Editor's Choice - A Core Outcome Set for Patients with Chronic Symptomatic Peripheral Arterial Disease

Area of Science:

• Cardiology
• Medical Informatics
• Clinical Research Methodology

Background:

• Peripheral arterial disease (PAD) research suffers from heterogeneous outcomes and selective reporting.
• Standardized outcome reporting is crucial for clinical research and the development of artificial intelligence (AI) predictive models.
• The VASCUL-AID project aims to create AI models for cardiovascular disease progression in PAD patients.

Purpose of the Study:

• To establish a Core Outcome Set (COS) for patients with chronic symptomatic PAD.
• To ensure research outcomes reflect the needs of all stakeholders, including patients.
• To standardize outcome reporting in both clinical and AI research for PAD.

Main Methods:

• The study followed Core Outcome Measures in Effectiveness Trials (COMET) recommendations.
• A longlist of outcomes was generated from a systematic literature review and patient/healthcare professional (HCP) focus groups.
• A Delphi study involving 153 HCPs and 92 patients, followed by an expert consensus meeting, finalized the COS.

Main Results:

• The initial longlist contained 67 outcomes.
• The Delphi study achieved an 85% participation rate.
• The final COS includes 11 essential outcomes: death, myocardial infarction, major amputation, acute limb ischaemia, thromboembolic complications, disease progression, pain-free walking distance, physical activity, health-related quality of life, smoking cessation, and good communication by healthcare providers.

Conclusions:

• This is the first COS specifically developed for patients with chronic symptomatic PAD.
• The COS is recommended for adoption in clinical trials and AI research involving PAD.
• Standardizing outcomes will enhance the quality and comparability of PAD research.