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What kind of randomised trials do patients and clinicians need?
1 Sunnybrook Health Sciences Centre; Toronto, Ontario, Canada
2 University of Dundee; Dundee, UK
| The first 150 words of the full text of this article appear below. |
In 1967 Daniel Schwartz and Joseph Lellouch1 argued that there are 2 kinds of randomised controlled trials (RCTs) embodying radically different attitudes to evaluation of treatment. They named these trials "pragmatic" and "explanatory" and stated that these 2 attitudes require different approaches to the design of an RCT. The pragmatic attitude seeks to directly inform real-world decisions among alternative treatments, and Schwartz and Lellouch show that this purpose is satisfied in trials that test feasible interventions on typical patients in common settings, with usual care as the comparator, to widen real-world applicability. The explanatory attitude, in contrast, is directed to understanding a biological process by testing the hypothesis that the specified biological response is explained by exposure to a particular treatment. Tight restrictions on eligible participants, intense and closely monitored treatment, inactive control interventions (such as placebo), and an idealised healthcare setting maximise the comparison between intervention and control groups
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