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Studies designed to provide insight into clinical practice in the real world are referred to as pragmatic trials. They are often described as focusing on practical aspects of designing a study that include the recruitment process and consent, adhering and the use of standard equipment.
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Another example of a pragmatic trial is the Home Blood Pressure Management (HBPM) study, which employed a variety of investigators and had participants from different geographic areas. This kind of heterogeneity is necessary for pragmatic trials to be valid and helps reduce bias in the results. However, too much heterogeneity can result in problems with the design of the trial.
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Pragmatic trials seek to replicate real-life settings and achieve maximum external validity. Usually, they are commissioned by policymakers and practitioners to help guide their decisions. They can also be used to determine the cause-effect relationship of an intervention and its effects. However, they should not be used in lieu for the use of explanation trials.
The pragmatism concept is controversial and there are doubts about whether pragmatic trials should replace or complement them. Schwartz and Lellouch1 suggested the distinction between explanatory trials, which prove the clinical or physiological hypothesis as well as pragmatic trials, which guide the policy and practice of. They also suggested an approach to pragmatic trials, which they called PRECIS.2 This tool was designed to define the characteristics of a pragmatic trial that include the recruitment process, the design and delivery of the intervention, and monitoring.
There is a growing increase in the number pragmatic trials that have been published. A recent Medline search using the keywords naturalistic and pragmatic, which was limited to controlled trials randomized to control (RCTs), yielded 34 articles, as shown in red in Figure 2. This indicates that the health sciences community is becoming more aware of the importance of pragmatism. However, it is important to note that the majority of these studies were conducted in primary care settings.