ABSTRACT

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.

part I|45 pages

Basic Concepts

chapter 1|7 pages

Introduction

chapter 2|14 pages

Variability between Clusters

chapter 3|21 pages

Choosing Whether to Randomise by Cluster

part II|137 pages

Design Issues

chapter 4|23 pages

Choice of Clusters

chapter 5|23 pages

Matching and Stratification

chapter 6|30 pages

Randomisation Procedures

chapter 7|34 pages

Sample Size

chapter 8|23 pages

Alternative Study Designs

part III|127 pages

Analytical Methods

chapter 9|14 pages

Basic Principles of Analysis

chapter 10|44 pages

Analysis Based on Cluster-Level Summaries

chapter 12|31 pages

Analysis of Trials with More Complex Designs

part IV|56 pages

Miscellaneous Topics

chapter 13|13 pages

Ethical Considerations

chapter 14|16 pages

Data Monitoring

chapter 15|24 pages

Reporting and Interpretation