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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Context. Breast cancer morbidity and mortality disproportionately affect medically underserved women. Most studies of the experience of living with advanced breast cancer do not focus on this population. A deeper understanding of racial/ ethnic minorities' and low-income patients' experiences is needed to reduce breast cancer health and health care disparities. Objectives. This qualitative, community-based participatory research study explores the lived experiences of medically underserved women with advanced breast cancer. Methods. We conducted in-depth, semistructured interviews with low-income patients from a community clinic and safetynet hospital, focusing on issues related to advanced breast cancer and end of life. Six team members independently coded transcripts, jointly reconciled coding differences, and identified key themes. Results. All 63 participants (83% response rate) had an income #200% of the federal poverty level; 68% identified as a racial/ethnic minority. Four predominant themes emerged: compounding of pre-existing financial distress, perceived bias/ lack of confidence in medical care received, balancing personal needs with the needs of others, and enhanced engagement with sources of life meaning. Conclusion. Participants resiliently maintained engaged lives yet described extreme financial duress and perceived provider bias, which are known contributors to worse quality of life and health outcomes. Participants downplayed their desire to discuss dying to accommodate pressure to ''stay positive'' and to mitigate others' discomfort. Improving care for underserved women with advanced cancer will require addressing disparities from screening through hospice, developing personalized opportunities to discuss death and dying, and enhancing access to and affordability of medical and social support.

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Medical students' perceptions of and responses to health care disparities during clinical clerkships. Acad Med.