The promises and challenges of pragmatism: lesson from of a recent clinical trial

Abstract

Pragmatic trials aim to answer the question "Can the intervention work under usual conditions?", whereas explanatory trials aim to answer "Can the intervention work under ideal conditions?" (1). Pragmatic trials, undertaken in routine practice settings, may provide more relevant evidence to support decision making for most stakeholders, such as patients, clinicians, health systems, payers, and policymakers. Furthermore, pragmatic trials leverage existing clinical infrastructure and can be implemented at a fraction of the cost of typical explanatory trials. As such, one might expect that pragmatic trials should be conducted more frequently. The reality is quite the opposite. The number of explanatory trials substantially outweigh that of pragmatic trials, although the level of pragmatism increased moderately over the past two decades (2-5).There are few purely explanatory or pragmatic trials (6). The pragmatism is a continuum assessed by the PRECIS-2 tool based on 9 dimensions. Each dimension can be rated from 1 (very explanatory) to 5 (very pragmatic). The PRECIS-2 tool is intended to be used at the trial design stage to help trialists make the purpose of the trial explicit and to ensure that the design choices are concordant with their intended purpose. In this letter, we rated a pivotal trial recently completed by our team to illustrate how the design choices we made affect the pragmatism.The example used here is electrocardiogram (ECG) artificial intelligence (AI)-Guided Screening for Low Ejection Fraction (EAGLE) trial, which is a pragmatic randomized controlled trial (RCT) that assessed an AIpowered clinical decision support tool for enabling early Cite this article as: Yao X, Noseworthy PA. The promises and challenges of pragmatism: lesson from of a recent clinical trial.