Design and analysis of cluster randomization trials in health research / Allan Donner, Neil Klar.

Includes bibliographical references (pages 152-173) and index.

Acknowledgements -- Preface -- 1. Introduction -- 2. The historical development of cluster randomized trials -- 2.1. Randomized trials before 1950 -- 2.2. Cluster randomized trials between 1950 and 1978 -- 2.3. Cluster randomized trials since 1978 -- 3. Issues arising in the planning of cluster randomization trials -- 3.1. Selecting interventions -- 3.2. Setting eligibility criteria -- 3.3. Measuring subject response -- 3.4. The most commonly used experimental designs -- 3.5. Factorial and crossover designs -- 3.6. Selecting an experimental design -- 3.7. The importance of cluster-level replication -- 3.8. Strategies for conducting successful trials -- 4. The role of informed consent and other ethical issues -- 4.1. The risk of harm -- 4.2. Informed consent -- 4.3. Subject blindness and informed consent -- 4.4. Randomized consent designs -- 4.5. Ethical issues and trial monitoring -- 5. Sample size estimation for cluster randomization designs -- 5.1. General issues of sample size estimation -- 5.2. The completely randomized design -- 5.3. The matched-pair design -- 5.4. The stratified design -- 5.5. Issues involving losses to follow-up -- 5.6. Strategies for achieving desired power -- 6. Analysis of binary outcomes -- 6.1. Selecting the unit of analysis -- 6.2. The completely randomized design -- 6.3. The matched-pair design -- 6.4. The stratified design -- 7. Analysis of quantitative outcomes -- 7.1. The completely randomized design -- 7.2. The matched-pair design -- 7.3. The stratified design -- 8. Analysis of count, time to event and categorical outcomes -- 8.1. Count and time to event data -- 8.2. Categorical data -- 9. Reporting of cluster randomization trials -- 9.1. Reporting of study design -- 9.2. Reporting of study results -- References -- Index.

"A cluster randomization trail is one in which intact social units, or clusters of individuals, are randomized to different intervention groups. Trials randomizing clusters have become particularly widespread in the evaluation of non-therapeutic interventions, including lifestyle modification,educational programs and innovations in the provision of health care. The units of randomization in such studies are diverse, ranging from relatively small clusters such as families or households, to entire neighborhoods or communities, but also encompassing workplaces, hospital wards, classroomsand medical practices. The increasing popularity of this design among health researchers over the past two decades has led to an extensive body of methodology on the subject. This book is the first to present a systematic and unified treatment of this topic; it contains distinctive chapters on thehistory of cluster randomized trials, ethical issues, meta-analysis and guidelines. Written by two of the leading authorities in the field, this book is an essential reference text for investigators in the planning or analysis stages of a study. It is also highly suitable for use as a textbook in agraduate-level course in research methodology, and is aimed at biostatisticians, epidemiologists, health service researchers and public health professionals."--Publisher description.

Machine converted from AACR2 source record.