Department of Immunology and Rheumatology, Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City, Mexico.
Department of Pathology, University Health Network, Toronto General Hospital, Canada.
Clin Exp Rheumatol. 2020 Jul-Aug;38 Suppl 126(4):130-133. Epub 2020 Jan 27.
To evaluate the performance of the 2016 ACR-EULAR classification Sjögren's syndrome (SS) criteria for classifying patients with secondary SS.
We randomly selected 300 patients with systemic lupus erythematosus, rheumatoid arthritis and scleroderma, as well as 50 with primary SS. SS diagnosis was established by two independent rheumatologists and was based on the combination of symptoms, signs, diagnostic tests and medical chart review. We evaluated the fulfillment of the 2002 AECG, 2012 ACR and 2016 ACR/EULAR criteria, and their performance using as the gold standard the clinical diagnosis.
We identified 154 patients with a clinical (definitive/probable) SS diagnosis, 95 patients (61.7%) fulfilled the AECG, 96 patients (62.3%) the ACR and 90 (58.4%) the 2016 ACR/EULAR criteria. Among the subset with definitive SS clinical diagnosis (n=99), 83 patients (83.8%) fulfilled the AECG, 77 (77.7%) the ACR and 79 (79.7%) the 2016 ACR/EULAR criteria. The concordance rate between the clinical diagnosis (definitive/probable) and the AECG, ACR and 2016 ACR/ EULAR criteria was κ=0.58, κ=0.55 and κ=0.60, respectively. The 2016 ACR/EULAR criteria showed the best AUCs results (0.87 definitive/probable diagnosis, 0.90 definitive diagnosis), followed by the AECG (0.82 definitive/probable diagnosis, 0.85 definitive diagnosis) and ACR (0.80 definitive/probable diagnosis, 0.79 definitive diagnosis) criteria. As a sensitivity analysis, the results were similar when excluding patients with primary SS.
Our study provides further evidence that the 2016 ACR/EULAR criteria are applicable in the setting of secondary SS.
评估 2016 年 ACR-EULAR 干燥综合征（SS）分类标准对继发性 SS 患者的分类性能。
我们随机选择了 300 例系统性红斑狼疮、类风湿关节炎和硬皮病患者，以及 50 例原发性 SS 患者。SS 的诊断由两名独立的风湿病学家确定，基于症状、体征、诊断试验和病历回顾的组合。我们评估了 2002 年 AECG、2012 年 ACR 和 2016 年 ACR/EULAR 标准的满足情况，并将临床诊断作为金标准评估其性能。
我们确定了 154 例临床（明确/可能）SS 诊断患者，95 例（61.7%）符合 AECG，96 例（62.3%）符合 ACR，90 例（58.4%）符合 2016 年 ACR/EULAR 标准。在明确的 SS 临床诊断亚组（n=99）中，83 例（83.8%）符合 AECG，77 例（77.7%）符合 ACR，79 例（79.7%）符合 2016 年 ACR/EULAR 标准。临床诊断（明确/可能）与 AECG、ACR 和 2016 年 ACR/EULAR 标准之间的一致性率分别为κ=0.58、κ=0.55 和 κ=0.60。2016 年 ACR/EULAR 标准显示出最佳 AUC 结果（0.87 明确/可能诊断，0.90 明确诊断），其次是 AECG（0.82 明确/可能诊断，0.85 明确诊断）和 ACR（0.80 明确/可能诊断，0.79 明确诊断）标准。作为敏感性分析，排除原发性 SS 患者后结果相似。
本研究进一步证明，2016 年 ACR/EULAR 标准适用于继发性 SS。
