Santos, Jhulia Dos; Dawson, Shoba; Conefrey, Carmel; Isaacs, Talia; Khanum, Mahwar; Faisal, Saba; Paramasivan, Sangeetha; (2024) Most UK cardiovascular disease trial protocols feature criteria that exclude ethnic minority participants: systematic review. Journal of Clinical Epidemiology , Article 111259. 10.1016/j.jclinepi.2024.111259. (In press).

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Abstract

Objectives: We systematically reviewed UK cardiovascular disease (CVD) randomised 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 non-clinical eligibility criteria from trial protocols and inductively categorised 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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