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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 described as focusing on practical aspects of study design that include the recruitment and consent process, as well as adherence and the use of standard equipment.

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Another example of a pragmatic trial is the Home Blood Pressure Management (HBPM) study, which used various investigators and participants from different geographical regions. This type of heterogeneity that is crucial for a pragmatic trial to be valid and to reduce bias in the results, is also necessary. However, too much heterogeneity can result in 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 validity externally. Usually, they are ordered by policymakers and practitioners to help inform their decisions. They can also be a great way to identify the causal relationship between the intervention and its effects. However, they shouldn't be used as a substitute for explanatory studies.

The pragmatism idea is controversial and there are concerns regarding whether pragmatic trials could replace tests for explanations or if they should be a complement to them. Schwartz and Lellouch1 suggested the distinction between explanation studies, which confirm the physiological hypothesis or clinical hypothesis, as well as pragmatic trials, which inform policy and practice decision-making. They also suggested the framework for pragmatic trials, called PRECIS.2 This tool attempted to define the features of a pragmatic trial that include the recruitment process, the design and implementation of the intervention, as well as monitoring.

The number of pragmatic trials is growing. A recent Medline search using the terms naturalistic and pragmatic, limited to controlled trials that are randomized (RCTs), yielded 34 articles, as shown in red in Figure 2. This suggests that the health sciences community has become more aware of the importance of pragmatic thinking. It is important to note, however, that the majority of studies were conducted in primary care settings.