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Pragmatic trials are those that are designed to inform the practice of clinical trials in real life. They are typically described by their focus on practical aspects of designing a study, including recruitment and consent, 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 included participants from various geographical areas. This kind of heterogeneity is necessary for pragmatic trials to be able to prove their validity, and it also helps to reduce the chance of bias in the results. However excessive heterogeneity could cause problems with the design of the trial.
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The aim of pragmatic trials is to mimic real-life scenarios and gain the highest level of validity externally. They are usually ordered by policymakers and practitioners to inform their decisions. They are also a good method of determining the cause-effect relationship between an intervention and its outcomes. However, they shouldn't be used as a substitute for explanation studies.
The concept of pragmatism is controversial, and there are doubts about whether pragmatic trials should be used to replace explanatory trials or complement them. Schwartz and Lellouch1 suggested the distinction between explanatory trials, which confirm the validity of a clinical or physiological hypothesis and pragmatic trials, which inform the practice and policy decisions. They also proposed a framework for pragmatic trials, called PRECIS.2 This tool was designed to define the characteristics of a practical trial which includes the recruitment process, the design and delivery of the intervention, as well as the follow-up.
There is a positive increase in the number pragmatic trials that are published. A recent Medline search using the terms naturalistic and pragmatic, limited to controlled trials randomized to control (RCTs), yielded 34 articles, shown in red in Figure 2. This indicates that the health sciences community is becoming more aware of the importance of pragmatic thinking. However, 프라그마틱 플레이 is important to keep in mind that the majority of these studies were conducted in primary care settings.