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Studies designed to provide insight into clinical practice in the real world are known as pragmatic trials. They are often focused on the practical aspects of the research design, like the recruitment and consent process, adherence, and the use of routinely available 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
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The aim of pragmatic trials is to replicate real-life situations and achieve the highest level of validity externally. They are typically requested by practitioners and policymakers to help guide their decisions. They are also a good method to determine the causality between the intervention and its effects. However, they shouldn't be used as a substitute for explanatory trials.
The concept of pragmatism is controversial and there are questions about whether pragmatic trials should replace explanatory trials or complement them. Schwartz and Lellouch1 suggested an distinction between explanation-based studies, which prove the physiological hypothesis or clinical hypothesis, as well as pragmatic trials, that inform the practice and policy decision-making. They also proposed the framework for pragmatic trials, which they called PRECIS.2 This tool sought to define the elements of a pragmatic study, including the recruitment process, the design and implementation of the intervention, and follow-up.
There is an encouraging increase in the number of pragmatic trials published. A recent Medline query that used the words pragmatic and naturalistic, which was restricted to randomised controlled trials (RCTs), returned 34 articles. These are shown in red on Figure 2. This indicates that the health sciences community has become more aware of the importance of pragmatism. However, it is important to note that the majority of these trials were conducted in primary care settings.