within approximately 10 hours . A significant relationship was found between the rate of aneuploidy for chromosome 16 and increasing maternal age : group 1 : 0 % , group 2 : 6.3 % , and group 3 : 11.7 % . Monosomy for chromosome 16 was found in 72.7 % of the 11 embryos carrying chromosome 16 anomalies , with the remaining three embryos having two trisomies and one tetrasomy . This new protocol was applied clinical ly to five patients undergoing preimplantation aneuploidy assessment . Aneuploidy for chromosome 16 was found in five embryos from three of those patients . CONCLUSIONS This study demonstrates that preimplantation genetic diagnosis of the major human aneuploidies is achievable within a time frame compatible with IVF . In addition , this study confirms , for embryos , the existing data from spontaneous abortions suggesting that chromosome 16 aneuploidy increases with maternal age . The high prevalence of embryonic monosomy , which is rarely found in spontaneous abortions , suggests that monosomy 16 could be a factor associated with failure of implantation , as well as pointing to a different mechanism involved in the generation of chromosome 16 aneuploidy OBJECTIVE To verify the percentage of chromosomally abnormal preimplantation embryos in patients with a poor prognosis and possibly to increase the chance of implantation by selecting chromosomally normal embryos . DESIGN A prospect i ve , r and omized , controlled study . SETTING In vitro fertilization program at the Reproductive Medicine Unit of the Società Italiana Studi Medicina della Riproduzione , Bologna , Italy . PATIENT(S ) In a total of 28 stimulated cycles , the maternal age was > or = 38 years and /or the patient had > or = 3 previous IVF failures , factors that indicated a poor prognosis . After consent , 11 patients underwent preimplantation genetic diagnosis for aneuploidy , whereas 17 controls underwent assisted zona hatching . INTERVENTION(S ) Simultaneous analysis of chromosomes X , Y , 13 , 18 , and 21 in a blastomere biopsied from day-3 embryos . Chromosomal analysis was performed with fluorescence in situ hybridization . Assisted zona hatching was performed on day-3 embryos from the control-group patients . MAIN OUTCOME MEASURE(S ) Embryo morphology , results of fluorescence in situ hybridization , clinical pregnancies , and implantation . RESULT ( S ) In the study group , a total of 61 embryos were analyzed by fluorescence in situ hybridization , and 55 % were chromosomally abnormal . Embryo transfer with at least one normal embryo was performed in 10 cycles . Four clinical pregnancies result ed , with a 28.0 % implantation rate . In the control group , 41 embryos were transferred in 17 cycles after the assisted zona hatching procedure , yielding four clinical pregnancies and an 11.9 % implantation rate . CONCLUSION ( S ) Infertile patients classified as having a poor prognosis have a high percentage of chromosomally abnormal embryos . The advantage of selecting and transferring embryos with normal fluorescence in situ hybridization results has an immediate impact on implantation OBJECTIVE To analyze the incidence of numeric chromosomal abnormalities in preimplantation embryos from women with unexplained recurrent miscarriage ( RM ) so as to seek an etiology and to determine whether the \n Output:\n " }, { "from": "agent", "value": "To date there is insufficient data to determine whether PGS is an effective intervention in IVF/ICSI for improving live birth rates .\nAvailable data on PGS for advanced maternal age showed no difference in live birth rate and ongoing pregnancy rate ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: BACKGROUND Inferior scapular notching following reverse shoulder arthroplasty is due to mechanical impingement and , in some studies , has been associated with poorer functional scores , lower patient satisfaction , and more limited shoulder motion . We aim ed to test the hypothesis that inferior positioning of the center of rotation with eccentric glenosphere design s decreases the adduction deficit before impingement occurs and improves clinical outcome . METHODS A r and omized , controlled , double-blinded trial was performed . According to the results of a power analysis , fifty patients undergoing reverse shoulder arthroplasty for the diagnosis of cuff tear arthropathy were r and omized intraoperatively to receive either a concentric or eccentric glenosphere . The glenoid baseplate was positioned flush to the inferior border of the glenoid before the glenosphere was then attached . Notching was assessed using an anteroposterior radiograph , and clinical outcome was assessed using the visual analog pain scale score , shoulder function rating , American Shoulder and Elbow Surgeons score , and Oxford shoulder score . Active forward elevation and external rotation were assessed . The outcome assessor was blinded to the treatment group . The mean follow-up period for the groups was forty-three and forty-seven months . RESULTS Patient demographics and preoperative scores were similar between the groups . At the time of the final follow-up , four patients ( 14.8 % ) in the concentric group had developed inferior scapular notching ( two with Nerot grade I and two with Nerot grade II ) , ranging in size from 1.1 to 7.4 mm , compared with one patient ( 4.3 % ; Nerot grade I ) in the eccentric group ( p = 0.36 ) . No notching occurred in any patient with glenoid overhang of > 3.5 mm . No significant difference between the groups was seen with respect to functional outcome scores , patient satisfaction , or shoulder motion . CONCLUSIONS There were no differences in notching rates or clinical outcomes between concentric and eccentric glenospheres following reverse shoulder arthroplasty . Inferior glenosphere overhang of > 3.5 mm , however , prevented notching . This may be achieved with a modified surgical technique , but eccentric glenospheres provide an additional option . LEVEL OF EVIDENCE Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence The choice is not clear cut and patients ’ expectations and preferences may affect the outcome In this issue Hay et al 1 report the results of a r and omised clinical trial evaluating the effectiveness of physiotherapy and corticosteroid injection for patients with unilateral shoulder pain . Shoulder pain is a common complaint ; estimates of the annual incidence in general practice vary from 6.6 to 25 cases per 1000 patients .2–4 Most patients are treated in primary care . If treatment with analgesics or non-steroidal anti-inflammatory drugs ( NSAIDs ) is not successful , patients with persistent symptoms are often referred for physiotherapy or treated with local infiltration of a corticosteroid.4 Until recently , evidence on the effectiveness of these interventions was scarce , particularly for primary care patients . Over the past few years two r and omised trials have been published that directly compared the effects of physiotherapy with corticosteroid injections.5,6 Both trials were carried out in Dutch general practice . The trial by Hay et al adds important and relevant information to this existing evidence . The trial is characterised by a thorough design , enrolled a relatively large number of patients , used relevant outcome measures , and achieved a nearly complete six months ’ follow up of participants . When examining the results of these three primary care trials , three issues arise for discussion . Firstly , the short term findings are rather different , with the Dutch trials clearly showing better effects of corticosteroid injections , whereas the English trial reports similar outcomes for the two interventions . Secondly , all three trials show minor and non-significant differences at long term follow up.1,6,7 Thirdly , the somewhat ambiguous overall evidence may leave substantial room for considering patient preferences and expectations when applying the results in clinical practice . Figure 1a shows the self reported change of symptoms at 5–7 weeks of follow up for BACKGROUND Glenoid component loosening remains a significant issue after anatomic shoulder arthroplasty . Pegged glenoid components have shown better lucency rates than keeled components in the short term ; however , midterm to long-term results have not fully been determined . We previously reported early outcomes of the current r and omized controlled group of patients , with higher glenoid lucency rates in those with a keeled glenoid . The purpose of this study was to evaluate the radiographic and clinical outcomes of these components at minimum 5-year follow-up . METHODS Fifty-nine total shoulder arthroplasties were performed in patients with primary glenohumeral osteoarthritis . Patients were r and omized to receive either a pegged or keeled glenoid component . Three raters grade d radiographic glenoid lucencies . Clinical outcome scores and active mobility outcomes were collected preoperatively and at yearly postoperative appointments . RESULTS Of the 46 shoulders meeting the inclusion criteria , 38 ( 82.6 % ) were available for minimum 5-year radiographic follow-up . After an average of 7.9 years , radiographic lucency was present in 100 % of pegged and 91 % of keeled components ( P = .617 ) . Grade 4 or 5 lucency was present in 44 % of pegged and 36 % of keeled components ( P = .743 ) . There were no differences in clinical outcome scores or active mobility outcomes between shoulders with pegged and keeled components at last follow-up . Within the initial cohort , 20 % of the keeled shoulders ( 6 of 30 ) and 7 % of the pegged shoulders ( 2 of 29 ) underwent revision surgery ( P = .263 ) . Kaplan-Meier analysis showed no significant difference in survival rates between groups ( P = .560 ) . CONCLUSION At an average 7.9-year follow-up , non-ingrowth , all-polyethylene pegged glenoid implants are equivalent to keeled implants with respect to radiolucency , clinical outcomes , and need for revision surgery BACKGROUND Presently , there are no approved nonoperative therapies for the ongoing treatment of persistent shoulder pain . Preliminary data suggest that intra-articular sodium hyaluronate injections may be beneficial for the treatment of persistent shoulder pain result ing from various etiologies . The present study evaluated the efficacy and safety of sodium hyaluronate ( Hyalgan ; molecular weight , 500 to 730 kDa ) for these patients . METHODS Six hundred and sixty patients with persistent shoulder pain and limitation result ing from glenohumeral joint osteoarthritis , rotator cuff tear , and /or adhesive capsulitis who had had a failure of conventional therapy were enrolled in this double-blind , r and omized , phosphate-buffered saline solution-controlled study , and 456 patients completed twenty-six weeks of follow-up . Patients were r and omized to receive either five weekly intra-articular injections of sodium hyaluronate , three weekly intra-articular injections of sodium hyaluronate followed by two weekly intra-articular injections of saline solution , or five weekly intra-articular injections of saline solution . The main outcomes were improvement in terms of shoulder pain on movement at thirteen weeks after the initiation of treatment ( as assessed with use of a 100-mm visual analog scale ) and the treatment effect throughout twenty-six weeks . RESULTS For the overall intent-to-treat population , patients who were managed with sodium hyaluronate had greater pain relief than controls did ; significant differences were noted at Week 7 ( for the five-injection hyaluronate group ) , Week 17 ( for the three and five-injection hyaluronate groups ) , and Week 26 ( for the three-injection hyaluronate group ) . Analysis of the stratified population s clearly established that this effect was due to benefits experienced by the patients with osteoarthritis . The treatment effect through twenty-six weeks was significant in patients with osteoarthritis in the three-injection ( p = 0.003 ) and five-injection ( p = 0.002 ) groups , with no significant difference for either regimen in patients without osteoarthritis . The safety profile was very favorable , with no product-related serious adverse effects and no between-group differences for any reported adverse event . CONCLUSIONS Although the primary end point of this study ( that is , improvement in terms of shoulder pain at thirteen weeks ) was not achieved , the overall findings , including secondary end points , indicate that sodium hyaluronate ( 500 to 730 kDa ) is effective and well tolerated for the treatment of osteoarthritis and persistent shoulder pain that is refractory to other st and ard nonoperative interventions BACKGROUND Controversy exists regarding the optimal technique of subscapularis mobilization during shoulder arthroplasty . The purpose of this study was to compare healing rates and subscapularis fatty infiltration in patients undergoing a lesser tuberosity osteotomy ( LTO ) versus subscapularis peel for exposure during shoulder arthroplasty . MATERIAL S AND METHODS Eighty-seven patients , with a mean age of 67.8 ± 10.9 years , undergoing shoulder arthroplasty , were r and omized to receive either an LTO ( n = 43 ) or peel ( n = 44 ) . Computed tomography scans were conducted preoperatively and at 12 months postoperatively . Outcome variables included healing rates and subscapularis Goutallier fatty infiltration grade , as well as subscapularis strength and Western Ontario Osteoarthritis of the Shoulder Index and American Shoulder and Elbow Surgeons outcome scores . RESULTS Computed tomography imaging was available in 91 % ( n = 79 ) of the cohort . The healing rates for the peel ( 100 % ) and for the LTO ( 95 % ) did not differ significantly ( P = .493 ) . Preoperatively , the mean fatty infiltration grade for the peel ( mean , 0.53 ) was not significantly different ( P = .925 ) from the LTO ( mean , 0.54 ) . Postoperatively , the Goutallier mean fatty infiltration grade for the peel ( mean , 0.95 ) did not differ significantly ( P = .803 ) from the LTO ( mean , 0.9 ) . A significant increase in subscapularis fatty infiltration grade occurred postoperatively from the preoperative status ( peel , P = .003 ; LTO , P = .0002 ) . No statistically significant associations were observed between postoperative fatty infiltration grade s and subscapularis strength , Western Ontario Osteoarthritis of the Shoulder Index scores , or American Shoulder and Elbow Surgeons scores . DISCUSSION No statistically significant differences were observed in the healing rates or subscapularis fatty infiltration grade s between the peel and the LTO . This trial does not show any clear difference in radiologic and clinical outcomes of one subscapularis management technique over the other BACKGROUND Both total shoulder arthroplasty and hemiarthroplasty have been used commonly to treat severe osteoarthritis of the shoulder ; however , their effect on disease-specific quality -of-life outcome is unknown . The purpose of this study was to compare the quality -of-life outcome following hemiarthroplasty with that following total shoulder arthroplasty in patients with osteoarthritis of the shoulder . METHODS Forty-two patients with a diagnosis of osteoarthritis of the shoulder were r and omized to receive a hemiarthroplasty or a total shoulder arthroplasty . One patient died , and all others were evaluated preoperatively and at six weeks and three , six , twelve , eighteen , and twenty-four months postoperatively with use of a st and ardized format including a disease-specific quality -of-life measurement tool ( Western Ontario Osteoarthritis of the Shoulder [ WOOS ] index ) , general shoulder rating scales ( University of California at Los Angeles [ UCLA ] shoulder scale , Constant score , and American Shoulder and Elbow Surgeons [ ASES ] evaluation form ) , general pain scales ( McGill pain score and visual analogue scale ) , and a global health measure ( Short Form-36 [ SF-36 ] ) . When a patient required revision of a hemiarthroplasty to a total shoulder arthroplasty , the last score before he or she \" crossed over \" was used for the analysis . RESULTS Significant improvements in disease-specific quality of life were seen two years after both the total shoulder arthroplasties and the hemiarthroplasties . There were no significant differences in quality of life ( WOOS score ) between the group treated with total shoulder arthroplasty and that treated with hemiarthroplasty ( 90.6 + /- 13.2 and 81.5 + /- 24.1 points , respectively ; p = 0.18 ) . The other outcome measures demonstrated similar findings . Two patients in the hemiarthroplasty group crossed over to the other group by undergoing a revision to a total shoulder arthroplasty because of glenoid arthrosis . CONCLUSIONS Both total shoulder arthroplasty and hemiarthroplasty improve disease-specific and general quality -of-life measurements . With the small number of patients in our study , we found no significant differences in these measurements between the two treatment groups . LEVEL OF EVIDENCE Therapeutic Level OBJECTIVES : To determine , in a population based study , the influence of occupational factors on the occurrence of shoulder pain and disability . METHODS : A r and om sample of patients was selected from the register of a general practice in the Greater Manchester area of the United Kingdom . Information was collected by a posted question naire with specific \n Output:\n " }, { "from": "agent", "value": "At two years , low- quality evidence from two trials ( down grade d for bias and imprecision ) suggested there may be a small but clinical ly uncertain improvement in pain and function .\nAlthough it is an established procedure , no high- quality r and omised trials have been conducted to determine whether shoulder replacement might be more effective than other treatments for osteoarthritis or rotator cuff tear arthropathy of the shoulder .\nWe remain uncertain about which type or technique of shoulder replacement surgery is most effective in different situations .\nWhen humeral hemiarthroplasty was compared to TSR surgery for osteoarthritis , low- quality evidence led to uncertainty about whether there is a clinical ly important benefit for patient-reported pain or function and suggested there may be little or no difference in quality of life .\nEvidence is insufficient to show whether TSR is associated with greater or less risk of harm than humeral hemiarthroplasty .\nAlthough reverse TSR is now the most commonly performed type of shoulder replacement , we found no studies comparing reverse TSR to any other type of treatment" } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: OBJECTIVES Improvement of psychosocial work environment has proved to be valuable for workers ' mental health . However , limited evidence is available for the effectiveness of participatory interventions . The purpose of this study was to investigate the effect on mental health among nurses of a participatory intervention to improve the psychosocial work environment . METHODS A cluster r and omized controlled trial was conducted in hospital setting s. A total of 434 nurses in 24 units were r and omly allocated to 11 intervention units ( n=183 ) and 13 control units ( n=218 ) . A participatory program was provided to the intervention units for 6 months . Depressive symptoms as mental health status and psychosocial work environment , assessed by the Job Content Question naire , the Effort-Reward Imbalance Question naire , and the Quality Work Competence question naire , were measured before and immediately after the 6-month intervention by a self-administered question naire . RESULTS No significant intervention effect was observed for mental health status . However , significant intervention effects were observed in psychosocial work environment aspects , such as Coworker Support ( p<0.01 ) and Goals ( p<0.01 ) , and borderline significance was observed for Job Control ( p<0.10 ) . CONCLUSIONS It is suggested that a 6-month participatory intervention is effective in improving psychosocial work environment , but not mental health , among Japanese nurses This study evaluated the effectiveness of a computer-based stress management training ( SMT ) program in improving employees ’ psychological well-being and work performance . A total of 12 work units ( N=263 ) were r and omly assigned to either an intervention group ( 8 work units , n=142 ) or to a wait-list control group ( 4 work units , n=121 ) . All participants were requested to answer online question naires assessing psychological well-being as a primary outcome , and coping style , social support , and knowledge about stress management as secondary outcomes at baseline ( T0 ) , immediately after the intervention ( T1 ) , and 2 months after the intervention ( T2 ) . The group × time interaction was tested using a mixed-model repeated measures ANOVA . Results showed a group × time interaction for “ knowledge about stress management ” in the entire sample . Among participants who had more than 3 d of training , a significant group × time interaction was observed for “ problem-solving ” and “ avoidance and suppression ” as well as “ knowledge about stress management . ” Our computer-based stress management program was effective for improving knowledge about stress management . It was also effective for improving coping skills in instances where participants had enough time ( at least 3 d ) to complete all sessions OBJECTIVE Evidence -based Practice ( EBP ) implementation is likely to be most efficient and effective in organizations with positive social context s ( i.e. , organizational culture , climate , and work attitudes of clinicians ) . The study objective was to test whether an organizational intervention labeled Availability , Responsiveness and Continuity ( ARC ) could improve the organizational social context s of community-based mental health programs for youth . METHOD The study r and omly assigned 26 community-based mental health programs for youth to ARC or control conditions . The organizational cultures , climates , and work attitudes of clinicians ( n = 197 ) in the programs were assessed with the Organizational Social Context ( OSC ) measure for mental health services at baseline and following the 18-month ARC intervention . RESULTS Hierarchical linear models ( HLM ) analyses indicated that organizational culture , climate , and work attitudes were significantly improved in the ARC condition after 18 months . Clinicians in programs assigned to ARC reported less rigid , less central ized and less apathetic organizational cultures , more engaged and functional organizational climates with less role conflict , and work attitudes with improved morale , job satisfaction , and organizational commitment . CONCLUSIONS ARC improved the organizational social context s of clinicians in community-based mental health programs for youth . Results suggest that organizational intervention strategies can be used to create the types of organizational social context s that are believed to be necessary for EBP implementation and other service innovations in mental health programs The Mental Health Action Checklist for a Better Workplace Environment ( MHACL ) is a tool for a worker participatory approach to improve work environments for worker mental health . The present study investigated the effects of an organizational intervention using the MHACL on reducing job stressors and the psychological distress of workers of a manufacturing enterprise in Japan with a controlled study design . Nine of 45 departments participated in a work environment improvement program , including planning workshops , implementation and monitoring , between July and December 2005 ( intervention group , n=321 ) . The remaining 36 departments served as the control group ( n=750 ) . Outcomes ( job stressors , worksite support , psychological distress , etc . ) , measured using the Brief Job Stress Question naire , as well as sick leave days taken from the company record , were recorded before and six months after the program for both groups . Among women , skill underutilization , supervisor and coworker support , psychological distress , and job satisfaction changed more favorably in the intervention group than in the control group ( p<0.05 ) . No significant favorable effect of the program was observed among men . Improvements in the outcomes were more prominent among departments with a 50 % or higher rate of worker participation in the planning workshops and among departments with a 50 % or higher rate of implemented vs. planned actions . A worker participatory organizational intervention using the MHACL seems effective for promoting mental health among Japanese white-collar women OBJECTIVES The purpose of this study was to evaluate the effectiveness of a multi-component worksite stress management training ( SMT ) program among employees belong to Japanese steel company . METHODS Five workplaces were assigned to an intervention group and two workplaces to a control group . SMT with monthly 30-min sessions were provided to the intervention group for 6 mo . Intention-to-treat analyses were conducted among respondents of the intervention ( n=96 ) and control groups ( n=53 ) . RESULTS Significant favorable intervention effects were found on knowledge ( p<0.001 ) and marginally significant ones on professional efficacy ( p=0.074 ) at one-month after completing the program . No significant intervention effects were observed on psychological distress , physical complaints , or job performance ( p>0.05 ) . However , in per- protocol analyses of those who attended all sessions , significant favorable effects were observed on psychological distress and job performance , as well as knowledge and professional efficacy ( p<0.05 ) . In addition , subgroup analyses revealed that those with initial low job control showed a favorable intervention effect only on knowledge ( p<0.001 ) , whereas those with initial high job control showed favorable intervention effects on knowledge ( p<0.001 ) , professional efficacy ( p=0.023 ) and anxiety ( p=0.033 ) . CONCLUSIONS The results suggest that the multi-component SMT program is effective at improving knowledge and professional efficacy , although job control appeared to moderate the effect of the program on professional efficacy . The program may also be effective at reducing psychological distress and increasing job performance , if participants complete all sessions We investigated the effectiveness of a theoretically based role induction ( RI ) intervention that aim ed to clarify supervisee and supervisor role expectations and reduce supervisee anxiety , compared to st and ard supervision ( no-RI ) . Initially , a feasibility study investigated whether a RI for beginning supervisees would work in the context of a replicated single-subject experimental design ; specifically , it assessed whether the RI condition ( n = 2 ) would result in decreased anxiety compared to baseline and a no-RI condition ( n = 2 ) . Results suggested that the RI appeared viable and mitigated supervisee anxiety . To address the deficiencies of the feasibility study , for the main study , a more rigorous experimental multiple-baseline research design with r and omization procedures was employed to test the effectiveness of the RI intervention for reducing supervisee anxiety in 2 developmentally different groups : beginning supervisees ( n = 4 ) and predoctoral interns ( n = 5 ) . Specifically , this study investigated whether supervisee anxiety would be lower following the RI intervention for both groups and whether beginning supervisees would experience larger decreases in anxiety relative to interns . The 3 most salient findings were ( a ) the efficacy of a RI procedure for reducing the anxiety of novice counselor trainees was tentatively supported , ( b ) anxiety varied , sometimes markedly , from session to session , but nevertheless was not as pervasive as theorized , and ( c ) supervisee developmental level appeared to moderate the effects of the RI on supervisee anxiety , such that the RI decreased anxiety for most beginning supervisees and initially increased anxiety for interns . Implication s for theory , research , and training are discussed OBJECTIVE To test whether feedback and discussion of ergonomic and psychosocial working environment data during 1 short session with individual , groups , or supervisors of VDU workers had effects on ( 1 ) the quality of implemented modifications in workplace design , working technique , or psychosocial aspects ; ( 2 ) psychological dem and s , decision latitude , and social support ; ( 3 ) comfort during computer work , emotional stress , and prevalence of musculoskeletal symptoms or eye discomfort . METHODS Thirty-six workgroups from 9 organizations were r and omized to 3 feedback conditions ( individual , workgroup , supervisor ) or control . Follow-up was 6 months after intervention . Question naire data aggregated on the workgroup level were used . RESULTS Effect ( positive ) on social support was indicated from feedback to supervisors . CONCLUSION Feedback and discussion of ergonomic and psychosocial working environment data with supervisors of white-collar VDU workers may have positive effect on social support measured as a group characteristic . Sources of potential bias are discussed In this quasi-experimental study among staff of 29 oncology wards , the authors evaluated the effects of a team-based burnout intervention program combining a staff support group with a participatory action research approach . Nine wards were r and omly selected to participate in the program . Before the program started ( Time 1 ) , directly after the program ended ( Time 2 ) , and 6 months later ( Time 3 ) , study participants filled out a question naire on their work situation and well-being . Results of multilevel analyses showed that staff in the experimental wards experienced significantly less emotional exhaustion at both Time 2 and Time 3 and less depersonalization at Time 2 , compared with the control wards . Moreover , changes in burnout levels were significantly related to changes in the perception of job characteristics over time BACKGROUND The aim of occupational health care management programs ( OHMP ) is to improve the health status of employees , increase work ability and reduce absence time . This includes better coping abilities , work-related self-efficacy and self-management which are important abilities that should be trained within OHMPs . OBJECTIVES To study the effectiveness of an OHMP including special interventions to enhance self-efficacy and self-management . PARTICIPANTS Employees from the German Federal Pension Agency . METHODS Effects of an OHMP on sickness absence was studied by comparing an intervention group and two control groups . A core feature of the OHMP were group sessions with all members of working teams , focussing on self-efficacy and self management of the individual participant as well as the team as a group ( focus groups ) . Participants in the OHMP were asked for their subjective evaluation of the focus groups . Rates of sickness absence were taken from the routine data of the employer . RESULTS Participants of the OHMP indicated that they had learned better ways of coping and communication and that they had generated intentions to make changes in their working situation . The rate of sickness absence in the intervention group decreased from 9.26 % in the year before the OHMP to 7.93 % in the year after the program , while there was in the same time anincrease of 7.9 % and 10.7 % in the two control groups . CONCLUSIONS The data suggest that OHMP with focus on self-efficacy and self management of individuals and teams are helpful in reducing work absenteeism \n Output:\n " }, { "from": "agent", "value": "We found that well-being and performance may be improved by : training workers to improve their own jobs ; training coupled with job re design ; and system wide approaches that simultaneously enhance job design and a range of other employment practice s. We found insufficient evidence to make any firm conclusions concerning the effects of training managers in job re design and that participatory approaches to improving job design have mixed effects .\nSuccessful implementation of interventions was associated with worker involvement and engagement with interventions , managerial commitment to interventions and integration of interventions with other organisational systems .\nPractitioner Summary : Improvements in well-being and performance may be associated with system-wide approaches that simultaneously enhance job design , introduce a range of other employment practice s and focus on worker welfare .\nTraining may have a role in initiating job re design or augmenting the effects of job design on well-being" } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: Background Distress and burnout among medical and psychology professionals are commonly reported and have implication s for the quality of patient care delivered . Already in the course of university studies , medicine and psychology students report mental distress and low life satisfaction . There is a need for interventions that promote better coping skills in students in order to prevent distress and future burnout . This study examines the effect of a seven-week Mindfulness-Based Stress Reduction ( MBSR ) programme on mental distress , study stress , burnout , subjective well-being , and mindfulness of medical and psychology students . Methods A total of 288 students ( mean age = 23 years , 76 % female ) from the University of Oslo and the University of Tromsø were r and omly allocated to an intervention or control group . The control group continued with their st and ard university courses and received no intervention . Participants were evaluated using self-reported measures both before and after the intervention . These were : the ‘ General Health Question naire , Maslach Burnout Inventory Student version , Perceived Medical School Stress , Subjective Well-being , and Five Facet Mindfulness Question naire ’ and additional indices of compliance . Results Following the intervention , a moderate effect on mental distress ( Hedges’g 0.65 , CI = .41 , .88 ) , and a small effect on both subjective well-being ( Hedges’g 0.40 , CI = .27 , .63 ) and the mindfulness facet ‘ non-reacting ’ ( Hedges’g 0.33 , CI = .10 , .56 ) were found in the intervention group compared with the control group . A higher level of programme attendance and reported mindfulness exercises predicted these changes . Significant effects were only found for female students who additionally reported reduced study stress and an increase in the mindfulness facet ‘ non-judging ’ . Gender specific effects of participation in the MBSR programme have not previously been reported , and gender differences in the present study are discussed . Conclusion Female medical and psychology students experienced significant positive improvements in mental distress , study stress , subjective well-being and mindfulness after participating in the MBSR programme . Trial registration 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 Almost all previous studies of the psychological sequelae of hypertension labelling have lacked a prospect i ve , longitudinal design which could allow for causal interpretations . The present study relies on question naire data from a hypertension screening carried out on the entire adult population of a medium-sized , Norwegian county ( total number of participants = 74977 ) . ' Labelled ' individuals , i.e. previously unaware hypertensives ( N = 173 ) , false positives ( N = 233 ) , and patients in need of continued BP control ( N = 474 ) have been followed up after 1 - 3 years , and comparisons are made with aware hypertensives ( N = 206 ) , patients previously treated for hypertension ( N = 118 ) , and a r and om sample of normotensives ( N = 2326 ) . ' Pre-labelling ' , baseline measures of subjective well-being had been carried out on all comparison groups in connection with the screening . Changes in psychological well-being are not significantly related to labelling or BP-status . However , there is a deterioration in psychological well-being among participants who have been subjected to one or more negative life events/stresses ( other than labelling ) in the preceding 12 months 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 The majority of mindfulness research to date has reported only on the group-level effects of interventions . Therefore , there is a need to better underst and who is most likely to benefit from mindfulness interventions . This study reports on moderation analyses from a two-centre r and omised controlled trial of mindfulness-based stress reduction ( MBSR ) among 288 medical and psychology students . The study investigated whether baseline personality factors ( neuroticism , conscientiousness and extroversion ) and baseline mindfulness moderated effects on mental distress , study stress and subjective well-being measured after the intervention . An increased effect of the intervention on mental distress and subjective well-being was found in students with higher scores on neuroticism . Students with higher scores on conscientiousness showed an increased effect of mindfulness training on study stress . The training protected students against an increase in mental distress and study stress and a decrease in subjective well-being that was seen in the control group . Baseline mindfulness and extroversion did not moderate the effects of the intervention on the outcomes . The majority of the 288 medical and psychology students in the study sample were female . Female participants scored significantly higher on neuroticism and conscientiousness , and they may therefore be an important target group for mindfulness interventions among students Research on mindfulness-based interventions ( MBIs ) for treating symptoms of a wide range of medical conditions has proliferated in recent decades . Mindfulness is the cultivation of nonjudgmental awareness in the present moment . It is both a practice and a way of being in the world . Mindfulness is purpose fully cultivated in a range of structured interventions , the most popular of which is mindfulness-based stress reduction ( MBSR ) , followed by mindfulness-based cognitive therapy ( MBCT ) . This paper begins with a discussion of the phenomenological experience of coping with a chronic and potentially life-threatening illness , followed by a theoretical discussion of the application of mindfulness in these situations . The literature evaluating MBIs within medical conditions is then comprehensively review ed , applying a levels of evidence rating framework within each major condition . The bulk of the research looked at diagnoses of cancer , pain conditions ( chronic pain , low back pain , fibromyalgia , and rheumatoid arthritis ) , cardiovascular disease , diabetes , human immunodeficiency virus (HIV)/acquired immune deficiency syndrome ( AIDS ) , and irritable bowel syndrome . Most outcomes assessed are psychological in nature and show substantial benefit , although some physical and disease-related parameters have also been evaluated . The field would benefit from more adequately powered r and omized controlled trials utilizing active comparison groups and assessing the moderating role of patient characteristics and program “ dose ” in determining outcomes Abstract Pursuing undergraduate medical training can be very stressful and academically challenging experience . A 5-week mindfulness-based stress management ( MBSM/Mindful-Gym ) program was developed to help medical students cope with stress . The aim of this study was to evaluate the effectiveness of the intervention in reducing stress among students in a medical school in Malaysia . Seventy-five medical students participated in the program . They were stratified according to years of studies and r and omly allocated to intervention ( N = 37 ) and control groups ( N = 38 ) . The following outcome variables were measured at pre- and post-intervention : mindfulness ( with Mindful Awareness Attention Scale ) ; perceived stress ( with Perceived Stress Scale ) ; mental distress ( with General Health Question naire ) , and self-efficacy ( with General Self-efficacy Scale ) . Hierarchical multiple regressions were used to analyse the effect of group ( intervention vs. control ) on changes in the outcome variables . There were significant improvements at one week post-intervention in all outcome variables : mindfulness ( β = 0.19 , ΔR2 = 0.04 , p = .040 , f2 = 0.05 ) , perceived stress ( β = −0.26 , ΔR2 = 0.07 , p = .009 , f2 = 0.10 ) ; mental distress ( β = −0.28 , ΔR2 = 0.10 , p = .003 , f2 = 0.15 ) ; and self-efficacy ( β = 0.30 , ΔR2 = 0.09 , p < .001 , f2 = 0.21 ) . Six months after the intervention , those who had joined the program reported higher self-efficacy compared to those in the control group ( β = 0.24 , ΔR2 = 0.06 , p = .020 , f2 = 0.08 ) ; but there was no difference in other outcome measures . More than 90 % of the participants found the program applicable in helping patients and all reported that they would recommend it to others . This study indicates that the program is potentially an effective stress management program for medical students in Malaysia BACKGROUND Nursing students often experience depression , anxiety , stress and decreased mindfulness which may decrease their patient care effectiveness . Mindfulness-based stress reduction ( MBSR ) effectively reduced depression , anxiety and stress , and increased mindfulness in previous research with other population s , but there is sparse evidence regarding its effectiveness for nursing students in Korea . OBJECTIVES To examine the effects of MBSR on depression , anxiety , stress and mindfulness in Korean nursing students . DESIGN A r and omized controlled trial . PARTICIPANTS / SETTING Fifty ( 50 ) nursing students at KN University College of Nursing in South Korea were r and omly assigned to two groups . Data from 44 students , MBSR ( n=21 ) and a wait list ( WL ) control ( n=23 ) were analyzed . METHODS The MBSR group practice d mindfulness meditation for 2 h every week for 8 weeks . The WL group did not receive MBSR intervention . St and ardized self-administered question naires of depression , anxiety , stress and mindfulness were administered at the baseline prior to the MBSR program and at completion ( at 8 weeks ) . RESULTS Compared with WL participants , MBSR participants reported significantly greater decreases in depression , anxiety and stress , and greater increase in mindfulness . CONCLUSION A program of MBSR was effective when it was used with nursing students in reducing measures of depression , anxiety and stress , and increasing their mindful awareness . MBSR shows promise for use with nursing students to address their experience of mild depression , anxiety and stress , and to increase mindfulness in academic and clinical work , warranting further study Background : Medical students experience a high burden of stress and suffer elevated rates of depression , burnout , and suicide compared to the general population , yet there is no consensus on how to address student wellness . Purpose s : The purpose of this study was to determine whether an abridged mindfulness based stress reduction ( MBSR ) intervention can improve measures of wellness in a r and omized sample of 1st-year medical students . Methods : Fifty-eight participants were r and omized to control or 8-week MBSR intervention and then invited to participate in the study . All participants were assessed using the Perceived Stress Scale ( PSS ) , the Resilience Scale ( RS ) , and Self-Compassion Scale ( SCS ) at 3 separate time points : baseline , at the conclusion of the study intervention ( 8 weeks ) , and at 6 months after the conclusion of the intervention . The intervention consisted of 75 minutes of weekly class time , suggested meditation at home , and a half-day retreat in the last week . Results : The intervention group achieved significant increase on SCS scores both at the conclusion of the study ( 0.58 , p = .002 ) , 95 % confidence interval ( CI ) [ 0.23 , 0.92 ] , and at 6 months ( 0.56 , p = .001 ) , 95 % CI [ 0.25 , 0.87 ] . PSS scores achieved significant reduction at the conclusion of the study ( 3.63 , p = .03 ) , 95 % CI [ 0.37 , 6.89 ] , but not at 6 months post study ( 2.91 , p = .08 ) , 95 % CI [ –0.37 , 6.19 ] . The study did not demonstrate a difference in RS after the intervention , though RS was significantly correlated with both SCS and PSS . Conclusions : An abridged MBSR intervention improves perceived stress and self-compassion in 1st-year medical students and may be a valuable curricular tool to enhance wellness and professional development Background : Medical students confront significant academic , psychosocial , and existential stressors throughout their training . Mindfulness-based stress reduction ( MBSR ) is an educational intervention design ed to improve coping skills and reduce emotional distress . Purpose : The purpose of this study was to examine the effectiveness of the MBSR intervention in a prospect i ve , nonr and omized , cohort-controlled study . Methods : Second-year students ( n = 140 ) elected to participate in a 10-week MBSR seminar . Controls ( n = 162 ) participated in a didactic seminar on complementary medicine . Profile of Mood States ( POMS ) was administered preintervention and postintervention . Results : Baseline total mood disturbance ( TMD ) was greater in the MBSR group compared with controls ( 38.7 ±33.3 vs. 28.0 ±31.2 ; p < . 01 ) . Despite this initial difference , the MBSR group scored significantly lower in TMD at the completion of the intervention period ( 31. \n Output:\n " }, { "from": "agent", "value": "Short term benefits relating to stress and mood were reported , despite all but one study condensing the curriculum .\nGender and personality emerged as factors likely to affect intervention results .\nFurther research with long-term follow-up is required to definitively conclude that mindfulness is an appropriate intervention to mentally prepare health and social care undergraduate students for their future careers" } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: OBJECTIVE Survival from acute coronary syndromes and major trauma has been shown to depend on timely access to definitive treatment . We sought to identify the significance of intensive care unit ( ICU ) admission delay ( lead-time ) on the outcome of critically-ill medical patients with other diagnoses . METHODS From 1 January 1997 to 31 December 2003 , a prospect i ve cohort study was performed in critically-ill patients requiring mechanical ventilatory support ( MV ) and /or renal replacement therapy ( RRT ) , admitted directly to the Northern Hospital ICU within 24 hours of arrival in the emergency department ( ED ) . Patients were excluded if , a ) they were admitted following surgery , major trauma or transfer from another hospital , or b ) their duration of ICU stay was < 8 hours . Data collected included de-identified patient demographics , final diagnosis , APACHE II mortality risk ( pm ) and lead-time ( i.e. difference between times of entrance to the ED and ICU . ) The primary outcome measure was hospital discharge status . RESULTS Six hundred and nineteen consecutive ICU admissions from the ED met the inclusion criteria and required MV ( n = 557 ) and /or RRT ( n = 162 . ) Non-survivors were older ( median age 73 vs. 54 yrs ) and sicker ( median pm 0.72 vs. 0.23 ) compared with survivors . Multivariate analysis using logistic regression identified lead-time as a significant predictor of mortality ( RR = 1.06 per hour , 95 % CI = 1.01 - 1.10 ; p=0.015 ) in addition to age , diagnosis and illness severity . CONCLUSIONS ICU admission delay ( lead-time ) is associated with a greater mortality-risk in critically ill medical patients requiring MV and /or RRT Introduction When the number of patients who require intensive care is greater than the number of beds available , intensive care unit ( ICU ) entry flow is obstructed . This phenomenon has been associated with higher mortality rates in patients that are not admitted despite their need , and in patients that are admitted but are waiting for a bed . The purpose of this study is to evaluate if a delay in ICU admission affects mortality for critically ill patients . Methods A prospect i ve cohort of adult patients admitted to the ICU of our institution between January and December 2005 were analyzed . Patients for whom a bed was available were immediately admitted ; when no bed was available , patients waited for ICU admission . ICU admission was classified as either delayed or immediate . Confounding variables examined were : age , sex , originating hospital ward , ICU diagnosis , co-morbidity , Acute Physiology and Chronic Health Evaluation ( APACHE ) II score , therapeutic intervention , and Sequential Organ Failure Assessment ( SOFA ) score . All patients were followed until hospital discharge . Results A total of 401 patients were evaluated ; 125 ( 31.2 % ) patients were immediately admitted and 276 ( 68.8 % ) patients had delayed admission . There was a significant increase in ICU mortality rates with a delay in ICU admission ( P = 0.002 ) . The fraction of mortality risk attributable to ICU delay was 30 % ( 95 % confidence interval ( CI ) : 11.2 % to 44.8 % ) . Each hour of waiting was independently associated with a 1.5 % increased risk of ICU death ( hazard ratio ( HR ) : 1.015 ; 95 % CI 1.006 to 1.023 ; P = 0.001 ) . Conclusions There is a significant association between time to admission and survival rates . Early admission to the ICU is more likely to produce positive outcomes STUDY OBJECTIVE We describe the frequency of undesirable events among patients boarding at a single , urban , tertiary , teaching emergency department ( ED ) through retrospective chart abstract ion . METHODS This was a chart review of all patients admitted during 3 r and omly selected days in 2003 ( n=162 ) to track the frequency of undesirable events such as missed relevant home medications , missed laboratory test results , arrhythmias , or other adverse events . RESULTS One hundred fifty-one charts were abstract ed ( 93.2 % ) ; 27.8 % had an undesirable event , 17.9 % missed a relevant home medication , and 3.3 % had a preventable adverse event . There was a higher frequency of undesirable events among older patients ( 35.9 % , aged > 50 years ; 7.3 % , aged 20 to 49 years ; 28.6 % , aged 0 to 19 years ) and those with more comorbidities ( 44.4 % among Charlson score > or=3 ; 30.8 % score 2 ; 36.1 % score 1 ; 14.5 % score 0 ) . CONCLUSION A substantial frequency of undesirable events occurs while patients board in the ED . These events are more frequent in older patients or those with more comorbidities . Future studies need to compare the rates of undesirable events among patients boarding in the ED versus inpatient units Background The dem and for critical care beds is increasing out of proportion to bed availability . As a result , some critically ill patients are kept in the Emergency Department ( ED boarding ) awaiting bed availability . The aim of our study is to examine the impact of boarding in the ED on the outcome of patients admitted to the Intensive Care Unit(ICU ) . Methods This was a retrospective analysis of ICU data collected prospect ively at King Abdulaziz Medical City , Riyadh from ED between January 2010 and December 2012 and all patients admitted during this time were evaluated for their duration of boarding . Patients were stratified into three groups according to the duration of boarding from ED . Those admitted less than 6 h were classified as Group I , between 6 and 24 h , Group II and more than 24 h as Group III . We carried out multivariate analysis to examine the independent association of boarding time with the outcome adjusting for variables like age , sex , APACHE , Mechanical ventilation , Creatinine , Platelets , INR . Results During the study period , 940 patients were admitted from the ED to ICU , amongst whom 227 ( 25 % ) were admitted to ICU within 6 h , 358 ( 39 % ) within 6–24 h and 355 ( 38 % ) after 24 h. Patients admitted to ICU within 6 h were younger [ 48.7 ± 22.2(group I ) years , 50.6 ± 22.6 ( group II ) , 58.2 ± 20.9 ( group III ) ( P = 0.04)]with less mechanical ventilation duration [ 5.9 ± 8.9 days ( Group I ) , 6.5 ± 8.1 ( Group II ) and 10.6 ± 10.5 ( Group III ) , P = 0.04 ] . There was a significant increase in hospital mortality [ 51(22.5 ) , 104(29.1 ) , 132(37.2 ) , P = 0.0006 ) and the ICU length of stay(LOS ) [ 9.55 days ( Group I ) , 9.8 ( Group II ) and 10.6 ( Group III ) , ( P = 0.002 ) ] with increase in boarding duration . In addition , the delay in admission was an independent risk factor for ICU mortality(OR for group III vs group I is 1.90 , P = 0.04 ) and hospital mortality(OR for group III vs Group I is 2.09 , P = 0.007 ) . Conclusion Boarding in the ED is associated with higher mortality . This data highlights the importance of this phenomenon and suggests the need for urgent measures to reduce boarding and to improve patient flow OBJECTIVE We hypothesized that critically ill patients who remain in the ED for more than 24 hours experience worse outcomes and longer lengths of stay than those transferred to the medical intensive care unit ( MICU ) within 24 hours . METHODS Medical records were examined of all patients admitted to the MICU directly from the ED of a 325-bed community teaching hospital between 2001 and 2002 . RESULTS Of 443 patients , 104 remained in the ED for 24 hours or longer ( ED > or=24 ) before being transferred to the MICU . There were no significant differences in demographic characteristics of the 339 who were in the ED for less than 24 hours ( ED < 24 ) as compared with ED > or=24 . APACHE II scores were 18.9+/-1.0 for a r and om sample of ED<24 and 20.5+/-0.9 for ED > or=24 ( P=.2 ) . Lengths of hospital stay were 10.9+/-0.8 days for ED<24 and 9.8+/-0.9 days for ED > or=24 ( P=.7 ) . Mortality rates were 26.8 % for ED<24 and 26.9 % for ED > or=24 ( P=.5 ) . CONCLUSIONS These data suggest that outcomes of critically ill patients transferred from the ED to our MICU within 24 hours were not better than those who remained in the ED for longer duration s. Larger studies are required to examine this hypothesis OBJECTIVE To assess the impact of delay in emergency department ( ED ) on outcome of critically ill patients admitted to the medical intensive care unit ( MICU ) . Outcome was defined as hospital mortality and as health-related quality of life ( HRQoL ) at 6 months after intensive care assessed by the 15D measure . The 15D is a generic , 15-dimensional , st and ardized measure of HRQoL. We hypothesized that prolonged stay in the ED is related to worse outcome . DESIGN AND SETTING A prospect i ve follow-up cohort study in university hospital . SUBJECTS All consecutive 1675 patients admitted to the MICU between July 2002 and June 2004 . RESULTS The 15D question naire was mailed to all patients alive at 6 months after admission . Of all MICU patients , 64 % were admitted from ED . The mean length of stay in the ED was 6.2 h ( 95%CI 5.9 - 6.5 h ) . The hospital mortality rate was 24.4 % ( 20.0 % in the ED vs. 33.0 % in the non-ED cohort , P < 0.001 ) and it was associated with higher age and degree of physiological derangement at admission . Neither the length of ED stay was associated with hospital mortality ( P = 0.82 ) nor with HRQoL at 6 months after MICU admission ( P = 0.34 ) . Altogether , HRQoL at 6 months was significantly lower compared with the age- and sex-matched general population ( P < 0.001 ) . CONCLUSIONS In a university hospital , the length of ED stay was not associated with the outcome of critically ill medical patients . However , we feel that the effect of ED treatment and delay on outcome and outcome prediction in the critically ill patients deserves further evaluation We hypothesized that a \" closed \" intensive care unit ( ICU ) was more efficient that an \" open \" one . ICU admissions were retrospectively analyzed before and after ICU closure at one hospital ; prospect i ve analysis in that ICU with an open ICU nearby was done . Illness severity was gauged by the Mortality Prediction Model ( MPM0 ) . Outcomes included mortality , ICU length of stay ( LOS ) , hospital LOS , and mechanical ventilation ( MV ) . There were no differences in age , MPM0 , and use of MV . ICU and hospital LOS were lower when \" closed \" ( ICU LOS : prospect i ve 6.1 versus 12.6 d , p < 0.0001 ; retrospective 6.1 versus 9.3 d , p < 0.05 ; hospital LOS : prospect i ve 19.2 versus 33.2 d , p < 0.008 ; retrospective 22.2 versus 31.2 d , p < 0.02 ) . Days on MV were lower when \" closed \" ( prospect i ve 2.3 versus 8.5 d , p < 0.0005 ; retrospective 3.3 versus 6.4 d , p < 0.05 ) . Pooled data revealed the following : MV predicted ICU LOS ; ICU organization and MPM0 predicted days on MV ; MV and ICU organization predicted hospital LOS ; mortality predictors were open ICU ( odds ratio [ OR ] 1.5 , p < 0.04 ) , MPM0 ( OR 1.16 for MPM0 increase 0.1 , p < 0.002 ) , and MV ( OR 2.43 , p < 0.0001 ) . We conclude that patient care is more efficient with a closed ICU , and that mortality is not adversely affected OBJECTIVES The authors assessed the effect of emergency department ( ED ) crowding on the nontreatment and delay in treatment for analgesia in patients who had acute abdominal pain . METHODS This was a secondary analysis of prospect ively enrolled nonpregnant adult patients presenting to an urban teaching ED with abdominal pain during a 9-month period . Each patient had four vali date d crowding measures assigned at triage . Main outcomes were the administration of and delays in time to analgesia . A delay was defined as waiting more than 1 hour for analgesia . Relative risk ( RR ) regression was used to test the effects of crowding on outcomes . RESULTS A total of 976 abdominal pain patients ( mean [ + /-st and ard deviation ] age = 41 [ + /-16.6 ] years ; 65 % female , 62 % black ) were enrolled , of whom 649 ( 67 % ) received any analgesia . Of those treated , 457 ( 7 \n Output:\n " }, { "from": "agent", "value": "The last remaining study included both ICU and non-ICU subgroups and showed conflicting results , with a positive association for non-ICU patients but no association for ICU patients .\nOur systematic review did not find a strong evidence for the association between ED boarding and IHM but there is a tendency toward this association ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: Introduction : There is debate on renal graft stenting during ureteroneocystostomy , patients with ureteral stents may encounter several complications such as encrustation , stent crustation which can lead to loss of kidney , and complications related to stent extraction : pain and UTI increasing related to cystoscopy for stent extraction accompanying excess expenses . This study design ed to reduce complications related to stent extraction . Material and Methods : 90 patients prepared for renal transplantation during 1 year r and omly classified to groups , study group : patients with attached stent to Foley catheter , control group : patients with conventional technique ( stent separated from Foley ) then in their follow up ; UTI , stent crustation , luts severity compared to each other . Results : Second week and fourth week UTI reported 25.6 % , 2.3 % in study group versus 34.9 % , 4.7 % in control group ( P value 0.48 and 0.5 ) . Urinary leakage was 3.3 % overall , that all of them occurred in separate stent group , 37.5 % vs. 0 % in the linked stent group . Stent crustation in separate stent was 25 % compared with 0 % in the linked stent . Conclusion : Low complications rate in linked stent group , despite the lack of significant statistical differences , but indicate the effectiveness and success of the new technique OBJECTIVES There are studies that show that double J stenting ( DJS ) increase BK nephropathy ( BKN ) 4 fold . DJS may cause vesicoureteral reflux ( VUR ) with normal bladder contraction . The aim of this study is to comparison risk of BKN , urinary tract infections ( UTI ) and postoperative urologic complications with the use DJS with anti-reflux device ( ARD-DJS ) and st and art double J stent ( St-DJS ) . Matherial and methods : Ninety patients ( male/female : 50/40 ) that had undergone kidney transplantations in Diyarbakır Training and Research Hospital and Dicle University , Faculty of Medicine Hospital between January 2012 and April 2015 were enrolled in the study . Demographic data , immunosuppression protocol s , presence of rejection , graft loss , postoperative urologic complications , UTI , plasma BK levels of the patients were evaluated retrospectively . RESULTS Median and IQR follow up time for ARD-DJS and St-DJS patients were 14 ( 12 - 18 ) months and 25 ( 16 - 30 ) months respectively . Five cases ( 5.5 % ) had BK viremia ( P=0.025 ) . All 5 cases with BK viremia were St-DJS users . CONCLUSION As a result for postoperative UTI and postoperative urinary complication risk there were no statistically significant difference between ARD-DJS use and St-DJS use during ureteral anastomosis . BKN univariate analysis were significantly less than those st-DJS used . Risc factors were evaluated . But results were not statistically significant in the logistic regression analysis . We think that to demonstrate this benefit , we need r and omized controlled studies with more patients and longer follow up Asymptomatic bacteriuria ( AB ) is frequent among kidney transplant patients during the first year post transplantation . Currently , there are no clear guidelines for the antibiotic treatment of AB among these patients . We examined the outcomes of treatment versus no treatment of AB in kidney transplant patients during the first year post transplantation . A retrospective cohort study including adults > 16 years of age transplanted in one center between 1/2004 and 12/2010 was undertaken . The primary outcome was a composite of hospitalization for symptomatic urinary tract infection ( UTI ) or more than 25 % reduction in the estimated glomerular filtration rate ( eGFR ) 30 days after the documentation of AB . Secondary outcomes included symptomatic UTIs following the episode of AB , persistent recurrent AB , total days in hospital , mortality , adverse events , and resistance development . A total of 112 patients with AB fulfilled the inclusion criteria . Twenty-two patients received antibiotic treatment ( 19.6 % ) , while 90 patients did not . The primary outcome occurred in 4/22 ( 18.2 % ) of the treated patients versus 5/90 ( 5.6 % ) of the untreated patients [ odds ratio ( OR ) = 3.78 , 95 % confidence interval ( CI ) 0.9–15 ] . The risk of developing symptomatic UTI after AB was almost three times higher ( p < 0.05 ) and the total number of hospitalization days at 6 months post AB was also significantly higher ( p < 0.026 ) in the treated group . No patient died during the study period . UTI caused by bacteria resistant to the antibiotic used for the treatment of AB occurred in 36 % of the treated patients . We observed no benefit for the antibiotic treatment of AB in the short- and long-term follow-up . A prospect i ve observational study is needed INTRODUCTION Duration of retaining ureteric stent in kidney transplantation is still controversial . Our study aim ed to compare healthcare expenditures in kidney transplant recipients with early or routine ureteric stent removal . METHODS This study was a post hoc analysis of data from a single-center parallel r and omized controlled open-label study . Ninety patients who underwent kidney transplantation at a university-based hospital in Thail and from April 2010 to January 2011 were enrolled . Patients were r and omized to early ureteric stent removal ( 8 days ) or routine ureteric stent removal ( 15 days ) after kidney transplantation . The costs of direct health care associated with kidney transplantation , urologic complication , and urinary tract infection ( UTI ) within the postoperative period among the 2 groups were compared . RESULTS Seventy-four patients ( 58 % living donor ) fulfilled the r and omized criteria ( early removal , n = 37 ; routine removal , n = 37 ) . By intention-to-treat analysis , incidence of UTI in early stent removal was less than the routine stent removal group ( 15/37 , 40.5 % vs 27/37 , 72.9 % ; P = .004 ) . Urologic complication showed no significant difference between the early and routine groups ( 4/37 vs 2/37 ; P = .39 ) . The cost-benefit analysis of early over routine stent removal was 2390 United States dollars ( USD ) per patient ( 11,182 vs 8792 USD ) . Presence of UTI significantly increase the hospitalization cost of 5131 USD per patient ( mean cost = 12,209 vs 7078 USD ; P < .001 ) . CONCLUSION UTI in the early post-kidney transplantation period increases healthcare cost . Early ureteric stent removal can reduce UTI and reduce hospitalization cost . This approach shows cost-benefit in the early management of kidney transplant recipients PURPOSE We evaluated the impact of the routine use of Double-J stents for decreasing urological complications in living related renal transplantation at a single center during the last 10 years . MATERIAL S AND METHODS Our 3-phase longitudinal study included 670 consecutive living related renal transplants from 1989 to 1998 . In phase 1 from 1989 to 1993 a stent was introduced as and when required in only 15 of 170 patients . In phase 2 from January 1994 to April 1995 we r and omized 57 and 43 cases to stenting and no stenting , respectively . The stent was removed after 4 weeks . In phase 3 from May 1995 to December 1998 all patients received a stent , which was removed 10 to 14 days just before discharge home . We review ed urological complications at various time frames to determine the impact of routine Double-J stenting on decreasing urological complications . RESULTS In phase 1 the major ureteral complication rate was 8.8 % , which decreased to 3 % in phase 2 when half of our cases were stented . In phase 3 there was only 1 ureteral complication ( 0.04 % ) in 400 patients , of whom all received a stent . The overall ureteral complication rate in nonstented and stented cases was 8.5 % ( 18 of 213 ) and 0.22 % ( 1 of 457 ) . There was no difference in urological complications or stent related problems whether the stent was removed at 4 or 2 weeks . However , stent removal at 2 weeks eliminated the possibility of a forgotten stent , avoided repeat hospitalization for stent removal and decreased the cost . Routine stenting was cost-effective and almost eliminated urological complications . CONCLUSIONS Routine Double-J stenting prevents ureteral complications . Early removal at 2 weeks is advisable . The short duration of stenting is effective and saves the cost of repeat hospitalization at a later date Prophylactic ureteric stenting has been shown to reduce ureteric leaks and collecting system obstruction following renal transplantation and is in widespread use . However , the optimal time for removal of ureteric stents after renal transplantation remains unclear . Aim of this study was to compare the result of early versus late removal of ureteric stents after kidney transplantation of the laparoscopically retrieved live related donor grafts . Eligible patients were live donor kidney transplant recipients with normal urinary tracts . All recipients underwent extravesical Lich – Gregoire ureteroneocystostomy over 4F/160 cm polyurethane double J stents by a uniform technique . They were r and omized on seventh postoperative day for early removal of stents on postoperative day 7 ( Group I ) , or for late removal on postoperative day 28 ( Group II ) . The incidence of urinary tract infections , asymptomatic bacteriuria , and urological complications were compared . Between 2007 and 2009 , 130 kidney transplants were performed at one centre of which 100 were enrolled for the study , and 50 each were r and omized into the two groups . Donor and recipient age , sex , native renal disease , immunosupression , number of rejection episodes , and antirejection therapy were similar in the two groups . The occurrence of symptomatic urinary tract infection during the follow-up period of 6 months was significantly less in the early stent removal group [ 5 out of 50 ( 10 % ) in Group I , vs 50 out of 15 ( 30 % ) in Group II , P=0.02 ] . Asymptomatic bacteriuria was documented in 2 out of 50 ( 4 % ) in Group I and 4 out of 50 ( 8 % ) in Group II ( P=0.3 ) . There was no statistically significant difference in the rate of ureteric leak , ureteric obstruction , or hematuria in the two groups ( P=1.0 ) . We conclude that , in kidney transplant recipients of laparoscopically retrieved live donor grafts , early stent removal at the end of first week reduces the incidence of urinary tract infection without increasing the rate of urine leak or ureteric obstruction \n Output:\n " }, { "from": "agent", "value": "Early removal of ureteral stents after renal transplant may be associated with reduced rates of UTI and ureteral stenosis ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: Context As life expectancy improves among Human Immunodeficiency Virus ( HIV ) patients , renal and cardiovascular diseases are increasingly prevalent in this population . Renal and cardiovascular disease are mutual risk factors and are characterized by albuminuria . Underst and ing the interactions between HIV , cardiovascular risk factors and renal disease is the first step in tackling this new therapeutic frontier in HIV . Methods In a rural primary health care centre , 903 HIV-infected adult patients were r and omly selected and data on HIV-infection and cardiovascular risk factors were collected . Glomerular filtration rate ( eGFR ) was estimated . Albuminuria was defined as an Albumin-Creatinine-Ratio above 30 mg/g . Multivariate logistic regression analysis was used to analyse albuminuria and demographic , clinical and HIV-associated variables . Results The study population consisted of 903 HIV-infected patients , with a median age of 40 years ( Inter-Quartile Range ( IQR ) 34–48 years ) , and included 625 ( 69 % ) women . The median duration since HIV diagnosis was 26 months ( IQR 12–58 months ) and 787 ( 87 % ) received antiretroviral therapy . Thirty-six ( 4 % ) of the subjects were shown to have diabetes and 205 ( 23 % ) hypertension . In the cohort , 21 % had albuminuria and 2 % an eGFR < 60 mL/min/1.73m2 . Albuminuria was associated with hypertension ( adjusted odds ratio ( aOR ) 1.59 ; 95 % confidence interval ( CI ) 1.05–2.41 ; p<0.05 ) , total cholesterol ( aOR 1.31 ; 95 % CI 1.11–1.54 ; p<0.05 ) , eGFR ( aOR 0.98 ; 95 % CI 0.97–0.99 ; p<0.001 ) and detectable viral load ( aOR 2.74 ; 95 % CI 1.56–4.79 ; p<0.001 ) . Hypertension was undertreated : 78 % were not receiving treatment , while another 11 % were inadequately treated . No patients were receiving lipid-lowering medication . Conclusion Glomerular filtration rate was well conserved , while albuminuria was common amongst HIV-infected patients in rural South Africa . Both cardiovascular and HIV-specific variables were associated with albuminuria . Improved cardiovascular risk prevention as well as adequate virus suppression might be the key to escape the vicious circle of renal failure and cardiovascular disease and improve the long-term prognosis of HIV-infected patients Aim : To identify whether the more recently developed equation for estimated glomerular filtration rate ( eGFR ) [ Chronic Kidney Disease Epidemiology Collaboration ( CKD-EPI ) ] is more closely associated with end-organ changes than previous equations in a group of black African descent . Methods : In 1221 r and omly recruited participants of black African ancestry in South Africa , we evaluated serum creatinine concentrations , echocardiographic left ventricular mass index ( n = 833 ) , carotid-femoral ( aortic ) pulse wave velocity ( PWV ) ( n = 1053 ) and carotid intima – media thickness ( n = 633 ) . We calculated eGFR from the Jelliffe , five Cockcroft – Gault , Salazar – Corcoran , Modification of Diet in Renal Disease ( MDRD ) and CKD-EPI equations . Results : After multivariate adjustments , eGFR calculated from all formulae was inversely associated with left ventricular mass index ( P < 0.0001 ) and PWV ( P < 0.05 to < 0.001 ) , but not with carotid intima – media thickness ( P > 0.08 ) . However , although eGFR determined from all equations except Cockcroft – Gault lean body weight or adjusted body weight was independently associated with left ventricular hypertrophy ( n = 390 of 833 ) , CKD-EPI-derived eGFR , but not eGFR determined from alternative equations , was independently associated with an increased PWV ( n = 88 of 1053 ) . eGFR derived from the CKD-EPI and MDRD equations showed a better performance ( area under the receiver operator characteristic curve ) for the detection of left ventricular hypertrophy ( P < 0.0005 ) than eGFR determined from alternative equations . Conclusions : In black Africans , eGFR derived from the CKD-EPI equation is better at detecting end-organ measures than eGFR derived from either the MDRD or alternative equations . To enhance risk prediction in black African communities , eGFR calculated from the CKD-EPI equation may be preferred to other equations Background and Objectives There have been few large population -based studies of the association between rheumatoid arthritis ( RA ) and chronic kidney disease ( CKD ) and glomerulonephritis . This nationwide cohort study investigated the risks of developing CKD and glomerulonephritis in patients with RA , and the associated risks for cardiovascular complications . Methods From the Taiwan National Health Insurance Research Data base , we identified a study cohort of 12,579 patients with RA and r and omly selected 37,737 subjects without RA as a control cohort . Each subject was individually followed for up for 5 years , and the risk of CKD was analyzed using Cox proportional hazards regression models . Results During the follow-up period , after adjusting for traditional cardiovascular risk factors RA was independently associated with a significantly increased risk of CKD ( adjusted hazard ratio [ aHR ] 1.31 ; 95 % confidence interval [ CI ] 1.23–1.40 ) and glomerulonephritis ( aHR 1.55 ; 95 % CI 1.37–1.76 ) . Increased risk of CKD was also associated with the use of non-steroidal anti-inflammatory drugs , cyclosporine , glucocorticoids , mycophenolate mofetil , and cyclophosphamide . Patients with comorbidities had even greater increased risk of CKD . Moreover , RA patients with concurrent CKD had significantly higher likelihood of developing ischemic heart disease and stroke . Conclusions RA patients had higher risk of developing CKD and glomerulonephritis , independent of traditional cardiovascular risk factors . Their increased risk of CKD may be attributed to glomerulonephritis , chronic inflammation , comorbidities , and renal toxicity of antirheumatic drugs . Careful monitoring of renal function in RA patients and tight control of their comorbid diseases and cardiovascular risk factors are warranted Background In the United States , HIV-related kidney disease disproportionately affects individuals of African descent ; however , there are few estimates of kidney disease prevalence in Africa . We evaluated the prevalence of kidney disease among HIV-infected and uninfected Rw and an women . Methods The Rw and an Women 's Interassociation Study and Assessment prospect ively enrolled 936 women . Associations with estimated glomerular filtration rate (eGFR)<60 mL/min/1.73 m2 and proteinuria were assessed in separate logistic regression models . Results Among 891 non-pregnant women with available data , 2.4 % had an eGFR<60 mL/min/1.73 m2 ( calculated by the Modification of Diet in Renal Disease equation , MDRD eGFR ) and 8.7 % had proteinuria ≥1 + . The prevalence of decreased eGFR varied markedly depending on the estimating method used , with the highest prevalence by Cockcroft-Gault . Regardless of the method used to estimate GFR , the proportion with decreased eGFR or proteinuria did not differ significantly between HIV-infected and -uninfected women in unadjusted analysis . After adjusting for age and blood pressure , HIV infection was associated with significantly higher odds of decreased MDRD eGFR but not proteinuria . Conclusion In a well-characterized cohort of Rw and an women , HIV infection was associated with decreased MDRD eGFR . The prevalence of decreased eGFR among HIV-infected women in our study was lower than that previously reported in African-Americans and in other Central and East African HIV population s , although there was substantial variability depending on the equation used to estimate GFR . Future studies are needed to optimize GFR estimates and to determine the impact of antiretroviral therapy on kidney disease in this population The objective is to investigate the accrual rate and risk factors of chronic kidney disease ( CKD ) in an inception cohort of patients with systemic lupus erythematosus ( SLE ) followed at a single tertiary center . A prospect ively collected data base of 256 consecutive patients with SLE followed over a 25-year period was systematic ally interrogated for demographic , disease manifestations , co-morbidities , and outcome . St and ardized SLE activity and damage scores were determined for the first and last study visits , and estimated glomerular filtration rate ( eGFR ; MDRD formula ) was calculated at the time of diagnosis and at each year of the follow-up . CKD was defined as eGFR < 60 ml/min/1.73 m2 . Results were analyzed with univariate and multivariate models and Kaplan-Meier curves , as appropriate . The cohort was predominantly female ( 90 % ) and Jewish ( 91.1 % ) . Mean age at diagnosis was 38 ± 15.5 years , mean SLE activity score 6.4 ± 3.8 , mean disease duration 8.8 ± 6.6 years , and mean damage score 0.2 ± 0.6 . Seventy-five patients ( 30.8 % ) were diagnosed with American College of Rheumatology (ACR)-defined lupus renal disease during the study period . There was a progressive decrease in eGFR over time . The prevalence of CKD was 46.7 % in patients with ACR-defined renal lupus disease and 16.4 % in those without . The hazards ratio for CKD was significantly higher in patients with lupus nephritis ( LN ) than without ( p < 0.001 ) . Earlier CKD was positively associated with hypertension ( p = 0.01 ) , older age at diagnosis ( p = 0.01 ) , and LN ( p < 0.001 ) , and negatively associated with hydroxychloroquine treatment ( p < 0.001 ) . The prevalence of CKD increases cumulatively in patients with SLE , also in those without overt lupus renal disease . Lupus renal disease poses a significant hazard for earlier development of CKD , and hypertension is a major risk factor for patients with and without nephritis . Antimalarial treatment is associated with renal preservation only in patients with lupus nephritis BACKGROUND We sought to investigate renal function in previously untreated symptomatic human immunodeficiency virus (HIV)-infected adults with CD4(+ ) cell counts of < 200 cells/mm(3 ) who were undergoing antiretroviral therapy ( ART ) in Africa . METHODS The study was an observational analysis within a r and omized trial of ART management strategies that included 3316 participants with baseline serum creatinine levels of < or = 360 micromol/L. Creatinine levels were measured before ART initiation , at weeks 4 and 12 of therapy , and every 12 weeks thereafter . We calculated estimated glomerular filtration rate ( eGFR ) using the Cockcroft-Gault formula . We analyzed the incidence of severely decreased eGFR ( < 30 mL/min/1.73 m(2 ) ) and changes in eGFR to 96 weeks , considering demographic data , type of ART , and baseline biochemical and hematological characteristics as predictors , using r and om-effects models . RESULTS Sixty-five percent of the participants were women . Median values at baseline were as follows : age , 37 years ; weight , 57 kg ; CD4(+ ) cell count , 86 cells/mm(3 ) ; and eGFR , 89 mL/min/1.73 m(2 ) . Of the participants , 1492 ( 45 % ) had mild ( > or = 60 but < 90 mL/min/1.73 m(2 ) ) and 237 ( 7 % ) had moderate ( > or = 30 but < 60 mL/min/1.73 m(2 ) ) impairments in eGFR . First-line ART regimens included zidovudine-lamivudine plus tenofovir disoproxil fumarate ( for 74 % of patients ) , nevirapine ( 16 % ) , and abacavir ( 9 % ) ( mostly nonr and omized allocation ) . After ART initiation , the median eGFR was 89 - 91 mL/min/1.73 m(2 ) for the period from week 4 through week 96 . Fifty-two participants ( 1.6 % ) developed severe reductions in eGFR by week 96 ; there was no statistically significant difference between these patients and others with respect to first-line ART regimen received ( P = .94 ) . Lower baseline eGFR or hemoglobin level , lower body mass index , younger age , higher baseline CD4(+ ) cell count , and female sex were associated with greater increases in eGFR over baseline , with small but statistically significant differences between regimens ( P < \n Output:\n " }, { "from": "agent", "value": "Conclusion In Africa , CKD is a public health problem , mainly attributed to high-risk conditions as hypertension and diabetes ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: BACKGROUND Warfarin , which requires coagulation monitoring , is associated with relatively high rates of thromboembolism despite providing adequate prophylaxis . This study compared an oral direct thrombin inhibitor , ximelagatran , with warfarin in order to evaluate the safety and efficacy of the medication for the prevention of venous thromboembolism in patients undergoing total knee arthroplasty . METHODS Following surgery , patients were r and omly assigned to fixed-dose oral ximelagatran ( 36 mg twice daily ) or warfarin ( target international normalized ratio , 2.5 ) , both administered for seven to twelve days in a double-blind , double-dummy design . Warfarin was initiated on the evening of the day of surgery , and ximelagatran , on the morning after surgery . The primary efficacy end point was the incidence of asymptomatic deep-vein thrombosis determined by bilateral venography , objective ly confirmed symptomatic deep-vein thrombosis or pulmonary embolism , and death from all causes during treatment . RESULTS Adequate venograms or confirmed symptomatic events ( efficacy population ) were obtained for 1949 patients . Venous thromboembolism and death from all causes occurred in 22.5 % ( 221 ) of 982 ximelagatran-treated patients and in 31.9 % ( 308 ) of 967 warfarin-treated patients ( p < 0.001 ) . Proximal deep-vein thrombosis and pulmonary embolism were observed in 3.1 % ( thirty ) and 0.2 % , respectively , of the patients in the ximelagatran group and in 3.4 % ( thirty-three ) and 0.4 % , respectively , of the patients in the warfarin group . The six deaths from all causes included 0.3 % ( four ) of the ximelagatran-treated patients and 0.2 % ( two ) of the warfarin-treated patients . Major bleeding was noted in 1 % ( twelve ) of the ximelagatran-treated patients and in 0.4 % ( five ) of the warfarin-treated patients ( p = 0.09 ) . CONCLUSIONS Oral ximelagatran ( 36 mg twice daily ) , administered without coagulation monitoring or dose adjustment and started the day after total knee arthroplasty , demonstrates superior efficacy compared with warfarin prophylaxis , with no wound complications and no significant difference with respect to bleeding events , although the rate of major bleeding events was greater with ximelagatran than with warfarin . LEVEL OF EVIDENCE Therapeutic Level BACKGROUND YM150 , a new oral direct factor Xa inhibitor is used as prophylaxis for venous thromboembolism ( VTE ) , a well-known risk after orthopaedic surgery . OBJECTIVES To assess the safety and efficacy of thromboprophylaxis with YM150 in a dose escalation study . PATIENTS / METHODS Patients ( 174 ) undergoing hip replacement surgery were r and omized per cohort to oral once daily YM150 or subcutaneous enoxaparin ( 40 mg daily ) in a 4:1 ratio for 7 - 10 days treatment . The YM150 doses were 3 , 10 , 30 and 60 mg by sequential four-dose escalation cohorts . The primary endpoint was major and /or clinical ly relevant non-major bleeding . The incidence of VTE was defined as a composite of verified symptomatic events and /or positive findings at bilateral venography on the last treatment day . An independent adjudication committee evaluated blindly the outcomes of the open-label study . RESULTS No major and three clinical ly relevant non-major bleeds were reported , 1 ( 2.9 % ; 95 % CI , 0.1 - 15.1 ) in the 3 mg and 2 ( 5.7 % ; 95 % CI , 1.0 - 18.8 ) in the 10 mg YM150 dose groups . Of 147 patients ( 84 % ) with an evaluable venogram , VTE was observed in 51.9 % ( 95 % CI , 31.9 - 71.4 ) , 38.7 % ( 95 % CI , 22.6 - 57.0 ) , 22.6 % ( 95 % CI , 9.7 - 39.4 ) , and 18.5 % ( 95 % CI , 7.5 - 36.5 ) in the YM150 dose groups 3 , 10 , 30 and 60 mg , respectively . A significant YM150 dose-related trend in VTE incidence was found ( P=0.006 ) . VTE with enoxaparin was 38.7 % ( 95 % CI , 22.6 - 57.0 ) . CONCLUSIONS YM150 , 10 - 60 mg daily , starting 6 - 10 h after primary hip replacement , was shown to be safe , well tolerated and effective AIM The efficacy and safety of the new oral , direct and selective thrombin inhibitor Ximelagatran and its active form Melagatran was analysed in patients undergoing total hip or knee replacement . METHODS AND PATIENTS Methro II , a r and omised , double-blind controlled dose-finding study , involved 1876 patients . Melagatran ( 1 , 1.5 , 2.25 or 3 mg ; twice daily ; start : immediately before surgery ) was given subcutaneously , followed by orally administered Ximelagatran ( 8 , 12 , 18 or 24 mg , twice daily , day after surgery ) and compared to subcutaneously administered dalteparin ( 5000 IE , once daily ) . Methro III was a r and omised , double blind controlled study involving 2788 patients . The fixed dose of 3 mg Melagatran was given ( start : 4 - 12 hours postoperatively ) followed by oral Ximelagatran ( 24 mg , twice daily , day after surgery ) compared to subcutaneous enoxaparin ( 40 mg , once daily ) . In both studies , dalteparin or enoxaparin was applied at the evening before operation ; the treatment lasted 8 to 11 days . A bilateral venography was performed at the last day of treatment . RESULTS In the Methro II study , 1270 patients underwent total hip , 606 total knee replacement . In both groups the thromboembolism rate was reduced depending on the dose of Ximelagatran/Melagatran . Compared to dalteparin , it was significantly lower for the Ximelagatran/Melagatran group with the highest dose . In the Methro III study 1923 patients underwent a total hip , 865 a total knee replacement . The thromboembolism rate was 31 % for the Ximelagatran/Melagatran group compared to 27 % for the enoxaparin group . In both studies blood loss and transfusion requirement were in the same range as with low weight molecular heparins . CONCLUSIONS A fixed subcutaneously given dose of Melagatran , followed by orally administered Ximelagatran is effective and well tolerated as prophylaxis against venous thromboembolism BACKGROUND Heparin-induced thrombocytopenia ( HIT ) is an intensely prothrombotic syndrome managed by discontinuation of heparin therapy and substitution of an alternative inhibitor of thrombin . We describe our experience with argatroban , a direct thrombin inhibitor , in patients with HIT or HIT with thrombosis ( HITTS ) . METHODS In this multicenter , nonr and omized prospect i ve study , 418 patients with HIT were administered intravenous argatroban , 2 micro g/kg per minute , adjusted to maintain the activated partial thromboplastin time at 1.5 to 3 times the baseline value for a mean of 5 to 7 days . Comparisons were made with a historical control cohort ( n = 185 ) . The prospect ively defined , primary efficacy end point was a composite of all-cause death , all-cause amputation , or new thrombosis in 37 days . Other end points included the components of the composite , death due to thrombosis , increased platelet count , and bleeding . RESULTS In the HIT arm , the composite end point was significantly reduced in argatroban-treated patients vs controls ( 28.0 % vs 38.8 % ; P = .04 ) . In the HITTS arm , the composite end point occurred in 41.5 % of argatroban-treated patients vs 56.5 % of controls ( P = .07 ) . By time-to-event analysis of the composite end point , argatroban therapy was significantly better than historical control therapy in HIT ( P = .02 ) and HITTS ( P = .008 ) . Argatroban therapy also significantly reduced new thrombosis in HIT and HITTS and death due to thrombosis in HITTS . There were no significant between-group differences in all-cause death or amputation . Platelet counts recovered more rapidly in argatroban-treated patients than in controls . Bleeding rates were similar between groups . CONCLUSION Argatroban therapy , compared with historical control , improves outcomes , particularly new thrombosis and death due to thrombosis , in patients with heparin-induced thrombocytopenia Background — Rivaroxaban ( BAY 59 - 7939)—an oral , direct Factor Xa inhibitor — could be an alternative to heparins and warfarin for the prevention and treatment of thromboembolic disorders . Methods and Results — This r and omized , double-blind , double-dummy , active-comparator – controlled , multinational , dose-ranging study assessed the efficacy and safety of once-daily rivaroxaban relative to enoxaparin for prevention of venous thromboembolism in patients undergoing elective total hip replacement . Patients ( n=873 ) were r and omized to once-daily oral rivaroxaban doses of 5 , 10 , 20 , 30 , or 40 mg ( initiated 6 to 8 hours after surgery ) or a once-daily subcutaneous enoxaparin dose of 40 mg ( given the evening before and ≥6 hours after surgery ) . Study drugs were continued for an additional 5 to 9 days ; m and atory bilateral venography was performed the following day . The primary end point ( composite of any deep vein thrombosis , objective ly confirmed pulmonary embolism , and all-cause mortality ) was observed in 14.9 % , 10.6 % , 8.5 % , 13.5 % , 6.4 % , and 25.2 % of patients receiving 5 , 10 , 20 , 30 , and 40 mg rivaroxaban , and 40 mg enoxaparin , respectively ( n=618 , per- protocol population ) . No significant dose – response relationship was found for efficacy ( P=0.0852 ) . Major postoperative bleeding was observed in 2.3 % , 0.7 % , 4.3 % , 4.9 % , 5.1 % , and 1.9 % of patients receiving 5 , 10 , 20 , 30 , and 40 mg rivaroxaban , and 40 mg enoxaparin , respectively ( n=845 , safety population ) , representing a significant dose – response relationship ( P=0.0391 ) . Conclusions — Rivaroxaban showed efficacy and safety similar to enoxaparin for thromboprophylaxis after total hip replacement , with the convenience of once-daily oral dosing and without the need for coagulation monitoring . When both efficacy and safety are considered , these results suggest that 10 mg rivaroxaban once daily should be investigated in phase III studies BACKGROUND For many patients with venous thromboembolism , secondary prevention with vitamin K antagonists is not extended beyond six months , since the risk of recurrence may be outweighed by the risk of major bleeding . METHODS In a double-blind , multicenter trial , we r and omly assigned 1233 patients with venous thromboembolism who had undergone six months of anticoagulant therapy to extended secondary prevention with the oral direct thrombin inhibitor ximelagatran ( 24 mg ) or placebo , taken twice daily , for 18 months without monitoring of coagulation . At base line , bilateral ultrasonography of the legs and perfusion lung scanning were performed . RESULTS Data from 612 patients in the ximelagatran group and 611 in the placebo group were analyzed . The occurrence of the primary end point , symptomatic recurrent venous thromboembolism , was confirmed in 12 patients assigned to ximelagatran and 71 patients assigned to placebo ( hazard ratio , 0.16 ; 95 percent confidence interval , 0.09 to 0.30 ; P<0.001 ) . Death from any cause occurred in 6 patients in the ximelagatran group and 7 patients in the placebo group , and bleeding occurred in 134 patients and 111 patients , respectively ( hazard ratio , 1.19 ; 95 percent confidence interval , 0.93 to 1.53 ; P=0.17 ) . The incidence of major hemorrhage was low ( six events in the ximelagatran group and five in the placebo group ) , and none of \n Output:\n " }, { "from": "agent", "value": "Therefore , the effect of the DTIs compared with LMWH appears to be influenced by the time of initiation of coagulation more than the effect of the drug itself .\nDirect thrombin inhibitors are as effective in the prevention of major venous thromboembolism in THR or TKR as LMWH and vitamin K antagonists .\nHowever , they show higher mortality and cause more bleeding than LMWH .\nNo severe hepatic complications were reported in the analysed studies .\nUse of ximelagatran is not recommended for VTE prevention in patients who have undergone orthopedic surgery ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: BACKGROUND Although question naires are used frequently with patients to self-report the severity of dyspnea as related to activities of daily living , the reliability of these instruments has not been established . The two purpose s of this study were to examine the test-retest reliability of three widely used dyspnea instruments and to compare dyspnea scores at different stages of disease . METHODS At paired baseline visits , 101 stable patients with COPD were tested ; at paired follow-up visits at 3 months , 89 of these patients were tested . At each visit , patients rated dyspnea with three instruments presented in r and om order and then performed post-bronchodilator therapy lung function tests . RESULTS Patient-reported dyspnea scores and lung function were similar at baseline ( interval , 6 + /- 5 days ) and follow-up visits ( interval , 4 + /- 2 days ) . Intraclass correlation coefficients at baseline and at follow-up were 0.82 and 0.82 , respectively , for the modified Medical Research Council scale ; 0.90 and 0.84 , respectively , for the self-administered computerized versions of the baseline dyspnea index and transition dyspnea indexes ; and 0.95 and 0.89 for the University of San Diego Shortness of Breath Question naire results . Dyspnea ratings were significantly related to the stage of disease severity based on percent predicted FEV(1 ) ( p < 0.001 ) . CONCLUSIONS Test-retest reliability was acceptable for patient-reported dyspnea scores using three clinical instruments at baseline and at the 3-month follow-up . Our results demonstrate for the first time that patient-reported dyspnea ratings are related to the stage of disease severity Reproducibility and validity are prerequisites for a useful clinical scale . We therefore prospect ively tested the reproducibility and validity of the New York Heart Association criteria and the Canadian Cardiovascular Society criteria for the assessment of cardiac functional class and compared these criteria with a new Specific Activity Scale based on the metabolic costs of specific activities . The New York Heart Association estimates made by two physicians had a reproducibility of only 56 % , and only 51 % of the estimates agreed with treadmill exercise performance . Functional estimates based on the Canadian Cardiovascular Society criteria were significantly more reproducible ( 73 % ) , but not significantly more valid . The Specific Activity Scale was as reproducible as the Canadian Cardiovascular Society criteria , and its 68 % validity was significantly higher than the validities of the other systems . The easily administered Specific Activity Scale was equally reproducible and valid when used by a nonphysician . It was especially better than the other systems for the evaluation of true class II patients and was significantly less likely to underestimate treadmill performance . Although no set of questions can perfectly predict exercise tolerance , the Specific Activity Scale deserves wider prospect i ve testing PURPOSE Overweight and obese subjects often perceive increased breathlessness during minor exertion and therefore avoid exercise . Respiratory muscle endurance training ( RMET ) can reduce the perception of breathlessness . We hypothesized that RMET 1 month before and during a 6-month ( 3 months supervised + 3 months unsupervised ) exercise and nutrition counseling program ( EN ) would improve the benefits of EN . METHODS Twenty-six overweight and obese subjects with significant perception of breathlessness during exercise ( age = 33 ± 9 yr , body mass index ( BMI ) = 31.3 ± 4.9 kg·m(-2 ) ) were r and omized to RMET+EN ( R+EN ) or EN alone . R+EN performed 30 min of normocapnic hyperpnea 5 wk(-1 ) before and 2 wk(-1 ) during EN . EN consisted of two strength and three endurance training sessions per week , as well as prescribed nutritional composition and a 2.1-kJ ( 500-kcal ) energy deficit per day . Both groups had an equal number of laboratory visits during the 7 months . Before and after 4 and 7 months , subjects performed a 12-min time trial ( TT ; 6 + 6 min , 2-min pause ) and an incremental cycling test ( ICT ) to exhaustion , and blood lipids were assessed . RESULTS Weight loss was significant and similar in both groups ( -4.2 vs -3.7 kg ; both P < 0.05 ) . During the first 4 months , distance covered in 12 min improved more ( P < 0.05 ) with R+EN ( 1678 vs 1824 m ; P < 0.001 ) than with EN alone ( 1638 vs 1698 m ; P < 0.05 ) , whereas after R+EN , breathlessness during the ICT was reduced . Blood lipids of the pooled group improved in those subjects with pathologic values before the study . Despite reduced training compliance during the unsupervised period , subjects of both groups maintained the benefits attained during the supervised period . CONCLUSIONS R+EN improved TT performance more than EN alone , despite similar weight loss , possibly owing to the reduced perception of breathlessness OBJECTIVE Our objective was to study the effects of physical training combined with dietary measures in obese adults . In a second step , we sought to compare two training protocol s and establish the additional contribution of strength training . METHODS We performed a r and omized , prospect i ve survey from July 2004 to November 2007 . Included patients were r and omized into three groups : a control group ( G1 ) , a group ( G2 ) performing dietary measures and a programme of treadmill training at 60 % of each individual 's maximum heart rate ( HRmax ) and a group ( G3 ) who followed the G2 programme supplemented with strength training . All patients underwent an initial and final assessment of anthropometric & cardiovascular parameters , muscle strength , dyspnoea during activities of daily living , metabolic disorders , psychological status and quality of life . RESULTS The greatest weight loss ( 7.24 % ) was observed in G3 . Reduction in waistline measurement ( WL ) of 4.3 % and 10.26 % were noted in G2 and G3 , respectively ( p < 0.001 ) . The percentage fat body mass fell by 10.4 % in G3 ( p < 0.001 ) and 8.6 % in G2 ( p = 0.03).We particularly noted an improvement in physical condition in groups 2 and 3 , with lower HR and blood pressure values at rest and at maximum effort . The overall improvement in both arm and leg muscle strength was greater for G3 than for G2 . Likewise , we noted an improvement in the metabolic parameters and depression & anxiety scores for the trained groups ( G2 , G3 ) , relative to the control group ( G1 ) . We also noted improvements in the total impact of weight on quality of life ( IWQOL ) lite score of 15.2 % in G2 and 18 % in G3 . CONCLUSION Our survey demonstrated the beneficial effect of combining dietary measures and physical training in obese patients . In addition to weight loss , the programme enabled a reduction in the patients ' body fat mass and abdominal obesity , a correction of metabolic disorders and an improvement in aerobic capacity . The improvement in all these parameters also enhanced the patients ' psychological status and quality of life . The addition of strength training produced notable improvements in weight loss , arm muscle strength and abdominal obesity We mimicked important mechanical and ventilatory aspects of restrictive lung disorders by employing chest wall strapping ( CWS ) and dead space loading ( DS ) in normal subjects to gain mechanistic insights into dyspnea causation and exercise limitation . We hypothesized that thoracic restriction with increased ventilatory stimulation would evoke exertional dyspnea that was similar in nature to that experienced in such disorders . Twelve healthy young men [ 28 + /- 2 ( SE ) yr of age ] completed pulmonary function tests and maximal cycle exercise tests under four conditions , in r and omized order : 1 ) control , 2 ) CWS to 60 % of vital capacity , 3 ) added DS of 600 ml , and 4 ) CWS + DS . Measurements during exercise included cardiorespiratory parameters , esophageal pressure , and Borg scale ratings of dyspnea . Compared with control , CWS significantly reduced the tidal volume response to exercise , increased dyspnea intensity at any given work rate or ventilation , and thus limited exercise performance . DS stimulated ventilation but had minimal effects on dyspnea and exercise performance . Adding DS to CWS further increased dyspnea by 1.7 + /- 0.6 st and ardized Borg units ( P = 0.012 ) and decreased exercise performance ( total work ) by 21 + /- 6 % ( P = 0.003 ) over CWS alone . Across conditions , increased dyspnea intensity correlated best with decreased resting inspiratory reserve volume ( r = -0.63 , P < 0.0005 ) . Dyspnea during CWS was described primarily as \" inspiratory difficulty \" and \" unsatisfied inspiration , \" similar to restrictive disorders . In conclusion , severe dyspnea and exercise intolerance were provoked in healthy normal subjects when tidal volume responses were constrained in the face of increased ventilatory drive during exercise BACKGROUND Maximal incremental exercise testing should be completed within 8 - 12 minutes . The ramp-slope influences the exercise duration . Oxygen-cost diagram ( OCD ) is a scoring scale for the capability of daily activity performed and therefore can be used to estimate the ramp-slope . METHODS The OCD-algorithm and the reported-algorithm were used prospect ively in r and om order for selecting optimal ramp-slope : Ramp-slope(OCD)=Score(OCD)xweight in kg/40 for men and weight/50 for women and Ramp-slope(reported)=(Predicted V(O2peak)-V(O2unloaded))/100 . Fifty-three dyspneic patients and 16 normal controls were enrolled to perform a ramp-pattern exercise . Fourteen patients not reaching maximum exercise levels were excluded . The exercise capacity , exercise time , and success rate of loaded exercise between 8 and 12 minutes were measured . RESULTS Comparing the reported-algorithm to the OCD-algorithm in normal controls , the only difference was that the ramp-slope was higher in males ; in patients , the ramp-slope was higher in males , the exercise time shorter and the success rate lower ( 8.6+/-3.3 vs. 9.4+/-2.1 min , 61.5 % vs. 84.6 % , both p<0.05 ) ; in obese patients , the ramp-slope was lower and the exercise time longer . CONCLUSION OCD score can predict the ramp-slope selection for exercise testing in normal controls and dyspneic patients . This may be affected by gender and body weight when using the reported-algorithm for dyspneic patients AIM To describe changes in chest pain and dyspnoea during a period of 15 years after coronary artery bypass grafting ( CABG ) and to define factors at the time of operation that were associated with the occurrence of these symptoms after 15 years . DESIGN Prospect i ve observational study in western Sweden . SUBJECTS All patients who underwent first-time CABG , without simultaneous valve surgery , between 1 June 1988 and 1 June 1991 . There were no exclusion criteria . FOLLOW-UP All patients were followed up prospect ively for 15 years . The evaluation of symptoms took place through postal question naires prior to and 5 , 10 and 15 years after the operation . RESULTS Totally , 2000 patients were included in the survey and 904 ( 45 % ) of them survived to 15 years . Among these 904 survivors , the percentage of patients with chest pain increased from 44 % to 50 % between the 5- and 15-year follow-up ( p=0.004 ) . The percentage of patients who reported symptoms of dyspnoea increased from 60 % after 5 years to 74 % after 15 years ( p<0.001 ) . Factors at the time of surgery that independently tended to predict chest pain after 15 years were higher age ( p=0.04 ) and prolonged duration of symptoms prior to surgery ( p=0.04 ) . Predictors of dyspnoea after 15 years were higher age ( p<0.0001 ) , the use of inotropic drugs at the time of surgery ( p=0.001 ) , a history of diabetes ( p=0.01 ) and obesity ( p=0.01 ) . CONCLUSION After CABG , relief from chest pain and dyspnoea is generally maintained over a long period of time . Eventually , however , functional-limiting symptoms tend to recur and about half the patients report symptoms of chest pain , while three-quarters report dyspnoea after 15 years . Even if no clear predictor of chest pain was found at the time of surgery , age , the use of inotropic drugs , diabetes and obesity predicted dyspnoea The primary purpose of this study was to determine if there are three distinct factors representing ratings of dyspnea during laboratory exercise , clinical ratings of dyspnea , and pulmonary function in patients with moderate to severe chronic obstructive pulmonary disease ( COPD ) ( n = 92 ) using factor analysis . Subjects ( mean age 66 + /- 7 yrs ; FEV1 % predicted 44.7 + /- 14.0 ) were r and omly assigned to one of three treatment groups to test the effects of three education and exercise training programs . Outcomes were evaluated at baseline and at 2 months after the intervention . Dyspnea ratings with laboratory exercise ( SOB ) were measured during incremental ( ITT ) and endurance ( ETT ) treadmill tests , and a six-minute walk ( 6MW ) using the modified Borg scale . Clinical measures of dyspnea were measured with the Baseline and Transitional Dyspnea Index ( BDI \n Output:\n " }, { "from": "agent", "value": "If sensation drives behavior , comprehensive data on the sensation of breathlessness might assist in underst and ing the behavioral consequences of interventions" } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: OBJECTIVES We assessed the prevalence of antituberculosis drug resistance among children with tuberculosis ( TB ) in the Western Cape Province of South Africa . METHODS Drug susceptibility testing for isoniazid and rifampin was prospect ively done on all children with culture-confirmed TB at Tygerberg Children 's Hospital , Cape Town , from March 2005 through February 2007 . Survey results were compared with results from 2 previous surveys . RESULTS We found 291 children had culture-confirmed TB . Resistance to isoniazid or rifampin increased from 21 of 306 ( 6.9 % ) to 41 of 319 ( 12.9 % ) and 43 of 285 ( 15.1 % ) in the first to third surveys ( P = .005 ) and multidrug resistance from 7 of 306 ( 2.3 % ) to 18 of 319 ( 5.6 % ) and 19 of 285 ( 6.7 % ; P = .033 ) . Although previously treated children had significantly more drug resistance than did new TB cases ( 19 of 66 [ 28.8 % ] vs 24 of 225 [ 10.7 % ] ; odds ratio = 3.39 ; 95 % confidence interval = 1.62 , 7.05 ) , evidence suggests transmission rather than acquisition of resistance . HIV infection was not significantly associated with drug resistance . CONCLUSIONS Results indicate a high and rising prevalence of anti-TB drug resistance among children in the Western Cape , which suggests ongoing transmission of drug-resistant strains within the community . Improved control of TB in adults , including early identification and treatment of drug-resistant cases , is necessary to reduce transmission to children A controlled clinical trial of three short-course chemotherapy regimens was undertaken in patients with newly diagnosed bacteriologically positive pulmonary tuberculosis . The patients were r and omly allocated to receive one of three regimens : rifampicin , streptomycin , isoniazid and pyrazinamide daily for 2 months , followed by streptomycin , isoniazid and pyrazinamide twice weekly for 3 months ( R/5 ) or for 5 months ( R/7 ) , or the same regimen as R/7 but without rifampicin ( Z/7 ) . A bacteriological relapse requiring retreatment occurred by 5 years in 7.1 % of 126 R/5 , 4.0 % of 124 R/7 and 6.7 % of 253 Z/7 patients with organisms initially sensitive to streptomycin and isoniazid ; none of these differences is statistically significant . Of the 31 relapses , 16 occurred within 2 years of the completion of chemotherapy and the remaining 15 between 2 and 5 years . Among 65 patients with initial drug resistance to streptomycin or isoniazid or both , there were six bacteriological relapses requiring retreatment The study included 359 cases of primary tuberculosis ( benign forms ) in children aged 0 - 14 years , out of which 181 non-complicated and 178 complicated forms . The therapeutical regimens were : 3HEZ2/3HE2 ( study subgroup ) and 6HE2/3H2 ( control ) for non-complicated forms , and 3HRZ2/3HR2 ( study subgroup ) and 3HES2/3HE2/3H2 ( control ) for complicated ones . Late results ( 5 years after treatment end ) were very good ( from clinical , radiological , bacteriological points of view ) in 100 % of cases . Thus , short-course regimens are preferable to longer ones ( over 6 months ) in the chemotherapy of the benign forms of pulmonary tuberculosis in children Background R and omized trials are essential in assessing the effects of healthcare interventions and are a key component in systematic review s of effectiveness . Search ing for reports of r and omized trials in data bases is problematic due to the absence of appropriate indexing terms until the 1990s and inconsistent application of these indexing terms thereafter . Objectives The objectives of this study are to devise a search strategy for identifying reports of r and omized trials in EMBASE which are not already indexed as trials in MEDLINE and to make these reports easily accessible by including them in the Cochrane Central Register of Controlled Trials ( CENTRAL ) in The Cochrane Library , with the permission of Elsevier , the publishers of EMBASE . Methods A highly sensitive search strategy was design ed for EMBASE based on free-text and thesaurus terms which occurred frequently in the titles , abstract s , EMTREE terms ( or some combination of these ) of reports of trials indexed in EMBASE . This search strategy was run against EMBASE from 1980 to 2005 ( 1974 to 2005 for four of the terms ) and records retrieved by the search , which were not already indexed as r and omized trials in MEDLINE , were downloaded from EMBASE , printed and read . An analysis of the language of publication was conducted for the reports of trials published in 2005 ( the most recent year completed at the time of this study ) . Results Twenty-two search terms were used ( including nine which were later rejected due to poor cumulative precision ) . More than a third of a million records were downloaded and scanned and approximately 80,000 reports of trials were identified which were not already indexed as r and omized trials in MEDLINE . These are now easily identifiable in CENTRAL , in The Cochrane Library . Cumulative sensitivity ranged from 0.1 % to 60 % and cumulative precision ranged from 8 % to 61 % . The truncated term ' r and om$ ' identified 60 % of the total number of reports of trials but only 35 % of the more than 130,000 records retrieved by this term were reports of trials . The language analysis for the sample year 2005 indicated that of the 18,427 reports indexed as r and omized trials in MEDLINE , 959 ( 5 % ) were in language s other than English . The EMBASE search identified an additional 658 reports in language s other than English , of which the highest number were in Chinese ( 320 ) . Conclusion The results of the search to date have greatly increased access to reports of trials in EMBASE , especially in some language s other than English . The search strategy used was subjectively derived from a small ' gold st and ard ' set of test records and was not vali date d in an independent test set . We intend to design an objective ly-derived vali date d search strategy using logistic regression based on the frequency of occurrence of terms in the approximately 80,000 reports of r and omized trials identified compared with the frequency of these terms across the entire EMBASE data base A controlled study of three short-course regimens was undertaken in South Indian patients with newly diagnosed , sputum-positive pulmonary tuberculosis . The patients were allocated at r and om to one of three regimens : a ) Rifampicin , streptomycin , isoniazid and pyrazinamide daily for 3 months ( R3 ) ; b ) the same regimen as above but followed by streptomycin , isoniazid and pyrazinamide twice-weekly for a further period of 2 months ( R5 ) ; c ) the same as R5 but without rifampicin ( Z5 ) . A bacteriological relapse requiring treatment occurred by 5 years in 16.8 % of 113 R3 , 5.2 % of 97 R5 , and 20.0 % of 115 Z5 patients with organisms sensitive to streptomycin and isoniazid initially . The differences in the relapse rates between the R3 and R5 regimens and the R5 and Z5 regimens were statistically significant ( p less than 0.01 for both ) . Considering patients with organisms initially resistant to streptomycin or isoniazid or both , 7 of 52 patients ( 4 R3 , 2 R5 , 1 Z5 ) had a bacteriological relapse requiring retreatment ABSTRACT The World Health Organization ( WHO ) recently issued revised first-line antituberculosis ( anti-TB ) drug dosage recommendations for children . No pharmacokinetic studies for these revised dosages are available for children < 2 years . The aim of the study was to document the pharmacokinetics of the first-line anti-TB agents in children < 2 years of age comparing previous and revised WHO dosages of isoniazid ( INH ; 5 versus 10 mg/kg/day ) , rifampin ( RMP ; 10 versus 15 mg/kg/day ) , and pyrazinamide ( PZA ; 25 versus 35 mg/kg/day ) and to investigate the effects of clinical covariates , including HIV coinfection , nutritional status , age , gender , and type of tuberculosis ( TB ) , and the effect of NAT2 acetylator status . Serum INH , PZA , and RMP levels were prospect ively assessed in 20 children < 2 years of age treated for TB following the previous and the revised WHO dosage recommendations . Sample s were taken prior to dosing and at 0.5 , 1.5 , 3 , and 5 h following dosing . The maximum drug concentration in serum ( Cmax ) , the time to Cmax ( tmax ) , and the area under the concentration-time curve ( AUC ) were calculated . Eleven children had pulmonary and 9 had extrapulmonary TB . Five were HIV infected . The mean Cmax ( μg/ml ) following the administration of previous/revised dosages were as follows : INH , 3.19/8.11 ; RMP , 6.36/11.69 ; PZA , 29.94/47.11 . The mean AUC ( μg·h/ml ) were as follows : INH , 8.09/20.36 ; RMP , 17.78/36.95 ; PZA , 118.0/175.2 . The mean Cmax and AUC differed significantly between doses . There was no difference in the tmax values achieved . Children less than 2 years of age achieve target concentrations of first-line anti-TB agents using revised WHO dosage recommendations . Our data provided supportive evidence for the implementation of the revised WHO guidelines for first-line anti-TB therapy in young children Fully intermittent short course chemotherapy regimens have been used successfully in adults but not in children . We report the results on 76 children with tuberculosis , excluding central nervous system tuberculosis and primary pulmonary complex . Isoniazid , rifampin and pyrazinamide were used for treatment . They were r and omly allocated to Regimen A ( 52 doses ) and Regimen B ( 94 doses ) . Overall efficacy of both schedules was greater than 95 % in 27 children with lymphatic , 43 with pulmonary and 6 with disseminated tuberculosis . Compliance in 10 children after 2 to 4 months of therapy was poor because rapid improvement was mistaken by parents for cure . Two children died , probably of underlying lung disease . Follow-up for up to 2 years did not reveal any case of relapse or recurrence of the disease . Therapy for 6 months involving administration of only 52 or 94 doses of drugs was found to be economical , effective and safe for treating children with tuberculosis INTRODUCTION Most patients with active pulmonary tuberculosis ( PTB ) are treated with a 6-month short course regimen . The purpose of the present study was to assess the efficacy of using 4 months of chemotherapy to treat patients with smear-negative PTB . METHODS A total of 314 patients were r and omised to a daily or combined ( daily and intermittent ) regimen as follows : ( 1 ) 2HRZ/2HR--2 months of isoniazid ( H ) , rifampicin ( R ) and pyrazinamide ( Z ) , followed by 2 months of H and R or ( 2 ) 2HRZ/2H3R3 - -2 months of HRZ as in regimen 1 , followed by H and R given 3 times weekly for 2 months or 4 months if initial sputum specimens were culture positive . RESULTS One hundred and fifty-eight patients were assigned to the daily regimen and 156 to the combined regimen . Of the 158 patients , 99 had negative cultures and 59 had positive cultures . There was no relapse among 96 culture-negative patients assessed at 30 months and 68 patients at 60 months . However , 6 patients had no radiological response while 1 was considered on review to have non-tuberculous disease . There was no relapse among 57 culture-positive patients assessed at 30 months and 41 at 60 months . In the combined regimen group , 102 had negative cultures and 54 had positive cultures . There was 1 relapse in the culture-negative group of 100 patients assessed at 30 months and 74 at 60 months . There was no radiological response in 5 patients . One patient in the culture-positive group failed therapy but there were no relapses during follow-up to 60 months . CONCLUSION A 4-month daily or combined regimen appears to be highly effective in the treatment of non-immunocompromised patients with smear- and culture-negative PTB Background . Treating childhood tuberculosis places a large burden on health services , and ways of lessening this were sought . Methods . A r and omized controlled trial was conducted to determine the effectiveness of fully intermittent twice weekly treatment for intrathoracic childhood tuberculosis and its effect on adherence to treatment , in comparison with daily ( weekday ) treatment . The setting was a district of Cape Town , South Africa , an area of high incident tuberculosis . We r and omized 206 children with confirmed ( 4 % ) , probable ( 94 % ) and suspected ( 2 % ) intrathoracic tuberculosis : 89 ( median age \n Output:\n " }, { "from": "agent", "value": "Trials conducted to date are insufficient to support or refute the use of intermittent twice- or thrice-weekly , short-course treatment regimens over daily short-course treatment in children with TB ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: The 1990 guidelines for adult weight published by the U.S. Department of Agriculture [ 1 ] recommend higher weights than previous st and ards . In particular , the guidelines for increased weight ( about 7 kg on average ) for persons age 35 years and older , with allowance for major weight gain in midlife , have stimulated much debate [ 2 - 4 ] . The basis for these recommendations is unclear . The report by And res [ 5 ] on which the recommendations may be based is fundamentally flawed because it ignored cigarette smoking . Although no apparent biological rationale exists for suggesting that persons increase their weight as they grow older , the health consequences of weight gain during adult life have not been clearly documented . In general , a strong association between body mass index and the risk for noninsulin-dependent diabetes mellitus has been observed . However , few studies have examined the consequences of weight gain during various periods of life . From a public health perspective , weight and weight gain are more easily understood than body mass index . Also , using change in weight as a basis for recommendations is attractive because it allows for differences in frame size , which are difficult to characterize . For these reasons , we quantified the relations between change in adult weight and the risk for noninsulin-dependent diabetes mellitus among women during 14 years of follow-up . We previously reported the relation between body mass index and clinical diabetes in this cohort after 8 years of follow-up [ 6 ] . Methods Established in 1976 , the Nurses ' Health Study cohort consists of 121 700 female registered nurses aged 30 to 55 years who responded to a mail question naire about their medical history and health behaviors . Additional details have been reported elsewhere [ 7 ] . The participants for our study were the 114 824 women who did not have diagnosed diabetes mellitus , coronary heart disease , stroke , or cancer when the cohort was enrolled in 1976 . On the basis of a sub sample of participants , we estimate that 98 % of the participants are white , a percentage that reflects the ethnic background of women trained as registered nurses before 1977 [ 8 ] . Ascertainment of Risk Factors Height and weight were ascertained on the 1976 question naire . On biennial follow-up question naires , we inquired about current weight and asked for information on whether diabetes mellitus , coronary heart disease , cancer , or other major illnesses had been diagnosed during the 2 years since the previous question naire . In 1980 , we asked women to record their weight at age 18 years , and in 1982 we inquired about a history of diabetes in the participants ' mothers , fathers , brothers , or sisters . Weight reported by the participants in this study has been shown to be highly valid in two sample s of Boston-area study participants . Self-reported current weight was highly correlated with measured weight ( Spearman correlation coefficient , 0.97 ) ; the average measured weight was 1.5 kg lower [ 9 , 10 ] . In a sub study done in a cohort of nurses aged 27 to 44 years , recalled weight at age 18 years was compared with self-reported weights at ages 17 to 21 years that were recorded on nursing-school physical examination forms . The mean recalled self-reported body mass index was 21.6 kg/m2 compared with an index of 22.1 kg/m2 noted on the examination records ( mean difference in weight , 1.4 kg ) . The Pearson correlation coefficient for weight was 0.87 and was independent of current age . Participants in the Nurses ' Health Study cohort weighed , on average , 3 kg less than a national sample of women in 1976 [ 11 ] . We used body mass index ( weight in kg divided by height in m2 ) as an index of relative weight and grouped it into 10 categories using whole-number cutpoints . We divided weight change between age 18 years and 1976 into eight categories . A body mass index of 24.0 kg/m2 represents the 50th percentile for middle-aged , white U.S. women , and an index of 29.0 kg/m2 represents the 75th percentile [ 11 ] . Diagnosis of Diabetes Mellitus We mailed supplementary question naires on symptoms , diagnostic tests , and therapy for hypoglycemia to women who responded positively on any follow-up question naire to the query Have you had physician-diagnosed diabetes mellitus ? The supplementary question naires were mailed in 1984 to women who reported that diabetes had been diagnosed between 1976 and 1984 and in 1986 , 1988 , and 1990 to women who reported diabetes on the question naires in those years . We excluded women who reported that diabetes had been diagnosed before they entered the study in 1976 . An incident case of diabetes was confirmed if at least one of the following was reported on the supplementary question naire : 1 ) one or more classic symptoms ( thirst , polyuria , weight loss , hunger , pruritus ) plus a fasting plasma glucose level of at least 140 mg/dL ( 7.8 mmol/L ) or a r and om plasma glucose level of at least 200 mg/dL [ 11.1 mmol/L ] ; 2 ) two or more elevated plasma glucose values on different occasions [ fasting level 140 mg/dL or r and om level 200 mg/dL , or both , or fasting level 200 mg/dL after 2 or more hours of testing for oral glucose tolerance ] in the absence of symptoms ; or 3 ) treatment with medication for hypoglycemia ( insulin or oral hypoglycemic agent ) . All women were 30 years of age or older at diagnosis . We excluded cases ( and subsequent follow-up after diagnosis ) of incident insulin-dependent ( type 1 ) diabetes ( n = 89 ) . We also excluded women classified as having gestational diabetes only ( diabetes first diagnosed during pregnancy and that persisted no more than 1 month after the end of pregnancy , with no subsequent diagnosis of diabetes when the woman was not pregnant ) . The remaining women with confirmed diabetes ( n = 2204 ) were classified as having noninsulin-dependent diabetes mellitus ; these women form the basis for our analysis . Our criteria for diabetes classification are consistent with those proposed by the National Diabetes Data Group [ 12 ] except that we did not use any weight criteria in classifying diabetes . To document the validity of the confirmation of diabetes by the supplementary question naire , we examined medical records in a r and om sample of the participants who reported diabetes . Of 84 women who reported diabetes and were classified as having noninsulin-dependent diabetes mellitus by supplementary question naires , 71 gave permission for review of their medical records ; medical records were obtained for 62 . An endocrinologist ( JEM ) who was unaware of the information reported on the supplementary question naires review ed the available records using the National Diabetes Data Group criteria . The diagnosis of noninsulin-dependent diabetes mellitus was confirmed by medical records in 61 of the 62 women ( 98.4 % ) . Statistical Analysis We computed incidence rates of noninsulin-dependent diabetes mellitus during the 14 years of follow-up for categories of body mass index calculated at baseline in 1976 and for categories of weight change between age 18 years and 1976 . Follow-up began when the 1976 question naire was returned and ended on the date of death or diagnosis of diabetes , cardiovascular disease , or cancer , or 1 June 1990 , whichever came first . Women who reported diabetes mellitus , coronary heart disease , stroke , or cancer on the baseline or follow-up question naires were excluded from subsequent follow-up . We obtained rates by dividing the number of incident cases by the number of person-years of follow-up in each category of body mass index or weight change . We computed relative risks as the rate of noninsulin-dependent diabetes mellitus in a specific category of body mass index divided by the rate among women with a body mass index less than 22.0 kg/m2 . Because family history was recorded in 1982 , we repeated analyses from 1982 to 1990 to examine weight change within strata of family history and defined weight change in adulthood as weight in 1982 minus weight at age 18 years . We used proportional hazard models to simultaneously evaluate the association with family history , body mass index at age 18 years , and weight gain . We calculated 95 % CIs for each relative risk . Results The mean weight SD of women in this cohort at age 18 years was 126.2 19.4 pounds ( 57 8.8 kg ) . Mean weight gain between age 18 years and 1976 varied monotonically with age from 7.6 pounds ( 3.4 kg ) among women 30 years of age to 19.0 pounds ( 8.6 kg ) for women 55 years of age . Reflecting these weight changes , the mean weight for each birth cohort ( in single years ) increased from 133 pounds ( 60.3 kg ) for women 35 years of age to 144 pounds ( 65.3 kg ) for women 55 years of age . The risk for diabetes increased as attained body mass index increased over the 1976 value ( index was up date d every 2 years ) ( Table 1 ) . Even women with a body mass index of 22.0 to 22.9 kg/m2 had a significant threefold elevation in age-adjusted relative risk compared with women with an index less than 22.0 kg/m2 . Women of average weight ( body mass index , 24 to 24.9 kg/m2 ) had a relative risk of 5.0 ( 95 % CI , 3.6 to 6.6 ) compared with women with an index less than 22 kg/m2 . Women with a body mass index of 31.0 kg/m2 or more had an age-adjusted relative risk of 40.0 or greater ( Table 1 ) . This association persisted within age strata , and body mass index remained a strong risk factor , even for women as old as 69 years . After adjustment for body mass index , women aged 60 to 64 years had a relative risk of 3.4 ( CI , 2.5 to 4.6 ) compared with women aged 40 to 44 years . The relation between body mass index and diabetes mellitus was similar in white and black women . The strong association between body mass index and the risk for diabetes mellitus persisted ( that is , remained unchanged ) when we repeated analyses that were limited to symptomatic cases of noninsulin-dependent diabetes mellitus ( report of at least one symptom at diagnosis , including thirst , polyuria , weight loss , hunger , or pruritus ) . Table 1 . Attained Body Mass Index and Objective To examine the prevalence of outcome reporting bias — the selection for publication of a subset of the original recorded outcome variables on the basis of the results — and its impact on Cochrane review s. Design A nine point classification system for missing outcome data in r and omised trials was developed and applied to the trials assessed in a large , unselected cohort of Cochrane systematic review s. Research ers who conducted the trials were contacted and the reason sought for the non-reporting of data . A sensitivity analysis was undertaken to assess the impact of outcome reporting bias on review s that included a single meta- analysis of the review primary outcome . Results More than half ( 157/283 ( 55 % ) ) the review s did not include full data for the review primary outcome of interest from all eligible trials . The median amount of review outcome data missing for any reason was 10 % , whereas 50 % or more of the potential data were missing in 70 ( 25 % ) review s. It was clear from the publications for 155 ( 6 % ) of the 2486 assessable trials that the research ers had measured and analysed the review primary outcome but did not report or only partially reported the results . For reports that did not mention the review primary outcome , our classification regarding the presence of outcome reporting bias was shown to have a sensitivity of 88 % ( 95 % CI 65 % to 100 % ) and specificity of 80 % ( 95 % CI 69 % to 90 % ) on the basis of responses from 62 trialists . A third of Cochrane review s ( 96/283 ( 34 % ) ) contained at least one trial with high suspicion of outcome reporting bias for the review primary outcome . In a sensitivity analysis undertaken for 81 review s with a single meta- analysis of the primary outcome of interest , the treatment effect estimate was reduced by 20 % or more in 19 ( 23 % ) . Of the 42 meta-analyses with a statistically significant result only , eight ( 19 % ) became non-significant after adjustment for outcome reporting bias and 11 ( 26 % ) would have overestimated the treatment effect by 20 % or more . Conclusions Outcome reporting bias is an under-recognised problem that affects the conclusions in a substantial proportion of Cochrane review s. Individuals conducting systematic review s need to address explicitly the issue of missing outcome data for their review to be considered a reliable source of evidence . Extra care is required during data extraction , review ers should identify when a trial reports that an outcome was measured but no results were reported or events observed , and contact with trialists should be encouraged Background and Purpose — Impaired glucose tolerance (IGT)–a prediabetic state – is an important risk factor for atherosclerosis . Acarbose , an & agr;-glucosidase inhibitor , was shown in the placebo-controlled prospect i ve study to prevent noninsulin-dependent diabetes mellitus ( STOP-NIDDM ) trial to reduce the risk of diabetes by 36 % in IGT subjects . This article reports \n Output:\n " }, { "from": "agent", "value": "There were no clear differences for any outcome measure between these two acarbose interventions and the associated comparator groups .\nAUTHORS ' CONCLUSIONS AGI may prevent or delay the development of T2DM in people with IGT .\nThere is no firm evidence that AGI have a beneficial effect on cardiovascular mortality or cardiovascular events" } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: Objectives In a double-blinded r and omized controlled clinical trial , the impact of face-bow registration for remounting complete dentures ( CDs ) on the occlusal parameters ( part I ) was evaluated . Material s and methods New CDs of 32 patients were duplicated and mounted after intraoral pin registration according to mean setting s ( group 1 ) and ( group 2 ) using a face-bow ( arbitrary hinge axis ) . The vertical dimension was reduced to the first occlusal contact point , and a bite record was fabricated in the articulator . The number of contacts and the number of teeth in contact were evaluated by a computer program ( laboratory result ) . After r and omization , half of the CDs were adjusted according to protocol of group 1 and group 2 and delivered to the patients . After 3 days ( T1 ) and 84 days ( T2 ) , clinical static contact points and teeth in contact were counted . Contact points and teeth in contact of both groups ( laboratory results ) and at different moments ( clinical results ) were analyzed statistically with the F test and bootstrapping . Results Laboratory : No. 2 ( face-bow ) showed more occlusal contact points than no. 1 ( mean setting ) , p > 0.05 . The number of teeth with at least one occlusal contact was significantly higher in no. 2 ( p = 0.027 ) . Clinic : The mean number of teeth with at least one clinical contact point was significantly higher in no. 1 ( no. 1 = 7.13 , no. 2 = 5.31 ; p = 0.042 ) . Extent of the vertical shift poorly correlated with number of laboratory occlusal contact points ( R2 = 0.017 ) . Conclusions Considering the complex multistep study design , a limited number of participants , and referring to one specific arbitrary face-bow , the following conclusion could be drawn : no substantial difference by the use of the arbitrary face-bow compared to a mean setting could be determined , when changing the vertical dimension in the articulator within a remounting procedure of complete dentures . Clinical relevance Further research is necessary to determine the effects of different arbitrary face-bows on the fabrication and adaptation of removable dentures BACKGROUND Complex procedures involving a facebow transfer and the use of lingualised teeth are deemed to have a positive influence on the chewing ability with complete dentures . OBJECTIVES To determine if patients ' ratings of their ability to chew depend on the method of complete denture fabrication . METHODS Edentulous patients ( n = 20 ) participated in a within-subject crossover trial . Each patient received two sets of new complete dentures . One pair was manufactured based on intraoral tracing of centric relation and facebow transfer ; semi-anatomical teeth with lingualised occlusion denture ( LOD ) were chosen . The second pair was made using a simplified procedure without facebow transfer ; jaw relations were recorded with wax occlusion rims , and anatomical teeth with a first premolar/canine-guidance ( CGD ) were selected . The dentures were delivered in r and omised order , and each was worn for 3 months . Three months after delivery , patients ' ratings of each new prosthesis were recorded on visual analogue scales for their ability to chew seven index foods . Repeated measurements analysis of variance was performed to investigate possible carry-over effects accounting for confounding by treatment period . RESULTS When comparing the two treatments , participants rated their ability to chew in general , to masticate carrots , hard sausage , steak and raw apple in particular , was significantly better with the CGD ( anatomical teeth ) than with the LOD ( p < 0.05 ) . CONCLUSION Comprehensive methods for the fabrication of complete dentures including semi-anatomical lingualised teeth and a full registration do not seem to influence the perceived chewing ability , when compared with more simple procedures . Chewing ability for tough foods appears to benefit from the use of anatomical teeth OBJECTIVES To compare subjective and objective outcomes of complete dentures fabricated with st and ard clinical protocol s , but omitted selected steps during the laboratory phase . MATERIAL S AND METHODS Forty-three edentulous patients ( mean age 58.1 years , SD 9.9 , range 35 - 78 ) , were consecutively recruited and r and omly assigned to one of four groups according to selected variations of laboratory steps : Group 1 ( n=10 ) , omission of secondary casts obtained from impressions in border moulded custom trays ; Group 2 ( n=10 ) , omission of secondary casts and face-bow articulator mounting ; Group 3 ( n=10 ) , omission of face-bow mounting ; Group 4 ( n=13 ) , no steps omitted ( control ) . Clinical procedures for all groups were identical , and performed by senior dental students under supervision of prosthodontists , all of whom were blinded to the Group . At 1- , 4- and 12-weeks after delivery , patients rated their overall satisfaction , as well as a range of functional factors using visual analogue scales . An independent blinded prosthodontist similarly rated four domains of denture quality at the 1-week follow-up . RESULTS No significant differences were noted among the groups in all aspects of patients ' assessment s at all the time points ( P>0.1 ) . There were no significant differences in prosthodontists ' ratings of denture quality in any of the domains examined ( P>0.1 ) . CONCLUSION Selected omissions of steps ( face-bow mounting and /or secondary casts ) during the laboratory phase of complete denture fabrication has only a minor role , if any , in subjective and objective outcomes , contrasting with the common belief that such omissions will adversely affect outcomes . CLINICAL SIGNIFICANCE General practitioners provide most complete dentures . Many do not follow all the procedures they were taught at dental school . Our finding that omitting frequently advocated steps made no difference to patient satisfaction or to denture quality suggests that cost-effectiveness through simplifications be considered in practice and in education OBJECTIVES To compare a simplified method to a conventional protocol for complete denture fabrication regarding masticatory performance and ability . METHODS A sample was formed by edentulous patients requesting treatment with maxillary and m and ibular complete dentures . Participants were r and omly divided into two groups : Group S , which received dentures fabricated by a simplified method , and Group C ( n=21 each ) , which received conventionally fabricated dentures . After three months following insertion , masticatory performance was evaluated by a colorimetric assay based on chewing two capsules as test food during twenty and forty cycles . Masticatory ability was assessed by a question naire with binary answers and a single question answered by means of a 0 - 10 scale . A third group ( DN ) formed by seventeen dentate volunteers served as an external comparator . Groups were compared by statistical tests suitable for data distribution ( α=0.05 ) . RESULTS Thirty-nine participants were assessed for three months ( twenty from Group C and nineteen from Group S ) . Groups C and S presented similar masticatory performance which corresponded to approximately 30 % of Group DN . Results for masticatory ability showed similarity between S and C , regardless of the assessment method , although an isolate question naire item showed more favourable results for the first group . CONCLUSIONS The simplified method for complete denture fabrication is able to restore masticatory function to a level comparable to a conventional protocol , both physiologically and according to patient 's perceptions . CLINICAL SIGNIFICANCE Although masticatory function is impaired by the loss of natural teeth and dentures can restore only a fraction of such function , patients can benefit from a simplified protocol for complete denture fabrication to the same extent they would by conventional techniques PURPOSE Conventional dentures will remain the only treatment available to most edentulous people for the foreseeable future . In this study , we compared the efficiency of two methods of making complete conventional dentures-the traditional academic st and ard ( T ) and a simplified technique ( S ) used in private practice . We have previously shown that they produce similar levels of patient satisfaction and denture quality . MATERIAL S AND METHODS Data were gathered during a r and omized controlled clinical trial of 122 subjects from initial examination until 6-month follow-up . For this report , the direct costs of providing one set of conventional complete dentures by T or S techniques were estimated . All material s used were recorded and their cost was calculated in Canadian dollars ( CAN$ ) . The costs of fabrication in an outside laboratory were added . Clinician 's labor time was recorded for every procedure . Between-group comparisons for each clinical procedure were carried out with independent t-tests . The number of patients in each group who needed postdelivery treatment was compared with Chi-square tests . The effect of group assignment and of treatment difficulty on outcomes was analyzed with multiple regression analysis . RESULTS The mean total cost of the T method was significantly greater than S ( CAN$166.3 ; p < 0.001 ) , and clinicians spent 90 minutes longer ( p < 0.001 ) on clinical care . The difficulty of the case had no significant influence on outcomes . CONCLUSIONS The results indicate that the S method is the more cost-efficient method and that there are no negative consequences that detract from the cost savings OBJECTIVES To compare the quality of conventional complete dentures fabricated with two different techniques . A r and omized controlled clinical trial was conducted to compare traditional ( T ) and simplified ( S ) methods of making complete conventional dentures on patients ' ratings of satisfaction , comfort and function at 3 and 6 months following delivery . The quality of the prostheses was rated by prosthodontists at 6 months . MATERIAL S AND METHODS One hundred twenty-two male and female edentulous individuals , aged 45 - 75 years , were r and omly allocated into groups that received dentures made with either T or S methods . Following delivery , patients ' ratings of several denture-related factors were measured using 100 mm visual analogue scales , and denture quality was assessed by blinded prosthodontists using ratings on a vali date d quantitative scale . RESULTS There were no significant differences between the two groups in patient ratings for overall satisfaction ( 3 months : mean T = 83 mm , mean S = 83 mm , P = 0.97 ; 6 months : mean T = 79 mm , mean S = 79 mm , P = 0.96 ) or in prosthodontists ' ratings of denture quality ( T = 66 , S = 63 ; P = 0.38 ) . CONCLUSION These results show that the quality of complete dentures does not suffer when manufacturing techniques are simplified to save time and material s. Dental educators should consider these findings when re- design ing prosthodontic training programs A Abbe flap \\ăb # e flăp\\ [ Robert Abbe , New York , N.Y. surgeon , 18511928 ] : eponym for a lip switch operation . A triangular , full thickness flap from the lower lip used to fill in a deficit in the upper lip . Specifically applied to the midportion of the upper or lower lip— called also lip switch operation Abbe , R. A new plastic operation for the relief of deformity due to double harelip . Med Rec 1898;53:477 . ab duct \\ăb dŭkt#\\ vt ( 1834 ) : to draw away from the median plane— comp ADDUCT ab er rant \\ă-bĕr#ant\\ adj ( ca . 