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Clinical trials that are designed to help inform practice in the real world are called pragmatic trials. They are often described as a focus on the practical aspects of designing a study that include the recruitment and consent process, as well as adherence and the use of routinely available equipment.
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A pragmatic study that involves various investigators and participants from different geographical areas is the Home Blood Pressure Management study (HBPM). This kind of heterogeneity, which is vital for a pragmatic trial to be reliable and to reduce bias in the results, is also necessary. However too much heterogeneity could lead to problems with the design of the trial.
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The aim of pragmatic trials is to mimic real-life scenarios and gain maximum validity externally. They are typically commissioned by practitioners and policy makers to guide their decision-making. They can be used to determine the causality of an intervention and its results. However, they should not be used to replace explanatory studies.
The pragmatism idea is controversial and there are questions about whether pragmatic trials should replace or complement them. Schwartz and Lellouch1 proposed an distinction between explanation-based studies, which confirm the physiological hypothesis or clinical hypothesis, and pragmatic trials, that inform the practice and policy decision-making. 프라그마틱 무료스핀 suggested the framework for pragmatic trials, which they called PRECIS.2 This tool was designed to define the characteristics of a pragmatic trial which includes recruitment, design and delivery of the intervention, as well as the follow-up.
There is a growing trend in the number of pragmatic trials that have been published. A recent Medline query that used the words naturalistic and pragmatic, restricted to randomised controlled trials (RCTs) returned 34 articles. These are shown in red on Figure 2. This suggests that the health sciences community has become more aware of the importance of pragmatism. However, it is important to remember that the majority of these trials were conducted in primary care settings.