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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 typically described by their focus on practical aspects of designing a study, including recruitment and consent, adherence and the use routinely available equipment.

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Another example of a pragmatic trial is the Home Blood Pressure Management (HBPM) study, which used various investigators and had participants from various geographical areas. This type of heterogeneity is required for pragmatic trials to be able to prove their validity and also helps to reduce bias in the results. However too much heterogeneity could lead to issues with the design of the trial.

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The aim of pragmatic trials is to replicate real-life scenarios and gain the highest level of validity externally. Usually, they are commissioned by policymakers and practitioners to guide their decisions. They can be used to determine the causality of an intervention with its outcomes. They should not, however, be used to replace the need for explanation studies.

The pragmatism concept is controversial and there are doubts about whether pragmatic trials should replace explanatory trials or complement them. Schwartz and Lellouch1 suggested a distinction between explanatory studies, which support the validity of a physiological or clinical hypothesis, and pragmatic trials that aid in the practice and policy decision-making. They also proposed a framework called PRECIS for pragmatic trials.2 This tool attempted to define the traits of a practical study, including recruitment, design, implementation of the intervention and follow-up.

The number of pragmatic trials is increasing. A recent Medline search using the words pragmatic and naturalistic, limited to randomised controlled trials (RCTs) returned 34 articles. These are shown in red on Figure 2. This indicates that the health sciences community has become more aware of the importance of pragmatic thinking. It is important to remember that the majority of these studies were conducted in primary care settings.