A general medical journal received an RCT from a seldom-published, single-author, in an eastern European country. The results were striking, with an effect size that surpassed that of established medications for this condition, so the manuscript was sent for peer review. One reviewer commented that the results were “so highly statistically significant it is almost too good to be true. Virtually every parameter was observed to be statistically superior in the [intervention] group”.
On closer inspection, a number of concerns arose regarding recruitment, inconsistencies and reporting.
The author denied fabrication, but the editors were not satisfied with his explanations. The manuscript was rejected and the journal approached the institution’s ethics committee, and then the director of the institution, who undertook an investigation.
The internal investigation reported that the author looked after many patients with the condition, some of whom were contacted and affirmed that the intervention was beneficial. The statistical analysis was confirmed by a university in the USA. The investigators believed that the conclusions were true and that there was no evidence of misconduct.
Does COPE have any comments or suggestions regarding the journal’s actions?
The Forum felt that as there was no evidence of misconduct and the editor had pursued all of the usual channels of investigation, there was little more that could be done. Some suggested obtaining the raw data and seeking expert advice from a statistician, although that may not be possible as the journal rejected the paper. All agreed that the editor had taken all of the appropriate steps and possibly gone as far as he could with this case.
At COPE’s sensible suggestion, the editor requested a copy of the external report vindicating the analysis, but this was not available. Although not satisfactory, the editor considers the case now closed.