2016 American College of Rheumatology/European League Against Rheumatism Classification Criteria for Primary Sjögren's Syndrome: A Consensus and Data-Driven Methodology Involving Three International Patient Cohorts.
2016 American College of Rheumatology/European League Against Rheumatism Classification Criteria for Primary Sjögren's Syndrome: A Consensus and Data-Driven Methodology Involving Three International Patient Cohorts.
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DOI：
10.1002/art.39859
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发表时间：
2017-01
期刊：
影响因子：
--
通讯作者：
International Sjögren's Syndrome Criteria Working Group
中科院分区：
文献类型：
--
作者：
Shiboski CH;Shiboski SC;Seror R;Criswell LA;Labetoulle M;Lietman TM;Rasmussen A;Scofield H;Vitali C;Bowman SJ;Mariette X;International Sjögren's Syndrome Criteria Working Group
采用美国风湿病学会（ACR）和欧洲抗风湿联盟（EULAR）的指南，制定并验证原发性干燥综合征（pSS）的一套国际分类标准。这些标准针对具有提示SS的体征/症状的个体。我们分配初步的重要性权重的候选标准项目的共识列表使用多标准决策分析。我们使用pSS病例和非SS对照的现有队列数据测试并调整了所得标准草案，病例/非病例状态来自专家临床判断。然后，我们在一个单独的患者队列中验证了分类标准的性能。最终分类标准基于5项的加权和：抗SSA（Ro）抗体阳性和局灶性淋巴细胞性涎腺炎，病灶评分≥ 1个病灶/mm 2，各评分3分;异常眼部染色评分≥ 5分（或货车Bijsterveld评分≥ 4分），Schirmer试验≤ 5 mm/5 min，未刺激唾液流速≤ 0.1 mL/min，各评分1分。上述项目总分≥ 4的个体（具有提示SS的体征/症状）符合pSS标准。在最终验证队列中，针对临床医生-专家推导的病例/非病例状态的灵敏度和特异性较高：分别为96%（95% CI：92%，98%）和95%（95% CI：92%，97%）。使用与最近ACR/EULAR批准的其他分类标准一致的方法，我们开发了一套数据驱动的pSS共识分类标准，该标准在验证中表现良好，非常适合作为临床试验的入选标准。
To develop and validate an international set of classification criteria for primary Sjögren’s Syndrome (pSS) using guidelines from the American College of Rheumatology (ACR) and the European League Against Rheumatism (EULAR). These criteria target individuals with signs/symptoms suggestive of SS. We assigned preliminary importance weights to a consensus list of candidate criteria items using multi-criteria decision analysis. We tested and adapted the resulting draft criteria using existing cohort data on pSS cases and non-SS controls, with case/non-case status derived from expert clinical judgment. We then validated the performance of the classification criteria in a separate cohort of patients. The final classification criteria are based on the weighted sum of 5 items: anti-SSA(Ro) antibody positivity and focal lymphocytic sialadenitis with a focus score ≥ 1 foci/mm2, each scoring 3; an abnormal ocular staining score ≥ 5 (or van Bijsterveld score ≥ 4), a Schirmer test ≤ 5 mm/5 min, and an unstimulated salivary flow rate ≤ 0.1 mL/min, each scoring 1. Individuals (with signs/symptoms suggestive of SS) who have a total score ≥ 4 for the items above, meet the criteria for pSS. Sensitivity and specificity against clinician-expert derived case/non-case status in the final validation cohort were high: 96% (95% CI: 92%, 98%), and 95% (95% CI: 92%, 97%), respectively. Using methodology consistent with other recent ACR/EULAR-approved classification criteria, we developed a single set of data-driven consensus classification criteria for pSS, that performed well in validation, and are well-suited as entry criteria for clinical trials.
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影响因子：
5
作者：
Coopman, Renaat;Speeckaert, Marijn M.;Delanghe, Joris R.
通讯作者：
Delanghe, Joris R.
影响因子：
3
作者：
Vidovic, Andelko;Juras, Danica Vidovic;Sabioncello, Ante
通讯作者：
Sabioncello, Ante
影响因子：
5
作者：
Aps, JKM;Van den Maagdenberg, K;Martens, LC
通讯作者：
Martens, LC
影响因子：
3.9
作者：
Selifanova, Elena;Beketova, Tatjana;Turkina, Anna
通讯作者：
Turkina, Anna
影响因子：
27.4
作者：
Shiboski, Caroline H.;Shiboski, Stephen C.;Mariette, Xavier
通讯作者：
Mariette, Xavier