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

doi:10.1016/j.ejvs.2023.08.066

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

Eur J Vasc Endovasc Surg. 2024 Jan;67(1):155-164. doi: 10.1016/j.ejvs.2023.08.066. Epub 2023 Sep 9.

Authors

Ewa M Zywicka¹, Eleanor McNally², Lucy Elliott³, Christopher P Twine⁴, Ronelle Mouton⁵, Robert J Hinchliffe⁶

Affiliations

¹ Translational Health Sciences, University of Bristol Medical School, Bristol, UK; Southmead Hospital, North Bristol NHS Trust, Bristol, UK. Electronic address: ewa.zywicka@bristol.ac.uk.
² University of Bristol Medical School, Bristol, UK.
³ Translational Health Sciences, University of Bristol Medical School, Bristol, UK; Southmead Hospital, North Bristol NHS Trust, Bristol, UK.
⁴ Translational Health Sciences, University of Bristol Medical School, Bristol, UK; Southmead Hospital, North Bristol NHS Trust, Bristol, UK. Electronic address: http://www.twitter.com/TwineVasc.
⁵ Translational Health Sciences, University of Bristol Medical School, Bristol, UK; Southmead Hospital, North Bristol NHS Trust, Bristol, UK. Electronic address: http://www.twitter.com/RonelleMouton.
⁶ Translational Health Sciences, University of Bristol Medical School, Bristol, UK; Southmead Hospital, North Bristol NHS Trust, Bristol, UK. Electronic address: http://www.twitter.com/robhinchliffe1.

PMID: 37678660
DOI: 10.1016/j.ejvs.2023.08.066

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. PROSPERO registration number: CRD42022288214.

Keywords: Angioplasty; Endovascular intervention; Peripheral arterial disease; Reporting standards.

Publication types

Systematic Review
Review

MeSH terms

Checklist
Humans
Peripheral Arterial Disease* / therapy
Randomized Controlled Trials as Topic
Reference Standards