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

Launched by RENJI HOSPITAL · Mar 7, 2025

Keywords

ClinConnect Summary

This clinical trial is looking to understand how well two questionnaires, called EQ-5D-Y-3L and EQ-5D-Y-5L, can measure the quality of life for children facing various health issues in China. The study will involve children aged 5 to 16 who have been diagnosed with pneumonia, certain brain tumors, or a condition called Immune Thrombocytopenic Purpura (ITP). Each child will participate with a primary caregiver, such as a parent or grandparent, who will also answer questions. This research aims to see how well these questionnaires perform compared to other tools that measure children's health-related quality of life.

Participants can expect to be involved in a series of assessments when they are admitted to the hospital and again shortly before they are discharged. The study will also include interviews to gather feedback on how easy the questionnaires are to understand and use. To be eligible, children must be able to communicate in Mandarin and have a clear understanding of their health situation. Their caregivers need to be actively involved in their care and also able to communicate in Mandarin. This trial is important because its findings could help improve the way we measure health-related quality of life in young patients, potentially leading to better healthcare decisions for children in the future.

Gender

ALL

Eligibility criteria

• 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.