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Pragmatic trials are those that are designed to provide information for the practice of clinical trials in real life. They are often characterized as a focus on the practical aspects of designing a study that include recruitment and consent, adherence and the use 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 is necessary for pragmatic trials to be valid, and it also helps reduce bias in the results. However excessive heterogeneity could cause 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. They are usually commissioned by practitioners and policy makers to guide their decision-making. They can also be a great way to identify the causal relationship between an intervention and its outcomes. They should not, however be used to replace explanatory studies.

The concept of pragmatism is controversial and there are concerns about whether pragmatic trials can replace explanatory tests or if they should serve as a complement to them. Schwartz and Lellouch1 suggested the distinction between explanation studies, which support the validity of a physiological or clinical hypothesis, and pragmatic trials, which inform policy and practice decision-making. They also suggested a framework for pragmatic trials, which they called PRECIS.2 This tool sought to define the characteristics of a practical trial that include recruitment, design and delivery of the intervention, and the follow-up.

There is an encouraging increase in the number pragmatic trials published. A recent Medline query that used the words pragmatic and naturalistic, which was restricted to randomised controlled trials (RCTs) returned 34 articles. These are highlighted in red on Figure 2. This suggests 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 trials were conducted in primary care settings.