Validation of the Cutaneous Dermatomyositis Disease Area and Severity Index: characterizing disease severity and assessing responsiveness to clinical change.

Validation of the Cutaneous Dermatomyositis Disease Area and Severity Index: characterizing disease severity and assessing responsiveness to clinical change.
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DOI:
10.1111/bjd.13915
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发表时间:
2015-10
期刊:
The British journal of dermatology
影响因子:
--
通讯作者:
Werth VP
Werth VP
中科院分区:
其他
文献类型:
--
作者:
Anyanwu CO;Fiorentino DF;Chung L;Dzuong C;Wang Y;Okawa J;Carr K;Propert KJ;Werth VP

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皮肤皮肌炎疾病面积和严重程度指数 (CDASI) 旨在用于临床试验和纵向患者评估。使用 CDASI 表征疾病严重程度,并评估该仪器对疾病活动的临床意义变化的反应性。使用 CDASI、医师总体评估 (PGA) 李克特量表和视觉模拟量表 (VAS) 对宾夕法尼亚大学 (UPenn,n = 93) 和斯坦福大学 (Stanford,n = 106) 的皮肤皮肌炎患者进行前瞻性评估。使用逻辑回归模型和受试者工作特征曲线分析数据以选择截止值。在宾夕法尼亚大学评估的患者的基线 CDASI 活动评分范围为 0 至 47(中位数 17),基线 PGA VAS 评分范围为 0 至 9.6(中位数 1.1)。在宾夕法尼亚大学,CDASI 活动评分为 19,可区分轻度、中度和重度疾病。在斯坦福大学,基线 CDASI 评分范围为 0 至 48(中位数 21),基线 PGA VAS 评分范围为 0 至 9.7(中位数 4.2),CDASI 活动评分为 14 或更少,表现为轻度疾病。当 PGA VAS 2 厘米的变化被视为临床显着改善时,CDASI 4 点(宾夕法尼亚大学)或 5 点(斯坦福)变化反映了最小的临床显着反应。 CDASI 是一种有效且反应灵敏的测量方法,可用于表征皮肤皮肌炎的严重程度并检测疾病活动的改善情况。截止值的变化可能是由于两个人群之间疾病严重程度的差异或外部黄金衡量标准使用的评估者之间的差异造成的。
The Cutaneous Dermatomyositis Disease Area and Severity Index (CDASI) was developed for use in clinical trials and longitudinal patient assessment. To characterize disease severity using the CDASI and assess responsiveness of this instrument to clinically meaningful changes in disease activity. Patients with cutaneous dermatomyositis at the University of Pennsylvania (UPenn, n = 93) and Stanford University (Stanford, n = 106) were prospectively evaluated using the CDASI, physician global assessment (PGA) Likert scales, and visual analog scale (VAS). Data was analyzed using logistic regression models and receiver operating characteristic curves to select cut-offs. Baseline CDASI activity scores for the patients evaluated at UPenn ranged from 0 to 47 (median 17), and baseline PGA VAS scores ranged from 0 to 9.6 (median 1.1). At UPenn a CDASI activity score of 19 differentiated mild from moderate and severe disease. At Stanford baseline CDASI scores ranged from 0 to 48 (median 21), baseline PGA VAS scores ranged from 0 to 9.7 (median 4.2) and CDASI activity scores of 14 or less characterized mild disease. When a 2 cm change in the PGA VAS was regarded as a clinically significant improvement, a 4-point (UPenn) or 5-point (Stanford) change in CDASI reflected a minimal clinically significant response. The CDASI is a valid and responsive measure that can be used to characterize cutaneous dermatomyositis severity and detect improvement in disease activity. Variations in cutoffs may be due to differences in disease severity between the two populations or inter-rater variations in use of the external gold measures.