在2013年,我们的杂志发表了一篇论文,描述an observational study comparing two drugs (A and B) for the management of a chronic disease over a period of 10 years. The conclusion in the paper was that mortality was higher in group A (97 deaths) compared with the other group B (52 deaths) (hazard ratio 1.76, 1.22 to 2.53; P=0.003). This analysis was done after adjustment for a large number of confounders, and was approved by our statistical advisor. The authors of the papers did acknowledge that this was an observational study, and did state that residual confounding might be present.
2014年,我们通过销售毒品A雇用的研究人员获得了一封令人担忧的担忧,他们认为2013年纸张的作者省略了可能影响结论的基本信息。似乎这种疾病的常规管理在10年内发生了大幅变化,这应该被视为应该对统计调整的混淆。该疾病常规管理的这种变化被记录在2014年发表的一篇文章中,但研究人员认为这些作者可能会更早地意识到这一点,并且应该在2013纸审查过程中披露了这些信息。
In our initial response in July 2014 to the letter of concern, we asked the researcher who sent us the letter of concern to send us a detailed rapid response to the 2013 paper, which we could publish. We have also asked advice of our statistical advisor who reviewed the 2013 paper, and he acknowledged that this information might impact on the statistical calculations and thus the conclusions of the paper. But with the data available to him, he is not able to make a definitive assessment of how much impact it would have. He has suggested to put these questions to the authors of the 2013 paper.
应对论坛的问题
- 提出关注的研究人员并没有通过向教作者送到作者并在我们的网站上发表作者并发布的快速反应来提出担忧。我们肯定会将问题提出给2013纸的作者,但我们想知道我们是否应该发布这些问题?
- 另一个问题是,由于统计计算的复杂性,我们完全依赖作者来判断日常管理数据是否会严重影响2013纸的结论。
该论坛同意编辑的行动方案 - 即邀请研究人员编写正式票据,陈述他的担忧,可以公开,然后可以邀请作者做出回应。这确保了该过程是透明的。但是,如果提出关注的研究人员不想让他担心公众,那么编辑可能会有很少的事情。
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.
因此,最好的选择可能是期刊发布关注,不一定揭示研究人员的身份,并邀请作者回应。
向关注致函的研究人员向发布的编辑发送了一封信,并由原始纸张的作者回答。
期刊的统计顾问已经发现响应令人满意。编辑现在考虑了现在关闭的情况。
评论
原作者选择性地忽略了研究时期的分析问题的含义下降了“[响应]研究人员认为这些作者可能意识到这一点早期,并且应该在审查期间披露这些信息2013纸的过程。“我建议,如果没有随后的2014篇论文,这样的假设和对此类模式的需要,那么就是这样的同样合理的是,还需要另一项研究(至少基于此评论中出现的内容)。也就是说,指出这个问题和原作者后续反应的信是科学企业应该工作的方式。对于这种思想发挥作用,不需要对不当行为的含义。