ABSTRACT
Randomized clinical trials (RCTs) are often considered the gold standard for establishing treatment efficacy of an intervention and help to advance the practice of evidence-based medicine. In general, standard RCTs are designed to optimize internal validity to efficiently demonstrate the efficacy of an intervention in a highly selected patient group. However, such designs have notable limitations, including a lack of generalizability and external validity, which may limit their direct applicability to routine clinical practice. The pragmatic trial aims to understand the real-world benefit of an intervention by incorporating design elements that allow for greater generalizability and clinical applicability of study results. The advent of a modern electronic health record system makes it feasible and relatively inexpensive to conduct studies in the context of routine clinical practice. The objective of a pragmatic trial is to capture the true effect of a treatment strategy in a real-world setting.
