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Pragmatic trials are studies designed to provide information for the practice of clinical trials in real life. They are often described as a focus on the practical aspects of study design, including recruitment and consent, adherence and the use of standard equipment.
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A pragmatic study that involves various investigators and participants from various geographical regions is the Home Blood Pressure Management study (HBPM). This kind of heterogeneity, which is essential for pragmatic trials to be valid and reduce bias in results, is also necessary. However excessive heterogeneity could lead to issues with the design of the trial.
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The goal of pragmatic trials is to simulate real-life scenarios and gain maximum validity externally. They are typically commissioned by policymakers and practitioners in order to inform their decisions. They can be used to determine the causality of an intervention with its outcomes. However, they should not be used to replace explanatory studies.
The concept of pragmatism 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, which inform the practice and policy decisions. They also suggested a framework known as PRECIS for pragmatic trials.2 The tool was designed to define the elements of a practical study which includes recruitment, design, delivery 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 controlled trials randomized to control (RCTs) produced 34 articles, shown in red in Figure 2. This suggests that the health sciences community is becoming more aware of the importance of pragmatic thinking. It is important to remember, however, that the majority were conducted in primary-care settings.