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Children and adults with cerebral palsy (CP) perform reduced physical activity (PA) levels and increased sedentary behaviour (SB), which predisposes them to negative health outcomes. SB is characterized in the typically developing population by an energy expenditure component of ≤1.5 metabolic equivalents of task (METs) while sitting, reclining or lying. There is no consensus on an operationalized definition of SB for the CP population. Furthermore, there are no established outcomes to inform guidelines promoting PA in this population. I will address these two research gaps by investigating the operationalization of SB and by identifying important health outcomes of PA, through expert opinions, in individuals with CP. The first chapter is a scoping review of the operationalization of SB in individuals with CP. I found that, in individuals with CP, i) the definition for SB in the typically developing population of ≤1.5 METs generally applies to sitting and lying, and ii) sitting and lying are reported as operationalizations of SB. The second chapter was a conference-based survey to identify critical and important health outcomes for PA in individuals with CP. Clinicians and researchers (n=55) who attended a workshop on PA in CP rated nine pre-determined health outcomes on a 9-point Likert-type scale from the Grading of Recommendations Assessment, Development and Evaluation Approach. The experts identified both the psychological aspects of health (i.e. anxiety and depression) as being critical. The physical health outcomes rated as critical were sleep, nutrition, and cardiorespiratory endurance, and those rated as important were body size, body composition, blood lipids and glucose, and blood pressure. Together, this research suggests that the operationalization of SB in individuals with CP is similar to that of the typically developing population, and that both the physical and mental aspects of health must be considered in future PA management. Thesis Master of Science Rehabilitation Science (MSc)

4070 Background: TOPAZ-1 (NCT03875235) is a randomized, double-blind, global, Phase 3 study evaluating the efficacy and safety of durvalumab (D) in combination with (+) gemcitabine and cisplatin (GC) as first-line treatment for patients (pts) with advanced biliary tract cancer (BTC).1 D + GC significantly improved overall survival (OS) versus placebo (PBO) + GC and represents a new treatment option. Methods: A pre-planned secondary objective of TOPAZ-1 was to assess pt-reported outcomes (PROs) for pts receiving D + GC versus PBO + GC. Pts with BTC were randomized 1:1 to D (1500 mg) or PBO, + G (1000 mg/m2) and C (25 mg/m2), for up to 8 cycles, followed by D or PBO monotherapy until disease progression, unacceptable toxicity, or other discontinuation criteria were met. PROs were assessed with the European Organisation for Research and Treatment of Cancer 30-item Quality of Life (QoL) Questionnaire, EORTC QLQ-C30 (C30), and the BTC 21-item module, EORTC QLQ-BIL21 (BIL21). Time to deterioration (TTD) was the primary assessment of PROs; defined as the time from randomization to the date of the first pre-specified, clinically meaningful deterioration (e.g. disease progression). The PRO analysis set included all pts from the full analysis set who completed a questionnaire. Results: Compliance rates for PROs were high at baseline (>81%) and remained high (majority >70% over 28 cycles) for both treatment groups. Baseline scores were comparable between treatment groups. Addition of D was well tolerated, with no significant difference in TTD in D + GC versus PBO + GC for pt-reported symptoms or functioning using either C30 or BIL21 (Table), or Global Health Status/QoL (hazard ratio [HR], 0.87; 95% confidence interval [CI], 0.69–1.12; p=0.279). Conclusions: Addition of D to GC improved OS (Oh D-Y, et al. J Clin Oncol 2022;40(suppl 4). Abs 378) and was well tolerated with no difference in TTD of QoL for pts, supporting D + GC as a new treatment option for pts with BTC. Clinical trial information: NCT03875235. [Table: see text]