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Pragmatic trials are trials designed to inform real-world clinical practice. They are often described by their focus on practical aspects of design which include the recruitment process and consent, adhering 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 had participants from different geographic areas. This type of heterogeneity is essential for practical trials to be valid and helps reduce bias in the results. However, too much heterogeneity could cause issues with the trial design.
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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 can also be used to determine the causality of an intervention and its effects. However, they should not be used in lieu for explanation trials.
The pragmatism concept is controversial, and there are doubts about whether pragmatic trials should replace explanatory trials or complement them. Schwartz and Lellouch1 suggested the distinction between explanation trials, which prove the clinical or physiological hypothesis, and pragmatic trials, which inform the practice and policy decisions. They also proposed a framework called PRECIS for pragmatic trials.2 The tool was designed to define the traits of a practical study that includes the recruitment, design, and delivery of the intervention and follow-up.
The number of pragmatic trials is growing. A recent Medline search using the words pragmatic and naturalistic, limited to randomised controlled trials (RCTs) returned 34 articles. These are highlighted in red on Figure 2. This is an indication that the health sciences community is becoming more sensitive to the issue of pragmatism. It is important to keep in mind, however, that the majority were conducted in primary-care settings.