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Clinical trials that are designed to help inform practice in the real world are called pragmatic trials. They are typically described by their focus on practical aspects of designing a study, including the recruitment process and consent, adhering and the use routinely available equipment.

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Another example of a trial that is pragmatic is the Home Blood Pressure Management (HBPM) study, which used different investigators and included participants from different geographic areas. This type of heterogeneity is essential for practical trials to be valid, and it also helps reduce bias in the results. However, too much heterogeneity can result in problems with the design of the trial.

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The aim of pragmatic trials is to replicate real-life scenarios and gain the highest level of validity externally. They are usually commissioned by practitioners and policy makers to aid in their decision-making. They can also be used to assess the causality of an intervention and its effects. However, they should not be used in lieu for the use of explanation studies.

The idea of pragmatism is controversial and there are concerns about whether pragmatic trials should replace tests for explanations or if they are an addition to them. Schwartz and Lellouch1 proposed a distinction between explanatory studies, which confirm the physiological hypothesis or clinical hypothesis, as well as pragmatic trials that aid in the practice and policy decision-making. They also suggested the framework for pragmatic trials, called PRECIS.2 This tool was designed to define the characteristics of a practical trial which includes the recruitment process, the design and delivery of the intervention, and monitoring.

The number of pragmatic trials is growing. A recent Medline query using the keywords pragmatic and naturalistic, which was restricted to randomised controlled trials (RCTs), returned 34 articles. They are displayed in red on Figure 2. This is an indication that the health science community is becoming more acquaint to the subject of pragmatic thinking. It is important to note, however, that the majority of studies were conducted in primary-care settings.