1798)1 : a deviation from the normal or usual course , form , or location 2 : straying from the normal way ab frac tion \\ăb frăk#shun\\ n ( 1991 ) : the pathologic loss of hard tooth substance caused by biomechanical loading forces . Such loss is thought to be due to flexure and chemical fatigue degradation of enamel and /or dentin at some location distant from the actual point of loading — comp ABLATION , ABRASION , ATTRITION , and EROSION ab la tion \\ă-bl a#shun\\ n ( 15c ) 1 : separation or detachment ; extirpation ; eradication 2 : removal of a part , especially by cutting — see ABFRACTION , EROSION abrade \\uh-br ad#\\ vt ( 1677 ) : to rub away the external covering or layer of a part — comp ATTRITION , EROSION abra sion \\ă-br a # shun\\ n ( 1656 ) 1 : the wearing away of a substance or structure ( such as the skin or the teeth ) through some unusual or abnormal mechanical process 2 : an abnormal wearing away of the tooth substance by causes other than mastication — comp ATTRITION , EROSION abra sive \\uh-br a # siv , -ziv\\ n ( 1853 ) : a substance used for abrading , smoothing , or polishing abra sive \\uh-br a # siv , -ziv\\ adj ( 1875 ) 1 : tending to abrade 2 : causing irritation — abra sive ly adv , abra sive ness n ab ra si vity \\uh-br a#siv-ı̆-t e , -ziv-ı̆-t e\\ v ( 1998 ) : the property of one material to wear away another material by means of frictional contact absorbed dose \\ab-sôrbd#,-zôrbd # d os\\ : the amount of energy from ionizing radiation absorbed per unit mass of matter , expressed in Gray units ab sorp tance \\ab-sôrp#tans , -zôrp#tans\\ n ( ca . 1931 ) : the ratio of the radiant energy absorbed by a body to that incident upon it ab sorp tion \\ab-sôrp#shun , -zôrp#-\\ n ( 1741 ) 1 : the uptake of substances into or through tissues , e.g. , mucosa , skin , and intestine 2 : in radiology , the uptake of energy by matter with which the radiation interacts — see A. of RADIATION — comp ADSORPTION absorption of radiation \\ab-sôrp#shun ŭv r a#d ea#shun\\ : collisionlike interactions between the individual particulate or quantum components of a beam of radiation and the subatomic parts of matter that occur at r and om during irradiation . Each interaction may result in partial or complete transfer of energy abut ment \\a-bŭt#ment\\ \n Output:\n " }, { "from": "agent", "value": "Conclusions : The use of facebow did not yield a superior fit or comfort of the complete dentures or occlusal splints .\nTherefore , there is no evidence of the utility facebow transfer for these prostheses ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: Objectives Describe proportions of individuals with patellofemoral pain ( PFP ) with an unfavourable recovery over 12 months ; identify clinical predictors of poor recovery at 3 and 12 months ; and determine baseline values of predictors that identify those with poor 12-month prognosis . Methods An observational analysis utilised data from 310 individuals with PFP enrolled in two r and omised clinical trials . Thirteen baseline variables ( participant , PFP , study characteristics ) were investigated for their prognostic ability . Pain , function and global recovery were measured at 3 and 12 months . Multivariate backward stepwise regression analyses ( treatment-adjusted , p<0.10 ) were performed for each follow-up measure . Receiver operator characteristic curves identified cut-points associated with unfavourable recovery at 12 months . Results 55 % and 40 % of participants had an unfavourable recovery at 3 and 12 months , respectively . Longer baseline pain duration was significantly associated with poor 3-month and 12-month recovery on measures of pain severity ( β 11.36 to 24.94 ) , Anterior Knee Pain ( AKP ) Scale ( −4.44 to −11.33 ) and global recovery ( OR : 2.32 to 6.11 ) . Greater baseline pain severity and lower AKP Scale score were significantly associated with poor recovery on multiple measures ( p<0.05 ) . Baseline duration > 2 months and AKP Scale score < 70/100 were associated with unfavourable 12-month recovery . Conclusions A substantial number of individuals with PFP have an unfavourable recovery over 12 months , irrespective of intervention . Knee pain duration > 2 months is the most consistent prognostic indicator , followed by AKP Scale score < 70 . Sports medicine practitioners should utilise interventions with known efficacy in reducing PFP , and promote early intervention to maximise prognosis . Trial registration Australian study : Australian Clinical Trials Registry ( ACTRN012605000463673 ) , Clinical Trials.gov ( NCT00118521 ) ; Dutch study : International St and ard R and omised Controlled Trial Number Register ( IS RCT N83938749 A prospect i ve study of 390 infantry recruits revealed that the medial tibial intercondylar distance and that the isometric strength of the quadriceps , tested at 85 degrees of flexion of the knee , had a statistically significant correlation with the incidence of patellofemoral pain caused by overactivity . Increased medial tibial intercondylar distance and increased strength of the quadriceps were therefore deemed to be risk factors for this syndrome Background Patellofemoral pain syndrome is one of the most common chronic knee injuries ; however , little research has been done to determine the risk factors for this injury . Hypothesis Altered lower extremity kinematics and kinetics , decreased strength , and altered postural measurements will be risk factors . Study Design Cohort study ( prognosis ) ; Level of evidence , 2 . Methods A total of 1597 participants were enrolled in this investigation and prospect ively followed from the date of their enrollment ( July 2005 , July 2006 , or July 2007 ) through January 2008 , a maximum of 2.5 years of follow-up . Each participant underwent baseline data collection during their pre-freshman summer at the United States Naval Academy . Baseline data collection included 3-dimensional motion analysis during a jump-l and ing task , 6 lower extremity isometric strength tests , and postural alignment measurements ( navicular drop and Q angle ) . Results Risk factors for the development of patellofemoral pain syndrome included decreased knee flexion angle , decreased vertical ground-reaction force , and increased hip internal rotation angle during the jump-l and ing task . Additionally , decreased quadriceps and hamstring strength , increased hip external rotator strength , and increased navicular drop were risk factors for the development of patellofemoral pain syndrome . Conclusion Multiple modifiable risk factors for patellofemoral pain syndrome pain have been identified in this investigation . To decrease the incidence of this chronic injury , the risk factors for patellofemoral pain syndrome need to be targeted in injury prevention programs . Clinical Relevance Prevention programs should focus on increasing strength of the lower extremity musculature along with instructing proper mechanics during dynamic movements to decrease the incidence of patellofemoral pain syndrome Objective : To prospect ively determine gait-related risk factors for patellofemoral pain . Design : A prospect i ve cohort study . Setting : Male and female recruits of the Belgian Royal Military Academy during a 6-week basic military training period . Participants : Eighty-four officer cadets ( 65 men , 19 women ) , who entered the Military Academy and were without a history of any knee or lower-leg complaints , participated in the study . Interventions : Before the start of the 6-week basic military training period , plantar pressure measurements during walking were performed . During the basic military training period , patellofemoral complaints were diagnosed and registered by a sports medicine physician . Main Outcome Measurements : Plantar pressure measurements during walking were performed using a footscan pressure plate ( RsScan International ) . Results : During the 6-week training period , 36 subjects developed patellofemoral pain ( 25 male and 11 female ) . Logistic regression analysis revealed that subjects who developed patellofemoral pain had a significantly more laterally directed pressure distribution at initial contact of the foot , a significantly shorter time to maximal pressure on the fourth metatarsal , and a significantly slower maximal velocity of the change in lateromedial direction of the center of pressure during the forefoot contact phase . Conclusions : Our findings suggest that the feet of the persons who developed anterior knee pain have a heel strike in a less pronated position and roll over more on the lateral side compared with the control group . The results of this study can be considered valuable in identifying persons at risk for patellofemoral pain Background Inappropriate control of the vastus medialis oblique and vastus lateralis muscles by the central nervous system can contribute to maltracking of the patella . Hypothesis The activation timing and amplitude of the vastus medialis oblique and vastus lateralis muscles will be different between normal subjects and patients with patellofemoral pain . Study Design Controlled laboratory study . Methods Subjects with patellofemoral pain and asymptomatic control subjects performed maximum voluntary knee extension contractions initiated from a flexed and an extended position . The activation timing and amplitude of the vastus lateralis and vastus medialis oblique muscles were quantified from the recorded electromyographic signals . Results There were no between-group differences in activation timing . The activation amplitude of the vastus medialis oblique and vastus lateralis muscles of the patellofemoral pain subjects was altered to the greatest extent during eccentric contractions and differed significantly from that of control subjects . Conclusions The activation amplitudes of the vastus medialis oblique and vastus lateralis muscles of subjects with patellofemoral pain are consistent with a laterally tracking patella during eccentric contractions . Clinical Relevance The findings suggest the clinical importance of determining whether altered activation patterns are sensitive to rehabilitation , and , if so , if subjective reports of knee joint pain and function parallel changes in the activation patterns as a result of rehabilitation PURPOSE There is emerging evidence that foot orthoses are effective in the management of patellofemoral pain syndrome ( PFPS ) . However , the identification of those most likely to benefit from foot orthoses has not been adequately explored . The aim of this study was to develop a preliminary clinical prediction rule to help identify individuals with PFPS who are most likely to benefit from foot orthoses . METHODS A total of 60 individuals with PFPS were issued with noncustomized prefabricated foot orthoses containing built-in arch supports and 4 ° rear foot varus wedging . Patient-reported level of improvement was documented at 12 wk . Potential baseline predictor variables of interest included patient demographics , pain characteristics , footwear motion control properties , foot and ankle characteristics , and functional performance measures . RESULTS Fourteen ( 25 % ) participants reported marked improvement at 12 wk . The number of participants with marked improvement increased to 78 % if three of the following four criteria were met : footwear motion control properties score of < 5.0 ( indicative of less supportive footwear ) , usual pain < 22.0 mm , ankle dorsiflexion range of motion ( knee flexed ) < 41 ° , and reduced single-leg squat pain when wearing the orthoses . CONCLUSIONS Individuals with PFPS who wear less supportive footwear , report lower levels of pain , exhibit less ankle dorsiflexion range of motion , and report an immediate reduction in pain with foot orthoses when performing a single-leg squat are more likely to benefit from foot orthoses Objective Patellar malalignment is a major cause of patellofemoral pain syndrome ( PFPS ) , but the relationship between clinical symptoms and changes in patellar position and knee muscle strength has not been confirmed . This study examined the effect of weight training on hip and knee muscle strength , patellofemoral joint contact area , and patellar tilt on subjects with and without PFPS , hoping to develop an optimal rehabilitation protocol for subjects with PFPS . Design The study uses a prospect i ve independent group comparison . Fifteen subjects with and without PFPS were assessed for knee strength , patellofemoral joint contact area , and patellar tilt angle using magnetic resonance imaging . The subjects with PFPS were also examined and given a numeric pain rating score and a Kujala patellofemoral score . The subjects performed lower-limb weight training 3 times/wk for 8 wks , and the outcomes were assessed both before and after training . Results Subjects with PFPS have increased their patellofemoral joint contact area after weight training ( P < 0.001 ) . No statistical significant change was found on the patellar tilt angle . The isometric and isokinetic knee strength in subjects with and without PFPS have increased after weight training ( P value increased from 0.007 to 0.05 ) . Both numeric pain rating and Kujala patellofemoral score in the PFPS group improved after training ( P < 0.001 ) . Conclusions Weight-training exercise increased knee muscle strength and the patellofemoral joint contact area , which could reduce mechanical stress in the joint , improving pain and function in subjects with PFPS Objective : To determine prospect ively gait-related intrinsic risk factors for patellofemoral pain ( PFP ) in a population of novice recreational runners . Design : Prospect i ve cohort study . Participants : 102 novice recreational runners ( 89 women ) with no history of knee or lower leg complaints . Interventions : The st and ing foot posture of the subjects was examined and plantar pressure measurements during running were collected . The subjects then participated in a 10-week “ start to run ” programme . During this period all sports injuries were registered by a sports medicine physician . Main outcome measurements : The relationship between the st and ing foot posture and PFP was investigated and gait-related intrinsic risk factors for PFP were determined . Results : The 17 runners who developed PFP exerted a significantly higher vertical peak force underneath the lateral heel and metatarsals 2 and 3 . Logistic regression analysis showed that a significantly higher vertical peak force underneath the second metatarsal and shorter time to the vertical peak force underneath the lateral heel were predictors for PFP . No significant evidence was found for an association between an excessively pronated or supinated foot posture and the development of PFP . Conclusions : The findings suggest that an excessive impact shock during heel strike and at the propulsion phase of running may contribute to an increased risk of developing PFP . The hypothesis that persons at risk for PFP show an altered static foot posture in comparison with non-afflicted persons is not supported by the results of this study Background : The prevalence of adolescent knee pain is 33 % , and patellofemoral pain ( PFP ) is the most common diagnosis with a nontraumatic onset . The 2-year prognosis of adolescent PFP compared with other types of knee pain is unknown . Purpose : To investigate the 2-year prognosis of knee pain among adolescents with and without a diagnosis of PFP . Study Design : Cohort study ; Level of evidence , 2 . Methods : In 2011 , a cohort of 2200 adolescents aged 15 to 19 years answered an online question naire on musculoskeletal pain . Of these , 504 reported knee pain , and 153 of these were clinical ly diagnosed with PFP . After 2 years , the 504 adolescents , as well as 252 r and omly selected adolescents who did not report knee pain in 2011 , were contacted again . Primary outcome at follow-up was the proportion of adolescents with knee pain during the last week prior to follow-up . Results : Overall , 55.9 % ( 95 % CI , 50.8%-60.9 % ) of those reporting knee pain at baseline also reported pain 2 years later . Adolescents diagnosed with PFP had a 1.26 ( 95 % CI , 1.05 - 1.50 ) higher relative risk ( RR ) of knee pain at follow-up compared with other types of knee pain . Adolescents with PFP were significantly more likely to reduce or stop sports participation compared with adolescents with other types of knee pain . Of those without knee pain at baseline , 12.8 % ( 95 % CI , 8.4%-17.2 % ) reported knee pain at follow-up in 2013 . Adolescents with knee pain at baseline had a 4.51 ( 95 % CI , 3.15 - 6.45 ) higher RR of knee pain at follow-up compared with adolescents without knee pain at baseline . Conclusion : Knee pain during adolescence , and PFP in particular , is in most cases present after 2 years and thus may not be self-limiting . \n Output:\n " }, { "from": "agent", "value": "No significant link between BMI and intervention outcomes in adults with PFP was identified .\nConclusions Higher BMI is present in PFP and PFOA , but not in adolescents with PFP ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: OBJECTIVE We investigated the efficacy and safety of the sodium glucose cotransporter 2 inhibitor , empagliflozin , added to multiple daily injections of insulin ( MDI insulin ) in obese patients with type 2 diabetes mellitus ( T2DM ) . RESEARCH DESIGN AND METHODS Patients inadequately controlled on MDI insulin ± metformin ( mean HbA1c 8.3 % [ 67 mmol/mol ] ; BMI 34.8 kg/m2 ; insulin dose 92 international units/day ) were r and omized and treated with once-daily empagliflozin 10 mg ( n = 186 ) , empagliflozin 25 mg ( n = 189 ) , or placebo ( n = 188 ) for 52 weeks . Insulin dose was to remain stable in weeks 1–18 , adjusted to meet glucose targets in weeks 19–40 , then stable in weeks 41–52 . The primary end point was change from baseline in HbA1c at week 18 . Secondary end points were changes from baseline in insulin dose , weight , and HbA1c at week 52 . RESULTS Adjusted mean ± SE changes from baseline in HbA1c were −0.50 ± 0.05 % ( −5.5 ± 0.5 mmol/mol ) for placebo versus −0.94 ± 0.05 % ( −10.3 ± 0.5 mmol/mol ) and −1.02 ± 0.05 % ( −11.1 ± 0.5 mmol/mol ) for empagliflozin 10 mg and empagliflozin 25 mg , respectively , at week 18 ( both P < 0.001 ) . At week 52 , further reductions with insulin titration result ed in changes from baseline in HbA1c of −0.81 ± 0.08 % ( −8.9 ± 0.9 mmol/mol ) , −1.18 ± 0.08 % ( −12.9 ± 0.9 mmol/mol ) , and −1.27 ± 0.08 % ( −13.9 ± 0.9 mmol/mol ) with placebo , empagliflozin 10 mg , and empagliflozin 25 mg , respectively , and final HbA1c of 7.5 % ( 58 mmol/mol ) , 7.2 % ( 55 mmol/mol ) , and 7.1 % ( 54 mmol/mol ) , respectively . More patients attained HbA1c < 7 % ( < 53 mmol/mol ) with empagliflozin ( 31–42 % ) versus placebo ( 21 % ; both P < 0.01 ) . Empagliflozin 10 mg and empagliflozin 25 mg reduced insulin doses ( −9 to −11 international units/day ) and weight ( −2.4 to −2.5 kg ) versus placebo ( all P < 0.01 ) at week 52 . CONCLUSIONS In obese , difficult-to-treat patients with T2DM inadequately controlled on high MDI insulin doses , empagliflozin improved glycemic control and reduced weight without increasing the risk of hypoglycemia and with lower insulin requirements Aims /hypothesisType 2 diabetes is difficult to manage in patients with a long history of disease requiring insulin therapy . Moreover , addition of most currently available oral antidiabetic agents increases the risk of hypoglycaemia . Vildagliptin is a dipeptidyl peptidase-IV inhibitor , which improves glycaemic control by increasing pancreatic beta cell responsiveness to glucose and suppressing inappropriate glucagon secretion . This study assessed the efficacy and tolerability of vildagliptin added to insulin therapy in patients with type 2 diabetes . Material s and methods This was a multicentre , 24-week , double-blind , r and omised , placebo-controlled , parallel-group study in patients with type 2 diabetes that was inadequately controlled ( HbA1c = 7.5–11 % ) by insulin . Patients received vildagliptin ( n = 144 ; 50 mg twice daily ) or placebo ( n = 152 ) while continuing insulin therapy . Results Baseline HbA1c averaged 8.4 ± 0.1 % in both groups . The adjusted mean change from baseline to endpoint ( AMΔ ) in HbA1c was −0.5 ± 0.1 % and −0.2 ± 0.1 % in patients receiving vildagliptin or placebo , respectively , with a significant between-treatment difference ( p = 0.01 ) . In patients aged ≥65 years , the AMΔ HbA1c was −0.7 ± 0.1 % in the vildagliptin group vs −0.1 ± 0.1 % in the placebo group ( p < 0.001 ) . The incidence of adverse events was similar in the vildagliptin ( 81.3 % ) and placebo ( 82.9 % ) groups . However , hypoglycaemic events were less common ( p < 0.001 ) and less severe ( p < 0.05 ) in patients receiving vildagliptin than in those receiving placebo . Conclusions /interpretationVildagliptin decreases HbA1c in patients whose type 2 diabetes is poorly controlled with high doses of insulin . Addition of vildagliptin to insulin therapy is also associated with reduced confirmed and severe hypoglycaemia . Clinical Trials.gov ID no. : NCT 00099931 Aims To investigate the efficacy and tolerability of empagliflozin added to basal insulin‐treated type 2 diabetes . Methods Patients inadequately controlled [ glycated haemoglobin ( HbA1c ) > 7 to ≤10 % ( > 53 to ≤86 mmol/mol ) ] on basal insulin ( glargine , detemir , NPH ) were r and omized to empagliflozin 10 mg ( n = 169 ) , empagliflozin 25 mg ( n = 155 ) or placebo ( n = 170 ) for 78 weeks . The baseline characteristics were balanced among the groups [ mean HbA1c 8.2 % ( 67 mmol/mol ) , BMI 32.2 kg/m2 ] . The basal insulin dose was to remain constant for 18 weeks , then could be adjusted at investigator 's discretion . The primary endpoint was change from baseline in HbA1c at week 18 . Key secondary endpoints were changes from baseline in HbA1c and insulin dose at week 78 . Results At week 18 , the adjusted mean ± st and ard error changes from baseline in HbA1c were 0.0 ± 0.1 % ( −0.1 ± 0.8 mmol/mol ) for placebo , compared with −0.6 ± 0.1 % ( −6.2 ± 0.8 mmol/mol ) and −0.7 ± 0.1 % ( −7.8 ± 0.8 mmol/mol ) for empagliflozin 10 and 25 mg , respectively ( both p < 0.001 ) . At week 78 , empagliflozin 10 and 25 mg significantly reduced HbA1c , insulin dose and weight vs placebo ( all p < 0.01 ) , and empagliflozin 10 mg significantly reduced systolic blood pressure vs placebo ( p = 0.004 ) . Similar percentages of patients had confirmed hypoglycaemia in all groups ( 35–36 % ) . Events consistent with urinary tract infection were reported in 9 , 15 and 12 % of patients on placebo , empagliflozin 10 and 25 mg , and events consistent with genital infection were reported in 2 , 8 and 5 % , respectively . Conclusions Empagliflozin for 78 weeks added to basal insulin improved glycaemic control and reduced weight with a similar risk of hypoglycaemia to placebo OBJECTIVE To evaluate the efficacy and tolerability of sitagliptin when added to insulin therapy alone or in combination with metformin in patients with type 2 diabetes . METHODS After a 2 week placebo run-in period , eligible patients inadequately controlled on long-acting , intermediate-acting or premixed insulin ( HbA1c > or = 7.5 % and < or = 11 % ) , were r and omised 1:1 to the addition of once-daily sitagliptin 100 mg or matching placebo over a 24-week study period . The study capped the proportion of r and omised patients on insulin plus metformin at 75 % . Further , the study capped the proportion of r and omised patients on premixed insulin at 25 % . The metformin dose and the insulin dose were to remain stable throughout the study . The primary endpoint was HbA1c change from baseline at week 24 . RESULTS Mean baseline characteristics were similar between the sitagliptin ( n = 322 ) and placebo ( n = 319 ) groups , including HbA1c ( 8.7 vs. 8.6 % ) , diabetes duration ( 13 vs. 12 years ) , body mass index ( 31.4 vs. 31.4 kg/m(2 ) ) , and total daily insulin dose ( 51 vs. 52 IU ) , respectively . At 24 weeks , the addition of sitagliptin significantly ( p < 0.001 ) reduced HbA1c by 0.6 % compared with placebo ( 0.0 % ) . A greater proportion of patients achieved an HbA1c level < 7 % while r and omised to sitagliptin as compared with placebo ( 13 vs. 5 % respectively ; p < 0.001 ) . Similar HbA1c reductions were observed in the patient strata defined by insulin type ( long-acting and intermediate-acting insulins or premixed insulins ) and by baseline metformin treatment . The addition of sitagliptin significantly ( p < 0.001 ) reduced fasting plasma glucose by 15.0 mg/dl ( 0.8 mmol/l ) and 2-h postmeal glucose by 36.1 mg/dl ( 2.0 mmol/l ) relative to placebo . A higher incidence of adverse experiences was reported with sitagliptin ( 52 % ) compared with placebo ( 43 % ) , due mainly to the increased incidence of hypoglycaemia ( sitagliptin , 16 % vs. placebo , 8 % ) . The number of hypoglycaemic events meeting the protocol -specified criteria for severity was low with sitagliptin ( n = 2 ) and placebo ( n = 1 ) . No significant change from baseline in body weight was observed in either group . CONCLUSION In this 24-week study , the addition of sitagliptin to ongoing , stable-dose insulin therapy with or without concomitant metformin improved glycaemic control and was generally well tolerated in patients with type 2 diabetes OBJECTIVE To evaluate the efficacy and long-term safety of linagliptin added to basal insulins in type 2 diabetes inadequately controlled on basal insulin with or without oral agents . RESEARCH DESIGN AND METHODS A total of 1,261 patients ( HbA1c ≥7.0 % [ 53 mmol/mol ] to ≤10.0 % [ 86 mmol/mol ] ) on basal insulin alone or combined with metformin and /or pioglitazone were r and omized ( 1:1 ) to double-blind treatment with linagliptin 5 mg once daily or placebo for ≥52 weeks . The basal insulin dose was kept unchanged for 24 weeks but could thereafter be titrated according to fasting plasma glucose levels at the investigators ’ discretion . The primary end point was the mean change in HbA1c from baseline to week 24 . The safety analysis incorporated data up to a maximum of 110 weeks . RESULTS At week 24 , HbA1c changed from a baseline of 8.3 % ( 67 mmol/mol ) by −0.6 % ( −6.6 mmol/mol ) and by 0.1 % ( 1.1 mmol/mol ) with linagliptin and placebo , respectively ( treatment difference −0.65 % [ 95 % CI −0.74 to −0.55 ] [ −7.1 mmol/mol ] ; P < 0.0001 ) . Despite the option to uptitrate basal insulin , it was adjusted only slightly upward ( week 52 , linagliptin 2.6 IU/day , placebo 4.2 IU/day ; P < 0.003 ) , result ing in no further HbA1c improvements . Frequencies of hypoglycemia ( week 24 , linagliptin 22.0 % , placebo 23.2 % ; treatment end , linagliptin 31.4 % , placebo 32.9 % ) and adverse events ( linagliptin 78.4 % , placebo 81.4 % ) were similar between groups . \n Output:\n " }, { "from": "agent", "value": "Without increasing hypoglycaemia , SGLT2 inhibitors showed better glycaemic control and greater weight reduction than DPP4 inhibitors in patients with T2DM inadequately controlled with insulin ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: BACKGROUND Convulsive status epilepticus is the most common neurological medical emergency and has high morbidity and mortality . Early treatment before admission to hospital is best with an effective medication that can be administered safely . We aim ed to find out whether there are differences in efficacy and adverse events between buccal administration of liquid midazolam and rectal administration of liquid diazepam in the acute treatment of seizures . METHODS At a residential school with on-site medical facilities 42 young people with severe epilepsy were enrolled . Continuous seizures of more than 5 min duration were r and omly treated with buccal midazolam or rectal diazepam . If the seizure did not stop within 10 min additional medication chosen by the attending physician was administered . We monitored oxygen saturation and blood pressure for 30 min after treatment . The main outcome measures were efficacy , time from arrival of the nurse to drug administration , time from drug administration to end of seizure , and incidence of adverse cardiorespiratory events . FINDINGS Buccal midazolam was used to treat 40 seizures in 14 students , and rectal diazepam 39 seizures in 14 students . Midazolam stopped 30 ( 75 % ) of 40 seizures and diazepam 23 ( 59 % ) of 39 ( p=0.16 ) . The median time from arrival of the nurse to administration of medication was 2 min . Time from administration to end of seizure did not differ significantly between the two treatments . No clinical ly important adverse cardiorespiratory events were identified in the two groups . Buccal midazolam was universally acceptable to the nursing and care staff . INTERPRETATION Buccal midazolam is at least as effective as rectal diazepam in the acute treatment of seizures . Administration via the mouth is more socially acceptable and convenient and may become the preferred treatment for long seizures that occur outside hospital OBJECTIVE The aim of this study was to evaluate the efficacy and safety of intramuscular midazolam in controlling convulsive status epilepticus in children , by comparing it with rectal diazepam . METHODS In this r and omized trial , 100 children ( 50 in each group ) with convulsive status epilepticus aged 1 month to 16 years were enrolled and r and omly assigned into two groups to receive either 0.3 mg/kg intramuscular midazolam or 0.5 mg/kg rectal diazepam . Main outcome measure was stopping of all motor activity after drug administration . Another measures were times between patient 's arrival to emergency department till drug administration , between drug administration to seizure cessation , and between patient 's arrival to seizure cessation . RESULTS Both medication were effective for seizure control and no significant difference was found between successful treatments after administering the medication ( P = 0.061 ) . In the midazolam group , in 96 % ( 48/50 ) of cases treatment was successful and in the diazepam group , in 94 % ( 47/50 ) of cases treatment was successful . Time from arrival to administering the medication was significantly shorter in midazolam group ( P = 0.017 ) . The majority of seizures in midazolam group were stopped in less than 66 s ( median ) compared to 130 s ( median ) for diazepam group , ( P < 0.001 ) . No serious adverse effects were seen in both groups . CONCLUSION IM midazolam is not superior but may be at least as effective as rectal diazepam for controlling of status epilepticus in children . Midazolam via IM route could be one of the choices in children with convulsive status seizures who have difficult IV access Lorazepam was compared with diazepam for the treatment of acute convulsions and status epilepticus in 102 children in a prospect i ve , open , ' odd and even date s ' trial . Convulsions were controlled in 76 per cent of patients treated with a single dose of lorazepam and 51 per cent of patients treated with a single dose of diazepam . Significantly fewer patients treated with lorazepam required additional anticonvulsants to terminate the seizure . Respiratory depression occurred in 3 per cent of lorazepam-treated patients and 15 per cent of diazepam-treated patients . No patient who received lorazepam required admission to the intensive care unit for either respiratory depression or persisting status epilepticus . Rectally administered lorazepam appeared to be particularly valuable ( 100 per cent efficacy ) when venous access was not possible INTRODUCTION The evidence based data to guide management in patients of benzodiazepine refractory status epilepticus ( SE ) is still lacking . We conducted a r and omized study to evaluate the comparative effect of intravenous ( IV ) phenytoin and intravenous valproate ( IV VA ) in patients of benzodiazepine refractory SE . BACKGROUND AND METHODS Hundred , age and sex matched , patients of benzodiazepine refractory SE were r and omly divided into Group A ( 50 patients ) , treated with IV VA and Group B ( 50 patients ) treated with IV phenytoin . Twelve patients , in whom SE was not controlled with a single drug , were switched over to the other group . Treatment was considered successful when all motor or EEG seizure activity ceased within 20 min after the beginning of the drug infusion and no return of seizure activity during the next 12h . Secondary study end points were adverse events to treatment , in-hospital complications and the neurological outcome at discharge . RESULTS In this study , IV VA was successful in 88 % and IV phenytoin in 84 % ( p>0.05 ) of patients of SE with a significantly better response in patients of SE < 2h ( p<0.05 ) . The total number of adverse events did not differ significantly between the two groups ( p>0.05 ) . There were no differences among the treatments with respect to recurrence after 12-h study period or the outcome at 7 days . CONCLUSION IV VA is as effective as IV phenytoin . It is easy to use , better tolerated and can be used as an alternative to IV phenytoin in patients of benzodiazepine refractory SE , especially in patients of cardio-respiratory disease . The better outcome in patients having shorter duration of SE ( < 2h ) suggests need of immediate treatment Summary Background Episodes of childhood convulsive status epilepticus ( CSE ) commonly start in the community . Treatment of CSE aims to minimise the length of seizures , treat the causes , and reduce adverse outcomes ; however , there is a paucity of data on the treatment of childhood CSE . We report the findings from a systematic , population -based study on the treatment of community-onset childhood CSE . Methods We collected data prospect ively on children in north London , UK , who had episodes of CSE ( ascertainment 62–84 % ) . The factors associated with seizure termination after first-line and second-line therapies , episodes of CSE lasting for longer than 60 min , and respiratory depression were analysed with logistic regression . Analysis was per protocol , and adjustment was made for repeat episodes in individuals . Results 182 children of median age 3·24 years ( range 0·16–15·98 years ) were included in the North London Convulsive Status Epilepticus in Childhood Surveillance Study ( NLSTEPSS ) between May , 2002 , and April , 2004 . 61 % ( 147 ) of 240 episodes were treated prehospital , of which 32 ( 22 % ) episodes were terminated . Analysis with multivariable models showed that treatment with intravenous lorazepam ( n=107 ) in the accident and emergency department was associated with a 3·7 times ( 95 % CI 1·7–7·9 ) greater likelihood of seizure termination than was treatment with rectal diazepam ( n=80 ) . Treatment with intravenous phenytoin ( n=32 ) as a second-line therapy was associated with a 9 times ( 95 % CI 3–27 ) greater likelihood of seizure termination than was treatment with rectal paraldehyde ( n=42 ) . No treatment prehospital ( odds ratio [ OR ] 2·4 , 95 % CI 1·2–4·5 ) and more than two doses of benzodiazepines ( OR 3·6 , 1·9–6·7 ) were associated with episodes that lasted for more than 60 min . Treatment with more than two doses of benzodiazepines was associated with respiratory depression ( OR 2·9 , 1·4–6·1 ) . Children with intermittent CSE arrived at the accident and emergency department later after seizure onset than children with continuous CSE did ( median 45 min [ range 11–514 min ] vs 30 min [ 5–90 min ] ; p<0·0001 , Mann-Whitney U test ) ; for each minute delay from onset of CSE to arrival at the accident and emergency department there was a 5 % cumulative increase in the risk of the episode lasting more than 60 min . Interpretation These data add to the debate on optimum emergency treatment of childhood CSE and suggest that the current guidelines could be up date d. Funding An anonymous donor to UCL Institute of Child Health ; the Wellcome Trust ; UK Department of Health National Institute for Health Research Biomedical Research Centres Funding Scheme ; Medical Research Council The objective of this study was to compare the efficacy of continuous midazolam and diazepam infusion for the control of refractory status epilepticus . An open-label , r and omized control study was undertaken at the Pediatric Emergency and Intensive Care Service of a multidisciplinary teaching and referral hospital . Subjects included 40 children , 2 to 12 years of age , with refractory status epilepticus ( motor seizures uncontrolled after two doses of diazepam , 0.3 mg/kg per dose , and phenytoin infusion , 20 mg/kg ) . Either continuous midazolam ( n = 21 ) or diazepam infusion ( n = 19 ) in incremental doses was administered . The primary outcome measure was the proportion of children in each group with successful control of refractory status epilepticus . The secondary outcome measure was the time to control seizure activity , recurrence of seizure after initial control , if any , the frequency of hypotension , and the need for ventilation . The two groups were similar in age ( mean ± SD = 4.9 ± 43.6 months ) and etiology . Twenty-three ( 57.5 % ) patients had acute central nervous system infection . Refractory status epilepticus was controlled in 18 ( 86 % ) and 17 ( 89 % ) patients in the midazolam and diazepam groups , respectively ( P = not significant ) . The median time to seizure control was 16 minutes in both groups , but in the midazolam group , seizures recurred in more children ( 57 % versus 16 % in diazepam group ; P < .05 ) . The maximum dose ( mean ± SD ) of midazolam and diazepam required was 5.3 ± 2.6 μg/kg/min and 0.04 ± 0.02 mg/kg/min , respectively . About half of the patients needed mechanical ventilation and 40 % had hypotension in both groups , but the mortality was higher in the midazolam group ( 38 % ) as compared to the diazepam group ( 10.5 % , P < . 1 > .05 ) . Continuous midazolam and diazepam infusions were equally effective for control of refractory status epilepticus . However , midazolam was associated with more seizure recurrence and higher mortality in refractory status epilepticus predominantly caused by central nervous system infections . ( J Child Neurol 2002;17:106 - 110 ) There is little evidence on which to judge the optimal treatment for convulsive status epilepticus ( CSE ) in children . This study compares the effect of intravenous ( iv ) lorazepam with iv diazepam as the first line of treatment of CSE . We studied all children with prolonged seizures arriving in the Accident and Emergency ( A&E ) Department in two separate periods . In the first 6-month period iv diazepam was used as st and ard treatment , in the second 1-year period iv lorazepam was used . We measured latency to stopping of seizure and any adverse events . A successful treatment was defined as one in which the seizure clinical ly ceased within 15 minutes after siting the iv cannula , requiring no further treatment . Intravenous diazepam ( 0.32 mg kg ( -1 ) ) was used in 17 of 26 patients , whilst iv lorazepam ( 0.13 mg kg ( -1 ) ) was used in 31 of 59 . There were no differences between the two groups regarding age , sex and seizure type . The seizure was successfully controlled 15 minutes after siting the iv cannula in 11 ( 65 % ) patients treated with diazepam ( median time of 3 minutes ) and in 20 ( 65 % ) patients treated with lorazepam ( median time of 5 minutes ) . These preliminary results suggest that iv lorazepam may be as effective as iv diazepam PURPOSE Intravenous lorazepam is considered the drug of first choice for control of acute convulsive seizures . However , re source or personnel constraints necessitate the study of alternative routes and medications . This study compared the efficacy and adverse effects of intranasal versus intravenous lorazepam in children aged 6 - 14 \n Output:\n " }, { "from": "agent", "value": "We have not identified any new high- quality evidence on the efficacy or safety of an anticonvulsant in stopping an acute tonic-clonic convulsion that would inform clinical practice .\nThere appears to be a very low risk of adverse events , specifically respiratory depression .\nIntravenous lorazepam and diazepam appear to be associated with similar rates of seizure cessation and respiratory depression .\nAlthough intravenous lorazepam and intravenous diazepam lead to more rapid seizure cessation , the time taken to obtain intravenous access may undermine this effect .\nIn the absence of intravenous access , buccal midazolam or rectal diazepam are therefore acceptable first-line anticonvulsants for the treatment of an acute tonic-clonic convulsion that has lasted at least five minutes .\nThere is no evidence provided by this review to support the use of intranasal midazolam or lorazepam as alternatives to buccal midazolam or rectal diazepam" } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: Background Many patients with cervical disc disease require leave from work , due to long-lasting , complex symptoms , including chronic pain and reduced levels of physical and psychological function . Surgery on a few segmental levels might be expected to resolve disc-specific pain and reduce neurological deficits , but not the non-specific neck pain and the frequent illness . No study has investigated whether post-surgery physiotherapy might improve the outcome of surgery . The main purpose of this study was to evaluate whether a well-structured rehabilitation programme might add benefit to the customary post-surgical treatment for cervical disc disease , with respect to function , disability , work capability , and cost effectiveness . Methods / Design This study was design ed as a prospect i ve , r and omised , controlled , multi-centre study . An independent , blinded investigator will compare two alternatives of rehabilitation . We will include 200 patients of working age , with cervical disc disease confirmed by clinical findings and symptoms of cervical nerve root compression . After providing informed consent , study participants will be r and omised to one of two alternative physiotherapy regimes ; ( A ) customary treatment ( information and advice on a specialist clinic ) ; or ( B ) customary treatment plus active physiotherapy . Physiotherapy will follow a st and ardised , structured programme of neck-specific exercises combined with a behavioural approach . All patients will be evaluated both clinical ly and subjectively ( with question naires ) before surgery and at 6 weeks , 3 months , 6 months , 12 months , and 24 months after surgery . The main outcome variable will be neck-specific disability . Cost-effectiveness will also be calculated . Discussion We anticipate that the results of this study will provide evidence to support physiotherapeutic rehabilitation applied after surgery for cervical radiculopathy due to cervical disc disease . Trial registration Clinical Trials.gov identifier : Study Design : Retrospective review of the prospect i ve American College of Surgeons National Surgical Quality Improvement Project ( ACS NSQIP ) data base with 30-day follow-up of 2164 patients undergoing elective anterior cervical discectomy and fusion ( ACDF ) . Objective : To determine factors independently associated with increased length of stay ( LOS ) and complications after ACDF to facilitate preoperative planning and setting of realistic expectations for patients and providers . Summary of Background Data : The effect of individual preoperative factors on LOS and complications has been evaluated in small-scale studies . Large data base analysis with multivariate analysis of these variables has not been reported . Methods : The ACS NSQIP data base from 2005 to 2010 was queried for patients undergoing ACDF procedures . Preoperative and perioperative variables were collected . Multivariate regression determined significant predictors ( P<0.05 ) of extended LOS and complications . Results : Average LOS was 2.0±4.0 days ( mean±SD ) with a range of 0–103 days . By multivariate analysis , age 65 years and above , functional status , transfer from facility , preoperative anemia , and diabetes were the preoperative factors predictive of extended LOS . Major complications , minor complications , and extended surgery time were the perioperative factors associated with increased LOS . The elongating effect of these variables was determined , and ranged from 0.5 to 5.0 days . Seventy-one patients ( 3.3 % ) had a total of 92 major complications , including return to operating room ( 40 ) , venous thrombotic events ( 13 ) , respiratory ( 21 ) , cardiac ( 6 ) , mortality ( 5 ) , sepsis ( 4 ) , and organ space infection ( 3 ) . Multivariate analysis determined ASA score ≥3 , preoperative anemia , age 65 years and above , extended surgery time , and male sex to be predictive of major complications ( odds ratios ranging between 1.756 and 2.609 ) . No association was found between levels fused and LOS or complications . Conclusion : Extended LOS after ACDF is associated with factors including age , anemia , and diabetes , as well as the development of postoperative complications . One in 33 patients develops a major complication postoperatively , which are associated with an increased LOS of 5 days Objectives The aims of this study are to answer the following questions ( 1 ) How does the pain intensity of lumbar and cervical disc surgery patients change within a postoperative time frame of 5 years ? ( 2 ) Which sociodemographic , medical , work-related , and psychological factors are associated with postoperative pain in lumbar and cervical disc surgery patients ? Methods The baseline survey ( T0 ; n = 534 ) was conducted 3.6 days ( SD 2.48 ) post-surgery in the form of face-to-face interviews . The follow-up interviews were conducted 3 months ( T1 ; n = 486 patients ) , 9 months ( T2 ; n = 457 ) , 15 months ( T3 ; n = 438 ) , and 5 years ( T4 ; n = 404 ) post-surgery . Pain intensity was measured on a numeric rating-scale ( NRS 0–100 ) . Estimated changes to and influences on postoperative pain by r and om effects were accounted by regression models . Results Average pain decreased continuously over time in patients with lumbar herniated disc ( Wald Chi² = 25.97 , p<0.001 ) . In patients with cervical herniated disc a reduction of pain was observed , albeit not significant ( Chi² = 7.02 , p = 0.135 ) . Two predictors were associated with postoperative pain in lumbar and cervical disc surgery patients : the subjective prognosis of gainful employment ( p<0.001 ) and depression ( p<0.001 ) . Conclusion In the majority of disc surgery patients , a long-term reduction of pain was observed . Cervical surgery patients seemed to benefit less from surgery than the lumbar surgery patients . A negative subjective prognosis of gainful employment and stronger depressive symptoms were associated with postoperative pain . The findings may promote multimodal rehabilitation concepts including psychological and work-related support Study Design . Population ‐based , cross‐sectional mailed survey . Objective . To determine the lifetime , period , and point prevalence of neck pain and its related disability among Saskatchewan adults and investigate the presence and strength of nonresponse bias . Summary of Background Data . In Europe , the life‐time and point prevalence of neck pain is almost as high as the prevalence of low back pain . Similarly , chronic neck pain is highly prevalent and a common source of disability in the working‐age population . However , no studies specifically have documented the prevalence of neck pain and its related disability in North America . Methods . The Saskatchewan Health and Back Pain Survey was mailed to 2184 r and omly selected Saskatchewan adults aged 20‐69 years . Fifty‐five percent of the study population participated . The presence of nonresponse bias was investigated through logistic regression and wave analysis . The Chronic Pain Question naire was used to classify the severity of chronic neck pain . Results . The age‐st and ardized lifetime prevalence of neck pain is 66.7 % ( 95 % confidence interval , 63.8‐69.5 ) , and the point prevalence is 22.2 % ( 95 % confidence interval , 19.7‐24.7 ) . The age‐st and ardized 6‐month prevalence of low‐intensity and low‐disability neck pain is 39.7 % ( 95 % confidence interval , 36.7‐42.7 ) , whereas it is 10.1 % ( 95 % confidence interval , 8.2‐11.9 ) for high‐intensity and low‐disability neck pain and 4.6 % ( 95 % confidence interval , 3.3‐5.8 ) for significantly disabling neck pain . The prevalence of low‐intensity and low‐disability neck pain decreases with age . More women experience high‐disability neck pain than men . Wave analysis suggests that the point prevalence and 6‐month prevalence of high‐intensity and low‐disability neck pain are overestimated in this survey . Conclusion . This cross‐sectional study shows that neck pain is highly prevalent in Saskatchewan and that it significantly disables 4.6 % ( 95 % confidence interval , 3.3‐5.8 ) of the adult population Study Design . Prospect i ve cohort study . Objective . To examine differences between preoperative and postoperative fear of movement and investigate the relationship between fear of movement and pain , disability and physical health after spinal surgery for degenerative conditions . Summary of Background Data . Consistent evidence supports the relationship between fear of movement and higher levels of pain and disability in various chronic pain population s. Fear of movement among patients undergoing spinal surgery for chronic pain has received little attention in the literature . Methods . Participants were 141 patients treated with surgery for lumbar and cervical degenerative conditions . Assessment s were conducted before surgery and 6 weeks and 3 months after hospitalization . Fear of movement was measured with the Tampa Scale for Kinesiophobia and outcomes were measured with the Brief Pain Inventory , Oswestry or Neck Disability Index , and 12-Item Short Form Health Survey ( SF-12 ) . Results . Follow-up rates were 91 % and 87 % for 6 weeks and 3 months , respectively . Fear of movement beliefs improved after surgery , but 49 % of patients continued to have high fear of movement at 6-week follow-up and 39 % at 3-month follow-up . Patients with higher levels of fear of movement had poorer postoperative outcomes . Multilevel linear regression analyses found that postoperative fear of movement was independently associated with postoperative pain intensity , pain interference , disability , and physical health ( P < 0.001 ) , after controlling for depression , age , sex , education , race , comorbidities , type and area of surgery , prior surgeries , and baseline outcome score . Preoperative fear of movement was not predictive of poorer surgical outcomes . Conclusion . Results demonstrate that postoperative but not preoperative fear of movement beliefs explain unique and significant variance in postoperative pain , disability , and physical health . Clinicians interested in improving surgical outcomes should address postoperative fear of movement along with other traditional clinical and medical risk factors . Recommendations include postoperative screening for high fear of movement beliefs and incorporating cognitive-behavioral techniques into postoperative rehabilitation for at-risk surgical spine patients BACKGROUND CONTEXT Spinal surgery in the workers compensation population shows evidence of less favorable outcomes than in general health cases . Although spine surgery has been alleged to be a cause of poor outcomes , such outcomes may be improved by appropriate postsurgical rehabilitation . PURPOSE To compare objective demographic , physical and psychological measurements and socioeconomic outcomes of treatment in work-related disabling cervical pain for the combination of anterior cervical fusion ( ACF ) plus functional restoration , compared with rehabilitation alone . STUDY DESIGN / SETTING A prospect i ve study of patients undergoing ACF for degenerative disc disease before rehabilitation for work-related musculoskeletal disorders versus neck pain unoperated controls , with data collected in an outpatient tertiary interdisciplinary rehabilitation setting . PATIENT SAMPLE A group of 52 patients completed a functional restoration treatment program after undergoing ACF ( Group S ) at one or two levels for degenerative cervical disc disease . During the study period , 625 patients with work-related neck pain were identified from the same study population , from which a rehabilitation ( Group R ) comparison group ( n=150 ) was identified who were stratified according to the number and location of other compensable body parts . OUTCOME MEASURES Socioeconomic outcomes relevant to chronic disabling work-related cervical spinal disorders are reported based on 1-year posttreatment interviews . Pre- to posttreatment assessment of pain intensity , disability , depression and cumulative physical capability were assessed prospect ively . METHODS All patients were totally or partially disabled before completing an intensive , medically supervised , functional restoration program combining quantitatively directed exercise progression with a multimodal disability management approach . Preprogram preparation included drug detoxification , psychotropic medication management and preparatory aerobic and mobility training . The intensive treatment phase involved strength and endurance training , with counseling geared to goals of work return and fitness maintenance . The 1-year structured clinical interview had a contact rate of 93 % to 95 % , and partial information acquisition on all patients . RESULTS Although Group S had lower work return and work retention outcomes , the differences were not significant . Group S patients had significantly more health utilization from a new provider in the year after completion of functional restoration ( 46 % vs 24 % ; OR=2.7 [ 1.3 , 5.3 ] , p<.004 ) . Group S patients were also more likely to be depressed , both at pre- and postrehabilitation . There were no significant differences in recurrent injury , additional surgery , physical measures or pain/disability self-report between the groups . CONCLUSIONS Workers compensation patients with chronic disabling work-related cervical spinal disorders who undergo a cervical fusion , combined with functional restoration , have socioeconomic outcomes after their surgery statistically similar to those for unoperated controls . Surgery patients had a higher rate of additional health-care-seeking behaviors from new providers and a greater likelihood of being clinical ly depressed before and after rehabilitation . This study suggests that cervical fusion for degenerative disc disease in workers compensation patients is not contraindicated , as long as interdisciplinary rehabilitation is available for complex cases after the surgical procedure Cervical total disk arthroplasty has proven to be an effective and safe alternative for anterior cervical diskectomy and fusion ( ACDF ) for the treatment of cervical disk degenerative disease . However , whether and when cervical \n Output:\n " }, { "from": "agent", "value": "There are low- to very-low- quality evidence that some interventions ( use of cervical collars after non-plated anterior cervical diskectomy an fusion , structured physiotherapy , and interactive patients ’ education ) provide some benefit within functioning , pain , and selected psychological variables in patients undergoing cervical disk surgery .\nConclusion : There is insufficient evidence with few trials of low quality to allow any conclusion to be drawn about the effectiveness , harms , and general ineffectiveness of rehabilitation for people who have had cervical disk surgery for pain or radiculopathy" } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: The efficacy and safety of microwave coagulation therapy ( MCT ) in patients with hepatocellular carcinoma ( HCC ) and impaired hepatic reserve were studied . Preoperative background factors , postoperative results , and prognostic factors were compared in 51 patients who underwent hepatic resection ( HR group ) and 38 patients who underwent microwave coagulation therapy ( MCT group ) . Before surgery , measures of hepatic function , including level of albumin ( P = 0.0072 ) , prothrombin time ( P<0.0001 ) , hepaplastin test ( P = 0.0088 ) , and the radioactivity of technetium-99 m galactosyl-human serum albumin 15 min in the liver after injection divided by that in both liver and heart ( P < 0.0001 ) were significantly lower in the MCT group than in the HR group . The indocyanine green dye retention rate at 15 min was significantly greater ( P<0.0001 ) in the MCT group than in the HR group , and a significant difference was noted in Child-Pugh grade between the groups ( P<0.0001 ) . Operative time ( P = 0.0014 ) and blood loss during surgery ( P = 0.0005 ) were significantly lower in the MCT group than in the HR group . In contrast , no significant differences were recognized between the groups in the changes in postoperative liver function , or in the rates of morbidity , mortality , local recurrence , and survival . Moreover , the type of treatment ( HR or MCT ) was not a prognostic factor . The results indicate that MCT can be used safely as an alternative to hepatic resection in patients with poor liver function without reducing the efficacy of local control The effect of percutaneous microwave ablation and laparoscopic resection on the prognosis of liver cancer was investigated . Ninety patients with liver cancer treated at our hospital from March 2010 to March 2012 were divided into group A and group B ( n=45 ) by using a r and om number table , and the surgical conditions and the prognosis were compared . The surgical conditions of patients in group A were significantly better than those in group B ( P<0.05 ) . The incidence of complications in group A was 6.67 % , which was obviously lower than that of group B ( P<0.05 ) . The local recurrence rate of group A was 20.00 % , and that of group B was 8.89 % , which showed a significant difference ( P<0.05 ) . The two groups did not differ significantly in terms of either total recurrence rate ( P>0.05 ) or 1-year , 2-year and 3-year survival ( P>0.05 ) . Both percutaneous microwave ablation and laparoscopic resection had a good long-term efficacy in liver cancer . However , percutaneous microwave ablation was superior as it caused less invasiveness , reduced the incidence of complications and improved prognosis of liver cancer Background Hepatic resection ( HRx ) or radiofrequency ablation may be carried out as the first-line treatment of hepatocellular carcinoma ( HCC ) . However , we have used intraoperative microwave ablation , named microwave coagulo-necrotic therapy ( MCN ) as part of our strategy for the treatment of HCCs for more than 15 years . Here we describe the treatment outcomes achieved at our institution as a high-volume center for microwave ablation . Methods Between July 1994 and December 2010 , 719 consecutive patients received MCN as their initial therapy for HCC ( mean tumor size 26.9 mm , mean number of lesions 2.51 ) at our institute . The therapeutic survival effect , local tumor progression , and overall recurrence were prospect ively evaluated and statistically analyzed . Results The 1- , 3- , 5- , 7- , and 10-year overall survival rates of all 719 patients were 97.7 , 79.8 , 62.1 , 45.3 , and 34.1 % , respectively . Thirty percent of the patients had Child – Pugh class B cirrhosis and the 5-year survival rate of these patients was 46.6 % . The 5-year survival of patients with ≥4 lesions ( n = 168 ) was 49.6 % and that of patients meeting the Milan criteria ( n = 470 ) was 70.9 % . The 1- , 3- , 5- , 7- , and 10-year overall survival rates for 390 patients treated with MCN who had ≤3 lesions with diameter ≤3 cm were 97.9 , 85.1 , 70.0 , 57.1 , and 43.0 % . No significant differences were found between the overall survival rates after MCN and the overall survival rates in 34 patients treated with HRx during the same period at our institute and under the same ( P = 0.3592 ) , nor were there any differences in disease-free survival ( P = 0.3496 ) and local recurrence rates between the MCN and HRx groups ( P = 0.5926 ) . Conclusion MCN is effective for the locoregional control of HCC , with results comparable to those of HRx . MCN should be considered as one of the first-choice treatments for HCC , even for patients with poor liver function or multiple lesions \n Output:\n " }, { "from": "agent", "value": "Conclusion In conclusion , our meta- analysis suggests that MWA may be superior to HRN as it is as effective as HRN in terms of overall survival , disease-free survival , tumor recurrence , and is associated with shorter operation time , less amount of blood loss , and fewer complications" } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: PURPOSE To investigate the utility of positron emission tomography ( PET ) in patients treated with stereotactic body radiotherapy ( SBRT ) for stage I non-small-cell lung cancer ( NSCLC ) on prospect i ve institutional trials . PATIENTS AND METHODS Fifty-eight patients with medically inoperable stage I NSCLC who participated in prospect i ve phase I and II trials of SBRT , had > or=2 years of follow-up , and received FDG-PET imaging are the focus of this evaluation . Fifty-seven of 58 patients received pre-SBRT FDG-PET to confirm stage I status . All patients received stereotactic body frame immobilization and treatment with 7 - 10 photon beams . SBRT total doses ranged from 24 to 72Gy in three fractions . No elective nodal irradiation was undertaken . Regular follow-up with planned CT imaging was performed on all patients . Post-SBRT FDG-PET was not m and ated by protocol and was typically ordered upon concern for disease recurrence . Thirty-eight post-SBRT PET studies were performed in 28 patients at a median 17.3 months following SBRT . RESULTS With a median follow-up of 42.5 months , the 3-year actuarial overall survival and local control for this select subset of our SBRT experience were 48.9 % and 74.8 % , respectively . Pre-SBRT FDG-PET SUV did not predict 3-year overall survival or local control . Fourteen of 57 patients eventually failed in nodal stations by CT and /or PET . Isolated first site of failure was nodal in 6 patients ( 10 % ) . Out of 28 patients with post-SBRT PET , 4 ( 14 % ) had delayed PET imaging ( 22 - 26 months after SBRT ) showing moderate hypermetabolic activity ( SUV 2.5 - 5.07 ) , but no evidence of local , nodal , or distant recurrence by clinical examination and conventional imaging performed 20 - 26 months following these concerning PET findings . CONCLUSIONS Isolated nodal recurrence following PET-staged I NSCLC treated with SBRT is uncommon . Moderate post-SBRT PET hypermetabolic activity may persist 2 years following treatment without definite evidence of recurrence . Further study is needed to confirm these results in larger population s with longer follow-up Objective To report serial 18F-fluorodeoxyglucose ( 18F-FDG ) positron emission tomography (PET)/computed tomography ( CT ) tumor response following CyberKnife radiosurgery for stage IA non-small cell lung cancer ( NSCLC ) . Methods Patients with biopsy-proven inoperable stage IA NSCLC were enrolled into this IRB-approved study . Targeting was based on 3 - 5 gold fiducial markers implanted in or near tumors . Gross tumor volumes ( GTVs ) were contoured using lung windows ; margins were exp and ed by 5 mm to establish the planning treatment volumes ( PTVs ) . Doses ranged from 42 - 60 Gy in 3 equal fractions . 18F-FDG PET/CT was performed prior to and at 3 - 6-month , 9 - 15 months and 18 - 24 months following treatment . The tumor maximum st and ardized uptake value ( SUVmax ) was recorded for each time point . Results Twenty patients with an average maximum tumor diameter of 2.2 cm were treated over a 3-year period . A mean dose of 51 Gy was delivered to the PTV in 3 to 11 days ( mean , 7 days ) . The 30-Gy isodose contour extended an average of 2 cm from the GTV . At a median follow-up of 43 months , the 2-year Kaplan-Meier overall survival estimate was 90 % and the local control estimate was 95 % . Mean tumor SUVmax before treatment was 6.2 ( range , 2.0 to 10.7 ) . During early follow-up the mean tumor SUVmax remained at 2.3 ( range , 1.0 to 5.7 ) , despite transient elevations in individual tumor SUVmax levels attributed to peritumoral radiation-induced pneumonitis visible on CT imaging . At 18 - 24 months the mean tumor SUVmax for controlled tumors was 2.0 , witha narrow range of values ( range , 1.5 to 2.8 ) . A single local failure was confirmed at 24 months in a patient with an elevated tumor SUVmax of 8.4 . Conclusion Local control and survival following CyberKnife radiosurgery for stage IA NSCLC is exceptional . Early transient increases in tumor SUVmax are likely related to radiation-induced pneumonitis . Tumor SUVmaxvalues return to background levels at 18 - 24 months , enhancing 18F-FDG PET/CT detection of local failure . The value of 18F-FDG PET/CT imaging for surveillance following lung SBRT deserves further study This study was performed to investigate the feasibility of FDG- and L-[methyl-11C]methionine (Met)-PET for the follow up of lung cancer after stereotactic radiotherapy ( SRT ) . Nine patients ( pt ) with solitary lung cancer underwent SRT . Met- and FDG-PET studies were performed one week before SRT and from one week to 8 months after SRT . Responses to SRT were complete in 2 pt and partial in 7 pt . Met- and FDG-PET scan showed high tracer uptake in all tumors before SRT . After SRT , st and ardized uptake values ( SUV ) of FDG and Met changed concordantly . Both decreased with time in 5 pt but did not decrease steadily in 4 pt , where 2 pt showed an increase at 1 to 2 weeks after SRT and 2 pt showed an increase at more than 3 months after SRT . The former appears to reflect the acute reaction to SRT and the latter radiation-induced pneumonitis . Although the addition of Met-PET did not provide additional information over FDG-PET , FDG- and Met-PET could be used to evaluate the treatment effect of SRT PURPOSE A Phase I dose escalation study of stereotactic body radiation therapy to assess toxicity and local control rates for patients with medically inoperable Stage I lung cancer . METHODS AND MATERIAL S All patients had non-small-cell lung carcinoma , Stage T1a or T1b N0 , M0 . Patients were immobilized in a stereotactic body frame and treated in escalating doses of radiotherapy beginning at 24 Gy total ( 3 x 8 Gy fractions ) using 7 - 10 beams . Cohorts were dose escalated by 6.0 Gy total with appropriate observation periods . RESULTS The maximum tolerated dose was not achieved in the T1 stratum ( maximum dose = 60 Gy ) , but within the T2 stratum , the maximum tolerated dose was realized at 72 Gy for tumors larger than 5 cm . Dose-limiting toxicity included predominantly bronchitis , pericardial effusion , hypoxia , and pneumonitis . Local failure occurred in 4/19 T1 and 6/28 T2 patients . Nine local failures occurred at doses < or = 16 Gy and only 1 at higher doses . Local failures occurred between 3 and 31 months from treatment . Within the T1 group , 5 patients had distant or regional recurrence as an isolated event , whereas 3 patients had both distant and regional recurrence . Within the T2 group , 2 patients had solitary regional recurrences , and the 4 patients who failed distantly also failed regionally . CONCLUSIONS Stereotactic body radiation therapy seems to be a safe , effective means of treating early-stage lung cancer in medically inoperable patients . Excellent local control was achieved at higher dose cohorts with apparent dose-limiting toxicities in patients with larger tumors PURPOSE Routine assessment was made of tumor metabolic activity as measured by 18F-fluorodeoxyglucose ( FDG ) positron emission tomography ( PET ) in Stage I non-small-cell lung cancer ( NSCLC ) . This report describes PET correlates prospect ively collected after stereotactic body radiotherapy ( SBRT ) for patients with medically inoperable NSCLC . METHODS AND MATERIAL S 14 consecutive patients with medically inoperable Stage I NSCLC were enrolled . All patients received SBRT to 60 - 66 Gy in three fractions . Patients underwent serial planned FDG-PET/computed tomography fusion imaging before SBRT and at 2 , 26 , and 52 weeks after SBRT . RESULTS With median follow-up of 30.2 months , no patients experienced local failure . One patient developed regional failure , 1 developed distant failure , and 1 developed a second primary . The median tumor maximum st and ardized uptake value ( SUV(max ) ) before SBRT was 8.70 . The median SUV(max ) values at 2 , 26 , and 52 weeks after SBRT were 6.04 , 2.80 , and 3.58 , respectively . Patients with low pre-SBRT SUV were more likely to experience initial 2-week rises in SUV , whereas patients with high pre-SBRT SUV commonly had SUV declines 2 weeks after treatment ( p = 0.036 ) . Six of 13 patients had primary tumor SUV(max ) > 3.5 at 12 months after SBRT but remained without evidence of local disease failure on further follow-up . CONCLUSIONS A substantial proportion of patients may have moderately elevated FDG-PET SUV(max ) at 12 months without evidence of local failure on further follow-up . Thus , slightly elevated PET SUV(max ) should not be considered a surrogate for local treatment failure . Our data do not support routine serial FDG-PET/computed tomography for follow-up of patients receiving SBRT for Stage I NSCLC PURPOSE To compare the quality -adjusted life expectancy and overall survival in patients with Stage I non-small-cell lung cancer ( NSCLC ) treated with either stereotactic body radiation therapy ( SBRT ) or surgery . METHODS AND MATERIAL S We constructed a Markov model to describe health states after either SBRT or lobectomy for Stage I NSCLC for a 5-year time frame . We report various treatment strategy survival outcomes stratified by age , sex , and pack-year history of smoking , and compared these with an external outcome prediction tool ( Adjuvant ! Online ) . RESULTS Overall survival , cancer-specific survival , and other causes of death as predicted by our model correlated closely with those predicted by the external prediction tool . Overall survival at 5 years as predicted by baseline analysis of our model is in favor of surgery , with a benefit ranging from 2.2 % to 3.0 % for all cohorts . Mean quality -adjusted life expectancy ranged from 3.28 to 3.78 years after surgery and from 3.35 to 3.87 years for SBRT . The utility threshold for preferring SBRT over surgery was 0.90 . Outcomes were sensitive to quality of life , the proportion of local and regional recurrences treated with st and ard vs. palliative treatments , and the surgery- and SBRT-related mortalities . CONCLUSIONS The role of SBRT in the medically operable patient is yet to be defined . Our model indicates that SBRT may offer comparable overall survival and quality -adjusted life expectancy as compared with surgical resection . Well-powered prospect i ve studies comparing surgery vs. SBRT in early-stage lung cancer are warranted to further investigate the relative survival , quality of life , and cost characteristics of both treatment paradigms This paper is an overview of the new response evaluation criteria in solid tumours : revised RECIST guideline ( version 1 . 1 ) , with a focus on up date d contents \n Output:\n " }, { "from": "agent", "value": "RESULTS Acute changes post-SABR predominantly appear as consolidation or ground glass opacities .\nLate changes often demonstrate a modified conventional pattern of fibrosis , evolving beyond 2years after treatment .\nSeveral CT features , including an enlarging opacity , correlate with recurrence .\nAlthough PET SUVmax may rise immediately post-SABR , an SUVmax⩾5 carries a high predictive value of recurrence .\nCT density changes are common post-SABR .\nThe available evidence suggests that recurrent disease should be suspected if high-risk CT changes are seen with SUVmax⩾5 on PET ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: BACKGROUND The Brief Motivational Intervention ( BMI ) is an effective treatment for alcohol misuse but has not been adequately tested for use in helplines for alcoholics . The main objective of this study was to evaluate the efficacy of a telephone-based BMI for Brazilians seeking help with alcohol use cessation . METHODS A r and omized , controlled trial was performed with Brazilian subjects . Participants were r and omly assigned to either the minimal intervention group ( i.e. , given reference material s ) or the BMI group . Alcohol abstinence was evaluated in a 6-month follow-up telephone counseling session . The analysis was based on the intention to treat ( ITT ) . RESULTS Of the 5,896 drug users who called the helpline , 700 ( 12 % ) used alcohol , 637 of whom enrolled in this study . At 6-month follow-up , 70 % of the BMI group had stopped consuming alcohol compared to 41 % in the control group ( odds ratio = 1.5 ; 95 % confidence interval = 1.2 - 1.9 ; p = 0.001 ) . CONCLUSIONS A helpline-based BMI helps alcohol users achieve abstinence Background In 2008 the World Health Organization ( WHO ) reported that South Africa had the highest tuberculosis ( TB ) incidence in the world . This high incidence rate is linked to a number of factors , including HIV co-infection and alcohol use disorders . The diagnosis and treatment package for TB and HIV co-infection is relatively well established in South Africa . However , because alcohol use disorders may present more insidiously , making it difficult to diagnose , those patients with active TB and misusing alcohol are not easily cured from TB . With this in mind , the primary purpose of this cluster r and omized controlled trial is to provide screening for alcohol misuse and to test the efficacy of brief interventions in reducing alcohol intake in those patients with active TB found to be misusing alcohol in primary health care clinics in three provinces in South Africa . Methods / Design Within each of the three selected health districts with the highest TB burden in South Africa , 14 primary health care clinics with the highest TB caseloads will be selected . Those agreeing to participate will be stratified according to TB treatment caseload and the type of facility ( clinic or community health centre ) . Within strata from 14 primary care facilities , 7 will be r and omly selected into intervention and 7 to control study clinics ( 42 clinics , 21 intervention clinics and 21 control clinics ) . At the clinic level systematic sampling will be used to recruit newly diagnosed TB patients . Those consenting will be screened for alcohol misuse using the AUDIT . Patients who screen positive for alcohol misuse over a 6-month period will be given either a brief intervention based on the Information-Motivation-Behavioural Skills ( IMB ) Model or an alcohol use health education leaflet . A total sample size of 520 is expected . Discussion The trial will evaluate the impact of alcohol screening and brief interventions for patients with active TB in primary care setting s in South Africa . The findings will impact public health and will enable the health ministry to formulate policy related to comprehensive treatment for TB and alcohol misuse , which will result in reduction in alcohol use and ultimately improve the TB cure rates . Trial registration numberPACTR : AIMS To assess the effectiveness of brief motivational intervention for alcohol and drug use in young adult primary care patients in a low-income population and country . METHODS A r and omized controlled trial in a public-sector clinic in Delft , a township in the Western Cape , South Africa recruited 403 patients who were r and omized to either single-session , nurse practitioner-delivered Brief Motivational Intervention plus referral list or usual care plus referral list , and followed up at 3 months . RESULTS Although rates of at-risk alcohol use and drug use did not differ by treatment arm at follow-up , patients assigned to the Brief Motivational Intervention had significantly reduced scores on ASSIST ( Alcohol , Smoking and Substance Involvement Screening Test ) for alcohol-the most prevalent substance . CONCLUSION Brief Motivational Intervention may be effective at reducing at-risk alcohol use in the short term among low-income young adult primary care patients ; additional research is needed to examine long-term outcomes Seven hundred and thirty one men admitted to medical wards were interviewed to identify problem drinkers who had not received previous treatment for alcoholism and who had some social support . One hundred and sixty one met the diagnostic criteria ; 156 agreed to a follow up interview and were allocated to one of two groups . One group received a session of counselling about their drinking habits from a nurse while the other received only routine medical care . Both groups reported a reduction in alcohol consumption when interviewed 12 months later , but the counselled group had a significantly better outcome than the control group . It is concluded that systematic screening for alcohol consumption and related problems should become a routine part of medical assessment and that advice on drinking habits is effective if given before irreversible physical or psychosocial problems have developed The aim of this study was to assess the effectiveness of Screening and Brief Intervention ( SBI ) for alcohol problems among university students in South Africa . The study design for this efficacy study is a r and omized controlled trial with 6- and 12-month follow-ups to examine the effects of a brief alcohol intervention to reduce alcohol use by hazardous and harmful drinkers in a university setting . The unit of r and omization is the individual university student identified as a hazardous or harmful drinker attending public recruitment venues in a university campus . University students were screened for alcohol problems , and those identified as hazardous or harmful drinkers were r and omized into an experimental or control group . The experimental group received one brief counseling session on alcohol risk reduction , while the control group received a health education leaflet . Results indicate that of the 722 screened for alcohol and who agreed to participate in the trial 152 ( 21.1 % ) tested positive for the Alcohol Use Disorder Identification Test ( AUDIT ) ( score 8 or more ) . Among the 147 ( 96.7 % ) university students who also attended the 12-month follow-up session , the intervention effect on the AUDIT score was −1.5 , which was statistically significant ( P = 0.009 ) . Further , the depression scores marginally significantly decreased over time across treatment groups , while other substance use ( tobacco and cannabis use ) , self-rated health status and Posttraumatic Stress Disorder ( PTSD ) scores did not change over time across treatment groups . The study provides evidence of effective brief intervention by assistant nurses with hazardous and harmful drinkers in a university setting in South Africa . The short duration of the brief intervention makes it a realistic c and i date for use in a university setting Background High prevalence rates of hazardous and harmful alcohol use have been found in a hospital outpatient setting in South Africa . Hospital setting s are a particularly valuable point of contact for the delivery of brief interventions because of the large access to patient population s each year . With this in mind , the primary purpose of this r and omized controlled trial is to provide screening for alcohol misuse and to test the effectiveness of brief interventions in reducing alcohol intake among hospital out patients in South Africa . Methods The study design for this effectiveness study is a r and omized controlled trial with 6- and 12-month follow-ups to examine the effects of a brief alcohol intervention to reduce alcohol use by hazardous or harmful drinkers in a hospital setting . Out patients were screened for alcohol problems , and those identified as hazardous or harmful drinkers were r and omized into an experimental or control group . The experimental group received one brief counselling session on alcohol risk reduction , while the control group received a health education leaflet . Results Of the 1419 screened for alcohol misuse who agreed to participate in the trial 392 ( 27.6 % ) screened positive for hazardous or harmful use on the Alcohol Use Disorder Identification Test ( AUDIT ) ( score 7/8 - 19 ) and 51 ( 3.6 % ) had an AUDIT score of 20 or more . Among the 282 ( 72 % ) hospital out patients who also attended the 12-month follow-up session , the time effects on the AUDIT scores were significant [ F ( 1,195 = 7.72 ) , P < 0.01 ] but the intervention effect on the AUDIT score was statistically not significant [ F ( 1,194 = 0.06 ) , P < 0.804 ] . Conclusion Given the lack of difference in outcome between control and intervention group , alcohol screening and the provision of an alcohol health education leaflet may in itself cause reduction in drinking . Trial registration At-risk alcohol use is increasing among women and it has been linked to important harm to their health . However , the effectiveness of brief intervention ( BI ) among women is unclear . Research on the most effective components of those interventions in the female population is necessary , especially in low and middle income countries . The aim of this study was to evaluate the impact of a BI , carried out among women in a household community setting , on their alcohol consumption . Participants were enrolled through a household survey , using a probabilistic sample of 905 adult women in the city of Juiz de Fora , Brazil . The 61 ( 6.7 % ) women who screened positive for at-risk drinking ( AUDIT score ≥ 8) were r and omly allocated to one of two groups : the Intervention Group ( n=32 ) , which received one single session of BI carried out in the household setting after screening , or the Control Group ( n=29 ) which did not receive BI . After three months , 46 ( 75.4 % ) participants completed the follow-up interview ( 23 in each group ) . All participants received an informative leaflet , and the Intervention Group received a 15 - 40 minute BI , which provided information on the adverse consequences of alcohol and strategies to help moderate consumption . Participants of both groups decreased their alcohol consumption after three months . The intervention group decreased the mean AUDIT score from 12.4 to 9.4 , while the control group reduced from 10.6 to 7.5 . Preliminary analyzes using general linear modelling indicate that there was no difference between the Intervention Group and the Control Group in relation to the main outcome ( total AUDIT score ) . Although no difference was found between groups , the results of this study are not conclusive and may reflect the small sample size of the trial . More studies are needed to better estimate the effectiveness of BI among women in a household setting Background The leading mental health causes of the global burden of disease are depression in women and alcohol use disorders in men . A major hurdle to the implementation of evidence -based psychological treatments in primary care in developing countries is the non-availability of skilled human re sources . The aim of these trials is to evaluate the effectiveness and cost-effectiveness of two psychological treatments developed for the treatment of depression and alcohol use disorders in primary care in India . Methods / design This study protocol is for parallel group , r and omized controlled trials ( Healthy Activity Program for moderate to severe depression , Counselling for Alcohol Problems for harmful and dependent drinking ) in eight primary health centres in Goa , India . Adult primary care attendees will be screened with the Patient Health Question naire for depression and , in men only , the Alcohol Use Disorders Identification Test for drinking problems . Screen-positive attendees will be invited to participate ; men who screen positive for both disorders will be invited to participate in the Counselling for Alcohol Problems trial . Those who consent will be allocated in a 1:1 ratio to receive either the respective psychological treatment plus enhanced usual care or enhanced usual care only using a computer generated allocation sequence , stratified by primary health centre and , for depression , by sex . The enhanced usual care comprises providing primary health centre doctors with context ualized World Health Organization guidelines and screening results . Psychological treatments will be delivered by lay counsellors , over a maximum period of three months . Primary outcomes are severity of disorder and remission rates at three months post-enrolment and , for the Counselling for Alcohol Problems trial , drinking and the impact of drinking on daily lives . Secondary outcomes include severity of disorder and remission rates at 12 months , disability scores , suicidal behaviour and economic impact , and cost-effectiveness at three and 12 months . 500 participants with depression and 400 participants with harmful drinking will be recruited . Primary analyses will be intention-to-treat . Discussion These trials may offer a new approach for the treatment of moderate-severe depression and drinking problems in primary care that is potentially scalable as it relies on delivery by a single pool of lay counsellors . Trial registration Both trials are registered with the International Society for the Registration of Clinical Trials ( Healthy Activity Programme registration number IS RCT N95149997 ; Counselling for Alcohol Problems registration number IS RCT N76465238 ) Background The aim of this study was to conduct a cluster r and omized control trial to assess the efficacy of screening and brief intervention ( SBI ) for conjoint alcohol and tobacco use among hospital out- patients . Method In all 620 hospital out- patients who screened positive for both tobacco and alcohol moderate risk in four hospitals were r and omized into 2 control and 1 intervention condition using the hospital as a unit of r and omization ( 2 intervention and 2 control hospitals ) to 405 patients in the two control groups ( tobacco only intervention , n = 199 , and alcohol only intervention , n = 206 ) and 215 in the intervention group . The intervention or control consisted of three counselling sessions . Results Results of the interaction ( Group × Time ) effects using GEE indicated that there were statistically significant differences between the three study groups over the 6-month follow-up on the ASSIST tobacco score ( Wald χ2 = 8.43 , P = 0.004 ) , and past week tobacco \n Output:\n " }, { "from": "agent", "value": "Conclusion This systematic review of RCTs on alcohol brief intervention conducted in middle-income countries suggests that brief intervention can help reduce self-reported hazardous or harmful alcohol use in primary -care population" } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: Several studies evaluating the clinical effectiveness of endocrine therapy alone in breast cancer patients aged 70 years or older reported comparable survival rates to conventional surgical therapy , although the incidence of local recurrences was higher . Primary endocrine therapy is therefore only recommended as an alternative approach in elderly woman with estrogen receptor positive tumors who are deemed inoperable or who refuse surgery . We report our experience with aromatase inhibitors as primary endocrine therapy for estrogen receptor positive breast cancer in postmenopausal woman who are impaired by other diseases , refuse surgery or are of old age . Fifty-six patients with fifty-seven ER+ operable breast cancers who refused surgery , were judged ineligible for surgery because of comorbidity , or were of old age were treated with endocrine therapy using aromatase inhibitors only . Digital mammography and high-end breast ultrasound were used to assess tumor sizes . The mean age of the patients was 74 years ( range 52 - 102 years ) . All patients suffered from breast cancer . The mean follow-up interval was 40 months ( range 5 - 92 months ) . Seven patients ( 12 % ) achieved complete clinical remission , 31 ( 57 % ) partial response giving an overall objective response rate of 69 % . In addition , seven ( 12 % ) patients showed stable disease , giving a clinical benefit rate ( complete remission + partial response + stable disease rate ) of 81 % . Eleven patients ( 19 % ) progressed after an initial partial response or stable disease . Only one patient ( 2 % ) progressed on endocrine therapy within the first months . Eventually , 22 ( 39 % ) patients underwent surgery after informed consent to achieve better local tumor control . Primary endocrine therapy with aromatase inhibitors may offer an effective and safe alternative to surgery giving a high local control rate in postmenopausal women who refuse surgery , who are judged ineligible for surgery , or are of old age Invasive lobular cancer ( ILC ) responds poorly to neoadjuvant chemotherapy but appears to respond well to endocrine therapy . We examined the effectiveness of neoadjuvant letrozole in postmenopausal women ( PMW ) with estrogen receptor (ER)-rich ILC . PMW were considered for treatment with neoadjuvant letrozole if they had ER-rich , large operable , or locally advanced cancers , or were unfit for surgical therapy . Tumor volume was estimated at diagnosis and at 3 months using calipers ( clinical ) , ultrasound , and mammography . At 3 months , if physically fit , women were assessed for surgery . Responsive women with cancers too large for breast-conserving surgery continued with letrozole . Patients had surgery or were switched to alternative therapy if tumor volume was increasing . Sixty-one patients ( mean age , 76.2 years ) with 63 ILCs were treated with letrozole for ≥3 months . The mean reduction in tumor volume at 3 months was 66 % ( median , 76 % ) measured clinical ly , 61 % ( median , 73 % ) measured by ultrasound , and 54 % ( median , 60 % ) measured by mammography . Surgery was possible at 3 months in 24 cancers in 24 patients , and all but two of the remaining patients continued with letrozole therapy for a median duration of 9 months . At the time of this publication , 40 patients with a total of 41 cancers have undergone surgery . The rate of successful breast conservation was 81 % ( 25/31 ) . Twenty-one patients have continued with letrozole monotherapy , and 19 remain controlled on letrozole at a median of 2.8 years . There is a high rate of response to letrozole in PMW with ER-rich ILC Eighty-eight patients presenting with operable breast cancer of 4 cm or greater in diameter ( T2 , T3 , N0 , N1 , M0 ) have received primary systemic therapy . Response was assessed following 12 weeks of systemic therapy by linear regression analysis of changes in tumour volume . Definitive locoregional surgery ( mastectomy n = 82 , wide local excision n = 6 ) was performed on completion of systemic therapy ( 3 - 6 months ) . Response was observed in 24 ( 39 % ) of the 61 patients who received endocrine therapy ; all 24 had tumours with an oestrogen receptor ( ER ) concentration of greater than or equal to 20 fmol mb-1 cytosol protein . Cytotoxic therapy was reserved for patients with tumours of ER concentration less than 20 fmol mg-1 cytosol protein ( n = 27 ) or when endocrine therapy had failed ( n = 20 ) . Response was observed in 34 patients ( 72 % ) . The overall survival rate at 3 years was 86 % , with 81 % remaining free from local relapse . We propose that the treatment policy outlined in this paper should now be tested against orthodox management by controlled r and omised trial Background In recent years , preoperative volume reduction of locally advanced breast cancers , result ing in higher rates of breast-conserving surgery ( BCS ) , has become increasingly important also in postmenopausal women . Clinical interest has come to center on the third-generation nonsteroidal aromatase inhibitors ( AIs ) , including letrozole , for such neoadjuvant endocrine treatment . This usually lasts 3–4 months and has been extended to up to 12 months , but optimal treatment duration has not been fully established . Methods This study was design ed as a multicenter , open-label , single-arm , exploratory phase IIb/III clinical trial of letrozole 2.5 mg , one tablet daily , for 4–8 months . The primary objective was to investigate the effect of neoadjuvant treatment duration on tumor regression and BCS eligibility to identify optimal treatment duration . Tumor regression ( by clinical examination , mammography , and ultrasound ) , shift towards BCS eligibility , and safety assessment s were the main outcome measures . St and ard parametric and nonparametric descriptive statistics were performed . Results Letrozole treatment was received by 32 of the enrolled 33 postmenopausal women ( median ( range ) : 67.0 ( 56–85 ) years ) with unilateral , initially BCS-ineligible primary breast cancer ( clinical stage ≥ T2 , N0 , M0 ) . Letrozole treatment duration in the modified intent-to-treat ( ITT ; required 4 months ' letrozole treatment ) analysis population ( 29 patients ) was 4 months in 14 patients and > 4 months in 15 patients . The respective per- protocol ( PP ) subgroup sizes were 14 and 11 . The majority of partial or complete responses were observed at 4 months , though some beneficial responses occurred during prolonged letrozole treatment . Compared with baseline , median tumor size in the ITT population was reduced by 62.5 % at Month 4 and by 70.0 % at final study visit ( Individual End ) . Similarly , in the PP population , respective reductions were 64.0 % and 67.0 % . Whereas initially all patients were mastectomy c and i date s , letrozole treatment enabled BCS ( lumpectomy ) in 22 ITT ( 75.9 % ) and 18 PP ( 72.0 % ) patients . Conclusion Over half of patients become BCS-eligible within 4 months of preoperative letrozole treatment . While prolonged treatment for up to 8 months can result in further tumor volume reduction in some patients , there is no clear optimum for treatment duration . Letrozole has a favorable overall safety and tolerability profile . Trial registration Clinical Trials.gov identifier NCT00535418 BACKGROUND Neoadjuvant aromatase inhibitor therapy has been reported to improve surgical outcomes for postmenopausal women with clinical stage II or III hormone receptor-positive breast cancer . A multicenter phase II clinical trial was conducted to investigate the value of this approach for US surgical practice . STUDY DESIGN One hundred fifteen postmenopausal women with > 2 cm , estrogen receptor ( ER ) or progesterone receptor (PgR)-positive breast cancer were enrolled in a trial of 16 to 24 weeks of letrozole 2.5 mg daily before operation . RESULTS One hundred six patients were eligible for primary analysis , 96 underwent operations , 7 received chemotherapy after progressive disease , and 3 did not undergo an operation . Baseline surgical status was marginal for breast-conserving surgery ( BCS ) in 48 ( 45 % ) , 47 were definitely ineligible for BCS ( 44 % ) , and 11 were inoperable by st and ard mastectomy ( 10 % ) . Overall Response Evaluation Criteria In Solid Tumors clinical response rate in the breast was 62 % , with 12 % experiencing progressive disease . Fifty percent underwent BCS , including 30 of 46 ( 65 % ) patients who were initially marginal for BCS and 15 of 39 ( 38 % ) patients who were initially ineligible for BCS . All 11 inoperable patients successfully underwent operations , including 3 ( 27 % ) who had BCS . Nineteen percent of patients undergoing mastectomy had a pathologic T1 tumor , suggesting that some highly responsive tumors were overtreated surgically . CONCLUSIONS Neoadjuvant aromatase inhibitor improves operability and facilitates BCS , but there was considerable variability in responsiveness . Better techniques to predict response , determine residual tumor burden before operation , and greater willingness to attempt BCS in responsive patients could additionally improve the rate of successful BCS It has been proposed that knowledge of estrogen receptor beta ( ER-beta ) expression may refine estrogen receptor alpha ( ER-alpha ) predictivity of response to endocrine therapy . We challenged this hypothesis in ER-alpha-positive breast cancers subjected to preoperative antiestrogen treatment . Forty-seven elderly ( > or = 65 years old ) women with nonmetastatic , ER-alpha-positive ( by immunohistochemistry ) primary breast cancers ( > 2 cm in diameter ) entered a neoadjuvant hormone therapy protocol ( 60 mg/day toremifene for 3 months ) . ER-alpha and ER-beta ( ERs ) mRNA was determined by semiquantitative RT-PCR , before ( on core needle biopsy ) and after ( on surgical specimens ) neoadjuvant treatment . Study end points included : ( 1 ) relation between treatment response and ER mRNA expression ; and ( 2 ) changes in ER expression after treatment . The response was clinical ly assessed as tumor size change at the end of the preoperative treatment . ER mRNA expression was assessable before and after treatment in 38 and 20 cases respectively . ER-beta was co-expressed with ER-alpha at variable levels and significantly correlated only with progesterone receptor ( P = 0.0285 ) . Objective clinical response , including patients with minor change ( > or = 25-<50 % tumor shrinkage after treatment ) , was documented in 68.4 % of cases and was independent of ER-beta levels or changes . ER-alpha levels were higher in tumors from patients in complete remission than in those from women achieving partial response or minor change compared with non-responsive patients ( median expression values : 801 versus 516 versus 320 arbitrary units ) and were consistently down-regulated by preoperative treatment . We conclude that in this elderly patient population with ER-alpha-positive tumors , ER-beta mRNA was neither predictive of response to preoperative toremifene nor provided additional information to the knowledge of ER-alpha mRNA levels , which , conversely , were directly correlated with likelihood of response OBJECTIVES To evaluate the efficacy and safety of combing aromatase inhibitor ( AI ) and cyclooxygenase-2 ( COX-2 ) inhibitor neoadjuvantly in postmenopausal patients with invasive hormone-sensitive breast cancer . METHODS Eighty-two patients were r and omly assigned to receive exemestane 25 mg daily and celecoxib 400 mg twice daily ( group A , n=30 ) , exemestane 25 mg daily ( group B , n=24 ) and letrozole 2.5 mg daily ( group C , n=28 ) . RESULTS All groups showed clinical responses ( 58.6 % for group A , 54.5 % for group B and 62.0 % for group C ) and decrease in tumor area ( 61.8 % for group A , 58.1 % for group B and 55.7 % for group C ) . 3 out of 5 patients with complete clinical response were observed from group A and 2 out of 69 patients operated with pathologic complete response were observed in group C. The mean microscopic tumor size was 2.53 cm for group A , 3.05 cm for group B and 2.10 cm for group C. The differences were only statistically significant when group C was compared with group B ( P=0.025 ) . The toxicity profiles among groups were satisfactory . CONCLUSION AI is effective in treating breast cancer and may be safely used preoperatively . The addition of COX-2 inhibitor may provide additional benefit In 1973 , the European Institute of Oncology performed the first prospect i ve neoadjuvant chemotherapy study in locally advanced , inoperable breast cancer . The original purpose was to downstage the primary tumor in order to achieve surgical resection . This approach has subsequently increased in popularity , and in the last 10 years , r and omized controlled trials of neoadjuvant chemotherapy have been performed with a view to further downstage the primary tumor and lymph nodes in order to achieve greater rates of breast-conserving surgery and to test whether systemic therapy given earlier would confer a survival benefit . Although the net result of these trials did demonstrate \n Output:\n " }, { "from": "agent", "value": "In studies comparing tamoxifen with aromatase inhibitors , the latter were superior in terms of tumor response and rates of breast-conserving surgery ( BCS ) ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: Context Economic barriers may contribute to the underutilization of angiotensin-converting enzyme ( ACE ) inhibitors in patients with diabetes . Contribution This analysis shows that the Medicare program could improve clinical outcomes and save money by providing full coverage of ACE inhibitors with no out-of-pocket expense for patients with diabetes . Clinical and economic benefits would exist even if full coverage only result ed in a modest increase ( 7.2 % ) in ACE inhibitor use . Implication s Insurers should consider a policy of covering the entire cost of drugs that improve outcomes and lengthen life . The Editors The prevalence of diabetes and its complications is increasing substantially in the United States ( 1 - 4 ) . As the population ages and the number of elderly Medicare beneficiaries increases relative to the rest of the population , so will the number of elderly persons with diabetes and the share of national health expenditures allocated to complications of diabetes . Angiotensin-converting enzyme ( ACE ) inhibitors slow the progression of renal disease ( 5 - 12 ) and reduce cardiac morbidity and mortality ( 13 - 15 ) in individuals with diabetes . Despite ample clinical ( 5 - 15 ) and economic ( 16 - 18 ) evidence of benefit , ACE inhibitors are underused in elderly individuals with diabetes ( 19 - 23 ) . A growing body of evidence suggests that drug copayments reduce the use of essential medications in the elderly ( 24 - 30 ) . Specifically , elderly individuals with diabetes seem to curtail essential drug use as their drug coverage decreases ( 26 , 31 ) . In 1999 , Medicare beneficiaries paid more than 40 % of their drug costs out of pocket ( 32 ) . Under the new Medicare drug benefit , out-of-pocket spending will continue to be substantial ( 33 ) , causing an ongoing potential barrier to the use of known effective drugs . A policy that bases patients ' out-of-pocket copayments on clinical benefit rather than cost of drugs has been proposed to improve value in health care ( 34 ) . We aim ed to assess the cost-effectiveness to Medicare of first-dollar coverage ( that is , no cost sharing ) of ACE inhibitors for elderly beneficiaries with diabetes . Methods Decision Analytic Model We developed a Markov model simulating the natural history of renal and cardiovascular complications in diabetes and risk reduction due to ACE inhibition ( Figure 1 ) . Model outcomes included progression of renal disease , cardiovascular events , life expectancy , quality -adjusted life expectancy , lifetime costs , and incremental cost-effectiveness ratios . Our model builds on previous models of ACE inhibition for diabetic nephropathy ( 16 ) . However , the primary complication of type 2 diabetes is cardiovascular disease , accounting for more than 60 % of deaths ; thus , we extend these models by adding a cardiovascular events component based on recent data from the Heart Outcomes Prevention Evaluation ( HOPE ) trial . The HOPE trial demonstrated that ACE inhibitors improve both renal and cardiovascular outcomes , compared with placebo , in patients with diabetes ( 13 , 14 , 35 ) . Figure 1 . Markov model of disease progression . CVD A cohort of individuals 65 years of age with diabetes enters the model and transitions through renal disease states and cardiovascular event states with rate of disease progression modified by the use of ACE inhibitors . The time horizon of the analysis is divided into 1-year cycles and the cohort is followed over its lifetime . Initial Population Distribution The cohort was initially distributed across disease states ( Table 1 ) on the basis of epidemiologic data obtained from the 19992000 National Health and Nutrition Examination Survey ( NHANES ) ( 36 ) , a nationally representative cross-sectional survey of the U.S. noninstitutionalized civilian population . Among individuals 65 years of age or older with self-reported diabetes , 28.2 % had microalbuminuria , 18.3 % had macroalbuminuria , 20.3 % had previous myocardial infa rct ion , and 14.5 % had previous stroke . Table 1 . Model Inputs : Disease Prevalence and Progression Likelihood of Events Renal Disease We obtained baseline risk for developing and progressing through the stages of nephropathy ( normoalbuminuria , microalbuminuria , macroalbuminuria , and end-stage renal disease [ ESRD ] ) from the placebo groups of trials in patients with type 2 diabetes ( 5 , 7 , 37 ) . We obtained risk reductions from ACE inhibitor treatment from clinical trials ( 5 - 7 ) ( Table 1 ) . While ACE inhibition may cause regression of diabetic nephropathy ( 8 , 11 , 46 , 47 ) , we assumed no regression to ensure conservative cost-effectiveness estimates . Cardiovascular Disease We obtained baseline cardiovascular risk and risk reduction with ACE inhibitors from the placebo and treatment groups , respectively , of the subset of individuals with diabetes who were enrolled in the HOPE trial ( 14 ) ( Table 1 ) . We obtained these rates after calibrating the model to match the composite end point reported by the HOPE trial . Individuals can die of myocardial infa rct ion or stroke or another cardiovascular cause , or they can survive and are then still subject to progression of renal disease and the possibility of subsequent cardiac events . Once an individual has a myocardial infa rct ion or stroke , the risk for subsequent cardiovascular events increases according to event recurrence rates in patients with diabetes ( 38 , 39 ) . Cardiovascular event rates also increase with increasing renal dysfunction , with increased risk obtained from a prospect i ve longitudinal study of patients with type 2 diabetes ( 40 ) . Noncardiovascular Mortality We based the age-dependent probability of death from causes other than cardiovascular disease or ESRD on year 2000 U.S. life table data ( 41 , 42 ) multiplied by a st and ardized mortality ratio for diabetes in the elderly ( 2 ) . We then applied a proportional hazards ( that is , multiplicative ) model to remove cardiovascular disease and ESRD mortality ( 42 ) from age-based diabetes hazards , because these are modeled separately in our model . We obtained age-dependent ESRD mortality rates from the U.S. Renal Data System ( 43 ) . Utilities Health state utilities , or measures of value for given health states , can be thought of as quality -of-life weights that are bounded by 1 for perfect health and 0 for death . When utilities are multiplied by the lengths of time individuals spend in their respective health states , the result ant metric is a quality -adjusted life expectancy ( measured in quality -adjusted life-years [ QALYs ] ) , which reflects both the quantity and quality of remaining years of life ( 48 ) . We obtained utilities for our study ( Table 2 ) from published studies ( 49 - 53 ) . Table 2 . Model Inputs : Utilities , Costs , and Discount Rate Costs Because we assessed a Medicare coverage decision , the base-case model took the Medicare perspective , including direct medical costs and future ( related and unrelated ) health care costs , because all are borne by Medicare . We performed additional analyses from the societal perspective to allow for comparison with other cost-effectiveness analyses . Because of the well-known difficulties in measuring price changes in the medical sector ( 57 , 58 ) , we st and ardized costs to 2003 U.S. dollars by using the Consumer Price Index for all urban consumers ( 59 ) . We based all costs , except medication costs , on Medicare cl aims data ( Table 2 ) . Event Costs We obtained Medicare expenditures occurring in the year of an event from the 2001 Medicare St and ard Analytic Files , a nationally representative 5 % r and om sample of fee-for-service Medicare beneficiaries , and limited them to beneficiaries 65 years or older with diabetes . We obtained annual expenditures associated with ischemic strokes , myocardial infa rct ions , and deaths ( both cardiovascular and noncardiovascular ) from these data . We assigned costs for the year of death on the basis of the costs incurred in the last year of life by beneficiaries who had a myocardial infa rct ion , a stroke , both events , or neither event in the year of their death . We obtained annual costs associated with treating patients with ESRD ( including costs of dialysis ; transplantation ; and other health care , including cardiovascular event care ) from the U.S. Renal Data System . The annual costs comprise Medicare payments for individuals with ESRD due to diabetes ( 54 ) . Ongoing Care Costs We obtained ongoing costs of care ( including medical costs of future years of life added ) for years in which no discrete event occurred from a diagnostic classification system . This system was developed for the Centers for Medicare & Medicaid Services ( CMS ) to make risk-adjusted payments to Medicare managed care plans on the basis of patient demographic characteristics and clinical risk factors ( 55 ) . Many expenditures depend on beneficiary demographic characteristics ( age , sex , and percentage of Medicaid enrollment ) , but incremental costs accrue for disease history ( that is , history of stroke , myocardial infa rct ion , and diabetes-related renal failure ) ( Table 2 ) . We based the annual cost of therapy ( $ 233 ) on the average wholesale price of lisinopril , a once-daily , off-patent ACE inhibitor ( 56 ) . Interventions The intervention of interest was Medicare first-dollar coverage of ACE inhibitors ( that is , Medicare bears the full drug costs with no beneficiary cost sharing ) . The comparator was current practice ( before the planned 2006 implementation of the new Medicare drug benefit ) ( 60 ) . For current practice , we assign a base rate of ACE inhibitor use from which Medicare accrues the benefits and cost offsets ( that is , avoided costly health outcomes ) , but we assume that Medicare bears none of the costs for drugs in this comparator group . With first-dollar coverage , we very conservatively assume that 100 % of the current practice drug costs get shifted to Medicare ( that is , all third-party payers currently paying for ACE inhibitors will drop this coverage , effectively shifting all ACE inhibitor costs to Medicare ) . ACE Inhibitor Use The rates of ACE inhibitor utilization with current AIMS The aim of the present analysis was to estimate the cost-effectiveness of intense insulin treatment after acute myocardial infa rct ion in patients with diabetes mellitus based on the results of the Diabetes Mellitus Insulin Glucose Infusion in Acute Myocardial Infa rct ion ( DIGAMI ) study . In this study 620 patients with diabetes mellitus and acute myocardial infa rct ion were r and omized to intense insulin treatment ( insulin group ) or to serve as controls given st and ard antidiabetic therapy . Mortality was significantly reduced in the insulin group . METHODS AND RESULTS The cost-effectiveness ratio was estimated as the incremental cost per life-year and quality -adjusted life-year gained of intense insulin treatment . The incremental costs were estimated as the difference in health care costs and indirect costs ( labour production ) during the first year of follow-up plus the future costs of increased survival . The life-years gained were based on the 5-year long-term follow-up experience and an assumed annual 20 % mortality risk for all patients thereafter . The health care costs were Euro 975 higher in the insulin group during the first year of follow-up , mainly due to a longer period of initial hospitalization related to the institution of multidose insulin . The estimated discounted gain in life-years of the insulin treatment was 0.94 years without and 0.66 with quality of life adjustment , respectively . The cost per life-year gained by intense insulin treatment was Euro 16 900 and the cost per quality -adjusted life-year gained was Euro 24 100 . Thus the estimated cost-effectiveness ratios were relatively low . CONCLUSION The results of the DIGAMI study indicate that intense insulin treatment after an acute myocardial infa rct ion in patients with diabetes mellitus has an acceptable level of cost-effectiveness Abstract Objective : To estimate the cost effectiveness of conventional versus intensive blood glucose control in patients with type 2 diabetes . Design : Incremental cost effectiveness analysis alongside r and omised controlled trial . Setting : 23 UK hospital clinic based study centres . Participants : 3867 patients with newly diagnosed type 2 diabetes ( mean age 53 years ) . Interventions : Conventional ( primarily diet ) glucose control policy versus intensive control policy with a sulphonylurea or insulin . Main outcome measures : Incremental cost per event-free year gained within the trial period . Results : Intensive glucose control increased trial treatment costs by £ 695 ( 95 % confidence interval £ 555 to £ 836 ) per patient but reduced the cost of complications by £ 957 ( £ 233 to £ 1681 ) compared with conventional management . If st and ard practice visit patterns were assumed rather than trial conditions , the incremental cost of intensive management was £ 478 ( -£275 to £ 1232 ) per patient . The within trial event-free time gained in the intensive group was 0.60 ( 0.12 to 1.10 ) years and the lifetime gain 1.14 ( 0.69 to 1.61 ) years . The incremental cost per event-free year gained was £ 1166 ( costs and effects discounted at 6 % a year ) and £ 563 ( costs discounted at \n Output:\n " }, { "from": "agent", "value": "A large majority of the ADA recommended interventions are cost-effective .\nII ) Very cost-effective— 1 ) intensive lifestyle interventions to prevent type 2 diabetes among persons with impaired glucose tolerance compared with st and ard lifestyle recommendations ; 2 ) universal opportunistic screening for undiagnosed type 2 diabetes in African Americans between 45 and 54 years old ; 3 ) intensive glycemic control as implemented in the UK Prospect i ve Diabetes Study in persons with newly diagnosed type 2 diabetes compared with conventional glycemic control ; 4 ) statin therapy for secondary prevention of cardiovascular disease compared with no statin therapy ; 5 ) counseling and treatment for smoking cessation compared with no counseling and treatment ; 6 ) annual screening for diabetic retinopathy and ensuing treatment in persons with type 1 diabetes compared with no screening ; 7 ) annual screening for diabetic retinopathy and ensuing treatment in persons with type 2 diabetes compared with no screening ; and 8) immediate vitrectomy to treat diabetic retinopathy compared with deferred vitrectomy .\nCONCLUSIONS Many interventions intended to prevent/control diabetes are cost saving or very cost-effective and supported by strong evidence ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: OBJECTIVE We performed a r and omised trial to evaluate if intensive supervised training of the back should be offered to all patients after a first lumbar diskectomy . METHODS Forty consecutive patients were , after a first lumbar diskectomy , r and omly allocated to 2 groups undergoing \" supervised training \" twice a week for 3 months in an outpatient clinic or \" home training \" after 2 hours of instruction . RESULTS The two rehabilitation models both showed a significant effect on spinal mobility , isokinetic trunk flexion strength , isokinetic trunk extension strength and daily function . These improvements were unchanged at follow up 3 months later . The pain score remained unchanged , however , throughout the trial in both groups . No differences in effect between the two rehabilitation models could be found for any of the assessed parameters . Thirteen patients did not complete the trial , including 9 from the supervised endurance trained group , mainly because of increased pain and reprolaps ( n = 4 ) . Four patients dropped out of the home trained group , only one because of increased pain . The differences in drop-out rate and training side effects were , however , not statistically significant . CONCLUSION We conclude that it is not worthwhile to implement 3 months of supervised intensive endurance training as opposed to home training in all cases of first lumbar diskectomy , although a beneficial effect and better compliance might be found for a selected group of such patients STUDY DESIGN A controlled clinical trial . OBJECTIVES To assess the effects of an integrated back stability ( IBS ) programme on a chronic low back pain ( CLBP ) population in a time restricted private clinic environment . BACKGROUND Studies assessing stability training CLBP have reported inconsistent results . Methods used within trials vary , with some authors focusing on muscle isolation and others using whole body movements . IBS uses an exercise progression beginning with posturally based exercise and progressing from muscle isolation through to complex movements . METHODS AND MEASURES Fifty-nine chronic low back patients were divided into control ( n=32 ) and intervention ( n=27 ) groups . Participants in the intervention group were prescribed a 6 week individualized exercise programme in three stages . In stage 1 , exercises addressed posture and movement dysfunction and activated the core stabilizing muscles . In stage 2 , ' back fitness ' was enhanced using progressive exercise principles . Stage 3 emphasized technique specific actions . Participants in the control group received a backcare advice leaflet only . RESULTS Pre- and post-test scores were analysed for each of the outcome measures within the control group using a Wilcoxin signed ranks test . At an alpha level of p < or=0.0071 , no differences were observed . For the intervention group , a Mann-Whitney U-test showed significant differences between groups in the Rol and and Morris Disability Question aire ( RMDQ ) , short form McGill Pain Question naire ( SF-MPQ ) , and the Tampa Scale of Kinesiophobia ( TSK ) ( p < or=0.0071 ) . Patient satisfaction was assessed by question naire , 89 % of patients considering their level of pain and functional impairment acceptable following the programme . CONCLUSION IBS significantly reduced pain and disability in the subject group studied . Patients reported a positive experience of the programme OBJECTIVE : To contrast the efficacy of two exercise programs , segmental stabilization and strengthening of abdominal and trunk muscles , on pain , functional disability , and activation of the transversus abdominis muscle ( TrA ) , in individuals with chronic low back pain . DESIGN : Our sample consisted of 30 individuals , r and omly assigned to one of two treatment groups : segmental stabilization , where exercises focused on the TrA and lumbar multifidus muscles , and superficial strengthening , where exercises focused on the rectus abdominis , abdominus obliquus internus , abdominus obliquus externus , and erector spinae . Groups were examined to discovere whether the exercises created contrasts regarding pain ( visual analogical scale and McGill pain question naire ) , functional disability ( Oswestry disability question naire ) , and TrA muscle activation capacity ( Pressure Biofeedback Unit = PBU ) . The program lasted 6 weeks , and 30‐minute sessions occurred twice a week . Analysis of variance was used for inter‐ and intra‐group comparisons . The significance level was established at 5 % . RESULTS : As compared to baseline , both treatments were effective in relieving pain and improving disability ( p<0.001 ) . Those in the segmental stabilization group had significant gains for all variables when compared to the ST group ( p<0.001 ) , including TrA activation , where relative gains were 48.3 % and ‐5.1 % , respectively . CONCLUSION : Both techniques lessened pain and reduced disability . Segmental stabilization is superior to superficial strengthening for all variables . Superficial strengthening does not improve TrA activation capacity Proper psychomotor performance is needed in work and in activities of daily living , but among subjects with low back pain this area has been studied Little . The present purpose was to evaluate the effect and permanence of a 3-mo . physical exercise program on the psychomotor performance of lower limbs in subjects with low back pain . The associations between psychomotor performance and intensity of low back pain and subjective disability were also evaluated . 