Buchbinder R, Bombardier C, Yeung M, Tugwell P
Wellesley Hospital Research Institute, University of Toronto, Ontario, Canada.
Arthritis Rheum. 1995 Nov;38(11):1568-80. doi: 10.1002/art.1780381108.
To determine the discriminant validity of the core set of outcome measures proposed by the American College of Rheumatology (ACR) and the Outcome Measures in Clinical Trials (OMERACT) conference committee to be used in clinical trials of rheumatoid arthritis (RA).
Utilizing data from a multicenter randomized double-blind clinical trial of low-dose cyclosporine and placebo in RA, we estimated the relative efficiency (RE) of measures to detect a treatment effect (relative to tender joint count, which was assigned a value of 1). Four pain measures (10-cm visual analog scale [VAS], 5-point categorical scale, Health Assessment Questionnaire [HAQ] pain index, Arthritis Impact Measurement Scales [AIMS] pain score) and 3 quality-of-life measures (Problem Elicitation Technique [PET], HAQ, AIMS) were compared.
Physician and patient global measures were the most responsive instruments, although neither was statistically superior to tender joint count. Swollen joint count, grip strength, pain measured on a 10-cm VAS, and functional status as measured by the PET and HAQ were all of intermediate responsiveness. Morning stiffness, 5-point pain scale, and erythrocyte sedimentation rate were the least responsive instruments.
This study provides further evidence to support the core set of outcome measures proposed by the ACR and OMERACT:
确定美国风湿病学会（ACR）和临床试验疗效指标（OMERACT）会议委员会提出的用于类风湿关节炎（RA）临床试验的核心疗效指标集的判别效度。
利用一项关于低剂量环孢素和安慰剂治疗RA的多中心随机双盲临床试验的数据，我们估计了各指标检测治疗效果的相对效率（RE）（相对于压痛关节计数，其赋值为1）。比较了4项疼痛指标（10厘米视觉模拟量表[VAS]、5分分类量表、健康评估问卷[HAQ]疼痛指数、关节炎影响测量量表[AIMS]疼痛评分）和3项生活质量指标（问题引出技术[PET]、HAQ、AIMS）。
医生和患者整体评估指标是反应最灵敏的工具，尽管在统计学上两者均不优于压痛关节计数。肿胀关节计数、握力、10厘米VAS测量的疼痛以及PET和HAQ测量的功能状态反应性均处于中等水平。晨僵、5分疼痛量表和红细胞沉降率是反应最不灵敏的工具。
本研究提供了进一步的证据来支持ACR和OMERACT提出的核心疗效指标集：
