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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 characterized by a focus on practical aspects of the research design, like the recruitment and consent process as well as adherence to the use of standard equipment.

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

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Pragmatic trials seek to replicate real-life settings and achieve maximum external validity. They are usually commissioned by policymakers and practitioners to help guide their decisions. They can also be used to assess the causal relationship between an intervention with its outcomes. However, they shouldn't be used as a substitute for explanation trials.

The concept of pragmatism is controversial, and there are questions about whether pragmatic trials should be used to replace explanatory trials or complement them. Schwartz and Lellouch1 made the distinction between explanation studies, which support the validity of a physiological or clinical hypothesis, as well as pragmatic trials, that inform the practice and policy decision-making. They also suggested a framework dubbed PRECIS for pragmatic trials.2 This tool attempted to define the elements of a practical study, including recruitment, design, delivery of the intervention and follow-up.

The number of pragmatic trials is growing. A recent Medline query using the keywords pragmatic and naturalistic, which was restricted to randomised controlled trials (RCTs) returned 34 articles. These are highlighted in red on Figure 2. This is a sign that the health sciences community is becoming more acquaint to the subject of pragmatism. It is important to note, however, that the majority of studies were conducted in primary-care settings.