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Studies designed to provide insight into clinical practice in the real world are known as pragmatic trials. They are typically characterized by a focus on the practical aspects of study design, such as recruitment and consent as well as adherence to the use of routinely available equipment.
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A pragmatic trial that uses various investigators and participants from various geographical regions is the Home Blood Pressure Management study (HBPM). This type of heterogeneity is necessary for pragmatic trials to be able to prove their validity, and it also helps reduce bias in the results. Too much heterogeneity, however could cause issues with the trial design.
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The goal of pragmatic trials is to mimic real-life situations and achieve maximum validity externally. They are typically requested by practitioners and policymakers to help guide their decisions. They can be used to determine the cause-effect relationship of an intervention and its results. However, they should not be used as a substitute for explanatory trials.
The concept of pragmatism is controversial and there are concerns about whether pragmatic trials should replace or complement them. Schwartz and Lellouch1 suggested an distinction between explanation-based studies, which support a physiological hypothesis or
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Www.google.com.Sb) clinical hypothesis, as well as pragmatic trials, that inform the decision-making process for policy and practice. They also suggested the framework for pragmatic trials, which they called PRECIS.2 This tool attempted to define the elements of a practical trial that include recruitment, design and delivery of the intervention, and the follow-up.
The number of pragmatic trials is growing. A recent Medline query using the keywords pragmatic and naturalistic, which was restricted to randomised controlled trials (RCTs), returned 34 articles. These are shown in red on Figure 2. This suggests that the health sciences community has become more aware of the importance of pragmatism. It is important to remember that the majority of these studies were conducted in primary care settings.