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Background: N-of-1 trials offer an innovative approach to delivering personalized clinical care together with population-level research. While increasingly used, these methods have raised some statistical concerns in the healthcare community. Methods: We discuss concerns of selection bias, carryover effects from treatment, and trial data analysis conceptually, then rigorously evaluate concerns of effect sizes, power and sample size through simulation study. Four variance structures for patient heterogeneity and model error are considered in a series of 5000 simulated trials with 3 cycles, which compare aggregated N-of-1 trials to parallel randomized controlled trials (RCTs) and crossover trials. Results: Aggregated N-of-1 trials outperformed both traditional parallel RCT and crossover designs when these trial designs were simulated in terms of power and required sample size to obtain a given power. N-of-1 designs resulted in a higher type-I error probability than parallel RCT and cross over designs when moderate-to-strong carryover effects were not considered or in the presence of modeled selection bias. However, N-of-1 designs allowed better estimation of patient-level random effects. These results reinforce the need to account for these factors when planning N-of-1 trials. Conclusion: N-of-1 trial designs offer a rigorous method for advancing personalized medicine and healthcare with the potential to minimize costs and resources. Interventions can be tested with adequate power with far fewer patients than traditional RCT and crossover designs. Operating characteristics compare favorably to both traditional RCT and crossover designs.

Introduction: Few studies have described observed sun-protection behaviours. We aimed to describe the prevalence of observed sun-protection behaviour of a high-risk population in tropical Queensland engaged in outdoor leisure activity, to act as a baseline for future comparisons and to highlight the need for further work to improve sun-protective behaviours in this high risk population.

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Interest in N-of-1 trials and single-case designs is increasing worldwide, particularly due to the movement towards personalised medicine and patient-centred healthcare [...]

Half of individuals with a whiplash injury experience ongoing pain and disability. Many are insufficiently active for good health, increasing their risk of preventable morbidity and mortality, and compounding the effects of the whiplash injury. This paper describes a protocol for evaluating the efficacy of a physical activity promotion intervention in adults with whiplash associated disorders. A multiple-baseline, single case experimental design will be used to evaluate the effects of a physical activity (PA) intervention that includes evidence-based behaviour change activities and relapse prevention strategies for six adults with chronic whiplash. A structured visual analysis supplemented with statistical analysis will be used to analyse: accelerometer-measured PA, confidence completing PA in the presence of neck pain, and pain interference.