Cluster Randomised Trials

Cluster Randomised Trials

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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

  • Hardback | 338 pages
  • 154 x 236 x 22mm | 621.42g
  • Taylor & Francis Inc
  • Chapman & Hall/CRC
  • Boca Raton, FL, United States
  • English
  • 22 black & white illustrations
  • 1584888164
  • 9781584888161
  • 782,600

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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Table of contents

BASIC CONCEPTS Introduction Randomised Trials Variability between Clusters Introduction 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 Introduction Rationale for Cluster Randomisation Using Cluster Randomisation to Capture Indirect Effects of Intervention Disadvantages and Limitations of Cluster Randomisation DESIGN ISSUES Choice of Clusters Introduction Types of Cluster Size of Clusters Strategies to Reduce Contamination Levels of Randomisation, Intervention, Data Collection, and Inference Matching and Stratification Introduction Rationale for Matching Disadvantages of Matching Stratification as an Alternative to Matching Choice of Matching Variables Choosing whether to Match or Stratify Randomisation Procedures Introduction Restricted Randomisation Some Practical Aspects of Randomisation Sample Size Introduction 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 Introduction Design Choices for Treatment Arms Design Choices for Impact Evaluation ANALYTICAL METHODS Basic Principles of Analysis Introduction Experimental and Observational Units Parameters of Interest Approaches to Analysis Baseline Analysis Analysis Based on Cluster-Level Summaries Introduction 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 Introduction Random Effects Models Generalised Estimating Equations Choice of Analytical Method Analysing for Effect Modification More Complex Analyses Analysis of Trials with More Complex Designs Introduction Analysis of Pair-Matched Trials Analysis of Stratified Trials Analysis of Other Study Designs MISCELLANEOUS TOPICS Ethical Considerations Introduction General Principles Ethical Issues in Group Allocation Informed Consent in Cluster Randomised Trials Other Ethical Issues Conclusion Data Monitoring Introduction Data Monitoring Committees Interim Analyses Reporting and Interpretation Introduction Reporting of Cluster Randomised Trials Interpretation and Generalisability References Index
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About Richard J. Hayes

London School of Hygiene & Tropical Medicine, London, UK Johns Hopkins Bloomberg School of Public Health, Baltimore, University of Kent, UK University of Copenhagen, Denmark Utrecht University, The Netherlands University of California, Berkeley, USA
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