How did NEJM respond when we tried to correct 20 misreported trials?

February 25, 2016 - by Carl Heneghan 14 Comments

It is well established that academic journals routinely permit outcome switching in the trial reports that they publish, despite public commitments to address this problem. For six weeks from October 2015, the COMPare team analysed every RCT published in the top 5 medical journals to check if they had correctly reported their pre-specified outcomes. Where we found discrepancies between the outcomes that were pre-specified and those reported, we wrote a letter to that journal to correct the record. The responses we have received from journals have been extremely varied: from full public engagement and transparent corrections in the BMJ, to inaccurate and concerning responses in the Annals of Internal Medicine.

New England Journal of Medicine (NEJM) is the highest impact factor journal in medicine. So far we have analysed 23 of their trials. To NEJM’s credit, of 32 primary outcomes pre-specified across these papers, 31 were correctly reported. However, 16 publications added in a total of 65 additional outcomes that were not pre-specified in the protocol or trial registry, and only 2 of these were declared as novel. Furthermore, a total of 160 pre-specified secondary outcomes spread across these publications were either not reported, or were reported incorrectly. Our full results and raw data are available here. Only 3 trials were perfectly reported.

Resistance and misunderstanding from the journal editors on outcome switching – What does the FDA say?

February 12, 2016 - by Carl Heneghan 1 Comment

There seems to be some resistance and misunderstanding from journal editors and the academic community on outcome switching, so we thought it would be useful to give an overview of what various authoritative bodies have to say on the topic. In this series, we will cover ICMJE, CONSORT, the FDA, and the Word Of God. Today, we look at the FDA.

Resistance and misunderstanding from the journal editors on outcome switching – What does the ICMJE say?

February 1, 2016 - by Carl Heneghan 1 Comment

There seems to be some resistance and misunderstanding from the journal editor and academic community on outcome switching, so we thought it would be useful to give an overview of what various authoritative bodies have to say on the topic. In this series, we will cover CONSORT, the FDA, ICMJE and the Word Of God. Today, we look at ICMJE.