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Clinical trials that are designed to help inform practice in the real world are referred to as pragmatic trials. They are typically focused on practical aspects of the study design, including recruitment and consent in adherence, as well as the use of standard equipment.
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A pragmatic trial that uses different investigators and participants from various geographical regions is the Home Blood Pressure Management study (HBPM). This kind of heterogeneity, which is vital for a pragmatic trial to be valid and reduce bias in results, is also necessary. A high degree of heterogeneity, however could cause issues with the design of the trial.
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The goal of pragmatic trials is to mimic real-life scenarios and to achieve maximum credibility externally. They are usually requested by practitioners and policymakers in order to inform their decisions. They can also be used to assess the causal relationship between an intervention and its results. However, they shouldn't be used in lieu for explanatory trials.
The pragmatism idea is controversial and there are questions about whether pragmatic trials should replace or complement them. Schwartz and Lellouch1 suggested the distinction between explanation trials, which confirm the validity of a clinical or physiological hypothesis as well as pragmatic trials that inform the policy and practice of. They also proposed an approach to pragmatic trials, dubbed PRECIS.2 This tool was designed to define the elements of a pragmatic trial that include the recruitment process, the design and delivery of the intervention, and the follow-up.
The number of pragmatic trials is growing. A recent Medline search using the terms naturalistic and pragmatic, which was limited to controlled trials that are randomized (RCTs) produced 34 articles, which are shown in red in Figure 2. This suggests that the health sciences community is becoming more aware of the importance of pragmatism. It is important to remember, however, that the majority were conducted in primary care settings.
