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.
Preface Authors Glossary Part A Basic Concepts Introduction Variability between Clusters Choosing Whether to Randomise by Cluster Part B Design Issues Choice of Clusters Matching and Stratification Randomisation Procedures Sample Size Alternative Study Designs Part C Analytical Methods Basic Principles of Analysis Analysis Based on Cluster-level Summaries Regression Analysis Based on Individual-level Data Analysis of Trials with More Complex Designs Part D Miscellaneous Topics Ethical Considerations Data Monitoring Reporting and InterpretationReferences Appendix