***TASK*** the task is to summarize an input biomedical literature in six sentences 
    ***INPUT*** the input is a biomedical literature 
    ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences 
    ***DOCUMENTATION*** 
    ***EXAMPLES*** 
    Input: OBJECTIVE Ethicists have debated whether patients with serious mental illness can appreciate the risks of research participation and make autonomous decisions . We compared the abilities of euthymic and manic bipolar patients to appreciate and make voluntary decisions regarding  research participation . METHODS Twenty-six subjects with mania and 25 euthymic subjects review ed hypothetical consent forms for three research studies of varying risk . We assessed subjects ' appreciation of : their diagnosis and need for treatment ; the research er 's role ; the risks of participation ; and the degree of influence of family , the treating clinician , and payment on decisions to participate . RESULTS Most subjects ( 92 % ) agreed they had bipolar disorder requiring medication treatment . Subjects were less likely to participate in riskier studies . About half of subjects erroneously believed that research ers would make decisions based solely on what would be the best care for them ( therapeutic misconception ) ; and in r and omized medication trials , they mistakenly believed they had improved chances of receiving one treatment over another . There were no differences between mood groups on these measures . Over half of subjects ( 59 % ) indicated that their mental health provider might influence them to participate in a study even when they did not want to , but most rejected a role for family in decision making . Payment was rated as having little impact on decisions to participate in research . CONCLUSION Mania does not substantially influence appreciation of research participation .  Subjects with bipolar disorder , regardless of mood state , are at risk for therapeutic misconception and optimistic bias . Special protections may be needed when mental health professionals approach their own patients to participate in research This r and omized study was design ed to assess the utility of an educational video in preparing cancer patients for decisions about clinical trial participation . The study assessed the effect of the video  on patients ' underst and ing and perceptions of clinical trials , its impact on decision making and patient‐provider communication , and patients ' satisfaction with the video BACKGROUND The informed consent of participants is ethically and legally required for most research involving human subjects . However , st and ardized methods for assessing the adequacy of informed consent to research are lacking . METHODS AND RESULTS We design ed a brief question naire , the  Quality of Informed Consent ( QuIC ) , to measure subjects ' actual ( objective ) and perceived ( subjective ) underst and ing of cancer clinical trials . The QuIC incorporates the basic elements of informed consent specified in federal regulations , assesses the therapeutic misconception ( the belief that all aspects of a clinical trial are design ed to directly benefit the subject ) , and employs the language and structure of the new National Cancer Institute template for informed consent documents . We modified the QuIC after receiving feedback from pilot tests with cancer research subjects , as well as validation from two independent expert panels . We then sent the QuIC to 287 adult cancer patients enrolled on phase I , II , or III clinical trials . Two hundred seven subjects ( 72 % ) completed the QuIC . To assess test-retest reliability , a r and om sample of 32 respondents was selected , of whom 17 ( 53 % ) completed the question naire a second time . The test-retest reliability was good with intraclass correlation coefficients of.66 for tests of objective underst and ing and .77 for tests of subjective underst and ing . The current version of the QuIC , which consists of 20 questions for objective underst and ing and 14 questions for subjective underst and ing , was tested for time and ease of administration in a sample of nine adult cancer patients . The QuIC required an average of 7.2 minutes to complete . CONCLUSIONS The QuIC is a brief , reliable , and valid question naire that holds promise as a st and ardized way to assess the outcome of the informed consent process in cancer clinical trials Background  Informed consent ( IC ) has been an international st and ard for decades for the ethical conduct of clinical trials . Yet frequently study participants have incomplete underst and ing of key issues , a problem exacerbated by language barriers or lack of familiarity with research concepts . Few investigators measure participant comprehension of IC , while even fewer conduct interim assessment s once a trial is underway . Methods and Findings We assessed comprehension of IC using a 20- question true/false quiz administered in 6-month intervals in the context of a placebo-controlled , r and omized trial for the prevention of tuberculosis among HIV-infected adults in Botswana ( 2004–2009 ) .  