{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,11]],"date-time":"2026-09-11T00:52:21Z","timestamp":1789087941579,"version":"build-2803163510"},"reference-count":18,"publisher":"BMJ","issue":"12","license":[{"start":{"date-parts":[[2025,12,31]],"date-time":"2025-12-31T00:00:00Z","timestamp":1767139200000},"content-version":"unspecified","delay-in-days":30,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["BMJ Open"],"accepted":{"date-parts":[[2025,12,19]]},"published-print":{"date-parts":[[2025,12]]},"abstract":"<jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>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.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>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.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Ethics and dissemination<\/jats:title>\n                    <jats:p>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.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Trial registration number<\/jats:title>\n                    <jats:p>COMET initiative (Registration No. 3346).<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1136\/bmjopen-2025-107868","type":"journal-article","created":{"date-parts":[[2025,12,31]],"date-time":"2025-12-31T12:00:34Z","timestamp":1767182434000},"page":"e107868","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":2,"title":["CORE-ALI: protocol for a pan-European mixed-methods study to develop a core outcome set for acute lower limb ischaemia"],"prefix":"10.1136","volume":"15","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-7040-3903","authenticated-orcid":false,"given":"Maram","family":"Darwish","sequence":"first","affiliation":[{"name":"Vascular Surgery, Cardiff and Vale University Health Board, Cardiff, UK"},{"name":"Health Education East Midlands, Nottingham, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lewis","family":"Meecham","sequence":"additional","affiliation":[{"name":"University Hospital of Wales, Cardiff, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Leszek","family":"Kukulski","sequence":"additional","affiliation":[{"name":"Department of Vascular, General and Transplantation Surgery, Wroclaw Medical University, Wroc\u0142aw, Poland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sabrina L M","family":"Zwetsloot","sequence":"additional","affiliation":[{"name":"Department of Vascular Surgery, Amsterdam UMC Locatie AMC, Amsterdam, 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