Department of Rheumatology, Medical University of Graz, Graz, Steiermark, Austria
Department of Rheumatology, Brunico Hospital, Brunico, Trentino-Alto Adige, Italy.
Ann Rheum Dis. 2023 Apr;82(4):556-564. doi: 10.1136/ard-2022-223367. Epub 2022 Dec 12.
To develop an Outcome Measures in Rheumatology (OMERACT) ultrasonography score for monitoring disease activity in giant cell arteritis (GCA) and evaluate its metric properties.
The OMERACT Instrument Selection Algorithm was followed. Forty-nine members of the OMERACT ultrasonography large vessel vasculitis working group were invited to seven Delphi rounds. An online reliability exercise was conducted using images of bilateral common temporal arteries, parietal and frontal branches as well as axillary arteries from 16 patients with GCA and 7 controls. Sensitivity to change and convergent construct validity were tested using data from a prospective cohort of patients with new GCA in which ultrasound-based intima-media thickness (IMT) measurements were conducted at weeks 1, 3, 6, 12 and 24.
Agreement was obtained (92.7%) for the OMERACT GCA Ultrasonography Score (OGUS), calculated as follows: sum of IMT measured in every segment divided by the rounded cut-off values of IMTs in each segment. The resulting value is then divided by the number of segments available. Thirty-five members conducted the reliability exercise, the interrater intraclass correlation coefficient (ICC) for the OGUS was 0.72-0.84 and the median intrareader ICC was 0.91. The prospective cohort consisted of 52 patients. Sensitivity to change between baseline and each follow-up visit up to week 24 yielded standardised mean differences from -1.19 to -2.16, corresponding to large and very large magnitudes of change, respectively. OGUS correlated moderately with erythrocyte sedimentation rate, C reactive protein and Birmingham Vasculitis Activity Score (corr 0.37-0.48).
We developed a provisional OGUS for potential use in clinical trials.
制定用于监测巨细胞动脉炎（GCA）疾病活动的风湿病疗效测量（OMERACT）超声评分，并评估其度量属性。
遵循 OMERACT 仪器选择算法。邀请 49 名 OMERACT 超声大血管血管炎工作组的成员参加了七轮 Delphi 研究。对 16 例 GCA 患者和 7 名对照者双侧颞动脉、顶额支和腋动脉的图像进行了在线可靠性练习。使用新 GCA 前瞻性队列的数据测试了变化的敏感性和收敛性结构有效性，其中在第 1、3、6、12 和 24 周进行了基于超声的内膜中层厚度（IMT）测量。
获得了 OMERACT GCA 超声评分（OGUS）的一致性（92.7%），其计算方法如下：在每个节段中测量的 IMT 之和除以每个节段的 IMT 截断值。然后将该值除以可用节段的数量。35 名成员进行了可靠性练习，OGUS 的组内评分者间和组内评分者内的 ICC 分别为 0.72-0.84 和 0.91。前瞻性队列包括 52 例患者。从基线到第 24 周的每个随访时，OGUS 的变化敏感性得出的标准化均数差值分别为-1.19 至-2.16，分别对应于大的和非常大的变化幅度。OGUS 与红细胞沉降率、C 反应蛋白和伯明翰血管炎活动评分中度相关（相关系数 0.37-0.48）。
我们制定了一个暂定的 OGUS，以潜在用于临床试验。
