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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 practical aspects of the study design, including the recruitment and consent process, adherence, and the use of 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 participants from different geographic areas. This type of heterogeneity is essential for pragmatic trials to be able to prove their validity, and it also helps to reduce the chance of bias in the results. However, too much heterogeneity can lead to issues with the design of the trial.

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Pragmatic trials seek to replicate real-world situations and have the highest external validity. Usually, they are ordered by policymakers and practitioners to guide their decisions. They can be used to determine the causality of an intervention and its results. They should, however, not be used to replace explanation studies.

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

There is an encouraging increase in the number of pragmatic trials that are 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 is an indication that the health sciences community is becoming more sensitive to the subject of pragmatism. It is important to keep in mind, however, that the majority were conducted in primary-care settings.