The goal of this observational study is to validate the EQ-5D-Y-3L and EQ-5D-Y-5L in measuring health-related quality of life (HRQoL) for paediatric patients with different health conditions in China. The main research questions focus on comparing the psychometric performance of EQ-5D-Y-3L and EQ-5D-Y-5L, evaluating the differences between self-complete (SC), interviewer-administered (IA), and proxy-administered (Proxy) versions, and assessing their validity against other HRQoL measures like PedsQL. The study will recruit 360 inpatient-caregiver dyads from three disease groups, i.e., pneumonia, paediatric central nervous system (CNS) solid tumours, and immune thrombocytopenic purpura (ITP), using cross-sectional and longitudinal surveys. Baseline assessments will be conducted at hospital admission, with follow-up at hospital discharge (within 14 days). A qualitative component will explore acceptability and interpretation of EQ-5D-Y. The findings will contribute to the methodological development of EQ-5D-Y, with potential implications for HRQoL measurement and economic evaluations in paediatric healthcare.
Children (Patients)
Age: 5-16 years old.
Health Status: Cognitively and physically capable of completing HRQoL assessments (for self-complete versions).
Language Proficiency: Able to understand and communicate in Mandarin Chinese.
Children (Patients)
Severe Cognitive or Developmental Impairment: Diagnosed with intellectual disability, autism spectrum disorder, or any neurological condition that prevents understanding and completing HRQoL assessments.
Comorbidities: Presence of another major chronic illness that could significantly affect HRQoL measurement (e.g., severe congenital heart disease, uncontrolled epilepsy).
Inability to Complete Study Follow-Up: Expected to be transferred to another hospital or relocated during follow-up.
Participants will be recruited from three tertiary hospitals different cities in China. The study will enroll paediatric patients aged 5-16 years who are receiving routine care for pneumonia, central nervous system (CNS) solid tumours, or immune thrombocytopenic purpura (ITP). These conditions represent common and clinically significant paediatric health issues requiring hospitalization or specialized treatment. The study will also recruit primary caregivers, who are typically parents or long-term family caregivers responsible for the child's daily care and medical decision-making.
Cohort
Prospective
Not listed
Change in EQ-5D-Y Summary Scores across three disease groups from Baseline to Follow-up
The EQ-5D-Y Summary Scores include: (1) Index Score which is derived using the Chinese value set for EQ-5D-Y-3L; (2) the Level Sum Score (LSS) which is calculated by summing the reported levels across five dimensions of the EQ-5D-Y-3L and EQ-5D-Y-5L (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression), with higher scores indicating worse health; and (3) the visual analogue scale (EQ VAS), a self-reported global health assessment measured on a 0 to 100 scale, where 0 represents the worst imaginable health and 100 represents the best imaginable health. The change in these scores from baseline to follow-up will be analyzed to assess test-retest reliability, responsiveness and known-groups validity, and will be compared across the three administration modes (self-complete, interviewer-administered, and proxy-reported) and across three disease groups.
Caregiver Burden and Spillover Effects Using EQ-5D-5L and EQ-HWB-S
The impact of caregiving burden on parents will be assessed using the EQ-5D-5L and EQ Health and Well-Being Scale (EQ-HWB-S), both of which generate preference-based index scores. The EQ-5D-5L assesses caregivers' health status across five dimensions-mobility, self-care, usual activities, pain/discomfort, and anxiety/depression-while the EQ-HWB-S captures a broader range of well-being aspects, including social and emotional impacts such as exhaustion, loneliness, and cognitive difficulties. Index scores for both instruments will be derived using the respective value sets, with higher scores indicating better health and well-being. Correlations between caregiver scores and children's EQ-5D-Y scores will be analyzed to explore spillover effects, distinguishing between caregiving-related burdens and broader family-level impacts.
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RenJi Hospital
Lead sponsor
The EuroQol Research Foundation
Collaborator
Guizhou Provincial People's Hospital
Collaborator
Guizhou Medical University
Collaborator
The Children's Hospital of Zhejiang University School of Medicine
Collaborator
The Affiliated Hospital Of Guizhou Medical University
Collaborator
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