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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 described as a focus on the practical aspects of design, including recruitment and consent, adherence and the use of standard equipment.

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Another example of a pragmatic trial is the Home Blood Pressure Management (HBPM) study, which used different investigators and included participants from various geographical areas. This type of heterogeneity, which is essential for pragmatic trials to be reliable and to reduce bias in the 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 simulate real-life scenarios and to achieve maximum credibility externally. They are usually requested by practitioners and policy makers to guide their decision-making. They can also be used to determine the cause-effect relationship of an intervention and its results. They should not, however, be used to replace the need for explanation studies.

The pragmatism concept is controversial and there are doubts about whether pragmatic trials should be used to replace explanatory trials or complement them. Schwartz and Lellouch1 suggested a distinction between explanatory trials, which validate the validity of a clinical or physiological hypothesis as well as pragmatic trials, which guide policy and practice decisions. They also proposed an approach to pragmatic trials, dubbed PRECIS.2 This tool was designed to define the features of a practical trial, including the recruitment process, the design and delivery of the intervention, as well as monitoring.

The number of pragmatic trials is growing. A recent Medline query that used the words pragmatic and naturalistic, limited to randomised controlled trials (RCTs), returned 34 articles. They are displayed in red on Figure 2. This indicates that the health science community is becoming increasingly sensitized to the subject of pragmatics. It is important to keep in mind that the majority of these studies were conducted in primary care settings.