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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 routinely available equipment.

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Another example of a practical trial is the Home Blood Pressure Management (HBPM) study, which utilized a variety of investigators and had participants from different geographic areas. This kind of heterogeneity is necessary for pragmatic trials to be able to prove their validity and also reduces the chance of bias in the results. A high degree of heterogeneity, however could cause issues with the trial design.

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The goal of pragmatic trials is to simulate real-life scenarios and to achieve maximum validity externally. They are usually commissioned by practitioners and policy makers to inform their decision making. They can also be used to assess the cause-effect relationship of an intervention and its effects. However, they should not be used as a substitute for explanatory trials.

The idea of pragmatism is controversial and there are doubts about whether pragmatic trials can be used to replace explanation tests or if they should serve as an addition to them. Schwartz and Lellouch1 suggested the distinction between explanatory trials, which validate the clinical or physiological hypothesis, and pragmatic trials that inform policy and practice decisions. They also suggested the framework for pragmatic trials, dubbed PRECIS.2 This tool sought to define the features of a pragmatic trial which includes recruitment, design and delivery of the intervention, as well as follow-up.

There is an encouraging increase in the number of pragmatic trials published. A recent Medline search using the keywords pragmatic and naturalistic, restricted to controlled trials randomized to control (RCTs), yielded 34 articles, as shown in red in Figure 2. This indicates that the health sciences community has become more aware of the importance of pragmatic thinking. It is important to keep in mind that the majority of these studies were conducted in primary care settings.