Diversity in clinical trial inclusion for peripheral artery disease lower extremity endovascular interventions: a systematic review protocol

Author:

Long Chandler1,Williams Abimbola O2ORCID,Jacobsen Caroline M2,McGovern Alysha M2ORCID,Hargens Liesl M2ORCID,Duval Sue23ORCID,Jaff Michael R4ORCID

Affiliation:

1. Duke Vascular & Endovascular Surgery, Duke University Medical Center, Duke University, Durham, NC 27707, USA

2. Health Economics and Market Access, Boston Scientific, Marlborough, MA 01752, USA

3. Division of Cardiology, Department of Medicine, University of Minnesota, Minneapolis, MN 55455, USA

4. Peripheral Interventions, Boston Scientific, Maple Grove, MN 55133, USA

Abstract

Aim: This review provides a study protocol for a systematic review of peripheral artery disease (PAD) clinical trials to examine the eligibility criteria, demographic representation, and enrollment strategies among PAD patients undergoing lower extremity (LE) endovascular interventions. Methods: This systematic review will be conducted according to the Cochrane Collaboration methodology for systematic reviews and following the Preferred Reporting Items for Systematic Reviews and Meta-Analysis Protocols (PRISMA-P). Eligible studies will include randomized controlled trials (RCTs) between January 2012 and December 2022. The primary outcome will be a description and summary of the frequency of the reporting of demographic characteristics. The feasibility of a meta-analysis or meta-regression will be explored, but if determined to be infeasible, the Synthesis Without Meta-analysis (SWiM) reporting guideline will be followed for the reporting of findings. Discussion: The findings may help to quantify existing inequities in clinical trial participation that may be addressed through optimizing enrollment strategies for future PAD trials. Systematic review registration: PROSPERO (CRD42022378304)

Publisher

Becaris Publishing Limited

Subject

Health Policy

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