[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100583234":3},{"organization":4,"armGroups":7,"interventions":10,"overallOfficials":10,"centralContacts":21,"locations":27,"responsibleParty":46,"collaborators":50,"id":60,"slug":61,"hasResults":62,"nctId":63,"briefTitle":64,"officialTitle":65,"acronym":10,"eligibilityCriteria":66,"healthyVolunteers":62,"sex":67,"minAge":68,"maxAge":69,"enrollmentInfo":70,"targetDuration":73,"studyType":74,"phases":10,"briefSummary":75,"conditions":76,"keywords":83,"overallStatus":91,"whyStopped":10,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":93,"startDateStruct":96,"completionDateStruct":98,"leadSponsor":100,"locationsCount":101},{"fullName":5,"class":6},"RenJi Hospital","OTHER",[8,12,15,18],{"label":9,"type":10,"description":11,"interventionNames":10},"Children with pneumonia",null,"Children with pneumonia will be recruited from inpatient wards at Guizhou Provincial People's Hospital and affiliated hospitals of Guizhou Medical University. These children are diagnosed with community-acquired pneumonia (CAP) and receive routine paediatric pneumonia treatment, including antibiotic therapy, oxygen support, intravenous fluids, and symptom monitoring, based on national clinical guidelines.",{"label":13,"type":10,"description":14,"interventionNames":10},"Children with central nervous system (CNS) solid tumours","Children with central nervous system (CNS) solid tumours will be recruited from The Children's Hospital affiliated with Zhejiang University School of Medicine. These children are diagnosed with CNS solid tumours, i.e., Neuroblastoma or Wilms tumour, and are either undergoing active treatment (including surgical resection, chemotherapy, and radiotherapy) or in post-treatment follow-up.",{"label":16,"type":10,"description":17,"interventionNames":10},"Children with immune thrombocytopenic purpura","Children with immune thrombocytopenic purpura (ITP) will be recruited from paediatric haematology departments at the No.1 Hospital Affiliated to Guizhou Medical University. These children are diagnosed with ITP, a rare autoimmune disorder characterized by low platelet counts and increased bleeding risk. Their treatment varies by disease severity, including observation, corticosteroids, intravenous immunoglobulin (IVIG), or thrombopoietin receptor agonists (TPO-RAs).",{"label":19,"type":10,"description":20,"interventionNames":10},"Family caregivers","Caregivers in this study include parents and family caregivers who provide long-term care and support for the child's well-being. Parents (biological or adoptive mothers and fathers) are the primary caregivers, responsible for medical decisions, daily care, and emotional support. Family caregivers, including grandparents, older siblings, aunts, or uncles, may assume caregiving roles due to parental absence or additional support needs, assisting with daily care, medical follow-ups, and emotional well-being.",[22],{"name":23,"role":24,"phone":25,"phoneExt":10,"email":26},"Wenjing Zhou, PhD","CONTACT","+31685281032","zhoujing2188@163.com",[28],{"facility":29,"status":10,"city":30,"state":31,"zip":32,"country":33,"countryCode":34,"cosmosGeoPoint":35,"geoPoint":40,"contacts":41},"Guizhou Medical University","Guiyang","Guizhou","550025","China","CN",{"type":36,"coordinates":37},"Point",[38,39],106.71667,26.58333,{"lat":39,"lon":38},[42],{"name":43,"role":24,"phone":44,"phoneExt":10,"email":45},"Zhihao Yang, PhD","+8618302637542","zhihao_yang_cn@126.com",{"type":47,"investigatorFullName":48,"investigatorTitle":49,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"PRINCIPAL_INVESTIGATOR","Wenjing Zhou","Principal Investigator",[51,53,55,56,58],{"name":52,"class":6},"The EuroQol Research Foundation",{"name":54,"class":6},"Guizhou Provincial People's Hospital",{"name":29,"class":6},{"name":57,"class":6},"The Children's Hospital of Zhejiang University School of Medicine",{"name":59,"class":6},"The Affiliated Hospital Of Guizhou Medical University","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":71,"type":72},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.",[77,78,79,80,81,82],"Quality of Life (QOL)","Patient-Reported Outcome Measures (PROMs)","Pneumonia Childhood","Neuroblastoma (NB)","Wilms Tumour","Immune Thrombocytopenic Purpura ( ITP )",[84,85,86,87,88,89,90],"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":94,"type":95},"2025-03-13","ACTUAL",{"date":97,"type":72},"2025-04-01",{"date":99,"type":72},"2027-12-31",{"name":5,"class":6},1]