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Schwartz and Lellouch1 suggested the distinction between explanatory trials, which validate the clinical or physiological hypothesis as well as pragmatic trials, which inform policy and practice decisions. They also proposed a framework for pragmatic trials, dubbed PRECIS.2 This tool sought to define the features of a practical trial that include recruitment, design and delivery of the intervention, and follow-up. The number of pragmatic trials is growing. A recent Medline search using the terms naturalistic and pragmatic, which was limited to controlled trials that are randomized (RCTs) resulted in 34 articles, as shown in red in Figure 2. This indicates that the health sciences community is becoming increasingly sensitized to the subject of pragmatics. It is important to note that the majority of these trials were conducted in primary care settings.
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