Possible omission of information essential for conclusions in a research paper

COPE Ethics Case

In this regular feature, we highlight an ethics dilemma from the searchable cases database operated by COPE, the Committee on Publication Ethics. In 2008, all Elsevier journals were enrolled in COPE so editors would have an alternative information resource when faced with research misconduct. The cases database contains details of, and advice given on, more than 500 cases and is just one of the many services COPE offers.

In this issue, we highlight a case in which a researcher felt that authors of a specific paper omitted essential information that might impact the conclusions.

Simply click on the link at the end of the article to find out what the COPE Forum advised.

Case number 14-11 (anonymized)

In 2013, our journal published a paper describing 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.

In 2014 we received a letter of concern by a researcher, employed by the company selling drug A, who felt that the authors of the 2013 paper omitted essential information that might impact on the conclusions. It appears that the routine management of this disease has changed substantially over the 10 year period, and this should have been treated as a confounder for which statistical adjustments should have been made. This change in routine management of the disease is documented in a paper published in 2014, but the researcher felt that these authors were probably aware of this much earlier and should have disclosed this information during the review process of their 2013 paper.

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.

Question(s) for the COPE Forum

The researcher who raised the concern has not made his concerns public by sending us a rapid response that we could put to the authors and publish, with their response, on our website. We will certainly put the questions to the authors of the 2013 paper, but we wonder if we should publish these concerns?

Another problem is that, due to the complexity of the statistical calculations, we are entirely dependent on the authors to judge whether the routine management data would have seriously impacted the conclusions of the 2013 paper.

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