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背景通过确保对卫生服务使用者和其他特定领域卫生保健决策者关注的指标进行常规测量,核心指标集(core outcome set,COS)可以提高研究的相关性。到目前为止,已经形成了200多个COS,但这些报告的透明度还不理想。如果COS的报告不够完整和透明,COS研究将无法实现其目标。方法与结果鉴于这些问题,由经验丰富的COS制定者、方法学家、期刊编辑、COS潜在用户(临床试验者、系统评价员和临床指南制定者)以及患者代表组成的一个国际性工作组,制定了核心指标集报告标准(Core Outcome Set-STAndards for Reporting,COS-STAR)声明,作为COS研究报告的指南。其形成过程先后包括初始报告条目产生阶段、代表关键利益相关方群体的200名人员的两轮德尔菲问卷调查,最后是一个共识会议。COS-STAR声明由一个包含18个条目的清单组成,这些条目是确保所有COS研究报告透明度和完整性的必要条目。条目清单重点规范了形成特定COS的研究报告需涉及的前言、方法、结果和讨论部分。COS-STAR声明的一个局限性在于其形成过程中缺乏低、中收入国家的代表性意见。而COS对在这些国家和地区开展的研究具有同等的相关性,故今后该指南可能需要不断完善,以应对这些国家和地区COS形成的任何其他挑战。结论随着COS研究的不断开展,COS-STAR声明将成为提高COS研究报告质量的有力工具,并使所有COS使用者受益。
Background The core outcome set (COS) can increase the relevance of research by ensuring routine measurement of indicators of interest to health service users and other health-care decision makers in specific areas. So far, more than 200 COS have been formed, but the transparency of these reports is not satisfactory. If the COS report is not complete and transparent, COS research will not achieve its goals. Methods and Results In light of these issues, an international working group of experienced COS makers, methodologists, journal editors, potential users of COS (clinical trial, systematic reviewers and clinical guideline developers), and patient representatives, A Core Outcome Set-STAndards for Reporting (COS-STAR) statement was prepared as a guideline for COS research reports. The formation process included two rounds of Delphi surveys of the initial report entry generation phase, the 200-member representation of key stakeholder groups, and finally a consensus meeting. The COS-STAR statement consists of a list of 18 entries that are necessary to ensure the transparency and completeness of all COS research reports. The list of entries focuses on the preface, methods, results, and discussion sections involved in forming the study for a particular COS. One of the limitations of the COS-STAR statement is the lack of representativeness of low- and middle-income countries in its formation. While COS is equally relevant to research conducted in these countries, the guideline may need to be refined in the future to address any additional challenges that COS in these countries may have. CONCLUSIONS As the COS study continues to evolve, the COS-STAR statement will be a powerful tool for improving the quality of COS research reports and will benefit all COS users.