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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 as focusing on practical aspects of study design, including the recruitment process and consent, adhering and the use routinely available equipment.

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Another example of a pragmatic trial is the Home Blood Pressure Management (HBPM) study, which utilized different investigators and had participants from different geographical regions. This kind of heterogeneity, that is crucial 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 design of the trial.

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Pragmatic trials aim to mimic real-world situations and have the highest external validity. They are usually commissioned by policymakers and practitioners to guide their decisions. They can also be used to assess the cause-effect relationship 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 doubts about whether pragmatic trials should be used to replace explanatory trials or complement them. Schwartz and Lellouch1 suggested a distinction between explanatory studies, which confirm a physiological hypothesis or clinical hypothesis, as well as pragmatic trials, which inform the practice and policy decision-making. They also suggested a framework known as PRECIS for pragmatic trials.2 The tool was designed to define the traits of a practical study which includes the recruitment, design, and delivery of the intervention and its follow-up.

There is a positive increase in the number of 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 shown in red on Figure 2. This suggests that the health sciences community is becoming more aware of the importance of pragmatic thinking. However, it is important to keep in mind that the majority of these studies were conducted in primary care settings.