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Trials designed to inform clinical practice in the real world are known as pragmatic trials. They are often focused on the practical aspects of the study design, including the recruitment and consent process as well as adherence to the use of commonly available equipment.
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Another example of a practical trial is the Home Blood Pressure Management (HBPM) study, which employed different investigators and had participants from different geographical regions. This kind of heterogeneity is necessary for pragmatic trials to be able to prove their validity and reduces bias in the results. However, too much heterogeneity can cause problems with the design of the trial.
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The goal of pragmatic trials is to simulate real-life situations and achieve the highest level of validity externally. They are typically commissioned by policy makers and practitioners to guide their decision-making. They can be used to determine the causal relationship between an intervention and its effects. They should not, however, be used to replace the need for explanation studies.
The pragmatism concept is controversial and there are questions about whether pragmatic trials should be used to replace explanatory trials or complement them. Schwartz and Lellouch1 made a distinction between explanatory studies, which prove a physiological hypothesis or clinical hypothesis, as well as pragmatic trials, that inform the decision-making process for policy and 프라그마틱 정품확인 practice. They also proposed a framework called PRECIS for pragmatic trials.2 This tool tried to define the characteristics of a pragmatic research study, including the recruitment, design, and delivery of the intervention, and follow-up.
There is a growing increase in the number pragmatic trials that have been published. A recent Medline search using the terms naturalistic and pragmatic, which was limited to randomized controlled trials (RCTs), yielded 34 articles, which are shown in red in Figure 2. This suggests that the health sciences community is becoming more aware of the importance of pragmatism. It is important to keep in mind that the majority of these studies were conducted in primary care settings.