Intrathecal baclofen in Australia: Ten years of collaborative data collection

Abstract

Objective: Paediatric intrathecal baclofen (ITB) therapy commenced in Australia in 1999 and is an established intervention in comprehensive cerebral palsy and movement disorder clinical management at six tertiary paediatric hospitals across Australia. In 2011, the Australian Paediatric ITB Research Group established a national ITB assessment protocol and adverse events database. This paper presents the first ten years of data. Design: Longitudinal, prospective, multisite, collaborative study. Method: Eighty-two participants were consented for the study between 2011 and 2020. Participants were aged 3.9yrs to 15.9yrs at implant (mean 10.6yrs, SD 3.3yrs; male = 46), 62 had cerebral palsy, 15 genetic conditions, 3 acquired brain injury and 2 spinal cord conditions. Classifications, or equivalents were: Gross Motor Function Classification System (GMFCS) level II = 2 III = 7 IV = 30 V = 43, Manual Ability Classification System (MACS) I = 5 II = 2 III = 16 IV = 18 V = 41, and Communication Function Classification System (CFCS) I = 10 II = 9 III = 17 IV = 10 V = 33. Demographic and test dose data was collected in addition to outcomes at baseline, 6-and 12-months post implant including: Canadian Occupational Performance Measure (COPM), Caregiver Priorities and Child Health Index of Life with Disabilities (CPCHILD), Modified Ashworth (MAS) and Barry Albright Dystonia Scale (BADS), and adverse event types, severity, interventions and outcomes. Results: Goal attainment using COPM (n = 25) showed the most common goals (n = 112) included ease of dressing (72%), positioning (56%), transfers (48%) and reducing movement disorder impact on functional tasks (48%). Statistically and clinically significant improvement in goal performance and satisfaction with performance were demonstrated at 6 and 12 months compared to baseline (p < 0.001). There was significant overall improvement in quality of life and caregiver burden, mean change 41.84 (SD 14.82) at baseline to 51.71 (SD 13.77) at 12 months (p < 0.0001) on CPCHILD (n = 40). Statistically significant decreases were found in MAS (p < 0.001) and BADS (p < 0.05) at 12 months. Between 2015 and 2021 adverse events (n = 36) were recorded for 23 participants (from n = 46) of which 64% required medical or surgical intervention, with ITB therapy continuing in 83% of cases. Conclusion: The Australian paediatric ITB audit is the first national study to capture clinical and adverse event data from a complete population of children with neurological impairment receiving a specific intervention. It demonstrates effectiveness of a collaborative, multisite project, with a focus on patient safety, utilising an online database to collect an agreed set of outcomes and adverse events to inform clinical practice and add to the evidence base. Significant improvement in quality of life, caregiver burden and goal attainment have been demonstrated. A further five years of national data collection is planned.L6381700572022-06-10 <br />