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Trials designed to inform clinical practice in the real world are known as pragmatic trials. They are typically described by their focus on practical aspects of study design that 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 geographical regions. This type of heterogeneity is essential for pragmatic trials to be valid 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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The goal of pragmatic trials is to replicate real-life situations and achieve the highest level of validity externally. Usually, they are requested by practitioners and policymakers in order to inform their decisions. 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 explanation studies.
The idea of pragmatism is controversial and there are concerns about whether pragmatic trials can replace tests for explanations or if they should be a complement to them. Schwartz and Lellouch1 suggested the distinction between explanation studies, which confirm a physiological hypothesis or clinical hypothesis, and pragmatic trials, which inform the practice and policy decision-making. They also suggested a framework for pragmatic trials, dubbed PRECIS.2 This tool attempted to define the features of a pragmatic study which includes recruitment, design and delivery of the intervention, and monitoring.
There is a positive trend in the number of pragmatic trials that have been published. A recent Medline search using the keywords naturalistic and pragmatic, limited to controlled trials randomized to control (RCTs), yielded 34 articles, shown in red in Figure 2. This is a sign that the health sciences community is becoming more sensitive to the issue of pragmatic thinking. It is important to note, however, 프라그마틱 플레이 that the majority of these studies were conducted in primary-care settings.