Most UK cardiovascular disease trial protocols feature criteria that exclude ethnic minority participants: a systematic review

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.

Keywords: Cardiovascular diseases; Equitable research; Ethnic minority groups; Randomized controlled trials; Recruitment; Systematic review.