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Trials designed to inform clinical practice in the real world are called pragmatic trials. They are typically described by their focus on practical aspects of study design, including 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 utilized different investigators and participants from different geographical regions. This kind of heterogeneity, that is crucial for pragmatic trials to be reliable and to reduce bias in the results is also essential. However excessive heterogeneity could result in problems with the design of the trial.

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The purpose of pragmatic trials is to simulate real-life scenarios and gain maximum credibility externally. They are usually requested by practitioners and policymakers in order to inform their decisions. They can also be used to assess the causality of an intervention with its outcomes. They should not, however, be used to replace explanation studies.

The pragmatism idea is controversial and there are doubts about whether pragmatic trials should replace explanatory trials or complement them. Schwartz and Lellouch1 suggested a distinction between explanatory studies, which prove a physiological hypothesis or clinical hypothesis, as well as pragmatic trials, which inform policy and practice decision-making. They also suggested a framework dubbed PRECIS for pragmatic trials.2 The tool was designed to define the traits of a pragmatic study that includes the recruitment, design, and delivery of the intervention and its follow-up.

There is a growing trend in the number of pragmatic trials published. A recent Medline query using the keywords naturalistic and pragmatic, restricted to randomised controlled trials (RCTs), returned 34 articles. They are displayed in red on Figure 2. This suggests that the health sciences community has become more aware of the importance of pragmatic thinking. It is important to note, however, that the majority of these studies were conducted in primary-care settings.