Celgene Corporation , Summit , NJ , USA.
Evidera , Bethesda , MD , USA.
J Dermatolog Treat. 2019 Dec;30(8):775-783. doi: 10.1080/09546634.2019.1577546. Epub 2019 Mar 5.
Pruritus is a prevalent and bothersome symptom of scalp psoriasis. Validated scales assessing scalp itch are needed to evaluate treatment efficacy. To evaluate comprehensibility and reproducibility of the Scalp Itch Numeric Rating Scale (NRS), a novel scale being used in a phase 3 study of apremilast. The Scalp Itch NRS, Modified Whole Body Itch NRS, Global Assessment of Psoriasis Severity-Scalp (GAPS-S), and Global Impression of Change-Scalp Itch (GIC-SI) were assessed among patients with moderate to severe scalp psoriasis. Convergent validity and test-retest reliability between two visits (7 ± 3 days apart) were assessed using intra-class and Spearman's correlations. Patients found the Scalp Itch NRS easy to use and understand. Convergent validity (Modified Whole Body Itch NRS Visit 1: = 0.71, Visit 2: = 0.92, < .0001; GAPS-S Visit 1: = 0.62, Visit 2: = 0.63, < .0001), and consistency with changes (Modified Whole Body Itch NRS: = 0.69, < .0001; GAPS-S: = 0.42, = .0029) were demonstrated. The Scalp Itch NRS showed strong test-retest reliability (intra-class correlation coefficient = 0.87; = 0.89). Change scores on the Scalp Itch NRS were consistent with change scores on the GIC-SI. The Scalp Itch NRS is a valid and reproducible measure of scalp itch in patients with moderate to severe scalp psoriasis. NCT03123471.
瘙痒是头皮银屑病的一种常见且令人困扰的症状。需要经过验证的头皮瘙痒评估量表来评估治疗效果。为了评估阿普米司特 3 期研究中使用的新型头皮瘙痒数字评分量表(NRS)的可理解性和可重复性。评估了中重度头皮银屑病患者的头皮瘙痒 NRS、改良全身瘙痒 NRS、头皮严重程度整体评估(GAPS-S)和头皮瘙痒整体变化印象(GIC-SI)。使用 ICC 和 Spearman 相关系数评估两次就诊(间隔 7 ± 3 天)之间的收敛效度和重测信度。患者认为头皮瘙痒 NRS 易于使用和理解。收敛效度(改良全身瘙痒 NRS 第 1 次就诊: = 0.71,第 2 次就诊: = 0.92,< 0.0001;GAPS-S 第 1 次就诊: = 0.62,第 2 次就诊: = 0.63,< 0.0001),以及与变化的一致性(改良全身瘙痒 NRS: = 0.69,< 0.0001;GAPS-S: = 0.42, = 0.0029)得到了证明。头皮瘙痒 NRS 具有很强的重测信度(ICC = 0.87; = 0.89)。头皮瘙痒 NRS 的评分变化与 GIC-SI 的评分变化一致。头皮瘙痒 NRS 是一种有效的、可重复的中重度头皮银屑病患者头皮瘙痒评估工具。NCT03123471。