COS-STAR: a reporting guideline for studies developing core outcome sets (protocol).

COS-STAR: a reporting guideline for studies developing core outcome sets (protocol).
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COS-Star:开发核心结果集(协议)的研究指南。

DOI:
10.1186/s13063-015-0913-9
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发表时间:
2015-08-22
期刊:
影响因子:
2.5
通讯作者:
COS-STAR Group
COS-STAR Group
中科院分区:
医学4区
文献类型:
--
作者:
Kirkham JJ;Gorst S;Altman DG;Blazeby J;Clarke M;Devane D;Gargon E;Williamson PR;COS-STAR Group

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核心结果集可以提高研究的效率和价值,因此,越来越多的研究希望开发核心结果集(COS)。然而,COS的可信度取决于在其制定过程中使用合理的方法,以及对所采用的进程进行明确和透明的报告。到目前为止,还没有关于报告COS研究的报告指南。这一研究方案的目的是为开发气候观测系统的研究制定一个报告准则,并强调这一过程中的一些重要方法考虑。这项研究将包括一个报告准则项目生成阶段,然后将用于一项德尔菲研究。预计德尔菲研究将包括两轮。第一轮将要求利益相关者对列出的项目进行评分,并添加他们认为相关的任何新项目。在第二轮过程中,将分别向参与者展示所有利益相关者群体的得分分布,并要求他们重新评分。将与专家小组和利益相关者代表举行最终共识会议,以审查指南项目清单。在协商一致会议之后,将起草一份报告指南,并将进行审查和测试,直到指南定稿。最终结果将是COS-STAR(核心结果集-报告标准),用于开发COS的研究指南和支持性解释性文件。为了评估气候观测系统的可信度和有用性,气候观测系统发展报告的读者需要关于其方法和拟议的一套核心成果的完整、明确和透明的信息。COS-STAR指南将使COS开发的所有利益相关者受益:COS开发人员,COS用户,例如试验人员和系统评审员,期刊编辑,政策制定者和患者团体。
Core outcome sets can increase the efficiency and value of research and, as a result, there are an increasing number of studies looking to develop core outcome sets (COS). However, the credibility of a COS depends on both the use of sound methodology in its development and clear and transparent reporting of the processes adopted. To date there is no reporting guideline for reporting COS studies. The aim of this programme of research is to develop a reporting guideline for studies developing COS and to highlight some of the important methodological considerations in the process. The study will include a reporting guideline item generation stage which will then be used in a Delphi study. The Delphi study is anticipated to include two rounds. The first round will ask stakeholders to score the items listed and to add any new items they think are relevant. In the second round of the process, participants will be shown the distribution of scores for all stakeholder groups separately and asked to re-score. A final consensus meeting will be held with an expert panel and stakeholder representatives to review the guideline item list. Following the consensus meeting, a reporting guideline will be drafted and review and testing will be undertaken until the guideline is finalised. The final outcome will be the COS-STAR (Core Outcome Set-STAndards for Reporting) guideline for studies developing COS and a supporting explanatory document. To assess the credibility and usefulness of a COS, readers of a COS development report need complete, clear and transparent information on its methodology and proposed core set of outcomes. The COS-STAR guideline will potentially benefit all stakeholders in COS development: COS developers, COS users, e.g. trialists and systematic reviewers, journal editors, policy-makers and patient groups.