| |
| |
| Acknowledgements | |
| |
| |
| Preface | |
| |
| |
| |
| Introduction | |
| |
| |
| |
| Why randomize clusters? | |
| |
| |
| |
| What is the impact of cluster randomization on the design and analysis of a trial? | |
| |
| |
| |
| Quantifying the effect of clustering | |
| |
| |
| |
| Randomized versus non-randomized comparisons | |
| |
| |
| |
| The unit of inference | |
| |
| |
| |
| Terminology: what's in a name? | |
| |
| |
| |
| The historical development of cluster randomized trials | |
| |
| |
| |
| Randomized trials before 1950 | |
| |
| |
| |
| Cluster randomized trials between 1950 and 1978 | |
| |
| |
| |
| Cluster randomized trails since 1978 | |
| |
| |
| |
| Issues arising in the planning of cluster randomization trials | |
| |
| |
| |
| Selecting interventions | |
| |
| |
| |
| Setting eligibility criteria | |
| |
| |
| |
| Measuring subject response | |
| |
| |
| |
| The most commonly used experimental designs | |
| |
| |
| |
| Factorial and crossover designs | |
| |
| |
| |
| Selecting an experimental design | |
| |
| |
| |
| The importance of cluster-level replication | |
| |
| |
| |
| Strategies for conducting successful trials | |
| |
| |
| |
| The role of informed consent and other ethical issues | |
| |
| |
| |
| The risk of harm | |
| |
| |
| |
| Informed consent | |
| |
| |
| |
| Subject blindness and informed consent | |
| |
| |
| |
| Randomized consent designs | |
| |
| |
| |
| Ethical issues and trial monitoring | |
| |
| |
| |
| Sample size estimation for cluster randomization designs | |
| |
| |
| |
| General issues of sample size estimation | |
| |
| |
| |
| The completely randomized design | |
| |
| |
| |
| The matched-pair design | |
| |
| |
| |
| The stratified design | |
| |
| |
| |
| Issues involving losses to follow-up | |
| |
| |
| |
| Strategies for achieving desired power | |
| |
| |
| |
| Analysis of binary outcomes | |
| |
| |
| |
| Selecting the unit of analysis | |
| |
| |
| |
| The completely randomized design | |
| |
| |
| |
| The matched-pair design | |
| |
| |
| |
| The stratified design | |
| |
| |
| |
| Analysis of quantitative outcomes | |
| |
| |
| |
| The completely randomized design | |
| |
| |
| |
| The matched-pair design | |
| |
| |
| |
| The stratified design | |
| |
| |
| |
| Analysis of count, time to event and categorical outcomes | |
| |
| |
| |
| Count and time to event data | |
| |
| |
| |
| Categorical data | |
| |
| |
| |
| Reporting of cluster randomization trials | |
| |
| |
| |
| Reporting of study design | |
| |
| |
| |
| Reporting of study results | |
| |
| |
| References | |
| |
| |
| Index | |