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Pragmatic trials are studies designed to provide information for the real-world practice of clinical. They are often characterized as focusing on practical aspects of designing a study which include the recruitment process and consent, adhering and the use of standard equipment.
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Another example of a trial that is pragmatic is the Home Blood Pressure Management (HBPM) study, which used a variety of investigators and included participants from various geographical areas. This type of heterogeneity, which is essential for a pragmatic trial to be valid and to reduce bias in the results is also essential. However excessive heterogeneity could lead to issues with the design of the trial.
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The purpose of pragmatic trials is to replicate real-life scenarios and to achieve maximum validity externally. They are typically requested by practitioners and policymakers to guide their decisions. They can also be a great way to identify the causality between an intervention and its outcomes. However, they should not be used to substitute for the use of explanation studies.
The idea of pragmatism is controversial and there are doubts about whether pragmatic trials should replace explanatory tests or if they are an addition to them. Schwartz and Lellouch1 made the distinction between explanation studies, which confirm the validity of a physiological or clinical hypothesis, as well as pragmatic trials, that inform the practice and policy decision-making. They also proposed a framework called PRECIS for pragmatic trials.2 This tool attempted to define the characteristics of a pragmatic study which includes recruitment, design, delivery of the intervention and follow-up.
There is an encouraging increase in the number pragmatic trials published. A recent Medline search using the terms pragmatic and naturalistic, restricted to controlled trials randomized to control (RCTs) produced 34 articles, which are shown in red in Figure 2. This indicates that the health sciences community is becoming more acquaint to the issue of pragmatics. However, it is important to remember that the majority of these studies were conducted in primary care settings.