90 subjects with nonspecific , subacute low back pain were assigned to one of the three groups : one given three months intensive training , one home exercise , or the control group . Four measurement sessions were made during the 1-yr . study . Psychomotor speed of lower limbs was analyzed with Choice Reaction Time , Movement Time , and Total Response Time . Flight Time of a vertical static jump was also measured . Muscle strength was assessed with conventional methods from trunk , lower limbs , and h and . Intensity of Current Back Pain was analyzed with the Borg scale . Subjective disability was evaluated with the Oswestry Index . Analysis showed that muscle strength and back pain intensity had associations with psychomotor performance but subjective disability or physical activity did not affect it noticeably . There were no changes in Choice Reaction Time , but Total Response Time and Movement Time decreased and Flight Time increased for all subjects . In the first postintervention measurement the home exercise group had significantly lower Movement Time than the intensively trained group . Back Pain Intensity decreased in both exercise groups for those subjects whose psychomotor performance values were below the mean value for the sample Design . R and omized prospect i ve study of the effects of three types of active therapy on back muscle function in chronic low back pain patients . Objectives . To quantify the effects of 3 months active therapy on strength , endurance , activation , and fatigability of the back entensor muscles . Summary of Background Data . Many studies have documented an association between chronic low back pain and diminished muscular performance capacity . Few studies have quantified the changes in these measures following interventions using objective measurement techniques or related them to changes in clinical outcome . Methods . A total of 148 individuals ( 57 % women ) with chronic low back pain ( age , 45.0 ± 10.0 years ; duration of low back pain , 10.9 ± 9.5 years ) were r and omized to a treatment that they attended for 3 months : active physiotherapy , muscle reconditioning on devices , or low-impact aerobics . Before and after therapy , assessment s were made of the following : trunk muscle strength ( in flexion , extension , lateral bending , and axial rotation ) , erector spinae activation ( maximal , and during forward bending movements ) , back extensor endurance ( Biering-S/orensen test ) , and erector spinae fatigability ( determined from changes in the median frequency of the surface electromyographic signal ) during isometric and dynamic tests . Results . A total of 132 of 148 patients ( 89 % ) completed the therapy . Isometric strength in each movement direction increased in all groups post-therapy ( P < 0.0008 ) , most notably in the devices group . Activation of the erector spinae during the extension tests also increased significantly in all groups and showed a weak , but significant , relationship with increased maximal strength ( P = 0.01 ) . Pretherapy 55 % of the subjects showed no relaxation of the back muscles at L5 when in the fully flexed position ; no changes were observed in any group post-therapy . Endurance time during the Biering-S/orensen test increased significantly post-therapy in all groups ( P = 0.0001 ) , but there were no significant changes in EMG-determined fatigability . Fatigability of the lumbar muscles at L5 ( EMG median frequency changes ) during the dynamic test increased post-therapy ( P = 0.0001 ) without group differences . Conclusion . Significant changes in muscle performance were observed in all three active therapy groups post-therapy , which appeared to be mainly due to changes in neural activation of the lumbar muscles and psychological changes concerning , for example , motivation or pain tolerance Study Design . A r and omized controlled study with 12 months intervention . Objective . To study the effectiveness of a training intervention with emphases on the control of lumbar neutral zone ( NZ ) and behavior modeling as secondary prevention of low back pain ( LBP ) and disability . Summary of Background Data . Improving the control of lumbar NZ and enhancing muscle activation patterns ensuring spinal stability have been proposed as means for secondary prevention of LBP and disability . In addition , cognitive behavior interventions have been shown to lower the risk of recurrence of LBP and long-term disability . Methods . Middle-aged working men with recent LBP but without severe disability were r and omly allocated to either a training ( TG , n = 52 ) or control group ( CG , n = 54 ) . The aim was to exercise twice a week for 12 months , once guided and once independently . The outcome measures were the changes in intensity of LBP , disability , self-evaluated future work ability , and neuromuscular fitness . Results . The intensity of LBP decreased significantly more ( 39 % ) in the TG than in CG at 12 months . The proportion of subjects with negative expectations about their future work ability decreased in both groups at 6 and 12 months ; however , the proportion was significantly bigger in TG compared with CG ( P = 0.028 ) . There effects on disability indexes and fitness were not statistically significant . Conclusions . Controlling lumbar NZ is a specific form of exercise and daily self-care with potential for prevention of recurrent nonspecific LBP and disability among middle aged working men Abstract Objective : To evaluate effectiveness of an exercise programme in a community setting for patients with low back pain to encourage a return to normal activities . Design : R and omised controlled trial of progressive exercise programme compared with usual primary care management . Patients ' preferences for type of management were elicited independently of r and omisation . Participants : 187 patients aged 18 - 60 years with mechanical low back pain of 4 weeks to 6 months ' duration . Interventions : Exercise classes led by a physiotherapist that included strengthening exercises for all main muscle groups , stretching exercises , relaxation session , and brief education on back care . A cognitive-behavioural approach was used . Main outcome measures : Assessment s of debilitating effects of back pain before and after intervention and at 6 months and 1 year later . Measures included Rol and disability question naire , Aberdeen back pain scale , pain diaries , and use of healthcare services . Results : At 6 weeks after r and omisation , the intervention group improved marginally more than the control group on the disability question naire and reported less distressing pain . At 6 months and 1 year , the intervention group showed significantly greater improvement in the disability question naire score ( mean difference in changes 1.35 , 95 % confidence interval 0.13 to 2.57 ) . At 1 year , the intervention group also showed significantly greater improvement in the Aberdeen back pain scale ( 4.44 , 1.01 to 7.87 ) and reported only 378 days off work compared with 607 in the control group . The intervention group used fewer healthcare re sources . Outcome was not influenced by patients ' preferences . Conclusions : The exercise class was more clinical ly effective than traditional general practitioner management , regardless of patient preference , and was cost effective . Key messages Patients with back pain need to return to normal activities as soon as possible but are often afraid that movement or activity may be harmful An exercise programme led by a physiotherapist in the community and based on cognitive-behavioural principles helped patients to cope better with their pain and function better even one year later Patients ' preferences for type of management did not affect outcome Patients in the intervention group tended to use fewer healthcare re sources and took fewer days off work This type of exercise programme should be more widely Study Design . A r and omized clinical trial with 1-year and 3-year telephone question naire follow-ups . Objective . To report a specific exercise intervention ’s long-term effects on recurrence rates in acute , first-episode low back pain patients . Summary of Background Data . The pain and disability associated with an initial episode of acute low back pain ( LBP ) is known to resolve spontaneously in the short-term in the majority of cases . However , the recurrence rate is high , and recurrent disabling episodes remain one of the most costly problems in LBP . A deficit in the multifidus muscle has been identified in acute LBP patients , and does not resolve spontaneously on resolution of painful symptoms and resumption of normal activity . Any relation between this deficit and recurrence rate was investigated in the long-term . Methods . Thirty-nine patients with acute , first-episode LBP were medically managed and r and omly allocated to either a control group or specific exercise group . Medical management included advice and use of medications . Intervention consisted of exercises aim ed at rehabilitating the multifidus in cocontraction with the transversus abdominis muscle . One year and three years after treatment , telephone question naires were conducted with patients . Results . Question naire results revealed that patients from the specific exercise group experienced fewer recurrences of LBP than patients from the control group . One year after treatment , specific exercise group recurrence was 30 % , and control group recurrence was 84 % ( P < 0.001 ) . Two to three years after treatment , specific exercise group recurrence was \n Output:\n " }, { "from": "agent", "value": "High- quality evidence is lacking to make specific clinical recommendations for or against the use of LNMT in the rehabilitation of individuals after MSK injury ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: STUDY OBJECTIVE Current risk stratification tools do not identify very-low-risk patients who can be safely discharged without prolonged emergency department ( ED ) observation , expensive rule-out protocol s , or provocative testing . We seek to develop a clinical prediction rule applicable within 2 hours of ED arrival that would miss fewer than 2 % of acute coronary syndrome patients and allow discharge within 2 to 3 hours for at least 30 % of patients without acute coronary syndrome . METHODS This prospect i ve , cohort study enrolled consenting eligible subjects at least 25 years old at a single site . At 30 days , investigators assigned a diagnosis of acute coronary syndrome or no acute coronary syndrome according to predefined explicit definitions . A recursive partitioning model included risk factors , pain characteristics , physical and ECG findings , and cardiac marker results . RESULTS Of 769 patients studied , 77 ( 10.0 % ) had acute myocardial infa rct ion and 88 ( 11.4 % ) definite unstable angina . We derived a clinical prediction rule that was 98.8 % sensitive and 32.5 % specific . Patients have very low risk of acute coronary syndrome if they have a normal initial ECG , no previous ischemic chest pain , and age younger than 40 years . In addition , patients at least 40 years old and with a normal ECG result , no previous ischemic chest pain , and low-risk pain characteristics have very low risk if they have an initial creatine kinase-MB ( CK-MB ) less than 3.0 microg/L or an initial CK-MB greater than or equal to 3.0 microg/L but no ECG or serum-marker increase at 2 hours . CONCLUSION The Vancouver Chest Pain Rule for early discharge defines a group of patients who can be safely discharged after a brief evaluation in the ED . Prospect i ve validation is needed INTRODUCTION We use clinical , ECG , and biochemical data to stratify risk in patients with chest pain without ST segment elevation . However , the prognostic performance of these studies in relation to time from onset of symptoms is unknown . PATIENTS AND METHOD In a single-center , prospect i ve study , 321 consecutive patients who had been admitted in the emergency room with a suspected acute coronary syndrome without ST segment elevation were included in the study . Blood sample s were collected for CK , CK-MB mass , myoglobin , and cardiac troponin T analysis 6 , 12 and 18 hours after the onset of pain and other clinical and ECG data were recorded . Univariate and multivariate analysis was used to identify independent prognostic predictors 6 and 12 hours after the onset of chest pain . RESULTS Five variables were independent predictors of the recurrence of ischemia . The model correctly classified 82 % of the patients . Age , history of coronary artery disease , prolonged chest pain at rest in the preceding 15 days , pain , ST-segment changes with pain , and cardiac troponin T in excess of 0.1 ng/m 12 hours after the onset of chest pain were identified by logistic regression . A similar model was analyzed at 6 hours , after changing the cutoff point for cardiac troponin T. Cardiac troponin T was considered positive with values of 0.04 ng/ml 6 hours after the onset of chest pain . CONCLUSIONS More than 80 % of the patients admitted to the emergency room with chest pain without ST segment elevation can be correctly classified for new ischemic recurrences using clinical , ECG , and biochemical parameters 6 hours after the onset of pain STUDY OBJECTIVE Accurate identification of the presence of acute myocardial infa rct ion in adult patients who present to the emergency department with anterior chest pain remains elusive . The artificial neural network is a powerful nonlinear statistical paradigm for the recognition of complex patterns , with the ability to maintain accuracy when some data required for network function are missing . Earlier studies revealed that the artificial neural network is able to accurately identify acute myocardial infa rct ion in patients experiencing chest pain . However , these studies did not measure network performance in real time , when a significant amount of data required for network function may not be available . They also did not use chemical cardiac marker data . METHODS Two thous and two hundred four adult patients presenting to the ED with anterior chest pain were used to train an artificial neural network to recognize the presence of acute myocardial infa rct ion . Only data available at the time of initial patient evaluation were used to replicate the conditions of real-time patient evaluation . Forty variables from patient histories , physical examinations , ECG results , and chemical cardiac marker determinations were used to train and then test the network . RESULTS The network correctly identified 121 of the 128 patients ( sensitivity 94.5 % ; 95 % confidence interval 90.6 % to 97.9 % ) with myocardial infa rct ion at a specificity of 95.9 % ( 95 % confidence interval 93.0 % to 98.5 % ) , despite the fact that an average of 5 % ( individual range 0 % to 35 % ) of the input data required by the network were missing on all patients . CONCLUSION Network accuracy and the maintenance of that accuracy when some data required for function are unavailable suggest that the artificial neural network may be a potential real time aid to the diagnosis of acute myocardial infa rct ion during initial patient evaluation BACKGROUND Appropriate treatment policies should include an accurate estimate of a patient 's baseline risk . Risk modeling to date has been underutilized in patients with acute coronary syndromes without persistent ST-segment elevation . METHODS AND RESULTS We analyzed the relation between baseline characteristics and the 30-day incidence of death and the composite of death or myocardial (re)infa rct ion in 9461 patients with acute coronary syndromes without persistent ST-segment elevation enrolled in the PURSUIT trial [ Platelet glycoprotein IIb/IIIa in Unstable angina : Receptor Suppression Using Integrilin ( eptifibatide ) Therapy ] . Variables examined included demographics , history , hemodynamic condition , and symptom duration . Risk models were created with multivariable logistic regression and vali date d by bootstrapping techniques . There was a 3.6 % mortality rate and 11.4 % infa rct ion rate by 30 days . More than 20 significant predictors for mortality and for the composite end point were identified . The most important baseline determinants of death were age ( adjusted chi(2)=95 ) , heart rate ( chi(2)=32 ) , systolic blood pressure ( chi(2)=20 ) , ST-segment depression ( chi(2)=20 ) , signs of heart failure ( chi(2)=18 ) , and cardiac enzymes ( chi(2)=15 ) . Determinants of mortality were generally also predictive of death or myocardial (re)infa rct ion . Differences were observed , however , in the relative prognostic importance of predictive variables for mortality alone or the composite end point ; for example , sex was a more important determinant of the composite end point ( chi(2)=21 ) than of death alone ( chi(2)=10 ) . The accuracy of the prediction of the composite end point was less than that of mortality ( C-index 0.67 versus 0.81 ) . CONCLUSIONS The occurrence of adverse events after presentation with acute coronary syndromes is affected by multiple factors . These factors should be considered in the clinical decision-making process Background : Most Canadian emergency departments use an unstructured , individualized approach to patients with chest pain , without data to support the safety and efficiency of this practice . We sought to determine the proportions of patients with chest discomfort in emergency departments who either had acute coronary syndrome ( ACS ) and were inappropriately discharged from the emergency department or did not have ACS and were held for investigation . Methods : Consecutive consenting patients aged 25 years or older presenting with chest discomfort to 2 urban tertiary care emergency departments between June 2000 and April 2001 were prospect ively enrolled unless they had a terminal illness , an obvious traumatic cause , a radiographically identifiable cause , severe communication problems or no fixed address in British Columbia or they would not be available for follow-up by telephone . At 30 days we assigned predefined explicit outcome diagnoses : definite ACS ( acute myocardial infa rct ion [ AMI ] or definite unstable angina ) or no ACS . Results : Of 1819 patients , 241 ( 13.2 % ) were assigned a 30-day diagnosis of AMI and 157 ( 8.6 % ) , definite unstable angina . Of these 398 patients , 21 ( 5.3 % ) were discharged from the emergency department without a diagnosis of ACS and without plans for further investigation . The clinical sensitivity for detecting ACS was 94.7 % ( 95 % confidence interval [ CI ] 92.5%– 96.9 % ) and the specificity 73.8 % ( 95 % CI 71.5%– 76.0 % ) . Of the patients without ACS or an adverse event , 71.1 % were admitted to hospital or held in the emergency department for more than 3 hours . Interpretation : The current individualized approach to evaluation and disposition of patients with chest discomfort in 2 Canadian tertiary care emergency departments misses 5.3 % of cases of ACS while consuming considerable health care re sources for patients without coronary disease . Opportunities exist to improve both safety and efficiency Identifying acute coronary syndrome is a difficult task in the emergency department because symptoms may be atypical and the electrocardiogram has low sensitivity . In this prospect i ve cohort study done in a tertiary community emergency hospital , we developed and tested a neural diagnostic tree in 566 consecutive patients with chest pain and no ST-segment elevation for the diagnosis of acute coronary syndrome . Multivariate regression and recursive partitioning analysis allowed the construction of decision rules and of a neural tree for the diagnosis of acute myocardial infa rct ion and acute coronary syndrome . Predictive variables of acute coronary syndrome were : age > or = 60 years ( odds ratio [ OR ] = 2.3 ; P = 0.0016 ) , previous history of coronary artery disease ( OR = 2.9 ; P = 0.0008 ) , diabetes ( OR = 2.8 ; P = 0.0240 ) , definite/probable angina-type chest pain ( OR = 17.3 ; P = 0.0000 ) and ischemic electrocardiogram ( ECG ) changes on admission ( OR = 3.5 ; P = 0.0002 ) . The receiver operating characteristic curve of possible diagnostic decision rules of the regression model disclosed a C-index of 0.904 ( 95 % confidence interval = 0.878 to 0.930 ) for acute coronary syndrome and 0.803 ( 95 % confidence interval 0.757 to 0.849 ) for acute myocardial infa rct ion . For both disorders , sensitivities of the neural tree were 99 % and 93 % , respectively , and negative predictive values were both 98 % . Negative likelihood ratios were 0.02 and 0.1 , respectively . It is concluded that this simple and easy-to-use neural diagnostic tree was very accurate in the identification of non-ST segment elevation chest pain patients without acute coronary syndrome . Patients identified as low probability of disease could receive immediate stress testing and be discharged if the test is negative STUDY OBJECTIVE The Thrombolysis in Myocardial Infa rct ion ( TIMI ) risk score is a 7-item tool derived from trials of patients with unstable angina/non-ST segment elevation myocardial infa rct ion for risk stratification with respect to outcomes . It has been retrospectively evaluated in emergency department ( ED ) patients with potential acute coronary syndrome but has not been prospect ively vali date d in this patient population . To vali date the use of the TIMI risk score in the ED , we prospect ively assess its potential utility in a broad ED chest pain patient population . METHODS This was a prospect i ve observational cohort study of consecutive ED chest pain patients enrolled from July 2003 until October 2004 . Data included demographics , medical and cardiac history , and components of the TIMI risk score . Investigators followed the hospital course daily for admitted patients , and 30-day follow-up was performed on hospitalized and discharged patients . The main outcome was death , acute myocardial infa rct ion , or revascularization as stratified by TIMI risk score at 30 days . RESULTS There were 1,481 eligible patient visits ; 30-day follow-up was completed on 1,458 ( 98.4 % ) patients . Patients had mean age of 53.2+/-14 years and were 40 % men , 66 % black , and 30 % white . Myocardial infa rct ion occurred in 95 patients . The incidence of each TIMI risk factor was age greater than 65 years 21 % , known coronary stenosis 18 % , 3 or more risk factors 26 % , ST-segment deviation 6 % , 2 or more anginal events in the previous 24 hours 33 % , aspirin use in the previous 7 days 35 % , and elevated markers 6 % . The incidence of 30-day death , acute myocardial infa rct ion , and revascularization according to TIMI score is as follows : TIMI 0 , 1.7 % ( 95 % confidence interval [ CI ] 0.42 to 2.95 ) ; TIMI 1 , 8.2 % ( 95 % CI 5.27 to 11.04 ) ; TIMI 2 , 8.6 % ( 95 % CI 5.02 to 12.0 \n Output:\n " }, { "from": "agent", "value": "Current prediction rules for ACS have substantial method ological limitations and have not been successfully implemented in the clinical setting ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: We recently published the results of a r and omised controlled trial of a nurse telephone consultation service in primary care out of hours.1 The new service , operating at evenings and weekends , significantly reduced general practitioners ’ workload and was at least as safe as the existing out of hours service . Contacts diminish sharply after about 10 pm,2 and , anecdotally , a higher proportion of night calls necessitate consultation with a general practitioner . We report here a parallel trial aim ed at establishing whether nurse telephone consultation was equally effective in managing workload at night Objective To determine the clinical effectiveness and cost-effectiveness of nurse-led care ( NLC ) for people with rheumatoid arthritis ( RA ) . Methods In a multicentre pragmatic r and omised controlled trial , the assessment of clinical effects followed a non-inferiority design , while patient satisfaction and cost assessment s followed a superiority design . Participants were 181 adults with RA r and omly assigned to either NLC or rheumatologist-led care ( RLC ) , both arms carrying out their normal practice . The primary outcome was the disease activity score ( DAS28 ) assessed at baseline , weeks 13 , 26 , 39 and 52 ; the non-inferiority margin being DAS28 change of 0.6 . Mean differences between the groups were estimated controlling for covariates following per- protocol ( PP ) and intention-to-treat ( ITT ) strategies . The economic evaluation ( NHS and healthcare perspectives ) estimated cost relative to change in DAS28 and quality -adjusted life-years ( QALY ) derived from EQ5D . Results Demographics and baseline characteristics of patients under NLC ( n=91 ) were comparable to those under RLC ( n=90 ) . Overall baseline-adjusted difference in DAS28 mean change ( 95 % CI ) for RLC minus NLC was −0.31 ( −0.63 to 0.02 ) for PP and -0.15 ( −0.45 to 0.14 ) for ITT analyses . Mean difference in healthcare cost ( RLC minus NLC ) was £ 710 ( −£352 , £ 1773 ) and −£128 ( −£1263 , £ 1006 ) for PP and ITT analyses , respectively . NLC was more cost-effective with respect to cost and DAS28 , but not in relation to QALY utility scores . In all secondary outcomes , significance was met for non-inferiority of NLC . NLC had higher ‘ general satisfaction ’ scores than RLC in week 26 . Conclusions The results provide robust evidence to support non-inferiority of NLC in the management of RA . Trial registration IS RCT Abstract Background : Disease management programmes ( DMPs ) improve quality of care for patients with heart failure ( HF ) . However , only a limited number of trials have studied the efficacy of such programmes for patients with heart failure with preserved ejection fraction ( HFPEF ) . Objective : To estimate the impact of a structured , nurse-led patient education programme and care plan in general practice on outcome parameters and events in patients with HFPEF . Methods : Single blinded r and omized clinical trial with an intervention over six months and a follow-up during 12 additional months . In the control group , the patients ( n = 41 ) were managed according to Russian national guidelines . Patients in the intervention group ( n = 44 ) received education on individual lifestyle changes and modifications of cardiovascular disease ( CVD ) risk factors , home-based exercise training and weekly nurse consultations in addition to usual care . Results : Six months after their inclusion , patients in the intervention group significantly improved body mass index , waist circumference , six-min walk test distance , total cholesterol , low-density lipoprotein , left ventricular end-diastolic volume index , quality of life and level of anxiety . After 18 months , there were 11 deaths ( 25 % ) or hospitalizations in the intervention group and 12 ( 29 % ) in the control group ( P = 0.134 ) . Cardiovascular mortality and readmission rate were not reduced significantly after six months of follow-up : the hazard ratio was 0.47 ( 95 % CI : 0.17–1.28 ; P = 0.197 ) . After 18 months , this was 0.85 ( 0.42–1.73 ; P = 0.658 ) . Conclusion : This primary care based DMP for patients with HFPEF improved the patients ’ emotional status and quality of life , positively influenced body weight , functional capacity and lipid profile , and attenuated heart remodelling Aim To compare and evaluate the treatment outcomes of a nurse-led rheumatology clinic and a rheumatologist-led clinic in patients with low disease activity or in remission who are undergoing biological therapy . Background Patients with chronic inflammatory arthritis treated with biological therapy are usually monitored by rheumatologists . Nurse-led rheumatology clinics have been proposed in patients with low disease activity or in remission . Design R and omized controlled trial . Methods A 12-month follow-up trial was conducted between October 2009 and August 2011 , where 107 patients were r and omized into two groups with a 6-month follow-up to a nurse-led rheumatology clinic based on person-centred care ( intervention group ; n = 53 ) or to a rheumatologist-led clinic ( control group ; n = 54 ) . The hypothesis was that the nurse-led clinic outcomes would not be inferior to those obtained from a rheumatologist-led clinic at the 12-month follow-up . The primary outcome was disease activity measured by Disease Activity Score 28 . Results A total of 47 patients in the intervention group and 50 in the control group completed the 12-month trial . The trial revealed no statistically significant differences between groups in mean change of Disease Activity Score 28 , Visual Analogue Scales for pain , the Health Assessment Question naire , satisfaction with or confidence in obtaining rheumatology care . Conclusion Patients with stable chronic inflammatory arthritis undergoing biological therapy could be monitored by a nurse-led rheumatology clinic without difference in outcome as measured by the Disease Activity Score 28 AIMS For children with stable asthma , to test non-inferiority of care provided by a hospital-based specialised asthma nurse versus a general practitioner ( GP ) or paediatrician . METHODS R and omised controlled trial evaluating st and ard care by a GP , paediatrician or an asthma nurse , with two-year follow-up . RESULTS 107 children were recruited , 45 from general practice and 62 from hospital . After two years , no significant differences between groups were found for airway responsiveness , FEV1 , asthma control , medication , school absence or parental work absence . In the general practice group there was a significantly lower frequency of regular review visits ( ' regular ' = at least one review per six months ) compared to the paediatrician and specialised asthma nurse group , both after one year [ 45.7 % versus 87.9 % and 94.3 % , respectively , ( p<0.0005 ) ] and after two years [ 26.5 % versus 87.9 % and 75.8 % , respectively , ( p<0.0005 ) ] . We found no significant differences in unplanned visits . In most cases the asthma nurse was able to provide care without consultation with the paediatrician . CONCLUSION The degree of disease control in stable childhood asthma managed by an asthma nurse is not inferior to traditional management by primary or secondary care physicians . The results also suggest that a lower review frequency does not detract from good disease control Background Enhanced secondary preventive follow-up after stroke or transient ischemic attack ( TIA ) is necessary for improved adherence to recommendations regarding blood pressure ( BP ) and low-density lipoprotein cholesterol ( LDL-C ) levels . We investigated whether nurse-led , telephone-based follow-up was more efficient than usual care at improving BP and LDL-C levels at 12 months after hospital discharge . Methods We r and omized 537 patients to either nurse-led , telephone-based follow-up ( intervention ) or usual care ( control ) . BP and LDL-C measurements were performed at 1 month ( baseline ) and 12 months post-discharge . Intervention group patients who did not meet target values at baseline received additional follow-up , including titration of medication and lifestyle counselling , to reach treatment goals ( BP < 140/90 mmHg , LDL-C < 2.5 mmol/L ) . Results At 12 months , mean systolic BP , diastolic BP and LDL-C was 3.3 ( 95 % CI 0.3 to 6.3 ) mmHg , 2.3 mmHg ( 95 % CI 0.5 to 4.2 ) and 0.3 mmol/L ( 95 % CI 0.1 to 0.4 ) lower in the intervention group compared to controls . Among participants with values above the treatment goal at baseline , the difference in systolic BP and LDL-C was more pronounced ( 8.0 mmHg , 95 % CI 4.0 to 12.1 , and 0.6 mmol/L , 95 % CI 0.4 to 0.9 ) . A larger proportion of the intervention group reached the treatment goal for systolic BP ( 68.5 vs. 56.8 % , p = 0.008 ) and LDL-C ( 69.7 % vs. 50.4 % , p < 0.001 ) . Conclusions Nurse-led , telephone-based secondary preventive follow-up , including medication adjustment , was significantly more efficient than usual care at improving BP and LDL-C levels by 12 months post-discharge . Trial Registration IS RCT N Registry IS RCT Background Recommendations for rheumatology nursing management of chronic inflammatory arthritis ( CIA ) from European League Against Rheumatism ( EULAR ) states that nurses should take part in the monitoring patients ’ disease and therapy in order to achieve cost savings . The aim of the study was to compare the costs of rheumatology care between a nurse-led rheumatology clinic ( NLC ) , based on person-centred care ( PCC ) , versus a rheumatologist-led clinic ( RLC ) , in monitoring of patients with CIA undergoing biological therapy . Methods Patients with CIA undergoing biological therapy ( n = 107 ) and a Disease Activity Score of 28 ≤ 3.2 were r and omised to follow-up by either NLC or RLC . All patients met the rheumatologist at inclusion and after 12 months . In the intervention one of two annual monitoring visits in an RLC was replaced by a visit to an NLC . The primary outcome was total annual cost of rheumatology care . Results A total of 97 patients completed the RCT at the 12 month follow-up . Replacing one of the two annual rheumatologist monitoring visits by a nurse-led monitoring visit , result ed in no additional contacts to the rheumatology clinic , but rather a decrease in the use of re sources and a reduction of costs . The total annual rheumatology care costs including fixed monitoring , variable monitoring , rehabilitation , specialist consultations , radiography , and pharmacological therapy , generated € 14107.7 per patient in the NLC compared with € 16274.9 in the RCL ( p = 0.004 ) , giving a € 2167.2 ( 13 % ) lower annual cost for the NLC . Conclusions Patients with CIA and low disease activity or in remission undergoing biological therapy can be monitored with a reduced re source use and at a lower annual cost by an NLC , based on PCC with no difference in clinical outcomes . This could free re sources for more intensive monitoring of patients early in the disease or patients with high disease activity . Trial registration The trial is registered as a clinical trial at the Clinical Trials.gov ( NCT01071447 ) . Registration date : October 8 , 2009 Background The ESTEEM trial was a cluster r and omised controlled trial that compared two telephone triage management systems ( general practitioner ( GP ) or a nurse supported by computer decision support software ) with usual care , in response to a request for same-day consultation in general practice . Aim To investigate associations between trial patients ’ demographic , health , and lifestyle characteristics , and their reported experiences of care . Setting Recruitment of 20 990 patients occurred between May 2011 and December 2012 in 42 GP practice s in Engl and ( 13 GP triage , 15 nurse triage , 14 usual care ) . Method Patients reported their experiences via a postal question naire issued 4 weeks after their initial request for a same-day consultation . Overall satisfaction , ease of accessing medical help/advice , and convenience of care were analysed using linear hierarchical modelling . Results Question naires were returned by 12 132 patients ( 58 % ) . Older patients reported increased overall satisfaction compared with patients aged 25–59 years , but patients aged 16–24 years reported lower satisfaction . Compared with white patients , patients from ethnic minorities reported lower satisfaction in all three arms , although to a lesser degree in the GP triage arm . Patients from ethnic minorities reported higher satisfaction in the GP triage than in usual care , whereas white patients reported higher satisfaction with usual care . Patients unable to take time away from work or who could only do so with difficulty reported lower satisfaction across all three trial arms . Conclusions Patient characteristics , such as age , ethnicity and ability to attend their practice during work hours , were associated with their experiences of care following a same-day consultation request in general practice \n Output:\n " }, { "from": "agent", "value": "Study findings suggest that care delivered by nurses , compared to care delivered by doctors , probably generates similar or better health outcomes for a broad range of patient conditions ( low‐ or moderate‐certainty evidence ): • Nurse‐led primary care may lead to slightly fewer deaths among certain groups of patients , compared to doctor‐led care .\nHowever , the results vary and it is possible that nurse‐led primary care makes little or no difference to the number of deaths ( low‐certainty evidence ) . •\nBlood pressure outcomes are probably slightly improved in nurse‐led primary care .\nOther clinical or health status outcomes are probably similar ( moderate‐certainty evidence ) .\n• Patient satisfaction is probably slightly higher in nurse‐led primary care ( moderate‐certainty evidence ) .\nQuality of life may be slightly higher ( low‐certainty evidence ) .\nThe effect of nurse‐led care on utilisation of care is mixed and depends on the type of outcome .\nConsultations are probably longer in nurse‐led primary care ( moderate‐certainty evidence ) , and numbers of attended return visits are slightly higher for nurses than for doctors ( high‐certainty evidence ) .\nAuthors ' conclusions This review shows that for some ongoing and urgent physical complaints and for chronic conditions , trained nurses , such as nurse practitioners , practice nurses , and registered nurses , probably provide equal or possibly even better quality of care compared to primary care doctors , and probably achieve equal or better health outcomes for patients .\nNurses probably achieve higher levels of patient satisfaction , compared to primary care doctors .\nFurthermore , consultation length is probably longer when nurses deliver care and the frequency of attended return visits is probably slightly higher for nurses , compared to doctors .\nThe effects of nurse‐led care on process of care and the costs of care are uncertain , and we also can not ascertain what level of nursing education leads to the best outcomes when nurses are substituted for doctors" } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: ABSTRACT BACKGROUND Physical inactivity is a significant risk factor for cardiovascular disease and remains highly prevalent in middle-aged women . OBJECTIVE We hypothesized that an interventionist-led ( IL ) , primary -care – based physical activity ( PA ) and weight loss intervention would increase PA levels and decrease weight to a greater degree than a self-guided ( SG ) program . DESIGN We conducted a r and omized trial . PARTICIPANTS Ninety-nine inactive women aged 45–65 years and with BMI ≥ 25 kg/m2 were recruited from three primary care clinics . INTERVENTIONS The interventionist-led ( IL ) group ( n = 49 ) had 12 weekly sessions of 30 min discussion s with 30 min of moderate-intensity PA . The self-guided ( SG ) group ( n = 50 ) received a manual for independent use . MAIN MEASURES Assessment s were conducted at 0 , 3 , and 12 months ; PA and weight were primary outcomes . Weight was measured with a st and ardized protocol . Leisure PA levels were assessed using the Modifiable Activity Question naire . Differences in changes by group were analyzed with a t-test or Wilcoxon rank-sum test . Mixed models were used to analyze differences in changes of outcomes by group , using an intention-to-treat principle . KEY RESULTS Data from 98 women were available for analysis . At baseline , mean ( SD ) age was 53.9 ( 5.4 ) years and 37 % were black . Mean weight was 92.3 ( 17.7 ) kg and mean BMI was 34.7 ( 5.9 ) kg/m2 . Median PA level was 2.8 metabolic equivalent hours per week ( MET-hour/week ) ( IQR 0.0 , 12.0 ) . At 3 months , IL women had a significantly greater increase in PA levels ( 7.5 vs. 1.9 MET-hour/week ; p = 0.02 ) than SG women ; there was no significant difference in weight change . At 12 months , the difference between groups was no longer significant ( 4.7 vs. 0.7 MET-hour/week ; p = 0.38 ) . Mixed model analysis showed a significant ( p = 0.048 ) difference in PA change between groups at 3 months only . CONCLUSIONS The IL intervention was successful in increasing the physical activity levels of obese , inactive middle-aged women in the short-term . No significant changes in weight were observed There is limited evidence demonstrating the benefits of physical activity with regard to mortality risk or the harms associated with sedentary behavior in black adults , so we examined the relationships between these health behaviors and cause-specific mortality in a prospect i ve study that had a large proportion of black adults . Participants ( 40 - 79 years of age ) enrolled in the Southern Community Cohort Study between 2002 and 2009 ( n = 63,308 ) were prospect ively followed over 6.4 years , and 3,613 and 1,394 deaths occurred in blacks and whites , respectively . Black adults who reported the highest overall physical activity level ( ≥32.3 metabolic equivalent-hours/day vs. < 9.7 metabolic equivalent-hours/day ) had lower risks of death from all causes ( hazard ratio ( HR ) = 0.76 . 95 % confidence interval ( CI ) : 0.69 , 0.85 ) , cardiovascular disease ( HR = 0.81 , 95 % CI : 0.67 , 0.98 ) , and cancer ( HR = 0.76 , 95 % CI : 0.62 , 0.94 ) . In whites , a higher physical activity level was associated with a lower risk of death from all causes ( HR = 0.76 , 95 % CI : 0.64 , 0.90 ) and cardiovascular disease ( HR = 0.69 , 95 % CI : 0.49 , 0.99 ) but not cancer ( HR = 0.95 , 95 % CI : 0.67 , 1.34 ) . Spending more time being sedentary ( > 12 hours/day vs. < 5.76 hours/day ) was associated with a 20%-25 % increased risk of all-cause mortality in blacks and whites . Blacks who reported the most time spent being sedentary ( ≥10.5 hours/day ) and lowest level of physical activity ( < 12.6 metabolic equivalent-hours/day ) had a greater risk of death ( HR = 1.47 , 95 % CI : 1.25 , 1.71 ) . Our study provides evidence that suggests that health promotion efforts to increase physical activity level and decrease sedentary time could help reduce mortality risk in black adults BACKGROUND Few primary care physicians routinely counsel for exercise , despite the benefits of physical activity and the high prevalence of inactivity . The objective of this study is to assess the effectiveness of Physician-Based Assessment and Counseling for Exercise ( PACE ) , a brief , behavior-based tool for primary care providers counseling healthy adults . METHODS This study is a r and omized controlled trial of 812 patients age 30 years or older registered for well visits at 32 primary care physician offices at a staff model health maintenance organization . Intervention physicians were trained to deliver PACE exercise counseling protocol s at the index visit , and one reminder telephone call occurred at 1 month . An enhanced intervention group received additional activity reminders . RESULTS At the 6-month follow-up , the control group did not differ significantly from the intervention group for energy expended ( 2,048 kcal/week versus 2,108 kcal/ week , P = 0.77 ) , time spent in walking or other moderate to vigorous activities ( 202 min/week versus 187 min/ week , P = 0.99 ) , mental health , physical function , or behaviors previously shown to predict activity change . Among the intervention patients , the stages-of-change score for Contemplators increased significantly compared with controls ( P = 0.03 ) , but without a significant change in energy expended . Baseline levels of physical activity counseling were high ( 50 % ) , as were baseline patient physical activity levels ( 61 % exercised at least three times a week ) . CONCLUSIONS These results suggest that a one-time PACE counseling session with minimal reinforcement , in a setting with high baseline levels of activity , does not further increase activity . The finding that Contemplators advanced in stage of behavior change suggests that further studies are needed to examine long-term , repeated counseling interventions OBJECTIVE To determine if lifestyle improved at a short term through an intervention to involve patients in cardiovascular risk management by the practice nurse . METHODS The IMPALA study ( 2006 , the Netherl and s ) was a cluster-r and omised controlled trial involving 25 general practice s and 615 patients who were eligible for cardiovascular risk management . The intervention consisted of ( 1 ) individual 10-year cardiovascular risk assessment , ( 2 ) risk communication , ( 3 ) use of a decision aid and ( 4 ) adapted motivational interviewing , applied by practice nurses in two consultations . Outcomes were smoking , alcohol , diet , physical activity and the secondary outcomes risk perception , anxiety , confidence about the decision and satisfaction with the communication , measured at baseline and after 12 weeks . RESULTS Patients of both groups improved their lifestyle , but no relevant significant differences between the groups were found . Intervention group patients improved in terms of the appropriateness of risk perception , although not significantly . Intervention group patients improved significantly in terms of appropriateness of anxiety and were more satisfied with the communication compared to control group patients . CONCLUSION The intervention seems to have improved the patients ' risk perception , anxiety and satisfaction with the communication , which are important conditions for shared decision making . However , we found no additional effect of the intervention on lifestyle Background The Health through Sport conceptual model links sport participation with physical , social and psychological outcomes and stresses the need for more underst and ing between these outcomes . The present study aims to uncover how sport participation , physical activity , social capital and mental health are interrelated by examining these outcomes in one model . Methods A cross-sectional survey was conducted in nine disadvantaged communities in Antwerp ( Belgium ) . Two hundred adults ( aged 18–56 ) per community were r and omly selected and visited at home to fill out a question naire on socio-demographics , sport participation , physical activity , social capital and mental health . A sample of 414 adults participated in the study . Results Structural Equation Modeling analysis showed that sport participation ( β = .095 ) and not total physical activity ( β = .027 ) was associated with better mental health . No association was found between sport participation and community social capital ( β = .009 ) or individual social capital ( β = .045 ) . Furthermore , only community social capital was linked with physical activity ( β = .114 ) , individual social capital was not ( β = -.013 ) . In contrast , only individual social capital was directly associated with mental health ( β = .152 ) , community social capital was not ( β = .070 ) . Conclusion This study emphasizes the importance of sport participation and individual social capital to improve mental health in disadvantaged communities . It further gives a unique insight into the functionalities of how sport participation , physical activity , social capital and mental health are interrelated . Implication s for policy are that cross-sector initiatives between the sport , social and health sector need to be supported as their outcomes are directly linked to one another Background Brisk walking in older people can increase step-counts and moderate to vigorous intensity physical activity ( MVPA ) in ≥10-minute bouts , as advised in World Health Organization guidelines . Previous interventions have reported step-count increases , but not change in objective ly measured MVPA in older people . We assessed whether a primary care nurse-delivered complex intervention increased objective ly measured step-counts and MVPA . Methods and Findings A total of 988 60–75 year olds , able to increase walking and r and omly selected from three UK family practice s , were invited to participate in a parallel two-arm cluster r and omised trial ; r and omisation was by household . Two-hundred-ninety-eight people from 250 households were r and omised between 2011 and 2012 ; 150 individuals to the intervention group , 148 to the usual care control group . Intervention participants received four primary care nurse physical activity ( PA ) consultations over 3 months , incorporating behaviour change techniques , pedometer step-count and accelerometer PA intensity feedback , and an individual PA diary and plan . Assessors were not blinded to group status , but statistical analyses were conducted blind . The primary outcome was change in accelerometry assessed average daily step-counts between baseline and 3 months , with change at 12 months a secondary outcome . Other secondary outcomes were change from baseline in time in MVPA weekly in ≥10-minute bouts , accelerometer counts , and counts/minute at 3 months and 12 months . Other outcomes were adverse events , anthropometric measures , mood , and pain . Qualitative evaluations of intervention participants and practice nurses assessed the intervention ’s acceptability . At 3 months , eight participants had withdrawn or were lost to follow-up , 280 ( 94 % ) individuals provided primary outcome data . At 3 months changes in both average daily step-counts and weekly MVPA in ≥10-minute bouts were significantly higher in the intervention than control group : by 1,037 ( 95 % CI 513–1,560 ) steps/day and 63 ( 95 % CI 40–87 ) minutes/week , respectively . At 12 months corresponding differences were 609 ( 95 % CI 104–1,115 ) steps/day and 40 ( 95 % CI 17–63 ) minutes/week . Counts and counts/minute showed similar effects to steps and MVPA . Adverse events , anthropometry , mood , and pain were similar in the two groups . Participants and practice nurses found the intervention acceptable and enjoyable . Conclusions The PACE-Lift trial increased both step-counts and objective ly measured MVPA in ≥10-minute bouts in 60–75 year olds at 3 and 12 months , with no effect on adverse events . To our knowledge , this is the first trial in this age group to demonstrate objective MVPA increases and highlights the value of individualised support incorporating objective PA assessment in a primary care setting . Trial Registration Controlled-Trials.com IS RCT CONTEXT Physical activity is important for health , yet few studies have examined the effectiveness of physical activity patient counseling in primary care . OBJECTIVE To compare the effects of 2 physical activity counseling interventions with current recommended care and with each other in a primary care setting . DESIGN The Activity Counseling Trial , a r and omized controlled trial with recruitment in 1995 - 1997 , with 24 months of follow-up . SETTING Eleven primary care facilities affiliated with 3 US clinical research centers . PARTICIPANTS Volunteer sample of 395 female and 479 male inactive primary care patients aged 35 to 75 years without clinical cardiovascular disease . INTERVENTIONS Participants were r and omly assigned to 1 of 3 groups : advice ( n = 292 ) , which included physician advice and written educational material s ( recommended care ) ; assistance ( n = 293 ) , which included all the components received by the advice group plus interactive mail and behavioral counseling at physician visits ; or counseling ( n = 289 ) , which included the assistance and advice group components plus regular telephone counseling and behavioral classes . MAIN OUTCOME MEASURES Cardiorespiratory fitness , measured by maximal oxygen uptake ( VO(2)max ) , and self-reported total \n Output:\n " }, { "from": "agent", "value": "Conclusion The majority of RCTs of physical activity interventions in primary care record sufficient information on PROGRESS-Plus factors to allow differential effects to be studied .\nHowever , very few actually report details of relevant analyses to determine which population subgroups may st and to benefit or be further disadvantaged by intervention efforts" } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: Abstract Objective To estimate the effect of adding exercise classes , spinal manipulation delivered in NHS or private premises , or manipulation followed by exercise to “ best care ” in general practice for patients consulting with back pain . Fig 1 Progress of the UK BEAM trial Design Pragmatic r and omised trial with factorial design . Setting 181 general practice s in Medical Research Council General Practice Research Framework ; 63 community setting s around 14 centres across the United Kingdom . Participants 1334 patients consulting their general practice s about low back pain . Main outcome measures Scores on the Rol and Morris disability question naire at three and 12 months , adjusted for centre and baseline scores . Results All groups improved over time . Exercise improved mean disability question naire scores at three months by 1.4 ( 95 % confidence interval 0.6 to 2.1 ) more than “ best care . ” For manipulation the additional improvement was 1.6 ( 0.8 to 2.3 ) at three months and 1.0 ( 0.2 to 1.8 ) at 12 months . For manipulation followed by exercise the additional improvement was 1.9 ( 1.2 to 2.6 ) at three months and 1.3 ( 0.5 to 2.1 ) at 12 months . No significant differences in outcome occurred between manipulation in NHS premises and in private premises . No serious adverse events occurred . Conclusions Relative to “ best care ” in general practice , manipulation followed by exercise achieved a moderate benefit at three months and a small benefit at 12 months ; spinal manipulation achieved a small to moderate benefit at three months and a small benefit at 12 months ; and exercise achieved a small benefit at three months but not 12 months BACKGROUND Spinal pain is common and frequently disabling . Management guidelines have encouraged referral from primary care for spinal manipulation . However , the evidence base for these recommendations is weak . More pragmatic trials and economic evaluations have been recommended . OBJECTIVES Our aim was to assess the effectiveness and health care costs of a practice -based osteopathy clinic for subacute spinal pain . METHODS A pragmatic r and omized controlled trial was carried out in a primary care osteopathy clinic accepting referrals from 14 neighbouring practice s in North West Wales . A total of 201 patients with neck or back pain of 2 - 12 weeks duration were allocated at r and om between usual GP care and an additional three sessions of osteopathic spinal manipulation . The primary outcome measure was the Extended Aberdeen Spine Pain Scale ( EASPS ) . Secondary measures included SF-12 , EuroQol and Short-form McGill Pain Question naire . Health care costs were estimated from the records of referring GPs . RESULTS Outcomes improved more in the osteopathy group than the usual care group . At 2 months , this improvement was significantly greater in EASPS [ 95 % confidence interval ( CI ) 0.7 - 9.8 ] and SF-12 mental score ( 95 % CI 2.7 - 10.7 ) . At 6 months , this difference was no longer significant for EASPS ( 95 % CI -1.5 to 10.4 ) , but remained significant for SF-12 mental score ( 95 % CI 1.0 - 9.9 ) . Mean health care costs attributed to spinal pain were significantly greater by 65 UK pounds in the osteopathy group ( 95 % CI 32 - 155 UK pounds ) . Though osteopathy also cost 22 UK pounds more in mean total health care cost , this was not significant ( 95 % CI - 159 to 142 UK pounds ) . CONCLUSION A primary care osteopathy clinic improved short-term physical and longer term psychological outcomes , at little extra cost . Rigorous multicentre studies are now needed to assess the generalizability of this approach A national telephone survey was conducted in 1998 using r and om-digit dialing and the first Osteopathic Survey of Healthcare in America ( OSTEOSURV-I ) instrument to determine patients ' satisfaction with their healthcare , as well as their perceptions of osteopathic medicine . Of the 1106 respondents , 243 ( 22.0 % ) had received medical care from an osteopathic physician , and another 307 ( 27.8 % ) cl aim ed to be aware of osteopathic physicians . Patients of osteopathic physicians reported the highest levels of satisfaction in 8 of the 11 elements studied when compared with patients of allopathic physicians , chiropractors , and nonphysician clinicians other than chiropractors . Respondents perceived osteopathic manipulative treatment ( OMT ) to be beneficial for musculoskeletal disorders ( P < .001 ) . In addition , respondents perceived that healthcare services provided by osteopathic physicians were similar to those provided by allopathic physicians ( P < .001 ) , but not to those provided by chiropractors ( P = .01 ) . A total of 97.9 % of current patients of osteopathic physicians agreed with the statement that osteopathic physicians practice d in their local community , compared with 80.6 % of former patients of osteopathic physicians and 67.8 % of patients who had never visited osteopathic physicians ( P < .001 ) . In general , the most favorable perceptions of osteopathic medicine were reported by current patients of osteopathic physicians , followed by former patients of such physicians . The least favorable perceptions came from patients who had never been patients of osteopathic physicians . The perception that OMT should be covered by health insurance was significantly associated with the use of osteopathic physicians ( odds ratio , 3.2 ; 95 % confidence interval , 1.5 to 6.7 , among patients who had ever been to an osteopathic physician ) . The results of our survey suggest that greater access to osteopathic services , including OMT , is desirable and that promotional efforts aim ed at encouraging the use of osteopathic medical services among the general population are warranted Abstract This single-blind r and omised clinical trial compared osteopathic manipulative treatment with chemonucleolysis ( used as a control of known efficacy ) for symptomatic lumbar disc herniation . Forty patients with sciatica due to this diagnosis ( confirmed by imaging ) were treated either by chemonucleolysis or manipulation . Outcomes ( leg pain , back pain and self-reported disability ) were measured at 2 weeks , 6 weeks and 12 months . The mean values for all outcomes improved in both groups . By 12 months , there was no statistically significant difference in outcome between the treatments , but manipulation produced a statistically significant greater improvement for back pain and disability in the first few weeks . A similar number from both groups required additional orthopaedic intervention ; there were no serious complications . Crude cost analysis suggested an overall financial advantage from manipulation . Because osteopathic manipulation produced a 12-month outcome that was equivalent to chemonucleolysis , it can be considered as an option for the treatment of symptomatic lumbar disc herniation , at least in the absence of clear indications for surgery . Further study into the value of manipulation at a more acute stage is warranted Abstract Objective To assess the cost effectiveness of adding spinal manipulation , exercise classes , or manipulation followed by exercise ( “ combined treatment ” ) to “ best care ” in general practice for patients consulting with low back pain . Design Stochastic cost utility analysis alongside pragmatic r and omised trial with factorial design . Setting 181 general practice s and 63 community setting s for physical treatments around 14 centres across the United Kingdom . Participants 1287 ( 96 % ) of 1334 trial participants . Main outcome measures Healthcare costs , quality adjusted life years ( QALYs ) , and cost per QALY over 12 months . Results Over one year , mean treatment costs relative to “ best care ” were £ 195 ( $ 360 ; € 279 ; 95 % credibility interval £ 85 to £ 308 ) for manipulation , £ 140 ( £ 3 to £ 278 ) for exercise , and £ 125 ( £ 21 to £ 228 ) for combined treatment . All three active treatments increased participants ' average QALYs compared with best care alone . Each extra QALY that combined treatment yielded relative to best care cost £ 3800 ; in economic terms it had an “ incremental cost effectiveness ratio ” of £ 3800 . Manipulation alone had a ratio of £ 8700 relative to combined treatment . If the NHS was prepared to pay at least £ 10 000 for each extra QALY ( lower than previous recommendations in the United Kingdom ) , manipulation alone would probably be the best strategy . If manipulation was not available , exercise would have an incremental cost effectiveness ratio of £ 8300 relative to best care . Conclusions Spinal manipulation is a cost effective addition to “ best care ” for back pain in general practice . Manipulation alone probably gives better value for money than manipulation followed by exercise Back pain is a common illness and chiropractors provide a large proportion of back pain care in the United States . This is the first study to systematic ally compare chiropractic patients with those who saw other providers for back pain . The authors analyzed data from the R AND Health Insurance Experiment , a community-based study of the use of health services . Insurance cl aims forms were examined for all visits specified by the patient as occurring for back pain . Visits were grouped into episodes using decision rules and clinical judgment . The primary provider of back pain care was defined as the provider who delivered most of the services . Sociodemographic and health status and attitudes variables of patients were examined for association with the choice of chiropractor . Multivariate logistic regression models were constructed to calculate adjusted odds ratios for independent predictors . There were 1020 episodes of back pain care made by 686 different persons and encompassing 8825 visits . Results indicated that chiropractors were the primary provider for 40 % of episodes , and retained as primary provider a greater percentage of their patients ( 92 % ) who had a second episode of back pain care than did medical doctors . Health insurance experiment site , white race , male sex , and high school education were independent predictors of choosing a chiropractor . Conclusions suggested that chiropractors were the choice of one third of all patients who sought back pain care , and provided care for 40 % of all episodes of care . Geographic site , education , gender , and income were independent patient factors predicting chiropractic use Fifty-four subjects volunteered to participate in a controlled study contrasting spinal manipulation with spinal mobilization without the rotational forces and leverage required to move facet joints . All suffered from regional low-back pain for less than 1 month , were ages 18–40 , had never previously undergone any form of spinal manipulation , and denied a prior episode of backache within the previous 6 months . R and omization was stratified at outset into those who suffered for less than 2 weeks and those whose discomfort had persisted for 2–4 weeks . Outcome was monitored by a question naire assessing functional impairment . A treatment effect of manipulation was demonstrated only in the strata with more prolonged illness at entry . In the first week following manipulation , these patients improved to a greater degree ( P=.009 , t test ) and more rapidly ( P < .025 , Wilcoxon rank-sum test ) The effectiveness of spinal manipulation carried out by a non-medical qualified osteopath was compared with that of short-wave diathermy ( SWD ) and a placebo ( detuned SWD ) in 109 patients with low back pain . More than half the subjects in each of the 3 treatment groups benefited immediately from therapy . Significant improvements were observed in the 3 groups at the end of 2 weeks ' treatment , and these were still apparent at 12 weeks . The outcome of treatment was unrelated to the initial severity or duration of pain or to the trend of pain towards deterioration or improvement . It is , therefore , unlikely that the results simply reflect the natural history of low back pain . Benefits obtained with osteopathy and SWD in this study may have been achieved through a placebo effect Previous studies have shown that dysmenorrhea produces low-back pain and an electromyographic ( EMG ) pattern typical of trauma-induced low-back pain . To determine the effects of high-velocity low-amplitude osteopathic manipulative treatment ( OMT ) on this type of low-back pain , 12 dysmenorrheic subjects were assigned to a group receiving OMT or to a group not receiving OMT ( or both ) . Eight subjects participated in both groups , the other four being equally distributed between groups . Osteopathic manipulative treatment significantly decreased EMG activity during extension of the lumbar spinae erector muscles and abolished the spontaneous EMG activity . These EMG changes coincided with the patient 's report of alleviated low-back pain and menstrual cramping . Osteopathic manipulative treatment did not change the creatinine kinase , lactate dehydrogenase or lactate-dehydrogenase isoenzyme activity , or myoglobin concentration A r and omized clinical trial of rotational manipulation was conducted on 95 patients with low back pain selected for ( 1 ) the absence of any contraindications for vertebral manipulation , ( 2 ) the absence of any psychosocial problems that might affect the outcome of treatment , ( 3 ) the absence of any previous experience with manipulative therapy , and ( 4 ) the presence of palpatory cues indicating that manipulation might be successful . Patients were r and omly assigned to one of two groups : an experimental group receiving manipulation therapy and a control group receiving soft-tissue massage . Comparison of the two groups indicated that ( 1 ) patients who received manipulative treatment were much more likely to report immediate relief after the first treatment , and ( 2 ) at discharge , there was no significant difference between the two groups because both showed substantial improvement In a multicentre trial 456 selected patients with low back pain were r and omly allocated to one of four treatments-manipulation , definitive physiotherapy , corset , or analgesic tablets . Patients were reassessed clinical ly after three weeks ' treatment and again after a further three weeks . Question naires were used to find out \n Output:\n " }, { "from": "agent", "value": "There were significant pain reductions with OMT regardless of whether trials were performed in the United Kingdom or the United States .\nSignificant pain reductions were also observed during short- , intermediate- , and long-term follow-up .\nConclusion OMT significantly reduces low back pain .\nThe level of pain reduction is greater than expected from placebo effects alone and persists for at least three months ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: Results from the r and omized trial conducted by the Health Insurance Plan ( HIP ) to determine the efficacy of breast cancer screening with mammography and palpation are reported for longer periods than previously available . By the end of 10 years after entry , the study group 's mortality due to breast cancer was about 30 % below the control group 's . Arithmetic gains due to screening were maintained through year 14 ; relative gains declined . With increases in the period of follow-up , cumulative survival rates among cases detected by mammography alone ( palpation negative during screening ) , decreased more rapidly than rates among other subgroups , but survival rates for mammography cases remained relatively high . Study women aged 40 - 49 years at entry began to show lower breast cancer mortality than those in the control group as duration of follow-up increased . Reservations are advanced about the acceptance of this finding as evidence of the efficacy of screening under age 50 under the conditions of the HIP study . The reservations are based on the observation that the decrease of mortality among the study group aged 45 - 49 at entry is concentrated entirely among cases diagnosed after they reached 50 years of age A trial in the UK to study the effect on mortality from breast cancer of invitation for annual mammography from the age of 40–41 , has r and omised a total of 160 921 women in the ratio 1 : 2 to the intervention and control arms . All breast cancers diagnosed in the two arms have been identified , and the histology review ed . This paper presents the results of an interim analysis using surrogate outcome measures to compare predicted breast cancer mortality in the two arms based on 1287 cases diagnosed to 31.12.1999 . Due to earlier diagnosis , there is currently an 8 % excess of invasive breast cancers in the intervention arm . The ratio of predicted deaths at 10 years in the intervention arm relative to the control arm , adjusted for this excess diagnosis , ranges from 0.89 ( 95 % confidence interval ( CI ) 0.78–1.01 ) to 0.90 ( 95 % CI 0.80–1.01 ) . Screening from age 40 may result in a lower reduction in breast cancer mortality than that observed in other trials including women below age 50 . This analysis based on surrogate outcome measures suggests that a reduction in breast cancer mortality may be observed in this trial . However , a number of assumptions have been necessary and firm conclusions must await the analysis of observed mortality from breast cancer The Canadian National Breast Screening Study ( CNBSS ) , conducted on women age 40 - 49 , was design ed to evaluate the efficacy of combined annual mammography and physical examination of the breasts in reducing breast cancer mortality in comparison to usual care ( UC ) controls . From January 1980 through March 1985 , 25,214 women were individually r and omized to the mammography/physical exam ( MP ) arm and 25,216 to the UC . The integrity of the r and omization has been review ed and confirmed to be unbiased . During an average , follow-up of 10.5 years from entry ( range : 8.75 - 13 years ) , 82 women died from breast cancer in the MP arm and 72 in the UC , for a rate ratio of 1.14 ( 95 % confidence interval : 0.83 - 1.56 ) . All-cause mortality was almost identical comparing the two groups ; the nonsignificant excess of breast cancer deaths in the MP arm was balanced by an excess of other cancer deaths in the UC arm Debate continues over the effectiveness of screening by mammography in women below age 50 . We report here on results of screening in the first 10 years of a r and omised trial to study the effect on breast cancer mortality of invitation to annual mammography from age 40 to 41 compared to first invitation to the 3-yearly UK national programme at age 50–52 . The trial is taking place in 23 NHS breast screening centres . Between 1991 and 1997 , 160 921 women were r and omised in the ratio 1 : 2 to intervention and control arms . Screening is by two views at first screen and single view subsequently ; data on screening up to and including round five are now complete . Uptake of invitation to screening is between 68 and 70 % at all but the latest screening rounds . Rates of referral for assessment are 4.6 % at first screen and 3.4 % at subsequent screens . Invasive cancer detection rates are 0.09 % at first screen , and similar at rescreens until the sixth and later screens . There is little evidence of regular mammography in the trial control arm . The setting of this trial within the NHS breast screening programme should ensure applicability of results to a national programme OBJECTIVES To evaluate the efficacy of the combination of annual screening with mammography , physical examination of the breasts and the teaching of breast self-examination in reducing the rate of death from breast cancer among women aged 40 to 49 years on entry . DESIGN Individually r and omized controlled trial . SETTING Fifteen urban centres in Canada with expertise in the diagnosis and treatment of breast cancer . PARTICIPANTS Women with no history of breast cancer and no mammography in the previous 12 months were r and omly assigned to undergo either annual mammography and physical examination ( MP group ) or usual care after an initial physical examination ( UC group ) . The 50,430 women enrolled from January 1980 through March 1985 were followed for a mean of 8.5 years . DATA COLLECTION Derived from the participants by initial and annual self-administered question naires , from the screening examinations , from the patients ' physicians , from the provincial cancer registries and by record linkage to the Canadian National Mortality Data Base . Expert panels evaluated histologic and death data . MAIN OUTCOME MEASURES Rates of referral from screening , rates of detection of breast cancer from screening and from community care , nodal status , tumour size , and rates of death from all causes and from breast cancer . RESULTS Over 90 % of the women in each group attended the screening sessions or returned the annual question naires , or both , over years 2 to 5 . The characteristics of the women in the two groups were similar . Compared with the Canadian population , the participants were more likely to be married , have fewer children , have more education , be in a professional occupation , smoke less and have been born in North America . The rate of screen-detected breast cancer on first examination was 3.89 per 1000 in the MP group and 2.46 per 1000 in the UC group ; more node-positive tumours were found in the MP group than in the UC group . During years 2 through 5 the ratios of observed to expected cases of invasive breast cancer were 1.26 in the MP group and 1.02 in the UC group . Of the women with invasive breast cancer through to 7 years , 191 and 157 women in the MP and UC groups respectively had no node involvement , 55 and 43 had one to three nodes involved , 47 and 23 had four or more nodes involved , and 38 and 49 had an unknown nodal status . There were 38 deaths from breast cancer in the MP group and 28 in the UC group . The ratio of the proportions of death from breast cancer in the MP group compared with those in the UC group was 1.36 ( 95 % confidence interval 0.84 to 2.21 ) . The survival rates were similar in the two groups . The highest survival rate occurred among women whose cancer had been detected by mammography alone . CONCLUSION The study was internally valid , and there was no evidence of r and omization bias . Screening with yearly mammography and physical examination of the breasts detected considerably more node-negative , small tumours than usual care , but it had no impact on the rate of death from breast cancer up to 7 years ' follow-up from entry BACKGROUND As mammographic screening becomes more widespread , larger numbers of tumours are diagnosed while small and node negative . METHODS We examined detection mode , tumour size , node status , histological type , therapy and outcome in 1053 breast cancers diagnosed in one county of the Swedish Two-County Trial of mammographic screening for breast cancer . RESULTS Of patients undergoing total mastectomy with axillary dissection , 65 % were found to be node negative . For tumours of size 1 - 9 mm , 95 % were node negative . The major effects on survival were tumour size , node status and histological type . Primary adjuvant therapy had no significant association with survival . CONCLUSIONS The advent of mammography has substantially enhanced the possibilities for less radical treatment . There is an urgent need for therapeutic trials utilizing mammographic-pathological correlations to ascertain in advance which tumours can and which can not benefit from more radical therapy Context Seven- and 10-year results of the Canadian National Breast Screening Study ( CNBSS ) showed no reduction in breast cancer mortality from five annual mammographies and breast examinations for 40- to 49-year-old women . Some authors have argued that longer follow-up would reveal important benefits . Contribution After 11 to 16 years , the cumulative rate ratios for mammography versus usual care were 0.97 ( 95 % CI , 0.74 to 1.27 ) for breast cancer mortality without adjustment for non study mammography and 1.06 ( CI , 0.80 to 1.40 ) with adjustment . Clinical Implication s The CNBSS suggests that screening 40- to 49-year-old women is unlikely to reduce breast cancer by 20 % or more . Controversy will persist because other studies suggest that screening causes small reductions in breast cancer mortality . The Editors The Canadian National Breast Screening Study -1 ( CNBSS-1 ) , an individually r and omized trial in women 40 to 49 years of age at study entry , evaluated the efficacy of annual mammography , breast physical examination , and instruction on breast self-examination in reducing breast cancer mortality ( 1 ) . The 7-year ( 2 ) and preliminary 10-year ( 3 ) mortality results were previously reported . At 7 years , 38 women in the mammography group and 28 women in the usual care group had died of breast cancer , for a rate ratio of 1.36 ( 95 % CI , 0.84 to 2.21 ) ( 2 ) . At 10 years , there were 82 breast cancer deaths in the mammography group and 72 in the usual care group ( rate ratio , 1.14 [ CI , 0.83 to 1.56 ] ) ( 3 ) . This article reports CNBSS-1 results after an average 13-year follow-up from study entry . Methods Patient Selection and Recruitment Participants were recruited through media publicity , personal invitation letters using population lists ( municipal registers and provincial health insurance registers ) , group mailings , and physicians ( 4 ) . Eligibility criteria were age 40 to 49 years , no previous diagnosis of breast cancer , not being pregnant , no mammography in the previous 12 months , and signed informed consent . The Human Experimentation Committee of the University of Toronto ( Toronto , Ontario , Canada ) and Human Experimentation Committees at 15 CNBSS collaborating centers approved the study . A total of 50 430 women age 40 to 49 years were enrolled from January 1980 through March 1985 . R and omization Before r and omization , all participants received an initial breast physical examination and instruction on breast self-examination . They were then immediately r and omly assigned to receive mammography and , thereafter , either annual screening with mammography and breast physical examination ( 25 214 women in the mammography group were available for analysis ) or usual care in the context of the Canadian health care system ( 25 216 women in the usual care group were available for analysis ) . Center coordinators r and omly assigned participants using prepared allocation lists , independent of breast physical examination findings . This sequence ensured that the conduct and interpretation of the breast physical examination would be unbiased by knowledge of whether mammography would follow . Intervention Screening Schedule In the mammography group , 62 % of women received five annual screenings . The remainder , recruited later , received four . Each screening examination comprised mammography , breast physical examination , and instruction and evaluation on breast self-examination . Women in the mammography group completed question naires at each rescreening visit . Women in the usual care group were not recalled for rescreening but were mailed annual question naires . We expected that these participants would continue their normal pattern of medical care as delivered through Canada 's universal health care coverage , including access to mammography for diagnosis . Study Procedures Two-view mammography was done on dedicated mammography units ( 5 ) , and second readers review ed mammograms deemed abnormal . Systematic audit procedures were used ( 6 ) . Nurses provided breast physical examination in 12 centers and physicians in 3 centers in Qubec ( 7 ) . These providers taught and evaluated breast self-examination while conducting their own examination ( 8) . If findings on breast physical examination or mammography were abnormal , participants were referred to a CNBSS review clinic . The study surgeon discussed mammography findings with the study radiologist , examined the participant , and decided whether further diagnostic procedures should be recommended to the woman 's physician . The woman 's physician determined whether and how to implement the study surgeon 's recommendations . Data Collection Protocol During the screening period , the center coordinators collected surgery and pathology reports for breast-related diagnostic and therapeutic procedures . The CNBSS pathologists review ed all slides . If the community and CNBSS pathologist disagreed , a panel of three to five CNBSS pathologists blindedly and independently review ed the slides . Extensive quality control procedures were used during data collection . After the screening centers closed in 1988 , the central CNBSS central office annually followed all women known to have breast cancer until 30 June 19 \n Output:\n " }, { "from": "agent", "value": "This could be because screening was better in some trials than in others at advancing the time of diagnosis .\nIf so , more cancers would be identified in such trials relative to the control group , and fewer of the cancers would have reached an advanced stage .\nConsequently , the differences in the reported reductions in breast cancer mortality can not be explained by differences in screening effectiveness .\nGiven that the size of the bias was similar to the estimated screening effect , screening appeared ineffective" } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: BACKGROUND The age-specific mortality rates and total deaths from specific cancers have not been documented for the various regions and sub population s of India . We therefore assessed the cause of death in 2001 - 03 in homes in small areas that were chosen to be representative of all the parts of India . METHODS At least 130 trained physicians independently assigned causes to 122,429 deaths , which occurred in 1·1 million homes in 6671 small areas that were r and omly selected to be representative of all of India , based on a structured non-medical surveyor 's field report . FINDINGS 7137 of 122,429 study deaths were due to cancer , corresponding to 556,400 national cancer deaths in India in 2010 . 395,400 ( 71 % ) cancer deaths occurred in people aged 30 - 69 years ( 200,100 men and 195,300 women ) . At 30 - 69 years , the three most common fatal cancers were oral ( including lip and pharynx , 45,800 [ 22·9 % ] ) , stomach ( 25,200 [ 12·6 % ] ) , and lung ( including trachea and larynx , 22,900 [ 11·4 % ] ) in men , and cervical ( 33,400 [ 17·1 % ] ) , stomach ( 27,500 [ 14·1 % ] ) , and breast ( 19,900 [ 10·2 % ] ) in women . Tobacco-related cancers represented 42·0 % ( 84,000 ) of male and 18·3 % ( 35,700 ) of female cancer deaths and there were twice as many deaths from oral cancers as lung cancers . Age-st and ardised cancer mortality rates per 100,000 were similar in rural ( men 95·6 [ 99 % CI 89·6 - 101·7 ] and women 96·6 [ 90·7 - 102·6 ] ) and urban areas ( men 102·4 [ 92·7 - 112·1 ] and women 91·2 [ 81·9 - 100·5 ] ) , but varied greatly between the states , and were two times higher in the least educated than in the most educated adults ( men , illiterate 106·6 [ 97·4 - 115·7 ] vs most educated 45·7 [ 37·8 - 53·6 ] ; women , illiterate 106·7 [ 99·9 - 113·6 ] vs most educated 43·4 [ 30·7 - 56·1 ] ) . Cervical cancer was far less common in Muslim than in Hindu women ( study deaths 24 , age-st and ardised mortality ratio 0·68 [ 0·64 - 0·71 ] vs 340 , 1·06 [ 1·05 - 1·08 ] ) . INTERPRETATION Prevention of tobacco-related and cervical cancers and earlier detection of treatable cancers would reduce cancer deaths in India , particularly in the rural areas that are underserved by cancer services . The substantial variation in cancer rates in India suggests other risk factors or causative agents that remain to be discovered . FUNDING Bill & Melinda Gates Foundation and US National Institutes of Health BACKGROUND National malaria death rates are difficult to assess because reliably diagnosed malaria is likely to be cured , and deaths in the community from undiagnosed malaria could be misattributed in retrospective enquiries to other febrile causes of death , or vice-versa . We aim ed to estimate plausible ranges of malaria mortality in India , the most populous country where the disease remains common . METHODS Full-time non-medical field workers interviewed families or other respondents about each of 122,000 deaths during 2001 - 03 in 6671 r and omly selected areas of India , obtaining a half-page narrative plus answers to specific questions about the severity and course of any fevers . Each field report was sent to two of 130 trained physicians , who independently coded underlying causes , with discrepancies resolved either via anonymous reconciliation or adjudication . FINDINGS Of all coded deaths at ages 1 month to 70 years , 2681 ( 3·6 % ) of 75,342 were attributed to malaria . Of these , 2419 ( 90 % ) were in rural areas and 2311 ( 86 % ) were not in any health-care facility . Death rates attributed to malaria correlated geographically with local malaria transmission ratesderived independently from the Indian malaria control programme . The adjudicated results show 205,000 malaria deaths per year in India before age 70 years ( 55,000 in early childhood , 30,000 at ages 5 - 14 years , 120,000 at ages 15 - 69 years ) ; 1·8 % cumulative probability of death from malaria before age 70 years . Plausible lower and upper bounds ( on the basis of only the initial coding ) were 125,000 - 277,000 . Malaria accounted for a substantial minority of about 1·3 million unattended rural fever deaths attributed to infectious diseases in people younger than 70 years . INTERPRETATION Despite uncertainty as to which unattended febrile deaths are from malaria , even the lower bound greatly exceeds the WHO estimate of only 15,000 malaria deaths per year in India ( 5000 early childhood , 10 000 thereafter ) . This low estimate should be reconsidered , as should the low WHO estimate of adult malaria deaths worldwide . FUNDING US National Institutes of Health , Canadian Institute of Health Research , Li Ka Shing Knowledge Institute Background Physician-coded verbal autopsy ( PCVA ) is the most widely used method to determine causes of death ( CODs ) in countries where medical certification of death is uncommon . Computer-coded verbal autopsy ( CCVA ) methods have been proposed as a faster and cheaper alternative to PCVA , though they have not been widely compared to PCVA or to each other . Methods We compared the performance of open- source r and om forest , open- source tariff method , InterVA-4 , and the King-Lu method to PCVA on five data sets comprising over 24,000 verbal autopsies from low- and middle-income countries . Metrics to assess performance were positive predictive value and partial chance-corrected concordance at the individual level , and cause-specific mortality fraction accuracy and cause-specific mortality fraction error at the population level . Results The positive predictive value for the most probable COD predicted by the four CCVA methods averaged about 43 % to 44 % across the data sets . The average positive predictive value improved for the top three most probable CODs , with greater improvements for open- source r and om forest ( 69 % ) and open- source tariff method ( 68 % ) than for InterVA-4 ( 62 % ) . The average partial chance-corrected concordance for the most probable COD predicted by the open- source r and om forest , open- source tariff method and InterVA-4 were 41 % , 40 % and 41 % , respectively , with better results for the top three most probable CODs . Performance generally improved with larger data sets . At the population level , the King-Lu method had the highest average cause-specific mortality fraction accuracy across all five data sets ( 91 % ) , followed by InterVA-4 ( 72 % across three data sets ) , open- source r and om forest ( 71 % ) and open- source tariff method ( 54 % ) . Conclusions On an individual level , no single method was able to replicate the physician assignment of COD more than about half the time . At the population level , the King-Lu method was the best method to estimate cause-specific mortality fractions , though it does not assign individual CODs . Future testing should focus on combining different computer-coded verbal autopsy tools , paired with PCVA strengths . This includes using open- source tools applied to larger and varied data sets ( especially those including a r and om sample of deaths drawn from the population ) , so as to establish the performance for age- and sex-specific CODs Background Computer-coded verbal autopsy ( CCVA ) is a promising alternative to the st and ard approach of physician-certified verbal autopsy ( PCVA ) , because of its high speed , low cost , and reliability . This study introduces a new CCVA technique and vali date s its performance using defined clinical diagnostic criteria as a gold st and ard for a multisite sample of 12,542 verbal autopsies ( VAs ) . Methods The R and om Forest ( RF ) Method from machine learning ( ML ) was adapted to predict cause of death by training r and om forests to distinguish between each pair of causes , and then combining the results through a novel ranking technique . We assessed quality of the new method at the individual level using chance-corrected concordance and at the population level using cause-specific mortality fraction ( CSMF ) accuracy as well as linear regression . We also compared the quality of RF to PCVA for all of these metrics . We performed this analysis separately for adult , child , and neonatal VAs . We also assessed the variation in performance with and without household recall of health care experience ( HCE ) . Results For all metrics , for all setting s , RF was as good as or better than PCVA , with the exception of a nonsignificantly lower CSMF accuracy for neonates with HCE information . With HCE , the chance-corrected concordance of RF was 3.4 percentage points higher for adults , 3.2 percentage points higher for children , and 1.6 percentage points higher for neonates . The CSMF accuracy was 0.097 higher for adults , 0.097 higher for children , and 0.007 lower for neonates . Without HCE , the chance-corrected concordance of RF was 8.1 percentage points higher than PCVA for adults , 10.2 percentage points higher for children , and 5.9 percentage points higher for neonates . The CSMF accuracy was higher for RF by 0.102 for adults , 0.131 for children , and 0.025 for neonates . Conclusions We found that our RF Method outperformed the PCVA method in terms of chance-corrected concordance and CSMF accuracy for adult and child VA with and without HCE and for neonatal VA without HCE . It is also preferable to PCVA in terms of time and cost . Therefore , we recommend it as the technique of choice for analyzing past and current verbal autopsies Background Physician review of a verbal autopsy ( VA ) and completion of a death certificate remains the most widely used approach for VA analysis . This study provides new evidence about the performance of physician-certified verbal autopsy ( PCVA ) using defined clinical diagnostic criteria as a gold st and ard for a multisite sample of 12,542 VAs . The study was also design ed to analyze issues related to PCVA , such as the impact of a second physician reader on the cause of death assigned , the variation in performance with and without household recall of health care experience ( HCE ) , and the importance of local information for physicians reading VAs . Methods The certification was performed by 24 physicians . The assignment of VA was r and om and blinded . Each VA was certified by one physician . Half of the VAs were review ed by a different physician with household recall of health care experience included . The completed death certificate was processed for automated ICD-10 coding of the underlying cause of death . PCVA was compared to gold st and ard cause of death assignment based on strictly defined clinical diagnostic criteria that are part of the Population Health Metrics Research Consortium ( PHMRC ) gold st and ard verbal autopsy study . Results For individual cause assignment , the overall chance-corrected concordance for PCVA against the gold st and ard cause of death is less than 50 % , with substantial variability by cause and physician . Physicians assign the correct cause around 30 % of the time without HCE , and addition of HCE improves performance in adults to 45 % and slightly higher in children to 48 % . Physicians estimate cause-specific mortality fractions ( CSMFs ) with considerable error for adults , children , and neonates . Only for neonates for a cause list of six causes with HCE is accuracy above 0.7 . In all three age groups , CSMF accuracy improves when household recall of health care experience is available . Conclusions Results show that physician coding for cause of death assignment may not be as robust as previously thought . The time and cost required to initially collect the verbal autopsies must be considered in addition to the analysis , as well as the impact of diverting physicians from servicing immediate health needs in a population to review VAs . All of these considerations highlight the importance and urgency of developing better methods to more reliably analyze past and future verbal autopsies to obtain the highest quality mortality data from population s without reliable death certification Background Verbal autopsy is important for detecting causes of death including HIV in areas with inadequate vital registration systems . Before antiretroviral therapy ( ART ) introduction , a verbal autopsy study in rural Ug and a found that half of adult deaths assessed were in HIV-positive individuals . We used verbal autopsy to compare the proportion of HIV-positive adult deaths in the periods before and after ART introduction . Methods Between 2006 and 2008 , all adult ( ≥ 13 years ) deaths in a prospect i ve population -based cohort study were identified by monthly death registration , and HIV serostatus was determined through annual serosurveys . A clinical officer interviewed a relative of the deceased using a verbal autopsy question naire . Two clinicians independently review ed the question naires and classified the deaths as HIV-positive or not . A third clinician was the tie-breaker in case of nonagreement . The performance of the verbal autopsy tool was assessed using HIV serostatus as the gold st and ard of comparison . We \n Output:\n " }, { "from": "agent", "value": "Sensitivity of PCVA versus hospital-assigned COD varied widely by cause , but showed consistently high specificity .\nAt the population level , the relative CSMF error between PCVA and hospital-based deaths indicated good performance for most CODs .\nR and om Forest had the best CSMF accuracy performance , followed closely by PCVA and the other CCVA methods , but with lower values for InterVA-3 .\nConclusions There is no single best-performing coding method for verbal autopsies across various studies and metrics .\nThere is little current justification for CCVA to replace PCVA , particularly as physician diagnosis remains the worldwide st and ard for clinical diagnosis on live patients ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: STUDY DESIGN Prospect i ve , r and omized , double-blinded , clinical trial using a repeated- measures design . OBJECTIVES To determine the short-term clinical efficacy of Kinesio Tape ( KT ) when applied to college students with shoulder pain , as compared to a sham tape application . BACKGROUND Tape is commonly used as an adjunct for treatment and prevention of musculoskeletal injuries . A majority of tape applications that are reported in the literature involve nonstretch tape . The KT method has gained significant popularity in recent years , but there is a paucity of evidence on its use . METHODS AND MEASURES Forty-two subjects clinical ly diagnosed with rotator cuff tendonitis/impingement were r and omly assigned to 1 of 2 groups : therapeutic KT group or sham KT group . Subjects wore the tape for 2 consecutive 3-day intervals . Self-reported pain and disability and pain-free active ranges of motion ( ROM ) were measured at multiple intervals to assess for differences between groups . RESULTS The therapeutic KT group showed immediate improvement in pain-free shoulder abduction ( mean + /- SD increase , 16.9 degrees + /- 23.2 degrees ; P = .005 ) after tape application . No other differences between groups regarding ROM , pain , or disability scores at any time interval were found . CONCLUSION KT may be of some assistance to clinicians in improving pain-free active ROM immediately after tape application for patients with shoulder pain . Utilization of KT for decreasing pain intensity or disability for young patients with suspected shoulder tendonitis/impingement is not supported . LEVEL OF EVIDENCE Therapy , level 1b- QUESTION Does Kinesio Taping reduce disability , pain , and kinesiophobia in people with chronic non-specific low back pain ? DESIGN R and omised trial , with concealed allocation , assessor blinding , and intention-to-treat analysis . PARTICIPANTS Sixty adults with chronic non-specific low back pain . INTERVENTION The experimental intervention was Kinesio Taping over the lumbar spine for one week ; the control intervention was sham taping . OUTCOME MEASURES The following outcomes were measured at baseline , immediately after the week with the tape in situ , and four weeks later : Oswestry Disability Index , Rol and - Morris Low Back Pain and Disability Question naire , pain on a 10-cm visual analogue scale , Tampa kinesiophobia scale , trunk flexion range of motion , and the McQuade test of trunk muscle endurance . RESULTS At one week , the experimental group had significantly greater improvement in disability , by 4 points ( 95 % CI 2 to 6 ) on the Oswestry score and by 1.2 points ( 95 % CI 0.4 to 2.0 ) on the Rol and -Morris score . However , these effects were not significant four weeks later . The experimental group also had a greater decrease in pain than the control group immediately after treatment ( mean between-group difference 1.1 cm , 95 % CI 0.3 to 1.9 ) , which was maintained four weeks later ( 1.0 cm , 95 % CI 0.2 to 1.7 ) . Similarly trunk muscle endurance was significantly better at one week ( by 23 sec , 95 % CI 14 to 32 ) and four weeks later ( by 18 sec , 95 % CI 9 to 26 ) . Other outcomes were not significantly affected . CONCLUSION Kinesio Taping reduced disability and pain in people with chronic non-specific low back pain , but these effects may be too small to be clinical ly worthwhile . TRIAL REGISTRATION ACTRN12612000402842 & NA ; Pain intensity is frequently measured on an 11‐point pain intensity numerical rating scale ( PI‐NRS ) , where 0=no pain and 10=worst possible pain . However , it is difficult to interpret the clinical importance of changes from baseline on this scale ( such as a 1‐ or 2‐point change ) . To date , there are no data driven estimates for clinical ly important differences in pain intensity scales used for chronic pain studies . We have estimated a clinical ly important difference on this scale by relating it to global assessment s of change in multiple studies of chronic pain . Data on 2724 subjects from 10 recently completed placebo‐controlled clinical trials of pregabalin in diabetic neuropathy , postherpetic neuralgia , chronic low back pain , fibromyalgia , and osteoarthritis were used . The studies had similar design s and measurement instruments , including the PI‐NRS , collected in a daily diary , and the st and ard seven‐point patient global impression of change ( PGIC ) , collected at the endpoint . The changes in the PI‐NRS from baseline to the endpoint were compared to the PGIC for each subject . Categories of ‘ much improved ’ and ‘ very much improved ’ were used as determinants of a clinical ly important difference and the relationship to the PI‐NRS was explored using graphs , box plots , and sensitivity/specificity analyses . A consistent relationship between the change in PI‐NRS and the PGIC was demonstrated regardless of study , disease type , age , sex , study result , or treatment group . On average , a reduction of approximately two points or a reduction of approximately 30 % in the PI‐NRS represented a clinical ly important difference . The relationship between percent change and the PGIC was also consistent regardless of baseline pain , while higher baseline scores required larger raw changes to represent a clinical ly important difference . The application of these results to future studies may provide a st and ard definition of clinical ly important improvement in clinical trials of chronic pain therapies . Use of a st and ard outcome across chronic pain studies would greatly enhance the comparability , validity , and clinical applicability of these studies OBJECTIVE The purpose of this prospect i ve , r and omized , controlled study was to determine the effects of kinesio taping in the treatment of patients with patellofemoral pain syndrome ( PFPS ) . METHODS Thirty-one women with PFPS ( mean age : 44.88 years ; range : 17 to 50 years ) were r and omly assigned to either a kinesio taping ( KT ) ( n=15 ) or control ( n=16 ) group . Both groups received the same muscle strengthening and soft tissue stretching exercises for six weeks and the KT group additionally received kinesio taping at four day intervals for six weeks . Visual analog scale was used to measure pain intensity . Tension of the iliotibial b and /tensor fascia lata and hamstring muscles and the mediolateral location of the patella were measured before the treatment and at the end of the third and sixth week . The Anterior Knee Pain Scale / Kujala Scale was used for the analysis of functional performance . RESULTS Comparing pretreatment and 6th week values , significant improvements were found in pain , soft tissue flexibility and functional performance of both groups ( p<0.05 ) . However , patellar shift was unchanged ( p>0.05 ) . The KT group had significantly better hamstring flexibility than the control group at the end of three weeks ( p<0.05 ) . CONCLUSION The addition of kinesio taping to the conventional exercise program does not improve the results in patients with PFPS , other than a faster improvement in hamstring muscle flexibility BACKGROUND Kinesio Taping ( KT ) has proved to be effective in various musculoskeletal conditions . Although its precise working mechanism has yet to be fully understood , it is believed to interact with neuromuscular function through mechanoceptor activation . No studies design ed to assess the effects of KT in chronic low back pain ( CLBP ) patients have yet been conducted . AIM The aim of this study was to determine the effects of KT on pain , disability and lumbar muscle function in sufferers of CLBP , both immediately and at a one-month follow-up examination . DESIGN The study consisted of two phases : phase I was based on an intra-subject pre-test/post-test procedure ; phase II was based on a r and omized , single-blinded controlled trial . SETTING Outpatient facility . POPULATION Thirty-nine CLBP patients were enrolled . METHODS KT plus exercise , KT alone or exercise alone have been used for four weeks . Pain , disability and lumbar muscle function were evaluated before and after the treatment period . RESULTS The patients in all three groups displayed a significant reduction in pain after treatment , though only the exercise-alone group displayed reduced disability . A return to normal lumbar muscle function was observed in 28 % of patients , but was not related to a reduction in pain . CONCLUSION When applied to CLBP patients , KT leads to pain relief and lumbar muscle function normalization shortly after its application ; these effects persist over a short follow-up period . CLINICAL REHABILITATION IMPACT KT may represent an effective adjunct therapy in the physical rehabilitation program of CLBP patients for immediate and acute pain control OBJECTIVES To define the minimum clinical ly important difference ( MCID ) for the visual analog scale ( VAS ) of pain severity by measuring the change in VAS associated with adequate pain control . METHODS The authors conducted a prospect i ve , observational study . Adult emergency department ( ED ) patients with acute pain ( < 72 hours ) were eligible . Patients rated their pain severity on a 100-mm VAS on presentation and at discharge . Patients were asked if they would accept any analgesic , then if they would accept a parenteral analgesic before treatment . At discharge , they were asked whether they had received adequate pain control . RESULTS The authors enrolled 143 patients ( mean age , 36 years ; 54 % female ) . The mean decrease in VAS was -30.0 mm ( 95 % confidence interval [ CI ] = -36.4 to -23.6 ) for the 116 of 143 ( 81 % ) patients with adequate pain control at discharge vs. -5.7 ( 95 % CI = -11.2 to -0.3 ) for the 27 with inadequate pain control ( p < 0.001 ) . At discharge , the mean VAS was 31.3 mm for those with adequate pain control vs. 55.1 for those without . Mean VAS for the 114 of 143 patients who would accept any analgesics initially was 64.7 vs. 47.1 for the 29 reporting no analgesic need . Initially , 77 patients would accept parenteral analgesics ( mean VAS = 72.5 mm ) . CONCLUSIONS A mean reduction in VAS of 30.0 mm represents a clinical ly important difference in pain severity that corresponds to patients ' perception of adequate pain control . Defining MCID based on adequate analgesic control rather than minimal detectable change may be more appropriate for future analgesic trials , when effective treatments for acute pain exist BACKGROUND AND PURPOSE Assessment of the quality of r and omized controlled trials ( RCTs ) is common practice in systematic review s. However , the reliability of data obtained with most quality assessment scales has not been established . This report describes 2 studies design ed to investigate the reliability of data obtained with the Physiotherapy Evidence Data base ( PEDro ) scale developed to rate the quality of RCTs evaluating physical therapist interventions . METHOD In the first study , 11 raters independently rated 25 RCTs r and omly selected from the PEDro data base . In the second study , 2 raters rated 120 RCTs r and omly selected from the PEDro data base , and disagreements were resolved by a third rater ; this generated a set of individual rater and consensus ratings . The process was repeated by independent raters to create a second set of individual and consensus ratings . Reliability of ratings of PEDro scale items was calculated using multirater kappas , and reliability of the total ( summed ) score was calculated using intraclass correlation coefficients ( ICC [ 1,1 ] ) . RESULTS The kappa value for each of the 11 items ranged from.36 to.80 for individual assessors and from.50 to.79 for consensus ratings generated by groups of 2 or 3 raters . The ICC for the total score was.56 ( 95 % confidence interval=.47-.65 ) for ratings by individuals , and the ICC for consensus ratings was.68 ( 95 % confidence interval=.57-.76 ) . DISCUSSION AND CONCLUSION The reliability of ratings of PEDro scale items varied from \" fair \" to \" substantial , \" and the reliability of the total PEDro score was \" fair \" to \" good . DESIGN R and omized clinical trial . OBJECTIVES To determine the short-term effects of Kinesio Taping , applied to the cervical spine , on neck pain and cervical range of motion in individuals with acute whiplash-associated disorders ( WADs ) . BACKGROUND Research ers have begun to investigate the effects of Kinesio Taping on different musculoskeletal conditions ( eg , shoulder and trunk pain ) . Considering the demonstrated short-term effectiveness of Kinesio Tape for the management of shoulder pain , it is suggested that Kinesio Tape may also be beneficial in reducing pain associated with WAD . METHODS AND MEASURES Forty-one patients ( 21 females ) were r and omly assigned to 1 of 2 groups : the experimental group received Kinesio Taping to the cervical spine ( applied with tension ) and the placebo group received a sham Kinesio Taping application ( applied without tension ) . Both neck pain ( 11-point numerical pain rating scale ) and cervical range-of-motion data were collected at baseline , immediately after the Kinesio Tape application , and at a 24-hour follow-up by an assessor blinded to the treatment allocation of the patients . Mixed-model analyses of variance ( ANOVAs ) were used to examine the effects of the treatment on each outcome variable , with group as the between-subjects variable and time as the within-subjects variable . The primary analysis was the group-by-time interaction . RESULTS The group-by-time interaction for the 2-by-3 mixed \n Output:\n " }, { "from": "agent", "value": "The combined results of this meta- analysis indicate that kinesiology tape may have limited potential to reduce pain in individuals with musculoskeletal injury ; however , depending on the conditions , the reduction in pain may not be clinical ly meaningful .\nKinesiology tape application did not reduce specific pain measures related to musculoskeletal injury above and beyond other modalities compared in the context of included articles ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: CONTEXT Education in simulated learning environments ( SLEs ) has grown rapidly across health care professions , yet no substantive r and omised controlled trial ( RCT ) has investigated whether SLEs can , in part , substitute for traditional clinical education . METHODS Participants were physiotherapy students ( RCT 1 , n = 192 ; RCT 2 , n = 178 ) from six Australian universities undertaking clinical education in an ambulatory care setting with patients with musculoskeletal disorders . A simulated learning programme was developed as a replica for clinical education in musculoskeletal practice to replace 1 week of a 4-week clinical education placement . Two SLE models were design ed . Model 1 provided 1 week in the SLE , followed by 3 weeks in clinical immersion ; Model 2 offered training in the SLE in parallel with clinical immersion during the first 2 weeks of the 4-week placement . Two single-blind , multicentre RCTs ( RCT 1 , Model 1 ; RCT 2 , Model 2 ) were conducted using a non-inferiority design to determine if the clinical competencies of students part-educated in SLEs would be any worse than those of students educated fully in traditional clinical immersion . The RCTs were conducted simultaneously , but independently . Within each RCT , students were stratified on academic score and r and omised to either the SLE group or the control ( ' Traditional ' ) group , which undertook 4 weeks of traditional clinical immersion . The primary outcome measure was a blinded assessment of student competency conducted over two clinical examinations at week 4 using the Assessment of Physiotherapy Practice ( APP ) tool . RESULTS Students ' achievement of clinical competencies was no worse in the SLE groups than in the Traditional groups in either RCT ( Margin [ Δ ] ≥ 0.4 difference on APP score ; RCT 1 : 95 % CI - 0.07 to 0.17 ; RCT 2 : 95 % CI - 0.11 to 0.16 ) . CONCLUSIONS These RCTs provide evidence that clinical education in an SLE can in part ( 25 % ) replace clinical time with real patients without compromising students ' attainment of the professional competencies required to practise OBJECTIVE The purpose of this study was to investigate a quantitative biomechanical evaluation method for contact forces exerted during a manual examination and treatment technique used in a learning environment . The evaluation was based on three-dimensional ( 3D ) force component data . METHODS A h and -/palm-held computerized 3D force component measuring system was used during a simple feedback experiment involving 20 second-year university students of physiotherapy who delivered 5 sets of grade d perpendicular manual push forces on the sensor part of the system , which was placed on the padded surface of an examination/treatment table . In an effect study with a multiple time-series design , a r and omly chosen subgroup of subjects received concurrent visual 3D kinetic/dynamic force-time feedback . RESULTS The students delivered grade d perpendicular forces with good intrasubject consistency ( intraclass correlation coefficient [ 3 , 1 ] : mean , 0.80 ; range , 0.76 - 0.88 ) but with poor intersubject consistency ( intraclass correlation coefficient [ 2 , 1 ] : mean , 0.38 ; range , 0.15 - 0.74 ) . A temporary performance improvement in forward-backward force direction deviations from the perpendicular in the subgroup given feedback indicates that students are sensitive to feedback training . CONCLUSION An evaluation tool using 3D contact force component measurement enables the assessment of the overall magnitude of the manual contact force as well as its directional aspect . Compared with existing evaluations based on 1-dimensional force components , this 3D system allows for a more complete and , at the same time , more specific quantitative evaluation of the manual contact forces . Three-dimensional dynamic/kinetic augmented feedback has the additional potential of helping students and practitioners to improve their palpation and force delivery skills This study was design ed to investigate whether concurrent quantitative feedback of performance could improve the learning of a joint mobilization technique . A group of 110 physical therapy students had been r and omly divided into two groups for teaching purpose s. All students had previously learned mobilization of peripheral joints and were currently learning spinal mobilization . From one of the groups , 22 students volunteered to comprise a control group , which was taught a spinal mobilization technique in the traditional way . Additional concurrent quantitative feedback of the level of force applied to the patient was given to 31 volunteers from the other group . These students formed the experimental group . A force plate was used for force measurement , and the feedback was given via an oscilloscope . The average force applied by the students ' instructors was taken as an \" ideal \" force . The oscilloscope showed both the applied force and the \" ideal \" force . Consistency was measured by the variance of the group 's performance . Accuracy was assessed by calculating the difference between the applied force and the \" ideal \" force . Results indicated that this feedback was associated with a significant improvement in accuracy and consistency in the application of the mobilizing force . This improvement was still present at a follow-up test conducted one week later . This result supports a greater use of such feedback in the teaching and practice of joint mobilization techniques , although the need for further research is emphasized Introduction Simulated learning environments ( SLEs ) are used worldwide in health professional education , including physiotherapy , to train certain attributes and skills . To date , no r and omized controlled trial ( RCT ) has evaluated whether education in SLEs can partly replace time in the clinical environment for physiotherapy cardiorespiratory practice . Methods Two independent single-blind multi-institutional RCTs were conducted in parallel using a noninferiority design . Participants were volunteer physiotherapy students ( RCT 1 , n = 176 ; RCT 2 , n = 173 ) entering acute care cardiorespiratory physiotherapy clinical placements . Two SLE models were investigated as follows : RCT 1 , 1 week in SLE before 3 weeks of clinical immersion ; RCT 2 , 2 weeks of interspersed SLE/ clinical immersion ( equivalent to 1 SLE week ) within the 4-week clinical placement . Students in each RCT were stratified on academic grade and r and omly allocated to an SLE plus clinical immersion or clinical immersion control group . The primary outcome was competency to practice measured in 2 clinical examinations using the Assessment of Physiotherapy Practice . Secondary outcomes were student perception of experience and clinical educator and patient rating of student performance . Results There were no significant differences in student competency between the SLE and control groups in either RCT , although students in the interspersed group ( RCT 2 ) achieved a higher score in 5 of 7 Assessment of Physiotherapy Practice st and ards ( all P < 0.05 ) . Students rated the SLE experience positively . Clinical educators and patients reported comparability between groups . Conclusions An SLE can replace clinical time in cardiorespiratory physiotherapy practice . Part education in the SLE satisfied clinical competency requirements , and all stakeholders were satisfied UNLABELLED The purpose of this study was to determine whether providing physical therapy ( PT ) students with instructions in proper ultrasound ( US ) pressure application would result in more optimal pressures compared with pressures obtained by students who were not instructed . Previous research determined that for transmission to be adequate , optimal pressure must be 600 g. A sample of convenience of PT students in our program participated in this study . Students were divided into two groups : 31 first-year students who were instructed ( group 1 ) and 34 third-year students who were not instructed ( group 2 ) in US pressure application . METHODS The students who were trained in this new parameter did so as part of the electromodalities course and were compared with untrained third-year students . Group 1 received specific verbal instructions during laboratory , and then performed the US to a gel pad placed on top of a digital scale while observing the digital pressure readout for feedback . This group was retested 7 months later to determine retention of skill acquisition . For data collection , all students applied US for 5 minutes with pressures recorded every 30 seconds and were blinded to the readout . The group without instructions had a mean pressure of 321.92 g ( SD , 257.82 ) , and the group with instructions had a mean of 607.29 g ( SD , 145.52 ) 4 weeks after training . The difference between means was significant ( t[60.4 ] = 8.54 , p < 0.000 ) . Follow-up scores 7 months later for group 1 showed a mean of 587.23 g ( SD , 284.17 ) , not significantly different from the first measurements ( p = 0.807 ) . The results showed a significant difference between groups , whereby students who received instructions outperformed those who did not , overall were more accurate in their perception of US pressure , and showed good retention skills , reaffirming that feedback is a valuable learning tool . For US to be effective , proper pressure must be exerted , and this should be a parameter instructed in schools where US is taught to improve treatment effectiveness Background and Purpose Joint mobilization is a complicated task to learn and to teach and is characterized by great intersubject variability . This study 's purpose was to investigate whether quantitatively augmented feedback could enhance the learning of joint mobilization and , more specifically , to compare the effects of training with concurrent or terminal feedback by using a joint translation simulator ( JTS ) . Subjects Thirty-six undergraduate physical therapist students were r and omly assigned to control ( no feedback ) , concurrent feedback , and terminal feedback groups . Methods The JTS was design ed to simulate tissue resistance based on load-displacement relationships of glenohumeral joint specimens . Subjects applied specific mobilization grade s of force on the JTS while quantitative feedback was given to the feedback groups either during a trial ( ie , concurrent feedback ) or after a trial ( ie , terminal feedback ) . The skill acquisition phase lasted a total of 40 minutes , and a total of 75 repetitions were performed for each grade of each joint model . Pretest and no-feedback retention tests were conducted . Results During acquisition and retention , both feedback groups performed more accurately than did the control group . No obviously superior performance was shown by the terminal feedback group compared with concurrent feedback group during retention testing . Discussion and Conclusion Subjects who trained with augmented feedback had less variability , and thus more consistency , than the control group subjects who received no feedback . Augmented feedback provides the student with a reference force and the status of his or her performance . The effectiveness of the JTS feedback compared with no feedback was clearly demonstrated . Skill acquisition in mobilization can be enhanced by either concurrent or terminal feedback Purpose To evaluate the effectiveness of a novel , simulation-based educational model rooted in scaffolding theory that capitalizes on a systematic progressive sequence of simulators that increase in realism ( i.e. , fidelity ) and information content . Method Forty-five medical students were r and omly assigned to practice intravenous catheterization using high-fidelity training , low-fidelity training , or progressive training from low to mid to high fidelity . One week later , participants completed a transfer test on a st and ardized patient simulation . Blinded expert raters assessed participants ' global clinical performance , communication , procedure documentation , and technical skills on the transfer test . Participants ' management of the re sources available during practice was also recorded . Data were analyzed using multivariate analysis of variance . The study was conducted in fall 2008 at the University of Toronto . Results The high-fidelity group scored higher ( P < .05 ) than the low-fidelity group on all measures except procedure documentation . The progressive group scored higher ( P < .05 ) than other groups for documentation and global clinical performance and was equivalent to the high-fidelity group for communication and technical skills . Total practice time was greatest for the progressive group ; however , this group required little practice time on the re source -intensive high-fidelity simulator . Conclusions Allowing students to progress in their practice on simulators of increasing fidelity led to superior transfer of a broad range of clinical skills . Further , this progressive group was re source -efficient , as participants concentrated on lower fidelity and lower re source -intensive simulators . It is suggested that clinical training curricula incorporate exposure to multiple simulators to maximize educational benefit and potentially save educator time \n Output:\n " }, { "from": "agent", "value": "While there were few r and omized controlled trials with vali date d outcome measures , some discoveries about simulation can positively affect the design of the PT entry-to- practice curricula .\nUsing simulators to provide specific output feedback can help students learn specific skills .\nComputer simulations can also augment students ' learning experience .\nHuman simulation experiences in managing the acute patient in the ICU are well received by students , positively influence their confidence , and decrease their anxiety .\nThere is evidence that simulated learning environments can replace a portion of a full-time 4-week clinical rotation without impairing learning .\nCONCLUSIONS Simulation-based learning activities are being effectively incorporated into PT curricula ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: Between 1978 and 1982 an experiment on group treatment for and by psoriasis sufferers was conducted , based on a pyramid of previous investigations since 1968 . Each group was facilitated by a duo consisting of a fellow sufferer and a physician , both having trained together . The subjects practice d the procedure described , directed toward self-care and mutual aid facilitated and supported by the duo , in a series of ten 2-hour weekly sessions . A pretest/posttest control group design was used . Comparing the results of the quantitative analysis of the experimental groups with those of the control groups , the experimental groups showed significant change . The results of the qualitative analysis showed that decrease of anxiety correlated with mastering of the skills involved . The key element affecting outcome was the balance in cooperation within the duo , the expertise of the patient lying in his personal experience of the condition , and the expertise of the physician in his knowledge and skills . One of the method 's main characteristics was the intrinsic complementarity of the duo partners OBJECTIVES The purpose of this study was to investigate the effects of a cognitive-behavioral psoriasis symptom management programme ( PSMP ) on patient-held perceptions about their condition and patients ' use of self-reported coping strategies , and to examine the influence of alexithymia scores at induction on response to treatment . DESIGN Age- and sex-matched case-controlled prospect i ve study . METHODS A total of 40 patients with psoriasis were treated in the PSMP , and an age- and sex-matched cohort received st and ard pharmacological care only . The Illness Perception Question naire was used to assess patients ' beliefs about illness identity , time-line , consequences , cure/control and perceptions of the cause of their psoriasis . Participants also completed the COPE question naire and the Toronto Alexithymia Scale ( TAS-20 ) . RESULTS Results suggested that at 6-month follow-up , patients who chose the PSMP showed significant reductions in illness identity ( the frequency and severity of symptoms that patients associate with their condition ) , the strength of belief in severity of consequences of their illness , and their attributions for emotional causes of their psoriasis . Perceptions about the anticipated course of the disease ( time-line ) , its cure or controllability , ideas about physical agents of causation , and coping strategies did not differ between PSMP patients or controls at 6-week or 6-month follow-up . Alexithymia had no effect on response to treatment . Regression analyses demonstrated the importance of both participation in the PSMP and demographic/ clinical history variables in accounting for significant variance in illness-perception-change scores . CONCLUSION The findings are generally supportive of multivariate models of intervention , but the lack of a demonstrated effect of the intervention on coping may have implication s for both the assessment of coping in psoriasis and the nature of psychological interventions proposed for its management Psychological difficulty , particularly in social situations , is widely reported by disfigured people , but many receive no formal psychological treatment . This study r and omly allocated 106 facially disfigured people either to receive a self-help leaflet offering cognitive-behavioural guidance or not . Participants were assessed pre-treatment and at 3 month follow-up . The untreated group then received the leaflet . Participants in the leaflet group fared better than controls on 3 of the 9 scales employed ( Social Leisure [ SAQ ] ( t=2.31 , p=0.012 ) , HADS anxiety ( t=2.22 , p=0.015 ) , HADS depression ( t=1.83 , p=0.036 ) . There is support for a cognitive-behavioural approach and the usefulness of self-help instructions in addressing the social difficulties of facially disfigured people . The approach merits further development and investigation Vitiligo is a progressive condition involving a loss of pigmentation in the skin ; it can be disfiguring and no effective treatment or cure exists . Although vitiligo 's medical effects have been studied extensively , little attention has been paid to its psychological impact or to the effects of psychological state on the illness itself . To address these issues , the present study examined the effect of cognitive behavioural therapy on coping with vitiligo and adaptation to the negative effects on body image , quality of life and self-esteem in adult patients . The study also examined whether any psychological gains acquired from psychological therapy would influence the progression of the condition itself . Two matched groups of vitiligo patients were compared , one of which received cognitive-behavioural therapy over a period of 8 weeks , while the other received no changes to their treatment status . All patients were assessed on self-esteem , body image and quality of life , prior to , immediately following and 5 months following the end of therapy . The progression of the condition was assessed by photographing patients prior to the start of counselling and 5 months following counselling . Results suggest that patients can benefit from cognitive behavioural therapy in terms of coping and living with vitiligo . There is also preliminary evidence to suggest that psychological therapy may have a positive effect on the progression of the condition itself . Implication s for incorporating psychological counselling into patient care and management are discussed Summary Background Patients with psoriasis may experience significant psychological and social disabilities . Stress or distress are proposed aggravators of the disease process in psoriasis . Preliminary studies to date have suggested that adjunctive psychological therapies may be effective in the clinical management of psoriasis \n Output:\n " }, { "from": "agent", "value": "None of the papers demonstrated adequately the clinical effectiveness of the interventions ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: OBJECTIVE : To evaluate the yield , economic , and radiation costs of 5 diagnostic algorithms compared with a protocol where all tests are performed ( ultrasonography scan , cystography , and late technetium99dimercaptosuccinic acid scan ) in children after the first febrile urinary tract infections . METHODS : A total of 304 children , 2 to 36 months of age , who completed the diagnostic follow-up ( ultrasonography , cystourethrography , and acute and late technetium99dimercaptosuccinic acid scans ) of a r and omized controlled trial ( Italian Renal Infection Study 1 ) were eligible . The guidelines applied to this cohort in a retrospective simulation were : Melbourne Royal Children ’s Hospital , National Institute of Clinical Excellence ( NICE ) , top down approach , American Academy of Pediatrics ( AAP ) , and Italian Society of Pediatric Nephrology . Primary outcomes were the yield of abnormal tests for each diagnostic protocol ; secondary outcomes were the economic and radiation costs . RESULTS : Vesicoureteral reflux ( VUR ) was identified in 66 ( 22 % ) children and a parenchymal scarring was identified in 45 ( 15 % ) . For detection of VUR ( 47/66 ) and scarring ( 45/45 ) , the top down approach showed the highest sensitivity ( 76 % and 100 % , respectively ) but also the highest economic and radiation costs ( € 52 268 . 624 mSv ) . NICE ( 19/66 ) and AAP ( 18/66 ) had the highest specificities for VUR ( 90 % ) and the Italian Society of Pediatric Nephrology had the highest specificity ( 20/45 ) for scars ( 86 % ) . NICE would have been the least costly ( € 26 838 ) and AAP would have result ed in the least radiation exposure ( 42 mSv ) . CONCLUSIONS : There is no ideal diagnostic protocol following a first febrile urinary tract infection . An aggressive protocol has a high sensitivity for detecting VUR and scarring but carries high financial and radiation costs with question able benefit Abstract . We attempted to verify in a group of 101 children with first urinary tract infection whether it was possible to identify groups of patients with different risks of developing renal scarring by taking into account both the extent of kidney involvement documented in the acute phase of infection using a dimercaptosuccinic acid ( DMSA ) scan , and the presence or absence of vesicoureteral reflux ( VUR ) . The frequency of persistent lesions in kidneys with mild-moderate lesions ( less than 50 % of kidney involvement ) in the presence of VUR or in non-refluxing kidneys was similar ( P=0.1447 ) , while the frequency of persistent lesions in kidneys with severe lesions in the presence of VUR was significantly higher than the frequency of persistent lesions in non-refluxing kidneys ( P=0.0089 ) . The extent of kidney involvement and the presence of VUR make possible the identification of different categories of risk of scarring : in the ” low risk group ” ( normal kidney with/without VUR ) the risk of scarring is 0 % ; in the ” intermediate risk group ” ( mild lesions with/without VUR ; extensive lesions without VUR ) the risk of scarring is between 14 % and 38 % , while in the ” high risk group ” ( extensive lesions with VUR ) the risk of scarring is 88 % . Quantifying the risk of scarring could help in planning the treatment or in modifying the later strategy BACKGROUND Guidelines from the American Academy of Pediatrics recommend obtaining a voiding cystourethrogram and a renal ultrasonogram for young children after a first urinary tract infection ; renal scanning with technetium-99m-labeled dimercaptosuccinic acid has also been endorsed by other authorities . We investigated whether imaging studies altered management or improved outcomes in young children with a first febrile urinary tract infection . METHODS In a prospect i ve trial involving 309 children ( 1 to 24 months old ) , an ultrasonogram and an initial renal scan were obtained within 72 hours after diagnosis , contrast voiding cystourethrography was performed one month later , and renal scanning was repeated six months later . RESULTS The ultrasonographic results were normal in 88 percent of the children ( 272 of 309 ) ; the identified abnormalities did not modify management . Acute pyelonephritis was diagnosed in 61 percent of the children ( 190 of 309 ) . Thirty-nine percent of the children who underwent cystourethrography ( 117 of 302 ) had vesicoureteral reflux ; 96 percent of these children ( 112 of 117 ) had grade I , II , or III vesicoureteral reflux . Repeated scans were obtained for 89 percent of the children ( 275 of 309 ) ; renal scarring was noted in 9.5 percent of these children ( 26 of 275 ) . CONCLUSIONS An ultrasonogram performed at the time of acute illness is of limited value . A voiding cystourethrogram for the identification of reflux is useful only if antimicrobial prophylaxis is effective in reducing reinfections and renal scarring . Renal scans obtained at presentation identify children with acute pyelonephritis , and scans obtained six months later identify those with renal scarring . The routine performance of urinalysis , urine culture , or both during subsequent febrile illnesses in all children with a previous febrile urinary tract infection will probably obviate the need to obtain either early or late scans BACKGROUND Antibiotics are widely administered to children with the intention of preventing urinary tract infection , but adequately powered , placebo-controlled trials regarding efficacy are lacking . This study from four Australian centers examined whether low-dose , continuous oral antibiotic therapy prevents urinary tract infection in predisposed children . METHODS We r and omly assigned children under the age of 18 years who had had one or more microbiologically proven urinary tract infections to receive either daily trimethoprim-sulfamethoxazole suspension ( as 2 mg of trimethoprim plus 10 mg of sulfamethoxazole per kilogram of body weight ) or placebo for 12 months . The primary outcome was microbiologically confirmed symptomatic urinary tract infection . Intention-to-treat analyses were performed with the use of time-to-event data . RESULTS From December 1998 to March 2007 , a total of 576 children ( of 780 planned ) underwent r and omization . The median age at entry was 14 months ; 64 % of the patients were girls , 42 % had known vesicoureteral reflux ( at least grade III in 53 % of these patients ) , and 71 % were enrolled after the first diagnosis of urinary tract infection . During the study , urinary tract infection developed in 36 of 288 patients ( 13 % ) in the group receiving trimethoprim-sulfamethoxazole ( antibiotic group ) and in 55 of 288 patients ( 19 % ) in the placebo group ( hazard ratio in the antibiotic group , 0.61 ; 95 % confidence interval , 0.40 to 0.93 ; P = 0.02 by the log-rank test ) . In the antibiotic group , the reduction in the absolute risk of urinary tract infection ( 6 percentage points ) appeared to be consistent across all subgroups of patients ( P > or = 0.20 for all interactions ) . CONCLUSIONS Long-term , low-dose trimethoprim-sulfamethoxazole was associated with a decreased number of urinary tract infections in predisposed children . The treatment effect appeared to be consistent but modest across subgroups . ( Australian New Zeal and Clinical Trials Registry number , ACTRN12608000470392 . A prospect i ve blind study comparing the findings of ultrasonography , intravenous pyelography , and voiding cystourethrography was conducted on 81 patients to examine the place of ultrasonography in the initial radiologic evaluation of children with urinary tract infection . The patients ' mean age was 4.8 years ; 15 were male . Forty-eight were in patients ( mean age , 3.2 years ) and 33 were out patients ( mean age 7.2 years ) . In 29 patients ( 35.8 % ) abnormality of the urinary system was detected by one or more of the three imaging procedures ; 21 were in patients and eight were out patients . The most frequent finding was vesicoureteral reflux , occurring in 62.1 % of the pathologic cases . The findings at ultrasonography correlated well with those of intravenous pyelography in 73 of the 81 studies ( 90.1 % ) , but they failed to demonstrate double collecting systems and several of the minor changes . However , ultrasonography in combination with cystourethrography identified all patients who had abnormal urinary systems , except for two children with negligible findings . Moreover , ultrasonography and cystourethrography together identified all 11 patients , nine of them in patients , in whom surgical treatment was indicated . It is concluded that ultrasonography can successfully replace intravenous pyelography as a screening imaging procedure for the urinary system , but because of the superiority of intravenous pyelography in the detection of some types of lesions , intravenous pyelography will be required whenever ultrasonography or cystourethrography results are abnormal . ( ABSTRACT TRUNCATED AT 250 WORDS OBJECTIVE To track the clinical evolution of febrile urinary tract infection ( UTI ) diagnosed in 0- to 3-month-old infants and characterize uropathogen frequencies , antimicrobial resistance rates , renal abnormalities , and differences in the sexes in this age group . STUDY DESIGN We observed prospect ively 46 infants identified in a cohort of 209 children with first UTI diagnosed between July 2006 and July 2008 at the age of 0 to 3 months . Renal ultrasound scanning and voiding cystourethrography examinations were performed in all infants . RESULTS Infants < 3 months old represented 21 % of all children with first UTI . Of these children , 26 % were female and 74 % were male . Escherichia coli was isolated in 88 % of cases and had a high rate of resistance to ampicillin ( 71 % ) and to trimethoprim/sulfamethoxazole ( 47 % ) ; 21 % of children had vesicoureteral reflux , which was of low- grade in 67 % of cases , with spontaneous resolution before 2 years in all cases . In infants with normal ultrasound scanning results , a low- grade vesicoureteral reflux was subsequently found in 10 % of cases . CONCLUSION Infants aged 0 to 3 months represent 21 % of children treated for febrile UTI . Boys represent 74 % of these cases . E coli is responsible for 88 % of UTIs , with a high rate of resistance to antibiotics . When ultrasound scanning examination results are normal , the risk of missing a significant renal abnormality is expected to be extremely low This prospect i ve study was done to assess the frequency of acute pyelonephritis ( APN ) in febrile children with positive urine culture as documented by Tc99 m DMSA scintigraphy ( DMSA ) and the frequency of vesicoureteric reflux ( VUR ) in these children . Secondly , to determine the frequency of APN , in febrile children with supportive evidence for UTI but with negative urine culture , as documented by DMSA and frequency of VUR in them . Thirdly to stress the utility of DMSA to diagnose APN in urine culture negative febrile children and to suggest DMSA as a clinical tool in evaluation of fever of unknown origin ( FUO ) . This study included 42 children with positive urine culture and 26 children with negative urine culture who had supportive evidence of UTI as determined by the predetermined criteria and diagnosed to have APN by DMSA . All of them had ultrasonogram ( USG ) , DMSA and voiding cystourethrogram ( VCU ) . They were followed up for a minimum period of 6 months . Out of the 42 children with positive urine culture 92.9 % had features of APN in the DMSA of whom 82.1 % had vesicoureteric relux ( VUR ) . The DMSA was abnormal in 26 children with negative urine culture , of whom 65.4 % had VUR . Ultrasound suggestive of parenchymal change was observed in 47.6 % in the culture positive group and 65.4 % in the culture negative group . In conclusion , it is suggested , that DMSA is a useful investigation for the diagnosis of APN in febrile UTI . DMSA is indicated in febrile children with negative urine culture but with supportive evidence of UTI and in FUO . An abnormal DMSA is a strong indication for work up for VUR We assessed the role of therapeutic delay time ( TDT ) in acute renal cortical scintigraphic lesion ( ASL ) and ultimate scar formation ( USF ) in children with first febrile UTI and whether it is affected by the presence of vesico-ureteral reflux ( VUR ) . 230 children , 90 girls and 140 boys with first febrile UTI were included . Radiologic ( USG , DMSA , and VCUG ) , clinical ( age , gender , peak fever , therapeutic delay time ) and laboratory ( CBC with differential count , ANC ( absolute neutroph \n Output:\n " }, { "from": "agent", "value": "Neither the renal ultrasound nor the DMSA scan is accurate enough to detect VUR ( of all grade s ) .\nAlthough a child with a negative DMSA test has an < 1 % probability of having high- grade VUR , performing a screening DMSA will result in a large number of children falsely labelled as being at risk for high- grade VUR ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: Abstract The longitudinal observations for ten years on 5209 men and women aged 30–62 in Framingham , Massachusetts , have been used for a prospect i ve investigation of the epidemiology of gallbladder disease . ‘ Definite ’ gallbladder disease was diagnosed in 427 persons on the evidence of pathology reports , surgery , X-ray and hospital admissions and 116 were ‘ doubtful ’ , having only the diagnosis suggested by a physician without further verification . The overall incidence of gallbladder disease was about twice as high in women as in men , and it increased with age in both sexes without any evidence of an excess in the forties . Gallbladder disease was not related to ‘ fairness ’ as measured by national origin . Increase in weight and number of pregnancies were each associated with increased incidence . Despite the presence of cholesterol in many gallstones and the elevation of serum cholesterol often noted with obesity and during pregnancy , no relationship was demonstrated between serum cholesterol level and gallbladder disease . Hemoglobin level was also not related in the population studied . Women with lower systolic blood pressures showed a somewhat reduced risk of gallbladder disease , but the possibility that a mutual relationship to weight could explain this has not been excluded . Slight negative correlations were noted between the disease incidence and height , and alcohol and cigarette consumption . These were small and in general not statistically significant . Dietary fat , protein and cholesterol intake , level of physical activity , age at menopause , marital status and precinct of residence were not related to gallbladder disease . Nor was an excess incidence noted in persons whose spouses had gallbladder disease . Persons entering the study with gallbladder disease showed no excess mortality . It is not yet clear whether such persons develop coronary heart disease at an excess rate . Potent environmental factors influencing the rate of development of gallbladder disease have yet to be identified . On the basis of present evidence , it would appear that more attention should be devoted to the anatomy and pathological physiology of the biliary tract in seeking a better underst and ing of the pathogenesis of gallbladder disease Ten healthy volunteers ( six men and four women , aged 22 - 41 years ) were studied in a crossover trial . The study was divided into three one week periods . During each period the subjects either ran on a treadmill , cycled on a bicycle ergometer , or rested in a chair for 1 hour every day . The exercise was performed at two thirds predicted maximum heart rate ( equivalent to 50 % VO2 max ) . The sequences were rotated ; no studies were performed in the perimenstrual period . Transit was measured by the method of measuring the excretion of a single dose of radio-opaque markers ; all stools were collected , weighed , and x rayed after the ingestion of radio-opaque markers . Dietary fibre and fluid intake were measured on the fourth day of each test period by 24 hour record . Lifestyle was otherwise unchanged . Transit time was dramatically accelerated by moderate exercise ( both jogging and cycling ) ; however , stool weight , defecation frequency , dietary fibre intake , and fluid intake did not change significantly . Whole gut transit changed from 51.2 hours ( 95 % confidence intervals 41.9 to 60.5 ) at rest to 36.6 hours ( 31.6 to 39.2 ) when riding and 34.0 hours ( 28.8 to 39.2 ) when jogging . Riding and running both differed significantly from resting ( p less than 0.01 ) ; the difference between riding and running was not significant PURPOSE Regular exercise reduces cardiovascular risk in humans by reducing cholesterol levels , but the underlying mechanisms have not been fully explored . Exercise might provoke changes in cholesterol and bile acid metabolism and thereby reduce cardiovascular risk . We examined whether voluntary wheel running in mice modulates cholesterol and bile acid metabolism . METHODS Male mice ( 10 wk old ) were r and omly assigned to have access to a voluntary running wheel for 2 wk ( RUN group ) or remained sedentary ( SED group ) . Running wheel activity was recorded daily . In a first experiment , fecal sterol outputs , fecal bile acid profiles , plasma parameters , and expression levels of genes involved in cholesterol and bile acid metabolism were determined . In a second experiment , bile flow , biliary bile acid profile , and biliary secretion rates of cholesterol , phospholipids , and bile acids were determined . RESULTS The RUN group ran an average of 10 km.d and displayed lower plasma cholesterol compared with SED ( P = 0.030 ) . Fecal bile acid loss was induced by approximately 30 % in running mice compared with SED ( P = 0.0012 ) . A approximately 30 % increase in fecal cholesterol output in RUN ( P = 0.014 ) was consistent with changes in parameters of cholesterol absorption , such as reduced plasma plant sterol-cholesterol ratio ( P = 0.044 ) and decreased jejunal expression of Npc1l1 ( P = 0.013 ) . Supportive of an increased cholesterol synthesis to compensate for fecal sterol loss were increased hepatic mRNA levels of HMGCoA reductase ( P = 0.006 ) and an increased plasma lathosterol-cholesterol ratio ( P = 0.0011 ) in RUN . CONCLUSIONS Voluntary wheel running increased cholesterol turnover in healthy mice owing to an increased fecal bile acid excretion and a decreased intestinal cholesterol absorption . Enhanced cholesterol turnover may contribute to the established reduction of cardiovascular risk induced by regular exercise Despite the high prevalence of gallbladder disease in industrialized countries , little is known about the predictors of the disease , especially in men . The authors prospect ively studied 16,785 alumni of Harvard University , aged 15 - 24 years , who were followed for up to 61 years . The health characteristics of these men were ascertained from their college entrance physical examination done in 1916 - 1950 , and up date d via mailed question naires in 1962 or 1966 ( 1962/1966 ) . Alumni subsequently self-reported physician-diagnosed gallbladder disease on further mailed question naires in 1972 or 1977 . Between college time and 1962/1966 , 371 gallbladder disease cases occurred . An additional 314 cases occurred after 1962/1966 . With respect to college characteristics , after adjustment for potential confounders , the authors found that body mass index ( BMI ) , smoking , physical activity , blood pressure , and consumption of alcohol , coffee , or tea were unrelated to risk . However , BMI in 1962/1966 was directly related to risk of subsequent gallbladder disease , as was BMI gain since college ( p , trend = 0.002 and 0.013 , respectively ) . Compared with men with BMI < 22.0 , men with BMI > or = 27.0 had a rate ratio of 2.71 ( 95 % confidence interval ( CI ) 1.57 - 4.66 ) for risk of contracting the disease . Men who gained > or = 6.0 BMI units since college had a rate ratio of 1.46 ( 95 % CI 0.86 - 2.46 ) compared with men who gained -0.9 to + 0.9 BMI units . Compared with never smokers , men who smoked pipes or cigars or < 1 pack of cigarettes daily in 1962/1966 had a rate ratio of 1.43 ( 95 % CI 1.00 - 2.06 ) , while heavier cigarette smokers had a rate ratio of 1.52 ( 95 % CI 1.03 - 2.24 ) . Neither physical activity nor physician-diagnosed hypertension or diabetes mellitus in 1962/1966 predicted risk Background Animal experiments have shown a protective effect of vitamin C on the formation of gallstones . Few data in humans suggest an association between reduced vitamin C intake and increased prevalence of gallstone disease . The aim of this study was to assess the possible association of regular vitamin C supplementation with gallstone prevalence . Methods An observational , population -based study of 2129 subjects aged 18 - 65 years r and omly selected from the general population in southern Germany was conducted . Abdominal ultrasound examination , completion of a st and ardized question naire , compilation of anthropometric data and blood tests were used . Data were collected in November and December 2002 . Data analysis was conducted between December 2005 and January 2006 . Results Prevalence of gallstones in the study population was 7.8 % ( 167/2129 ) . Subjects reporting vitamin C supplementation showed a prevalence of 4.7 % ( 11/232 ) , whereas in subjects not reporting regular vitamin C supplementation , the prevalence was 8.2 % ( 156/1897 ) . Female gender , hereditary predisposition , increasing age and body-mass index ( BMI ) were associated with increased prevalence of gallstones . Logistic regression with backward elimination adjusted for these factors showed reduced gallstone prevalence for vitamin C supplementation ( odds ratio , OR 0.34 ; 95 % confidence interval , CI 0.14 to 0.81 ; P = 0.01 ) , increased physical activity ( OR 0.62 ; 95 % CI , 0.42 to 0.94 ; P = 0.02 ) , and higher total cholesterol ( OR 0.65 ; 95 % CI , 0.52 to 0.79 ; P < 0.001 ) . Conclusion Regular vitamin C supplementation and , to a lesser extent , increased physical activity and total cholesterol levels are associated with a reduced prevalence of gallstones . Regular vitamin C supplementation might exert a protective effect on the development of gallstones BACKGROUND Gallstones are a highly prevalent condition ; however , the nutritional and lifestyle risk factors of this disease are not well understood . OBJECTIVE We evaluated the association between diet , physical activity , and incident cases of gallstones diagnosed by ultrasound in a population -based , case-control study . DESIGN One hundred patients with newly diagnosed gallstones and 290 r and omly selected control subjects without gallstones were enrolled in the study . The presence of gallstones was determined by ultrasonography . Both patients and control subjects completed a question naire about their usual diet and physical activity for the 12 mo before the ultrasonography . The association between diet and physical activity and risk of gallstone formation was analyzed by using multiple logistic regression . RESULTS Body mass index and intake of refined sugars were directly associated with risk of gallstone formation , whereas physical activity , dietary monounsaturated fats , dietary cholesterol , and dietary fibers from cellulose were inversely associated with risk of gallstone formation . Saturated fats were a risk factor for gallstone formation and the association appeared to be stronger for men than for women . CONCLUSION These findings suggest that a sedentary lifestyle and a diet rich in animal fats and refined sugars and poor in vegetable fats and fibers are significant risk factors for gallstone formation By means of loxiglumide , a potent and highly specific antagonist for cholecystokinin ( CCK ) , the effects of blocking CCK receptors on gastrointestinal motility were investigated in a placebo-controlled study in healthy young men ( aged 21 - 39 , mean 24 years ) . Gallbladder contraction stimulated by ingestion of a liquid test meal was completely abolished by oral administration of loxiglumide 30 min before the test meal . Gastric emptying of radio-opaque markers ingested with the test meal was significantly accelerated by loxiglumide ( area under the curve [ markers x h ] 33.3 [ SEM 3.8 ] vs 17.9 [ 2.7 ] after placebo ) . No effect of loxiglumide was found on small-bowel transit time , but 7 days ' treatment with oral loxiglumide ( 800 mg three times daily ) significantly shortened colonic transit time ( 29.4 [ 4.1 ] h after placebo , 15.0 [ 3.4 ] h after loxiglumide ) . It is concluded that CCK is an important mediator of meal-induced gallbladder contraction and is involved in the regulation of gastrointestinal motility in man Background The effects of vegetable preference and leisure-time physical activity ( LPA ) on cancer have been inconsistent . We examined the effects of dietary preference and physical activity , as well as their combined effect on cancer risk . Methods This prospect i ve cohort study included 444,963 men , older than 40 years , who participated in a national health examination program begun in 1996 . Based on the answer to the question \" What kind of dietary preference do you have ? \" we categorized dietary preference as ( 1 ) vegetables , ( 2 ) mixture of vegetables and meat , and ( 3 ) meats . We categorized LPA as low ( < 4 times/wk , < 30 min/session ) , moderate ( 2–4 times/wk , ≥ 30 min/session or ≥ 5 times/wk , < 30 min/session ) , or high ( ≥ 5 times/wk , ≥ 30 min/session ) . We obtained cancer incidence data for 1996 through 2002 from the Korean Central Cancer Registry . We used a st and ard Poisson regression model with a log link function and person-time offset \n Output:\n " }, { "from": "agent", "value": "Results The impact of physical activity upon gallbladder function remains unclear ; acute activity could augment emptying by stimulating cholecystokinin release , and one of two training experiments found a small increase in gallbladder motility .\nThe largest and most recent cross-sectional and case-control trials show a reduced risk of gallbladder disease in active individuals .\nConclusions Although there remains a need for further research , regular physical activity seems likely to reduce the risk of both gallstones and gallbladder cancer .