Cluster Randomised Trials

Cluster Randomised Trials

  • Electronic book text
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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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Product details

  • Electronic book text | 338 pages
  • Chapman & Hall/CRC
  • London, United Kingdom
  • 22 Illustrations, black and white
  • 1584888172
  • 9781584888178

Table of contents



Randomised Trials

Variability between Clusters


The Implications of between-Cluster Variability: Some Examples

Measures of between-Cluster Variability

The Design Effect

Sources of within-Cluster Correlation

Choosing whether to Randomise by Cluster


Rationale for Cluster Randomisation

Using Cluster Randomisation to Capture Indirect Effects of Intervention

Disadvantages and Limitations of Cluster Randomisation


Choice of Clusters


Types of Cluster

Size of Clusters

Strategies to Reduce Contamination

Levels of Randomisation, Intervention, Data Collection, and Inference

Matching and Stratification


Rationale for Matching

Disadvantages of Matching

Stratification as an Alternative to Matching

Choice of Matching Variables

Choosing whether to Match or Stratify

Randomisation Procedures


Restricted Randomisation

Some Practical Aspects of Randomisation

Sample Size


Sample Size for Unmatched Trials

Sample Size for Matched and Stratified Trials

Estimating the between-Cluster Coefficient of Variation

Choice of Sample Size in Each Cluster

Further Issues in Sample Size Calculation

Alternative Study Designs


Design Choices for Treatment Arms

Design Choices for Impact Evaluation


Basic Principles of Analysis


Experimental and Observational Units

Parameters of Interest

Approaches to Analysis

Baseline Analysis

Analysis Based on Cluster-Level Summaries


Point Estimates of Intervention Effects

Statistical Inference Based on the t Distribution

Statistical Inference Based on a Quasilikelihood Approach

Adjusting for Covariates

Nonparametric Methods

Analysing for Effect Modification

Regression Analysis Based on Individual-Level Data


Random Effects Models

Generalised Estimating Equations

Choice of Analytical Method

Analysing for Effect Modification

More Complex Analyses

Analysis of Trials with More Complex Designs


Analysis of Pair-Matched Trials

Analysis of Stratified Trials

Analysis of Other Study Designs


Ethical Considerations


General Principles

Ethical Issues in Group Allocation

Informed Consent in Cluster Randomised Trials

Other Ethical Issues


Data Monitoring


Data Monitoring Committees

Interim Analyses

Reporting and Interpretation


Reporting of Cluster Randomised Trials

Interpretation and Generalisability


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Review quote

... an informative and readable text on the design, conduct, and analysis of cluster randomized trials (cRCTs). ...the book is rich with examples providing practical illustrations of concepts ... This book by Hayes and Moulton adds new insights into the field ... I would recommend this book highly ... This book would also provide an excellent resource for those who deliver courses on clinical trials and would be an excellent addition to the reference library of any trials unit.
-Marion K. Campbell, Clinical Trials, 2011

This comprehensive book covers all the main topics associated with design, conduct, and analysis of cluster randomised trials (CRTs). It follows a logical structure, which is easy to read and avoids excessive mathematical detail, making the book more accessible to wider readership. ... One of the great advantages of this useful handy book is that it does not just follow the theory; research-based examples aid understanding and bridge theory with practical applications. ...In summary, this book is an excellent introduction to the field of CRTs. It explains the methodology and conduct of CRTs in an accessible way. In addition, theory is complemented by practical examples. On this basis, I would highly recommend the book to all interested parties. If the aim of this book is to help readers to understand and apply a range of methods for the design and analysis of CRTs, then it is successful and accomplishes it well.
-Pharmaceutical Statistics, 2011

... the authors have achieved their aim in providing a suitable introduction to even the more advanced issues for everyone involved in the planning, conduct and analysis of these studies.
-ISCB News #49, June 2010

...This is a well-written book which I definitely recommend, especially as a textbook for graduate or postgraduate level studies, or as a reference book for researchers working on the design or analysis of CRTs. ...
-Journal of the Royal Statistical Society, Series A, Volume 173, Issue 1, January 2010

... highly recommend this book for its unique and very important strengths. In particular, Hayes and Moulton should be congratulated for their focus on infectious diseases, a research topic which has received limited attention from statisticians interested in randomized trials. The broader discussion of direct and indirect effects of intervention is also very valuable.
-Neil Klar, Journal of Biopharmaceutical Statistics, 2010, Issue 1

...The authors point out that the CRT is relatively new and that, although the topic is covered here pretty comprehensively, it is still an active research area. It's difficult to think of any important issue or aspect that is not discussed here, and at length and in depth. ... There is no heavy mathematics so the material is accessible to a wide range of readers. ...
-International Statistical Review (2009), 77, 2
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