Chua Ai-Ping, Finch Aureliano Paolo, Rahman Shaffinaz Abd, Cruz Mary Anne Relimbo Dela, Montaniel Emelita Naval, Ravichandran Kaayathiri, Luo Nan
Department of Medicine, JurongHealth Campus, National University Health System, Singapore, Singapore.
Saw Swee Hock School of Public Health, National University of Singapore, Singapore, Singapore.
Qual Life Res. 2025 May 21. doi: 10.1007/s11136-025-03985-0.
The EQ-5D-5L may not adequately capture the health-related quality of life in patients with sleep disturbances. We examined the psychometric properties of a hybrid PROM comprising a module of four sleep-related bolt-ons and EQ-5D-5L.
We employed a sequential exploratory mixed method by first qualitatively testing the face validity of "sleep", "cognition", "tiredness" and "relationship" and refining these bolt-ons through in-depth interviews with 23 patients and clinicians. We then quantitatively assessed their performance by administering the four bolt-ons, appended to EQ-5D-5L, and three condition-specific patient-reported outcome measures (cPROMs) during two clinical visits of patients with respiratory-related sleep disorders. We compared ceiling effects and construct validity of EQ-5D-5L with and without the bolt-ons by testing a priori hypotheses about the cPROMs and polysomnographic characteristics via correlation and areas under the curves (AUC) analyses, respectively. We examined their responsiveness among "treated/improved" participants using standardized response means (SRM) and AUC analysis, and reliability among "untreated/no change" participants using intra-class correlation coefficient (ICC) or Cohen's Kappa (k).
110 participants (mean [SD] age: 47[13]) were recruited and 90 returned for their review assessments (mean [SD] interval: 2.2 [2.1] months). The bolt-ons led to a reduction of 42.7% in ceiling effects. The bolt-ons were better correlated with cPROMs and exhibited higher discriminatory power and responsiveness, with comparable reliability to EQ-5D-5L. A combined module of the four bolt-ons provided better results than individual bolt-ons.
A "hybrid" PROM of sleep bolt-ons module added to EQ-5D-5L improved its psychometric properties among patients with sleep disturbances.
EQ-5D-5L可能无法充分反映睡眠障碍患者的健康相关生活质量。我们研究了一种混合患者报告结局量表（PROM）的心理测量特性，该量表包括一个由四个与睡眠相关的附加模块和EQ-5D-5L组成。
我们采用了一种序贯探索性混合方法，首先对“睡眠”“认知”“疲劳”和“人际关系”的表面效度进行定性测试，并通过对23名患者和临床医生进行深入访谈来完善这些附加模块。然后，我们通过在呼吸相关睡眠障碍患者的两次临床就诊期间，对附加在EQ-5D-5L上的四个附加模块以及三项特定疾病患者报告结局指标（cPROMs）进行定量评估，来评估它们的性能。我们通过分别对cPROMs和多导睡眠图特征进行相关性分析和曲线下面积（AUC）分析，检验关于cPROMs和多导睡眠图特征的先验假设，比较了有附加模块和无附加模块时EQ-5D-5L的天花板效应和结构效度。我们使用标准化反应均值（SRM）和AUC分析检验了它们在“接受治疗/病情改善”参与者中的反应性，使用组内相关系数（ICC）或科恩kappa系数（k）检验了它们在“未接受治疗/无变化”参与者中的可靠性。
招募了110名参与者（平均[标准差]年龄：47[13]岁），90名参与者返回进行复查评估（平均[标准差]间隔时间：2.2[2.1]个月）。附加模块使天花板效应降低了42.7%。附加模块与cPROMs的相关性更好，具有更高的区分能力和反应性，与EQ-5D-5L的可靠性相当。四个附加模块的组合模块比单个附加模块提供了更好的结果。
在EQ-5D-5L基础上增加睡眠附加模块的“混合”PROM改善了睡眠障碍患者的心理测量特性。
