Newton Louise, DeLozier Amy M, Griffiths Philip C, Hill Jennifer N, Hudgens Stacie, Symonds Tara, Gable Jonathon C, Paik Jim, Wyrwich Kathleen W, Eichenfield Lawrence F, Abetz-Webb Linda, Silverberg Jonathan I
Clinical Outcomes Solutions, Unit 68, Basepoint, Shearway Rd, Shearway Business Park, Folkestone, Kent, CT19 4RH, UK.
Eli Lilly and Company, Lilly Corporate Center, Indianapolis, IN, 46285, USA.
J Patient Rep Outcomes. 2019 Jul 16;3(1):42. doi: 10.1186/s41687-019-0128-z.
Atopic dermatitis (AD) is a common skin disorder characterized by chronic inflammation, altered skin barrier function, and inflammatory cell skin infiltration that decreases health-related quality of life (HRQoL). The study objective was to understand the patient perspective of AD burden and determine suitable patient-reported outcome (PRO) measures.
This mixed methods study involved the collection of qualitative and quantitative information from adults (≥ 18 years old) and adolescents (12 - 17 years old) with clinician-confirmed AD regarding their experiences of AD symptoms and its impact on HRQoL. The first part of the study included three stages: in-person concept elicitation (CE) interviews, a 2-week daily electronic diary (eDiary) study, and in-person cognitive debriefing (CD) interviews. An Itch numeric rating scale (NRS) (v1.0) and a Skin Pain NRS (v1.0) evaluation during CD interviews required participants to think about their 'worst' itch and 'worst' skin pain in the past 24 h. Other PRO measures allowed for psychometric testing. The second part of the study involved telephone-depth interviews (TDIs) and qualitative feedback from participants who had not participated in the CD interviews. Qualitative data were thematically analyzed. Psychometric evaluation of NRS measures was performed using eDiary data.
In the CE interviews, itch and/or itching and skin pain were the most prevalent symptoms consistently discussed by participants. Both NRS measures demonstrated strong psychometric reliability and were applicable across ages with suitable concurrent validity. During the CD interviews, some participants focused their answers on their 'average' itch/itching in the past 24 h, rather than their 'worst' itch. Some participants answered the Skin Pain NRS thinking about general pain or other types of pain, rather than skin pain specifically. Consequently, modifications to both measures addressed these issues and re-tested as paper-and-pen versions in subsequent TDIs. Itch NRS (v2.0) modifications helped participants focus on their worst itching. Most participants preferred Skin Pain NRS v2.0b, which included skin pain descriptors.
Itching and skin pain are the most important and relevant AD symptoms. The Itch NRS (v2.0) and Skin Pain NRS (v2.0b) appear to be appropriate endpoints for the assessment of itching and skin pain severity for clinical trials with adults and adolescents with AD.
特应性皮炎（AD）是一种常见的皮肤疾病，其特征为慢性炎症、皮肤屏障功能改变以及炎症细胞浸润皮肤，这会降低健康相关生活质量（HRQoL）。本研究的目的是了解患者对AD负担的看法，并确定合适的患者报告结局（PRO）指标。
这项混合方法研究涉及从临床确诊为AD的成年人（≥18岁）和青少年（12 - 17岁）收集关于AD症状体验及其对HRQoL影响的定性和定量信息。研究的第一部分包括三个阶段：面对面的概念激发（CE）访谈、为期2周的每日电子日记（eDiary）研究以及面对面的认知反馈（CD）访谈。在CD访谈期间，通过瘙痒数字评定量表（NRS）（v1.0）和皮肤疼痛NRS（v1.0）评估，要求参与者思考他们在过去24小时内“最严重”的瘙痒和“最严重”的皮肤疼痛。其他PRO指标用于心理测量测试。研究的第二部分涉及电话深度访谈（TDI）以及未参与CD访谈的参与者的定性反馈。对定性数据进行了主题分析。使用eDiary数据对NRS指标进行心理测量评估。
在CE访谈中，瘙痒和/或瘙痒感以及皮肤疼痛是参与者一致讨论的最常见症状。两种NRS指标均显示出很强的心理测量可靠性，并且适用于各个年龄段，具有适当的同时效度。在CD访谈期间，一些参与者将他们的回答集中在过去24小时内的“平均”瘙痒/瘙痒感上，而不是“最严重”的瘙痒。一些参与者在回答皮肤疼痛NRS时考虑的是一般疼痛或其他类型的疼痛，而不是特定的皮肤疼痛。因此，对这两种指标进行了修改以解决这些问题，并在随后的TDI中作为纸笔版本重新进行测试。瘙痒NRS（v2.0）的修改帮助参与者关注他们最严重的瘙痒。大多数参与者更喜欢皮肤疼痛NRS v2.0b，它包括了皮肤疼痛描述词。
瘙痒和皮肤疼痛是最重要且相关的AD症状。瘙痒NRS（v2.0）和皮肤疼痛NRS（v2.0b）似乎是评估AD成人和青少年临床试验中瘙痒和皮肤疼痛严重程度的合适终点指标。
