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Pragmatic trials are those that are designed to provide information for real-world clinical practice. They are typically described as focusing on practical aspects of design which include the recruitment and consent process, as well as adherence and the use routinely available 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 kind of heterogeneity is required for practical trials to be valid, and it also reduces bias in the results. However excessive heterogeneity could 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. Usually, they are commissioned by policymakers and practitioners to inform their decisions. They can also be used to determine the cause-effect relationship of an intervention and its results. They should, however, not be used to replace explanatory studies.
The idea of pragmatism is controversial and there are doubts about whether pragmatic trials can replace explanatory tests or if they are an addition to them. Schwartz and Lellouch1 suggested the distinction between explanatory trials, which confirm the clinical or physiological hypothesis and pragmatic trials, which guide policy and practice decisions. They also proposed the framework for pragmatic trials, called PRECIS.2 This tool was designed to define the features of a practical trial, including the recruitment process, the design and delivery of the intervention, and follow-up.
There is an encouraging trend in the number of pragmatic trials published. A recent Medline search using the keywords naturalistic and pragmatic, which was limited to controlled trials randomized to control (RCTs), yielded 34 articles, as shown in red in Figure 2. This is a sign that the health sciences community is becoming more sensitive to the issue of pragmatism. It is important to note, however, that the majority were conducted in primary-care settings.