Key Design Considerations Using a Cohort Stepped-Wedge Cluster Randomised Trial in Evaluating Community-Based Interventions: Lessons Learnt from an Australian Domiciliary Aged Care Intervention Evaluation

Mohammadreza Mohebbi, Masoumeh Sanagou, Goetz Ottmann

Abstract


The ‘stepped-wedge cluster randomised trial’ (SW-CRT) harbours promise when for ethical or practical reasons the recruitment of a control group is not possible or when a staggered implementation of an intervention is required. Yet SW-CRT designs can create considerable challenges in terms of methodological integration, implementation, and analysis. While cross-sectional methods in participants recruitment of the SW-CRT have been discussed in the literature the cohort method is a novel feature that has not been considered yet. This paper provides a succinct overview of the methodological, analytical, and practical aspects of cohort SW-CRTs. We discuss five issues that are of special relevance to SW-CRTs. First, issues relating to the design, secondly size of clusters and sample size; thirdly, dealing with missing data in the fourth place analysis; and finally, the advantages and disadvantages of SW-CRTs are considered. An Australian study employing a cohort SW-CRT to evaluate a domiciliary aged care intervention is used as case study. The paper concludes that the main advantage of the cohort SW-CRT is that the intervention rolls out to all participants. There are concerns about missing a whole cluster, and difficulty of completing clusters in a given time frame due to involvement frail older people. Cohort SW-CRT designs can be successfully used within public health and health promotion context. However, careful planning is required to accommodate methodological, analytical, and practical challenges.


Keywords


Clinical trials, Stepped wedge design, missing data, sample size, Cluster randomized trial

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ISSN: 1929-6029