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Pragmatic trials are trials designed to inform the real-world practice of clinical. They are often characterized by a focus on the practical aspects of the study design, such as the recruitment and consent process as well as adherence to the use of standard equipment.

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Another example of a pragmatic trial is the Home Blood Pressure Management (HBPM) study, which employed a variety of investigators and participants from various geographical areas. This kind of heterogeneity, which is vital for pragmatic trials to be reliable and lessen the chance of bias, is also necessary. A high degree of heterogeneity, however, can cause problems with the trial design.

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The aim of pragmatic trials is to replicate real-life scenarios and to achieve maximum validity externally. They are typically commissioned by practitioners and policy makers to guide their decision-making. They can be used to determine the cause-effect relationship of an intervention and its results. However, they should not, be used to replace explanation studies.

The concept of pragmatism is controversial, and there are questions about whether pragmatic trials should replace or complement them. Schwartz and Lellouch1 made the distinction between explanation studies, which support the validity of a physiological or clinical hypothesis, as well as pragmatic trials, that inform the practice and policy decision-making. They also suggested an approach to pragmatic trials, called PRECIS.2 This tool was designed to define the elements of a pragmatic study which includes recruitment, design and delivery of the intervention, as well as the follow-up.

There is a positive increase in the number pragmatic trials that are published. A recent Medline search using the terms naturalistic and pragmatic, which was limited to randomized controlled trials (RCTs) resulted in 34 articles, shown in red in Figure 2. This is a sign that the health sciences community is becoming more sensitive to the subject of pragmatics. It is important to note, however, that the majority of these studies were conducted in primary care settings.