Summary Recent years have seen a surge of interest in stepped-wedge cluster randomized trials (SW-CRTs). SW-CRTs include several design variations and methodology is rapidly developing. Accordingly, a variety of power and sample size calculation software for SW-CRTs has been developed. However, each calculator may support only a selected set of design features and may not be appropriate for all scenarios. Currently, there is no resource to assist researchers in selecting the most appropriate calculator for planning their trials. In this paper, we review and classify 18 existing calculators that can be implemented in major platforms, such as R, SAS, Stata, Microsoft Excel, PASS and nQuery. After reviewing the main sample size considerations for SW-CRTs, we summarize the features supported by the available calculators, including the types of designs, outcomes, correlation structures and treatment effects; whether incomplete designs, cluster-size variation or secular trends are accommodated; and the analytical approach used. We then discuss in more detail four main calculators and identify their strengths and limitations. We illustrate how to use these four calculators to compute power for two real SW-CRTs with a continuous and binary outcome and compare the results. We show that the choice of calculator can make a substantial difference in the calculated power and explain these differences. Finally, we make recommendations for implementing sample size or power calculations using the available calculators. An R Shiny app is available for users to select the calculator that meets their requirements (https://douyang.shinyapps.io/swcrtcalculator/).

Health researchers are familiar with the concept of trial power, a number that prior to the start of a trial is intended to describe the probability that the results of the trial will correctly conclude that the intervention has an effect. Trial power, as calculated using standard software, is an expected power that arises from averaging hypothetical trial results over all possible treatment allocations that could be generated by the randomization algorithm . However, in the trial that ultimately is conducted, only one treatment allocation will occur , and the corresponding attained power (conditional on the allocation that occurred) is not guaranteed to be equal to the expected power and may be substantially lower. We provide examples illustrating this issue, discuss some circumstances when this issue is a concern, define and advocate the examination of the pre-randomization power distribution for evaluating the risk of obtaining unacceptably low attained power, and suggest the use of randomization restrictions to reduce this risk. In trials that randomize only a modest number of units, we recommend that trial designers evaluate the risk of getting low attained power and, if warranted, modify the randomization algorithm to reduce this risk.

Background: In a cross-sectional stepped-wedge trial with unequal cluster sizes, attained power in the trial depends on the realized allocation of the clusters. This attained power may differ from the expected power calculated using standard formulae by averaging the attained powers over all allocations the randomization algorithm can generate. We investigated the effect of design factors and allocation characteristics on attained power and developed models to predict attained power based on allocation characteristics. Method: Based on data simulated and analyzed using linear mixed-effects models, we evaluated the distribution of attained powers under different scenarios with varying intraclass correlation coefficient (ICC) of the responses, coefficient of variation (CV) of the cluster sizes, number of cluster-size groups, distributions of group sizes, and number of clusters. We explored the relationship between attained power and two allocation characteristics: the individual-level correlation between treatment status and time period, and the absolute treatment group imbalance. When computational time was excessive due to a scenario having a large number of possible allocations, we developed regression models to predict attained power using the treatment-vs-time period correlation and absolute treatment group imbalance as predictors. Results: The risk of attained power falling more than 5% below the expected or nominal power decreased as the ICC or number of clusters increased and as the CV decreased. Attained power was strongly affected by the treatment-vs-time period correlation. The absolute treatment group imbalance had much less impact on attained power. The attained power for any allocation was predicted accurately using a logistic regression model with the treatment-vs-time period correlation and the absolute treatment group imbalance as predictors. Conclusion: In a stepped-wedge trial with unequal cluster sizes, the risk that randomization yields an allocation with inadequate attained power depends on the ICC, the CV of the cluster sizes, and number of clusters. To reduce the computational burden of simulating attained power for allocations, the attained power can be predicted via regression modeling. Trial designers can reduce the risk of low attained power by restricting the randomization algorithm to avoid allocations with large treatment-vs-time period correlations.