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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age5-16
SponsorRenJi Hospital

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

360 Participants
are grouped into 4 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