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They should not, however be used to replace the need for explanation studies.<br><br>The concept of pragmatism is controversial, and there are questions regarding whether pragmatic trials could be used to replace explanation tests or if they should be an addition to them. Schwartz and Lellouch1 proposed the distinction between explanation studies, which prove a physiological hypothesis or clinical hypothesis, and pragmatic trials, that inform policy and practice decision-making. They also proposed an approach to pragmatic trials, dubbed PRECIS.2 This tool sought to define the features of a pragmatic trial that include the recruitment process, the design and implementation of the intervention, and follow-up.<br><br>There is a growing increase in the number of pragmatic trials published. A recent Medline search using the terms naturalistic and pragmatic, limited to randomized controlled trials (RCTs) produced 34 articles, which are shown in red in Figure 2. 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