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Pragmatic trials are studies designed to inform the real-world practice of clinical. They are often characterized by a focus on the practical aspects of study design, including recruitment and consent as well as adherence to the use of commonly available equipment.
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Another example of a pragmatic trial is the Home Blood Pressure Management (HBPM) study, which utilized a variety of investigators and included participants from various geographical areas. This type of heterogeneity which is vital for pragmatic trials to be valid and to reduce bias in the results is also essential. Too much heterogeneity, however can result in problems with the trial design.
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Pragmatic trials aim to mimic real-life situations and attain maximum external validity. They are typically requested by practitioners and policymakers to help inform their decisions. They can also be a great method to determine the causality between an intervention and its results. They should, however, not be used to replace explanation studies.
The concept of pragmatism is controversial and there are questions about whether pragmatic trials should replace explanatory trials or complement them. Schwartz and Lellouch1 suggested the distinction between explanation trials, which validate a physiological or clinical hypothesis, and pragmatic trials that inform policy and practice decisions. They also proposed an approach to pragmatic trials, which they called PRECIS.2 This tool attempted to define the characteristics of a pragmatic study that include recruitment, design and delivery of the intervention, as well as monitoring.
There is a positive increase in the number of pragmatic trials published. A recent Medline search using the keywords naturalistic and pragmatic, which was limited to randomized controlled trials (RCTs) resulted in 34 articles, shown in red in Figure 2. This suggests that the health sciences community has become more aware of the importance of pragmatic thinking. It is important to keep in mind, however, that the majority of these studies were conducted in primary care settings.