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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 a focus on the practical aspects of study design which include recruitment and consent, adherence and the use routinely available equipment.

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Another example of a trial that is pragmatic is the Home Blood Pressure Management (HBPM) study, which utilized various investigators and participants from different geographical regions. This type of heterogeneity is essential for pragmatic trials to be able to prove their validity, and it also reduces bias in the results. However, too much heterogeneity can lead to issues with the design of the trial.

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The purpose of pragmatic trials is to replicate real-life situations and achieve maximum credibility externally. They are usually commissioned by practitioners and policy makers to guide their decision-making. They can also be used to determine the causal relationship between an intervention and its effects. However, they shouldn't be used as a substitute for the use of explanation studies.

The pragmatism idea is controversial and there are doubts about whether pragmatic trials should replace or complement them. Schwartz and Lellouch1 made an distinction between explanation-based studies, which prove the physiological hypothesis or clinical hypothesis, and pragmatic trials that aid in the practice and policy decision-making. They also suggested the framework for pragmatic trials, dubbed PRECIS.2 This tool was designed to define the characteristics of a practical trial that include the recruitment process, the design and implementation of the intervention, and monitoring.

The number of pragmatic trials is increasing. A recent Medline search using the keywords naturalistic and pragmatic, limited to controlled trials that are randomized (RCTs) produced 34 articles, which are shown in red in Figure 2. This suggests that the health sciences community is becoming more aware of the importance of pragmatism. It is important to note that the majority of these studies were conducted in primary care settings.