Limitations of “pragmatic” trials

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Abstract
Clinical trials testing the value of therapeutic interventions range between the two extremes of maximal internal or external validity. The former study, often called an efficacy trial, tests a treatment under optimal (that is, near laboratory) conditions, in which features such as the patient sample, the intervention, and the outcome measures are narrowly defined. Their research question is usually whether the treatment is efficacious when used under optimal conditions. Unfortunately this can mean that the findings are not generalisable—that is, the results of such studies cannot necessarily be transferred to the wider population.

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