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Clinical trials that are designed to help inform practice in the real world are referred to as pragmatic trials. They are typically described as a focus on the practical aspects of designing a study that include recruitment and consent, adherence and the use of routinely available equipment.

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A pragmatic trial that uses different investigators and participants from different geographical areas is the Home Blood Pressure Management study (HBPM). This kind of heterogeneity is essential for pragmatic trials to be able to prove their validity and also reduces the chance of bias in the results. However, too much heterogeneity can lead to 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 commissioned by practitioners and policy makers to aid in their decision-making. They can be used to determine the causal relationship between an intervention with its outcomes. They should, however, not, be used to replace the need for explanation studies.

The pragmatism concept is controversial and there are concerns about whether pragmatic trials should replace explanatory trials or complement them. Schwartz and Lellouch1 suggested an distinction between explanation-based studies, which support a physiological hypothesis or clinical hypothesis, and pragmatic trials, that inform policy and practice decision-making. They also proposed a framework called 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 an encouraging increase in the number of pragmatic trials that have been published. A recent Medline search using the terms naturalistic and pragmatic, which was limited to controlled trials randomized to control (RCTs), yielded 34 articles, as shown in red in Figure 2. This indicates that the health sciences community is becoming increasingly sensitized to the subject of pragmatic thinking. It is important to note that the majority of these studies were conducted in primary-care settings.