Evidence map›Paper›PMID 41475821›Full record

ArticleBMJ open2025

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

Maram Darwish, Lewis Meecham, Leszek Kukulski, Sabrina L M Zwetsloot, Mario D'Oria, Laura Schönherr, Petar Zlatanovic, Vincent Jongkind, Robert Hinchliffe, Florian K Enzmann and 1 more

Abstract read
In one paragraph

Article in BMJ open, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

11 authors.

Maram DarwishVascular Surgery, Cardiff and Vale University Health Board, Cardiff, UK.ORCID http://orcid.org/0000-0001-7040-3903
Lewis MeechamUniversity Hospital of Wales, Cardiff, UK.
Leszek KukulskiDepartment of Vascular, General and Transplantation Surgery, Wroclaw Medical University, Wrocław, Poland.
Sabrina L M ZwetslootDepartment of Vascular Surgery, Amsterdam UMC Locatie AMC, Amsterdam, Netherlands.
Mario D'OriaDivision of Vascular and Endovascular Surgery, Trieste University Integrated Healthcare Company, Trieste, Italy.ORCID http://orcid.org/0000-0002-7156-7827
Laura SchönherrDepartment of Vascular Surgery, Medical University of Innsbruck, Innsbruck, Austria.
Petar ZlatanovicClinic for Vascular and Endovascular Surgery, University Clinical Center of Serbia, Belgrade, Serbia.
Vincent JongkindAmsterdam University Medical Centres, Duivendrecht, Netherlands.
Robert HinchliffePopulation Health Sciences, University of Bristol, Bristol, UK.
Florian K EnzmannDepartment of Vascular Surgery, Medical University of Innsbruck, Innsbruck, Austria fkenzmann@gmail.com.
European Vascular Research Collaborative (EVRC)

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundAcute 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.

methodsCORE-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).

Indexed as

IschemiaLower ExtremityOutcome Assessment, Health CareAcute DiseaseDelphi TechniqueEuropeHumansResearch DesignDelphi TechniquePatient Reported Outcome MeasuresSTATISTICS & RESEARCH METHODSTreatment OutcomeVASCULAR SURGERY

Identifiers

PMID41475821
PMCPMC12766812

What Socratic holds

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LicenceCC BY-NC
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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.