Measurement of long-term outcomes in observational and randomised controlled trials.

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.