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Clinical trials that are designed to help inform practice in the real world are known as pragmatic trials. They are typically characterized by a focus on the practical aspects of the research design, like the recruitment and consent process, adherence, and the use of standard equipment.

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A pragmatic study that involves various investigators and participants from diverse geographical locations is the Home Blood Pressure Management study (HBPM). This type of heterogeneity is essential for pragmatic trials to be valid and helps to reduce bias in the results. However excessive heterogeneity could result in issues with the design of the trial.

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The goal of pragmatic trials is to simulate real-life scenarios and to achieve maximum validity externally. They are typically commissioned by policy makers and practitioners to guide their decision-making. They are also a good method to determine the cause-effect relationship between an intervention and its outcomes. However, they shouldn't be used to substitute for the use of explanation studies.

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

There is an encouraging increase in the number of pragmatic trials that have been published. A recent Medline search using 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 is becoming more aware of the importance of pragmatic thinking. It is important to note, however, that the majority of these studies were conducted in primary care settings.