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Pragmatic trials are studies designed to provide information for real-world clinical practice. They are often characterized as a focus on the practical aspects of designing a study which include recruitment and consent, adherence and the use routinely available equipment.

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A pragmatic study that involves different investigators and participants from various geographical regions is the Home Blood Pressure Management study (HBPM). This type of heterogeneity, which is essential for a pragmatic trial to be reliable and reduce bias in results, is also necessary. However too much heterogeneity could lead to issues with the design of the trial.

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The aim of pragmatic trials is to replicate real-life scenarios and gain maximum validity externally. They are typically requested by practitioners and policymakers to help guide their decisions. They can also be a great way to identify the causality between an intervention and its outcomes. However, they should not be used in lieu for explanatory trials.

The idea of pragmatism is controversial and there are concerns about whether pragmatic trials can replace tests for explanations or if they are an alternative to them. Schwartz and Lellouch1 proposed a distinction between explanatory studies, which confirm a physiological hypothesis or clinical hypothesis, as well as pragmatic trials, that inform the practice and policy decision-making. They also proposed a framework called PRECIS for pragmatic trials.2 This tool attempted to define the traits of a pragmatic study, including recruitment, design, implementation of the intervention, and follow-up.

There is a growing trend in the number of pragmatic trials that are published. A recent Medline search using the words naturalistic and pragmatic, restricted to randomised controlled trials (RCTs), returned 34 articles. These are shown in red on Figure 2. This suggests that the health sciences community has become more aware of the importance of pragmatic thinking. It is important to keep in mind, however, that the majority of these studies were conducted in primary-care settings.