Johanna Glaser|Sarah Nouri|Alicia Fernández|Rebecca L. Sudore|Dean Schillinger|Michele Klein?Fedyshin|Yael Schenker
Interventions to Improve Patient Comprehension in Informed Consent for Medical and Surgical Procedures: An Updated Systematic Review
University of California, San Francisco|University of California, San Francisco|San Francisco General Hospital|University of California, San Francisco|University of California, San Francisco|San Francisco VA Health Care System|San Francisco General Hospital|University of California, San Francisco|University of Pittsburgh|University of Pittsburgh
background patient comprehension fundamental valid informed consent current practices often result inadequate patient comprehension purpose updated review evaluate characteristics outcomes interventions improve patient comprehension clinical informed consent data sources systematic searches medline embase 20082018 study selection included randomized nonrandomized controlled trials evaluating interventions improve patient comprehension clinical informed consent data extraction reviewers independently abstracted data using standardized form comparing results resolving disagreements consensus data synthesis fiftytwo studies 60 interventions met inclusion criteria compared standard informed consent statistically significant improvement patient comprehension seen 43 614 written interventions 56 1527 audiovisual interventions 67 23 multicomponent interventions 85 1113 interactive digital interventions 100 33 verbal discussion testfeedback teachback interventions eightyfive percent studies 4452 evaluated patients understanding risks 69 4152 general knowledge procedure 35 1852 understanding benefits 31 1652 understanding alternatives participants education level reported heterogeneously 8 452 studies examined effects according health literacy studies 79 4152 specify participants raceethnicity limitations variation interventions outcome measures precluded conduct metaanalysis calculation mean effect size control group processes variable inconsistently characterized nearly half studies 44 2352 high risk bias patient comprehension outcome conclusions interventions improve patient comprehension informed consent heterogeneous interactive interventions particularly testfeedback teachback components appear superior future research emphasize key elements informed consent explore effects among vulnerable populations