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Clinical trials that are designed to help inform practice in the real world are referred to as pragmatic trials. 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 of standard equipment.

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

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The purpose of pragmatic trials is to replicate real-life scenarios and to achieve maximum validity externally. They are usually requested by practitioners and policymakers to guide their decisions. They can also be a great method of determining the causal relationship between the intervention and its effects. They should not, however, be used to replace the need for explanation studies.

The idea of pragmatism is controversial and there are concerns about whether pragmatic trials can replace explanatory tests or if they should serve as an addition to them. Schwartz and Lellouch1 suggested the distinction between explanation trials, which validate the clinical or physiological hypothesis and pragmatic trials, which guide the practice and policy decisions. They also proposed an approach to pragmatic trials, called PRECIS.2 This tool attempted to define the features of a pragmatic trial, including recruitment, design and delivery of the intervention, and monitoring.

The number of pragmatic trials is growing. A recent Medline search using the words pragmatic and naturalistic, which was restricted to randomised controlled trials (RCTs) returned 34 articles. They are displayed in red on Figure 2. This suggests that the health sciences community has become more aware of the importance of pragmatic thinking. However, it is important to keep in mind that the majority of these studies were conducted in primary care settings.