Article

Randomized Controlled Trials

Christine Paul, Robert Sanson-Fisher and Mariko Carey

in Public Health

ISBN: 9780199756797
Published online February 2011 | | DOI: http://dx.doi.org/10.1093/obo/9780199756797-0047
Randomized Controlled Trials

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Randomized controlled trials (RCTs) have become the accepted approach, or “gold standard,” for producing robust evidence to guide decisions about the effectiveness of proposed public health interventions, programs, or practices. While other research designs are in common use, the “levels of evidence” concept clearly places RCTs as the peak or most preferred approach to the production of evidence. The historical roots of RCTs lie in recognition of the important information to be gained from having comparison or control groups. However, attempts to translate the clinical framework underlying the classical RCT design into the complex public health context have illuminated the limitations of RCTs as a tool for public health evaluation. This conundrum has also been associated with a rise in the use and sophistication of variants on the RCT design such as cluster randomization. These designs bring with them additional challenges that must be considered at trial development. A thorough understanding of the ethical issues and key criteria for methodological rigor is also key to a best-practice approach to understanding, designing, and reporting RCTs in the public health context.

Article.  5849 words. 

Subjects: Public Health and Epidemiology

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