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Clinical trials that are designed to help inform practice in the real world are referred to as pragmatic trials. They are often characterized by their focus on practical aspects of design that include recruitment and consent, adherence and the use routinely available equipment.

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Another example of a pragmatic trial is the Home Blood Pressure Management (HBPM) study, which utilized different investigators and included participants from various geographical areas. This type of heterogeneity, that is crucial for pragmatic trials to be reliable and reduce bias in results is also essential. Too much heterogeneity, however can result in problems with the design of the trial.

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Legality

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The goal of pragmatic trials is to mimic real-life scenarios and gain maximum credibility externally. They are usually ordered by policymakers and practitioners in order to guide their decisions. They can be used to determine the cause-effect relationship of an intervention and its results. They should not, however, be used to replace explanatory studies.

The pragmatism idea is controversial and there are doubts about whether pragmatic trials should be used to replace explanatory trials or complement them. Schwartz and Lellouch1 proposed a distinction between explanatory studies, which prove the validity of a physiological or clinical hypothesis, and pragmatic trials, that inform policy and practice decision-making. They also suggested the framework for pragmatic trials, which they called PRECIS.2 This tool sought to define the elements of a pragmatic trial which includes recruitment, design and delivery of the intervention, and the follow-up.

The number of pragmatic trials is growing. A recent Medline query using the keywords naturalistic and pragmatic, restricted to randomised controlled trials (RCTs) returned 34 articles. They are displayed in red on Figure 2. This suggests that the health sciences community is becoming more aware of the importance of pragmatism. It is important to note that the majority of these studies were conducted in primary care settings.