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Pragmatic trials are those that are designed to inform real-world clinical practice. They are typically characterized by a focus on the practical aspects of the study design, such as recruitment and consent in adherence, as well as 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 a variety of investigators and included participants from different geographic areas. This type of heterogeneity, which is vital for a pragmatic trial to be valid and reduce bias in results, is also necessary. However, too much heterogeneity, can cause problems with the design of the trial.

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The purpose of pragmatic trials is to mimic real-life situations and achieve maximum validity externally. They are usually requested by practitioners and policy makers to aid in their decision-making. They are also a good method of determining the cause-effect relationship between an intervention and its outcomes. However, they shouldn't be used as a substitute for the use of explanation trials.

The concept of pragmatism is controversial, and there are questions about whether pragmatic trials can replace explanatory tests or if they should be a complement to them. Schwartz and Lellouch1 suggested the distinction between explanatory trials, which validate the clinical or physiological hypothesis as well as pragmatic trials that inform policy and practice decisions. They also suggested a framework dubbed PRECIS for pragmatic trials.2 The tool was designed to define the traits of a practical study that includes the recruitment, design, and delivery of the intervention and follow-up.

The number of pragmatic trials is increasing. A recent Medline search using the terms naturalistic and pragmatic, limited to controlled trials randomized to control (RCTs) resulted in 34 articles, which are shown in red in Figure 2. This suggests that the health sciences community is becoming more aware of the importance of pragmatism. It is important to note, however, that the majority of studies were conducted in primary-care settings.