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International prospective observational study investigating the disease course and heterogeneity of paediatric-onset inflammatory bowel disease: the protocol of the PIBD-SETQuality inception cohort study
- Source :
- BMJ Open, BMJ Open, 10(7). BMJ Publishing Group
- Publication Year :
- 2020
- Publisher :
- BMJ Publishing Group, 2020.
-
Abstract
- IntroductionPatients with paediatric-onset inflammatory bowel disease (PIBD) may develop a complicated disease course, including growth failure, bowel resection at young age and treatment-related adverse events, all of which can have significant and lasting effects on the patient’s development and quality of life. Unfortunately, we are still not able to fully explain the heterogeneity between patients and their disease course and predict which patients will respond to certain therapies or are most at risk of developing a more complicated disease course. To investigate this, large prospective studies with long-term follow-up are needed. Currently, no such European or Asian international cohorts exist. In this international cohort, we aim to evaluate disease course and which patients are most at risk of therapy non-response or development of complicated disease based on patient and disease characteristics, immune pathology and environmental and socioeconomic factors.Methods and analysisIn this international prospective observational study, which is part of the PIBD Network for Safety, Efficacy, Treatment and Quality improvement of care (PIBD-SETQuality), children diagnosed with inflammatory bowel disease Ethics and disseminationMedical ethical approval has been obtained prior to patient recruitment for all sites. The results will be disseminated through peer-reviewed scientific publications.Trial registration numberNCT03571373.
- Subjects :
- medicine.medical_specialty
Internationality
medicine.medical_treatment
Disease
Gastroenterology and Hepatology
Inflammatory bowel disease
paediatric gastroenterology
immunology
Cohort Studies
03 medical and health sciences
0302 clinical medicine
Quality of life
Clinical Protocols
inflammatory bowel disease
Risk Factors
Surveys and Questionnaires
medicine
Humans
030212 general & internal medicine
Prospective Studies
Prospective cohort study
Intensive care medicine
Child
business.industry
Incidence
General Medicine
Bowel resection
medicine.disease
Inflammatory Bowel Diseases
Quality Improvement
Patient recruitment
Child, Preschool
Cohort
Disease Progression
Observational study
business
030217 neurology & neurosurgery
Subjects
Details
- Language :
- English
- ISSN :
- 20446055
- Volume :
- 10
- Issue :
- 7
- Database :
- OpenAIRE
- Journal :
- BMJ Open
- Accession number :
- edsair.doi.dedup.....d9d75c3c0be5b492604b1279d121341a