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Pragmatic trials are those that are designed to provide information for the practice of clinical trials in real life. They are typically described as a focus on the practical aspects of study design that include the recruitment process and consent, adhering and the use of standard equipment.
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Another example of a practical trial is the Home Blood Pressure Management (HBPM) study, which employed various investigators and included participants from different geographical regions. This kind of heterogeneity is necessary for pragmatic trials to be able to prove their validity and helps reduce bias in the results. A high degree of heterogeneity, however, can cause problems with the trial design.
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The aim of pragmatic trials is to replicate real-life scenarios and to achieve maximum validity externally. They are typically commissioned by policy makers and practitioners to guide their decision-making. They can also be used to assess the cause-effect relationship of an intervention and its results. They should not, however be used to replace the need for explanation studies.
The idea of pragmatism is controversial, and there are questions regarding whether pragmatic trials could replace tests for explanations or if they should be an alternative to them. Schwartz and Lellouch1 proposed an distinction between explanation-based studies, which prove the physiological hypothesis or clinical hypothesis, as well as pragmatic trials, which inform the decision-making process for policy and practice. They also proposed a framework for pragmatic trials, called PRECIS.2 This tool attempted to define the features of a pragmatic study that include the recruitment process, the design and implementation of the intervention, as well as follow-up.
There is a positive trend in the number of pragmatic trials published. A recent Medline search using the terms naturalistic and pragmatic, which was limited to randomized controlled trials (RCTs) resulted in 34 articles, as shown in red in Figure 2. This suggests that the health sciences community has become more aware of the importance of pragmatic thinking. It is important to remember, 프라그마틱 무료스핀 however, that the majority of studies were conducted in primary care settings.