{
  "abstract": "Background Acute lower limb ischaemia (ALI) is a life- and limb-threatening vascular emergency requiring urgent intervention. Despite advancements in therapeutic strategies, outcome reporting for ALI remains inconsistent, limiting evidence synthesis and guideline development. The CORE-ALI study aims to develop a Core Outcome Set (COS) to standardise outcome reporting and ensure the inclusion of both clinical and patient-centred metrics.Methods CORE-ALI will use a structured, multi-phase methodology guided by the Core Outcome Measures in Effectiveness Trials (COMET) initiative and the Core Outcome Set-STAndards for Reporting (COS-STAR) guidelines. Phase 1 involves stakeholder engagement through semi-structured interviews with patients, clinicians and policymakers from diverse European healthcare systems. Qualitative data will be analysed using thematic analysis to generate a preliminary list of outcomes. In Phase 2, a multi-round Delphi survey (anticipated two to three rounds) will prioritise and refine outcomes through consensus building, with quantitative data analysed using descriptive and non-parametric statistical methods. Phase 3 will culminate in a consensus meeting to finalise the COS. Multilingual accommodations will ensure inclusivity, and General Data Protection Regulation (GDPR)-compliant platforms will secure data handling.Ethics and dissemination The study has received ethics approval from the Ethics Committee of the Medical University of Innsbruck (EK Nr: 1082/2025) on 20/05/2025. Additional local ethics approvals are required and will be obtained at all participating sites prior to the initiation of recruitment. The final Core outcome set will be disseminated through peer-reviewed publications, presentations at international conferences and engagement with professional societies and patient organisations.Trial registration number COMET initiative (Registration No. 3346).",
  "authors": [
    {
      "affiliations": [
        "Vascular Surgery, Cardiff and Vale University Health Board, Cardiff, UK",
        "Health Education East Midlands, Nottingham, UK"
      ],
      "name": "Maram Darwish"
    },
    {
      "affiliations": [
        "University Hospital of Wales, Cardiff, UK"
      ],
      "name": "Lewis Meecham"
    },
    {
      "affiliations": [
        "Department of Vascular, General and Transplantation Surgery, Wroclaw Medical University, Wrocław, Poland"
      ],
      "name": "Leszek Kukulski"
    },
    {
      "affiliations": [
        "Department of Vascular Surgery, Amsterdam UMC Locatie AMC, Amsterdam, Netherlands"
      ],
      "name": "Sabrina L M Zwetsloot"
    },
    {
      "affiliations": [
        "Division of Vascular and Endovascular Surgery, Trieste University Integrated Healthcare Company, Trieste, Italy"
      ],
      "name": "Mario D’Oria"
    },
    {
      "affiliations": [
        "Department of Vascular Surgery, Medical University of Innsbruck, Innsbruck, Austria"
      ],
      "name": "Laura Schönherr"
    },
    {
      "affiliations": [
        "Clinic for Vascular and Endovascular Surgery, University Clinical Center of Serbia, Belgrade, Serbia"
      ],
      "name": "Petar Zlatanovic"
    },
    {
      "affiliations": [
        "Amsterdam University Medical Centres, Duivendrecht, Netherlands"
      ],
      "name": "Vincent Jongkind"
    },
    {
      "affiliations": [
        "Population Health Sciences, University of Bristol, Bristol, UK"
      ],
      "name": "Robert Hinchliffe"
    },
    {
      "affiliations": [
        "Department of Vascular Surgery, Medical University of Innsbruck, Innsbruck, Austria"
      ],
      "name": "Florian K Enzmann"
    },
    {
      "affiliations": [],
      "name": "European Vascular Research Collaborative (EVRC)"
    }
  ],
  "title": "CORE-ALI: protocol for a pan-European mixed-methods study to develop a core outcome set for acute lower limb ischaemia",
  "uid": "45f71a75-c0f2-54f9-a452-78ec6d20e47c"
}