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Clinical trials that are designed to help inform practice in the real world are known as pragmatic trials. They are typically described as focusing on practical aspects of study design, including the recruitment and consent process, as well as adherence and the use of routinely available equipment.

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A pragmatic study that involves various investigators and participants from different geographical areas is the Home Blood Pressure Management study (HBPM). This type of heterogeneity is necessary for practical trials to be valid and also helps to reduce bias in the results. However too much heterogeneity could result in issues with the design of the trial.

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The goal of pragmatic trials is to mimic real-life situations and achieve maximum validity externally. They are usually requested by practitioners and policymakers to help inform their decisions. They are also a good method to determine the cause-effect relationship between the 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 questions about whether pragmatic trials should replace explanatory trials or complement them. Schwartz and Lellouch1 suggested the distinction between explanation trials, which confirm the validity of a clinical or physiological hypothesis, and pragmatic trials, which inform the practice and policy decisions. They also proposed an approach to pragmatic trials, called PRECIS.2 This tool was designed to define the elements of a practical trial that include the recruitment process, the design and implementation of the intervention, as well as follow-up.

The number of pragmatic trials is increasing. A recent Medline query that used the words naturalistic and pragmatic, restricted to randomised controlled trials (RCTs), returned 34 articles. They are displayed in red on Figure 2. This suggests that the health sciences community is becoming more aware of the importance of pragmatism. It is important to note, however, that the majority of studies were conducted in primary-care settings.