\nA substantial number of individuals must be persuaded to exercise in order to avoid one case of gallbladder disease , but the attempt appears warranted because of the other health benefits of regular physical activity" } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: BACKGROUND The continued high mortality and morbidity rates for unintentional childhood injuries remain a public health concern . This article reports on the influence of a home visitation programme ( HVP ) on household hazards associated with unintentional childhood injuries in a South African low-income setting . METHODS A r and omised controlled trial ( n=211 households ) was conducted in a South African informal settlement . Community members were recruited and trained as paraprofessional visitors . Four intervention visits were conducted over 3 months , focusing on child development , and the prevention of burn , poison , and fall injuries . The HVP , a multi-component intervention , included educational inputs , provision of safety devices , and an implicit enforcement strategy . The intervention effect ( IE ) was measured with a st and ardised risk assessment index that compared post-intervention scores for intervention and control households . RESULTS A significant reduction was observed in the hazards associated with electrical and paraffin appliances , as well as in hazards related to poisoning . Non-significant changes were observed for burn safety household practice s and fall injury hazards . CONCLUSIONS This study confirmed that a multi-component HVP effectively reduced household hazards associated with electrical and paraffin appliances and poisoning among children in a low-income South African setting Objective : To access an underserved , mobile segment of a monolingual Spanish speaking population and to improve maternal self efficacy for home safety behaviors using a culturally appropriate intervention . Design : A pre- and post-test experimental design tested differences in maternal childhood injury health beliefs ( MCIHB ) and controllable safety hazards ( CHS ) . Participants were r and omly assigned to experimental and control groups . Baseline data assessed demographic and study variables comparability . The intervention included counseling , assessment of maternal safety practice s , and provision of safety items . Setting : A non-urban area in Texas where low income , largely migrant Hispanics represent the majority of residents . Participants : Eighty two mothers of 1–4 year old children . Results : The 95 % retention rate of an itinerant , hard to reach population suggests that minority participants may be receptive to culturally appropriate home visits . The intervention group demonstrated improved self efficacy for home safety behaviors ( F ( 2 , 77 ) = 7.50 , p = 0.01 ) . Mothers with stronger self efficacy and fewer perceived barriers had fewer accessible in-home hazards . Observed home hazard predictors were : ( a ) never being married ; ( b ) poor home repair , ( c ) lower self efficacy for safety behaviors ; and ( d ) control group status . Conclusions : Safety items coupled with a home visit tailored to child age and maternal culture was an effective intervention in a hard to reach population . This study contributes to design ing research for a monolingual population with limited local language proficiency and community residency . Injuries represent a major source of health disparities in these neglected population OBJECTIVE To determine whether educational baby books are an effective method for increasing low-income , first-time mothers ' safety practice s during their child 's first 18 months . METHODS Primiparous women ( n = 167 ) were r and omly assigned to 1 of 3 groups : an educational book group , a noneducational book group , or a no-book group . Home visits and interviews measured safety practice s when women were in their third trimester of pregnancy ( baseline ) and when their children were 2 , 4 , 6 , 9 , 12 , and 18 months of age . RESULTS Women in the educational book group had fewer risks in their homes and exercised more safety practice s than the no-book group ( - 20 % risk reduction ; effect size = -.30 ) . When the safety practice s involved little time or expense ( eg , putting away sharp objects ) , the educational book group was significantly more likely to engage in these behaviors than the no-book group ( 40 % higher practice s ; effect size = 0.19 ) or noneducational book group ( 27 % higher practice s ; effect size = 0.13 ) . However , no differences were found between groups for behaviors that required high effort in time , money , or hassle ( eg , installing latches on cabinets ) . CONCLUSIONS Educational baby books appear to be an easy and low-cost way to increase the safety practice s of new mothers , especially if the practice s involve little to no time , money , or hassle OBJECTIVE To test the efficacy of installing safety devices in the homes of young children on total injury rates and on injuries deemed a priori modifiable by the installation of these devices . DESIGN A nested , prospect i ve , r and omized controlled trial . SETTING Indoor environment of housing units . PARTICIPANTS Mothers and their children from birth to 3 years old participating in the Home Observation and Measures of the Environment study . Among 8878 prenatal patients , 1263 ( 14.2 % ) were eligible , 413 ( 32.7 % ) agreed to participate , and 355 were r and omly assigned to the intervention ( n = 181 ) or control ( n = 174 ) groups . INTERVENTION Installation of multiple passive measures ( eg , stair gates , cabinet locks , and smoke detectors ) to reduce exposure to injury hazards . Injury hazards were assessed at home visits by teams of trained research assistants using a vali date d survey . MAIN OUTCOME MEASURE Modifiable and medically attended injury ( ie , telephone calls , office visits , and emergency visits for injury ) . RESULTS The mean age of children at intervention was 6.3 months . Injury hazards were reduced in the intervention homes but not in the control homes at 1 and 2 years ( P < .004 ) . There was no difference in the rate for all medically attended injuries in intervention children compared with controls : 14.3 injuries ( 95 % confidence interval [ CI ] , 9.7 - 21.1 injuries ) vs 20.8 injuries ( 95 % CI , 14.4 - 29.9 injuries ) per 100 child-years ( P = .17 ) ; but there was a significant reduction in the rate of modifiable medically attended injuries in intervention children compared with controls : 2.3 injuries ( 95 % CI , 1.0 - 5.5 injuries ) vs 7.7 injuries ( 95 % CI , 4.2 - 14.2 injuries ) per 100 child-years ( P = .03 ) . CONCLUSION An intervention to reduce exposure to hazards in homes led to a 70 % reduction in the rate of modifiable medically attended injury . TRIAL REGISTRATION clinical trials.gov Identifier : NCT00129324 OBJECTIVE To assess the effectiveness of an emergency department (ED)-based home safety intervention on caregivers ' behaviors and practice s related to home safety . METHODS We conducted a r and omized , clinical trial of 96 consecutive caregivers of children who were younger than 5 years and presented to an urban pediatric ED for evaluation of an acute unintentional injury sustained in the home . After completing a structured home safety question naire via face-to-face interview , caregivers were r and omly assigned to receive either comprehensive home safety education and free safety devices or focused , injury-specific ED discharge instructions . Participants were contacted by telephone 2 months after the initial ED visit for repeat administration of the safety question naire . The pretest and posttest question naires were scored such that the accrual of points correlated with reporting of safer practice s. Scores were then normalized to a 100-point scale . The overall safety score reflected performance on the entire question naire , and the 8 category safety scores reflected performance in single areas of home injury prevention ( fire , burn , poison , near-drowning , aspiration , cuts/piercings , falls , and safety device use ) . The main outcome was degree of improvement in safety practice s as assessed by improvement in safety scores . RESULTS The intervention group demonstrated a significantly higher average overall safety score at follow-up than the control group ( 73.3 % + /- 8.4 % vs 66.8 % + /-11.1 ) and significant improvements in poison , cut/piercing , and burns category scores . Caregivers in the intervention group also demonstrated greater improvement in reported use of the distributed safety devices . CONCLUSIONS This educational and device disbursement intervention was effective in improving the home safety practice s of caregivers of young children . Moreover , the ED was used effectively to disseminate home injury prevention information Objective : to evaluate the effectiveness of a school-based injury prevention program . Design : Cluster r and omised controlled trial . Setting : 20 primary schools in Nottingham , UK . Participants : 459 children aged 7 to 10 years . Intervention : The “ Risk Watch ” program delivered by teachers , aim ed at improving bike and pedestrian , falls , poisoning and fire and burns safety . Main outcome measures : Safety knowledge , observed safety skills and self-reported safety behaviour . Results : At follow-up , intervention group children correctly answered more fire and burn prevention knowledge questions than control group children ( difference between means 7.0 % ( 95 % CI 1.5 % to12.6 % ) ) . Children in intervention group schools were more likely to know the correct actions to take if clothes catch fire and the correct way to wear a cycle helmet ( difference between school means 35.3 % ( 95 % CI 22.7 % to 47.9 % ) and 6.3 % ( 95 % CI 1.4 % to 11.1 % ) respectively ) . They were also more likely to know the correct actions to take in a house fire and on finding tablets ( OR 2.80 ( 95 % CI 1.08 to 7.22 ) and OR 3.50 ( 95 % CI 1.18 to 10.38 ) respectively ) and correctly demonstrated more safety skills than control group children ( difference between means 11.9 % ( 95 % CI 1.4 % to 22.5 % ) ) . There was little evidence to suggest the first year of the program impacted on self-reported safety behaviours . Conclusions : The Risk Watch program delivered by teachers in primary schools increased some aspects of children ’s safety knowledge and skills and primary schools should consider delivering this program . Longer term , larger scale evaluations are required to examine retention of knowledge and skills and impact on safety behaviours and child injury rates Abstract Objective To assess the effectiveness of safety advice and safety equipment in reducing unintentional injuries for families with children aged under 5 years and living in deprived areas . Design R and omised controlled trial . Setting 47 general practice s in Nottingham . Participants 3428 families with children under 5 . Intervention A st and ardised safety consultation and provision of free and fitted stair gates , fire guards , smoke alarms , cupboard locks , and window locks . Main outcome measures Primary outcome measures were whether a child in the family had at least one injury that required medical attendance and rates of attendance in primary and secondary care and of hospital admission for injury over a two year period . Secondary outcome measures included possession of safety equipment and safety practice s. Results No significant difference was found in the proportion of families in which a child had a medically attended injury ( odds ratio 1.14 , 95 % confidence interval 0.98 to 1.50 ) or in the rates of attendance in secondary care ( incidence rate ratio 1.02 , 0.90 to 1.13 ) or admission to hospital ( 1.02 , 0.70 to 1.48 ) . However , children in the intervention arm had a significantly higher attendance rate for injuries in primary care ( 1.37 , 1.11 to 1.70 , P = 0.003 ) . At both one and two years ' follow up , families in the intervention arm were significantly more likely to have a range of safety practice s , but absolute differences in the percentages were relatively small . Conclusions The intervention result ed in significant improvements in safety practice s for up to two years but did not reduce injuries that necessitated medical attendance . Although equipment was provided and fitted free of charge , the observed changes in safety practice s may not have been large enough to affect injury rates Objective : To investigate the effectiveness of a paraprofessional home visitation program ( HVP ) to improve home safety and prevent injuries among children living in low-income setting s. Methods : The HVP was implemented in two low-income communities in South Africa . In each community , approximately 200 households were r and omly selected for the trial . Eligible households were those with children aged ⩽10 years . Intervention households received four visits , one every two weeks , by trained paraprofessionals that focused on a specific injury topic and consisted of : information dissemination about specific injury prevention practice s ; home inspection accompanied by information about home hazards ; and the supply of safety devices . The key outcomes to measure the presence of home hazards were scores for burns ( safety practice s , paraffin , and electrical ) , poisoning , and falls . Results : Significant reductions were found for injury risks related to burn safety practice s. For injury risks related to electrical burns , paraffin burns , and poisoning , a decline was also noted although this was not statistically significant . No decline was noted for fall-related risks . Conclusions : Subject to further replication and evaluation , home visits by paraprofessionals providing safety education , home inspection , and safety devices be considered for integration into a comprehensive child injury prevention strategy in low-income communities BACKGROUND During the 20-month period September 1993 to April 1995 , a health education injury prevention programme focusing on home injuries among the young ( < or = 18 years old ) and elderly ( > or = 65 years old ) on the Greek isl and of Naxos was undertaken , its effectiveness was evaluated by comparing the subsequent injury experience in sentinel population groups in Naxos as well as in Spetses , another isl and of similar sociodemographic profile , where no such intervention programme had been formally implemented . METHODS On the isl and -of Naxos an injury prevention campaign was initially undertaken involving virtually all opinion leaders and implemented through lectures , workshops and publicity in \n Output:\n " }, { "from": "agent", "value": "There was a lack of evidence that interventions reduced poisoning rates ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: BACKGROUND The assessment and treatment of trauma patients begins in the prehospital environment . Studies have vali date d the shock index as a correlate for mortality and the identification of shock in trauma patients . We investigated the use of the first shock index obtained in the prehospital environment and the first shock index obtained upon arrival in the trauma center as correlates for other outcomes to evaluate its usefulness as a triage tool . METHODS This is a retrospective review of data from a level I trauma center . Prehospital and trauma center shock indices for 16,269 patients were evaluated as correlates for duration of hospital stay , duration of stay in the intensive care unit , the number of ventilator days , blood product use , and destination of transfer from the trauma center . RESULTS Pearson correlation coefficients revealed that the relationship of prehospital and trauma center shock indices were correlates for duration of hospital stay , duration of stay in the intensive care unit , the number of ventilator days , and blood product use . A chi-square analysis found that shock indices ≥0.9 indicate a higher likelihood of disposition to the intensive care unit , operating room , or death . CONCLUSION A prehospital shock index for trauma correlates with measures of hospital re source use and mortality . A prospect i ve study is needed to determine the use of this measure as a triage tool BACKGROUND Emergency Medical Services ( EMS ) personnel provide care in the out-of-hospital setting . The EMS report , including blood volume estimates , influences hospital management . Our objective was to assess the accuracy of EMS blood volume estimates . METHODS In this prospect i ve , observational study , EMS providers were asked to view four simulated blood loss scenarios in r and om order . Each scenario used a specific volume of spilled blood corresponding to the loss likely to cause the four classes of hemorrhagic shock . Estimates are reported using median and interquartile ranges . RESULTS Ninety-two EMS providers gave 368 estimates . Only 8 % were within 20 % of the actual volume . Furthermore , only 24 % were within 50 % of actual volume . There was no correlation between accuracy and any demographic variable , level of training , or years of EMS experience . CONCLUSION EMS personnel are unable to estimate \" blood \" volume accurately irrespective of level of training BACKGROUND Visually estimated amount of blood loss may influence decision making in the prehospital setting . The purpose of this study was to determine the ability and accuracy of paramedics and emergency physicians to visually estimate a volume of external blood loss and the influence of different vital signs . METHODS In a prospect i ve , blinded , observational design , participants were asked to visually estimate the amount of blood in six simulated trauma scenarios . Casualties were provided with a simulated injury , and a certain amount of artificial blood that was poured on the casualties ' clothing and on the floor . In addition , vital signs ( i.e. , blood pressure and heart rate ) were given . Each two moulage patients were provided with the same injury pattern and the same simulated blood loss . Although one patient seemed to be normovolemic , the other seemed to be hypovolemeic by the given vital signs . RESULTS With regard to all given amounts of blood loss , providing vital parameters suggesting instability ( i.e. , low blood pressure , high heart rate ) led to a higher estimation of the lost blood volume in both paramedics and emergency physicians . However , estimations were influenced impressively by the given parameters . For both stable and unstable patients , small actual volumes were overestimated , whereas higher volumes tended to be underestimated . Neither occupational status ( emergency physician or paramedic ) nor gender or level of experience influenced accuracy of estimated blood loss significantly INTRODUCTION AND AIMS The use of intravenous oxygen carriers ( packed red blood cells ( PRBC ) , whole blood and synthetic haemoglobins ( HBOCs ) for selected pre-hospital trauma resuscitation cases has been reported , despite a lack of vali date d clinical indications . The aim of this study was to retrospectively identify a sub-group of adult major trauma patients most likely to benefit from pre-hospital oxygen carrier administration and determine the predictive relationship between pre-hospital shock index ( SI ) [ pulse rate/systolic blood pressure ] and haemorrhagic shock , blood transfusion and mortality . METHODS A retrospective review of adult major trauma patients recorded in The Alfred Trauma Registry was conducted . Patients were included if they received at least 1L of pre-hospital crystalloid and spent over 30 min in transit . The association of shock index and transfusion was determined . Patients were further sub-grouped by mode of transport to determine the population of trauma patients who could be included into prospect i ve studies of intravenous oxygen carriers . RESULTS There were 1149 patients included of whom 311 ( 21.9 % ) received an acute blood transfusion . The SI correlated well with transfusion practice . A SI ≥ 1.0 , calculated after at least 1L of crystalloid transfusion , identified patients with a high specificity ( 93.5 % ; 95 % CI : 91.8 - 94.8 ) for receiving a blood transfusion within 4h of hospital arrival . While patients transported by helicopter had higher injury severity and blood transfusion requirement , there were no difference in physiological variables and outcomes when compared to patients transported by road car . CONCLUSIONS A shock index ≥ 1.0 is an easily calculated variable that may identify patients for inclusion into trials for pre-hospital oxygen carriers . Shocked patients have high mortality rates whether transported by road car or by helicopter . The efficacy of pre-hospital intravenous oxygen carriers should be trialled using a shock index ≥ 1.0 despite fluid resuscitation as the clinical trigger for administration BACKGROUND It remains unclear whether the American College of Surgeons Committee on Trauma ( ACSCOT ) \" step 1 \" field physiologic criteria could be further restricted without substantially sacrificing sensitivity . We assessed whether more restrictive physiologic criteria would improve the specificity of this triage step without missing high-risk patients . METHODS We analyzed an out-of-hospital , consecutive patient , prospect i ve cohort of injured adults > or=15 years collected from December 1 , 2005 , to February 28 , 2007 , by 237 emergency medical service agencies transporting to 207 acute care hospitals in 11 sites across the United States and Canada . Patients were included based on ACSCOT field decision scheme physiologic criteria systolic blood pressure < or=90 , respiratory rate < 10 or > 29 breaths/min , Glasgow Coma Scale score < or=12 , or field intubation . Seven field physiologic variables and four additional demographic and mechanism variables were included in the analysis . The composite outcome was mortality ( field or in-hospital ) or hospital length of stay > 2 days . RESULTS Of 7,127 injured persons , 6,259 had complete outcome information and were included in the analysis . There were 3,631 ( 58.0 % ) persons with death or LOS > 2 days . Using only physiologic measures , the derived rule included advanced airway intervention , shock index > 1.4 , Glasgow Coma Scale < 11 , and pulse oximetry < 93 % . Rule validation demonstrated sensitivity 72 % ( 95 % confidence interval : 70%-74 % ) and specificity 69 % ( 95 % confidence interval : 67%-72 % ) . Inclusion of demographic and mechanism variables did not significantly improve performance measures . CONCLUSIONS We were unable to omit or further restrict any ACSCOT step 1 physiologic measures in a decision rule practical for field use without missing high-risk trauma patients OBJECTIVES There are many patient assessment challenges in the prehospital setting , especially the estimation of external blood loss . Previous studies of experienced paramedics have demonstrated that external blood loss estimation is highly inaccurate . The objective of this study was to determine if undergraduate paramedic students could accurately estimate external blood loss on four surfaces commonly found in the prehospital environment . METHODS This prospect i ve , observational , blinded study used a convenience sample of undergraduate students study ing at Monash University during 2006 . Students were provided with four clinical vignettes using four different surfaces and varying simulated blood amounts . RESULTS Accurate estimation occurred with the vinyl simulation ( 100 ml ) , with a mean value of the estimations of 98 ml ( 95 % Confidence Interval ( CI ) 84 - 113 ml ) . Carpet and concrete surfaces were both associated with large under-estimations . The carpet simulation ( 1,000 ml ) had a mean value for the estimations of 347 ml ( 95 % CI 320 - 429 ml ) . The concrete simulation ( 1,500 ml ) had a mean value for the estimations of 885ml ( 95 % CI 771 - 999 ml ) . Conversely , the clothing simulation ( 500 ml ) emphasized over-estimation , with a mean value for the estimations of 1,253 ml ( 95 % CI 1,093 - 1,414 ml ) . There was no relationship between increased accuracy and clinical experience , exposure , educational qualifications , or age of students . CONCLUSIONS External blood loss estimation by undergraduate paramedic students generally is too inaccurate to be of any clinical benefit . Particularly , absorbent and impermeable surfaces precipitated inaccuracies by undergraduate paramedic students OBJECTIVE The aim of this study was to determine the hemodynamic response and calculated shock index ( SI = heart rate [HR]/systolic blood pressure [ SBP ] ) in early acute blood loss . METHODS This was a prospect i ve observational study that enrolled healthy blood donors . Patients were excluded if not eligible for blood donation . Baseline vital signs were obtained , 450 mL of blood was removed over 20 minutes , and vital signs were repeated immediately postdonation while lying and after 1 and 5 minutes of st and ing . Difference was tested using a paired t test with P<.01 set for significance . RESULTS Forty-six patients were enrolled ; means for each time interval are shown below with 95 % confidence intervals . CONCLUSIONS A significant elevation in mean SI was observed in healthy volunteers after st and ing for 1 and 5 minutes . Although significant changes in HR and SBP were observed , these indices were still within \" normal \" limits . The SI may be more useful in early hemorrhage than either the HR or SBP alone OBJECT This study sought to define hemorrhagic shock from blood pressure and heart rate and then to provide a treatment policy based on response to initial fluid therapy . MATERIAL S This was a prospect i ve clinical observational study conducted in eight hospitals . Subjects were consecutive patients with trauma who met any of the field triage conditions proposed by the Committee on Trauma of the American College of Surgeons . Initial fluid therapy was performed in patients with suspected hemorrhagic shock . Patients who required blood transfusion ≥ 4 U within 24 hours or interventions for active bleeding within 24 hours were classified into a \" bleeding group \" ( B ) . A \" nonbleeding group \" ( non-B ) comprised patients who did not require blood transfusion ≥ 4 U or other interventions within 24 hours . Our committee maintained the data base of survey items . Four of the hospitals were selected at r and om to provide training data and that was used in a recursive partitioning analysis to predict the B group . Data on patients in the other four facilities were used for validation . RESULTS There were a total of 400 patients studied . The training set consisted of 261 patients , 50 of whom were classified into the B group . A total of 94 % patients with hemorrhagic shock suspected clinical ly , shock index at admission ( first SI ) ≥ 0.8 , and SI at 1 L of fluid resuscitation ( second SI ) ≥ 1.0 were assigned to the B group . The non-B group ( 92 % ) were patients those whose first SI was < 0.8 and base deficits at admission ≥ -1.0 . Validation data consisted of 139 patients . The sensitivity , specificity , and accuracy of these data to predict the B group were 71 % , 93 % , and 89 % , respectively . CONCLUSIONS Patients whose first SI was ≥ 0.8 and second SI ≥ 1.0 would be diagnosed as \" nonresponders \" by American College of Surgeons . Patients with first SI < 0.8 and base deficits ≥ -1.0 will not be c and i date s for the B group Background The epidemiology of traumatic deaths was periodically described during the development of the American trauma system between 1977 and 1995 . Recognizing the impact of aging population s and the potential changes in injury mechanisms , the purpose of this work was to provide a comprehensive , prospect i ve , population -based study of Australian trauma-related deaths and compare the results with those of l and mark studies . Methods All prehospitalization and in-hospital trauma deaths occurring in an inclusive trauma system at a single Level 1 trauma center [ 400 patients with an injury severity score ( ISS ) > 15/year ] underwent autopsy and were prospect ively evaluated during 2005 . High-energy ( HE ) and low-energy ( LE ) deaths were categorized based on the mechanism of the injury , time frame ( prehospitalization , < 48 hours , 2–7 days , > 7 days ) , and cause [ which was determined by an expert panel and included central nervous system-related ( CNS ) , exsanguination , CNS + exsanguination , airway , multiple organ failure ( MOF ) ] . Data are presented as a percent or the mean ± SEM . Results There were 175 deaths during the 12-month period . For the 103 HE fatalities ( age 43 ± 2 years , ISS 49 ± 2 , male 63 % ) , the predominant mechanisms were motor vehicle related ( 72 % ) , falls ( 4 % ) , gunshots ( 8 % ) , stabs ( \n Output:\n " }, { "from": "agent", "value": "The SI is a readily available tool and may be useful in predicting CB on arrival to hospital ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: Purpose This study evaluated the effectiveness of contrast-enhanced ultrasound ( CEUS ) , performed immediately after percutaneous ethanol injection ( PEI ) or radiofrequency thermal ablation ( RFTA ) , by comparing results with the computed tomography ( CT ) follow-up . Material s and methods Sixty-nine consecutive patients with a diagnosis of hepatocellular carcinoma ( HCC ) were included in this prospect i ve study . All patients underwent PEI or RFTA . After treatment , three CEUS enhancement patterns were observed : isovascular , hypovascular and avascular , which were compared with the CT findings . Sensitivity of the avascular pattern at CEUS and effectiveness of the ablative procedures were evaluated and compared with the chi-square test . Results Ninety hypervascular HCCs , with a mean diameter of 2.6 cm ( 0.5–4.9 cm ) , underwent PEI ( n=54 ) and RFTA ( n=36 ) . In the first group , CT identified complete necrosis in 28/54 ( 52 % ) lesions , 21 ( 75 % ) of which had avascular , one ( 4 % ) isovascular and six ( 21 % ) hypovascular patterns at CEUS . In the second group , CT showed complete necrosis in 31/36 ( 86 % ) lesions , all ( 100 % ) of which had a corresponding avascular pattern at CEUS . Sensitivity , specificity , positive predictive value , negative predictive value and accuracy of the avascular pattern at CEUS compared with CT findings were 75 % , 69 % , 72 % , 72 % and 72 % for PEI and 100 % , 20 % , 89 % , 100 % and 89 % , for RFTA , respectively . A statistically significant difference ( p<0.05 ) between the sensitivity of CEUS after PEI and after RFTA and between the necrosis obtained by RFTA and PEI were observed . Conclusions CEUS performed immediately after percutaneous ablation of hepatocellular carcinoma to evaluate treatment efficacy is compulsory in the case of RFTA but not for PEI.RiassuntoObiettiviStimare l’efficacia dell’ecografia con mezzo di contrasto ( CEUS ) eseguita immediatamente dopo iniezione percutanea di etanolo ( PEI ) o termoablazione con radiofrequenza ( RFTA ) , confront and o i risultati con la tomografia computerizzata ( TC ) di follow-up . Material i e metodiSessantanove pazienti consecutivi con diagnosi di epatocarcinoma ( HCC ) sono stati studiati prospetticamente . Le lesioni sono state trattate con PEI o RFTA . Sono stati descritti tre pattern di enhancement alla CEUS ( 1 , isovascolare ; 2 , ipovascolare ; 3 , avascolare ) e quindi confrontati con la TC di follow-up . La sensibilitá nel riconoscimento del pattern CEUS avascolare dopo PEI e RFTA e l’efficacia delle procedure ablative sono state valutate e confrontate tra loro con il test del gC2.RisultatiNovanta HCC ipervascolari , con diametro medio di 2,6 cm ( 0,5–4,9 cm ) , sono stati sottoposti a PEI ( 54 ) e RFTA ( 36 ) . Nel primo gruppo , la TC ha evidenziato necrosi completa in 28/54 ( 52 % ) lesioni , di cui 21 ( 75 % ) con pattern CEUS avascolare , 1 ( 4 % ) isovascolare e 6 ( 21 % ) ipovascolare . Nel secondo gruppo , la TC ha mostrato necrosi completa in 31/36 ( 86 % ) lesioni , tutte ( 100 % ) con pattern CEUS avascolare . Sensibilità , specificità , valore predittivo positivo e negativo ed accuratezza diagnostica per necrosi completa alla TC del pattern CEUS avascolare sono 75 % , 69 % , 72 % , 72 % e 72 % dopo PEI , 100 % , 20 % , 89 % , 100 % e 89 % dopo RFTA . La differenza tra la sensibilita della CEUS dopo PEI o RFTA e la differenza tra l’efficacia dei trattamenti è risultata statisticamente significativa ( p<0,05 ) . Conclusion iLa CEUS al termine della procedura ablativa dell’epatocarcinoma ai fini della valutazione del successo terapeutico è m and atoria dopo RFTA , ma non dopo PEI The purpose of this study was to assess the efficacy of conventional ultrasound ( US ) and contrast-enhanced ultrasound ( CEUS ) in guiding and assessing early therapeutic response to radiofrequency ( RF ) ablation for hepatocellular carcinomas ( HCCs ; up to 3 lesions , each ≤3 cm in diameter ) and to report the short-term follow-up results . Between September 2011 and January 2013 , 63 patients with 78 HCCs ( ≤3 cm ) underwent conventional US- and CEUS-guided percutaneous RF ablation . CEUS was repeated after 20 - 30 min to assess therapeutic response , and local efficacy was further confirmed by contrast-enhanced magnetic resonance imaging ( MRI ) 1 mo after tumor ablation . Patients were followed periodically to look for local tumor or disease progression . Survival probability was estimated with the Kaplan-Meier method . Complete ablation was achieved for 76 ( 97.4 % ) of 78 HCCs in one ( n = 73 ) or two ( n = 3 ) sessions . No major complications were observed in any patient . The overall concordance in assessment of therapeutic efficacy of RF ablation between CEUS and MRI was 97.4 % ( 76/78 tumors ) . The concordance test gave a value of κ = 0.74 ( p < 0.001 ) , indicating that CEUS had a high diagnostic agreement with MRI . During a mean follow-up of 20 mo , the local tumor progression rate was 5.3 % ( 4/76 tumors ) . The 1- , 1.5- and 2-y cumulative survival rates were 98.4 % , 96.1 % and 92.6 % , respectively . Although CEUS has some intrinsic limitations , the combined use of conventional US and CEUS provides a safe and efficient tool to guide RF ablation for HCCs 3 cm or smaller , with encouraging results in terms of survival rate and minimal complications . Moreover , the immediate post-procedural CEUS can be a reliable alternative to contrast-enhanced MRI for assessing the early therapeutic response to RF ablation Abstract Background : Radiofrequency ablation ( RFA ) is increasingly used for the local destruction of unresectable hepatic malignancies . There is little information on its optimal approach or potential complications . Methods : Since late 1997 , we have undertaken 91 RFA procedures to ablate 231 unresectable primary or metastatic liver tumors in 84 patients . RFA was performed via celiotomy ( n=39 ) , laparoscopy ( n=27 ) , or a percutaneous approach ( n=25 ) . Patients were followed with spiral computed tomographic ( CT ) scans at 1 to 2 weeks postprocedure and then every 3 months for 2 years . Results : Intraoperative ultrasound ( IOUS ) detected intrahepatic disease not evident on the preoperative scans of 25 of 66 patients ( 38 % ) undergoing RFA via celiotomy or laparoscopy . In 38 of 84 patients ( 45 % ) , RFA was combined with resection or cryosurgical ablation ( CSA ) , or both . RFA was used to treat an average of 2.8 lesions per patient , and the median size of treated lesions was 2 cm ( range , 0.3–9 cm ) . The average hospital stay was 3.6 days overall ( 1.8 days for percutaneous and laparoscopic cases ) . Ten patients underwent a second RFA procedure ( sequential ablations ) and , in one case , a third RFA procedure for large ( one patient ) , progressive ( seven patients ) , and /or recurrent ( three patients ) lesions . Seven ( 8 % ) patients had complications : one skin burn ; one postoperative hemorrhage ; two simple hepatic abscesses ; one hepatic abscess associated with diaphragmatic heat necrosis following sequential percutaneous ablations of a large lesion ; one postoperative myocardial infa rct ion ; and one liver failure . There were three deaths , one ( 1 % ) of which was directly related to the RFA procedure . Three of the complications , including one RFA-related death , occurred after percutaneous RFA . At a median follow-up of 9 months ( range , 1–27 months ) , 15 patients ( 18 % ) had recurrences at an RFA site , and 36 patients ( 43 % ) remained clinical ly free of disease . Conclusions : Celiotomy or laparoscopic approaches are preferred for RFA because they allow IOUS , which may demonstrate occult hepatic disease . Operative RFA also allows concomitant resection , CSA , or placement of a hepatic artery infusion pump , and isolation of the liver from adjacent organs . Percutaneous RFA should be reserved for patients at high risk for anesthesia , those with recurrent or progressive lesions , and those with smaller lesions sufficiently isolated from adjacent organs . Complications may be minimized when these approaches are applied selectively BACKGROUND AND OBJECTIVE Publication bias and other sample size effects are issues for meta-analyses of test accuracy , as for r and omized trials . We investigate limitations of st and ard funnel plots and tests when applied to meta-analyses of test accuracy and look for improved methods . METHODS Type I and type II error rates for existing and alternative tests of sample size effects were estimated and compared in simulated meta-analyses of test accuracy . RESULTS Type I error rates for the Begg , Egger , and Macaskill tests are inflated for typical diagnostic odds ratios ( DOR ) , when disease prevalence differs from 50 % and when thresholds favor sensitivity over specificity or vice versa . Regression and correlation tests based on functions of effective sample size are valid , if occasionally conservative , tests for sample size effects . Empirical evidence suggests that they have adequate power to be useful tests . When DORs are heterogeneous , however , all tests of funnel plot asymmetry have low power . CONCLUSION Existing tests that use st and ard errors of odds ratios are likely to be seriously misleading if applied to meta-analyses of test accuracy . The effective sample size funnel plot and associated regression test of asymmetry should be used to detect publication bias and other sample size related effects OBJECTIVE We investigated contrast-enhanced three-dimensional ultrasonography ( CE 3D US ) with contrast agent Sonazoid for evaluating the effect of percutaneous radiofrequency ( RF ) ablation of hepatocellular carcinomas ( HCCs ) . METHODS 63 HCCs were treated by US-guided percutaneous RF ablation . CE 3D US after bolus injection of 0.2 mL of Sonazoid was performed 5 - 7 days before and 1 day after RF ablation . CE 3D computed tomography ( CT ) was performed 5 - 7 days before and 1 month after the ablation , and during the follow-up period . Multiplanar images in three orthogonal planes and US/CT angiograms were reconstructed on both modalities . Two blinded observers review ed the images on both modalities to evaluate the ablation effects . RESULTS After RF ablation , the evaluation on CE 3D US and that on CE 3D CT achieved concordance in 61 lesions . Among them , 59 lesions were detected with the absence of tumor vessels and tumor enhancement and evaluated as adequate ablation , and the remaining two lesions were detected with residual tumors . The kappa value for agreement between the findings on the two modalities was 0.65 . When 1-month CE 3D CT scans were used as reference st and ard , the sensitivity , specificity , and accuracy of 1-day CE 3D US for detecting adequate ablation were 97 % , 100 % , and 97 % , respectively . CONCLUSION By demonstrating the ablated areas and residual tumors in three dimensions , CE 3D US with Sonazoid was shown to be useful for evaluating the effect of RF ablation of HCCs , and there was good concordance with the results obtained by CE 3D CT PURPOSE To assess the utility of contrast-enhanced agent detection imaging ( ADI ) in the assessment of the therapeutic response to percutaneous radiofrequency ( RF ) ablation in patients with hepatocellular carcinoma ( HCC ) . MATERIAL S AND METHODS Ninety patients with a total of 97 nodular HCCs ( mean , 2.1+/-1.3 cm ; range , 1.0 - 5.0 cm ) treated with percutaneous RF ablation under the ultrasound guidance were evaluated with contrast-enhanced ADI after receiving an intravenous bolus injection of a microbubble contrast agent ( SH U 508A ) . We obtained serial contrast-enhanced ADI images during the time period from 15 to 90 s after the initiation of the bolus contrast injection . All of the patients underwent a follow-up four-phase helical CT at 1 month after RF ablation , which was then repeated at 2 - 4 month intervals during a period of at least 12 months . The results of the contrast-enhanced ADI were compared with those of the follow-up CT in terms of the presence or absence of residual unablated tumor and local \n Output:\n " }, { "from": "agent", "value": "Conclusion This study confirmed that CEUS exhibits high sensitivity and specificity in assessing therapeutic responses to RFA for liver tumors" } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: The aim of this study was to evaluate the diagnostic value of a new somatostatin analog , 68Ga-labeled 1,4,7,10-tetraazacyclododecane-N , N′,N″,N″′-tetraacetic acid-d-Phe1-Tyr3-octreotide ( 68Ga-DOTA-TOC ) , for PET in patients with known or suspected neuroendocrine tumors . PET was compared with conventional scintigraphy and dedicated CT . Methods : Eighty-four patients ( 48 men , 36 women ; age range , 28–79 y ; mean age ± SD , 58.2 ± 12.2 y ) were prospect ively studied . For analysis , patients were divided into 3 groups : detection of unknown primary tumor in the presence of clinical or biochemical suspicion of neuroendocrine malignancy ( n = 13 patients ) , initial tumor staging ( n = 36 patients ) , and follow-up after therapy ( n = 35 patients ) . Each patient received 100–150 MBq 68Ga-DOTA-TOC . Imaging results of PET were compared with 99mTc-labeled hydrazinonicotinyl-Tyr3-octreotide ( 99mTc-HYNIC-TOC ) and 111In-DOTA-TOC . CT was also performed on every patient using a multidetector scanner . Each imaging modality was interpreted separately by observers who were unaware of imaging findings before comparison with PET . The gold st and ard for defining true-positive ( TP ) , true-negative ( TN ) , false-positive ( FP ) , and false-negative ( FN ) results was based on all available histologic , imaging , and follow-up findings . Results : PET was TP in 69 patients , TN in 12 patients , FP in 1 patient , and FN in 2 patients , indicating a sensitivity of 97 % , a specificity of 92 % , and an accuracy of 96 % . The FP finding was caused by enhanced tracer accumulation in the pancreatic head , and the FN results were obtained in patients with a tumor of the gastrointestinal tract displaying liver metastases . 68Ga-DOTA-TOC showed higher diagnostic efficacy compared with SPECT ( TP in 37 patients , TN in 12 patients , FP in 1 patient , and FN in 34 patients ) and diagnostic CT ( TP in 41 patients , TN in 12 patients , FP in 5 patients , and FN in 26 patients ) . This difference was of statistical significance ( P < 0.001 ) . However , the combined use of PET and CT showed the highest overall accuracy . Conclusion : 68Ga-DOTA-TOC PET shows a significantly higher detection rate compared with conventional somatostatin receptor scintigraphy and diagnostic CT with clinical impact in a considerable number of patients BACKGROUND : Endoscopic ultrasonography ( EUS ) and somatostatin receptor scintigraphy ( SRS ) can detect a high percentage of gastroenteropancreatic neuroendocrine tumours especially in the upper gastrointestinal tract . The ability of these procedures to localise primary tumour lesions and metastases of gastrinomas and insulinomas was evaluated in comparison with transabdominal ultrasonography ( US ) , computed tomography ( CT ) and magnetic resonance imaging ( MRI ) . PATIENTS AND METHODS : In a prospect i ve trial , patients with gastrinomas ( n = 10 ) and insulinomas ( n = 10 ) diagnosed by clinical signs and laboratory tests were assessed by EUS , SRS , US , CT and MRI . RESULTS : In 10 patients with gastrinoma and 10 patients with insulinoma , a total of 14 separate primary tumour lesions were histologically confirmed for each of the tumour entities . The mean diameter was 2.1 cm for gastrinomas and 1.5 cm for insulinomas . All insulinomas and nine gastrinoma lesions were located in the pancreas . Three gastrinomas were found in the duodenal wall , one in a periduodenal lymph node , and one in the liver , For gastrinomas , sensitivities were 79 % with EUS , 86 % with SRS and 29 % with CT , US , and MRI . For insulinomas , sensitivities were 93 % with EUS , 14 % with SRS , 21 % with CT and 7 % with US and MRI . CONCLUSIONS : EUS is of high value for localising primary lesions of both tumour entities . SRS is a very sensitive procedure for diagnosing of gastrinomas but not insulinomas . CT , US and MRI are primarily useful for visualising metastases Purpose Neuroendocrine tumours ( NETs ) can be imaged with scintigraphy using radiolabelled somatostatin analogues . The aim of our study was to compare the value of 68Ga-DOTATOC PET and 111In-DTPAOC SPECT ( Octreoscan ) in the detection of NET manifestations . Methods Twenty-seven NET patients were prospect ively examined . 68Ga-DOTATOC PET and 111In-DTPAOC SPECT were performed using st and ard techniques . Treatment was not applied in between . Mean and maximum st and ardised uptake values ( SUVs ) were calculated for PET findings . Tumour/non-tumour ratios were calculated for SPECT findings . Findings were compared by a region-by-region analysis and verified with histopathology , CT and MRI within 21 days . Results SUVs of positive lesions on 68Ga-DOTATOC PET ranged from 0.7 to 29.3 ( mean SUV ) and from 0.9 to 34.4 ( maximum SUV ) . Tumour/non-tumour ratios on 111In-DTPAOC SPECT ranged from 1.8 to 7.3 . In imaging lung and skeletal manifestations , 68Ga-DOTATOC PET was more efficient than 111In-DTPAOC SPECT . All discrepant lung findings and 77.8 % of discrepant osseous findings were verified as true positive PET interpretations . In regional comparison of liver and brain , 68Ga-DOTATOC PET and 111In-DTPAOC SPECT were identical . In lymph nodes , the pancreas and the gastro-intestinal system , different values of the two techniques were not indicated in regional analyses . In a single patient , surgical interventions were changed on the basis of 68Ga-DOTATOC PET findings . Conclusion 68Ga-DOTATOC PET is superior to 111In-DTPAOC SPECT in the detection of NET manifestations in the lung and skeleton and similar for the detection of NET manifestations in the liver and brain . 68Ga-DOTATOC PET is advantageous in guiding the clinical management Radiolabeled somatostatin analogs represent valuable tools for both in vivo diagnosis and therapy of neuroendocrine tumors ( NETs ) because of the frequent tumoral overexpression of somatostatin receptors ( sst ) . The 2 compounds most often used in functional imaging with PET are 68Ga-DOTATATE and 68Ga-DOTATOC . Both lig and s share a quite similar sst binding profile . However , the in vitro affinity of 68Ga-DOTATATE in binding the sst subtype 2 ( sst2 ) is approximately 10-fold higher than that of 68Ga-DOTATOC . This difference may affect their efficiency in the detection of NET lesions because it is the sst2 that is predominantly overexpressed in NET . We thus compared the diagnostic value of PET/CT with both radiolabeled somatostatin analogs ( 68Ga-DOTATATE and 68Ga-DOTATOC ) in the same NET patients . Methods : Forty patients with metastatic NETs underwent 68Ga-DOTATOC and 68Ga-DOTATATE PET/CT as part of the work-up before prospect i ve peptide receptor radionuclide therapy . The performance of both imaging methods was analyzed and compared for the detection of individual lesions per patient and for 8 defined body regions . A region was regarded positive if at least 1 lesion was detected in that region . In addition , radiopeptide uptake in terms of the maximal st and ardized uptake value ( SUVmax ) was compared for concordant lesions and renal parenchyma . Results : Seventy-eight regions were found positive with 68Ga-DOTATATE versus 79 regions with 68Ga-DOTATOC ( not significant ) . Overall , however , significantly fewer lesions were detected with 68Ga-DOTATATE than with 68Ga-DOTATOC ( 254 vs. 262 , P < 0.05 ) . Mean 68Ga-DOTATATE SUVmax across all lesions was significantly lower than 68Ga-DOTATOC ( 16.0 ± 10.8 vs. 20.4 ± 14.7 , P < 0.01 ) . Mean SUVmax for renal parenchyma was not significantly different between 68Ga-DOTATATE and 68Ga-DOTATOC ( 12.7 ± 3.0 vs. 13.2 ± 3.3 ) . Conclusion : 68Ga-DOTATOC and 68Ga-DOTATATE possess a comparable diagnostic accuracy for the detection of NET lesions , with 68Ga-DOTATOC having a potential advantage . The approximately 10-fold higher affinity for the sst2 of 68Ga-DOTATATE does not prove to be clinical ly relevant . Quite unexpectedly , SUVmax of 68Ga-DOTATOC scans tended to be higher than their 68Ga-DOTATATE counterparts Abstract . Neuroendocrine tumours displaying somatostatin receptors have been successfully visualised with somatostatin receptor imaging ( SRI ) . However , there may be differences in sensitivity depending on the site of the primary tumour and /or its metastases . We studied 131 patients affected by neuroendocrine tumours of the gastro-entero-pancreatic ( GEP ) tract . A pathological diagnosis was obtained in 116 patients , while in 15 the diagnosis was based on instrumental results and follow-up . Fifty-one patients were examined for staging purpose s , 80 were in follow-up . Images were acquired 24 and 48 h after the injection of 150–220 MBq of indium-111 pentetreotide . Whole-body and SPET images were obtained in all patients . Patients were also studied with computed tomography ( CT ) , ultrasound ( US ) , and other procedures . Tumours were classified according to their site of origin : pancreas n = 39 , ileum n = 32 , stomach n = 16 , appendix n = 9 , duodenum n = 5 , jejunum n = 5 , rectum n = 3 , biliary tract n = 2 , colon n = 2 , caecum n = 1 , liver metastases from unknown primary = 15 , widespread metastases from unknown primary = 2 . Sensitivity for primary tumour localisation was as follows : SRI = 62 % ; CT = 43 % ; US = 36 % ; other procedures = 45 % . Sensitivity for liver metastases : SRI = 90 % ; CT = 78 % ; US = 88 % ; other procedures = 71 % . Sensitivity for the detection of extrahepatic soft tissue lesions was : SRI = 90 % ; CT = 66 % ; US = 47 % ; other procedures = 61 % . Sensitivity for the detection of the primary tumour in patients with metastases from unknown primary sites : SRI 4/17 ; CT 0/13 ; US 0/12 ; other procedures 1/10 . In 28 % of the patients SRI revealed previously unknown lesions , and in 21 % it determined a modification of the scheduled therapy . Our study confirms the important role of SRI in the management of GEP tumours . However , we feel that a critical investigation should address its role in locating primary tumours , in particular in patients with metastases from unknown primary sites Abstract Objective To evaluate the role of 68Ga-labelled [ 1 , 4 , 7 , 10-tetraazacyclododecane-1 , 4 , 7 , 10-tetraacetic acid]-1-NaI3-Octreotide ( 68Ga-DOTA-NOC ) whole body positron emission tomography-computed tomography ( PET-CT ) as a functional imaging approach for phaeochromocytoma and paraganglioma . Methods Thirty-five unrelated patients ( Median age-34.4 years ; range : 15–71 ) were evaluated in this prospect i ve study . PET-CT was performed after injection of 132–222 MBq of 68Ga-DOTA-NOC . Images were evaluated by two experienced nuclear medicine physicians both qualitatively as well as quantitatively ( st and ardised uptake value-SUVmax ) . In addition we compared the findings with 131I Metaiodobenzylguanidine ( MIBG ) scintigraphy , which was available for 25 patients . Histopathology and /or conventional imaging with biochemical markers were taken as the reference st and ard . Results 44 lesions were detected on 68Ga- \n Output:\n " }, { "from": "agent", "value": "ConclusionS MSR PET has good diagnostic performance for evaluation of NET in the thorax and abdomen , better than SRS which has been the previous st and ard method .\nThis meta- analysis gives further support for switching to SMSR PET" } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: Isepamicin is a new aminoglycoside antibiotic which possesses greater stability to aminoglycoside-inactivating enzymes compared with other available aminoglycosides . In this prospect i ve , r and omised , open trial , the safety and efficacy of intravenous administration of isepamicin was compared with that of intravenous amikacin in seriously ill adults with nosocomial pneumonia or septicaemia . Each study aminoglycoside was administered concurrently with ceftazidime or imipenem . Patients were r and omised to receive isepamicin 15 mg/kg once daily , isepamicin 7.5 mg/kg twice daily or amikacin 7.5 mg/kg twice daily . For patients with nosocomial pneumonia , the proportions of patients in the intent-to-treat population ( n = 130 ) who were clinical ly cured at the end of treatment were similar in each treatment group : 18/44 ( 41 % ) isepamicin once daily ; 19/45 ( 42 % ) isepamicin twice daily ; and 17/41 ( 42 % ) amikacin . Corresponding results for the efficacy population ( n = 58 ) were : 12/20 ( 60 % ) isepamicin once daily ; 14/21 ( 67 % ) isepamicin twice daily ; 9/17 ( 53 % ) amikacin . In patients with septicaemia , clinical cure was achieved in 8/10 ( 80 % ) patients treated with isepamicin once daily , compared with 8/13 ( 62 % ) patients who received isepamicin twice daily , and 7/12 ( 58 % ) patients treated with amikacin . For both diagnoses , there were no statistically significant differences between the treatment groups in clinical cure rate . The most commonly isolated target pathogen was Pseudomonas aeruginosa . For both nosocomial pneumonia and septicaemia , the proportion of patients in the intent-to-treat population whose pretreatment valid target pathogens were eliminated was similar in each treatment group . In total , 51 patients ( 30 % ) died during study , mostly due to disease progression or complications , or concurrent illness . All three treatment regimens were well tolerated . The proportion of patients experiencing at least one adverse event was 11 % , 25 % and 9 % for isepamicin once daily , isepamicin twice daily and amikacin , respectively . The incidence of ototoxicity and nephrotoxicity was relatively low in both treatment groups We evaluated the antimicrobial activity of fosfomycin against a r and omly selected sample of 30 Klebsiella pneumoniae , 30 Pseudomonas aeruginosa , and 30 Acinetobacter baumannii multidrug-resistant , clinical isolates from patients in a general tertiary care hospital in Athens , Greece . St and ard laboratory methods were used for susceptibility testing to commonly used antibiotics and the detection of extended-spectrum-β-lactamase ( ESBL ) and metallo-β-lactamase ( MBL ) production . The minimum inhibitory concentration ( MIC ) of fosfomycin for each isolate was determined by the agar dilution method . All K. pneumoniae isolates were both ESBL and MBL producers ; all P. aeruginosa isolates were ESBL producers . The K. pneumoniae strains had fosfomycin MICs distributed across a range of 8 - 64 μg/ml ; MIC50 was 16 μg/ml and MIC90 32 μg/ml . The fosfomycin MICs of the P. aeruginosa strains had a distribution across a range of 4 to over 512 μg/ml ; MIC50 was 32 μg/ml and MIC90 128 μg/ml . The fosfomycin MICs of the A. baumannii strains had a distribution across a range of 64 to over 512 μg/ml ; MIC50 was 256 μg/ml and MIC90 more than 512 μg/ml . Although st and ardized fosfomycin MIC interpretative breakpoints for the species studied are lacking , the findings of our study support the idea that fosfomycin may be further investigated as one among a decreasing list of therapeutic options for the treatment of infections due to multidrug-resistant strains of , primarily , K. pneumoniae and , secondly , P. aeruginosa In a prospect i ve multicentre open trial , hospitalised adult patients with acute lower respiratory tract infections , mainly pneumonia or bronchitis , were r and omised to receive either isepamicin 8 or 15 mg/kg once daily depending on the severity of the infection or amikacin 7.5 mg/kg twice daily . Patients with infections known to be caused by Pseudomonas aeruginosa were to be given concomitant treatment with ceftazidime . In the intent-to-treat population , i.e. patients who received at least one dose r and omised treatment , a clinical cure or improvement at the end of treatment was seen in 112/125 ( 90 % ) isepamicin patients and 55/60 ( 92 % ) amikacin patients . The corresponding rates for patients with a primary diagnosis of pneumonia were 45/52 ( 87 % ) and 25/28 ( 89 % ) . Cure/improvement rates for patients with P. aeruginosa as the causative pathogen ( 34 of whom also received ceftazidime ) were 28/30 ( 93 % ) and 16/18 ( 89 % ) , respectively . In the efficacy population ( patients who had a valid pretreatment culture and who met other evaluability criteria ) , total elimination ( documented or presumed if infection had resolved ) of target pathogens occurred in 54/63 ( 86 % ) of isepamicin patients and 25/30 ( 83 % ) of amikacin patients . P. aeruginosa , Escherichia coli , Klebsiella pneumoniae and Staphylococcus aureus were commonly isolated pathogens . Treatment-related adverse were mainly mild or moderate in severity and occurred in 10 % of isepamicin patients and 13 % of amikacin patients . Four patients ( 3 isepamicin and 1 amikacin ) discontinued treatment because of severe adverse events and a further isepamicin patient withdrew because of a mild adverse event . Nephrotoxicity and ototoxicity occurred infrequently Intensive care unit (ICU)-acquired infections as a result of multidrug-resistant Gram-negative pathogens remain a serious problem in critically ill patients . Adult ICU patients who received intravenous fosfomycin were prospect ively examined to assess its safety and effectiveness as an adjunct to the antimicrobial therapy of life-threatening infections caused by carbapenem-resistant Klebsiella pneumoniae . Fosfomycin was administered intravenously in 11 patients for treatment of hospital-acquired infections caused by carbapenem-resistant K. pneumoniae . Fosfomycin ( 2 - 4 g every 6 h ) was administered in combination with other antibiotics . The mean + /- SD duration of treatment was 14 + /- 5.6 days . All patients had good bacteriological and clinical outcome of infection . All-cause hospital mortality was two out of 11 ( 18.2 % ) patients . No patient experienced adverse events related to the administration of fosfomycin . Intravenous fosfomycin may be a beneficial and safe adjunctive treatment in the management of life-threatening ICU-acquired infections caused by carbapenem-resistant K. pneumoniae ABSTRACT Directed evolution by r and om PCR mutagenesis of the gene for the aminoglycoside 2″-IIa phosphotransferase generated R92H/D268N and N196D/D268N mutant enzymes , result ing in elevated levels of resistance to amikacin and isepamicin but not to other aminoglycoside antibiotics . Increases in the activities of the mutant phosphotransferases for isepamicin are the result of decreases in Km values , while improved catalytic efficiency for amikacin is the result of both a decrease in Km values and an increase in turnover of the antibiotic . Enzymes with R92H , D268N , and D268N single amino acid substitutions did not result in elevated MICs for aminoglycosides Two hundred and three patients with skin and skin structure infections were treated with isepamicin once daily or amikacin twice daily in an open , r and omised , comparative multicentre trial . Patients were r and omised to treatment with isepamicin or amikacin in a 2:1 ratio . Severe infections ( 63 patients ) were treated with isepamicin 15 mg/kg once daily ( n = 15 ) or amikacin 7.5 mg/kg twice daily ( n - 18 ) , less severe infections ( 140 patients ) with isepamicin 8 mg/kg once daily ( n = 93 ) or amikacin 7.5 mg/kg twice daily ( n = 47 ) . The overall clinical response rate at the end of treatment was excellent in all treatment groups ( 94 - 96 % cured or improved ) with no significant differences between isepamicin and amikacin in patients with either server or less severe infections . The most commonly isolated target pathogens were Pseudomonas aeruginosa , Escherichia coli , Proteus mirabilis and Staphylococcus aureus . Overall , in patients who had a valid target pathogen isolated prior to treatment and who met other evaluability criteria , bacteriological eradication was achieved in over 90 % of patients ; amikacin patients with severe infections had a somewhat lower eradication rate ( 82 % ) . Over all infections , 4/110 ( 4 % ) patients in the isepamicin group and 5/54 ( 9 % ) patients in the amikacin had organisms which persisted . Adverse events were reported in 12 % of patients in the isepamicin group and 6 % in the amikacin group . The most frequently reported adverse event in the isepamicin group as headache . Two patients ( one in each treatment group ) , both of whom experienced skin rashes , were withdrawn . Potentially clinical ly significant changes in serum creatinine occurred in two patients , who received isepamicin and one who received amikacin ( who was withdrawn from the study ) . Ototoxicity was rare , occurring in one patient treated with isepamicin In this study we compared the efficacy and safety of isepamicin versus amikacin at a dose of 7.5 mg/kg i.v . q12h for 10 - 14 days in children with pyelonephritis . Sixteen children were enrolled in the study ; ten received isepamicin and six amikacin . Urine cultures grew Escherichia coli in all patients . All patients were treated successfully with either isepamicin or amikacin . Clinical and bacteriological response rates were 100 % for both groups . No adverse events occurred . Peak serum levels ranged from 9.05 to 30.70 mg/l ( median : 16.165 ) and from 12.20 to 25.90 mg/l ( median : 19.05 ) for isepamicin and amikacin , respectively . Trough serum levels ranged from 0.11 to 3.20 mg/l ( median : 0.75 ) and from 0.1 to 2.1 mg/l ( median : 0.655 ) , respectively . Isepamicin was shown to be as effective and safe as amikacin in the treatment of children with pyelonephritis and might prove an advantageous alternative in areas with high incidence of resistance to other aminoglycosides The efficacy and safety of isepamicin 7.5 mg/kg of body weight twice daily or amikacin the same dosage regimen for the treatment of various infections in neutropenic and non-neutropenic paediatric patients were compared in a prospect i ve r and omised trial . In total , 306 patients were enrolled and received at least one dose of r and omised treatment ( 204 isepamicin , 102 amikacin : intent-to-treat population ) ; 181 patients satisfied all criteria for evaluability ( 120 isepamicin , 61 amikacin : efficacy population ) . Clinical cure or improvement rates in the isepamicin and amikacin groups were : intent-to-treat population , 188/204 ( 92 % ) and 94/102 ( 92 % ) , respectively ; efficacy population , 117/120 ( 98 % ) and 58/61 ( 95 % ) , respectively . The bacteriological elimination rate ( efficacy population ) in the isepamicin and amikacin treatment groups was 75/76 ( 99 % ) vs 35/38 ( 92 % ) . Nephrotoxicity , defined as an increase in serum creatinine of 0.5 mg/dL or > or = 44.2 mumol/L from baseline , occurred in 4/187 ( 2 % ) and 1/191 ( 1 % ) children treated with isep \n Output:\n " }, { "from": "agent", "value": "In conclusion , isepamicin might be active in vitro against Gram-negative bacteria with resistance to amikacin and other aminoglycosides" } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: Background Flaxseed has received attention for its anti-inflammatory and antioxidant role . The present study hypothesizes if flaxseed added to a weight loss diet could improve the lipid and metabolic profiles and decrease risk factors related to cardiovascular disease . Methods In a prospect i ve , single blinded 42 days protocol , subjects were allocated into two groups with low carbohydrates intake : GriceLC ( 35 % of carbohydrate and 60 g of raw rice powder per day ) and GflaxLC ( 32 % of carbohydrate and 60 g of flaxseed powder per day ) . Blood pressure , anthropometric measures and serum levels of isoprostane , C-reactive protein , Tumor Necrosis Factor-alpha , glucose , lipidic profile , uric acid , adiponectin , leptin and insulin were measured at baseline and at the end of interventions . Serum and urinary enterodiol and enterolactione were also measured . Results A total of 27 men with cardiovascular risk factors were evaluated , with mean age of 33 ± 10 years to GriceLC and 40 ± 9 years to GflaxLC . Both groups experienced weight loss and systolic blood pressure reduction . A decrease in inflammatory markers ( CRP and TNF-α ) was observed after flaxseed intake ( mean decrease of 25 % and 46 % for GflaxLC respectively ) . All groups also showed improvement in levels of total cholesterol , LDL-c , uric acid and adiponectin . Only GflaxLC group showed a decrease in triglyceride levels . Conclusion This study suggests that flaxseed added to a weight loss diet could be an important nutritional strategy to reduce inflammation markers such as CRP and TNF-α . Trial registration Clinical Trials.gov NCT02132728 Background Dietary fibers have been proposed to play a role in cardiovascular risk as well as body weight management . Flaxseeds are a good source of dietary fibers , and a large proportion of these are water-soluble viscous fibers . Method Here , we examine the effect of flaxseed dietary fibers in different food matrices on blood lipids and fecal excretion of fat and energy in a double-blind r and omized crossover study with 17 subjects . Three different 7-d diets were tested : a low-fiber control diet ( Control ) , a diet with flaxseed fiber drink ( 3/day ) ( Flax drink ) , and a diet with flaxseed fiber bread ( 3/day ) ( Flax bread ) . Total fat and energy excretion was measured in feces , blood sample s were collected before and after each period , and appetite sensation registered 3 times daily before main meals . Results Compared to control , Flax drink lowered fasting total-cholesterol and LDL-cholesterol by 12 and 15 % , respectively , ( p < 0.01 ) , whereas Flax bread only produced a reduction of 7 and 9 % , respectively ( p < 0.05 ) . Fecal fat and energy excretion increased by 50 and 23 % with Flax drink consumption compared to control ( p < 0.05 ) , but only fecal fat excretion was increased with Flax bread compared to control ( p < 0.05 ) . Conclusion Both Flax drink and Flax bread result ed in decreased plasma total and LDL-cholesterol and increased fat excretion , but the food matrix and /or processing may be of importance . Viscous flaxseed dietary fibers may be a useful tool for lowering blood cholesterol and potentially play a role in energy balance . Trial Registration Clinical Trials.gov : Malnutrition and chronic inflammation in dialysis patients negatively impact their survival prognosis , and nutrients , such as omega-3 oils , are postulated to reduce proinflammatory response . In this r and omized , double-blind , multicenter , placebo-controlled trial , we investigated the effects of flaxseed oil ( FO ) on the inflammatory state of patients with chronic renal failure undergoing renal replacement therapy with hemodialysis ( HD ) . We hypothesized that FO supplementation lowers C-reactive protein ( CRP ) levels . One hundred sixty patients with chronic renal failure who received HD therapy of 3 dialysis units over a 3-month period in South Brazil were included . The patients received blind doses of FO ( 1 g twice a day ) and placebo ( mineral oil , 1 g twice a day ) for a period of 120 days . Inflammation was observed in 89 patients ( 61 % ) at the beginning of the study . There was a correlation between CRP and the body mass index ( R(s ) = 0.22 ; P = .022 ) and high-density lipoprotein cholesterol ( R(s ) = -0.23 ; P = .032 ) , and the CRP levels decreased significantly over time in the group that received FO compared with the control group ( P < .001 ) . During the study period , 33.3 % of the FO group changed from an inflamed to a not-inflamed category , whereas only 16.9 % changed in the mineral oil group ( P = .04 ) . We conclude that the administration of FO decreases the CRP levels and that inflammation in HD patients appears to be correlated to their body mass index and reduced high-density lipoprotein cholesterol levels . Studies with a larger number of patients and over a longer duration are necessary to corroborate these findings Flaxseed is one of the richest sources of lignans and is increasingly used in food products or as a supplement . Plant lignans can be converted by intestinal bacteria into the so-called enterolignans , enterodiol and enterolactone . For a proper evaluation of potential health effects of enterolignans , information on their bioavailability is essential . The aim of this study was to investigate whether crushing and milling of flaxseed enhances the bioavailability of enterolignans in plasma . In a r and omized , crossover study , 12 healthy subjects supplemented their diet with 0.3 g whole , crushed , or ground flaxseed/(kg body weight . d ) . Each subject consumed flaxseed for 10 successive days separated by 11-d run-in/wash-out periods , in which the subjects consumed a diet poor in lignans . Blood sample s were collected at the end of each run-in/wash-out period , and at the end of each supplement period . Plasma enterodiol and enterolactone were measured using LC-MS-MS . The mean relative bioavailability of enterolignans from whole compared with ground flaxseed was 28 % ( P < or = 0.01 ) , whereas that of crushed compared with ground flaxseed was 43 % ( P < or = 0.01 ) . Crushing and milling of flaxseed substantially improve the bioavailability of the enterolignans BACKGROUND An increase in plasma n-3 fatty acid content , particularly eicosapentaenoic acid ( 20:5n-3 ; EPA ) and docosahexaenoic acid ( 22:6n-3 ; DHA ) , is observed after consumption of fish oil-enriched supplements . Because alpha-linolenic acid ( 18:3n-3 ; ALA ) is the direct precursor of EPA and DHA , ALA-enriched supplements such as flax may have a similar effect , although this hypothesis has been challenged because of reported low conversion of ALA into DHA . OBJECTIVE To address this question , we design ed a clinical trial in which flax oil , fish-oil , and sunflower oil ( placebo group ) capsules were given to firefighters ( n = 62 ) , a group traditionally exposed to cardiovascular disease risk factors . DESIGN Firefighters were r and omly divided into 6 experimental groups receiving 1.2 , 2.4 , or 3.6 g flax oil/d ; 0.6 or 1.2 g fish oil/d ; or 1 g sunflower oil/d for 12 wk . Blood was drawn every 2 wk , and the total phospholipid fatty acid composition of red blood cells was determined . RESULTS As expected , fish oil produced a rapid increase in erythrocyte DHA and total n-3 fatty acids . The consumption of either 2.4 or 3.6 g flax oil/d ( in capsules ) was sufficient to significantly increase erythrocyte total phospholipid ALA , EPA , and docosapentaenoic acid ( 22:5n-3 ) fatty acid content . There were no differences among groups in plasma inflammatory markers or lipid profile . CONCLUSIONS The consumption of ALA-enriched supplements for 12 wk was sufficient to elevate erythrocyte EPA and docosapentaenoic acid content , which shows the effectiveness of ALA conversion and accretion into erythrocytes . The amounts of ALA required to obtain these effects are amounts that are easily achieved in the general population by dietary modification The occurrence of menopause is associated with an increased risk of cardiovascular events , and this has partly been attributed to the decline in circulating levels of estrogen . A lignan complex rich in the plant lignan secoisolariciresinol diglucoside ( SDG ) was isolated from flaxseed . SDG is metabolized by the colonic microflora to the mammalian lignans enterodiol and enterolactone and is hypothesized to be cardioprotective due to their structural similarity to estrogen . The aim of this study was to investigate the effect of a lignan complex , providing 500 mg/d of SDG , on markers of endothelial function . Healthy postmenopausal women ( n = 22 ) completed a r and omized , double-blind , placebo-controlled , crossover study . Women consumed daily a low-fat muffin , with or without a lignan complex , for 6 wk , separated by a 6-wk washout period . Flow-mediated , endothelium-dependent vasodilatation ( FMD ) and nitroglycerine-mediated , endothelium-independent vasodilatation were measured at the end of each intervention period . The sum of Plasma nitrite and nitrate ( NOx ) , endothelin-1 ( ET-1 ) , and asymmetric dimethylarginine ( ADMA ) were measured at the beginning and end of each intervention period . FMD was 3.6 + /- 0.9 % ( mean + /- SEM ) after the lignan complex intervention period compared with 3.9 + /- 0.7 % after the placebo period ( P = 0.72 ) . Plasma concentrations of NOx , ET-1 , and ADMA were not affected . We conclude that daily consumption for 6 wk of a low-fat muffin enriched with a lignan complex had no effect on endothelial function in healthy postmenopausal women Phytoestrogens are increasingly incorporated into the diet of menopausal women . However , there are limited data on the efficacy of flaxseed on the consequences of estrogen deficiency in menopausal women . The purpose of the study was to assess the effects of flaxseed incorporation into the diet of healthy menopausal women . One hundred and ninety-nine menopausal women were r and omly assigned to consume 40 g flaxseed/d ( n = 101 ) or wheat germ placebo ( n = 98 ) for 12 months . At baseline and at month 12 , serum levels of lipids , bone mineral density ( BMD ) , and menopausal symptoms were evaluated . Statistical analysis was performed under the intention to treat principle . Flaxseed reduced serum total ( -0.20 + /- 0.51 mmol/liter ; P = 0.012 ) and high-density lipoprotein ( -0.08 + /- 0.24 mmol/liter ; P = 0.031 ) cholesterol concentrations compared with wheat germ placebo . BMD did not differ significantly between the two arms . Both flaxseed and wheat germ reduced ( P < 0.0001 ) the severity scores of menopausal symptoms , but no statistical difference was found between the two arms . Our findings suggest that 1-yr incorporation of flaxseed into the diet produced a favorable , but not clinical ly significant , effect on blood cholesterol and caused no significant change in BMD or symptoms in healthy menopausal women Objective : Alpha-linolenic acid ( ALA ) is the natural precursor of the cardioprotective long-chain n−3 fatty acids . Available data indicate a possible beneficial effect of ALA on cardiovascular disease ( CVD ) , but the response of various CVD risk factors to increased ALA intake is not well characterized . The purpose of the present study was to examine the effect of increased ALA intake on blood pressure in man . Design , setting , subjects and interventions : We used a prospect i ve , two-group , parallel-arm design to examine the effect of a 12-week dietary supplementation with flaxseed oil , rich in ALA ( 8 g/day ) , on blood pressure in middle-aged dyslipidaemic men ( n=59 ) . The diet of the control group was supplemented with safflower oil , containing the equivalent n−6 fatty acid ( 11 g/day linoleic acid ( LA ) ; n=28 ) . Arterial blood pressure was measured at the beginning and at the end of the dietary intervention period . Results : Supplementation with ALA result ed in significantly lower systolic and diastolic blood pressure levels compared with LA ( P=0.016 and P=0.011 , respectively , from analysis of variance ( ANOVA ) for repeated measures ) . Conclusions : We observed a hypotensive effect of ALA , which may constitute another mechanism accounting in part for the apparent cardioprotective effect of this n−3 fatty acid . Sponsorship : Greek Ministry of Development , General Secretariat for Research and Technology Flaxseed contains & ohgr; \n Output:\n " }, { "from": "agent", "value": "This meta- analysis of RCTs showed significant reductions in both SBP and DBP following supplementation with various flaxseed products" } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: Abstract BACKGROUND : This study evaluated the efficacy of bupropion for relapse prevention in smokers with and without a past history of major depressive disorder . Changes in depressive symptoms were also examined . DESIGN : Data were gathered prospect ively from a r and omized , double-blind relapse prevention trial of bupropion conducted at five study sites . A total of 784 smokers ( 54 % female , 97 % white ) were enrolled . Using the Structured Clinical Interview for Depression , 17 % of the subjects reported a past history of major depressive disorder at baseline . All subjects received open-label bupropion SR ( 300 mg/d ) for 7 weeks . Subjects abstinent from smoking at the end of 7 weeks ( N=429 ) were r and omized to bupropion SR ( 300 mg/d ) or placebo for the remainder of the year and followed for 1 year off medication . The primary outcome measures were median time to relapse to smoking and the 7-day point-prevalence smoking abstinence rate . Self-reported abstinence from smoking was verified by expired air carbon monoxide . The Beck Depression Inventory was used to assess depressive symptoms at baseline and at weeks 8 and 12 . RESULTS : Median time to relapse did not differ by past history of major depressive disorder . Bupropion was associated with higher point-prevalence smoking abstinence at the end of medication compared to placebo ( P=.007 ) , independent of a past history of major depressive disorder . Moreover , change in depressive symptoms during the double-blind phase did not differ for those with and without a past history of major depressive disorder . CONCLUSIONS : Extended use of bupropion for relapse prevention is effective for smokers with and without a history of major depression 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 BACKGROUND This study was conducted to determine the efficacy of the nicotine patch in smoking cessation when combined with self-help material s , three brief visits , and telephone counseling . METHODS One hundred fifty-nine healthy volunteers who smoked at least one pack of cigarettes per day and desired to quit smoking were enrolled in a double-blind trial with 6-week treatment and 6-month follow-up periods . After review of self-help material s , subjects were r and omly assigned to regimens of nicotine or placebo patches . Subjects wore two patches per day for 4 weeks ( 25 mg of nicotine per 24 hours ) , then one patch per day for 2 weeks . Return visits were at the ends of weeks 4 and 6 . Telephone counseling was given during weeks 1 , 2 , 3 , and 5 . Abstinence at 6 weeks was defined as zero cigarettes smoked for the previous 28 days , verified by exhaled carbon monoxide less than 8 ppm at 4 weeks and 6 weeks . Abstinence at 3 and 6 months was defined as self-report of zero cigarettes since the previous contact , verified by carbon monoxide value at 6 months . RESULTS Abstinence rates at 6 weeks , 3 months , and 6 months were 29.5 % , 21.8 % , and 20.5 % in the active group , and 8.8 % , 3.8 % , and 2.5 % in the placebo group ( P < or = .001 for each comparison ) , respectively . Skin irritation was the main side effect , causing 1.3 % to drop out . CONCLUSION The nicotine patch is efficacious in smoking cessation over a 6-month period , when combined with only self-help material s , three brief visits , and telephone counseling The authors present results of a r and omized clinical trial of the efficacy of extended treatment with bupropion SR in producing longer term cigarette smoking cessation . Adult smokers ( N = 362 ) received open-label treatment ( 11 weeks ) that combined relapse prevention training , bupropion SR , and nicotine patch followed by extended treatment ( 14 weeks ) with bupropion SR or matching placebo . Abstinence percentages were relatively high ( week 11 : 52 % ; week 25 : bupropion , 42 % ; placebo , 38 % ; week 52 : bupropion , 33 % ; placebo , 34 % ) , but bupropion SR did not surpass placebo . Gender and baseline craving level were identified as significant , independent moderators of treatment response . Men were more likely to abstain than women ( week 11 : 59 % vs. 43 % , p = .001 ; week 25 : 48 % vs. 31 % , p = .001 ; week 52 : 39 % vs. 27 % , p = .01 ) . Because most smokers suffer relapse with any current cessation treatment , the comparatively high abstinence percentages achieved in this trial are of interest PURPOSE AND METHODS Cognitive behavior therapy ( CBT ) constitutes the basis of smoking cessation programs . Quitting rates are usually increased by the concomitant use of CBT and pharmacotherapy . There are studies showing the efficacy of bupropion and nortriptyline compared to placebo , but there is just one published comparison between these drugs , unfortunately with low power to detect significant differences . This study was design ed to compare the efficacy of bupropion , nortriptyline and placebo in a group of smokers who also received intensive counseling therapy . We conducted a double blind , double-dummy , placebo-controlled trial for smoking cessation that lasted 9 weeks . Patients were r and omized to receive nortriptyline 75 mg/day ( 52 subjects ) , bupropion 300 mg/day ( 53 subjects ) or placebo ( 51 subjects ) . All smokers also received the same intensive cognitive behavior therapy . The target day for quitting smoking was usually day 10 . Intensive counseling was provided at baseline , weekly during treatment , and at 10 , 13 , 16 , 20 and 26 weeks . Abstinence was defined as continuous when the subject was not smoking since the target-quitting day ( self-report ) and had an expired carbon monoxide concentration of 10 ppm or less . RESULTS The sustained abstinence rates at 6 months were 21.6 % in the placebo group , 30.8 % in the nortriptyline group ( p = 0.40 ) , and 41.5 % in the bupropion group ( p = 0.05 ) . The odds ratio was not statistically different for smokers using nortriptyline or bupropion ( OR 1.60 ; 95 % CI 0.66 - 3.86 ; p = 0.35 ) . The most common adverse events were dry mouth and drowsiness in the nortriptyline group and dry mouth and insomnia in the bupropion group . CONCLUSIONS Treatment with CBT + bupropion result ed in a better 6-month rate of smoking cessation compared to CBT+nortriptyline or CBT + placebo . Abstinence rate in the nortriptyline group was not statistically different from patients in the bupropion or placebo group Background — Smoking cessation is a key component of secondary cardiovascular disease prevention . Varenicline , a partial & agr;4&bgr;2 nicotinic acetylcholine receptor agonist , is effective for smoking cessation in healthy smokers , but its efficacy and safety in smokers with cardiovascular disease are unknown . Methods and Results — A multicenter , r and omized , double-blind , placebo-controlled trial compared the efficacy and safety of varenicline with placebo for smoking cessation in 714 smokers with stable cardiovascular disease . Participants received varenicline ( 1 mg twice daily ) or placebo , along with smoking-cessation counseling , for 12 weeks . Follow-up lasted 52 weeks . The primary end point was carbon monoxide – confirmed continuous abstinence rate for weeks 9 through 12 ( last 4 weeks of treatment ) . The continuous abstinence rate was higher for varenicline than placebo during weeks 9 through 12 ( 47.0 % versus 13.9 % ; odds ratio , 6.11 ; 95 % confidence interval [ CI ] , 4.18 to 8.93 ) and weeks 9 through 52 ( 19.2 % versus 7.2 % ; odds ratio , 3.14 ; 95 % CI , 1.93 to 5.11 ) . The varenicline and placebo groups did not differ significantly in cardiovascular mortality ( 0.3 % versus 0.6 % ; difference , −0.3 % ; 95 % CI , −1.3 to 0.7 ) , all-cause mortality ( 0.6 % versus 1.4 % ; difference , −0.8 % ; 95 % CI , −2.3 to 0.6 ) , cardiovascular events ( 7.1 % versus 5.7 % ; difference , 1.4 % ; 95 % CI , −2.3 to 5.0 ) , or serious adverse events ( 6.5 % and 6.0 % ; difference , 0.5 % ; 95 % CI , −3.1 to 4.1 ) . As a result of adverse events , 9.6 % of varenicline and 4.3 % of placebo participants discontinued study drug . Conclusions — Varenicline is effective for smoking cessation in smokers with cardiovascular disease . It was well tolerated and did not increase cardiovascular events or mortality ; however , trial size and duration limit definitive conclusions about safety . Clinical Trial Registration Information— URL : http://www . clinical trials.gov/ct2/show/NCT00282984 . Unique identifier : NCT00282984 The use of nicotine chewing gum combined with psychological support improves the success rate in stopping smoking . We studied the safety and efficacy of a transdermal nicotine patch in stopping smoking . We conducted a double-blind r and omized study comparing the effect of a 16-hour nicotine patch ( 15 + /- 3.5 mg of nicotine in 16 hours ) with those of a placebo patch . Of the 289 smokers ( 207 women and 82 men ) enrolled in the study , 145 were treated with nicotine patches and 144 with placebo patches for 16 weeks . The rates of sustained abstinence were significantly better with active treatment than with the placebo : 53 , 41 , 24 and 17 % of those in the nicotine-patch group were abstinent after 6 , 12 , 26 , and 52 weeks , respectively , as compared with 17 , 10 , 5 and 4 % of those in the placebo-patch group ( p less than 0.0001 ) . Only two subjects with the nicotine patch and one with the placebo patch withdrew from the study because of side effects . The nicotine skin patch proved to be safe and effective , as demonstrated by a higher rate of abstinence than with the placebo BACKGROUND Currently available smoking cessation therapies have limited success rates . Varenicline tartrate is a novel , selective nicotinic receptor partial agonist developed specifically for smoking cessation . This study evaluated the efficacy , tolerability , and safety of 3 varenicline doses for smoking cessation . Bupropion hydrochloride was included as an active control . METHODS A phase 2 , multicenter , r and omized , double-blind , placebo-controlled study of healthy smokers ( 18 - 65 years old ) . Subjects were r and omized to varenicline tartrate , 0.3 mg once daily ( n = 128 ) , 1.0 mg once daily ( n = 128 ) , or 1.0 mg twice daily ( n = 127 ) , for 6 weeks plus placebo for 1 week ; to 150-mg sustained-release bupropion hydrochloride twice daily ( n = 128 ) for 7 weeks ; or to placebo ( n = 127 ) for 7 weeks . RESULTS During the treatment phase , the continuous quit rates for any 4 weeks were significantly higher for varenicline tartrate , 1.0 mg twice daily ( 48.0 % ; P<.001 ) and 1.0 mg once daily ( 37.3 % ; P<.001 ) , than for placebo ( 17.1 % ) . The bupropion rate was 33.3 % ( P = .002 vs placebo ) . The carbon monoxide-confirmed continuous quit rates from week 4 to week 52 were significantly higher in the varenicline tartrate , 1.0 mg twice daily , group compared with the placebo group ( 14.4 % vs 4.9 % ; P = .002 \n Output:\n " }, { "from": "agent", "value": "No pharmacological intervention significantly affected smoking cessation rates .\nWeight management education only , is not effective and may reduce abstinence .\nPersonalised weight management support may be effective and not reduce abstinence , but there are too few data to be sure .\nCBT to accept WG did not limit PCWG and may not promote abstinence in the long term .\nExercise interventions significantly reduced weight in the long term , but not the short term .\nBupropion , fluoxetine , NRT and varenicline reduce PCWG while using the medication .\nAlthough this effect was not maintained one year after stopping smoking , the evidence is insufficient to exclude a modest long-term effect ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: UNLABELLED Hip osteoarthritis ( OA ) is a degenerative disease , and total hip arthroplasty ( THA ) is one of the surgical procedures of choice to improve the OA patient 's quality of life . Without a rehabilitation program , THA patients will develop functional limitations . A r and omized double-blind trial was performed between July 2009 and October 2011 to compare in a short follow-up time two groups of patients who underwent THA for OA . The THA protocol ( THAP ) group received verbal instructions and physiotherapy exercise demonstrations , and the THA physiotherapy care protocol ( THAPCP ) group received the same verbal instructions and demonstrations associated with daily exercise practice guided by a physiotherapist . The outcomes that were assessed preoperatively and 15 d postoperatively in 106 patients were muscle strength force , goniometry , Medical Outcomes Study 36-Item Short Form Health Survey , and Merle d'Aubigné and Postel score . Higher muscle strength force scores and degrees in range of motion were found in the THAPCP group . Higher improvements were also observed for the THAPCP group compared with the THAP group in the Merle d'Aubigné and Postel score . At the end of the follow-up period , the intervention in the THAPCP group improved functional capacity , quality of life , mobility , muscle strength , goniometry , and pain . It appears to be a safe tool for accelerating recovery in THA patients . CLINICAL TRIAL REGISTRATION Clinical Trials.gov ; NCT01491048 Background In-hospital progressive resistance training ( PRT ) has been shown to be an effective method of rehabilitation following hip surgery . The aim of this study was to assess whether a home-based PRT program would be beneficial in improving patients ’ muscle strength and physical function compared to st and ard rehabilitation . Methods Subjects ( n = 49 ) either received home-based PRT rehabilitation ( n = 25 ) or st and ard rehabilitation ( n = 24 ) in a prospect i ve single blinded r and omized trial carried out over a two-year period . The primary outcome measure was the maximal voluntary contraction of the operated leg quadriceps ( MVCOLQ ) with secondary measures of outcome being the sit to st and score ( ST ) , timed up and go ( TUG ) , stair climb performance ( SCP ) , the 6 min walk test ( 6MWT ) , and lean mass of the operated leg ( LM ) . Results Twenty-six patients completed follow up at 1 year ( n = 13 per group ) for the final comparative analysis . All the outcome measures showed marked progressive improvements from the baseline measures at 9–12 months post op ( Estimated effect ( std error ) ; p value)- MVCOLQ 26.50 ( 8.71 ) N p = 0.001 ; ST 1.37 ( 0.33 ) p = 0.0001 ; TUG −1.44 ( 0.45 ) s p = 0.0001 ; SCP −3.41(0.80)s p = 0.0001 ; 6MWT 45.61 (6.10)m p = 0.0001 ; LM 20 (204)g p = 0.326 ) following surgery for both groups . Overall , there was no significant effect for participation in the exercise regime compared with st and ard care for all outcomes assessed . Conclusions Overall , this study demonstrated that there is no significant difference between the two groups for participation in the home-based PRT exercise programme when compared to st and ard care for all outcomes .Trial registration IS RCT N 1309951 . Registered February 2011 OBJECTIVE To examine the physical function , gait , and quality of life of patients after total hip replacement ( THR ) r and omly assigned to either a targeted home- or center-based exercise program . DESIGN R and omized controlled trial . SETTING Rehabilitation research center in Australia . PARTICIPANTS Twenty-three patients with unilateral THR were r and omly assigned to a supervised center-based exercise group ( n=11 ) or an unsupervised home-based exercise group ( n=12 ) . INTERVENTION The center-based group completed an 8-week targeted exercise program while under the direct supervision of a physiotherapist . After initial instruction , the home-based group completed the 8-week targeted exercise program at home without further supervision . MAIN OUTCOME MEASURES Quality of life , physical function , and spatiotemporal measures of gait . RESULTS No significant interaction ( group by time ) or main effects of grouping were found . Within each group , quality of life , and stair climbing improved significantly ( P<.05 ) as did Timed Up & Go test and 6-minute walk test performances ( P<.05 ) . Walking speed increased by 16 cm/s ( P<.01 ) , cadence by 8 steps/min ( P<.05 ) , step length by 4.7 cm ( P<.05 ) , and double-support time reduced by a factor of 16 % . Step length symmetry showed significant improvement ( P<.05 ) over time . Step length differential between the affected and unaffected limbs reduced from 4.0 to 2.7 cm . CONCLUSIONS The targeted strengthening program was effective for both the home- and center-based groups . No group differences were found in the majority of the outcome measures . This finding is important because it shows that THR patients can achieve significant improvements through a targeted strengthening program delivered at a center or at home Abstract Purpose : The purpose of this study was to investigate the effects of an exercise program focusing on hip external rotator muscle on physical recovery in the early post-operative period of total hip arthroplasty ( THA ) . Methods : Patients who underwent THA were r and omized to an exercise group ( n = 14 ) or a control group ( n = 14 ) . In exercise group , the hip external rotator exercise program was performed 5 times per week for four weeks . Outcome measures were hip pain , hip range of motion , muscle strength of lower extremity and Timed Up and Go ( TUG ) test . Results : Both the hip abductor strength ( effect size = 0.60 ) and TUG test ( effect size= −0.53 ) in the exercise group improved significantly after the intervention . Conclusions : The results of the present study demonstrated that exercise program focusing on hip external rotator muscle was an effective intervention , especially in improving both hip abductor strength and walking ability in the acute post-THA stage . Implication for Rehabilitation After THA , in order to safely progress patients back to their desired activity level , there is a need to develop rehabilitation strategies to expedite and promote the recovery during the acute postoperative period . Exercise program focusing on hip external rotator muscle may lead to significant improvement of hip abductor muscle strength and gait ability in the acute post-THA stage OBJECTIVES To better underst and how immobilization and surgery affect muscle size and function in the elderly and to identify effective training regimes . DESIGN A prospect i ve r and omized , controlled study . SETTING Bispebjerg University Hospital , Copenhagen , Denmark . PARTICIPANTS Thirty-six patients ( aged 60 - 86 ) scheduled for unilateral hip replacement due to primary hip osteoarthrosis . INTERVENTION Patients were r and omized to st and ard home-based rehabilitation ( 1 h/d x 12 weeks ) , unilateral neuromuscular electrical stimulation of the operated side ( 1 h/d x 12 weeks ) , or unilateral resistance training of the operated side ( 3/wk x 12 weeks ) . MEASUREMENTS Hospital length of stay ( LOS ) , quadriceps muscle cross-sectional area ( CSA ) , isokinetic muscle strength , and functional performance . Patients were tested presurgery and 5 and 12 weeks postsurgery . RESULTS Mean+/-st and ard error LOS was shorter for the resistance training group ( 10.0+/-2.4 days , P<.05 ) than for the st and ard rehabilitation group ( 16.0+/-7.2 days ) . Resistance training , but not electrical stimulation or st and ard rehabilitation , result ed in increased CSA ( 12 % , P<.05 ) and muscle strength ( 22 - 28 % , P<.05 ) . Functional muscle performance increased after resistance training ( 30 % , P<.001 ) and electrical stimulation ( 15 % , P<.05 ) but not after st and ard rehabilitation . CONCLUSION Postoperative resistance training effectively increased maximal muscle strength , muscle mass , and muscle function more than a st and ard rehabilitation regime . Furthermore , it markedly reduced LOS in elderly postoperative patients OBJECTIVE To examine if 2 weekly sessions of supervised progressive resistance training ( PRT ) in combination with 5 weekly sessions of unsupervised home-based exercise is more effective than 7 weekly sessions of unsupervised home-based exercise in improving leg-extension power of the operated leg 10 weeks after total hip replacement ( THR ) in patients with lower pre-operative function . METHOD A total of 73 patients scheduled for THR were r and omised ( 1:1 ) to intervention group ( IG , home based exercise 5 days/week and PRT 2 days/week ) or control group ( CG , home based exercise 7 days/week ) . The primary endpoint was change in leg extension power at 10 week follow up . Secondary outcomes were isometric hip muscle strength , sit-to-st and test , stair climb test , 20 m walking speed and patient-reported outcome ( HOOS ) . RESULTS Sixty-two completed the trial ( 85 % ) . Leg extension power increased from baseline to the 10 week follow up in both groups ; mean [ 95 % CI ] IG : 0.29 [ 0.13 ; 0.45 ] and CG : 0.26 [ 0.10 ; 0.42 ] W/kg , with no between-group difference ( primary outcome ) ( P = 0.79 ) . Maximal walking speed ( P = 0.008 ) and stair climb performance ( P = 0.04 ) improved more in the IG compared to CG , no other between-group differences existed . CONCLUSIONS In this trial , supervised PRT twice a week in addition to 5 weekly sessions of unsupervised exercise for 10 weeks was not superior to 7 weekly sessions of unsupervised home-based exercise for 10 weeks in improving the primary outcome , leg-extension power of the operated leg , at the primary endpoint 10 weeks after surgery in THR patients with lower pre-operative function . TRIAL REGISTRATION NCT01214954 Husby VS , Helgerud J , Bjørgen S , Husby OS , Benum P , Hoff J : Early postoperative maximal strength training improves work efficiency 6–12 months after osteoarthritis induced total hip arthroplasty in patients younger than 60 years . Objective : To assess physical outcome of early maximal strength training after total hip arthroplasty . Design : Six- and 12-mo follow-up of 24 ( 22 ) total hip arthroplasty patients r and omly assigned to 4 wks of maximal strength training and conventional rehabilitation and to conventional rehabilitation only was conducted . After the intervention period , all patients attended conventional rehabilitation . Outcome measures were hip abduction and leg press strength , gait patterns , work efficiency , maximal oxygen consumption , and health-related quality of life . Results : Work efficiency was significantly higher in the strength training and conventional rehabilitation group compared with the conventional rehabilitation – only group after 6 and 12 mos by 29 % and 30 % , respectively . Leg press for the healthy leg and rate of force development for the operated leg were significantly higher in the strength training and conventional rehabilitation group compared with the conventional rehabilitation – only group 12 mos postoperatively by 36 % and 74 % , respectively . Conclusions : This study demonstrates higher work efficiency after 6 and 12 mos and improved rate of force development after 12 mos in total hip arthroplasty patients who performed early maximal strength training combined with conventional rehabilitation after total hip arthroplasty surgery compared with total hip arthroplasty patients receiving conventional rehabilitation only . However , the study indicates that a prolonged maximal strength training program and aerobic endurance training are required to fully recover total hip arthroplasty patients Background Total Hip Arthroplasty ( THA ) is being used more commonly in younger higher dem and patients . The purpose of this r and omized pilot study was to explore a ) feasibility of comprehensive postoperative rehabilitation compared to usual care following primary THA in subjects < 65 years , b ) appropriate outcome measures including performance-based measures and c ) timing of assessment s. Methods 21 subjects who underwent primary THA were r and omized to receive a three-month out-patient rehabilitation program ( Intervention ) or usual postoperative care ( Control ) . Subjects were assessed preoperatively , six-weeks postoperatively ( Pre-intervention ) and four and 12 months postoperatively ( Post-intervention ) . Self-report measures were the Western Ontario McMaster Osteoarthritis Index ( WOMAC ) and R and 36-Item Health Survey ( R AND -36 ) . Performance-based measures included lower extremity strength , walking speed and endurance , and gait laboratory assessment . Results Ten Control and 11 Intervention subjects with an average age of 53.4 ( SD9.3 ) years were r and omized . All Intervention subjects completed the program without adverse effects . Although no statistically significantly results were reported , four months postoperatively , Intervention subjects had clinical ly important differences ( CID ) in strength compared with Control subjects . Walking endurance , WOMAC and R AND scores improved significantly with no CID noted between groups . Ten ( 48 % ) subjects reported a ceiling effect on the WOMAC ( 9 ( 43 % ) subjects on Pain ; 1 ( 5 % ) subject on \n Output:\n " }, { "from": "agent", "value": "Because of the wide variety in characteristics of the physiotherapeutic exercise and control interventions , follow-up length and outcome measures , limited evidence was found on the effectiveness of physiotherapeutic exercise following THA .\nThe insufficient therapeutic validity and potentially high risk of bias in studies involving physiotherapeutic exercise interventions limit the ability to assess the effectiveness of these interventions following THA ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: Kidney transplant recipients receiving calcineurin inhibitor-based immunosuppression incur increased long-term risks of cancer and kidney fibrosis . Switch to mammalian target of rapamycin ( mTOR ) inhibitors may reduce these risks . Steroid or Cyclosporin Removal After Transplant using Everolimus ( SOCRATES ) , a 36-month , prospect i ve , multinational , open-label , r and omized controlled trial for de novo kidney transplant recipients , assessed whether everolimus switch could enable elimination of mycophenolate plus either steroids or CNI without compromising efficacy . Patients received cyclosporin , mycophenolate and steroids for the first 14 days then everolimus with mycophenolate and CNIwithdrawal ( CNI-WD ) ; everolimus with mycophenolate and steroid withdrawal ( steroid-WD ) ; or cyclosporin , mycophenolate and steroids ( control ) . 126 patients were r and omized . The steroid WD arm was terminated prematurely because of excess discontinuations . Mean eGFR at month 12 for CNI-WD versus control was 65.1 ml/min/1.73 m2 vs. 67.1 ml/min/1.73 m2 by ITT , which met predefined noninferiority criteria ( P = 0.026 ) . The CNI-WD group experienced a higher rate of BPAR(31 % vs. control 13 % , P = 0.048 ) and showed a trend towards higher composite treatment failure ( BPAR , graft loss , death , loss to follow-up ) . The 12 month results from SOCRATES show noninferiority in eGFR , but a significant excess of acute rejection when everolimus was commenced at week 2 to enable a progressive withdrawal of mycophenolate and cyclosporin in kidney transplant recipients The glomerular filtration rate ( GFR ) is traditionally considered the best overall index of renal function in health and disease ( 1 ) . Because GFR is difficult to measure in clinical practice , most clinicians estimate the GFR from the serum creatinine concentration . However , the accuracy of this estimate is limited because the serum creatinine concentration is affected by factors other than creatinine filtration ( 2 , 3 ) . To circumvent these limitations , several formulas have been developed to estimate creatinine clearance from serum creatinine concentration , age , sex , and body size ( 4 - 12 ) . Despite more recent studies that have related serum creatinine concentration to GFR ( 13 - 24 ) , no formula is more widely used to predict creatinine clearance than that proposed by Cockcroft and Gault ( 4 ) . This formula is used to detect the onset of renal insufficiency , to adjust the dose of drugs excreted by the kidney , and to evaluate the effectiveness of therapy for progressive renal disease . More recently , it has been used to document eligibility for reimbursement from the Medicare End Stage Renal Disease Program ( 25 ) and for accrual of points for patients on the waiting list for cadaveric renal transplantation ( 26 ) . Major clinical decisions in general medicine , geriatrics , and oncology ( as well as nephrology ) are made by using the Cockcroft-Gault formula and other formulas to predict the level of renal function . Therefore , these formulas must predict GFR as accurately as possible . The Modification of Diet in Renal Disease ( MDRD ) Study , a multicenter , controlled trial , evaluated the effect of dietary protein restriction and strict blood pressure control on the progression of renal disease ( 27 - 30 ) . During the baseline period , GFR , serum creatinine , and several variables that affect the relation between them were measured in patients with chronic renal disease . The purpose of our study was to develop an equation from MDRD Study data that could improve the prediction of GFR from serum creatinine concentration . Methods Baseline Cohort and Measurement Methods in the Modification of Diet in Renal Disease Study The overall study design and methods of recruitment for the MDRD Study have been described elsewhere ( 31 , 32 ) . A total of 1785 patients entered the baseline period . Of these patients , 1628 ( 91 % ) also underwent measurement of GFR and the other variables described below ; these patients constitute the study group for these analyses . Glomerular filtration rate was measured as the renal clearance of 125I-iothalamate ( 33 , 34 ) . Creatinine clearance was computed from creatinine excretion in a 24-hour urine collection and a single measurement of serum creatinine . Serum and urine creatinine were measured by using a kinetic alkaline picrate assay with a normal range in serum of 62 to 124 mol/L ( 0.7 to 1.4 mg/dL ) ( 35 ) . Glomerular filtration rate and creatinine clearance were expressed per 1.73 m2 of body surface area by multiplying measured values by 1.73/body surface area ( 36 ) . The serum and urine specimens were also used for other measurements , including serum albumin ( bromcresol green method [ 35 ] ) , serum urea nitrogen ( urease method [ 35 ] ) , and urine urea nitrogen ( urease method [ 35 ] ) . Protein intake ( g/d ) was estimated as 6.25 [ UUN ( g/d ) + 0.031 ( g/kg per day ) SBW ( kg ) ] , where UUN is urine urea nitrogen , SBW is st and ard body weight , and 0.031 g/kg per day is a constant reflecting the rate of excretion of nitrogen in compounds other than urine urea ( 37 , 38 ) . The diagnosis of diabetes and the cause of renal disease were assigned on the basis of chart review at the clinical center ( 39 ) . Statistical Analysis Descriptive Statistics The relation of renal function measurements to other baseline characteristics was assessed by using contingency tables , t-tests , analysis of variance , and linear regression , as appropriate . Nonparametric tests ( Wilcoxon rank-sum tests and Kruskal-Wallis tests ) gave consistent results . A P value less than 0.01 was considered statistically significant . Multivariable Analysis of Glomerular Filtration Rate We used stepwise multiple regression to determine a set of variables that jointly predicted GFR . The stepwise regression models were developed by using a training sample consisting of a r and om sample of 1070 of the 1628 patients . We found that the variability of the difference between the observed and predicted GFR values was greater for higher GFR values . This increase was eliminated by performing multiple regressions on log-transformed data . To facilitate clinical interpretation , the results were re-expressed in terms of the original units . Consequently , the prediction equation is a multiplicative model ; regression coefficients refer to the change in geometric mean GFR associated with unit changes in the independent variable . Predicted GFR is expressed in mL/min per 1.73 m2 . The following variables were considered for possible inclusion in the regression model : weight , height , sex , ethnicity , age , diagnosis of diabetes , serum creatinine concentration , serum urea nitrogen level , serum albumin level , serum phosphorus level , serum calcium level , mean arterial pressure , urine creatinine level , urine urea nitrogen level , urine protein level , and urine phosphorus level . The cause of renal disease was not included because in clinical practice , the cause may be unknown or clinicians may not use the same classification method as the investigators in the MDRD Study . A P value less than 0.001 was used as the criterion for entry of a variable into the model . Because of the difficulty in collecting complete 24-hour urine sample s in clinical practice , an additional stepwise regression was performed to develop a prediction model that did not include urine biochemistry variables . Finally , because of the interest in developing a prediction equation to assess eligibility for Medicare reimbursement and listing for cadaveric renal transplantation , we repeated the analysis restricting the population to the subgroup of patients with higher serum creatinine concentrations ( > 221 mol/L [ 2.5 mg/dL ] ; n=509 in the training sample ) . Methods for Comparing Equations To Predict Glomerular Filtration Rate We first developed coefficients for each prediction equation ( including the selection of the predictor variables for the stepwise regressions ) using the data from the training sample to predict log GFR . Each prediction equation also included a multiplicative constant to account for any consistent bias in the application of that equation in the MDRD Study Group . This was particularly important for equations that are intended to estimate creatinine clearance , which is known to be higher than GFR . The regression coefficients determined in the training sample were then applied to obtain predicted GFRs in a separate validation sample consisting of the remaining 558 patients ( 172 patients with serum creatinine concentration>221 mol/L [ 2.5 mg/dL ] ) . These predicted GFR values were compared with the actual GFRs in the validation sample to evaluate the performance of each prediction equation . In this way , separate data sets were used to construct the equations and assess their accuracy after removal of systematic bias . For each equation , we computed overall R 2 ( percentage of variability in log GFR explained by the regression model ) and the 50th , 75th , and 90th percentiles of the distribution of the percentage absolute difference between measured and predicted GFRs in the validation sample . The 50th percentiles indicate the typical size of the errors in prediction of GFR , and the 75th and 90th percentiles assess the sizes of the larger errors that occurred for each model . Development of Final Prediction Equations To improve the accuracy of the final MDRD Study prediction equations , the regression coefficients derived from the training sample were up date d on the basis of data from all 1628 patients . As a result , the st and ard errors of the regression coefficients in the final MDRD Study prediction equations are slightly smaller than those derived from the training sample ; thus , the accuracy of the final prediction equations may be slightly better ( by about 0.1 % to 0.2 % ) than their accuracy as assessed in the validation sample . Results Demographic and Clinical Characteristics The mean age ( SD ) of the cohort was 50.6 12.7 years . Sixty percent of patients were male , 88 % were white , and 6 % were diabetic . Causes of renal disease were glomerular disease ( 32 % ) , polycystic kidney disease ( 22 % ) , tubulointerstitial disease ( 7 % ) , and other or unknown renal diseases ( 40 % ) . Mean protein intake was 0.99 0.24 g/kg of body weight per day and mean arterial pressure was 99.4 12.2 mm Hg . Mean weight was 79.6 16.8 kg , body surface area was 1.91 0.23 m2 , serum urea nitrogen concentration was 11.4 5.7 mmol/L [ 32 16 mg/dL ] , and serum albumin concentration was 40.0 4.0 g/L [ 4.0 0.4 g/dL ] , respectively . Glomerular Filtration Rate , Creatinine Clearance , and Serum Creatinine Concentration Renal function measurements for the study group and for various subgroups are shown in Table 1 . Mean GFR for the population was 0.38 mL s 2 m 2 ( 39.8 mL/min per 1.73 m2 ) , with lower values in patients with lower protein intake , white patients compared with black patients , and older patients ( 55 years ) compared with younger patients ( P<0.01 ) . The mean value of creatinine clearance was 0.81 mL s 2 m 2 ( 48.6 mL/min per 1.73 m2 ) and was lower in older patients and patients with lower protein intake ( P 0.01 ) . The mean serum creatinine concentration was 203 mol/L ( 2.3 mg/dL ) and was higher in men , patients with lower protein intake , and patients with higher mean arterial pressure ( P 0.01 ) . Figure 1 shows the well-known reciprocal relation of serum creatinine concentration to GFR for subgroups based on sex and ethnicity . At any given GFR , the serum creatinine concentration is significantly higher in men than in women and in black persons than in white persons ( P<0.001 ) . Table 1 . Association of Renal BACKGROUND Non-nephrotoxic immunosuppressive strategies that allow reduction of calcineurin-inhibitor exposure without compromising safety or efficacy remain a goal in kidney transplantation . Immunosuppression based on the mammalian-target-of-rapamycin inhibitor everolimus was assessed as a strategy for elimination of calcineurin-inhibitor exposure and optimisation of renal-graft function while maintaining efficacy . METHODS In the ZEUS multicentre , open-label study , 503 patients ( aged 18 - 65 years ) who had received de-novo kidney transplants were enrolled . After initial treatment with ciclosporin , based on trough concentrations , and enteric-coated mycophenolate sodium ( 1440 mg/day , orally ) , corticosteroids ( ≥5 mg/day prednisolone or equivalent , orally ) , and basiliximab induction ( 20 mg , intravenously , on day 0 [ 2 h before transplantation ] , and on day 4 ) , 300 ( 60 % ) patients were r and omly assigned at 4·5 months in a 1:1 ratio to undergo calcineurin-inhibitor elimination ( everolimus-based regimen that was based on trough concentrations [ 6 - 10 ng/mL ] and enteric-coated mycophenolate sodium [ 1440 mg/day ] with corticosteroids ) , or continue st and \n Output:\n " }, { "from": "agent", "value": "Discontinuation secondary to adverse events was more common in patients on mTORi , whereas the incidence of skin cancers and cytomegalovirus infection was lower in patients on mTORi ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: The recovery of patients undergoing total shoulder arthroplasty ( TSA ) can be adversely affected by a number of complications . Autologous platelet gel ( APG ) , produced by activating platelet-rich plasma ( PRP ) , has been shown to improve hemostasis and wound healing and reduce infections in some surgical procedures . Activated platelet-poor plasma ( PPP ) has also been used as a hemostatic agent . This study examines the effects of APG and PPP treatment on TSA patients postoperatively . After Institutional Review Board ( IRB ) approval , 40 patients undergoing TSA at our institution were prospect ively enrolled in our study . They were r and omized into either a control ( n = 20 ) or study ( n = 20 ) group , with the study group receiving APG and PPP treatment . Preoperative demographic data , pre- and postoperative laboratory data , pain scores , pain medication , complications , pre- and postoperative range of motion measurements , and postoperative lengths of stay were recorded for each group . The preoperative internal rotation index was significantly higher in the control group compared with treatment patients ( 4.64 + /- 4.46 vs. 1.88 + /- 2.44 , p < .05 ) . The percent hemoglobin retained postoperatively was higher in the treatment group at 24 ( 84.54 + /- 5.32 vs. 79.87 + /- 8.73 ) and 72 hours ( 87.46 + /- 16.03 vs. 76.70 vs. 5.96 ) , but neither difference reached statistical significance . The treatment group had significantly lower pain scores ( p = .007 ) and total fentanyl requirements ( p < .05 ) compared with control patients . The internal rotation index improvement factor ( postoperative internal rotation index/preoperative internal rotation index ) was significantly higher in the treatment group vs. the control group ( p < .05 ) . Although it did not reach statistical significance , the treatment group was discharged almost 9 hours earlier than the control group ( 64.44 + /- 15.23 vs. 73.39 + /- 15.37 ) . APG and PPP treatment decreased pain and provided a greater increase in internal rotation measurements postoperatively OBJECTIVES The aim of this study was to evaluate the effects of moderately intensive pool exercise therapy on patients with rheumatoid arthritis ( RA ) . METHODS Forty-six patients with chronic RA were r and omly assigned to a treatment group and a control group . The treatment group ( n = 20 ) exercised in a temperate pool twice a week for 12 weeks . The control group ( n = 23 ) continued with their previous activities . Aerobic capacity , measured by means of a submaximum bicycle test , and the physical component of the SF-36 were chosen as the primary outcome measures . Two tests of muscle endurance were chosen as the secondary outcome measure . Additional functional tests and instruments were included . RESULTS No significant differences between the groups were found for the primary outcome measures . Significant improvements in the following aspects of muscular function ( P < 0.05 ) were found in the treatment group when their performance was compared with that of the control group : isometric shoulder endurance , grip force , dynamic endurance of lower extremities ( chair test ) and muscle function of lower extremities . Significant improvements were also found for vitality ( SF-36 ) compared with the control group . The improvements in the training group were maintained for 3 months . CONCLUSIONS Pool exercise therapy of moderate intensity significantly improved muscle endurance in the upper and lower extremities in patients with RA , while no impact on aerobic capacity was found . However , the study population was small and there is a need for further studies with larger population SUMMARY Objective : To evaluate the efficacy and safety of oxaprozin in comparison with diclofenac in patients with periarthritis pain of the shoulder previously unsuccessfully treated with nonsteroidal anti-inflammatory drugs other than diclofenac and oxaprozin . Methods : In this open , multicentre , r and omised , controlled study , eligible patients with periarthritis of the shoulder were r and omised to receive either oxaprozin 1200 mg once daily ( n = 49 ) or diclofenac 50 mg three times daily ( n = 47 ) . The treatment period was 15 ± 1 days . The study was planned on a hypothesis of equivalence between the two study drugs . The primary study endpoint was the change from baseline at day 15 in the patient-assessed shoulder pain score . Secondary efficacy variables included investigator-assessed shoulder function , patient-assessed quality of life on the Short-Form-36 ( SF-36 ) Acute Health Survey and both patients ’ and investigators ’ overall assessment of efficacy . Results : At day 15 , the mean changes in shoulder pain score from baseline in the oxaprozin and diclofenac groups were –5.85 ± SD 4.62 and –5.54 ± SD 4.41 , respectively . The difference between the two groups was not statistically significant , confirming the hypothesis of the study that oxaprozin is as effective as diclofenac . Investigator-assessed shoulder function improved in both groups but more so in the oxaprozin group ( p = 0.028 at day 15 ) . Quality of life as measured by SF-36 total score was also improved in both treatment groups , with a trend toward greater improvement in the oxaprozin group . Furthermore , a significantly more favourable effect on the SF-36 ‘ mental health ’ item was observed in oxaprozin compared with diclofenac-treated patients at day 15 ( p = 0.0202 ) . As assessed by investigators , the overall efficacy of oxaprozin was superior to that for diclofenac at visit 3 ( 8 ± 1 days ) ( p = 0.0067 ) . Patients also assessed the overall efficacy of oxaprozin as superior to that of diclofenac at visits 3 ( 8 ± 1 days ) ( p = 0.0235 ) and 4 ( 15 ± 1 days ) ( p = 0.0272 ) . Only six adverse events , all of which were mild or moderate in intensity and occurred in four diclofenac recipients , were observed in the study . Conclusions : As expected , once-daily oxaprozin proved to be as effective as diclofenac three times daily in reducing the primary efficacy variable of patient-assessed shoulder pain score in patients with periarthritis of the shoulder refractory to previous treatments with other NSAIDs . Oxaprozin was shown to be superior to diclofenac in improving shoulder function and was considered by investigators and patients to have greater overall efficacy than diclofenac . In addition , oxaprozin showed a trend toward superior results in improving patients ’ quality of life compared with diclofenac . A trend towards better tolerability results for oxaprozin compared with diclofenac was also noted HypothesisArthroscopic acromioclavicular joint ( ACJ ) resection for asymptomatic ACJ arthritis combined with rotator cuff repair leads to more satisfactory pain relief and decrease reoperation rate when inferiorly directed osteophytes present at the undersurface of ACJ . Material s and methods Between January 2006 and May 2008 , a total of 83 patients ( 83 shoulders ) , 40 males and 43 females , who were planned to have arthroscopic repair of a tear measuring 1–3 cm in the anterior-posterior dimension with advanced ACJ arthritis with inferiorly directed osteophytes at the undersurface of the ACJ on MRI were entered into this study . Patients were r and omized into two groups . Group 1 included 31 patients , who underwent arthroscopic distal clavicle resection combined with rotator cuff repair . Group 2 included 52 patients , who underwent isolated rotator cuff repair . Patients were evaluated preoperatively and postoperatively using the University of California Los Angeles ( UCLA ) score and the American Shoulder and Elbow Surgeons ( ASES ) score . Pain , tenderness on ACJ , and cross body adduction test were compared between groups . Results The mean follow-up was 31.7 months ( range 34–38 ) . The UCLA scores and ASES scores were lower in group 1 at week 6 ( p < .05 ) , and week 12 ( p < .05 ) , but higher at the last follow-up at 2 years ( p < .05 ) postoperatively . VAS score was higher in group 1 at week 6 ( p < .05 ) , and at week 12 ( p < .05 ) , but lower in group 2 at the last follow-up ( p < .05 ) . Only in group 2 , two ( 3.8 % ) cases developed ACJ pain during follow-up and one ( 1.9 % ) case underwent reoperation for additional ACJ resection . Conclusions This study shows that distal clavicle resection combined with rotator cuff repair for asymptomatic ACJ arthritis with inferiorly directed osteophytes lower functional scores due to temporary pain in early postoperative periods , but better functional outcomes with satisfactory pain relief and no reoperation rate were observed after 2 years Multiple joint replacement in 1 operative session is frequently performed in the lower extremity but less often in the upper extremity . The purpose of the present study is to determine whether a 1-stage arthroplasty of the ipsilateral shoulder and elbow affects the clinical outcome . Replacement of the ipsilateral shoulder and elbow was performed in 34 rheumatoid patients ( 42 upper extremities ) . In 11 patients ( 13 upper limbs ) , the shoulder and elbow arthroplasty was a 1-stage procedure . The average follow-up of the whole group was 4.5 years ( range , 2 - 12 years ) . The patients were in a prospect i ve study and evaluated clinical ly and radiographically . With a 1-stage procedure , the hospitalization time was shorter . The overall Hospital for Special Surgery shoulder score and its items ( pain , function , and strength ) were similar at follow-up in the 2 groups , and only the motion score showed more improvement in the 1-stage group . The clinical outcome of elbow arthroplasty was similar in both groups , regardless of the sequence of surgery . From this study , it may be concluded that a 1-stage procedure for shoulder and elbow arthroplasty will reduce the hospitalization time and does not adversely affect the clinical outcome BACKGROUND Both total shoulder arthroplasty and hemiarthroplasty have been used commonly to treat severe osteoarthritis of the shoulder ; however , their effect on disease-specific quality -of-life outcome is unknown . The purpose of this study was to compare the quality -of-life outcome following hemiarthroplasty with that following total shoulder arthroplasty in patients with osteoarthritis of the shoulder . METHODS Forty-two patients with a diagnosis of osteoarthritis of the shoulder were r and omized to receive a hemiarthroplasty or a total shoulder arthroplasty . One patient died , and all others were evaluated preoperatively and at six weeks and three , six , twelve , eighteen , and twenty-four months postoperatively with use of a st and ardized format including a disease-specific quality -of-life measurement tool ( Western Ontario Osteoarthritis of the Shoulder [ WOOS ] index ) , general shoulder rating scales ( University of California at Los Angeles [ UCLA ] shoulder scale , Constant score , and American Shoulder and Elbow Surgeons [ ASES ] evaluation form ) , general pain scales ( McGill pain score and visual analogue scale ) , and a global health measure ( Short Form-36 [ SF-36 ] ) . When a patient required revision of a hemiarthroplasty to a total shoulder arthroplasty , the last score before he or she \" crossed over \" was used for the analysis . RESULTS Significant improvements in disease-specific quality of life were seen two years after both the total shoulder arthroplasties and the hemiarthroplasties . There were no significant differences in quality of life ( WOOS score ) between the group treated with total shoulder arthroplasty and that treated with hemiarthroplasty ( 90.6 + /- 13.2 and 81.5 + /- 24.1 points , respectively ; p = 0.18 ) . The other outcome measures demonstrated similar findings . Two patients in the hemiarthroplasty group crossed over to the other group by undergoing a revision to a total shoulder arthroplasty because of glenoid arthrosis . CONCLUSIONS Both total shoulder arthroplasty and hemiarthroplasty improve disease-specific and general quality -of-life measurements . With the small number of patients in our study , we found no significant differences in these measurements between the two treatment groups . LEVEL OF EVIDENCE Therapeutic Level HYPOTHESIS The correct implantation of the glenoid component is of paramount importance in total shoulder arthroplasty ( TSA ) . We hypothesized that the accuracy of the glenoid positioning in the transverse plane can be improved using intraoperative navigation . MATERIAL S AND METHODS This prospect i ve , r and omized clinical study comprised 2 groups of 10 patients each with osteoarthritis of the shoulder TSA , with or without intraoperative navigation . Glenoid version was measured on axial computed tomography scans preoperatively and 6 weeks postoperatively . RESULTS The operating time was significantly longer in the navigation group ( 169.5 + /- 15.2 vs 138 + /- 18.4 min ) . We found an average change of retroversion from 15.4 degrees + /- 5.8 degrees ( range , 3.0 degrees -24.0 degrees ) preoperatively to 3.7 degrees + /- 6.3 degrees ( range , -8.0 degrees to 15.0 degrees ) postoperatively in the navigation group compared with 14.4 degrees + /- 6.1 degrees ( range , 2.0 degrees -24.0 degrees ) preoperatively to 10.9 degrees + /- 6.8 degrees ( range , 0. \n Output:\n " }, { "from": "agent", "value": "The studies identified were unable to provide a clear indication of best intervention for shoulder arthritis .\nSparse evidence is available for all other interventions , regardless of whether operative or non-operative ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: The objective of this study was to investigate the effect of bracket type ( conventional and self-ligating ) on the levels of Streptococcus mutans and total bacterial counts in whole saliva of orthodontic patients . Thirty-two male and female patients were selected using the following inclusion criteria : adolescents ( mean age 13.6 years , range 11 - 17 years ) , fixed appliances in both arches , non-smoker , and no reported oral habits . Demographic and oral hygiene characteristics were determined for each subject . The patients were subdivided into two groups with r and om allocation of bracket type ( conventional or self-ligating ) . An initial saliva sample was obtained before the initiation of treatment ( T1 ) and a second sample 2 - 3 months following appliance bonding ( T2 ) . Salivary S. mutans and total bacteria were enumerated and analysed after growth in culture . The demographic and clinical characteristics of the sample s were analysed with a t- or chi-square test , where applicable , to assess the r and om allocation of bracket group to participants . The results of S. mutans and total facultative bacterial counts were log transformed and statistically analysed with analysis of covariance with bracket ( conventional versus self-ligating ) as the categorical variable and initial total bacterial counts or initial S. mutans levels serving as the covariate . No difference was found in the demographics and oral hygiene indices between the two groups , verifying the r and om assignment of brackets to the population sample . The levels of S. mutans in whole saliva of orthodontically treated patients do not seem to be significantly different between conventional and self-ligating brackets . The pre-treatment levels of S. mutans are significant predictors of the levels of S. mutans after placement of orthodontic appliances , while this was not the case for total bacterial counts OBJECTIVE To determine the effects of fixed orthodontic appliances on periodontal health and microbiological composition of subgingival dental plaque . MATERIAL AND METHODS This prospect i ve longitudinal self-controlled study was conducted on 32 adolescents ( 13 males , 19 females ) , who were scheduled for fixed orthodontic treatment between 2002 and 2005 . Dental plaque accumulation , gingival inflammation and pocket probing depth were measured at the mesio-vestibular angle of the examined group of teeth followed by collection of subgingival dental plaque sample s in the same points . These periodontal indices and microbiological parameters were determined prior to the placement of fixed appliances and 1 , 3 and 6 months after the beginning of orthodontic treatment . RESULTS All values of both clinical and microbiological parameters started to increase after the placement of fixed appliances . Maximum values were reached 3 months after fixed appliance placement followed by their decrease in the last registration period of 6 months after the placement of fixed appliances . CONCLUSIONS Treatment with fixed appliances in adolescents may transitionally increase the values of all periodontal indices and stimulate the growth of periodontopathogenic bacteria , but without destructive effects on deep periodontal tissues The aim of this study was to determine the influence of oral hygiene instruction ( OHI ) on oral hygiene status and on the reduction of inducing bacteria ( Streptococcus mutans and Lactobacillus spp . ) in 30 subjects ( 12 males and 18 females ) with an age range from 10 to 14 years . The patients were instructed on how to carry out effective oral hygiene close to brackets and ligatures , and in the use of dental floss for cleaning spaces around brackets , between the teeth and under archwires . The plaque index ( PI ) was used to measure oral hygiene status , and the level of S. mutans and Lactobacillus spp . was determined using the colour reaction time test before and after 1 month of OHI . Statistical analysis included a Student 's t-test and chi-square test . The results showed that OHI significantly improved oral hygiene . The percentage of patients with a PI exceeding 1 decreased from 23.3 to 10 per cent and for those with a PI below 0.1 it increased from 20 to 60 per cent . The level of S. mutans and Lactobacillus spp . was not reduced . The percentage of subjects with excessive levels of S. mutans ( above 10(6 ) bacteria in 1 ml of saliva ) decreased after OHI but only from 73.3 to 70 per cent . For Lactobacillus spp . , a level above 10(5 ) of bacteria in 1 ml of saliva was found for all subjects at both time points . Patients with fixed appliances , trained in scrupulous tooth cleaning , remain at risk of developing caries and should be carefully monitored OBJECTIVE To evaluate the effects of fixed orthodontic treatment with steel-ligated conventional brackets and self-ligating brackets on halitosis and periodontal health . MATERIAL S AND METHODS Sixty patients , at the permanent dentition stage aged 12 to 18 years , who had Angle Class I malocclusion with mild-to-moderate crowding were r and omly selected . Inclusion criteria were nonsmokers , without systematic disease , and no use of antibiotics and oral mouth rinses during the 2-month period before the study . The patients were subdivided into three groups r and omly : the group treated with conventional brackets ( group 1 , n = 20 ) ligated with steel ligature wires , the group treated with self-ligating brackets ( group 2 , n = 20 ) , and the control group ( group 3 , n = 20 ) . The periodontal records were obtained 1 week before bonding ( T1 ) , immediately before bonding ( T2 ) , 1 week after bonding ( T3 ) , 4 weeks after bonding ( T4 ) , and 8 weeks after bonding ( T5 ) . Measurements of the control group were repeated within the same periods . The volatile sulfur components determining halitosis were measured with the Halimeter at T2 , T3 , T4 , and T5 . A two-way repeated measures of analysis of variance ( ANOVA ) was used to compare the groups statistically . RESULTS No statistically significant group × time interactions were found for plaque index , gingival index , pocket depth , bleeding on probing , and halitosis , which means three independent groups change like each other by time . The risk of tongue coating index ( TCI ) being 2 was 10.2 times higher at T1 than at T5 ( P < .001 ) . Therefore , the probability of higher TCI was decreased by time in all groups . CONCLUSIONS The self-ligating brackets do not have an advantage over conventional brackets with respect to periodontal status and halitosis This article introduces the approach of GRADE to rating quality of evidence . GRADE specifies four categories-high , moderate , low , and very low-that are applied to a body of evidence , not to individual studies . In the context of a systematic review , quality reflects our confidence that the estimates of the effect are correct . In the context of recommendations , quality reflects our confidence that the effect estimates are adequate to support a particular recommendation . R and omized trials begin as high- quality evidence , observational studies as low quality . \" Quality \" as used in GRADE means more than risk of bias and so may also be compromised by imprecision , inconsistency , indirectness of study results , and publication bias . In addition , several factors can increase our confidence in an estimate of effect . GRADE provides a systematic approach for considering and reporting each of these factors . GRADE separates the process of assessing quality of evidence from the process of making recommendations . Judgments about the strength of a recommendation depend on more than just the quality of evidence OBJECTIVE To determine the effect of bracket type on halitosis , periodontal status , and microbial colonization . MATERIAL S AND METHODS Forty-six patients scheduled for fixed orthodontic treatment ( age 11 - 16 years ) were selected from the orthodontic department of Suleyman Demirel University . Patients were divided into two groups with r and om distribution of brackets ; 23 patients were treated with self-ligating brackets ( group SLBs ) , the others with conventional brackets ( group CBs ) . Halitosis measurements and periodontal and microbial records were obtained before the placement of brackets ( T0 ) , 1 week later ( T1 ) , and 5 weeks after bonding ( T2 ) . Periodontal parameters , including plaque index ( PI ) , gingival index ( GI ) , and bleeding on probing index ( BOP ) , were obtained from all the bonded teeth . Halitosis measurements were performed at the same time . Microbial sample s were obtained from the buccal surfaces of all the bonded teeth . Data were analyzed by using a repeated-measurement analysis of variance test for the comparison of parameters between groups and times . RESULTS Periodontal parameters and halitosis results were higher in the CBs group than in the SLBs group ( P<.05 ) . In the SLBs group , halitosis and BOP values revealed no pronounced changes between T1 and T2 ( P>.05 ) . Intra- and intergroup comparisons showed that there were no statistically significant differences for microbial colonization between all the time intervals ( P>.05 ) . CONCLUSION Bracket type has an effect on halitosis and periodontal status . Therefore , self-ligating brackets may be advised in order to prevent patients from developing halitosis and to increase the likelihood of good oral hygiene during orthodontic treatment A longitudinal and transverse study has been carried out on 22 orthodontic patients during their first year of treatment to assess levels of plaque control and gingival inflammation . The scores were of full data and the patients r and omly arranged on a split mouth cross-over design to study the effects of patient oral care and selective tooth cleaning on levels of oral health . The results are analysed in respect of upper fixed , lower fixed and upper removable appliances , comparing and contrasting quadrants that have been treated differently . Plaque levels appear constant , whereas levels of gingival inflammation are consistently worse during treatment but only in certain areas of the mouth . Levels of plaque and gingivitis are well controlled . There appears to be no hygiene disadvantage to an upper removable appliance when compared with an upper fixed appliance though the effect differs in relation to the tooth aspect considered . The significance of the findings is discussed The presence of clinical ly detectable areas of decalcification ( observable as whitened areas ) following the removal of orthodontic appliances is well recognized . The aim of the present study was to determine quantitatively the amount of demineralization and the ability of commercially available products to inhibit or reverse orthodontically related demineralization . Twenty orthodontic patients scheduled to have premolars extracted were r and omly divided into four groups -- one control and three test groups . The extracted premolars ( numbering 58 ) were bracketed using an acid-etch composite system ; each patient was given precise oral hygiene instructions and supplied with a sodium fluoride ( 1,100 ppm fluoride ) dentifrice and an orthodontic toothbrush . The control group brushed only with the supplied dentifrice . In addition to brushing with the dentifrice , those in test group I rinsed once each night with a sodium fluoride ( 0.05 % ) mouthrinse ; group II received a weekly topical APF treatment ( 1.2 % fluoride ) ; and Group III received a weekly topical APF treatment and rinsed once each night with the sodium fluoride mouthrinse . All premolars were extracted after 1 calendar month . Mineral profiles were determined on cross-sectioned teeth 50 to 75 micron occlusal and cervical to the brackets , directly underneath the brackets , and 500 micron away from the brackets . The control teeth ( dentifrice only ) demonstrated up to 15 % demineralization to a depth of 50 micron . All of the test teeth produced rehardening and /or inhibition of demineralization ( P less than 0.01 ) . Those in test group III showed a particularly hard outer layer . The study demonstrated that measurable demineralization occurred around orthodontic appliances after only 1 month and this demineralization can be completely inhibited and /or reversed by the use of commercially available fluoride products Fixed or removable orthodontic appliances impede the maintenance of oral hygiene and result in plaque accumulation . Plaque retention surrounding orthodontic appliances leads to enamel demineralization caused by organic acids produced by bacteria in the dental plaque . Many studies have evaluated the effects of fixed orthodontic appliances on microbial flora and periodontal status , but only a few have evaluated the method of ligation as an additional factor . The aim of this study was to determine the changes in microbial flora and periodontal status after orthodontic bonding and to determine whether two different archwire ligation techniques affect these changes . A total of 21 orthodontic patients scheduled for fixed orthodontic treatment were selected for this split-mouth study . Two commonly used auxiliaries ( elastomeric rings and ligature wires ) for tying archwires were tested . Microbial and periodontal records were obtained before bonding ( T0 ) , one week later ( T1 ) , and five weeks after bonding ( T2 ) . Paired t-test and Wilcoxon signed rank test were used to compare the groups statistically . Although , teeth ligated with elastomeric rings exhibited slightly greater numbers of microorganisms than teeth ligated with steel ligature wires , the differences were not statistically significant and could be ignored . The two archwire ligation techniques showed no significant differences in the gingival index , bonded bracket plaque index , or pocket depths of the bonded teeth . However , teeth ligated with elastomeric rings were more prone to bleeding . Therefore , elastomeric ring use is not recommended in patients with poor oral hygiene OBJECTIVE To determine the effect of different bracket design s ( conventional brackets and self-ligating brackets ) on periodontal clinical parameters and periodontal pathogens in subgingival plaque . MATERIAL AND METHODS The following inclusion criteria were used : requirement of orthodontic treatment plan starting with alignment and leveling , good general health , healthy periodontium , no antibiotic therapy in the previous 6 months \n Output:\n " }, { "from": "agent", "value": "At 4 - 6 weeks after bracket placement there was no evidence to support the use of either type of bracket for achieving improved plaque- ( PI ) and gingival index ( GI ) .