Model misspecification in stepped wedge trials: Random effects for time or treatment.

Mixed models are commonly used to analyze stepped wedge trials (SWTs) to account for clustering and repeated measures on clusters. One critical issue researchers face is whether to include a random time effect or a random treatment effect. When the wrong model is chosen, inference on the treatment effect may be invalid. We explore asymptotic and finite-sample convergence of variance component estimates when the model is misspecified and how misspecification affects the estimated variance of the treatment effect. For asymptotic results, we rely on analytical solutions rather than simulation studies, which allow us to succinctly describe the convergence of misspecified estimates, even though there are multiple roots for each misspecified model. We found that both direction and magnitude of the bias associated with model-based standard errors depends on the study design and magnitude of the true variance components. We identify some scenarios in which choosing the wrong random effect has a large impact on model-based inference. However, many trends depend on trial design and assumptions about the true correlation structure, so we provide tools for researchers to investigate specific scenarios of interest. We use data from an SWT on disinvesting from weekend services in hospital wards to demonstrate how these results can be applied as a sensitivity analysis, which quantifies the impact of misspecification under a variety of settings and directly compares the potential consequences of different modeling choices. Our results will provide guidance for prespecified model choices and supplement sensitivity analyses to inform confidence in the validity of results.