Quizzes were offered in both Setswana and English . To enroll in the TB trial , participants were required to have ≥16/20 correct responses  . We examined concepts understood and the degree to which underst and ing changed over three-years . We analyzed 5,555 quizzes from 1,835 participants . The participants ' highest education levels were : 28 % primary , 59 % secondary , 9 % tertiary and 7 % no formal education . Eighty percent of participants passed the enrollment quiz  ( Quiz1 ) on their first attempt and the remainder passed on their second attempt . Those having higher than primary education and those who took the quiz in English were more likely to receive a passing score on their first attempt ( adjusted odds ratios and 95 % confidence intervals , 3.1 ( 2.4–4.0 ) and 1.5 ( 1.2 , 1.9 ) , respectively ) . The trial 's purpose or procedures were understood by 90–100 % of participants , while 44–77 % understood r and omization , placebos , or risks . Participants who failed Quiz1 on their initial attempt were more likely to fail quizzes later in the trial . Pass rates improved with quiz re-administration in subsequent years . Conclusions Administration of a comprehension quiz at enrollment and during follow-up was feasible in a large , international collaboration and efficiently determined IC comprehension by trial participants . Strategies to improve underst and ing of concepts like placebos and r and omization are needed . Comprehension assessment s throughout a study may reinforce key concepts This pilot study examined knowledge , underst and ing and perceived acceptability of key method ological concepts in clinical trials among injecting drug users ( IDUs ) in Sydney , Australia . Participants were clinical trial-experienced ( n = 17 ) and trial-naïve ( n = 99 ) IDUs recruited from community needle and syringe programs , and through institutions involved in clinical trials with IDU participants . Cross-sectional data were collected via a study -specific interviewer-administered survey . Following detailed verbal explanations , higher proportions of trial-experienced than trial-naïve participants demonstrated an underst and ing of all clinical trial concepts assessed , including  single blinding ( 94 % versus 60 % ) ; placebo ( 94 % versus 49 % ) ; equipoise ( 71 % versus 60 % ) ; comparison ( 59 % versus 46 % ) ; r and omisation ( 59 % versus 21 % ) ; and double blinding ( 47 % versus 3 % ) . Multivariate analyses indicated a better underst and ing among trial-experienced participants . Participants who demonstrated an underst and ing of  ' placebo '  and  ' double blinding ' were significantly more likely to perceive these concepts to be acceptable than those who did not . Results indicate the need for targeted education programs that adequately inform IDUs about clinical trial concepts prior to recruitment to a clinical trial , and support adaptations of informed consent procedures to ensure trial participants ' comprehensive underst and ing of method ologies and their implication Enrollment of an adequate number of subjects for a clinical trial is a perennial challenge and this might arguably be even more difficult and complex in trials involving patients with schizophrenia . In this paper , we used a modification of the Prospect i ve Preference Approach ( PPA ) as a prelude to an actual r and omized placebo-controlled trial of a cognitive-enhancing agent for patients with schizophrenia . This approach sought to test and enhance subjects ' underst and ing of the key concepts of the trial , and administered the PPA at baseline and following a brief educational module . The motivations and concerns regarding potential participation in the proposed trial were also elicited by the PPA . Of one hundred ninety patients with schizophrenia recruited for this PPA study , only 12 ( 6.3 % ) were assessed to have understood all key trial-related concepts after the initial explanation and baseline PPA administration ( prior to the educational module ) . Following the education module , however , there was significant increase in the number of patients who understood all key trial elements . Younger age and higher level of education were significant factors associated with better underst and ing of the proposed trial . The main reasons cited for wishing to participate in clinical trials were personal medical benefits and altruistic desire to help others . Concerns regarding the safety of the trial medication were expressed in over 80 % of the subjects . PPA administration with educational module supplementation may provide a valuable addition to clinical trial procedures in patients with schizophrenia Patient satisfaction measures have previously addressed satisfaction with medical care , satisfaction with providers , and satisfaction with outcomes , but not satisfaction with the health care decision itself . As patients become more involved in health care decisions , it is important to underst and specific dynamics of the decision itself The  Satisfaction with Decision ( SWD ) scale  measures satisfaction with health care decisions . It was developed in the context of postmenopausal hormone-replacement therapy decisions The six-item scale has excellent reliability ( Cronbach 's alpha = 0.86 ) . Discriminant validity , tested by performing principal- components analysis of items pooled from the SWD scale and two conceptually related measures , was good . Correlation of the  SWD scale  with measures of satisfaction with other aspects of the decision-making process showed the  SWD scale  was correlated most highly ( 0.64 ) with " decisional confidence , " and least