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Trials designed to inform clinical practice in the real world are referred to as pragmatic trials. They are often described by their focus on practical aspects of designing a study, including the recruitment and consent process, as well as adherence and 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 employed different investigators and participants from different geographic areas. This type of heterogeneity, that is crucial for a pragmatic trial to be valid and to reduce bias in the results, is also necessary. A high degree of heterogeneity, however can result in problems with the design of the trial.

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Pragmatic trials seek to replicate real-life settings and achieve maximum external validity. They are usually ordered by policymakers and practitioners to help guide their decisions. They are also a good method to determine the causality between an intervention and its outcomes. However, they shouldn't be used in lieu for explanatory studies.

The pragmatism idea is controversial and there are concerns regarding whether pragmatic trials could replace tests for explanations or if they are an alternative to them. Schwartz and Lellouch1 suggested the distinction between explanation trials, which prove the clinical or physiological hypothesis as well as pragmatic trials, which guide the practice and policy decisions. They also proposed an approach to pragmatic trials, dubbed PRECIS.2 This tool was designed to define the elements of a pragmatic study that include the recruitment process, the design and delivery of the intervention, and the follow-up.

There is a positive increase in the number of pragmatic trials published. A recent Medline query that used the words naturalistic and pragmatic, restricted to randomised controlled trials (RCTs) returned 34 articles. They are displayed in red on Figure 2. This indicates that the health sciences community is becoming more sensitive to the subject of pragmatic thinking. However, it is important to remember that the majority of these trials were conducted in primary care settings.