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Studies designed to provide insight into clinical practice in the real world are called pragmatic trials. They are typically described by their focus on practical aspects of designing a study which include the recruitment and consent process, as well as adherence and the use of standard equipment.

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Another example of a trial that is pragmatic is the Home Blood Pressure Management (HBPM) study, which employed different investigators and included participants from different geographical regions. This type of heterogeneity, that is crucial for pragmatic trials to be reliable and reduce bias in results, is also necessary. However excessive heterogeneity could cause issues with the design of the trial.

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Pragmatic trials seek to replicate real-world situations and have the highest external validity. They are typically commissioned by practitioners and policy makers to aid in their decision-making. They can also be used to determine the cause-effect relationship of an intervention and its effects. However, they should not, be used to replace explanatory studies.

The concept of pragmatism is controversial and there are concerns about whether pragmatic trials should replace explanatory trials or complement them. Schwartz and Lellouch1 suggested the distinction between explanation trials, which prove the validity of a clinical or physiological hypothesis, and pragmatic trials, which guide the practice and policy decisions. They also suggested a framework for pragmatic trials, dubbed PRECIS.2 This tool sought to define the features of a pragmatic study that include recruitment, design and delivery of the intervention, as well as follow-up.

The number of pragmatic trials is increasing. A recent Medline search using the words pragmatic and naturalistic, which was restricted to randomised controlled trials (RCTs), returned 34 articles. They are displayed in red on Figure 2. This suggests that the health sciences community has become more aware of the importance of pragmatic thinking. It is important to remember that the majority were conducted in primary-care settings.