Shwan Akam, Gonzalez-Aguado Maria, Sayers Rob D, Houghton John S M
Department of Cardiovascular Sciences, University of Leicester, Leicester, United Kingdom.
Leicester Vascular Institute, University Hospitals of Leicester NHS Trust, Leicester, United Kingdom.
PLoS One. 2025 Jul 17;20(7):e0328453. doi: 10.1371/journal.pone.0328453. eCollection 2025.
Symptomatic peripheral artery disease (PAD) presents as intermittent claudication or chronic limb-threatening ischaemia (CLTI). PAD research suffers from wide heterogeneity and non-comparability of outcome measures. The solution is to develop a core outcome set (COS) - a minimum standard of outcomes developed and agreed by key stakeholders (patients, healthcare professionals, and researchers). There are currently no agreed COSs for research in PAD. The aim of this project is to develop two separate COSs for symptomatic PAD; for each of intermittent claudication and CLTI.
METHODS/DESIGN: The COSs will be developed according to Core Outcome Measures in Effectiveness Trials (COMET) guidelines. Two comprehensive systematic reviews will be supplemented by qualitative interviews of patients and carers and focus groups of healthcare professionals and researchers. A three-round Delphi consensus process followed by a stakeholder meeting will agree the final COSs. Full ethical approval has been granted by Health Research Authority, HRA and Health and Care Research Wales, HCRW (Brighton and Sussex REC reference 24/LO/0258).
Two separate core outcome sets for research involving patients with intermittent claudication and CLTI will be developed. This will aid study design and ensure meaningful results of clinical trials to guide patient management and development of best-practice guidelines for symptomatic PAD.
COMET registrations: 1590 and 2650.
有症状的外周动脉疾病（PAD）表现为间歇性跛行或慢性肢体威胁性缺血（CLTI）。PAD研究存在结果测量的广泛异质性和不可比性。解决方案是制定一个核心结局集（COS）——由关键利益相关者（患者、医疗保健专业人员和研究人员）制定并认可的最低结局标准。目前尚无针对PAD研究的公认COS。本项目的目的是为有症状的PAD制定两个单独的COS；分别针对间歇性跛行和CLTI。
方法/设计：COS将根据有效性试验核心结局测量（COMET）指南制定。两项全面的系统评价将辅以对患者和护理人员的定性访谈以及医疗保健专业人员和研究人员的焦点小组讨论。三轮德尔菲共识过程之后召开一次利益相关者会议，以确定最终的COS。健康研究管理局（HRA）以及威尔士卫生与社会护理研究局（HCRW）已给予全面伦理批准（布莱顿和萨塞克斯研究伦理委员会参考号24/LO/0258）。
将为涉及间歇性跛行和CLTI患者的研究制定两个单独的核心结局集。这将有助于研究设计，并确保临床试验能得出有意义的结果，以指导患者管理并制定有症状PAD的最佳实践指南。
COMET注册编号：1590和2650。
