Eirion Slade, MPhys; Henry Drysdale, BSc; Ben Goldacre, MBBS; on behalf of the COMPare Team
Disclosures: Disclosures can be viewed at www.acponline.org/authors/icmje/ConflictOfInterestForms.do?msNum=L15-0614.
This article was published at www.annals.org on 22 December 2016.
Slade E., Drysdale H., Goldacre B., ; Discrepancies Between Prespecified and Reported Outcomes. Ann Intern Med. 2016;164:374. doi: 10.7326/L15-0614
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Published: Ann Intern Med. 2016;164(5):374.
Published at www.annals.org on 22 December 2015
TO THE EDITOR:
Gepner and colleagues' article (1) reports outcomes that differ from those initially registered (2). One prespecified primary outcome was reported incorrectly as a secondary outcome. In addition, the article reports 5 “primary outcomes” and 9 secondary outcomes that were not prespecified without flagging them as such. One prespecified secondary outcome also was not reported anywhere in the article.
Annals of Internal Medicine endorses the CONSORT (Consolidated Standards of Reporting Trials) guidelines (3) on best practice in trial reporting. To reduce the risk for selective outcome reporting, CONSORT includes a commitment that all prespecified primary and secondary outcomes should be reported and that, where new outcomes are reported, it should be made clear that these were added at a later date, and when and why this was done should be explained.
The Centre for Evidence-Based Medicine Outcome Monitoring Project (COMPare) (4) aims to review all trials published going forward in a sample of top journals, including Annals. When outcomes have been incorrectly reported, we are writing letters to correct the record and audit the extent of this problem in the hopes of reducing its prevalence. This trial has been published and is being used to inform decision making, and this comment is a brief correction on a matter of fact obtained by comparing 2 pieces of published literature. We are maintaining a Web site (www.COMPare-Trials.org) where we will post the submission and publication dates of this comment alongside a summary of the data on each trial that we have assessed.
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