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Studies designed to provide insight into clinical practice in the real world are known as pragmatic trials. They are typically characterized by a focus on the practical aspects of study design, including the recruitment process and consent, adherence, and the use of standard equipment.

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

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The goal of pragmatic trials is to replicate real-life situations and achieve maximum validity externally. They are typically commissioned by policymakers and practitioners to help guide their decisions. They also provide a useful method to determine the cause-effect relationship between the intervention and its effects. They should not, however, be used to replace explanation studies.

The concept of pragmatism is controversial and there are questions about whether pragmatic trials should replace explanatory trials or complement them. Schwartz and Lellouch1 suggested a distinction between explanatory trials, which validate the clinical or physiological hypothesis, and pragmatic trials, which guide policy and practice decisions. They also suggested the framework for pragmatic trials, called PRECIS.2 This tool was designed to define the elements of a pragmatic trial, including the recruitment process, the design and delivery of the intervention, and monitoring.

There is an encouraging increase in the number of pragmatic trials that are published. A recent Medline query using the keywords naturalistic and pragmatic, 프라그마틱 홈페이지 restricted to randomised controlled trials (RCTs), returned 34 articles. These are highlighted in red on Figure 2. This suggests that the health sciences community is becoming more aware of the importance of pragmatic thinking. It is important to note that the majority of studies were conducted in primary-care settings.