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

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Another example of a trial that is pragmatic is the Home Blood Pressure Management (HBPM) study, which utilized different investigators and included participants from different geographic areas. This kind of heterogeneity is essential for practical trials to be valid, and it also reduces bias in the results. Too much heterogeneity, however could cause issues with the trial design.

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Pragmatic trials seek to replicate real-life settings and achieve maximum external validity. They are usually ordered by policymakers and practitioners to guide their decisions. They can also be used to assess the causal relationship between an intervention and its results. However, they shouldn't be used as a substitute for explanatory trials.

The concept of pragmatism is controversial, and there are questions about whether pragmatic trials can be used to replace explanation tests or if they should be an addition to them. Schwartz and Lellouch1 proposed an distinction between explanation-based studies, which prove a physiological hypothesis or clinical hypothesis, and pragmatic trials that aid in policy and practice decision-making. They also suggested an approach to pragmatic trials, which they called PRECIS.2 This tool sought to define the elements of a practical trial, including the recruitment process, the design and delivery of the intervention, and the follow-up.

The number of pragmatic trials is growing. A recent Medline search using the keywords pragmatic and naturalistic, restricted to controlled trials randomized to control (RCTs) resulted in 34 articles, as shown in red in Figure 2. This indicates 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 trials were conducted in primary care settings.