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Pragmatic trials are those that are designed to inform the practice of clinical trials in real life. They are often described as a focus on the practical aspects of designing a study, including the recruitment process and consent, adhering and the use routinely available equipment.

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Another example of a trial that is pragmatic is the Home Blood Pressure Management (HBPM) study, which employed a variety of investigators and included participants from various geographical areas. This type of heterogeneity that is crucial for pragmatic trials to be valid and reduce bias in results, is also necessary. However, too much heterogeneity, can cause problems with the design of the trial.

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The aim of pragmatic trials is to replicate real-life situations and achieve maximum validity externally. They are typically commissioned by policymakers and practitioners to help inform their decisions. They can also be used to assess the causality of an intervention with its outcomes. However, they should not be used in lieu for explanatory trials.

The pragmatism idea is controversial and there are doubts about whether pragmatic trials can replace explanatory tests or if they are a complement to them. Schwartz and Lellouch1 proposed the distinction between explanation studies, which prove a physiological hypothesis or clinical hypothesis, and pragmatic trials, which inform the practice and policy decision-making. They also proposed an approach to pragmatic trials, dubbed PRECIS.2 This tool sought to define the characteristics of a pragmatic study which includes the recruitment process, the design and delivery of the intervention, and follow-up.

The number of pragmatic trials is growing. A recent Medline search using the keywords pragmatic and naturalistic, restricted to controlled trials that are randomized (RCTs) produced 34 articles, which are shown in red in Figure 2. This suggests that the health sciences community is becoming more aware of the importance of pragmatism. However, it is important to note that the majority of these trials were conducted in primary care settings.