Design and Analysis of Cluster Randomization Trials in Health Research by Wiley
A cluster randomization trial is one in which intact social units, or clusters of individuals, are randomized to different intervention groups. Trials randomizing clusters have become particularly widespread in the evaluation of non-therapeutic interventions, including lifestyle modification, educational programmes and innovations in the provision of health care. The increasing popularity of this design among health researchers over the past two decades has led to an extensive body of methodology on the subject. This is the first book to present a systematic and united treatment of this topic; it contains distinctive chapters on the history of cluster randomized trials, ethical issues and reporting guidelines.
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Cluster Randomised Trials discusses the design, conduct, and analysis of health trials that randomise groups of individuals to different treatments. It explores the advantages of cluster randomization, with special attention given to evaluating the effects of interventions against infectious diseases.
Avoiding unnecessary mathematical detail, the book covers basic concepts underlying the use of cluster randomisation, such as direct, indirect, and total effects. The authors also present an array of design issues in cluster randomised trials (CRTs), including strategies for minimizing contamination effects, the use of stratification and restricted randomisation to improve balance between treatment arms, special methods for sample size calculation, and alternatives to the simplest two-arm CRT. After covering analytical methods for CRTs, such as regression methods, the authors examine ethical issues, trial monitoring, interim analyses, reporting, and interpretation.
Although the book mainly focuses on medical and public health applications, it shows that the rigorous evidence of intervention effects provided by CRTs has the potential to inform public policy in a wide range of other areas. The book encourages readers to apply the methods to their own trials, reproduce the analyses presented, and explore alternative approaches.
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