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Studies designed to provide insight into clinical practice in the real world are known as pragmatic trials. They are often described as focusing on practical aspects of design that include the recruitment process and consent, adhering and the use routinely available equipment.
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A pragmatic trial that uses a variety investigators and includes participants from diverse geographical locations is the Home Blood Pressure Management study (HBPM). This kind of heterogeneity is essential for pragmatic trials to be able to prove their validity and helps reduce bias in the results. However, too much heterogeneity can lead to issues with the design of the trial.
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The goal of pragmatic trials is to replicate real-life scenarios and to achieve maximum credibility externally. They are usually commissioned by policymakers and practitioners in order to guide their decisions. They can also be a great way to identify the cause-effect relationship between an intervention and its outcomes. However, they shouldn't be used to substitute for the use of explanation studies.
The concept of pragmatism is controversial and there are questions about whether pragmatic trials should replace or complement them. Schwartz and Lellouch1 suggested the distinction between explanatory trials, which confirm the clinical or physiological hypothesis, and pragmatic trials that inform the practice and policy decisions. They also proposed the framework for pragmatic trials, dubbed PRECIS.2 This tool was designed to define the elements of a pragmatic trial, including the recruitment process, the design and delivery of the intervention, and follow-up.
There is an encouraging increase in the number of pragmatic trials that are published. A recent Medline search using the terms pragmatic and naturalistic, restricted to randomized controlled trials (RCTs), yielded 34 articles, which are shown in red in Figure 2. This suggests that the health sciences community has become more aware of the importance of pragmatism. It is important to keep in mind that the majority of these studies were conducted in primary care settings.