\nAt 3 - 6 months , there was scarce evidence of greater PI increase for conventional brackets .\nGI and pocket depth pooled estimates did not reveal significant differences between the two systems .\nOverall , non-significant differences on the periodontal status of adolescents undergoing orthodontic treatment with either conventional or self-ligating brackets were detected .\nCLINICAL SIGNIFICANCE The periodontal status of adolescents undergoing orthodontic treatment is of considerable importance ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: Abstract Background : Although early gastric cancer ( T1 , NX ) in Japan has been reported to have an excellent prognosis , the experience with this cancer in the United States is limited . The treatment of these tumors in Japan is becoming less aggressive as “ good prognostic factors ” are increasingly recognized . Our objective was to identify predictors of nodal disease and survival in a large cohort of Western patients with T1 tumors . Methods : A retrospective review of our prospect i ve data base from July 1985 to March 1998 revealed 165 patients undergoing surgical resection for T1 gastric tumors . Clinicopathological factors analyzed and compared included presence of positive nodes , tumor size ( 4.5 vs.,4.5 cm ) , depth ( mucosal vs. submucosal ) , grade ( poor vs. moderate and well ) , and tumor site ( proximal vs. distal ) , presence of venous or perineural invasion , and Lauren ’s classification . Factors predicting lymph node involvement and disease-specific survival were evaluated by univariate and multivariate analysis . Results : Median follow-up time was 36 months . The actuarial 5-year survival was 88 % . Thirteen patients ( 8 % ) died of disease . Lymph node involvement was present in 31 tumors ( 19 % ) , with a 5-year survival of 91 % with negative nodes vs. 78 % with positive nodes . On univariate and multivariate analysis , the presence of tumor submucosal invasion ( P,.05 ) , venous invasion ( P 5.02 ) , and size of 4.5 cm and larger ( P 5.02 ) was significantly associated with an increased risk for nodal positivity . On univariate analysis of survival , node-positive tumors ( P 5.02 ) and tumors 4.5 cm and larger ( P 5.008 ) were significantly associated with decreased survival . On multivariate analysis , only node-positive tumors were significantly ( P 5.01 ) associated with decreased survival . Those tumors that were limited to the mucosa and less than 4.5 cm in size ( n = 47 ) had a 4 % rate of positive nodes . In contrast , those tumors that were 4.5 cm and larger and had penetrated into the submucosa ( n = 16 ) had a 56 % chance of positive nodes . Conclusions : Early gastric carcinoma in North America has an excellent prognosis , similar to that in Japan . Tumors that are limited to the mucosa and smaller than 4.5 cm could be considered for limited resection without lymphadenectomy BACKGROUND In Japan the surgical approach to treatment of potentially curable gastric cancer , including extended lymphadenectomy , seems in retrospective surveys to give better results than the less radical procedures favoured in Western countries . There has , however , been no evidence from r and omised trials that extended lymphadenectomy ( D2 gastric resection ) confers a survival advantage . This question was addressed in a trial involving thirty-two surgeons in Europe . METHODS In a prospect i ve r and omised controlled trial , D1 resection ( level 1 lymphadenectomy ) was compared with D2 resection ( levels 1 and 2 lymphadenectomy ) . Central r and omisation ( 200 patients in each arm ) followed a staging laparotomy . FINDINGS The D2 group had greater postoperative hospital mortality ( 13 % vs 6.5 % ; p=0.04 [ 95 % Cl 9 - 18 % for D2 , 4 - 11 % for D1 ] and higher overall postoperative morbidity ( 46 % vs 28 % ; p<0.001 ) ; their postoperative stay was also longer . The excess postoperative morbidity and mortality in the D2 group was accounted for by distal pancreaticosplenectomy and splenectomy . In the whole group ( 400 patients ) , survival beyond three years was 30 % in patients whose gastrectomy included en-bloc pancreatico-splenic resection versus 50 % in the remainder . INTERPRETATION D2 gastric resections are followed by higher morbidity and mortality than D1 resections . These disadvantages are consequent upon additional pancreatectomies and distal splenectomies , and in long-term follow-up the higher mortality when the pancreas and spleen are resected may prove to nullify any survival benefit from D2 procedures The contention that the R2 radical gastrectomy for localized and potentially curable gastric carcinoma may be superior to gastrectomy without lymphadenectomy ( R1 ) was assessed by r and omized trial . Five years after commencement 403 patients have been evaluated at surgery and only 43 ( 11 per cent ) found eligible ( S0–2 , P0 , H0 , N0–1 ) , 22 of whom underwent R1 and 21 R2 gastrectomy . Seven patients had final histological stages in excess of the protocol . The R2 group had a longer operating time ( P<0.005 ) , a greater blood transfusion requirement ( P<0.005 ) , a longer hospital stay ( 0.05>P>0.025 ) and required reoperation in four cases . There were no postoperative deaths . Four patients have died from the disease in the R1 group and five in the R2 group , there being no difference in the probability of survival at a median follow‐up of 3.1 years . The small proportion of patients suitable for radical R2 surgery , the high associated morbidity and the fact that survival advantage has yet to be proven in trial suggest that this procedure should not yet be performed outside of controlled clinical trials This prospect i ve r and omized study compared the survival of patients with tumour node metastasis ( TNM ) stage T2 N1–2 gastric cancer treated by gastrectomy alone or gastrectomy followed by uracil – tegafur BackgroudApplication of laparoscopy-assisted distal gastrectomy ( LADG ) for early gastric cancer ( EGC ) is still controversial because of scant evidence of long-term safety and feasibility . We evaluated the long-term outcome of LADG compared with conventional open distal gastrectomy ( ODG ) for EGC . Methods Between March 1999 and July 2006 , 106 patients underwent LADG and 105 patients underwent ODG for EGC . Clinicopathologic characteristics , postoperative outcomes , hospital course , postoperative morbidity , postoperative mortality , and long-term outcomes , including cancer recurrence and survival , were retrospectively compared between the two groups . Survival of all patients was confirmed with 55-month median follow-up . Results Postoperative recovery was significantly faster in the LADG group ; passing flatus occurred earlier , starting a liquid diet began sooner , and postoperative hospital stay was shorter ( p < 0.05 ) . Mean operation time was significantly longer in the LADG group . Postoperative complications in the LADG group occurred less frequently compared with in the ODG group ( 4.7 % versus 13.3 % , p = 0.046 ) . Tumor recurrence occurred in two cases ( 0.9 % ) and death related to recurrence occurred in only one patient ( 0.5 % ) . Overall 5-year survival rate ( 5-YSR ) of all patients was 95.5 % , while disease-specific 5-YSR was 98.8 % . There was no significant difference in survival rates between the two groups ; overall 5-YSR of the ODG and LADG groups was 94.9 % and 95.9 % , respectively . Conclusions Our data suggest that LADG for EGC is feasible and safe . We expect the results of the present study to be confirmed by prospect i ve r and omized analysis Curative resection is the treatment of choice for potentially curable gastric cancer . Two major Western studies in the 1990s failed to show a benefit from D2 dissection . They showed extremely high postoperative mortality after D2 dissection , and were criticised for the potential inadequacy of the pretrial training in the new technique of D2 dissection , prior to the phase III studies being initiated . The inclusion of pancreatectomy and splenectomy in D2 dissection was associated with increased morbidity and mortality . Following these results , we started a phase II trial to evaluate the safety and efficacy of pancreas-preserving D2 dissection . The results of this trial regarding the safety of pancreas preserving D2 dissection were published in 1998 . In this paper , we present the survival results of this phase II trial to confirm the rationale of carrying out a phase III study comparing D1 vs D2 dissection for curable gastric cancer . Italian patients with histologically proven gastric adenocarcinoma were registered in the Italian Gastric Cancer Study Group Multicenter trial . The study was carried out based on the General Rules of the Japanese Research Society for Gastric Cancer . A strict quality control system was achieved by a supervising surgeon of the reference centre who had stayed at the National Cancer Center Hospital , Tokyo , to learn the st and ard D2 gastrectomy and the postoperative management . The st and ard procedure entailed removal of the first and second tier lymph nodes . During total gastrectomy , the pancreas was preserved according to the Maruyama technique . Complete follow-up was available to death or 5 years in 100 % of patients and the median follow-up time was 4.38 years . Out of 297 consecutive patients registered , 191 patients were enrolled in the study between May 1994 and December 1996 . The overall morbidity rate was 20.9 % . The postoperative in-hospital mortality was 3.1 % . The overall 5-year survival rate among all eligible patients was 55 % . Survival was strictly related to stage , depth of wall invasion , lymph node involvement and type of gastrectomy ( distal vs total).Our results suggest a survival benefit for pancreas-preserving D2 dissection in Italian patients with gastric cancer if performed in experienced centres . A phase III trial among exclusively experienced centres is urgently needed BACKGROUND A multicenter , r and omized , clinical trial was initiated to evaluate the possible benefits of extended D2 ( D2 + ) lymphadenectomy after potentially curative resection of gastric cancer . METHODS St and ard D2 lymphadenectomy was defined according to the Japanese Gastric Cancer Association classification . D2 + lymph node dissection additionally included the removal of para-aortic nodes . RESULTS Of 781 patients screened , 275 were r and omized to st and ard D2 ( n = 141 ) or extended D2 + ( n = 134 ) lymphadenectomy . The overall morbidity rates were comparable in D2 ( 27.7 % ; 95 % confidence interval [ CI ] , 20.3 - 35.1 ) and D2 + ( 21.6 % ; 95 % CI , 13.7 - 29.5 ) groups ( P = .248 ) . Pre-existing cardiac disease , splenectomy , and excessive blood loss were identified as risk factors for overall and nonsurgical complications . Postoperative mortality rates were 4.9 % ( 95 % CI , 1.4 - 8.5 ) and 2.2 % ( 95 % CI , 0 - 4.7 ) , respectively ( P = .376 ) . CONCLUSIONS The interim safety analysis failed to show any significant difference with regard to the extent of lymph node dissection . The surgical outcome was not different between the 2 surgeries Background The prognosis of patients with gastric cancer and para-aortic lymph node ( PALN ) metastasis is poor . Recent Japanese r and omized trials concluded that prophylactic PALN dissection is not effective for curable advanced gastric cancer . However , the value of curative resection in patients with pathologically positive PALN is not determined yet . Methods We retrospectively identified 178 patients with pathologically positive PALN who underwent curative resection at the Cancer Institute Hospital from 1980 to 2004 . Patient characteristics were analyzed and independent prognostic factors for death were identified by Cox proportional hazard model . Results Partial gastrectomy was the most frequently performed procedure ( 142 of 178 ) . Postoperative morbidity and mortality rates were 30 and 2 % , respectively , with a 5-year survival rate of 13.0 % . Multivariate analysis revealed the total number of positive nodes ( hazard ratio , 1.804 ; 95 % confidence interval , 1.221–2.665 ) and macroscopic type ( hazard ratio , 1.697 ; 95 % confidence interval , 1.138–2.530 ) as independent prognostic factors , while age , sex , histology , pathological tumor depth , and degree of PALN dissection were not statistically significant . The 5-year survival rate increased to 28.6 % in patients with ≤15 positive nodes and macroscopic type other than type 4 . Conclusions Prophylactic PALN dissection can not be justified in curable advanced gastric cancer . However , R0 resection including PALN retrieval might be beneficial in patients with pathologically positive PALN , providing patients are carefully selected and operations are performed safely BACKGROUND / AIMS A r and omized study was performed to evaluate morbidity and mortality after D2 ( level 1 and 2 lymphadenectomy ) and D4 ( D2 plus lymphadenectomy of para-aortic lymph nodes ) dissection for advanced gastric cancer . METHODOLOGY Two hundred and fifty-six patients with advanced gastric adenocarcinoma were enrolled ( 128 to each group ) . Patients were r and omly allocated into D2 ( N = 128 ) or D4 ( N = 128 ) group . The first and second tiers of lymph nodes \n Output:\n " }, { "from": "agent", "value": "Two large western r and omized trials , meta-analyses and a recent systematic review were unable to demonstrate overall benefit from extended lymphadenectomy ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: Objective Rapid and effective hemostasis at femoral puncture sites minimizes both the hospital stay and patient discomfort . Therefore , a variety of arterial closure devices have been developed to facilitate the closure of femoral arteriotomy . The objective of this prospect i ve study was to compare the efficacy of two different closure devices ; a collagen plug device ( Angio-Seal ) and a suture-mediated closure device ( the Closer S ) . Material s and Methods From March 28 , 2003 to August 31 , 2004 , we conducted a prospect i ve study in which 1,676 cases of 1,180 patients were treated with two different types of closure device . Angio-Seal was used in 961 cases and the Closer S in 715 cases . The efficacy of the closure devices was assessed , as well as complications occurring at the puncture sites . Results Successful immediate hemostasis was achieved in 95.2 % of the cases treated with Angio-Seal , and in 89.5 % of the cases treated with the Closer S ( p < 0.05 ) . The rates of minor and major complications occurring between the two groups were not significantly different . In the Closer S group , we observed four major complications ( 0.6 % ) , that consisted of one massive retroperitoneal hemorrhage ( surgically explored ) and three pseudoaneurysms . In the Angio-Seal group , we observed three major complications ( 0.3 % ) that consisted of one femoral artery occlusion , one case of infection treated with intravenous antibiotics and one pseudoaneurysm . Conclusion The use of Angio-Seal was found to be more effective than that of the Closer S with regard to the immediate hemostasis of the femoral puncture sites . However , we detected no significant differences in the rate at which complications occurred OBJECTIVES The aim was to investigate whether the fascia suture technique ( FST ) can reduce access closure time and procedural costs compared with the Prostar technique ( Prostar ) in patients undergoing endovascular aortic repair and to evaluate the short- and mid-term outcomes of both techniques . METHODS In this two center trial , 100 patients were r and omized to access closure by either FST or Prostar between June 2006 and December 2009 . The primary endpoint was access closure time . Secondary outcome measures included access related costs and evaluation of the short- and mid-term complications . Evaluation was performed peri- and post-operatively , at discharge , at 30 days and at 6 months follow up . RESULTS The median access closure time was 12.4 minutes for FST and 19.9 minutes for Prostar ( p < .001 ) . Prostar required a 54 % greater procedure time than FST , mean ratio 1.54 ( 95 % CI 1.25 - 1.90 , p < .001 ) according to regression analysis . Adjusted for operator experience the mean ratio was 1.30 ( 95 % CI 1.09 - 1.55 , p = .005 ) and for patient body mass index 1.59 ( 95 % CI 1.28 - 1.96 , p < .001 ) . The technical failure rate for operators at proficiency level was 5 % ( 2/40 ) compared with 28 % ( 17/59 ) for those at the basic level ( p = .003 ) . The proficiency level group had a technical failure rate of 4 % ( 1/26 ) for FST and 7 % ( 1/14 ) for Prostar , p = 1.00 , while corresponding rates for the basic level group were 27 % ( 6/22 ) for FST and 30 % ( 11/37 ) for Prostar ( p = .84 ) . There was a significant difference in cost in favor of FST , with a median difference of € 800 ( 95 % CI 710 - 927 , p < .001 ) . CONCLUSIONS In aortic endovascular repair FST is a faster and cheaper technique than the Prostar technique This study investigated the usefulness of collagen plugging with VasoSeal in patients after PTCA compared to a control group having identical sheath dwell times and therefore comparable levels of anticoagulation . A total of 150 patients were enrolled in this prospect i ve and r and omized study . Sheaths were pulled at exactly 5 h after arterial puncture . Time to hemostasis and local complications were determined . There were no statistical differences in baseline characteristics . The mean time to hemostasis in the collagen group was significantly shorter ( 3 + /- 3 min ) than that of the control group ( 17.4 + /- 7 min ) . At 24 h , 23 % of the collagen group patients had a small , 1 % a medium and 4 % a large hematoma . In the control group , 32 % had a small , 4 % a medium sized , but no patient a large hematoma . After collagen , one patient developed a pseudoaneurysm needing vascular surgery . In the control group , no major complication occurred . Compared to patients with manual compression at an identical sheath dwell time and an identical level of anticoagulation , there was a significant reduction in time to hemostasis but no statistical difference regarding local complications . Although the incidence of medium or large hematoma was low , the trend towards a decreased risk of smaller hematomas seemed to be counterbalanced by an increased risk of larger hematomas Background : The StarClose ® Vascular Closure System ( Abbott Vascular , Redwood City , CA ) features a nitinol clip that is design ed to achieve closure of the femoral arteriotomy access site . The CLIP Study was performed to assess the safety and efficacy of StarClose when compared with st and ard manual compression following 5–6 French diagnostic or interventional percutaneous procedures . A sub study of this trial was design ed to assess the utility of duplex ultrasonography to assess patency of the femoral artery and to determine access site complications ( pseudoaneurysm , arteriovenous fistula , hematoma , deep vein thrombosis ) in a multicenter prospect i ve trial . This is the report of the duplex ultrasound ( DUS ) sub study of the CLIP trial . Methods : A total of 17 U.S. sites enrolled 596 subjects with 483 subjects r and omized at a 2:1 ratio to receive StarClose or manual compression of the arteriotomy after a percutaneous procedure . The study included roll‐in ( n = 113 ) , diagnostic ( n = 208 ) , and interventional ( n = 275 ) arms with a primary safety endpoint of major vascular complications through 30 days and a primary efficacy endpoint of postprocedure time to hemostasis . A sub study of the CLIP interventional arm evaluated DUS images of the closure site at five study sites , targeting 100 subjects at day 30 following hemostasis . The DUS protocol was devised and implemented by an independent vascular ultrasound core laboratory with extensive experience in vascular device trials . DUS inguinal region from 6 cm proximal to 6 cm distal to the arteriotomy puncture was performed . A qualitative examination was performed to determine the presence of iatrogenic vascular injuries : hematoma , pseudoaneurysm ( PSA ) , arteriovenous fistula ( AVF ) , and arterial/venous thrombosis or stenosis using 2‐dimensional gray scale , color , and focused Doppler images . Results : DUS of 96 subjects r and omized to StarClose ( n = 71 ) and compression ( n = 25 ) were performed and evaluated . There was no evidence of hematoma , PSA , or AVF observed in the StarClose group . No StarClose subjects in the sub study had a PSA or AVF . All patients in the sub study demonstrated patency of the access site artery and vein without thrombosis or stenosis . Finally , in the entire study cohort , no clinical ly‐driven DUS studies demonstrated iatrogenic vascular injury or vessel thrombosis in the StarClose treated patients . Conclusion : DUS , a safe and reliable method for determining the safety and efficacy of access site closure devices , is a reliable , safe , inexpensive and accurate method of assessing vascular access site complications in multicenter trials . In this sub study of the CLIP study , DUS found no statistical difference in access site complications between the StarClose and manual compression groups . Both groups maintained vessel patency without stenosis , thrombosis , hematoma , pseudoaneurysm , or AV fistula . © 2006 Wiley‐Liss , OBJECTIVE The first multicenter r and omized controlled trial was design ed and conducted to assess the safety and effectiveness of totally percutaneous endovascular aortic aneurysm repair ( PEVAR ) with use of a 21F endovascular stent graft system and either an 8 F or 10 F suture-mediated closure system ( the PEVAR trial , NCT01070069 ) . A noninferiority trial design was chosen to compare percutaneous access with st and ard open femoral exposure . METHODS Between 2010 and 2012 , 20 U.S. institutions participated in a prospect i ve , Food and Drug Administration-approved r and omized trial to evaluate percutaneous femoral artery access and closure by a \" preclose \" technique in conjunction with endovascular abdominal aortic aneurysm repair . A total of 151 patients were allocated by a 2:1 design to percutaneous access/closure ( n = 101 ) or open femoral exposure ( n = 50 [ FE ] ) . PEVAR procedures were performed with either the 8 F Perclose ProGlide ( n = 50 [ PG ] ) or the 10 F Prostar XL ( n = 51 [ PS ] ) closure devices . All endovascular abdominal aortic aneurysm repair procedures were performed with the Endologix 21 F profile ( outer diameter ) sheath-based system . Patients were screened by computed tomography with three-dimensional reconstruction and independent physician review for anatomic suitability and adequate femoral artery anatomy for percutaneous access . The primary trial end point ( treatment success ) was defined as procedural technical success and absence of major adverse events and vascular complications at 30 days . An independent access closure sub study evaluated major access-related complications . Clinical utility and procedural outcomes , ankle-brachial index , blood laboratory analyses , and quality of life were also evaluated with continuing follow-up to 6 months . RESULTS Baseline characteristics were similar among groups . Procedural technical success was 94 % ( PG ) , 88 % ( PS ) , and 98 % ( FE ) . One-month primary treatment success was 88 % ( PG ) , 78 % ( PS ) , and 78 % ( FE ) , demonstrating noninferiority vs FE for PG ( P = .004 ) but not for PS ( P = .102 ) . Failure rates in the access closure sub study analyses demonstrated noninferiority of PG ( 6 % ; P = .005 ) , but not of PS ( 12 % ; P = .100 ) , vs FE ( 10 % ) . Compared with FE , PG and PS yielded significantly shorter times to hemostasis and procedure completion and favorable trends in blood loss , groin pain , and overall quality of life . Initial noninferiority test results persist to 6 months , and no aneurysm rupture , conversion to open repair , device migration , or stent graft occlusion occurred . CONCLUSIONS Among trained operators , PEVAR with an adjunctive preclose technique using the ProGlide closure device is safe and effective , with minimal access-related complications , and it is noninferior to st and ard open femoral exposure . Training , experience , and careful application of the preclose technique are of paramount importance in ensuring successful , sustainable outcomes Objectives : To compare Angio‐Seal ( AS ) and StarClose ( SC ) and manual compression ( MC ) on efficacy of hemostasis , complication rate , safety of early mobilization , and patient comfort . Background : Closure of the femoral artery after cardiac catheterization can be obtained through different methods . Today , physicians can choose from a number of different devices to achieve arterial closure . Methods : In a prospect i ve trial 450 patients were r and omized to AS , SC , or MC . Patients were mobilized 1 to 2 hr after device placement , and 6 hr after MC . Data were collected during hospital admission and by telephone at one month after hospital discharge . Results : Devices were used in 138/150 allocated to AS and 124/150 allocated to SC patients ( 92 % vs. 83 % , P = 0.015 ) Patients with MC experienced more pain during sheath removal than patients receiving a device , and rated their period of bed rest as less comfortable . Oozing and need for pressure b and age at the puncture site were observed in 37 AS patients and 57 SC patients ( 25 % vs. 38 % , P = 0.002 ) . Hematoma occurred in 15 AS patients , in 17 SC patients , and in 14 MC patients ( 11 vs. 14 vs. 9 % , ns ) . Conclusion : There is no difference in safety between the three methods of arterial closure . SC was more often not used or successfully deployed . SC patients more often had continuing oozing . On patient comfort , closure devices performed better than MC . Early ambulation in patients with a closure device is safe . AS is the preferred method of arterial closure after cardiac catheterization . © 2008 Wiley‐Liss , Despite advances in other aspects of cardiac catheterization , manual or mechanical compression followed by 4 to 8 hours of bed rest remains the mainstay of postprocedural femoral access site management . Suture-mediated closure may prove to be an effective alternative , offering earlier sheath removal and ambulation , and potentially a reduction in hemorrhagic complications . The Suture To Ambulate aNd Discharge trial ( ST AND I ) evaluated the 6Fr Techstar device in 20 \n Output:\n " }, { "from": "agent", "value": "However , both metal clip-based and suture-based VCDs were associated with reduced time to haemostasis when compared with extrinsic compression .\nNo difference was demonstrated in the incidence of vascular injury or mortality when VCDs were compared with extrinsic compression .\nNo difference was demonstrated in the efficacy or safety of VCDs with different mechanisms of action ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: PURPOSE In metastatic colorectal cancer , phase III studies have demonstrated the superiority of fluorouracil ( FU ) with leucovorin ( LV ) in combination with irinotecan or oxaliplatin over FU + LV alone . This phase III study investigated two sequences : folinic acid , FU , and irinotecan ( FOLFIRI ) followed by folinic acid , FU , and oxaliplatin ( FOLFOX6 ; arm A ) , and FOLFOX6 followed by FOLFIRI ( arm B ) . PATIENTS AND METHODS Previously untreated patients with assessable disease were r and omly assigned to receive a 2-hour infusion of l-LV 200 mg/m(2 ) or dl-LV 400 mg/m(2 ) followed by a FU bolus 400 mg/m(2 ) and 46-hour infusion 2,400 to 3,000 mg/m(2 ) every 46 hours every 2 weeks , either with irinotecan 180 mg/m(2 ) or with oxaliplatin 100 mg/m(2 ) as a 2-hour infusion on day 1 . At progression , irinotecan was replaced by oxaliplatin ( arm A ) , or oxaliplatin by irinotecan ( arm B ) . RESULT Median survival was 21.5 months in 109 patients allocated to FOLFIRI then FOLFOX6 versus 20.6 months in 111 patients allocated to FOLFOX6 then FOLFIRI ( P = .99 ) . Median second progression-free survival ( PFS ) was 14.2 months in arm A versus 10.9 in arm B ( P = .64 ) . In first-line therapy , FOLFIRI achieved 56 % response rate ( RR ) and 8.5 months median PFS , versus FOLFOX6 which achieved 54 % RR and 8.0 months median PFS ( P = .26 ) . Second-line FOLFIRI achieved 4 % RR and 2.5 months median PFS , versus FOLFOX6 which achieved 15 % RR and 4.2 months PFS . In first-line therapy , National Cancer Institute Common Toxicity Criteria grade 3/4 mucositis , nausea/vomiting , and grade 2 alopecia were more frequent with FOLFIRI , and grade 3/4 neutropenia and neurosensory toxicity were more frequent with FOLFOX6 . CONCLUSION Both sequences achieved a prolonged survival and similar efficacy . The toxicity profiles were different Colorectal cancer continues to be an important public health concern , despite improvements in screening and better systemic chemotherapy . The integration of targeted therapies in the treatment of colon cancer has result ed in significant improvements in efficacy outcomes . Angiogenesis is important for tumor growth and metastasis and is an important target for new biological agents . Bevacizumab is a humanized recombinant antibody that prevents vascular endothelial growth factor ( VEGF ) receptor binding , and inhibits angiogenesis and tumor growth . The addition of bevacizumab to fluoropyrimidine-based chemotherapy , with or without irinotecan or oxaliplatin , in both the first- and second-line treatment of metastatic colorectal cancer , significantly increased median progression-free survival and overall survival in select r and omized phase III studies . Ongoing studies are evaluating the role of bevacizumab in the adjuvant treatment of colon cancer . Common toxicities associated with bevacizumab include hypertension , bleeding episodes , and thrombotic events . This review will focus on the integration of bevacizumab in the treatment paradigm of colon cancer and the management of its side effects Summary Background In the Medical Research Council ( MRC ) COIN trial , the epidermal growth factor receptor (EGFR)-targeted antibody cetuximab was added to st and ard chemotherapy in first-line treatment of advanced colorectal cancer with the aim of assessing effect on overall survival . Methods In this r and omised controlled trial , patients who were fit for but had not received previous chemotherapy for advanced colorectal cancer were r and omly assigned to oxaliplatin and fluoropyrimidine chemotherapy ( arm A ) , the same combination plus cetuximab ( arm B ) , or intermittent chemotherapy ( arm C ) . The choice of fluoropyrimidine therapy ( capecitabine or infused fluouroracil plus leucovorin ) was decided before r and omisation . R and omisation was done central ly ( via telephone ) by the MRC Clinical Trials Unit using minimisation . Treatment allocation was not masked . The comparison of arms A and C is described in a companion paper . Here , we present the comparison of arm A and B , for which the primary outcome was overall survival in patients with KRAS wild-type tumours . Analysis was by intention to treat . Further analyses with respect to NRAS , BRAF , and EGFR status were done . The trial is registered , IS RCT N27286448 . Findings 1630 patients were r and omly assigned to treatment groups ( 815 to st and ard therapy and 815 to addition of cetuximab ) . Tumour sample s from 1316 ( 81 % ) patients were used for somatic molecular analyses ; 565 ( 43 % ) had KRAS mutations . In patients with KRAS wild-type tumours ( arm A , n=367 ; arm B , n=362 ) , overall survival did not differ between treatment groups ( median survival 17·9 months [ IQR 10·3–29·2 ] in the control group vs 17·0 months [ 9·4–30·1 ] in the cetuximab group ; HR 1·04 , 95 % CI 0·87–1·23 , p=0·67 ) . Similarly , there was no effect on progression-free survival ( 8·6 months [ IQR 5·0–12·5 ] in the control group vs 8·6 months [ 5·1–13·8 ] in the cetuximab group ; HR 0·96 , 0·82–1·12 , p=0·60 ) . Overall response rate increased from 57 % ( n=209 ) with chemotherapy alone to 64 % ( n=232 ) with addition of cetuximab ( p=0·049 ) . Grade 3 and higher skin and gastrointestinal toxic effects were increased with cetuximab ( 14 vs 114 and 67 vs 97 patients in the control group vs the cetuximab group with KRAS wild-type tumours , respectively ) . Overall survival differs by somatic mutation status irrespective of treatment received : BRAF mutant , 8·8 months ( IQR 4·5–27·4 ) ; KRAS mutant , 14·4 months ( 8·5–24·0 ) ; all wild-type , 20·1 months ( 11·5–31·7 ) . Interpretation This trial has not confirmed a benefit of addition of cetuximab to oxaliplatin-based chemotherapy in first-line treatment of patients with advanced colorectal cancer . Cetuximab increases response rate , with no evidence of benefit in progression-free or overall survival in KRAS wild-type patients or even in patients selected by additional mutational analysis of their tumours . The use of cetuximab in combination with oxaliplatin and capecitabine in first-line chemotherapy in patients with widespread metastases can not be recommended . Funding Cancer Research UK , Cancer Research Wales , UK Medical Research Council , Merck BACKGROUND Patients with metastatic colorectal cancer that harbors KRAS mutations in exon 2 do not benefit from anti-epidermal growth factor receptor ( EGFR ) therapy . Other activating RAS mutations may also be negative predictive biomarkers for anti-EGFR therapy . METHODS In this prospect ive-retrospective analysis , we assessed the efficacy and safety of panitumumab plus oxaliplatin , fluorouracil , and leucovorin ( FOLFOX4 ) as compared with FOLFOX4 alone , according to RAS ( KRAS or NRAS ) or BRAF mutation status . A total of 639 patients who had metastatic colorectal cancer without KRAS mutations in exon 2 had results for at least one of the following : KRAS exon 3 or 4 ; NRAS exon 2 , 3 , or 4 ; or BRAF exon 15 . The overall rate of ascertainment of RAS status was 90 % . RESULTS Among 512 patients without RAS mutations , progression-free survival was 10.1 months with panitumumab-FOLFOX4 versus 7.9 months with FOLFOX4 alone ( hazard ratio for progression or death with combination therapy , 0.72 ; 95 % confidence interval [ CI ] , 0.58 to 0.90 ; P=0.004 ) . Overall survival was 26.0 months in the panitumumab-FOLFOX4 group versus 20.2 months in the FOLFOX4-alone group ( hazard ratio for death , 0.78 ; 95 % CI , 0.62 to 0.99 ; P=0.04 ) . A total of 108 patients ( 17 % ) with nonmutated KRAS exon 2 had other RAS mutations . These mutations were associated with inferior progression-free survival and overall survival with panitumumab-FOLFOX4 treatment , which was consistent with the findings in patients with KRAS mutations in exon 2 . BRAF mutations were a negative prognostic factor . No new safety signals were identified . CONCLUSIONS Additional RAS mutations predicted a lack of response in patients who received panitumumab-FOLFOX4 . In patients who had metastatic colorectal cancer without RAS mutations , improvements in overall survival were observed with panitumumab-FOLFOX4 therapy . ( Funded by Amgen and others ; PRIME Clinical Trials.gov number , NCT00364013 . ) PURPOSE The phase III CRYSTAL study demonstrated that addition of cetuximab to fluorouracil , leucovorin , and irinotecan ( FOLFIRI ) significantly improved overall survival , progression-free survival , and objective response in the first-line treatment of patients with KRAS codon 12/13 ( exon 2 ) wild-type metastatic colorectal cancer ( mCRC ) . Outcome was reassessed in subgroups defined by extended RAS mutation testing . PATIENTS AND METHODS Existing DNA sample s from KRAS exon 2 wild-type tumors from CRYSTAL study patients were reanalyzed for other RAS mutations in four additional KRAS codons ( exons 3 and 4 ) and six NRAS codons ( exons 2 , 3 , and 4 ) using beads , emulsion , amplification , and magnetics technology . No tissue microdissection was performed . A ≥ 5 % mutant allele cutoff was used to call mutations . RESULTS Mutation status was evaluable in 430 ( 64.6 % ) of 666 patients with KRAS exon 2 wild-type tumors . Other RAS mutations were detected in 63 ( 14.7 % ) of 430 patients . In those with RAS wild-type tumors , a significant benefit across all efficacy end points was associated with the addition of cetuximab to FOLFIRI . In patients with other RAS tumor mutations , no difference in efficacy outcomes between treatment groups was seen . The safety profile in RAS subgroups was similar and in line with expectations . CONCLUSION In the first-line treatment of mCRC , patients with RAS wild-type tumors derived a significant benefit from the addition of cetuximab to FOLFIRI ; patients with RAS tumor mutations did not . Molecular testing of tumors for all activating RAS mutations is essential before considering anti-epidermal growth factor receptor therapy , thereby allowing the further tailoring of cetuximab administration to maximize patient benefit PURPOSE We performed this phase III study to compare the irinotecan , leucovorin ( LV ) , and fluorouracil ( FU ) regimen ( FOLFIRI ) versus the oxaliplatin , LV , and FU regimen ( FOLFOX4 ) in previously untreated patients with advanced colorectal cancer . PATIENTS AND METHODS A total of 360 chemotherapy-naive patients were r and omly assigned to receive , every 2 weeks , either arm A ( FOLFIRI : irinotecan 180 mg/m(2 ) on day 1 with LV 100 mg/m(2 ) administered as a 2-hour infusion before FU 400 mg/m(2 ) administered as an intravenous bolus injection , and FU 600 mg/m(2 ) as a 22-hour infusion immediately after FU bolus injection on days 1 and 2 [ LV5FU2 ] ) or arm B ( FOLFOX4 : oxaliplatin 85 mg/m(2 ) on day 1 with LV5FU2 regimen ) . RESULTS One hundred sixty-four and 172 patients were assessable in arm A and B , respectively . Overall response rates ( ORR ) were 31 % in arm A ( 95 % CI , 24.6 % to 38.3 % ) and 34 % in arm B ( 95 % CI , 27.2 % to 41.5 % ; P = .60 ) . In both arms A and B , median time to progression ( TTP ; 7 v 7 months , respectively ) , duration of \n Output:\n " }, { "from": "agent", "value": "Finally , metastatic colorectal cancer patients progressing after all st and ard therapies ( maintaining a good ECOG performance status ) could be c and i date s for further therapies such as regorafenib and TAS-102 ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: Prognosis studies are investigations of future events or the evaluation of associations between risk factors and health outcomes in population s of patients ( 1 ) . The results of such studies improve our underst and ing of the clinical course of a disease and assist clinicians in making informed decisions about how best to manage patients . Prognostic research also informs the design of intervention studies by helping define subgroups of patients who may benefit from a new treatment and by providing necessary information about the natural history of a disorder ( 2 ) . There has recently been a rapid increase in the use of systematic review methods to synthesize the evidence on research questions related to prognosis . It is essential that investigators conducting systematic review s thoroughly appraise the method ologic quality of included studies to be confident that a study 's design , conduct , analysis , and interpretation have adequately reduced the opportunity for bias ( 3 , 4 ) . Caution is warranted , however , because inclusion of method ologically weak studies can threaten the internal validity of a systematic review ( 4 ) . This follows abundant empirical evidence that inadequate attention to biases can cause invalid results and inferences ( 5 - 9 ) . However , there is limited consensus on how to appraise the quality of prognosis studies ( 1 ) . A useful framework to assess bias in such studies follows the basic principles of epidemiologic research ( 10 , 11 ) . We focus on 6 areas of potential bias : study participation , study attrition , prognostic factor measurement , confounding measurement and account , outcome measurement , and analysis . The main objectives of our review of review s are to describe methods used to assess the quality of prognosis studies and to describe how well current practice s assess potential biases . Our secondary objective is to develop recommendations to guide future quality appraisal , both within single studies of prognostic factors and within systematic review s of the evidence . We hope this work facilitates future discussion and research on biases in prognosis studies and systematic review s. Methods Literature Search and Study Selection We identified systematic review s of prognosis studies by search ing MEDLINE ( 1966 to October 2005 ) using the search strategy recommended by McKibbon and colleagues ( 12 ) . This strategy combines broad search terms for systematic review s ( systematic review .mp ; meta- analysis .mp ) and a sensitive search strategy for prognosis studies ( cohort , incidence , mortality , follow-up studies , prognos * , predict * , or course ) . We also search ed the reference lists of included review s and method ologic papers to identify other relevant publications . We restricted our search to English- language publications . One review er conducted the search and selected the studies . Systematic review s , defined as review s of published studies with a comprehensive search and systematic selection , were included if they assessed the method ologic quality of the included studies by using 1 or more explicit criteria . We excluded studies if they were meta-analyses of independent patient data only , if their primary goal was to investigate the effectiveness of an intervention or specific diagnostic or screening tests , or if they included studies that were not done on humans . Data Extraction and Synthesis Individual items included in the quality assessment of the systematic review s were recorded as they were reported in the publication ( that is , the information that would be available to readers and future review ers ) . We review ed journal Web sites and contacted the authors of the systematic review s for additional information when authors made such an offer in their original papers . When review s assessed different study design s by using different sets of quality items , we extracted only those items used to assess cohort studies . We constructed a comprehensive list of distinct items that the review s used to assess the quality of their included studies . The full text of each review was screened . All items used by the review authors to assess the quality of studies were extracted into a computerized spreadsheet by 1 review er . Two experienced review ers , a clinical epidemiologist and an epidemiologist , independently synthesized the quality items extracted from the prognosis review s to determine how well the systematic review s assessed potential biases . We did this in 3 steps : 1 ) identified distinct concepts or domains addressed by the quality items ; 2 ) grouped each extracted quality item into the appropriate domain or domains ; and 3 ) identified the domains necessary to assess potential biases in prognosis studies . We then used this information to assess how well the review s ' quality assessment included items from the domains necessary to assess potential biases . After completing each of the first 3 steps , the review ers met to attempt to reach a consensus . The consensus process involved each review er presenting his or her observations and results , followed by discussion and debate . A third review er was available in cases of persistent disagreement or uncertainty . In the first step , all domains addressed by the quality items were identified . The first review er iteratively and progressively defined the domains as items were extracted from the included review s. The second review er defined domains from a r and om list of all extracted quality items . Limited guidance was provided to the review ers so that their assessment s and definitions of domains would be independent . The review ers agreed on a final set of domains that adequately and completely defined all of the extracted items . In the second step , review ers independently grouped each extracted item into the appropriate domains . Review ers considered each extracted item by asking , What is each particular quality item addressing ? or What are the review 's authors getting at with the particular quality assessment item ? . Items were grouped into the domain or domains that best represented the concepts being addressed . For example , the extracted items at least 80 % of the group originally identified was located for follow-up and follow-up was sufficiently complete or does n't jeopardize validity were each independently classified by both review ers as assessing the domain completeness of follow-up adequate , whereas the extracted item quantification and description of all subjects lost to follow-up was classified as assessing the domain completeness of follow-up described . In the third step , we identified the domains necessary to assess potential biases . Each review er considered the ability of the identified domains to adequately address , at least in part , 1 of the following 6 potential biases : 1 ) study participation , 2 ) study attrition , 3 ) prognostic factor measurement , 4 ) confounding measurement and account , 5 ) outcome measurement , and 6 ) analysis . Domains were considered to adequately address part of the framework if information garnered from that domain would inform the assessment of potential bias . For example , both review ers judged that the identified domain study population represents source population or population of interest assessed potential bias in a prognosis study , whereas the domain research question definition did not , although the latter is an important consideration in assessing the inclusion of studies in a systematic review . Finally , on the basis of our previous ratings , we looked at whether each review included items from the domains necessary to assess the 6 potential biases . We calculated the frequency of systematic review s by assessing each potential bias and the number of review s that adequately assessed bias overall . From this systematic synthesis , we developed recommendations for improving quality appraisal in future systematic review s of prognosis studies . We used Microsoft Access and Excel 2002 ( Microsoft Corp. , Redmond , Washington ) for data management and SAS for Windows , version 9.1 ( SAS Institute , Inc. , Cary , North Carolina ) for descriptive statistics . Role of the Funding Sources The funding sources , the Canadian Institutes of Health Research , the Canadian Chiropractic Research Foundation , the Ontario Chiropractic Association , and the Ontario Ministry of Health and Long Term Care , did not have a role in the collection , analysis , or interpretation of the data or in the decision to su bmi t the manuscript for publication . Results We identified 1384 potentially relevant articles . Figure 1 shows a flow chart of studies that were included and excluded . Figure 2 shows the number of review s identified by year of publication . We excluded 131 systematic review s of prognosis studies that did not seem to include any quality assessment of the included studies ; this represented 44 % of prognosis review s. We included 163 review s of prognosis studies in our analysis ( 13 - 175 ) . The most common topics were cancer ( 15 % ) , musculoskeletal disorders and rheumatology ( 13 % ) , cardiovascular ( 10 % ) , neurology ( 10 % ) , and obstetrics ( 10 % ) . Other review s included a wide range of health and health care topics . Sixty-three percent of the review s investigated the association between a specific prognostic factor and a particular outcome ; the remainder investigated multiple prognostic factors or models . The number of primary studies included in each systematic review ranged from 3 to 167 ( median , 18 [ interquartile range , 12 to 31 ] ) . A complete description of the included review s is available from the authors on request . Figure 1 . Flow diagram of inclusion and exclusion criteria of systematic review s. Figure 2 . Number of systematic review s of prognosis studies identified over time . Quality Items One hundred fifty-three review s provided adequate detail to allow extraction of quality items . Eight hundred eighty-two distinct quality items were extracted from the review s. Most review s developed their own set of quality items , with only a few applying criteria from previous review s. Most quality items BACKGROUND Blockade of programmed death 1 ( PD-1 ) , an inhibitory receptor expressed by T cells , can overcome immune resistance . We assessed the antitumor activity and safety of BMS-936558 , an antibody that specifically blocks PD-1 . METHODS We enrolled patients with advanced melanoma , non-small-cell lung cancer , castration-resistant prostate cancer , or renal-cell or colorectal cancer to receive anti-PD-1 antibody at a dose of 0.1 to 10.0 mg per kilogram of body weight every 2 weeks . Response was assessed after each 8-week treatment cycle . Patients received up to 12 cycles until disease progression or a complete response occurred . RESULTS A total of 296 patients received treatment through February 24 , 2012 . Grade 3 or 4 drug-related adverse events occurred in 14 % of patients ; there were three deaths from pulmonary toxicity . No maximum tolerated dose was defined . Adverse events consistent with immune-related causes were observed . Among 236 patients in whom response could be evaluated , objective responses ( complete or partial responses ) were observed in those with non-small-cell lung cancer , melanoma , or renal-cell cancer . Cumulative response rates ( all doses ) were 18 % among patients with non-small-cell lung cancer ( 14 of 76 patients ) , 28 % among patients with melanoma ( 26 of 94 patients ) , and 27 % among patients with renal-cell cancer ( 9 of 33 patients ) . Responses were durable ; 20 of 31 responses lasted 1 year or more in patients with 1 year or more of follow-up . To assess the role of intratumoral PD-1 lig and ( PD-L1 ) expression in the modulation of the PD-1-PD-L1 pathway , immunohistochemical analysis was performed on pretreatment tumor specimens obtained from 42 patients . Of 17 patients with PD-L1-negative tumors , none had an objective response ; 9 of 25 patients ( 36 % ) with PD-L1-positive tumors had an objective response ( P=0.006 ) . CONCLUSIONS Anti-PD-1 antibody produced objective responses in approximately one in four to one in five patients with non-small-cell lung cancer , melanoma , or renal-cell cancer ; the adverse-event profile does not appear to preclude its use . Preliminary data suggest a relationship between PD-L1 expression on tumor cells and objective response . ( Funded by Bristol-Myers Squibb and others ; Clinical Trials.gov number , NCT00730639 . ) BACKGROUND T-cell infiltration in estrogen receptor (ER)-negative breast tumours has been associated with longer survival . To investigate this association and the potential of tumour T-cell infiltration as a prognostic and predictive marker , we have conducted the largest study of T cells in breast cancer to date . PATIENTS AND METHODS Four studies totalling 12 439 patients were used for this work . Cytotoxic ( CD8 + ) and regulatory ( forkhead box protein 3 , FOXP3 + ) T cells were quantified using immunohistochemistry ( IHC ) . IHC for CD8 was conducted using available material from all four studies ( 8978 sample s ) and for FOXP3 from three studies ( 5239 sample s)-multiple imputation was used to resolve missing data from the remaining patients . Cox regression was used to test for associations with breast cancer-specific survival . RESULTS In ER-negative tumours [ triple-negative breast cancer and human epidermal growth factor receptor 2 ( human epidermal growth factor receptor 2 ( HER2 ) positive ) ] , presence of CD8 + T cells within the tumour was associated with a 28 % [ 95 % confidence interval ( CI ) 16 % to 38 % ] reduction in the hazard of breast cancer-specific mortality , and CD8 + T cells within the stroma with a 21 % ( 95 % CI 7 % to 33 % ) reduction in hazard . In ER-positive HER2-positive tumours , CD8 + T cells within the tumour were associated with a 27 % ( 95 % CI 4 % to 44 % ) reduction in hazard . In ER-negative disease , there was evidence for greater benefit from anthracyclines in the National Epirubicin Adjuvant Trial in patients with CD8 + tumours [ hazard ratio ( HR ) = 0.54 ; 95 % CI 0.37 - 0.79 ] versus CD8-negative tumours ( HR = 0.87 ; 95 % CI 0.55 - 1.38 ) . The difference in effect between these subgroups was significant when limited to cases with complete data ( P heterogeneity = 0.04 ) and approached significance in imputed data ( P heterogeneity = 0.1 ) . CONCLUSIONS The presence of CD8 + T cells in breast cancer is associated with a significant reduction in the relative risk of death from disease in both the ER-negative [ supplementary Figure S1 , available at Annals of Oncology online ] and the ER-positive HER2-positive subtypes . Tumour lymphocytic infiltration may improve risk stratification in breast cancer patients classified into these subtypes . NEAT Clinical Tri \n Output:\n " }, { "from": "agent", "value": "Discussion Immunomodulation seems to be a promising strategy in solid tumors .\nPD-1 and PD-L1 are key physiologic suppressors of the cytotoxic immune reaction ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: PURPOSE This study is an integrated efficacy analysis of the five clinical trials of tositumomab and iodine-131 tositumomab in patients with relapsed or refractory low- grade , follicular , or transformed low- grade non-Hodgkin 's lymphoma ( NHL ) that result ed in the regulatory approval of the iodine-131 tositumomab by the US Food and Drug Administration . PATIENTS AND METHODS This integrated analysis included 250 patients . Patients received a single course of iodine-131 tositumomab . Responses were assessed by an independent panel of radiologists and oncologists . RESULTS Response rates in the five trials ranged from 47 % to 68 % ; complete response rates ranged from 20 % to 38 % . With a median follow-up of 5.3 years , the 5-year progression-free survival was 17 % . Eighty-one ( 32 % ) of 250 patients had a time to progression of > or = 1 year ( termed durable response population ) . For the durable response population , 44 % had not progressed at > or = 2.5 to > or = 9.5 years and had a median duration of response of 45.8 months . The median duration of complete response was not reached . The durable response population had many poor prognostic characteristics , including bone marrow involvement ( 41 % ) , bulky disease > or = 5 cm ( 49 % ) , and transformed histology ( 23 % ) . Forty-three percent of the patients had been treated with more than four prior therapies and 36 % had not responded to their most recent therapy . CONCLUSION The tositumomab and iodine-131 tositumomab therapeutic regimen produces high response rates in patients with relapsed or refractory low- grade , follicular , and transformed low- grade NHL , with a sizable subgroup of patients achieving long-term durable responses BACKGROUND The role of rituximab in combination with different CHOP ( cyclophosphamide , doxorubicin , vincristine , and prednisone)-like chemotherapy regimens in young patients with good-prognosis diffuse large-B-cell lymphoma remains to be defined . We aim ed to compare CHOP-like chemotherapy and rituximab with CHOP-like chemotherapy alone in these patients . METHODS 824 patients who were from 18 countries ; aged 18 - 60 years ; and who had no risk factors or one risk factor according to age-adjusted International Prognostic Index ( IPI ) , stage II-IV disease , or stage I disease with bulk were enrolled . These patients were r and omly assigned to six cycles of CHOP-like chemotherapy and rituximab ( n=413 ) or to six cycles of CHOP-like chemotherapy alone ( n=411 ) . Bulky and extranodal sites received additional radiotherapy . The primary endpoint was event-free survival ; secondary endpoints were response , progression under therapy , progression-free survival , overall survival , and frequency of toxic effects . Analyses were done by intention to treat and per protocol . This trial is registered at http://www . clinical trials.gov , NCT 00064116 . FINDINGS After a median follow-up of 34 months ( range 0.03 - 61 ) , patients assigned chemotherapy and rituximab had increased 3-year event-free survival compared with those assigned chemotherapy alone ( 79 % [ 95 % CI 75 - 83 ] vs 59 % [ 54 - 64 ] ; difference between groups 20 % [ 13 - 27 ] , log-rank p<0.0001 ) , and had increased 3-year overall survival ( 93 % [ 90 - 95 ] vs 84 % [ 80 - 88 ] ; difference between groups 9 % [ 3 - 13 ] , log-rank p=0.0001 ) . Event-free survival was affected by treatment group , presence of bulky disease , and age-adjusted IPI : after chemotherapy and rituximab , a favourable subgroup ( ie , IPI=0 , no bulk ) could be defined from a less-favourable subgroup ( ie , IPI=1 or bulk , or both ) . Groups did not differ in the frequency of adverse events . INTERPRETATION Rituximab added to six cycles of CHOP is an effective treatment for young patients with good-prognosis diffuse large-B-cell lymphoma . The definition of two prognostic subgroups allows for a more refined therapeutic approach for these patients BACKGROUND We conducted a multinational , r and omized study to compare radiotherapy alone with radiotherapy plus cetuximab , a monoclonal antibody against the epidermal growth factor receptor , in the treatment of locoregionally advanced squamous-cell carcinoma of the head and neck . METHODS Patients with locoregionally advanced head and neck cancer were r and omly assigned to treatment with high-dose radiotherapy alone ( 213 patients ) or high-dose radiotherapy plus weekly cetuximab ( 211 patients ) at an initial dose of 400 mg per square meter of body-surface area , followed by 250 mg per square meter weekly for the duration of radiotherapy . The primary end point was the duration of control of locoregional disease ; secondary end points were overall survival , progression-free survival , the response rate , and safety . RESULTS The median duration of locoregional control was 24.4 months among patients treated with cetuximab plus radiotherapy and 14.9 months among those given radiotherapy alone ( hazard ratio for locoregional progression or death , 0.68 ; P=0.005 ) . With a median follow-up of 54.0 months , the median duration of overall survival was 49.0 months among patients treated with combined therapy and 29.3 months among those treated with radiotherapy alone ( hazard ratio for death , 0.74 ; P=0.03 ) . Radiotherapy plus cetuximab significantly prolonged progression-free survival ( hazard ratio for disease progression or death , 0.70 ; P=0.006 ) . With the exception of acneiform rash and infusion reactions , the incidence of grade 3 or greater toxic effects , including mucositis , did not differ significantly between the two groups . CONCLUSIONS Treatment of locoregionally advanced head and neck cancer with concomitant high-dose radiotherapy plus cetuximab improves locoregional control and reduces mortality without increasing the common toxic effects associated with radiotherapy to the head and neck . ( Clinical Trials.gov number , NCT00004227 . It is unclear whether new treatment modalities have improved the survival of follicular lymphoma patients . Some data show that there has been no improvement in survival in the last 3 decades of the 20th century , whereas the results of recent retrospective studies suggest that evolving therapy has improved the outcome for follicular lymphoma patients BACKGROUND We present the combined results of two trials that compared adjuvant chemotherapy with or without concurrent trastuzumab in women with surgically removed HER2-positive breast cancer . METHODS The National Surgical Adjuvant Breast and Bowel Project trial B-31 compared doxorubicin and cyclophosphamide followed by paclitaxel every 3 weeks ( group 1 ) with the same regimen plus 52 weeks of trastuzumab beginning with the first dose of paclitaxel ( group 2 ) . The North Central Cancer Treatment Group trial N9831 compared three regimens : doxorubicin and cyclophosphamide followed by weekly paclitaxel ( group A ) , the same regimen followed by 52 weeks of trastuzumab after paclitaxel ( group B ) , and the same regimen plus 52 weeks of trastuzumab initiated concomitantly with paclitaxel ( group C ) . The studies were amended to include a joint analysis comparing groups 1 and A ( the control group ) with groups 2 and C ( the trastuzumab group ) . Group B was excluded because trastuzumab was not given concurrently with paclitaxel . RESULTS By March 15 , 2005 , 394 events ( recurrent , second primary cancer , or death before recurrence ) had been reported , triggering the first scheduled interim analysis . Of these , 133 were in the trastuzumab group and 261 in the control group ( hazard ratio , 0.48 ; P<0.0001 ) . This result crossed the early stopping boundary . The absolute difference in disease-free survival between the trastuzumab group and the control group was 12 percent at three years . Trastuzumab therapy was associated with a 33 percent reduction in the risk of death ( P=0.015 ) . The three-year cumulative incidence of class III or IV congestive heart failure or death from cardiac causes in the trastuzumab group was 4.1 percent in trial B-31 and 2.9 percent in trial N9831 . CONCLUSIONS Trastuzumab combined with paclitaxel after doxorubicin and cyclophosphamide improves outcomes among women with surgically removed HER2-positive breast cancer . ( Clinical Trials.gov numbers , NCT00004067 and NCT00005970 . BACKGROUND The monoclonal antibody 3H1 mimics the external structure of the carcinoembryonic antigen ( CEA ) . It therefore has the potential , via the anti-idiotypic network , to stimulate immune responses to CEA that may benefit colorectal cancer patients . PATIENTS AND METHODS A total of 630 patients with previously untreated metastatic colorectal cancer were r and omised in a 2:1 fashion to receive bolus 5-fluorouracil ( 5-FU ) and leucovorin ( LV ) plus either 3H1 ( n = 422 ) or placebo ( n = 208 ) . RESULTS The addition of 3H1 to 5-FU and LV did not result in increased toxicity . Survival for the full intent-to-treat population was 14.7 months for the 3H1 arm and 15.2 months for the placebo arm ( P = 0.80 ) . Anti-CEA antibody responses were observed in 70 % of patients treated with 3H1 . Patients with a negative CEA response had a median survival of 8.3 months ( 95 % CI 7.5 - 11.0 ) compared with patients with a strong response : median survival not reached ( P < 0.001 ) . CONCLUSION 3H1 is safe and effectively induces immune responses to CEA . Addition of 3H1 to 5-FU and LV was not shown to improve overall patient outcomes . However , improved survival in patients developing anti-CEA responses to 3H1 are provocative and should be studied in further clinical trials UNLABELLED Orthotopic liver transplantation ( OLT ) is the only curative therapy of HCC with underlying cirrhosis , but due to HCC metastasis and recurrence , its benefit is limited to a small population who meet the strict selection criteria . We previously reported that Licartin ( [ 131I ] mAb HAb18G/CD147 ) was safe and effective in treating HCC patients , and its antigen , HAb18G/CD147 , was closely related to HCC invasion and metastasis . Here , we reported a r and omized controlled trial to assess the post-OLT antirecurrence efficacy of Licartin in advanced HCC patients . We r and omized 60 post-OLT patients with HCC , who were at tumor stage 3/4 and outside the Milan criteria before OLT , into 2 groups . Three weeks after OLT , the treatment group received 15.4 MBq/kg of Licartin , while the control group received placebo intravenously for 3 times with an interval of 28 days . At 1-year follow-up , the recurrence rate significantly decreased by 30.4 % ( P = 0.0174 ) and the survival rate increased by 20.6 % ( P = 0.0289 ) in the treatment group , compared with those in the control group . For the control group versus the treatment group , the hazard ratio for recurrence was 3.60 ( 95 % confidence interval [ CI ] , 1.50 - 8.60 ) and that for death was 3.87 ( 95 % CI , 1.23 - 12.21 ) . Licartin treatment also result ed in an earlier decreased AFP level and a longer time of normal AFP level than placebo ( P = 0.0016 ) . No Licartin-related toxic effects were observed . CONCLUSION Licartin is a promising drug for preventing post-OLT tumor recurrence in advanced HCC patients excluded by the currently strict criteria for OLT . HAb18G/CD147 can be a good drug target The potential benefits of extended rituximab treatment have been investigated in a r and omized trial comparing the st and ard schedule with prolonged treatment in 202 patients with newly diagnosed or refractory/relapsed follicular lymphoma ( FL ) . All patients received st and ard treatment ( rituximab 375 mg/m(2 ) weekly x 4 ) . In 185 evaluable patients , the overall response rate was 67 % in chemotherapy-naive patients and 46 % in pretreated cases ( P < .01 ) . Patients responding or with stable disease at week 12 ( n = 151 ) were r and omized to no further treatment or prolonged rituximab administration ( 375 mg/m(2 ) every 2 months \n Output:\n " }, { "from": "agent", "value": "( 1 ) Many of the significant advances in cancer management in recent years have centered on the development and introduction of molecularly targeted therapies , such as monoclonal antibodies and tyrosine kinase inhibitors.(2 ) Despite targeted therapy that has clearly benefited and even cured certain patients ( eg , imatinib , trastuzumab ) , the ultimate goal of curing cancer , and the more immediate goal of replacing non-targeted chemotherapies with less toxic , targeted agents has yet to be achieved for most cancer patients .(3 ) Based on a systematic review of r and omized controlled trials , examples of significant benefits in selected cancers are provided:(a ) Non-Hodgkin 's lymphoma ( NHL ) - A large meta- analysis and several individual r and omised , controlled trials ( RCTs ) report that rituximab plus chemotherapy has a major survival advantage over chemotherapy alone in patients with NHL ; an overview of six clinical trials supports the survival benefit of rituximab plus chemotherapy.(b ) Renal cell carcinoma ( RCC ) - Temsirolimus or sunitinib has a significant survival benefit relative to interferon-alpha , and sorafenib carries such a benefit in patients resistant to st and ard therapy.(c ) Colorectal cancer ( CRC ) - An overview of three RCTs in metastatic CRC revealed that bevacizumab plus 5-fluorouracil/leucovorin possesses a significant survival advantage over 5-fluorouracil/leucovorin and irinotecan/5-fluorouracil/leucovorin.(d ) Non-small-cell lung cancer ( NSCLC ) - In refractory NSCLC , erlotinib significantly prolongs survival , particularly in nonsmokers , and gefitinib may have some utility in patients of Asian ethnicity.(e ) Head and neck squamous-cell carcinoma ( HNSCC ) - Cetuximab plus radiotherapy ( versus radiotherapy alone ) significantly improves locoregional control and survival ( hazard ratio [ HR ] 0.68 ; p = 0.005 ) without worsening radiotherapy-related toxicity" } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: R and omized controlled trials have yielded promising results for internet-delivered cognitive behavior therapy ( iCBT ) for patients with social anxiety disorder ( SAD ) . The present study investigated anxiety-related neural changes after iCBT for SAD . The amygdala is a critical hub in the neural fear network , receptive to change using emotion regulation strategies and a putative target for iCBT . Twenty-two subjects were included in pre- and post-treatment functional magnetic resonance imaging at 3 T assessing neural changes during an affective face processing task . Treatment outcome was assessed using social anxiety self-reports and the Clinical Global Impression-Improvement ( CGI-I ) scale . ICBT yielded better outcome than ABM ( 66 % vs. 25 % CGI-I responders ) . A significant differential activation of the left amygdala was found with relatively decreased reactivity after iCBT . Changes in the amygdala were related to a behavioral measure of social anxiety . Functional connectivity analysis in the iCBT group showed that the amygdala attenuation was associated with increased activity in the medial orbitofrontal cortex and decreased activity in the right ventrolateral and dorsolateral ( dlPFC ) cortices . Treatment-induced neural changes with iCBT were consistent with previously reported studies on regular CBT and emotion regulation in general Patients with anxiety disorders exhibit excessive neural reactivity in the amygdala , which can be normalized by effective treatment like cognitive behavior therapy ( CBT ) . Mechanisms underlying the brain ’s adaptation to anxiolytic treatments are likely related both to structural plasticity and functional response alterations , but multimodal neuroimaging studies addressing structure – function interactions are currently missing . Here , we examined treatment-related changes in brain structure ( gray matter ( GM ) volume ) and function ( blood – oxygen level dependent , BOLD response to self-referential criticism ) in 26 participants with social anxiety disorder r and omly assigned either to CBT or an attention bias modification control treatment . Also , 26 matched healthy controls were included . Significant time × treatment interactions were found in the amygdala with decreases both in GM volume ( family-wise error ( FWE ) corrected PFWE=0.02 ) and BOLD responsivity ( PFWE=0.01 ) after successful CBT . Before treatment , amygdala GM volume correlated positively with anticipatory speech anxiety ( PFWE=0.04 ) , and CBT-induced reduction of amygdala GM volume ( pre – post ) correlated positively with reduced anticipatory anxiety after treatment ( PFWE⩽0.05 ) . In addition , we observed greater amygdala neural responsivity to self-referential criticism in socially anxious participants , as compared with controls ( PFWE=0.029 ) , before but not after CBT . Further analysis indicated that diminished amygdala GM volume mediated the relationship between decreased neural responsivity and reduced social anxiety after treatment ( P=0.007 ) . Thus , our results suggest that improvement-related structural plasticity impacts neural responsiveness within the amygdala , which could be essential for achieving anxiety reduction with CBT Background Amygdala is considered as the core pathogenesis of generalized social anxiety disorder ( GSAD ) . However , it is still unclear whether effective group cognitive behavioral therapy ( CBT ) could modulate the function of amygdala-related network . We aim ed to examine the resting-state functional connectivity ( rsFC ) of the amygdala before and after group CBT . Methods Fifteen patients with GSAD were scanned on a 3 T MR system before and after 8 weeks of group CBT . For comparison , nineteen healthy control participants also underwent baseline fMRI scanning . We used bilateral amygdala as seed regions and the rsFC maps of the right and left amygdala were created separately in a voxel-wise way . Clusters survived two-tailed Gaussian R and om Field ( GRF ) correction at p < 0.05 ( voxel z value > 2.3 ) . Results Compared with baseline , patients with CBT showed significantly decreased connectivity of the left amygdala with the right putamen , the left dorsal medial prefrontal cortex ( dmPFC ) and the right dorsal anterior cingulate cortex ( dACC ) . Especially , the changes of the connectivity between the left amygdala and the dACC positively correlated with changes of the anxiety symptom in patients . Furthermore , in relative to controls , patients showed higher connectivity of left amygdala with dmPFC and dACC at baseline , while normal after CBT . Conclusions Short-term group CBT could down-regulate the abnormal higher connectivity of prefrontal-amygdala network , along with clinical improvement . This may provide a potential biomarker to monitor the treatment effect of CBT in GSAD patients Social anxiety disorder ( SAD ) is characterized at a neurobiological level by disrupted activity in emotion regulation neural circuitry . Previous work has demonstrated amygdala hyperreactivity and disrupted prefrontal responses to social cues in individuals with SAD ( Kim et al. , 2011 ) . While exposure-based psychological treatments effectively reduce SAD symptoms , not all individuals respond to treatment . Better underst and ing of the neural mechanisms involved offers the potential to improve treatment efficacy . In this study , we investigated functional connectivity in emotion regulation neural circuitry in a r and omized controlled treatment trial for SAD . Participants with SAD underwent fMRI scanning while performing an implicit emotion regulation task prior to treatment ( n=62 ) . Following 12 weeks of cognitive behavioral therapy , acceptance and commitment therapy , or wait-list , participants completed a second scan ( n=42 ) . Psychophysiological interaction analyses using amygdala seed regions demonstrated differences between SAD and healthy control participants ( HC ; n=16 ) in right amygdala-vmPFC connectivity . SAD participants demonstrated more negative amygdala-to-vmPFC connectivity , compared to HC participants , an effect that was correlated with SAD symptom severity . Post-treatment symptom reduction was correlated with altered amygdala-to-vm/vlPFC connectivity , independent of treatment type . Greater symptom reduction was associated with more negative amygdala-to-vm/vlPFC connectivity . These findings suggest that effective psychological treatment for SAD enhances amygdala-prefrontal functional connectivity Background : Cognitive behavioral therapy ( CBT ) is an effective treatment for panic disorder with agoraphobia ( PD/AG ) . It is unknown , how variants of CBT differentially modulate brain networks involved in PD/AG . This study was aim ed to evaluate the effects of therapist-guided ( T+ ) versus self-guided ( T- ) exposure on the neural correlates of fear conditioning in PD/AG . Method : In a r and omized , controlled multicenter clinical trial in medication-free patients with PD/AG who were treated with 12 sessions of manualized CBT , functional magnetic resonance imaging ( fMRI ) was used during fear conditioning before ( t1 ) and after CBT ( t2 ) . Quality -controlled fMRI data from 42 patients and 42 healthy subjects ( HS ) were obtained . Patients were r and omized to two variants of CBT ( T+ , n = 22 , and T- , n = 20 ) . Results : The interaction of diagnosis ( PD/AG , HS ) , treatment group ( T+ , T- ) , time point ( t1 , t2 ) and stimulus type ( conditioned stimulus : yes , no ) revealed activation in the left hippocampus and the occipitotemporal cortex . The T+ group demonstrated increased activation of the hippocampus at t2 ( t2 > t1 ) , which was positively correlated with treatment outcome , and a decreased connectivity between the left inferior frontal gyrus and the left hippocampus across time ( t1 > t2 ) . Conclusion : After T+ exposure , contingency-encoding processes related to the posterior hippocampus are augmented and more decoupled from processes of the left inferior frontal gyrus , previously shown to be dysfunctionally activated in PD/AG . Linking single procedural variants to neural substrates offers the potential to inform about the optimization of targeted psychotherapeutic interventions BACKGROUND Neurofunctional changes underlying effective antianxiety treatments are incompletely characterized . This study explored the effects of citalopram and cognitive-behavioral therapy on regional cerebral blood flow ( rCBF ) in social phobia . METHODS By means of positron emission tomography with oxygen 15-labeled water , rCBF was assessed in 18 previously untreated patients with social phobia during an anxiogenic public speaking task . Patients were matched for sex , age , and phobia severity , based on social anxiety question naire data , and r and omized to citalopram medication , cognitive-behavioral group therapy , or a waiting-list control group . Scans were repeated after 9 weeks of treatment or waiting time . Outcome was assessed by subjective and psychophysiological state anxiety measures and self-report question naires . Questions were readministered after 1 year . RESULTS Symptoms improved significantly and roughly equally with citalopram and cognitive-behavioral therapy , whereas the waiting-list group remained unchanged . Four patients in each treated group and 1 waiting-list patient were classified as responders . Within both treated groups , and in responders regardless of treatment approach , improvement was accompanied by a decreased rCBF-response to public speaking bilaterally in the amygdala , hippocampus , and the periamygdaloid , rhinal , and parahippocampal cortices . Between-group comparisons confirmed that rCBF in these regions decreased significantly more in treated groups than control subjects , and in responders than nonresponders , particularly in the right hemisphere . The degree of amygdalar-limbic attenuation was associated with clinical improvement a year later . CONCLUSIONS Common sites of action for citalopram and cognitive-behavioral treatment of social anxiety were observed in the amygdala , hippocampus , and neighboring cortical areas , ie , brain regions subserving bodily defense reactions to threat The 16-item Quick Inventory of Depressive Symptomatology ( QIDS ) , a new measure of depressive symptom severity derived from the 30-item Inventory of Depressive Symptomatology ( IDS ) , is available in both self-report ( QIDS-SR(16 ) ) and clinician-rated ( QIDS-C(16 ) ) formats . This report evaluates and compares the psychometric properties of the QIDS-SR(16 ) in relation to the IDS-SR(30 ) and the 24-item Hamilton Rating Scale for Depression ( HAM-D(24 ) ) in 596 adult out patients treated for chronic nonpsychotic , major depressive disorder . Internal consistency was high for the QIDS-SR(16 ) ( Cronbach 's alpha = .86 ) , the IDS-SR(30 ) ( Cronbach 's alpha = .92 ) , and the HAM-D(24 ) ( Cronbach 's alpha = .88 ) . QIDS-SR(16 ) total scores were highly correlated with IDS-SR(30 ) ( .96 ) and HAM-D(24 ) ( .86 ) total scores . Item-total correlations revealed that several similar items were highly correlated with both QIDS-SR(16 ) and IDS-SR(30 ) total scores . Roughly 1.3 times the QIDS-SR(16 ) total score is predictive of the HAM-D(17 ) ( 17-item version of the HAM-D ) total score . The QIDS-SR(16 ) was as sensitive to symptom change as the IDS-SR(30 ) and HAM-D(24 ) , indicating high concurrent validity for all three scales . The QIDS-SR(16 ) has highly acceptable psychometric properties , which supports the usefulness of this brief rating of depressive symptom severity in both clinical and research setting Background : The present study examined the prevalence of social phobia in the Swedish general population and demographic characteristics associated with this anxiety disorder . Methods : Data were obtained by means of a postal survey administrated to 2000 r and omly selected adults . A question naire , vali date d against clinical interviews and established social phobia scales , was used to assess social distress in a broad range of phobic situations , as well as the diagnostic criteria for social phobia corresponding to DSM-IV . Interpretable question naires were obtained from 1202 respondents ( 60.1 % ) . Results : The point prevalence of social phobia was estimated at 15.6 % , but prevalence rates varied between 1.9 and 20.4 % across the different levels of distress and impairment used to define cases . Public speaking was the most common social fear . Social phobia was associated with female gender , low educational attainment , psychiatric medication use , and lack of social support . Conclusions : Although the exact diagnostic boundaries for social phobia are difficult to determine , it can be concluded that social anxiety is a distressing problem for a considerable proportion of the general population BACKGROUND Learning by conditioning is a key ability of animals and humans for acquiring novel behavior necessary for survival in a changing environment . Aberrant conditioning has been considered a crucial factor in the etiology and maintenance of panic disorder with agoraphobia ( PD/A ) . Cognitive-behavioral therapy ( CBT ) is an effective treatment for PD/A. However , the neural mechanisms underlying the effects of CBT on conditioning processes in PD/A are unknown . METHODS In a r and omized , controlled , multicenter clinical trial in medication-free patients with PD/A who were treated with 12 sessions of manualized CBT , functional magnetic resonance imaging ( fMRI ) was used during fear conditioning before and after CBT . Quality -controlled f \n Output:\n " }, { "from": "agent", "value": "Conclusion : Neuroimaging studies suggest that abnormalities in hippocampus , amygdala , iFG , uncus and areas linked with emotional regulation ( dlPFC and ACC ) , predict a good outcome to psychotherapy in anxiety disorders .\nHighlightsNeuroimaging studies suggest that hippocampus , amygdala , iFG , uncus dlPFC and ACC predict a good outcome to psychotherapy in anxiety disorders" } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: Objective To determine whether transvaginal ultrasound measurement of bladder wall thickness could replace ambulatory urodynamics when investigating women with lower urinary tract dysfunction not explained by conventional laboratory urodynamic studies OBJECTIVE Estimate the prevalence of urinary incontinence ( UI ) , overactive bladder ( OAB ) , and other lower urinary tract symptoms ( LUTS ) among men and women in five countries using the 2002 International Continence Society ( ICS ) definitions . METHODS This population -based , cross-sectional survey was conducted between April and December 2005 in Canada , Germany , Italy , Sweden , and the United Kingdom using computer-assisted telephone interviews . A r and om sample of men and women aged > /= 18 yr residing in the five countries and who were representative of the general population s in these countries was selected . Using 2002 ICS definitions , the prevalence estimates of storage , voiding , and postmicturition LUTS were calculated . Data were stratified by country , age cohort , and gender . RESULTS A total of 19,165 individuals agreed to participate ; 64.3 % reported at least one LUTS . Nocturia was the most prevalent LUTS ( men , 48.6 % ; women , 54.5 % ) . The prevalence of storage LUTS ( men , 51.3 % ; women , 59.2 % ) was greater than that for voiding ( men , 25.7 % ; women , 19.5 % ) and postmicturition ( men , 16.9 % ; women , 14.2 % ) symptoms combined . The overall prevalence of OAB was 11.8 % ; rates were similar in men and women and increased with age . OAB was more prevalent than all types of UI combined ( 9.4 % ) . CONCLUSIONS The EPIC study is the largest population -based survey to assess prevalence rates of OAB , UI , and other LUTS in five countries . To date , this is the first study to evaluate these symptoms simultaneously using the 2002 ICS definitions . The results indicate that these symptoms are highly prevalent in the countries surveyed \n Output:\n " }, { "from": "agent", "value": "Conclusions There is lack of data to reliably estimate accuracy of BWT in DO" } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: Asthma self-management programmes have been shown to increase children 's knowledge about asthma and improve their management practice s and health status . However , existing programmes have rarely addressed the unique learning needs of very young children . This study aim ed to develop and assess the effectiveness of a video tape and picture book design ed to teach children about the prevention and management of acute episodes of asthma . The information content of the educational re sources was determined by analysis of relevant medical information and asthma management skills . Social Learning Theory and consideration of the developmental stage of the target population informed the format and style of presentation of the re sources . Eighty children aged between 2 and 5 years who had been diagnosed with asthma by their medical practitioner and who required daily asthma medication participated in a controlled experimental study . The study evaluated the impact of the asthma education re sources on children 's knowledge about asthma , compliance with medication regimens and health status . Children were r and omly allocated to one of three experimental groups . Children in these groups were exposed to either the video tape alone , the book alone or both the video tape and book , or to a control group who viewed material s unrelated to asthma . The results for the three experimental groups were compared with the control group who did not receive exposure to any of the asthma education re sources . The results showed that children in each experimental group had significantly greater gains in asthma-related knowledge than children in the control group and children exposed to both re sources showed the greatest increases in knowledge . Children in each of the three experimental groups also had better compliance and health than children in the control group . These findings indicate that carefully design ed asthma education re sources are useful for providing even the youngest children with information about asthma and its management The parents of asthmatic children treated in the pediatric respiratory service of Wolfson Hospital were r and omly divided into two groups . One group compromised 26 parents who voluntarily attended a teaching session . After completion of the course , a question naire was completed by parents who had attended the course and parents who had not . The first group showed greater knowledge of all aspects of the disease and , after a year 's follow up , it was noted that there was a statistically significant lower hospitalization rate of their asthmatic child This study was conducted to test the efficacy of AIR WISE , an individually administered asthma self-management program . Subjects were paired and r and omly assigned to either an experimental group ( N = 7 ) or a control group ( N = 7 ) . The frequency of experimental group emergency visits , analyzed over a 12-month posttreatment period , was substantially less than those of the control group , supporting the hypothesis that AIR WISE is effective in high-utilizer children through improved self-management An educational training program for children with asthma , aged between 8 and 13 years , was evaluated in an 18-month r and omized , controlled experiment , including three follow-up evaluations . The objective of the program is to improve coping with asthma in daily life . The program , ten 1-hour sessions , is a combination of self-management training and cognitive behaviour therapy in a group , using games and learning material s specifically design ed for this age group . From 195 asthmatic children , 112 with inadequate self-management abilities were selected ; these children were r and omly divided into an experimental group and two control groups . The results indicated highly significant differences in favor of the experimental group on the psychological and medical variables . There were no drop-outs during the program . The conclusion is that this multi-faceted program is an effective method of teaching children how to cope with their asthma and helping them to achieve a less anxious and more realistic attitude towards their illness Twenty children with severe asthma using continual oral beta 2 agonists were r and omized equally into either a behavioral intervention group or a control group . The behavioral intervention consisted of : symptom discrimination of asthma signals , self-management techniques of breathlessness , and contingency management of asthma-related behavior . The purpose of the study was to evaluate the effects of the behavioral treatment when superimposed on a regular medical treatment . The design consisted of a four-week baseline period , a four-week intervention period , and a four-week follow-up period . Results showed that the group receiving the behavioral intervention significantly reduced their use of beta 2 agonist spray doses and days of school absenteeism without increasing the number of asthma symptoms compared with the control group . It was concluded that children with severe asthma may benefit substantially from a behavioral program in addition to their regular medical treatment Care of asthmatic children is often episodic and more therapeutic than preventive . A 2-year r and omized , controlled trial involving 95 children measured the impact of a comprehensive home and ambulatory program for pediatric asthma management using objective outcome measures . Interventions for the study group during the first year included 3-month clinic visits , education , and home visits by a specially trained research nurse . Control subjects continued to receive regular care from a family physician or pediatrician . Eight-nine subjects ( 93 % ) completed the study . Study subjects had less school absenteeism than control subjects ( 10.7 vs. 16.0 days , P = .04 ) and showed significantly better small airway function after 1 year . Asthma severity improved in 13 study subjects and worsened in 5 . The reverse was true for control subjects . Study subjects exhibited better metered aerosol technique than control subjects ( P = .0005 ) . Fewer days were spent in hospital by the study subjects admitted compared with control subjects ( 3.67 vs 11.2 days , P = .02 ) . After 1 year , more study than control families ( 72.1 % vs 33.1 % , P = .006 ) reported that their asthmatic child took responsibility for the asthma management . The intervention failed to reduce exposure to secondh and smoke or to household pets . There were no significant differences in medical visits , theophylline levels , or records of asthma symptoms . One year after discontinuing the intervention , a marked \" washout \" effect was observed . Comprehensive ambulatory programs of childhood asthma management can improve objective measures of illness severity but must be sustained A r and omised controlled study of an educational programme for children with asthma and their families was carried out by community child health nurses . Three hundred and sixty eight children aged 2 to 14 years were enrolled in the study after admission to hospital for asthma . The intervention group was visited monthly by a nurse for six months . The subjects were assessed six months later by a postal , self administered question naire . European children in the intervention group were taking significantly more drugs for the treatment of asthma six months after the index admission to hospital than those in the control group ( mean ( SD ) intake 2.7 ( 1.1 ) v 2.1 ( 1.0 ) , respectively ) . In particular , they were using more theophylline ( 56.6 % v 37.0 % ) and inhaled steroids ( 34.9 % v 21.0 % ) . There was no difference between the groups for parental reports of improvement , of missed schooling , and in severe attacks of asthma of not responding to the usual treatment at home . European children in the intervention group used the hospital services for severe attacks of asthma more than controls ( 34.2 % v 10.5 % ) . There were more re-admissions in the European intervention group in the subsequent six months after the index admission than in the control group ( mean ( SD ) 0.51 ( 0.97 ) v 0.29 ( 0.65 ) . Re-admission continued to be higher in the 12 months after the nurse had stopped visiting ( 0.81 ( 1.65 ) v 0.25 ( 0.65 ] . There was no difference in the duration of hospital stay between the intervention and control groups . For Polynesian children there was no difference between the groups for any outcome measures A r and omized control trial of a curriculum , A.C.T. ( Asthma Care Training ) for Kids , was conducted . Seventy-six children between the ages of 8 and 12 years , whose asthma required treatment with medications at least 25 % of the days per month , were r and omly assigned to control and experimental groups . The control group received 4 1/2 hours of lecture presentations on asthma and its management . The experimental groups ( consisting of four to seven children and their parents ) received five 1-hour sessions comprising \" the treatment . \" Children and their parents were interviewed before the sessions and 3 , 6 , and 12 months after the completion of the experimental treatment . Use of emergency rooms and hospitals was determined by review ing the records of these patients ( all members of the Los Angeles Kaiser Permanente health care system ) for the period of 1 year before and 1 year after the treatment . Results include ( 1 ) equivalent increases in knowledge and changes in beliefs in both groups , ( 2 ) significant changes in the self-reported compliance behaviors of the experimental group only , and ( 3 ) significant reductions in emergency room visits and days of hospitalization among those receiving the experimental treatment , compared with the control group . These changes represent an estimated savings of approximately $ 180 per child per year for those in the experimental group Children with asthma are at special risk for problems in psychological functioning , as are children with other chronic illnesses . We conducted a controlled trial of a combined education and stress management program among children ages 6 to 14 years with asthma . Eighty-one children were r and omly assigned to an intervention or a control group ; 56 children completed data collection , 29 intervention and 27 control . Psychological status was assessed by the Child Behavior Checklist ( CBCL ) before and after the intervention , as were children 's knowledge of asthma , stress ( as measured by children 's life events ) , and functional status ( as indicated by such activities as school attendance , time playing with friends , and daily chore performance ) . Children in the intervention group had a significant improvement in the total Behavior Problems score ( p < .04 ) and Internalizing scale ( p < .01 ) on the CBCL and a significant increase in daily chores ( p < .04 ) compared with the control group . Before intervention , the two groups had statistically significant positive relationships between negative life events and behavior problem scores . After intervention , children in the control group still demonstrated a significant relationship between negative life events and total and Internalizing Behavior Problem scores , although participation in the intervention group negated that relationship . Children in the intervention group whose knowledge of asthma increased were more likely to report an increase in daily chores ( p < .02 ) . We conclude that the intervention had a beneficial effect on psychological status and on children 's daily activities . The effect may have occurred in part by decreasing the likelihood that perceived stress from negative life events led to poorer adjustment To evaluate a health education program to improve family management of asthma , 310 children with asthma and their 290 parents were r and omly assigned to a program or control group . Program families participated in health education design ed to resolve specific management problems and build self-confidence in the ability to manage asthma . Following education , program parents scored better on an asthma self-management index than parents in the control group ( + 1.57 versus -0.83 , P less than 0.0001 ) . Program parents also scored better on two subindices of the self-management index : attack management ( + 0.87 vs. + 0.42 , P less than 0.05 ) and preventive measures ( + 0.42 vs. -0.35 , P less than 0.05 ) . Also , program parents reported significantly more use of guidelines to determine appropriate levels of physical activity for children . Following education , program children reported more use of three management steps than control children : productive cough or postural drainage ( 59 % vs. 35 % , P less than 0.004 ) , breathing and relaxation exercises ( 80 % vs. 65 % , P less than 0.05 ) , and attempts to stay calm ( 12 % vs. 2 % , P less than 0.05 ) . Program children reported significantly less worry than control children about the limitations asthma imposes and about making mistakes at school A r and omized trial of an instructional method was conducted in which school nurses taught children asthma self-management principles and skills , including peak flow monitoring , in 20-min , individual sessions over an 8-week period . Thirty-six children participated . An intervention group of 18 children received the teaching sessions . A control group of 18 children received regular care by the nurses , but no teaching sessions . The sample included 64 % boys , 69 % African-Americans , and 69 % Medicaid recipients . The average age of subjects was 10.2 years . The two groups were demographically similar , but despite r and om assignment , the control group had a significantly earlier age of onset of asthma and tended to have had more asthma attacks in the preceding year . These factors were statistically controlled in outcome analyses . Results of group comparisons showed no significant differences in the number of postintervention emergency room visits and days absent from school . However , nurses reported that children who practice d breathing exercises had less anxiety during exacerbations , and the nurses ' knowledge of the children 's baseline peak expiratory flow rates facilitated care of the children . Nurses expressed the opinion that the individual sessions with students might be useful in motivating them to participate effectively in later group sessions . The intervention was well accepted by students , parents , and nurses . We believe that this intervention is promising as a practical , low-cost approach to enhancing children 's asthma self-management skills and warrants further testing in a larger sample , with the intervention conducted over a longer period This study was design ed to answer three main questions : 1 ) Does asthma self-management education reduce asthma morbidity ? 2 ) Are the two programmes \" Living With Asthma \" and \" Open Airways \" equally effective in doing so ? 3 ) Is a shortened version of these programmes ( 4 weeks ) as effective as the longer original programme ( 8 weeks ) ? Twelve Italian centres of paediatric bronchopneumology selected 312 children with asthma , who were stratified by disease severity , gender and age , and then r and omly assigned to an Experimental group which received an educational programme or to a Comparison group , which did not . Of the 312 children selected , 209 ( 114 Experimental \n Output:\n " }, { "from": "agent", "value": "Effects of education were greater for most outcomes in moderate-severe , compared with mild-moderate asthma , and among studies employing peak flow versus symptom-based strategies .\nREVIEW ER 'S CONCLUSIONS Asthma self-management education programs in children improve a wide range of measures of outcome ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: Objective To explore the causes of failure to activate the rapid response system ( RRS ) . The organisation has a recognised incidence of staff failing to act when confronted with a deteriorating patient and leading to adverse outcomes . Design A multi- method study using the following : a point prevalence survey to determine the incidence of abnormal simple bedside observations and activation of the rapid response team by clinical staff ; a prospect i ve audit of all patients experiencing a cardiac arrest , unplanned intensive care unit admission or death over an 8-week period ; structured interviews of staff to explore cognitive and sociocultural barriers to activating the RRS . Setting Southern Health is a comprehensive healthcare network with 570 adult in-patient beds across four metropolitan teaching hospitals in the south-eastern sector of Melbourne . Measurements Frequency of physiological instability and outcomes within the in-patient hospital population . Qualitative data from staff interviews were thematically coded . Results The incidence of physiological instability in the acute adult population was 4.04 % . Nearly half of these patients ( 42 % ) did not receive an appropriate clinical response from the staff , despite most ( 69.2 % ) recognising their patient met physiological criteria for activating the RRS , and being ‘ quite ’ , or ‘ very ’ concerned about their patient ( 75.8 % ) . Structured interviews with 91 staff members identified predominantly sociocultural reasons for failure to activate the RRS . Conclusions Despite an organisational commitment to the RRS , clinical staff act on local cultural rules within the clinical environment that are usually not explicit . Better underst and ing of these informal rules may lead to more appropriate activation of the RRS Background Increasing dem and s on general practice to manage chronic disease may warrant organisational change at the practice level . Staff 's readiness for organisational change can act as a facilitator or barrier to implementing interventions aim ed at organisational change . Objectives To explore general practice staff readiness for organisational change and its association with staff and practice s characteristics . Methods This is a cross-sectional study of practice s in three Australian states involved in a r and omised control trial on the effectiveness of an intervention to enhance the role of non-general practitioner staff in chronic disease management . Readiness for organisational change , job satisfaction and practice characteristics were assessed using question naires . Results 502 staff from 58 practice s completed question naires . Practice characteristics were not associated with staff readiness for change . A multilevel regression analysis showed statistically significant associations between staff readiness for organisational change ( range 1 to 5 ) and having a non- clinical staff role ( vs general practitioner ; B=−0.315 ; 95 % CI −0.47 to −0.16 ; p<0.001 ) , full-time employment ( vs part-time ; B=0.175 , 95 % CI 0.06 to 0.29 ; p<0.01 ) and lower job satisfaction ( B=−0.277 , 95 % CI −0.40 to −0.15 ; p<0.001 ) . Conclusions The results suggest that different approaches are needed to facilitate change which addresses the mix of practice staff . Moderately low job satisfaction may be an opportunity for organisational change BACKGROUND Surgery has become an integral part of global health care , with an estimated 234 million operations performed yearly . Surgical complications are common and often preventable . We hypothesized that a program to implement a 19-item surgical safety checklist design ed to improve team communication and consistency of care would reduce complications and deaths associated with surgery . METHODS Between October 2007 and September 2008 , eight hospitals in eight cities ( Toronto , Canada ; New Delhi , India ; Amman , Jordan ; Auckl and , New Zeal and ; Manila , Philippines ; Ifakara , Tanzania ; London , Engl and ; and Seattle , WA ) representing a variety of economic circumstances and diverse population s of patients participated in the World Health Organization 's Safe Surgery Saves Lives program . We prospect ively collected data on clinical processes and outcomes from 3733 consecutively enrolled patients 16 years of age or older who were undergoing noncardiac surgery . We subsequently collected data on 3955 consecutively enrolled patients after the introduction of the Surgical Safety Checklist . The primary end point was the rate of complications , including death , during hospitalization within the first 30 days after the operation . RESULTS The rate of death was 1.5 % before the checklist was introduced and declined to 0.8 % afterward ( P=0.003 ) . Inpatient complications occurred in 11.0 % of patients at baseline and in 7.0 % after introduction of the checklist ( P<0.001 ) . CONCLUSIONS Implementation of the checklist was associated with concomitant reductions in the rates of death and complications among patients at least 16 years of age who were undergoing noncardiac surgery in a diverse group of hospitals Background Service development innovation in health technology and practice is viewed as a pressing need within the field of mental health yet is relatively poorly understood . Macro-level theories have been criticised for their limited explanatory power and they may not be appropriate for underst and ing local and fine-grained uncertainties of services and barriers to the sustainability of change . This study aim ed to identify context ual influences inhibiting or promoting the acceptance and integration of innovations in mental health services in both National Health Service ( NHS ) and community setting s. Methods A comparative study using qualitative and case study data collection methods , including semi-structured interviews with key stakeholders and follow-up telephone interviews over a one-year period . The analysis was informed by learning organisation theory . Drawn from 11 mental health innovation projects within community , voluntary and NHS setting s , 65 participants were recruited including service users , commissioners , health and non-health professionals , managers , and caregivers . The methods deployed in this evaluation focused on process- outcome links within and between the 11 projects . Results Key barriers to innovation included resistance from corporate departments and middle management , complexity of the innovation , and the availability and access to re sources on a prospect i ve basis within the host organisation . The results informed the construction of a proposed model of innovation implementation within mental health services . The main components of which are context , process , and outcomes . Conclusions The study produced a model of conducive and impeding factors drawn from the composite picture of 11 innovative mental health projects , and this is discussed in light of relevant literature . The model provides a rich agenda to consider for services wanting to innovate or adopt innovations from elsewhere . The evaluation suggested the importance of study ing innovation with a focus on context , process , and outcomes Background Despite recent high- quality evidence for their cost-effectiveness , thiazides are underused for controlling hypertension . The goal of this study was to design and test a practice -based intervention aim ed at increasing the use of thiazide-based antihypertensive regimens . Methods This quasi-experimental study was carried out in general medicine ambulatory practice s of a large , academically-affiliated Veterans Affairs hospital . The intervention group consisted of the practitioners ( 13 staff and 215 trainees ) , nurses , and patients ( 3,502 ) of the teaching practice ; non-r and omized concurrent controls were the practitioners ( 31 providers ) and patients ( 18,292 ) of the non-teaching practice s. Design of the implementation intervention was based on Rogers ' Diffusion of Innovations model . Over 10.5 months , intervention teams met weekly or biweekly and developed and disseminated informational material s among themselves and to trainees , patients , and administrators . These teams also review ed summary electronic-medical-record data on thiazide use and blood pressure ( BP ) goal attainment . Outcome measures were the proportion of hypertensive patients prescribed a thiazide-based regimen , and the proportion of hypertensive patients attaining BP goals regardless of regimen . Thirty-three months of time-series data were available ; statistical process control charts , change point analyses , and before-after analyses were used to estimate the intervention 's effects . Results Baseline use of thiazides and rates of BP control were higher in the intervention group than controls . During the intervention , thiazide use and BP control increased in both groups , but changes occurred earlier in the intervention group , and primary change points were observed only in the intervention group . Overall , the pre-post intervention difference in proportion of patients prescribed thiazides was greater in intervention patients ( 0.091 vs. 0.058 ; p = 0.0092 ) , as was the proportion achieving BP goals ( 0.092 vs. 0.044 ; p = 0.0005 ) . At the end of the implementation period , 41.4 % of intervention patients were prescribed thiazides vs. 30.6 % of controls ( p < 0.001 ) ; 51.6 % of intervention patients had achieved BP goals vs. 44.3 % of controls ( p < 0.001 ) . Conclusion This multi-faceted intervention appears to have result ed in modest improvements in thiazide prescribing and BP control . The study also demonstrates the value of electronic medical records for implementation research , how Rogers ' model can be used to design and launch an implementation strategy , and how all members of a clinical microsystem can be involved in an implementation effort Background The Promoting Action on Research Implementation in Health Services framework , or PARIHS , is a conceptual framework that posits key , interacting elements that influence successful implementation of evidence -based practice s. It has been widely cited and used as the basis for empirical work ; however , there has not yet been a literature review to examine how the framework has been used in implementation projects and research . The purpose of the present article was to critically review and synthesize the literature on PARIHS to underst and how it has been used and operationalized , and to highlight its strengths and limitations . Methods We conducted a qualitative , critical synthesis of peer- review ed PARIHS literature published through March 2009 . We synthesized findings through a three-step process using semi-structured data abstract ion tools and group consensus . Results Twenty-four articles met our inclusion criteria : six core concept articles from original PARIHS authors , and eighteen empirical articles ranging from case reports to quantitative studies . Empirical articles generally used PARIHS as an organizing framework for analyses . No studies used PARIHS prospect ively to design implementation strategies , and there was generally a lack of detail about how variables were measured or mapped , or how conclusions were derived . Several studies used findings to comment on the framework in ways that could help refine or vali date it . The primary issue identified with the framework was a need for greater conceptual clarity regarding the definition of sub-elements and the nature of dynamic relationships . Strengths identified included its flexibility , intuitive appeal , explicit acknowledgement of the outcome of ' successful implementation , ' and a more expansive view of what can and should constitute ' evidence . ' Conclusions While we found studies reporting empirical support for PARIHS , the single greatest need for this and other implementation models is rigorous , prospect i ve use of the framework to guide implementation projects . There is also need to better explain derived findings and how interventions or measures are mapped to specific PARIHS elements ; greater conceptual discrimination among sub-elements may be necessary first . In general , it may be time for the implementation science community to develop consensus guidelines for reporting the use and usefulness of theoretical frameworks within implementation studies Objective Implementation of a surgical checklist depends on many organisational factors and on socio-cultural patterns . The objective of this study was to identify barriers to effective implementation of a surgical checklist and to develop a best use strategy . Setting 18 cancer centres in France . Design The authors first assessed use compliance and completeness rates of the surgical checklist on a r and om sample of 80 surgical procedures performed under general or loco-regional anaesthesia in each of the 18 centres . They then developed a typology of the organisational and cultural barriers to effective checklist implementation and defined each barrier 's contents using data from collective and semi-structured individual interviews of key staff , the results of an email question naire sent to the 18 centres , and direct observations over 20 h in two centres . Results The study consisted of 1440 surgical procedures , 1299 checklists , and 28 578 items . The mean compliance rate was 90.2 % ( 0 , 100 ) . The mean completion rate was 61 % ( 0 , 84 ) . 11 barriers to effective checklist implementation were identified . Their incidence varied widely across centres . The main barriers were duplication of items within existing checklists ( 16/18 centres ) , poor communication between surgeon and anaesthetist ( 10/18 ) , time spent completing the checklist for no perceived benefit , and lack of underst and ing and timing of item checks ( 9/18 ) , ambiguity ( 8/18 ) , unaccounted risks ( 7/18 ) and a time-honoured hierarchy ( 6/18 ) . Conclusions Several of the barriers to the successful implementation of the surgical checklist depended on organisational and cultural factors within each centre . The authors propose a strategy for change for checklist design , use and assessment , which could be used to construct a feedback loop for local team organisation and national initiatives Background Data of the German Competence Network for Community-Acquired Pneumonia showed a gap between the recommendations of the national guideline for management of community-acquired pneumonia ( CAP ) and the routine care . We developed and evaluated an implementation strategy to improve the quality of care of patients with CAP . Method A prospect i ve , r and omised , controlled trail was conducted within CAPNETZ . In four local clinical centres ( LCC ) , the guideline was implemented by different strategies . The other four LCC served as control group . Indicators for guideline adherence comprised initial site of treatment , initial antibiotic treatment and duration of antibiotic treatment . As patient-related factors , we assessed the effect of guideline implementation on 30-day mortality and length of hospital stay . Results Active guideline implementation yielded an increased proportion of guideline adherence to the length of antibiotic treatment in out patients ( + 9.2 % ) , the recommended antibiotic treatment ( + \n Output:\n " }, { "from": "agent", "value": "Obstacles in implementation are the mirror image of these : for example , when people fail to prepare , have insufficient capacity for implementation or when the setting is resistant to change , then care quality is at risk , and patient safety can be compromised ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: The objective of this study was to determine the impact of stress reduction on blood pressure ( BP ) in adolescents by the Transcendental Meditation ( TM ) program . African-American adolescents ( aged 16.2 + /- 1.3 years ) with high normal systolic BP were r and omly assigned to either 4-month TM ( n = 50 ) or health education control ( n = 50 ) groups . Ambulatory 24-h BP measures were recorded at pretest , 2- and 4-month post-tests , and 4-month follow-up . Greater decreases in daytime systolic BP ( P < .04 ) and diastolic BP ( P < .06 ) in the TM group compared with the control group across the visits demonstrate a beneficial impact of the TM program in youth at risk for the development of hypertension Background Slow , controlled breathing has been shown by cross-spectral techniques to potentiate arterial baroreflex control of heart rate . However , crucial aspects of the effects of slow breathing on the arterial baroreflex remain unsettled , namely whether the major function of the arterial baroreflex ( i.e. the control of blood pressure ) is also potentiated and whether baroreflex function is differentially modulated according to the age of the individual . Objective To examine the bradycardic and depressor responses to selective carotid baroreceptor stimulation by the neck chamber technique ( −15 and −30 mmHg neck suction ) and the cross-spectral R – R interval/systolic blood pressure relationship ( α index ) . Methods In 24 resting , supine healthy male volunteers ( aged 19–66 years , mean ±SEM 37.5 ± 3.19 years ) , blood pressure ( Finapres ) , R – R interval ( electrocardiogram ) and ventilation ( impedance ) were recorded continuously . Both assessment s were performed during spontaneous breathing and during 6 cycles/min controlled ventilation in r and om order . Results The depressor and bradycardic responses to neck suction were significantly larger during slow breathing than in spontaneous breathing ( + 32 and + 85 % , respectively ; both P < 0.01 ) . The α index was also significantly larger during slow breathing ( + 62 % ; P < 0.01 ) . Even after the volunteers were divided into older ( > 50 years , n = 9 ) and younger ( < 30 years , n = 9 ) groups , the baroreflex potentiation related to slow breathing was clearcut and significant for both the depressor ( + 46 and + 24 % older and younger volunteers ; both P < 0.01 ) and the bradycardic ( + 130 and + 73 % older and younger volunteers ; both P < 0.01 ) responses . When the assessment was made by computing the cross-spectral α index , a marked potentiation related to slow breathing was observed in younger volunteers ( + 99 % ; P < 0.01 ) , whereas in older volunteers only a trend to an enhancement ( by 32 % ; P < 0.055 ) was observed . Conclusions Slow controlled breathing is associated with potentiation of both the depressor and the cardio-inhibitory components of the arterial baroreflex , the potentiation being largely similar regardless of the age of the individual In man evaluation of neural cardiovascular regulation makes use of a variety of tests which address the excitatory and reflex inhibitory neural influences that control circulation . Because interpretation of these tests is largely based on the magnitude of the elicited haemodynamic responses , their reproducibility in any given subject is critical . In 39 subjects with continuous blood pressure ( intra-arterial catheter ) and heart rate monitoring we measured the blood pressure and heart rate rises during h and -grip and cold-pressor test , the heart rate changes occurring during baroreceptor stimulation and deactivation by injection of phenylephrine and trinitroglycerine , and the heart rate and blood pressure changes occurring with alteration in carotid baroreceptor activity by a neck chamber . Each test was carefully st and ardized and performed at 30 min intervals for a total of six times in each subject . The results showed that the responses to any test were clearly different from one another and that this occurred in all subjects studied . For the group as a whole the average response variability ( coefficient of variation ) ranged from 10.2 % for the blood pressure response to carotid baroreceptor stimulation to 44.2 % for the heart rate response to cold-pressor test . The variability of the responses was not related to basal blood pressure or heart rate , nor to the temporal sequence of the test performance . Thus tests employed for study ing neural cardiovascular control in man produce responses whose reproducibility is limited . This phenomenon may make it more difficult to define the response magnitude typical of each subject , as well as its comparison in different conditions and diseases OBJECTIVE --To establish whether stress management had a larger effect than a control treatment on resting blood pressure , ambulatory blood pressure , and left ventricular mass . DESIGN --A 12 week baseline period of habituation to measurement of blood pressure was followed by r and omisation to either stress management or mild exercise for six months and follow up six months later . SETTING --General practice , district general hospital , and medical school . PATIENTS --Of the 184 patients aged under 60 with mild primary hypertension who entered the baseline habituation period , 88 were excluded because they failed to meet the entry criteria or they withdrew from the study . The remaining 46 men and 50 women underwent treatment . INTERVENTIONS --10 clinical sessions and daily practice at home of either stress management based on relaxation or non-aerobic stretching exercises . Mildly stressful 15 minute interviews before and after treatment . MAIN OUTCOME MEASURES --Diastolic and systolic blood pressure in the clinic and during 12 hours of ambulatory recording , and left ventricular mass measured by echocardiography . RESULTS --The patients ' blood pressure fell during habituation ( systolic pressure from 152 mmHg to 140 mmHg , diastolic pressure from 98 to 93 mm Hg ) , but neither resting nor ambulatory blood pressure was changed by the treatments . Left ventricular mass was also unchanged . Blood pressure rose during the stressful interview , but this rise was reduced by stress management ( systolic pressure rose by 7.4 mmHg before treatment and by 3.7 mmHg after treatment ) . CONCLUSION --Stress management of a type advocated for treating mild primary hypertension is ineffective in lowering blood pressure in patients who are well habituated to measuring blood pressure 34 hypertensive patients were assigned at r and om either to six weeks ' treatment by yoga relaxation methods with bio-feedback or to placebo therapy ( general relaxation ) . Both groups showed a reduction in blood-pressure ( from 168/100 to 141/84 mm . Hg in the treated group and from 169/101 to 160/96 mm Hg in the control group ) . The difference was highly significant . The control group was then trained in yoga relaxation , and their blood-pressure fell to that of the other group ( now used as controls ) BACKGROUND In chronic heart failure ( CHF ) , impaired pulmonary function can independently contribute to oxygen desaturation and reduced physical activity . We investigated the effect of breathing rate on oxygen saturation and other respiratory indices . METHODS Arterial oxygen saturation ( SaO2 ) and respiratory indices were recorded during spontaneous breathing ( baseline ) and during controlled breathing at 15 , six , and three breaths per min in 50 patients with CHF and in 11 healthy volunteers ( controls ) . 15 patients with CHF were r and omly allocated 1 month of respiratory training to decrease their respiratory rate to six breaths per min . Respiratory indices were recorded before training , at the end of training , and 1 month after training . FINDINGS During spontaneous breathing , mean SaO2 was lower in CHF patients than in controls ( 91 - 4 % [ SD 0.4 ] vs 95.4 % [ 0.2 ] , p<0.001 ) . Controlled breathing increased SaO2 at all breathing rates in patients with CHF . Compared with baseline , minute ventilation increased at 15 breaths per min ( + 45.9 % [ 9.8 ] , p<0.01 ) , did not change at six breaths per min , and decreased at three breaths per min ( -40.3 % [ 4.8 ] , p<0.001 ) . In the nine CHF patients who had 1 month of respiratory training , resting SaO2 increased from 92.5 % ( 0.3 ) at baseline to 93.2 % ( 0.4 ) ( p<0.05 ) , their breathing rate per min decreased from 13.4 ( 1.5 ) to 7.6 ( 1.9 ) ( p<0.001 ) , peak oxygen consumption increased from 1157 ( 83 ) to 1368 ( 110 ) L/min ( p<0.05 ) , exercise time increased from 583 ( 29 ) to 615 ( 23 ) min/s ( p<0.05 ) , and perception of dyspnoea reduced from a score of 19.0 ( 0.4 ) to 17.3 ( 0.9 ) on the Borg scale ( p<0.05 ) . There were no changes in the respiratory indices in the patients who did not have respiratory training . INTERPRETATION Slowing respiratory rate reduces dyspnoea and improves both resting pulmonary gas exchange and exercise performance in patients with CHF CONTEXT Weight loss , sodium reduction , increased physical activity , and limited alcohol intake are established recommendations that reduce blood pressure ( BP ) . The Dietary Approaches to Stop Hypertension ( DASH ) diet also lowers BP . To date , no trial has evaluated the effects of simultaneously implementing these lifestyle recommendations . OBJECTIVE To determine the effect on BP of 2 multicomponent , behavioral interventions . DESIGN , SETTING , AND PARTICIPANTS R and omized trial with enrollment at 4 clinical centers ( January 2000-June 2001 ) among 810 adults ( mean [ SD ] age , 50 [ 8.9 ] years ; 62 % women ; 34 % African American ) with above-optimal BP , including stage 1 hypertension ( 120 - 159 mm Hg systolic and 80 - 95 mm Hg diastolic ) , and who were not taking antihypertensive medications . INTERVENTION Participants were r and omized to one of 3 intervention groups : ( 1 ) \" established , \" a behavioral intervention that implemented established recommendations ( n = 268 ) ; ( 2 ) \" established plus DASH,\"which also implemented the DASH diet ( n = 269 ) ; and ( 3 ) an \" advice only \" comparison group ( n = 273 ) . MAIN OUTCOME MEASURES Blood pressure measurement and hypertension status at 6 months . RESULTS Both behavioral interventions significantly reduced weight , improved fitness , and lowered sodium intake . The established plus DASH intervention also increased fruit , vegetable , and dairy intake . Across the groups , gradients in BP and hypertensive status were evident . After subtracting change in advice only , the mean net reduction in systolic BP was 3.7 mm Hg ( P<.001 ) in the established group and 4.3 mm Hg ( P<.001 ) in the established plus DASH group ; the systolic BP difference between the established and established plus DASH groups was 0.6 mm Hg ( P = .43 ) . Compared with the baseline hypertension prevalence of 38 % , the prevalence at 6 months was 26 % in the advice only group , 17 % in the established group ( P = .01 compared with the advice only group ) , and 12 % in the established plus DASH group ( P<.001 compared with the advice only group ; P = .12 compared with the established group ) . The prevalence of optimal BP ( < 120 mm Hg systolic and < 80 mm Hg diastolic ) was 19 % in the advice only group , 30 % in the established group ( P = .005 compared with the advice only group ) , and 35 % in the established plus DASH group ( P<.001 compared with the advice only group ; P = .24 compared with the established group ) . CONCLUSION Individuals with above-optimal BP , including stage 1 hypertension , can make multiple lifestyle changes that lower BP and reduce their cardiovascular disease risk \n Output:\n " }, { "from": "agent", "value": "There is at present insufficient good- quality evidence to conclude whether or not TM has a cumulative positive effect on blood pressure" } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: Temporolimbic circuits play a crucial role in the regulation of human emotion . A highly sensitive single-shot multiecho functional magnetic resonance imaging ( fMRI ) technique with gradient compensation of local magnetic field inhomogeneities and real-time data analysis were used to measure increases in amygdala activation during single 60-s trials of self-induced sadness . Six healthy male and female subjects performed a vali date d mood induction paradigm with r and omized presentation of sad or neutral faces in 10 trials per scan . Subjects reported the intensity of experienced sadness after each trial . Immediate feedback of amygdala activation was given to the subjects during the ongoing scan to reinforce mood induction . Correspondence between increased intensity of predominantly left sided amygdala activation and self-rating of sadness was found in 78 % of 120 sad trials , in contrast to only 14 % of neutral trials . Amygdala activation was reproducible during repeated scanning sessions and displayed the strongest correlation with self-rating among all regions . These results suggest that amygdala activation may be closely associated with self-induced sadness . This novel real-time fMRI technology is applicable to a wide range of neuroscience studies , particularly those of the limbic system , and to neuropsychiatric conditions , such as depression , in which pathology of the amygdala has been implicated The impact of voxel geometry on the blood oxygenation level-dependent ( BOLD ) signal detectability in the presence of field inhomogeneity is assessed and a quantitative approach to selecting appropriate voxel geometry is developed in this report . Application of the developed technique to BOLD sensitivity improvement of the human amygdala is presented . Field inhomogeneity was measured experimentally at 1.5 T and 3 T and the dominant susceptibility field gradient in the human amygdala was observed approximately along the superior-inferior direction . Based on the field mapping studies , an optimal selection for the slice orientation would be an oblique pseudo-coronal plane with its frequency-encoding direction parallel to the field gradient measured from each subject . Experimentally this was confirmed by comparing the normalized st and ard deviation of time-series echo-planar imaging signals acquired with different slice orientations , in the absence of a functional stimulus . A further confirmation with a carefully design ed functional magnetic resonance imaging study is needed . Although the BOLD sensitivity may generally be improved by a voxel size commensurable with the activation volume , our quantitative analysis shows that the optimal voxel size also depends on the susceptibility field gradient and is usually smaller than the activation volume . The predicted phenomenon is confirmed with a hybrid simulation , in which the functional activation was mathematically added to the experimentally acquired rest-period echo-planar imaging data The amygdala is known to play an important role in conscious and unconscious processing of emotional and highly arousing stimuli . Neuroanatomical evidence suggests that the amygdala participates in the control of autonomic responses , such as skin conductance responses ( SCRs ) , elicited by emotionally salient stimuli , but little is known regarding its functional role in such control . We investigated this issue by showing emotional visual stimuli of varying arousal to patients with left ( n = 12 ) , right ( n = 8) , and bilateral ( n = 3 ) amygdala damage and compared their results with those from 38 normal controls . Stimuli were presented both subliminally ( using backward masking ) and supraliminally under lateralized presentation to one visual hemifield . We collected SCRs as a physiological index of emotional responses . Subjects subsequently rated each stimulus on valence and arousal under free viewing conditions . There were two key findings : ( 1 ) impaired overall SCR after right amygdala damage ; and ( 2 ) impaired correlation of SCR with the rated arousal of the stimuli after left amygdala damage . The second finding was strengthened further by finding a positive correlation between the evoked SCR magnitude and postsurgery amygdala volume , indicating impaired autonomic responses with larger tissue damage . Bilateral amygdala damage result ed in severe impairments on both of the above measures . Our results provide support for the hypothesis that the left and right amygdalae subserve different functions in emotion processing : the left may decode the arousal signaled by the specific stimulus , whereas the right may provide a global level of autonomic activation triggered automatically by any arousing stimulus We compared the sensitivity of st and ard single-shot 2D echo planar imaging ( EPI ) to three advanced EPI sequences , i.e. , 2D multi-echo EPI , 3D high resolution EPI and 3D dual-echo fast EPI in fixed effect and r and om effects group level fMRI analyses at 3 T. The study focused on how well the variance reduction in fixed effect analyses achieved by advanced EPI sequences translates into increased sensitivity in the r and om effects group level analysis . The sensitivity was estimated in a functional MRI experiment of an emotional learning and a reward based learning tasks in a group of 24 volunteers . Each experiment was acquired with the four different sequences . The task-related response amplitude , contrast level and respective t-value were proxies for the functional sensitivity across the brain . All three advanced EPI methods increased the sensitivity in the fixed effects analyses , but st and ard single-shot 2D EPI provided a comparable performance in r and om effects group analysis when whole brain coverage and moderate resolution are required . In this experiment inter-subject variability determined the sensitivity of the r and om effects analysis for most brain regions , making the impact of EPI pulse sequence improvements less relevant or even negligible for r and om effects analyses . An exception concerns the optimization of EPI reducing susceptibility-related signal loss that translates into an enhanced sensitivity e.g. in the orbitofrontal cortex for multi-echo EPI . Thus , future optimization strategies may best aim at reducing inter-subject variability for higher sensitivity in st and ard fMRI group studies at moderate spatial resolution OBJECTIVE Patients with depression show blunted amygdala hemodynamic activity to positive stimuli , including autobiographical memories . The authors examined the therapeutic efficacy of real-time functional MRI neurofeedback ( rtfMRI-nf ) training aim ed at increasing the amygdala 's hemodynamic response to positive memories in patients with depression . METHOD In a double-blind , placebo-controlled , r and omized clinical trial , unmedicated adults with depression ( N=36 ) were r and omly assigned to receive two sessions of rtfMRI-nf either from the amygdala ( N=19 ) or from a parietal control region not involved in emotional processing ( N=17 ) . Clinical scores and autobiographical memory performance were assessed at baseline and 1 week after the final rtfMRI-nf session . The primary outcome measure was change in score on the Montgomery-Åsberg Depression Rating Scale ( MADRS ) , and the main analytic approach consisted of a linear mixed-model analysis . RESULTS In participants in the experimental group , the hemodynamic response in the amygdala increased relative to their own baseline and to the control group . Twelve participants in the amygdala rtfMRI-nf group , compared with only two in the control group , had a > 50 % decrease in MADRS score . Six participants in the experimental group , compared with one in the control group , met conventional criteria for remission at study end , result ing in a number needed to treat of 4 . In participants receiving amygdala rtfMRI-nf , the percent of positive specific memories recalled increased relative to baseline and to the control group . CONCLUSIONS rtfMRI-nf training to increase the amygdala hemodynamic response to positive memories significantly decreased depressive symptoms and increased the percent of specific memories recalled on an autobiographical memory test . These data support a role of the amygdala in recovery from depression The optimum parameters for single-shot gradient-recalled ( GR ) EPI-based fMRI studies of the limbic region are systematic ally established at 3 T via their ability to mitigate intravoxel dephasing-measured via SNR and T2 * in the amygdalae- and their implication s for temporal resolution ( or brain coverage ) . Conventional imaging parameters ( 64 x 64 matrix size and 4 - 6 mm thick slices ) are confirmed to be inadequate for functional studies at 3 T. Measurements of main magnetic field variations across the amygdalae suggest that such variations are equal in the craniocaudal and anterior-posterior directions , and slightly lower in the mediolateral direction , with this and other considerations leading us to conclude an oblique axial orientation to be most suitable . In-plane resolution of approximately 1.7 mm was sufficient to recover signal in the area of the amygdalae . SNR was found to peak at a slice thickness of between 2.0 and 2.5 mm , dependent on the subject . T2 * time in the amygdalae was measured with a st and ard EPI protocol to be 22 + /- 3 ms . Using the optimized ( high resolution ) EPI protocol proposed here , the measured T2 * time increased to 48 + /- 2 ms ( compared with 43 + /- 3 ms for a reference FLASH scan ) , only slightly lower than the cortex ( 49 + /- 2 ms measured with optimized EPI and 52 + /- 2 ms with FLASH ) . The FLASH measurement of 43 ms is taken to be a suitable effective echo time ( TE(eff ) ) to achieve maximum BOLD sensitivity in the amygdalae . Time series data acquired with these parameters showed a 60 % increase in SNR in the amygdala over that obtained with a st and ard low-resolution protocol and suggest sufficient SNR and BOLD sensitivity to make functional studies feasible . Arteries , but no substantial draining veins , were found in high-resolution BOLD venograms of the region . Our results indicate that EPI protocol s need to be carefully optimized for structures of interest if reliable results from single subjects are to be established in this brain region Self-regulation of brain activity in humans based on real-time feedback of functional magnetic resonance imaging ( fMRI ) signal is emerging as a potentially powerful , new technique . Here , we assessed whether patients with Parkinson 's disease ( PD ) are able to alter local brain activity to improve motor function . Five patients learned to increase activity in the supplementary motor complex over two fMRI sessions using motor imagery . They attained as much activation in this target brain region as during a localizer procedure with overt movements . Concomitantly , they showed an improvement in motor speed ( finger tapping ) and clinical ratings of motor symptoms ( 37 % improvement of the motor scale of the Unified Parkinson 's Disease Rating Scale ) . Activation during neurofeedback was also observed in other cortical motor areas and the basal ganglia , including the subthalamic nucleus and globus pallidus , which are connected to the supplementary motor area ( SMA ) and crucial nodes in the pathophysiology of PD . A PD control group of five patients , matched for clinical severity and medication , underwent the same procedure but did not receive feedback about their SMA activity . This group attained no control of SMA activation and showed no motor improvement . These findings demonstrate that self-modulation of cortico-subcortical motor circuits can be achieved by PD patients through neurofeedback and may result in clinical benefits that are not attainable by motor imagery alone \n Output:\n " }, { "from": "agent", "value": "We identified critical features influencing inference on the quality of the intervention as : the inclusion of a Practice Run , a Transfer Run and a Control Group in the protocol , and to choose adequate Emotion Regulation strategies-in particular , the effective recall of autobiographic memories .