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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 often characterized by their focus on practical aspects of designing a study which include the recruitment and consent process, as well as adherence and the use of routinely available equipment.

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A pragmatic trial that uses different investigators and participants from various geographical regions is the Home Blood Pressure Management study (HBPM). This kind of heterogeneity is necessary for pragmatic trials to be able to prove their validity, and it also helps reduce bias in the results. However excessive heterogeneity could lead to problems with the design of the trial.

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Pragmatic trials aim to mimic real-life situations and attain maximum external validity. Usually, they are commissioned by policymakers and practitioners in order to guide their decisions. They are also a good method of determining the causality between the intervention and its effects. However, they should not be used to substitute for explanation studies.

The concept of pragmatism is controversial and there are doubts about whether pragmatic trials should replace or complement them. Schwartz and Lellouch1 suggested the distinction between explanatory trials, which prove a physiological or clinical hypothesis and pragmatic trials, which inform policy and practice decisions. They also suggested an approach to pragmatic trials, dubbed PRECIS.2 This tool attempted to define the elements of a practical trial that include the recruitment process, the design and delivery of the intervention, as well as the follow-up.

There is a positive trend in the number of pragmatic trials that have been published. A recent Medline search using the terms naturalistic and pragmatic, limited to controlled trials that are randomized (RCTs) produced 34 articles, as shown in red in Figure 2. This indicates that the health science community is becoming more acquaint to the issue of pragmatic thinking. It is important to remember that the majority of these trials were conducted in primary care settings.