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Clinical trials that are designed to help inform practice in the real world are referred to as pragmatic trials. They are often characterized by their focus on practical aspects of study design which include recruitment and consent, adherence and the use of standard 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 had participants from different geographic areas. This type of heterogeneity is required for pragmatic trials to be able to prove their validity, and it also helps reduce the chance of bias in the results. However, too much heterogeneity can result in problems with the design of the trial.

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The purpose of pragmatic trials is to replicate real-life scenarios and to achieve the highest level of validity externally. Usually, they are requested by practitioners and policymakers to inform their decisions. They also provide a useful method to determine the causal relationship between the intervention and its effects. They should not, however be used to replace the need for explanation studies.

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

There is a positive increase in the number of pragmatic trials published. A recent Medline search using the terms naturalistic and pragmatic, limited to controlled trials randomized to control (RCTs) produced 34 articles, shown in red in Figure 2. This indicates that the health sciences community is becoming more aware of the importance of pragmatic thinking. It is important to remember that the majority of studies were conducted in primary care settings.