How to select outcome measurement instruments for outcomes included in a "Core Outcome Set" - a practical guideline.
How to select outcome measurement instruments for outcomes included in a "Core Outcome Set" - a practical guideline.
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DOI：
10.1186/s13063-016-1555-2
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发表时间：
2016-09-13
期刊：
影响因子：
2.5
通讯作者：
Terwee CB
中科院分区：
文献类型：
--
作者：
Prinsen CA;Vohra S;Rose MR;Boers M;Tugwell P;Clarke M;Williamson PR;Terwee CB
与有效性试验中的核心结果衡量（COMET）倡议合作，基于常识的健康衡量工具选择标准（COSMIN）倡议旨在制定一项关于如何选择结果衡量工具的指南（即，构建体或结构域）。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。通过文献回顾，以确定潜在的相关任务的结果测量工具的选择，德尔菲研究进行了国际专家小组，代表不同的利益相关者。在连续三轮中，小组成员被要求对不同任务在选择结果测量工具中的重要性进行评级，以证明他们的选择，并添加其他相关任务。当70%或更多的小组成员同意并且少于15%的小组成员不同意时，共识被定义为实现。在481名受邀专家中，120名同意参加，其中95名（79%）完成了第一份德尔菲问卷。我们在选择COS结局测量工具的四个主要步骤上达成了共识：步骤1，概念考虑;步骤2，通过系统综述和/或文献检索找到现有的结局测量工具;步骤3，通过评价结局测量工具的测量特性和可行性方面对结局测量工具进行质量评估;第四步，关于为COS中包含的结果选择结果测量工具的一般性建议（共识范围为70%至99%）。这项研究导致了一个共识为基础的指导方针的方法，选择结果的结果测量工具，包括在COS。COS开发人员可以使用该指南来定义如何度量核心成果。本文的在线版本（doi：10.1186/s13063-016-1555-2）包含补充材料，可供授权用户使用。
In cooperation with the Core Outcome Measures in Effectiveness Trials (COMET) initiative, the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) initiative aimed to develop a guideline on how to select outcome measurement instruments for outcomes (i.e., constructs or domains) included in a “Core Outcome Set” (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. Informed by a literature review to identify potentially relevant tasks on outcome measurement instrument selection, a Delphi study was performed among a panel of international experts, representing diverse stakeholders. In three consecutive rounds, panelists were asked to rate the importance of different tasks in the selection of outcome measurement instruments, to justify their choices, and to add other relevant tasks. Consensus was defined as being achieved when 70 % or more of the panelists agreed and when fewer than 15 % of the panelists disagreed. Of the 481 invited experts, 120 agreed to participate of whom 95 (79 %) completed the first Delphi questionnaire. We reached consensus on four main steps in the selection of outcome measurement instruments for COS: Step 1, conceptual considerations; Step 2, finding existing outcome measurement instruments, by means of a systematic review and/or a literature search; Step 3, quality assessment of outcome measurement instruments, by means of the evaluation of the measurement properties and feasibility aspects of outcome measurement instruments; and Step 4, generic recommendations on the selection of outcome measurement instruments for outcomes included in a COS (consensus ranged from 70 to 99 %). This study resulted in a consensus-based guideline on the methods for selecting outcome measurement instruments for outcomes included in a COS. This guideline can be used by COS developers in defining how to measure core outcomes. The online version of this article (doi:10.1186/s13063-016-1555-2) contains supplementary material, which is available to authorized users.
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影响因子：
3.7
作者：
Gargon E;Gurung B;Medley N;Altman DG;Blazeby JM;Clarke M;Williamson PR
通讯作者：
Williamson PR
影响因子：
2.5
作者：
Williamson PR;Altman DG;Blazeby JM;Clarke M;Devane D;Gargon E;Tugwell P
通讯作者：
Tugwell P
影响因子：
7.2
作者：
Boers, Maarten;Kirwan, John R.;Tugwell, Peter
通讯作者：
Tugwell, Peter
影响因子：
7.2
作者：
Terwee, Caroline B.;Bot, Sandra D. M.;de Vet, Henrica C. W.
通讯作者：
de Vet, Henrica C. W.
影响因子：
3.5
作者：
Mokkink, Lidwine B.;Terwee, Caroline B.;Patrick, Donald L.;Alonso, Jordi;Stratford, Paul W.;Knol, Dirk L.;Bouter, Lex M.;de Vet, Henrica C. W.
通讯作者：
de Vet, Henrica C. W.