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Clinical trials that are designed to help inform practice in the real world are known as pragmatic trials. They are often characterized as focusing on practical aspects of design, including recruitment and consent, adherence and the use of routinely available equipment.

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Another example of a practical trial is the Home Blood Pressure Management (HBPM) study, which utilized different investigators and included participants from different geographical regions. This kind of heterogeneity, which is vital for a pragmatic trial to be valid and reduce bias in results, is also necessary. Too much heterogeneity, however, can cause problems with the trial design.

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Pragmatic trials seek to replicate real-world situations and have the highest external validity. They are typically commissioned by policymakers and practitioners in order to inform their decisions. They can also be a great method to determine the cause-effect relationship between the intervention and its effects. However, they shouldn't be used in lieu for explanation studies.

The idea of pragmatism is controversial and there are doubts about whether pragmatic trials can replace explanatory tests or if they should be a complement to them. Schwartz and Lellouch1 proposed an distinction between explanation-based studies, which prove the validity of a physiological or clinical hypothesis, as well as pragmatic trials that aid in policy and practice decision-making. They also suggested a framework known as PRECIS for pragmatic trials.2 The tool was designed to define the elements of a practical study, including recruitment, design, delivery of the intervention, and follow-up.

The number of pragmatic trials is increasing. A recent Medline search using the terms pragmatic and naturalistic, restricted to randomized controlled trials (RCTs), yielded 34 articles, shown in red in Figure 2. This is an indication that the health sciences community is becoming more sensitive to the subject of pragmatic thinking. It is important to note, however, that the majority of studies were conducted in primary-care settings.