Dataset Information

Intrathecal baclofen therapy in paediatrics: a study protocol for an Australian multicentre, 10-year prospective audit.

ABSTRACT:

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.

SUBMITTER: Stewart K

PROVIDER: S-EPMC5541593 | biostudies-literature | 2017 Jun

REPOSITORIES: biostudies-literature

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Publications

Intrathecal baclofen therapy in paediatrics: a study protocol for an Australian multicentre, 10-year prospective audit.

Stewart Kirsty K Hutana Gavin G Kentish Megan M

BMJ open 20170621 6

<h4>Introduction</h4>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.<h4>Methods and analysis</h4>The Australian ITB Audit ...[more]

PMID: 28637739

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Project description:Persistent postconcussive symptoms (PCSs) is the persistence of somatic, cognitive, physical, psychological and/or behavioural changes lasting more than 1 month following concussion. Persistent concussion impacts the quality of life through impaired cognition, memory and attention affecting school performance, mood and social engagement. No large epidemiological studies have determined the true prevalence of persistent concussion symptoms. Validated, easy-to-use prognosticators do not exist for clinicians to identify children at highest risk. The goal of Predicting and Preventing Postconcussive Problems in Pediatrics study is to derive a clinical prediction rule for the development of persistent postconcussion symptoms in children and adolescents presenting to emergency department following acute head injury.This study is a prospective, multicentre cohort study across nine academic Canadian paediatric emergency departments. We will recruit the largest prospective epidemiological cohort of children with concussion. Eligible children will be followed using Post-Concussion Symptom Inventory, a validated tool in children as young as 5 years. Patients will follow-up at 1, 2, 4, 8 and 12 weeks postinjury. The main outcome will be the presence/absence of PCSs defined as three or more persistent concussion symptoms 1 month following the injury. 1792 patients provide adequate power to derive a clinical decision rule using multivariate analyses to find predictor variables sensitive for detecting cases of persistent postconcussion symptoms.Results of this large prospective study will enable clinicians to identify children at highest risk, optimise treatment and provide families with realistic and appropriate anticipatory guidance. Ethics has been obtained through the Children's Hospital of Eastern Ontario Research Ethics Board. Results will be disseminated at international conferences and in four manuscripts to peer-reviewed journals.This study is registered at Clinicaltrials.gov through the US National Institute of Health/National Library of Medicine (NCT01873287; http://clinicaltrials.gov/ct2/show/NCT01873287).

Project description:AIM:To investigate the effects of continuous intrathecal baclofen (ITB) therapy in children with cerebral palsy (CP) and other neurological conditions. METHOD:This systematic review was conducted using standardized methodology, searching four electronic databases (PubMed, Embase, CINAHL, Cochrane Library) for relevant literature published between inception and September 2017. Included studies involved continuous ITB as an intervention and outcome measures relating to all International Classification of Functioning, Disability and Health: Children and Youth (ICF-CY) components. RESULTS:Thirty-three studies were identified, of which one, including 17 children with spastic CP, produced level II evidence, and the others, mainly non-controlled cohort studies, level IV and V. Outcomes at body function level were most frequently reported. Results suggest continuous ITB may be effective in reducing spasticity and dystonia in CP, as well as other neurological conditions, and may improve the ease of care and quality of life of children with CP, but the level of evidence is low. INTERPRETATION:Despite three decades of applying ITB in children and a relatively large number of studies investigating the treatment effects, a direct link has not yet been demonstrated because of the low scientific quality of the primary studies. Further investigation into the effects of continuous ITB at all levels of the ICF-CY is warranted. Although large, controlled trials may be difficult to realize, national and international collaborations may provide opportunities. Also, multicentre prospective cohort studies with a long-term follow-up, employing harmonized outcome measures, can offer prospects to expand our knowledge of the effects of continuous ITB therapy in children. WHAT THIS PAPER ADDS:There is low-level evidence for continuous intrathecal baclofen (ITB) in children with cerebral palsy. Continuous ITB is effective in reducing spasticity and dystonia in non-controlled cohort studies. Evaluation of individual goals and systematic assessment of long-term effects in large cohort studies are required.

Dataset Information

Intrathecal baclofen therapy in paediatrics: a study protocol for an Australian multicentre, 10-year prospective audit.

Introduction

Methods and analysis

Ethics and dissemination

Trial registration number

Publications

Intrathecal baclofen therapy in paediatrics: a study protocol for an Australian multicentre, 10-year prospective audit.

Similar Datasets

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