To the Editor We read with interest the study by Sepehrvand et al,1 which described secular trends in the conduct of pragmatic or explanatory cardiovascular randomized clinical trials over 2 decades. We believe extension of this thoughtful analysis can provide additional insights into pragmatic vs explanatory trials.
Pragmatic compared with explanatory trials are intended to study the effectiveness of interventions in routine clinical practice to facilitate enrollment and increase generalizability. They achieve this by incorporating broader eligibility criteria, more flexible interventions, simpler assessment of patient or physician compliance/adherence, and a more inclusive analysis of outcomes. Although each of these characteristics has some appeal, an unintended consequence may be that their cumulative effect lowers the likelihood of identifying an efficacious intervention. The latter would ultimately decrease the rate of evidence-based improvements in care.
Fernandes A, Bartlett ES, Nichol G. Pragmatic vs Explanatory Trials. JAMA Cardiol. 2020;5(4):487–488. doi:10.1001/jamacardio.2019.6111
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