Exploring the Reporting Standards of Randomised Controlled Trials Involving Endovascular Interventions for Peripheral Arterial Disease: A Systematic Review

Ewa M. Zywicka*, Eleanor McNally, Lucy Elliott, Christopher P. Twine, Ronelle Mouton, Robert J. Hinchliffe

*Corresponding author for this work

Research output: Contribution to journalReview article (Academic Journal)peer-review

Abstract

Objective
Endovascular technology innovation requires rigorous evaluation in high quality randomised controlled trials (RCTs). However, due to numerous methodological challenges, RCTs evaluating endovascular interventions are complex and potentially difficult to design, conduct, and report. This systematic review aimed to assess the quality of reporting of RCTs for endovascular interventions for lower limb peripheral arterial disease (PAD).

Data Sources and Review Methods
A systematic review of Medline, Embase, and the Cochrane Library databases from inception to December 2021 was performed to identify RCTs including participants with PAD undergoing any infrainguinal lower limb endovascular intervention. Study data were extracted and assessed against the Consolidating Standards of Reporting Trials extension for Non-Pharmacological Treatments (CONSORT-NPT) and the Template for Intervention Description and Replication (TIDieR) checklists. Descriptive statistics were used to summarise general study details and reporting standards of the trials.

Results
After screening 6 567 abstracts and 526 full text articles, 112 eligible studies were identified, reporting on 228 different endovascular devices and techniques. Details judged sufficient to replicate the investigated intervention were provided for 47 (21%) interventions. It was unclear whether the description was reported with sufficient details in a further 56 (24%), and the description was judged inadequate in 125 (55%). Any intervention descriptions were provided for 184 (81%), with variable levels of detail (some in 134 [59%] and precise in 50 [22%]). Standardisation of intervention or some aspect of this was reported in 25 (22%) trials, but only one specified that adherence to the study protocol would be monitored.

Conclusion
The quality of the reporting standards of RCTs investigating lower limb endovascular treatments is severely limited because the interventions are poorly described, standardised, and reported.
Original languageEnglish
Pages (from-to)155-164
Number of pages10
JournalEuropean Journal of Vascular and Endovascular Surgery
Volume67
Issue number1
Early online date4 Sept 2023
DOIs
Publication statusPublished - 1 Jan 2024

Bibliographical note

Funding Information:
This work was undertaken with the support of the NIHR Biomedical Research Centre at University Hospitals Bristol NHS Foundation Trust and the University of Bristol , the Linder Foundation , and the Department of Research & Innovation at North Bristol NHS Trust (award/grant number N/A).

Publisher Copyright:
© 2023 The Author(s)

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