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Studies designed to provide insight into clinical practice in the real world are referred to as pragmatic trials. They are usually focused on practical aspects of the study design, such as the recruitment and consent process as well as adherence to the use of commonly available equipment.
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Another example of a practical trial is the Home Blood Pressure Management (HBPM) study, which utilized different investigators and included participants from different geographic areas. This kind of heterogeneity is essential for pragmatic trials to be able to prove their validity and helps to reduce bias in the results. However, too much heterogeneity can result in issues with the design of the trial.
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The aim of pragmatic trials is to simulate real-life scenarios and gain maximum validity externally. Usually, they are ordered by policymakers and practitioners to guide their decisions. They are also a good way to identify the causality between an intervention and its outcomes. However, they should not, be used to replace explanation studies.
The concept of pragmatism is controversial, and there are questions about whether pragmatic trials should be used to replace explanation tests or if they should serve as an addition to them. Schwartz and Lellouch1 made an distinction between explanation-based studies, which prove a physiological hypothesis 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 The tool was designed to define the characteristics of a practical study that includes the recruitment, design, and delivery of the intervention and its follow-up.
The number of pragmatic trials is increasing. A recent Medline query using the keywords 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 pragmatism. It is important to note, however, that the majority of these studies were conducted in primary-care settings.