International Consensus on Core Outcomes in Vascular Surgery: A Delphi Study Protocol

Abstract

Objective

Currently, it is unknown which patients suffering from peripheral arterial disease (PAD) and a small (less than 5 cm) abdominal aortic aneurysm (AAA) will experience disease progression or develop adverse cardiovascular events. VASCUL-AID is a European consortium that aims to build an AI-driven user interface for cardiovascular disease progression in patients with PAD and AAA. Currently, there is no consensus on the core outcomes of PAD and small AAA, resulting in bias in outcome reporting and lack of standardization. The main objective of the current study is to create a European clinician- and patient-approved core outcome set (COS) that should be applied as outcome measures in all future research on patients with intermittent claudication (IC) and small AAAs.

 

Methods

Systematic literature searches will identify outcomes related to AAA and PAD. Patient-centred outcomes identified through focus groups with stakeholders (patients and patient representatives, and healthcare professionals) will be added to the AAA and PAD outcome longlists. Subsequently, a three-round Delphi survey study will be conducted with two stakeholder groups (n=30 for each stakeholder group from every participating country). To finalize the definitive COS, an expert consensus meeting is held with stakeholders to discuss the twenty most important outcomes from the Delphi study. The final core outcome sets for IC and AAA will consist of a maximum of twelve outcomes.

 

In developing this COS, the Core Outcome Set-STAndards for Development (COS-STAD) recommendations and the Core Outcome Measures in Effectiveness Trials (COMET) Handbook are adhered to. The COS will be published in accordance with the COS-STAndards for Reporting statement. For the Delphi study, recommendations as reported by Sinha et al. will be complied with.

 

Conclusion

Each core outcome sets will consist of a maximum of twelve outcomes. These outcomes should be reported as a minimum in research on small abdominal aortic aneurysms and peripheral arterial disease.

Keywords: Abdominal aortic aneurysms, Peripheral arterial disease, Artificial intelligence, Core outcome set, Delphi study