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Pragmatic trials are those that are designed to provide information for real-world clinical practice. They are typically characterized by a focus on the practical aspects of the study design, such as the recruitment process and consent in adherence, as well as 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, that is crucial for pragmatic trials to be reliable and reduce bias in results, is also necessary. However, too much heterogeneity can cause problems with the design of the trial.
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The aim of pragmatic trials is to simulate real-life situations and achieve maximum validity externally. They are typically ordered by policymakers and practitioners to inform their decisions. They can be used to determine the causality of an intervention and its results. However, they should not be used as a substitute for explanatory trials.
The pragmatism idea is controversial, and there are questions about whether pragmatic trials should be used to replace explanatory trials or complement them. Schwartz and Lellouch1 suggested a distinction between explanatory trials, which confirm a physiological or clinical hypothesis as well as 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 traits of a pragmatic study which includes recruitment, design, delivery of the intervention and its follow-up.
The number of pragmatic trials is growing. A recent Medline query using the keywords pragmatic and naturalistic, limited to randomised controlled trials (RCTs), returned 34 articles. These are shown in red on Figure 2. This is an indication that the health sciences community is becoming more sensitive to the subject of pragmatism. It is important to remember that the majority of studies were conducted in primary-care settings.