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Pragmatic trials are those that are designed to inform the real-world practice of clinical. They are usually focused on the practical aspects of research design, like recruitment 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 used a variety of investigators and included participants from different geographic areas. This type of heterogeneity is required for pragmatic trials to be able to prove their validity, and it also helps reduce the chance of bias in the results. A high degree of heterogeneity, however can result in problems with the design of the trial.

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The goal of pragmatic trials is to mimic real-life scenarios and to achieve the highest level of validity externally. They are usually commissioned by practitioners and policy makers to inform their decision making. They can be used to determine the causality of an intervention with its outcomes. They should not, however be used to replace explanatory studies.

The concept of pragmatism is controversial and there are doubts about whether pragmatic trials should replace explanatory trials or complement them. Schwartz and Lellouch1 suggested the distinction between explanation trials, which confirm the clinical or physiological hypothesis as well as pragmatic trials, which guide policy and practice decisions. They also suggested the framework for pragmatic trials, called PRECIS.2 This tool attempted to define the elements of a practical trial that include the recruitment process, the design and delivery of the intervention, as well as monitoring.

The number of pragmatic trials is increasing. A recent Medline query using the keywords pragmatic and naturalistic, limited to randomised controlled trials (RCTs) returned 34 articles. These are shown in red on Figure 2. This indicates that the health sciences community is becoming increasingly sensitized to the issue of pragmatics. It is important to note, however, that the majority of these studies were conducted in primary-care settings.