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Methodological issues in the design and analysis of community intervention trials 

Methodological issues in the design and analysis of community intervention trials
Methodological issues in the design and analysis of community intervention trials

Allan Donner

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date: 04 July 2022

With the literature on community intervention trials showing rapid growth over the last two decades, there is an increasing need to better understand their methodological foundation. A key feature of such trials is the allocation of intact communities or clusters of individuals rather than individuals themselves to different intervention groups. Examples include trials evaluating a mass education intervention delivered through the media or alterations in the hygiene of villages located in developing countries. Only recently however has it been recognized that the application of standard approaches to the design and analysis of such trials can lead to serious problems of interpretation. This is because methods which are extensively discussed in the clinical trial literature tend to assume that the outcomes on individuals within the same cluster are statistically independent, when in fact responses on individuals in the same community invariably tend to be more similar than responses on individuals in different communities. Moreover the development of methods that take into account within-cluster dependencies become particularly challenging when a relatively small number of large communities are enrolled in the trial. This has led to the popularity of designs not frequently seen in large scale clinical trials, such as pair-matching and repeated cross-sectional surveys. In this chapter we discuss a range of such issues, including the advantages and disadvantages of different study designs, methods of assuring adequate statistical power, and choice of analytic approach. Ethical issues arising from the need to obtain informed consent at both the cluster level and at the level of the individual are also discussed.

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