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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 by a focus on practical aspects of the study design, such as the recruitment and consent process, adherence, and the use of standard equipment.
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A pragmatic trial that uses a variety investigators and includes participants from different geographical areas is the Home Blood Pressure Management study (HBPM). This type of heterogeneity which is essential for a pragmatic trial to be reliable and to reduce bias in the results is also essential. However too much heterogeneity could cause problems with the design of the trial.
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Pragmatic trials seek to replicate real-life situations and attain maximum external validity. They are usually requested by practitioners and policy makers to guide their decision-making. They can be used to determine the causality of an intervention and its results. They should, however, not, be used to replace the need for explanation studies.
The concept of pragmatism is controversial, and there are questions regarding whether pragmatic trials could replace tests for explanations or if they should serve as a complement to them. Schwartz and Lellouch1 made a distinction between explanatory studies, which prove the physiological hypothesis or clinical hypothesis, as well as pragmatic trials, which inform the practice and policy decision-making. They also suggested an approach to pragmatic trials, which they called PRECIS.2 This tool was designed to define the characteristics of a pragmatic study which includes recruitment, design and delivery of the intervention, 프라그마틱 슬롯 팁 and follow-up.
The number of pragmatic trials is growing. A recent Medline search using the terms naturalistic and pragmatic, limited to controlled trials that are randomized (RCTs) produced 34 articles, shown in red in 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.
