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Studies designed to provide insight into clinical practice in the real world are known as pragmatic trials. They are typically focused on practical aspects of the study design, such as recruitment and consent, adherence, and the use of standard equipment.

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A practical trial that employs a variety investigators and includes 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 valid and reduce bias in results is also essential. However too much heterogeneity could result in problems with the design of the trial.

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The aim of pragmatic trials is to mimic real-life situations and achieve the highest level of validity externally. They are usually requested by practitioners and policy makers to guide their decision-making. They also provide a useful method to determine the causality between an intervention and its outcomes. However, they shouldn't be used to substitute for explanatory trials.

The pragmatism concept is controversial and there are doubts about whether pragmatic trials should be used to replace explanatory trials or complement them. Schwartz and Lellouch1 suggested a distinction between explanatory studies, which confirm the validity of a physiological or clinical hypothesis, and pragmatic trials that aid in the practice and policy decision-making. They also suggested a framework for pragmatic trials, which they called PRECIS.2 This tool sought to define the elements of a practical trial that include the recruitment process, the design and delivery of the intervention, and follow-up.

There is a growing increase in the number of pragmatic trials published. A recent Medline search using the words naturalistic and pragmatic, restricted to randomised controlled trials (RCTs) returned 34 articles. They are displayed in red on Figure 2. This indicates that the health sciences community has become more aware of the importance of pragmatism. It is important to remember, however, that the majority of these studies were conducted in primary care settings.