Abstract
Methods A review of all 3156 articles submitted to The BMJ between September 2013 and July 2014. Trial registry entries, protocols and trial reports of randomised controlled trials published by The BMJ and a random sample of those rejected were reviewed to determine the frequency and type of outcome discrepancies between pre-specified and reported outcomes. Editorial, peer reviewer comments and author responses were also examined to ascertain any reasons for discrepancies.
Highlights
Adding, omitting or changing pre-specified outcomes can result in bias because it increases the potential for unacknowledged or post-hoc revisions of the planned analyses
Selective reporting in clinical trials - an examination of discrepancy rates in pre-specified and reported outcomes in articles submitted to the BMJ
Journals have adopted initiatives such as requiring the prospective registration of trials to promote the transparency of reporting in clinical trials
Summary
Adding, omitting or changing pre-specified outcomes can result in bias because it increases the potential for unacknowledged or post-hoc revisions of the planned analyses. Journals have adopted initiatives such as requiring the prospective registration of trials to promote the transparency of reporting in clinical trials
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