A Practical Guide to Cluster Randomised Trials in Health Services Research

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  • Edition: 1st
  • Format: Hardcover
  • Copyright: 2012-02-20
  • Publisher: Wiley

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There is relatively little literature on cluster randomized trials, with only two previous books on the subject, both now quite old, and neither were focused on the practical aspects of the trials. This book provides that much needed practical guide to the design, execution and analysis of cluster randomized trials in health services research. It also provides an overview of the topic's numerous recent developments since the 2000 publication of the last book in this area. The opening chapter defines and introduces cluster randomized trials, before going on to present an overview of the subject's history and recent developments. The following chapters focus on all the major issues presented in the order in which investigators think about issues when they are designing a trial. The chapters focus on: trial quality, reporting, how to design an intervention, how to ensure the validity of results, how to choose both the design and the analysis of the trial, sample size calculations, choosing an intra-cluster correlation coefficient, the uses of piloting, how to conduct a cost-effectiveness analysis, and how these trials should be synthesized. The book alsos contain numerous tables, graphs and diagrams and a substantial number examples of recent trials.

Author Biography

Sandra Eldridge – Senior Lecturer, Medical Statistics, Queen Mary, University of London, UK
Dr Eldridge is well experienced in designing and analyzing high quality cluster randomized trials, having worked on ten such trials since the mid 1990s. An award-winning speaker on randomized trials, Dr Eldridge has given numerous presentations in many settings and conferences over the last seven years.

Table of Contents

Prefacep. xiii
Notationp. xv
Table of cases: Trials used as examples in more than one chapter in the bookp. xviii
Introductionp. 1
Introduction to randomised trialsp. 2
Explanatory or pragmatic trialsp. 2
How does a cluster randomised trial differ from other trials?p. 3
Between-cluster variabilityp. 9
Why carry out cluster randomised trials?p. 10
Quality of evidence from cluster randomised trialsp. 13
Historical perspectivesp. 16
Summaryp. 18
Referencesp. 19
Recruitment and ethicsp. 22
Selecting clusters and participants to enhance external validityp. 22
Ethics of cluster randomised trialsp. 24
Selection and recruitment of participants to enhance internal validityp. 35
Retention of participants in the trialp. 41
Summaryp. 41
Referencesp. 41
Designing interventionsp. 44
Lack of effectiveness of interventions evaluated in cluster randomised trialsp. 45
What is a complex intervention?p. 46
Phases in the development of a complex interventionp. 50
Identifying evidence for potential intervention effect (pre-clinical phase)p. 50
Understanding more about intervention components (modelling phase)p. 53
Developing the optimum intervention and study design (exploratory trial phase)p. 55
What is the intervention?p. 57
Summaryp. 58
Referencesp. 58
Pilot and feasibility studiesp. 60
What is a pilot study?p. 60
Reasons for conducting pilot and feasibility studiesp. 63
Designing a pilot or feasibility studyp. 69
Reporting and interpreting pilot studiesp. 71
Summaryp. 72
Referencesp. 73
Designp. 74
Parallel designs with only two armsp. 75
Cohort versus cross-sectional designsp. 85
Parallel designs with more than two armsp. 88
Crossover designsp. 92
Further design considerationsp. 95
Summaryp. 96
Referencesp. 96
Analysisp. 99
Data collection and managementp. 99
Analysis - an Introductionp. 101
Analyses for two-arm, completely randomised, stratified or minimised designsp. 104
Analyses for other designsp. 124
Intention to treat and missing valuesp. 129
Analysis planningp. 131
Summaryp. 132
Referencesp. 133
Sample size calculationsp. 137
Factors affecting sample size for cluster randomised designsp. 138
Calculating sample size using the intra-cluster correlation coeffi cientp. 142
Sample size calculations for ratesp. 145
Restricted number of clustersp. 146
Trials with a small number of clustersp. 149
Variability in cluster sizep. 150
Comparison of different measures of between-cluster variabilityp. 154
Matched and stratifi ed designsp. 160
Sample size for other designsp. 166
Summaryp. 169
Referencesp. 169
The intra-cluster correlation coeffi cientp. 172
What is the ICC?p. 173
Sources of ICC estimatesp. 175
Choosing the ICC for use in sample size calculationsp. 179
Calculating ICC valuesp. 185
Uncertainty in ICCsp. 192
Summaryp. 193
Referencesp. 193
Other topicsp. 196
Systematic reviewsp. 197
Cost effectiveness analysesp. 207
Process evaluationp. 212
Monitoringp. 213
Summaryp. 215
Referencesp. 215
Trial reportingp. 218
Trial quality and reporting qualityp. 218
Steps to improve trial reporting in the early stages of the trialp. 227
Reporting randomised trials in journal and conference abstractsp. 230
Application of CONSORT statement to cluster randomised trialsp. 232
Summaryp. 262
Referencesp. 263
Indexp. 267
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