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The concept of pragmatism is controversial, and there are questions about whether pragmatic trials should be used to replace explanatory trials or complement them. Schwartz and Lellouch1 suggested the distinction between explanation trials, which prove the validity of a clinical or physiological hypothesis and pragmatic trials that inform the practice and policy decisions. They also proposed a framework for pragmatic trials, which they called PRECIS.2 This tool attempted to define the elements of a pragmatic study which includes the recruitment process, the design and implementation of the intervention, as well as monitoring. There is a positive increase in the number of pragmatic trials that are published. A recent Medline query that used the words naturalistic and pragmatic, restricted to randomised controlled trials (RCTs) returned 34 articles. These are highlighted in red on Figure 2. This is a sign that the health science community is becoming more sensitive to the issue of pragmatism. It is important to keep in mind that the majority of these studies were conducted in primary-care settings.
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