内容效度是成果测度的基本要求。在审查了业务需求和现有定义后,内容有效性我们被定义为:在多大程度上,一项措施在定义的范围内对指定结构或属性的关键相关元素进行全面和真实的评估,对于既定的目标受众和背景,这是明确和公平的。2002年,2005年和2019年的ICF联系规则为描述和评估结果指标的内容提供了越来越清晰的流程。ICF核心集提供了对不同健康状况重要的核心结构的国际参考标准。在内容验证期间,两者作为参考标准都很重要。为了总结它们作为参考标准的用途,提出了以下汇总指标:(1)衡量ICF联系,(2)衡量(简要或全面)核心集绝对联系,(3)测量(简要或全面)核心集独特的联系,(4)核心集表示,和(5)核心集独特的残疾表示。需要评估受访者如何参与内容的方法来补充ICF链接。认知访谈是一种理想的方法,因为它用于探索受访者如何根据结果衡量标准解释和校准对单个项目的反应。我们提出了一个对这些响应进行分类的框架:清晰度/理解,相关性,响应定义不充分,参考点,透视修改,和校准跨项目。我们对24份使用ICF链接进行内容验证的手稿进行了分析,因为更新的链接规则发布后发现,作者通常使用链接来验证现有措施,涉及多个评估者,使用2005年的链接规则,概念级别的汇总内容(例如,减值,活动,参与)和/或使用核心集作为参考标准。很少,ICF链接用于创建新措施的项目池/概念框架,应用了2019年链接规则的全部范围,使用的汇总指标,或与认知访谈等定性方法进行综合ICF链接。我们得出的结论是,ICF链接是在PROM开发或验证过程中实现内容有效性的强大工具。最佳做法包括使用更新的ICF链接规则,ICF的三角剖分与参与者对清晰度和相关性的评估相联系,最好使用认知访谈方法获得,以及定义的汇总指标的应用。
Content validity is a fundamental requirement of outcome measures. After reviewing operational needs and existing definitions, content validity we as defined as: the extent to which a measure provides a comprehensive and true assessment of the key relevant elements of a specified construct or attribute across a defined range, clearly and equitably for a stated target audience and context. ICF linkage rules from 2002, 2005, and 2019 have provide increasingly clear processes for describing and evaluating content of outcome measures. ICF Core Sets provide international reference standards of the core constructs of importance for different health conditions. Both are important as reference standards during content validation. To summarize their use as reference standards, the following summary indicators were proposed: (1) Measure to ICF linkage, (2) Measure to (Brief or Comprehensive) Core Set Absolute Linkage, (3) Measure to (Brief or Comprehensive) Core Set Unique Linkage, (4) Core Set Representation, and (5) Core Set Unique Disability Representation. Methods to assess how respondents engage with content are needed to complement ICF-
linking. Cognitive interviewing is an ideal method since it used to explore how respondents interpret and calibrate response to individual items on an outcome measure. We proposed a framework for classifying these responses: Clarity/Comprehension, Relevance, Inadequate response definition, Reference Point, Perspective modification, and Calibration Across Items. Our analysis of 24 manuscripts that used ICF
linking for content validation since updated
linking rules were published found that authors typically used linking to validate existing measures, involved multiple raters, used 2005
linking rules, summarized content at a concept level (e.g., impairment, activity, participation) and/or use core sets as a reference standard. Infrequently, ICF linking was used to create item pools/conceptual frameworks for new measures, applied the full scope of the 2019
linking rules, used summary indicators, or integrated ICF-
linking with qualitative methods like cognitive interviews. We conclude that ICF linkage is a powerful tool for content validity during development or validation of PROM. Best practices include use of updated ICF
linking rules, triangulation of ICF
linking with participant assessments of clarity and relevance preferably obtained using cognitive interview methods, and application of defined summary indicators.