Felson D T
Boston University Arthritis Center, Boston University School of Medicine, MA 02118.
J Rheumatol. 1993 Mar;20(3):531-4.
Rheumatoid arthritis (RA) clinical trials often include at least 10 measures of disease activity (e.g., tender and swollen joint counts, erythrocyte sedimentation rate, patient pain, grip strength, etc.), and each trial contains different measures. Using dissimilar disease activity (outcome) measures to assess therapies makes it impossible to judge therapies against a common standard. Furthermore, multiple statistical testing is performed, and outcome measures are often used which are insensitive to change. Ultimately, to compare different RA therapies, the same outcomes should be measured in all trials. In the first stage of an effort to develop a core set of outcome measures to be used in all RA trials, we present an approach to the selection of the measures. This approach is based on a critical evaluation of whether commonly used outcome measures have construct, face, content, criterion, and discriminant validity. In addition, our approach includes testing whether these measures are redundant. Also, selected evidence on the validity of currently used outcome measures is reviewed.
类风湿性关节炎（RA）临床试验通常至少包括10种疾病活动度测量指标（如压痛和肿胀关节计数、红细胞沉降率、患者疼痛程度、握力等），而且每项试验所包含的测量指标各不相同。使用不同的疾病活动度（结果）测量指标来评估治疗方法，使得无法依据共同标准来评判各种治疗方法。此外，还会进行多次统计检验，而且所使用的结果测量指标往往对变化不敏感。最终，为了比较不同的RA治疗方法，所有试验都应测量相同的结果。在努力制定一套可用于所有RA试验的核心结果测量指标的第一阶段，我们提出了一种选择测量指标的方法。该方法基于对常用结果测量指标是否具有结构效度、表面效度、内容效度、标准效度和区分效度的批判性评估。此外，我们的方法还包括检验这些测量指标是否冗余。同时，还会对目前使用的结果测量指标有效性的相关选定证据进行综述。