\nSurprisingly , the Regulated vs. Control Condition was lacking in most of the studies , precluding valid inference of amygdala neuromodulation within Session .\nThe best controlled studies nevertheless showed positive effects .\nThe type of stimulus/interface did not seem critical for amygdala modulation .\nWe also identified potential effects of lateralization of amygdala responses following Up- or Down-Regulation , and the impact of fMRI parameters for data acquisition and analysis ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: A case-control study was conducted within Group Health Cooperative of Puget Sound to evaluate the relation between prior vasectomy and the risk of prostate cancer . Cases consisted of 175 men newly diagnosed with histologically confirmed prostate cancer during 1989 - 1991 . A total of 258 controls , matched to cases on birth year and membership status , were r and omly selected from the general membership of the plan . Information was collected from mailed question naires and medical records on medical history , including prior vasectomy , anthropometric measures , family history of prostate cancer , personal habits , and medical care utilization , and demographic factors . Conditional logistic regression analyses showed that the odds ratio for prostate cancer associated with vasectomy was 0.86 ( 95 % confidence interval 0.57 - 1.32 ) after adjustment for confounders . The odds ratio estimate did not differ substantially by age at vasectomy or time since vasectomy . However , the odds ratio estimate for prostate cancer associated with vasectomy tended to be increased among men who had a father or brother with prostate cancer . Nevertheless , the increased risk may be related to detection bias or differential participation rates due to both vasectomy status and a family history of prostate cancer . These results suggest no overall association between vasectomy and prostate cancer OBJECTIVES CP/CPPS is a commonly observed distress in male patients . Because of its little-known etiology , no effective therapy has been developed which has promising outcomes . Therefore , there is a need to develop a valid model which can mimic the etiology of CP/CPPS . MATERIAL S AND METHODS Fifty male C57BL/6 mice were r and omly and averagely divided into 5 groups of 10 mice each . The control group was injected with 0.9 % NaCl solution . Aluminum hydroxide and T2 groups were injected with aluminum hydroxide adjuvant and T2 peptide . T2 plus complete Freund adjuvant ( CFA ) with aluminum hydroxide group was injected with a mixture of T2 , CFA and aluminum hydroxide adjuvant . At the same time , CFA group was injected with complete Freund adjuvant . Hematoxylin-eosin stain and immunohistochemistry were used to investigate inflammatory lesion and expression of IL-β1 . Furthermore , TNF-α and CRP protein levels were evaluated by using commercially available ELISA kits . The ANOVA test was used to compare the statistical differences among groups . RESULTS Prostates from a mixture of T2 plus CFA with aluminum hydroxide immunized mice showed elevated lesions and high level of inflammatory cells infiltration compared to the other groups . In addition , the levels of TNF-α , IL-β1 , and CRP were also higher in the T2 plus CFA with aluminum hydroxide group as compared to the other groups . CONCLUSION Our results showed that T2 with CFA plus aluminum hydroxide adjuvant injection could successfully induce CP/CPPS in mice . This autoimmune novel model provides a useful , economic , safer , and easy tool for exploring the etiology and pathophysiology of CP/CPPS which will improve the therapeutic outcomes PURPOSE Black men are diagnosed with prostate cancer more often than white men , present with more advanced disease and have worse stage specific survival . Given the high risk of incidence and mortality in this population , determining potentially modifiable factors is important . Recent studies have suggested a link between chronic inflammation and development of prostate cancer . In concurrence , population based studies of white men have revealed an increased risk of prostate cancer with history of sexually transmitted diseases and prostatitis . MATERIAL S AND METHODS We explored the chronic inflammation hypothesis of prostate cancer development among black men by examining sexual activity , sexually transmitted diseases and prostatitis in a population based study of 129 patients and 703 controls 40 to 79 years old . RESULTS After adjusting for age , income , cigarette smoking , and history of digital rectal examination and prostate specific antigen tests in the last 5 years , we observed that a history of gonorrhea infection and prostatitis increased the odds of prostate cancer 1.78-fold ( 95 % CI 1.13 , 2.79 ) and 4.93-fold ( 95 % CI 2.79 , 8.74 ) , respectively . Men reporting 25 or more sexual partners were 2.80 ( 95 % CI 1.29 , 6.09 ) times more likely to be diagnosed with cancer compared to men with 5 or fewer partners . CONCLUSIONS Our findings support the significance of prior sexual practice s , exposure to sexually transmitted microbial agents and history of prostatic infection in the natural history of prostate cancer in black men . Additional prospect i ve research incorporating serological markers of infectious agents or predictive markers of chronic inflammation should serve to eluci date the possible causal pathway of recurring or persistent infection in the etiology of prostate cancer in black men Background Prostatitis and sexually transmitted diseases ( STDs ) have been positively associated with prostate cancer in previous case-control studies . However , results from recent prospect i ve studies have been inconclusive . Method ogy/Principal Findings We investigated the association between prostatitis , STDs , and prostate cancer among African American , Asian American , Latino , and White participants of the California Men 's Health Study . Our analysis included 68,675 men , who completed a detailed baseline question naire in 2002–2003 . We identified 1,658 incident prostate cancer cases during the follow-up period to June 30 , 2006 . Cox proportional hazards models were used to estimate relative risks and 95 % confidence intervals . Overall , men having a history of prostatitis had an increased risk of prostate cancer than men with no history ( RR = 1.30 ; 95 % CI : 1.10–1.54 ) . Longer duration of prostatitis symptoms was also associated with an increased risk of prostate cancer ( P trend = 0.003 ) . In addition , among men screened for prostate cancer ( 1 or 2 PSA tests ) , a non-significant positive association was observed between prostatitis and prostate cancer ( RR = 1.10 ; 95 % CI : 0.75–1.63 ) . STDs were not associated with overall prostate cancer risk . In racial/ethnic stratified analysis , Latinos reporting any STDs had an increased risk of disease than those with no STDs ( RR = 1.43 ; 95 % CI : 1.07–1.91 ) . Interestingly , foreign-born Latinos displayed a larger risk associated with STDs ( RR = 1.87 ; 95 % CI : 1.16–3.02 ) than U.S. born Latinos ( RR = 1.15 ; 95 % CI : 0.76–3.02 ) . Conclusion In summary , results from this prospect i ve study suggest that prostatitis and STDs may be involved in prostate cancer susceptibility . While we can not rule out the possible influence of incidental detection , future studies are warranted to further investigate the role of infectious agents related to prostatitis and STDs in prostate cancer development Background : The incidence of prostate cancer is much lower in Asian men than in Western men . This study investigated whether prostate cancer is associated with prostatitis , benign prostatic hyperplasia ( BPH ) , and other medical conditions in the low-incidence population . Methods : From the cl aims data obtained from the universal National Health Insurance of Taiwan , we identified 1184 patients with prostate cancer diagnosed from 1997 to 2008 . Controls comprised 4736 men r and omly selected from a cancer-free population . Both groups were 50 years of age or above . Medical histories between the two groups were compared . Results : Multivariate logistic regression analysis showed that prostatitis and BPH had stronger association with prostate cancer than the other medical conditions tested . Compared with men without prostatitis and BPH , a higher odds ratio ( OR ) for prostate cancer was associated with BPH ( 26.2 , 95 % confidence interval ( CI ) 20.8–33.0 ) than with prostatitis ( 10.5 , 95 % CI=3.36–32.7 ) . Men with both conditions had an OR of 49.2 ( 95 % CI=34.7–69.9 ) . Conclusion : Men with prostate cancer have strong association with prostatitis and /or BPH . Prostatitis interacts with BPH , result ing in higher estimated relative risk of prostate cancer in men suffering from both conditions AIMS Interstitial cystitis/bladder pain syndrome ( IC/BPS ) is a prevalent disorder that may contribute to bladder cancer ( BC ) . This cohort study set out to investigate the association between IC/BPS and BC by using a population -based data set . METHODS The data for this study were source d from the Taiwan National Health Insurance program . The case cohort comprised 7,562 patients with IC/BPS , and 22,686 r and omly selected subjects were used as a comparison cohort . A Cox proportional hazards regression model ( stratified by age group , geographic location , urbanization level , and the index year ) was constructed to estimate the risk of subsequent BC following a diagnosis of IC/BPS . We also ran the analysis utilizing an alternative comparison cohort composed of patients with urinary incontinence ( UI ) . RESULTS In the study sample of 30,248 patients , 96 patients ( 0.32 % ) received a diagnosis of BC during the 3-year follow-up period ; 48 ( 0.63 % of patients with IC/BPS ) were from the study cohort ; and 48 ( 0.21 % of patients without IC/BPS ) were from the comparison cohort . The incidence rate of BC was 2.12 ( 95 % CI : 1.58 - 2.78 ) per 1,000 person-years in patients with IC/BPS and 0.70 ( 95 % CI : 0.52 - 0.92 ) per 1,000 person-years in comparison patients . Cox proportional analysis revealed that the adjusted HR for BC during the 3-year follow-up period for patients with IC/BPS was 2.95 ( 95 % CI : 1.97 - 4.41 ) that of comparison subjects . When performing the analysis with the alternative UI comparison cohort , the adjusted HR for BC was 1.96 ( 95 % CI : 1.14 - 3.39 ) . CONCLUSIONS This investigation detected a novel association between BC and prior IC/BPS A population -based case-control study of prostate cancer was performed in King County , Washington , in White men and Black men aged 40 - 64 years , between 1993 and 1996 . Incident prostate cancer cases ( n = 753 ) were identified from the Seattle-Puget Sound Surveillance , Epidemiology , and End Results ( SEER ) cancer registry . Controls ( n = 703 ) were identified through r and om digit dialing and were frequency matched to cases on age . Sexual behavior , medical history , and other potential prostate cancer risk factors were ascertained through an in-person interview . There was no relation between sexual orientation and prostate cancer , although the number of men who had sex with men was small . Risk estimates increased directly with the lifetime number of female sexual partners ( trend p < 0.001 ) but not with male partners ( trend p = 0.62 ) . Risk also increased with decreasing age at first intercourse , but this effect disappeared after adjusting for the number of female partners . Prior infection with gonorrhea was positively associated with risk ( odds ratio = 1.50 ; 95 % confidence interval : 1.0 , 2.2 ) , but no effect was seen among men with other sexually transmitted diseases . No relation between lifetime frequency of sexual intercourse and risk of prostate cancer was apparent . These findings are consistent with previous studies that support an infectious etiology for prostate cancer OBJECTIVES To determine the risk factors for the self-reported history of prostatitis and to determine whether a self-reported history of prostatitis is related to the diagnosis of prostate cancer . METHODS R and om digit dialing was used to select a group of controls aged 40 to 64 years without prostate cancer matched by age with a group of patients with prostate cancer in a study on the epidemiology of prostate cancer . Controls were divided into those who reported a diagnosis of prostatitis ( cases ) and those who denied ever having had prostatitis ( controls ) . We adjusted for the time from a prostatitis diagnosis to the in-person interview . We also compared the number of men with a prostatitis diagnosis to the number of men diagnosed and not diagnosed with prostate cancer . RESULTS Of the 645 control men without a history of prostate cancer , 58 ( 9.0 % ) reported a diagnosis of prostatitis . The men with prostatitis had a mean age of 39.5 years at diagnosis . The urinary symptoms among prostatitis cases and controls was similar . Prostatitis cases more frequently reported urinary ( P < or = 0.05 ) or urethral infections ( P < or = 0.01 ) before diagnosis . Men with prostatitis were more likely to have procedures aim ed at diagnosing both prostatic and other diseases . Men with prostate cancer reported a diagnosis of prostatitis more often than the noncancer controls ( 13.6 % versus 9.0 % ) . After controlling for the number of prostate-specific antigen tests this difference disappeared . CONCLUSIONS Nine percent of a r and omly selected group of middle-aged men reported they had been diagnosed with prostatitis . The prevalence of a prostatitis diagnosis is similar in men with and without prostate cancer Background : Sexually transmissible infections ( STI ) have been variably associated with increased risks of prostate cancer , largely in case-control studies . Methods : In the Prostate , Lung , Colorectal , and Ovarian Cancer Screening Trial , \n Output:\n " }, { "from": "agent", "value": "Conclusions : Significant correlations were revealed among prostatitis , BPH and PCa .\nProstatitis or BPH could lead to escalating risks of PCa .\nMeanwhile , people with a history of prostatitis might be more vulnerable to BPH" } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: OBJECTIVE : This study aim ed to assess the associations between parity , mode of delivery , and pelvic floor disorders . METHODS : The prevalence of pelvic organ prolapse , stress urinary incontinence , overactive bladder , and anal incontinence was assessed in a r and om sample of women aged 25–84 years by using the vali date d Epidemiology of Prolapse and Incontinence Question naire . Women were categorized as nulliparous , vaginally parous , or only delivered by cesarean . Adjusted odds ratios and 95 % confidence intervals ( CIs ) for each disorder were calculated with logistic regression , controlling for age , body mass index , and parity . RESULTS : In the 4,458 respondents the prevalence of each disorder was as follows : 7 % prolapse , 15 % stress urinary incontinence , 13 % overactive bladder , 25 % anal incontinence , and 37 % for any one or more pelvic floor disorders . There were no significant differences in the prevalence of disorders between the cesarean delivery and nulliparous groups . The adjusted odds of each disorder increased with vaginal parity compared with cesarean delivery : prolapse = 1.82 ( 95 % CI 1.04–3.19 ) , stress urinary incontinence = 1.81 ( 95 % CI 1.25–2.61 ) , overactive bladder = 1.53 ( 95 % CI 1.02–2.29 ) , anal incontinence = 1.72 ( 95 % CI 1.27–2.35 ) , and any one or more pelvic floor disorders = 1.85 ( 95 % CI 1.42–2.41 ) . Number-needed-to-treat analysis revealed that 7 women would have to deliver only by cesarean delivery to prevent one woman from having a pelvic floor disorder . CONCLUSION : The risk of pelvic floor disorders is independently associated with vaginal delivery but not with parity alone . Cesarean delivery has a protective effect , similar to nulliparity , on the development of pelvic floor disorders when compared with vaginal delivery . LEVEL OF EVIDENCE : OBJECTIVES : To investigate whether postpartum fecal incontinence is less common in women who had a cesarean delivery and more common in women who had an operative vaginal birth compared with women who had a spontaneous vaginal birth for their first newborn , and whether postpartum fecal incontinence is more common in women who report intimate-partner violence . METHODS : This was a multicenter , prospect i ve , nulliparous pregnancy cohort ( n=1,507 ) using st and ardized measures to assess frequency and severity of fecal incontinence in pregnancy and at 3 , 6 , 9 , and 12 months postpartum . RESULTS : Approximately 17 % reported fecal incontinence at some point in the first 12 months postpartum , with 12.8 % reporting fecal incontinence beyond the first 3 months postpartum . Fecal incontinence at 4 to12 months postpartum was significantly more common among women who had experienced emotional violence , physical violence , or both in the first 12 months postpartum ( 18.8 % compared with 11.5 % , adjusted odds ratio [ OR ] 1.62 , 95 % confidence interval [ CI ] 1.05–2.50 ) . Compared with spontaneous vaginal birth , cesarean delivery ( 13.1 % compared with 11.3 % , adjusted OR 0.99 , 95 % CI 0.65–1.53 ) , and operative vaginal birth ( 15.0 % compared with 11.3 % , adjusted OR 1.33 , 95 % CI 0.86–2.07 ) did not significantly alter the likelihood of fecal incontinence beyond the first 3 months postpartum . CONCLUSION : Underst and ing causal pathways for postpartum fecal incontinence requires attention to the interplay of pregnancy and birth events and upstream factors such as intimate-partner violence . This has implication s for how clinicians present evidence and discuss risks associated with vaginal birth and cesarean delivery . In this nulliparous cohort , method of birth was not a major determinant of fecal incontinence status beyond 3 months postpartum . LEVEL OF EVIDENCE : Background This study was carried out to identify risk factors associated with urinary incontinence in women three months after giving birth . Methods Urinary incontinence before and during pregnancy was assessed at study enrolment early in the third trimester . Incontinence was re-assessed three months postpartum . Logistic regression analysis was used to assess the role of maternal and obstetric factors in causing postpartum urinary incontinence . This prospect i ve cohort study in 949 pregnant women in Quebec , Canada was nested within a r and omised controlled trial of prenatal perineal massage . Results Postpartum urinary incontinence was increased with prepregnancy incontinence ( adjusted odds ratio [ adj0R ] 6.44 , 95 % CI 4.15 , 9.98 ) , incontinence beginning during pregnancy ( adjOR 1.93 , 95 % CI 1.32 , 2.83 ) , and higher prepregnancy body mass index ( adjOR 1.07/unit of BMI , 95 % CI 1.03,1.11 ) . Caesarean section was highly protective ( adjOR 0.27 , 95 % CI 0.14 , 0.50 ) . While there was a trend towards increasing incontinence with forceps delivery ( adjOR 1.73 , 95 % CI 0.96 , 3.13 ) this was not statistically significant . The weight of the baby , episiotomy , the length of the second stage of labour , and epidural analgesia were not predictive of urinary incontinence . Nor was prenatal perineal massage , the r and omised controlled trial intervention . When the analysis was limited to women having their first vaginal birth , the same risk factors were important , with similar adjusted odds ratios . Conclusions Urinary incontinence during pregnancy is extremely common , affecting over half of pregnant women . Urinary incontinence beginning during pregnancy roughly doubles the likelihood of urinary incontinence at 3 months postpartum , regardless whether delivery is vaginal or by Caesarean section STUDY OBJECTIVE : To investigate the prevalence and lifetime risk factors for urinary incontinence in middle aged women . DESIGN : Nationally representative birth cohort study with prospect i ve data on childhood enuresis , measured adult height and weight , childbearing histories and measures of socioeconomic status up date d at regular contacts , and measures of menopausal status , symptomatology and health care in midlife . SETTING : Engl and , Scotl and and Wales . PARTICIPANTS : General population sample of 1333 women aged 48 years . MAIN RESULTS : Fifty per cent reported symptoms of stress incontinence and 22 % reported symptoms of urge incontinence in the previous year . Eight per cent had severe symptoms . Women who at age 6 years had wet in the day or several nights a week were more likely to suffer severe incontinence and report urge symptoms but occasional bedwetting was not associated with an increased risk in adult life . Those who were older at the birth of their children and who had vaginal deliveries had an excess risk of stress symptoms . Heavier adult body weight was also a risk factor for these symptoms and for severe incontinence . Postmenopausal women were less likely to report stress symptoms . These risk factors remained significant after taking account of the increased reporting of incontinence among women with high levels of general symptomatology and general practitioner visits , and of stress symptoms among better educated women . CONCLUSIONS : Urinary incontinence is a common problem among middle aged women . This is the first prospect i ve study of a general population sample to support the postulated link between childhood enuresis and adult incontinence . Child-bearing has long term adverse effects , particularly for older mothers . Overweight is a common risk factor The purpose of this study was to evaluate pelvic organ support during pregnancy and following delivery . This was a prospect i ve observational study . Pelvic organ prolapse quantification ( POPQ ) examinations were performed during each trimester of pregnancy and in the postpartum . Statistical comparisons of POPQ stage and of the nine measurements comprising the POPQ between the different time intervals were made using Wilcoxon ’s signed rank and the paired t-test . Comparison of POPQ stage by mode of delivery was made using Fisher ’s exact test . One hundred thirty-five nulliparous women underwent 281 pelvic organ support evaluations . During both the third trimester and postpartum , POPQ stage was significantly higher compared to the first trimester ( p<0.001 ) . In the postpartum , POPQ stage was significantly higher in women delivered vaginally compared to women delivered by cesarean ( p=0.02 ) . In nulliparous pregnant women , POPQ stage appears to increase during pregnancy and does not change significantly following delivery . In the postpartum , POPQ stage may be higher in women delivered vaginally compared to women delivered by cesarean OBJECTIVE This study was undertaken to compare maternal outcomes at 2 years postpartum after planned cesarean section and planned vaginal birth for the singleton fetus in breech presentation at term . STUDY DESIGN In selected centers in the Term Breech Trial , mothers completed a structured question naire at 2 or more years postpartum to determine their health in the previous 3 to 6 months . RESULTS A total of 917 of 1159 ( 79.1 % ) mothers from 85 centers completed a follow-up question naire at 2 years postpartum . There were no differences between groups in breast feeding , relationship with child or partner , pain , subsequent pregnancy , incontinence , depression , urinary , menstrual or sexual problems , fatigue , or distressing memories of the birth experience . Planned cesarean section was associated with a higher risk of constipation ( P = .02 ) . CONCLUSION Maternal outcomes at 2 years postpartum are similar after planned cesarean section and planned vaginal birth for the singleton breech fetus at term OBJECTIVE The purpose of this study was to determine the relative effects of pregnancy and mode of delivery on the prevalence of urinary and fecal incontinence . STUDY DESIGN This was a prospect i ve , observational multicenter study of women presenting to 6 gynecology clinics . Demographic data collected included : height , weight , gravidity , parity , and number of vaginal deliveries . Patients were diagnosed with incontinence by question naire . St and ard univariate logistic regression analyses ' were performed to determine the contribution of pregnancy , mode of delivery , and BMI on the prevalence of urinary and fecal incontinence . RESULTS One thous and and four women were enrolled over an 18-month period . Two hundred and thirty-seven and 128 subjects had urinary and fecal incontinence , respectively . Odds ratio ( 95 % CI ) calculated for the prevalence of urinary incontinence by pregnancy and mode of delivery were : any term pregnancy vs no term pregnancy was 2.46 ( 1.53 - 3.95 ) , any term pregnancy but no vaginal deliveries ( cesarean section only ) vs no term pregnancy was 1.95 ( 0.99 - 3.80 ) , any term pregnancy and at least 1 vaginal delivery vs no term pregnancy was 2.53 ( 1.57 - 4.07 ) , and any term pregnancy but no vaginal delivery ( cesarean section only ) vs any term pregnancy , and at least 1 vaginal delivery was 1.30 ( 0.77 - 3.95 ) . Odds ratio ( 95 % CI ) calculated for the prevalence of fecal incontinence by pregnancy and mode of delivery were : any term pregnancy vs no term pregnancy was 2.26 ( 1.22 - 4.19 ) , any term pregnancy but no vaginal deliveries ( cesarean section only ) vs no term pregnancy was 1.13 ( 0.43 - 2.96 ) , any term pregnancy and at least 1 vaginal delivery vs no term pregnancy was 2.41 ( 1.30 - 4.49 ) , and any term pregnancy but no vaginal deliveries ( cesarean section only ) vs any term pregnancy , and at least 1 vaginal delivery was 2.15 ( 0.97 - 4.77 ) . BMI and age did not impact these results . CONCLUSION Pregnancy increases the risk of urinary and fecal incontinence . Cesarean section does not decrease the risk of urinary or fecal incontinence compared to pregnancy with a vaginal delivery Objective To evaluate the long term effect of a postpartum pelvic floor muscle training course in prevention and treatment of urinary incontinence We compared the prevalence and risk of lower urinary tract symptoms in healthy primiparous women in relation to vaginal birth or elective cesarean section 9 months after delivery . We performed a prospect i ve controlled cohort study including 220 women delivered by elective cesarean section and 215 by vaginal birth . All subjects received an identical question naire on lower urinary tract symptoms in late pregnancy , at 3 and 9 months postpartum . Two hundred twenty subjects underwent elective cesarean section , and 215 subjects underwent vag \n Output:\n " }, { "from": "agent", "value": "RESULTS Compared to vaginal delivery , caesarean section appears to protect against urinary incontinence , but the effect decreases after patients reach their fifties .\nThe risk of pelvic organ prolapse increases ( dose-response effect ) with the number of vaginal deliveries compared to caesarean sections .\nThere are few reliable studies on the association between mode of delivery and anal incontinence , but meta-analyses may indicate that caesarean section does not offer protection after the postpartum period .\nWomen with previous anal sphincter rupture during vaginal delivery are a sub-group with an elevated risk of anal incontinence .\nThe degree of severity of pelvic floor dysfunction is frequently unreported in the literature .\nINTERPRETATION The prevalence of urinary incontinence and pelvic organ prolapse is lower in women who have only delivered by caesarean section than in those who have delivered vaginally .\nFor urinary incontinence this difference appears to level out with increasing age .\nThere is no basis for identifying sub-groups with a high risk of pelvic floor injury , with the exception of women who have previously had an anal sphincter rupture .\nCaesarean section will have a limited primary preventive effect on pelvic floor dysfunction at a population level" } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: A 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 ) BACKGROUND There is general support for general practitioners ( GPs ) using patient-centred styles . However , there is limited British evidence of beneficial outcomes for patients from such styles . AIM To explore whether , for patients presenting for new episodes of care , the GP 's consulting style , specifically the patient-centredness of the consultation , is related to five generic outcomes . METHOD General practitioners in South Wales were recruited , and one surgery consulting session was audiotape recorded for each participating clinician . Question naires were given to consenting patients before their consultations , immediately afterwards , and , by post , at two weeks to measure the following outcomes : doctor-patient agreement ( on the nature of the problem and management ) , patient satisfaction , resolution of symptoms , resolution of concerns , and functional health status . From the patients consulting for a new episode of care and completing all three question naires , one patient was selected at r and om for each GP and the audiotape of their consultation rated for patient-centredness . Statistical analysis employed correlation coefficients and t-tests , followed by multiple regression and logistic regression to control for potential confounders . RESULTS In total , 143 patients consulting 143 GPs were studied . The patient-centred score was positively and statistically significantly associated with patient satisfaction ( Pearson correlation = 0.28 ; P = 0.002 ) . No other associations were found with the other outcomes measured . CONCLUSION The study presents evidence that patient-centred styles of consulting produce benefits in terms of increased patient satisfaction for patients consulting for new episodes of care in Britain BACKGROUND No study has yet assessed the impact of physicians ' skills acquisition after a communication skills training programme on the evolution of patients ' anxiety following a medical consultation . This study aim ed to compare the impact , on patients ' anxiety , of a basic communication skills training programme ( BT ) and the same programme consoli date d by consolidation workshops ( CW ) , and to investigate physicians ' communication variables associated with patients ' anxiety . PATIENTS AND METHODS Physicians , after attending the BT , were r and omly assigned to CW or to a waiting list . The control group was not a non-intervention group . Consultations with a cancer patient were recorded . Patients ' anxiety was assessed with the State Trait Anxiety Inventory before and after a consultation . Communication skills were analysed according to the Cancer Research Campaign Workshop Evaluation Manual . RESULTS No statistically significant change over time and between groups was observed . Mixed-effects modelling showed that a decrease in patients ' anxiety was linked with screening questions ( P = 0.045 ) , physicians ' satisfaction about support given ( P = 0.004 ) and with patients ' distress ( P < 0.001 ) . An increase in anxiety was linked with breaking bad news ( P = 0.050 ) and with supportive skills ( P = 0.013 ) . No impact of the training programme was observed . CONCLUSIONS This study shows the influence of some communication skills on the evolution of patients ' anxiety . Physicians should be aware of these influences From previous studies there is a lot of evidence that in primary care setting s , many patients tend to express their mental problems in terms of physical symptoms . Therefore , the general practitioner ( GP ) needs to recognize mental problems at an early stage . Early recognition allows for adequate treatment that might speed up recovery . The present article reports on a study exploring the GP 's ability to recognize mental illness , the communication style that is supposed to support this ability , the subsequent treatment of mental problems , and the patient 's recovery . Two data bases were used . First , an observation study , involving 351 videotaped consultations held by 15 GPs , yielded information on communication style and recognition abilities . Patients in this study were selected r and omly . The second data base obtained treatment data and measures of patient recovery from a 1-year follow-up study dealing with the treatment and course of mental illness . Patients in this study were selected because their GPs considered their problems \" mainly psychosocial by nature \" . Half of them were categorized within psychological and social diagnostic categories of the International Classification for Primary Care ( ICPC ) , the other half were categorized within physical disease categories , with an assessment by the GP that the complaints were mainly psychosocial . Results showed no significant relationships between the recognition of mental illness and nine communication features supposed to induce these abilities . There was a tendency however , for a positive association between recommended communicative behaviour of the GP and his or her tendency to give frequently psychosocial evaluations of the patient 's complaints . Also , there was a negative tendency between this recommended behaviour and the degree of agreement between the GP 's evaluation and the score on a psychiatric screening question naire . This agreement is called \" accuracy \" . Frequent psychosocial evaluations were related to exploring behaviour and mental health referral in case of psychosocial complaints . Further , relationships between the GPs ' recognition ability and various measures of patients ' recovery did not prove univocal . Both positive , negative and absent relationships were found OBJECTIVE Patients ' affect and expectancies can set off placebo effects and thus impact patients ' health . We assessed the relative effects of physicians ' affect-oriented communication style and raising expectations on patients ' affective state and outcome expectancies . METHOD Thirty healthy women presented severe menstrual pain in a scripted consultation with a general practitioner ( GP ) . In a 2x2 r and omized controlled trial , the GP communicated in a warm , empathic or cold , formal way and raised positive or uncertain expectations . Effects on subjects ' state anxiety , affective state and outcome expectancies were assessed . RESULTS Only warm , empathic communication combined with positive expectations led to a significant and relevant decrease in state anxiety . Subjects ' positive and negative affects were influenced by GPs affect-oriented communication style . Negative affect and outcome expectancies are influenced by GP suggestions about outcomes . CONCLUSION Manipulations in physicians ' affect-oriented and expectancy-related communication can have a large impact on patients ' affective state and outcome expectations . A combination of a warm , empathic communication style and raising positive expectations result ed in optimal subject outcomes . PRACTICE IMPLICATION S Physicians should take into account that communicating in warm , empathic way combined with raising positive expectations seems to lead to the most favorable effects on patients ' state anxiety and outcome expectancies This study extends the literature on personality and job performance through the use of r and om coefficient modeling to test the validity of the Big Five personality traits in predicting overall sales performance and sales performance trajectories -- or systematic patterns of performance growth -- in 2 sample s of pharmaceutical sales representatives at maintenance and transitional job stages ( K. R. Murphy , 1989 ) . In the maintenance sample , conscientiousness and extraversion were positively associated with between-person differences in total sales , whereas only conscientiousness predicted performance growth . In the transitional sample , agreeableness and openness to experience predicted overall performance differences and performance trends . All effects remained significant with job tenure statistically controlled . Possible explanations for these findings are offered , and theoretical and practical implication s of findings are discussed OBJECTIVE To ascertain whether the quality of physician-patient communication makes a significant difference to patient health outcomes . DATA SOURCES The MEDLINE data base was search ed for articles published from 1983 to 1993 using \" physician-patient relations \" as the primary medical subject heading . Several bibliographies and conference proceedings were also review ed . STUDY SELECTION R and omized controlled trials ( RCTs ) and analytic studies of physician-patient communication in which patient health was an outcome variable . DATA EXTRACTION The following information was recorded about each study : sample size , patient characteristics , clinical setting , elements of communication assessed , patient outcomes measured , and direction and significance of any association found between aspects of communication and patient outcomes . DATA SYNTHESIS Of the 21 studies that met the final criteria for review , 16 reported positive results , 4 reported negative ( i.e. , nonsignificant ) results , and 1 was inconclusive . The quality of communication both in the history-taking segment of the visit and during discussion of the management plan was found to influence patient health outcomes . The outcomes affected were , in descending order of frequency , emotional health , symptom resolution , function , physiologic measures ( i.e. , blood pressure and blood sugar level ) and pain control . CONCLUSIONS Most of the studies review ed demonstrated a correlation between effective physician-patient communication and improved patient health outcomes . The components of effective communication identified by these studies can be used as the basis both for curriculum development in medical education and for patient education programs . Future research should focus on evaluating such educational programs BACKGROUND No study has yet assessed the impact of physicians ' skills acquisition after a communication skills training program on changes in patients ' and relatives ' anxiety following a three-person medical consultation . This study aim ed at comparing , in a r and omized study , the impact , on patients ' and relatives ' anxiety , of a basic communication skills training program and the same program consoli date d by consolidation workshops and at investigating physicians ' communication variables associated with patients ' and relatives ' anxiety . METHODS Consultations with a cancer patient and a relative were recorded and analyzed by the Cancer Research Campaign Workshop Evaluation Manual . Patients ' and relatives ' anxiety were assessed with the State-Trait Anxiety Inventory-State . RESULTS No statistically significant change over time and between groups was observed . Mixed-effects modeling of changes in patients ' and relatives ' anxiety showed that decreases in both patients ' and relatives ' anxiety were linked with patients ' and relatives ' self-reported distress ( p = 0.031 and 0.005 ) , and that increases in both patients ' and relatives ' anxiety were linked with physicians ' breaking bad news ( p = 0.028 and 0.005 ) . CONCLUSION No impact of the training program was observed . Results indicate the need to further study communication skills which may help reduce patients ' and relatives ' anxiety especially when breaking bad news OBJECTIVE Effective doctor-patient communication , including a shared underst and ing , is associated with treatment adherence across medicine . However , communication is affected by a diagnosis of schizophrenia and reaching a shared underst and ing can be challenging . During conversation , people detect and deal with possible misunderst and ing using a conversational process called repair . This study tested the hypothesis that more frequent repair in psychiatrist-patient communication is associated with better treatment adherence in schizophrenia . METHODS Routine psychiatric consultations involving patients with ( DSM-IV ) schizophrenia or schizoaffective disorder were audio-visually recorded . Consultations were coded for repair and patients ' symptoms and insight assessed . Adherence was assessed six months later . A principal components analysis reduced the repair data for further analysis . R and om effects models examined the association between repair and adherence , adjusting for symptoms , consultation length and the amount patients spoke . RESULTS 138 consultations were recorded , 118 were followed up . Patients requesting clarification of the psychiatrist 's talk and the clarification provided by the psychiatrist was associated with adherence six months later ( OR 5.82 , 95 % CI 1.31 - 25.82 , p=0.02 ) . CONCLUSION The quality of doctor-patient communication also appears to influence adherence in schizophrenia . PRACTICE IMPLICATION S Future research should investigate how patient clarification can be encouraged among patients and facilitated by psychiatrists ' communication Context In primary , acute-care visits , patients frequently present with more than 1 concern . Various visit factors prevent additional concerns from being articulated and addressed . Objective To test an intervention to reduce patients ’ unmet concerns . Design Cross-sectional comparison of 2 experimental questions , with videotaping of office visits and pre and postvisit surveys . Setting Twenty outpatient offices of community-based physicians equally divided between Los Angeles County and a midsized town in Pennsylvania . Participants A volunteer sample of 20 family physicians ( participation rate = 80 % ) and 224 patients approached consecutively within physicians ( participation rate = 73 % ; approximately 11 participating for each enrolled physician ) seeking care for an acute condition . InterventionAfter seeing 4 nonintervention patients , physicians were r and omly assigned to solicit additional concerns by asking 1 of the following 2 questions after patients presented their chief concern : “ Is there anything else you want to address in the visit today ? ” ( ANY condition ) and “ Is there something else you want to address in the visit today ? ” ( SOME condition).Main Outcome Measures Patients ’ unmet concerns : concerns listed on previsit surveys but not addressed during visits , visit time , unanticipated concerns : concerns that were addressed during the visit but not listed on previsit surveys . Results Relative to nonintervention cases , the implemented SOME intervention eliminated 78 % of unmet concerns ( odds ratio ( OR ) = .154 , p = .001 ) . The ANY intervention could not be significantly distinguished from the control condition ( p = .122 ) . Neither intervention affected visit length , or patients ’ ; expression of unanticipated concerns not listed in previsit surveys . Conclusions Patients ’ unmet concerns can be dramatically reduced by a simple inquiry framed in the SOME form . Both the learning and implementation of the intervention require very little time PURPOSE This study explores how weight-related topics are discussed between physicians and their overweight and obese female patients . METHODS We surveyed and audio-recorded preventive health and chronic care visits with 25 overweight and obese female patients . We coded both for quantity ( content and time ) of weight-related discussion s and quality ( adherence to Motivational Interviewing [ MI ] techniques ) . We then tested correlations of these measures with \n Output:\n " }, { "from": "agent", "value": "Results The findings showed that physician work engagement was associated with fewer reported medical errors and that job satisfaction was associated with better communication and patient satisfaction .\nAutonomy and learning opportunities were positively associated with physician work engagement .\nWork engagement was positively associated with teaching performance .\nIn addition , physician work engagement was most likely supported by personality trait conscientiousness ( e. g. responsibility ) .\nConclusion Given the reported associations of physician work engagement with aspects of their professional performance , hospitals could support physician work engagement in service of optimal performance in residency training and patient care ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: Background There are conflicting reports of antiretroviral therapy ( ART ) effectiveness comparisons between primary healthcare ( PHC ) facilities and hospitals in low-income setting s. This comparison has not been evaluated on a broad scale in South Africa . Methodology /Principal Findings A retrospective cohort study was conducted including ART-naïve adults from 59 facilities in four provinces in South Africa , enrolled between 2004 and 2007 . Kaplan-Meier estimates , competing-risks Cox regression , generalised estimating equation population -averaged models and logistic regression were used to compare death , loss to follow-up ( LTFU ) and virological suppression ( VS ) between PHC , district and regional hospitals . 29 203 adults from 47 PHC facilities , nine district hospitals and three regional hospitals were included . Patients at PHC facilities had more advanced WHO stage disease when starting ART . Retention in care was 80.1 % ( 95 % CI : 79.3%–80.8 % ) , 71.5 % ( 95 % CI : 69.1%–73.8 % ) and 68.7 % ( 95 % CI : 67.0%–69.7 % ) at PHC , district and regional hospitals respectively , after 24 months of treatment ( P<0.0001 ) . In adjusted regression analyses , LTFU was independently increased at regional hospitals ( aHR 2.19 ; 95 % CI : 1.94−2.47 ) and mortality was independently elevated at district hospitals ( aHR 1.60 ; 95 % CI : 1.30−1.99 ) compared to PHC facilities after 12 months of ART . District and regional hospital patients had independently reduced probabilities of VS , aOR 0.76 ( 95 % CI : 0.59−0.97 ) and 0.64 ( 95 % CI : 0.56−0.75 ) respectively compared to PHC facilities over 24 months of treatment . Conclusions / Significance ART outcomes were superior at PHC facilities , despite PHC patients having more advanced clinical stage disease when starting ART , suggesting that ART can be adequately provided at this level and supporting the South African government 's call for rapid up-scaling of ART at the primary level of care . Further prospect i ve research is required to determine the degree to which outcome differences are attributable to either facility level characteristics or patient co-morbidity at hospital level BACKGROUND We investigated virological response and the emergence of resistance in the Nevirapine or Abacavir ( NORA ) sub study of the Development of Antiretroviral Treatment in Africa ( DART ) trial . METHODS Six hundred symptomatic antiretroviral-naive human immunodeficiency virus (HIV)-infected adults ( CD4 cell count , < 200 cells/mm(3 ) ) from 2 Ug and an centers were r and omized to receive zidovudine-lamivudine plus abacavir or nevirapine . Virology was performed retrospectively on stored plasma sample s at selected time points . In patients with HIV RNA levels > 1000 copies/mL , the residual activity of therapy was calculated as the reduction in HIV RNA level , compared with baseline . RESULTS Overall , HIV RNA levels were lower in the nevirapine group than in the abacavir group at 24 and 48 weeks ( P < .001 ) , although no differences were observed at weeks 4 and 12 . Virological responses were similar in the 2 treatment groups for baseline HIV RNA level < 100,000 copies/mL. The mean residual activity at week 48 was higher for abacavir in the presence of the typically observed resistance pattern of thymidine analogue mutations ( TAMs ) and M184V ( 1.47 log(10 ) copies/mL ) than for nevirapine with M184V and nonnucleoside reverse-transcriptase inhibitor mutations , whether accompanied by TAMs ( 0.96 log(10 ) copies/mL ) or not ( 1.18 log(10 ) copies/mL ) . CONCLUSIONS There was more extensive genotypic resistance in both treatment groups than is generally seen in re source -rich setting s. However , significant residual activity was observed among patients with virological failure , particularly those receiving zidovudine-lamivudine plus abacavir OBJECTIVE To assess the effectiveness of generic anti-retroviral drugs in terms of survival and virological and immunological responses , as well as their tolerability and the emergence of viral resistance . METHODS A total of 109 HIV-1-infected patients were enrolled in a prospect i ve cohort study in Yaoundé , Cameroon . Available generic drugs were a fixed-dose combination ( FDC ) of zidovudine ( ZDV ) and lamivudine ( 3TC ) , an FDC of 3TC , stavudine ( d4 T ) and nevirapine ( NVP ) , and individual formulations of ZDV , 3TC and NVP . RESULTS At baseline , the median CD4 cell count was 150/mm3 [ interquartile range ( IQR ) 61 - 223 ] and median viral load was 5.4 log10 copies/ml ( IQR 4.8 - 5.6 ) ; 78 % of patients received ZDV/3TC/NVP and 22 % received 3TC/d4T/NVP . Median follow-up was 16 months ( IQR 11 - 23 ) . The survival probability was high ( 0.92 at 12 months ) ; plasma viral load declined by a median of 3.3 log10 copies/ml and 86.9 % of the intention-to-treat population had viral load < 400 copies/ml at 12 months ; CD4 count had increased by a median of 106 cells/mm3 at 12 months ; drug resistance rarely emerged ( incidence rate 3.2 per 100 person-years ) ; and the treatments were reasonably well-tolerated ( incidence rate of severe adverse effects 7.8 per 100 person-years ) . CONCLUSION Together with previous pharmacological and clinical studies , this prospect i ve study suggests that these generic antiretroviral drugs can be used in developing countries Background : Numerous national antiretroviral ( ARV ) treatment initiatives offering protease inhibitor-sparing combination antiretroviral therapy ( cART ) have recently commenced in southern Africa , the first of which began in Botswana in January 2002 . Evaluation of the efficacy and tolerability of various protease inhibitor-sparing cART regimens requires intensive study in the region , as does investigation of the development of drug resistance and the optimal means of sustaining adherence . The “ Tshepo ” Study is the first large-scale , r and omized , clinical trial that addresses these important issues among HIV-1 subtype C-infected ARV treatment-naive adults in southern Africa . Methods : The Tshepo Study is a completed , open-labeled , r and omized study that enrolled 650 ARV-naive adults between December 2002 and 2004 . The study is a 3 × 2 × 2 factorial design comparing the efficacy and tolerability among factors : ( 1 ) 3 combinations of nucleoside reverse transcriptase inhibitors ( NRTIs ) : zidovudine ( ZDV ) + lamivudine ( 3TC ) , ZDV + didanosine ( ddI ) , and stavudine ( d4 T ) + 3TC ; ( 2 ) 2 different nonnucleoside reverse transcriptase inhibitors ( NNRTIs ) : nevirapine and efavirenz ; and ( 3 ) 2 different adherence strategies : the current national “ st and ard of care ” versus an “ intensified adherence strategy ” incorporating a “ community-based directly observed therapy . ” Study patients were stratified into 2 balanced CD4 + T-cell count groups : less than 201 versus 201 - 350 cells per cubic millimeter with viral load greater than 55,000 copies per milliliter . Following Data Safety Monitoring Board recommendations in April 2006 , ZDV/ddI-containing arms were discontinued due to inferiority in primary end point , namely , virologic failure with resistance . We report both overall data and pooled data from patients receiving ZDV/ddI- versus ZDV/3TC- and d4T/3TC-containing cART through April 1 , 2006 . Results : Four hundred fifty-one females ( 69.4 % ) and 199 males with a median age of 33.3 years were enrolled into the study . The median follow-up as of April 1 , 2006 , was 104 weeks , and loss to follow-up rate at 2 years was 4.1 % . The median baseline CD4 + T-cell count was 199 cells per cubic millimeter [ interquartile ratio ( IQR ) 136 - 252 ] , and the median plasma HIV-1 RNA level was 193,500 copies per milliliter ( IQR 69 - 250 , 472 - 500 ) . The proportion of participants with virologic failure and genotypic resistance mutations was 11 % in those receiving ZDV/ddI-based cART versus 2 % in those receiving either ZDV/3TC- or d4T/3TC-based cART ( P = 0.002 ) . The median CD4 + T-cell count increase at 1 year was 137 cells per cubic millimeter ( IQR 74 - 223 ) and 199 cells per cubic millimeter ( IQR 112 - 322 ) at 2 years with significantly lower gain in the ZDV/ddI arm . At 1 and 2 years , respectively , 92.0 % and 88.8 % of patients had an undetectable plasma HIV-1 RNA level ( ≤400 copies/mL ) . Kaplan-Meier survival estimates at 1 and 2 years were 96.6 % and 95.4 % . One hundred twenty patients ( 18.2 % ) had treatment-modifying toxicities , of which the most common were lipodystrophy , anemia , neutropenia , and Stevens-Johnson syndrome . There was a trend toward difference in time to treatment-modifying toxicity by pooled dual-NRTI combination and no difference in death rates . Conclusions : The preliminary study results show overall excellent efficacy and tolerability of NNRTI-based cART among HIV-1 subtype C-infected adults . ZDV/ddI-containing cART , however , is inferior to the dual NRTIs d4T/3TC or ZDV/3TC when used with an NNRTI for first-line cART Background Little is known about immunovirological treatment outcomes and adherence in HIV/AIDS patients on antiretroviral therapy ( ART ) treated using a simplified management approach in rural areas of developing countries , or about the main factors influencing those outcomes in clinical practice . Methods Cross-sectional immunovirological , pharmacological , and adherence outcomes were evaluated in all patients alive and on fixed-dose ART combinations for 24 months , and in a r and om sample of those treated for 12 months . Risk factors for virological failure ( > 1,000 copies/ml ) and subtherapeutic antiretroviral ( ARV ) concentrations were investigated with multiple logistic regression . Results At 12 and 24 months of ART , 72 % ( n = 701 ) and 70 % ( n = 369 ) of patients , respectively , were alive and in care . About 8 % and 38 % of patients , respectively , were diagnosed with immunological failure ; and 75 % and 72 % of patients , respectively , had undetectable HIV RNA ( < 400 copies/ml ) . Risk factors for virological failure ( > 1,000 copies/ml ) were poor adherence , tuberculosis diagnosed after ART initiation , subtherapeutic NNRTI concentrations , general clinical symptoms , and lower weight than at baseline . About 14 % of patients had low ARV plasma concentrations . Digestive symptoms and poor adherence to ART were risk factors for low ARV plasma concentrations . Conclusion Efforts to improve both access to care and patient management to achieve better immunological and virological outcomes on ART are necessary to maximize the duration of first-line therapy Objectives : To determine short- and long-term efficacy of modified directly observed therapy ( m-DOT ) on antiretroviral adherence . Design : R and omized controlled trial . Setting and Analytic Approach : From September 2003 to November 2004 , 234 HIV-infected adults were assigned m-DOT ( 24 weeks of twice weekly health center visits for nurse-observed pill ingestion , adherence support , and medication collection ) or st and ard care . Follow-up continued until week 72 . Self-reported and pill-count adherence and , secondarily , viral suppression and body mass index measures are reported . Generalized estimating equations adjusted for intraclient clustering and covariates were used . Results : During weeks 1 - 24 , 9.1 % ( 9/99 ) of m-DOT participants reported missing doses compared with 19.1 % ( 20/105 ) of controls ( P = 0.04 ) and 96.5 % ( 517/571 ) of m-DOT pill-count measures were ≥95 % compared with 86.1 % ( 4 \n Output:\n " }, { "from": "agent", "value": "The pooled estimates of viral suppression recorded after 12 months of ART in LMICs provide benchmarks that other ART programmes can use to set realistic goals and perform predictive modelling ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: Background —Delay from onset of acute coronary syndrome ( ACS ) symptoms to hospital admission continues to be prolonged . To date , community education campaigns on the topic have had disappointing results . Therefore , we conducted a clinical r and omized trial to test whether an intervention tailored specifically for patients with ACS and delivered one-on-one would reduce prehospital delay time . Methods and Results — Participants ( n=3522 ) with documented coronary heart disease were r and omized to experimental ( n=1777 ) or control ( n=1745 ) groups . Experimental patients received education and counseling about ACS symptoms and actions required . Patients had a mean age of 67±11 years , and 68 % were male . Over the 2 years of follow-up , 565 patients ( 16.0 % ) were admitted to an emergency department with ACS symptoms a total of 842 times . Neither median prehospital delay time ( experimental , 2.20 versus control , 2.25 hours ) nor emergency medical system use ( experimental , 63.6 % versus control , 66.9 % ) was different between groups , although experimental patients were more likely than control to call the emergency medical system if the symptoms occurred within the first 6 months following the intervention ( P=0.036 ) . Experimental patients were significantly more likely to take aspirin after symptom onset than control patients ( experimental , 22.3 % versus control , 10.1 % , P=0.02 ) . The intervention did not result in an increase in emergency department use ( experimental , 14.6 % versus control , 17.5 % ) . Conclusions —The education and counseling intervention did not lead to reduced prehospital delay or increased ambulance use . Reducing the time from onset of ACS symptoms to arrival at the hospital continues to be a significant public health challenge . Clinical Trial Registration — clinical trials.gov . Identifier NCT00734760 Background There has been increasing interest in the ability of the internet to produce behaviour change . The focus of this study was to describe program exposure across three intervention groups from a r and omised trial ( RT ) comparing traditional face-to-face , internet-mediated ( combined internet plus face-to-face ) , and internet-only program delivery . Methods Baseline and immediately post-intervention survey data , and exposure rates from participants that commenced the RT were included ( n = 192 ) . Exposure was defined as either face-to-face attendance , website usage , or a combination of both for the internet-mediated group . Characteristics of participants who were exposed to at least 75 % of the program material were explored . Descriptive analysis and logistical regression were used to examine differences between groups for program exposure . Results All groups showed decrease in program exposure over time . Differences were also observed ( χ2 = 10.37 , p < 0.05 ) , between intervention groups . The internet-mediated ( OR = 2.4 , 95 % CI 1.13–5.1 ) and internet-only ( OR = 2.96 , 95 % CI 1.38–6.3 ) groups were more likely to have been exposed to at least 75 % of the program compared to the face-to-face group . Participants with high physical activity self-efficacy were 1.82 ( 95 % CI 1.15–2.88 ) times more likely to have been exposed to 75 % of the program , and those allocated to the face-to-face group were less likely to have attended 75 % of the face-to-face sessions if they were classified as obese ( OR = 0.21 95 % CI 0.04–0.96 ) . Conclusion These results suggest that the internet groups were as effective as the face-to-face delivery mode in engaging participants in the program material . However , different delivery methods may be more useful to different sub- population s. It is important to explore which target groups that internet-based programs are best suited , in order to increase their impact The goal of evidence -based medicine is ultimately to improve patient outcomes and quality of care . Systematic review s of the available published evidence are required to identify interventions that lead to improvements in behavior , health , and well-being . Authoritative literature review s depend on the quality of published research and research reports . The Consoli date d St and ards for Reporting Trials ( CONSORT ) Statement ( www.consort-statement.org ) was developed to improve the design and reporting of interventions involving r and omized clinical trials ( RCTs ) in medical journals . We describe the 22 CONSORT guidelines and explain their application to behavioral medicine research and to evidence -based practice . Additional behavioral medicine-specific guidelines ( e.g. , treatment adherence ) are also presented . Use of these guidelines by clinicians , educators , policymakers , and research ers who design , report , and evaluate or review RCTs will strengthen the research itself and accelerate efforts to apply behavioral medicine research to improve the processes and outcomes of behavioral medicine practice BACKGROUND The literature suggests that people delay too long prior to attending emergency departments with acute coronary syndrome ( ACS ) symptoms . This delay is referred to as prehospital delay . Patient decision delay contributes most significantly to prehospital delay . OBJECTIVES Using a r and omized controlled trial , we tested an educational intervention to reduce patient prehospital delay in ACS and promote appropriate responses to symptoms . METHODS Eligible patients who were admitted across five emergency departments ( EDs ) in Dublin were recruited to the study ( n = 1944 ; control : 972 , intervention : 972 ) . RESULTS Median baseline prehospital delay times did not differ significantly between the groups at baseline ( Mann-Whitney U , p = 0.34 ) ( CONTROL : 4.28 h , 25(th ) percentile = 1.71 , 75(th ) percentile = 17.37 ; Intervention 3.96 h , 25(th ) percentile = 1.53 , 75(th ) percentile = 18.51 ) . Both groups received usual in-hospital care . In addition , patients r and omized to the intervention group received a 40-min individualized education session using motivational techniques . This was reinforced 1 month later by telephone . Of the 1944 , 314 ( 16.2 % ) were readmitted with ACS symptoms : 177 ( 18.2 % ) and 137 ( 14.1 % ) of the intervention and control groups , respectively . Prehospital delay times were again measured . Median delay time was significantly lower in the intervention compared to the control group ( 1.7 h vs. 7.1 h ; p ≤ 0.001 ) . Appropriately , those in the intervention group reported their symptoms more promptly to another person ( p = 0.01 ) and fewer consulted a general practitioner ( p = 0.02 ) . There was no significant difference in ambulance use ( p = 0.51 ) or nitrate use ( p = 0.06 ) between the groups . CONCLUSION It is possible to reduce prehospital delay time in ACS , but the need for renewed emphasis on ambulance use is important Loss to follow-up is often hard to avoid in r and omised trials . This article suggests a framework for intention to treat analysis that depends on making plausible assumptions about the missing data and including all participants in sensitivity We describe a framework for defining pilot and feasibility studies focusing on studies conducted in preparation for a r and omised controlled trial . To develop the framework , we undertook a Delphi survey ; ran an open meeting at a trial methodology conference ; conducted a review of definitions outside the health research context ; consulted experts at an international consensus meeting ; and review ed 27 empirical pilot or feasibility studies . We initially adopted mutually exclusive definitions of pilot and feasibility studies . However , some Delphi survey respondents and the majority of open meeting attendees disagreed with the idea of mutually exclusive definitions . Their viewpoint was supported by definitions outside the health research context , the use of the terms ‘ pilot ’ and ‘ feasibility ’ in the literature , and participants at the international consensus meeting . In our framework , pilot studies are a subset of feasibility studies , rather than the two being mutually exclusive . A feasibility study asks whether something can be done , should we proceed with it , and if so , how . A pilot study asks the same questions but also has a specific design feature : in a pilot study a future study , or part of a future study , is conducted on a smaller scale . We suggest that to facilitate their identification , these studies should be clearly identified using the terms ‘ feasibility ’ or ‘ pilot ’ as appropriate . This should include feasibility studies that are largely qualitative ; we found these difficult to identify in electronic search es because research ers rarely used the term ‘ feasibility ’ in the title or abstract of such studies . Investigators should also report appropriate objectives and methods related to feasibility ; and give clear confirmation that their study is in preparation for a future r and omised controlled trial design ed to assess the effect of an intervention PURPOSE To compare delay and circumstances of decisions to seek care in patients with acute myocardial infa rct ion ( AMI ) in the United States ( US ) , Engl and , Australia , South Korea , and Japan . DESIGN Comparative prospect i ve design . METHODS Patients diagnosed with AMI ( N = 913 ) were interviewed within 72 hours of hospital admission for confirmed AMI using the Response to Symptoms Question naire . Delay times were calculated from review of emergency room records and patients ' interviews . Analysis of variance was used to test differences in delay time among countries . FINDINGS Median delay ranged from 2.5 hours in Engl and to 6.4 hours in Australia , with the three Pacific Rim countries reporting median delay times > 4 hours . The majority of patients experienced initial symptoms at home ( range : 56 % in Japan to 73 % in the US ) with the most common witness being a family member ( 32 % in South Korea to 48 % in Engl and ) . Ambulance use was widely divergent with the highest use in Engl and ( 85 % ) and the lowest use in the US ( 42 % ) . CONCLUSIONS In all countries , median delay was too long to obtain maximum benefit from AMI therapies , particularly thrombolysis . Education and counseling of patients and families to reduce prehospital delay in AMI episodes might be more effective if the various factors influencing patients ' first responses to symptoms are considered , as well as differences in health care systems 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 CONTEXT Delayed access to medical care in patients with acute myocardial infa rct ion ( AMI ) is common and increases myocardial damage and mortality . OBJECTIVE To evaluate a community intervention to reduce patient delay from symptom onset to hospital presentation and increase emergency medical service ( EMS ) use . DESIGN AND SETTING The Rapid Early Action for Coronary Treatment Trial , a r and omized trial conducted from 1995 to 1997 in 20 US cities ( 10 matched pairs ; population range , 55,777 - 238,912 ) in 10 states . PARTICIPANTS A total of 59,944 adults aged 30 years or older presenting to hospital emergency departments ( EDs ) with chest pain , of whom 20,364 met the primary population criteria of suspected acute coronary heart disease on admission and were discharged with a coronary heart disease-related diagnosis . INTERVENTION One city in each pair was r and omly assigned to an 18-month intervention that targeted mass media , community organizations , and professional , public , and patient education to increase appropriate patient actions for AMI symptoms ( primary population , n=10,563 ) . The other city in each pair was r and omly assigned to reference status ( primary population , n=9801 ) . MAIN OUTCOME MEASURES Time from symptom onset to ED arrival and EMS use , compared between intervention and reference city pairs . RESULTS General population surveys provided evidence of increased public awareness and knowledge of program messages . Patient delay from symptom onset to hospital arrival at baseline ( median , 140 minutes ) was identical in the intervention and reference communities . Delay time decreased in intervention communities by -4.7 % per year ( 95 % confidence interval [ CI ] , -8.6 % to -0.6 % ) , but the change did not \n Output:\n " }, { "from": "agent", "value": "DISCUSSION Positive results changing intentions would lead to a r and omized controlled trial of the behaviour change intervention in clinical practice , assessing patient delay in the event of actual symptoms ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: Aims The efficacy and safety of insulin degludec ( IDeg ) was compared with insulin detemir ( IDet ) , both administered once daily ( OD ) as basal treatment in participants with type 1 diabetes mellitus ( T1DM ) . The primary outcome was non-inferiority of IDeg to IDet in glycated haemoglobin ( HbA1c ) reduction after 26 weeks . Methods This multinational , 26-week , controlled , open-label , parallel-group trial r and omized adults with T1DM to IDeg or IDet as OD basal insulin treatment combined with mealtime bolus insulin aspart ( IAsp ) . Participants with T1DM treated with any basal – bolus insulin regimen for ≥12 months prior to the trial , a mean HbA1c ≤ 10.0 % ( 85.8 mmol/mol ) and body mass index ( BMI ) ≤35.0 kg/m2 at screening participated in the trial ( IDeg : N = 302 ; IDet : N = 153 ) . Results After 26 weeks , HbA1c decreased 0.73 % ( 8.0 mmol/mol ) ( IDeg ) and 0.65 % ( 7.1 mmol/mol ) ( IDet ) [ estimated treatment difference ( ETD ) IDeg – IDet : −0.09 % ( −0.23 ; 0.05)95%CI ( −10.0 mmol/mol [ −2.6 ; 0.6]95 % CI ) ; confirming non-inferiority ] . Mean fasting plasma glucose improved in both groups , and was lower with IDeg than IDet [ ETD IDeg – IDet : −1.66 mmol/l ( −2.37 ; −0.95)95 % CI , p < 0.0001 ] . The rate of confirmed hypoglycaemia was similar with IDeg and IDet [ 45.83 vs. 45.69 episodes per patient-year of exposure ( PYE ) ; estimated rate ratio ( RR ) IDeg/IDet : 0.98 ( 0.80 ; 1.20)95 % CI , p = 0.86 ] . The rate of nocturnal confirmed hypoglycaemia was lower with IDeg than IDet [ 4.14 vs. 5.93 episodes per PYE ; RR IDeg/IDet : 0.66 ( 0.49 ; 0.88)95 % CI , p = 0.0049 ] . Adverse event profiles were similar between groups . Conclusion IDeg administered OD in basal – bolus therapy effectively improved long-term glycaemic control in participants with T1DM with a lower risk of nocturnal confirmed hypoglycaemia than IDet OBJECTIVE To compare ultra-long-acting insulin degludec with glargine for efficacy and safety in insulin-naive patients with type 2 diabetes inadequately controlled with oral antidiabetic drugs ( OADs ) . RESEARCH DESIGN AND METHODS In this 1-year , parallel-group , r and omized , open-label , treat-to-target trial , adults with type 2 diabetes with A1C of 7−10 % taking OADs were r and omized 3:1 to receive once daily degludec or glargine , both with metformin . Insulin was titrated to achieve prebreakfast plasma glucose ( PG ) of 3.9−4.9 mmol/L. The primary end point was confirmation of noninferiority of degludec to glargine in A1C reduction after 52 weeks in an intent-to-treat analysis . RESULTS In all , 1,030 participants ( mean age 59 years ; baseline A1C 8.2 % ) were r and omized ( degludec 773 , glargine 257 ) . Reduction in A1C with degludec was similar ( noninferior ) to that with glargine ( 1.06 vs. 1.19 % ) , with an estimated treatment difference of degludec to glargine of 0.09 % ( 95 % CI −0.04 to 0.22 ) . Overall rates of confirmed hypoglycemia ( PG < 3.1 mmol/L or severe episodes requiring assistance ) were similar , with degludec and glargine at 1.52 versus 1.85 episodes/patient-year of exposure ( PYE ) . There were few episodes of nocturnal confirmed hypoglycemia in the overall population , and these occurred at a lower rate with degludec versus glargine ( 0.25 vs. 0.39 episodes/PYE ; P = 0.038 ) . Similar percentages of patients in both groups achieved A1C levels < 7 % without hypoglycemia . End-of-trial mean daily insulin doses were 0.59 and 0.60 units/kg for degludec and glargine , respectively . Adverse event rates were similar . CONCLUSIONS Insulins degludec and glargine administered once daily in combination with OADs provided similar long-term glycemic control in insulin-naive patients with type 2 diabetes , with lower rates of nocturnal hypoglycemia with degludec Purpose The efficacy and safety of insulin degludec/insulin aspart ( IDegAsp ) once daily ( OD ) compared with insulin glargine U100 ( IGlar ) OD over 52 weeks in insulin-naïve adults with type 2 diabetes mellitus ( T2DM ) was investigated . Methods In this open-label , parallel-group treat-to-target trial , participants were r and omized ( 1:1 ) to receive IDegAsp OD ( breakfast , n = 266 ) or IGlar OD ( as per label , n = 264 ) . Participants then entered a 26-week extension phase ( IDegAsp OD , n = 192 ; IGlar OD , n = 221 ) . The primary endpoint was change from baseline to Week 26 in HbA1c . Results After 26 and 52 weeks , mean HbA1c decreased to similar levels in both groups . After 52 weeks , the mean estimated treatment difference was –0.08 % ( –0.26 , 0.09 95%CI ) , confirming the non-inferiority of IDegAsp OD versus IGlar OD evaluated at Week 26 . After 52 weeks , there was a similar reduction in mean fasting plasma glucose in both treatment groups . The rate of confirmed hypoglycemic episodes was 86 % higher ( p < 0.0001 ) whereas the rate of nocturnal hypoglycemia was 75 % lower ( p < 0.0001 ) for IDegAsp versus IGlar . Conclusion Nocturnal-confirmed hypoglycemia was higher with IGlar whereas overall and diurnal hypoglycemia were higher with IDegAsp dosed at breakfast . These results highlight the importance of administration of IDegAsp with the main meal of the day , tailored to the individual patient ’s needs . Trial Registration Clinical Trials.gov : NCT01045707 [ core ] ) and NCT01169766 [ ext OBJECTIVE Insulin degludec ( IDeg ) is a basal insulin that forms soluble multihexamers after subcutaneous injection , result ing in an ultra-long action profile . We assessed the efficacy and safety of IDeg formulations administered once daily in combination with mealtime insulin aspart in people with type 1 diabetes . RESEARCH DESIGN AND METHODS In this 16-week , r and omized , open-label trial , participants ( mean : 45.8 years old , A1C 8.4 % , fasting plasma glucose [ FPG ] 9.9 mmol/L , BMI 26.9 kg/m2 ) received subcutaneous injections of IDeg(A ) ( 600 μmol/L ; n = 59 ) , IDeg(B ) ( 900 μmol/L ; n = 60 ) , or insulin glargine ( IGlar ; n = 59 ) , all given once daily in the evening . Insulin aspart was administered at mealtimes . RESULTS At 16 weeks , mean A1C was comparable for IDeg(A ) ( 7.8 ± 0.8 % ) , IDeg(B ) ( 8.0 ± 1.0 % ) , and IGlar ( 7.6 ± 0.8 % ) , as was FPG ( 8.3 ± 4.0 , 8.3 ± 2.8 , and 8.9 ± 3.5 mmol/L , respectively ) . Estimated mean rates of confirmed hypoglycemia were 28 % lower for IDeg(A ) compared with IGlar ( rate ratio [ RR ] : 0.72 [ 95 % CI 0.52–1.00 ] ) and 10 % lower for IDeg(B ) compared with IGlar ( RR : 0.90 [ 0.65–1.24 ] ) ; rates of nocturnal hypoglycemia were 58 % lower for IDeg(A ) ( RR : 0.42 [ 0.25–0.69 ] ) and 29 % lower for IDeg(B ) ( RR : 0.71 [ 0.44–1.16 ] ) . Mean total daily insulin dose was similar to baseline . The frequency and pattern of adverse events was similar between insulin treatments . CONCLUSIONS In this clinical exploratory phase 2 trial in people with type 1 diabetes , IDeg is safe and well tolerated and provides comparable glycemic control to IGlar at similar doses , with reduced rates of hypoglycemia Background : The First Basal Insulin Evaluation ( FINE ) Asia study is a multinational , prospect i ve , observational study of insulin-naïve Type 2 diabetes mellitus ( T2DM ) patients in Asia , uncontrolled ( A1c ≥ 8 % ) on oral hypoglycemic agents , design ed to evaluate the impact of basal insulin initiation . Methods : Basal insulin was initiated with or without concomitant oral therapy and doses were adjusted individually . All treatment choices , including the decision to initiate insulin , were at the physician 's discretion to reflect real-life practice . Results : Patients ( n= 2679 ) from 11 Asian countries were enrolled ( mean [ ±SD ] duration of diabetes 9.3 ± 6.5 years ; weight 68.1 ± 12.7 kg ; A1c 9.8 ± 1.6 % ) . After 6 months of basal insulin ( NPH insulin , insulin glargine , or insulin detemir ) , A1c decreased to 7.7 ± 1.4 % ; 33.7 % patients reached A1c < 7 % . Fasting blood glucose ( FBG ) decreased from 11.7 ± 3.6 to 7.2 ± 2.5 mmol/L and 36.8 % of patients reached FBG < 6.1 mmol/L. The mean daily insulin dose prescribed increased marginally from 0.18 to 0.23 U/kg per day at baseline to 0.22–0.24 U/kg per day at Month 6 . Mean changes in body weight and reported rates of hypoglycemia were low over the duration of the study . Conclusions : Initiation of insulin therapy is still being delayed by approximately 9 years , result ing in many Asian patients developing severe hyperglycemia . Initiating insulin treatment with basal insulin was effective and safe in Asian T2DM patients in a real-world setting , but insulin needs may differ from those in Western countries Aims To evaluate the long‐term safety and efficacy of a simplified basal – bolus regimen of once‐daily insulin degludec/insulin aspart ( IDegAsp ) with additional IAsp vs. a st and ard basal – bolus insulin regimen of insulin detemir ( IDet ) with IAsp in adults with Type 1 diabetes . Methods This was an open‐label trial comprising a 26‐week core phase followed by a 26‐week extension phase . Participants were r and omized to IDegAsp once daily at the main meal and IAsp at remaining meals ( IDegAsp+IAsp ) , or IDet ( once or twice daily ) and IAsp at all meals ( IDet+IAsp ) . Insulins were titrated to target plasma glucose of < 5 mmol/l ( < 90 mg/dl ) at pre‐breakfast ( IDegAsp and IDet ) and at pre‐meal ( IAsp ) . Results After 52 weeks , the overall confirmed hypoglycaemia rate was 31.8 episodes/patient‐years of exposure ( PYE ) with IDegAsp+Asp and 36.7 episodes/PYE with IDet+IAsp , and the rate of nocturnal confirmed hypoglycaemia was significantly lower with IDegAsp+Asp than with IDet+IAsp ( 3.1 vs. 5.4 episodes/PYE , respectively ; P < 0.05 ) . Adverse event rates were comparable between groups . Mean HbA1c decreased from baseline by 0.7 % ( IDegAsp+IAsp ) and 0.6 % ( IDet+IAsp ) , achieving 60 or 61 mmol/mol ( 7.6 % or 7.7 % , respectively ) , at Week 52 . The \n Output:\n " }, { "from": "agent", "value": "No statistically significant differences in HbA1c were seen between any two insulins or formulations .\nNo differences in glycaemic control were seen between insulin degludec , detemir and glargine .\nHypoglycaemia was less probable with degludec than glargine , and patients taking detemir gained less body weight than those given degludec or glargine .\nIn type 2 diabetes , withdrawals as a result of adverse events were more probable with detemir than glargine" } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: OBJECTIVES To study the feasibility and effectiveness of a discharge planning intervention . DESIGN Quasi-experimental pre-post study design . SETTING General medicine wards at three hospitals : an academic medical center , a community teaching hospital , and a community-based nonteaching hospital . PARTICIPANTS All patients aged 65 and older admitted to the hospitalist services . INTERVENTION The intervention toolkit had five core elements : admission form with geriatric cues , facsimile to the primary care provider , interdisciplinary worksheet to identify barriers to discharge , pharmacist-physician collaborative medication reconciliation , and predischarge planning appointments . MEASUREMENTS Thirty-day readmission and return to emergency department rates and patient satisfaction with discharge . Odds ratios were determined , and site effects were examined accordig to interaction terms and Breslow Day statistics . RESULTS Two hundred thirty-seven patients were followed during the preintervention period , and 185 were exposed to the intervention . Patients characteristics were similar across the two time periods . The proportion of patients with high- quality transitions home , measured according to Coleman 's Care Transition Measures , increased from 68 % to 89 % ( odds ratio (OR)=3.49 , 95 % confidence interval (CI)=2.06 - 5.92 ) . Return to the emergency department within 3 days of discharge was lower in the intervention period ( 10 % vs 3 % , OR=0.25 , 95 % CI=0.10 - 0.62 ) . At 30 days , there was a lower rate of readmission ( 22 % vs 14 % , OR=0.59 , 95 % CI=0.34 - 0.97 ) and fewer visits to the emergency department ( 21 % vs 14 % , OR=0.61 , 95 % CI=0.36 - 1.03 ) ( P=.06 ) . CONCLUSION When hospitalized elderly patients are treated with consideration of their specific needs , healthcare outcomes can be improved Background : Hospital discharge is an interlace of care when patients are at a high risk of medication discrepancies as they transition from hospital to home . These discrepancies are important , as they may contribute to drug-related problems , medication errors , and adverse drug events . Objective : To Identify , characterize , and assess the clinical impact of unintentional medication discrepancies at hospital discharge . Methods : All consecutive general internal medicine patients admitted for at least 72 hours to a tertiary care teaching hospital were prospect ively assessed . Patients were excluded if they were discharged with verbal prescriptions ; died during hospitalization ; or transferred from or to a nursing home , another institution , or another unit within the same hospital . The primary endpoint was to determine the number of patients with at least one unintended medication discrepancy on hospital discharge . Medication discrepancies were assessed through comparison of a best possible medication discharge list with the actual discharge prescriptions . Secondary objectives were to characterize and assess the potential clinical impact of the unintentional discrepancies . Results : From March 14,2006 , to June 2,2006,430 patients were screened for eligibility ; 150 patients were included in the study . Overall , 106 ( 70.7 % ) patients had at least one actual or potential unintentional discrepancy . Sixty-two patients ( 41.3 % ) had at least one actual unintentional medication discrepancy al hospital discharge and 83 patients ( 55.3 % ) had at least one potential unintentional discrepancy . The most common unintentional discrepancies were an incomplete prescription requiring clarification , which could result in a patient delay in obtaining medications ( 49.5 % ) , and the omission of medications ( 22.9 % ) . Of the 105 unintentional discrepancies , 31 ( 29.5 % ) had the potential to cause possible or probable patient discomfort and /or clinical deterioration . Conclusions : Medication discrepancies occur commonly on hospital discharge . Underst and ing the type and frequency of discrepancies can help clinicians better underst and ways to prevent them . Structured medication reconciliation may help to prevent discharge medication discrepancies Objective Heart failure patients are regularly admitted to hospital and frequently use multiple medication . Besides intentional changes in pharmacotherapy , unintentional changes may occur during hospitalisation . The aim of this study was to investigate the effect of a clinical pharmacist discharge service on medication discrepancies and prescription errors in patients with heart failure . Setting A general teaching hospital in Tilburg , the Netherl and s. Method An open r and omized intervention study was performed comparing an intervention group , with a control group receiving regular care by doctors and nurses . The clinical pharmacist discharge service consisted of review of discharge medication , communicating prescribing errors with the cardiologist , giving patients information , preparation of a written overview of the discharge medication and communication to both the community pharmacist and the general practitioner about this medication . Within 6 weeks after discharge all patients were routinely scheduled to visit the outpatient clinic and medication discrepancies were measured . Main outcome measure The primary endpoint was the frequency of prescription errors in the discharge medication and medication discrepancies after discharge combined . Results Forty-four patients were included in the control group and 41 in the intervention group . Sixty-eight percent of patients in the control group had at least one discrepancy or prescription error against 39 % in the intervention group ( RR 0.57 ( 95 % CI 0.37–0.88 ) ) . The percentage of medications with a discrepancy or prescription error in the control group was 14.6 % and in the intervention group it was 6.1 % ( RR 0.42 ( 95 % CI 0.27–0.66 ) ) . Conclusion This clinical pharmacist discharge service significantly reduces the risk of discrepancies and prescription errors in medication of patients with heart failure in the 1st month after discharge BACKGROUND Prior studies suggest that unintended medication discrepancies that represent errors are common at the time of hospital admission . These errors are particularly worthy of attention because they are not likely to be detected by computerized physician order entry systems . METHODS We prospect ively studied patients reporting the use of at least 4 regular prescription medications who were admitted to general internal medicine clinical teaching units . The primary outcome was unintended discrepancies ( errors ) between the physicians ' admission medication orders and a comprehensive medication history obtained through interview . We also evaluated the potential seriousness of these discrepancies . All discrepancies were review ed with the medical team to determine if they were intentional or unintentional . All unintended discrepancies were rated for their potential to cause patient harm . RESULTS After screening 523 admissions , 151 patients were enrolled based on the inclusion criteria . Eighty-one patients ( 53.6 % ; 95 % confidence interval , 45.7%-61.6 % ) had at least 1 unintended discrepancy . The most common error ( 46.4 % ) was omission of a regularly used medication . Most ( 61.4 % ) of the discrepancies were judged to have no potential to cause serious harm . However , 38.6 % of the discrepancies had the potential to cause moderate to severe discomfort or clinical deterioration . CONCLUSIONS Medication errors at the time of hospital admission are common , and some have the potential to cause harm . Better methods of ensuring an accurate medication history at the time of hospital admission are needed BACKGROUND Hospitalization and subsequent discharge home often involve discontinuity of care , multiple changes in medication regimens , and inadequate patient education , which can lead to adverse drug events ( ADEs ) and avoidable health care utilization . Our objectives were to identify drug-related problems during and after hospitalization and to determine the effect of patient counseling and follow-up by pharmacists on preventable ADEs . METHODS We conducted a r and omized trial of 178 patients being discharged home from the general medicine service at a large teaching hospital . Patients in the intervention group received pharmacist counseling at discharge and a follow-up telephone call 3 to 5 days later . Interventions focused on clarifying medication regimens ; review ing indications , directions , and potential side effects of medications ; screening for barriers to adherence and early side effects ; and providing patient counseling and /or physician feedback when appropriate . The primary outcome was rate of preventable ADEs . RESULTS Pharmacists observed the following drug-related problems in the intervention group : unexplained discrepancies between patients ' preadmission medication regimens and discharge medication orders in 49 % of patients , unexplained discrepancies between discharge medication lists and postdischarge regimens in 29 % of patients , and medication nonadherence in 23 % . Comparing trial outcomes 30 days after discharge , preventable ADEs were detected in 11 % of patients in the control group and 1 % of patients in the intervention group ( P = .01 ) . No differences were found between groups in total ADEs or total health care utilization . CONCLUSIONS Pharmacist medication review , patient counseling , and telephone follow-up were associated with a lower rate of preventable ADEs 30 days after hospital discharge . Medication discrepancies before and after discharge were common targets of intervention Purpose To examine the impact of systematic medication reconciliations upon hospital admission and of a medication review while in hospital on the number of inappropriate medications and unscheduled drug-related hospital revisits in elderly patients . Methods This was a prospect i ve , controlled study in 210 patients , aged 65 years or older , who were admitted to one of three internal medicine wards at a University Hospital in Sweden . Intervention patients received the complete Lund Integrated Medicines Management model ( medication reconciliation upon admission and discharge , and medication review and monitoring ) provided by a multi-professional team , including a clinical pharmacist . Control patients received st and ard care and medication reconciliation upon discharge . Blinded review ers evaluated the appropriateness of the prescribing ( using the Medication Appropriateness Index ) on admission and discharge , and assessed the probability that a drug-related problem was the reason for any patient readmitted to hospital or visiting the emergency department within 3 months of discharge ( using World Health Organisation causality criteria ) . Results There was a greater decrease in the number of inappropriate drugs in the intervention group than in the control group for both the intention-to-treat population { 51 % [ 95 % confidence interval ( CI ) 43–58 % ] vs. 39 % ( 95 % CI 30–48 % ) ; p = 0.0446 } and the per- protocol population [ 60 % ( 95 % CI 51–67 % ) vs. 44 % ( 95 % CI 34–52 % ) ; p = 0.0106 ) ] . There were six revisits to hospital in the intervention group which were judged as ‘ possibly , probably or certainly drug-related ’ , compared with 12 in the control group ( p = 0.0469 ) . Conclusions In this study , medication reconciliation and review provided by a clinical pharmacist in a multi-professional team significantly reduced the number of inappropriate drugs and unscheduled drug-related hospital revisits among elderly patients OBJECTIVE To quantify admission medication discrepancies in a tertiary-care , general pediatric population , to describe their clinical importance and associated factors , and to assess a screening approach to pharmacist involvement . METHODS A total of 272 patients were studied prospect ively at hospital admission . The study pharmacist performed a medication history and compared it to physicians ' admission medication orders . Discrepancies between the 2 were coded as intentional but undocumented or unintentional . Unintentional discrepancies were rated for potential to cause harm by 3 physicians . Additional data collected included patients ' reason for admission and presence of chronic conditions , whether physicians used a medication reconciliation form , the characteristics of patients ' home medication regimen , and the time required to perform a pharmacist history and reconciliation . Interrater reliability and associations between baseline characteristics and discrepancy rates were explored . RESULTS Eighty patients ( 30 % ) had at least one undocumented intentional discrepancy ( range , 0 - 7 ) . At least one unintentional discrepancy ( range , 0 - 9 ) was found in 59 patients ( 22 % ) . Of the unintentional discrepancies , 23 % had moderate and 6 % had severe potential to cause discomfort or deterioration . Ratings were similar among the 3 physicians . Characteristics associated with higher risk of clinical ly important discrepancies were : use of the medication reconciliation form , > or = 4 prescription medications , and antiepileptic drug use . Logistic regression revealed that only the variable > or = 4 medications was independently associated with clinical ly important discrepancies . CONCLUSIONS Admission medication errors are common in this tertiary-care , general pediatric population , and nearly a third represent potential adverse events . The use of a medication reconciliation form by physicians without pharmacist involvement does not appear to reduce errors . A cutoff of > or = 4 prescription medications is highly sensitive for identifying patients at risk of clinical ly important discrepancies Background Medication reconciliation has been m and ated by the Irish government at transfer of care . Research is needed to determine the contribution of clinical pharmacists to the process . Objective To describe the contribution of emergency department based clinical pharmacists to admission medication reconciliation in Irel and . Main Outcome Measure Frequency of clinical pharmacist ’s activities . Setting Two public university teaching hospitals . Methodology Adults admitted via the accident and emergency department , from a non-acute setting , reporting the use of at least three regular prescription medic \n Output:\n " }, { "from": "agent", "value": "Pharmacist-led medication reconciliation programmes are effective at improving post-hospital healthcare utilisation .\nThis review supports the implementation of pharmacist-led medication reconciliation programmes that include some component aim ed at improving medication safety" } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: BACKGROUND In the treatment of severe malaria , intravenous artesunate is more rapidly acting than intravenous quinine in terms of parasite clearance , is safer , and is simpler to administer , but whether it can reduce mortality is uncertain . METHODS We did an open-label r and omised controlled trial in patients admitted to hospital with severe falciparum malaria in Bangladesh , India , Indonesia , and Myanmar . We assigned individuals intravenous artesunate 2.4 mg/kg bodyweight given as a bolus ( n=730 ) at 0 , 12 , and 24 h , and then daily , or intravenous quinine ( 20 mg salt per kg loading dose infused over 4 h then 10 mg/kg infused over 2 - 8 h three times a day ; n=731 ) . Oral medication was substituted when possible to complete treatment . Our primary endpoint was death from severe malaria , and analysis was by intention to treat . FINDINGS We assessed all patients r and omised for the primary endpoint . Mortality in artesunate recipients was 15 % ( 107 of 730 ) compared with 22 % ( 164 of 731 ) in quinine recipients ; an absolute reduction of 34.7 % ( 95 % CI 18.5 - 47.6 % ; p=0.0002 ) . Treatment with artesunate was well tolerated , whereas quinine was associated with hypoglycaemia ( relative risk 3.2 , 1.3 - 7.8 ; p=0.009 ) . INTERPRETATION Artesunate should become the treatment of choice for severe falciparum malaria in adults AIMS To obtain pharmacokinetic data for artesunate ( ARTS ) and its active metabolite dihydroartemisinin ( DHA ) following i.m . ARTS and rectal DHA administration . METHODS Twelve Vietnamese patients with uncomplicated falciparum malaria were r and omized to receive either i.v . or i.m . ARTS ( 120 mg ) , with the alternative preparation given 8 h later in an open crossover design . A further 12 patients were given i.v . ARTS ( 120 mg ) at 0 h and rectal DHA ( 160 mg ) 8 h later . RESULTS Following i.v . bolus , ARTS had a peak concentration of 42 microm ( 16 mg l(-1 ) , elimination t1/2 = 3.2 min , CL = 2.8 l h(-1 ) kg(-1 ) and V = 0.22 l kg(-1 ) . The Cmax for DHA was 9.7 microm ( 2.7 mg l(-1 ) ) , t1/2 = 59 min , CL = 0.64 l h(-1 ) kg(-1 ) and V = 0.8 l kg(-1 ) . Following i.m . ARTS , Cmax was 2.3 microm ( 3.7 mg l(-1 ) ) , the apparent t1/2 = 41 min , CL = 2.9 l h(-1 ) kg(-1 ) and V = 2.6 l kg(-1 ) . The relative bioavailability of DHA was 88 % , Cmax was 4.1 microm ( 1.16 mg l(-1 ) ) and t1/2 = 64 min . In the rectal DHA study , relative bioavailability of DHA was 16 % . CONCLUSIONS For patients with uncomplicated falciparum malaria i.m . ARTS is a suitable alternative to i.v . ARTS , at equal doses . To achieve plasma DHA concentrations equivalent to parenteral administration of ARTS , rectal DHA should be given at approximately four-fold higher milligram doses . Further studies are needed to determine whether these recommendations can be applied to patients with severe malaria Summary Background Severe malaria is a major cause of childhood death and often the main reason for paediatric hospital admission in sub-Saharan Africa . Quinine is still the established treatment of choice , although evidence from Asia suggests that artesunate is associated with a lower mortality . We compared parenteral treatment with either artesunate or quinine in African children with severe malaria . Methods This open-label , r and omised trial was undertaken in 11 centres in nine African countries . Children ( < 15 years ) with severe falciparum malaria were r and omly assigned to parenteral artesunate or parenteral quinine . R and omisation was in blocks of 20 , with study numbers corresponding to treatment allocations kept inside opaque sealed paper envelopes . The trial was open label at each site , and none of the investigators or trialists , apart from for the trial statistician , had access to the summaries of treatment allocations . The primary outcome measure was in-hospital mortality , analysed by intention to treat . This trial is registered , number IS RCT N50258054 . Findings 5425 children were enrolled ; 2712 were assigned to artesunate and 2713 to quinine . All patients were analysed for the primary outcome . 230 ( 8·5 % ) patients assigned to artesunate treatment died compared with 297 ( 10·9 % ) assigned to quinine treatment ( odds ratio [ OR ] stratified for study site 0·75 , 95 % CI 0·63–0·90 ; relative reduction 22·5 % , 95 % CI 8·1–36·9 ; p=0·0022 ) . Incidence of neurological sequelae did not differ significantly between groups , but the development of coma ( 65/1832 [ 3·5 % ] with artesunate vs 91/1768 [ 5·1 % ] with quinine ; OR 0·69 95 % CI 0·49–0·95 ; p=0·0231 ) , convulsions ( 224/2712 [ 8·3 % ] vs 273/2713 [ 10·1 % ] ; OR 0·80 , 0·66–0·97 ; p=0·0199 ) , and deterioration of the coma score ( 166/2712 [ 6·1 % ] vs 208/2713 [ 7·7 % ] ; OR 0·78 , 0·64–0·97 ; p=0·0245 ) were all significantly less frequent in artesunate recipients than in quinine recipients . Post-treatment hypoglycaemia was also less frequent in patients assigned to artesunate than in those assigned to quinine ( 48/2712 [ 1·8 % ] vs 75/2713 [ 2·8 % ] ; OR 0·63 , 0·43–0·91 ; p=0·0134 ) . Artesunate was well tolerated , with no serious drug-related adverse effects . Interpretation Artesunate substantially reduces mortality in African children with severe malaria . These data , together with a meta- analysis of all trials comparing artesunate and quinine , strongly suggest that parenteral artesunate should replace quinine as the treatment of choice for severe falciparum malaria worldwide . Funding The Wellcome Trust Abstract Objective : The pharmacokinetics and bioavailability of artemether and dihydroartemisinin were investigated in eight Thai males following the administration of single oral and intramuscular doses of artemether ( 300 mg ) in a r and omized two-way cross-over study . Results : Both oral and intramuscular artemether were well-tolerated . In most cases , artemether and dihydroartemisinin were detected in plasma after 30 min and declined to levels below the limit of detection within 18–24 h. Compared with intramuscular administration , oral administration of artemether result ed in a relatively rapid but incomplete absorption [ Cmax : 474 vs 540 ng · ml−1 ; tmax : 2.0 vs 3.9 h ; AUC : 2.17 vs 5.20 μg · h · ml−1 ] . Geographic means of lag-time and absorption half-life ( t1/2a ) of oral vs intramuscular artemether were 0.28 and 1.1 h vs 0.30 and 2 h , respectively . t1/2z was significantly shortened after the oral dose [ 2.8 vs 6.9 h ] . Mean oral bioavailability relative to intramuscular administration was 43.2 % . The ratio of the AUCs of artemether to dihydroartemisinin was significantly lower after the oral than after the intramuscular dose ( geometric mean : 0.29 vs 0.60 ) This article introduces the approach of GRADE to rating quality of evidence . GRADE specifies four categories-high , moderate , low , and very low-that are applied to a body of evidence , not to individual studies . In the context of a systematic review , quality reflects our confidence that the estimates of the effect are correct . In the context of recommendations , quality reflects our confidence that the effect estimates are adequate to support a particular recommendation . R and omized trials begin as high- quality evidence , observational studies as low quality . \" Quality \" as used in GRADE means more than risk of bias and so may also be compromised by imprecision , inconsistency , indirectness of study results , and publication bias . In addition , several factors can increase our confidence in an estimate of effect . GRADE provides a systematic approach for considering and reporting each of these factors . GRADE separates the process of assessing quality of evidence from the process of making recommendations . Judgments about the strength of a recommendation depend on more than just the quality of evidence ABSTRACT The first-dose pharmacokinetic properties of intramuscular ( i.m . ) artesunate ( ARTS ; 2.4 mg/kg immediately [ stat ] , followed by 1.2 mg/kg i.m . daily ) and artemether ( ARM ; 3.2 mg/kg i.m . stat , followed by 1.6 mg/kg i.m . daily ) were compared in Vietnamese adults with severe falciparum malaria . A total of 19 patients were studied ; 9 received ARTS , and 10 received ARM . ARTS was absorbed very rapidly ; concentrations in plasma peaked between 1,362 and 8,388 nmol/liter ( median , 5,710 nmol/liter ) within 20 min of injection and then declined with a median ( range ) half-life ( t1/2 ) of 30 ( 3 to 67 ) min . ARTS was hydrolyzed rapidly and completely to the biologically active metabolite dihydroartemisinin ( DHA ) . Peak DHA concentrations in plasma ranged between 1,718 and 7,080 nmol/liter ( median , 3,060 nmol/liter ) and declined with a t1/2 of 52 ( 26 to 69 ) min . In contrast , ARM was slowly and erratically absorbed . The absorption profile appeared biphasic . Maximum ARM concentrations in plasma ranged between 67 nmol/liter ( a value close to the 50 % inhibitory concentration for some Plasmodium falciparum isolates ) and 1,631 nmol/liter ( median , 574 nmol/liter ) and occurred at a median ( range ) of 10 ( 1.5 to 24 ) h. There was relatively little conversion to DHA . After i.m . injection in cases of severe malaria , absorption of the water-soluble ARTS is rapid and extensive , whereas the oil-based ARM is slowly and erratically absorbed , with relatively little conversion to the more active DHA . On the basis of this pharmacological study , parenteral ARTS is preferable to ARM as an initial antimalarial therapy , particularly in the most seriously ill patients . These findings should be formally assessed by a r and omized clinical trial ABSTRACT Artesunate ( ARS ) is a water-soluble artemisinin derivative that is a potential alternative to quinine for the treatment of severe childhood malaria . We studied the pharmacokinetics and bioavailability of ARS given by the intramuscular ( i.m . ) route in an open crossover study design . Fourteen children were r and omized to receive intravenous ( i.v . ) ARS in a loading dose ( 2.4 mg/kg of body weight ) followed 12 h later by an i.m . dose ( 1.2 mg/kg ) ( group I ) , and 14 children were r and omized to receive i.m . ARS ( 2.4 mg/kg ) followed by an i.v . dose of ARS ( 1.2 mg/kg ) ( group II ) . We carried out a two-compartment analysis of ARS and dihydroartemisinin ( DHA ; the principal antimalarial metabolite ) levels in 21 children ( groups I and II combined ) . Absorption of i.m . ARS was rapid , with the maximum concentration of DHA in serum being achieved in less than 1 h in most children ( median time to the maximum concentration of drug in serum , 35.1 min ; range , 10.8 to 71.9 min ) . The absolute bioavailability of DHA was a median of 86.4 % ( range , 11.4 to 462.1 % ) , the median steady-state volume of distribution was 1.3 liters/kg ( range , 0.5 to 7.9 liters/kg ) , and the median clearance was 0.028 liters/kg/min ( range , 0.001 to 1.58 liters/kg/min ) . There were no major adverse events attributable to ARS . Parasite clearance kinetics were comparable between the two treatment groups . These results support the \n Output:\n " }, { "from": "agent", "value": "Authors ' conclusions Artemether appears to be more effective than quinine in children and adults .\nArtemether compared to artesunate has not been extensively studied , but in adults it appears inferior .\nThese findings are consistent with the WHO recommendations that artesunate is the drug of choice , but artemether is acceptable when artesunate is not available ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: Background Professional societies recommend shared decision making ( SDM ) for prostate cancer screening , however , most efforts have promoted informed rather than shared decision making . The objective of this study is to 1 ) examine the effects of a prostate cancer screening intervention to promote SDM and 2 ) determine whether framing prostate information in the context of other clearly beneficial men ’s health services affects decisions . Methods We conducted two separate r and omized controlled trials of the same prostate cancer intervention ( with or without additional information on more clearly beneficial men ’s health services ) . For each trial , we enrolled a convenience sample of 2 internal medicine practice s , and their interested physicians and male patients with no prior history of prostate cancer ( for a total of 4 practice s , 28 physicians , and 128 men across trials ) . Within each practice site , we r and omized men to either 1 ) a video-based decision aid and research er-led coaching session or 2 ) a highway safety video . Physicians at each site received a 1-hour educational session on prostate cancer and SDM . To assess intervention effects , we measured key components of SDM , intent to be screened , and actual screening . After finding that results did not vary by trial , we combined data across sites , adjusting for the r and om effects of both practice and physician . Results Compared to an attention control , our prostate cancer screening intervention increased men ’s perceptions that screening is a decision ( absolute difference + 41 % ; 95 % CI 25 to 57 % ) and men ’s knowledge about prostate cancer screening ( absolute difference + 34 % ; 95 % CI 19 % to 50 % ) , but had no effect on men ’s self-reported participation in shared decisions or their participation at their preferred level . Overall , the intervention decreased screening intent ( absolute difference −34 % ; 95 % CI −50 % to −18 % ) and actual screening rates ( absolute difference −22 % ; 95 % CI −38 to −7 % ) with no difference in effect by frame . Conclusions SDM interventions can increase men ’s knowledge , alter their perceptions of prostate cancer screening , and reduce actual screening . However , they may not guarantee an increase in shared decisions . Trial registration # BACKGROUND Whether the provision of evidence -based information improves satisfaction with decision-making is unclear . OBJECTIVE To examine whether information about risks and benefits of cancer screening leads to a higher satisfaction with the decision that was made . METHODS R and omized mail survey in the general population , among 2333 adults aged 30 - 60 years . The survey included a hypothetical cancer screening scenario that included varying amounts of information about benefits and risks of screening ( factorial r and omized design ) . The decision process was evaluated by a 6 item scale , with scores between 0 ( lowest score ) and 100 ( highest score ) . RESULTS Substantial proportions of respondents \" completely agreed \" that the decision reflected what was most important to them ( 61.2 % ) , were satisfied with their decision ( 56.0 % ) , were certain of their decision ( 54.1 % ) , thought that the best choice for them was obvious ( 53.5 % ) and that the decision was easy to make ( 44.1 % ) . The Cronbach alpha coefficient of the scale was 0.88 , the mean score was 82.5 , and the st and ard deviation 17.5 . Providing information about benefits increased the decision evaluation score only modestly ( + 1.1 , p=0.11 ) ; in contrast , providing information about risks sharply reduced the score ( -5.1 , p<0.001 ) . Those who refused the screening test had lower scores than those who accepted the screening test ( 69.2 versus 85.6 , p<0.001 ) . CONCLUSIONS Contrary to expectations , informing potential participants about the risks of cancer screening lowered their assessment of the decision process BACKGROUND Few health promotion trials have evaluated strategies to increase regular mammography screening . We conducted a r and omized controlled trial of two theory-based interventions in a population -based , nationally representative sample of women veterans . METHODS Study c and i date s 52 years and older were r and omly sample d from the National Registry of Women Veterans and r and omly assigned to three groups . Groups 1 and 2 received interventions that varied in the extent of personalization ( tailored and targeted vs targeted-only , respectively ) ; group 3 was a survey-only control group . Postintervention follow-up surveys were mailed to all women after 1 and 2 years . Outcome measures were self-reported mammography coverage ( completion of one postintervention mammogram ) and compliance ( completion of two postintervention mammograms ) . In decreasingly conservative analyses ( intention-to-treat [ ITT ] , modified intention-to-treat [ MITT ] , and per- protocol [ PP ] ) , we examined crude coverage and compliance estimates and adjusted for covariates and variable follow-up time across study groups using Cox proportional hazards regression . For the PP analyses , we also used logistic regression . RESULTS None of the among-group differences in the crude incidence estimates for mammography coverage was statistically significant in ITT , MITT , or PP analyses . Crude estimates of compliance differed at statistically significant levels in the PP analyses and at levels approaching statistical significance in the ITT and MITT analyses . Absolute differences favoring the intervention over the control groups were 1%-3 % for ITT analysis , 1%-5 % for MITT analysis , and 2%-6 % for the PP analysis . Results from Cox modeling showed no statistically significant effect of the interventions on coverage or compliance in the ITT , MITT , or PP analyses , although hazard rate ratios ( HRRs ) for coverage were consistently slightly higher in the intervention groups than the control group ( range for HRRs = 1.05 - 1.09 ) . A PP analysis using logistic regression produced odds ratios ( ORs ) that were consistently higher than the corresponding hazard rate ratios for both coverage and compliance ( range for ORs = 1.15 - 1.29 ) . CONCLUSIONS In none of our primary analyses did the tailored and targeted intervention result in higher mammography rates than the targeted-only intervention , and there was limited support for either intervention being more effective than the baseline survey alone . We found that adjustment for variable follow-up time produced more conservative ( less favorable ) intervention effect estimates BACKGROUND Many new drugs are aggressively promoted . The public may not realize that even with US Food and Drug Administration ( FDA ) approval , important uncertainties about the benefits and harms of these drugs remain . We assessed the US public 's underst and ing of the meaning of FDA drug approval and tested how brief explanations communicating drug uncertainties affect consumer choices . METHODS We conducted an Internet-based r and omized controlled trial using a national sample of US adults from a research panel of approximately 30,000 households . A total of 2944 participants were r and omized to receive 1 of 3 explanations about a pair of cholesterol drugs ( 1 approved based only on a surrogate outcome [ lower cholesterol ] and 1 based on a patient outcome [ reduced myocardial infa rct ions ] ) . Participants were r and omized a second time to receive 1 of 3 explanations about a pair of heartburn drugs ( 1 newly approved and 1 approved 8 years earlier ) . Controls received no explanation ; the nondirective group received explanations ( for the cholesterol drugs , surrogates do not always translate into patient outcomes ; for the heartburn drugs , it takes time to establish the safety of new drugs ) ; the directive group received explanations plus advice to \" Ask for a drug shown to reduce heart attacks or ask for one with a longer track record . \" The primary outcomes were choice : the cholesterol drug reducing myocardial infa rct ions , and the older heartburn drug . RESULTS Thirty-nine percent mistakenly believed that the FDA approves only \" extremely effective \" drugs ; 25 % mistakenly believed that the FDA approves only drugs without serious side effects . Explanations affected choices : 71 % of those in the directive group , 71 % in the nondirective group , and 59 % of controls chose the cholesterol drug that reduced myocardial infa rct ions ( absolute difference , 12 % [ 95 % confidence interval , 7%-18 % ] for each explanation vs control ) . For the heartburn drugs , 53 % of the directive group , 53 % of the nondirective group , and 34 % of controls chose the older drug ( absolute difference , 19 % [ 95 % confidence interval , 13%-24 % ] for each explanation vs control ) . CONCLUSIONS A substantial proportion of the public mistakenly believes that the FDA approves only extremely effective drugs and drugs lacking serious side effects . Brief explanations highlighting uncertainties about the benefit of drugs approved based on surrogate outcomes and the safety of new prescription drugs improved choices . Nondirective explanations worked as well as directive ones . TRIAL REGISTRATION clinical trials.gov Identifiers : NCT00950157 , NCT00950131 BACKGROUND Providing comprehensive information about the risks and benefits of cancer screening is ethically necessary , but information about risks may decrease participation . This study explored the impact of information on intended participation using a r and omised factorial design . METHODS We conducted a mail survey of 2333 adults living in Geneva , Switzerl and . Each participant was given one r and omly chosen version of a scenario that described a hypothetical cancer screening test , and was asked whether he or she would accept to undergo screening . The versions varied in terms of the amount of information about risks and benefits . RESULTS Respondents who received information about risks associated with screening were more likely to refuse participation ( odds ratio 2.6 ( 95 % confidence interval ( CI ) 2.0 - 3.5 ) ) than those who received minimal information . In contrast , information about benefits had no impact on intended participation ( odds ratio 1.0 ( 95 % CI 0.8 - 1.2 ) ) . The impact of information about risks was significantly stronger in women than in men , in respondents who were in poorer health , who have had a doctor visit in the past 6months , those who have had a cancer screening test in the past 3years , and those who reported a high desire for autonomy in medical decisions . CONCLUSIONS Informing potential participants about the risks of screening may reduce participation rates . Enhanced information about the benefits of screening does not counterbalance this effect BACKGROUND Public agencies responsible for implementing health care policies often adapt and disseminate clinical practice guidelines , but the effectiveness of mass dissemination of guidelines is unknown . AIM To study the effects of guideline dissemination on physicians ' prescribing practice s for the treatment of stable angina pectoris . DESIGN R and omized controlled trial . METHODS A sample of 3293 Quebec physicians were r and omly assigned to receive a one-page summary of clinical practice guidelines on the treatment of stable angina ( in February 1999 ) , to receive the summary and a reminder ( in February and March 1999 , respectively ) , or to receive no intervention ( controls ) . The prescribing profiles of participants , as well as sociodemographic characteristics of the physicians and their patients , were examined for June-December 1999 . RESULTS The intervention had no effect on prescription rates of beta-blockers , antiplatelet agents , or hypolipaemic drugs . Compared to 1997 data for the same physicians , there was an overall 10 % increase in appropriate prescription rates , irrespective of the intervention . DISCUSSION In-house production and dissemination of clinical practice guidelines may not improve physicians ' practice patterns if there is pre-existing substantial scientific consensus on the issue Doctors commonly use genomic testing for breast cancer recurrence risk . We sought to assess whether the st and ard genomic report provided to doctors is a good approach for communicating results to patients . During 2009–2010 , we interviewed 133 patients with stages I or II , node-negative , hormone receptor – positive breast cancer and eligible for the Oncotype DX genomic test . In a r and omized experiment , patients viewed six vignettes that presented hypothetical recurrence risk test results . Each vignette described a low , intermediate , or high chance of breast cancer recurrence in 10 years . Vignettes used one of five risk formats of increasing complexity that we derived from the st and ard report that accompanies the commercial assay or a sixth format that used an icon array . Among women who received the genomic recurrence risk test , 63 % said their doctors showed them the st and ard report . The st and ard report format yielded among the most errors in identification of whether a result was low , intermediate , or high risk ( i.e. , the gist of the results ) , whereas a newly developed risk continuum format yielded the fewest errors ( 17 % vs. 5 % ; OR 0.23 ; 95 % CI 0.10–0.52 ) . For high recurrence risk results presented in the st and ard format , women made errors 35 % of the time . Women rated the st and ard report as one of the least underst and able and least-liked formats , but they rated the risk continuum format as among the most underst and able and most liked . Results differed little by health literacy , numeracy , prior receipt of genomic test results during clinical care , and actual genomic test results . The st and ard genomic recurrence risk report was more difficult for women to underst and and interpret than the other formats . A less complex report , potentially including the risk continuum format , would be more effective in communicating test results to patients BACKGROUND Few studies compare the influence of different types of dietary interventions on the dietary practice s of Latinas in the short and long term . The present study examined the 1-year impact of two innovative behavior-change approaches to reduce dietary fat and increase fiber . DESIGN Three-group r and omized controlled \n Output:\n " }, { "from": "agent", "value": "For KQ 1 , we found that investigators frequently blend more than one communication strategy in interventions .\nFor KQ 2 , we found that , compared with single dissemination strategies , multicomponent dissemination strategies are more effective at enhancing clinician behavior , particularly for guideline adherence .\nKey findings for KQ 3 indicate that evidence on communicating overall strength of recommendation and precision was insufficient , but certain ways of communicating directness and net benefit may be helpful in reducing uncertainty .\nThe lack of comparative research evidence to inform communication and dissemination of evidence , including uncertain evidence , impedes timely clinician , patient , and policymaker awareness , uptake , and use of evidence to improve the quality of care ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: BACKGROUND Oral contraceptive ( OC ) knowledge deficits may contribute to OC discontinuation . We examined the effect of an innovative educational intervention on young women 's OC knowledge . STUDY DESIGN As part of a r and omized trial evaluating the impact of text message reminders on OC continuation , we assessed OC knowledge in 659 women ages 13 - 25 years . Women received routine care or routine care plus 6 months of daily educational text messages . We administered a comprehensive 41-item OC knowledge survey at baseline and 6 months . RESULTS Mean OC knowledge scores improved over time for all women ( baseline 22.8 , 56 % correct versus 24.7 , 60 % at 6 months ) , including knowledge of OC 's mechanisms of action ( p=.004 ) , effectiveness ( p<.001 ) , side effects ( p=.03 ) and benefits ( p<.001 ) . Mean 6-month scores were greater in the intervention ( 25.5 ) than the control group (23.7)(p<.001 ) . In multivariable linear regression models , the text message intervention most strongly predicted OC knowledge ( β=1.6 , 95 % confidence interval 0.9 - 2.2 ) . CONCLUSION Daily educational text messages can modestly improve knowledge of OCs , which may promote successful contraceptive outcomes Objectives To compare two post-abortion family planning ( FP ) service packages on contraceptive use and repeat abortion rate among young women in three cities in China . Methods In this cluster-r and omized trial , one FP service package included provision of limited information and referral to existing FP services , and the other , more comprehensive , package consisted – in addition to the above simple package – of individual counselling , free provision of contraceptive material s , and involvement of the male partner . Eight matched pairs of hospitals were certified by central ized r and omization . Women undergoing abortion were followed up for six months , and data were collected in two rounds , before and after the intervention . Results We followed a total of 2336 women younger than 25 years ( 555 before and 555 after the simple intervention package ; 634 before and 592 after the comprehensive intervention package ) . Both packages increased use of any contraceptive method , but the comprehensive approach also increased use of more effective methods . Odds ratios for consistent and correct use of condoms were 2.32 ( 95 % confidence interval 1.55–3.46 ) and 2.78 ( 1.81–4.26 ) , respectively , compared with the simple package . The rates of unwanted pregnancies and repeat abortions were somewhat reduced for both packages , with no significant statistical difference between them . Conclusion Couples who received the comprehensive post-abortion FP service appear to use more effective contraceptive methods and show better compliance OBJECTIVE To evaluate the success of efforts to educate youth not only to use prescription contraceptives to avoid pregnancy , but also to use condoms to avoid sexually transmitted diseases , including infection with the human immunodeficiency virus . METHODS Longitudinal study of 383 African-American youth aged 9 to 15 years enrolled in a r and omized , controlled trial of an acquired immunodeficiency syndrome ( AIDS ) risk reduction intervention . Data about contraceptive practice s were obtained at baseline and 6 , 12 , and 18 months later using a culturally and developmentally appropriate risk assessment tool administered with \" talking \" computers ( Macintosh , Apple Computer Inc , Cupertino , Calif ) . RESULTS Approximately three fourths of sexually active youth used some form of contraception in each 6-month round , with almost half of the youth using combinations of contraceptives . Among all youth at baseline and among control youth throughout the study , more than half used condoms and more than two thirds who used oral contraceptives also used condoms . Receipt of an AIDS education intervention was associated with use of more effective contraceptive practice s ( eg , condoms and another prescription or nonprescription method of birth control ) . After receiving the intervention , more than 80 % of the youth who used oral contraceptives also used condoms . Contraceptive practice s showed considerable stability . Knowledge about AIDS was positively associated with use of more effective contraceptive methods . CONCLUSIONS Many youth are using condoms and prescription birth control simultaneously , and these use rates can be increased through AIDS education interventions OBJECTIVE : To estimate whether daily educational text messages affect oral contraceptive pill ( OCP ) continuation at 6 months . METHODS : We r and omized young women electing OCPs at an urban family planning health center to either routine care or routine care plus 180 days of daily educational text messages . Investigators masked to treatment allocation r and omized participants who were not masked to treatment . The primary outcome measure was self-reported OCP continuation through a telephone call at 6 months ( contacts between 5 and 8 months ) . RESULTS : We enrolled 962 participants ( 480 intervention and 482 routine care ) and obtained continuation data on 683 ( 346 and 337 , respectively ) . At the follow-up , 64 % of participants r and omized to the intervention were still OCP users compared with 54 % of the routine care group ( P=.005 ) . Continuation was highest in the intervention group if the interview took place while the intervention was ongoing ( 75 % compared with 54 % , P=.003 ) ; the effect of the intervention on continuation was less after the intervention ended ( 60 % compared with 54 % , P=.16 ) . Participants receiving the intervention were more likely to continue oral contraception than control participants at 6 months ( odds ratio 1.44 , 95 % confidence interval 1.03–2.00 ) in analyses adjusted for age , race or ethnicity , age at coitarche , pregnancy history , and OCP experience . CONCLUSION : The use of daily educational text messages improves OCP continuation at 6 months over routine care alone . Ten women would need to receive this simple intervention to improve continuation in one . This effect is strongest in the women whose follow-up took place while the text intervention was ongoing . CLINICAL TRIAL REGISTRATION : Clinical Trials.gov , www . Clinical Trials.gov , NCT00677703 . LEVEL OF EVIDENCE : CONTEXT Adolescent females often have questions or concerns about their contraceptive methods , and they may discontinue use if these questions are not answered . Little evidence exists on whether follow-up phone calls to address young women 's concerns can help sustain contraceptive use . METHODS Between 2005 and 2007 , a total of 805 females aged 14 - 18 attending a reproductive health clinic in San Francisco were r and omly assigned to receive either regular clinic services or regular clinic services plus nine follow-up phone calls over 12 months . The young women were surveyed at baseline and roughly six , 12 and 18 months later to measure condom and contraceptive use , rates of pregnancy and STDs , and other outcomes and mediators . Multiple linear and logistic regression repeated measures analyses were used to assess the program 's effects . RESULTS Clinic counselors completed only 2.7 calls per patient , and made 7.8 attempts for every completed call . Although contraceptive use increased from baseline to follow-up at six months in both groups , levels of condom and contraceptive use , and rates of pregnancy and STDs , did not differ between the intervention and control groups at any of the follow-up assessment s. Moreover , the intervention did not improve clinic utilization or satisfaction or have consistent positive effects on participants ' attitudes . CONCLUSIONS Reaching young women by phone after a clinic visit for contraception is challenging and does not appear to provide significant benefits beyond those provided by basic clinic services . More intensive interventions may be needed to markedly change adolescent sexual and contraceptive behavior OBJECTIVE To evaluate the impact of a preconception counseling program tailored for teens with type 1 diabetes on cognitive , psychosocial , and behavioral outcomes and to assess its cost-effectiveness . RESEARCH DESIGN AND METHODS A total of 88 teens with type 1 diabetes from two sites were r and omized into the READY-Girls ( Reproductive-health Education and Awareness of Diabetes in Youth for Girls ) intervention ( IG ) ( n = 43 ) or st and ard care ( SC ) ( n = 45 ) groups . During three diabetes clinic visits , IG subjects viewed a two-part CD-ROM , read a book , and met with a nurse . Program effectiveness was measured by knowledge , attitudes , intentions , and behaviors regarding diabetes , pregnancy , sexuality , and preconception counseling . Assessment s occurred at baseline , before and after viewing program material s , and at 9 months . Economic analyses included an assessment of re source utilization , direct medical costs , and a break-even cost analysis . RESULTS Age range was 13.2–19.7 years ( mean ± SD 16.7 ± 1.7 years ) ; 6 % ( n = 5 ) were African American , and 24 % ( n = 21 ) were sexually active . Compared with baseline and SC subjects , IG subjects demonstrated a significant group-by-time interaction for benefit and knowledge of preconception counseling and reproductive health : increasing immediately after the first visit ( P < 0.001 ) and being sustained for 9 months ( P < 0.05 benefits ; P < 0.001 knowledge ) . For IG subjects , preconception counseling barriers decreased over time ( P < 0.001 ) , and intention and initiation of preconception counseling and reproductive health discussion s increased ( P < 0.001 ) . Costs of adverse reproductive outcomes are high . Direct medical costs of READY-Girls were low . CONCLUSIONS READY-Girls was beneficial and effects were sustained for at least 9 months . This low-cost self-instructional program can potentially empower young women with type 1 diabetes to make well-informed reproductive health choices , adding little time burden or cost to their diabetes management Recent efforts to involve patients more actively in therapeutic decisions have suggested the relevance of computer-based interventions at clinic visits . This paper presents a longitudinal , experimental study evaluating a computer-based contraceptive decision aid in Chicago and Madison family planning clinic visits . Patient interviews at three time points evaluated patient acceptance by and program impact on 949 young women . Both Chicago and Madison patients reported high acceptance . The program result ed in improved short-term knowledge and confidence in oral contraceptive ( OC ) efficacy for Chicago and Madison patients . In addition , compared to their control group , Madison experimental group patients had higher OC knowledge 1 year after the initial visit and a trend for fewer pregnancies ( P < 0.074 ) . Compared to their control group , a higher percent of the Chicago experimental group patients adopted OC 's after stating their intention to do so at the initial visit . Exposure to the computer program had no observable impact on the number of months on the oral contraceptive for Chicago or Madison patients . Overall findings suggest the usefulness of informatics tools as a supplement to patient-provider interactions Many college women are at risk for pregnancy , and binge drinking college women are often at risk for alcohol-exposed pregnancy . Brief interventions with sustainable outcomes are needed , particularly for college women who are binge drinking , at risk for pregnancy , and at increased risk of alcohol-exposed pregnancy . Two-hundred-twenty-eight women at a Mid-Atlantic urban university at risk for alcohol-exposed pregnancy enrolled in the r and omized clinical trial , and 207 completed the 4 month follow-up . The BALANCE intervention used Motivational Interviewing plus feedback to target drinking and contraception behaviors . Main outcome measures included ( 1 ) the rate of risk for alcohol-exposed pregnancy , ( 2 ) the rate of risk drinking , and ( 3 ) the rate of pregnancy risk . At 4-month follow-up , the rate of alcohol-exposed pregnancy risk was significantly lower in the intervention ( 20.2 % ) than the control condition ( 34.9 % ) , ( P < .02 ) . Assignment to the intervention condition halved the odds of women remaining at risk for alcohol-exposed pregnancy , while not receiving the intervention doubled the odds of continued alcohol-exposed pregnancy risk ( OR = 2.18 ; 95 % CI = 1.16–4.09 ) . A baseline history of blackouts , continued high blood alcohol drinking days at 1 month , and continued risk for pregnancy at 1 month independently contributed to a multivariate model of continued alcohol-exposed pregnancy risk at 4 month follow-up . BALANCE reduced alcohol-exposed pregnancy risk , with similar outcomes to longer interventions . Because early response predicted sustained alcohol-exposed pregnancy risk reduction , those who fail to achieve initial change could be identified for further intervention . The BALANCE intervention could be adopted into existing student health or university alcohol programs . The risks of unintended pregnancy and alcohol-exposed pregnancy among binge drinking women in college merit greater prevention efforts A significant number of college women are at risk for alcohol-exposed pregnancy ( AEP ) owing to binge drinking paired with using contraception ineffectively . This article describes a r and omized controlled trial of a one-session motivational interviewing-based intervention to reduce AEP risk among college women and presents 1-month outcomes demonstrating the early impact of this intervention . There were 228 female students from a mid-Atlantic urban university enrolled in the trial . Eligibility criteria were being in the age range of 18 - 24 years and being at risk for AEP . Risk for AEP was defined as having sexual intercourse with a man in the past 90 days while using contraception ineffectively ( no \n Output:\n " }, { "from": "agent", "value": "Few studies tested brief strategies for young people .\nMore intensive strategies could be more effective , but would also be challenging for many clinics to implement" } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: Abstract Objective : To assess the medicalising effect of prescribing antibiotics for sore throat . Setting : 11 general practice s in Engl and . Design : R and omised trial of three approaches to sore throat : a 10 day prescription of antibiotics , no antibiotics , or a delayed prescription if the sore throat had not started to settle after three days . Patients : 716 patients aged 4 and over with sore throat and an abnormal physical sign : 84 % had tonsillitis or pharyngitis . Outcome measures : Number and rate of patients making a first return with sore throat , pharyngitis , or tonsillitis . Early returns ( within two weeks ) and complications ( otitis media , sinusitis , quinsy ) . Outcomes were documented in 675 subjects ( 94 % ) . Results : Mean follow up time was similar ( antibiotic group 1.07 years , other two groups 1.03 years ) . More of those initially prescribed antibiotics initially returned to the surgery with sore throat ( 38 % v 27 % , adjusted hazard ratio for return 1.39 , 95 % confidence interval 1.03 to 1.89 ) . Antibiotics prescribed for sore throat during the previous year had an additional effect ( hazard ratio 1.69 , 1.20 to 2.37 ) . Longer duration of illness ( > 5 days ) was associated with increased return within six weeks ( hazard ratio 2.90 , 1.70 to 4.92 ) . Prior attendance with upper respiratory conditions was also associated with increased reattendance . There was no difference between groups in early return ( 13/238 ( 5.5 % ) v 27/437 ( 6 % ) ) , or complications ( 2/236 ( 0.8 % ) v3/434 ( 0.7 % ) ) . Conclusions : Complications and early return result ing from no or delayed prescribing of antibiotics for sore throat are rare . Both current and previous prescribing for sore throat increase reattendance . To avoid medicalising a self limiting illness doctors should avoid antibiotics or offer a delayed prescription for most patients with sore throat . Key messages Sore throat is one of the commonest presentations of upper respiratory illness in primary care and attendence is increasing Complications are rare with no , or delayed , antibiotic prescription Prescribing antibiotics increases reattendance for future episodes Unless patients are very ill general practitioners should consider exploring concerns , explain the natural history , and avoid or delay prescribing In this double-blind study of 60 infants with undifferentiated respiratory diseases , antibiotics seemed of no benefit in shorten ing the median duration of illness or in preventing secondary complications . The conclusion is drawn that the danger of complications from the antibiotics them selves is greater than the good which many physicians believe that antibiotics produce in such diseases The benefits of antibiotic treatment and a nasopharyngeal culture in children with longst and ing cough were analysed in a prospect i ve r and omized open study . Clinical ly suspected pertussis was excluded . Of 40 children given erythromycin for 7 days , 35 ( 88 % ) recovered in one week , compared with 17/47 ( 36 % ) untreated ( p < 0.0001 ) . Erythromycin eliminated Moraxella catarrhalis from the nasopharynx in 21/31 children ( 68 % ) , compared with spontaneous disappearance in 7/35 ( 20 % ) untreated controls ( p < 0.001 ) . Purulent bronchitis or otitis media occurred in 2 children ( 5 % ) in the treatment group and in 21 ( 45 % ) in the control group ( p < 0.01 ) . To evaluate the clinical role of isolated pathogens , the 47 untreated subjects were studied . Seven of 35 children harbouring M. catarrhalis recovered , compared with 8/12 in whom this bacterium was absent ( p < 0.01 ) . No correlation was found between the isolation of Haemophilus influenzae or Streptococcus pneumoniae and the clinical outcome . Children with persistent cough > 10 days may benefit from erythromycin treatment . M. catarrhalis in the nasopharynx indicates prolonged symptoms and increased risk of bacterial complications The clinical responses of children with upper respiratory infections to 1 of 3 treatment regimens ( tetracycline , penicillin , and placebo ) were evaluated in relation to the bacterial and viral pathogens cultured from nasopharyngeal swabs . The 3 treatment groups were similar in size and in the frequency and type of pathogens recovered . The groups did not differ in their response to the treatment regimens in terms of mean duration of fever , failure to improve , the development of complications , or the persistance of bacterial pathogens in the nasopharynx Abstract The recommended treatment for mild acute respiratory infections ( ARI ) in children is supportive care only , but many physicians , especially in developing countries , continue to prescribe antibiotic treatment because they believe it prevents progression to more severe ARI . To find out whether ampicillin treatment conferred any benefit over supportive care alone , a r and omised , controlled trial was carried out among 889 children ( under 5 years ) with mild ARI in Indonesia . 