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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 focused on the practical aspects of the study design, such as the recruitment process and consent as well as adherence to the use of standard equipment.
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A pragmatic trial that uses a variety investigators and includes participants from various geographical regions is the Home Blood Pressure Management study (HBPM). This kind of heterogeneity is necessary for practical trials to be valid and reduces bias in the results. However too much heterogeneity could cause issues with the design of the trial.
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The purpose of pragmatic trials is to simulate real-life scenarios and gain the highest level of validity externally. They are typically ordered by policymakers and practitioners in order to inform their decisions. They are also a good way to identify the causality between an intervention and its outcomes. They should not, however be used to replace the need for explanation studies.
The pragmatism idea is controversial and there are questions about whether pragmatic trials should replace or complement them. Schwartz and Lellouch1 made the distinction between explanation studies, which confirm the physiological hypothesis or clinical hypothesis, as well as pragmatic trials that aid in the decision-making process for policy and practice. They also proposed an approach to pragmatic trials, which they called PRECIS.2 This tool sought to define the characteristics of a practical trial which includes the recruitment process, the design and implementation of the intervention, as well as monitoring.
The number of pragmatic trials is growing. A recent Medline query using the keywords pragmatic and naturalistic, limited to randomised controlled trials (RCTs) returned 34 articles. These are shown 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 note, however, that the majority of these studies were conducted in primary care settings.