A method to reduce imbalance for site-level randomized stepped wedge implementation trial designs.

ABSTRACT:

Background

Controlled implementation trials often randomize the intervention at the site level, enrolling relatively few sites (e.g., 6-20) compared to trials that randomize by subject. Trials with few sites carry a substantial risk of an imbalance between intervened (cases) and non-intervened (control) sites in important site characteristics, thereby threatening the internal validity of the primary comparison. A stepped wedge design (SWD) staggers the intervention at sites over a sequence of times or time waves until all sites eventually receive the intervention. We propose a new randomization method, sequential balance, to control time trend in site allocation by minimizing sequential imbalance across multiple characteristics. We illustrate the new method by applying it to a SWD

SUBMITTER: Lew RA 

PROVIDER: S-EPMC6500026 | biostudies-literature | 2019 May

REPOSITORIES: biostudies-literature