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Clinical trials that are designed to help inform practice in the real world are known as pragmatic trials. They are typically characterized by a focus on practical aspects of the study design, including recruitment and consent as well as adherence to the use of commonly available equipment.

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A practical trial that employs a variety investigators and includes participants from different geographical areas is the Home Blood Pressure Management study (HBPM). This type of heterogeneity, which is essential for a pragmatic trial to be valid and reduce bias in results, is also necessary. However, too much heterogeneity can result in problems with the trial design.

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Pragmatic trials aim to mimic real-world situations and have the highest external validity. They are usually commissioned by policy makers and practitioners to guide their decision-making. They are also a good method to determine the causality between the intervention and its effects. However, they should not, be used to replace the need for explanation studies.

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

The number of pragmatic trials is increasing. A recent Medline search using the keywords naturalistic and pragmatic, limited to controlled trials randomized to control (RCTs) resulted in 34 articles, shown in red in Figure 2. This indicates that the health sciences community has become more aware of the importance of pragmatic thinking. It is important to keep in mind, however, that the majority were conducted in primary-care settings.