Core Outcome Set–STAndards for Reporting: The COS-STAR Statement

BackgroundCore outcome sets (COS) can enhance the relevance of research by ensuring that outcomes of importance to health service users and other people making choices about health care in a particular topic area are measured routinely. Over 200 COS to date have been developed, but the clarity of these reports is suboptimal. COS studies will not achieve their goal if reports of COS are not complete and transparent.Methods and FindingsIn recognition of these issues, an international group that included experienced COS developers, methodologists, journal editors, potential users of COS (clinical trialists, systematic reviewers, and clinical guideline developers), and patient representatives developed the Core Outcome Set–STAndards for Reporting (COS-STAR) Statement as a reporting guideline for COS studies. The developmental process consisted of an initial reporting item generation stage and a two-round Delphi survey involving nearly 200 participants representing key stakeholder groups, followed by a consensus meeting. The COS-STAR Statement consists of a checklist of 18 items considered essential for transparent and complete reporting in all COS studies. The checklist items focus on the introduction, methods, results, and discussion section of a manuscript describing the development of a particular COS. A limitation of the COS-STAR Statement is that it was developed without representative views of low- and middle-income countries. COS have equal relevance to studies conducted in these areas, and, subsequently, this guideline may need to evolve over time to encompass any additional challenges from developing COS in these areas.ConclusionsWith many ongoing COS studies underway, the COS-STAR Statement should be a helpful resource to improve the reporting of COS studies for the benefit of all COS users.背景 核心结局指标集（Core Outcome Sets, COS）可通过确保常规测量对卫生服务使用者及特定主题领域内医疗决策相关方具有重要性的结局指标，提升研究的相关性。截至目前，已开发出200余项COS，但相关报告的清晰度欠佳。若COS的研究报告不够完整透明，COS相关研究便无法达成其既定目标。 方法与结果 鉴于上述问题，一个由资深COS开发者、方法学家、期刊编辑、COS潜在使用者（临床试验研究者、系统综述制作者与临床指南制定者）以及患者代表组成的国际工作组，制定了核心结局指标集报告规范（Core Outcome Set–STAndards for Reporting, 简称COS-STAR），作为COS研究的报告指南。其制定流程包括初始报告条目生成阶段、两轮涵盖近200名关键利益相关方代表的德尔菲调查，以及一次共识会议。COS-STAR规范包含一份共18项条目的清单，这些条目被认为是所有COS研究实现透明化、完整化报告的必备要素。该清单条目聚焦于描述特定COS开发过程的稿件的引言、方法、结果与讨论部分。COS-STAR规范的一项局限在于，其制定过程未纳入中低收入国家的代表性意见。由于COS对这些地区开展的研究同样具有重要意义，该指南后续或需随时间演进，以涵盖在这些地区开发COS时可能遇到的额外挑战。 结论 鉴于当前有大量COS相关研究正在推进，COS-STAR规范可作为一项实用资源，助力改善COS研究的报告质量，惠及所有COS使用者。