Ghafoori Parima, Patel Dharm S, Raymond Kimberly, Brennan Elizabeth, Foster April Mitchell, Jackson Kristi, Birch Helen J, Chen Wen-Hung
GSK, 1250 South Collegeville Rd, Collegeville, PA, 19426, USA.
QualityMetric Incorporated, Johnston, RI, USA.
J Patient Rep Outcomes. 2025 Apr 10;9(1):41. doi: 10.1186/s41687-025-00871-8.
Atopic dermatitis (AD) is a chronic inflammatory skin disease that impacts patient health and quality of life. Understanding patient experience of relevant symptoms and impacts of AD is crucial for improving outcomes. This study aimed to characterise adult (≥ 18 years) and adolescent (12-17 years) patients' experiences of AD and assess the content validity of selected patient-reported outcomes (PROs).
This non-interventional, cross-sectional, qualitative study recruited US-based, English-speaking adults and adolescents with moderate-to-severe AD, either naïve or experienced with biologics. A 90-minute interview was conducted via teleconferencing software, consisting of concept elicitation (CE) of AD experiences and cognitive debriefing (CD), where participants provided feedback on PROs assessing skin pain, sleep disturbance, and fatigue. Interview data were coded and analysed using qualitative data software to determine the AD experience and content validity of selected PROs. A conceptual disease model was developed from the CE portion of the interview. Results from the CD portion were mapped to this model to evaluate the conceptual coverage of the PROs.
In total, 16 adults (mean age 48 years, 56% White, 63% female, 50% biologic naïve) and 20 adolescents (mean age 16 years, 60% White, 75% female, 50% biologic naïve) were included in the analysis. During CE, 13 symptoms and impacts in 7 domains were identified. The most reported symptom was itchiness (adults, 100%; adolescents, 100%) and the most reported impact was emotional functioning (adults, 94%; adolescents 95%). Participants also commonly reported experiencing pain/discomfort (adults, 69%; adolescents, 80%) and sleep disturbance (adults, 88%; adolescents, 75%). Fatigue was reported by 94% of adults across CE and CD segments. When probed during CE, 65% of adolescents identified fatigue as an impact of AD. During CD, 70-100% of participants confirmed the selected PROs were comprehensible and relevant.
This study provides evidence that the experience of AD is similar between adults and adolescents as well as biologic-naïve and biologic-experienced participants. Relevant disease concepts in patients with AD were identified, and content validity was established for the selected PROs, supporting their use in future clinical studies.
特应性皮炎（AD）是一种慢性炎症性皮肤病，会影响患者的健康和生活质量。了解患者对AD相关症状的体验及其影响对于改善治疗效果至关重要。本研究旨在描述成人（≥18岁）和青少年（12 - 17岁）患者的AD体验，并评估所选患者报告结局（PROs）的内容效度。
这项非干预性、横断面定性研究招募了美国境内、以英语为母语、患有中度至重度AD的成人和青少年，这些患者未曾使用过生物制剂或有生物制剂使用经验。通过电话会议软件进行了一次90分钟的访谈，包括AD体验的概念引出（CE）和认知反馈（CD），参与者对评估皮肤疼痛、睡眠障碍和疲劳的PROs提供反馈。使用定性数据软件对访谈数据进行编码和分析，以确定AD体验和所选PROs的内容效度。从访谈的CE部分构建了一个概念性疾病模型。将CD部分的结果映射到该模型，以评估PROs的概念覆盖范围。
总共16名成人（平均年龄48岁，56%为白人，63%为女性，50%未曾使用过生物制剂）和20名青少年（平均年龄16岁，60%为白人，75%为女性，50%未曾使用过生物制剂）纳入分析。在CE过程中，确定了7个领域中的13种症状和影响。报告最多的症状是瘙痒（成人，100%；青少年，100%），报告最多的影响是情绪功能（成人，94%；青少年，95%）。参与者还普遍报告经历疼痛/不适（成人，69%；青少年，80%）和睡眠障碍（成人，88%；青少年，75%）。在CE和CD环节中，94%的成人报告有疲劳感。在CE过程中进行询问时，65%的青少年将疲劳确定为AD的一种影响。在CD过程中，70 - 100%的参与者确认所选的PROs易于理解且相关。
本研究提供了证据表明，成人和青少年以及未曾使用过生物制剂和有生物制剂使用经验的参与者之间的AD体验相似。确定了AD患者的相关疾病概念，并确立了所选PROs的内容效度，支持其在未来临床研究中的应用。
