***TASK*** the task is to summarize an input biomedical literature in six sentences 
    ***INPUT*** the input is a biomedical literature 
    ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences 
    ***DOCUMENTATION*** 
    ***EXAMPLES*** 
    Input: Objectives To determine the incremental net health benefits of dabigatran etexilate 110 mg and 150 mg twice daily and warfarin in patients with non-valvular atrial fibrillation and to estimate the cost effectiveness of dabigatran in the United Kingdom . Design Quantitative benefit-harm and economic analyses using a discrete event simulation model to extrapolate the findings of the RE-LY ( R and omized Evaluation of Long-Term Anticoagulation Therapy ) study to a lifetime horizon . Setting UK National Health Service . Population Cohorts of 50 000 simulated patients at moderate to high risk of stroke with a mean baseline CHADS2 ( Congestive heart failure , Hypertension , Age≥75 years , Diabetes mellitus , previous Stroke/transient ischaemic attack ) score of 2.1 . Main outcome measures Quality adjusted life years ( QALYs ) gained and incremental cost per QALY of dabigatran compared with warfarin . Results Compared with warfarin , low dose and high dose dabigatran were associated with positive incremental net benefits of 0.094 ( 95 % central range −0.083 to 0.267 ) and 0.146 ( −0.029 to 0.322 ) QALYs . Positive incremental net benefits result ed for high dose dabigatran in 94 % of simulations versus warfarin and in 76 % of those versus low dose dabigatran . In the economic analysis , high dose dabigatran dominated the low dose , had an incremental cost effectiveness ratio of £ 23 082 ( € 26 700 ; $ 35 800 ) per QALY gained versus warfarin , and was more cost effective in patients with a baseline CHADS2 score of 3 or above . However , at centres that achieved good control of international normalised ratio , such as those in the UK , dabigatran 150 mg was not cost effective , at £ 42 386 per QALY gained . Conclusions This analysis supports regulatory decisions that dabigatran offers a positive benefit to harm ratio when compared with warfarin . However , no subgroup for which dabigatran 110 mg offered any clinical or economic advantage over 150 mg was identified . High dose dabigatran will be cost effective only for patients at increased risk of stroke or for whom international normalised ratio is likely to be less well controlled OBJECTIVE To assess and compare the quality of nonstructured and structured abstract s  of original research articles in three medical journals . DESIGN Blind , criterion-based observational study . SAMPLE R and om sample of 300 abstract s ( 25 abstract s per journal each year ) of articles published in the British Medical Journal ( BMJ ) , the Canadian Medical Association Journal and the Journal of the American Medical Association ( JAMA ) in 1988 and 1989 ( nonstructured abstract s )  and in 1991 and 1992  ( structured abstract s ) . MAIN OUTCOME MEASURES The quality of abstract s  was measured against 33 objective criteria , which were divided into eight categories ( purpose , research design , setting , subjects , intervention , measurement of variables , results and conclusions ) . The quality score was determined by dividing the number of criteria present by the number applicable ; the score varied from 0 to 1 . RESULTS The overall mean quality scores for nonstructured and structured abstract s were 0.57 and 0.74 respectively ( p < 0.001 ) . The frequency in meeting the specific criteria was generally higher for the structured abstract s than for the nonstructured ones . The mean quality score was higher for nonstructured abstract s in JAMA than for those in BMJ ( 0.60 v. 0.54 , p < 0.05 ) . The scores for structured abstract s  did not differ significantly between the three journals . CONCLUSIONS The findings support recommendations that promote the use of structured abstract s. Further studies should be performed to assess the effect of time on the quality of abstract s and the extent to which abstract s reflect the content of the articles Abstract Objective To compare the distribution of P values in abstract s of r and omised controlled trials with that in observational studies , and to check P values between 0.04 and 0.06 . Design Cross sectional study of all 260 abstract s in PubMed of articles published in 2003 that contained “ relative risk ” or “ odds ratio ” and reported results from a r and omised trial , and r and om sample s of 130 abstract s from cohort studies and 130 from case-control studies . P values were noted or calculated if unreported . Main outcome measures Prevalence of significant P values in abstract s and distribution of P values between 0.04 and 0.06 . Results The first result