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Pragmatic trials are studies designed to provide information for the real-world practice of clinical. They are typically described by their focus on practical aspects of study design that include the recruitment process and consent, adhering and the use of routinely available equipment.
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A pragmatic study that involves different investigators and participants from different geographical areas is the Home Blood Pressure Management study (HBPM). This type of heterogeneity is essential for practical trials to be valid and also helps to reduce bias in the results. However too much heterogeneity could result in problems with the design of the trial.
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The aim of pragmatic trials is to mimic real-life scenarios and to achieve the highest level of validity externally. They are usually requested by policy makers and practitioners to aid in their decision-making. They can also be used to determine the cause-effect relationship of an intervention with its outcomes. However, they should not be used as a substitute for the use of explanation studies.
The concept of pragmatism is controversial and there are concerns about whether pragmatic trials should be used to replace explanatory trials or complement them. Schwartz and Lellouch1 suggested the distinction between explanatory trials, which prove the clinical or physiological hypothesis, and pragmatic trials, which guide the practice and policy decisions. They also suggested an approach to pragmatic trials, called PRECIS.2 This tool was designed to define the characteristics of a pragmatic study, including the recruitment process, the design and delivery of the intervention, and the follow-up.
There is a growing increase in the number pragmatic trials published. A recent Medline search using the keywords pragmatic and naturalistic, restricted to randomized controlled trials (RCTs), yielded 34 articles, 프라그마틱 as shown in red in Figure 2. This is an indication that the health sciences community is becoming more sensitive to the subject of pragmatism. It is important to note, however, that the majority of these studies were conducted in primary-care settings.
