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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 described by their focus on practical aspects of study design, including the recruitment process and consent, adhering and the use of standard equipment.

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Another example of a practical trial is the Home Blood Pressure Management (HBPM) study, which used a variety of investigators and participants from different geographic areas. This type of heterogeneity that is crucial for a pragmatic trial to be reliable and reduce bias in results, is also necessary. However excessive heterogeneity could result in issues with the design of the trial.

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Pragmatic trials aim to mimic real-life situations and attain maximum external validity. They are typically ordered by policymakers and practitioners to help guide their decisions. They are also a good method of determining the causality between the intervention and its effects. However, they shouldn't be used to substitute for explanatory studies.

The concept of pragmatism is controversial and there are questions about whether pragmatic trials should replace explanatory trials or complement them. Schwartz and Lellouch1 proposed an distinction between explanation-based studies, which prove a physiological hypothesis or clinical hypothesis, as well as pragmatic trials, which inform the practice and policy decision-making. They also suggested a framework dubbed PRECIS for pragmatic trials.2 The tool was designed to define the elements of a pragmatic research study which includes recruitment, design, delivery of the intervention and follow-up.

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 suggests that the health sciences community has become more aware of the importance of pragmatic thinking. It is important to keep in mind that the majority of these studies were conducted in primary-care settings.