***TASK*** the task is to summarize an input biomedical literature in six sentences 
    ***INPUT*** the input is a biomedical literature 
    ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences 
    ***DOCUMENTATION*** 
    ***EXAMPLES*** 
    Input: We investigated whether a short course in communication skills for physicians would improve the quality of informed consent in a r and omized clinical adjuvant trial on breast cancer . In this prospect i ve , case-controlled intervention study , physicians and research nurses who introduced the cancer treatment trial to patients at three of the participating hospitals first attended a one-day communication skills course . The quality of informed consent was then evaluated by addressing a st and ardized question naire , QuIC , to trial patients at the three intervention hospitals and at control hospitals . Response rate was 90.0 % ( n = 288 ) . Of the patients treated by the intervention group , 73 % were very satisfied with the information received compared with 56 % of those of the control group ( p = 0.003 ) . The patients of the intervention group considered the time given for making their decision sufficient more often than those of the controls ( 98 % vs. 90 % , p=0.004 ) . The patients of the intervention group recalled more often than those of the controls that the physician had also offered other therapeutic options than the trial treatment ( 91 % vs. 97 % , p=0.032 ) . They also understood the main aim of the study better than the patients of the controls ( 89 % vs. 78 % , p=0.030 ) . In conclusion , a short communication skills course for the trial physicians and nurses improved the quality of informed consent and patient satisfaction in the trial OBJECTIVES : To study whether linguistic analysis and changes in information leaflets can improve readability and underst and ing . DESIGN : R and omised , controlled study . Two information leaflets concerned with trials of drugs for conditions/diseases which are commonly known were modified , and the original was tested against the revised version . SETTING : Denmark . PARTICIPANTS : 235 persons in the relevant age groups . MAIN MEASURES : Readability and underst and ing of contents . RESULTS : Both readability and underst and ing of contents was improved : readability with regard to both information leaflets and underst and ing with regard to one of the leaflets . CONCLUSION : The results show that both readability and underst and ing can be improved by increased attention to the linguistic features of the information AIMS International guidelines on ethics in biomedical research require that the informed consent of all enrolled participants is obtained . A written document describing the research , the informed consent ( IC ) document , must be given to all participants by the investigator . Most IC documents are long , containing much information . The aim of the present study was to determine whether the modification of the IC document by a working group or systematic improvement in its lexicosyntactic readability can improve comprehension of the written information given to patients participating in biomedical research . METHODS One hundred and fifty-nine patients were r and omized to read one of the three versions of the IC document : unchanged document , document modified using systematic improvement of lexicosyntactic readability and document modified by a working group . RESULTS Neither the improvement in the lexicosyntactic readability , nor the intervention of the working group significantly improved the score of objective comprehension for the subjects included in this study : it was 66.6 ( 95 % confidence interval 64.0 , 69.2 ) for the control group , 68.8 ( 66.2 , 71.4 ) for the group with the document improved for lexicosyntactic readability and 69.2 ( 66.0 , 72.4 ) for the group who read the document improved by the working group ( P= 0.38 ) . CONCLUSIONS We failed to show that improving IC document comprehension through a lexicosyntactic approach or by a working group leads to better comprehension Background Studies on different methods to supplement the traditional informed consent process have generated conflicting results . This study was design ed to evaluate whether participants who received group counseling prior to administration of informed consent understood the key components of the study and the consent better than those who received individual counseling , based on the hypothesis that group counseling would foster discussion among potential participants and enhance their underst and ing of the informed consent . Methods Parents of children participating in a trial of nutritional supplementation were r and omized to receive either  group counseling or individual counseling prior to administration of the informed consent . To assess the participant 's comprehension , a structured question naire was administered approximately 48 - 72 hours afterwards by interviewers who were blinded to the allocation group of the respondents . Results A total of 128 parents were recruited and follow up was established with 118 ( 90.2 % ) for the study . All respondents were aware of their child 's participation in a research study and the details of sample collection . However , their underst and ing of study purpose , r and omization and withdrawal was poor . There was no difference in comprehension of key elements of the informed consent between