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Studies designed to provide insight into clinical practice in the real world are called pragmatic trials. They are often characterized as a focus on the practical aspects of study design that include recruitment and consent, adherence and the use routinely available equipment.
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Another example of a practical trial is the Home Blood Pressure Management (HBPM) study, which utilized different investigators and included participants from various geographical areas. This type of heterogeneity which is essential for pragmatic trials to be reliable and to reduce bias in the results, is also necessary. However excessive heterogeneity could lead to issues with the design of the trial.
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Pragmatic trials aim to mimic real-world situations and have the highest external validity. They are usually requested by practitioners and policy makers to inform their decision making. They also provide a useful method to determine the causal relationship between the intervention and its effects. However, they should not be used in lieu for the use of explanation trials.
The pragmatism concept is controversial and there are questions about whether pragmatic trials should replace explanatory trials or complement them. Schwartz and Lellouch1 proposed the distinction between explanation studies, which support a physiological hypothesis or clinical hypothesis, as well as pragmatic trials, which inform the practice and policy decision-making. They also proposed a framework called PRECIS for pragmatic trials.2 The tool was designed to define the elements of a pragmatic research study, including recruitment, design, delivery of the intervention and its follow-up.
There is a growing increase in the number pragmatic trials that are published. A recent Medline search using the terms naturalistic and pragmatic, which was limited to controlled trials that are randomized (RCTs), yielded 34 articles, as shown in red in Figure 2. This is a sign that the health sciences community is becoming more sensitive to the subject of pragmatism. It is important to note that the majority of these trials were conducted in primary care settings.