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Testing different thresholds for patient global assessment in defining remission for rheumatoid arthritis: are the current ACR/EULAR Boolean criteria optimal?
Annals of the Rheumatic Diseases ( IF 20.3 ) Pub Date : 2020-02-05 , DOI: 10.1136/annrheumdis-2019-216529
Paul Studenic 1 , David Felson 2, 3 , Maarten de Wit 4 , Farideh Alasti 1 , Tanja A Stamm 5 , Josef S Smolen 1 , Daniel Aletaha 6
Affiliation  

Objectives This study aimed to evaluate different patient global assessment (PGA) cut-offs required in the American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) Boolean remission definition for their utility in rheumatoid arthritis (RA). Methods We used data from six randomised controlled trials in early and established RA. We increased the threshold for the 0–10 score for PGA gradually from 1 to 3 in steps of 0.5 (Boolean1.5 to Boolean3.0) and omitted PGA completely (BooleanX) at 6 and 12 months. Agreement with the index-based (Simplified Disease Activity Index (SDAI)) remission definition was analysed using kappa, recursive partitioning (classification and regression tree (CART)) and receiver operating characteristics. The impact of achieving each definition on functional and radiographic outcomes after 1 year was explored. Results Data from 1680 patients with early RA and 920 patients with established RA were included. The proportion of patients achieving Boolean remission increased with higher thresholds for PGA from 12.4% to 19.7% in early and 5.9% to 12.3% in established RA at 6 months. Best agreement with SDAI remission occurred at PGA cut-offs of 1.5 and 2.0, while agreement decreased with higher PGA (CART: optimal agreement at PGA≤1.6 cm; sensitivity of PGA≤1.5 95%). Changing PGA thresholds at 6 months did not affect radiographic progression at 12 months (mean ꙙsmTSS for Boolean, 1.5, 2.0, 2.5, 3.0, BooleanX: 0.35±5.4, 0.38±5.14, 0.41±5.1, 0.37±4.9, 0.34±4.9, 0.27±4.7). However, the proportion attaining HAQ≤0.5 was 90.2%, 87.9%, 85.2%, 81.1%, 80.7% and 73.1% for the respective Boolean definitions. Conclusion Increasing the PGA cut-off to 1.5 cm would provide high consistency between Boolean with the index-based remission; the integer cut-off of 2.0 cm performed similarly.

中文翻译:

在定义类风湿关节炎缓解时测试患者整体评估的不同阈值:当前的 ACR/EULAR 布尔标准是否最佳?

目的 本研究旨在评估美国风湿病学会/欧洲抗风湿病联盟 (ACR/EULAR) 布尔缓解定义所需的不同患者总体评估 (PGA) 临界值在类风湿性关节炎 (RA) 中的应用。方法 我们使用了早期和确诊 RA 中六项随机对照试验的数据。我们将 PGA 0-10 分的阈值逐渐从 1 增加到 3,步长为 0.5(Boolean1.5 到 Boolean3.0),并在 6 个月和 12 个月时完全省略 PGA(BooleanX)。使用 kappa、递归分区(分类和回归树 (CART))和受试者操作特征来分析与基于指数(简化疾病活动指数 (SDAI))缓解定义的一致性。探讨了一年后实现每个定义对功能和放射学结果的影响。结果 纳入了 1680 名早期 RA 患者和 920 名确诊 RA 患者的数据。随着 PGA 阈值的提高,达到布尔缓解的患者比例从早期的 12.4% 增加到 19.7%,在 6 个月时已确诊的 RA 中从 5.9% 增加到 12.3%。与 SDAI 缓解的最佳一致性发生在 PGA 截止值 1.5 和 2.0 时,而一致性随着 PGA 的升高而降低(CART:PGA≤1.6 cm 时的最佳一致性;PGA ≤1.5 95% 的敏感性)。6 个月时更改 PGA 阈值不会影响 12 个月时的放射学进展(Boolean、1.5、2.0、2.5、3.0、BooleanX 的平均值 ꙙsmTSS:0.35±5.4、0.38±5.14、0.41±5.1、0.37±4.9、0.34±4.9、 0.27±4.7)。然而,对于各自的布尔定义,达到HAQ≤0.5的比例分别为90.2%、87.9%、85.2%、81.1%、80.7%和73.1%。结论 将 PGA 截止值增加到 1.5 cm 将提供布尔值与基于指数的缓解之间的高度一致性;2.0 cm 的整数截止值表现类似。
更新日期:2020-02-05
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