Background:
Every year, thousands of patients face the life-changing consequences of Acute Limb Ischemia (ALI), including limb loss and death. Despite advances in treatment, there is no agreement on how to measure success. Most studies focus on technical outcomes like restored blood flow, but patients care more about recovery, pain management, and quality of life. This project will address these gaps to improve treatment and care.
Aim:
We aim to develop a Core Outcome Set (COS) for ALI. A COS is a list of outcomes that should be measured in all studies of a condition. It will help ensure ALI research focuses on outcomes that matter most to patients and healthcare teams.
Research Plan:
• Step 1: Interview patients, their relatives, healthcare professionals, and policymakers to identify the most important outcomes.
• Step 2: Use a Delphi consensus process (a series of structured surveys) to help stakeholders refine and prioritize the outcomes.
• Step 3: Conduct an expert consensus meeting to finalize the COS.
Working with Diverse Communities:
This project has been shaped by input from patients, healthcare professionals, and policymakers across Europe. A systematic review and findings from a large European cohort study highlighted the need for better outcome measures in ALI care, particularly those that reflect patient priorities.
Patients will continue to influence every stage of this research. RJ, an ALI survivor, is part of the research team and brings her lived experience to guide the project. A diverse group of patients and carers from underrepresented communities will review materials, share feedback, and shape the COS, ensuring it is inclusive and relevant for all.
Dissemination:
The final list of outcomes will be widely shared through:
• Medical journals and international conferences
• Patient-friendly materials to improve public understanding
• Clinical guidelines, research protocols, and registries to ensure real-world impact
Relevance to Existing COS Initiatives
A previous effort to develop a Core Outcome Set (COS) for Acute Limb Ischemia (ALI) was registered in the COMET database (initiated in 2021 at Amsterdam UMC). The project aimed to address heterogeneity in outcome reporting for ALI but was discontinued when the original PhD candidate chose a different research focus.
Recognizing the continued need for an ALI COS, members of the original steering group, including Prof. Robert Hinchliffe and Dr. Vincent Jongkind, have invited our team to carry the project forward.
Our study builds on prior work by:
• Expanding stakeholder engagement across multiple European centers, ensuring broader representation
• Incorporating patient perspectives through qualitative interviews and direct involvement in all research phases
• Aligning with Core Outcome Set development standards and NIHR EDI principles to ensure inclusivity
• Enhancing methodological robustness by integrating findings from a large European cohort study, ensuring real-world relevance
This revised project represents an evolution and continuation of the initial COS effort, addressing previous limitations while ensuring the final outcome set is widely adopted and impactful.
• Maram Darwish - Medical Doctor and PhD Candidate
Institution: Cardiff and Vale University Health Board (CAVUHB)
Email: maram.darwish@nhs.net
• Florian Enzmann - Vascular Surgeon and Principal Investigator
Institution: Innsbruck Medical University, Innsbruck
Email: fkenzmann@gmail.com
• Dr. Lewis Meecham - Vascular Surgeon and Principal Investigator
Institution: Cardiff and Vale University Health Board (CAVUHB)
Email: Lewis.meecham@wales.nhs.uk
• Prof. Dr. Mario Giovanni Gerardo D'Oria - Professor of Vascular surgery
Institution: University Hospital of Trieste, Italy
Email: mario.doria88@outlook.com
• Dr. Doukas Panagiotis - Vascular surgeon
Institution: University Hospital RWTH Aachen, Aachen, Germany
Email: pdoukas@ukaachen.de
• Dr. Petar Zlatanovic - Vascular surgeon
Institution: Vascular and Endovascular Surgery, University Clinical Centre of Serbia
Email: petar91goldy@gmail.com
• Dr. Péter Osztrogonácz - Vascular surgeon
Institution: Semmelweis University, Budapest, Hungary
Email: osztrogonaczp@gmail.com
• Dr. Leszek Kukulski - Vascular surgeon
Institution: Wroclaw Medical University: Wroclaw, Poland
Email: leszekkukulski@gmail.com
• Dr. Laura Schoenherr - Medical Doctor
Institution: Innsbruck Medical University, Innsbruck
Email: laura.schoenherr@i-med.ac.at
• Sabrina S.L.M. Zwetsloot - Medical Doctor and PhD Candidate
Institution: Amsterdam University Medical Centers - location AMC
Email: s.l.zwetsloot@amsterdamumc.nl
Steering Committee Members
• Prof. Dr. Robert J. Hinchliffe, MD - Professor of Vascular Surgery
Institution: University of Bristol
Email: robert.hinchliffe@bristol.ac.uk
• Dr. Vincent Jongkind - Vascular Surgeon
Institution: Amsterdam University Medical Centers - location AMC
Email: v_jongkind@yahoo.com
• Prof. Dr. Sandip Nandhra - Professor of Vascular Surgery
Institution: Newcastle Upon Tyne Hospitals NHS Foundation Trust
Email: sjnandhra@gmail.com
Collaborators
• European Vascular Research Collaborative (EVRC)
Description: A multidisciplinary research collaborative for those involved or interested in the care of individuals with vascular conditions.
Website: eurovascresearch.com
Contact Email: info@eurovascresearch.com
Disease Category: Heart & circulation
Disease Name: Acute Lower Limb Ischemia
Age Range: 18 - 120
Sex: Either
Nature of Intervention: Any
- Clinical experts
- Consumers (caregivers)
- Consumers (patients)
- Guideline developers
- Other
- Patient/ support group representatives
- Researchers
- Service providers
- Statisticians
- COS for clinical trials or clinical research
- COS for practice
- Consensus meeting
- Delphi process
- Interview
This study follows established Core Outcome Set (COS) development methodology, including:
Systematic Review: Identification of existing outcomes reported in studies on Acute Limb Ischemia (ALI).
Delphi Consensus Process: A multi-round Delphi survey involving key stakeholders, including vascular surgeons, interventional radiologists, nurses, and patients, to refine and prioritize outcomes.
Consensus Meeting: A final consensus meeting with stakeholders to finalize the core outcome set for ALI.
Stakeholder Involvement & Equity: Emphasis on patient and clinician engagement, with consideration of underrepresented groups as per NIHR EDI principles.
Integration & Dissemination: The final COS will be integrated into future clinical trials and vascular registries to standardize outcome reporting in ALI.