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Studies designed to provide insight into clinical practice in the real world are referred to as pragmatic trials. They are often characterized by a focus on the practical aspects of study design, such as recruitment and consent in adherence, as well as the use of routinely available equipment.

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A pragmatic study that involves different investigators and participants from different geographical areas is the Home Blood Pressure Management study (HBPM). This kind of heterogeneity, which is essential for a pragmatic trial to be valid and lessen the chance of bias, is also necessary. Too much heterogeneity, however, can cause problems with the trial design.

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Pragmatic trials aim to mimic real-world situations and have the highest external validity. They are usually requested by policy makers and practitioners to guide their decision-making. They can also be used to assess the causality of an intervention and its effects. However, they shouldn't be used in lieu for explanatory studies.

The pragmatism concept is controversial and there are doubts about whether pragmatic trials should be used to replace explanatory trials or complement them. Schwartz and Lellouch1 made a distinction between explanatory studies, which support the validity of a physiological or clinical hypothesis, as well as pragmatic trials, that inform policy and practice decision-making. They also suggested the framework for pragmatic trials, called PRECIS.2 This tool attempted to define the features 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 that used the words pragmatic and naturalistic, which was restricted to randomised controlled trials (RCTs), returned 34 articles. They are displayed in red on Figure 2. This is a sign that the health sciences community is becoming increasingly sensitized to the subject of pragmatism. It is important to note, however, that the majority were conducted in primary-care settings.