Overview of classical test theory and item response theory for the quantitative assessment of items in developing patient-reported outcomes measures.
Overview of classical test theory and item response theory for the quantitative assessment of items in developing patient-reported outcomes measures.
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DOI：
10.1016/j.clinthera.2014.04.006
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发表时间：
2014-05
影响因子：
3.2
通讯作者：
Hays RD
中科院分区：
文献类型：
--
作者：
Cappelleri JC;Jason Lundy J;Hays RD
美国食品药品监督管理局的患者报告结局（PRO）指南文件将内容有效性定义为“工具测量感兴趣概念的程度”（FDA，2009，第12页）。“建构效度现在通常被视为心理测量的统一形式的效度，包括内容效度和标准效度”（Strauss & Smith，2009，第7页）。因此，在评价措施的有效性时，质量和数量信息都是必不可少的。我们回顾了经典的测试理论和项目反应理论的方法来评估PRO措施，包括频率的反应，每个类别的项目在一个多项目的规模，规模分数的分布，地板和天花板效应，项目反应选项和总分之间的关系，以及在何种程度上假设的“困难”（严重程度）的项目顺序所代表的观察到的反应。经典的测试理论和项目反应理论可以提供一个定量评估的项目和规模在内容效度阶段的病人报告的结果措施是有用的。根据具体的措施类型和具体情况，应考虑其中一种或两种方法，以帮助最大限度地提高PRO措施的内容有效性。
The U.S. Food and Drug Administration’s patient-reported outcome (PRO) guidance document defines content validity as “the extent to which the instrument measures the concept of interest” (FDA, 2009, p. 12). “Construct validity is now generally viewed as a unifying form of validity for psychological measurements, subsuming both content and criterion validity” (Strauss & Smith, 2009, p. 7). Hence both qualitative and quantitative information are essential in evaluating the validity of measures. We review classical test theory and item response theory approaches to evaluating PRO measures including frequency of responses to each category of the items in a multi-item scale, the distribution of scale scores, floor and ceiling effects, the relationship between item response options and the total score, and the extent to which hypothesized “difficulty” (severity) order of items is represented by observed responses. Classical test theory and item response theory can be useful in providing a quantitative assessment of items and scales during the content validity phase of patient-reported outcome measures. Depending on the particular type of measure and the specific circumstances, either one or both approaches should be considered to help maximize the content validity of PRO measures.
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