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)
Ma J, Kramer MK, Ciechanowski P. Efficacy vs Effectiveness—Reply. JAMA Intern Med. 2013;173(13):1263–1264. doi:10.1001/jamainternmed.2013.7065
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