Design & Analysis of Cluster Randomised and Stepped Wedge Trials

By the end of this course, attendees will be able to critique and apply a range of appropriate design approaches and analytical methods for cluster randomised and stepped wedge trials.

The course will cover:

• Key concepts of cluster randomised trials, including measures of between-cluster variation and the rationale for cluster randomisation
• Design of cluster-randomised trials, including stratification and randomisation procedures
• Calculation of sample size
• Analysis of cluster randomised trials using both cluster-level summaries and individual-level data (random effects models and generalised estimating equations)
• Design and analysis of stepped wedge trials
• Ethical considerations, data monitoring and reporting of CRTs

Teaching will be through lectures, discussions and practical sessions. There will be a strong emphasis on practical exercises involving participants in the use of Stata to analyse illustrative datasets from a variety of trials. The emphasis is on developing an understanding of the underlying assumptions and principles behind the design and analysis of cluster randomised and stepped wedge trials, on the practical application of the techniques to analyse such trials, and on the correct interpretation of the results. Methods will be illustrated using trials of interventions against infectious and non-infectious diseases, conducted in low, middle and high-income settings.