Better reporting of randomised controlled trials: the CONSORT statement
BMJPublished 7 September 1996Open access
Douglas G. Altman
Citations614
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Study Snapshot
ObjectiveStudy objective
MethodsResearch methodology
PopulationPopulation studied
Sample sizeSample sizes
OutcomesStudy outcomes here
ResultsStudy results comes here
LimitationsResearch study limitations comes here
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TL;DR
It is entirely reasonable to require higher standards for papers reporting randomised trials than those describing other types of study, since randomised controlled trials are the best way to compare the effectiveness of different interventions.
Keywords
Social SciencesDecision SciencesMedicine
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