Patient-Focused Outcomes Center of Expertise, Eli Lilly and Company, Indianapolis, IN, USA.
Clinical Outcomes Assessment, DRG Abacus, Manchester, UK.
Br J Dermatol. 2020 Dec;183(6):1065-1072. doi: 10.1111/bjd.19024. Epub 2020 May 26.
Valid patient-reported outcome (PRO) measures are required to evaluate alopecia areata (AA) treatments.
To develop a content-valid and clinically meaningful PRO measure to assess AA scalp hair loss with scores comparable with the five-response-level Alopecia Areata Investigator Global Assessment (AA-IGA™).
A draft PRO measure was developed based on input from 10 clinical experts in AA. The PRO measure was cognitively debriefed, modified and finalized through two rounds of qualitative semistructured interviews with patients with AA who had experienced ≥ 50% scalp hair loss. Data were thematically analysed.
Adults (round 1: n = 25; round 2: n = 15) and adolescents aged 15-17 years (round 1: n = 5) in North America participated. All patients named scalp hair loss as a key AA sign or symptom. Patients demonstrated the ability to self-report their current amount of scalp hair using percentages. In round 1 not all patients interpreted the measurement concept consistently; therefore, the PRO was modified to clarify the measurement concept to improve usability. Following modifications, patients in round 2 responded without difficulty to the PRO measure. Patients confirmed that they could use the five-level response scale to rate their scalp hair loss: no missing hair, 0%; limited, 1-20%; moderate, 21-49%; large, 50-94%; nearly all or all, 95-100%. Almost all patients deemed hair regrowth resulting in ≤ 20% scalp hair loss a treatment success.
The Scalp Hair Assessment PRO™ is a content-valid, clinically meaningful assessment of distinct gradations of scalp hair loss for evaluating AA treatment for patients with ≥ 50% hair loss at baseline.
评估斑秃（AA）治疗方法需要有效的患者报告结局（PRO）测量工具。
开发一种内容有效且具有临床意义的 PRO 测量工具，以评估 AA 头皮脱发，其评分可与五级反应水平的斑秃评估员全球评估（AA-IGA）相媲美。
根据 10 位 AA 临床专家的意见制定了一份 PRO 草案。通过对经历≥50%头皮脱发的 AA 患者进行两轮半结构式定性访谈，对 PRO 进行认知审查、修改和最终确定。对数据进行主题分析。
来自北美的成年人（第 1 轮：n=25；第 2 轮：n=15）和 15-17 岁的青少年（第 1 轮：n=5）参与了研究。所有患者均将头皮脱发视为 AA 的主要体征或症状之一。患者能够使用百分比来自我报告当前头皮毛发的数量。在第 1 轮中，并非所有患者都能始终如一地理解测量概念；因此，对 PRO 进行了修改，以明确测量概念，提高可用性。修改后，第 2 轮的患者可轻松回答 PRO 测量工具。患者确认他们可以使用五级反应量表来评估头皮脱发：无脱发，0%；有限，1-20%；中度，21-49%；大量，50-94%；几乎全部或全部，95-100%。几乎所有患者都认为头发再生导致头皮脱发≤20%为治疗成功。
头皮毛发评估 PRO 是一种内容有效的、具有临床意义的评估工具，可用于评估基线时≥50%脱发患者的 AA 治疗方法，用于评估头皮脱发的不同分级。
