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Review
. 2015 Nov;45(Pt A):55-60.
doi: 10.1016/j.cct.2015.07.006. Epub 2015 Aug 3.

Current issues in the design and analysis of stepped wedge trials

James P Hughes  1 , Tanya S Granston  2 , Patrick J Heagerty  2
Affiliations
Review

Current issues in the design and analysis of stepped wedge trials

James P Hughes et al. Contemp Clin Trials. 2015 Nov.

Abstract

The use of stepped wedge designs in cluster-randomized trials and implementation studies has increased rapidly in recent years but there remains considerable debate regarding the merits of the design. We discuss three key issues in the design and analysis of stepped wedge trials - time-on-treatment effects, treatment effect heterogeneity and cohort studies.

Keywords: Cluster randomized trial; Implementation research; Stepped wedge design.

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Figures

Figure 1
Figure 1
Schematic representation of parallel versus stepped wedge cluster randomized designs with 8 clusters. Each row represents a cluster. C = Control condition, T = Treatment condition
Figure 2
Figure 2
Contours of Var(θ̂) × 105 as a function of τ and η for selected m and T using the Washington State Expedited Treatment Trial (??) balanced stepped wedge design: μ = 0.05, σ2 = 0.05 * 0.95, 24 clusters and h = 6 (T = 5) or h = 3 (T = 9)
See this image and copyright information in PMC

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