Abstract
This article reviews the essential ingredients and innovations in the design and analysis of group-randomized trials. The methods literature for these trials has grown steadily since they were introduced to the biomedical research community in the late 1970s, and we summarize those developments. We review, in addition to the group-randomized trial, methods for two closely related designs, the individually randomized group treatment trial and the stepped-wedge group-randomized trial. After describing the essential ingredients for these designs, we review the most important developments in the evolution of their methods using a new bibliometric tool developed at the National Institutes of Health. We then discuss the questions to be considered when selecting from among these designs or selecting the traditional randomized controlled trial. We close with a review of current methods for the analysis of data from these designs, a case study to illustrate each design, and a brief summary.
Highlights
Randomized trials are the gold standard in biomedical research because they provide the strongest evidence for causal inference by minimizing the risk of bias in the assignment of participants to treatments
A grouprandomized trials (GRTs) differs from the randomized controlled trial (RCT) by randomizing groups rather than individuals to study conditions, with outcomes measured in participants from each group [105]
The key feature of the individually randomized group treatment (IRGT) is that the method of intervention delivery leads to correlation among outcomes taken on groups of participants in the same study condition, creating the same type of intracluster correlation (ICC) seen in GRTs
Summary
Randomized trials are the gold standard in biomedical research because they provide the strongest evidence for causal inference by minimizing the risk of bias in the assignment of participants to treatments. A GRT differs from the RCT by randomizing groups rather than individuals to study conditions, with outcomes measured in participants from each group [105].
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