Section of Biostatistics, Department of Public Health, University of Copenhagen, Copenhagen, Denmark.
Section for Sports Traumatology M51, Bispebjerg and Frederiksberg Hospital, Copenhagen, Denmark.
Scand J Med Sci Sports. 2021 Jun;31(6):1225-1238. doi: 10.1111/sms.13908. Epub 2021 Jan 22.
The aim was to provide an overview of the different statistical methods for validation of patient-reported outcome measures, ranging from simple statistical methods available in all software packages to advanced statistical models that require specialized software. A non-technical summary of classical test theory (CTT) and modern test theory (MTT) is provided. Specifically, confirmatory factor analysis, item response theory, and Rasch analysis is outlined. One CTT and three MTT methods were used to validate the two subscales (Symptoms and Quality of Life) from the Knee Injury and Osteoarthritis Outcome Score (KOOS). For each methodology, two analyses were considered: (i) a unidimensional analysis ignoring the pre-specified dimensionality, and (ii) a two-dimensional analysis using the pre-specified dimensionality. While CTT did not adequately address central issues regarding the validity of the KOOS subscales, the three MTT methods yielded very similar results. In conclusion, MTT methods offer analysis of all relevant properties related to the validity of patient-reported outcome measures, while this is not the case for CTT. Claims about sufficient validity based on CTT methods are inadequate and should not be trusted.
目的是提供一个对患者报告结局测量验证的不同统计方法的概述，从所有软件包中都可用的简单统计方法到需要专门软件的高级统计模型。提供了经典测试理论（CTT）和现代测试理论（MTT）的非技术摘要。具体来说，验证性因子分析、项目反应理论和 Rasch 分析进行了概述。使用一种 CTT 和三种 MTT 方法来验证膝关节损伤和骨关节炎结果评分（KOOS）的两个分量表（症状和生活质量）。对于每种方法学，考虑了两种分析：（i）不考虑预先指定的维度的单维分析，以及（ii）使用预先指定的维度的二维分析。虽然 CTT 没有充分解决 KOOS 分量表有效性的核心问题，但三种 MTT 方法得出了非常相似的结果。总之，MTT 方法提供了与患者报告结局测量有效性相关的所有相关属性的分析，而 CTT 则没有。基于 CTT 方法的充分有效性的说法是不充分的，不应被信任。
