ArticleBMJ open2025
Validation of EuroQol instruments in paediatric patients and their caregivers in China: protocol for a prospective observational study.
Article in BMJ open, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06873672 (Using EQ-5D-Y to Measure the Health of Patients for Multiple Paediatric Health Conditions), which is not on this map. Not yet cited in PubMed.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Using EQ-5D-Y to Measure the Health of Patients for Multiple Paediatric Health Conditions: a Project to Validate the Self-complete, Interviewer-administered and Proxy Administered Versions of EQ-5D-Y-3L and EQ-5D-Y-5L in China
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0 citing papers in PubMed.
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Authors and funding
7 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
introductionThe EQ-5D-Y (the youth version of EQ-5D) is widely used to assess children's health-related quality of life (HRQoL), yet its psychometric properties across administration modes remain insufficiently explored, particularly in paediatric oncology and rare diseases. Additionally, the broader impact of childhood illness on family caregivers (spillover effects) is underexamined. This study aims to evaluate the validity, reliability and responsiveness of the three-level version of EQ-5D-Y (EQ-5D-Y-3L) and the five-level version of EQ-5D-Y (EQ-5D-Y-5L) across different modes while also assessing the EQ-5D five-level version (EQ-5D-5L) and the new EQ Health and Well-being Short Version (EQ-HWB-9) in capturing spillover effects. Originally designed for social care interventions, the EQ-HWB-9 is expected to be applicable to caregivers. METHODS AND ANALYSIS: This prospective observational study will recruit children aged 5-16 years with pneumonia, central nervous system (CNS) solid tumours or immune thrombocytopenic purpura (ITP) from three hospitals in China, along with their caregivers. A total of 360 dyads (patients and their caregivers) are planned for recruitment. Children will complete EQ-5D-Y-3L, EQ-5D-Y-5L and Paediatric Quality of Life Inventory (PedsQL) in self-complete (SC), interviewer-administered (IA) and proxy-reported modes by caregivers. Caregivers will complete EQ-5D-5L and EQ-HWB-9 to assess spillover effects. Data will be collected at baseline and follow-up (2-3 weeks). Primary outcomes include psychometric assessments (construct validity, reliability and responsiveness) of all the instruments. Secondary outcomes include HRQoL scores, ceiling effects and the correlation between EQ-5D-Y and PedsQL. A qualitative substudy will explore children's response interpretation and factors contributing to ceiling effects. Statistical analyses will include intraclass correlation coefficients for test-retest reliability, analysis of variance for known-groups validity, effect sizes for responsiveness, regression for spillover effects and thematic analysis for qualitative data. ETHICS AND DISSEMINATION: Ethical approval has been obtained from three ethics committees: the Guizhou Medical University (IRB:2024159), the Children's Hospital, Zhejiang University School of Medicine (IRB:2024-IRB-0158-P-01) and Guizhou Provincial People's Hospital (IRB:2024073). Written informed consent will be secured from caregivers, and assent will be obtained from children aged 8 years and older. Study findings will be disseminated through national/international conferences and peer-reviewed journals. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov, NCT06873672.
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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.