Reporting Characteristics of Randomized Controlled Trials of Endovascular Therapy for Peripheral Artery Disease: A Systematic Review

OBJECTIVES: Examining the reporting characteristics of randomized controlled trials (RCTs) of lower-extremity (LE) endovascular interventions in patients with peripheral artery disease (PAD) is essential to ensure transparency and quality in the reporting of research findings. This systematic review examined the reporting characteristics of trial registries and protocols in LE endovascular RCTs involving PAD patients.

METHODS: This study followed the PRISMA guidelines and was registered in PROSPERO (CRD:42022378304). A validated search filter was applied across six databases to identify LE endovascular trials for PAD registered between 2012 and 2022.

RESULTS: Fifty-nine records (35 RCTs, 14 publications, and 10 protocols) across 691 locations were identified. Of these, 19 (54.3%) were single- or double-blind, 5 (14.3%) were either phase 3 or 4, and 10 (28.6%) were 1:1 randomized RCTs. The median time from the trial start date to peer-reviewed publication was 5 years (range:3-8 years). The majority of the trials were conducted in the US or Germany. Six of the 10 publications indexed in the registry had no study results posted. Eleven trials had completed recruitment (range:2014-2022), and five posted their study results in the registry. Information on enrollment strategies varied across protocols: recruitment (7), patient reimbursement (3), and withdrawal of patients (6). Protocol reporting characteristics varied: cultural competency training for clinical research or principal investigators (0); reporting methods for withdrawing patients from RCTs (6); and providing participant-facing materials in other languages (2). All publications reported age and sex; however, only four reported on race. Reporting of demographic characteristics by clinical outcomes was rarely performed, and no publication reported socio-economic status.

CONCLUSIONS: This study highlights the need for improved transparency and standardized reporting practices in clinical trials. Addressing reporting issues could enhance the reliability of findings, ultimately advancing clinical decision-making and patient care in PAD.