DOI: 10.12688/hrbopenres.14518.1 ISSN: 2515-4826

Mapping equity, diversity, and inclusion in pivotal device clinical investigations: A scoping review protocol

Maria Luisa Buzelli, Shoba Dawson, Declan Devane
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Introduction Clinical trials are critical to healthcare innovation, yet they often fail to include diverse and representative populations. Ensuring equity, diversity, and inclusion in such trials is vital to improve the generalizability and fairness of clinical evidence. Objective This scoping review aims to map how equity, diversity, and inclusion are considered and reported in pivotal device clinical investigations across therapeutic areas. The review will identify how equity, diversity and inclusion principles are applied and highlight any gaps in the recruitment, inclusion, and reporting of underrepresented groups. Inclusion criteria Pivotal device clinical investigations published within the last five years will be included to ensure alignment with contemporary equity framework guiding data extraction. Methods and analysis The review will be conducted using the Joanna Briggs Institute (JBI) methodological guidance and results will be reported in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews (PRISMA-ScR) guidelines. The protocol has been registered with DOI: 10.17605/OSF.IO/85PSU. Comprehensive searches will be conducted across MEDLINE, Embase, CENTRAL. Data extraction will be guided by established equity frameworks (PROGRESS-Plus, PRO-EDI, CONSORT-Equity and INCLUDE Ethnicity), to capture equity, diversity, and inclusion considerations in study design, conduct and reporting. Two reviewers will independently screen and extract data using a standardised, pilot-tested charting form to ensure consistency. No formal quality appraisal of the included studies will be undertaken, as the purpose of a scoping review is to map the existing evidence rather than to assess methodological quality. Ethics and Dissemination Ethical approval is not required for this research, as it is a review of published literature. Results will be disseminated through a peer-reviewed open-access journal publication, conference presentations, and stakeholder engagement activities.

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