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Pragmatic trials are those that are designed to provide information for real-world clinical practice. They are usually focused on the practical aspects of the study design, including the recruitment process and consent as well as adherence to the use of routinely available equipment.

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A pragmatic study that involves different investigators and participants from various geographical regions is the Home Blood Pressure Management study (HBPM). This type of heterogeneity, that is crucial for a pragmatic trial to be reliable and lessen the chance of bias, is also necessary. However, too much heterogeneity can result in problems with the design of the trial.

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The goal of pragmatic trials is to replicate real-life scenarios and gain the highest level of validity externally. They are typically commissioned by policy makers and practitioners to aid in their decision-making. They are also a good way to identify the causality between an intervention and its results. They should not, however, be used to replace explanatory studies.

The concept of pragmatism is controversial and there are questions about whether pragmatic trials should replace explanatory trials or complement them. Schwartz and Lellouch1 suggested the distinction between explanatory trials, which prove the clinical or physiological hypothesis and pragmatic trials, which guide policy and practice decisions. They also proposed an approach to pragmatic trials, which they called PRECIS.2 This tool was designed to define the elements of a pragmatic study which includes the recruitment process, the design and delivery of the intervention, and monitoring.

There is an encouraging trend in the number of pragmatic trials that are published. A recent Medline query using the keywords naturalistic and pragmatic, restricted to randomised controlled trials (RCTs), returned 34 articles. These are shown in red on Figure 2. This indicates that the health science community is becoming more sensitive to the issue of pragmatism. However, it is important to note that the majority of these studies were conducted in primary care settings.