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Clinical trials that are designed to help inform practice in the real world are referred to as pragmatic trials. They are usually focused on practical aspects of the study design, such as the recruitment and consent process in adherence, as well as the use of routinely available equipment.
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Another example of a practical trial is the Home Blood Pressure Management (HBPM) study, which employed various investigators and included participants from different geographic areas. This kind of heterogeneity is required for pragmatic trials to be able to prove their validity and also helps reduce the chance of bias in the results. A high degree of heterogeneity, however, can cause problems with the trial design.
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The purpose of pragmatic trials is to mimic real-life scenarios and gain the highest level of validity externally. They are usually ordered by policymakers and practitioners to help inform their decisions. They can be used to determine the cause-effect relationship of an intervention with its outcomes. However, they should not be used in lieu for explanation trials.
The concept of pragmatism is controversial and there are doubts regarding whether pragmatic trials could be used to replace explanation tests or if they should serve as an alternative to them. Schwartz and Lellouch1 suggested the distinction between explanatory trials, which validate the clinical or physiological hypothesis, and pragmatic trials, which guide the practice and policy decisions. They also suggested a framework dubbed PRECIS for pragmatic trials.2 The tool was designed to define the characteristics of a practical study, including recruitment, design, delivery of the intervention and its follow-up.
There is a positive increase in the number of pragmatic trials that have been published. A recent Medline search using the terms naturalistic and pragmatic, which was limited to controlled trials randomized to control (RCTs), yielded 34 articles, as shown in red in Figure 2. This indicates that the health sciences community is becoming increasingly sensitized to the subject of pragmatics. However, it is important to keep in mind that the majority of these trials were conducted in primary care settings.