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Pragmatic trials are those that are designed to inform the practice of clinical trials in real life. They are often characterized as focusing on practical aspects of design which include recruitment and consent, adherence and the use of standard equipment.
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Another example of a pragmatic trial is the Home Blood Pressure Management (HBPM) study, which utilized various investigators and participants from different geographic areas. This type of heterogeneity is necessary for pragmatic trials to be valid and also helps reduce bias in the results. However, too much heterogeneity could cause issues with the trial design.
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Pragmatic trials seek to replicate real-life situations and attain maximum external validity. They are typically ordered by policymakers and practitioners to help guide their decisions. They can be used to determine the cause-effect relationship of an intervention with its outcomes. They should, however, not, be used to replace explanation studies.
The idea of pragmatism is controversial, and there are questions about whether pragmatic trials should be used to replace explanation tests or if they are a complement to them. Schwartz and Lellouch1 proposed the distinction between explanation studies, which confirm the validity of a physiological or clinical hypothesis, as well as pragmatic trials, which inform policy and practice decision-making. They also proposed the framework for pragmatic trials, which they called PRECIS.2 This tool sought to define the features of a pragmatic trial, including the recruitment process, the design and delivery of the intervention, as well as follow-up.
The number of pragmatic trials is increasing. A recent Medline search using the words pragmatic and naturalistic, which was restricted to randomised controlled trials (RCTs) returned 34 articles. These are highlighted in red on Figure 2. This is an indication that the health sciences community is becoming more sensitive to the subject of pragmatic thinking. However, it is important to note that the majority of these studies were conducted in primary care settings.