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Pragmatic trials are studies designed to inform the real-world practice of clinical. They are often characterized as a focus on the practical aspects of design which include recruitment and consent, adherence and the use of standard equipment.

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Another example of a pragmatic trial is the Home Blood Pressure Management (HBPM) study, which employed a variety of investigators and participants from different geographic areas. This kind of heterogeneity, that is crucial for a pragmatic trial to be valid and to reduce bias in the results is also essential. A high degree of heterogeneity, however could cause issues with the trial design.

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The purpose of pragmatic trials is to replicate real-life situations and achieve maximum credibility externally. They are typically requested by practitioners and policymakers to guide their decisions. They can also be used to assess the causality of an intervention and its results. However, they should not, be used to replace the need for explanation studies.

The pragmatism concept is controversial, and there are questions about whether pragmatic trials should be used to replace explanatory trials or complement them. Schwartz and Lellouch1 suggested the distinction between explanatory trials, which validate a physiological or clinical hypothesis as well as pragmatic trials that inform the practice and policy decisions. They also suggested the framework for pragmatic trials, called PRECIS.2 This tool sought to define the elements of a pragmatic trial, including the recruitment process, the design and implementation of the intervention, as well as monitoring.

The number of pragmatic trials is increasing. A recent Medline query that used the words pragmatic and naturalistic, which was restricted to randomised controlled trials (RCTs) returned 34 articles. They are displayed in red on Figure 2. This indicates that the health sciences community has become more aware of the importance of pragmatism. It is important to keep in mind, however, that the majority of these studies were conducted in primary care settings.