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Pragmatic trials are those that are designed to provide information for the practice of clinical trials in real life. They are typically characterized by a focus on practical aspects of the study design, such as the recruitment and consent process in adherence, as well as the use of routinely available equipment.
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Another example of a pragmatic trial is the Home Blood Pressure Management (HBPM) study, which employed different investigators and had participants from different geographical regions. This kind of heterogeneity is required for pragmatic trials to be able to prove their validity and reduces the chance of bias in the results. Too much heterogeneity, however, can cause problems with the trial design.
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Pragmatic trials seek to replicate real-world situations and have the highest external validity. Usually, they are requested by practitioners and policymakers to guide their decisions. They can also be used to assess the causal relationship between an intervention and its effects. However, they should not be used as a substitute for explanation trials.
The pragmatism idea is controversial, and there are doubts about whether pragmatic trials should replace or complement them. Schwartz and Lellouch1 suggested the distinction between explanation trials, which validate the validity of a clinical or physiological hypothesis, and pragmatic trials, which guide the practice and policy decisions. They also proposed an approach to pragmatic trials, dubbed PRECIS.2 This tool was designed to define the elements of a practical trial which includes recruitment, design and delivery of the intervention, and monitoring.
The number of pragmatic trials is growing. A recent Medline search using the keywords naturalistic and pragmatic, which was limited to controlled trials that are randomized (RCTs) resulted in 34 articles, which are shown in red in Figure 2. This suggests that the health sciences community is becoming more aware of the importance of pragmatism. However, it is important to keep in mind that the majority of these studies were conducted in primary care settings.