BACKGROUND: Randomised controlled trials (RCTs) are the gold standard for evaluating treatment efficacy. However, the outcomes of RCTs often lack clinical utility and usually do not address real-world effectiveness. AIMS: To review how traditional RCTs may be triangulated with other methodologies such as observational studies and pragmatic trials by highlighting recently reported studies, outcomes used and their respective merits. METHOD: Literature review focusing on drug treatment. RESULTS: Recently reported observational and some pragmatic studies show a degree of consistency in reported results and use outcomes that have face validity for clinicians. CONCLUSIONS: No single experimental paradigm or outcome provides the necessary data to optimise treatment of mental illness in the clinical setting.
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Hodgson et al. (2007) studied this question.