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Pragmatic trials are those that are designed to provide information for the practice of clinical trials in real life. They are typically described as a focus on the practical aspects of design that include the recruitment process and consent, adhering and the use of routinely available equipment.

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Another example of a pragmatic trial is the Home Blood Pressure Management (HBPM) study, which employed various investigators and had participants from various geographical areas. This kind of heterogeneity is required for pragmatic trials to be able to prove their validity and reduces bias in the results. However too much heterogeneity could lead to problems with the design of the trial.

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The purpose of pragmatic trials is to simulate real-life scenarios and to achieve maximum credibility externally. They are usually requested by practitioners and policymakers to guide their decisions. They can be used to determine the causal relationship between an intervention with its outcomes. They should not, however, be used to replace the need for explanation studies.

The idea of pragmatism is controversial and there are doubts about whether pragmatic trials should replace explanatory tests or if they should be an alternative to them. Schwartz and Lellouch1 suggested an distinction between explanation-based studies, which prove a physiological hypothesis or clinical hypothesis, as well as pragmatic trials, that inform the decision-making process for policy and practice. They also suggested a framework for pragmatic trials, which they called PRECIS.2 This tool was designed to define the elements of a practical trial which includes the recruitment process, the design and delivery of the intervention, as well as monitoring.

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