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. This has been defined as a comparative study in which the units randomized are pre-existing natural or self-selected groups whose members have an identifiable feature in common, and in which outcomes are measured in all, or a representative sample of the individual members of the groups Donner and Klar The groups used in CRTs vary widely and range in size from families to entire communities. The common feature shared by members of a cluster may be:.

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.

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. This correlation is measured by the intraclass correlation , also known as the intracluster correlation. Though this correlation is a known component of cluster randomised controlled trials, a large proportion of the trials fail to account for it. Failing to control for intraclass correlation negatively affects both the statistical power and the incidence of Type I errors of an analysis.

Thank you for visiting nature. You are using a browser version with limited support for CSS. To obtain the best experience, we recommend you use a more up to date browser or turn off compatibility mode in Internet Explorer. In the meantime, to ensure continued support, we are displaying the site without styles and JavaScript. An Author Correction to this article was published on 19 October We aimed to assess whether a triple-faceted intervention program administered in the primary care setting could decrease the risk of insufficient adherence to primary care physician PCP appointments among this patient population. We conducted a cluster-randomized controlled study to assess the effects of a 1-year intervention.

Cluster Randomized Trials

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.

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. The intracluster correlation ICC measures the degree of similarity between individuals within clusters. CRTs can be designed in several ways; it is essential that researchers carefully plan the study, from sample size calculations to ICC calculation to analysis, in order to get valid and meaningful results. In this article we review and discuss the considerations essential to conducting a successful CRT using both frequentist and Bayesian approaches, and we discuss recent trends in CRT analysis, including highlighting new methodology for both binary and continuous data.

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. Competing interests: The authors have declared that no competing interests exist. Cluster randomized trials CRTs , also known as group randomized, place-based, or community intervention trials, are increasingly important for the evaluation of interventions in health research [1] — [7].


PDF | In a cluster randomized trial, also called a group randomized trial, Find, read and cite all the research you need on ResearchGate. The Korean Health Study [5] provides an example of the use of stratified.


Cluster randomised controlled trial

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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.

Allan Donner and Neil Klar. London: Arnold, , pp. ISBN:

Cluster Randomized Trials: Considerations for Design and Analysis

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Joanna D.

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Arnulfo E.

Robarts Research Institute. London, Canada Cluster randomization trials are experiments in which intact social challenges in both design and analysis.

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