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Pragmatic trials are those that are designed to inform real-world clinical practice. They are often focused on the practical aspects of the study design, such as recruitment and consent in adherence, as well as the use of commonly available equipment.
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A pragmatic trial that uses different investigators and participants from diverse geographical locations is the Home Blood Pressure Management study (HBPM). This type of heterogeneity, which is essential for pragmatic trials to be valid and reduce bias in results is also essential. However, too much heterogeneity could cause issues with the trial design.
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Pragmatic trials seek to replicate real-life situations and attain maximum external validity. They are usually ordered by policymakers and practitioners in order to guide their decisions. They can be used to determine the causality of an intervention and its effects. However, they should not be used as a substitute for explanatory trials.
The concept of pragmatism 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 prove a physiological or clinical hypothesis and pragmatic trials that inform policy and practice decisions. 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 follow-up.
There is a positive trend in the number of pragmatic trials that are published. A recent Medline search using the terms naturalistic and pragmatic, limited to randomized controlled trials (RCTs) produced 34 articles, which are 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 remember, however, that the majority of studies were conducted in primary-care settings.