慢性手部湿疹对健康相关生活质量影响的患者报告结果测量方法:手部湿疹影响量表 (HEIS) 的开发与验证。

IF 3.5 3区 医学 Q1 DERMATOLOGY Dermatology and Therapy Pub Date : 2024-10-21 DOI:10.1007/s13555-024-01267-0
Elke Weisshaar, Yasemin Topal Yüksel, Tove Agner, Lotte Seiding Larsen, Laura Grant, Rob Arbuckle, Amy M Jones, Piper Fromy, Cherry Lou Balita-Crisostomo, Nanna Nyholm Mathiasen, Henrik Thoning, Christian Apfelbacher
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引用次数: 0

摘要

简介:慢性手部湿疹(CHE)是一种炎症性皮肤病,会对健康相关生活质量(HRQoL)造成严重影响。手部湿疹影响量表(HEIS)是一种新的患者报告结果(PRO)测量方法,旨在评估手部湿疹对健康相关生活质量(HRQoL)关键领域的影响。本研究旨在开发和评估 HEIS 的内容和心理测量有效性:HEIS 最初是在文献综述和概念激发访谈的基础上开发的。对 CHE 患者进行了定性认知汇报访谈(n = 20),以评估项目的相关性和理解程度、回答选项和回忆期。然后,利用一项 2b 期试验(NCT03683719)的数据(n = 258)对心理计量特性(项目表现、维度、可靠性、有效性、反应性和有意义变化阈值的估计)进行了评估:结果:认知汇报确认了所有项目都能被患者理解并与之相关。项目间相关性(均大于 0.50)和确认性因子分析(因子载荷≥ 0.80)支持 HEIS 评分的单维性,并且大部分支持 HEIS 日常活动近端限制 (PDAL) 评分,只有一个项目的载荷低于预设阈值。项目属性和之前的定性工作支持将该项目保留在总分中,但从 HEIS PDAL 领域中删除。内部一致性(Cronbach's alpha ≥ 0.89)和测试-再测可靠性(类内相关系数≥ 0.79)结果都非常好。与同期测量结果的相关性很强(0.66-0.87),严重程度组之间存在显著差异(p 结论:HEIS 的 9 个条目测量结果与同期测量结果的相关性很强(0.66-0.87):9个项目的HEIS是首个针对CHE的PRO测量方法,是根据监管指南开发和验证的,用于评估CHE对HRQoL关键领域的影响。这篇文章提供了强有力的内容和心理测量有效性的证据,表明 HEIS 评分和 HEIS PDAL 评分提高≥1.3 分,HEIS Emb 评分提高≥1.5 分,代表了有临床意义的重要变化:试验注册:NCT03683719。
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Development and Validation of a Patient-Reported Outcome Measure of the Impact of Chronic Hand Eczema on Health-Related Quality of Life: the Hand Eczema Impact Scale (HEIS).

Introduction: Chronic Hand Eczema (CHE) is an inflammatory skin disease that causes significant impact on health-related quality of life (HRQoL). The Hand Eczema Impact Scale (HEIS) is a new patient-reported outcome (PRO) measure designed to assess the impact of CHE on key domains of HRQoL. This study aimed to develop and evaluate content and psychometric validity of the HEIS.

Methods: The HEIS was initially developed on the basis of a literature review and concept elicitation interviews. Qualitative cognitive debriefing interviews (n = 20) were conducted with patients with CHE to assess relevance and understanding of items, response options, and recall period. Psychometric properties (item performance, dimensionality, reliability, validity, responsiveness, and estimation of meaningful change thresholds) were then assessed using data (n = 258) from a phase 2b trial (NCT03683719).

Results: Cognitive debriefing confirmed all items were understood and relevant to patients. Inter-item correlations (all > 0.50) and confirmatory factor analysis (factor loadings ≥ 0.80) supported unidimensionality of the HEIS score, and mostly provided support for the HEIS Proximal Daily Activity Limitations (PDAL) score, with only one item loading below the prespecified threshold. Item properties and previous qualitative work supported retaining this item in the total score but removed from the HEIS PDAL domain. Internal consistency (Cronbach's alpha ≥ 0.89) and test-retest reliability (intra-class correlation coefficient ≥ 0.79) results were very strong. Strong correlations with concurrent measures (0.66-0.87) and significant differences between severity groups (p < 0.001) supported construct validity. Large effect sizes for mean change scores in participants that improved and significant differences between groups indicated ability to detect change. Anchor-based analyses supported within-individual responder definitions of ≥ 1.3 points for improvements in both HEIS score and HEIS PDAL score (covering three items) and of ≥ 1.5 points for HEIS embarrassment with the appearance of hands (Emb) score (covering two items).

Conclusions: The 9-item HEIS is the first CHE-specific PRO measure developed and validated according to regulatory guidance for assessment of the impact of CHE on key domains of HRQoL. This article provides evidence of strong content and psychometric validity and shows improvements of ≥ 1.3 points in HEIS score and HEIS PDAL score, and improvements of ≥ 1.5 points in HEIS Emb score represent clinically meaningful, important changes.

Trial registration: NCT03683719.

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来源期刊
Dermatology and Therapy
Dermatology and Therapy Medicine-Dermatology
CiteScore
6.00
自引率
8.80%
发文量
187
审稿时长
6 weeks
期刊介绍: Dermatology and Therapy is an international, open access, peer-reviewed, rapid publication journal (peer review in 2 weeks, published 3–4 weeks from acceptance). The journal is dedicated to the publication of high-quality clinical (all phases), observational, real-world, and health outcomes research around the discovery, development, and use of dermatological therapies. Studies relating to diagnosis, pharmacoeconomics, public health and epidemiology, quality of life, and patient care, management, and education are also encouraged. Areas of focus include, but are not limited to all clinical aspects of dermatology, such as skin pharmacology; skin development and aging; prevention, diagnosis, and management of skin disorders and melanomas; research into dermal structures and pathology; and all areas of aesthetic dermatology, including skin maintenance, dermatological surgery, and lasers. The journal is of interest to a broad audience of pharmaceutical and healthcare professionals and publishes original research, reviews, case reports/case series, trial protocols, and short communications. Dermatology and Therapy will consider all scientifically sound research be it positive, confirmatory or negative data. Submissions are welcomed whether they relate to an International and/or a country-specific audience, something that is crucially important when researchers are trying to target more specific patient populations. This inclusive approach allows the journal to assist in the dissemination of quality research, which may be considered of insufficient interest by other journals. The journal appeals to a global audience and receives submissions from all over the world.
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