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Clinical trials that are designed to help inform practice in the real world are referred to as pragmatic trials. They are typically described as focusing on practical aspects of design which include the recruitment process and consent, adhering and the use routinely available equipment.

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Another example of a pragmatic trial is the Home Blood Pressure Management (HBPM) study, which employed different investigators and participants from different geographic areas. This kind of heterogeneity, which is essential for a pragmatic trial to be reliable and to reduce bias in the results is also essential. However too much heterogeneity could cause problems with the design of the trial.

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Pragmatic trials aim to mimic real-world situations and have the highest external validity. They are usually commissioned by policy makers and practitioners to aid in their decision-making. They can also be used to determine the causality of an intervention with its outcomes. However, they should not be used to replace explanation studies.

The pragmatism idea is controversial and there are doubts about whether pragmatic trials should be used to replace explanatory trials or complement them. Schwartz and Lellouch1 made a distinction between explanatory studies, which confirm a physiological hypothesis or clinical hypothesis, as well as pragmatic trials, which inform policy and practice decision-making. They also suggested the framework for pragmatic trials, dubbed PRECIS.2 This tool sought to define the features of a practical trial which includes recruitment, design and delivery of the intervention, as well as monitoring.

The number of pragmatic trials is increasing. A recent Medline query that used the words naturalistic and pragmatic, restricted to randomised controlled trials (RCTs) returned 34 articles. These are shown in red on Figure 2. This is a sign that the health science community is becoming increasingly sensitized to the issue of pragmatism. It is important to keep in mind that the majority of these studies were conducted in primary care settings.