Center of Clinical Epidemiology, Hôpital Hotel Dieu; INSERM U738, Université Paris-René Descartes, Paris, France Department of Rheumatology, INSERM U802, Assistance Publique-Hopitaux de Paris, Hôpital Bicêtre; Université Paris-Sud 11; INSERM U1012, Le Kremlin Bicêtre, France.
Department of Rheumatology, Skane University Hospital Malmö, Lund University, Malmö, Sweden.
Ann Rheum Dis. 2015 May;74(5):859-66. doi: 10.1136/annrheumdis-2013-204615. Epub 2014 Jan 17.
To validate the two recently developed disease activity indexes for assessment of primary Sjögren's syndrome (SS): the European League Against Rheumatism (EULAR) SS Patient Reported Index (ESSPRI) and the EULAR SS Disease Activity Index (ESSDAI).
A prospective international 6-month duration validation study was conducted in 15 countries. At each visit, physicians completed ESSDAI, SS disease activity index (SSDAI), Sjögren's Systemic Clinical Activity Index (SCAI) and physician global assessment (PhGA); and patients completed ESSPRI, Sicca Symptoms Inventory (SSI), Profile of Fatigue and Discomfort (PROFAD) and patient global assessment (PGA). Psychometric properties (construct validity, responsiveness and reliability) were evaluated and compared between scores.
Of the 395 patients included, 145 (37%) and 251 (64%) had currently active or current or past systemic manifestations, respectively. EULAR scores had higher correlation with the gold standard than other scores (ESSDAI with PhGA: r=0.59; ESSRPI with PGA: r=0.70). Correlations between patient and systemic scores were very low (ranging from 0.07 to 0.29). All systemic scores had similar large responsiveness in improved patients. Responsiveness of patient scores was low but was significantly higher for ESSPRI compared with SSI and PROFAD. Reliability was very good for all scores.
ESSDAI and ESSPRI had good construct validity. All scores were reliable. Systemic scores had a large sensitivity to change in patients whose disease activity improves. Patient scores had a small sensitivity to change, however, significantly better for ESSPRI. Systemic and patient scores poorly correlated, suggesting that they are 2 complementary components that should be both evaluated, but separately.
验证两种最近开发的原发性干燥综合征（SS）疾病活动指数，用于评估：欧洲抗风湿病联盟（EULAR）SS 患者报告指数（ESSPRI）和 EULAR SS 疾病活动指数（ESSDAI）。
在 15 个国家进行了一项为期 6 个月的前瞻性国际验证研究。在每次就诊时，医生完成 ESSDAI、SS 疾病活动指数（SSDAI）、干燥综合征系统临床活动指数（SCAI）和医生整体评估（PhGA）；患者完成 ESSPRI、干燥症状评估（SSI）、疲劳和不适量表（PROFAD）和患者整体评估（PGA）。评估和比较了各评分的心理测量特性（构念效度、反应度和信度）。
纳入的 395 例患者中，分别有 145 例（37%）和 251 例（64%）当前存在或当前或过去存在系统性表现。EULAR 评分与金标准的相关性高于其他评分（ESSDAI 与 PhGA：r=0.59；ESSPRI 与 PGA：r=0.70）。患者和系统性评分之间的相关性非常低（范围为 0.07 至 0.29）。所有系统性评分在病情改善的患者中均具有相似的高反应性。患者评分的反应性较低，但 ESSPRI 明显高于 SSI 和 PROFAD。所有评分的信度均非常好。
ESSDAI 和 ESSPRI 具有良好的构念效度。所有评分均可靠。在病情改善的患者中，系统性评分对变化的敏感性较大。然而，患者评分的变化敏感性较低，但 ESSPRI 显著更高。系统性和患者评分相关性较差，表明它们是两个互补的组成部分，应同时评估，但应分别评估。
