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Intrathecal baclofen therapy in paediatrics: a study protocol for an Australian multicentre, 10-year prospective
Kirsty Stewart1,2, Gavin Hutana3, Megan Kentish4
1Kids Rehab, The Children's Hospital at Westmead, Sydney, Australia.
Insights
The Australian Paediatric Intrathecal Baclofen (ITB) Audit is a national study tracking outcomes and adverse events in children receiving ITB therapy. This research aims to standardize care and improve quality of life for pediatric patients.
Area of Science:
- Paediatric Neurology
- Clinical Audit
- Health Outcomes Research
Background:
- Intrathecal baclofen (ITB) use is increasing in Australian pediatric hospitals.
- Standardized assessment and reporting of adverse events are needed.
- The Australian Paediatric ITB Research Group (APIRG) was formed to address these needs.
Purpose of the Study:
- To develop and implement a National ITB Audit tool for Australian children and adolescents.
- To capture comprehensive clinical outcomes and adverse events data.
- To inform ITB clinical practice, patient selection, and quality of life assessments.
Main Methods:
- A 10-year, longitudinal, prospective clinical audit.
- Data collection across body functions, participation, and activity domains of the ICF.
- Data captured at baseline, 6, 12 months, and ongoing adverse events.
Main Results:
- This is the first Australian study to capture data from a complete population of children with neurological impairment receiving ITB.
- The audit collects data on clinical outcomes and adverse events.
- Data will inform clinical practice and decision-making regarding ITB therapy.
Conclusions:
- The Australian ITB Audit will provide crucial data on the use and impact of ITB in pediatric populations.
- Findings will guide clinical practice, improve patient selection, and enhance management of adverse events.
- The study will investigate the impact of ITB on patient and family quality of life.
Introduction:
Increasing clinical use of Intrathecal baclofen (ITB) in Australian tertiary paediatric hospitals, along with the need for standardised assessment and reporting of adverse events, saw the formation of the Australian Paediatric ITB Research Group (APIRG). APIRG developed a National ITB Audit tool designed to capture clinical outcomes and adverse events data for all Australian children and adolescents receiving ITB therapy.
Methods And Analysis:
The Australian ITB Audit is a 10 year, longitudinal, prospective, clinical audit collecting all adverse events and assessment data across body functions and structure, participation and activity level domains of the ICF. Data will be collected at baseline, 6 and 12 months with ongoing capture of all adverse event data. This is the first Australian study that aims to capture clinical and adverse event data from a complete population of children with neurological impairment receiving a specific intervention between 2011 and 2021. This multi-centre study will inform ITB clinical practice in children and adolescents, direct patient selection, record and aid decision making regarding adverse events and investigate the impact of ITB therapy on family and patient quality of life.
Ethics And Dissemination:
This project was approved by the individual Human Research Ethics committees at the six Australian tertiary hospitals involved in the study. Results will be published in various peer reviewed journals and presented at national and international conferences.
Trial Registration Number:
ACTRN 12610000323022; Pre-results.
