Strober Bruce, Zhao Yang, Tran Mary Helen, Gnanasakthy Ari, Nyirady Judit, Papavassilis Charis, Nelson Lauren M, McLeod Lori D, Mordin Margaret, Gottlieb Alice B, Elewski Boni E, Lebwohl Mark
Department of Dermatology, University of Connecticut Health Center, University of Connecticut, Farmington, CT, USA.
Probity Medical Research, Waterloo, Ontario, Canada.
Int J Dermatol. 2016 Mar;55(3):e147-55. doi: 10.1111/ijd.13117. Epub 2015 Oct 30.
This analysis aimed to confirm the reliability, validity, and responsiveness of the Psoriasis Symptom Diary (PSD) using data from two Phase III studies in patients with moderate to severe chronic plaque psoriasis.
Data from two randomized, double-blind, double-dummy, placebo-controlled, multicenter Phase III studies (n = 820) assessing the efficacy and safety of secukinumab were used. The PSD (24-h recall; 0-10 numeric rating scale) was electronically administered each evening. Test-retest reliability was determined using intraclass correlations. Construct validity hypotheses were evaluated via correlations with the Psoriasis Area and Severity Index (PASI), Investigator's Global Assessment (IGA), Dermatology Life Quality Index (DLQI), EuroQoL 5-Dimension Health Status Questionnaire, and Patient Global Impression of Change (PGIC). Discriminating ability and responsiveness were evaluated by estimating mean differences and effect sizes between known groups (using the PASI and IGA). Phase II-derived, anchor-based PGIC thresholds and cumulative distribution function (CDF) plots described meaningful change.
Items on the PSD yielded high intraclass coefficients (>0.90). Correlations were in the anticipated direction and by week 12 were moderate to strong (0.41-0.73) in magnitude, demonstrating construct validity. Average PSD item scores differed predictably and significantly between known groups. Responsiveness effect size estimates were moderate to large (0.6-1.5), and CDF plots showed the percentage of responders to be consistently higher in treatment than in placebo arms across the range of change in PSD scores.
The PSD is reliable, valid, and responsive, and represents a valid tool to enhance treatment decisions in patients with moderate to severe plaque psoriasis.
本分析旨在利用两项针对中度至重度慢性斑块状银屑病患者的III期研究数据，证实银屑病症状日记（PSD）的可靠性、有效性和反应性。
使用两项随机、双盲、双模拟、安慰剂对照、多中心III期研究（n = 820）的数据，评估司库奇尤单抗的疗效和安全性。PSD（24小时回忆法；0 - 10数字评分量表）于每晚以电子方式进行管理。采用组内相关系数确定重测信度。通过与银屑病面积和严重程度指数（PASI）、研究者整体评估（IGA）、皮肤病生活质量指数（DLQI）、欧洲五维健康状况问卷以及患者整体变化印象（PGIC）的相关性，评估结构效度假设。通过估计已知组之间的平均差异和效应大小（使用PASI和IGA），评估区分能力和反应性。基于II期研究得出的、以锚定法确定的PGIC阈值和累积分布函数（CDF）图描述了有意义的变化。
PSD各项的组内系数较高（>0.90）。相关性呈预期方向，到第12周时强度为中度至高度（0.41 - 0.73），表明具有结构效度。已知组之间PSD项目平均得分的差异具有可预测性且显著。反应性效应大小估计值为中度至高度（0.6 - 1.5），CDF图显示，在PSD评分变化范围内，治疗组的反应者百分比始终高于安慰剂组。
PSD可靠、有效且具有反应性，是增强中度至重度斑块状银屑病患者治疗决策的有效工具。