447 were r and omly allocated ampicillin ( 25 - 30 mg/kg body weight three times daily for 5 days ) plus supportive care ( continued breastfeeding , clearing of the nose , and paracetamol to control fever ) ; 442 were allocated supportive care only . The treatment groups were almost identical after r and omisation in terms of age , sex , level of parental education , history of measles immunisation , and fever . After 1 week the percentages cured were nearly identical ( 204 [ 46 % ] ampicillin ; 209 [ 47 % ] control ) , as were the percentages of cases progressing to moderate ARI ( 56 [ 13 % ] vs 53 [ 12 % ] ) . The effect of treatment was not modified by age , sex , measles immunisation status , or the educational level of the parents . At the 2-week follow-up , the percentages cured were 62 % ( 277 ) in the ampicillin group and 58 % ( 256 ) in the control group ; 14 % of both groups had progressed to moderate ARI ; and 24 % ( 107 ) and 28 % ( 123 ) , respectively , still had mild ARI . None of the differences in outcome between the ampicillin and control groups was statistically significant . Thus , ampicillin plus supportive care offers no benefit over supportive care alone for treatment of mild ARI in young Indonesian children One hundred forty-two children with purulent nasopharyngitis were r and omized to four treatment groups with an antibiotic ( cephalexin ) alone or combined with a decongestant/ antihistamine ( pseudoephedrine/triprolidine ) or their corresponding placebo equivalents . Follow-up evaluations by parents and physicians and bacteriologic evaluations were performed after 5 to 6 days of therapy . Groups were comparable with regard to age , sex , race , number of patients withdrawn from the study , fever greater than 38.0 dec , appearance of nasal discharge , nasal crusting and number of days until follow-up . Initial cultures from patients grew : Streptococcus pneumoniae , 46 % ; Haemophilus influenzae type b , 21 % ; and Streptococcus pyogenes , 8 % . Nasal crusting was significantly associated with the growth of S. pneumoniae or H. influenzae type b. There were no significant differences between active drug and placebo treatment groups for change in nasal discharge , complications or apparent drug benefit . Cephalexin therapy did not result in a decrease in cultivation of pathogenic organisms from the nasopharynx . Significantly more side effects were attributed to pseudoephedrine/triprolidine treatment than to placebo . Routine culture or treatment of purulent nasopharyngitis should not be considered unless future controlled clinical trials demonstrate some therapeutic benefit 52 children with severe cough persisting for more than 10 days were r and omized to treatment with amoxycillin/clavulanic acid or placebo in a prospect i ve double-blinded study . Clinical ly suspected cases of pertussis were excluded , yet 12 ( 23 % ) of the children had laboratory verified pertussis infection . The nasopharyngeal colonization showed a predominance of Moraxella catarrhalis which was isolated in 37 ( 71 % ) children . Streptococcus pneumoniae and Haemophilus influenzae were isolated in 11 ( 20 % ) and 16 ( 30 % ) children , respectively . The antibiotic-treated group had a significantly better recovery in both the pediatrician 's estimation ( p = 0.02 ) and the independent parental judgement ( p = 0.002 ) . These findings are consistent with the view that Moraxella catarrhalis could be directly involved in the pathogenesis of persistent cough in children \n Output:\n " }, { "from": "agent", "value": "In view of the lack of efficacy and low complication rates , antibiotic treatment of children with URTI is not supported by current evidence from r and omised trials ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: OBJECTIVE Because of its high prevalence and serious consequences for victims , sexual violence is a significant problem on college campuses . Sexual assault prevention programs based on the byst and er intervention model have been shown to be effective ; however , current programs are limited in terms of ease of distribution . To address this issue , we developed and evaluated \" Take Care , \" an online byst and er intervention program . To our knowledge , this is the first empirical evaluation of an online byst and er intervention program design ed to prevent sexual violence . METHOD Ninety-three participants ( 80.6 % female , 19.4 % male ) recruited from social psychology classes at a mid-size university were r and omly assigned to view one of two online programs : Take Care or a control program on study skills . Before viewing the programs , participants completed measures of byst and er behaviors and feelings of efficacy for performing such behaviors . Measures were administered again post-intervention and at a two-month follow-up assessment . RESULTS Participants who viewed Take Care reported greater efficacy for engaging in byst and er behaviors at post-treatment and two months following treatment , compared to those who viewed the control program . In addition , participants who viewed Take Care reported performing relatively more byst and er behaviors for friends at the two-month follow-up assessment , compared to participants who viewed the control program . CONCLUSIONS These results suggest that sexual violence prevention programs may be effectively adapted to an online format Background Byst and er intervention approaches offer promise for reducing rates of sexual violence on college campuses . Most interventions are in-person small-group formats , which limit their reach and reduce their overall public health impact . Objective This study evaluated the efficacy of RealConsent , a Web-based byst and er approach to sexual violence prevention , in enhancing prosocial intervening behaviors and preventing sexual violence perpetration . Methods A r and om probability sample of 743 male undergraduate students ( aged 18 to 24 years ) attending a large , urban university located in the southeastern United States was recruited online and r and omized to either RealConsent ( n=376 ) or a Web-based general health promotion program ( n=367 ) . Participants were surveyed online at baseline , postintervention , and 6-months postintervention . RealConsent was delivered via a password-protected Web portal that contained six 30-minute media-based and interactive modules covering knowledge of informed consent , communication skills regarding sex , the role of alcohol and male socialization in sexual violence , empathy for rape victims , and byst and er education . Primary outcomes were self-reported prosocial intervening behaviors and sexual violence perpetration . Secondary outcomes were theoretical mediators ( eg , knowledge , attitudes ) . Results At 6-month follow-up RealConsent participants intervened more often ( P=.04 ) and engaged in less sexual violence perpetration ( P=.04 ) compared to controls . In addition , RealConsent participants reported greater legal knowledge of sexual assault ( P<.001 ) , greater knowledge of effective consent ( P<.001 ) , less rape myths ( P<.001 ) , greater empathy for rape victims ( P<.001 ) , less negative date rape attitudes ( P<.001 ) , less hostility toward women ( P=.01 ) , greater intentions to intervene ( P=.04 ) , less hyper-gender ideology ( P<.001 ) , less positive outcome expectancies for nonconsensual sex ( P=.03 ) , more positive outcome expectancies for intervening ( P<.001 ) , and less comfort with other men ’s inappropriate behaviors ( P<.001 ) . Conclusions Our results support the efficacy of RealConsent . Due to its Web-based format , RealConsent has potential for broad-based dissemination thereby increasing its overall public health impact on sexual violence . Trial Registration Clinical trials.gov : NCT01903876 ; http:// clinical trials.gov/show/NCT01903876 ( Archived by WebCite at http://www.webcitation.org/6S1PXxWKt ) Colleges and universities are high-risk setting s for sexual and relationship violence . To address these problems , institutions of higher education have implemented prevention programs , many of which train students as potential byst and ers who can step in to help diffuse risky situations , identify and challenge perpetrators , and assist victims . The impact of byst and er sexual and relationship violence prevention programs on long-term behavior of byst and ers has remained a key unanswered question for those who seek to offer the most effective programs as well as for policy makers . In this study , the research ers experimentally evaluated the effectiveness of the Bringing in the Byst and er ® in-person program . Participants were 948 1st-year college students of whom 47.8 % were women and 85.2 % identified as White ( 15 % also identified as Hispanic in a separate question ) between the ages of 18 and 24 at two universities ( one a rural , primarily residential campus and the other an urban , highly commuter campus ) in the northeastern United States . To date , this is the first study to have found positive behavior changes as long-lasting as 1 year following an educational workshop focusing on engaging byst and ers in preventing sexual and relationship violence . Even so , many questions remain to be answered about prevention and intervention of this type . More prospect i ve research is needed on byst and er-focused prevention of these forms of violence to help underst and and better predict the complicated relationships both between and among the attitudes and behaviors related to preventing sexual and relationship violence . In this regard , we make specific recommendations for design ing and evaluating programs based on our findings relating to the importance of moderators , especially two key understudied ones , readiness to help and opportunity to intervene Using a cross-sectional survey of a r and om sample of 7,945 college undergraduates , we report on the association between having received Green Dot active byst and er behavior training and the frequency of actual and observed self-reported active byst and er behaviors as well as violence acceptance norms . Of 2,504 students aged 18 to 26 who completed the survey , 46 % had heard a Green Dot speech on campus , and 14 % had received active byst and er training during the past 2 years . Trained students had significantly lower rape myth acceptance scores than did students with no training . Trained students also reported engaging in significantly more byst and er behaviors and observing more self-reported active byst and er behaviors when compared with nontrained students . When comparing self-reported active byst and er behavior scores of students trained with students hearing a Green Dot speech alone , the training was associated with significantly higher active byst and er behavior scores . Those receiving byst and er training appeared to report more active byst and er behaviors than those simply hearing a Green Dot speech , and both intervention groups reported more observed and active byst and er behaviors than nonexposed students The aim of the present study was to investigate two interventions based on Acceptance and Commitment Therapy ( ACT ) for depressive symptoms : A face-to-face treatment ( ACT group ) was compared to a guided self-help treatment delivered via the Internet consisting of two assessment sessions ( pre and post ) and an ACT-based Internet program ( iACT ) . Out patients experiencing at least mild depressive symptoms were r and omized to either approach . The iACT treatment group received access to an ACT-based Internet program and supportive web-based contact over a period of 6 weeks . The face-to-face group received ACT-based treatment once a week over the same period of time . In both groups , the results showed a significant effect on depression symptomatology , and general wellbeing after treatment and at the 18-month follow-up . However , the data indicated that the iACT group changed differently regarding depressive symptoms and wellbeing as compared to the face-to face ACT group . Results showed large pre-treatment to 18-month follow-up within-group effect sizes for all symptom measures in the iACT treatment group ( 1.59 - 2.08 ) , and for most outcome measures in the face-to-face ACT group ( 1.12 - 1.37 ) . This non-inferiority study provides evidence that guided Internet-delivered ACT intervention can be as effective as ACT-based face-to-face treatment for out patients reporting depressive symptoms , and it may offer some advantages over a face-to-face intervention Dating violence is a significant problem for older adolescents with implication s for the survivor 's health . Survivors disclose the violence to friends who are often ill equipped to help them manage the consequences . The purpose of this pilot study was to evaluate the effectiveness and feasibility of Friends Helping Friends , a community-level education program to teach older adolescents to recognize and intervene in dating violence . A convenience sample of 101 students aged 18 to 22 years were nonr and omly allocated to a treatment or control group and completed pre- and post-test measures . Compared with the control group , treatment group participants reported increased perceived responsibility to help , skills to act as a byst and er , and intention to help and decreased rape myth acceptance . Friends Helping Friends shows promise as an effective strategy for older adolescent females in the prevention and response to dating violence OBJECTIVE The present research reports on two r and omized controlled trials evaluating TakeCARE , a video byst and er program design ed to help prevent sexual violence on college campuses . METHOD In Study 1 , students were recruited from psychology courses at two universities . In Study 2 , first-year students were recruited from a required course at one university . In both studies , students were r and omly assigned to view one of two videos : TakeCARE or a control video on study skills . Just before viewing the videos , students completed measures of byst and er behavior toward friends and ratings of self-efficacy for performing such behaviors . The efficacy measure was administered again after the video , and both the byst and er behavior measure and the efficacy measure were administered at either one ( Study 1 ) or two ( Study 2 ) months later . RESULTS In both studies , students who viewed TakeCARE , compared to students who viewed the control video , reported engaging in more byst and er behavior toward friends and greater feelings of efficacy for performing such behavior . In Study 1 , feelings of efficacy mediated effects of TakeCARE on byst and er behavior ; this result did not emerge in Study 2 . CONCLUSIONS This research demonstrates that TakeCARE , a video byst and er program , can positively influence byst and er behavior toward friends . Given its potential to be easily distributed to an entire campus community , TakeCARE might be an effective addition to campus efforts to prevent sexual violence Abstract Rape myth acceptance , likelihood of raping , and sexually coercive behavior of 145 fraternity men r and omly assigned to a control group or a rape-prevention program were surveyed . One third of 23 fraternities on a mid-Atlantic public university campus volunteered to participate in the study . The rape-prevention intervention consisted of “ the men 's program , ” a victim empathy-based presentation titled “ How to help a sexual assault survivor : What men can do . ” Although no evidence of change in sexually coercive behavior was found , significant 7-month declines in rape myth acceptance and the likelihood of committing rape were shown among program participants . In the case of rape myth acceptance , the 7-month decrement remained lower in the participant group than in the control group . Implication s of using these initial findings from the men 's program for rape-prevention programming are discussed OBJECTIVE The aim of this study was to compare the outcomes following an eight-session , small group , therapist-led , intervention for body dissatisfaction , and disordered eating in adult women , delivered either in face-to-face or synchronous , internet mode . METHOD Community women with high body dissatisfaction and internet access were r and omly assigned to either face-to-face delivery ( N = 42 ) , internet delivery ( N = 37 ) , or delayed treatment control ( N = 37 ) . All groups were assessed at baseline and 8 - 9 weeks later . The intervention groups were reassessed at 6-months follow-up . RESULTS Both intervention groups showed large improvements in body dissatisfaction compared with the delayed treatment control and these improvements were maintained at follow-up . However , posttreatment improvements were greater in the face-to-face than internet intervention . CONCLUSION In adult women , it is desirable to deliver the body image intervention in a face-to-face mode , but the internet mode is effective and has the potential to increase access to therapy This article reports findings from a longitudinal , experimental evaluation of a peer education theater program , Students Challenging Realities and Educating Against Myths ( SCREAM ) Theater . This study examines the impact of SCREAM Theater on a range of byst and er-related outcomes ( i.e. byst and er intentions , byst and er efficacy , perception of friend norms and byst and er behaviors ) in situations involving sexual violence and whether there was a differential impact of the program by participant sex . First-year college students completed three waves of surveys ( pretest , first post-test and second post-test ) . All participants received one dose of the intervention during summer orientation after the pretest . After the first post-test , participants were r and omly assigned to receive two additional doses , or to a control condition , in which they received no additional doses . Students in both one- and three-dose groups reported a number of positive increases . Overall , an intent-to-treat analysis ( n = 1390 ) indicated three doses of the intervention during the first semester of college result ed in better outcomes than the one-time intervention during summer orientation alone . Although both male and female students ' scores increased during the study period , female students consistently scored higher than male students on each outcome . The findings suggest that peer education theater holds promise for byst and er intervention education on college campuses \n Output:\n " }, { "from": "agent", "value": "Results : Students who participated in a byst and er program , compared to those who had not , had more pro-social attitudes/beliefs about sexual violence and intervening to prevent it , and engaged in more byst and er behavior .\nProgram effects diminished over time , but meaningful changes persisted for at least three months following program delivery .\nLonger programs had greater effects than shorter programs on attitudes/beliefs .\nConclusions : Byst and er programs can be a valuable addition to colleges ' violence prevention efforts" } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: R and omized controlled trials ( RCTs ) are conducted under idealized and rigorously controlled conditions that may compromise their external validity . A literature review was conducted of published English language articles that reported the findings of studies assessing external validity by a comparison of the patient sample included in RCTs reporting on pharmaceutical interventions with patients from everyday clinical practice . The review focused on publications in the fields of cardiology , mental health , and oncology . A range of data bases were interrogated ( MEDLINE ; EMBASE ; Science Citation Index ; Cochrane Methodology Register ) . Double- abstract review and data extraction were performed as per protocol specifications . Out of 5,456 de-duplicated abstract s , 52 studies met the inclusion criteria ( cardiology , n = 20 ; mental health , n = 17 ; oncology , n = 15 ) . Studies either performed an analysis of the baseline characteristics ( demographic , socioeconomic , and clinical parameters ) of RCT -enrolled patients compared with a real-world population , or assessed the proportion of real-world patients who would have been eligible for RCT inclusion following the application of RCT inclusion /exclusion criteria . Many of the included studies concluded that RCT sample s are highly selected and have a lower risk profile than real-world population s , with the frequent exclusion of elderly patients and patients with co-morbidities . Calculation of in eligibility rates in individual studies showed that a high proportion of the general disease population was often excluded from trials . The majority of studies ( n = 37 [ 71.2 % ] ) explicitly concluded that RCT sample s were not broadly representative of real-world patients and that this may limit the external validity of the RCT . Authors made a number of recommendations to improve external validity . Findings from this review indicate that there is a need to improve the external validity of RCTs such that physicians treating patients in real-world setting s have the appropriate evidence on which to base their clinical decisions . This goal could be achieved by trial design modification to include a more representative patient sample and by supplementing RCT evidence with data generated from observational studies . In general , a thoughtful approach to clinical evidence generation is required in which the trade-offs between internal and external validity are considered in a holistic and balanced manner Background Patients with schizophrenia have lower longevity than the general population as a consequence of a combination of risk factors connected to the disease , lifestyle and the use of medications , which are related to weight gain . Methods A multicentric , r and omized , controlled-trial was conducted to test the efficacy of a 12-week group Lifestyle Wellness Program ( LWP ) . The program consists of a one-hour weekly session to discuss topics like dietary choices , lifestyle , physical activity and self-esteem with patients and their relatives . Patients were r and omized into two groups : st and ard care ( SC ) and st and ard care plus intervention ( LWP ) . Primary outcome was defined as the weight and body mass index ( BMI ) . Results 160 patients participated in the study ( 81 in the intervention group and 79 in the SC group ) . On an intent to treat analysis , after three months the patients in the intervention group presented a decrease of 0.48 kg ( CI 95 % -0.65 to 1.13 ) while the st and ard care group showed an increase of 0.48 kg ( CI 95 % 0.13 to 0.83 ; p=0.055 ) . At six-month follow-up , there was a significant weight decrease of −1.15 kg , ( CI 95 % -2.11 to 0.19 ) in the intervention group compared to a weight increase in the st and ard care group ( + 0.5 kg , CI 95 % -0.42–1.42 , p=0.017 ) . Conclusion In conclusion , this was a multicentric r and omized clinical trial with a lifestyle intervention for individuals with schizophrenia , where the intervention group maintained weight and presented a tendency to decrease weight after 6 months . It is reasonable to suppose that lifestyle interventions may be important long-term strategies to avoid the tendency of these individuals to increase weight . Clinical trials.gov Background People with severe mental illnesses ( SMI ) are at increased risk of cardiovascular disease ( CVD ) . Clinical guidelines recommend regular screening for CVD risk factors . We evaluated a nurse led intervention to improve screening rates across the primary - secondary care interface . Methods Six community mental health teams ( CMHTs ) were r and omised to receive either the nurse led intervention plus education pack ( n = 3 ) or education pack only ( n = 3 ) . Intervention ( 6 months ) : The nurse promoted CVD screening in primary care and then in CMHTs . Patients who remained unscreened were offered screening by the nurse . After the intervention participants with SMI were recruited from each CMHT to collect outcome data . Main outcome : Numbers screened during the six months , confirmed in General Practice notes . Results All six CMHTs approached agreed to r and omisation . 121 people with SMI participated in outcome interviews during two waves of recruitment ( intervention arm n = 59 , control arm n = 62 ) . Participants from both arms of the trial had similar demographic profiles and rates of previous CVD screening in the previous year , with less than 20 % having been screened for each risk factor . After the trial , CVD screening had increased in both arms but participants from the intervention arm were significantly more likely to have received screening for blood pressure ( 96 % vs 68 % ; adjusted Odds Ratio ( OR ) 13.6 ; 95 % CI : 3.5 - 38.4 ) , cholesterol ( 66.7 % vs 26.9 % , OR 6.1 ; 3.2 - 11.5 ) , glucose ( 66.7 % vs 36.5 % OR 4.4 ; 2.7 - 7.1 ) , BMI ( 92.5 % vs 65.2 % OR 6.5 ; 2.1 - 19.6 ) , and smoking status ( 88.2 % vs 57.8 % OR 5.5 ; 3.2 - 9.5 ) and have a 10 year CVD risk score calculated ( 38.2 % vs 10.9 % ) OR 5.2 1.8 - 15.3 ) . Within the intervention arm approximately half the screening was performed in general practice and half by the trial nurse . Conclusions The nurse-led intervention was superior , result ing in an absolute increase of approximately 30 % more people with SMI receiving screening for each CVD risk factor . The feasibility of the trial was confirmed in terms of CMHT recruitment and the intervention , but the response rate for outcome collection was disappointing ; possibly a result of the cluster design . The trial was not large or long enough to detect changes in risk factors . Trial Registration International St and ard R and omised Controlled Trial Registration Number ( IS RCT RN ) 58625025 Physical activity is an important aspect of good health for everyone ; it is even more important for psychiatric patients who usually live an unhealthy lifestyle . In recent years , there has been growing focus on the use of soccer as a vehicle to improve the health of subjects with severe mental illness . The aim of this study was to investigate the effects of soccer practice on the self-reported health quality of life ( SRHQL ) and sports performance ( SP ) in psychotic subjects . Eighteen male patients with diagnosis of schizophrenia were r and omized into either a trained ( TG ) or a control group ( CG ) . The TG was trained for 12 weeks using two soccer training sessions per week . The CG did not perform any regular sports activity during the experimental period . Anthropometric measurements , SRHQL , personal time records in a 30 meter sprint test and slalom test running with a ball were evaluated before and after the experimental period . SRHQL was assessed using Short Form-12 question naire measuring physical and mental component summary scores . After the training period , the TG showed a relevant decrease by 4.6 % in bodyweight ( BW ) and body mass index compared to baseline . Conversely , the CG showed an increased BW and body mass index by 1.8 % from baseline to posttest . Moreover , after 12 weeks we found that control patients increased their BW significantly when compared to trained patients ( Δ = 5.4 % ; P < 0.05 ) . After the training period , comparing the baseline TG ’s Short Form-12-scores to posttest results , we found an improvement of 10.5 % and 10.8 % in physical component summary and mental component summary , respectively . In addition , performances on the 30 meter sprint test and slalom test running with a ball in the TG improved significantly ( P < 0.01 ) from baseline to posttest when compared to CG . Soccer practice appears able to improve psychophysical health in individuals with diagnosis of schizophrenia . Indeed , our study demonstrated that programmed soccer physical activity could reduce antipsychotic medication-related weight gain and improve SRHQL and sports performance in psychotic subjects OBJECTIVE Persons with chronic mental disorders are disproportionately burdened with physical health conditions . We determined whether Life Goals Collaborative Care compared to usual care improves physical health in patients with mental disorders within 12 months . METHODS This single-blind r and omized controlled effectiveness study of a collaborative care model was conducted at a midwestern Veterans Affairs urban outpatient mental health clinic . Patients ( N = 293 out of 474 eligible approached ) with an ICD-9-CM diagnosis of schizophrenia , bipolar disorder , or major depressive disorder and at least 1 cardiovascular disease risk factor provided informed consent and were r and omized ( February 24 , 2010 , to April 29 , 2015 ) to Life Goals ( n = 146 ) or usual care ( n = 147 ) . A total of 287 completed baseline assessment s , and 245 completed 12-month follow-up assessment s. Life Goals included 5 weekly sessions that provided semistructured guidance on managing physical and mental health symptoms through healthy behavior changes , augmented by ongoing care coordination . The primary outcome was change in physical health-related quality of life score ( Veterans R AND 12-item Short Form Health Survey [ VR-12 ] physical health component score ) . Secondary outcomes included control of cardiovascular risk factors from baseline to 12 months ( blood pressure , lipids , weight ) , mental health-related quality of life , and mental health symptoms . RESULTS Among patients completing baseline and 12-month outcomes assessment s ( N = 245 ) , the mean age was 55.3 years ( SD = 10.8 ; range , 25 - 78 years ) , and 15.4 % were female . Intent-to-treat analysis revealed that compared to those in usual care , patients r and omized to Life Goals had slightly increased VR-12 physical health scores ( coefficient = 3.21 ; P = .01 ) . CONCLUSIONS Patients with chronic mental disorders and cardiovascular disease risk who received Life Goals had improved physical health-related quality of life . TRIAL REGISTRATION Clinical Trials.gov identifiers : NCT01487668 and NCT01244854 Objective : Weight gain is common for individuals with serious mental illness ( SMI ) receiving antipsychotic drug therapy . Contingency management ( CM ) is a behavioral intervention that rewards positive performance and has demonstrated effectiveness in reducing drug use in SMI population s. This study evaluated the feasibility of using CM to promote weight loss in individuals with SMI over 8 weeks . Method : 30 individuals ( BMI ≥ 28 kg/m2 ) were r and omized to one of three conditions : i ) The combination of a st and ardized lifestyle modification ( LM ) program for individuals with SMI and payment for group attendance ( CMattendance ) , ii ) The combination of LM and payment for weight loss ( CMweight ) , and iii ) waitlist control ( CON ) . After the waitlist period , those participants joined a LM group and received payment for behavioral change ( CMbehavior ) . Results : Subjects in the CMattendance and in the CMweight group lost a mean of 1.16 kg and 1.23 kg , respectively , while subjects in the CON gained a mean of 0.68 kg . Subjects receiving CMbehavior , lost a mean of 2.54 kg , which was a significant weight loss compared to the control period . Conclusion : LM supplemented with CM may facilitate weight loss in patients taking antipsychotic medications ; financial reimbursement for behavioral change may be particularly effective in this population 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 Life expectancy in patients with schizophrenia is reduced by 20 years for men and 15 years for women compared to the general population . About 60 % of the excess mortality is due to physical illnesses , with cardiovascular disease being dominant . CHANGE was a r and omized , parallel-group , superiority , multi-centre trial with blinded outcome assessment , testing the efficacy of an intervention aim ed to improve cardiovascular risk profile and hereby potentially reduce mortality . A total of 428 patients with schizophrenia spectrum disorders and abdominal obesity were recruited and central ly r and omized 1:1:1 to 12 months of lifestyle coaching plus care coordination plus treatment as usual ( N=138 ) , or care coordination plus treatment as usual ( N=142 ) , or treatment as usual alone ( N=148 ) . The primary outcome was 10-year risk of cardiovascular disease assessed post-treatment and st and ardized to age 60 . At follow-up , the mean 10-year risk of cardiovascular disease was 8.4 ± 6.7 % in the group receiving lifestyle coaching , 8.5 ± \n Output:\n " }, { "from": "agent", "value": "Conclusion : There is a statistically significant , but clinical ly insignificant , mean effect of individualized lifestyle interventions for weight reduction in people with SMI" } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: OBJECTIVE To assess the association between recent cigarette smoking ( CS ) in female and male partners and assisted reproduction technology ( ART ) outcomes . DESIGN Cohort prospect i ve study . SETTING University ART program in Chile . PATIENT(S ) One hundred sixty-six couples seeking pregnancy through ART . INTERVENTION(S ) Follicular fluid ( FF ) and serum cotinine concentrations were measured in female partners . Self-reported CS data were collected through personal interviews . MAIN OUTCOME MEASURE(S ) The association between female recent smoking , assessed by FF and serum cotinine concentrations , and ART outcomes , such as number of ova retrieved and implantation rates , and the association between self-reported male recent smoking and live birth rates . RESULT ( S ) A significant age-adjusted association between increased FF cotinine level and decreased number of ova retrieved was found . The male partner 's smoking habit significantly decreased the live birth rate from 21.1 % to 7.8 % . Serum cotinine concentrations paralleled those of FF . CONCLUSION ( S ) The hypothesis of a detrimental effect of recent female smoking over implantation rates is rejected . However , recent male smoking is associated with significantly decreased live birth rates even after adjusting for confounders . Female recent smoking was significantly associated with decreased number of retrieved ova Several studies published within the past 10 years indicate that smoking reduces fecundity , but not all studies have found this effect , and smoking cessation is not used routinely in infertility treatment in Europe . The present study was design ed to examine male and female smoking at the start of a couple 's waiting time to a planned pregnancy . Two types of sample s were used : population -based sample s of women aged 25 - 44 years who were r and omly selected in different countries from census registers and electoral rolls , in which the unit of analysis was the couple ; and pregnancy-based sample s of pregnant women ( at least 20 weeks ' pregnant ) who were consecutively recruited during prenatal care visits , in which the unit of analysis was a pregnancy . More than 4,000 couples were included in each sample , and 10 different regions in Europe took part in data collection . The data were collected between August 1991 and February 1993 by personal interview in all population -based sample s and in all but three regions of the pregnancy sample , where self-administered question naires were used . The results based on the population sample showed a remarkably coherent association between female smoking and subfecundity in each individual country and in all countries together , both with the first pregnancy ( odds ratio ( OR ) = 1.7 , 95 % confidence interval ( CI ) 1.3 - 2.1 , at the upper level of exposure ) and during the most recent waiting time to pregnancy ( OR = 1.6 , 95 % CI 1.3 - 2.1 ) . Results based on the pregnancy sample were similar ( OR = 1.7 , 95 % CI 1.3 - 2.3 ) . No significant association was found with male smoking ( in the population sample , OR = 0.9 , 95 % CI 0.7 - 1.1 ( first pregnancy ) and OR = 1.0 , 95 % CI 0.9 - 1.3 ( most recent waiting time ) ; in the pregnancy sample , OR = 0.9 , 95 % CI 0.7 - 1.1 ) . The fecundity distribution among smokers appeared to be shifted toward longer waiting times without a change in the shape of the distribution . Women who have difficulty conceiving should try to stop smoking or to reduce their smoking to less than 10 cigarettes per day The electromechanical activity of the uterus was studied in 18 healthy women ( mean age 38.3+/-14.2 SD years ; 8 were nulliparous , 10 multiparous ) aim ing at characterizing a normal electrohysterogram . Two monopolar silver-silver chloride electrodes were applied to the uterine and one to the cervical mucosa . The uterine pressure was measured by a water-perfused tube connected to a pressure transducer . Monophasic , negatively deflected slow waves or pacesetter potentials ( PPs ) were recorded from the 2 uterine electrodes . They had regular rhythm and exhibited the same frequency , amplitude and velocity of conduction by the 2 electrodes . The PPs were followed r and omly by bursts of action potentials ( APs ) . The APs and not the PPs were associated with uterine pressure rise . PPs from the cervix were registered only occasionally . The occurrence of the electric activity is believed to depend on the smooth muscle fibers content which is high in the uterine body and meagre in the cervix . The APs seem to have contractile activity which might act to sweep away the uterine secretions . According to the uterocervical reflex , the cervix dilates upon uterine contractions . A normal electrohysterogram could be characterized . It might show a different pattern in the various uterine pathologic conditions and may thus represent an investigative tool in the diagnosis of such disorders OBJECTIVE To evaluate the predictive value of serial uterine artery Doppler ultrasound for embryo implantation in in-vitro fertilization (IVF)-intracytoplasmic sperm injection ( ICSI ) cycles . METHODS This was a prospect i ve observational study at the VU University Medical Center , Amsterdam . Patients with an indication for IVF or IVF-ICSI according to departmental protocol underwent controlled ovarian hyperstimulation followed by IVF or IVF-ICSI and embryo transfer and had serial Doppler ultrasound performed during this treatment cycle . Patient and cycle characteristics , number of conceptions and ongoing pregnancies and pulsatility index ( PI ) of both uterine arteries on different cycle days were assessed and results were compared between patients who conceived and those who did not . RESULTS Of the 102 patients enrolled into the study , 83 underwent embryo transfer . Of these , 41 became pregnant and 42 did not ( Group 1 ) . Of the 41 pregnancies , 30 were ongoing ( Group 2 ) and 11 miscarried ( Group 3 ) . Between Groups 1 , 2 and 3 , linear regression revealed no significant difference between any of the variables examined except in the quality of transferred embryos . There was no significant difference in the mean PI of the left and right uterine arteries on any day of the cycle , or in the change in PI during the cycle . Receiver-operating characteristics curves derived to determine the performance of PI to predict pregnancy outcome supported our findings that the uterine artery PI is not a suitable marker for identifying patients with implantation failure . Multivariate analysis showed no relationship between pregnancy and PI between groups , but it did show a relationship between pregnancy and some patient and cycle characteristics . CONCLUSION In an unselected group of patients undergoing IVF or IVF-ICSI and embryo transfer , serial Doppler ultrasound examination of the uterine artery does not discriminate between cycles result ing in ongoing pregnancy , miscarriage and no pregnancy The authors earlier conducted a retrospective study of time to pregnancy among a group of pregnant women in Minnesota , in order to investigate the relation between cigarette smoking and fecundability . Further analysis of these data shows that women who had been exposed as children to cigarette smokers had increased fertility . This finding lacks biologic plausibility . However , the authors found a similar association in a group of North Carolina women whose fecundability had been measured prospect ively . Furthermore , both groups showed an apparent dose-response effect . The authors briefly describe this unexpected finding so that it might be more fully explored in other studies OBJECTIVE To study acute hemodynamic alterations in the fetal-placental maternal system immediately after maternal exposure to nicotine . METHODS This is a noncontrolled experimental study involving 21 pregnant smoking women , r and omly selected , with uncomplicated pregnancies and without risk factors for fetal heart disease . Patients underwent ultrasound and fetal echocardiography before and after smoking a cigarette . They were asked to abstain from smoking for 12 hours before the study . The mean nicotine content of the cigarettes used in the study was 0.5 mg of nicotine and 6 mg of carbon monoxide . RESULTS The average number of cigarettes smoked per a day prior to the study was 9.67 . Gestational age ranged between 18 and 36 weeks . The mean maternal heart rate was elevated ( P<0.001 ) as was the mean fetal heart rate ( P=0.044 ) . Maternal systolic blood pressure ( P=0.004 ) and diastolic blood pressure ( P=0.033 ) were also elevated after smoking . A decrease occurred in the systolic/diastolic ratio in the right uterine artery ( P=0.014 ) and in the left uterine artery ( P=0.039 ) . The other hemodynamic variables remained unchanged . CONCLUSION Cigarette smoking can cause changes in physiologic variables of fetal-placental circulation , but it does not change fetal cardiac function , in the dose of nicotine and its components used in this study . The decrease in systolic/diastolic ratio in the uterine arteries is probably related to a dose-dependent nicotine pattern BACKGROUND Smoking has been reported to promote infertility . The zona pellucida plays an important role in fertilization and implantation . We report , for the first time , the effect of cigarette smoking on zona pellucida thickness of oocytes and embryos as one of the factors that may interfere with fertility . METHODS This study comprised 169 women , grouped according to their smoking habits : 31 active smokers , whose husb and s do not smoke ; 44 active smokers , whose husb and s smoke ; 65 passive smokers , because of smoking husb and s and 29 non-smokers ( women and husb and s ) . Zona pellucida thickness was measured prospect ively on printed photos of 903 oocytes and 456 embryos . RESULTS The zona pellucida thickness of oocytes and embryos of non-smoking women was significantly thinner than those of active and passive smokers . However , no significant differences were observed in the natural ability of the zona pellucida to become thinner after 48 h in culture . CONCLUSIONS Our study demonstrates that active and passive cigarette smoking increases the zona pellucida thickness of oocytes and embryos . Our findings also show that active and passive smoking has no significant effect on the thinning mechanism of the zona pellucida , which implies that it is independent of the initial zona pellucida thickness Objectives The ratio of trans-3′hydroxycotinine/cotinine ( 3HC/COT ) is a marker of CYP2A6 activity , an important determinant of nicotine metabolism . This analysis sought to conduct a combined genetic epidemiologic and pharmacogenetic investigation of the 3HC/COT ratio in plasma and urine . Methods One hundred and thirty-nine twin pairs [ 110 monozygotic and 29 dizygotic ] underwent a 30-min infusion of stable isotope-labelled nicotine and its major metabolite , cotinine , followed by an 8-h in-hospital stay . Blood and urine sample s were taken at regular intervals for analysis of nicotine , cotinine , and metabolites . DNA was genotyped to confirm zygosity and for variation in the gene for the primary nicotine metabolic enzyme , CYP2A6 ( variants genotyped : * 1B , * 1 × 2 , * 2 , * 4 , * 9 , * 12 ) . Univariate biometric analyses quantified genetic and environmental influences on each measure in the presence and absence of covariates , including measured CYP2A6 genotype . Results There was a substantial amount of variation in the free 3HC/COT ratio in plasma ( 6 h postinfusion ) attributable to additive genetic influences ( 67.4 % , 95 % confidence interval=55.9–76.2 % ) . The heritability estimate was reduced to 61.0 and 49.4 % , respectively , after taking into account the effect of covariates and CYP2A6 genotype . In urine ( collected over 8 h ) , the estimated amount of variation in the 3HC/COT ratio attributable to additive genetic influences was smaller ( 47.2 % , 95 % confidence interval=0–67.2 % ) and decreased to 44.6 and 42.0 % after accounting for covariates and genotype . Conclusion Additive genetic factors are prominent in determining variation in plasma 3HC/COT but less so in determining variation in urine 3HC/COT In the present study we investigated the effect of a woman 's smoking status on the quality of the oocyte , zygote , and on day 3 pre-embryo , as well as the likelihood of achieving an ongoing pregnancy at 8 weeks . Smokers presented a higher number of nonfertilized oocytes than nonsmokers ( 20.1 % vs. 10.8 % of fertilization failure ) , by comparable clinical pregnancy rate for smokers ( 40.8 % ; 28/72 ) and for nonsmokers ( 39.2 % ; 23/58 ) OBJECTIVE To search for a possible correlation between an effective marker of smoking and uterine and placental resistance during pregnancy . STUDY DESIGN A prospect i ve study was conducted at the Intercommunal Hospital Center of Montreuil , France : 81 healthy pregnant women underwent uterine and placental Doppler and cotidin blood assay , the \n Output:\n " }, { "from": "agent", "value": "The effects of cigarette smoke are dose-dependent and are influenced by the presence of other toxic substances and hormonal status .\nIndividual sensitivity , dose , time and type of exposure also play a role in the impact of smoke constituents on human fertility .\nAll stages of reproductive functions are targets of cigarette smoke toxicants ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: BACKGROUND Approximately 3,000 new cases of oral cancer are diagnosed each year in Canada . Most of these cases occur among older adults with a history of tobacco use or excessive alcohol consumption . Preventive interventions for oral cancer include counselling of patients to modify risk factors and screening to identify precancerous and early-stage lesions . This report presents evidence -based guidelines on the prevention of oral cancer and precancer among asymptomatic patients . METHODS Literature search es of the 1966 - 1999 MEDLINE and CANCERLIT data bases were completed using the major MeSH heading mouth neoplasms . References from articles and recommendations of organizations were also review ed . The evidence -based methods of the Canadian Task Force on Preventive Health Care were used to assess evidence and to develop guidelines . Advice from experts and other recommendations were taken into consideration . RESULTS In cohort and case-control studies , smoking cessation decreased the risk of oral cancer and precancer . R and omized controlled trials ( RCTs ) indicate counselling by trained health care professionals is effective in promoting smoking cessation . Although counselling has been effective for the reduction of excessive alcohol consumption in RCTs , no studies have examined whether alcohol reduction reduces the risk of oral cancer or precancer . The usefulness of general population screening is limited by the low prevalence and incidence of the disease , the potential for false-positive diagnoses and the poor compliance with screening and referral . There is no evidence that screening of the general population or high-risk groups leads to a reduction in mortality or morbidity from oral cancer . INTERPRETATION There is good evidence to specifically consider smoking cessation counselling in a periodic health examination ( grade A recommendation ) . For population screening , there is fair evidence to specifically exclude screening for oral cancer ( grade D recommendation ) . For opportunistic screening during periodic examinations , there is insufficient evidence to recommend inclusion or exclusion of screening for oral cancer ( grade C recommendation ) . For patients at high risk , annual examination by physician or dentist should be considered . Risk factors include tobacco use and excessive consumption of alcohol . These recommendations are similar to those made by the Canadian Task Force on the Periodic Health Examination in 1994 and by the U.S. Preventive Services Task Force in 1996 A r and omized intervention trial is in progress in Kerala , India , to evaluate the effectiveness of oral visual inspection by trained health workers ( HWs ) in the prevention of oral cancer . Fourteen health workers with college graduation as the basic qualification were trained in oral visual inspection to identify oral cancers and precancers among the participants of the screening trial and to refer them for further confirmation and management . The aim of the present study was to evaluate the reproducibility and validity of the screening test provided by the health worker against the reference oral visual findings of three physicians . A total of 2069 subjects who had already been examined were re-examined by the health workers and physicians . The sensitivity and the specificity of the oral visual inspection were 94.3 % and 99.3 % respectively . There was moderate agreement between the findings of the initial and the repeat mouth examinations carried out by the health workers , which were on average 6 months apart . There was almost perfect agreement ( kappa = 0.85 ) between the findings of the health workers and the physicians in identifying the different types of oral precancerous lesions . The findings of our study indicate that it is possible to train re source persons to perform the oral cancer screening test as accurately as doctors , although experience appears to be a crucial component of health workers ' accuracy . The efficacy of such an approach to reduce the incidence of and mortality from oral cancer , however , remains to be proven Oral cancer is caused by chewing and smoking of tobacco . To assess the feasibility of primary prevention of oral cancer , two cohorts were studied in base-line surveys and then followed up annually for 10-yr in Ernakulam district of Kerala state . The intervention cohort consisted of 12212 tobacco users aged 15 yr and over , who were exposed to a concentrated program of education against tobacco use . The control cohort was a non-concurrent cohort of 6075 tobacco users studied using similar methods but with a minimal amount of advice against tobacco use . The stoppage of tobacco use increased and the incidence rate of leukoplakia decreased significantly and substantially in the intervention cohort compared to the control cohort . The decrease in the incidence of leukoplakia was indicative of the decrease in the risk of oral cancer since the two were intimately related . This study demonstrated feasibility of primary prevention of oral cancer A cluster r and omized controlled oral cancer screening trial is on-going in the Triv and rum district , India , to evaluate the efficacy of screening in reducing oral cancer mortality . Subjects , aged 35 years and above , in 13 clusters in the Triv and rum district , India , were r and omized to the intervention ( screening ) group ( 7 clusters , 78969 subjects ) to receive three rounds of screening by oral visual inspection by trained health workers at 3-year intervals or to a control group ( 6 clusters , 74739 subjects ) . Two rounds of screening were completed between 1995 and 2002 during which 69896 ( 88.5 % ) subjects were screened at least once , and 59.7 % of the 4408 screen-positive subjects were further investigated . In the intervention group , 344404 person-years were accrued and 329326 person-years were in the control group . In the intervention group , 149 incident oral cancer cases and 65 deaths from oral cancer were observed , and 106 incident cases and 62 deaths from oral cancer were observed in the control group . The programme sensitivity for detection of oral precancerous lesions and cancer was 81.5 % and the programme specificity was 84.8 % ; the programme positive predictive value was 39.6 % . In the intervention group 37.6 % of the cases were in stages I-II , as opposed to 18.9 % in the control group . The 3 year survival rate was 57.5 % in the intervention and 38.8 % in the control group ( P<0.05 ) . The age st and ardized oral cancer mortality rates were 21.2/100000 person-years in the intervention and 21.3/100000 in the control group . After completing two rounds of screening , oral cancer mortality rates were similar in both study groups It is well established that most invasive oral cancers arise from precancerous lesions such as leukoplakia , erythroplakia and oral submucous fibrosis . One of the approaches for control of oral cancer is to detect oral precancerous lesions early in their development and prevent their malignant transformation to invasive cancer either by chemoprevention or by surgical excision of the lesions , with concurrent control of tobacco and alcohol use and other specific aetiological factors . However , the value of specific approaches such surgery in long-term control of lesions and prevention of malignant transformation is not known . We describe our experience with cold knife surgical excision of 59 cases of non-homogeneous leukoplakia of the oral cavity diagnosed in the context of a community-based oral cancer cluster r and omised oral cancer screening trial in Kerala , India . Two-thirds of these revealed dysplasia on histology . After a minimum follow-up of 12 months ( range 12 - 37 months ) after surgical excision , 44 ( 74.8 % ) were remaining disease free with no evidence of recurrent/new lesions ; during follow-up , three ( 5 % ) developed new luekoplakic lesions , and six ( 10.1 % ) developed recurrent lesions , while six ( 10.1 % ) could not be traced after treatment . There was no event of malignant change during follow-up . The proportion of subjects remaining with no evidence of disease at 3 years by Kaplan-Meier method of analysis was 62.1 % ( 95 % CI : 0.36 - 0.87 ) . Accrual and long-term follow-up of large number of surgically treated cases may provide valuable leads to management policies of oral leukoplakia , since , as of now , the added value of specific treatments over and above primary prevention by tobacco and alcohol control remains to be established The aim of the study was to evaluate dental health care workers ' ability to recognise oral cancer and pre-cancer from colour photographic slides . A set of 80 slides was prepared , 40 were negative ( normal mucosa or lesions with no malignant potential ) and 40 were positive ( cancer or potentially malignant lesions ) . The slides were arranged in r and om order and projected in a st and ard format . The performance was evaluated in terms of mean sensitivity , specificity , mean correct score and likelihood ratio . There were no significant differences between the three groups of dentists ( consultants , juniors hospital dentists and general dentists ) , all performed better than the auxiliaries . The chances of a consultant making a correct decision were 5.5 times better than for an auxiliary and 2.7 times better than for a junior hospital dentist . The slide show enables a comparison of health care workers to be made and may be useful for the evaluation , training and calibration of examiners for an oral cancer screening programme BACKGROUND A study group composed of research ers from across the United States undertook a study to evaluate the sensitivity and specificity of OralCDx ( OralScan Laboratories Inc. ) , a computer-assisted method of analysis of the oral brush biopsy , in the detection of precancerous and cancerous lesions of the oral mucosa . METHODS The study group conducted a multicenter double-blind study comparing results of OralCDx analysis with those of scalpel biopsy of suspicious oral lesions , as well as using OralCDx on oral lesions that appeared benign clinical ly . RESULTS In 945 patients , OralCDx independently detected every case of histologically confirmed oral dysplasia and carcinoma ( sensitivity = 100 percent , false-negative rate = 0 percent ) . Every OralCDx \" positive \" result was subsequently confirmed by histology as dysplasia or carcinoma . The specificity for the OralCDx \" positive \" result was 100 percent , while the specificity for the OralCDx \" atypical \" results was 92.9 percent . In 4.5 percent of clinical ly benign-appearing lesions that would not have received additional testing or attention other than clinical follow-up , OralCDx uncovered dysplasia or carcinoma ( statistical sensitivity > 96 percent , P < .05 , n = 131 ; statistical specificity for the OralCDx \" positive \" result > 97 percent and for the \" atypical \" result > 90 percent , P < .05 , n = 196 ) . CONCLUSIONS The authors propose that this multicenter trial demonstrates that OralCDx is a highly accurate method of detecting oral precancerous and cancerous lesions . OralCDx can aid in confirming the nature of apparently benign oral lesions and , more significantly , revealing those that are precancerous and cancerous when they are not clinical ly suspected of being so . All OralCDx \" atypical \" and \" positive \" results should be referred for scalpel biopsy and histology to completely characterize the lesion . CLINICAL IMPLICATION S Given the difficulty in clinical ly differentiating premalignant and malignant lesions from benign lesions with a similar appearance , OralCDx appears to determine the significance of an oral lesion definitively and detect innocuous-appearing oral cancers at early , curable stages BACKGROUND Oral cancer screening procedures are design ed to collectively allow early detection of cancers in a body area accessible to visual and physical examination , as well as to facilitate timely treatment , awareness , and the ongoing education of the public . METHODS A state fair was selected for this activity because of the availability of a r and om population compatible with meeting these goals . A total of 1,151 individuals participated in this free elective activity . RESULTS Of this number 4.17 % were deemed to have oral pathologic states necessitating professional intervention , and 1.82 % were clinical ly diagnosed as having potential dysplastic or precancerous lesions . No clinical oral cancer was detected in this population . Nevertheless , by virtue of screening and detecting clinical ly premalignant lesions , the screening test advanced the diagnosis of potential oral cancers . CONCLUSIONS The outcome adds support to oral cancer screening as a procedure applicable in reducing morbidity and mortality from oral cancers Oral cancer satisfies the criteria for a suitable disease for screening , and oral visual inspection is a suitable test for oral cancer screening . The efficacy of screening in reducing mortality from oral cancer has not yet been evaluated . The authors describe a cluster‐r and omized , controlled oral cancer screening trial in southern India and its early results The utilisation of primary health workers ( HWs ) for cancer control in developing countries has often been suggested , based on the experience of feasibility studies in India and Sri Lanka . We initiated a project in 1988 to evaluate the long-term feasibility of using trained HWs in secondary prevention of oral cancer , to bring about earlier detection of oral cancer in the communities served by them . Two hundred and eighty-two HWs attached to 14 primary health centres ( PHCs ) , serving approximately 0.92 million rural population in the northern half of Triv and rum district in Kerala , India , were trained in oral visual inspection to detect precancerous , malignant and other suspicious lesions of the oral cavity and refer them for confirmation and treatment . They were asked to examine subjects aged 35 years and above and to give person to person health education on tobacco in their target population . The HWs belonging to the PHCs serving approximately 1 million rural population in the southern half of Triv and rum district were not trained , and this region served \n Output:\n " }, { "from": "agent", "value": "Given the limitation of evidence and the potential method ological weakness in the included study , it is valid to say that there is no evidence to recommend inclusion or exclusion of screening programs for oral cancer using visual examination in the general population ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: Purpose Abemaciclib , a cyclin-dependent kinase 4 and 6 inhibitor , demonstrated efficacy as monotherapy and in combination with fulvestrant in women with hormone receptor (HR)-positive , human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer previously treated with endocrine therapy . Methods MONARCH 3 is a double-blind , r and omized phase III study of abemaciclib or placebo plus a nonsteroidal aromatase inhibitor in 493 postmenopausal women with HR-positive , HER2-negative advanced breast cancer who had no prior systemic therapy in the advanced setting . Patients received abemaciclib or placebo ( 150 mg twice daily continuous schedule ) plus either 1 mg anastrozole or 2.5 mg letrozole , daily . The primary objective was investigator-assessed progression-free survival . Secondary objectives included response evaluation and safety . A planned interim analysis occurred after 189 events . Results Median progression-free survival was significantly prolonged in the abemaciclib arm ( hazard ratio , 0.54 ; 95 % CI , 0.41 to 0.72 ; P = .000021 ; median : not reached in the abemaciclib arm , 14.7 months in the placebo arm ) . In patients with measurable disease , the objective response rate was 59 % in the abemaciclib arm and 44 % in the placebo arm ( P = .004 ) . In the abemaciclib arm , diarrhea was the most frequent adverse effect ( 81.3 % ) but was mainly grade 1 ( 44.6 % ) . Comparing abemaciclib and placebo , the most frequent grade 3 or 4 adverse events were neutropenia ( 21.1 % v 1.2 % ) , diarrhea ( 9.5 % v 1.2 % ) , and leukopenia ( 7.6 % v 0.6 % ) . Conclusion Abemaciclib plus a nonsteroidal aromatase inhibitor was effective as initial therapy , significantly improving progression-free survival and objective response rate and demonstrating a tolerable safety profile in women with HR-positive , HER2-negative advanced breast cancer PURPOSE To compare the efficacy and tolerability of tamoxifen with that of letrozole , an oral aromatase inhibitor , with tamoxifen as first-line therapy in postmenopausal women with advanced breast cancer . PATIENTS AND METHODS Nine hundred seven patients were r and omly assigned letrozole 2.5 mg once daily ( 453 patients ) or tamoxifen 20 mg once daily ( 454 patients ) . Patients had estrogen receptor- and /or progesterone receptor-positive tumors , or both receptors were unknown . Recurrence during adjuvant antiestrogen therapy or within the following 12 months or prior endocrine therapy for advanced disease precluded enrollment . One prior chemotherapy regimen for metastatic disease was allowed . The primary end point was time to progression ( TTP ) . Secondary end points included overall objective response rate ( ORR ) , its duration , rate and duration of clinical benefit , time to treatment failure ( TTF ) , overall survival , and tolerability . RESULTS TTP was significantly longer for letrozole than for tamoxifen ( median , 41 v 26 weeks ) . Treatment with letrozole reduced the risk of progression by 30 % ( hazards ratio , 0.70 ; 95 % confidence interval , 0.60 to 0.82 , P = .0001 ) . TTP was significantly longer for letrozole irrespective of dominant site of disease , receptor status , or prior adjuvant antiestrogen therapy . Similarly , TTF was significantly longer for letrozole ( median , 40 v 25 weeks ) . ORR was higher for letrozole ( 30 % v 20 % ; P = .0006 ) , as was the rate of clinical benefit ( 49 % v 38 % ; P = .001 ) . Survival data are currently immature and not reported here . Both treatments were well tolerated . CONCLUSION Letrozole was significantly superior to tamoxifen in TTP , TTF , ORR , and clinical benefit rate . Our results support its use as first-line endocrine therapy in postmenopausal women with advanced breast cancer PURPOSE The efficacy and tolerability of anastrozole ( Arimidex ; AstraZeneca , Wilmington , DE , and Macclesfield , United Kingdom ) and tamoxifen were compared as first-line therapy for advanced breast cancer in 353 postmenopausal women . PATIENTS AND METHODS The r and omized , double-blind , multicenter study was design ed to evaluate anastrozole 1 mg once daily relative to tamoxifen 20 mg once daily in patients with hormone receptor-positive tumors or tumors of unknown receptor status who were eligible for endocrine therapy . Primary end points were objective response ( OR ) , defined as complete ( CR ) or partial ( PR ) response , time to progression ( TTP ) , and tolerability . RESULTS Anastrozole was as effective as tamoxifen in terms of OR ( 21 % v 17 % of patients , respectively ) , with clinical benefit ( CR + PR + stabilization > or = 24 weeks ) observed in 59 % of patients on anastrozole and 46 % on tamoxifen ( two-sided P = .0098 , retrospective analysis ) . Anastrozole had a significant advantage over tamoxifen in terms of TTP ( median TTP of 11.1 and 5.6 months for anastrozole and tamoxifen , respectively ; two-sided P = .005 ) . The tamoxifen : anastrozole hazards ratio was 1.44 ( lower one-sided 95 % confidence limit , 1.16 ) . Both treatments were well tolerated . However , thromboembolic events and vaginal bleeding were reported in fewer patients who received anastrozole compared with those who received tamoxifen ( 4.1 % v 8.2 % [ thromboembolic events ] and 1.2 % v 3.8 % [ vaginal bleeding ] , respectively ) . CONCLUSION Anastrozole satisfied the predefined criteria for equivalence to tamoxifen . Furthermore , we observed both a significant increase in TTP and a lower incidence of thromboembolic events and vaginal bleeding with anastrozole . These findings indicate that anastrozole should be considered as first-line therapy for postmenopausal women with advanced breast cancer This paper is an overview of the new response evaluation criteria in solid tumours : revised RECIST guideline ( version 1 . 1 ) , with a focus on up date d contents BACKGROUND A phase 2 study showed that progression-free survival was longer with palbociclib plus letrozole than with letrozole alone in the initial treatment of postmenopausal women with estrogen-receptor (ER)-positive , human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer . We performed a phase 3 study that was design ed to confirm and exp and the efficacy and safety data for palbociclib plus letrozole for this indication . METHODS In this double-blind study , we r and omly assigned , in a 2:1 ratio , 666 postmenopausal women with ER-positive , HER2-negative breast cancer , who had not had prior treatment for advanced disease , to receive palbociclib plus letrozole or placebo plus letrozole . The primary end point was progression-free survival , as assessed by the investigators ; secondary end points were overall survival , objective response , clinical benefit response , patient-reported outcomes , pharmacokinetic effects , and safety . RESULTS The median progression-free survival was 24.8 months ( 95 % confidence interval [ CI ] , 22.1 to not estimable ) in the palbociclib-letrozole group , as compared with 14.5 months ( 95 % CI , 12.9 to 17.1 ) in the placebo-letrozole group ( hazard ratio for disease progression or death , 0.58 ; 95 % CI , 0.46 to 0.72 ; P<0.001 ) . The most common grade 3 or 4 adverse events were neutropenia ( occurring in 66.4 % of the patients in the palbociclib-letrozole group vs. 1.4 % in the placebo-letrozole group ) , leukopenia ( 24.8 % vs. 0 % ) , anemia ( 5.4 % vs. 1.8 % ) , and fatigue ( 1.8 % vs. 0.5 % ) . Febrile neutropenia was reported in 1.8 % of patients in the palbociclib-letrozole group and in none of the patients in the placebo-letrozole group . Permanent discontinuation of any study treatment as a result of adverse events occurred in 43 patients ( 9.7 % ) in the palbociclib-letrozole group and in 13 patients ( 5.9 % ) in the placebo-letrozole group . CONCLUSIONS Among patients with previously untreated ER-positive , HER2-negative advanced breast cancer , palbociclib combined with letrozole result ed in significantly longer progression-free survival than that with letrozole alone , although the rates of myelotoxic effects were higher with palbociclib-letrozole . ( Funded by Pfizer ; PALOMA-2 Clinical Trials.gov number , NCT01740427 . ) PURPOSE To compare the clinical activity of the pure antiestrogen fulvestrant at 500 mg/mo ( double the approved dose ) with the aromatase inhibitor anastrozole as first-line endocrine therapy for advanced hormone receptor-positive breast cancer in postmenopausal women . PATIENTS AND METHODS FIRST ( Fulvestrant First-Line Study Comparing Endocrine Treatments ) is a phase II , r and omized , open-label , multicenter study of a fulvestrant high-dose ( HD ) regimen ( 500 mg/mo plus 500 mg on day 14 of month 1 ) versus anastrozole ( 1 mg/d ) . The primary efficacy end point was clinical benefit rate ( CBR ) , defined as the proportion of patients experiencing an objective response ( OR ) or stable disease for > or = 24 weeks . The primary analysis was performed 6 months after the last patient was r and omly assigned . RESULTS CBR was similar for fulvestrant HD ( n = 102 ) and anastrozole ( n = 103 ) , 72.5 % v 67.0 % , respectively ( odds ratio , 1.30 ; 95 % CI , 0.72 to 2.38 ; P = .386 ) . Objective response rate ( ORR ) was also similar between treatments : fulvestrant HD , 36.0 % ; anastrozole , 35.5 % . Time to progression ( TTP ) was significantly longer for fulvestrant versus anastrozole ( median TTP not reached for fulvestrant HD v 12.5 months for anastrozole ; hazard ratio , 0.63 ; 95 % CI , 0.39 to 1.00 ; P = .0496 ) . Duration of OR and CB also numerically favored fulvestrant HD . Both treatments were well tolerated , with no significant differences in the incidence of prespecified adverse events . CONCLUSION First-line fulvestrant HD was at least as effective as anastrozole for CBR and ORR and was associated with significantly longer TTP . Fulvestrant HD was generally well tolerated , with a safety profile similar to that of anastrozole \n Output:\n " }, { "from": "agent", "value": "Similarly , overall response rate and clinical benefit rate were higher for patients who received the combination therapy than for patients allocated to AI alone .\nConclusion The addition of CDK 4/6 inhibitors ( either abemaciclib , palbociclib , or ribociclib ) to an AI ( anastrozole or letrozole ) significantly improved PFS , overall response rate , and clinical benefit rate in comparison with a nonsteroidal AI alone" } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: Background Increasing clinical data supports a low α/β ratio for prostate adenocarcinoma , potentially lower than that of surrounding normal tissues . A hypofractionated , weekly radiation therapy ( RT ) schedule should result in improved tumour control , reduced acute toxicity , and similar or decreased late effects . We report the toxicity profile of such treatment . Material s and Methods We conducted a multi-institution phase I/II trial of three-dimensional conformal radiation therapy ( 3D-CRT ) for favourable-risk prostate cancer ( T1a-T2a , Gleason ≤ 6 and PSA < 10 ng/ml ) . RT consisted of 45 Gy in nine 5 Gy fractions , once weekly . Primary end-points were feasibility and late gastrointestinal ( GI ) toxicity ( RTOG scale ) , while secondary end-points included acute GI toxicity , acute and late genitourinary ( GU ) toxicity , biochemical control , and survival . Results Between 2006 and 2008 , 80 patients were treated . No treatment interruptions occurred . The median follow-up is 33 months ( range : 20 - 51 ) . Maximal grade 1 , 2 , and 3 acute ( < 3 months ) GU toxicity was 29 % , 31 % and 5 % respectively ( no grade 4 ) . Acute GI grade 1 toxicity was reported in 30 % while grade 2 occurred in 14 % ( no grade 3 or 4 ) . Crude late grade ≥ 3 toxicity rates at 31 months were 2 % for both GU and GI toxicity . Cumulative late grade ≥ 3 GI toxicity at 3 years was 11 % . Two patients had PSA failure according to the Phoenix definition . The three-year actuarial biochemical control rate is 97 % . Conclusions Weekly RT with 45 Gy in 9 fractions is feasible and results in comparable toxicity . Long term tumour control and survival remain to be assessed BACKGROUND / AIM Based on a radiobiological assumption of a low alpha/beta ( α/β ) ratio for prostate cancer , hypofractionated radiotherapy has increasingly gained traction in the clinical practice and recent guidelines have confirmed the non-inferiority of this approach . Nevertheless , the largest studies that have used hypofractionation so far , employed image-guided radiation therapy/intensity modulated radiation therapy ( IGRT/IMRT ) facilities that might have overcome the radiobiological advantages , which remain to be fully confirmed . The aim of this trial was to evaluate the feasibility of a hypofractionated schedule delivered with 3D-Conformal Radiotherapy to prostate and seminal vesicles in combination with hormonal therapy . PATIENTS AND METHODS The study included 97 consecutive patients with localized prostate cancer ( PCa ) , irrespective of risk class , treated with a schedule of 62 Gy in 20 fractions over 5 weeks ( 4 fractions of 3.1 Gy each per week ) . According to National Comprehensive Cancer Network ( NCCN ) prognostic classification , patients were divided into a favourable group ( 19 % ) , intermediate group ( 41 % ) and unfavourable group ( 40 % ) . Early and late toxicities were scored using the radiation toxicity grading/European Organisation for Research and Treatment of Cancer ( RTOG/EORTC ) criteria . Additionally , the international prostate symptom index ( IPSS ) for benign prostate hypertrophy was used to evaluate obstructive urinary symptoms . Biochemical outcome was reported according to the Phoenix definition for biochemical failure . Hormonal therapy ( HT ) was administrated in 92 % of patients . RESULTS After a median follow-up of 39 months ( range=25 - 52 ) , maximum ≥G2 late genitourinary ( GU ) and gastrointestinal ( GI ) toxicities occurred in 8 % and 11 % patients , respectively . The corresponding figures for acute toxicities were 24 % and 15 % . Patients with higher IPSS score before enrolment had significantly worse urinary function after treatment . Only 2 % of patients died from PCa . Biochemical non- evidence of disease ( bNED ) was 83 % for all patients . CONCLUSION Our study confirms that 3D conformal radiotherapy ( 3DCRT ) remains a safe and effective method to deliver a dose-escalated hypofractionated regimen for PCa patients in all risk classes with acceptable toxicity rates and optimal biochemical control Objective : To report on the design , methodology , and early outcome results of a multi-institutional registry study of prostate cancer radiosurgery . Methods : The Registry for Prostate Cancer Radiosurgery ( RPCR ) was established in 2010 to further evaluate the efficacy and toxicity of prostate radiosurgery ( SBRT ) for the treatment of clinical ly localized prostate cancer . Men with prostate cancer were asked to voluntarily participate in the registry . Demographic , baseline medical , and treatment-related data were collected and stored electronically in a Health Insurance Portability and Accountability Act-compliant data base , maintained by Advertek , Inc. Enrolled men were asked to complete short , multiple choice question naires regarding their bowel , bladder , and sexual function . Patient-reported outcome forms were collected at baseline and at regular intervals ( every 3–6 months ) following treatment . Serial prostate-specific antigen measurements were obtained at each visit and included in the collected data . Results : From July 2010 to July 2013 , nearly 2000 men from 45 participating sites were enrolled in the registry . The majority ( 86 % ) received radiosurgery as monotherapy . At 2 years follow-up , biochemical disease-free survival was 92 % . No Grade 3 late urinary toxicity was reported . One patient developed Grade 3 gastrointestinal toxicity ( rectal bleeding ) . Erectile function was preserved in 80 % of men < 70 years old . Overall compliance with data entry was 64 % . Conclusion : Stereotactic radiosurgery is an alternative option to conventional radiotherapy for the treatment of organ-confined prostate cancer . The RPCR represents the collective experience of multiple institutions , including community-based cancer centers , with outcome results in keeping with published , prospect i ve trials of prostate SBRT Background and purpose For localized prostate cancer , treatment options include external beam radiotherapy ( EBRT ) , radical prostatectomy ( RP ) , and brachytherapy ( BT ) . Erectile dysfunction ( ED ) is a common side-effect . Our aim was to evaluate penile erectile function ( EF ) before and after BT , EBRT , or RP using a vali date d self-administered quality -of-life survey from a prospect i ve registry . Material and methods Analysis included 478 patients undergoing RP ( n = 252 ) , EBRT ( n = 91 ) , and BT ( n = 135 ) with at least 1 year of follow-up and EF documented using IIEF-5 scores at baseline , 6 weeks , 6 months , 1 year , and annually thereafter . Results Differences among treatments were most pronounced among patients with no or mild initial ED ( IIEF-5 ≥ 17 ) . Overall , corrected for baseline EF and age , BT was associated with higher IIEF-5 scores than RP ( + 7.8 IIEF-5 score ) or EBRT ( + 3.1 IIEF-5 score ) . EBRT was associated with better IIEF-5 scores than RP ( + 4.7 IIEF-5 score ) . In patients undergoing EBRT or RP with bilateral nerve sparing ( NS ) , recovery of EF was observed and during follow-up , the differences to BT were not statistically significant . Overall age had a negative impact on EF preservation ( corrected for baseline IIEF ) . Conclusion In our series , EF was adversely affected by each treatment modality . Considered overall , BT provided the best EF preservation in comparison to EBRT or RP.ZusammenfassungHintergrund und ZielDie externe Radiotherapie ( EBRT ) , die radikale Prostatektomie ( RP ) sowie die Brachytherapie ( BT ) stellen Beh and lungsoptionen für das lokalisierte Prostatakarzinom dar . Die erektile Dysfunktion ( ED ) ist eine häufige Nebenwirkung dieser Therapien . Unser Ziel war es , die penile erektile Funktion ( EF ) vor und nach BT , EBRT und RP mit Hilfe eines validierten , vom Patienten ausgefüllten Lebensqualitätsfragebogens aus einer prospektiven Date nbank zu beurteilen . Material und Method enMit einer minimalen Nachbeobachtungszeit von einem Jahr wurden 478 Patienten analysiert , die eine RP ( n = 252 ) , EBRT ( n = 91 ) oder BT ( n = 135 ) erhalten hatten und deren EF mit dem IIEF-5-Score vor Therapie sowie nach 6 Wochen , 6 Monaten , nach einem Jahr und danach jährlich ermittelt worden sind . ErgebnisDie größten therapiebedingten Unterschiede wurden bei Patienten ohne oder nur mit milder initialer ED beobachtet ( IIEF-5 ≥ 17 ) . Korrigiert für die EF und das Alter bei Therapie , war die BT mit höherem IIEF-5-Score assoziiert als die RP ( + 7,8 IIEF-5-Score ) oder die EBRT ( + 3,1 IIEF-5-Score ) . Die EBRT war mit einem besseren IIEF-5-Score assoziiert als die RP ( + 4,7 IIEF-5-Score ) . Bei Patienten mit bilateraler nervenschonender RP oder einer EBRT wurde eine Erholung der EF beobachtet ; i m Verlauf war der Unterschied zur BT nicht mehr statistisch signifikant . Insgesamt hatte ein höheres Alter einen negativen Einfluss auf die Erhaltung der EF ( korrigiert für Ausgangs-EF).SchlussfolgerungIn unserer Serie verschlechterte sich die EF durch alle Therapieformen . Insgesamt bot die BT die beste EF-Erhaltung verglichen mit der EBRT oder RP PURPOSE To compare the toxicity between hypofractionation vs. conventional fractionation schedules in patients with high-risk prostate cancer . METHODS AND MATERIAL S Between January 2003 and December 2007 , 168 patients were r and omized to receive either hypofractionated ( 62 Gy in 20 fractions within 5 weeks , 4 fractions/wk ) or conventionally fractionated ( 80 Gy in 40 fractions within 8 weeks ) three-dimensional conformal radiotherapy to the prostate and seminal vesicles . All patients had undergone a 9-month course of total and rogen deprivation , with radiotherapy starting 2 months after initiation of the total and rogen deprivation . RESULTS The median follow-up was 32 and 35 months in the hypofractionation and conventional fractionation arms , respectively . For the patients developing acute toxicity , no difference between the two fractionation groups was found in either severity or duration of gastrointestinal or genitourinary toxicity . Also , no difference was found in the incidence and severity of late gastrointestinal and genitourinary toxicity between the two treatment schedules , with a 3-year rate of Grade 2 or greater toxicity of 17 % and 16 % for the hypofractionation arm and 14 % and 11 % for the conventional fractionation arm , respectively . A statistically significant correlation between acute and late gastrointestinal toxicity was found only in the conventional fractionation group . CONCLUSION Our findings suggest that the hypofractionation regimen used in our study is safe , with only a slight , nonsignificant increase in tolerable and temporary acute toxicity compared with the conventional fractionation schedule . The severity and frequency of late complications was equivalent between the two treatment groups PURPOSE To compare the toxicity and efficacy of hypofractionated ( 62 Gy/20 fractions/5 weeks , 4 fractions per week ) vs. conventional fractionation radiotherapy ( 80 Gy/40 fractions/8 weeks ) in patients with high-risk prostate cancer . METHODS AND MATERIAL S From January 2003 to December 2007 , 168 patients were r and omized to receive either hypofractionated or conventional fractionated schedules of three-dimensional conformal radiotherapy to the prostate and seminal vesicles . All patients received a 9-month course of total and rogen deprivation ( TAD ) , and radiotherapy started 2 months thereafter . RESULTS The median ( range ) follow-up was 32 ( 8 - 66 ) and 35 ( 7 - 64 ) months in the hypofractionation and conventional fractionation arms , respectively . No difference was found for late toxicity between the two treatment groups , with 3-year Grade 2 rates of 17 % and 16 % for gastrointestinal and 14 % and 11 % for genitourinary in the hypofractionation and conventional fractionation groups , respectively . The 3-year freedom from biochemical failure ( FFBF ) rates were 87 % and 79 % in the hypofractionation and conventional fractionation groups , respectively ( p = 0.035 ) . The 3-year FFBF rates in patients at a very high risk ( i.e. , pretreatment prostate-specific antigen ( iPSA ) > 20 ng/mL , Gleason score > or=8 , or T > or=2c ) , were 88 % and 76 % ( p = 0.014 ) in the former and latter arm , respectively . The multivariate Cox analysis confirmed fractionation , iPSA , and Gleason score as significant prognostic factors . CONCLUSIONS Our findings suggest that late toxicity is equivalent between the two treatment groups and that the hypofractionated schedule used in this trial is superior to the conventional fractionation in terms of FFBF BACKGROUND Studies have reported a low α/β ratio \n Output:\n " }, { "from": "agent", "value": "Results Several large-scale trials on moderate hypofractionation with single doses from 2.4–3.4 Gy have recently finished recruiting or have published first results suggestive of equivalent outcomes although there might be a trend for increased short-term and possibly even long-term toxicity ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: Summary A main reason for investigating the clinical effects and possible merits of post-operative corticosteroid administration was its practical implication s in traumatology . It was also hoped to obtain information relevant to the analgesic activity of steroid . A crossover study has been done in 12 healthy subjects , each of whom had two separate , but identical operations for removal of non-erupted 3rd molar teeth on each side of the jaw . 3 h after surgery , either betamethasone 9 mg ( Celeston Chronodose ® ) or placebo was injected intramuscularly in a r and omized fashion . A paired comparison was made of the post-operative courses . All but 1 patient experienced less pain after the steroid injection . Surprisingly , some patients reported pronounced relief within min after the injection , whereas in others there was a time-lag . Swelling , measured on the 3rd day , was reduced by 47 % after the steroid as compared to placebo . There was poor agreement between the steroid-induced reductions in pain and swelling . This exemplifies the dissociation between pain and other inflammatory events , and indicates that the analgesic and anti-inflammatory properties of a steroid may depend on discrete mechanisms , which may show considerable individual variation . From overall assessment , all 12 patients favoured the post-operative course when the steroid was administered . Almost the same levels of pain relief , reduction in swelling , and preference were reached in the present patients , who received the steroid 3 h post-operatively , as had previously been found in a similar trial in which the drug was injected prior to surgery . The results suggest that short term corticosteroid administration may be a valuable means of reducing pain and excessive inflammatory response after surgical or accidental soft tissue/bone injury OBJECTIVE To determine the effect of preoperative dexamethasone sodium phosphate administration on posttonsillectomy morbidity for electrocautery ( \" hot \" ) and sharp ( \" cold \" ) dissection techniques . DESIGN Prospect i ve , r and omized , double-blind study . SETTING University pediatric hospital and county teaching hospital . Subjects A total of 219 children , aged 9 months to 12 years , undergoing tonsillectomy . Intervention Participants who underwent tonsillectomy were r and omly assigned to receive either intravenous dexamethasone sodium phosphate ( 1 mg/kg ) or placebo . OUTCOME MEASURES Pain scores , oral intake , and emesis on postoperative day ( POD ) 1 . RESULTS A total of 106 subjects ( 62 undergoing hot and 44 cold tonsillectomies ) received preoperative steroids , and 113 ( 56 hot and 57 cold tonsillectomies ) received placebo . On POD 1 , pain scores reported by patients ( P = .02 ) , parents ( P = .002 ) , and physicians ( P<.001 ) were significantly lower in subjects receiving steroids than in those receiving placebo . Emesis was reduced from a mean of 2.1 ( placebo group ) to 1.2 episodes ( steroid group ) ( P = .02 ) . Oral intake improved from 24.5 % of normal diet ( placebo ) to 31.7 % ( steroid group ) ( P = .004 ) . When all 4 groups were compared ( cold placebo , cold steroid , hot placebo , and hot steroid ) , pain scores reported by physicians and parents were significantly lower in the cold steroid group than in the other groups . CONCLUSIONS Perioperative dexamethasone use reduces posttonsillectomy morbidity in pediatric patients in the early postoperative period after hot or cold tonsillectomy . The combination of steroid and cold dissection technique provided the greatest advantage in reducing posttonsillectomy subjective pain levels Edema contributes substantially to the postoperative discomfort and morbidity of adenotonsillectomy . In a double-blind study , 58 children undergoing adenotonsillectomy were given a single intraoperative dose of either dexamethasone or saline . The steroid markedly affected the postoperative course in the first day after surgery . According to parental reports , the percentage of patients vomiting was reduced from 48 to 4 % . Severe throat pain was reported in 57 % of controls and only 20 % of dexamethasone patients . Twice as many steroid patients as controls tolerated some soft food on the first postoperative day . It appears that dexamethasone can greatly improve patient diet and comfort after adenotonsillectomy A prospect i ve , r and omized , double-blind study to determine the postoperative efficacy of steroids in tonsillectomy was performed in 49 children . A single dose of intravenous dexamethasone or placebo was administered after each child was anesthetized . Postoperatively each child was examined for objective signs of trismus ( measured by interincisor distance ) , temperature elevation , and weight loss , as well as for subjective signs of mouth odor , oral intake , pain , level of activity , and analgesic usage . There were no statistical differences noted in any of the variables compared in the two groups and the complication rates were also A prospect i ve , r and omized , double-blinded , placebo-controlled clinical trial was conducted in 41 patients evaluating the effect of a single preoperative dose of intravenous dexamethasone on postoperative vomiting and pain in children undergoing elective tonsillectomy . Dexamethasone was found to significantly reduce the incidence of vomiting in the first 24 hours postoperatively ( P=0.02 ) , the time to first intake of solids ( P=0.001 ) , the need to administer a rescue antiemetic ( P=0.005 ) and intravenous fluid therapy requirements ( P=0.006 ) in the postoperative period . No significant difference was found between the dexamethasone and placebo groups in the time to first intake of fluids , pain scores or analgesic requirement postoperatively . These results indicate that dexamethasone substantially reduces morbidity after tonsillectomy in children In this prospect i ve , r and omized , double-blind , placebo-controlled study , we examined the effect of preoperative dexamethasone on postoperative nausea and vomiting ( PONV ) and 24-h recovery in children undergoing tonsillectomy . One hundred thirty children , 2 - 12 yr of age , ASA physical status I or II , completed the study . All children received oral midazolam 0.5 - 0.6 mg/kg preoperatively . Anesthesia was induced with halothane and nitrous oxide in 60 % oxygen and maintained with nitrous oxide and isoflurane . Intubation was facilitated by mivacurium 0.2 mg/kg . Each child received fentanyl 1 [ micro sign]g/kg IV before initiation of surgery , as well as dexamethasone 1 mg/kg ( maximal dose 25 mg ) ( steroid group ) or an equal volume of saline ( control group ) . Intraoperative fluids were st and ardized to 25 - 30 mL/kg lactated Ringer 's solution . All tonsillectomies were performed under the supervision of one attending surgeon using an electrodissection technique . Postoperatively , fentanyl and acetaminophen with codeine elixir were administered as needed for pain . Rescue antiemetics were administered when a child experienced two episodes of retching and /or vomiting . Before home discharge , the incidence of PONV , need for rescue antiemetics , quality of oral intake , and analgesic requirements did not differ between groups . However , during the 24 h after discharge , more patients in the control group experienced PONV ( 62 % vs 24 % in the steroid group ) and complained of poor oral intake . Additionally , more children in the control group ( 8 % vs 0 % in the steroid group ) returned to the hospital for the management of PONV and /or poor oral intake . The preoperative administration of dexamethasone significantly decreased the incidence of PONV over the 24 h after home discharge in these children . Implication s : In this double blind , placebo-controlled study , we examined the efficacy of a single large dose ( 1 mg/kg ; maximal dose 25 mg ) of preoperative dexamethasone on posttonsillectomy postoperative nausea and vomiting ( PONV ) in children 2 - 12 yr of age undergoing tonsillectomy . Compared with placebo , dexamethasone significantly decreased the incidence of PONV in the 24 h after discharge , improved oral intake , decreased the frequency of parental phone calls , and result ed in no hospital returns for the management of PONV and /or poor oral intake . ( Anesth Analg 1998;87:57 - 61 BACKGROUND The minimum effective dose of dexamethasone in conjunction with 50 microg x kg(-1 ) ondansetron was evaluated in the treatment for vomiting after elective tonsillectomy or adenotonsillectomy . METHODS A total of 102 healthy children between 2 and 12 years of age participated in this prospect i ve , r and omized , double-blind study . A single intravenous ( i.v . ) dose of dexamethasone ( 50 , 100 , 150 microg x kg(-1 ) , maximum dose 8 mg ) with ondansetron ( 50 microg x kg(-1 ) ) was administered just before the end of surgery . Equal volumes of normal saline were given to the control group . General anaesthesia was induced and maintained by inhalation of N2O/O2 and sevoflurane . All other preoperative and postoperative medications ( including a supplementary dose of antiemetics if necessary ) , anaesthesia and surgical techniques were st and ardized . RESULTS No significant differences were observed between groups in postoperative vomiting on the day of surgery and the next day , or in the need for postoperative pain medication and supplementary doses of antiemetics ( P > 0.05 ) . CONCLUSIONS These results indicate that surgical technique and anaesthetic management used in this study could be the cause of the lower incidence of nausea and vomiting . Assessment of nausea and vomiting in a prospect i ve study with larger groups of patients may reflect different results OBJECTIVE To determine the effects of a single dose of dexamethasone sodium phosphate on postoperative morbidity in children undergoing tonsillectomy . DESIGN R and omized , double-blind , placebo-control clinical trial . SETTING Academic , tertiary care children 's hospital . PATIENTS Sixty-nine children ( 35 boys , 34 girls ) , aged 3 to 18 years , undergoing tonsillectomy with or without adenoidectomy . INTERVENTION Patients were r and omized to receive a single dose of intravenous dexamethasone or saline . MAIN OUTCOME MEASURES Pain scores , determined by a Faces Scale , were obtained at 4-hour intervals during the first postoperative day and daily for 7 days thereafter . Total use of an analgesic ; type of diet ; level of activity ; presence of halitosis , nausea , emesis , or fever ; and incidence of postoperative bleeding were also compared between the two groups . RESULTS The two groups of children were similar in age , gender , diagnosis , and surgical time . Pain scores in the postoperative period were identical while the patients were in the hospital and for the first 7 days after discharge . No statistically significant differences were noted in pain scores , nausea , emesis , halitosis , analgesic medications required , diet , or activity levels between the two groups of patients . CONCLUSION A single intraoperative dose of dexamethasone did not appreciably affect postoperative morbidity in children undergoing tonsillectomy Purpose Previous studies on dexamethasone ’s antiemetic and analgesic potential in children undergoing tonsillectomy have produced conflicting results . The aim of this study was to evaluate the effects of a single dose of dexamethasone on the incidence and severity of postoperative vomiting and pain in children undergoing electrocautery tonsillectomy under st and ardized general anesthesia . Methods In a double-blinded study 120 patients were r and omly allocated to receive either dexamethasone 0.5 mg·kg−1 ( maximum dose 8 mg)iv or an equivalent volume of saline preoperatively . The incidence of early and late vomiting , need for rescue antiemetics , time to first oral intake , time to first dem and of analgesia and analgesic consumption were compared in both groups . Pain scores used included Children ’s Hospital Eastern Ontario Pain Scale , “ faces ” , and a 0–10 visual analogue pain scale . Results Compared with placebo , dexamethasone significantly decreased the incidence of early and late vomiting ( P < 0.05,P < 0.001 respectively ) . Fewer patients in the dexamethasone group needed antiemetic rescue ( P < 0.01 ) . The time to first oral intake was shorter , and the time to first dose of analgesic was longer in the dexamethasone group ( P < 0.01 ) . Pain scores 30 min after extubation were lower ( P < 0.05 ) in the dexamethasone group . At 12 and 24 hr postoperative swallowing was still significantly less painful in the dexamethasone group than in the control group ( P < 0.01 ) . Conclusion Preoperative dexamethasone 0.5 mg·kg−1iv reduced both postoperative vomiting and pain in children after electrocautery tonsillectomy . RésuméObjectifLes études antérieures sur le potentiel analgésique \n Output:\n " }, { "from": "agent", "value": ": A single , intraoperative dose of dexamethasone may reduce post-tonsillectomy pain on postoperative day 1 , by a factor of 1 on a 10-point pain scale ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: Background : Controversy surrounds the optimal composition , dosage , and duration of therapies for eradication of Helicobacter pylori . We prospect ively compared omeprazole-based dual and triple therapies in the eradication of H. pylori in a r and omized manner . Methods : Between June 1995 and March 1997 , 1000 consecutive patients with acid-peptic disease associated with H. pylori infection ( duodenal ulcer , 388 patients , gastric ulcer , 179 patients ; duodenitis , 173 patients ; gastritis , 260 patients ) were prospect ively recruited . They were r and omized to either a 2-wk ( OA ) course of omeprazole 20 mg and amoxicillin 1 g , both given twice daily , or treatment for 1 wk ( OCM ) with omeprazole 20 mg once daily , clarithromycin 500 mg twice daily , and metronidazole 400 mg twice daily . Results : The age of these 1000 patients ranged from 16 to 90 yr , with a mean of 54.9 yr . Side effects occurred in 29.6 % ( 95 % confidence interval [ CI ] 25.6–33.8 % ) and 10.6 % ( 95 % CI 8.0–13.6 % ) of patients taking OCM and OA , respectively ( p < 0.0001 ) . Apart from taste disturbance , however , there were no significant differences in the incidences of side effects between the two groups . One patient in the OA group and four patients of the OCM group could not tolerate the medications , and therefore did not complete treatment ( p= 0.37 ) . Seven and 13 patients in the OA and OCM groups , respectively , refused a second endoscopy ( p= 0.25 ) . The remaining 975 patients underwent a second endoscopy . Positive endoscopic findings were significantly more common in the OA group ( 51/492 ; 10.4 % ; 95 % CI 7.8–13.4 % ) than in the OCM group ( 25/483 ; 5.2 % ; 95 % CI 3.4–7.5 % ) in the per- protocol ( PP ) analysis ( p= 0.004 ) . On intent-to-treat ( ITT ) analysis , the overall eradication rates in the OA and OCM groups were 73.6 % ( 95 % CI 69.5–77.4 % ) and 92 % ( 95 % CI 89.3–94.2 % ) , respectively ( p < 0.0001 ) . On PP analysis , the corresponding rates were 74.8 % ( 95 % CI 70.7–78.6 % ) and 95.2 % ( 95 % CI 92.9–97.0 % ) , respectively ( p < 0.0001 ) . Conclusions : A course of omeprazole , clarithromycin , and metronidazole for 1 wk is a safe , well-tolerated , efficacious , and cost-effective treatment for H. pylori infection BACKGROUND The proton pump inhibitor (PPI)-based 7-day triple therapy is the regimen with the highest cure rates for eradication of Helicobacter pylori infection and has been recommended as the first-line regimen in the world . It had been reported that a 1-day quadruple therapy could also successfully cure 95 % of the H. pylori infected patients . OBJECTIVES To observe the efficacy of 1-day high-dose quadruple therapy versus 7-day triple therapy for treatment of H. pylori infection , and to observe side-effects of the two different regimens . METHODS This r and omized , open , parallel-controlled study was conducted at Renji Hospital between November 2004 to March 2005 . A total of 80 consecutive patients with non-ulcer dyspepsia , who were H. pylori positive proven by both rapid urease test and histology were included and r and omly assigned to 1-day quadruple therapy or 7-day triple therapy . Thirty-nine patients were administered with 1-day high-dose quadruple therapy including esomeprazole 40 mg b.i.d . , colloidal bismuth subcitrate 440 mg q.i.d . , amoxicillin 2 g q.i.d . and metronidazole ( 400 mg q.i.d . ) for 1 day . Forty-one patients received a st and ard 7-day triple therapy consisting of esomeprazole 20 mg b.i.d . , clarithromycin 500 mg b.i.d . and amoxicillin 1 g b.i.d . for 7 days . The eradication rates were evaluated by the (13)C-urea breath test at least 4 weeks after completion of a course treatment . RESULTS Seventy-seven patients completed the trial and three patients dropped out . The eradication rates in the 1-day therapeutic group and the 7-day therapeutic group were 39.5 % ( 15/38 ) and 84.6 % ( 33/39 ) , respectively . There was a statistically significant difference between the two groups ( P < 0.0001 ) . Short-lasting and self-limiting side effects including thirst , a metallic taste , diarrhea and abdominal pain were reported in three patients ( 7.9 % ) in the 1-day group and seven patients ( 18 % ) in the 7-day group ( P = 0.31 ) . CONCLUSIONS A 1-day high-dose quadruple therapy with amoxicillin , metronidazole , bismuth salt , and esomeprazole is not effective for eradication of H. pylori compared with the st and ard 7-day triple therapy The seasonal pattern of community-based acute bleeding from the upper gastrointestinal ( UGI ) tract was studied prospect ively in 1988 - 1991 . Out of 3343 emergency admissions to the Departments of General Surgery , 321 ( 9.6 % ) were due to acute UGI bleeding . There was a significant monthly variation in the total number of admissions , as well as in the number of admissions due to acute UGI bleeding ( p < 0.0001 ) . However , there was no correlation between the two . Significant seasonal fluctuations were noted both in the absolute number of admissions due to acute UGI bleeding and in the percentage of UGI bleeding admissions of the total number of admissions to the Departments of General Surgery ( p = 0.0002 ) . During summer ( July through September ) , the incidence declined significantly to a nadir of 5.5 % of total number of admissions in July . The seasonal fluctuation correlated closely with the incidence of duodenal ulcer , but not with that of gastric ulcer . The seasonal pattern was consistent both in patients who had used aspirin or other nonsteroidal anti-inflammatory drugs as well as in those who had not AIM To compare the one-day quadruple therapy with a st and ard 7-d triple therapy for H pylori eradication in a rural population of China . METHODS A total of 396 patients with (13)C-urea breath test positive for H pylori were assigned into two groups : 239 patients received one-day quadruple therapy ( amoxicillin 2000 mg qid ; metronidazole 500 mg qid ; bismuth citrate 900 mg qid and lansoprazole 60 mg once daily ) and 157 patients received 7-d st and ard triple therapy ( amoxicillin 1000 mg bid ; clarithromycin 500 mg bid and lansoprazole 30 mg bid ) . All the patients underwent a (13)C-UBT to assess the eradication of H pylori infection six weeks after treatment . RESULTS Two hundred and twenty-nine patients completed the one-day therapy ( 95.8 % ) and 148 patients completed the 7-d therapy ( 94.2 % ) . The one-day therapy eradicated H pylori infection in 64 patients ( 27.95 % ) . In contrast , 103 patients ( 69.59 % ) were H pylori negative after the 7-d therapy ( P < 0.01 ) . CONCLUSION This pilot study suggests there is no beneficial effect of the one-day therapy in treatment of H pylori infection compared with the 7-d st and ard therapy Background —Eradication ofHelicobacter pylori cures and prevents the relapse of duodenal ulceration and also results in histological resolution of chronic active gastritis . Aim —To compare four treatment regimens lasting seven days of a proton pump inhibitor and two antibiotics in the eradication of H pylori . Patients —Men or women with H pylori positive duodenal ulceration or gastritis , or both . Methods —A single blind , prospect ively r and omised , parallel group , comparative , multicentre study . After a positive CLO test , patients underwent histology , H pylori culture , and a 13C urea breath test to confirm H pyloristatus . Treatment with one of four regimens : LAC , LAM , LCM , or OAM , where L is 30 mg of lansoprazole twice daily , A is 1 g of amoxycillin twice daily , M is 400 mg of metronidazole twice daily , C is 250 mg of clarithromycin twice daily , and O is 20 mg of omeprazole twice daily , was assigned r and omly . A follow up breath test was done at least 28 days after completing treatment . Results —H pylori eradication ( intention to treat ) was 104/121 ( 86.0 % ) with LAC , 87/131 ( 66.4 % ) with LAM , 103/118 ( 87.3 % ) with LCM , and 94/126 ( 74.6 % ) with OAM . There was a significant difference ( p < 0.001 ) in the proportion of patients in whom eradication was successful between LAC and LCM when compared with LAM , but no significant difference ( p = 0.15 ) between LAM and OAM . Metronidazole resistance before treatment was identified as a significant prognostic factor with regard to eradication of H pylori . The regimens which contained metronidazole were significantly less effective than those without metronidazole in the presence of pretreatment resistant H pylori . There was no difference among the treatment groups with regard to the incidence and severity of adverse events reported . Conclusions —All four treatment regimens were safe and effective in eradicating H pylori in the patient population studied . LAC was the most efficacious treatment in patients with pretreatment metronidazole resistant H pylori , and was significantly better than LAM and OAM in this group of patients BACKGROUND AND PURPOSE Rabeprazole is a new proton pump inhibitor producing rapid inhibition of gastric acid secretion . This may potentiate the inhibitory effect of antibiotics against Helicobacter pylori . This study compared the efficacy , safety , and tolerability of 4- and 7-day rabeprazole-based triple therapies versus 7-day omeprazole-based triple therapy . METHODS A total of 70 H. pylori-infected peptic ulcer patients were r and omly assigned to 1 of 3 groups : RAC4 ( rabeprazole 20 mg , amoxicillin 1000 mg , and clarithromycin 500 mg twice daily for 4 days ) , RAC7 ( rabeprazole 20 mg , amoxicillin 1000 mg , and clarithromycin 500 mg twice daily for 7 days ) , and OAC7 ( omeprazole 20 mg , amoxicillin 1000 mg , and clarithromycin 500 mg twice daily for 7 days ) . Endoscopy , Campylobacter-like organism ( CLO ) test , H. pylori culture , and 13C-urea breath test were performed before r and omization and 8 weeks after the start of triple therapy . RESULTS Intention-to-treat ( ITT ) eradication rates for the RAC4 , RAC7 , and OAC7 groups were 87 % ( 20/23 ) , 83%(19/23 ) , and 88 % ( 21/24 ) , respectively , and per- protocol ( PP ) eradication rates were 91 % ( 20/22 ) , 95 % ( 19/20 ) , and 100 % ( 21/21 ) , respectively . There was no significant difference among the ITT or PP eradication rates of the 3 groups . All 3 regimens were well tolerated and compliance was excellent . CONCLUSIONS One-week RAC and 1-week OAC are equally effective for H. pylori eradication in peptic ulcer patients . The duration of RAC triple therapy can be shortened to 4 days without compromising its efficacy BACKGROUND Eradication of Helicobacter pylori infection has had an impact on the treatment and recurrence rates of peptic ulcer disease and malignancies such as mucosa-associated lymphoid t \n Output:\n " }, { "from": "agent", "value": "Moreover , slightly fewer adverse-effects were found in short-term protocol s. Conclusions Although more economical , short- duration protocol s are inferior to 7-d PPI-based triple protocol s with regarding to eradication rate of H. pylori .\nProtocol s of more than 3 d , however , may be equivalent to 7-d protocol" } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: The aim of this study was to assess whether a combination of gemcitabine ( GEM ) with either paclitaxel ( PTX ) or vinorelbine ( VNR ) could be more effective than GEM or PTX alone in elderly or unfit advanced non-small-cell lung cancer ( NSCLC ) patients . A total of 264 NSCLC patients aged > 70 years with ECOG performance status (PS)⩽2 , or younger with PS=2 , were r and omly treated with : GEM 1200 mg m−2 on days 1 , 8 and 15 every 28 days ; PTX 100 mg m−2 on days 1 , 8 and 15 every 28 days ; GEM 1000 mg m−2 plus PTX 80 mg m−2 ( GT ) on days 1 and 8 every 21 days ; GEM 1000 mg m−2 plus VNR 25 mg m−2 ( GV ) on days 1 and 8 every 21 days . In all arms , an intra- patients dose escalation was applied over the first three courses , provided that no toxicity of WHO grade ⩾2 had previously occurred . At present time , 217 ( 82 % ) patients had died . The median ( months ) and 1-year survival probability were 5.1 and 29 % for GEM , 6.4 and 25 % for PTX , 9.2 and 44 % for GT , and 9.7 and 32 % for GV . Multivariate analysis showed that PS⩽1 ( hazard ratio (HR)=0.67 ; 95 % CI 0.51–0.90 ) , and doublet treatments ( HR=0.76 ; 95 % CI 0.59–0.99 ) were significantly associated with longer survival . Doublets produced no more toxicity than single agents . GT should be considered a reference regimen for elderly NSCLC patients with PS⩽1 PURPOSE The objective of this trial was to compare two vinorelbine-based doublets with carboplatin ( CBDCA-VC ) or with gemcitabine ( VG ) in patients with stage IIIB-IV non-small cell lung cancer ( NSCLC ) . PATIENTS AND METHODS A total of 316 patients with advanced NSCLC previously untreated were r and omized to either vinorelbine 30 mg/m(2 ) D1,8 with carboplatin AUC 5 D1 ( VC ) or vinorelbine 25mg/m(2 ) with gemcitabine ( VG ) 1000 mg/m(2 ) both given D1,8 every 3 weeks . The primary endpoint was response rate with secondary parameters being survival ( OS ) , progression-free survival ( PFS ) , tolerance and clinical benefit . RESULTS The median number of cycles was four in each arm with a total of 1268 cycles . The objective response ( OR ) on intent-to-treat was 20.8 % in VC and 28 % in VG ( p=0.15 ) . Median PFS was 3.9 months in VC and 4.4 months ( mo ) in VG ( p=0.18 ) . Median survival was significantly longer ( p=0.01 ) for VG with 11.5 mo compared to 8.6 mo in VC with 1 year survival at 48.9 and 34.4 % , respectively . Tolerance was better in the VG arm as compared to the VC patients . Four toxic deaths were recorded in the VC group . Clinical benefit response rate was 32.4 % compared to 40.9 % in 111 and 110 evaluable patients in VC and VG , respectively . CONCLUSION VG compared to VC result ed in a similar overall response rate , favourable median survival and a better toxicity profile . For non-cisplatin-based chemotherapy , VG is a useful alternative This r and omised multicentre trial was conducted to establish the optimal duration of palliative chemotherapy in advanced non-small-cell lung cancer ( NSCLC ) . We compared a policy of three vs six courses of new-generation platinum-based combination chemotherapy with regard to effects on quality of life ( QoL ) and survival . Patients with stage IIIB or IV NSCLC and WHO performance status ( PS ) 0–2 were r and omised to receive three ( C3 ) or six ( C6 ) courses of carboplatin ( area under the curve ( AUC ) 4 , Chatelut 's formula , equivalent to Calvert 's AUC 5 ) on day 1 and vinorelbine 25 mg m−2 on days 1 and 8 of a 3-week cycle . Key end points were QoL at 18 weeks , measured with EORTC Quality of Life Question naire (QLQ)-C30 and QLQ-LC13 , and overall survival . Secondary end points were progression-free survival and need of palliative radiotherapy . Two hundred and ninety-seven patients were r and omised ( C3 150 , C6 147 ) . Their median age was 65 years , 30 % had PS 2 and 76 % stage IV disease . Seventy-eight and 54 % of C3 and C6 patients , respectively , completed all scheduled chemotherapy courses . Compliance with QoL question naires was 88 % . There were no significant group differences in global QoL , pain or fatigue up to 26 weeks . The dyspnoea palliation rate was lower in the C3 arm at 18 and 26 weeks ( P<0.05 ) , but this finding was inconsistent across different methods of analysis . Median survival in the C3 group was 28 vs 32 weeks in the C6 group ( P=0.75 , HR 1.04 , 95 % CI 0.82–1.31 ) . One- and 2-year survival rates were 25 and 9 % vs 25 and 5 % in the C3 and C6 arm , respectively . Median progression-free survival was 16 and 21 weeks in the C3 and C6 groups , respectively ( P=0.21 , HR 0.86 , 95 % CI 0.68–1.08 ) . In conclusion , palliative chemotherapy with carboplatin and vinorelbine beyond three courses conveys no survival or consistent QoL benefits in advanced NSCLC To determine a st and ard combination chemotherapy for patients with advanced non-small-cell lung cancer ( NSCLC ) , we conducted a phase III trial of irinotecan ( CPT-11 ) to test the hypotheses that CPT-11+cisplatin is superior to cisplatin+vindesine and that CPT-11 monotherapy is not inferior to cisplatin+vindesine . A total of 398 patients with previously untreated NSCLC were r and omised to receive cisplatin+CPT-11 ( CPT-P ) , cisplatin+vindesine ( VDS-P ) or CPT-11 alone ( CPT ) . In the CPT-P arm , CPT-11 60 mg m−2 was administered on days 1 , 8 and 15 , and cisplatin 80 mg m−2 was administered on day 1 . In the VDS-P arm , cisplatin 80 mg m−2 was administered on day 1 , and vindesine 3 mg m−2 was administered on days 1 , 8 and 15 . In the CPT arm , CPT-11 100 mg m−2 was administered on days 1 , 8 and 15 . The median survival time was 50.0 weeks for patients on CPT-P , 45.6 weeks for those on VDS-P and 46.0 weeks for those on CPT ( P=0.115 , CPT-P vs VDS-P ; P=0.089 , CPT vs VDS-P ) , and the hazard ratio was 0.85 ( 95 % confidence interval ( CI ) : 0.65–1.11 ) for CPT-P vs VDS-P and 0.83 ( 0.64–1.09 ) for CPT vs VDS-P. The response rate was 43.7 % for patients on CPT-P , 31.7 % for those on VDS-P and 20.5 % for those on CPT . Major adverse reactions were grade 4 neutropenia observed in 37 , 54 and 8 % of the patients on CPT-P , VDS-P and CPT , respectively ; and grade s 3 and 4 diarrhoea observed in 12 , 3 and 15 % of the patients , respectively . CPT-P therapy produces comparable survival to VDS-P in patients with advanced NSCLC . CPT-11 monotherapy is not inferior to VDS-P in terms of survival . The CPT-11-containing regimen is one of the most efficacious and well tolerated in the treatment of advanced NSCLC OBJECTIVE To determine , in stage IV non-small-cell lung cancer ( NSCLC ) , if the combination of gemcitabine-a new active drug-with ifosfamide ( IG ) or with the cisplatin-carboplatin association ( CCG ) will improve survival ( primary end point ) in comparison with a first-generation regimen , cisplatin-carboplatin-ifosfamide ( CCI ) . PATIENTS AND METHODS A total of 284 chemotherapy-naïve patients with metastatic NSCLC were r and omised . Four were ineligible and 16 were not assessable for responses . Cisplatin was given at 60 mg/m2 on day 1 , carboplatin AUC 3 mg.min/ml on day 1 , ifosfamide 4.5 g/m2 on day 1 and gemcitabine 1 g/m2 on days 1 , 8 and 15 . Courses were repeated every 4 weeks . Response was assessed after three courses and chemotherapy was continued in responding patients until best response . There were 94 eligible patients in the CCI arm , 92 in CCG and 94 in the IG arm . RESULTS The objective response rates for CCI , CCG and IG were 23 % [ 95 % confidence interval ( CI ) 15 % to 32 % ] , 29 % ( 95 % CI 20 % to 39 % ) and 25 % ( 95 % CI 16 % to 33 % ) , respectively ( P = 0.61 ) . Median survival time was 24 , 34 and 30 weeks , respectively ( P = 0.20 ) . One-year survival was 23 , 33 and 35 % , and 2-year survival was 11 , 14 and 17 % , respectively . In some subgroups ( older patients , women ) , there was a significant survival advantage for CCG and IG compared with CCI . Toxicity was tolerable : severe alopecia was less frequent in the CCG arm , and IG was associated with significantly more thrombopenia while CCG was associated with more leucopenia . CONCLUSION In stage IV NSCLC , treatment with regimens including the new drug gemcitabine were associated with a better but not statistically significant observed survival compared with a classical first-generation cisplatin-containing regimen . The non-platinum combination of gemcitabine was as effective as its combination with platinum The aim of this study was to compare the efficacy of single‐agent weekly docetaxel with the combination of docetaxel and gemcitabine in elderly and /or poor performance status patients with advanced nonsmall cell lung cancer ( NSCLC ) PURPOSE The purpose of this study was to determine whether the addition of the epidermal growth factor receptor tyrosine kinase inhibitor gefitinib ( Iressa , ZD1839 ; AstraZeneca , Wilmington , DE ) to st and ard first-line gemcitabine and cisplatin provides clinical benefit over gemcitabine and cisplatin alone in patients with advanced or metastatic non-small-cell lung cancer ( NSCLC ) . Gefitinib has demonstrated encouraging efficacy in advanced NSCLC in phase II trials in pretreated patients , and a phase I trial of gefitinib in combination with gemcitabine and cisplatin showed favorable tolerability . PATIENTS AND METHODS This was a phase III r and omized , double-blind , placebo-controlled , multicenter trial in chemotherapy-naive patients with unresectable stage III or IV NSCLC . All patients received up to six cycles of chemotherapy ( cisplatin 80 mg/m(2 ) on day 1 and gemcitabine 1,250 mg/m(2 ) on days 1 and 8 of the 3-week cycle ) plus either gefitinib 500 mg/d , gefitinib 250 mg/d , or placebo . Daily gefitinib or placebo was continued until disease progression . End points included overall survival ( primary ) , time to progression , response rates , and safety evaluation . RESULTS A total of 1,093 patients were enrolled . There was no difference in efficacy end points between the treatment groups : for the gefitinib 500 mg/d , gefitinib 250 mg/d , and placebo groups , respectively , median survival times were 9.9 , 9.9 , and 10.9 months ( global ordered log-rank [ GOLrank ] P = .4560 ) , median times to progression were 5.5 , 5.8 , and 6.0 months ( GOLrank ; P = .7633 ) , and response rates were 49.7 % , 50.3 % , and 44.8 % . No significant unexpected adverse events were seen . CONCLUSION Gefitinib in combination with gemcitabine and cisplatin in chemotherapy-naive patients with advanced NSCLC did \n Output:\n " }, { "from": "agent", "value": "R and omized studies suggest that platinum-based doublets ( platinum plus new agent ) are the st and ard of care for first-line systemic therapy .\nNo one new agent is clearly superior for use in combination with a platinum agent .\nThe survival advantage of platinum-based doublets over nonplatinum combinations or older combinations is modest .\nThe addition of bevacizumab to carboplatin and paclitaxel has shown improved survival , although multiple exclusion criteria limit the applicability of these data to a subset of patients .\nIn patients at least 70 years of age or with Eastern Collaborative Oncology Group performance status 2 , a new single agent is an alternative .\nTreatment beyond four to six cycles impedes quality of life without prolonging life .\nEmerging data suggest that the choice of chemotherapy agent may be influenced by histologic subtype .\nIn NSCLC , a combination of a platinum agent plus a new agent continues to be the st and ard of care ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: BACKGROUND AND 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 In a prospect i ve controlled trial we compared the clinical outcome for unselected acute stroke patients in a non-intensive stroke unit ( n = 110 ) and in general medical wards ( n = 183 ) . The patients were comparable in age , marital state and functional impairment on admission . Case fatality rates over the first year after the stroke were similar in the two groups . By three months after the stroke , 15 % of the survivors initially admitted to the stroke unit and 39 % of those admitted to general medical wards remained hospitalized ( p less than 0.001 ) . The corresponding figures by one year after the cerebrovascular accident were 12 % and 28 % , respectively ( p less than 0.05 ) . A greater proportion of surviving stroke unit patients was independent in walking ( 0.10 greater than p greater than 0.05 ) , personal hygiene ( p less than 0.05 ) and dressing ( p less than 0.001 ) . Essential features of the stroke unit are team work headed by a stroke nurse , staff , patient and family education and very early onset of rehabilitation . We conclude that this strategy improves functional outcome and reduces the need for long-term hospital care In a r and omized controlled trial we compared the clinical outcome of acute stroke patients , 110 of whom were allocated to treatment in a stroke unit and 110 to treatment in general medical wards . No significant difference existed between these groups with regard to sex , age , marital status , medical history , or functional impairment on admission . Outcome was measured at 6 and 52 weeks after the stroke by the proportion of patients at home , the proportion of patients in an institution , the mortality , and the functional state . After 6 weeks 56.4 % of the patients r and omized to the stroke unit and 32.7 % of the patients r and omized to the general medical wards were at home ( p = 0.0004 ) , and after 52 weeks 62.7 % and 44.6 % , respectively , were at home ( p = 0.002 ) . After 6 weeks 36.3 % of the patients from the stroke unit and 50.0 % from the general medical wards were in an institution ( p = 0.02 ) ; after 52 weeks 12.7 % and 22.7 % , respectively , were institutionalized ( p = 0.016 ) . After 6 weeks mortality was 7.3 % for the stroke unit group and 17.3 % for the general medical wards group ( p = 0.027 ) . After 52 weeks mortality was 24.6 % for the stroke unit group and 32.7 % for the general medical wards group ( difference not significant ) . Functional state was significantly better for patients treated in the stroke unit after both 6 and 52 weeks . We conclude that care of patients with acute stroke in a stroke unit improves clinical outcome compared with treatment in general medical wards Background and Purpose The aim of the study was to compare the effect of conventional treatment with the effect of acute stroke unit care integrated with geriatric stroke unit care continuum . Methods A 1-year study was undertaken with 2:1 r and omization to stroke unit care or conventional care , with assessment by an independent team . The study was composed of 249 elderly patients ( aged ≥70 years ) hospitalized for acute stroke , without previous cerebral lesion and without recognized need of care . Main outcome measures were patients at home after 1 year , ability in daily living activities , health-related quality of life score according to question naire , death or institutional care , and death or dependence . Results One hundred two patients ( 61 % ) in the stroke unit and 49 patients ( 59 % ) in the general ward group were alive and at home after 1 year ( 95 % CI −10 % to 16 % ) . There were no significant differences in daily life activities or quality of life . In patients with concomitant cardiac disease , there was a reduction in death or institutional care after 3 months in the stroke unit group compared with the group receiving conventional care ( 28 % versus 49 % , respectively ; 95 % CI −40 % to −3 % ) . This effect did not remain after 1 year . Patients seeking care after 24 hours often had mild stroke and lived alone . Conclusions There was no effect on the number of patients living at home after 1 year , but after 3 months of stroke unit care , a beneficial effect was found on mortality and the need for institutional care among those with concomitant heart disease . This study involved patients who were considerably older than those investigated in previous r and omized studies of acute stroke unit care ; thus , these findings will contribute to the specialized register of controlled trials in stroke Background and Purpose : Few studies have assessed the influence of the organization of stroke care on health-related quality of life ( HRQoL ) . The present study compared HRQoL 6 months after stroke between subjects who had been treated in an acute stroke unit ( SU ) and those treated in general medical wards ( GMW ) . Methods : In total 550 subjects≧60 years of age with acute stroke were prospect ively allocated according to date of birth ( day of the month ) to treatment in an SU with short length of stay or GMWs . In the present study , 325 survivors at 5 days with Sc and inavian stroke scale ( SSS ) orientation score > 5 and SSS speech score > 5 were included . We assessed HRQoL with the Short Form 36 ( SF-36 ) question naire 6 months after stroke onset and estimated utility values from the SF-36 scores . Results : Of the 325 eligible subjects , 158 were allocated to an SU and 167 to GMWs . Among 296 survivors at 6 months , 115 subjects ( 79 % of survivors ) in the SU group completed the question naire and 121 ( 80 % ) in the GMW group . There was no statistically significant difference between the treatment groups on any of the 8 SF-36 scales or the 2 component summary scales . After integrating death in the comparison of HRQoL , there was still no difference in outcome between the groups . Conclusion : An acute SU with a short length of stay , offering early treatment and rehabilitation , could not show an improvement in the HRQoL of stroke patients ≧60 years 6 months after stroke compared with initial treatment in GMWs There is ample evidence from r and omized trials that for patients with stroke , stroke unit care is superior to care in general medical or neurological wards . This evidence , which has been adopted by international guidelines has to be implemented into daily stroke care . This consensus document prepared by the Belgian Stroke Council provides a set of minimum criteria to meet international st and ards for stroke care . It is intended to provide help in the creation of stroke units in centers who do not currently have one and to provide a benchmark for centres already having organised stroke care BACKGROUND AND PURPOSE To assess the impact of a stroke unit ( SU ) on acute phase treatment when compared to a conventional general ward treatment ( GW ) . METHOD Seventy-four patients with acute stroke were r and omized between a SU and conventional general ward ( GW ) . We compared both groups regarding the length of hospital stay , lethality and functional and clinical status within 6 months , using the Sc and inavian scale and Barthel index . RESULTS Thirty-five and thirty-nine patients were allocated at SU and GW , respectively . Lethality on the 10th day at SU and GW achieved 8.5 % and 12.8 % respectively ( p= 0.41 ) , whereas 30-days mortality rates achieved 14.2 % and 28.2 % ( p= 0.24 ) , 17.4 % and 28.7 % on the 3rd month ( p= 0.39 ) , and 25.7 % and 30.7 % on the 6th month ( p= 0.41 ) . Thirty-day survival curve achieved 1.8 log rank ( p= 0.17 ) , with a trend for lower lethality in the SU . In order to save one death in 6 months in SU , NNT ( the number need to treat ) was 20 ; to get one more home independent patient NNT was 15 . No significant difference was found between the length of hospital stay and morbidity . CONCLUSION No significant benefit was found in SU patients compared to GW group . However , an evident benefit in absolute numbers was observed in lethality , survival curve and NNT in thirty days period after stroke . Further collaborative studies or incresead number of patients are required to define the role of SU Follow-up of a controlled trial of the management of acute stroke in the elderly showed that the improvement in functional outcome at the time of discharge from hospital that had been achieved through establishing a stroke unit had disappeared by one year . Factors that might have contributed to this included overprotection by the families of patients who had been treated in the stroke unit , who were not permitted to carry out activities of daily living in which they were independent , and the early discharge from medical units of patients whose full rehabilitation potential had not been realised . Prolonging the benefits of short-term gains in functional outcome through the intervention of a stroke unit requires that all the links in the chain of stroke rehabilitation are maintained , including the proper orientation of patients ' families before discharge from hospital BACKGROUND Stroke unit is the most effective treatment method to benefit stroke patients . Our study is to evaluate the early effectiveness of a hospital stroke unit ( SU ) . METHODS Three hundred and ninety-two patients who had suffered from acute strokes and who were admitted to our hospital between December 2001 and January 2003 were recruited for this controlled study . All patients were sent at r and om to either the SU or the general ward ( GW ) for treatment . The following indices were measured by : Barthel Index ( BI ) , National Institute of Health Stroke Scale ( NIHSS ) , Oxford H and icap Scale ( OHS ) . RESULTS The mean change in BI score between the day of admission and the day of discharge was 20.00 + /- 24.36 for the SU group and 10.63 + /- 23.59 for the GW group . A difference that is statistically significant ( P = 0.000 ) . The mean change in NIHSS score was -2.01 + /- 6.61 for the SU group and 0.55 + /- 7.44 for the GW group . A difference that is also statistically significant ( P = 0.000 ) . Finally , the mean change in OHS score was -0.74 + /- 1.04 for the SU group and -0.28 + /- 0.98 for the GW group , also a statistically significant difference ( P = 0.000 ) . Among SU patients , patient satisfaction was higher ( P = 0.000 ) , the rehabilitation success rate was higher ( P = 0.000 ) , and there were fewer complications ( P = 0.000 ) . CONCLUSION Compared to GW patients , stroke patients treated in a special SU were able to return to normal daily activities earlier , with better social abilities , and have reduced neurological defects , without increasing the overall economic burden BACKGROUND Organised specialist care for stroke improves outcome , but the merits of different methods of organisation are in doubt . This study compares the efficacy of stroke unit with stroke team or domiciliary care . METHODS A single-blind , r and omised , controlled trial was undertaken in 457 acute-stroke patients ( average age 76 years , 48 % women ) r and omly assigned to stroke unit , general wards with stroke team support , or domiciliary stroke care , within 72 h of stroke onset . Outcome was assessed at 3 , 6 , and 12 months . The primary outcome measure was death or institutionalisation at 12 months . Analyses were by intention to treat . FINDINGS 152 patients were allocated to the stroke unit , 152 to stroke team , and 153 to domiciliary stroke care . 51 ( 34 % ) patients in the domiciliary group were admitted to hospital after r and omisation . Mortality or institutionalisation at 1 year were lower in patients on a stroke unit than for those receiving care from a stroke team ( 21/152 [ 14 % ] vs 45/149 [ 30 % ] ; p<0.001 ) or domiciliary care ( 21/152 [ 14 % ] vs 34/144 [ 24 % ] ; \n Output:\n " }, { "from": "agent", "value": "The findings from this study were broadly in line with the original Cochrane review : acute stroke units can improve survival and independency , as well as reduce the chance of hospitalization and the length of inpatient stay .\nThis result could have an impact on the future dem and for healthcare services for individuals that survive a stroke but became dependent on their care-givers ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: Acitretin , the principal and free acid metabolite of etretinate , was used to treat patients with stable , plaque-type psoriasis . For the first 8 weeks , 38 patients received placebo or acitretin , 10 , 25 , 50 , or 75 mg daily , in a double-blind manner . After the double-blind phase , the patients were allowed to continue for a total of 6 months of acitretin therapy at an average dosage of 50 mg/day . When the patients flared after stopping therapy , an additional 6-month course of acitretin therapy was offered . Acitretin , which was as effective as etretinate , had to be given at a dosage of 50 mg/day or more to obtain a significant benefit . Side effects frequently occurred in patients receiving acitretin , 25 mg/day or more , but were generally mild and did not warrant discontinuation of therapy . They were similar to those of etretinate therapy ; cheilitis , peeling of palms and soles , and alopecia occurred most frequently . The most common abnormal laboratory test results were elevations in serum triglycerides and , to a lesser extent , serum cholesterol and liver transaminase levels . Acitretin , in view of its much shorter half-life and similar efficacy and side-effect profile compared with etretinate , may be a preferable therapy for psoriasis , especially in women of childbearing age Acitretin , the active metabolite of etretinate , has the clinical advantage of a much shorter terminal elimination half-life . We report the results of a double-blind , placebo-controlled trial of acitretin ( Soriatane ) in 15 patients with moderate to severe psoriasis . Patients received 25 mg or 50 mg daily of acitretin or placebo in a double-blind fashion for 8 weeks and then were given 25 to 75 mg acitretin daily during an open study . Only two placebo patients completed the double-blind phase ; one patient 's psoriasis worsened , and one showed no significant change . All 15 patients then completed at least 8 weeks with 25 to 75 mg acitretin daily , with a moderate change in erythema , scaling , and in duration ( mean 28 % to 37 % improvement ) but with minimal change in the percentage of body surface area involved . Prolonged treatment ( greater than or equal to 20 weeks ) with acitretin result ed in further significant improvement and a 44 % reduction of involved surface area from baseline Acitretin , a metabolite of etretinate , was given to 38 patients for the treatment of psoriasis . During the first 8 weeks patients received either placebo , 10 mg , 25 mg , 50 mg , or 75 mg of acitretin daily in a double-blind manner . The dosages of 10 mg and 25 mg daily did not achieve any statistically significant improvement in psoriasis over placebo ; however , both the 50 and 75 mg dosages were statistically significantly better than placebo . Side effects were primarily mucocutaneous and occurred in most patients receiving 25 mg or more of acitretin daily . After the double-blind period , patients continued treatment in an open fashion until they had received a total of 24 weeks of acitretin therapy . Most patients received 50 mg of acitretin daily , which adequately cleared their psoriasis . After approximately 3 months without acitretin , most patients required retreatment . Subsequent 24-week courses of therapy were generally effective and well tolerated . The most common laboratory abnormalities were elevations of triglyceride , cholesterol , and liver transaminase levels . The efficacy and side effects of acitretin appear to be similar to those of etretinate ; the principal advantage of acitretin is its shorter half-life . Although acitretin is a potent teratogen , its rapid elimination makes it a viable treatment for psoriasis among women of childbearing potential BACKGROUND Psoriasis vulgaris may benefit from treatment with fumaric acid and /or its derivatives ; however , because different preparations have been used , results have been contradictory and difficult to interpret . OBJECTIVE The purpose of this clinical trial was to evaluate the therapeutic value of fumaric acid derivatives . METHODS A r and omized double-blind study was carried out in patients with psoriasis , comparing a well-characterized formulation of fumaric acid derivatives with placebo . RESULTS The results indicated statistically significant superiority of the fumaric acid derivatives over placebo . Adverse events ( flush , gastrointestinal disturbances ) were initially relatively frequent , but decreased thereafter . CONCLUSION Fumaric acid derivatives were found to be effective and safe in the treatment of psoriasis In a 4-month double-blind study the effects of dimethylfumaric acid esters ( DMFAE-EC ) and DMFAE plus salts of monoethylfumaric acid esters ( fumaric acid combination , FAC-EC ) in enteric-coated tablets were compared in 22 respectively 23 patients with psoriasis . In both groups about 50 % showed a considerable improvement , i.e. the initial score was more than halved . The therapeutic effects showed no significant differences in both groups with respect to the total psoriasis score or the different parameters . In the FAC-EC group the effects were obtained more rapidly . Most frequently observed side effects in both groups were flushings , stomachache and diarrhea . Due to these complaints 3 respectively 8 patients discontinued therapy . Eosinophilia , leukopenia and lymphopenia were the most frequently observed differences in lab tests . It was concluded that FAC-EC had no significantly better effect than monotherapy with DMFAE-EC . Moreover , enteric coating of the tablets did not prevent stomach complaints . Until more information has been obtained about the pharmacokinetics , the toxicity and optimal composition of the drug , the fumaric acid therapy in psoriasis should be seen as experimental Background : Calcipotriol is an established topical therapy for psoriasis vulgaris . Objective : This study aim ed to investigate whether the addition of calcipotriol to fumaric acid ester ( FAE ) monotherapy had an additive efficacy and an FAE-sparing effect in patients with severe plaque psoriasis . Methods : This multicentre , r and omised , double-blind , vehicle-controlled study included 143 patients for up to 13 weeks treatment . Group A received FAE tablets ( Fumaderm ® ) with an increasing daily dosage from 105 to 1,075 mg + ointment vehicle . Group B received FAE tablets + calcipotriol ointment ( 50 µg/g ) . Ointments were applied twice daily . Clinical response was assessed using percentage changes in the Psoriasis Area and Severity Index ( PASI ) , from baseline to treatment end . Results : The mean percentage change in the PASI was –76.1 % in group B and –51.9 % in group A , the difference between treatments was –24.2 % ( 95 % CI from –34.2 to –14.2 % ; p < 0.001 ) . Group B responded more rapidly to treatment . Investigators ’ and patients ’ overall efficacy assessment s were significantly more favourable for group B ( p ≤ 0.001 ) . Group B was prescribed less FAE than group A. This difference was greatest at the last visit ( mean daily dose 529 and 685 mg , respectively ; p = 0.006 ) . Overall adverse events in the two groups were similar . Conclusion : This study shows that the combination of calcipotriol and FAEs is significantly more effective and faster acting than FAE monotherapy in the treatment of severe plaque psoriasis . The combination has a slight FEA-sparing effect and therefore a superior benefit/risk ratio \n Output:\n " }, { "from": "agent", "value": "One head‐to‐head study of very low‐ quality evidence comparing FAEs with methotrexate reported comparable efficacy and dropout rates , although FAEs caused more flushing ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: & NA ; Tramadol hydrochloride is a synthetic & mgr;‐opioid agonist with additional monoaminergic activity . Tramadol 's analgesic effect has been equated with that of pethidine , with a more favourable side‐effect profile . Tramadol has been the most‐selling prescription analgesic in Germany for several years , and it is now available in many other European countries , but still there is a lack of adequately controlled clinical studies of its analgesic properties . The purpose of this study was to compare the analgesic efficacy of 50 and 100 mg oral tramadol with our st and ard analgesic for postoperative pain treatment , 1000 mg paracetamol + 60 mg codeine , and placebo . A single‐dose , parallel group , double‐blind design was used . One hundred forty‐four patients were enrolled the day after total hip replacement if they had a pain intensity of 60 mm or more on a 0–100 mm visual analogue scale . Treatments were compared on the basis of pain intensity and derived variables ( pain intensity difference , and summed pain intensity differences ) , the need of rescue medication , and a global evaluation . Serum concentrations confirmed rapid and good absorption comparable with the reported in healthy volunteers . The active drug control , paracetamol + codeine , was significantly superior to placebo for all efficacy variables ( P = 0.0002–0.004 ) , confirming good assay sensitivity . Paracetamol + codeine was also significantly superior to both 50 mg tramadol ( P = 0.002–0.03 ) and 100 mg tramadol ( P = 0.002–0.02 ) . There was no difference between placebo and 50 and 100 mg tramadol for any of the efficacy variables . Adverse events were more common with tramadol than with the active control ( P < 0.02 ) , with significantly more emetic episodes after 50 and 100 mg tramadol ( P < 0.05 ) . Thus , this double‐blind , placebo‐ and active drug‐controlled study after orthopaedic surgery shows that 50 and 100 mg oral tramadol is well absorbed but has no significant analgesic effect in doses that are tolerable as single doses by mouth . We emphasize the importance of proper study design with documented assay sensitivity and sufficiently high initial pain intensity for differentiation between analgesics of different potencies 1 In a double-blind crossover study identical oral surgical procedures were performed on two separate occasions in 24 out patients . 