Quality of Life (QOL)Patient-Reported Outcome Measures (PROMs)Pneumonia ChildhoodNeuroblastoma (NB)Wilms TumourImmune Thrombocytopenic Purpura ( ITP )
Study summary
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
Sex
ALL
Min age
5 Years
Max age
16 Years
Healthy volunteers
No
Inclusion Criteria:
* Children (Patients)
1. Age: 5-16 years old.
2. Diagnosis: Clinically confirmed diagnosis of one of the following conditions:
Pneumonia (hospitalized due to community-acquired pneumonia); Central Nervous System (CNS) Solid Tumours (receiving active treatment or in post-treatment follow-up); Immune Thrombocytopenic Purpura (ITP) (diagnosed with acute or chronic ITP).
3. Health Status: Cognitively and physically capable of completing HRQoL assessments (for self-complete versions).
4. Language Proficiency: Able to understand and communicate in Mandarin Chinese.
5. Consent: Written informed consent obtained from the primary caregiver and verbal or written assent from the child (if age-appropriate).
* Caregivers (Parents/Family Caregivers)
1. Primary Caregiver: Must be a parent or a long-term family caregiver (e.g., grandparent, older sibling, aunt, or uncle).
2. Involvement: Directly responsible for the daily care and medical decision-making of the child.
3. Language Proficiency: Able to understand and complete both the self-complete and proxy-reported HRQoL assessments in Mandarin Chinese.
4. Consent: Willing to provide informed consent for participation.
Exclusion Criteria:
* Children (Patients)
1. Severe Cognitive or Developmental Impairment: Diagnosed with intellectual disability, autism spectrum disorder, or any neurological condition that prevents understanding and completing HRQoL assessments.
2. Severe Physical Disability:
Conditions that make it impossible to respond to surveys (e.g., advanced neuromuscular disease, severe paralysis).
3. Comorbidities: Presence of another major chronic illness that could significantly affect HRQoL measurement (e.g., severe congenital heart disease, uncontrolled epilepsy).
4. Recent Participation in Similar Studies:
If the child has participated in another HRQoL validation study within the past 6 months.
5. Inability to Complete Study Follow-Up: Expected to be transferred to another hospital or relocated during follow-up.
* Caregivers (Parents/Family Caregivers)
1. Not the Primary Caregiver:
2. Individuals who do not have daily caregiving responsibilities for the child.
Cognitive Impairment or Severe Health Conditions:
3. Caregivers with severe mental illness, dementia, or a medical condition that affects their ability to complete surveys.
4. Language Barrier: Unable to understand and complete HRQoL assessments in Mandarin Chinese.
5. Refusal to Participate: Caregivers who decline to provide informed consent.
Primary outcome measure(s)
Change in EQ-5D-Y Summary Scores across three disease groups from Baseline to Follow-up — From Day 1 (hospital admission) to hospital discharge (within 14 days) 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.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
We use cookies to analyse site traffic and improve your experience. With your consent, we may also use cookies for advertising. You can change your choice at any time on our Cookie Policy page. See also our Privacy Policy.