Gabes M, Apfelbacher C
Institute of Social Medicine and Health Economics, Otto-von-Guericke-University Magdeburg, Magdeburg, Germany.
Medical Sociology, Department of Epidemiology and Preventive Medicine, University of Regensburg, Regensburg, Germany.
J Eur Acad Dermatol Venereol. 2021 Feb;35(2):458-463. doi: 10.1111/jdv.16848. Epub 2020 Aug 17.
The Harmonising Outcome Measures for Eczema (HOME) initiative has agreed that quality of life should be measured in all atopic eczema clinical trials. Various candidate instruments exist for this domain but their content validity in atopic eczema is largely unclear.
To assess the content validity of quality-of-life candidate instruments for atopic eczema in infants, children and adults in order to aid the decision on what instrument to include in the core outcome set for the quality-of-life domain.
Six group discussions were conducted at the HOME VII Meeting in Tokyo. Each group was composed of 8-12 patients or parents of patients, clinicians, methodologists and pharmaceutical industry delegates and discussed one or two candidate instruments. The COSMIN criteria on relevance, comprehensiveness and comprehensibility were used to determine the overall content validity rating per instrument.
Content validity of the Infant's Dermatitis Quality of Life Index, Children's Dermatology Life Quality Index and the Childhood Atopic Dermatitis Impact Scale (CADIS) long-form was rated as sufficient (+). Results for the CADIS short-form, DLQI and Skindex were inconsistent (±). DISABKIDS, Infants and Toddlers Dermatology Quality of Life and ABS-A were classified as having insufficient content validity.
The content validity rating allowed for a comparison of all candidate instruments and informed the consensus-seeking process regarding the core instrument for the quality-of-life domain.
湿疹统一疗效评估指标（HOME）倡议已达成共识，即在所有特应性皮炎临床试验中均应测量生活质量。针对该领域存在多种候选工具，但其在特应性皮炎中的内容效度在很大程度上尚不清楚。
评估婴儿、儿童和成人特应性皮炎生活质量候选工具的内容效度，以辅助决定在生活质量领域的核心结局集中纳入何种工具。
在东京举行的HOME VII会议上进行了六次小组讨论。每个小组由8至12名患者或患者家长、临床医生、方法学家和制药行业代表组成，讨论一种或两种候选工具。使用COSMIN关于相关性、全面性和可理解性的标准来确定每种工具的总体内容效度评级。
婴儿性皮炎生活质量指数、儿童皮肤病生活质量指数和儿童特应性皮炎影响量表（CADIS）长版的内容效度被评为充分（+）。CADIS短版、皮肤病生活质量指数（DLQI）和皮肤指数（Skindex）的结果不一致（±）。儿童残疾评定量表（DISABKIDS）、婴幼儿皮肤病生活质量量表和成人及儿童皮肤病生活质量量表（ABS-A）被归类为内容效度不足。
内容效度评级有助于对所有候选工具进行比较，并为生活质量领域核心工具的共识达成过程提供信息。
