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Trials designed to inform clinical practice in the real world are known as pragmatic trials. They are often described by their focus on practical aspects of design, 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 employed various investigators and participants from different geographic areas. This type of heterogeneity which is essential for pragmatic trials to be reliable and to reduce bias in the results is also essential. Too much heterogeneity, however could cause issues with the trial design.

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Pragmatic trials are designed to replicate real-life settings and achieve maximum external validity. Usually, they are commissioned by policymakers and practitioners in order to guide their decisions. They can also be used to assess the cause-effect relationship of an intervention with its outcomes. They should, however, not, be used to replace explanatory studies.

The concept of pragmatism is controversial, and there are questions about whether pragmatic trials should be used to replace explanatory trials or complement them. Schwartz and Lellouch1 made a distinction between explanatory studies, which support a physiological hypothesis or clinical hypothesis, as well as pragmatic trials, that inform policy and practice decision-making. They also suggested a framework dubbed PRECIS for pragmatic trials.2 This tool tried to define the characteristics of a pragmatic study which includes the recruitment, design, and delivery of the intervention and its follow-up.

The number of pragmatic trials is increasing. 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 is an indication that the health sciences community is becoming increasingly sensitized to the subject of pragmatism. However, it is important to note that the majority of these trials were conducted in primary care settings.