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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 focused on practical aspects of the research design, like the recruitment process and consent as well as adherence to 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 kind of heterogeneity is essential for practical trials to be valid, and it also helps to reduce bias in the results. However too much heterogeneity could result in problems with the design of the trial.

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Pragmatic trials aim to mimic real-life settings and achieve maximum external validity. They are typically commissioned by practitioners and policy makers to inform their decision making. They also provide a useful way to identify the cause-effect relationship between the intervention and its effects. However, they should not be used as a substitute for explanatory trials.

The concept of pragmatism is controversial and there are doubts about whether pragmatic trials can replace explanatory tests or if they should be an alternative to them. Schwartz and Lellouch1 suggested the distinction between explanatory trials, which validate the clinical or physiological hypothesis and pragmatic trials, which inform the practice and policy decisions. They also proposed a framework for pragmatic trials, which they called PRECIS.2 This tool sought to define the features of a pragmatic study which includes the recruitment process, the design and implementation of the intervention, as well as the follow-up.

The number of pragmatic trials is growing. A recent Medline query using the keywords naturalistic and pragmatic, restricted to randomised controlled trials (RCTs) returned 34 articles. These are highlighted in red on Figure 2. This is a sign that the health sciences community is becoming more sensitive to the issue of pragmatic thinking. It is important to note that the majority of these trials were conducted in primary care settings.