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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 often described by their focus on practical aspects of design, including the recruitment and consent process, as well as adherence 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 used various investigators and included participants from different geographical regions. This kind of heterogeneity is required for pragmatic trials to be able to prove their validity, and it also helps to reduce bias in the results. However excessive heterogeneity could result in problems 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 requested by policy makers and practitioners to guide their decision-making. They can also be used to determine the causality of an intervention and its effects. They should, however, not be used to replace explanatory studies.

The concept of pragmatism is controversial, and there are questions about whether pragmatic trials should be used to replace explanation tests or if they are an alternative to them. Schwartz and Lellouch1 made an distinction between explanation-based studies, which confirm a physiological hypothesis or clinical hypothesis, as well as pragmatic trials that aid in policy and practice decision-making. They also suggested a framework dubbed PRECIS for pragmatic trials.2 This tool attempted to define the traits of a practical study that 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 keywords naturalistic and pragmatic, which was limited to controlled trials that are randomized (RCTs) produced 34 articles, which are shown in red in Figure 2. This indicates that the health science community is becoming increasingly sensitized to the issue of pragmatics. It is important to keep in mind that the majority were conducted in primary-care settings.