Interventions to Improve Patient Comprehension in Informed Consent for Medical and Surgical Procedures: An Updated Systematic Review
| Autor: | Johanna Glaser, Sarah Nouri, Alicia Fernandez, Rebecca L. Sudore, Dean Schillinger, Michele Klein-Fedyshin, Yael Schenker |
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| Rok vydání: | 2020 |
| Předmět: |
Adult
Male understanding Clinical Trials and Supportive Activities Article interpersonal communication Young Adult 03 medical and health sciences 0302 clinical medicine Clinical Research Humans 030212 general & internal medicine Diagnostic Techniques and Procedures intervention Aged Surgical Procedures Informed Consent Health Policy Professional-Patient Relations Middle Aged Operative Health Literacy Surgical Procedures Operative Applied Economics Public Health and Health Services Health Policy & Services 030221 ophthalmology & optometry Female Patient Safety Generic health relevance Comprehension comprehension |
| Zdroj: | Medical decision making : an international journal of the Society for Medical Decision Making, vol 40, iss 2 Med Decis Making |
| ISSN: | 1552-681X 0272-989X |
| DOI: | 10.1177/0272989x19896348 |
| Popis: | 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. |
| Databáze: | OpenAIRE |
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