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Pragmatic trials are studies designed to inform the practice of clinical trials in real life. They are typically described as a focus on the practical aspects of designing a study, including the recruitment and consent process, as well as adherence and the use of routinely available equipment.
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Another example of a pragmatic trial is the Home Blood Pressure Management (HBPM) study, which utilized a variety of investigators and included participants from different geographical regions. This kind of heterogeneity, that is crucial for pragmatic trials to be reliable and to reduce bias in the results is also essential. However too much heterogeneity could lead to issues with the design of the trial.
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Pragmatic trials are designed to replicate real-life settings and achieve maximum external validity. They are typically commissioned by policymakers and practitioners to inform their decisions. They are also a good method of determining 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 doubts about whether pragmatic trials should replace or complement them. Schwartz and Lellouch1 proposed the distinction between explanation studies, which support the physiological hypothesis or clinical hypothesis, and pragmatic trials, which inform the practice and policy decision-making. They also suggested a framework dubbed PRECIS for pragmatic trials.2 This tool tried to define the elements of a pragmatic study, including the recruitment, design, and delivery of the intervention and follow-up.
There is an encouraging increase in the number pragmatic trials that have been published. A recent Medline search using the terms naturalistic and pragmatic, which was limited to controlled trials that are randomized (RCTs) resulted in 34 articles, shown in red in Figure 2. This indicates that the health sciences community is becoming more aware of the importance of pragmatic thinking. It is important to note that the majority of these trials were conducted in primary care settings.