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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 their focus on practical aspects of design that include recruitment and consent, adherence and the use routinely available equipment.

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A pragmatic study that involves a variety investigators and includes participants from diverse geographical locations is the Home Blood Pressure Management study (HBPM). This kind 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 seek to replicate real-world situations and have the highest external validity. Usually, they are requested by practitioners and policymakers to guide their decisions. They can also be used to assess the causality of an intervention and its effects. They should, however, not, be used to replace the need for explanation studies.

The concept of pragmatism is controversial, and there are concerns about whether pragmatic trials should replace or complement them. Schwartz and Lellouch1 suggested a distinction between explanatory studies, which support the validity of a physiological or clinical hypothesis, as well as pragmatic trials that aid in the decision-making process for policy and practice. They also suggested a framework dubbed PRECIS for pragmatic trials.2 This tool tried to define the elements of a practical study that includes the recruitment, design, and delivery of the intervention and follow-up.

There is an encouraging increase in the number of pragmatic trials that have been published. A recent Medline search using the keywords naturalistic and pragmatic, limited to controlled trials that are randomized (RCTs) resulted in 34 articles, as shown in red in Figure 2. This suggests that the health sciences community is becoming more aware of the importance of pragmatism. However, it is important to note that the majority of these studies were conducted in primary care settings.