Prinsen Cecilia A C, Vohra Sunita, Rose Michael R, King-Jones Susanne, Ishaque Sana, Bhaloo Zafira, Adams Denise, Terwee Caroline B
Department of Epidemiology and Biostatistics, VU University Medical Center, Van der Boechorststraat 7, 1081 BT Amsterdam, The Netherlands.
Trials. 2014 Jun 25;15:247. doi: 10.1186/1745-6215-15-247.
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.
METHODS/DESIGN: 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.
有效性试验核心结局指标（COMET）倡议旨在促进“核心结局集”（COS）的开发与应用。核心结局集是指在特定疾病或试验人群的所有临床试验中都应测量和报告的一组商定的最小结局指标。核心结局测量工具选择（COMIS）项目的总体目标是制定一份关于如何为核心结局集中包含的结局选择测量工具的指南。作为该项目的一部分，我们阐述了目前为就核心结局集中包含的结局选择测量工具的方法达成共识所做的努力。
方法/设计：一个由代表不同利益相关方的国际专家组成的小组正在进行一项德尔菲研究，目的是形成一份结局测量工具选择指南。在文献综述的基础上，制定了一份德尔菲问卷，以确定工具选择中可能相关的任务。德尔菲研究分多轮进行。在第一轮中，要求小组成员对结局测量工具选择中不同任务进行重要性评分。鼓励他们说明选择理由并添加其他相关任务。如果至少70%的小组成员认为一项任务“强烈推荐”或“可取”，且没有反对意见，则达成共识。这些任务将纳入指南。至少50%的小组成员认为“不相关”的任务将从指南中排除。不确定情况的任务将进入第二轮。目前正在汇总第一轮的所有回复，并将在第二轮反馈给小组成员。只有在第二轮结果需要时才会进行第三轮。
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中基于共识的首选方法。基于此咨询过程，将制定一份关于核心结局集中包含的结局的测量工具选择指南。
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