A hybrid approach to comparing parallel-group and stepped-wedge cluster-randomized trials with a continuous primary outcome when there is uncertainty in the intra-cluster correlation.

ABSTRACT:

Background/aims

To evaluate how uncertainty in the intra-cluster correlation impacts whether a parallel-group or stepped-wedge cluster-randomized trial design is more efficient in terms of the required sample size, in the case of cross-sectional stepped-wedge cluster-randomized trials and continuous outcome data.

Methods

We motivate our work by reviewing how the intra-cluster correlation and standard deviation were justified in 54 health technology assessment reports on cluster-randomized trials. To enable uncertainty at the design stage to be incorporated into the design specification, we then describe how sample size calculation can be performed for cluster- randomized trials in the 'hybrid' framework, which places priors on design parameters and controls the expected powe

SUBMITTER: Sarkodie SK 

PROVIDER: S-EPMC9940131 | biostudies-literature | 2022 Sep

REPOSITORIES: biostudies-literature