The Cochrane Collaboration has robust, open, and methodologically mature processes aimed at ensuring that Cochrane Reviews provide the best available evidence of the effects of healthcare interventions. These include documented methodologies, training, internal and external peer review, an open feedback system, and a willingness to embrace continuous improvement. However, it can be expected that, despite these best endeavours, flaws may appear in Cochrane Reviews from time to time. Most of these flaws will be relatively minor, but may occasionally be more severe. The procedure to be followed in the event of a serious error is outlined here.
For the purpose of this process a Cochrane Review is defined as containing a serious error when one or more of the following events occur:
- Following the recommendations of the review could result in harm to patients or populations of interest (other than known adverse effects).
- The reported treatment effect is inconsistent with the real effect shown in the reported data.
Process to be followed
The Editor in Chief must be notified of all suspected or confirmed serious errors. The Editor in Chief and the Co-ordinating Editor of the Cochrane Review Group (CRG) that published the Cochrane Review will examine the review in light of the notification.
If they do not consider the error to be a serious error, the Editor and Chief and the Co-ordinating Editor of the CRG will agree a timetable for correcting the error depending on the nature of the error.
If the error is deemed serious or dangerous (according to the definitions), the following steps will be followed with urgency.
- CRG to withdraw review immediately (in lieu of being able to retract articles at the moment). The reason for withdrawal must mention the serious error.
- EiC to notify the Co-ordinating Editors’ Executive, CEO, Co-Chairs of The Cochrane Collaboration, and the CRG’s reference Cochrane Centre. These individuals will make a decision on the need for further communications. They will also be kept informed of developments as the next steps are worked through.
- Editor in Chief, in consultation with CRG Co-ordinating Editor, the Co-ordinating Editors’ Executive, and publisher, will release advisory press notice to list used for usual review dissemination activities (e.g. press release, social media, cochrane.org), and withdraw original press release if affected and/or if there was one. Additionally, the Editor in Chief, in conjunction with the CRG Co-ordinating Editor, the Co-ordinating Editors’ Executive, and CEO will determine whether there are groups external to the Collaboration (such as funders) that should be notified.
- CRG Co-ordinating Editor with input from the Editor in Chief and his staff to examine cause of error and possible solutions. CRG Co-ordinating Editor to compile a written report for the Editor in Chief describing the error, how it was caused, why it was not identified before publication, and what changes the CRG has or will make to editorial process to prevent a recurrence.
- CRG Co-ordinating Editor with input from the Editor in Chief and his staff to work with authors to revise the review and to determine at what stage review should re-enter editorial process (e.g. it may need to go to peer review again).
- CRG Managing Editor to republish review when approved for publication by CRG Co-ordinating Editor and Editor in Chief.
- Editor in Chief, in consultation with CRG Co-ordinating Editor, the Co-ordinating Editors’ Executive, and publisher, to agree dissemination activities for republished review.
The CRG and the Cochrane Review authors will be supported throughout the process.
Suggestions for improvements
The Editor in Chief welcomes suggestions for improvements to this procedure.