Rentz Anne M, Skalicky Anne M, Esser Dirk, Zema Carla, Becker Karin, Bodhani Amit, Revicki Dennis A
Evidera, Bethesda, MD, USA.
Boehringer Ingelheim GmbH, Ingelheim am Rhein, Germany.
J Dermatolog Treat. 2020 Aug;31(5):460-469. doi: 10.1080/09546634.2019.1709612. Epub 2020 Mar 20.
The primary objective of the study was to evaluate the measurement properties of the patient-reported four-item Psoriasis Symptom Scale (PSS).: Analysis of phase-III data on the efficacy of risankizumab to assess psychometric characteristics of the PSS in patients with moderate-to-severe psoriasis. PSS items had a good range of symptom severity coverage. The PSS had good test-retest reliability (ICCs >0.90). Convergent and discriminant validity was indicated by moderate-to-strong correlations between the PSS and Dermatology Life Quality Index (DLQI), PSS pain item and EQ-5D pain/discomfort item at week 12 (0.63), and moderate negative correlation with EQ-Visual Analog Scale score at week 12 (-0.37). Known groups validity demonstrated as mean PSS total scores varied by Psoriasis Area and Severity Index (PASI) and Static Physician's Global Assessment (sPGA) defined groups ( < .0001). PSS total scores were responsive to changes in PASI score ( < .0001) and sPGA ( < .0001). PSS minimal, clinical, and meaningful change is estimated to be 1 to 2 points; a preliminary responder definition is a total change score of 3 to 4 points. The PSS is a short, valid unidimensional measure of psoriasis symptom severity, well suited for use in clinical trials.
该研究的主要目的是评估患者报告的四项银屑病症状量表（PSS）的测量属性：分析司库奇尤单抗疗效的III期数据，以评估中重度银屑病患者PSS的心理测量特征。PSS项目对症状严重程度的覆盖范围良好。PSS具有良好的重测信度（组内相关系数>0.90）。PSS与皮肤病生活质量指数（DLQI）、第12周时PSS疼痛项目与EQ-5D疼痛/不适项目之间存在中度至强相关性（0.63），表明具有收敛效度和区分效度，且与第12周时的EQ视觉模拟量表评分呈中度负相关（-0.37）。已知组效度表现为PSS总分因银屑病面积和严重程度指数（PASI）以及静态医生整体评估（sPGA）定义的组别而异（<0.0001）。PSS总分对PASI评分（<0.0001）和sPGA（<0.0001）的变化有反应。PSS的最小、临床和有意义变化估计为1至2分；初步的缓解者定义是总变化分数为3至4分。PSS是一种简短、有效的银屑病症状严重程度单维度测量方法，非常适合用于临床试验。
