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Clinical trials that are designed to help inform practice in the real world are called pragmatic trials. They are often characterized as focusing on practical aspects of design which include recruitment and consent, adherence and the use of routinely available equipment.
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A practical trial that employs different investigators and participants from diverse geographical locations is the Home Blood Pressure Management study (HBPM). This type of heterogeneity is essential for pragmatic trials to be able to prove their validity, and it also helps to reduce bias in the results. However, too much heterogeneity can result in issues with the design of the trial.
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Pragmatic trials seek to replicate real-life situations and attain maximum external validity. Usually, they are commissioned by policymakers and practitioners in order to guide their decisions. They can also be a great way to identify the causality between an intervention and its outcomes. They should, however, not be used to replace explanatory studies.
The idea of pragmatism is controversial and there are concerns about whether pragmatic trials should replace tests for explanations or if they should be an addition to them. Schwartz and Lellouch1 suggested a distinction between explanatory trials, which prove the clinical or physiological hypothesis, and pragmatic trials that inform the policy and practice of. They also proposed a framework called PRECIS for pragmatic trials.2 The tool was designed to define the elements of a practical study which includes recruitment, design, implementation of the intervention and its follow-up.
The number of pragmatic trials is growing. A recent Medline search using the keywords pragmatic and naturalistic, restricted to randomized controlled trials (RCTs) produced 34 articles, as shown in red in Figure 2. This indicates that the health sciences community is becoming more sensitive to the issue of pragmatic thinking. It is important to note that the majority of these trials were conducted in primary care settings.
