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Clinical trials that are designed to help inform practice in the real world are called pragmatic trials. They are often described by their focus on practical aspects of designing a study that include recruitment and consent, adherence and the use of standard equipment.

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A pragmatic trial that uses a variety investigators and includes participants from different geographical areas is the Home Blood Pressure Management study (HBPM). This type of heterogeneity is necessary for pragmatic trials to be valid and also helps to reduce bias in the results. A high degree of heterogeneity, however could cause issues with the design of the trial.

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Pragmatic trials seek to replicate real-world situations and have the highest external validity. They are usually ordered by policymakers and practitioners to help inform their decisions. They are also a good way to identify the cause-effect relationship between the intervention and its effects. However, they should not be used as a substitute for the use of explanation trials.

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 addition to them. Schwartz and Lellouch1 made the distinction between explanation studies, which prove a physiological hypothesis or clinical hypothesis, as well as pragmatic trials, that inform the decision-making process for policy and practice. They also proposed an approach to pragmatic trials, dubbed PRECIS.2 This tool attempted to define the features of a pragmatic study which includes the recruitment process, the design and delivery of the intervention, as well as the follow-up.

There is a positive increase in the number pragmatic trials that are published. A recent Medline search using the words naturalistic and pragmatic, restricted to randomised controlled trials (RCTs), returned 34 articles. These are highlighted in red on Figure 2. This indicates that the health sciences community is becoming more sensitive to the subject of pragmatics. It is important to remember that the majority were conducted in primary-care settings.