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Clinical trials that are designed to help inform practice in the real world are known as pragmatic trials. They are often characterized as a focus on the practical aspects of designing a study, including the recruitment process and consent, adhering and the use of standard equipment.

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A pragmatic study that involves a variety investigators and includes participants from different geographical areas is the Home Blood Pressure Management study (HBPM). This kind of heterogeneity is necessary for practical trials to be valid and also helps reduce bias in the results. However, too much heterogeneity can lead to issues with the design of the trial.

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Pragmatic trials are designed to replicate real-world situations and have the highest external validity. They are usually ordered by policymakers and practitioners to inform their decisions. They can also be used to assess the causality of an intervention and its results. They should not, however be used to replace the need for explanation studies.

The concept of pragmatism is controversial, and there are questions about whether pragmatic trials should replace explanatory trials or complement them. Schwartz and Lellouch1 suggested a distinction between explanatory trials, which confirm the clinical or physiological hypothesis as well as pragmatic trials, which inform policy and practice decisions. They also proposed a framework called PRECIS for pragmatic trials.2 The tool was designed to define the elements of a pragmatic study, including recruitment, design, delivery of the intervention, and follow-up.

There is a positive trend in the number of pragmatic trials that are published. A recent Medline search using the terms naturalistic and pragmatic, limited to controlled trials that are randomized (RCTs), yielded 34 articles, which are shown in red in Figure 2. This indicates that the health sciences community has become more aware of the importance of pragmatic thinking. It is important to keep in mind that the majority of studies were conducted in primary-care settings.