in the abstract was statistically significant in 70 % of the trials , 84 % of cohort studies , and 84 % of case-control studies . Although many of these results were derived from subgroup or secondary analyses , or biased selection of results , they were presented without reservations in 98 % of the trials . P values were more extreme in observational studies ( P < 0.001 ) and in cohort studies than in case-control studies ( P = 0.04 ) . The distribution of P values around P = 0.05 was extremely skewed . Only five trials had 0.05 ≤ P < 0.06 , whereas 29 trials had 0.04 ≤ P < 0.05 . I could check the calculations for 27 of these trials . One of four non-significant results was significant . Four of the 23 significant results were wrong , five were doubtful , and four could be discussed . Nine cohort studies and eight case-control studies reported P values between 0.04 and 0.06 , but in all 17 cases P < 0.05 . Because the analyses had been adjusted for confounders , these results could not be checked . Conclusions Significant results in abstract s are common but should generally be disbelieved CONTEXT The section of a research article most likely to be read is the abstract , and therefore it is particularly important that the abstract reflect the article faithfully . OBJECTIVE To assess abstract s accompanying research articles published in 6 medical journals with respect to whether data in the abstract could be verified in the article itself . DESIGN Analysis of simple r and om sample s of 44 articles and their accompanying abstract s published during 1 year(July 1 , 1996-June 30 , 1997 ) in each of 5 major general medical journals ( Annals of Internal Medicine , BMJ , JAMA , Lancet , and New Engl and Journal of Medicine ) and a consecutive sample of 44 articles published during 15 months ( July 1 , 1996-August 15 , 1997 ) in the CMAJ . MAIN OUTCOME MEASURE Abstract s were considered deficient if they contained data that were either inconsistent with corresponding data in the article 's body ( including tables and figures ) or not found in the body at all . RESULTS The proportion of deficient abstract s varied widely ( 18%-68 % ) and to a statistically significant degree ( P<.001 ) among the 6 journals studied . CONCLUSIONS Data in the abstract that are inconsistent with or absent from the article 's body are common , even in large-circulation general medical journals Objectives To evaluate the cost effectiveness of 40 mg simvastatin daily continued for life in people of different ages with differing risks of vascular disease . Design A model developed from a r and omised trial was used to estimate lifetime risks of vascular events and costs of treatment and hospital admissions in the United Kingdom . Setting 69 hospitals in the UK . Participants 20 536 men and women ( aged 40 - 80 ) with coronary disease , other occlusive arterial disease , or diabetes . Interventions 40 mg simvastatin daily versus placebo for an average of 5 years . Main outcome measures Cost effectiveness of 40 mg simvastatin daily expressed as additional cost per life year gained . Major vascular event defined as non-fatal myocardial infa rct ion or death from coronary disease , any stroke , or revascularisation procedure . Results were extrapolated to younger and older age groups at lower risk of vascular disease than were studied directly , as well as to lifetime treatment . Results At the April 2005 UK price of � 4.87 ( € 7 ; $ 9 ) per 28 day pack of generic 40 mg simvastatin , lifetime treatment was cost saving in most age groups and vascular disease risk groups studied directly . Gains in life expectancy and cost savings decreased with increasing age and with decreasing risk of vascular disease . People aged 40 - 49 with 5 year risks of major vascular events of 42 % and 12 % at start of treatment gained 2.49 and 1.67 life years , respectively . Treatment with statins  remained cost saving or cost less than � 2500 per life year gained in people as young as 35 years or as old as 85 with 5 year risks of a major vascular event as low as 5 % at the start of treatment . Conclusions Treatment with statins  is cost effective in a wider population than is routinely treated at present BACKGROUND Baseline data collected on each patient at r and omisation in controlled clinical trials can be used to describe the population of patients , to assess comparability of treatment groups , to achieve balanced r and omisation , to adjust treatment comparisons for prognostic factors , and to undertake subgroup analyses . We assessed the extent and quality of such practice s in major clinical trial reports . METHODS A sample of 50 consecutive clinical -trial reports was obtained from four major medical journals during July to September , 1997 . We tabulated the detailed information on uses of baseline data by use of a st and ard form . FINDINGS Most trials presented baseline comparability in a table . These tables were often unduly large , and about half the trials inappropriately used significance tests for baseline comparison . Methods of r and omisation , including possible stratification , were often poorly described . There was little consistency over whether to use covariate adjustment and the criteria for selecting baseline factors for which to adjust were often unclear . Most trials emphasised the simple unadjusted results and covariate adjustment usually made negligible difference . Two-thirds of the reports presented subgroup findings , but mostly without appropriate statistical tests for interaction . Many reports put too much emphasis on subgroup analyses that commonly lacked statistical power . INTERPRETATION Clinical trials need a predefined statistical analysis plan for uses of baseline data , especially covariate-adjusted analyses and subgroup analyses . Investigators and journals need to adopt improved st and ards of statistical reporting , and exercise caution when drawing conclusions from subgroup findings Background Recent r and omised trials have demonstrated a statistically significant effect of trastuzumab on disease-free survival when used as adjuvant therapy for human epidermal growth factor receptor 2 protein (HER2)-positive resectable early stage breast cancer , with a treatment course lasting either 9 or 52 weeks . However , the cost effectiveness of adjuvant trastuzumab with respect to mortality remains uncertain , especially in an Australian setting . Objective To estimate the cost effectiveness of trastuzumab in Australia , in a cohort of 50-year-old patients with HER2-positive breast cancer over a lifetime , using ( i ) disease-free survival and cardiotoxicity data from recent r and omised trials ; ( ii ) information on long-term survival of patients with treated primary breast cancer ; and ( iii ) costs of treating local and distant relapses and disease from causes other than breast cancer . Methods A Markov model consisting of four health states ( remission , loco-regional recurrence , metastatic disease and death ) was developed . Transition probabilities corresponded to patterns of relapse and metastases seen in recent trials . The model was run until age 100 years to allow calculation of average survival . Outcome measures were life-years and QALYs ( calculated using utility weights reported in the literature ) .The model was calibrated to reflect literature evidence that the risk of breast cancer recurrence following primary treatment diminishes progressively to zero after about 20 years . It was assumed that the morbidity benefit of trastuzumab observed in trials would be present for 5 years but would then diminish progressively to zero after 8 years . Costs ( year 2005 values ) and benefits were discounted at 3 % per annum . Results For every 1000 patients treated with a 52-week course of trastuzumab , there were 136 fewer breast cancer deaths ( relative risk reduction 28 % ) . The incremental cost-effectiveness ratios ( ICERs ) were Australian dollars ($A)13 730 per year of life saved ( YOLS ) and $ A22 793 per QALY . The net incremental cost was $ A56.3 million ( $ A414 012/cancer death avoided ) . Cost effectiveness declined ( ICER = $ A27 734/QALY ) in older patients ( age 65 years at treatment initiation).The ICER was driven mainly by the drug acquisition costs , the assumption of the duration of benefit and the discount rate . Cost offsets from reduced costs of treating recurrent or metastatic breast cancer during follow-up were present but these factors were of less importance according to sensitivity analyses . The 9-week treatment schedule approached economic dominance ( ICER = $ A1700/QALY ) because of decreased costs , improved relative risk for prevention of metastases and more cancer deaths avoided ( 196 ) . Conclusion The results suggest that trastuzumab as adjuvant therapy for early breast cancer may be cost effective when given over either 52 or 9 weeks at current acquisition costs in Australia . However , the overall budget impact of the 52-week course is significant , and the 9-week course appears economically attractive The CONSORT ( Consoli date d St and ards of Reporting Trials ) statement is used worldwide to improve the reporting of r and omized , controlled trials . Schulz and colleagues describe the latest version , CONSORT 2010 , which up date s 
    Output:
    
We hope that the ISPOR CHEERS statement and the accompanying task force report guidance will lead to more consistent and transparent reporting , and ultimately , better health decisions .