Statistics in medicine
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Statistics in medicine · May 2002
Study control, violators, inclusion criteria and defining explanatory and pragmatic trials.
Important differences between explanatory and pragmatic studies were originally argued by Schwartz and Lellouch. Three important differences between the two types of study involve study control, study violators and inclusion criteria. It was originally argued that explanatory studies are highly controlled, and pragmatic studies may be looser and more like 'real life'. ⋯ Routine criticism of randomized controlled trials for being unrepresentative is unwarranted. We should accept that most trials in humans are 'explanatory'. The division line should be moved, so that pragmatic studies are in the domain of non-therapeutics and complex treatments.