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Pragmatic trials are those that are designed to provide information for real-world clinical practice. They are typically focused on the practical aspects of the research design, like the recruitment and consent process as well as adherence to the use of commonly available equipment.

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Another example of a trial that is pragmatic is the Home Blood Pressure Management (HBPM) study, which employed different investigators and had participants from various geographical areas. This kind of heterogeneity is necessary for practical trials to be valid, and it also helps to reduce bias in the results. However, too much heterogeneity can result in problems with the design of the trial.

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The purpose of pragmatic trials is to replicate real-life scenarios and to achieve the highest level of validity externally. They are usually commissioned by policymakers and practitioners to inform their decisions. They can be used to determine the cause-effect relationship of an intervention and its effects. However, they should not be used to replace explanation studies.

The concept of pragmatism is controversial, and there are questions regarding whether pragmatic trials could replace explanatory tests or if they are a complement to them. Schwartz and Lellouch1 suggested the distinction between explanation trials, which prove the validity of a clinical or physiological hypothesis as well as pragmatic trials that inform the practice and policy decisions. They also suggested the framework for pragmatic trials, called PRECIS.2 This tool sought to define the elements of a practical trial, including recruitment, design and delivery of the intervention, and the follow-up.

There is a growing increase in the number of pragmatic trials published. A recent Medline search using the terms naturalistic and pragmatic, which was limited to controlled trials randomized to control (RCTs) produced 34 articles, shown in red in Figure 2. This indicates that the health science community is becoming increasingly sensitized to the issue of pragmatic thinking. It is important to keep in mind, however, that the majority were conducted in primary-care settings.