Evidence-Based Public Health: Moving Beyond Randomized Trials
Cesar G. Victora, MD, PhD,
Jean-Pierre Habicht, MD, PhD and
Jennifer Bryce, EdD
Cesar G. Victora is with the Post-Graduate Program in Epidemiology, Federal University of Pelotas, Pelotas, Brazil. Jean-Pierre Habicht is with the Division of Nutritional Sciences, Cornell University, Ithaca, NY. At the time this report was written, Jennifer Bryce was with the Department of Child and Adolescent Health and Development of the World Health Organization, Geneva, Switzerland.
Correspondence: Requests for reprints should be sent to Cesar G. Victora, MD, PhD, Post-Graduate Programme in Epidemiology, Universidade Federal de Pelotas, CP 464, 96001970, Pelotas, RS, Brazil (e-mail: dcdesjarla{at}aol.com).
Randomized controlled trials (RCTs) are essential for evaluatingthe efficacy of clinical interventions, where the causal chainbetween the agent and the outcome is relatively short and simpleand where results may be safely extrapolated to other settings.
However, causal chains in public health interventions are complex,making RCT results subject to effect modification in differentpopulations. Both the internal and external validity of RCTfindings can be greatly enhanced by observational studies usingadequacy or plausibility designs. For evaluating large-scaleinterventions, studies with plausibility designs are often theonly feasible option and may provide valid evidence of impact.
There is an urgent need to develop evaluation standards andprotocols for use in circumstances where RCTs are not appropriate.
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