Cluster Randomised Trials, Second Edition

Richard J. Hayes, Lawrence H. Moulton

June 27, 2017 by Chapman and Hall/CRC
Reference - 398 Pages - 30 B/W Illustrations
ISBN 9781498728225 - CAT# K25918
Series: Chapman & Hall/CRC Biostatistics Series


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    • Presents simple methods that are easy to apply with readily available statistical software and that perform well under the conditions experienced in most CRTs
    • Provides substantial material on study design options
    • Presents an array of design issues in CRTs, including minimising contamination effects, stratification and restricted randomisation, and sample size calculation.
    • Covers ethical issues, trial monitoring, interim analyses, reporting, and interpretation.
    • Includes a variety of practical examples from both developing and industrialized countries, with many of the examples based on the authors’ own research
    • Illustrates the application of analytical methods through several data sets from actual trials
    • Shows how data can be analysed using Stata®



Cluster Randomised Trials, Second Edition discusses the design, conduct, and analysis of trials that randomise groups of individuals to different treatments. It explores the advantages of cluster randomisation, 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.

In the time since the publication of the first edition, the use of cluster randomised trials (CRTs) has increased substantially, which is reflected in the updates to this edition. There are greatly expanded sections on randomisation, sample size estimation, and alternative designs, including new material on stepped wedge designs. There is a new section on handling ordinal outcome data, and an appendix with descriptions and/or generating code of the example data sets.

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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