with " desire to participate in health care de cisions " and " satisfaction with provider " The  SWD  scale predicts decision certainty in this study . Use in an independent study showed that the  SWD scale  was correlated with the likelihood of patients ' intentions to get a flu shot . Further investigation in relation to other health decisions will establish the utility of the  SWD scale  as an outcome measure Key words : patient satisfaction ; medical decision making ; decision support ( Med Decis Making 1996;16:58 - 64 PURPOSE To examine both the use of the consent document during the informed consent process for pediatric leukemia clinical trials , as well as relationships between the use of the document and parental underst and ing of essential elements of informed consent . METHODS Participants included 140 parents of children diagnosed with pediatric leukemia . Informed consent conferences in which r and omized clinical trials were discussed were observed , audiotaped , and coded for specific behaviors . Parents were also interviewed within 48 h of their participation in informed consent conferences . RESULTS Observations revealed that 74 % of cases included explanation of consent documents during consent conferences . Parents who reported that they read the consent document were more likely to underst and differences between the clinical trial and off study therapy and were more likely to underst and the right to withdraw . Reading of the consent document was not associated with underst and ing of voluntariness . In comparison to racial/ethnic majority parents , racial/ethnic minority parents were less likely to report that they read the consent document , underst and voluntariness or the right to withdraw , and were less likely to be able to distinguish between the clinical trial and off study therapy . Low SES was associated with a lower probability of reading the consent document and being able to distinguish between clinical trials and off study therapy . CONCLUSIONS Attention to the importance of reading the consent document and improving communication during consent conferences is likely to enhance underst and ing of essential elements of informed consent Objectives : To explore how subjects in a placebo-controlled vitamin A supplementation trial among Ghanaian women aged 15–45 years perceive the trial and whether they know that not all trial capsules are the same , and to identify factors associated with this knowledge . Methods : 60  semistructured interviews and 12 focus groups were conducted to explore subjects ’ perceptions of the trial . Steps were taken to address areas of low comprehension , including retraining fieldworkers . 1971 trial subjects were r and omly selected for a survey measuring their knowledge that not all trial capsules are the same . The subjects ’ fieldworkers were also interviewed about their characteristics and trial knowledge . Factors associated with knowledge were explored using multi-level modeling . Results : Although subjects knew they were taking part in research , most thought they were receiving an active and beneficial medication . Variables associated with knowledge were education and district of residence . Radio broadcasts benefited those with some schooling . Fieldworkers ’ characteristics were not associated with subjects ’ knowledge . Conclusions : Research and debate on new or improved consent procedures are urgently required , particularly for subjects with little education BACKGROUND Consent to participate in research is an important component of the conduct of ethical clinical trials . Current consent practice s are largely policy-driven . This study was conducted to assess comprehension of study information and satisfaction with the consent form between subjects r and omized to concise or to st and ard informed consent forms as one approach to developing evidence -based consent practice s. METHODS Participants ( N=111 ) who enrolled into two Phase I investigational influenza vaccine protocol s ( VRC 306 and VRC 307 ) at the NIH Clinical Center were r and omized to one of two IRB-approved consents ; either a st and ard or concise form . Concise consents had an average of 63 % fewer words . All other aspects of the consent process were the same . Question naires about the study and the consent process were completed at enrollment and at the last visit in both studies . RESULTS Subjects using concise consent forms scored as well as those using st and ard length consents in measures of comprehension ( 7 versus 7 , p=0.79 and 20 versus 21 , p=0.13 ) , however , the trend was for the concise consent group to report feeling better informed . Both groups thought the length and detail of the consent form were appropriate . CONCLUSIONS R and omization of study subjects to different length IRB-approved consent forms as one method for developing evidence -based consent practice s , result ed in no differences in study comprehension or satisfaction with the consent form . A 
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Findings indicate ( a ) inconsistent assessment of participant reading or health literacy level , ( b ) measurement variation associated with use of nonst and ardized tools , and ( c ) continued therapeutic misconception and lack of underst and ing among research participants of r and omization , placebo , benefit , and risk .