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Clinical trials that are designed to help inform practice in the real world are known as pragmatic trials. They are often characterized as focusing on practical aspects of designing a study, including the recruitment process and consent, adhering and the use of standard equipment.
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Another example of a practical trial is the Home Blood Pressure Management (HBPM) study, which utilized a variety of investigators and participants from different geographic areas. This type of heterogeneity is essential for pragmatic trials to be valid and also helps to reduce bias in the results. However, too much heterogeneity can result in problems with the trial design.
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The purpose of pragmatic trials is to simulate real-life scenarios and to achieve the highest level of validity externally. Usually, they are ordered by policymakers and practitioners in order to inform their decisions. They can also be a great method to determine the causality between the intervention and its effects. However, they should not, be used to replace explanatory studies.
The concept of pragmatism is controversial, and there are doubts about whether pragmatic trials should be used to replace explanatory trials or complement them. Schwartz and Lellouch1 suggested a distinction between explanatory trials, which confirm a physiological or clinical hypothesis as well as pragmatic trials that inform policy and practice decisions. They also proposed a framework called PRECIS for pragmatic trials.2 This tool tried to define the elements of a pragmatic research study that includes the recruitment, design, and delivery of the intervention and its follow-up.
There is a growing trend in the number of pragmatic trials that have been published. A recent Medline search using the terms pragmatic and naturalistic, restricted to controlled trials that are randomized (RCTs), yielded 34 articles, as shown in red in Figure 2. This indicates that the health sciences community is becoming more aware of the importance of pragmatism. It is important to note that the majority of these trials were conducted in primary care settings.