A paper that compared two gauges of needles to take samples of pancreatic masses has been retracted after authors unintentionally included patients from another trial.
“Randomized Trial Comparing the Flexible 19G and 25G Needles for Endoscopic Ultrasound-Guided Fine Needle Aspiration of Solid Pancreatic Mass Lesions,” published a year ago in Pancreas, notes that:
A total of 100 patients with solid pancreatic mass lesions constituted the study cohort and were randomized equally to the 2 needle groups.
The problem? According to the retraction note, some of those patients weren’t supposed to be included:
The randomized trial involved 72 patients between two participating centers. The published article includes 100 patients. The authors added 28 patients to show statistically that there was no difference in the main outcomes measures despite changing the sample size to 100 patients. The 28 patients with large pancreatic masses were subjects of another similar randomized trial (NCT01815606: Trial Comparing 19 and 25G Needles for Fine Needle Aspiration (FNA) of Solid Pancreatic Mass Lesions Greater Than 35 mm) that has not been published or findings analyzed; the authors do not intend to publish the findings of that trial. The intent of the authors was only to prove that an increase in sample size would have no bearing on the eventual findings of the study. It was not their intent to include this sample in the publication.
Last author Shyam Varadarajulu, who works at Florida Hospital, told us via phone that he had submitted the manuscript to a few journals. In one case, to demonstrate to a reviewer that findings from the small study would be replicated in a larger sample, they provided some extra analysis — not intending for that version to be published. But when the paper was rejected, and they submitted it to Pancreas, someone working for Varadarajulu uploaded the wrong copy.
Usually I do submissions, but she uploaded it. I should have supervised the uploading.
He told us that the journal only had minor edits, and unfortunately he only realized the mistake
when it came online toward the end of last year. I called [the journal] and I said I think someone uploaded the wrong manuscript.
Since the accidental publication also included patient data, he contacted the other authors, and the institutional review boards at his hospital and the University of Alabama, where his co-authors work.
He told us he’s not planning on republishing the data with the correct number of patients:
If this manuscript has zero citations, that means it’s not a very high priority manuscript. What is the point of republishing a manuscript that has zero citations? It’s not a rocket science study that was published in Nature or Science.
Indeed, the article has not been cited, according to Thomson Scientific’s Web of Knowledge.
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As first author, I did all the uploading and submission stuff myself, and there was only one version of the paper. FAIL on the PI’s protocols for doing the submissions.
I’m sorry but I need to strongly disagree that it is not worth to re-publish the paper “because it has zero citations”. You have an ethical commitment with the patients you enroll, randomize and bother to evaluate and follow-up to make their involvement count. At this point, you should honor their commitment and make the data available: if the question is not high priority enough they should have think about that before getting the patients involved. Now it is too late.
Um…they enrolled 72 patients in one study, and how many others in a second study (larger?), and they don’t intend to publish either and seem rather bored by the whole thing? Who funded these studies? Who approved them? If I was the IRB at these institutions I would take a closer look at any future protocols submitted by the PIs here. I’m not an expert on IRB review but I know enough about animals studies to know that if I submitted a proposal to the IACUC that I never intended to publish and viewed as not very important, it would get rejected under the “3Rs” that are supposed to be guiding principles. Human studies should get at least that much scrutiny. How does “it’s not a high priority study” comport with the Helsinki Guidelines and “respect for persons.”