Interventions to Improve Patient Comprehension in Informed Consent for Medical and Surgical Procedures: An Updated Systematic Review

Interventions to Improve Patient Comprehension in Informed Consent for Medical and Surgical Procedures: An Updated Systematic Review
Review Article
Johanna Glaser, Sarah Nouri, Alicia Fernandez, Rebecca L. Sudore, Dean Schillinger, Michele Klein-Fedyshin, Yael Schenker
Medical Decision Making, 16 January 2020
Abstract
Background
Patient comprehension is fundamental to valid informed consent. Current practices often result in inadequate patient comprehension.
Purpose
An updated review to evaluate the characteristics and outcomes of interventions to improve patient comprehension in clinical informed consent.
Data Sources
Systematic searches of MEDLINE and EMBASE (2008–2018).
Study Selection
We included randomized and nonrandomized controlled trials evaluating interventions to improve patient comprehension in clinical informed consent.
Data Extraction
Reviewers independently abstracted data using a standardized form, comparing all results and resolving disagreements by consensus.
Data Synthesis
Fifty-two studies of 60 interventions met inclusion criteria. Compared with standard informed consent, a statistically significant improvement in patient comprehension was seen with 43% (6/14) of written interventions, 56% (15/27) of audiovisual interventions, 67% (2/3) of multicomponent interventions, 85% (11/13) of interactive digital interventions, and 100% (3/3) of verbal discussion with test/feedback or teach-back interventions. Eighty-five percent of studies (44/52) evaluated patients’ understanding of risks, 69% (41/52) general knowledge about the procedure, 35% (18/52) understanding of benefits, and 31% (16/52) understanding of alternatives. Participants’ education level was reported heterogeneously, and only 8% (4/52) of studies examined effects according to health literacy. Most studies (79%, 41/52) did not specify participants’ race/ethnicity.
Limitations
Variation in interventions and outcome measures precluded conduct of a meta-analysis or calculation of mean effect size. Control group processes were variable and inconsistently characterized. Nearly half of studies (44%, 23/52) had a high risk of bias for the patient comprehension outcome.
Conclusions
Interventions to improve patient comprehension in informed consent are heterogeneous. Interactive interventions, particularly with test/feedback or teach-back components, appear superior. Future research should emphasize all key elements of informed consent and explore effects among vulnerable populations.

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