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Clinical trials that are designed to help inform practice in the real world are known as pragmatic trials. They are usually characterized by a focus on practical aspects of the research design, like the recruitment and consent process as well as adherence to the use of routinely available equipment.

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A pragmatic study that involves different investigators and participants from various geographical regions is the Home Blood Pressure Management study (HBPM). This kind of heterogeneity, which is essential for pragmatic trials to be reliable and reduce bias in results is also essential. Too much heterogeneity, however could cause issues with the trial design.

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The goal of pragmatic trials is to replicate real-life scenarios and to achieve the highest level of validity externally. They are usually commissioned by policymakers and practitioners in order to guide their decisions. They can also be used to determine the causal relationship between an intervention and its effects. However, they should not, be used to replace the need for explanation studies.

The pragmatism concept is controversial, and there are questions about whether pragmatic trials should be used to replace explanatory trials or complement them. Schwartz and Lellouch1 proposed a distinction between explanatory studies, which support the physiological hypothesis or clinical hypothesis, and pragmatic trials, which inform the decision-making process for policy and practice. They also proposed a framework called PRECIS for pragmatic trials.2 This tool tried to define the characteristics of a pragmatic study that includes the recruitment, design, and delivery of the intervention and its follow-up.

The number of pragmatic trials is growing. A recent Medline search using the keywords naturalistic and pragmatic, limited to controlled trials that are randomized (RCTs), yielded 34 articles, shown in red in Figure 2. This is an indication that the health science community is becoming more sensitive to the issue of pragmatism. However, it is important to keep in mind that the majority of these trials were conducted in primary care settings.