One suggestion was that the editor could publish the concerns anonymously and invite the authors to respond. Another suggestion was to treat this as you would a whistleblower by investigating the issue, and asking the authors to respond specifically to the questions raised by the researcher if necessary. It is clear that the editor has concerns about the paper and these should be addressed in some way.
In 2008, our journal published a phase 2 randomised controlled trial of a new medicine. In 2011, the regulatory authority in the country where the study was performed decided to undertake routine monitoring of completed studies and this trial was selected for random inspection. The author informed the journal of the inspection and provided a translation of the report (independently verified as accurate by our journal).
论坛建议，如果编辑不能决定做什么，可以临时发表一份关注声明。如果编辑认为方法论不足以检测副作用，那么他应该考虑收回这篇论文。显然，需要进行纠正。在表示关切时，除了与同意有关的问题外，还应提及副作用表可能不正确的事实。编辑在论坛上说，他不认为有任何不当行为，作者是真诚地写这篇论文的。 On a show of hands, nine people suggested that the editor should do an expression of concern detailing the chain of events. Only two people thought the paper should be retracted. Hence the consensus was that it would be appropriate to put a statement of concern on the paper.
In March 2012, the high profile journal published the large RCT which randomized more than 2000 patients to drug treatment by the two different routes. The main conclusion was of no difference in survival for route X versus route Y. This finding rendered meaningless the finding of the meta-analysis accepted by our journal 6 weeks previously.
The authors of the meta-analysis were then emailed asking if they would now update their meta-analysis with inclusion of the RCT data.
应对国家期刊编辑应该考虑retracting a publication if they have clear evidence that the findings are unreliable. The authors of the meta-analysis knew their findings were unreliable at the time they submitted their revised paper and we now wish to have the paper retracted
Advice:
The Forum agreed there were grounds for retraction of the paper. Clinical decisions are often based on meta-analyses and the editor cannot rely on all readers being aware of the newly published meta-analysis in the other journal. However, the ideal situation would be for the author to correct the published paper. Although the author has refused to do this, the Forum suggested that the editor should contact the author again, asking him to correct the paper. The editor should tell the author that if he refuses to correct the paper, then the editor will be left with no option but to retract the paper.
Following the Forum’s advice, the editor emailed the corresponding author of the paper, copying in the co-authors, stating that he hoped the authors would agree to update the meta-analysis whereupon the matter would be concluded. He told the authors that if they did not agree to provide an update, he would retract the paper. The editor received no reply and therefore retracted the paper. 撤回通知指出，本文的结果是不可靠的，因为他们未能解决来自大型RCT的数据，提交人在提交之前访问，这违反了论文的结论。通知称，提交人被要求更新文件以包括RCT调查结果，但除了其中一位作者之外，他们拒绝了。由于这种意见差异，本提交人要求从作者名单中删除，期刊加入的请求。通知表示，在这种情况下，应考虑到推荐撤回的问题，本文已被撤回。
2011年5月的Vice-Rector per的一封信onnel of a reputable university was sent to the editor mentioning that two articles published in the journal contained two statements not supported by documented evidence. The two statements related to: (1) approval of the local ethics committee and (2) representation of the experimental evidence.
With regard to point (1), the authors stated in the article that they had approval in 1995 for their research protocols but the authorities state that there is no written documentation of this agreement and that this cannot substitute for formal approval of the research. The journal and the university rules indicate that formal approval of an ethics committee is required.
The author of the articles, who received a copy of the letter from the Vice-Rector, asked to have some time to send in his rebuttal of the accusations. For both issues the answers provided by the authors were submitted to the university and were judged as unsatisfactory.
An additional question to COPE: should other editors be informed of this? In a sister journal, an article was submitted mentioning the same very outdated ethics approval.
Advice:
The Forum agreed that this was a very interesting but complicated case. There are two issues here: (1) approval of the local ethics committee and (2) representation of the experimental evidence.
When contacting us, the reviewer wanted to know if he could contact the editor of journal 2, make it known that he had seen supplementary material when he had reviewed the paper and explain his concerns to the editor. We advised him to write to the editor of journal 2 in confidence, explain what had happened and say that we had reservations about breaching confidentiality in this way but thought that the benefits of doing so outweigh the risks.
杂志2的编辑现在已经联系我们要求看补充材料。不幸的是，我们不再有可用的文件（我们不存档他们那么长），但我们有审查。 考普的问题 • Should we share with journal 2 the reviews we still have? •原则上，我们是否可以共享补充文件和原始提交文件（尽管它们不再可用）？
The editor of journal 2 published six letters in total: two letters about the paper with replies from the author, and a further letter about the commentary accompanying the paper, together with a reply from the author of the commentary.
We felt that this was an important trial that needed to be reported, mainly because of the excess mortality in the intervention arm, but we had the rather odd situation that the authors wanted to emphasise the positive, and the need for further trials of this intervention, whereas the reviewers and editors saw the paper as delivering a negative message and feel actually that the paper will be the death knell for this treatment.
(2)As to the contribution of X (one of the members of the DSMB), we have to admit a simple language problem. In our use of the word “supervision”, the word meant that he took a final comprehensive look at our data analysis before the paper was submitted for publication. Importantly, he never supervised (like an academic supervisor) data analysis at any time point before database lock and processing of the data by the clinical research organization. We will change the terminology accordingly.”
Our concerns overall therefore were that this paper not only reports the outcomes in a way that is not appropriate, but also the composition of the DSMB and the presence of some DSMB members as authors means that the trial may not have had adequate independent oversight.
We are bringing this to COPE as this paper raised a number of serious issues we had not come across before. We would appreciate the Forum’s opinion on whether we handled this correctly.
Advice:
Some of the members of the Forum suggested that perhaps the journal should have a formal policy that DSMBs should be independent and not involved in the study in any way. The Forum questioned whether these authors fulfil the criteria for authorship, as outlined in the ICJME guidelines. One opinion was that perhaps the paper should not have been rejected until the outcome of the investigation was known. However, most agreed that rejecting the paper was the correct decision and the editor might consider contacting the ethics committee who approved the study if no response is received from the authors’ institution.
2009年11月 Following an internal investigation by the author’s institution, a number of serious problems were encountered, including: lack of ethics approval, lack of written consent, lack of treatment-allocation concealment and an inability to verify the authenticity of the data. We therefore retracted the paper on 10 October 2009.
We received a case report describing the diagnosis and treatment of a middle-aged woman who presented to a gastroenterology service in England with weight loss and a right iliac fossa mass. The authors did a barium swallow, duodenal and gastric biopsies, and diagnosed Crohn’s disease by the radiological appearances on follow-through. They did not do a colonoscopy, or biopsy the mass in the terminal ileum. They treated the patient with immunosuppression, and she came back four times over the following year with no improvement, and died of small-bowel obstruction due to her leiomyosarcoma. The editor who received this case report telephoned the corresponding author to ask if he wished to resubmit it to the section on medical error, but he did not feel that the case indicated any error on their part. The editor then sent the case for peer review, and the reviewer pointed out that it was standard care in his country (Australia) to do a colonoscopy and biopsy a tumour before diagnosing Crohn’s disease, and that in the developing world, tuberculosis of the terminal ileum was a more likely diagnosis, one that the authors hadn’t considered. The file was discussed at the editorial meeting, and the editors decided to reject the case report, but felt that their duty as doctors had not been adequately fulfilled, but were unsure as to how to proceed. What should they do now?