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Pragmatic trials are studies designed to provide information for the practice of clinical trials in real life. They are typically characterized by a focus on the practical aspects of the study design, such as recruitment and consent in adherence, as well as the use of standard equipment.
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Another example of a practical trial is the Home Blood Pressure Management (HBPM) study, which employed a variety of investigators and included participants from various geographical areas. This type of heterogeneity, which is essential for pragmatic trials to be valid and reduce bias in results, is also necessary. However too much heterogeneity could result in problems with the design of the trial.
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Pragmatic trials aim to mimic real-world situations and have the highest external validity. They are typically commissioned by policy makers and practitioners to guide their decision-making. They can also be a great method of determining the causality between the intervention and its effects. However, they shouldn't be used to substitute for explanatory trials.
The concept of pragmatism is controversial and there are questions about whether pragmatic trials should be used to replace explanatory trials or complement them. Schwartz and Lellouch1 made a distinction between explanatory studies, which prove the physiological hypothesis or clinical hypothesis, and pragmatic trials, which inform the decision-making process for policy and practice. They also suggested an approach to pragmatic trials, which they called PRECIS.2 This tool attempted to define the elements of a pragmatic trial which includes the recruitment process, the design and delivery of the intervention, and the follow-up.
The number of pragmatic trials is growing. A recent Medline search using the keywords naturalistic and pragmatic, which was limited to controlled trials randomized to control (RCTs) produced 34 articles, which are shown in red in Figure 2. This suggests that the health sciences community is becoming more aware of the importance of pragmatic thinking. However, it is important to keep in mind that the majority of these trials were conducted in primary care settings.