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However, they shouldn't be used to substitute for the use of explanation trials. The pragmatism concept is controversial and there are concerns about whether pragmatic trials should replace explanatory trials or complement them. Schwartz and Lellouch1 suggested the distinction between explanatory trials, which validate the clinical or physiological hypothesis as well as pragmatic trials that inform the policy and practice of. They also proposed an approach to pragmatic trials, dubbed PRECIS.2 This tool attempted to define the characteristics of a pragmatic trial which includes recruitment, design and delivery of the intervention, as well as monitoring. The number of pragmatic trials is increasing. A recent Medline search using the words pragmatic and naturalistic, which was restricted to randomised controlled trials (RCTs) returned 34 articles. These are highlighted in red on Figure 2. This indicates that the health sciences community is becoming increasingly sensitized to the issue of pragmatics. However, it is important to note that the majority of these studies were conducted in primary care settings.
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