Endovascular Interventions Frameworks

ENDO-STAR Framework

Standardised framework for the description of infrainguinal endovascular interventions in clinical trials

The evaluation of endovascular interventions through randomised controlled trials (RCTs) is fundamentally important for evidence-based care. Information about intervention delivery is needed in order to confidently interpret trial results, however, this information is not reported consistently.

The research team at University of Bristol has successfully developed and pilot-tested Endo-STAR, a framework to optimise the design, conduct and reporting of clinical trials of infra-inguinal endovascular interventions for PAD, aiming to ensure that the information provided in a protocol or manuscript describing endovascular interventions provides enough information for the intervention to be understood by the reader, replicated by a researcher, used by a clinician to make clinical decisions, and included in comparative effectiveness studies. The development of the framework is meant to be used in concert with the CONSORT (CONSORT-NPT) and TIDIER guidelines.

Please click the tabs below to review the Endo-STAR framework and additional materials. Please click on the to expand each section.

"…unlike 20 milligram tablets, no two surgical procedures are the same and achieving standardization of interventions within RCTs is difficult…"

Blencowe, N et al. ‘Delivering Successful Randomized Controlled Trials in Surgery: Methods to Optimize Collaboration and Study Design’. Clinical Trials 14, no. 2 (April 2017): 211–18.

Standardised framework for endovascular infrainguinal lower limb interventions

Explanation

How to use the framework.

Writing the Trial Protocol- The framework will be used for deconstructing endovascular interventions into their components and steps to ensure that the standardisation of each component is considered a priori and documented within the trial protocol.
Standardising intervention- The intervenion could be required to be performed in a standardized way in every patient and across all trial centres as specified in the trial protocol.
Monitoring adherence to trial protocol- The interventions will be monitored to ensure the intervention is performed as specified in the trial protocol.
Reporting Guideline- To ensure appropriate details are provided when reporting results of the trial.
The framework has been developed to be as comprehensive as possible. This will allow users to consider every step and componend while writing a trial protocol. It might not be always necessaru or appropriate to standardise each component or step of intervention. For this reason the intervention standardisation should be considered and agreed upon by the research team based on the overall trial design (for example pragmatic versus explanatory).

Focus groups materials

Please find pubblications relevant to the project

Protocol for a systematic review of reporting standards of lower limb endovascular interventions in peripheral arterial disease Zywicka EM, Elliott L, Twine CP, Mouton R, Hinchliffe RJ. Syst Rev. 2023 Feb 15;12(1):20.

Reference: Systematic reviews; Protocol for a systematic review of reporting standards of lower limb endovascular interventions in peripheral arterial disease .
Exploring the Reporting Standards of Randomised Controlled Trials Involving Endovascular Interventions for Peripheral Arterial Disease: A Systematic Review. Zywicka EM, McNally E, Elliott L, Twine CP, Mouton R, Hinchliffe RJ. Eur J Vasc Endovasc Surg. 2023 Sep 9:S1078-5884(23)00731-1.

Reference:European Journal of Vascular and Endovascular Surgery ; Exploring the Reporting Standards of Randomised Controlled Trials Involving Endovascular Interventions for Peripheral Arterial Disease: A Systematic Review.
CONSORT-NPT - This is an evidence-based reporting guideline developed initially in 2008 as an extension to the original statement, that addressed methodological issues specific to trials of nonpharmacologic treatments (NPTs), such as surgery, rehabilitation, or psychotherapy.

Reference: Annals of Internal Medicine; CONSORT Statement for Randomized Trials of Nonpharmacologic Treatments: A 2017 Update and a CONSORT Extension for Nonpharmacologic Trial Abstracts (Accessed March 2023).
TIDieR - Checklist and guideline developed by an international group of experts and stakeholders to improve the completeness of reporting, and ultimately the replicability, of interventions.

Reference: The BMJ; Better reporting of interventions: template for intervention description and replication (TIDieR) checklist and guide. (Accessed March 2023).