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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 often characterized as focusing on practical aspects of study design which include recruitment and consent, adherence and the use of standard 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 kind of heterogeneity, that is crucial for a pragmatic trial to be valid 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 mimic real-life scenarios and to achieve maximum credibility externally. They are typically commissioned by policy makers and practitioners to guide their decision-making. They can be used to determine the causal relationship between an intervention and its effects. However, they shouldn't be used as a substitute for explanation trials.

The pragmatism idea is controversial and there are questions about whether pragmatic trials should be used to replace explanatory trials or complement them. Schwartz and Lellouch1 suggested an distinction between explanation-based studies, which confirm a physiological hypothesis or clinical hypothesis, and pragmatic trials that aid in the practice and policy decision-making. They also suggested the framework for pragmatic trials, called PRECIS.2 This tool sought to define the characteristics of a practical trial that include the recruitment process, the design and implementation of the intervention, as well as the follow-up.

The number of pragmatic trials is growing. A recent Medline query that used the words naturalistic and pragmatic, restricted to randomised controlled trials (RCTs), returned 34 articles. They are displayed in red on Figure 2. This is a sign that the health science community is becoming more sensitive to the subject of pragmatism. However, it is important to keep in mind that the majority of these trials were conducted in primary care settings.