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Trials designed to inform clinical practice in the real world are known as pragmatic trials. They are typically described as focusing on practical aspects of designing a study which include the recruitment and consent process, as well as adherence and the use of standard equipment.

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Another example of a pragmatic trial is the Home Blood Pressure Management (HBPM) study, which employed different investigators and included participants from different geographic areas. This kind of heterogeneity is essential for pragmatic trials to be valid and helps reduce bias in the results. However too much heterogeneity could result in problems with the design of the trial.

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Pragmatic trials seek to replicate real-life settings and achieve maximum external validity. Usually, they are commissioned by policymakers and practitioners in order to inform their decisions. They can also be a great method of determining the causality between an intervention and its outcomes. However, they should not, be used to replace explanatory studies.

The idea of pragmatism is controversial, and there are questions regarding whether pragmatic trials could replace tests for explanations or if they should serve as an alternative to them. Schwartz and Lellouch1 suggested the distinction between explanatory trials, which confirm the clinical or physiological hypothesis as well as pragmatic trials that inform the practice and policy decisions. They also suggested the framework for pragmatic trials, called PRECIS.2 This tool attempted to define the features of a pragmatic trial which includes the recruitment process, the design and delivery of the intervention, and the follow-up.

There is a growing increase in the number pragmatic trials published. A recent Medline search using the keywords naturalistic and pragmatic, limited to controlled trials that are randomized (RCTs) produced 34 articles, as shown in red in Figure 2. This suggests that the health sciences community has become more aware of the importance of pragmatic thinking. It is important to remember that the majority were conducted in primary-care settings.