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Studies designed to provide insight into clinical practice in the real world are known as pragmatic trials. They are often described as focusing on practical aspects of study design which include the recruitment and consent process, as well as adherence and the use of standard equipment.

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A practical trial that employs different investigators and participants from different geographical areas is the Home Blood Pressure Management study (HBPM). This kind of heterogeneity, which is vital for a pragmatic trial to be reliable and to reduce bias in the results is also essential. A high degree of heterogeneity, however can result in problems with the design of the trial.

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The aim of pragmatic trials is to mimic real-life scenarios and to achieve maximum credibility externally. They are typically commissioned by practitioners and policy makers to guide their decision-making. They can also be used to determine the causality of an intervention and its results. However, they should not, be used to replace explanation studies.

The concept of pragmatism is controversial and there are concerns about whether pragmatic trials should be used to replace explanatory trials or complement them. Schwartz and Lellouch1 suggested an distinction between explanation-based studies, which support the validity of a physiological or clinical hypothesis, as well as pragmatic trials, that inform the decision-making process for policy and practice. They also suggested the framework for pragmatic trials, called PRECIS.2 This tool sought to define the elements of a practical trial which includes recruitment, design and delivery of the intervention, and monitoring.

The number of pragmatic trials is increasing. A recent Medline search using the keywords pragmatic and naturalistic, restricted to controlled trials randomized to control (RCTs) resulted in 34 articles, which are shown in red in Figure 2. This indicates that the health sciences community has become more aware of the importance of pragmatism. It is important to keep in mind that the majority of these studies were conducted in primary care settings.