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Trials designed to inform clinical practice in the real world are referred to as pragmatic trials. They are typically described as a focus on the practical aspects of design, including the recruitment and consent process, as well as adherence and the use routinely available equipment.

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Another example of a pragmatic trial is the Home Blood Pressure Management (HBPM) study, which utilized different investigators and participants from various geographical areas. This kind of heterogeneity, which is essential for a pragmatic trial to be reliable and lessen the chance of bias, is also necessary. However too much heterogeneity could lead to issues with the design of the trial.

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The aim of pragmatic trials is to mimic real-life situations and achieve maximum validity externally. They are usually commissioned by policymakers and practitioners to guide their decisions. They can also be used to determine the cause-effect relationship of an intervention and its effects. However, they should not be used in lieu for explanatory studies.

The concept of pragmatism is controversial, and there are questions regarding whether pragmatic trials could be used to replace explanation tests or if they should be an alternative to them. Schwartz and Lellouch1 suggested the distinction between explanation studies, which support the physiological hypothesis or clinical hypothesis, as well as pragmatic trials that aid in the decision-making process for policy and practice. They also proposed a framework called PRECIS for pragmatic trials.2 The tool was designed to define the elements of a practical study which includes recruitment, design, implementation of the intervention, and follow-up.

There is an encouraging increase in the number 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, which are shown in red in Figure 2. This is an indication that the health science community is becoming more sensitive to the subject of pragmatic thinking. It is important to keep in mind that the majority of these studies were conducted in primary-care settings.