Current issues in the design and analysis of stepped wedge trials

James P Hughes; Tanya S Granston; Patrick J Heagerty

doi:10.1016/j.cct.2015.07.006

Current issues in the design and analysis of stepped wedge trials

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

Authors

James P Hughes¹, Tanya S Granston², Patrick J Heagerty²

Affiliations

¹ Department of Biostatistics, University of Washington, Seattle, WA, United States; Fred Hutchinson Cancer Research Center, Seattle, WA, United States. Electronic address: jphughes@u.washington.edu.
² Department of Biostatistics, University of Washington, Seattle, WA, United States.

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.

Publication types

Research Support, N.I.H., Extramural
Review

MeSH terms

Cohort Studies
Cross-Sectional Studies
Humans
Randomized Controlled Trials as Topic / methods*
Research Design*
Time Factors

Abstract

Publication types

MeSH terms

Grant support