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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 as a focus on the practical aspects of designing a study which include the recruitment and consent process, as well as adherence and the use routinely available equipment.
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Another example of a trial that is pragmatic is the Home Blood Pressure Management (HBPM) study, which employed different investigators and had participants from different geographic areas. This kind of heterogeneity is essential for pragmatic trials to be able to prove their validity and also helps to reduce the chance of bias in the results. Too much heterogeneity, however could cause issues with the design of the trial.
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Pragmatic trials are designed to replicate real-world situations and have the highest external validity. They are typically requested by practitioners and policymakers to inform their decisions. They are also a good way to identify the causality between an intervention and its results. However, they shouldn't be used as a substitute for explanatory studies.
The pragmatism concept is controversial and there are concerns about whether pragmatic trials should replace or complement them. Schwartz and Lellouch1 proposed a distinction between explanatory studies, which support the validity of a physiological or clinical hypothesis, as well as pragmatic trials that aid in policy and practice decision-making. They also proposed a framework called PRECIS for pragmatic trials.2 This tool attempted to define the elements of a pragmatic study that includes the recruitment, design, and delivery of the intervention, 프라그마틱 슬롯 체험 and follow-up.
The number of pragmatic trials is increasing. A recent Medline search using the keywords pragmatic and naturalistic, restricted to randomized controlled trials (RCTs) resulted in 34 articles, as shown in red in Figure 2. This suggests that the health sciences community is becoming more aware of the importance of pragmatism. However, it is important to keep in mind that the majority of these trials were conducted in primary care settings.