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Studies designed to provide insight into clinical practice in the real world are referred to as pragmatic trials. They are typically focused on the practical aspects of study design, such as recruitment and consent as well as adherence to the use of routinely available equipment.
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Another example of a practical trial is the Home Blood Pressure Management (HBPM) study, which used different investigators and participants from various geographical areas. This type of heterogeneity is necessary for pragmatic trials to be valid and also reduces bias in the results. However, too much heterogeneity can result in problems with the design of the trial.
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The purpose of pragmatic trials is to replicate real-life scenarios and to achieve the highest level of validity externally. They are usually commissioned by practitioners and policy makers to aid in 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 explanatory studies.
The concept of pragmatism is controversial and there are concerns about whether pragmatic trials should replace or complement them. Schwartz and Lellouch1 suggested the distinction between explanation trials, which validate the clinical or physiological hypothesis as well as pragmatic trials, which guide policy and practice decisions. They also proposed a framework for pragmatic trials, which they called PRECIS.2 This tool was designed to define the characteristics of a pragmatic trial which includes the recruitment process, the design and delivery of the intervention, as well as monitoring.
There is a growing increase in the number pragmatic trials that have been published. A recent Medline search using the terms naturalistic and pragmatic, 프라그마틱 슬롯 which was limited to controlled trials randomized to control (RCTs), yielded 34 articles, which are shown in red in Figure 2. This is an indication that the health sciences community is becoming increasingly sensitized to the subject of pragmatics. It is important to keep in mind that the majority of these studies were conducted in primary-care settings.