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Open Access Commentary

Against pragmatism: on efficacy, effectiveness and the real world

David M Kent* and Georgios Kitsios

Author Affiliations

Institute for Clinical Research and Health Policy Studies and Department of Medicine, Tufts Medical Center, Tufts University School of Medicine, Boston, USA

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Trials 2009, 10:48  doi:10.1186/1745-6215-10-48

Published: 6 July 2009

Abstract

Explanatory and pragmatic trials represent ends of a continuum of attitudes about clinical trial design. Recent literature argues that pragmatic trials are more informative about clinical care in the real world. Although there is place for more pragmatic studies to inform clinical practice and health policy decision-making, we are concerned that it is generally under-appreciated that extrapolating the results of broadly inclusive pragmatic trials to the care of real patients may often be as problematic as extrapolating the results of narrowly focused explanatory or efficacy trials. Simplistic interpretation of pragmatic trials runs the risk of driving harmful policies.