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Trials designed to inform clinical practice in the real world are known as pragmatic trials. They are typically described as focusing on practical aspects of designing a study that include recruitment and consent, adherence and 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 type of heterogeneity which is essential for a pragmatic trial to be valid and to reduce bias in the results, is also necessary. However too much heterogeneity could lead to problems 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. Usually, they are requested by practitioners and policymakers to inform their decisions. They can also be used to determine the causality of an intervention and its results. They should, however, not be used to replace explanatory studies.

The pragmatism idea is controversial, and there are concerns about whether pragmatic trials should be used to replace explanatory trials or complement them. Schwartz and Lellouch1 suggested a distinction between explanatory studies, which support the physiological hypothesis or clinical hypothesis, and pragmatic trials that aid in policy and practice decision-making. They also proposed a framework for pragmatic trials, dubbed PRECIS.2 This tool attempted to define the features of a pragmatic study, including recruitment, design and delivery of the intervention, as well as monitoring.

There is a growing trend in the number of pragmatic trials published. A recent Medline query using the keywords naturalistic and pragmatic, restricted to randomised controlled trials (RCTs) returned 34 articles. These are shown in red on Figure 2. This indicates 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 trials were conducted in primary care settings.