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Clinical trials that are designed to help inform practice in the real world are known as pragmatic trials. They are typically characterized by a focus on the practical aspects of research design, like recruitment and consent as well as adherence to the use of standard equipment.
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A practical trial that employs various investigators and participants from diverse geographical locations is the Home Blood Pressure Management study (HBPM). This type of heterogeneity is necessary for practical trials to be valid and helps reduce the chance of bias in the results. However, too much heterogeneity can result in issues with the design of the trial.
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Pragmatic trials are designed to replicate real-life situations and attain maximum external validity. They are typically commissioned by policy makers and practitioners to inform their decision making. They can also be used to determine the cause-effect relationship of an intervention and its effects. They should not, however, be used to replace explanatory studies.
The concept of pragmatism is controversial and there are doubts about whether pragmatic trials should be used to replace explanatory trials or complement them. Schwartz and Lellouch1 made the distinction between explanation 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 for pragmatic trials, called PRECIS.2 This tool sought to define the elements of a pragmatic study which includes the recruitment process, the design and delivery of the intervention, and the follow-up.
The number of pragmatic trials is increasing. A recent Medline search using the keywords naturalistic and pragmatic, which was limited to randomized controlled trials (RCTs) resulted in 34 articles, as shown in red in Figure 2. This suggests that the health sciences community is becoming more aware of the importance of pragmatism. It is important to remember that the majority were conducted in primary-care settings.