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Cited by 521Ethics in Clinical ResearchEthics and bioethics in healthcarePatient-Provider Communication in Healthcare

Improving understanding in the research informed consent process: a systematic review of 54 interventions tested in randomized control trials

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Nishimura, Adam, Carey, Jantey, Erwin, Patricia J, Tilburt, Jon C, Murad, M Hassan, McCormick, Jennifer B·2013·BMC Medical Ethics
DOI 10.1186/1472-6939-14-28PMC PMC3733934
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Abstract

Background: Obtaining informed consent is a cornerstone of biomedical research, yet participants comprehension of presented information is often low. The most effective interventions to improve understanding rates have not been identified. Purpose: To systematically analyze the random controlled trials testing interventions to research informed consent process. The primary outcome of interest was quantitative rates of participant understanding; secondary outcomes were rates of information retention, satisfaction, and accrual. Interventional categories included multimedia, enhanced consent documents, extended discussions, test/feedback quizzes, and miscellaneous methods. Methods: The search spanned from database inception through September 2010. It was run on Ovid MEDLINE, Ovid EMBASE, Ovid CINAHL, Ovid PsycInfo and Cochrane CENTRAL, ISI Web of Science and Scopus. Five reviewers working independently and in duplicate screened full abstract text to determine eligibility. We included only RCTs. 39 out of 1523 articles fulfilled review criteria (2.6%), with a total of 54 interventions. A data extraction form was created in Distiller, an online reference management system, through an iterative process. One author collected data on study design, population, demographics, intervention, and analytical technique. Results: Meta-analysis was possible on 22 interventions: multimedia, enhanced form, and extended discussion categories; all 54 interventions were assessed by review. Meta-analysis of multimedia approaches was associated with a non-significant increase in understanding scores (SMD 0.30, 95% CI, -0.23 to 0.84); enhanced consent form, with significant increase (SMD 1.73, 95% CI, 0.99 to 2.47); and extended discussion, with significant increase (SMD 0.53, 95% CI, 0.21 to 0.84). By review, 31% of multimedia interventions showed significant improvement in understanding; 41% for enhanced consent form; 50% for extended discussion; 33% for test/feedback; and 29% for miscellaneous.Multiple sources of variation existed between included studies: control processes, the presence of a human proctor, real vs. simulated protocol, and assessment formats. Conclusions: Enhanced consent forms and extended discussions were most effective in improving participant understanding. Interventions of all categories had no negative impact on participant satisfaction or study accrual. Identification of best practices for studies of informed consent interventions would aid future systematic comparisons.

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  • Interventions to improve informed consent processes and participant understanding have met with minimal success.

    “These attempts have met with minimal success; across four systematic reviews (25, 39, 100, 136), the only intervention consistently shown to be effective was one-on-one discussion with a person knowledgeable about the study.”

    From Lessons from HeLa Cells: The Ethics and Policy of Biospecimens (2016) · cites this paper as [100]

    The Discussion (page unavailable) says extended discussions had the most consistent results, but only 50% significantly improved understanding; it concludes that no intervention category had consistent efficacy. It also reports significant improvements from enhanced consent forms, contrary to the claim that one-on-one discussion was the only effective intervention. (LLM, conf=0.88)

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  • The available evidence on interventions to improve informed consent is notably limited, with studies often suffering from lack of power, nonrandomized designs, poor generalizability, questionable methods for measuring comprehension outcomes, and/or too narrow a focus on a single aspect of the consent process.

    “However, all four reviews found the available evidence notably limited, with the studies often suffering from lack of power, nonrandomized designs, poor generalizability, questionable methods for measuring comprehension outcomes, and/or too narrow a focus on a single aspect of the consent process.”

    From Lessons from HeLa Cells: The Ethics and Policy of Biospecimens (2016) · cites this paper as [100]

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  • Across four systematic reviews, the only intervention consistently shown to be effective was one-on-one discussion with a person knowledgeable about the study.

    “These attempts have met with minimal success; across four systematic reviews (25, 39, 100, 136), the only intervention consistently shown to be effective was one-on-one discussion with a person knowledgeable about the study.”

    From Lessons from HeLa Cells: The Ethics and Policy of Biospecimens (2016) · cites this paper as [100]

    The Discussion says extended discussions produced the most consistent improvement in understanding, supporting the claim's emphasis on conversation. But only three of six extended-discussion interventions showed significant improvement, and the paper explicitly says no intervention category had consistent efficacy. This review also does not establish the asserted conclusion across four systematic reviews. (LLM, conf=0.88)

    Experimental — accuracy not yet measured

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Authors
Nishimura, A., Carey, J., Erwin, P. J., Tilburt, J. C., Murad, M. H., & McCormick, J. B.
Affiliations
  • University of Washington (US)
  • Mayo Clinic (US)
Corresponding author
McCormick, Jennifer B
ORCID
Venue
BMC Medical Ethics
Publisher
Springer Science and Business Media LLC
Published
2013-07-23
Volume
14
Issue
1
Pages
28-28
ISSN
1472-6939 (ISSN-L)
DOI
10.1186/1472-6939-14-28
PMC
PMC3733934
OpenAlex
W2147388986
Cited by
521
References
0
Citations by year
2026: 41 · 2025: 39 · 2024: 29 · 2023: 23 · 2022: 54 · 2021: 66 · 2020: 39 · 2019: 46 · 2018: 40 · 2017: 45 · 2016: 33 · 2015: 37 · 2014: 23 · 2013: 4
FWCI
4.61
Type
journal article
Language
en
Open access
Licence
Locations
  • BMC Medical Ethics (publishedVersion, cc-by)
  • Europe PMC (PubMed Central) (publishedVersion, cc-by)
  • PubMed Central (publishedVersion, cc-by)
  • PubMed (publishedVersion)
Funders
  • Mayo Clinic (UL1 RR024150, UL1-TR000135, RR024150)
  • National Institutes of Health (UL1TR000135)
  • National Center for Research Resources (UL1RR024150)
  • National Center for Advancing Translational Sciences (TR000135, RR024150)
Topics
  • Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Ethics in Clinical Research
  • Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Ethics and bioethics in healthcare
  • Health Sciences › Health Professions › General Health Professions › Patient-Provider Communication in Healthcare
Keywords
informed consent, participant comprehension, research ethics, information retention, participant satisfaction, randomized controlled trials
MeSH terms
Communication, Humans, Informed Consent, Research Design, Confounding Factors, Epidemiologic, Randomized Controlled Trials as Topic, Multimedia, Internet, Comprehension, Consent Forms

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