School of Primary Care, Population Sciences and Medical Education, University of Southampton, Southampton, England, UK; Health Economics Group, Norwich Medical School, University of East Anglia, Norwich, England, UK.
Centre of Evidence Based Dermatology, University of Nottingham, Nottingham, England, UK.
Value Health. 2024 Dec;27(12):1771-1778. doi: 10.1016/j.jval.2024.08.010. Epub 2024 Oct 10.
This study aimed to assess the practicality, validity, and responsiveness of the proxy Child Health Utility-9 Dimensions (CHU9D) in children aged 2 to 5 years.
We used data from the Barrier Enhancement for Eczema Prevention trial, a UK randomized controlled trial testing whether daily emollients in infancy could prevent eczema in high-risk infants. The main parent/carer completed the proxy CHU9D using developers' additional guidance for completion in those younger than 5 years and the Patient-Oriented Eczema Measure (POEM) at ages 2, 3, 4, and 5 years. Practicality was assessed by completion rates. Construct validity assessed whether CHU9D could discriminate between those with/without eczema and between eczema severity levels on POEM. Responsiveness was determined by ability to discriminate between 3 groups: (1) those whose POEM score deteriorated ≥3 points, (2) those whose change was not clinically important (-2.9 to 2.9 points), and (3) those whose POEM score improved ≥3 points. Analysis was conducted in Stata 17.
Of 1394 children participating in the Barrier Enhancement for Eczema Prevention trial, study questionnaires were completed by 1212 (87%), 981 (70%), 990 (71%), and 976 (70%) at 2, 3, 4, and 5 years. Of these the CHU9D was completed by 1066 (88.0%), 685 (69.8%), 925 (93.4%), and 923 (94.6%), respectively. Mean utility at all time points was approximately 0.934 (range 0.443-1). For construct validity, very small differences in the CHU9D between known groups were observed (P < .01). A total of 801 participants had responsiveness data: 13% deteriorated, 72% had nonclinically important change, and 15% improved. Mean utility change (standardized response mean) for these groups was -0.0198 (0.21), 0.0041 (0.05), and 0.0175 (0.21) showing small change and small responsiveness.
Proxy CHU9D in 2- to 5-year-old children shows potential but further research is needed.
本研究旨在评估儿童健康效用-9 维度（CHU9D）代理版在 2 至 5 岁儿童中的实用性、有效性和反应度。
我们使用了英国一项随机对照试验（即增强湿疹预防试验）的数据，该试验旨在检验婴儿期每日使用保湿剂是否可以预防高危婴儿的湿疹。主要的父母/照顾者使用开发者为年龄小于 5 岁儿童提供的额外指导来完成代理版 CHU9D，并在 2、3、4 和 5 岁时使用患者导向湿疹量表（POEM）进行评估。实用性通过完成率来评估。结构有效性评估 CHU9D 是否可以区分有/无湿疹以及 POEM 上的湿疹严重程度。反应度通过区分以下 3 组的能力来确定：（1）POEM 评分恶化≥3 分的患者；（2）POEM 评分变化无临床意义（-2.9 至 2.9 分）的患者；（3）POEM 评分改善≥3 分的患者。分析在 Stata 17 中进行。
在增强湿疹预防试验中，共有 1394 名儿童参与，其中 1212 名（87%）、981 名（70%）、990 名（71%）和 976 名（70%）在 2、3、4 和 5 岁时完成了研究问卷。在这些儿童中，分别有 1066 名（88.0%）、685 名（69.8%）、925 名（93.4%）和 923 名（94.6%）完成了 CHU9D。所有时间点的平均效用约为 0.934（范围 0.443-1）。对于结构有效性，在已知组之间观察到 CHU9D 存在非常小的差异（P<.01）。共有 801 名参与者具有反应性数据：13%的患者病情恶化，72%的患者变化无临床意义，15%的患者病情改善。这些组的平均效用变化（标准化反应均值）为-0.0198（0.21）、0.0041（0.05）和 0.0175（0.21），表明变化较小，反应度较小。
2 至 5 岁儿童的代理版 CHU9D 具有潜力，但需要进一步研究。
