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Pragmatic trials are studies designed to provide information for the practice of clinical trials in real life. They are often characterized by their focus on practical aspects of design which include the recruitment and consent process, as well as adherence and the use routinely available equipment.

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Another example of a pragmatic trial is the Home Blood Pressure Management (HBPM) study, which used various investigators and included participants from different geographic areas. This type of heterogeneity which is essential for pragmatic trials to be reliable and to reduce bias in the results is also essential. However, too much heterogeneity can cause problems with the design of the trial.

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The goal of pragmatic trials is to replicate real-life situations and achieve the highest level of validity externally. Usually, they are ordered by policymakers and practitioners in order to guide their decisions. They can also be used to assess the cause-effect relationship of an intervention and its results. They should not, however be used to replace explanation studies.

The pragmatism idea is controversial and there are concerns regarding whether pragmatic trials could be used to replace explanation tests or if they should be an alternative to them. Schwartz and Lellouch1 proposed an distinction between explanation-based studies, which confirm a physiological hypothesis or clinical hypothesis, and pragmatic trials, that inform the decision-making process for policy and practice. They also proposed a framework called PRECIS for pragmatic trials.2 This tool tried to define the characteristics of a pragmatic study which includes recruitment, design, delivery of the intervention, and follow-up.

There is a positive increase in the number pragmatic trials published. A recent Medline search using the terms pragmatic and naturalistic, restricted to randomized controlled trials (RCTs) resulted in 34 articles, as shown in red in Figure 2. This indicates that the health sciences community is becoming more aware of the importance of pragmatic thinking. However, it is important to remember that the majority of these trials were conducted in primary care settings.