About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Not listed
Trial groups
Sponsors and collaborators
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