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
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 360
- 试验地点
- 1
- 主要终点
- Change in EQ-5D-Y Summary Scores across three disease groups from Baseline to Follow-up
研究概览
简要总结
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.
详细描述
[Research Background] Health-related quality of life (HRQoL) is a key indicator of well-being in paediatric patients, particularly for those with chronic illnesses. The EQ-5D-Y-3L and EQ-5D-Y-5L are widely used HRQoL measurement tools, but their psychometric properties in Chinese paediatric populations remain underexplored. Understanding how these instruments perform across different administration modes (self-complete, interviewer-administered, and proxy) and in comparison to other established HRQoL measures such as Pediatric Quality of Life Inventory (PedsQL) is essential for improving their application in paediatric healthcare. This study aims to evaluate the validity, reliability, and responsiveness of EQ-5D-Y instruments in children with pneumonia, central nervous system (CNS) solid tumours, and immune thrombocytopenic purpura (ITP) in China, contributing to better HRQoL assessment and economic evaluations in paediatric healthcare.
[Study Design] Prospective observational study.
[Primary Objectives] (1) Compare the psychometric performance (validity, reliability, responsiveness) of EQ-5D-Y-3L and EQ-5D-Y-5L in a Chinese paediatric population. (2) Evaluate differences between self-complete (SC), interviewer-administered (IA), and proxy versions of EQ-5D-Y. (3) Assess how EQ-5D-Y compares with PedsQL in measuring paediatric HRQoL.
[Secondary Objectives] (1) Explore caregiver burden and potential spillover effects using EQ-5D-5L and EQ-HWB-S. (2) Examine the influence of children's disease severity, treatment type, and administration mode on children's HRQoL outcomes. (3) Investigate differences in HRQoL measurement properties across three distinct paediatric disease groups.
[Participants] 360 paediatric patient-caregiver dyads, recruited from three hospitals in China. Disease groups include: Pneumonia (n=120), CNS solid tumours (n=120), and Immune thrombocytopenic purpura (ITP) (n=120).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 5 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Change in EQ-5D-Y Summary Scores across three disease groups from Baseline to Follow-up
时间窗: 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.
次要结局
- Caregiver Burden and Spillover Effects Using EQ-5D-5L and EQ-HWB-S(At hospital admission (Day 1))
研究者
Wenjing Zhou
Principal Investigator
RenJi Hospital