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斑块状银屑病患者中银屑病症状量表(PSS)的可靠性、有效性及检测变化的能力。

Reliability, validity, and the ability to detect change of the Psoriasis Symptom Scale (PSS) in patients with plaque psoriasis.

作者信息

Rentz Anne M, Skalicky Anne M, Esser Dirk, Zema Carla, Becker Karin, Bodhani Amit, Revicki Dennis A

机构信息

Evidera, Bethesda, MD, USA.

Boehringer Ingelheim GmbH, Ingelheim am Rhein, Germany.

出版信息

J Dermatolog Treat. 2020 Aug;31(5):460-469. doi: 10.1080/09546634.2019.1709612. Epub 2020 Mar 20.

Abstract

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.

摘要

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。

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