Department of Cardiovascular Sciences, University of Leicester, Leicester, UK.
Leicester Vascular Institute, University Hospitals of Leicester NHS Trust, Leicester, UK.
BJS Open. 2024 Oct 29;8(6). doi: 10.1093/bjsopen/zrae126.
This review aimed to compile an exhaustive list of all outcome measures and identify different characteristics of the outcomes reported in studies of intermittent claudication as the first step in developing a core outcome set for intermittent claudication.
Medline and Embase were searched for all studies including individuals with intermittent claudication and reporting ≥1 outcome from January 2015 to August 2024. Abstract, full text screening and data extraction were performed by two investigators independently. All reported outcome measures were extracted verbatim and categorized by Dodd's domains (Core Outcome Measures in Effectiveness Trials registration: COMIC Study, 1590; https://www.comet-initiative.org/Studies/Details/1590).
4985 studies were screened and 408 were included. A total of 541 unique outcomes across 25 Dodd's domains were identified. Ankle-brachial pressure index was the most frequently reported outcome. Among the 541 unique outcomes, 386 outcomes were only reported once. Only 38.9% of the studies exclusively included patients with intermittent claudication. Patient-reported outcomes were reported in 36.2% of studies. There were wide variations in the definition of commonly used outcome measures (for example, major adverse limb event and primary patency) across different studies.
There is substantial heterogeneity in reported outcomes in studies of intermittent claudication. Most reported outcomes are clinical/physiology oriented rather than patient centred. Development of a core outcome set for intermittent claudication is vital to improve and standardize reporting in future research.
本综述旨在编制一份详尽的所有结局指标清单，并确定间歇性跛行研究报告的结局的不同特征，这是为间歇性跛行制定核心结局集的第一步。
检索了 Medline 和 Embase 中所有纳入间歇性跛行患者且报告至少 1 项结局的研究，检索时间范围为 2015 年 1 月至 2024 年 8 月。两名研究者独立进行摘要、全文筛选和数据提取。逐字提取所有报告的结局指标，并按 Dodd 领域进行分类（有效性试验注册的核心结局测量：COMIC 研究，1590；https://www.comet-initiative.org/Studies/Details/1590）。
筛选出 4985 篇研究，纳入 408 篇。共确定了 25 个 Dodd 领域的 541 个独特结局指标。踝肱血压指数是最常报告的结局。在 541 个独特的结局指标中，386 个结局仅报告了一次。只有 38.9%的研究仅纳入间歇性跛行患者。36.2%的研究报告了患者报告的结局。在不同研究中，常用结局指标的定义存在很大差异（例如，主要肢体不良事件和原发性通畅率）。
在间歇性跛行的研究中，报告的结局存在很大的异质性。大多数报告的结局都是以临床/生理学为导向，而不是以患者为中心。制定间歇性跛行的核心结局集对于提高和规范未来研究的报告至关重要。
