原文

译文

Metrological Properties of Composite Scoring Systems for Synovitis in Rheumatoid Arthritis: Results From a Randomized, Prospective, Multicentre Study

Peter Mandl ¹, Peter V. Balint², Yves Brault³, Marina Backhaus⁴, Maria-Antonietta D'Agostino⁵, Walter Grassi⁶, Désirée van der Heijde⁷, Eugenio De Miguel⁸, Richard J. Wakefield⁹, Isabelle Logeart³ and Maxime Dougados¹⁰, ¹Medical University of Vienna, Vienna, Austria, ²National Institute of Rheumatology and Physiotherapy, Budapest, Hungary, ³Pfizer, Paris, France, ⁴Charite University Hospital, Berlin, Germany, ⁵Versailles-Saint Quentin en Yvelines University- APHP, Ambroise-Paré Hospital, Boulogne-Billancourt, France, ⁶Università Politecnica delle Marche, Jesi, Italy, ⁷Department of Rheumatology, Leiden University Medical Center, Leiden, Netherlands, ⁸La Paz University Hospital, Madrid, Spain, ⁹Leeds Institute of Molecular Medicine, University of Leeds and NIHR Leeds Musculoskeletal Biomedical Research Unit, Leeds Teaching Hospitals, Leeds, United Kingdom, ¹⁰Paris-Descartes University, Cochin Hospital, Paris, France

Presentation Number: 174

Background/Purpose: To propose different global composite scoring systems for measuring synovitis in rheumatoid arthritis (RA), utilizing information derived from clinical, grey-scale ultrasound (GS) and Power Doppler ultrasound (PD) examination. To evaluate intra-observer reliability, face validity, predictive validity and discriminant capacity as compared to DAS28 and SDAI. To assess the classification of patients according to disease activity using the various composite scoring systems.

Method: This 52-week, prospective, open-label, randomized, parallel-group, multicenter, outpatient study was conducted in RA subjects with moderate disease receiving etanercept (ETN) combined with methotrexate or various DMARDs. A total of 12 different scoring systems were evaluated, based on clinical, GS and PD-derived data, and calculated according to the DAS28 or SDAI indices. In the composite indices the 28-swollen joint count (SJC) was either replaced by the number of swollen joints showing also signs of synovitis on either GS and/or PD, or supplemented by joints deemed non-swollen on clinical examination in which the presence of synovitis was detected by either GS and/or PD (Table 1). Intra-observer reliability of each proposed synovitis scoring system was calculated by intraclass correlation coefficient and standard error of measurement. Face validity was evaluated as the degree of association between CRP or ESR and each scoring system, and was assessed using Pearson's correlation coefficient. For discriminant capacity the ETN and the conventional DMARD treatment groups were evaluated separately and the difference in standardized response mean was calculated between baseline and week 12.

Result: Data from 62 patients were analyzed. Reliability, face validity and discriminative capacity were found to be similar for the composite indices as compared to their respective, clinical data-based counterparts. Using composite indices in which the SJC was supplemented also by joints in which synovitis was detected by either GS and/or PD, a significantly larger number of patients could be classified as having high disease activity at the screening visit (Table 1).

Conclusion: Composite scoring systems had similar metrological properties as their clinical counterparts but allowed for a significantly larger number of patients to be reclassified to either high or moderate disease activity at the screening visit, thus influencing eligibility for biologic therapy.

评价RA滑膜炎的综合评分系统的计量学特点: 来自一项随机、前瞻、多中心研究的结果

Mandl P, et al. ACR 2011. Present No: 174.

背景/目的: 应用临床、灰阶超声(GS)、能量多普勒超声(PD)检查的信息, 提出不同的测量类风湿关节炎(RA) 滑膜炎的全面综合评价系统。评价与DAS28和SDAI相比, 不同系统的可靠性、表面效度、预测效用和判别能力。并评价依据不同积分系统的疾病活动度分类的患者。

方法: 这项为期52周、前瞻性、开放、随机、平行对照、多中心的门诊病人研究, 对接受依那西普(ETN)联合甲氨蝶呤或各种DMARDs治疗的中度RA患者进行问卷调查。根据临床、GS和PD数据及DAS28或SDAI值共评价了12个不同的积分系统。参数中28关节肿胀计数(SJC) 可以用GS和/或PD显示滑膜炎并有临床表现的关节数代替, 也可以用临床检查无肿胀但GS和/或PD证实有滑膜炎的关节数进行补充(表1)。通过组内相关系数和标准测量误差计算不同滑膜积分系统间的可靠性。表面效度的评价依据Pearson相关系数计算其与CRP或ESR以及其他评分系统的相关性。对ETN和DMARD传统治疗组分别进行判别能力的评价, 并计算基线值和12周之间的标准治疗反应差值。

结果: 对62例患者的数据进行了分析。综合指数与其回顾性临床数据的可靠性相类似。应用综合指数, 更多的患者可能在筛选时就被分类为高活动度, 因为SJC中增加了GS和/或PD检测到的滑膜炎关节（表1）。

结论: 综合得分系统计量属性与临床指标相似, 但可以在基线时分类出更大数量的中到重度活动的患者, 从而影响生物疗法的适用范围。