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Clinical trials that are designed to help inform practice in the real world are called pragmatic trials. They are often characterized as focusing on practical aspects of design that include recruitment and consent, adherence and the use routinely available 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 type of heterogeneity, which is essential for a pragmatic trial to be valid and to reduce bias in the results is also essential. However, too much heterogeneity can lead to problems with the design of the trial.

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The goal of pragmatic trials is to replicate real-life situations and achieve maximum validity externally. They are usually requested by practitioners and policymakers to help guide their decisions. They can also be used to assess the causality of an intervention and its results. However, they should not be used as a substitute for explanatory trials.

The concept of pragmatism is controversial and there are doubts about whether pragmatic trials should be used to replace explanation tests or if they are a complement to them. Schwartz and Lellouch1 made the distinction between explanation studies, which confirm the physiological hypothesis or clinical hypothesis, as well as pragmatic trials that aid in the decision-making process for policy and practice. They also proposed a framework for pragmatic trials, dubbed PRECIS.2 This tool attempted to define the elements of a practical trial which includes recruitment, design and delivery of the intervention, as well as follow-up.

There is a positive increase in the number of pragmatic trials that have been published. A recent Medline query that used the words pragmatic and naturalistic, which was restricted to randomised controlled trials (RCTs), returned 34 articles. These are highlighted in red on Figure 2. This indicates that the health sciences community has become more aware of the importance of pragmatic thinking. However, it is important to remember that the majority of these studies were conducted in primary care settings.