Clinical Epidemiology Research and Training Unit, Boston University School of Medicine, Boston, MA 02118, USA.
Arthritis Res Ther. 2012 Jun 29;14(3):R156. doi: 10.1186/ar3896.
In development of the American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) rheumatoid arthritis (RA) remission definitions using clinical trials data, one criterion used to compare different remission definitions was whether, compared with those not in remission, those in remission had evidence of later disease stability defined by x-ray and functional status. Validation of the RA remission criteria using observational study data is necessary before recommending their use in practice.
Using data from those who met RA criteria in the ESPOIR cohort, we matched each person in remission with a person not in remission and then carried out analyses comparing later stability of x-ray and health assessment questionnaire (HAQ) between the two groups. We compared the predictive validity of the same candidate definitions of remission evaluated in the ACR/EULAR process. To minimize potential bias and produce more stable results, we used a bootstrap resampling approach to select those not in remission, repeating the sample matching analysis process 500 times.
Results were similar to those of clinical trials analyzed for the ACR/EULAR remission criteria. Specifically, the ACR/EULAR remission definitions using either an simple disease activity index (SDAI) ≤ 3.3, clinical disease activity index (CDAI) ≤ 2.8 or a definition of remission requiring tender joint count, swollen joint count, patient global assessment all ≤ 1 performed as well or better than other candidate definitions of remission in terms of predicting later x-ray and function stability.
ACR/EULAR definitions of remission developed for trials are similarly valid in observational studies in RA and could be used in practice.
在美国风湿病学会（ACR）/欧洲抗风湿病联盟（EULAR）制定类风湿关节炎（RA）缓解定义的临床试验数据中，用来比较不同缓解定义的标准之一是，与未缓解者相比，缓解者是否有放射学和功能状态定义的后续疾病稳定证据。在推荐这些缓解标准在实践中使用之前，使用观察性研究数据对 RA 缓解标准进行验证是必要的。
使用 ESPOIR 队列中符合 RA 标准的患者数据，我们将每个缓解患者与一个未缓解患者进行匹配，然后对两组患者的放射学和健康评估问卷（HAQ）的后续稳定性进行分析比较。我们比较了在 ACR/EULAR 过程中评估的相同缓解候选定义的预测有效性。为了最小化潜在的偏差并产生更稳定的结果，我们使用自举重采样方法选择未缓解者，重复 500 次样本匹配分析过程。
结果与为 ACR/EULAR 缓解标准进行分析的临床试验相似。具体而言，使用简单疾病活动指数（SDAI）≤3.3、临床疾病活动指数（CDAI）≤2.8或需要压痛关节计数、肿胀关节计数、患者整体评估均≤1 的缓解定义的 ACR/EULAR 缓解定义在预测放射学和功能稳定性方面与其他缓解候选定义一样有效或更好。
为临床试验制定的 ACR/EULAR 缓解定义在 RA 的观察性研究中同样有效，可以在实践中使用。
