Yael Schenker|Alicia Fernández|Rebecca L. Sudore|Dean Schillinger
Interventions to Improve Patient Comprehension in Informed Consent for Medical and Surgical Procedures
University of California, San Francisco|San Francisco VA Medical Center|Health Services Research & Development|San Francisco General Hospital|University of California, San Francisco|San Francisco VA Medical Center|Health Services Research & Development|San Francisco General Hospital|University of California, San Francisco|San Francisco VA Medical Center|Health Services Research & Development|San Francisco General Hospital|University of California, San Francisco|San Francisco VA Medical Center|Health Services Research & Development|San Francisco General Hospital
background patient understanding clinical informed consent often poor little known effectiveness interventions improve comprehension extent interventions address different elements understanding informed consent purpose systematically review communication interventions improve patient comprehension informed consent medical surgical procedures data sources systematic literature search englishlanguage articles medline 19492008 embase 19742008 performed addition published bibliography empirical research informed consent reference lists eligible studies reviewed study selection randomized controlled trials controlled trials nonrandom allocation included compared comprehension informed consent medical surgical procedure studies used quantitative objective measure understanding included studies addressed informed consent needed recommended procedure actual patients data extraction reviewers independently extracted data using standardized form results compared disagreements resolved consensus data synthesis fortyfour studies eligible intervention categories included written information audiovisualmultimedia extended discussions testfeedback techniques majority studies assessed patient understanding procedural risks elements included benefits alternatives general knowledge procedure 6 44 studies assessed 4 elements understanding interventions generally effective improving patient comprehension especially regarding risks general knowledge limitations many studies failed include adequate description study population outcome measures varied widely conclusions wide range communication interventions improve comprehension clinical informed consent decisions enhance informed consent consider importance different elements understanding beyond procedural risks well feasibility acceptability intervention clinicians patients conceptual clarity regarding key elements informed consent knowledge help focus improvements standardize evaluations