[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"wilms-tumour\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:wilms-tumour":30},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":22,"studyType":23,"phases":4,"briefSummary":24,"conditions":25,"keywords":32,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":41,"lastUpdatePostDateStruct":42,"startDateStruct":45,"completionDateStruct":47,"leadSponsor":49,"locationsCount":5},"100583234","validation-of-the-eq-5d-y-3l-and-eq-5d-y-5l-for-paediatric-patients-in-china-100583234",false,"NCT06873672","Validation of the EQ-5D-Y-3L and EQ-5D-Y-5L for Paediatric Patients in China","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","Inclusion Criteria:\n\n* Children (Patients)\n\n  1. Age: 5-16 years old.\n  2. Diagnosis: Clinically confirmed diagnosis of one of the following conditions:\n\n     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).\n  3. Health Status: Cognitively and physically capable of completing HRQoL assessments (for self-complete versions).\n  4. Language Proficiency: Able to understand and communicate in Mandarin Chinese.\n  5. Consent: Written informed consent obtained from the primary caregiver and verbal or written assent from the child (if age-appropriate).\n* Caregivers (Parents\u002FFamily Caregivers)\n\n  1. Primary Caregiver: Must be a parent or a long-term family caregiver (e.g., grandparent, older sibling, aunt, or uncle).\n  2. Involvement: Directly responsible for the daily care and medical decision-making of the child.\n  3. Language Proficiency: Able to understand and complete both the self-complete and proxy-reported HRQoL assessments in Mandarin Chinese.\n  4. Consent: Willing to provide informed consent for participation.\n\nExclusion Criteria:\n\n* Children (Patients)\n\n  1. Severe Cognitive or Developmental Impairment: Diagnosed with intellectual disability, autism spectrum disorder, or any neurological condition that prevents understanding and completing HRQoL assessments.\n  2. Severe Physical Disability:\n\n     Conditions that make it impossible to respond to surveys (e.g., advanced neuromuscular disease, severe paralysis).\n  3. Comorbidities: Presence of another major chronic illness that could significantly affect HRQoL measurement (e.g., severe congenital heart disease, uncontrolled epilepsy).\n  4. Recent Participation in Similar Studies:\n\n     If the child has participated in another HRQoL validation study within the past 6 months.\n  5. Inability to Complete Study Follow-Up: Expected to be transferred to another hospital or relocated during follow-up.\n* Caregivers (Parents\u002FFamily Caregivers)\n\n  1. Not the Primary Caregiver:\n  2. Individuals who do not have daily caregiving responsibilities for the child.\n\n     Cognitive Impairment or Severe Health Conditions:\n  3. Caregivers with severe mental illness, dementia, or a medical condition that affects their ability to complete surveys.\n  4. Language Barrier: Unable to understand and complete HRQoL assessments in Mandarin Chinese.\n  5. Refusal to Participate: Caregivers who decline to provide informed consent.","ALL","5 Years","16 Years",{"count":20,"type":21},360,"ESTIMATED","2 Weeks","OBSERVATIONAL","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.",[26,27,28,29,30,31],"Quality of Life (QOL)","Patient-Reported Outcome Measures (PROMs)","Pneumonia Childhood","Neuroblastoma (NB)","Wilms Tumour","Immune Thrombocytopenic Purpura ( ITP )",[33,34,35,36,37,38,39],"Quality of life","children","psychometric measurements","Paediatric pneumonia","Paediatric central nervous system solid tumour","paediatric immune thrombocytopenic purpura","spillover effect","NOT_YET_RECRUITING","2025-03-07",{"date":43,"type":44},"2025-03-13","ACTUAL",{"date":46,"type":21},"2025-04-01",{"date":48,"type":21},"2027-12-31",{"name":50,"class":51},"RenJi Hospital","OTHER"]