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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 a focus on practical aspects of the study design, including the recruitment process and consent in adherence, as well as the use of standard equipment.

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The aim of pragmatic trials is to replicate real-life scenarios and to achieve maximum credibility externally. Usually, they are requested by practitioners and policymakers to help guide their decisions. They can also be used to assess the cause-effect relationship of an intervention and its results. However, they shouldn't be used as a substitute for the use of explanation trials.

The pragmatism concept is controversial and there are concerns about whether pragmatic trials should replace or complement them. Schwartz and Lellouch1 proposed an distinction between explanation-based studies, which support a physiological hypothesis or clinical hypothesis, and pragmatic trials, that inform the decision-making process for policy and practice. They also suggested a framework known as PRECIS for pragmatic trials.2 The tool was designed to define the elements of a pragmatic study, including the recruitment, design, and delivery of the intervention and follow-up.

The number of pragmatic trials is growing. A recent Medline search using the terms naturalistic and pragmatic, which was limited to controlled trials randomized to control (RCTs), yielded 34 articles, shown in red in Figure 2. This indicates that the health sciences community is becoming more acquaint to the issue of pragmatic thinking. It is important to note that the majority were conducted in primary-care settings.