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Clinical trials that are designed to help inform practice in the real world are known as pragmatic trials. They are typically described by their focus on practical aspects of study design which include recruitment and consent, 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 utilized different investigators and included participants from different geographic areas. This type of heterogeneity, which is vital for pragmatic trials to be valid and reduce bias in results, is also necessary. A high degree of heterogeneity, however can result in problems with the trial design.

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The purpose of pragmatic trials is to replicate real-life scenarios and to achieve maximum validity externally. They are usually requested by practitioners and policy makers to aid in their decision-making. They are also a good way to identify the cause-effect relationship between an intervention and its outcomes. However, they shouldn't be used in lieu for explanation studies.

The pragmatism idea is controversial, and there are concerns about whether pragmatic trials should be used to replace explanatory trials or complement them. Schwartz and Lellouch1 made the distinction between explanation studies, which confirm a physiological hypothesis or clinical hypothesis, as well as pragmatic trials, that inform policy and practice decision-making. They also proposed a framework for pragmatic trials, dubbed PRECIS.2 This tool attempted to define the characteristics of a pragmatic study 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 search using the terms pragmatic and naturalistic, restricted to controlled trials that are randomized (RCTs) produced 34 articles, which are shown in red in Figure 2. This is an indication that the health science community is becoming increasingly sensitized to the issue of pragmatism. It is important to keep in mind that the majority were conducted in primary-care settings.