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Studies designed to provide insight into clinical practice in the real world are known as pragmatic trials. They are often characterized by their focus on practical aspects of designing a study, including the recruitment and consent process, as well as adherence and the use of standard equipment.
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Another example of a pragmatic trial is the Home Blood Pressure Management (HBPM) study, which used a variety of investigators and participants from different geographical regions. This kind of heterogeneity is essential for practical trials to be valid, and it also helps to reduce the chance of bias in the results. However excessive heterogeneity could result in problems with the design of the trial.
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The purpose of pragmatic trials is to mimic real-life scenarios and gain the highest level of validity externally. Usually, they are ordered by policymakers and practitioners to inform their decisions. They can also be used to determine the causality of an intervention and its effects. However, they should not be used to substitute for the use of explanation studies.
The concept of pragmatism is controversial, and there are questions regarding whether pragmatic trials could replace explanatory tests or if they should be an addition to them. Schwartz and Lellouch1 made a distinction between explanatory studies, which confirm the physiological hypothesis or 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, called PRECIS.2 This tool attempted to define the characteristics of a practical trial which includes the recruitment process, the design and delivery of the intervention, and monitoring.
The number of pragmatic trials is growing. A recent Medline query that used the words pragmatic and naturalistic, which was restricted to randomised controlled trials (RCTs) returned 34 articles. These are highlighted 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.