The hunt for efficient, incomplete designs for stepped wedge trials with continuous recruitment and continuous outcome measures

Abstract

Background: We consider the design of stepped wedge trials with continuous recruitment and continuous outcome measures. Suppose we recruit from a fixed number of clusters where eligible participants present continuously, and suppose we have fine control over when each cluster crosses to the intervention. Suppose also that we want to minimise the number of participants, leading us to consider “incomplete” designs (i.e. without full recruitment). How can we schedule recruitment and cross-over at different clusters to recruit efficiently while achieving good precision? Methods: The large number of possible designs can make exhaustive searches impractical. Instead we consider an algorithm using iterative improvements to hunt for an efficient design. At each iteration (starting from a complete design) a single participant – the one with the smallest impact on precision – is removed, and small changes preserving total sample size are made until no further improvement in precision can be found. Results: Striking patterns emerge. Solutions typically focus recruitment and cross-over on the leading diagonal of the cluster-by-time diagram, but in some scenarios clusters form distinct phases resembling before-and-after designs. Conclusions: There is much to be learned about optimal design for incomplete stepped wedge trials. Algorithmic searches could offer a practical approach to trial design in complex settings generally.