Determining the Minimally Important Difference in the Clinical Disease Activity Index for Improvement and Worsening in Early Rheumatoid Arthritis Patients
Determining the Minimally Important Difference in the Clinical Disease Activity Index for Improvement and Worsening in Early Rheumatoid Arthritis Patients
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DOI：
10.1002/acr.22606
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发表时间：
2015-10-01
影响因子：
4.7
通讯作者：
Bykerk, V. P.
中科院分区：
文献类型：
--
作者：
Curtis, J. R.;Yang, S.;Bykerk, V. P.
目标。类风湿性关节炎(RA)疾病活动性量化的简化方法被越来越多地使用。一些指标的最小临床重要差异(MCID)，如临床疾病活动指数(CDAI)，在现实世界的临床环境中尚未得到很好的定义，特别是对于疾病活动程度较低/中等的早期RA患者。来自加拿大早期关节炎队列患者的数据被用来检查登记后第一年CDAI的绝对变化，按疾病活动分层。以患者自我报告的改善或恶化为金标准，得出MCID分界点，以优化敏感性和特异性的总和。根据患者自我报告的改善情况(金标准)以及疼痛变化、健康评估问卷(HAQ)和28个关节疾病活动评分(DAS28)的改善情况，计算敏感度、特异度、阳性预测值和阴性预测值。使用接收器操作员曲线下的面积来检验辨别能力。对于疾病活跃度低的患者，使用类似的方法评估MCID的恶化情况。共有578名患者(平均+/-SD年龄54.1+/-15.3岁，75%女性，中位数[四分位数范围]疾病持续5.3[3.3，8.0]个月)为改善分析贡献了1,169对就诊对。MCID改善的临界点是12(疾病活动性高的患者：CDAI&>22)，6(中度：CDAI 10-22)，1(低疾病活跃度：CDAI
Objective. Simplified measures to quantify rheumatoid arthritis (RA) disease activity are increasingly used. The minimum clinically important differences (MCID) for some measures, such as the Clinical Disease Activity Index (CDAI), have not been well-defined in real-world clinic settings, especially for early RA patients with low/moderate disease activity.Methods. Data from Canadian Early Arthritis Cohort patients were used to examine absolute change in CDAI in the first year after enrollment, stratified by disease activity. MCID cut points were derived to optimize the sum of sensitivity and specificity versus the gold standard of patient self-reported improvement or worsening. Sensitivity, specificity, positive predictive values, and negative predictive values were calculated against patient self-reported improvement (gold standard) and for change in pain, Health Assessment Questionnaire (HAQ), and Disease Activity Score in 28 joints (DAS28) improvement. Discrimination was examined using the area under receiver operator curves. Similar methods were used to evaluate MCIDs for worsening for patients who achieved low disease activity.Results. A total of 578 patients (mean +/- SD age 54.1 +/- 15.3 years, 75% women, median [interquartile range] disease duration 5.3 [3.3, 8.0] months) contributed 1,169 visit pairs to the improvement analysis. The MCID cut points for improvement were 12 (patients starting in high disease activity: CDAI >22), 6 (moderate: CDAI 10-22), and 1 (low disease activity: CDAI