Core Outcomes in Research and Evidence for Acute Lower Limb Ischemia
Research type
Research Study
Full title
Core Outcomes in Research and Evidence for Acute Lower Limb Ischemia (CORE-ALI)
IRAS ID
361282
Contact name
Maram Darwish
Contact email
Sponsor organisation
CARDIFF & VALE UNIVERSITY LHB
Duration of Study in the UK
2 years, 0 months, 1 days
Research summary
Acute limb ischaemia (ALI) is a sudden reduction in blood flow to the leg or foot, which can cause severe pain, tissue damage, amputation, or even death. It is a medical emergency that requires urgent treatment. However, research studies on ALI often report very different outcomes, making it difficult to compare findings or improve patient care consistently.
This study aims to develop a Core Outcome Set (COS) — a standardised list of the most important outcomes that should be reported in all future clinical research and audits on ALI. This will help ensure that studies are consistent, comparable, and focused on what really matters to patients and healthcare professionals.
We have already completed a review of the literature on outcomes reported in ALI studies and will update this search to include the most recent evidence. We will then carry out a two-round online survey (Delphi process), inviting healthcare professionals, researchers, and policy-makers with experience in ALI to rate the importance of different outcomes. This will be followed by an online meeting to discuss and agree on the final list.
Although patients are not directly taking part in the survey or meeting, a survivor of ALI, is part of the research team and is helping ensure that the final outcome set reflects patient priorities and experiences.
REC name
South Central - Berkshire B Research Ethics Committee
REC reference
25/SC/0260
Date of REC Opinion
6 Aug 2025
REC opinion
Further Information Favourable Opinion