PubMed · 2011 · 550 citations · 1 references
Public HealthInternal MedicineEvidence-based PracticeExperimental DesignPragmaticsClinical PragmaticsClinical Trial DesignClinical Trial EthicsClinical TrialsStudy DesignTrial ProcedureExplanatory Clinical TrialsExploratory Clinical TrialsPragmatic Trial Design
Clinical trials are the primary tool for evaluating interventions, with pragmatic trials assessing effectiveness in routine practice and explanatory trials testing efficacy under optimal conditions, and pragmatic designs are increasingly valued for their generalizability. This review aims to clarify the concept of pragmatism and argue that pragmatic and explanatory trials lie on a continuum rather than a strict dichotomy. The authors analyze pragmatic trials by highlighting their limitations and the significant influence of their design on medical practice.
Clinical trials have been the main tool used by the health sciences community to test and evaluate interventions, Trials can fall into two broad categories: pragmatic and explanatory. Pragmatic trials are designed to evaluate the effectiveness of interventions in real-life routine practice conditions, whereas explanatory trials aim to test whether an intervention works under optimal situations. Pragmatic trials produce results that can be generalized and applied in routine practice settings. Since most results from exploratory trials fail to be broadly generalizable, the "pragmatic design" has gained momentum. This review describes the concept of pragmatism, and explains in particular that there is a continuum between pragmatic and explanatory trials, rather than a dichotomy. Special focus is put on the limitations of the pragmatic trials, while recognizing the importance for and impact of this design on medical practice.
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