Assessing the adequacy of procedure-specific consent forms in orthopaedic surgery against current methods of operative consent. (57/133)

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The readability of information and consent forms in clinical research in France. (58/133)

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Informed consent: time for more transparency. (59/133)

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Informed consent--practical considerations. (60/133)

Informed consent is a legal document that summarizes what will take place in a study in a language the study subjects can understand and is the process by which a person decides whether or not to participate in a study. The document is not limited to explaining the intervention or potential risks and benefits but is also the source of understanding why the study is being done and what the particular study will add to what is already known. Overall, informed consent is a document providing important transparency and clarity about the study. While consent forms are mandatory prior to study approval by internal review boards, they are not published as part of study results and are not part of clinical trial registries. The central role of an informed consent document in any study could be vitally expanded and enhanced with inclusion and full disclosure of its content through clinical trial registries and published reports in the literature, bringing improved transparency to the entire clinical trial process. Transparency is important for the maintenance of high standards in clinical research and for public trust of the process, a sometimes underrecognized factor in healthcare initiatives.  (+info)

Assessing the content, presentation, and readability of dental informed consents. (61/133)

Informed consents are important aids in helping patients make optimal decisions. Little knowledge exists about the quality of dental informed consents. Fifty-two informed consents used throughout the University of Texas Health Science Center at Houston Dental Branch were evaluated based on the quality of their content, readability, and presentation. Content quality was judged on four basic elements: description of procedure, risk, benefits, and alternatives. Of the clinical consents, 26 percent of forms contained all four of the basic content elements, 48 percent contained three of four elements, 16 percent contained two of four elements, and 10 percent contained one of four elements. Presentation quality was judged on twelve criteria items. The average clinical consent included seven out of twelve presentation items, and the average nonclinical consent included eight out of twelve items. Readability was judged using three standard instruments for rating readability: Flesch Reading Ease, Flesch-Kincaid Grade-Level, and Simple Measure of Gobbledygook (SMOG) grading. Average Flesch-Kincaid Grade-Level was 12.7 (range, 7.4 to 19.1), significantly higher than the recommended ninth grade level (p<.001). The results suggest that many existing dental informed consents may be improved by 1) increasing the comprehensiveness of the content, 2) improving the design and layout, and 3) reducing the readability levels for patient comprehension.  (+info)

Simplifying informed consent for biorepositories: stakeholder perspectives. (62/133)

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Neurocognitive indicators predict results of an informed-consent quiz among substance-dependent treatment seekers entering a randomized clinical trial. (63/133)

OBJECTIVE: This study sought to determine the extent to which key aspects of a clinical trial's protocol were recalled by participants entering a clinical trial for alcohol and illicit substance-use treatment after standard informed-consent procedures, as well as to explore the possible relationships between recall, neuropsychological functioning, and substance-use outcomes. METHOD: Before entering a randomized clinical trial testing the effectiveness of a computer-based training version of cognitive-behavioral therapy, 76 participants (55% male) meeting criteria for current substance dependence (according to the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition) completed a 14-item true/false quiz that assessed their comprehension of basic information provided in the consent form. RESULTS: Only 15% of participants correctly answered all 14 consent quiz items. The percentage of correct recall was associated with measures of intelligence (r= .29, p = .01) and attention (r = -.26, p = .04). Quiz scores were also moderately associated with the amount of substance use during the treatment period (r = -.26, p = .03). CONCLUSIONS: These findings highlight the importance of formally evaluating research participants' understanding of the informed-consent process, and they call to attention the potential utility of a brief neuropsychological screening to identify individuals in need of enhanced consent procedures, particularly within vulnerable populations, such as substance users.  (+info)

The Cool Little Kids randomised controlled trial: population-level early prevention for anxiety disorders. (64/133)

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