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Pragmatic trials are studies designed to inform the real-world practice of clinical. They are often focused on the practical aspects of study design, including the recruitment and consent process, adherence, and the use of commonly available equipment.
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A practical trial that employs a variety investigators and includes participants from various geographical regions 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 too much heterogeneity could lead to problems with the design of the trial.
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The goal of pragmatic trials is to simulate real-life scenarios and to achieve the highest level of validity externally. They are typically requested by practitioners and policymakers to help guide their decisions. They can also be a great method to determine the causality between an intervention and its outcomes. However, they should not be used as a substitute for the use of explanation trials.
The concept of pragmatism is controversial and there are doubts regarding whether pragmatic trials could be used to replace explanation tests or if they are an alternative to them. Schwartz and Lellouch1 suggested the distinction between explanatory trials, which prove the clinical or physiological hypothesis, and pragmatic trials that inform policy and practice decisions. They also proposed a framework for pragmatic trials, which they called PRECIS.2 This tool sought to define the elements of a pragmatic study which includes the recruitment process, the design and delivery of the intervention, as well as monitoring.
There is a positive increase in the number pragmatic trials published. A recent Medline search using the terms pragmatic and naturalistic, restricted to controlled trials randomized to control (RCTs), yielded 34 articles, shown in red in Figure 2. This is a sign that the health sciences community is becoming more acquaint to the subject of pragmatics. It is important to note, however, that the majority of these studies were conducted in primary-care settings.