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Trials designed to inform clinical practice in the real world are called pragmatic trials. They are often focused on practical aspects of the research design, like recruitment and consent, adherence, and the use of standard equipment.

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A pragmatic study that involves a variety investigators and includes participants from various geographical regions is the Home Blood Pressure Management study (HBPM). This kind of heterogeneity is required for pragmatic trials to be valid and helps to reduce the chance of bias in the results. However excessive heterogeneity could cause issues with the design of the trial.

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The goal of pragmatic trials is to mimic 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 causality of an intervention and its effects. They should, however, not be used to replace explanatory studies.

The concept of pragmatism is controversial, and there are concerns about whether pragmatic trials should be used to replace explanatory trials or complement them. Schwartz and Lellouch1 suggested the distinction between explanation trials, which confirm a physiological or clinical hypothesis, and pragmatic trials, which inform the policy and practice of. They also proposed a framework for pragmatic trials, called PRECIS.2 This tool sought to define the features of a pragmatic study that include recruitment, design and delivery of the intervention, as well as 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 has become more aware of the importance of pragmatic thinking. It is important to keep in mind that the majority of studies were conducted in primary-care settings.