Silverberg Jonathan I, Simpson Eric L, Calimlim Brian M, Litcher-Kelly Leighann, Li Xiaoran, Sun Xiaowu, Leshem Yael A
Department of Dermatology, The George Washington University School of Medicine and Health Sciences, Washington, DC, USA.
Department of Dermatology, Oregon Health & Science University, Portland, OR, USA.
Dermatol Ther (Heidelb). 2022 Dec;12(12):2817-2827. doi: 10.1007/s13555-022-00836-5. Epub 2022 Nov 4.
Three patient-reported outcome (PRO) questionnaires-Worst Pruritus Numerical Rating Scale (WP-NRS), Atopic Dermatitis Symptom Scale (ADerm-SS), and Atopic Dermatitis Impact Scale (ADerm-IS)-were developed to assess the symptoms and impacts of atopic dermatitis (AD). Severity strata for these PROs are needed to aid in their interpretation.
Using data from a global, randomized, double-blind, placebo-controlled, phase 3 clinical trial (NCT03568318) of patients with moderate-severe AD (age ≥ 12 years), equipercentile linking analyses were conducted to define severity strata applying the Patient Global Impression of Severity as an anchor. Analyses were conducted separately for adults and adolescents, and then harmonized between the two age groups.
The sample included 769 adults and 113 adolescents. For the WP-NRS, 0 was associated with absent, 1-2 with minimal, 3 with mild, 4-7 with moderate, and 8-10 with severe. For the ADerm-SS Skin Pain, 0 was associated with absent, 1 with minimal, 2 with mild, 3-6 with moderate, and 7-10 with severe. For ADerm-SS 7-Item Total Symptom Score (TSS-7), 0-1 was associated with absent, 2-11 with minimal, 12-22 with mild, 23-47 with moderate, and 48-70 with severe. For ADerm-IS Sleep, 0 was associated with absent, 1-3 with minimal, 4-6 with mild, 7-20 with moderate, and 21-30 with severe. For ADerm-IS Daily Activities, 0 was associated with absent, 1-2 with minimal, 3-7 with mild, 8-25 with moderate, and 26-40 with severe. For ADerm-IS Emotional State, 0 was associated with absent, 1-2 with minimal, 3-8 with mild, 9-22 with moderate, and 23-30 with severe.
These severity strata provide score interpretations of the WP-NRS, ADerm-SS, and ADerm-IS, translating these scores to simple and intuitive outcomes, which can inform clinical studies and clinical practice.
NCT03568318.
为评估特应性皮炎（AD）的症状和影响，开发了三种患者报告结局（PRO）问卷——最严重瘙痒数字评定量表（WP-NRS）、特应性皮炎症状量表（ADerm-SS）和特应性皮炎影响量表（ADerm-IS）。需要这些PRO的严重程度分层来辅助对其进行解读。
利用一项针对中重度AD患者（年龄≥12岁）的全球、随机、双盲、安慰剂对照3期临床试验（NCT03568318）的数据，进行等百分位链接分析，以将患者总体严重程度印象作为锚定来定义严重程度分层。分别对成人和青少年进行分析，然后在两个年龄组之间进行协调。
样本包括769名成人和113名青少年。对于WP-NRS，0表示无，1 - 2表示轻微，3表示轻度，4 - 7表示中度，8 - 10表示重度。对于ADerm-SS皮肤疼痛，0表示无，1表示轻微，2表示轻度，3 - 6表示中度，7 - 10表示重度。对于ADerm-SS 7项总症状评分（TSS-7），0 - 1表示无，2 - 11表示轻微，12 - 22表示轻度，23 - 47表示中度，48 - 70表示重度。对于ADerm-IS睡眠，0表示无，1 - 3表示轻微，4 - 6表示轻度，7 - 20表示中度，21 - 30表示重度。对于ADerm-IS日常活动，0表示无，1 - 2表示轻微，3 - 7表示轻度，8 - 25表示中度，26 - 40表示重度。对于ADerm-IS情绪状态，0表示无，1 - 2表示轻微，3 - 8表示轻度，9 - 22表示中度，23 - 30表示重度。
这些严重程度分层提供了WP-NRS、ADerm-SS和ADerm-IS的评分解读，将这些评分转化为简单直观的结果，可为临床研究和临床实践提供参考。
NCT03568318。