the intervention and control arm . Conclusions The results suggest that the group counseling might not influence the overall comprehension of the informed consent process . Further research is required to devise better ways of improving participants ' underst and ing of r and omization in clinical trials . Trial Registration Clinical Trial Registry - India ( CTRI ) : To determine subjects ' perception of the purpose of informed consent , 113 subjects were recruited from a dose-controlled clinical trial of didanosine ( ddI ) . Subjects were surveyed regarding how they made decisions regarding their medical care in general , about how they obtained information about this trial in particular , and several aspects of the informed consent procedure . Subjects were then r and omly allocated to receive information about the trial by either a written only format or a written and verbal format 1 week before commencement of the trial . An eight-item instrument assessed knowledge of ddI prior to and subsequent to receiving information . Most subjects obtained information about HIV-related issues from their specialist ( 70 % ) or general ( 51 % ) medical practitioner . A large proportion of subjects ( 88 % ) reported that they believed their specialist medical practitioner always acted in their best interest . The majority of subjects ( 79 % ) believed that subjects should be allowed the choice between participating in the clinical trial and receiving the drug outside the trial mechanism . Of the subjects , 96 % believed that informed consent was necessary in clinical trials ; however , their opinions of the purpose of informed consent varied widely . Although they signed the informed consent , 44 % of the subjects stated that they did not underst and ' all ' of the information that was provided . We found that the provision of information by written mode alone , or written and verbal modes were both associated with significant increases in knowledge levels and that there was a significant interaction in the degree of change between the two methods , with the written plus verbal method showing the most improvement over time . There was an interaction between degree of improvement in knowledge of didanosine in subjects who received written information versus those who received written and verbal knowledge and time ( pre- versus post-consent ) and a significant main effect for time . All subjects were relatively well-informed about the drug and stated that specialist and general medical practitioners were their major source of knowledge for all aspects of their HIV health care Obtaining informed consent for clinical investigations represents a major legal , ethical , and moral consideration in human experimentation . Mechanisms for informing the patient vary widely , and usually no system exists to confirm the degree of information retained by the patient . A Veterans Administration Cooperative Study , begun in 1975 , has used a videotape information package in addition to a st and ard written consent form to ensure uniformity . Each presentation was followed by a question naire to assess the amount of material learned before attempting r and omization . Repeated showings were occasionally necessary and did not affect the rate of r and omization . A videotape presentation , especially in cooperative studies , ensures uniformity , makes allowance for varying educational levels of patients , and provides documentation of the degree of informed consent IN THE EARLY 1890S , DR WILLIAM HALSTED DEVELOPED radical mastectomy for breast cancer . Surgeons performed the Halsted procedure for more than 80 years even though there was little systematic evidence for its success . Then a new breed of scholars subjected the procedure to formal methods of evaluation unknown to Halsted . The methods —r and omized controlled trials ( RCTs ) principal among them — led to a surprise : radical mastectomy had no advantage over simpler forms of treatment . This is but 1 example of the hard-won victory of evidence over belief in medicine . The pioneers of the formal evaluation of medical practice s raised questions that traditional practitioners did not welcome . But in time , formal evaluation prevailed . The pioneers developed a hierarchy of evidentiary rigor relating the design of a study to the confidence that could be placed in the findings , from the lowly , nearly valueless anecdote to the royalty of evidence , the RCT . Concurrently , a similar story of hard-won learning unfolded in the so-called quality movement . Scholars illuminated the scale and types of defects in the processes of care and the outcomes , including high rates of unscientific care , inappropriate care , geographic variations in practice , latent disagreements among specialists , and oftenunrecognized medical injury to patients . Like the pioneers of evidence -based medicine , students of medical quality were at first largely ignored , but no longer . In 1999 and 2001 , the Institute of Medicine published 2 l and mark reports on the evidence for quality failures and called urgently for re design of care systems to achieve improvements . The story could end here happily with 2 great streams of endeavor merging into a framework for conjoint action : improving clinical evidence and improving the process of care . Instead , the 2 endeavors are often in unhappy tension . Neither disputes that progress toward health care ’s main