The Localized Scleroderma Cutaneous Assessment Tool: Responsiveness to change in a pediatric clinical population
The Localized Scleroderma Cutaneous Assessment Tool: Responsiveness to change in a pediatric clinical population
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DOI：
10.1016/j.jaad.2013.02.007
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发表时间：
2013-08-01
影响因子：
13.8
通讯作者：
Torok, Kathryn S.
中科院分区：
文献类型：
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作者：
Kelsey, Christina E.;Torok, Kathryn S.
背景：在如何准确捕捉局限性硬皮病(LS)的疾病结果方面缺乏共识，这阻碍了有效治疗方案的发展。LS皮肤评估工具(LoSCAT)由改良的LS皮肤严重程度指数(MLoSSI)和LS损伤指数组成，具有临床应用的潜力。目的：本文的目的是进一步评估LoSCAT的临床反应。基于疾病活动与疾病损害的可改变的性质，我们期望mLoSSI对变化做出反应。方法：在两次研究访问中，一名医生完成了对29名LS患者的LoSCAT和疾病活动和疾病损害的医生全球评估(PGA)。使用Spearman相关分析来检验LoSCAT的变化与PGA分数之间的关系。为了评价对照组的有效性，根据疾病活动分类对患者进行分组，并比较各组的变化分数。结果：mLoSSI评分的变化与疾病活动的PGA评分的变化密切相关，而LS损伤指数评分的变化与疾病损害的PGA评分的变化弱相关。疾病活动性的mLoSSI和PGA表现出对比的群体效度。活动测量的最小临床重要性差异大于各自的测量标准误差。限制：只有2次研究访问被纳入分析。结论：这项研究进一步证明，LoSCAT，特别是mLoSSI，是一种反应灵敏的、有效的LS活动测量方法，应该在未来的治疗研究中使用。
Background: Lack of agreement on how to accurately capture disease outcomes in localized scleroderma (LS) has hindered the development of efficacious treatment protocols. The LS Cutaneous Assessment Tool (LoSCAT), consisting of the modified LS Skin Severity Index (mLoSSI) and the LS Damage Index, has potential for use in clinical trials.Objective: The goal of this article is to further evaluate the clinical responsiveness of the LoSCAT. Based on the modifiable nature of disease activity versus damage, we expected the mLoSSI to be responsive to change.Methods: At 2 study visits, a physician completed the LoSCAT and Physician Global Assessment (PGA) of Disease Activity and of Disease Damage for 29 patients with LS. Spearman correlations were used to examine the relationships between the change in the LoSCAT and the PGA scores. To evaluate contrasted group validity, patients were grouped according to disease activity classification and change scores of groups were compared. Minimal clinically important differences were calculated and compared with the standard error of measurement.Results: Change in the mLoSSI score correlated strongly with change in the PGA of Disease Activity score, whereas change in the LS Damage Index score correlated weakly with change in the PGA of Disease Damage score. The mLoSSI and PGA of Disease Activity exhibited contrasted group validity. Minimal clinically important differences for the activity measures were greater than the respective standard errors of measurement.Limitations: Only 2 study visits were included in analysis.Conclusion: This study gives further evidence that the LoSCAT, specifically the mLoSSI, is a responsive, valid measure of activity in LS and should be used in future treatment studies.