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Pragmatic trials are those that are designed to inform the practice of clinical trials in real life. They are typically described by their focus on practical aspects of design, including recruitment and consent, 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 had participants from various geographical areas. This type of heterogeneity is essential for pragmatic trials to be valid and also helps to reduce the chance of bias in the results. However, too much heterogeneity, can cause 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 commissioned by policymakers and practitioners to help guide their decisions. They can also be used to determine the causality of an intervention and its results. However, they shouldn't be used as a substitute for the use of explanation studies.

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

There is a positive increase in the number pragmatic trials published. A recent Medline query using the keywords pragmatic and naturalistic, which was restricted to randomised controlled trials (RCTs), returned 34 articles. These are highlighted in red on Figure 2. This suggests that the health sciences community has become more aware of the importance of pragmatism. It is important to keep in mind that the majority were conducted in primary-care settings.