Core Outcome Set-STAndards for Development: The COS-STAD recommendations.

Core Outcome Set-STAndards for Development: The COS-STAD recommendations.
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DOI:
10.1371/journal.pmed.1002447
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发表时间:
2017-11
期刊:
影响因子:
15.8
通讯作者:
Williamson PR
Williamson PR
中科院分区:
医学1区
文献类型:
--
作者:
Kirkham JJ;Davis K;Altman DG;Blazeby JM;Clarke M;Tunis S;Williamson PR

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核心结果集 (COS) 的使用可确保研究人员衡量和报告最有可能与其研究用户相关的结果。迄今为止,已系统地确定了数百个 COS 项目,但尚未对这些研究进行正式的质量评估。核心成果集-发展标准 (COS-STAD) 项目旨在确定国际组织商定的 COS 研究设计的最低标准,同时还存在针对 COS 发展研究最终报告的其他具体指南(核心成果集-报告标准 [COS-STAR])。由经验丰富的 COS 开发人员、方法学家、期刊编辑、COS 潜在用户(临床试验人员、系统评价人员和临床指南开发人员)以及患者代表组成的国际小组提出了 COS-STAD 建议,以帮助提高 COS 开发的质量并支持评估 COS 是否使用合理的方法开发。对专家进行的公开调查产生了初步的项目清单,并通过两轮德尔福调查进行了完善,涉及代表主要利益相关群体的近 250 名参与者。参与者使用 1-9 等级对每个项目进行重要性评级。某个项目应包含在最低标准中的共识被定义为每个利益相关者群体中至少 70% 的投票参与者提供 7 到 9 分之间的分数。德尔福调查之后,与代表多个利益相关者群体的研究管理小组进行了共识讨论。 COS-STAD 包含 11 条最低标准,是所有 COS 开发项目的最低设计建议。这些建议重点关注 3 个关键领域:范围、利益相关者和共识过程。 COS-STAD 项目制定了 11 条最低标准,供 COS 开发人员在规划项目时以及用户在决定 COS 是否采用合理方法开发时遵循。 Paula Williamson 及其同事报告了核心成果设定的发展标准,研究人员应使用这些标准来改进其研究报告。
The use of core outcome sets (COS) ensures that researchers measure and report those outcomes that are most likely to be relevant to users of their research. Several hundred COS projects have been systematically identified to date, but there has been no formal quality assessment of these studies. The Core Outcome Set-STAndards for Development (COS-STAD) project aimed to identify minimum standards for the design of a COS study agreed upon by an international group, while other specific guidance exists for the final reporting of COS development studies (Core Outcome Set-STAndards for Reporting [COS-STAR]). An international group of experienced COS developers, methodologists, journal editors, potential users of COS (clinical trialists, systematic reviewers, and clinical guideline developers), and patient representatives produced the COS-STAD recommendations to help improve the quality of COS development and support the assessment of whether a COS had been developed using a reasonable approach. An open survey of experts generated an initial list of items, which was refined by a 2-round Delphi survey involving nearly 250 participants representing key stakeholder groups. Participants assigned importance ratings for each item using a 1–9 scale. Consensus that an item should be included in the set of minimum standards was defined as at least 70% of the voting participants from each stakeholder group providing a score between 7 and 9. The Delphi survey was followed by a consensus discussion with the study management group representing multiple stakeholder groups. COS-STAD contains 11 minimum standards that are the minimum design recommendations for all COS development projects. The recommendations focus on 3 key domains: the scope, the stakeholders, and the consensus process. The COS-STAD project has established 11 minimum standards to be followed by COS developers when planning their projects and by users when deciding whether a COS has been developed using reasonable methods. Paula Williamson and colleagues report on the core outcome set standards for development that researchers should use for improving reporting of their research.
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