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Pragmatic trials are studies designed to inform the real-world practice of clinical. They are often characterized as a focus on the practical aspects of designing a study that include recruitment and consent, adherence and the use routinely available equipment.
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Another example of a trial that is pragmatic is the Home Blood Pressure Management (HBPM) study, which employed different investigators and included participants from different geographic areas. This kind of heterogeneity is necessary for pragmatic trials to be valid, and it also helps reduce the chance of bias in the results. However, too much heterogeneity can result in issues with the design of the trial.
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The purpose of pragmatic trials is to simulate real-life scenarios and to achieve the highest level of validity externally. They are usually requested by policy makers and practitioners to guide their decision-making. They can also be used to determine the causality of an intervention and its effects. However, they should not, be used to replace the need for explanation studies.
The pragmatism concept is controversial, and there are concerns about whether pragmatic trials should be used to replace explanatory trials or complement them. Schwartz and Lellouch1 suggested an distinction between explanation-based studies, which support a physiological hypothesis or clinical hypothesis, as well as pragmatic trials, that inform policy and practice decision-making. They also proposed a framework for pragmatic trials, dubbed PRECIS.2 This tool was designed to define the characteristics of a pragmatic trial which includes the recruitment process, the design and implementation of the intervention, and follow-up.
There is a positive increase in the number of pragmatic trials that have been published. A recent Medline search using the keywords pragmatic and naturalistic, restricted to controlled trials randomized to control (RCTs), yielded 34 articles, shown in red in Figure 2. This indicates that the health sciences community has become more aware of the importance of pragmatism. It is important to note that the majority of these trials were conducted in primary care settings.