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

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 andMeta-Analysis Protocols (PRISMAP). 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) Plain language summary What is this article about? This study aims to review clinical trials focused on peripheral artery disease (PAD) patients who have received below-the-knee catheter-based interventions. It investigates the criteria for trial inclusion, how different groups of patients are represented in these trials, and the methods used for recruiting participants. How will the results be gathered? To achieve this, established methods for systematic reviews will be followed. This review will focus on randomized controlled trials published between 2012 and 2022. This study will explore the feasibility of pooling all studies together to find important patterns. If not, a guideline to summarize the study findings will be used. Why is this research important? This research is important because it helps identify any existing disparities in clinical trial participation. By understanding these disparities, principal investigators can suggest ways to improve how participants are selected for future PAD trials. Ultimately, this will lead to more effective PAD treatments and enhance the quality of life for patients with this condition.