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Pragmatic trials are studies designed to inform the practice of clinical trials in real life. They are often characterized as a focus on the 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 pragmatic trial that uses a variety investigators and includes participants from various geographical regions is the Home Blood Pressure Management study (HBPM). This type of heterogeneity which is vital for a pragmatic trial to be reliable and reduce bias in results, is also necessary. However, too much heterogeneity can lead to issues with the design of the trial.

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The purpose of pragmatic trials is to replicate real-life scenarios and gain maximum credibility externally. They are usually commissioned 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 results. They should not, however be used to replace explanatory studies.

The pragmatism idea is controversial and there are doubts regarding whether pragmatic trials could replace tests for explanations or if they should be an alternative to them. Schwartz and Lellouch1 made a distinction between explanatory studies, which confirm the validity of a physiological or clinical hypothesis, as well as pragmatic trials, that inform policy and practice decision-making. They also proposed a framework called PRECIS for pragmatic trials.2 This tool attempted to define the elements of a practical study which includes recruitment, design, delivery of the intervention and follow-up.

There is a positive trend in the number of pragmatic trials that have been published. A recent Medline search using the keywords naturalistic and pragmatic, limited to randomized controlled trials (RCTs) produced 34 articles, shown in red in Figure 2. This is a sign that the health science community is becoming more acquaint to the subject of pragmatism. It is important to keep in mind, however, that the majority of these studies were conducted in primary care settings.