Adam Nishimura|Jantey Carey|Patricia J. Erwin|Jon C. Tilburt|M. Hassan Murad|Jennifer B. McCormick
Improving understanding in the research informed consent process: a systematic review of 54 interventions tested in randomized control trials
University of Washington|Mayo Clinic|Mayo Clinic|Mayo Clinic|Mayo Clinic|Mayo Clinic
obtaining informed consent cornerstone biomedical research yet participants comprehension presented information often low effective interventions improve understanding rates identifiedto systematically analyze random controlled trials testing interventions research informed consent process primary outcome interest quantitative rates participant understanding secondary outcomes rates information retention satisfaction accrual interventional categories included multimedia enhanced consent documents extended discussions testfeedback quizzes miscellaneous methodsthe search spanned database inception september 2010 run ovid medline ovid embase ovid cinahl ovid psycinfo cochrane central isi web science scopus five reviewers working independently duplicate screened full abstract text determine eligibility included rcts 39 1523 articles fulfilled review criteria 26 total 54 interventions data extraction form created distiller online reference management system iterative process one author collected data study design population demographics intervention analytical techniquemetaanalysis possible 22 interventions multimedia enhanced form extended discussion categories 54 interventions assessed review metaanalysis multimedia approaches associated nonsignificant increase understanding scores smd 030 95 ci 023 084 enhanced consent form significant increase smd 173 95 ci 099 247 extended discussion significant increase smd 053 95 ci 021 084 review 31 multimedia interventions showed significant improvement understanding 41 enhanced consent form 50 extended discussion 33 testfeedback 29 miscellaneousmultiple sources variation existed included studies control processes presence human proctor real vs simulated protocol assessment formatsenhanced consent forms extended discussions effective improving participant understanding interventions categories negative impact participant satisfaction study accrual identification best practices studies informed consent interventions would aid future systematic comparisons