Substantial risks associated with few clusters in cluster randomized and stepped wedge designs

March 3, 2016

This paper addresses the implications and risks involved in the use of novel cluster randomized trial designs that aim to maximize the informational value from relatively few clusters, including increased probability of chance imbalances and type I and type II error, limited perceived or actual generalizability, and fewer options for statistical analysis. Read the full article at this link.

Reporting of stepped wedge cluster randomised trials: extension of the CONSORT 2010 statement with explanation and elaboration

November 9, 2018

This report presents the Consolidated Standards of Reporting Trials (CONSORT) extension for the stepped wedge cluster randomised trial (SW-CRT). The statement was developed to allow for the unique characteristics of this increasingly used study design, and the guideline was developed using a Delphi survey and consensus meeting and is informed by the CONSORT statements for individual and cluster randomised trials. Reporting items along with explanations and examples are provided. Read the full article at this link.