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Clinical trials that are designed to help inform practice in the real world are called pragmatic trials. They are often characterized as a focus on the practical aspects of design which include 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 utilized different investigators and included participants from different geographical regions. This type of heterogeneity, that is crucial for pragmatic trials to be valid and to reduce bias in the results is also essential. Too much heterogeneity, however could cause issues with the design of the trial.

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Pragmatic trials seek to replicate real-life settings and achieve maximum external validity. They are usually requested by policy makers and practitioners to guide their decision-making. They can also be used to assess the causal relationship between an intervention and its effects. However, they should not be used as a substitute for explanatory trials.

The pragmatism concept is controversial and there are concerns about whether pragmatic trials should replace explanatory trials or complement them. Schwartz and Lellouch1 made an distinction between explanation-based studies, which support the physiological hypothesis or clinical hypothesis, as well as pragmatic trials that aid in policy and practice decision-making. They also suggested an approach to pragmatic trials, called PRECIS.2 This tool attempted to define the elements of a practical trial which includes the recruitment process, the design and implementation of the intervention, and the follow-up.

The number of pragmatic trials is growing. A recent Medline query using the keywords pragmatic and naturalistic, limited 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 keep in mind, however, that the majority were conducted in primary-care settings.