Protocol of the COSMIN study: COnsensus-based Standards for the selection of health Measurement INstruments.
Protocol of the COSMIN study: COnsensus-based Standards for the selection of health Measurement INstruments.
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DOI：
10.1186/1471-2288-6-2
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发表时间：
2006-01-24
影响因子：
4
通讯作者：
de Vet, H C W
中科院分区：
文献类型：
--
作者：
Mokkink, L B;Terwee, C B;de Vet, H C W
背景：选择适当的测量仪器取决于仪器的拟定用途、要测量的概念、测量属性（例如内部一致性、再现性、内容和结构有效性、响应性和可解释性）、要求、受试者的负担以及可用仪器的成本。就测量性能而言，对于健康状况测量仪器的测量性能评价还没有足够具体的标准，对于什么是良好的测量性能也没有明确的标准。在本文中，我们描述了 COSMIN 研究的协议，其目标是制定一个清单，其中包含用于选择健康测量仪器的基于共识的标准，包括满足这些标准的明确标准。我们将重点关注与健康相关的患者报告结果（HR-PRO），即在纵向设计中用作结果测量的患者报告的健康测量工具，不包括医疗保健相关的 PRO，例如护理满意度或依从性。 COSMIN 标准将以易于应用的清单的形式提供。方法：将进行一项国际德尔菲研究，以就应评估哪些测量属性以及如何评估测量属性以及良好测量属性的标准达成共识。德尔菲研究将使用两个输入来源：（1）对测量仪器的系统评价中发现的测量属性的属性、标准和标准进行系统评价；（2）对方法论文章进行额外的文献检索，提供标准和标准的综合清单。德尔菲研究将包括四轮（书面）德尔菲研究，由大约 30 名具有临床医学、生物统计学、心理学和流行病学不同背景的专家小组成员组成。随后将通过评估检查表的评估者间再现性对最终检查表进行现场测试。 讨论：由于研究主要是匿名的，因此将避免面对面小组会议中常见的问题，例如某些人在沟通过程中的主导地位。通过进行德尔菲研究并让许多专家参与，清单具有足够可信度以被接受和实施的可能性将会增加。
BACKGROUND: Choosing an adequate measurement instrument depends on the proposed use of the instrument, the concept to be measured, the measurement properties (e.g. internal consistency, reproducibility, content and construct validity, responsiveness, and interpretability), the requirements, the burden for subjects, and costs of the available instruments. As far as measurement properties are concerned, there are no sufficiently specific standards for the evaluation of measurement properties of instruments to measure health status, and also no explicit criteria for what constitutes good measurement properties. In this paper we describe the protocol for the COSMIN study, the objective of which is to develop a checklist that contains COnsensus-based Standards for the selection of health Measurement INstruments, including explicit criteria for satisfying these standards. We will focus on evaluative health related patient-reported outcomes (HR-PROs), i.e. patient-reported health measurement instruments used in a longitudinal design as an outcome measure, excluding health care related PROs, such as satisfaction with care or adherence. The COSMIN standards will be made available in the form of an easily applicable checklist.METHOD: An international Delphi study will be performed to reach consensus on which and how measurement properties should be assessed, and on criteria for good measurement properties. Two sources of input will be used for the Delphi study: (1) a systematic review of properties, standards and criteria of measurement properties found in systematic reviews of measurement instruments, and (2) an additional literature search of methodological articles presenting a comprehensive checklist of standards and criteria. The Delphi study will consist of four (written) Delphi rounds, with approximately 30 expert panel members with different backgrounds in clinical medicine, biostatistics, psychology, and epidemiology. The final checklist will subsequently be field-tested by assessing the inter-rater reproducibility of the checklist.DISCUSSION: Since the study will mainly be anonymous, problems that are commonly encountered in face-to-face group meetings, such as the dominance of certain persons in the communication process, will be avoided. By performing a Delphi study and involving many experts, the likelihood that the checklist will have sufficient credibility to be accepted and implemented will increase.