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PUBLIC HEALTH MATTERS |
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, 96001–970, Pelotas, RS, Brazil (e-mail: dcdesjarla{at}aol.com).
Randomized controlled trials (RCTs) are essential for evaluating the efficacy of clinical interventions, where the causal chain between the agent and the outcome is relatively short and simple and 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 different populations. Both the internal and external validity of RCT findings can be greatly enhanced by observational studies using adequacy or plausibility designs. For evaluating large-scale interventions, studies with plausibility designs are often the only feasible option and may provide valid evidence of impact.
There is an urgent need to develop evaluation standards and protocols for use in circumstances where RCTs are not appropriate.
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