Thorough definitions and descriptions of the objectives and outcomes in clinical trials lead to results that are more readily interpretable and more easily generalisable. Indeed, the failure to prospectively define both objectives and outcomes in sufficient detail, and to describe how these are to be measured, has been a major criticism of some randomised trials.1 Items 5 and 6 of the CONSORT statement checklist relate to objectives and outcomes in randomised trials.2
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- NHMRC Clinical Trials Centre, University of Sydney, Camperdown, NSW, Australia.
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