AI Article Synopsis
- The study reviewed UK cardiovascular disease randomized controlled trial protocols to assess how many use eligibility criteria that could unfairly exclude ethnic minority participants.
- Of 70 trial protocols analyzed, a significant majority required written consent and often mandated English language proficiency, which could limit EM participation.
- The findings suggest that existing protocols need to be revised to adopt more inclusive criteria, considering ethnicity and other identities to enhance diversity in clinical trials.*
Article Abstract
Objectives: We systematically reviewed UK cardiovascular disease (CVD) randomized controlled trial (RCT) protocols to identify the proportion featuring eligibility criteria that may disproportionately exclude ethnic minority (EM) participants.
Methods: We searched MEDLINE, Embase, and Cochrane Library databases, January 2014-June 2022, to identify UK CVD RCT protocols. We extracted nonclinical eligibility criteria from trial protocols and inductively categorized the trials by their language, consent, and broad (ambiguous) criteria. Findings are narratively reported.
Results: Of the seventy included RCT protocols, most (87.1%; 61/70) mentioned consent within the eligibility criteria, with more than two-thirds (68.9%; 42/61) indicating a requirement for 'written' consent. Alternative consent pathways that can aid EM participation were absent. English language requirement was present in 22.9% (16/70) of the studies and 37.1% (26/70) featured broad criteria that are open to interpretation and subject to recruiter bias. Only 4.3% (3/70) protocols mentioned the provision of translation services.
Conclusion: Most UK CVD trial protocols feature eligibility criteria that potentially exclude EM groups. Trial eligibility criteria must be situated within a larger inclusive recruitment framework, where ethnicity is considered alongside other intersecting and disadvantaging identities.
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| http://dx.doi.org/10.1016/j.jclinepi.2024.111259 | DOI Listing |
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