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Studies designed to provide insight into clinical practice in the real world are referred to as pragmatic trials. They are often characterized by a focus on the practical aspects of the study design, including recruitment and consent as well as adherence to the use of routinely available equipment.
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A pragmatic trial that uses various investigators and participants from various geographical regions is the Home Blood Pressure Management study (HBPM). This kind of heterogeneity, which is essential for a pragmatic trial to be reliable and lessen the chance of bias, is also necessary. However too much heterogeneity could cause problems with the design of the trial.
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Pragmatic trials are designed to replicate real-life settings and achieve maximum external validity. They are typically ordered by policymakers and practitioners to help inform their decisions. They also provide a useful method to determine the cause-effect relationship between an intervention and its results. However, they shouldn't be used as a substitute for the use of explanation trials.
The concept of pragmatism is controversial, and there are questions about whether pragmatic trials should replace explanatory tests or if they should serve as a complement to them. Schwartz and Lellouch1 suggested a distinction between explanatory trials, which confirm the clinical or physiological hypothesis, and pragmatic trials, which inform policy and practice decisions. They also proposed a framework called PRECIS for pragmatic trials.2 This tool tried to define the elements of a pragmatic study, including recruitment, design, delivery of the intervention, and follow-up.
There is a positive increase in the number of pragmatic trials published. A recent Medline search using the terms naturalistic and pragmatic, limited to controlled trials that are randomized (RCTs), yielded 34 articles, as shown in red in Figure 2. This suggests that the health sciences community is becoming more aware of the importance of pragmatism. It is important to note that the majority of these trials were conducted in primary care settings.