CORE-ALI: protocol for a pan-European mixed-methods study to develop a core outcome set for acute lower limb...

Area of Science:

• Vascular Surgery
• Clinical Trial Methodology
• Health Outcomes Research

Background:

• Acute lower limb ischaemia (ALI) is a critical vascular emergency with inconsistent outcome reporting.
• Standardized outcome metrics are needed for evidence synthesis and guideline development in ALI management.
• The CORE-ALI study addresses this by developing a Core Outcome Set (COS).

Purpose of the Study:

• To establish a consensus-driven Core Outcome Set (COS) for acute lower limb ischaemia (ALI).
• To ensure the inclusion of both clinical and patient-centered outcomes in ALI research.
• To standardize outcome reporting for improved evidence synthesis and clinical guidelines.

Main Methods:

• A multi-phase methodology adhering to COMET and COS-STAR guidelines.
• Phase 1: Stakeholder interviews (patients, clinicians, policymakers) and thematic analysis.
• Phase 2 & 3: Multi-round Delphi survey and consensus meeting to finalize the COS.

Main Results:

• Preliminary list of outcomes generated from qualitative data.
• Prioritization and refinement of outcomes through Delphi survey consensus.
• Finalization of the Core Outcome Set (COS) in Phase 3.

Conclusions:

• The CORE-ALI study will provide a standardized COS for ALI research.
• This will enhance the quality and comparability of evidence on ALI treatments.
• The COS will facilitate better clinical decision-making and patient care in ALI.