Alternatives to the randomized controlled trial

Stephen G. West, Naihua Duan, Willo Pequegnat, Paul Gaist, Don C. Des Jarlais, David Holtgrave, José Szapocznik, Martin Fishbein, Bruce Rapkin, Michael Clatts, Patricia Dolan Mullen

Research output: Contribution to journalReview articlepeer-review


Public health researchers are addressing new research questions (e.g., effects of environmental tobacco smoke, Hurricane Katrina) for which the randomized controlled trial (RCT) may not be a feasible option. Drawing on the potential outcomes framework (Rubin Causal Model) and Campbellian perspectives, we consider alternative research designs that permit relatively strong causal inferences. In randomized encouragement designs, participants are randomly invited to participate in one of the treatment conditions, but are allowed to decide whether to receive treatment. In quantitative assignment designs, treatment is assigned on the basis of a quantitative measure (e.g., need, merit, risk). In observational studies, treatment assignment is unknown and presumed to be nonrandom. Major threats to the validity of each design and statistical strategies for mitigating those threats are presented.

Original languageEnglish (US)
Pages (from-to)1359-1366
Number of pages8
JournalAmerican journal of public health
Issue number8
StatePublished - Aug 1 2008

ASJC Scopus subject areas

  • Public Health, Environmental and Occupational Health


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