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However, they should not be used in lieu for explanation trials. The pragmatism idea is controversial, and there are questions regarding whether pragmatic trials could be used to replace explanation tests or if they should be a complement to them. Schwartz and Lellouch1 made a distinction between explanatory studies, which confirm a physiological hypothesis or clinical hypothesis, and pragmatic trials, that inform the decision-making process for policy and practice. They also proposed a framework called PRECIS for pragmatic trials.2 The tool was designed to define the elements of a pragmatic study which includes recruitment, design, delivery of the intervention and its follow-up. The number of pragmatic trials is growing. A recent Medline search using the keywords naturalistic and pragmatic, limited to controlled trials that are randomized (RCTs) resulted in 34 articles, which are shown in red in Figure 2. This is an indication that the health science community is becoming more sensitive to the issue of pragmatic thinking. It is important to remember, however, that the majority of these studies were conducted in primary-care settings.
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