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Pragmatic trials are those that are designed to inform the real-world practice of clinical. They are typically described as focusing on practical aspects of design which include recruitment and consent, adherence and the use of standard equipment.
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A practical trial that employs different investigators and participants from various geographical regions is the Home Blood Pressure Management study (HBPM). This type of heterogeneity is required for pragmatic trials to be valid and helps to reduce the chance of bias in the results. However, too much heterogeneity can result in problems with the trial design.
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The goal of pragmatic trials is to simulate real-life scenarios and to achieve maximum credibility externally. They are typically ordered by policymakers and practitioners to help guide their decisions. They also provide a useful way to identify the cause-effect relationship between an intervention and its outcomes. However, they shouldn't be used to substitute for explanatory studies.
The pragmatism idea is controversial, and there are concerns about whether pragmatic trials should replace explanatory trials or complement them. Schwartz and Lellouch1 suggested the distinction between explanatory trials, which prove the clinical or physiological hypothesis, and pragmatic trials that inform the policy and practice of. They also suggested the framework for pragmatic trials, dubbed PRECIS.2 This tool sought to define the features of a practical trial that include the recruitment process, the design and delivery of the intervention, as well as the follow-up.
The number of pragmatic trials is increasing. A recent Medline search using the terms pragmatic and naturalistic, restricted to controlled trials that are randomized (RCTs) resulted in 34 articles, as shown in red in Figure 2. This is a sign that the health sciences community is becoming more sensitive to the subject of pragmatic thinking. It is important to note that the majority of these studies were conducted in primary care settings.