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Pragmatic trials are those that are designed to provide information for the practice of clinical trials in real life. They are typically described as a focus on the practical aspects of study design, including the recruitment process and consent, adhering and the use of standard equipment.

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Another example of a pragmatic trial is the Home Blood Pressure Management (HBPM) study, which used different investigators and participants from various geographical areas. This kind of heterogeneity is necessary for pragmatic trials to be able to prove their validity and also helps reduce the chance of bias in the results. Too much heterogeneity, however 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 usually commissioned by practitioners and policy makers to guide their decision-making. They can also be used to assess the cause-effect relationship of an intervention with its outcomes. However, they shouldn't be used to substitute for explanatory trials.

The pragmatism idea is controversial and there are concerns about whether pragmatic trials should replace tests for explanations or if they are a complement to them. Schwartz and Lellouch1 suggested the distinction between explanation trials, which confirm the validity of a clinical or physiological hypothesis as well as pragmatic trials, which guide the practice and policy decisions. They also proposed a framework called PRECIS for pragmatic trials.2 The tool was designed to define the characteristics of a practical study which includes the recruitment, design, and delivery of the intervention and follow-up.

There is an encouraging increase in the number of pragmatic trials published. A recent Medline search using the terms naturalistic and pragmatic, limited to controlled trials randomized to control (RCTs) resulted in 34 articles, as shown in red in Figure 2. This suggests that the health sciences community is becoming more aware of the importance of pragmatic thinking. It is important to note that the majority of these studies were conducted in primary-care settings.