design and analysis of cluster randomization trials in health research pdf

Design And Analysis Of Cluster Randomization Trials In Health Research Pdf

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The cluster randomized trial CRT is commonly considered a relatively new research study design Donner and Klar ; Eldridge and Kerry ; Murray Here we trace to a few very early reports the idea of comparing interventions applied to groups of individuals, through the evolution of this idea to the modern-day CRT.

PLoS Med 9 11 : e This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript. Members of the Ottawa Ethics of Cluster Randomized Trials Consensus Group participated in this project as individuals and not as representatives of their employers. Authorship does not imply the approval of this document by the authors' employers or other organizations with which they are affiliated.

Design and Analysis of Cluster Randomization Trials in Health Research

Allan Donner and Neil Klar. London: Arnold, , pp. ISBN: Randomizing individuals to treatments is not always feasible and cluster randomized trials are increasingly being utilized in the evaluation of health care interventions. However, standard textbooks on clinical trial methodology rarely explore the statistical, practical and ethical concerns raised by cluster randomization.

Furthermore, research into these issues is not confined to the biostatistics literature but is spread across several fields. The result has been poor standards of design, analysis and reporting, which this book seeks to rectify by providing researchers with a unified account of the issues particular to cluster randomized trials.

The first chapter sets out the questions trial designers should ask themselves when considering whether or not to randomize by cluster. For a given number of trial participants, randomization by cluster is typically less statistically powerful than randomization by individual.

Therefore, a decision to randomize by cluster should be based on a number of logistical and ethical issues. These are illustrated through the use of diverse examples from the trials literature. After reviewing the history of cluster randomized trials, the authors address concerns in the planning of such trials, including the limitations of the matched-pair design and the value of a large number of clusters in any experimental design. There follows an important chapter dealing with ethics.

The emphasis on statistical issues in the literature is understandable, given the continued publication of results from poorly designed trials. However, controversy surrounding informed consent and the need to balance community-wide benefits with possible individual risks of harm are just two examples of the ethical issues identified as needing more attention.

Chapters 5 to 8 account for over half of the book and examine the statistical issues inherent in cluster randomization. Chapter 5 explains how to perform cluster-adjusted power calculations under a variety of trial designs and gives recommendations on dealing with problems of subject or cluster withdrawal.

The next three chapters deal with data analysis: the reader selects the chapter relevant to the nature of the outcome data under consideration, whether continuous, binary or other. The appropriate methods are then grouped together according to whether the trial uses pair-matching, stratification or a completely randomized design. A certain amount of repetition is, therefore, inevitable to anyone reading the whole book.

However, researchers wanting guidance on how to analyse their particular trial will welcome this approach for two reasons. First, it lists all the principal methods of analysis appropriate to their trial. Second, it gives an appreciation of the relative merits of these methods. The authors, as world experts in the field, provide a clear and comprehensive account of the issues in cluster randomization and the book is essential for any investigator planning such a trial.

In conjunction with a standard text on trial design this book is also recommended reading as part of a course on research methodology. Familiarity with issues in biostatistics is necessary for a complete understanding of the quantitative chapters but the reader can appreciate the relative merits of alternative methods of analysis from tables comparing results.

New developments such as Empirical Bayes estimation are omitted but the authors acknowledge the difficulty in deciding where to draw the line in this rapidly expanding field.

Furthermore, ongoing methodological research may necessitate revision of some of the recommendations, in particular those pertaining to categorical and binary data. However, the book succeeds admirably in providing a set of guidelines that should enable trialists to conduct cluster randomized trials with the methodological rigour that is routinely expected of individually randomized ones.

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Cluster randomised controlled trial

Handbook of Epidemiology pp Cite as. A cluster randomized trial is one in which groups of subjects are randomized rather than individuals. They are sometimes known as group randomized trials. This chapter will describe the design and analysis of such trials. Skip to main content. This service is more advanced with JavaScript available. Advertisement Hide.

Skip to search form Skip to main content You are currently offline. Some features of the site may not work correctly. Donner and N. Donner , N. Klar Published Medicine, Computer Science. The historical development of cluster randomized trials.

Allan Donner and Neil Klar. London: Arnold, , pp. ISBN: Randomizing individuals to treatments is not always feasible and cluster randomized trials are increasingly being utilized in the evaluation of health care interventions. However, standard textbooks on clinical trial methodology rarely explore the statistical, practical and ethical concerns raised by cluster randomization. Furthermore, research into these issues is not confined to the biostatistics literature but is spread across several fields.

Cluster Randomized Trials: Considerations for Design and Analysis

Scientists often use randomized controlled trials to compare a newly developed treatment to the existing one, or to a placebo. Patients are randomly assigned to a treatment, and they are compared with respect to the outcome of interest. The cluster randomized trial CRT is a type of randomized controlled trial in which the treatments are randomized at the group, rather than individual, level.

Allan Donner and Neil Klar. London: Arnold, , pp. ISBN: Randomizing individuals to treatments is not always feasible and cluster randomized trials are increasingly being utilized in the evaluation of health care interventions. However, standard textbooks on clinical trial methodology rarely explore the statistical, practical and ethical concerns raised by cluster randomization.

A cluster randomised controlled trial is a type of randomised controlled trial in which groups of subjects as opposed to individual subjects are randomised. A bibliometric study documented an increasing number of publications in the medical literature on cluster randomised controlled trials since the s. Advantages of cluster randomised controlled trials over individually randomised controlled trials include:. Disadvantages compared with individually randomised controlled trials include greater complexity in design and analysis, and a requirement for more participants to obtain the same statistical power.

Cluster randomised controlled trial

Allan Donner and Neil Klar. London: Arnold, , pp. ISBN: Randomizing individuals to treatments is not always feasible and cluster randomized trials are increasingly being utilized in the evaluation of health care interventions. However, standard textbooks on clinical trial methodology rarely explore the statistical, practical and ethical concerns raised by cluster randomization. Furthermore, research into these issues is not confined to the biostatistics literature but is spread across several fields. The result has been poor standards of design, analysis and reporting, which this book seeks to rectify by providing researchers with a unified account of the issues particular to cluster randomized trials.

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