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Studies designed to provide insight into clinical practice in the real world are known as pragmatic trials. They are typically described by their focus on practical aspects of designing a study, including the recruitment and consent process, as well as adherence and 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 utilized different investigators and included participants from different geographic areas. This type of heterogeneity, that is crucial for a pragmatic trial to be valid and reduce bias in results is also essential. However, too much heterogeneity can 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 maximum credibility externally. They are usually commissioned by practitioners and policy makers to guide their decision-making. They also provide a useful way to identify the cause-effect relationship between an intervention and its outcomes. However, they should not be used as a substitute for explanatory studies.
The pragmatism idea is controversial and there are doubts about whether pragmatic trials should be used to replace explanation tests or if they are a complement to them. 프라그마틱 환수율 and Lellouch1 suggested an distinction between explanation-based studies, which prove the physiological hypothesis or clinical hypothesis, and pragmatic trials that aid in policy and practice decision-making. They also proposed an approach to pragmatic trials, which they called PRECIS.2 This tool attempted to define the elements of a practical trial, including the recruitment process, the design and delivery of the intervention, as well as follow-up.
There is an encouraging increase in the number of pragmatic trials that have been published. A recent Medline search using the keywords naturalistic and pragmatic, limited to controlled trials randomized to control (RCTs), yielded 34 articles, shown in red in Figure 2. This suggests that the health sciences community has become more aware of the importance of pragmatic thinking. It is important to keep in mind that the majority of these studies were conducted in primary care settings.