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Comment & Response
July 8, 2013

Efficacy vs Effectiveness—Reply

Author Affiliations
  • 1Palo Alto Medical Foundation Research Institute and Stanford Prevention Research Center, Stanford University School of Medicine, Palo Alto, California
  • 2Diabetes Prevention Support Center, Graduate School of Public Health, University of Pittsburgh, Pittsburgh, Pennsylvania
  • 3Training Xchange, Center for Commercialization, Department of Psychiatry and Behavioral Sciences, University of Washington, Seattle
JAMA Intern Med. 2013;173(13):1263-1264. doi:10.1001/jamainternmed.2013.7065

In Reply The comment by Pagoto and Lemon raises several important considerations articulated well by others relating to the design, conduct, and reporting of clinical research studies to better inform clinical and policy decisions. Such studies may be simply differentiated as efficacy (explanatory) vs effectiveness (pragmatic) ones, but rarely studies are purely explanatory or pragmatic.1,2 Instead, choices about participants, interventions, delivery agents, retention and fidelity assurance strategies, and analysis approaches call for characterization of clinical research designs as a multidimensional continuum, not a dichotomy, and the levels of pragmatism may vary across these dimensions within any given study. “This multidimensional structure should be borne in mind by trial designers and end-users alike so that overly simplistic labeling of trials can be avoided,” as suggested Thorpe et al.1(pE57)