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Clinical trials that are designed to help inform practice in the real world are referred to as pragmatic trials. They are typically described as a focus on the practical aspects of designing a study that include the recruitment and consent process, as well as adherence and the use of standard equipment.
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A pragmatic trial that uses different investigators and participants from different geographical areas is the Home Blood Pressure Management study (HBPM). This type of heterogeneity, which is essential for a pragmatic trial to be valid and to reduce bias in the results, is also necessary. However excessive heterogeneity could cause problems with the design of the trial.
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Legality
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Pragmatic trials are designed to replicate real-life settings and achieve maximum external validity. They are usually commissioned by policymakers and practitioners in order to inform their decisions. They can also be a great way to identify the cause-effect relationship between an intervention and its results. However, they should not be used to substitute for explanation trials.
The pragmatism idea is controversial and there are doubts about whether pragmatic trials should be used to replace explanatory trials or complement them. Schwartz and Lellouch1 made the distinction between explanation studies, which prove a physiological hypothesis or clinical hypothesis, and pragmatic trials, that inform the practice and policy decision-making. They also suggested a framework dubbed PRECIS for pragmatic trials.2 This tool tried to define the characteristics of a pragmatic research study that includes recruitment, design, delivery of the intervention and follow-up.
The number of pragmatic trials is growing. A recent Medline search using the keywords naturalistic and pragmatic, limited to controlled trials randomized to control (RCTs), yielded 34 articles, which are shown in red in Figure 2. This suggests that the health sciences community has become more aware of the importance of pragmatism. However, it is important to keep in mind that the majority of these trials were conducted in primary care settings.