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Trials designed to inform clinical practice in the real world are known as pragmatic trials. They are usually characterized by a focus on the practical aspects of the study design, including the recruitment process and consent as well as adherence to the use of commonly available equipment.
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A pragmatic trial that uses different investigators and participants from various geographical regions is the Home Blood Pressure Management study (HBPM). This type of heterogeneity, which is essential for pragmatic trials to be reliable and
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The purpose of pragmatic trials is to replicate real-life scenarios and to achieve maximum credibility externally. They are typically commissioned by policymakers and practitioners in order to inform their decisions. They can also be used to assess the cause-effect relationship of an intervention with its outcomes. However, they shouldn't be used in lieu for the use of explanation studies.
The pragmatism concept 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 confirm a physiological hypothesis or clinical hypothesis, as well as pragmatic trials, which inform the decision-making process for policy and practice. They also suggested the framework for pragmatic trials, dubbed PRECIS.2 This tool attempted to define the characteristics of a pragmatic study, including 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 words pragmatic and naturalistic, limited to randomised controlled trials (RCTs) returned 34 articles. These are shown in red on Figure 2. This is an indication that the health sciences community is becoming more sensitive to the issue of pragmatic thinking. However, it is important to note that the majority of these trials were conducted in primary care settings.
