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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 focused on the practical aspects of study design, such as recruitment and consent in adherence, as well as 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 type of heterogeneity is necessary for pragmatic trials to be able to prove their validity and also helps reduce bias in the results. Too much heterogeneity, however could cause issues with the trial design.
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Pragmatic trials seek to replicate real-life settings and achieve maximum external validity. They are typically commissioned by policy makers and practitioners to inform their decision making. They can be used to determine the cause-effect relationship of an intervention and its effects. However, they should not, be used to replace explanatory studies.
The idea of pragmatism is controversial and there are doubts about whether pragmatic trials can replace explanatory tests or if they are a complement to them. Schwartz and Lellouch1 suggested the distinction between explanation studies, which confirm the physiological hypothesis or clinical hypothesis, and pragmatic trials, which inform policy and practice decision-making. They also proposed a framework for pragmatic trials, which they called PRECIS.2 This tool sought to define the elements of a pragmatic study, including the recruitment process, the design and implementation of the intervention, and monitoring.
The number of pragmatic trials is growing. A recent Medline search using the terms naturalistic and pragmatic, limited to randomized controlled trials (RCTs) produced 34 articles, as shown in red in Figure 2. This indicates that the health sciences community has become more aware of the importance of pragmatic thinking. However, it is important to remember that the majority of these studies were conducted in primary care settings.