van den Berg Rosaline, de Hooge Manouk, Bakker Pauline A C, van Gaalen Floris, Navarro-Compán Victoria, Fagerli Karen Minde, Landewé Robert, van Oosterhout Maikel, Ramonda Roberta, Reijnierse Monique, van der Heijde Désirée
From the Department of Rheumatology, and the Department of Radiology, Leiden University Medical Center, Leiden, the Netherlands; Department of Rheumatology, University Hospital La Paz, Madrid, Spain; Department of Rheumatology, Diakonhjemmet Hospital, Oslo, Norway; Amsterdam Rheumatology Center, Amsterdam; Department of Rheumatology, Groene Hart Ziekenhuis (GHZ) hospital, Gouda, the Netherlands; Rheumatology Unit, Department of Medicine, DIMED University of Padua, Padua, Italy.R. van den Berg, PhD; M. de Hooge, MSc; P.A. Bakker, MD; F. van Gaalen, MD, PhD, Department of Rheumatology, Leiden University Medical Center; V. Navarro-Compán, MD, Department of Rheumatology, Leiden University Medical Center, and Department of Rheumatology, University Hospital La Paz; K.M. Fagerli, MD, PhD, Department of Rheumatology, Diakonhjemmet Hospital; R. Landewé, MD, PhD, Amsterdam Rheumatology Center; M. van Oosterhout, MD, PhD, Department of Rheumatology, GHZ hospital; R. Ramonda, MD, Rheumatology Unit, Department of Medicine, DIMED University of Padua; M. Reijnierse, MD, PhD, Department of Radiology, Leiden University Medical Center; D. van der Heijde, MD, PhD, Department of Rheumatology, Leiden University Medical Center.
J Rheumatol. 2015 Jul;42(7):1186-93. doi: 10.3899/jrheum.140806. Epub 2015 May 1.
To evaluate metric properties of the SpondyloArthritis Research Consortium of Canada (SPARCC) score of the sacroiliac (SI) joints.
Patients with back pain (≥ 3 months, ≤ 2 years, onset < 45 years) were included in the SPACE cohort (SpondyloArthritis Caught Early). Patients with (possible) axial spondyloarthritis had followup visits after 3 and 12 months and were treated according to clinical practice. Magnetic resonance imaging (MRI) of the SI joints (MRI-SI) was scored in 2 independent campaigns (campaign 1: at baseline and 3 months; campaign 2: at baseline, 3 months, and 12 months) by 2 different blinded reader pairs, applying the Assessment of Spondyloarthritis International Society (ASAS) definition (MRI-SI+ vs MRI-SI-; discordant cases were adjudicated by a third reader) and SPARCC score (mean of 2 agreeing readers). Calculations were made for agreement between SPARCC score cutoff values and a consensus judgment of MRI-SI+ (ASAS definition) as external standard, change in SPARCC score, and smallest detectable changes (SDC) over 3 and 12 months.
SPARCC score ≥ 2 showed best agreement with MRI-SI+ in both campaigns. Regarding observed changes in relation to SDC, SPARCC score changed in 70/151 patients; 26/70 patients changed > SDC (3.4), of whom 20 patients received stable treatment over 3 months in campaign 1. Over 3 months, 20/68 patients showed changes in SPARCC score; 11/20 > SDC (2.1), of whom 8 patients received stable treatment. Over 1 year, 23/74 patients changed their SPARCC score; 14/23 changed > SDC (2.4), of whom 7 received stable treatment in campaign 2.
SPARCC score ≥ 2 can be used as surrogate for a consensus judgment of MRI-SI+ (ASAS definition) in clinical trials. The SDC ranged from 2.1-3.4 dependent on reader pair and were close to the proposed minimum important change of 2.5.
评估加拿大脊柱关节炎研究联盟（SPARCC）骶髂关节评分的测量属性。
背痛患者（≥3个月，≤2年，发病年龄<45岁）纳入SPACE队列研究（早期发现的脊柱关节炎）。（可能的）轴性脊柱关节炎患者在3个月和12个月后进行随访，并根据临床实践进行治疗。由2组不同的盲法阅片者对骶髂关节磁共振成像（MRI-SI）进行评分（第1次：基线和3个月时；第2次：基线、3个月和12个月时），采用国际脊柱关节炎评估协会（ASAS）的定义（MRI-SI+与MRI-SI-；不一致的病例由第三位阅片者判定）和SPARCC评分（2位阅片者一致评分的平均值）。计算SPARCC评分临界值与以MRI-SI+的共识判断（ASAS定义）作为外部标准之间的一致性、SPARCC评分的变化以及3个月和12个月期间的最小可检测变化（SDC）。
在两次研究中，SPARCC评分≥2与MRI-SI+的一致性最佳。关于观察到的相对于SDC的变化，151例患者中有70例SPARCC评分发生变化；70例患者中有26例变化>SDC（3.4），其中20例患者在第1次研究的3个月内接受稳定治疗。3个月内，68例患者中有20例SPARCC评分发生变化；20例中有11例变化>SDC（2.1），其中8例患者接受稳定治疗。1年内，74例患者中有23例SPARCC评分发生变化；23例中有14例变化>SDC（2.4），其中7例在第2次研究中接受稳定治疗。
在临床试验中，SPARCC评分≥2可作为MRI-SI+（ASAS定义）共识判断的替代指标。SDC范围为2.1-3.4，取决于阅片者组，且接近提议的最小重要变化值2.5。
