Ethical and epistemic issues in the design and conduct of pragmatic stepped-wedge cluster randomized clinical trials.

ABSTRACT: Stepped-wedge cluster randomized trial (SW-CRT) designs are increasingly employed in pragmatic research; they differ from traditional parallel cluster randomized trials in which an intervention is delivered to a subset of clusters, but not to all. In a SW-CRT, all clusters receive the intervention under investigation by the end of the study. This approach is thought to avoid ethical concerns about the denial of a desired intervention to participants in control groups. Such concerns have been cited in the literature as a primary motivation for choosing SW-CRT design, however SW-CRTs raise additional ethical concerns related to the delayed implementation of an intervention and consent. Yet, PCT investigators may choose SW-CRT designs simply because they are concerned that other study designs

SUBMITTER: Federico CA 

PROVIDER: S-EPMC9272561 | biostudies-literature | 2022 Apr

REPOSITORIES: biostudies-literature