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Clinical trials that are designed to help inform practice in the real world are known as pragmatic trials. They are often characterized as a focus on the practical aspects of designing a study, including the recruitment process and consent, adhering and the use of standard equipment.

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Another example of a trial that is pragmatic is the Home Blood Pressure Management (HBPM) study, which used a variety of investigators and had participants from various geographical areas. This type of heterogeneity, which is essential for pragmatic trials to be reliable and to reduce bias in the results, is also necessary. However, too much heterogeneity could cause issues with the design of the trial.

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The purpose of pragmatic trials is to replicate real-life scenarios and gain maximum credibility externally. Usually, they are commissioned by policymakers and practitioners to help inform their decisions. They also provide a useful method of determining the cause-effect relationship between the intervention and its effects. However, they should not be used in lieu for the use of explanation trials.

The idea of pragmatism is controversial and there are concerns regarding whether pragmatic trials could replace tests for explanations or if they should serve as an alternative to them. Schwartz and Lellouch1 proposed a distinction between explanatory studies, which prove the physiological hypothesis or clinical hypothesis, as well as pragmatic trials that aid in the practice and policy decision-making. They also proposed the framework for pragmatic trials, called PRECIS.2 This tool sought to define the characteristics of a pragmatic study, including the recruitment process, the design and implementation of the intervention, and the follow-up.

There is a positive trend in the number of pragmatic trials that are published. A recent Medline search using the terms naturalistic and pragmatic, limited to controlled trials randomized to control (RCTs), yielded 34 articles, which are shown in red in Figure 2. This is a sign that the health sciences community is becoming more sensitive to the issue of pragmatic thinking. It is important to note that the majority of these studies were conducted in primary care settings.