Pragmatic Trials and Approaches to Transforming Care

When considering medical interventions and tools for learning and advancing a field, one perspective is to test a drug, device, or intervention in a highly controlled setting, where inclusion and exclusion criteria are very strict. Such criteria can limit the impact of bias and confounders, while providing rigor in assessing the impact of an intervention. However, when evaluating data from a clinical trial and assessing whether these criteria apply to the patient who sits in front of you, this approach creates a challenge: such strict criteria often mean that the person for whom you want to apply “the evidence” is not appropriate. For this reason, there has been a move to conduct more pragmatic trials that are designed to test the effectiveness of the intervention in broad routine clinical practice. Often, interventions that show a dramatic impact in the setting of a clinical trial fail to be effective in broader settings. This phenomenon is called regression to the mean [1]. So one way to try to approach the assessment of drug, device, and surgical interventions is to evaluate them using a pragmatic trial approach.This establishes a broader base for the intervention and, prospectively, you can identify the subgroups where the interventions could be found to be more effective. This improves applicability of the results.