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arXiv · 2511.06912

Bayesian design and analysis of two-arm cluster randomised trials using assurance: extension to binary outcomes and comparison of MCMC and INLA

Abdullah Aloufi·Kevin Wilson·Nina Wilson·Lisa Shaw·Christopher Price
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Abstract

The paper considers two different designs; a two-arm superiority cluster randomised controlled trial (RCT) with a continuous outcome, and a twoarm superiority cluster RCT with a binary outcome. From a Bayesian perspective, for the analysis of the trial we use a (generalised) linear mixed effects model. We summarise the inference for the treatment effect for a cluster RCT based on the posterior distribution. Based on this inference we use assurance to choose the sample size. We consider and compare two different methods for the inference: Markov Chain Monte Carlo (MCMC) and Integrated Nested Laplace Approximations (INLA), and consider their implications for the assurance. We consider the Specialist Pre-hospital redirection for ischemic stroke thrombectomy (SPEEDY) trial, an RCT which has co-primary outcomes of thrombectomy rate and time to thrombectomy, as a case study for the developed Bayesian RCT designs. We demonstrate our novel approach to the sample size calculation using assurance on the SPEEDY trial, based on the results of a formal prior elicitation exercise with two clinical experts. The paper considers a range of different scenarios for cluster RCTs to evaluate INLA and MCMC, to determine when each inference scheme should be used, balancing the computational cost in terms of speed and accuracy. We make recommendations for when each should be used.

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Abdullah Aloufi, Kevin Wilson, Nina Wilson, Lisa Shaw, Christopher Price. 2025-11-10. Bayesian design and analysis of two-arm cluster randomised trials using assurance: extension to binary outcomes and comparison of MCMC and INLA. https://arxiv.org/abs/2511.06912

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