The CLASI (Cutaneous Lupus Erythematosus Disease Area and Severity Index): An outcome instrument for cutaneous lupus erythematosus
The CLASI (Cutaneous Lupus Erythematosus Disease Area and Severity Index): An outcome instrument for cutaneous lupus erythematosus
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DOI：
10.1111/j.0022-202x.2005.23889.x
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发表时间：
2005-11-01
影响因子：
6.5
通讯作者：
Werth, VP
中科院分区：
文献类型：
--
作者：
Albrecht, J;Taylor, L;Werth, VP
我们开发并验证了一种可用于临床试验的红斑狼疮测量工具（CLASI-皮肤红斑狼疮疾病面积和严重程度指数）。仪器有单独的损坏和活动评分。一个由7名美国皮肤流变学专家和“美国流变学学会系统性红斑狼疮反应标准委员会”组成的小组评估了内容效度。在初步会议之后，我们对评分员进行了标准化访谈，并对工具进行了轻微修改。最终的工具进行了评估，由五名皮肤科医生和六名居民谁得分九名患者，以估计在两个会议之间和内部的评级可靠性。与专家的磋商确定了文书内容的有效性。可靠性研究表明，活动评分的评定者间可靠性的类内相关系数（ICC）为0.86（95%置信区间（CI）= 0.73-0.99），损伤评分的ICC为0.92（95% CI = 0.85-1.00）。活动评分的评定者内可靠性的斯皮尔曼rho（Sp）为0.96（95% CI = 0.89 - 1.00），损伤评分的Sp为0.99（95% CI = 0.97-1.00）。临床反应性需要在一项正在进行的前瞻性临床试验中进行评价。
We developed and validated a measurement instrument (CLASI-Cutaneous Lupus Erythematosus Disease Area and Severity Index) for lupus erythematosus that could be used in clinical trials. The instrument has separate scores for damage and activity. A group of seven American Dermato-Rheumatologists and the "American College of Rheumatology Response Criteria Committee on SLE (systemic lupus erythematosus)" assessed content validity. After a preliminary session, we conducted standardized interviews with the raters and made slight changes to the instrument. The final instrument was evaluated by five dermatologists and six residents who scored nine patients to estimate inter- and intra-rater reliability in two sessions. Consultation with experts has established content validity of the instrument. Reliability studies demonstrated an intra-class correlation coefficient (ICC) for inter-rater reliability of 0.86 for the activity score (95% confidence interval (CI) = 0.73-0.99) and of 0.92 for the damage score (95% CI = 0.85-1.00). The Spearman's rho (Sp) for intra-rater reliability for the activity score was 0.96 (95% CI = 0.89 to 1.00) and for the damage score Sp was 0.99 (95% CI = 0.97-1.00). Clinical responsiveness needs to be evaluated in a prospective clinical trial, which is ongoing.