Show Summary Details
Page of

Methodological issues in the design and analysis of community intervention trials 

Methodological issues in the design and analysis of community intervention trials
Chapter:
Methodological issues in the design and analysis of community intervention trials
Author(s):

Allan Donner

DOI:
10.1093/med/9780199218707.003.0033
Page of

PRINTED FROM OXFORD MEDICINE ONLINE (www.oxfordmedicine.com). © Oxford University Press, 2016. All Rights Reserved. Under the terms of the licence agreement, an individual user may print out a PDF of a single chapter of a title in Oxford Medicine Online for personal use (for details see Privacy Policy and Legal Notice).

date: 19 June 2019

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 low- and middle-income 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 that 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 becomes 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.

Access to the complete content on Oxford Medicine Online requires a subscription or purchase. Public users are able to search the site and view the abstracts for each book and chapter without a subscription.

Please subscribe or login to access full text content.

If you have purchased a print title that contains an access token, please see the token for information about how to register your code.

For questions on access or troubleshooting, please check our FAQs, and if you can't find the answer there, please contact us.