Essential Ingredients and Innovations in the Design and Analysis of Group-Randomized Trials

• Published in: Annual review of public health Vol. 41; no. 1; pp. 1 - 19
• Main Authors: Murray, David M, Taljaard, Monica, Turner, Elizabeth L, George, Stephanie M
• Format: Journal Article
• Language: English
• Published: United States Annual Reviews 02-04-2020
• Subjects: Bibliometrics; cluster-randomized trial; group-randomized trial; Humans; individually randomized group treatment trial; National Institutes of Health (U.S.); Randomized Controlled Trials as Topic - methods; Research Design; stepped-wedge cluster-randomized trial; stepped-wedge group-randomized trial; United States; United States; individually randomized group treatment trial; stepped-wedge group-randomized trial; group-randomized trial; stepped-wedge cluster-randomized trial; cluster-randomized trial
• ISSN: 0163-7525; 1545-2093
• DOI: 10.1146/annurev-publhealth-040119-094027

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.