2 At one operation they were given tablets containing paracetamol + codeine phosphate ( 400 mg + 30 mg ) , and at the other plain paracetamol ( 400 mg ) . The day of operation 2 tablets were taken 3 , 6 and 9 h after surgery , the following two days 1 tablet four times daily . 3 Several measurements / assessment s were recorded for a paired comparison of the postoperative courses . 4 No increase In the analgesic effect could be demonstrated by addition of codeine to paracetamol . 5 On the day of operation 18 patients reported adverse effects like nausea , dizziness and drowsiness with paracetamol + codeine , while only 3 patients experienced side effects with paracetamol alone ( P less than 0.001 ) . 6 Measurements revealed almost identical swelling after the two operations . 7 Compared with results obtained in previous studies , the present findings indicate that paracetamol may exert anti-inflammatory activity and reduce postoperative swelling , even when given 3 h after surgery . 8 On the day of operation and the following two days 20 patients preferred the treatment with plain paracetamol , while only 4 favoured paracetamol + codeine ( P less than 0.001 ) The purpose of the present investigation was to compare the analgesic efficacy of flurbiprofen , a nonsteroidal anti-inflammatory drug , which is a phenyl propionic acid derivative , with acetaminophen and placebo in 63 adult out patients with moderate to severe dental pain following periodontal surgery . After surgery was completed under local anesthesia , the patients received under double-blind conditions an envelope containing four tablets of either flurbiprofen 100 mg , acetaminophen 500 mg , or placebo and they were instructed to take one tablet every 6 hours when postoperative pain reached moderate to severe intensity . To determine analgesic efficacy and patients recorded pain intensity on a scale of 0 to 3 . Patients were allowed to remedicate after 1 hour if pain was not reduced . Flurbiprofen was shown to possess an adequate analgesic effect superior to either placebo ( P less than 0.005 ) or acetaminophen ( P less than 0.01 ) in the parameters studied . Our results seem to further support earlier data obtained with the drug in dental patients with postoperative pain after the surgical removal of impacted third molars ; therefore , it is concluded that flurbiprofen used as directed is a new alternative for the proper treatment of pain following periodontal surgery 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 In a double‐blind , r and omized , single‐dose trial the analgesic contribution of acetaminophen , 1000 mg , and codeine , 60 mg , was determined . The study was a 2 × 2 factorial experiment in which 120 patients suffering from pain as a result of oral surgery rated their pain intensity and pain relief for up to 5 hours after a single dose of one of : 1000 mg acetaminophen , 60 mg codeine , 1000 mg acetaminophen plus 60 mg codeine , or placebo . The factorial analysis showed that both 1000 mg acetaminophen and 60 mg codeine made a statistically significant ( P < 0.05 ) contribution to the analgesic effectiveness of the combination on all measures of efficacy ( sum of pain intensity differences , largest pain intensity difference , total pain relief , largest pain relief , and time to remedication ) . The incidence of adverse effects did not appear to differ among the treatments , including placebo To determine the relative analgesic efficacy of ibuprofen 400 mg and acetaminophen 1000 mg , we conducted a single-dose , double-blind , placebo-controlled , r and omized clinical trial using a st and ard assay for analgesic agents , the dental pain model . At regular intervals over 6 hours , 184 patients who had undergone dental impaction surgery rated pain intensity and relief on categorical scales and pain half-gone on a dichotomous nominal scale ; a categorical overall evaluation was completed at the end of 6 hours . Both active agents were effective compared to placebo . Ibuprofen 400 mg was more effective than acetaminophen 1000 mg for Sum Pain Intensity Difference ( SPID ) , Total Pain Relief ( TOTPAR ) , sum pain half-gone , and overall evaluation ( P less than .05 to P less than .001 ) . The time-effect curves demonstrated a greater peak effect and longer duration of action for ibuprofen 400 mg compared to acetaminophen 1000 mg . Side effects were reported in five ibuprofen patients , 11 acetaminophen-treated patients , and seven placebo patients . Based on the results of this clinical study , we conclude that ibuprofen 400 mg is a safe and more effective analgesic than acetaminophen 1000 mg for patients with acute pain A double-blind , placebo-controlled trial was carried out in 299 patients suffering from post-episiotomy pain to compare the analgesic effectiveness and tolerance of single doses of 500 mg dipyrone and 500 mg paracetamol . Assessment s of pain relief over a 6-hour period showed that dipyrone produced significantly better results than placebo within half an hour of intake and maintained this superiority throughout the 6 hours . It also afforded consistently better pain relief than paracetamol and was significantly more effective at the 6-hour assessment . Side-effects were few and mild In a double‐blind , single‐dose , parallel‐group study , ketorolac ( 5 , 10 , or 20 mg ) was compared with acetaminophen ( 500 or 1000 mg ) when taken by mouth for postoperative orthopedic pain . Analgesic measurements were made by trained nurse observers who used st and ard verbal rating and visual analog scales . Acetaminophen , 1000 mg , was statistically superior to 500 mg acetaminophen , demonstrating assay sensitivity . Ketorolac , 20 mg , was distinguished from 500 mg acetaminophen , 5 mg ketorolac , and 10 mg ketorolac , but not from 1000 mg acetaminophen . The higher doses of ketorolac induced a longer lasting peak analgesic effect than did acetaminophen , but the magnitude of the peak pain relief was changed little by an increased ketorolac dose . Overall , 10 mg ketorolac appeared equivalent to 1000 mg acetaminophen . Acetaminophen , 500 mg , induced less sedation than the higher doses of ketorolac , but neither drug caused untoward side effects A double-blind r and omized analgesic trial was carried out on 180 patients undergoing surgical removal of an impacted lower wisdom tooth . The patients took their first dose of either 1000 mg paracetamol plus 60 mg codeine or 650 mg paracetamol plus 65 mg dextropropoxyphene when pain appeared after the decline of the local anaesthesia . If needed , another two doses were available during the observation period ( ≤10 h ) . The analgesic efficacy of paracetamol/codeine was overall superior to paracetamol/dextropropoxyphene in all variables . Sufficient pain relief was obtained in most patients . The pain reduction after the first dose was 64 % in the group receiving paracetamol/codeine compared with 53 % in the group receiving paracetamol/dextropropoxyphene and the mean duration s of effect of the first dose were 6.6 and 5.8 h , respectively . Side-effects appeared in all patient groups but were most frequent in women taking paracetamol/codeine One hundred sixty-one patients with postoperative pain were treated at a single center in a double-blind , r and omized , parallel study design ed to compare the efficacy and safety of single oral doses of ketoprofen ( 50 and 150 mg ) , an acetaminophen ( 650 mg ) plus codeine ( 60 mg ) combination , and placebo . From 1 through 4 hours after administration of the study drugs , the mean summed pain intensity difference ( SPID ) and time-weighted total pain relief ( TOPAR ) scores for the three active treatments generally were significantly ( P less than 0.05 ) higher than those for placebo but not significantly different from each other . At the 6-hour evaluation , the ketoprofen groups , but not the acetaminophen-codeine group , had higher ( P less than 0.05 ) mean SPID and TOPAR scores than the placebo group , as a result of a shorter duration of pain relief in the acetaminophen-codeine group . The 6-hour TOPAR scores were significantly ( P less than 0.05 ) higher for both ketoprofen groups than for the acetaminophen-codeine group ; the ketoprofen 150 mg group also had significantly ( P less than 0.05 ) higher mean 6-hour SPID and global subjective assessment scores . As a result of a higher frequency of somnolence , there was a significantly ( P less than 0.05 \n Output:\n " }, { "from": "agent", "value": "Drug-related study withdrawals were rarely reported .\nStudies reported a variable incidence of adverse effects that were generally mild and transient .\nThere were no statistically significant differences in the frequency of reported adverse effects between paracetamol 975/1000 mg and placebo .\nREVIEW ER 'S CONCLUSIONS Single doses of paracetamol are effective analgesics for acute postoperative pain and give rise to few adverse effects" } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: Objective This prospect i ve r and omized study determined the influence of closed-suction drainage on the incidence of postoperative complications after elective hepatic resection . Summary Background Data Routine drainage is no longer advocated after several intra-abdominal surgical procedures . Methods A series of 81 patients who underwent elective hepatic resection were r and omly allocated to either a nondrainage group ( n = 39 ) and a drainage group with closed-suction drainage ( n = 42 ) . Indications for resection were 42 benign lesions and 39 malignant tumors , including 19 with cirrhosis . Major hepatic resection was performed in 25 patients and minor resection , in 56 . All patients underwent ultrasonography with puncture for bacteriologic cultures of all fluid collection s within the first 5 postoperative days . Results One patient died in each group . Ultrasonography found a significantly higher rate of subphrenic collection s in the drainage group compared with the nondrainage group ( respectively , 36 % vs. 15 % , p < 0.05 ) . These collection s were more frequently infected in the drainage group ( n = 6 ) than in the nondrainage group ( n = 2 ) . After major liver resection , the rate of intra-abdominal postoperative complications ( i.e. , subphrenic fluid collection s , hematomas , and bilomas ) was similar between the two groups . Conclusion Minor liver resection is safer without drainage . Major liver resection can be performed with or without abdominal drainage OBJECTIVES To analyze sources search ed in Cochrane review s , to determine the proportion of trials included in review s that are indexed in major data bases , and to compare the quality of these trials with those from other sources . METHODS All new systematic review s in the Cochrane Library , Issue1 2001 , that were restricted to r and omized controlled trials ( RCTs ) or quasi- RCTs were selected . The sources search ed in the review s were recorded , and the trials included were checked to see whether they were indexed in four major data bases . Trials not indexed were checked to determine how they could be identified . The quality of trials found in major data bases was compared with those found from other sources . RESULTS The range in the number of data bases search ed per review ranged between one and twenty-seven . The proportion of the trials in the four data bases were Cochrane Controlled Trials Register = 78.5 % , MEDLINE = 68.8 % , Embase = 65.0 % , and Science/Social Sciences Citation Index = 60.7 % . Search ing another twenty-six data bases after Cochrane Controlled Trials Register ( CCTR ) , MEDLINE , and Embase only found 2.4 % additional trials . There was no significant difference between trials found in the CCTR , MEDLINE , and Embase compared with other trials , with respect to adequate allocation concealment or sample size . CONCLUSIONS There was a large variation between review s in the exhaustiveness of the literature search es . CCTR was the single best source of RCTs . Additional data base search ing retrieved only a small percentage of extra trials . Contacting authors and manufacturers to find unpublished trials appeared to be a more effective method of obtaining the additional better quality trials Background and aims The clinical value of synbiotics in surgical patients remains unclear . The aim of this study was to investigate the effect of synbiotics on intestinal integrity and microflora , as well as on surgical outcome , in patients undergoing high-risk hepatectomy . Methods Fifty-four patients with biliary cancer were r and omly allocated to two groups before hepatectomy . One group received postoperative enteral feeding that included synbiotics ; the other received enteral feeding only . Lactulose/mannitol ( L/M ) ratio , serum diamine oxidase ( DAO ) activity , and fecal microflora and organic acid concentrations were determined . Postoperative infectious complications were recorded . Results Of the 54 patients , 44 completed the trial ( 21 receiving synbiotics and 23 others as controls ) . Postoperative changes in L/M ratios and serum DAO activities were identical between the two groups . Numbers of beneficial bacteria increased in the synbiotics group after surgery but decreased in controls . Numbers of harmful microorganisms decreased in the synbiotics group but increased in controls . Total organic acid concentrations increased in the synbiotics group but decreased in controls . Incidence of infectious complications was 19 % ( 4/21 ) in the synbiotics group and 52 % ( 12/23 ) in controls ( P<0.05 ) . All study patients tolerated surgery ( mortality 0 % ) . Conclusions Synbiotics , combined with early enteral nutrition , can reduce postoperative infections . This beneficial effect presumably involves correction of an intestinal microbial imbalance induced by surgical stress Introduction : Despite advances in antibiotic prophylaxis , postoperative wound infection remains a major source of morbidity after digestive surgery . Its prevention is a challenging problem , especially in high-risk patients . The authors introduced a new method to prevent surgical wound infections and evaluated its efficacy in a prospect i ve , r and omized trial in markedly high-risk patients . Methods : Patients with biliary tract carcinoma who were scheduled to undergo combined liver and extrahepatic bile duct resection with biliary reconstruction were r and omly assigned to one of two groups , well matched in terms of clinical characteristics at baseline . In one group the new treatment was employed ( sealed group , n=31 ) , and in the other the wound was treated in the usual fashion ( open group , n=28 ) . In the sealed group , povidone-iodine gel was administered to the subcutaneous tissue , and the skin and peritoneum were approximated with a continuous suture . Wound infection was registered up to 30 days after surgery . Results : Wound infection occurred in 18 patients : 5 ( 16 % ) patients in the sealed group and 13 ( 46 % ) in the open group ( P<0.05 ) . All 18 underwent preoperative percutaneous transhepatic biliary drainage and had positive bile culture findings . In 13 of these 18 patients ( 72 % ) the micro-organisms isolated from the infected wound were identical to those in the bile . Conclusions : Our results confirm the close association between infected bile and wound infection in hepatobiliary surgery . Our new method , “ direct wound sealing , ” is simple , easy to perform , virtually cost-free , and has the potential to prevent wound infections even in markedly high-risk patients Methods for combining data from several studies exist and appear to be quite useful . None satisfactorily addresses the question of what studies should be combined . This issue is the most serious method ological limitation . Even studies with statistically significant interaction might still be combined if the effect were in the same direction . Thus , substantial scientific input is required as to what criteria must be met by each potential study . Much can be learned from combining or pooling data but it must be done cautiously . Pooling exercises do not replace well design ed prospect i ve clinical trials . Efforts for establishing basic design criteria to allow for multicentre and multicountry trials to be more easily combined might be useful . Objective To analyze postoperative leukocyte functions in patients undergoing hemihepatectomy , and to assess the effect of treatment with the endotoxin-neutralizing agent bactericidal/permeability-increasing protein ( rBPI21 ) . Summary Background Data Extensive liver resection is associated with a high incidence of infectious complications . Because elimination of pathogenic microorganisms occurs mainly by leukocytes , this increased rate of infections is most likely due to an impaired function of these cells . Endotoxin , translocated from the gut into the systemic circulation as a result of increased gut permeability and reduced hepatic clearance function after major liver resection , may play an important role in the impairment of posthepatectomy leukocyte function . Methods To investigate whether hemihepatectomy results in impaired leukocyte functions and to determine the role of endotoxin in this process , leukocyte oxidative burst and leukocyte antigen expression were studied in three groups of patients : patients undergoing a hemihepatectomy and receiving rBPI21 treatment , patients undergoing hemihepatectomy and receiving placebo , and as an extra control group patients undergoing other major abdominal surgeries . Blood sample s were collected before surgery , 2 hours after surgery , and at days 1 , 2 , 5 , and 7 . Phorbol myristate acetate-stimulated oxidative burst was measured using dihydrorhodamine , and leukocyte surface expression of the antigens CD11b , CD16 , and CD14 was investigated by indirect immunofluorescence . Both oxidative burst and membrane surface expression were quantified by flow cytometry . An indication of the antiendotoxin effect of rBPI21 treatment was provided by assessment of plasma lipopolysaccharide binding protein ( LBP ) levels by enzyme-linked immunosorbent assay . Results The oxidative burst in the hemihepatectomized patients receiving placebo and the controls increased 2 hours after surgery , whereas it decreased in the rBPI21-treated patients , result ing in significant differences between the groups . On day 1 , neutrophil CD11b expression and monocyte CD14 expression in the rBPI21-treated patients and controls were significantly lower than in the placebo group . At 2 hours , CD16 expression in the placebo-treated patients was significantly higher than in the rBPI21-treated patients and controls . On day 5 and day 7 , plasma LBP levels were significantly higher in the placebo-treated patients compared with the rBPI21-treated patients . Conclusions The results of this study show that patients undergoing major liver resection have an increased activation of leukocytes compared with those undergoing other major abdominal surgery . This enhanced activation may contribute to the increased risk of infection in these patients . Administration of the endotoxin-neutralizing agent rBPI21 to hemihepatectomy patients was shown to reduce plasma LBP levels , to preserve leukocyte functions partially , and to reduce leukocyte activation to the level of other , nonhepatic abdominal surgery OBJECTIVES Although the usefulness of antimicrobial prophylaxis for clean-contaminated surgery has been recognized , only a few r and omized controlled studies on the duration of administration after hepatectomy have been performed . We investigated the duration of antimicrobial prophylaxis after hepatectomy . METHODS The subjects were 180 patients who underwent hepatectomy without reconstruction of the biliary or intestinal tract between April 2003 and March 2006 at our department . The patients were r and omly allocated to groups to be treated with flomoxef sodium as antimicrobial prophylaxis for 2 days ( 89 patients ) or 5 days ( 91 patients ) , including the operation day . The presence or absence of systemic inflammatory response syndrome ( SIRS ) and infections was investigated . RESULTS No significant differences were noted in patient background between the two groups . Infections occurred in seven and six patients in the 2 day and 5 day treatment groups ( 7.9 % and 6.6 % ) , respectively , showing no significant difference between the two groups . No significant difference was noted when the cases were divided into surgical site infections and remote infections . The positive rate of SIRS was significantly higher in the 2 day treatment group than in the 5 day treatment group on days 2 and 3 after surgery . The risk factors in patients who developed infections were blood loss , operation time and the complication of biliary fistula . CONCLUSIONS Two day administration of flomoxef sodium may be sufficient for antimicrobial prophylaxis after hepatectomy . However , when SIRS is positive on post-operative day 2 , and induction of liver failure is of concern , it may be safer to continue antimicrobial drug administration until SIRS is eliminated PURPOSE A prospect i ve , r and omized trial was performed to determine if intra-abdominal drainage catheters are necessary after elective liver resection . PATIENTS AND METHODS Between April 1992 and April 1994 , 120 patients subjected to liver resection , stratified by extent of resection and by surgeon , were r and omized to receive or not receive operative closed-suction drainage . Operative blood loss was not an exclusion criteria , and no patient who consented to the study was excluded . RESULTS Eighty-seven patients ( 73 % ) had resection of one hepatic lobe or more ( 27 lobectomies , 54 trisegmentectomies , and 6 bilobar atypical resections ) and 33 had less than a lobectomy ( 8 wedge resections or enucleations , 9 segmentectomies , and 16 bisegmentectomies ) . Eighty-four patients ( 70 % ) had metastatic cancer and 36 patients ( 30 % ) had primary liver pathology . There were no differences in outcome , including length of hospital stay ( no drain , 13.4 + /- 0.9 days ; drain , 13.1 + /- 0.8 days ; P = not significant [ NS ] ) , mortality ( no drain , 3.3 % ; drain , 3.3 % ) , complication rate ( no drain , 43 % ; drain , 48 % ; P = NS ) , or requirement for subsequent percutaneous drainage ( no drain , 18 % ; drain , 8 % ; P = NS ) . All infected collection s ( n = 3 ) occurred in operatively drained patients . Two other complications were directly related to the operatively placed \n Output:\n " }, { "from": "agent", "value": "There was no significant differences in mortality or severe morbidity in any of the comparisons .\nThere is currently no evidence to support or refute the use of any treatment to reduce infectious complications after liver resections ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: Background — Accumulating evidence suggests that the ubiquitous anion nitrite ( NO2− ) is a physiological signaling molecule , with roles in intravascular endocrine nitric oxide transport , hypoxic vasodilation , signaling , and cytoprotection . Thus , nitrite could enhance the efficacy of reperfusion therapy for acute myocardial infa rct ion . The specific aims of this study were ( 1 ) to assess the efficacy of nitrite in reducing necrosis and apoptosis in canine myocardial infa rct ion and ( 2 ) to determine the relative role of nitrite versus chemical intermediates , such as S-nitrosothiols . Methods and Results — We evaluated infa rct size , microvascular perfusion , and left ventricular function by histopathology , microspheres , and magnetic resonance imaging in 27 canines subjected to 120 minutes of coronary artery occlusion . This was a blinded , prospect i ve study comparing a saline control group ( n=9 ) with intravenous nitrite during the last 60 minutes of ischemia ( n=9 ) and during the last 5 minutes of ischemia ( n=9 ) . In saline-treated control animals , 70±10 % of the area at risk was infa rct ed compared with 23±5 % in animals treated with a 60-minute nitrite infusion . Remarkably , a nitrite infusion in the last 5 minutes of ischemia also limited the extent of infa rct ion ( 36±8 % of area at risk ) . Nitrite improved microvascular perfusion , reduced apoptosis , and improved contractile function . S-Nitrosothiol and iron-nitrosyl-protein adducts did not accumulate in the 5-minute nitrite infusion , suggesting that nitrite is the bioactive intravascular nitric oxide species accounting for cardioprotection . Conclusions — Nitrite has significant potential as adjunctive therapy to enhance the efficacy of reperfusion therapy for acute myocardial infa rct ion OBJECTIVE --To assess the possible benefits of intravenous isosorbide dinitrate in acute myocardial infa rct ion and oral isosorbide mononitrate in subacute myocardial infa rct ion . METHODS --316 patients presenting with acute myocardial infa rct ion were entered into double blind placebo controlled clinical trials assessing infa rct size by enzyme release , ventricular size and function by echocardiography , reperfusion by continuous 12 lead ST segment monitoring and late potentials by high resolution electrocardiography . RESULTS --301 patients , of whom 292 ( 97 % ) received thrombolytic treatment , were r and omised on admission to intravenous isosorbide dinitrate or placebo . Overall , there was no significant effect of treatment on infa rct size , ST segment resolution , ventricular remodelling , or late potentials at day 3 . A trend was observed towards a reduction in infa rct size in patients with non-Q wave infa rct ion treated with isosorbide dinitrate . Heterogeneity of nitrate effect was observed in relation to the degree of ST segment elevation on presentation with a clear benefit of isosorbide dinitrate in patients with moderate ST segment elevation ( 472 U/l v 704 U/l , P = 0.003 ) and a trend towards a deleterious effect in patients with marked ST segment elevation ( 1152 U/l v 1058 U/l , P = 0.2 ) . ST segment re-elevation was more common among patients receiving nitrate treatment than in those assigned to placebo ( 29 v 16 , P < 0.05 ) . Some 160 patients underwent a further r and omisation to sustained release isosorbide mononitrate or placebo on day 3 . Echocardiographic volumes after 6 weeks of treatment were similar in the two groups . CONCLUSIONS --No benefit was observed with administration of nitrates in the treatment groups as a whole for either acute or subacute infa rct ion . There was , however , evidence of heterogeneity of effect in the different subgroups of acute infa rct ion , and the possibility that nitrates may have differing actions in different groups of patients should be considered This study was design ed to determine whether a sodium nitropruside infusion during the reperfusion ( payback ) period of cardiopulmonary bypass would minimize arrhythmias during the early postoperative period of coronary artery bypass surgery . A double-blind r and omized study was carried out in 38 patients with no previous history of ventricular arrhythmias . Seventeen received 5 % dextrose in water ( D5W ) and 21 received sodium nitroprusside at the rate of 2 microgram per kilogram per minute during the payback period . The pump flow was kept constant at 2.2 liters per square meter per minute , and mean pressure was maintained at greater than 50 mm Hg . There was a statistically significant difference between the two groups in the number of patients who developed ventricular arrhythmias ( 13 of 17 , or 76 % , in the D5W group versus 6 of 21 , or 29 % , in the sodium nitroprusside group ; p less than 0.005 ) . Twelve of the 13 patients in the D5W group experienced arrhythmias ( 6 ventricular tachycardia and 6 ventricular premature depolarization ) within the first 24 hours , compared to 5 of 12 patients in the nitroprusside group ( 3 ventricular tachycardia and 2 ventricular premature depolarization ) . Only 1 patient in each group developed ventricular arrhythmia after the first postoperative day . One patient in each group experienced atrial arrhythmia during the first 24 hours . After 24 hours , atrial arrhythmias developed in 5 patients in the D5W group ( 35 % ) and 3 patients in the sodium nitroprusside group ( 17 % ) ( p greater than 0.05 ) . The arterial pH ranged from 7.35 to 7.55 , with a Po2 greater than 70 torr and a serum potassium of 3.7 + /- 0.36 mEq per liter in the D5W group and 3.4 + /- 0.34 mEq per liter in the nitroprusside group during the period of arrhythmias . Sodium nitroprusside given during the payback period of cardiopulmonary bypass appears to minimize ventricular arrhythmias in the early postoperative period of coronary artery bypass surgery STUDY OBJECTIVE In order to assess the effects of inhaled nitric oxide ( iNO ) in preventing early-onset lung edema from occurring after lung transplantation , we measured extravascular lung water ( EVLW ) in a group of lung transplant recipients who were at high risk for developing ischemia-reperfusion-induced lung injury . DESIGN Prospect i ve , r and omized study . SETTING S Surgical ICU in a teaching hospital . PATIENTS Thirty double-lung transplant recipients . INTERVENTIONS Patients were r and omized to receive or not receive 20 ppm iNO at the time of reperfusion ( ie , before any occurrence of lung edema ) . In the NO group , iNO was then administered for a 12-h period . A double-dilution technique was used for the serial assessment of EVLW , intrathoracic blood volume , and cardiac index . St and ard hemodynamic and pulmonary parameters were also recorded during the first 3 postoperative days . MEASUREMENTS AND RESULTS Patients who received iNO did not have a different lung water content compared to control subjects ( p = 0.61 [ by analysis of variance ( ANOVA ) ] ) . Blood oxygenation ( ie , Pao(2)/fraction of inspired oxygen [ Fio(2 ) ] ratio ) did not differ between the two groups ( p = 0.61 [ by ANOVA ] ) . In both groups , EVLW and Pao(2)/Fio(2 ) ratio dropped significantly over time , regardless of the use of iNO ( p < 0.01 [ by ANOVA ] ) . CONCLUSIONS In the population studied , prophylactic iNO that was administered at 20 ppm had no effect on pulmonary edema formation and resolution following lung transplantation Free oxygen radicals are produced after coronary artery occlusion and reperfusion . Polyunsaturated fatty acids are oxidized by free radicals to lipid peroxides . Measurements of plasma malondialdehyde ( MDA ) formed by the breakdown of lipid peroxides are often used as markers of lipid peroxidation . The effect of intravenous nitroglycerin on plasma MDA levels was studied in 43 patients who received thrombolytic therapy for acute myocardial infa rct ion . Plasma MDA levels in patients were elevated on admission to the hospital compared with healthy controls , and normalized within 48 hours . A greater increase in plasma MDA concentrations after thrombolysis was found in patients with noninvasive signs of reperfusion than in patients judged to have a persistent occlusion . In the 23 patients receiving immediate intravenous nitroglycerin infusion , plasma MDA levels did not change from baseline to 90 minutes ( 0.92+/-0.22 and 0.92+/-0.23 micromol/L , p=0.99 ) , whereas a significant increase was found in the 20 control patients who did not receive nitroglycerin ( from 0.83+/-0.22 to 1.01+/-0.30 micromol/L , p=0.0004 ) ( p=0.036 for the difference between groups ) . Successful reperfusion after thrombolytic therapy entails increased lipid peroxidation . Intravenous nitroglycerin reduces lipid peroxidation during myocardial ischemia and reperfusion & NA ; The authors studied the relationship between cardiac cytokine release and pump function and whether low‐dose application of sodium nitroprusside ( SNP ) improves cardiac performance during coronary artery bypass graft ( CABG ) creation . Cardiac reperfusion and application of nitric oxide have an influence on cytokine release . However , the functional consequences are unclear . Patients with CABGs ( n = 30 ) with severely compromised left ventricular ejection fraction ( < 40 % ) were treated with either SNP ( 0.5 & mgr;g/kg/min ) or placebo for the first 60 minutes of reperfusion after cardiac arrest . Interleukin (IL)‐6 , IL‐8 , and tumor necrosis factor (TNF)–&agr ; were determined in blood sample s from the radial artery and coronary sinus during reperfusion ( 5 , 35 , and 75 minutes ) . Hemodynamic measurements were performed before and after cardiopulmonary bypass and at the end of surgery . In all patients , the cardiac index at the end of surgery correlated negatively with levels of TNF‐&agr ; at 5 minutes ( r = 0.398 ; P < 0.05 ) , IL‐8 at 35 minutes ( r = 0.394 ; P < 0.05 ) , and IL‐6 at 75 minutes of reperfusion ( r = 0.421 ; P < 0.025 ) . Sodium nitroprusside improved the cardiac index immediately after reperfusion ( 4.4 L/min/m2 ± 0.3 vs. 3.7 L/min/m2 ± 0.1 ; P = 0.014 ) and at the end of surgery ( 3.8 L/min/m2 ± 0.3 vs. 3.0 L/min/m2 ± 0.2 ; P = 0.023 ) . The negative correlation between cardiac index and transcardiac cytokines suggests that reducing cardiac inflammatory reaction improves postischemic cardiac function . This was achieved by treating CABG patients with the nitric oxide donor SNP at a dosage without vasodilatory action OBJECTIVE Acute renal failure remains a common and serious complication of cardiac surgery . In this r and omized trial , we aim ed to assess whether sodium nitroprusside ( SNP ) infusion during cardiopulmonary bypass ( CPB ) could prevent renal dysfunction after coronary artery bypass grafting ( CABG ) surgery . METHODS Between October 2004 and May 2006 , 240 consecutive patients with stable angina undergoing elective CABG for multi-vessel coronary artery disease were prospect ively r and omized into control ( n=116 , 72 men , mean age 61.3+/-9.7 years ) or SNP groups ( n=124 , 81 men , 60.8+/-10.8 years ) . SNP group received SNP after initiation of rewarming period during CPB at a dose of 0.1mg/kg/h and the infusion was concluded by weaning from CPB . The anesthetic and CPB regimes were st and ardized . Blood urea nitrogen ( BUN ) , serum creatinine ( SCr ) , estimated glomerular filtration rate ( eGFR ) , creatinine clearance ( C(Cr ) ) , urine output , serum cardiac specific troponin I ( cTnI ) , creatine kinase cardiac isoenzyme ( CKMB ) , and CPK were measured preoperatively and daily until day 5 after surgery . RESULTS There were no differences in baseline levels of BUN , SCr , eGFR , C(Cr ) , cTnI , CKMB , CPK levels and EuroSCORES between the groups . Although the duration s of cross clamp \n Output:\n " }, { "from": "agent", "value": "In 20 ( 77 % ) of 26 studies and four ( 67 % ) of six high- quality studies , patients treated with NO-donor agents experienced reduced I/R injury compared with controls .\nDespite a paucity of high- quality clinical investigations , the preponderance of evidence to date suggests that administration of NO-donor agents may be an effective treatment for I/R injury in human subjects" } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: BACKGROUND Increases in both the portion size and energy density of food have both been shown to increase energy intake , but the combined effects of such increases have not been investigated . OBJECTIVE The objective was to determine the combined effects of energy density and portion size on energy intake in women . DESIGN This study used a within-subjects design . Once a week for 6 wk , 39 women were served breakfast , lunch , and dinner ad libitum . The main entrée at lunch was formulated in 2 versions that varied in energy density ( 5.23 or 7.32 kJ/g ) , each of which was served in 3 different portion sizes ( 500 , 700 , or 900 g ) . The 2 versions were matched for macronutrient composition and palatability . Breakfast and dinner were st and ard meals . RESULTS Increases in portion size and energy density led to independent and additive increases in energy intake ( P < 0.0001 ) . Subjects consumed 56 % more energy ( 925 kJ ) when served the largest portion of the higher energy-dense entrée than when served the smallest portion of the lower energy-dense entrée . Subjects did not compensate for the additional intake by eating less at the subsequent meal . Despite substantial differences in energy intake , no systematic differences in ratings of hunger and fullness across conditions were observed . CONCLUSIONS The energy density and the portion size of a food act independently to affect energy intake . The findings indicate that large portions of foods with a high energy density may facilitate the overconsumption of energy BACKGROUND An impaired ability to compensate for calories and increased eating in the absence of hunger ( EAH ) has been associated with increased energy intake and weight gain in unrelated children . OBJECTIVE The aims of this study were to compare caloric compensation [ the percentage compensation index ( % COMPX ) ] and EAH in weight-discordant siblings aged 5 - 12 y. DESIGN In a crossover , behavioral genetics design , 47 same-sex sibling pairs ( 53 % female , 55 % full siblings ) were served dinner once a week for 3 wk . Across conditions , siblings were served the same dinner , but 25 min before dinner , they either consumed in full or did not consume 1 of 2 preloads that varied in energy density ( ED ; 0.57 or 0.97 kcal/g ) . On the day when no preload was consumed , EAH was assessed after dinner and defined as the number of calories consumed from snacks . RESULTS Overweight/obese siblings undercompensated [ % COMPX : -48.8 ± 56.3 ( mean ± SEM ) ] and therefore overate after the high-ED preload , whereas normal-weight siblings showed accurate compensation ( % COMPX : 101.3 ± 51.9 ; P = 0.03 ) . Furthermore , overweight/obese siblings consumed 34 % more calories ( 93 kcal ) in the absence of hunger than did normal-weight siblings ( P = 0.01 ) . Within-pair resemblances for % COMPX and EAH were stronger for full siblings ( P < 0.049 ) than for half siblings ( P > 0.23 ) . CONCLUSIONS An impaired ability to regulate short-term energy intake , which includes incomplete adjustment for calorie differences in a preload and eating when satiated , may represent a behavioral phenotype for obesity in children . Future studies should test whether teaching children to focus on internal satiety cues may prevent at-risk children from overeating Background The purpose of this study was to determine whether a high-protein afternoon yogurt snack improves appetite control , satiety , and reduces subsequent food intake compared to other commonly-consumed , energy dense , high-fat snacks . Findings Twenty , healthy women ( age : 27 ± 2 y ; BMI : 23.4 ± 0.7 kg/m2 ) completed the r and omized crossover design study which included 3 , 8-h testing days comparing the following 160 kcal afternoon snacks : high-protein yogurt ( 14 g protein/25 g CHO/0 g fat ) ; high-fat crackers ( 0 g protein/19 g CHO/9 g fat ) ; and high-fat chocolate ( 2 g protein/19 g CHO/9 g fat ) . Participants were acclimated to each snack for 3 consecutive days . On day 4 , the participants consumed a st and ardized breakfast and lunch ; the respective snack was consumed 3-h post-lunch . Perceived hunger and fullness were assessed throughout the afternoon until dinner was voluntarily requested . An ad libitum dinner was then provided . The consumption of the yogurt snack led to greater reductions in afternoon hunger vs. chocolate ( p < 0.01 ) . No differences in afternoon fullness were detected . The yogurt snack also delayed eating initiation by approximately 30 min compared to the chocolate snack ( p < 0.01 ) and approximately 20 min vs. crackers ( p = 0.07 ) . The yogurt snack led to approximately 100 fewer kcals consumed at dinner vs. the crackers ( p = 0.08 ) and chocolate ( p < 0.05 ) . No other differences were detected . Conclusion These data suggest that , when compared to high-fat snacks , eating less energy dense , high-protein snacks like yogurt improves appetite control , satiety , and reduces subsequent food intake in healthy women This study tested the hypothesis that the amount ( weight or volume ) of food consumed affects the satiating potency of a food , independent of its energy content . Normal-weight young men ( n = 20 ) were tested in a within-subjects design . Subjects were served a milk-based drink or no drink ( control ) , followed 30 min later by a self-selected lunch and > 4 h later by a self-selected dinner . Milk drinks were equal in energy content ( 2088 kJ , or 499 kcal ) and had similar proportions of fat ( 30.3 % ) , carbohydrate ( 54.7 % ) , and protein ( 15 % ) across three volumes : 300 , 450 , and 600 mL. Ratings of palatability , sensory properties , and energy content of the drinks and of hunger completed before consumption of the preloads were not significantly different among conditions . The results showed that preload volume affected energy intake at lunch ( P < or = 0.009 ) such that energy intake was less after the 600-mL preload than after the 300-mL preload . This effect was still present when energy intake at dinner was included ( P < or = 0.022 ) . At lunch , including energy from the preload , subjects overate relative to the control condition ( 4323 + /- 322 kJ ) after the 300- ( 5263 + /- 321 kJ ) and 450-mL ( 5011 + /- 300 kJ ) preloads but not after the 600-mL ( 4703 + /- 353 kJ ) preload . Thus , the best adjustment for the energy in the preloads was with the largest , least energy-dense drink . Consistent with the effects on intake , the volume of the drinks affected ratings of hunger and fullness . These results indicate that the volume consumed is an important determinant of satiety after milk drinks under these conditions BACKGROUND The results of previous studies indicated that energy density , independent of fat content , influences energy intake . In most studies , however , both fat content and energy density were lower than in typical American diets . OBJECTIVE We examined the influence of energy density on intake when fat content was above , below , or similar to the amount of fat typically consumed and when energy density was closer to that of American diets . DESIGN Lean ( n = 19 ) and obese ( n = 17 ) women consumed all meals daily in our laboratory during 6 experimental sessions . The main entrées , consumed ad libitum , were formulated to vary in fat content ( 25 % , 35 % , and 45 % of energy ) and energy density ( 5.23 kJ/g , or low energy density , and 7.32 kJ/g , or high energy density ) but to have similar palatability . RESULTS Energy density influenced energy intake across all fat contents in both lean and obese women ( P < 0.0001 ) . Women consumed less energy in the low ( 7531 kJ ) than in the high ( 9414 kJ ) energy density condition . Despite this 20 % lower energy intake , there were only small differences in hunger ( 7 % ) and fullness ( 5 % ) . Women consumed a similar volume , but not weight , of food daily across conditions . Differences in intake by weight , but not volume , occurred because for some versions of manipulated foods , weight and volume were not directly proportional . CONCLUSIONS Energy density affected energy intake across different fat contents and at levels of energy density comparable with those in typical diets . Furthermore , our findings suggest that cues related to the amount of food consumed have a greater influence on short-term intake than does the amount of energy consumed BACKGROUND Studies have shown that energy intake increases when both the fat content and energy density of the entire diet increases . When the fat content and energy density vary independently of one another , however , energy density , but not fat content , influences intake . OBJECTIVE The present study examined whether energy intake in lean and obese women is affected when either the energy density or the fat content of a portion of the diet is manipulated and palatability is held constant . DESIGN In a within-subjects design , 17 lean and 17 obese women consumed meals in the laboratory for four , 4-d test periods . In 3 of these test periods the energy density ( 4.4 and 6.7 kJ/g ) or the fat content ( 16 % and 36 % of energy ) of compulsory entrees representing 50 % of each subject 's usual energy intake was manipulated . Additional self-selected foods were consumed ad libitum at meals and as snacks . RESULTS There were no systematic differences in palatability of the manipulated foods across conditions . Obese and lean participants responded similarly to the dietary manipulations . Intake of self-selected foods at meals was reduced significantly by 16 % for both lean and obese subjects in the low- compared with the high-energy-density condition . The fat content of the compulsory foods had no significant effect on energy intake . Ratings of hunger did not differ between diets . CONCLUSION These results indicate that when a portion of the diet was manipulated , the energy density , but not the fat content , of the foods affected total energy intake at meals in both lean and obese women BACKGROUND Little is known about the long-term effects of dietary energy density ( ED ) on weight gain . OBJECTIVE The objective was to assess the long-term relation between changes in dietary ED and age-related weight gain . DESIGN We conducted a prospect i ve study of 50 026 women ( x + /- SD age : 36.5 + /- 4.6 y ) in the Nurses ' Health Study II followed from 1991 to 1999 . Dietary ED and body weight were ascertained in 1991 , 1995 , and 1999 . Total dietary ED was calculated by dividing each subject 's daily energy intake ( kcal ) by the reported weight ( g ) of all foods consumed . RESULTS Dietary ED was positively correlated with saturated fat ( r = 0.16 ) , trans fat ( r = 0.15 ) , and the glycemic index ( r = 0.16 ) , but was inversely correlated with vegetable protein ( r = -0.30 ) , vegetables ( r = -0.27 ) , and fruit ( r = -0.17 ) . ED was not significantly correlated with total fat intake as a percentage of energy ( r = 0.08 ) . Women who increased their dietary ED during follow-up the most ( 5th quintile ) had a significantly greater multivariate-adjusted weight gain than did those who decreased their dietary ED ( 1st quintile ) ( 8-y time period : 6.42 kg compared with 4.57 kg ; P for trend < 0.001 ) . However , the amount of weight change over time varied considerably according to the ED values of individual foods and beverages . CONCLUSION A high dietary ED reflects a dietary pattern higher in saturated and trans fats and refined carbohydrates . Increases in dietary ED were associated with greater weight gain among middle-aged women during 8 y of follow-up . However , public health recommendations can not be made simply on the basis of ED values of individual foods and beverages Although several studies have assessed the influence of the glycemic index on body weight and blood pressure among adults , limited evidence exists for the pediatric age population . In the current study , we compared the effects of low glycemic index ( LGI ) diet to the healthy nutritional recommendation (HNR)-based diet on obesity and blood pressure among adolescent girls in pubertal ages . This 10-week parallel r and omized clinical trial comprised of 50 overweight or obese and sexually mature girls less than 18 years of age years , who were r and omly assigned to LGI or HNR-based diet . Macronutrient distribution was equivalently prescribed in both groups . Blood pressure , weight and waist circumference were measured at baseline and after intervention . Of the 50 participants , 41 subjects ( include 82 % ) completed the study . The GI of the diet in the LGI group was 42.67 ± 0.067 . A within-group analysis illustrated that in comparison to the baseline values , the body weight and body mass index ( not waist circumference and blood pressure ) decreased significantly after the intervention in both groups ( P = \n Output:\n " }, { "from": "agent", "value": "In summary , the current analysis revealed that we can restrict the energy intake by consuming an LED preload .\nMoreover , consuming an LED preload could favorably affect preload+meal energy intake" } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: Abstract A total of 119 bone marrow transplant patients suffering from oral mucositis pain were enrolled in a r and omized , double‐blind , parallel‐group trial comparing the efficacy of patient‐controlled analgesia with morphine , hydromorphone and sufentanil . Patient ratings of pain and side‐effects on visual analog scales were gathered daily from the start of patient‐controlled analgesia ( PCA ) therapy until the discontinuation of opioid treatment either because of resolution of oral mucositis pain , intolerable side‐effects , inadequate pain control , or complications related to transplantation . Of the 119 enrolled subjects , 100 met the evaluable criteria of developing oral mucositis and remaining on the study for at least 2 days . Multivariate analysis of the outcome measures indicated that the analgesia achieved in all three opioid groups was nearly equivalent , while measures of side‐effects , especially for the combination of sedation , sleep and mood disturbances , were statistically lower in the morphine group than in hydromorphone or sufentanil groups . Patients in the hydromorphone group exhibited the most variability in pain control . Event analysis also indicated significant differences in time to treatment failure between the three groups , with the morphine arm exhibiting clear superiority . The proportion of patients discontinued because of inadequate pain relief was much higher in the sufentanil group ( 7/36 ) as compared to the hydromorphone ( 0/34 ) or the morphine group ( 1/30 ) . The daily opioid consumption pattern showed a continual dose escalation during the first week of therapy for all groups , coincident with worsening mucositis . Morphine consumption reached a plateau by day 5 , whereas hydromorphone and sufentanil consumption continued to rise until days 7 and 9 , respectively . Sufentanil dose requirement increased by approximately 10‐fold compared to morphine and hydromorphone , whose requirements increased only 5‐fold , suggesting the possibility of development of acute pharmacological tolerance in some patients with this phenylpiperidine opioid . This study provides support for the recommendation that morphine is the opioid of first choice when patient‐controlled analgesia is employed for the treatment of severe oropharyngeal pain in bone marrow transplantation ( BMT ) patients Abstract This study investigated the analgesic effects of three intravenous bolus doses of hydromorphone ( 10 , 20 , 40 & mgr;g/kg ) on experimental pain measures in normal humans . Ten healthy male volunteers participated in four study sessions , one for each of the hydromorphone doses as well as a placebo ( saline ) . They received the four treatments in counterbalanced order under double‐blind conditions and with study days at least 1 week apart . During each session subjects underwent repeated electrical tooth pulp stimulation at intensities sufficient to elicit a rating of ‘ strong pain ’ before drug administration . Subjective pain reports ( PRs ) and dental evoked potential amplitude measures ( EPs ) served as analgesic effect indicators . We observed dose‐dependent analgesia as measured by both PR ( P=0.009 ) and EP ( P=0.017 ) . Area under the PR versus time curve as well as the EP versus time curve decreased in a log dose‐dependent fashion . Although the peak effect was poorly defined , the onset of analgesia was rapid , within 5 min , and maximum analgesic effect was seen between 10 and 20 min after maximum plasma hydromorphone concentration . However , within sessions we found a poor correspondence between hydromorphone plasma concentration and effect . Compared to pain report data from other human studies done in our laboratory , hydromorphone has a shorter time to peak effect compared to morphine , and overall , hydromorphone hydrochloride is approximately five times as potent as morphine sulfate on a milligram basis Goals of workThe purpose of this trial was to evaluate the effect of long-term treatment with either oral sustained-release hydromorphone ( HM ) or morphine ( M ) on nausea , emesis , and constipation . Material s and methods In a prospect i ve , open-labeled , controlled trial , 100 out patients with cancer pain and treatment with HM or M were enrolled . Mobility , pain , and gastrointestinal symptoms were assessed by the ECOG performance status , selected items of the EORTC question naire and Numerical Rating Scales ( NRS ) . Data were analyzed using descriptive and confirmatory statistics ( paired t-test , chi square test , Poisson regression).Main results Demographic and medical data were comparable in both treatment groups . Taking into account different conversion factors , opioid doses ( M 94.4 mg/d vs. HM 137.6 [ HM/M = 1:5 ] , p = 0.05 and HM 206.4 [ HM/M = 1:7.5 ] , p = 0.0002 , respectively ) were higher under hydromorphone and NRS of pain ( M 2.3 vs. HM 3.6 , p = 0.0002 ) lower under morphine . Nausea and emesis did not attenuate in 33 % of patients . NRS of nausea ( M 2.5 vs. HM 1.5 ; p = 0.01 ) , incidences of emesis ( M 0.7/d vs. HM 0.1/d , p = 0.0001 ) , the consumption of antiemetics ( M 26 vs. HM 14 , p = 0.01 ) , and the number of constipated patients ( M 8 vs. HM 2 , p = 0.04 ) were higher in the morphine group . An extended use of substances for symptom control revealed constipating effects ( M 31 vs. HM 13 , p = 0.0003 ) and was associated with a higher incidence of constipation in the morphine group . Conclusions Symptom control in out patients with cancer pain may be complicated by a symptom controlling medication . Particularly , antiemetics revealed potentially constipating effects . Despite lower opioid doses , morphine provided a better pain control but produced more side effects . Comparing hydromorphone with morphine , it remains unclear if fewer incidences of constipation and nausea in the hydromorphone group were related to pharmacodynamic effects or to a less effective pain control with significantly higher NRS for pain . However , the conversion factor of oral hydromorphone and morphine needs to be question ed To compare the safety and efficacy of subcutaneous and intravenous infusion of opioid analgesics , a r and omised , double-blind , crossover trial was carried out in in patients . 15 patients with severe cancer pain received two 48 h infusions of hydromorphone -- one subcutaneously and one intravenously in r and omly allocated order . The study was made double-blind by the use of two infusion pumps throughout ; during the active subcutaneous infusion the intravenous pump delivered saline and vice versa . Serial measurements of pain intensity , pain relief , mood , and sedation by means of visual analogue scales showed no clinical ly or statistically significant difference between the two infusion routes . Side-effects were slight , and the mean number of morphine injections for breakthrough pain did not differ significantly between the routes ( 4.8 [ SD 4.5 ] for intravenous vs 5.3 [ 5.6 ] for subcutaneous ) . Plasma hydromorphone concentrations measured at 24 h and 48 h of infusion showed stable steady-state pharmacokinetics ; the mean bioavailability from subcutaneous infusion was 78 % of that with intravenous infusion . Because of the simplicity , technical advantages , and cost-effectiveness of continuous subcutaneous opioid infusion into the chest wall or trunk , intravenous opioid infusion for the management of severe cancer pain should be ab and oned Background Long-acting opioid formulations are advocated for maintaining pain control in chronic cancer pain . OROS ® hydromorphone is a sustained-release formulation of hydromorphone that requires dosing once daily to maintain therapeutic concentrations . The objective of this study was to demonstrate the clinical equivalence of immediate-release and sustained-release formulations of hydromorphone and morphine for chronic cancer pain . Methods 200 patients with cancer pain ( requiring ≤ 540 mg/d of oral morphine ) participated in this double-blind , parallel-group trial . Patients were r and omized to receive hydromorphone or morphine ( immediate-release for 2–9 days , sustained-release for 10–15 days ) . Efficacy was assessed with the Brief Pain Inventory ( BPI ) , investigator and patient global evaluations , Eastern Cooperative Oncology Group performance status , and the Mini-Mental State Examination . The primary endpoint was the ' worst pain in the past 24 hours ' item of the BPI , in both the immediate-release and sustained-release study phases , with treatments deemed equivalent if the 95 % confidence intervals ( CI ) of the between-group differences at endpoint were between -1.5 and 1.5 . No equivalence limits were defined for secondary endpoints . Results Least-squares mean differences ( 95 % CI ) between groups were 0.2 ( -0.4 , 0.9 ) in the immediate-release phase and -0.8 ( -1.6 , -0.01 ) in the sustained-release phase ( intent-to-treat population ) , indicating that the immediate-release formulations met the pre-specified equivalence criteria , but that the lower limit of the 95 % CI ( -1.6 ) was outside the boundary ( -1.5 ) for the sustained-release formulations . BPI ' pain now PM ' was significantly lower with OROS ® hydromorphone compared with controlled-release morphine ( least-squares mean difference [ 95 % CI ] , -0.77 [ -1.49 , -0.05 ] ; p = 0.0372 ) . Scores for other secondary efficacy variables were similar between the two sustained-release treatments . At endpoint , > 70 % of investigators and patients rated both treatments as good to excellent . The safety profiles of hydromorphone and morphine were similar and typical of opioid analgesics . Conclusion Equivalence was demonstrated for immediate-release formulations of hydromorphone and morphine , but not for the sustained-release formulations of OROS ® hydromorphone and controlled-release morphine . The direction of the mean difference between the treatments ( -0.8 ) and the out-of-range lower limit of the 95 % CI ( -1.6 ) were in favor of OROS ® hydromorphone . Trial registration Clinical Trials.gov : PURPOSE To evaluate the safety and efficacy of a new slow-release preparation of hydromorphone ( SRH ) in the treatment of cancer pain . PATIENTS AND METHODS Ninety-five adult patients from three Canadian Palliative Care Centers with no evidence of mental impairment received treatment for cancer pain with an oral opioid analgesic . After informed consent was obtained , patients underwent titration to a stable dose of immediate-release hydromorphone ( IRH ) for 48 hours , and were then r and omized to receive IRH or SRH for 5 days in a double-blind basis . During day 6 , a crossover took place , and patients received the alternate drug for 5 days . Pain intensity was assessed using a visual analog scale ( VAS ) and ordinal scale ( OS ) . Side effects were assessed using VAS . Patients and investigators made a blinded global rating of efficacy a blinded final choice between SRH and IRH . RESULTS In 75 assessable patients , pain intensity of the VAS and OS were ( mean + /- SD ) 27 + /- 21 and 1.3 + /- 0.6 on IRH , versus 29 + /- 21 ( P = .13 ) and 1.3 + /- 0.6 ( P = .19 ) on SRH , respectively . The total number of extra doses of opioids , global rating , and final blinded choice by both patients and investigators were not significantly different between IRH and SRH . Differences in side effects were not significant . CONCLUSION Our findings suggest that SRH is as safe and effective as IRH in the treatment of cancer pain The use of oxycodone to treat chronic cancer pain has been hampered by its short elimination half‐life , which necessitates administration every 4 hours . This study compared the clinical efficacy and safety of a novel oxycodone formulation with that of hydromorphone in the treatment of cancer pain INTRODUCTION The purpose of this trial was to evaluate the effect of long-term treatment with oral sustained-release hydromorphone , transdermal fentanyl , and transdermal buprenorphine on nausea , emesis and constipation . PATIENTS AND METHODS R and omly selected out patients with cancer pain receiving one of the study medications were enrolled in a prospect i ve , open-labeled , controlled trial ( n=174 ) . Mobility , pain , and gastrointestinal symptoms were assessed directly and per selected item on the ECOG ( Eastern Cancer Oncology Group ) , EORTC ( European Organisation for Research and Treatment of Cancer ) question naires , NRS ( Numerical Rating Scales ) , and analyzed statistically . RESULTS Demographic and medical data were comparable in all groups . Only 15 % of patients suffered from constipation . 59 % took the prescribed laxatives . The incidence of stool free periods > 72 h was significantly higher with transdermal opioids ( transdermal fentanyl : 22 % ; transdermal buprenorphine : 21 % ; oral hydromorphone : 2 % ; p=0.003 ) . 21 % of patients revealed nausea and emesis . The mean NRS for nausea ( transdermal fentanyl:1.3 ; transdermal buprenorphine : 1.2 ; oral hydromorphone : 1.5 ; p=0.6 ) , the consumption of antiemetics ( transdermal fentanyl : 42 % ; transdermal buprenorphine : 33 \n Output:\n " }, { "from": "agent", "value": "The RCTs comparing hydromorphone with morphine and oxycodone showed similar analgesic results , while the comparison of side effects showed minor differences , not consistent across studies .\nIn conclusion there is evidence to support the efficacy and tolerability of hydromorphone for moderate to severe cancer pain as an alternative to morphine and oxycodone , while there is no evidence to demonstrate its superiority or inferiority in comparison with morphine as the first choice opioid for the same indication" } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: OBJECTIVE To evaluate the efficacy and safety of alpha-lipoic acid given intravenously , followed by oral treatment in type 2 diabetic patients with symptomatic polyneuropathy . RESEARCH DESIGN AND METHODS In a multicenter r and omized double-blind placebo-controlled trial ( Alpha-Lipoic Acid in Diabetic Neuropathy [ ALADIN ] III Study ) , 509 out patients were r and omly assigned to sequential treatment with 600 mg alpha-lipoic acid once daily intravenously for 3 weeks , followed by 600 mg alpha-lipoic acid three times a day orally for 6 months ( A-A ; n = 167 ) ; 600 mg alpha-lipoic acid once daily intravenously for 3 weeks , followed by placebo three times a day orally for 6 months ( A-P ; n = 174 ) ; and placebo once daily intravenously for 3 weeks , followed by placebo three times a day orally for 6 months ( P-P ; n = 168 ) . Outcome measures included the Total Symptom Score ( TSS ) for neuropathic symptoms ( pain , burning , paresthesias , and numbness ) in the feet , and the Neuropathy Impairment Score ( NIS ) . Data analysis was based on the intention to treat . RESULTS No significant differences between the groups were noted for the demographic variables and the nerve function parameters at baseline . The TSS in the feet decreased from baseline to day 19 ( median [ range ] ) by -3.7 ( -12.6 to 5.0 ) points in the group given alpha-lipoic acid intravenously and by -3.0 ( -12.3 to 8.0 ) points in the placebo group ( P = 0.447 ) , but the area under curve on a daily basis was significantly smaller in the active as compared with the placebo group ( 85.6 [ 0 - 219 ] vs. 95.9 [ 5.5 - 220 ] ) ; P = 0.033 ) . After 7 months , the changes in the TSS from baseline were not significantly different between the three groups studied , which could be due to increasing intercenter variability in the TSS during the trial . The NIS decreased after 19 days by -4.34+/-0.35 points ( mean + /- SEM ) in A-A and A-P and -3.49+/-0.58 points in P-P ( P = 0.02 for alpha-lipoic acid versus placebo ) and after 7 months by -5.82+/-0.73 points in A-A , -5.76+/-0.69 points in A-P , and -4.37+/-0.83 points in P-P ( P = 0.09 for A-A vs. P-P ) . The rates of adverse events were not different between the groups throughout the study . CONCLUSIONS These findings indicate that a 3-week intravenous treatment with alpha-lipoic acid , followed by a 6-month oral treatment , had no effect on neuropathic symptoms distinguishable from placebo to a clinical ly meaningful degree , possibly due to increasing intercenter variability in symptom scoring during the study . However , this treatment was associated with a favorable effect on neuropathic deficits without causing significant adverse reactions . Long-term trials that focus on neuropathic deficits rather than symptoms as the primary criterion of efficacy are needed to see whether oral treatment with alpha-lipoic acid over several years may slow or reverse the progression of diabetic neuropathy BACKGROUND Amelioration of insulin resistance could improve both glycaemic control and cardiovascular risk factors in patients with type 2 diabetes mellitus . Alpha-lipoic acid has been shown to improve insulin action after parenteral administration . OBJECTIVE the aim of the study was to assess the effect of oral administration of alpha-lipoic acid on insulin sensitivity in patients with type 2 diabetes . DESIGN twelve patients ( mean+/-sD ; age 52.9+/-9.9 yrs ; body mass index 33.9+/-7.4 kg/m(2 ) ) were treated with oral alpha-lipoic acid , 600 mg twice daily over a period of 4 weeks . twelve subjects with normal glucose tolerance served as a control group in terms of insulin sensitivity ( Is ) . Is was measured by a 2h manual hyperinsulinaemic ( insulin infusion rate-40 mU/m(2 ) body surface area/min ) euglycaemic ( blood glucose kept at 5 mmol/l ) clamp technique and expressed as a glucose disposal rate ( M ) and insulin sensitivity index ( IsI ) . RESULTS At the end of the treatment period , Is of diabetic patients was significantly increased : M from 3.202+/-1.898 to 5.951+/-2.705 mg/kg/min ( mean+/-sD ) , p<0.01 ; and IsI from 4.706+/-2.666 to 7.673+/-3.559 mg/kg/min per mIU/l x 100 ( mean+/-sD ) , p<0.05 . the difference was not statistically significant between the Is of diabetic patients after alpha-lipoic acid therapy and control subjects . CONCLUSION short-term oral alpha-lipoic acid treatment increases peripheral insulin sensitivity in patients with type 2 diabetes mellitus BACKGROUND The diabetic state , in both humans and experimental animals , is associated with oxidative stress . Lipid peroxidation of nerve membranes has been suggested as a mechanism by which peripheral nerve ischemia and hypoxia could cause neuropathy . Lipoic acid ( LA ) is a powerful inhibitor of iron-dependent lipid peroxidation and reactive oxygen species . The treatment of diabetic peripheral and cardiac autonomic neuropathy with LA is based on good clinical and experimental evidence . MATERIAL S AND METHODS To investigate the magnitude of the oxidative stress , serum ceruloplasmin ( Cp ) and lipid peroxide ( Lp ) levels were measured in 10 patients with diabetic neuropathy , before and 70 days after treatment with single dose of 600 mg LA/day . For other 12 healthy age- and sex-matched control subjects the serum Cp and Lp levels were evaluated . RESULTS Our results show that hyperglycemia is a factor for an increase in serum ceruloplasmin in patients with diabetic neuropathy compared to healthy subjects ( p < 0.0001 ) . High serum ceruloplasmin ( Cp ) level in patients with diabetes may be related to antioxidant defense . The treatment of diabetic neuropathy with LA does not affect significantly the serum Cp activity . The serum Lp levels after LA administration were significantly lower ( p < 0.005 ) than those before treatment . CONCLUSIONS The antioxidant therapy with LA improves and may prevent diabetic neuropathy . This improvement is associated with a reduction in the indexes of lipid peroxidation . Oxidative stress appears to be primarily due to the processes of nerve ischemia and hyperglycemia autooxidation Diabetic polyneuropathy is a serious complication in patients with diabetes mellitus . In addition to the maintenance of a sufficient metabolic control , alpha-lipoic acid ( ALA ) ( Thioctacid , Asta Medica ) is known to have beneficial effects on diabetic polyneuropathy although the exact mechanism by which ALA exerts its effect is unknown . In order to study the effect of ALA on microcirculation in patients with diabetes mellitus and peripheral neuropathy one group of patients ( 4 female , 4 male , age 60+/-3 years , diabetes duration 19+/-4 years , BMI 24.8+/-1.3 kg/m2 ) received 1200 mg ALA orally per day over 6 weeks ( trial 1 ) . A second group of patients ( 5 female , 4 male , age 65+/-3 years , diabetes duration 14+/-4 years , BMI 23.6+/-0.7 kg/m2 ) was studied before and after they had received 600 mg ALA or placebo intravenously over 15 minutes in order to investigate whether ALA has an acute effect on microcirculation ( trial 2 ) . Patients were investigated by nailfold video-capillaroscopy . Capillary blood cell velocity was examined at rest and during postreactive hyperemia ( occlusion of the wrist for 2 minutes , 200 mmHg ) which is a parameter of the perfusion reserve on dem and . The oral therapy with ALA result ed in a significant decrease in the time to peak capillary blood cell velocity ( tpCBV ) during postocclusive hyperemia ( trial 1 : 12.6+/-3.1 vs 35.4+/-10.9 s , p<0.05 ) . The infusion of ALA also decreased the tpCBV in patients with diabetic neuropathy ( trial 2 : before : 20.8+/-4,5 , ALA : 11.74+/-4.4 , placebo : 21.9 - 5.0 s , p<0.05 ALA vs both placebo and before infusions ) indicating that ALA has an acute effect on microcirculation . Capillary blood cell velocity at rest ( rCBV ) , hemodynamic parameters , hemoglobinA1c and local skin temperature remained unchanged in both studies . These results demonstrate that in patients with diabetic polyneuropathy ALA improves microcirculation as indicated by an increased perfusion reserve on dem and . The observed effects are apparently acute effects . With the restriction of the pilot character of this investigation the findings support the assumption that ALA might exert its beneficial effects at least partially by improving microcirculation which is likely to occur also at the level of the vasa nervorum OBJECTIVE —The aim of this trial was to evaluate the effects of α-lipoic acid ( ALA ) on positive sensory symptoms and neuropathic deficits in diabetic patients with distal symmetric polyneuropathy ( DSP ) . RESEARCH DESIGN AND METHODS —In this multicenter , r and omized , double-blind , placebo-controlled trial , 181 diabetic patients in Russia and Israel received once-daily oral doses of 600 mg ( n = 45 ) ( ALA600 ) , 1,200 mg ( n = 47 ) ( ALA1200 ) , and 1,800 mg ( ALA1800 ) of ALA ( n = 46 ) or placebo ( n = 43 ) for 5 weeks after a 1-week placebo run-in period . The primary outcome measure was the change from baseline of the Total Symptom Score ( TSS ) , including stabbing pain , burning pain , paresthesia , and asleep numbness of the feet . Secondary end points included individual symptoms of TSS , Neuropathy Symptoms and Change ( NSC ) score , Neuropathy Impairment Score ( NIS ) , and patients ’ global assessment of efficacy . RESULTS —Mean TSS did not differ significantly at baseline among the treatment groups and on average decreased by 4.9 points ( 51 % ) in ALA600 , 4.5 ( 48 % ) in ALA1200 , and 4.7 ( 52 % ) in ALA1800 compared with 2.9 points ( 32 % ) in the placebo group ( all P < 0.05 vs. placebo ) . The corresponding response rates ( ≥50 % reduction in TSS ) were 62 , 50 , 56 , and 26 % , respectively . Significant improvements favoring all three ALA groups were also noted for stabbing and burning pain , the NSC score , and the patients ’ global assessment of efficacy . The NIS was numerically reduced . Safety analysis showed a dose-dependent increase in nausea , vomiting , and vertigo . CONCLUSIONS —Oral treatment with ALA for 5 weeks improved neuropathic symptoms and deficits in patients with DSP . An oral dose of 600 mg once daily appears to provide the optimum risk-to-benefit ratio Aims To evaluate the efficacy and safety of short‐term oral treatment with the antioxidant thioctic acid ( TA ) on neuropathic symptoms and deficits in patients with Type 2 diabetes mellitus with symptomatic polyneuropathy Anti-oxidant treatment has been shown to prevent nerve dysfunction in experimental diabetes mellitus , thus providing a rationale of potential therapeutic value for diabetic patients . The effects of the anti-oxidant alpha-lipoic acid ( thioctic acid ) were studied in a 3-week multicentre , r and omized , double-blind placebo-controlled trial ( Alpha-Lipoic Acid in Diabetic Neuropathy ; ALADIN ) in 328 non-insulin-dependent diabetic patients with symptomatic peripheral neuropathy who were r and omly assigned to treatment with intravenous infusion of alpha-lipoic acid using three doses ( 1200 , 600 , or 100 mg ALA ) or placebo ( PLAC ) . Neuropathic symptoms ( pain , burning , paraesthesiae , and numbness ) were scored at baseline and at each visit ( days 2 - 5 , 8 - 12 , and 15 - 19 ) prior to infusion . In addition , the Hamburg Pain Adjective List , a multidimensional specific pain question naire , and the Neuropathy Symptom and Disability Scores were assessed at baseline and day 19 . According to the protocol 260 ( 65/63/66/66 ) patients \n Output:\n " }, { "from": "agent", "value": "The results of this meta- analysis provide evidence that treatment with ALA ( 300 - 600 mg/day i.v .\nfor 2 - 4 weeks ) is safe and that the treatment can significantly improve both nerve conduction velocity and positive neuropathic symptoms ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: Objective : To investigate the lifelong health effects , costs , and cost-effectiveness of a quality improvement collaborative focusing on improving diabetes management in an integrated care setting . Study Design and Methods : Economic evaluation from a healthcare perspective with lifetime horizon alongside a nonr and omized , controlled , before-after study in the Netherl and s. Analyses were based on 1861 diabetes patients in 6 intervention and 9 control regions , representing 37 general practice s and 13 out-patient clinics . Change in the United Kingdom Prospect i ve Diabetes Study score , remaining lifetime , and costs per quality -adjusted life year gained were calculated . Probabilistic life tables were constructed using the United Kingdom Prospect i ve Diabetes Study risk engine , a vali date d diabetes model , and nonparametric bootstrapping of individual patient data . Results : Annual United Kingdom Prospect i ve Diabetes Study risk scores reduced for cardiovascular events ( hazard ratio : 0.83 and 0.98 ) and cardiovascular mortality ( hazard ratio : 0.78 and 0.88 ) for men and women , respectively . Life expectancy improved by 0.97 and 0.76 years for men and women , and quality -adjusted life years by 0.44 and 0.37 , respectively . Higher life expectancy in the intervention group increased lifelong costs by & OV0556;860 for men and & OV0556;645 for women . Initial program costs were about & OV0556;22 per patient . The incremental costs per quality -adjusted life year were & OV0556;1937 for men and & OV0556;1751 for women compared with usual care costs . There is a probability > 95 % that the collaborative is cost-effective , using a threshold of & OV0556;20,000 per quality -adjusted life year . Conclusion : Optimizing integrated and patient-centered diabetes care through a quality -improvement collaborative is cost-effective compared with usual care An evaluation was undertaken on the effectiveness and efficiency of care coordination as a means of delivering health services to Australian veterans with a diagnosis of congestive heart failure . The veterans participated in a r and omized controlled trial of care coordination that was supported by the Department of Veterans ' Affairs ( DVA ) . Of 490 veterans who were recruited , 409 were surveyed at baseline ( 214 in the intervention group and 195 controls ) . At follow-up , 288 were surveyed ( 155 intervention and 133 controls ) . Information on cost of care and quality of life ( QOL ) was collected before the commencement of coordinated care and at follow-up after 12 months . Cost of care data were obtained from DVA records . Information on QOL was obtained from telephone interviews , using the Short Form ( SF-12 ) Health Survey and the EuroQol Group EQ-5D survey . There were no significant differences in costs of care between the intervention ( coordinated care ) and control groups of veterans . Nor were there significant differences between the intervention and control groups in QOL measurements with either of the evaluation tools that were used . Because evidence of benefit from coordinated care may be slow to emerge in patients with chronic disease , it would be desirable for future work in this area to include long term , good quality comparative studies on selected veteran population s. Such studies should measure QOL and economic outcomes in addition to clinical indicators Abstract Background World-wide healthcare systems are faced with an epidemic of type 2 diabetes . In the United Kingdom , clinical care is primarily provided by general practitioners ( GPs ) rather than hospital specialists . Intermediate care clinics for diabetes ( ICCD ) potentially provide a model for supporting GPs in their care of people with poorly controlled type 2 diabetes and in their management of cardiovascular risk factors . This study aims to ( 1 ) compare patients with type 2 diabetes registered with practice s that have access to an ICCD service with those that have access only to usual hospital care ; ( 2 ) assess the cost-effectiveness of the intervention ; and ( 3 ) explore the views and experiences of patients , health professionals and other stakeholders . Methods / Design This two-arm cluster r and omized controlled trial ( with integral economic evaluation and qualitative study ) is set in general practice s in three UK Primary Care Trusts . Practice s are r and omized to one of two groups with patients referred to either an ICCD ( intervention ) or to hospital care ( control ) . Intervention group : GP practice s in the intervention arm have the opportunity to refer patients to an ICCD - a multidisciplinary team led by a specialist nurse and a diabetologist . Patients are review ed and managed in the ICCD for a short period with a goal of improving diabetes and cardiovascular risk factor control and are then referred back to practice .or Control group : St and ard GP care , with referral to secondary care as required , but no access to ICCD . Participants are adults aged 18 years or older who have type 2 diabetes that is difficult for their GPs to control . The primary outcome is the proportion of participants reaching three risk factor targets : HbA1c ( ≤7.0 % ) ; blood pressure ( < 140/80 ) ; and cholesterol ( < 4 mmol/l ) , at the end of the 18-month intervention period . The main secondary outcomes are the proportion of participants reaching individual risk factor targets and the overall 10-year risks for coronary heart disease(CHD ) and stroke assessed by the United Kingdom Prospect i ve Diabetes Study ( UKPDS ) risk engine . Other secondary outcomes include body mass index and waist circumference , use of medication , reported smoking , emotional adjustment , patient satisfaction and views on continuity , costs and health related quality of life . We aim ed to r and omize 50 practice s and recruit 2,555 patients . Discussion Forty-nine practice s have been r and omized , 1,997 patients have been recruited to the trial , and 20 patients have been recruited to the qualitative study . Results will be available late 2012.Trial registration [ Clinical Trials.gov : Identifier NCT00945204 Objective : To assess the cost effectiveness and cost effectiveness acceptability of symptom control delivered by shared care ( SCSC ) and aggressive treatment delivered in hospital ( ATH ) for established rheumatoid arthritis ( RA ) . Methods : Economic data were collected within the British Rheumatoid Outcome Study Group r and omised controlled trial of SCSC and ATH . A broad perspective was used ( UK National Health Service , social support services and patients ) . Cost per quality adjusted life year ( QALY ) gained , net benefit statistics and cost effectiveness acceptability curves were estimated . Costs and outcomes were discounted at 3.5 % . Sensitivity analysis tested the robustness of the results to analytical assumptions . Results : The mean ( SD ) cost per person was £ 4540 ( 4700 ) in the SCSC group and £ 4440 ( 4900 ) in the ATH group . The mean ( SD ) QALYs per person for 3 years were 1.67 ( 0.56 ) in the SCSC group and 1.60 ( 0.60 ) in the ATH group . If decision makers are prepared to pay ⩾£2000 to gain 1 QALY , SCSC is likely to be cost effective in 60–90 % of cases . Conclusions : The primary economic analysis and sensitivity analyses indicate that SCSC is likely to be more cost effective than ATH in 60–90 % of cases . This result seems to be robust to assumptions required by the analysis . This study is one of a limited number of r and omised controlled trials to collect detailed re source use and health status data and estimate the costs and QALYs of treatment for established RA . This trial is one of the largest RA studies to use the EuroQol Background To estimate the proportion of diabetic patients ( DPts ) with peripheral vascular disease treated at a primary health care site after an endocrinologist-based intervention , who meet ATP III and Steno targets of metabolic control , as well as to compare the outcome with the results of the patients treated by endocrinologists . Methods A controlled , prospect i ve over 30-months period study was conducted in area 7 of Madrid . One hundred twenty six eligible diabetic patients diagnosed as having peripheral vascular disease between January 2003 and June 2004 were included in the study . After a treatment period of three months by the Diabetes team at St Carlos Hospital , 63 patients were r and omly assigned to continue their follow up by diabetes team ( Group A ) and other 63 to be treated by the family physicians ( FP ) at primary care level with continuous diabetes team coordination ( Group B ) . 57 DPts from Group A and 59 from Group B , completed the 30 months follow-up period . At baseline both groups were similar in age , weight , time from diagnosis and metabolic control . The main outcomes of this study were the proportion of patients meeting ATP III and Steno goals for HbA1c ( % ) , Cholesterol , HDL cholesterol , LDL cholesterol , triglycerides , blood pressure , albumine-to-creatinine excretion ratio ( ACR ) , body mass index ( BMI ) , waist circumference ( WC ) , anti-aggregation treatment and smoking status . Results At the end of the follow up , no differences were found between the groups . More than 37 % of diabetic patients assigned to be treated by FP achieved a HbA1c < 6.5 % , more than 50 % a ACR < 30 mg/g , and more than 80 % reached low risk values for cholesterol , LDL cholesterol , triglycerides , diastolic blood pressure and were anti-aggregated , and 12 % remained smokers . In contrast , less than 45 % achieved a systolic blood pressure < 130 mm Hg , less than 12 % had a BMI < 25 Kg.m-2 ( versus 23 % in group A ; p < 0.05 ) and 49%/30 % ( men/women ) had a waist circumference of low risk . Conclusion Improvements in metabolic control among diabetic patients with peripheral vascular disease treated at a primary health care setting is possible , reaching similar results to the patients treated at a specialized level . Despite such an improvement , body weight control remains more than poor in both levels , mainly at primary care level . General practitioner and endocrinologist coordination care may be important to enhance diabetes management in primary care setting s . Trial registration Clinical Trial number IS RCT Objective : Despite evidence demonstrating that risk-factor management is effective in reducing recurrent cerebrovascular disease , there are very few structured care programmes for stroke survivors . The aim was to implement and evaluate an integrated care programme in stroke . Methods : 186 patients with stroke were r and omised to either the treatment ( integrated care ) or control ( usual care ) group and were followed up over 12 months . The Integrated Care for the Reduction of Secondary Stroke ( ICARUSS ) model of integrated care involved collaboration between a specialist stroke service , a hospital coordinator and a patient ’s general practitioner . The primary aim was to promote the management of vascular risk factors through ongoing patient contact and education . Results : In the 12 months poststroke , systolic blood pressure ( sBP ) decreased in the treatment group but increased in controls . The group difference was significant , and remained so when age , sex , disability and sBP at discharge were accounted for ( p = 0.04 ) . Treatment patients also exhibited better modification of body mass index ( p = 0.007 ) and number of walks taken ( p<0.001 ) than controls . Rankin scores indicated significantly reduced disability in treatment patients relative to controls in the year poststroke ( p = 0.003 ) . Conclusions : Through an integrated system of education , advice and support to both patient and GP , the ICARUSS model was effective in modifying a variety of vascular risk factors and therefore should decrease the likelihood or recurrent stroke or vascular event 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 To test the feasibility and efficacy \n Output:\n " }, { "from": "agent", "value": "This review suggests that shared care improves depression outcomes and probably has mixed or limited effects on other outcomes .\nReview findings support the growing evidence base for shared care in the management of depression , particularly stepped care models of shared care ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: BACKGROUND Endomyocardial biopsy is the st and ard method of monitoring for rejection in recipients of a cardiac transplant . However , this procedure is uncomfortable , and there are risks associated with it . Gene-expression profiling of peripheral-blood specimens has been shown to correlate with the results of an endomyocardial biopsy . METHODS We r and omly assigned 602 patients who had undergone cardiac transplantation 6 months to 5 years previously to be monitored for rejection with the use of gene-expression profiling or with the use of routine endomyocardial biopsies , in addition to clinical and echocardiographic assessment of graft function . We performed a noninferiority comparison of the two approaches with respect to the composite primary outcome of rejection with hemodynamic compromise , graft dysfunction due to other causes , death , or retransplantation . RESULTS During a median follow-up period of 19 months , patients who were monitored with gene-expression profiling and those who underwent routine biopsies had similar 2-year cumulative rates of the composite primary outcome ( 14.5 % and 15.3 % , respectively ; hazard ratio with gene-expression profiling , 1.04 ; 95 % confidence interval , 0.67 to 1.68 ) . The 2-year rates of death from any cause were also similar in the two groups ( 6.3 % and 5.5 % , respectively ; P=0.82 ) . Patients who were monitored with the use of gene-expression profiling underwent fewer biopsies per person-year of follow-up than did patients who were monitored with the use of endomyocardial biopsies ( 0.5 vs. 3.0 , P<0.001 ) . CONCLUSIONS Among selected patients who had received a cardiac transplant more than 6 months previously and who were at a low risk for rejection , a strategy of monitoring for rejection that involved gene-expression profiling , as compared with routine biopsies , was not associated with an increased risk of serious adverse outcomes and result ed in the performance of significantly fewer biopsies . ( Clinical Trials.gov number , NCT00351559 . Purpose This prospect i ve study was to evaluate the significance of fecal calprotectin and lactoferrin for the prediction of ulcerative colitis ( UC ) relapse . Methods Eighty UC patients in remission for ≥3 months on mesalamine as maintenance therapy were included . At entry , stool sample s were collected for the measurement of calprotectin and lactoferrin . All patients were followed up for the following 12 months . To identify predictive factors for relapse , time-dependent analyses using the Kaplan-Meier graphs and Cox 's proportional hazard model were applied . Results During the 12 months , 21 patients relapsed . Mean calprotectin and lactoferrin levels were significantly higher in patients with relapse than those in remission ( calprotectin—173.7 vs 135.5 μg/g , P = 0.02 ; lactoferrin—165.1 vs 130.7 μg/g , P = 0.03 ) . A cutoff value of 170 μg/g for calprotectin had a sensitivity of 76 % and a specificity of 76 % to predict relapse , while a cutoff value of 140 μg/g for lactoferrin had a sensitivity of 67 % and a specificity of 68 % . In a multivariate analysis , calprotectin ( ≥170 μg/g ) was a predictor of relapse ( hazard ratio , 7.23 ; P = 0.002 ) . None of the following parameters were significantly associated with relapse : age , gender , duration of UC , number of UC episode , severity of the previous episode , extent of UC , extraintestinal manifestation , and lactoferrin level . Conclusions Fecal calprotectin showed a higher sensitivity and specificity than fecal lactoferrin for predicting UC relapse . Fecal calprotectin level appeared to be a significant predictor of relapse in patients with quiescent UC on mesalamine as maintenance therapy Background : This study examined whether fecal calprotectin can be used in daily practice as a marker to monitor patients with ulcerative colitis ( UC ) receiving infliximab maintenance therapy . Methods : This prospect i ve multicenter study enrolled adult patients with UC in clinical remission under infliximab maintenance therapy . Fecal calprotectin levels were measured every 4 weeks . Sigmoidoscopies were performed at inclusion and at study end . Relapse was defined as a clinical need for change in treatment or an endoscopic Mayo subscore of ≥2 at week 52 . Sustained deep remission was defined as a partial Mayo score <3 at all points and an endoscopic Mayo score 0 at week 52 . Results : Full analysis was possible for 87 of 113 included patients with UC ( 77 % ) . Of these patients , 30 ( 34.4 % ) were considered to be in sustained deep remission and 13 ( 14.9 % ) to have relapsed . Calprotectin levels in patients with sustained deep remission remained very low ( median < 40 mg/kg at all time points ) . Patients who flared had significantly higher calprotectin levels ( median > 300 mg/kg ) already 3 months before the flare . Further receiver operator curve analysis suggested that a calprotectin level > 300 mg/kg had a reasonable sensitivity ( 58.3 % ) and specificity ( 93.3 % ) to model flare . Two consecutive calprotectin measurements of > 300 mg/kg with 1-month interval were identified as the best predictor of flare ( 61.5 % sensitivity and 100 % specificity ) . Conclusions : Fecal calprotectin can be used in daily practice to monitor patients with UC receiving infliximab maintenance therapy . Two consecutive measurements > 300 mg/kg is more specific than a single measurement for predicting relapse BACKGROUND & AIMS Unfractionated heparin has been found to reduce symptoms and improve healing as adjuvant therapy in patients with ulcerative colitis . The current study evaluated the efficacy and safety of unfractionated heparin in the treatment of ulcerative colitis in comparison with methylprednisolone . METHODS A multicenter r and omized trial with blinded endpoint evaluation was conducted in patients hospitalized for moderate or severe ulcerative colitis . Patients were r and omized to receive heparin as a continuous infusion or methylprednisolone ( 0.75 - 1 mg x kg(-1 ) x day(-1 ) ) . RESULTS Twenty-five patients entered the study : 13 received methylprednisolone and 12 received heparin . By day 10 , 69 % of patients in the methylprednisolone group , but none in the heparin group , achieved significant improvement or remission . C-reactive protein levels significantly decreased in the methylprednisolone group but not in the heparin group . Three patients in the heparin group were withdrawn before day 10 because of an adverse event : rectal bleeding needing transfusion ( 2 cases ) or surgery ( 1 case ) . The proportion of patients with persistent rectal bleeding at day 10 was 31 % in the methylprednisolone group and 90 % in the heparin group ( P<0.05 ) . CONCLUSIONS Unfractionated heparin as monotherapy is not effective in the treatment of moderate or severe ulcerative colitis and is associated with significant bleeding complications Background and Aims Microarray analysis of RNA expression allows gross examination of pathways operative in inflammation . We aim ed to determine whether genes expressed in whole blood early following initiation of intravenous corticosteroid treatment can be associated with response . Methods From a prospect ively accrued cohort of 128 pediatric patients hospitalized for intravenous corticosteroid treatment of severe UC , we selected for analysis 20 corticosteroid responsive ( hospital discharge or PUCAI ≤45 by day 5 ) and 20 corticosteroid resistant patients ( need for second line medical therapy or colectomy , or PUCAI > 45 by day 5 ) . Total RNA was extracted from blood sample s collected on day 3 of intravenous corticosteroid therapy . The eluted transcriptomes were quantified on Affymetrix Human Gene 1.0 ST arrays . The data was analysed by the local-pooled error method for discovery of differential gene expression and false discovery rate correction was applied to adjust for multiple comparisons . Results A total of 41 genes differentially expressed between responders and non-responders were detected with statistical significance . Two of these genes , CEACAM1 and MMP8 , possibly inhibited by methylprednisolone through IL8 , were both found to be over-expressed in non-responsive patients . ABCC4 ( MRP4 ) as a member of the multi-drug resistance superfamily was a novel c and i date gene for corticosteroid resistance . The expression pattern of a cluster of 10 genes selected from the 41 significant hits were able to classify the patients with 80 % sensitivity and 80 % specificity . Conclusions Elevated expression of several genes involved in inflammatory pathways was associated with resistance to intravenous corticosteroid therapy early in the course of treatment . Gene expression profiles may be useful to classify resistance to intravenous corticosteroids in children with severe UC and assist with clinical management decisions BACKGROUND & AIMS In a prospect i ve study of children with severe ulcerative colitis ( UC ) , we aim ed to assess outcomes and to identify predictors of nonresponse to intravenous corticosteroids . METHODS A total of 128 children ( 47 % males ; 12.9 + /- 3.9 y ) hospitalized for severe UC were enrolled from 10 pediatric centers . Clinical and laboratory data and the Pediatric UC Activity Index ( PUCAI ) were recorded throughout the admission . Patients were followed up for 1 year postdischarge . RESULTS Thirty-seven ( 29 % ; 95 % confidence interval [ CI ] , 22%-37 % ) children failed intravenous corticosteroids and received , within 10.5 + /- 6.4 days , cyclosporine ( n = 1 ; 3 % ) , colectomy ( n = 3 ; 8 % ) , or infliximab ( n = 33 ; 89 % ) . Several predictors were associated with intravenous corticosteroids failure , but the best model included number of stools , amount of blood , age , and new-onset disease ( odds ratio [ OR ] , 1.9 ; 95 % CI , 1.1 - 3.5 ; OR , 2.5 ; 95 % CI , 1.3 - 4.6 ; OR , 1.2 ; 95 % CI , 1.04 - 1.36 ; and OR , 0.27 ; 95 % CI , 0.1 - 0.7 , respectively ) . The PUCAI , followed closely by the Travis rule , strongly predicted response when compared with other measures ( Seo and Lindgren indices , C-reactive protein level , and fecal calprotectin level ) ( P < .001 ) . Aim ing for sensitivity on day 3 , a PUCAI greater than 45 screened for patients likely to fail intravenous corticosteroids ( negative predictive value , 94 % ; positive predictive value , 43 % ; P < .001 ) . Aim ing for specificity on day 5 , a PUCAI score greater than 70 optimally guided implementation of salvage therapy ( positive predictive value , 100 % ; negative predictive value , 79 % ; P < .001 ) . Twenty-five of 33 children treated with infliximab responded . The overall cumulative colectomy rate was 9 % and 19 % by discharge and 1-year , respectively . The day 3 PUCAI score predicted response up to 1 year postdischarge ( P < .001 ; time to salvage therapy ) . CONCLUSIONS The PUCAI , calculated on days 3 and 5 of steroid therapy , can identify patients requiring salvage therapy . Infliximab is an effective therapy in steroid-refractory pediatric UC OBJECTIVES : Ustekinumab induction therapy was studied in a placebo-controlled trial of patients with Crohn 's disease ( CD ; n=104 ) . In patients receiving ustekinumab , 49 % achieved clinical response at week 8 vs. 40 % for placebo ( P=0.34 ) . In a subgroup of patients previously treated with infliximab ( n=49 ) , 59 % receiving ustekinumab responded vs. 26 % receiving placebo ( P=0.02 ) . METHODS : C-reactive protein ( CRP ) concentrations were analyzed from serum collected at baseline and at week 8 . Change from baseline CRP concentration after treatment , the relationship between baseline CRP concentration and clinical response , and the relationship between baseline CRP concentration and disease location were investigated . RESULTS : Mean changes from baseline CRP at week 8 in the primary group were −0.3 and −3.1 mg/l after treatments with placebo ( n=43 ) and ustekinumab ( n=46 ) , respectively ( P=0.074 ) . In the infliximab-experienced subgroup , the mean changes were + 2.0 ( placebo , n=23 ) and −2.6 mg/l ( ustekinumab , n=20 ) ( P=0.004 ) . Patients with baseline CRP ≥10 mg/l tended to have lower placebo and a higher ustekinum \n Output:\n " }, { "from": "agent", "value": "In Crohn disease , elevated CRP levels at baseline predict response to anti-tumour necrosis factor agents , and normalization is usually associated with clinical and endoscopic remission .\nCRP and hemoglobin levels can be used to help predict clinical relapse in the context of withdrawal of therapy ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: Identification of high-risk individuals will facilitate early diagnosis , reduce overall costs , and also improve the current poor survival from lung cancer . The Liverpool Lung Project prospect i ve cohort of 8,760 participants ages 45 to 79 years , recruited between 1998 and 2008 , was followed annually through the hospital episode statistics until January 31 , 2013 . Cox proportional hazards models were used to identify risk predictors of lung cancer incidence . C-statistic was used to assess the discriminatory accuracy of the models . Models were internally vali date d using the bootstrap method . During mean follow-up of 8.7 years , 237 participants developed lung cancer . Age [ hazard ratio ( HR ) , 1.04 ; 95 % confidence interval ( CI ) , 1.02–1.06 ] , male gender ( HR , 1.48 ; 95 % CI , 1.10–1.98 ) , smoking duration ( HR , 1.04 ; 95 % CI , 1.03–1.05 ) , chronic obstructive pulmonary disease ( HR , 2.43 ; 95 % CI , 1.79–3.30 ) , prior diagnosis of malignant tumor ( HR , 2.84 ; 95 % CI , 2.08–3.89 ) , and early onset of family history of lung cancer ( HR , 1.68 ; 95 % CI , 1.04–2.72 ) were associated with the incidence of lung cancer . The LLPi risk model had a good calibration ( goodness-of-fit χ2 7.58 , P = 0.371 ) . The apparent C-statistic was 0.852 ( 95 % CI , 0.831–0.873 ) and the optimism-corrected bootstrap resampling C-statistic was 0.849 ( 95 % CI , 0.829–0.873 ) . The LLPi risk model may assist in identifying individuals at high risk of developing lung cancer in population -based screening programs . Cancer Prev Res ; 8(6 ) ; 570–5 . © 2015 AACR BACKGROUND Although there is no proven benefit associated with screening for lung cancer , screening programs are attracting many individuals who perceive themselves to be at high risk due to smoking . We sought to determine whether the risk of lung cancer varies predictably among smokers . METHODS We used data on 18 172 subjects enrolled in the Carotene and Retinol Efficacy Trial (CARET)-a large , r and omized trial of lung cancer prevention-to derive a lung cancer risk prediction model . Model inputs included the subject 's age , sex , asbestos exposure history , and smoking history . We assessed the model 's calibration by comparing predicted and observed rates of lung cancer across risk deciles and vali date d it by assessing the extent to which a model estimated on data from five CARET study sites could predict events in the sixth study site . We then applied the model to evaluate the risk of lung cancer among smokers enrolled in a study of lung cancer screening with computed tomography ( CT ) . RESULTS The model was internally valid and well calibrated . Ten-year lung cancer risk varied greatly among participants in the CT study , from 15 % for a 68-year-old man who has smoked two packs per day for 50 years and continues to smoke , to 0.8 % for a 51-year-old woman who smoked one pack per day for 28 years before quitting 9 years earlier . Even among the subset of CT study participants who would be eligible for a clinical trial of cancer prevention , risk varied greatly . CONCLUSIONS The risk of lung cancer varies widely among smokers . Accurate risk prediction may help individuals who are contemplating voluntary screening to balance the potential benefits and risks . Risk prediction may also be useful for research ers design ing clinical trials of lung cancer prevention STUDY OBJECTIVES To develop and vali date a model for estimating the risk of lung cancer death in current and former smokers . The model is intended for use in analyzing a population of subjects who are undergoing lung cancer screening or receiving lung cancer chemoprevention , to determine whether the intervention has altered lung cancer mortality . DESIGN / SETTING / PATIENTS Model derivation was based on analyses of the placebo arm of the Carotene and Retinol Efficacy Trial . Model validation was based on analyses of three other longitudinal cohorts . MEASUREMENTS Observed and predicted number of deaths due to lung cancer . RESULTS In internal validation , the model was highly concordant and well calibrated . In external validation , the model predictions were similar to what was observed in all of the validation analyses . The predicted and observed deaths within 6 years were very similar when assessed in the Johns Hopkins Hospital trial of chest radiography and sputum cytology screening ( 176 predicted , 184 observed , p = 0.53 ) , the Memorial Sloan-Kettering Cancer Center trial of chest radiography and sputum cytology screening ( 108 predicted , 114 observed , p = 0.57 ) , and the National Health and Nutrition Evaluation Survey part I ( 24 predicted , 21 observed , p = 0.52 ) . CONCLUSIONS The number of lung cancer deaths in a population of current or former smokers can be accurately predicted , making model-based evaluations of prevention and early detection interventions a useful adjunct to definitive r and omized trials . We illustrate this potential use with a small example Background : This prospect i ve cohort study aim ed to identify symptom and patient factors that influence time to lung cancer diagnosis and stage at diagnosis . Methods : Data relating to symptoms were collected from patients upon referral with symptoms suspicious of lung cancer in two English regions ; we also examined primary care and hospital records for diagnostic routes and diagnoses . Descriptive and regression analyses were used to investigate associations between symptoms and patient factors with diagnostic intervals and stage . Results : Among 963 participants , 15.9 % were diagnosed with primary lung cancer , 5.9 % with other thoracic malignancies and 78.2 % with non-malignant conditions . Only half the cohort had an isolated first symptom ( 475 , 49.3 % ) ; synchronous first symptoms were common . Haemoptysis , reported by 21.6 % of cases , was the only initial symptom associated with cancer . Diagnostic intervals were shorter for cancer than non-cancer diagnoses ( 91 vs 124 days , P=0.037 ) and for late-stage than early-stage cancer ( 106 vs 168 days , P=0.02 ) . Chest/shoulder pain was the only first symptom with a shorter diagnostic interval for cancer compared with non-cancer diagnoses ( P=0.003 ) . Conclusions : Haemoptysis is the strongest symptom predictor of lung cancer but occurs in only a fifth of patients . Programmes for expediting earlier diagnosis need to focus on multiple symptoms and their evolution The epidemiology of lung cancer is changing in many parts of the world . In the industrialized countries , there is a trend that the incidence in men is declining , while it is increasing for women . Also , adenocarcinomas are becoming relatively more common , especially among men . The purpose of this study was to investigate whether such trends also occur in Sweden and also to describe other aspects of an unselected lung cancer material today , such as symptoms , stage and smoking habits . In the county of Gaevleborg , Sweden , practically all patients with lung cancer are referred to the lung department , and thus a total material of lung cancer patients with only a minimal selection bias can be studied . All patients with lung cancer in the county from January 1 , 1997 to December 31 , 1999 , were investigated prospect ively regarding stage , type of cancer , and symptoms . In all , there were 364 patients , 237 ( 65.1 % ) men and 127 ( 34.9 % ) women . The mean age for men was 69.8 and for women , 68.1 years . 91.9 % of the men and 78.6 % of the women were smokers or ex-smokers . In general the men were heavier smokers than were the women ( P<0.0001 ) . Adenocarcinoma was the most common subtype found in women and squamous cell carcinoma in men . The excess of adenocarcinoma in women was due to never-smoking women ; for smoking and ex-smoking men and women , the proportion of adenocarcinomas was the same . In all , 240 patients ( 68.0 % ) were diagnosed at Stage IIIb ( 27.2 % ) or IV ( 40.8 % ) , with no significant differences between the sexes . The most common first symptom was cough . Only 7.0 % of patients were asymptomatic . In conclusion , the trend of an increasing proportion of adenocarcinoma in lung cancer is seen also in Sweden . A depressingly high percentage of patients present in late stages and are thus inoperable \n Output:\n " }, { "from": "agent", "value": "The positive predictive value ( PPV ) of diagnostic symptoms depends on an individual 's prior risk of lung cancer , as well as their presenting symptom pattern ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: Our previous studies in Parkinson 's disease have shown that both levodopa and expectancy of receiving levodopa reduce cortical excitability . We design ed this study to evaluate how degree of expectancy and other individual factors modulate placebo response in Parkinson 's patients . Twenty-six Parkinson 's patients were r and omized to 1 of 3 groups : 0 % , 50 % , and 100 % expectancy of receiving levodopa . All subjects received placebo regardless of expectancy group . Subjects completed the NEO-Five Factor Inventory , General Perceived Self-Efficacy Scale , and Perceived Stress Scale . Cortical excitability was measured by the amplitude of motor-evoked potential ( MEP ) evoked by transcranial magnetic stimulation . Objective physical fatigue of extensor carpi radialis before and after placebo levodopa was also measured . Responders were defined as subjects who responded to the placebo levodopa with a decrease in MEP . Degree of expectancy had a significant effect on MEP response ( P < .05 ) . Subjects in the 50 % and 100 % expectancy groups responded with a decrease in MEP , whereas those in the 0 % expectancy group responded with an increase in MEP ( P < .05 ) . Responders tended to be more open to experience than nonresponders . There were no significant changes in objective physical fatigue between the expectancy groups or between responders and nonresponders . Expectancy is associated with changes in cortical excitability . Further studies are needed to examine the relationship between personality and placebo effect in Parkinson 's patients . © 2013 Movement Disorder Society The age-related response to placebo and active antihypertensive treatment was evaluated in 742 elderly hypertensive patients who were followed in the double-blind placebo-controlled trial conducted by the European Working Party on High blood pressure in the Elderly ( EWPHE ) . In the two treatment groups , the fall in systolic and diastolic blood pressures after 3 months was negatively correlated with age ( P less than 0.02 ) , indicating that the hypotensive effect of placebo and active treatment was more pronounced in older patients . Further comparison of the two treatment groups failed to demonstrate any statistical differences in the slopes of the hypotensive effect on age . These conclusions were not altered by cumulative adjustments for baseline blood pressure , pulse rate , serum creatinine and the presence of cardiovascular complications at entry . In conclusion , in the present study , a similar blood-pressure-lowering action which increased with age was observed on active and placebo treatment ; thus , proof that an observed age-related hypotensive effect is caused by a particular drug requires comparison with a control group on placebo OBJECTIVES Our prior work has shown that there is improvement in self-reported sleep in persons receiving placebo in hypnotic clinical trials . We examined the components of the \" placebo response \" in a hypnotic clinical trial . METHODS This was an exploratory analysis of a r and omized , double-blind clinical trial of eszopiclone versus placebo in the treatment of persons with depression and insomnia who were also receiving fluoxetine at a clinic of a teaching hospital . Sixty adults with both depression and insomnia symptoms , who were free of significant primary sleep disorders , received open-label fluoxetine for 9weeks . Patients were further r and omized 1:1 to receive either masked eszopiclone 3 mg or placebo at bedtime after the first week of fluoxetine . We examined the respective contributions of three factors associated with the \" placebo effect \" : ( 1 ) regression to the mean , ( 2 ) expectancy , and ( 3 ) social desirability . RESULTS There was evidence for regression to the mean for the continuous measurement of the Insomnia Severity Index ( ISI ) and the Hamilton Depression Rating Scale . There was evidence for expectancy in self-reported Wake After Sleep Onset , continuous measurement of ISI , and dichotomous remission/non-remitter measurement of ISI . There was evidence of social desirability affecting self-reported Total Sleep Time . CONCLUSIONS Factors that have been associated with the \" placebo effect \" are operating in hypnotic clinical trials . However , the role of each factor differs depending upon which self-reported variable is being considered . The findings have implication s for clinical trial design in insomnia Objective : To examine the frequency , temporal development , and stability of objective ly derived motor changes during placebo treatment in PD and to define the clinical domains and demographic groups most affected . Background : Placebo effects are documented in neurology , but the timing and specific disabilities most susceptible to changes during placebo treatment in PD have not been examined . Methods : The authors examined the placebo-treated group from a r and omized , multicenter , placebo-controlled clinical trial of monotherapy ropinerole in PD patients without motor fluctuations . In 105 patients , they evaluated placebo-associated effects on the motor section of the Unified Parkinson ’s Disease Rating Scale ( UPDRS ) , dividing the motor examination into four categories : tremor , bradykinesia , rigidity , and gait/balance/midline functions . The motor UPDRS and its subscales were compared over time ( at baseline and at 4 , 12 , and 24 weeks ) using Wilcoxon ’s signed rank test . They applied a rigorous definition of placebo-associated improvement as an improvement over baseline score in motor UPDRS of at least 50 % or a change in at least two motor items at any one visit by ≥2 points . Results : During the 6-month study , 16 % of subjects improved on placebo treatment . The prevalence of response was steady ( 8 to 9 % ) at any one visit without a predominance of an early effect . No patient showed a placebo-associated improvement on all visits . All domains of parkinsonian disability were subject to placebo-associated improvement , with a trend toward more response in bradykinesia and rigidity than in tremor or gait/balance/midline function . Gender , age , disease duration , and baseline disability score did not influence the likelihood of improvement in association with placebo treatment . Conclusion : Based on a rigorous definition of placebo-associated improvement , prominent improvements in objective measures of PD disability occur during clinical trials . Because placebo-associated improvements occur throughout a 6-month trial , placebo-controlled studies in PD should be at least 6 months to capture early as well as late improvements OBJECTIVE Placebo response and the rate of failed clinical trials are increasing in schizophrenia , resembling previous experience with antidepressant clinical trials . In depression , the percent of patients r and omized to placebo was shown to be strongly associated with drug-placebo differences ( signal detection).We hypothesized that this factor would also be important in recent schizophrenia clinical trials . To test this hypothesis a data base of acute schizophrenia placebo-controlled studies conducted between 1997 and 2008 was constructed . The data base contained 27 studies , with 79 active treatment arms . As percentage of patients r and omized to placebo increased , mean placebo improvement decreased ( p = 0.047 ) and mean drug-placebo differences tended to increase ( p = 0.166 ) . The frequency of significant contrasts from studies with ≥ 25 % r and omized to placebo was 83.3 % , compared with 58.3 % in studies with < 25 % r and omized to placebo . Caveats to these findings include limited data and confounding of potentially influential factors . These limitations prevent definitive conclusions . However , results are consistent with previous findings in depression where having a higher percent of patients r and omized to placebo increased drug-placebo differences Placebo may yield beneficial effects that are indistinguishable from those of active medication , but the factors underlying proneness to respond to placebo are widely unknown . Here , we used functional neuroimaging to examine neural correlates of anxiety reduction result ing from sustained placebo treatment under r and omized double-blind conditions , in patients with social anxiety disorder . Brain activity was assessed during a stressful public speaking task by means of positron emission tomography before and after an 8 week treatment period . Patients were genotyped with respect to the serotonin transporter-linked polymorphic region ( 5-HTTLPR ) and the G-703 T polymorphism in the tryptophan hydroxylase-2 ( TPH2 ) gene promoter . Results showed that placebo response was accompanied by reduced stress-related activity in the amygdala , a brain region crucial for emotional processing . However , attenuated amygdala activity was demonstrable only in subjects who were homozygous for the long allele of the 5-HTTLPR or the G variant of the TPH2 G-703 T polymorphism , and not in carriers of short or T alleles . Moreover , the TPH2 polymorphism was a significant predictor of clinical placebo response , homozygosity for the G allele being associated with greater improvement in anxiety symptoms . Path analysis supported that the genetic effect on symptomatic improvement with placebo is mediated by its effect on amygdala activity . Hence , our study shows , for the first time , evidence of a link between genetically controlled serotonergic modulation of amygdala activity and placebo-induced anxiety relief OBJECTIVE To search for predictors of placebo response in clinical trials of lisdexamfetamine dimesylate for the treatment of DSM-IV-TR-defined attention-deficit/hyperactivity disorder ( ADHD ) in children and adults . METHOD We used data from 2 clinical trials : ( 1 ) a 4-week , phase 3 , multicenter , r and omized , double-blind , forced-dose , parallel-group study of children aged 6 to 12 years with ADHD ( n = 290 ) and ( 2 ) a 4-week , r and omized , double-blind , placebo-controlled , parallel-group , forced-dose titration study in adult subjects , aged 18 - 55 years with ADHD ( n = 420 ) . Response and remission were defined using the ADHD Rating Scale-IV and the Clinical Global Impressions-Improvement scale . RESULTS Symptom remission was inversely correlated with baseline severity in both children and adults ( P < .001 ) , with less robust effects seen for response . The time to response and remission was delayed in adult subjects prescribed placebo versus lisdexamfetamine dimesylate , while response time in children was also significantly slower with placebo versus lisdexamfetamine dimesylate ( P < .01 ) . We found little evidence that demographic factors , prior pharmacotherapy , the emergence of adverse events during the trial , or changes in ADHD symptoms from the screening to baseline assessment s predicted placebo response . Certain comorbid medical symptoms reduced the response and remission rates to placebo in children ( P < .001 ) and adults ( P < .001 ) . CONCLUSIONS In both children and adults , baseline symptom severity was the most consistent predictor of remission with placebo while the temporal profile of response reliably differentiated placebo from medication responders . Placebo effects are most likely to be minimized in shorter trials enrolling more severely impaired subjects . The impact of medical and psychiatric comorbidities on placebo response merits further investigation . TRIAL REGISTRATION clinical trials.gov identifiers NCT00556296 and NCT00334880 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 20 % decrease in FEV(1 ) nearly doubled ) ; 18 % of subjects were placebo responders by using conservative definitions . Experimental manipulation of physician behavior altered perceptions of the physician but not the magnitude or frequency of the placebo response . CONCLUSIONS Objective placebo effects exist in asthma . These responses are of significant magnitude and likely to be meaningful clinical ly . The placebo response was not modulated by alterations in physician behavior in this study . CLINICAL IMPLICATION S The placebo response in patients with asthma is important in underst and ing the limitations of clinical research studies and in maximizing safe and effective therapies . This article confirms the existence of a strong placebo response in an objective and clinical ly relevant measure of disease activity OBJECTIVE There has been concern about a high rate of placebo response and a substantial failure rate in recent clinical trials in major depressive disorder ( MDD ) . This report explores differences in efficacy data from placebo-controlled MDD trials su bmi tted in support of new drug applications ( NDAs ) over a 25-year period . METHOD We compiled efficacy data from 81 r and omized , double-blind clinical trials , with 21,611 evaluable patients , that were su bmi tted to the US Food and Drug Administration as part of NDAs for an antidepressant cl aim between 1983 and 2008 . Trial data were limited to completed , r and omized , multicenter , \n Output:\n " }, { "from": "agent", "value": "While younger age may contribute to the PR in some conditions , sex does not .\nThere is currently no evidence that the PR is different in the elderly .\nPR are , however , markedly influenced by the symptom severity at baseline , and by the likelihood of receiving active treatment in placebo-controlled trials" } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: Background Various adipokines are reported to be associated with the development of heart failure ( HF ) through insulin resistance and chronic inflammation . Omentin-1 is a novel adipokine and is associated with incident coronary artery disease . However , it remains unclear whether serum omentin-1 levels are associated with cardiac prognosis in patients with HF . Methods We measured serum omentin-1 levels at admission in 136 consecutive patients with HF , and 20 control subjects without signs of significant heart disease . We prospect ively followed patients with HF to endpoints of cardiac death or re-hospitalization for worsening HF . Results Serum omentin-1 levels were markedly lower in HF patients with cardiac events compared with to without . The patients who were in New York Heart Association ( NYHA ) functional class IV showed significantly lower serum omentin-1 levels compared to those in class II and III , whereas serum omentin-1 levels did not correlate with serum brain natriuretic peptide levels ( r = 0.217 , P = 0.011 ) . We divided the HF patients into three groups based on the tertiles of serum omentin-1 level ( low T1 , middle T2 , and high T3 ) . Multivariate Cox hazard analysis showed that the lowest serum omentin-1 level ( T1 ) was independently associated with cardiac events after adjustment for confounding factors ( hazard ratio 5.78 , 95 % confidence interval 1.20 - 12.79 ) . We divided the HF patients into two groups according to the median serum omentin-1 levels . Kaplan-Meier analysis revealed that the patients with low serum omentin-1 levels had a higher risk of cardiac events compared with those with high serum omentin-1 levels ( log-rank test p < 0.001 ) . Conclusion Decreased serum omentin-1 levels were associated with a poor cardiac outcome in patients with HF BACKGROUND Epidemiological studies have reported that patients with type 2 diabetes mellitus ( DM ) have increased mortality and morbidity from cardiovascular diseases , independent of other risk factors . However , most of these studies have been performed in selected patient groups . The purpose of the present study was prospect ively to assess the impact of type 2 DM on cardiovascular morbidity and mortality in an unselected population . METHODS A total of 13,105 subjects from the Copenhagen City Heart Study were followed up prospect ively for 20 years . Adjusted relative risks of first , incident , admission for , or death from ischemic heart disease , acute myocardial infa rct ion , or stroke , as well as total mortality in persons with type 2 DM compared with healthy controls , were estimated . RESULTS The relative risk of first , incident , and admission for myocardial infa rct ion was increased 1.5- to 4.5-fold in women and 1.5- to 2-fold in men , with a significant difference between sexes . The relative risk of first , incident , and admission for stroke was increased 2- to 6.5-fold in women and 1.5- to 2-fold in men , with a significant difference between sexes . In both women and men the relative risk of death was increased 1.5 to 2 times . CONCLUSIONS In persons with type 2 DM , the risk of having an incident myocardial infa rct ion or stroke is increased 2- to 3-fold and the risk of death is increased 2-fold , independent of other known risk factors for cardiovascular diseases OBJECTIVE Omentin is a protein expressed and secreted from visceral but not subcutaneous adipose tissue , which increases insulin sensitivity in human adipocytes . However , its pathophysiologic role in humans remains largely unknown . The objective of this study is to assess plasma omentin-1 levels in patients with type 2 diabetes mellitus ( T2DM ) and matched control subjects and to investigate the effects of liraglutide on plasma omentin-1 levels in patients with T2DM . PATIENTS AND METHODS Thirty T2DM patients with poor glycemic control after more than 3 months of treatment with one or two OHA(s ) ( T2DM ) , and 30 matched normal glycaemic controls ( NGT ) participated in the study . The T2DM group was given an injection of liraglutide once-daily for 16 weeks . Plasma omentin-1 levels were measured by enzyme-linked immunosorbent assay and the relationship between plasma omentin-1 levels and metabolic parameters was also analyzed . RESULTS Plasma omentin-1 levels were lower in T2DM than in the control ( 19.3 ± 4.0 μg/L vs. 26.4 ± 6.0 μg/L , P < 0.01 ) . Plasma omentin-1 levels increased significantly in T2DM patients after treatment with liraglutide compared with pre-treatment ( 19.3 ± 4.0 μg/L vs. 21.2 ± 3 . 9 μg/L , P < 0.01 ) . In all diabetic patients , multiple regression analysis showed that FINS and HOMA-IR were independently associated with plasma omentin-1 levels . CONCLUSIONS In T2DM patients , plasma omentin-1 levels decreased , but significantly increased after the treatment with liraglutide and metformin . These data suggest that liraglutide may play a role in increasing omentin-1 levels in T2DM patients \n Output:\n " }, { "from": "agent", "value": "Conclusion We found that serum omentin level is significantly lower in T2DM and IGT patients but not in T1DM ones .\nThese data could be used by clinicians for early diagnosis and management of diabetes ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: AIMS Recent guidelines recommend regular exercise in the management of patients with chronic heart failure ( CHF ) . This study was design ed to compare the safety and efficacy of conventional bicycle exercise and functional electrical stimulation ( FES ) of the legs as forms of home-based exercise training for patients with stable CHF . METHODS AND RESULTS Forty-six patients ( 38 male ) with stable NYHA Class II/III heart failure underwent a 6-week training programme using either a bicycle ergometer or electrical stimulation of the quadriceps and gastrocnemius muscles . In the bike group , significant increases were seen in 6-min walk ( 44.6 m , 95 % confidence interval ( CI ) 29.3 - 60.9 m ) , treadmill exercise time ( 110 s , 95 % CI 72.2 - 148.0 s ) , maximum leg strength ( 5.32 kg , 95 % CI 3.18 - 7.45 kg ) , and quadriceps fatigue index ( 0.08 , 95 % CI 0.04 - 0.12 ) following training . In the stimulator group , similar significant increases were seen following training for 6-min walk ( 40.6 m , 95 % CI 28.2 - 53.0 m ) , treadmill exercise time ( 67 s , 95 % CI 11.8 - 121.8s ) , maximum leg strength ( 5.35 kg , 95 % CI 1.53 - 9.17 kg ) , and quadriceps fatigue index ( 0.10 , 95 % CI 0.04 - 0.17 ) . Peak VO(2)did not change in either group following training , indicating a low-intensity regime . Quality of life scores improved following training when the bicycle and stimulator groups were considered together , but not when considered separately ( -0.43 , 95 % CI -8.13 to -0.56 ) . CONCLUSIONS FES produces beneficial changes in muscle performance and exercise capacity in patients with CHF . Within this study , the benefits were similar to those observed following bicycle training . FES could be offered to patients with heart failure as an alternative to bicycle training as part of a home-based rehabilitation programme Systemic arterial compliance ( SAC ) makes an important contribution to cardiac afterload , and thus is a significant determinant of left ventricular work . Previous studies have suggested that arterial compliance may be reduced in patients with congestive heart failure ( CHF ) , and that SAC is increased after a 4-week exercise training programme in healthy , sedentary individuals . The present study aim ed to investigate the effects of an 8-week exercise training programme on arterial mechanical properties , left ventricular performance and quality of life in CHF patients . A total of 21 patients with NYHA class II or III CHF ( mean+/-S.D. age 55+/-13 years ) were r and omly allocated to either an 8-week exercise training group or a \" usual lifestyle \" control group . SAC , as determined non-invasively using applanation tonometry and Doppler aortic velocimetry , increased from 0.57+/-0.11 to 0.77+/-0.14 arbitrary compliance units ( mean+/-S.E.M. ; P=0.01 ) in the exercise group , while no change occurred in the control group . Left ventricular structure and function was assessed by echocardiography , and these parameters were unchanged over the 8-week study period . Exercise training significantly increased exercise capacity , measured by a 6-min walking test ( 474+/-27 to 547+/-34 m ; P=0.008 ) . Quality of life , as assessed using the Minnesota Living with Heart Failure Evaluation , demonstrated a decrease in heart failure symptoms from 46+/-7 to 24+/-5 units ( P=0.01 ) following the exercise training programme . These data show that exercise training improves SAC in patients with CHF . The accompanying improvement in exercise capacity may be due , in part , to an improvement in arterial function AIM To assess changes in quality of life ( QoL ) and oxygen consumption produced by two different patterns of physical training in patients with congestive heart failure ( CHF ) . MATERIAL AND METHODS 42 men ( mean age 55.9+/-8.1 years ) with ischaemic CHF lasting 3.1+/-1.0 years . Patients were r and omised into three groups each consisting of 14 men : group A -- with constant workload , group B-with progressive/increasing workload , each trained up to 6 months and group C -- not trained . QoL was assessed at baseline and at 6 months by means of the Psychological General Well-being Index ( PGWB ) and the Subjective Symptoms Assessment Profile ( SSA-P ) . Cardiopulmonary exercise test and echocardiography were performed twice . RESULTS At 6 months improvement in PGWB total index was observed , both in groups A and B ( p<0.01 ) . Men from groups A and B reported less cardiac symptoms ( p<0.01 ) , emotional distress ( p<0.01 ) , peripheral circulatory symptoms ( p<0.01 ) and dizziness ( p<0.01 ) in SSA-P. Improvement in sexual life was observed only in group B ( p<0.01 ) . Overall improvement of QoL was greater in group B than in group A as well as oxygen uptake ( p<0.01 ) . Higher QoL correlated positively with peak VO2 only in group B ( r=0.56 , p<0.05 ) . CONCLUSIONS Physical training improves QoL in men with CHF , but only progressive/increasing workload seems to markedly improve oxygen uptake . Improvement of QoL is related to psychological well-being and physical complaints associated with CHF Background Heart rate recovery ( HRR1 ) immediately after exercise reflects parasympathetic activity , which is markedly attenuated in chronic heart failure ( CHF ) patients . The aim of our study was to examine both continuous and interval exercise training effects on HRR1 in these patients . Design The population study consisted of 29 stable CHF patients that participated at a rehabilitation program of 36 sessions , three times per week . Of the 29 patients , 24 completed the program . Patients were r and omly assigned to interval { n = 10 [ 100 % peak work rate ( WRp ) for 30 s , alternating with rest for 30 s ] } and to continuous training [ n = 14 ( 50%WRp ) ] . Methods All patients performed a symptom-limited cardiopulmonary exercise test on a cycle ergometer before and after the completion of the program . Measurements included peak oxygen uptake ( VO2p ) , anaerobic threshold ( AT ) , WRp , first degree slope of VO2 during the first minute of recovery ( VO2/t-slope ) , chronotropic response [ % chronotropic reserve ( CR ) = ( peak HR - resting HR ) × 100/(220 - age - resting HR ) ] , HRR1 ( HR difference from peak exercise to one minute after ) . Results After the completion of the rehabilitation program there was a significant increase of WRp , VO2p , AT and VO2/t-slope ( by 30 % , P=0.01 ; 6 % , P=0.01 ; 10 % , P=0.02 ; and 27 % , P=0.03 respectively for continuous training and by 21 % , P≤0.05 ; 8 % , P=0.01 ; 6 % , P = NS ; and 48 % , P=0.02 respectively for interval training ) . However , only patients exercised under the continuous training regime had a significant increase in HRR1 ( 15.0±9.0 to 24.0±12bpm ; P=0.02 ) and CR ( 57±19 to 72±21 % , P=0.02 ) , in contrast with those assigned to interval training ( HRR1 : 21 ± 11 to 21 ± 8 bpm ; P = NS and CR : 57 ± 18 to 59 ± 21 % , P = NS ) . Conclusions Both continuous and interval exercise training program improves exercise capacity in CHF patients . However , continuous rather than interval exercise training improves early HRR1 , a marker of parasympathetic activity , suggesting a greater contribution to the autonomic nervous system AIMS Hydrotherapy , i.e. exercise in warm water , as a rehabilitation program has been considered potentially dangerous in patients with chronic heart failure ( CHF ) due to the increased venous return caused by the hydrostatic pressure . However , hydrotherapy has advantages compared to conventional training . We studied the applicability of an exercise programme in a temperature-controlled swimming pool , with specific reference to exercise capacity , muscle function , quality of life and safety . METHODS AND RESULTS Twenty-five patients with CHF ( NYHA II-III , age 72.1+/-6.1 ) were r and omised into either 8 weeks of hydrotherapy ( n=15 ) , or into a control group ( n=10 ) . The training program was well tolerated with no adverse events . Patients in the hydrotherapy group improved their maximal exercise capacity ( + 6.5 vs.-5.9 W , P=0.001 ) , isometric endurance in knee extension ( + 4 vs.-9 s , P=0.01 ) together with an improvement in the performance of heel-lift ( + 4 vs. -3 n.o . , P=<0.01 ) , shoulder abduction ( + 12 vs. -8 s , P=0.01 ) and shoulder flexion ( + 6 vs. + 4 , P=0.01 ) in comparison to patients in the control group . CONCLUSION Physical training in warm water was well tolerated and seems to improve exercise capacity as well as muscle function in small muscle groups in patients with CHF . This new approach broadens the variety of training regimes for older patients with CHF BACKGROUND Heart failure , a condition predominantly affecting the elderly , represents an ever-increasing clinical and financial burden for the NHS . Cardiac rehabilitation , a service that incorporates patient education , exercise training and lifestyle modification , requires further evaluation in heart failure management . AIM The aim of this study was to determine whether a cardiac rehabilitation programme improved on the outcomes of an outpatient heart failure clinic ( st and ard care ) for patients , over 60 years of age , with chronic heart failure . METHODS Two hundred patients ( 60 - 89 years , 66 % male ) with New York Heart Association ( NYHA ) II or III heart failure confirmed by echocardiography were r and omised . Both st and ard care and experimental groups attended clinic with a cardiologist and specialist nurse every 8 weeks . Interventions included exercise prescription , education , dietetics , occupational therapy and psychosocial counselling . The main outcome measures were functional status ( NYHA , 6-min walk ) , health-related quality of life ( MLHF and EuroQol ) and hospital admissions . RESULTS There were significant improvements in MLHF and EuroQol scores , NYHA classification and 6-min walking distance ( meters ) at 24 weeks between the groups ( p<0.001 ) . The experimental group had fewer admissions ( 11 vs. 33 , p<0.01 ) and spent fewer days in hospital ( 41 vs. 187 , p<0.001 ) . CONCLUSIONS Cardiac rehabilitation , already widely established in the UK , offers an effective model of care for older patients with heart failure AIMS Patients with chronic heart failure ( CHF ) exhibit detrimental changes in skeletal muscle that contribute to their impaired physical performance . This study investigates the possibility of counteracting these changes by chronic low-frequency electrical stimulation ( CLFS ) of left and right thigh muscles . METHODS AND RESULTS ( mean+/-SD ) 32 CHF patients ( 53+/-10 years ) with an LVEF of 22+/-5 % , NYHA II-IV , undergoing optimized drug therapy , were r and omized in a CLFS group ( CLFSG ) or a control group ( controls ) . The groups differed in terms of the intensity of stimulation , which elicited strong muscle contractions only in the CLFSG , whereas the controls received current input up to the sensory threshold without muscle contractions . Functional capacity was assessed by peak VO(2 ) , work capacity , and a 6-min-walk ( 6-MW ) . Muscle biopsies were analyzed for myosin heavy chain ( MHC ) isoforms , citrate synthase ( CS ) and glyceraldehydephosphate dehydrogenase ( GAPDH ) activities . Peak VO(2)(mlmin(-1)kg -1 ) increased from 9.6+/-3.5 to 11.6+/-2.8 ( P<0.001 ) in the CLFSG , and decreased from 10.6+/-2.8 to 9.4+/-3.2 ( P<0.05 ) in the controls . The increase in the CLFSG was paralleled by increases in maximal workload ( P<0.05 ) and oxygen uptake at the anaerobic threshold ( P<0.01 ) . The corresponding values of the controls were unchanged , as also the 6-MW values , the MHC isoform distribution , and both CS and GAPDH activities . In the CLFSG , the 6-MW values increased ( P<0.001 ) , CS activity was elevated ( P<0.05 ) , GAPDH activity decreased ( P<0.01 ) , and the MHC isoforms were shifted in the slow direction with increases in MHCI at the expense of MHCIId/x ( P<0.01 ) . CONCLUSIONS Our results suggest that CLFS is a suitable treatment to counteract detrimental changes in skelet \n Output:\n " }, { "from": "agent", "value": "Study findings suggest that the favorable physiological responses to exercise might slow some of the pathophysiological progression of HF ." } ]