Background

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]).

Methods and findings

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.

Conclusions

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.

中文翻译：

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核心成果集标准：发展标准：COS-STAD建议

背景

核心结果集（COS）的使用可确保研究人员测量和报告最可能与他们的研究用户相关的结果。迄今为止，已经系统地确定了数百个COS项目，但是尚未对这些研究进行正式的质量评估。核心成果集-标准发展计划（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，同时还存在用于最终报告COS发展研究的其他具体指南（核心成果集） -STAndards进行报告[COS-STAR]）。

方法和发现

由经验丰富的COS开发人员，方法学家，期刊编辑，COS的潜在用户（临床试验员，系统评价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COS评估是否已使用合理方法开发了COS。专家的公开调查产生了初步的项目清单，并通过德尔菲进行的两轮调查进行了完善，涉及来自主要利益相关者团体的近250名参与者。参与者使用1–9量表为每个项目分配了重要等级。将一项项目纳入最低标准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，其得分在7到9之间。在进行德尔菲调查之后，与代表多个利益相关者团体的研究管理小组进行了共识性讨论。COS-STAD包含11个最低标准，这是所有COS开发项目的最低设计建议。这些建议集中在三个关键领域：范围，利益相关者和共识过程。

结论

COS-STAD项目已建立11个最低标准，COS开发人员在规划项目时要遵循这些最低标准，而用户在确定是否已使用合理方法开发COS时要遵循这些最低标准。