Validation of the EQ-5D-Y-3L and EQ-5D-Y-5L for Paediatric Patients in China

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.

NCT Number	NCT06873672
Lead Sponsor	RenJi Hospital Collaborators: The EuroQol Research Foundation, Guizhou Provincial People's Hospital, Guizhou Medical University, The Children's Hospital of Zhejiang University School of Medicine, The Affiliated Hospital Of Guizhou Medical University
Conditions	Quality of Life (QOL), Patient-Reported Outcome Measures (PROMs), Pneumonia Childhood, Neuroblastoma (NB), Wilms Tumour, Immune Thrombocytopenic Purpura ( ITP )
Enrollment	360 participants
Start Date	2025-04-01
Primary Completion	2027-03-31 (estimated)
Study Completion	2027-12-31 (estimated)
Updated on ClinicalTrials.gov	2025-03-13