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Clinical trials that are designed to help inform practice in the real world are called pragmatic trials. They are typically characterized by a focus on the practical aspects of the study design, such as recruitment and consent, adherence, and the use of routinely available equipment.

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A pragmatic trial that uses different investigators and participants from different geographical areas is the Home Blood Pressure Management study (HBPM). This kind of heterogeneity, which is vital for a pragmatic trial to be reliable and reduce bias in results, is also necessary. A high degree of heterogeneity, however could cause issues with the trial design.

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The purpose of pragmatic trials is to mimic real-life scenarios and to achieve maximum credibility externally. They are usually requested by practitioners and policy makers to aid in their decision-making. They can also be a great method to determine the causality between an intervention and its results. However, they should not be used in lieu for explanation trials.

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

There is an encouraging trend in the number of pragmatic trials that are published. A recent Medline query using the keywords naturalistic and pragmatic, restricted to randomised controlled trials (RCTs), returned 34 articles. These are shown in red on Figure 2. This is an indication that the health sciences community is becoming increasingly sensitized to the subject of pragmatism. It is important to note that the majority of these studies were conducted in primary care settings.