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Studies designed to provide insight into clinical practice in the real world are known as pragmatic trials. They are typically described by their focus on practical aspects of designing a study, including recruitment and consent, adherence and the use of routinely available equipment.
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Another example of a pragmatic trial is the Home Blood Pressure Management (HBPM) study, which used various investigators and had participants from different geographical regions. 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 could lead to issues with the design of the trial.
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The aim of pragmatic trials is to mimic real-life situations and achieve maximum credibility externally. They are usually requested by policy makers and practitioners to aid in their decision-making. They can also be used to determine the causal relationship between an intervention and its results. They should not, however be used to replace explanation 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 the distinction between explanation studies, which prove the physiological hypothesis or clinical hypothesis, as well as pragmatic trials, that inform the decision-making process for policy and practice. They also proposed an approach to pragmatic trials, dubbed PRECIS.2 This tool was designed to define the characteristics of a pragmatic trial, including the recruitment process, the design and delivery of the intervention, as well as monitoring.
The number of pragmatic trials is growing. A recent Medline search using the terms naturalistic and pragmatic, which was limited to randomized controlled trials (RCTs), yielded 34 articles, which are shown in red in Figure 2. This indicates that the health sciences community is becoming more acquaint to the issue of pragmatism. It is important to keep in mind, however, that the majority were conducted in primary-care settings.