Checking a child health questionnaire in children with pneumonia, tumours or ITP
Tests a quality-of-life questionnaire in children aged 5 to 16 with pneumonia, ITP or tumours.
Plain-language title generated from the registry record
Registry title: Validation of the EQ-5D-Y-3L and EQ-5D-Y-5L for Paediatric Patients in China
Key facts
- Where
- Guiyang, ChinaSee the site
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 5 and 16 years old?
Source: NCT06873672, who can take part
Where in China
- Guizhou Medical UniversityGuiyang, ChinaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- RenJi Hospital
- Trial code
- NCT06873672
- Record updated
- 13 March 2025
- Original description
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.Read full original descriptionShow less
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
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.
Inclusion: Children (Patients); Age: 5-16 years old; 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); Health Status: Cognitively and physically capable of completing HRQoL assessments (for self-complete versions); Language Proficiency: Able to understand and communicate in Mandarin Chinese; Consent: Written informed consent obtained from the primary caregiver and verbal or written assent from the child (if age-appropriate); Caregivers (Parents/Family Caregivers); Primary Caregiver: Must be a parent or a long-term family caregiver (e.g., grandparent, older sibling, aunt, or uncle); Involvement: Directly responsible for the daily care and medical decision-making of the child; Language Proficiency: Able to understand and complete both the self-complete and proxy-reported HRQoL assessments in Mandarin Chinese; Consent: Willing to provide informed consent for participation.
Exclusion: 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; Severe Physical Disability:; Conditions that make it impossible to respond to surveys (e.g., advanced neuromuscular disease, severe paralysis); Comorbidities: Presence of another major chronic illness that could significantly affect HRQoL measurement (e.g., severe congenital heart disease, uncontrolled epilepsy); Recent Participation in Similar Studies:; If the child has participated in another HRQoL validation study within the past 6 months; Inability to Complete Study Follow-Up: Expected to be transferred to another hospital or relocated during follow-up; Caregivers (Parents/Family Caregivers); Not the Primary Caregiver:; Individuals who do not have daily caregiving responsibilities for the child; Cognitive Impairment or Severe Health Conditions:; Caregivers with severe mental illness, dementia, or a medical condition that affects their ability to complete surveys; Language Barrier: Unable to understand and complete HRQoL assessments in Mandarin Chinese; Refusal to Participate: Caregivers who decline to provide informed consent.