goal , the relief of illness and pain , requires research of many kinds : basic , clinical , systems , epidemiologic . The disagreement centers on epistemology — ways to get at “ truth ” and how those ways should vary depending on the knowledge sought . Individuals most involved in day-to-day improvement work fear that if “ evidence ” is too narrowly defined and the approach to gathering evidence too severely constrained , progress may be the victim . For example , the RCT is a powerful , perhaps unequaled , research design to explore the efficacy of conceptually neat components of clinical practice —tests , drugs , and procedures . For other crucially important learning purpose s , however , it serves less well . Recent controversies about the evaluation of rapid response  teams  provide a case in point . These controversies show the importance of adjusting research methods to fit research questions . Although only 10 % to 15 % of in patients resuscitated outside intensive care units survive to hospital discharge , early warning signs are present in a large percentage of patients who ultimately experience cardiac arrest .  Rapid response team systems bring expert clinicians to the bedsides of deteriorating patients before arrest occurs . In the mid 1990s , based largely on reports from Australian investigators , the Institute for Healthcare Improvement and others began introducing the concept to willing hospitals . Local experience strongly suggested that these systems often , although not always , were associated with improved outcomes , including reduced anxiety among nursing staff ; increased interdisciplinary teamwork ; decreased cardiac arrests outside of intensive care units ; and , in some cases , declines in mortality . The evidence base took a turn in June 2005 with the publication of the Medical Early Response Intervention and Therapy ( MERIT ) Study , a cluster r and omized prospect i ve trial that cl aim ed to find no beneficial effect of these teams on several primary outcomes . Controversy has continued since then regarding the scientific evidence for rapid response systems . In fact , the MERIT trial was not negative ; it was inconclusive . The study team encountered an array of serious problems in execution , common in social science . For example , although the study ’s power calculation assumed a baseline rate of 30 events per 1000 admissions , the actual rate proved to be fewer than 7 events per 1000 admissions ; thus , the study was ef fect ively underpowered by 500 % . Crosscontamination abounded ; some control hospitals implemented rapid response protocol s , and several study Recruitment to cancer clinical trials needs to be improved , as does patient knowledge and underst and ing about clinical trials , in order for patients to make an informed choice about whether or not to take part . Audiovisual patient information ( AVPI ) has been shown to improve knowledge and underst and ing in various areas of practice , but there is limited information about its effect in the cancer clinical trial setting , particularly in relation to consent rates . In this study , 173 patients were r and omised to receive either the AVPI , in addition to the st and ard trial-specific written information , or the written information alone . There was no difference in clinical trial recruitment rates between the two groups with similar study entry rates : 72.1 % in the AVPI group and 75.9 % in the st and ard information group . The estimated odds ratio for refusal ( intervention/no intervention ) was 1.19 ( 95 % CI 0.55–2.58 , P=0.661 ) . Knowledge scores increased more in the AVPI group compared to the st and ard group ( P=0.0072 ) . The change in anxiety score between the arms was also statistically significant ( P=0.011 ) with anxiety improving in the intervention arm more than in the no intervention arm . Audiovisual patient information was shown to be a useful tool in improving patient knowledge and anxiety , but further work is necessary in relation to its effect on clinical trial recruitment rates Procedures must be developed to ensure that valid informed consent is obtained from participants in HIV vaccine efficacy trials . A prototype informed consent process was evaluated among 4,892 persons at high risk for HIV infection in the HIV Network for Prevention Trials Vaccine Preparedness Study ( VPS ) , a prospect i ve cohort study of HIV seroincidence in eight U.S. metropolitan areas . Twenty percent of VPS participants were selected at r and om to undergo the prototype informed consent process at VPS month 3 . Participants ' knowledge of 10 key HIV vaccine trial concepts and willingness to participate in HIV vaccine efficacy trials were assessed and compared at baseline and semiannually thereafter for 18 months . Knowledge of HIV vaccine trial concepts was low at baseline . Participation in the prototype process was associated with substantial and sustained increases in knowledge ( relative risks for the 10 items , 1.04–2.26 ) , which were of similar magnitude across HIV risk groups , race/ethnicity , and educational levels . It is recommended that the prototype informed consent process be adopted for future HIV vaccine 
    Output:
    
Conclusions Enhanced consent forms and extended discussion s were most effective in improving participant underst and ing .
Interventions of all categories had no negative impact on participant satisfaction or study accrual .