Santos, J.D., Dawson, S. orcid.org/0000-0002-6700-6445, Conefrey, C. et al. (4 more authors) (2024) Most UK cardiovascular disease trial protocols feature criteria that exclude ethnic minority participants: a systematic review. Journal of Clinical Epidemiology, 167. 111259. ISSN 0895-4356
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.
Metadata
Item Type: | Article |
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Authors/Creators: |
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Copyright, Publisher and Additional Information: | © 2024 The Authors. Published by Elsevier Inc. This is an open access article under the CC BY license (http://creativecommons.org/licenses/by/4.0/). |
Keywords: | Recruitment; Randomized controlled trials; Cardiovascular diseases; Systematic review; Ethnic minority groups; Equitable research |
Dates: |
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Institution: | The University of Sheffield |
Academic Units: | The University of Sheffield > Faculty of Medicine, Dentistry and Health (Sheffield) > School of Medicine and Population Health |
Depositing User: | Symplectic Sheffield |
Date Deposited: | 07 Feb 2024 17:35 |
Last Modified: | 07 Feb 2024 17:35 |
Status: | Published |
Publisher: | Elsevier BV |
Refereed: | Yes |
Identification Number: | 10.1016/j.jclinepi.2024.111259 |
Open Archives Initiative ID (OAI ID): | oai:eprints.whiterose.ac.uk:207681 |