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Trials designed to inform clinical practice in the real world are referred to as pragmatic trials. They are often characterized by a focus on practical aspects of the study design, including the recruitment process and consent, adherence, and the use of routinely available equipment.

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Another example of a practical trial is the Home Blood Pressure Management (HBPM) study, which utilized various investigators and had participants from different geographical regions. This kind of heterogeneity, that is crucial for pragmatic trials to be valid and to reduce bias in the results, is also necessary. However excessive heterogeneity could cause issues with the design of the trial.

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The goal of pragmatic trials is to simulate real-life scenarios and to achieve maximum credibility externally. They are usually requested by practitioners and policy makers to inform their decision making. They can also be used to determine the causal relationship between an intervention and its results. However, they shouldn't be used in lieu for the use of explanation studies.

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 the distinction between explanation studies, which confirm the physiological hypothesis or clinical hypothesis, as well as pragmatic trials, which inform the decision-making process for policy and practice. They also suggested an approach to pragmatic trials, which they called PRECIS.2 This tool was designed to define the features of a pragmatic study that include the recruitment process, the design and delivery of the intervention, as well as the follow-up.

The number of pragmatic trials is growing. A recent Medline search using the terms naturalistic and pragmatic, which was limited to controlled trials that are randomized (RCTs) resulted in 34 articles, which are shown in red in Figure 2. This suggests that the health sciences community is becoming more aware of the importance of pragmatic thinking. However, it is important to remember that the majority of these trials were conducted in primary care settings.