Hartford Christopher, Alexis Andrew, Wang Zhixiao, Levit Noah A, Banderas Benjamin, Yaworsky Andrew, Love Emily, Shumel Brad, Bégo-Le-Bagousse Gaëlle, Rofail Diana
Regeneron Pharmaceuticals Inc., Tarrytown, NY, USA.
Weill Cornell Medicine, New York, NY, USA.
Br J Dermatol. 2025 Apr 28;192(5):863-873. doi: 10.1093/bjd/ljae494.
The prevalence and burden of atopic dermatitis (AD) are disproportionately high in people with skin of colour. Previous research has shown that the risk of xerosis and/or dyspigmentation is heightened in this population and may be more bothersome. However, no patient-reported instruments have been developed specifically for these disease sequelae in patients with skin of colour.
To develop and perform content validation of patient-reported outcome (PRO) questionnaires to assess AD-related xerosis and dyspigmentation in patients with skin of colour.
A targeted literature review was conducted to understand and identify AD-related disease sequelae and quality-of-life impacts relevant to patients with skin of colour and any instruments used to assess AD in the target population. Two draft PRO questionnaires assessing xerosis (X-AD) and dyspigmentation (D-AD) were developed and refined following advice meetings with three clinical experts. Questionnaire content validity was explored during hybrid concept elicitation and cognitive debriefing interviews with 15 adult and adolescent patients with skin of colour who have moderate-to-severe AD.
Ten concept-focused articles, 3 websites, 17 labels, 1 U.S. Food and Drug Administration compendium and 1 clinical trial confirmed that xerosis and dyspigmentation are important AD-related disease sequelae. Patients with skin of colour [47% girls/women; mean (SD) age 33.3 (21.2) years] reported that the questionnaires were relevant to their AD experience in an appropriate recall timeframe and were readily understood, and that meaningful responses were easy to select. The final X-AD consisted of one 11-point numerical rating scale (NRS) assessing xerosis severity and two items assessing the level of bother associated with xerosis appearance and feeling over the past week (0-4 verbal rating scale). The final D-AD consisted of two 11-point NRS items assessing dyspigmentation severity and two items assessing the level of bother associated with how dyspigmentation looked over the past week.
The X-AD/D-AD questionnaires were well understood and effective in capturing the experiences of xerosis and dyspigmentation in the target population in an appropriate and comprehensive way. This study supports the initial development of the questionnaires in accordance with regulatory guidelines and best practices; however, psychometric validation is required to evaluate the properties of each questionnaire and develop score interpretation guidelines.
特应性皮炎（AD）在有色人种中的患病率和负担极高。先前的研究表明，该人群中皮肤干燥和/或色素沉着异常的风险增加，且可能更令人困扰。然而，尚未开发出专门针对有色人种患者这些疾病后遗症的患者报告工具。
开发并进行患者报告结局（PRO）问卷的内容验证，以评估有色人种患者中与AD相关的皮肤干燥和色素沉着异常。
进行了有针对性的文献综述，以了解和确定与有色人种患者相关的AD相关疾病后遗症和生活质量影响，以及用于评估目标人群中AD的任何工具。在与三位临床专家进行咨询会议后，制定并完善了两份评估皮肤干燥（X-AD）和色素沉着异常（D-AD）的PRO问卷草案。在与15名患有中度至重度AD的成年和青少年有色人种患者进行混合概念引出和认知反馈访谈期间，探讨了问卷的内容效度。
十篇聚焦概念的文章、3个网站、17个标签、1份美国食品药品监督管理局纲要和1项临床试验证实，皮肤干燥和色素沉着异常是重要的AD相关疾病后遗症。有色人种患者[47%为女孩/女性；平均（标准差）年龄33.3（21.2）岁]报告称，问卷在适当的回忆时间范围内与他们的AD经历相关，易于理解，且易于选择有意义的答案。最终的X-AD包括一个评估皮肤干燥严重程度的11点数字评定量表（NRS）和两个评估过去一周与皮肤干燥外观和感觉相关的困扰程度的项目（0-4级言语评定量表）。最终的D-AD包括两个评估色素沉着异常严重程度的11点NRS项目和两个评估过去一周与色素沉着异常外观相关的困扰程度的项目。
X-AD/D-AD问卷易于理解，能够以适当且全面的方式捕捉目标人群中皮肤干燥和色素沉着异常的经历。本研究支持根据监管指南和最佳实践对问卷进行初步开发；然而，需要进行心理测量学验证，以评估每份问卷的特性并制定分数解释指南。
