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Clinical trials that are designed to help inform practice in the real world are called pragmatic trials. They are typically focused on practical aspects of the study design, such as recruitment and consent as well as adherence to the use of standard equipment.
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A pragmatic trial that uses different investigators and participants from different geographical areas is the Home Blood Pressure Management study (HBPM). This kind of heterogeneity is required for pragmatic trials to be valid and reduces the chance of bias in the results. However excessive heterogeneity could lead to problems with the design of the trial.
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The purpose of pragmatic trials is to replicate real-life situations and achieve the highest level of validity externally. They are usually requested by practitioners and policy makers to guide their decision-making. They can also 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 idea of pragmatism is controversial and there are concerns about whether pragmatic trials can be used to replace explanation tests or if they should be an addition to them. Schwartz and Lellouch1 suggested a distinction between explanatory studies, which confirm a physiological hypothesis or clinical hypothesis, and pragmatic trials that aid in policy and practice decision-making. They also proposed the framework for pragmatic trials, which they called PRECIS.2 This tool attempted to define the characteristics of a practical trial that include recruitment, 프라그마틱 슬롯 팁 design and delivery of the intervention, and follow-up.
There is a positive trend in the number of pragmatic trials that are published. A recent Medline search using the terms pragmatic and naturalistic, restricted to controlled trials that are randomized (RCTs) resulted in 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 remember that the majority of these studies were conducted in primary care settings.