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Schwartz and Lellouch1 proposed an distinction between explanation-based studies, which support the validity of a physiological or clinical hypothesis, and pragmatic trials, which inform policy and practice decision-making. They also proposed an approach to pragmatic trials, which they called PRECIS.2 This tool sought to define the characteristics of a pragmatic trial, including the recruitment process, the design and implementation of the intervention, as well as the follow-up. There is a growing increase in the number pragmatic trials that have been published. A recent Medline search using the words naturalistic and pragmatic, restricted to randomised controlled trials (RCTs), returned 34 articles. These are shown in red on Figure 2. This indicates that the health science community is becoming more sensitive to the issue of pragmatism. However, it is important to keep in mind that the majority of these trials were conducted in primary care settings.
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