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Trials designed to inform clinical practice in the real world are referred to as pragmatic trials. They are typically described as focusing on practical aspects of study design that include the recruitment process and consent, adhering and the use of routinely available equipment.

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

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The purpose of pragmatic trials is to simulate real-life scenarios and to achieve maximum validity externally. They are usually commissioned by practitioners and policy makers to guide their decision-making. They can also be used to determine the causality of an intervention with its outcomes. However, they should not be used to replace explanation studies.

The pragmatism idea is controversial and there are questions about whether pragmatic trials should replace or complement them. Schwartz and Lellouch1 suggested an distinction between explanation-based studies, which confirm 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, which they 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 increasing. A recent Medline search using the terms pragmatic and naturalistic, restricted to controlled trials randomized to control (RCTs) produced 34 articles, which are shown in red in Figure 2. This is an indication that the health sciences community is becoming more sensitive to the issue of pragmatics. It is important to remember that the majority of these studies were conducted in primary care settings.