Core Outcome Measures in Effectiveness Trials (COMET) initiative: protocol for an international Delphi study to achieve consensus on how to select outcome measurement instruments for outcomes included in a 'core outcome set'.

Core Outcome Measures in Effectiveness Trials (COMET) initiative: protocol for an international Delphi study to achieve consensus on how to select outcome measurement instruments for outcomes included in a 'core outcome set'.
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DOI:
10.1186/1745-6215-15-247
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发表时间:
2014-06-25
期刊:
影响因子:
2.5
通讯作者:
Terwee CB
Terwee CB
中科院分区:
医学4区
文献类型:
--
作者:
Prinsen CA;Vohra S;Rose MR;King-Jones S;Ishaque S;Bhaloo Z;Adams D;Terwee CB

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有效性试验的核心结果指标(COMET)倡议旨在促进“核心结果集”(COS)的开发和应用。COS是一组商定的最低限度结局,应在特定疾病或试验人群的所有临床试验中进行测量和报告。核心成果衡量工具选择项目的总体目标是制定一项准则,指导如何为纳入COS的成果选择成果衡量工具。作为该项目的一部分,我们描述了我们目前的努力,以实现共识的方法选择结果的结果测量工具,将包括在COS。一个代表不同利益攸关方的国际专家小组正在进行一项德尔菲研究,目的是为成果计量工具的选择制定一项准则。通过文献回顾,德尔菲问卷调查,以确定潜在的相关任务的工具选择。德尔菲研究分几轮进行。在第一轮中,小组成员被要求在选择结果测量工具时对不同任务的重要性进行评级。鼓励他们说明选择的理由,并增加其他相关任务。如果至少有70%的小组成员认为一项任务是“高度推荐”或“可取的”,并且没有提供反对意见,则达成共识。这些任务将包括在指南中。至少50%的小组成员认为“不相关”的任务将被排除在指南之外。不确定的任务将被带到第二轮。目前正在汇总第一轮的所有答复,并将在第二轮中反馈给小组成员。只有在第二轮的结果需要的情况下,才会进行第三轮。由于德尔菲法允许大量国际专家参与,我们认为它是我们研究的首选共识法。在这一磋商进程的基础上,将制定一项准则,指导如何选择将纳入COS的成果的工具。
The Core Outcome Measures in Effectiveness Trials (COMET) initiative aims to facilitate the development and application of ‘core outcome sets’ (COS). A COS is an agreed minimum set of outcomes that should be measured and reported in all clinical trials of a specific disease or trial population. The overall aim of the Core Outcome Measurement Instrument Selection (COMIS) project is to develop a guideline on how to select outcome measurement instruments for outcomes included in a COS. As part of this project, we describe our current efforts to achieve a consensus on the methods for selecting outcome measurement instruments for outcomes to be included in a COS. A Delphi study is being performed by a panel of international experts representing diverse stakeholders with the intention that this will result in a guideline for outcome measurement instrument selection. Informed by a literature review, a Delphi questionnaire was developed to identify potentially relevant tasks on instrument selection. The Delphi study takes place in a series of rounds. In the first round, panelists were asked to rate the importance of different tasks in the selection of outcome measurement instruments. They were encouraged to justify their choices and to add other relevant tasks. Consensus was reached if at least 70% of the panelists considered a task ‘highly recommended’ or ‘desirable’ and if no opposing arguments were provided. These tasks will be included in the guideline. Tasks that at least 50% of the panelists considered ‘not relevant’ will be excluded from the guideline. Tasks that were indeterminate will be taken to the second round. All responses of the first round are currently being aggregated and will be fed back to panelists in the second round. A third round will only be performed if the results of the second round require it. Since the Delphi method allows a large group of international experts to participate, we consider it to be the preferred consensus-based method for our study. Based upon this consultation process, a guideline will be developed on instrument selection for outcomes to be included in a COS.
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发表时间: 1998-09-01
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