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Trials designed to inform clinical practice in the real world are referred to as pragmatic trials. They are typically characterized by a focus on the practical aspects of research design, like the recruitment process and consent as well as adherence to the use of routinely available equipment.

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A pragmatic trial that uses various investigators and participants from different geographical areas is the Home Blood Pressure Management study (HBPM). This kind of heterogeneity is required for practical trials to be valid, and it also reduces bias in the results. However too much heterogeneity 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 commissioned by policy makers and practitioners to inform their decision making. They can also be used to assess the cause-effect relationship of an intervention with its outcomes. However, they should not be used as a substitute for explanatory trials.

The pragmatism idea is controversial and there are doubts about whether pragmatic trials should replace or complement them. Schwartz and Lellouch1 proposed the distinction between explanation studies, which confirm the physiological hypothesis or clinical hypothesis, and pragmatic trials, which inform the decision-making process for policy and practice. They also proposed a framework for pragmatic trials, 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 increasing. A recent Medline query using the keywords pragmatic and naturalistic, limited to randomised controlled trials (RCTs) returned 34 articles. These are shown in red on Figure 2. This is an indication that the health science community is becoming more acquaint to the issue of pragmatic thinking. It is important to remember that the majority of these studies were conducted in primary care settings.