Amsterdam UMC, Vrije Universiteit Amsterdam, Department of Surgery, Amsterdam Cardiovascular Sciences, Amsterdam, the Netherlands; Vrije Universiteit Amsterdam, Department of Physiology, Amsterdam Cardiovascular Sciences, Amsterdam, the Netherlands; Amsterdam Cardiovascular Sciences, Microcirculation, Amsterdam, the Netherlands; Department of Surgery, Dijklander Hospital, Hoorn, the Netherlands.
Amsterdam UMC, Vrije Universiteit Amsterdam, Department of Surgery, Amsterdam Cardiovascular Sciences, Amsterdam, the Netherlands.
Eur J Vasc Endovasc Surg. 2024 Nov;68(5):600-604. doi: 10.1016/j.ejvs.2024.07.042. Epub 2024 Aug 5.
Inconsistencies in outcome data of therapeutic strategies for acute lower limb ischaemia (ALI) have hindered the synthesis of findings. A core outcome set (COS) may offer a solution to this problem by defining a minimum set of outcomes that are considered essential to all stakeholders involved. The first step in developing a COS is to review the previously reported outcomes on various treatment strategies for ALI.
PubMed, Embase, Cochrane Central Register of Controlled Trials (CENTRAL), and Web of Science databases were searched from inception to August 2023.
This systematic review was conducted in accordance with the Core Outcome Measures in Effectiveness Trials (COMET) initiative framework, adhering to Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines, and was pre-registered with PROSPERO (CRD42022320073). Abstracts were independently screened by two authors for full text review. All outcomes and their definitions were extracted from selected papers. Outcomes with different terminologies were then categorised into an agreed outcome term. The list of agreed outcomes was given a standardised outcome domain and core area using a 38 item standardised taxonomy.
Of 6 184 articles identified, 176 relevant studies were included, yielding 1 325 verbatim outcomes. After deduplication, 72 unique verbatim outcomes were categorised into five broad outcome domains. Outcomes considered key to the evaluation of treatment of ALI were further categorised as delivery of care (19.4%), vascular outcomes (13.8%), and adverse events (12.5%). The three most frequently reported agreed outcomes were amputation (14.1%), death (12.3%), and general bleeding (11.6%).
This systematic review provides an overview of currently reported outcomes in the literature of interventions for ALI. After categorisation into agreed outcome terms, 72 outcomes were identified that can be used in the development of a COS.
急性下肢缺血（ALI）治疗策略的结果数据不一致，阻碍了研究结果的综合分析。核心结局集（COS）可以通过定义一组对所有相关利益方都至关重要的最小结局集来解决这个问题。制定 COS 的第一步是回顾各种 ALI 治疗策略的先前报告结局。
从建库到 2023 年 8 月，检索了 PubMed、Embase、Cochrane 中央对照试验注册库（CENTRAL）和 Web of Science 数据库。
本系统评价按照核心结局测量有效性试验（COMET）倡议框架进行，遵循系统评价和荟萃分析的首选报告项目（PRISMA）指南，并在 PROSPERO（CRD42022320073）上进行了预先注册。两位作者独立筛选摘要进行全文审查。从选定的论文中提取所有结局及其定义。然后将具有不同术语的结局归入商定的结局术语。使用 38 项标准化分类法，将商定的结局列表赋予标准化结局域和核心领域。
在 6184 篇文章中，有 176 篇相关研究被纳入，产生了 1325 个逐字结局。经过去重，72 个独特的逐字结局被分为五个广泛的结局域。被认为对 ALI 治疗评估至关重要的结局进一步分为护理提供（19.4%）、血管结局（13.8%）和不良事件（12.5%）。报告频率最高的三个商定结局是截肢（14.1%）、死亡（12.3%）和一般出血（11.6%）。
本系统评价提供了干预 ALI 文献中报告结局的概述。在分类为商定的结局术语后，确定了 72 个可用于制定 COS 的结局。
