Darchini-Maragheh Emadodin, Moussa Anthony, Yoong Nicole, Bokhari Laita, Jones Leslie, Sinclair Rodney
Department of Medicine, University of Melbourne, Melbourne, Victoria, Australia.
Sinclair Dermatology, East Melbourne, Victoria, Australia.
JAMA Dermatol. 2025 Apr 1;161(4):421-429. doi: 10.1001/jamadermatol.2024.6660.
Alopecia areata (AA) has a high prevalence worldwide and causes considerable morbidity in patients. Patient-reported outcomes (PROs) have become an important component of clinical outcome assessment. The quality of existing AA-specific PRO measures (PROMs) has not been evaluated to date.
To identify and critically appraise the quality of the measurement properties of existing AA-specific PROMs and provide evidence-based recommendations on the most valid PROMs.
Using the predefined eligibility criteria, a systematic search was undertaken using 3 databases to screen the literature for available AA-specific PROMs after 2000. Original developmental studies and related validation studies that reported at least 1 measurement property of the primary PROM were retrieved. The Consensus Based Standards for the Selection of Health Measurement Instruments guidelines were used to examine the quality of the psychometric properties of retrieved PROMs. The quality of evidence was graded using the Grading of Recommendations Assessment, Development and Evaluation approach. Data were analyzed from April to July 2024.
A total of 15 articles were identified, including 8 developmental studies (describing 11 PROMs) and 7 validation studies. Three PROMs (Scale of Alopecia Areata Distress, Alopecia Areata Quality of Life Index, and Alopecia Areata Patients' Quality of Life) were AA-specific health-related quality-of-life instruments. Five instruments were single-item symptom-based PROMs (PRO measures for eyebrow, eyelash, nail appearance, and eye irritation, and Scalp Hair Assessment PRO). Three PROMs (Alopecia Areata Patient Priority Outcomes [AAPPO], Alopecia Areata Severity Self-Assessment, and Alopecia Areata Symptom Impact Scale) were based on both constructs. All PROMs were developed based on adult individuals. Seven PROMs (Scale of Alopecia Areata Distress, AAPPO, and all 5 symptom-based PROMs) featured very good development design. Content validity was the most frequently reported measurement property, rated to be sufficient for 8 PROMs. Internal consistency was reported for 5 PROMs with sufficient quality. AAPPO was the only PROM with high-quality evidence of sufficient structural validity and internal consistency. AAPPO was also the only PROM assessed for test-retest reliability, which was judged to be sufficient. No study reported measurement error.
This systematic review shows that there is still an unmet need for high-quality validation studies on the internal structure of AA-specific PROMs. Recommendations have been provided to help improve the rigor of the validation of AA-specific PROMs. Use of standards in psychometric testing of instruments could enhance the quality of instruments.
斑秃（AA）在全球范围内具有较高的患病率，给患者带来了相当大的发病负担。患者报告结局（PROs）已成为临床结局评估的重要组成部分。迄今为止，尚未对现有的斑秃特异性PRO测量工具（PROMs）的质量进行评估。
识别并严格评估现有斑秃特异性PROMs测量属性的质量，并就最有效的PROMs提供循证建议。
使用预先确定的纳入标准，通过3个数据库进行系统检索，以筛选2000年后文献中可用的斑秃特异性PROMs。检索了报告主要PROM至少1种测量属性的原始开发研究和相关验证研究。采用基于共识的健康测量工具选择标准指南来检查检索到的PROMs心理测量属性的质量。使用推荐分级评估、制定和评价方法对证据质量进行分级。数据于2024年4月至7月进行分析。
共识别出15篇文章，包括8项开发研究（描述了11种PROMs）和7项验证研究。三种PROMs（斑秃困扰量表、斑秃生活质量指数和斑秃患者生活质量）是斑秃特异性的健康相关生活质量工具。五种工具是基于单项症状的PROMs（眉毛、睫毛、指甲外观、眼部刺激的PRO测量工具以及头皮毛发评估PRO）。三种PROMs（斑秃患者优先结局[AAPPO]、斑秃严重程度自我评估和斑秃症状影响量表）基于两种结构。所有PROMs均基于成年个体开发。七种PROMs（斑秃困扰量表、AAPPO以及所有5种基于症状的PROMs）具有非常好的开发设计。内容效度是最常报告的测量属性，8种PROMs的内容效度被评为充分。5种PROMs报告了质量足够的内部一致性。AAPPO是唯一具有充分结构效度和内部一致性高质量证据的PROM。AAPPO也是唯一进行了重测信度评估的PROM，其重测信度被判定为充分。没有研究报告测量误差。
本系统综述表明，对于斑秃特异性PROMs内部结构的高质量验证研究仍存在未满足的需求。已提供建议以帮助提高斑秃特异性PROMs验证的严谨性。在工具的心理测量测试中使用标准可以提高工具的质量。
