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Trials designed to inform clinical practice in the real world are called 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 commonly available equipment.
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A pragmatic trial that uses a variety investigators and includes participants from various geographical regions is the Home Blood Pressure Management study (HBPM). This type of heterogeneity is essential for pragmatic trials to be able to prove their validity and helps to reduce the chance of bias in the results. Too much heterogeneity, however could cause issues with the trial design.
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Pragmatic trials aim to mimic real-world situations and have the highest external validity. Usually, they are requested by practitioners and policymakers in order to inform their decisions. They can also be a great method of determining the causal relationship between an intervention and its outcomes. However, 슬롯 they should not, be used to replace explanatory studies.
The pragmatism concept is controversial and there are doubts about whether pragmatic trials should replace explanatory trials or complement them. Schwartz and Lellouch1 made an distinction between explanation-based studies, which confirm the physiological hypothesis or clinical hypothesis, as well as pragmatic trials that aid in the practice and policy decision-making. They also suggested an approach to pragmatic trials, called PRECIS.2 This tool was designed to define the characteristics of a practical trial, including recruitment, design and delivery of the intervention, and the follow-up.
The number of pragmatic trials is growing. A recent Medline search using the keywords naturalistic and pragmatic, which was limited to randomized controlled trials (RCTs) resulted in 34 articles, which are shown in red in Figure 2. This indicates that the health sciences community is becoming more acquaint to the subject of pragmatic thinking. It is important to keep in mind that the majority of these trials were conducted in primary care settings.