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

作者：Maria Luisa Buzelli, Shoba Dawson, Declan Devane · 发表于：HRB Open Research · 年份：2026 · DOI：10.12688/hrbopenres.14518.1 · 研究领域：Ethics in Clinical Research、Health Policy Implementation Science、Biomedical Ethics and Regulation

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 indepen...