How journal editors kept questionable women’s health data out of the literature years before retractions – Retraction Watch

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John Carlisle

In July 2017, Mohamed Rezk from the Department of Obstetrics and Gynecology at Menoufia University in Egypt submitted a manuscript to the journal Anesthesia with a colleague.

The manuscript, “Analgesic and antiemetic effect of intraperitoneal magnesium sulfate in laparoscopic salpingectomy: a randomized controlled trial,” caught the attention of John Carlisle, editor of the journal whose name will be familiar to readers of Retraction Watch in as a detective whose statistical analyzes identified hundreds of articles containing implausible clinical trial data.

The baseline data seemed mundane, Carlisle told us, but the outcome data did not. Out of 24 values ​​that could have been odd or even numbers, they were all even.

The probability of that being “0.0000000000000000000 something,” Carlisle said.

A few days after receiving the submission, Carlisle emailed Rezk and asked to see individual patient data from the trial. Rezk responded the same day that his co-author had the data and was out of the country and unreachable for three months. Carlisle emailed the co-author and got no response.

Three months later, in October, Carlisle followed Rezk up and requested the data again. Rezk responded the same day and asked to remove the manuscript.

After discussing it with Andrew Klein, Anesthesia‘s editor, Carlisle declined. He wrote to Rezk: “We will keep your manuscript for review, during which time you may not submit it to another journal. We will contact your employers to request individual patient data and evidence of ethics approval.

Klein emailed Rezk’s institution director a few days later, but never received a response.

Carlisle and another detective, John Loadsman, looked at some of Rezk’s other published essays and found two with outcome values ​​that were all multiples of 5 or 10, which Loadsman then posted on PubPeer.

Both Anesthesia the editors appear to have kept the questionable article out of the literature, as retractions and expressions of concern began to mount for Rezk, and a systematic analysis of his work by other sleuths found “At first glance evidence of data fabrication.

In the years that have passed, Rezk and his co-author do not appear to have published an article with the same title as their submission to Anesthesia. Carlisle told us, “I don’t know why Dr. Rezk didn’t submit this trial to another journal. Authors of essays we believe to have been fabricated have generally published their articles elsewhere.

Years later, starting in October 2021, some of the articles published by Rezk began to be flagged with expressions of concern and retractions, due to the work of data sleuths including Ben Mol , an obstetrics researcher at Monash University in Australia.

After noticing two unusual randomized controlled trials of which Rezk was the first author, Mol and a few colleagues analyzed all his publications describing clinical studies.

Jim Thornton, an obstetrics researcher at the University of Nottingham, posted some observations on PubPeer, and the group described their findings in a preprint, first reported by Jezebel, which was accepted with minor revisions at Archives of Gynecology and Obstetrics:

Dr. Rezk is the author of 51 studies, 17 RCTs and 34 cohort studies. Two pairs of RCTs (four trials) showed extensive copying of baseline and outcome data. Another set of four trials and two cohort studies each recruited identical patients from the same hospital over overlapping time periods. The recruitment rates reported in two of these RCTs were implausible, and there were many examples of identical baseline data between the same two RCTs and a third trial. In 15 of the trials, we were able to compare the number of participants assigned to each group. In two cases, the randomization method (shuffled cards) would lead to groups of exactly equal size. In eight of the other thirteen, groups of exactly equal size were obtained, and in two other trials, differential loss to follow-up led to groups of exactly equal size for analysis.

Nineteen of the 34 cohort studies were flagged as being prospective or including a prospective component, but 11 of them were received by the review before the last participant could be followed up. One cohort reported a biologically implausible disease rate and another an implausible recruitment rate. Two cohorts of women with hypertension during pregnancy reported identical summary statistics repeatedly in the tables showing baseline characteristics. Two other cohorts of women with rheumatic heart disease during pregnancy, with identical recruitment criteria and overlapping recruitment periods, reported implausible differences in baseline BMI and neonatal mortality. Finally, the probability of observing the excess of even categorical variables reported in Dr. Rezk’s articles is globally infinitesimal.

Mol and his colleagues concluded that an investigation was warranted and that Rezk’s papers should be marked with expressions of concern in the meantime:

Our assessment of Dr. Rezk’s work shows At first glance evidence of data fabrication. We call for an investigation of these studies, including an evaluation and reanalysis of the original data. Until then, Dr. Rezk’s studies should neither directly nor through meta-analyses be used to inform clinical practice.

In an Aug. 31 email to editors and publishers of various journals, Mol asked that they tag every article by Rezk and other authors at his institution with expressions of concern by the end of September, then give authors a chance to defend their work. If, after two months, they could not prove that their data was reliable, the documents should be removed, Mol wrote:

Any further delay is unacceptable to us. While we appreciate the time and effort that each of you individually invests in this process, I think we all agree that the process is flawed and puts patients at risk.

It cannot go on like this; we hope you understand this.

To all editors and publishers, if for any reason you decide to keep these articles unretracted and without any warning, we expect you to explain to the academic community why you are doing so.

Four of Rezk’s articles were taken down and eight raised concerns, with a total of nearly 100 citations for the 12 articles.

Eight of the flagged articles were published in Taylor & Francis journals, and the expressions of concern and retraction notices were nearly identical – and vague. A representative opinion:

We, the editors and publisher of The European Journal of Contraception and Reproductive Health Careremoved the following item:

Mohamed Rezk, Tarek Sayyed, Alaa Masood & Ragab Dawood (2017) Risk of bacterial vaginosis, Trichomonas vaginalis infection and Candida albicans in new users of combined hormonal contraception vs LNG-IUS, The European Journal of Contraception & Reproductive Health Care, 22 :5, 344–348, DOI: 10.1080/13625187.2017.1365835

Since publication, significant concerns have been raised about the integrity of the data and results reported in the article. When approached for an explanation, the authors were unable to address the concerns raised and were unable to provide their original data or sufficient supporting information. As verifying the validity of published work is essential to the integrity of the scientific record, we therefore retract the article. The corresponding author mentioned in this publication has been informed. The authors do not agree with the retraction.

We were informed in our decision-making by our Policy on Publishing Ethics and Integrity and the COPE Guidelines on Retractions.

The retracted article will remain online to maintain the scientific record, but will be digitally watermarked on each page as “Retracted.”

The notice of retraction of “Nicorandil versus nifedipine for the treatment of preterm labor: a randomized clinical trial”, which was published in the European Journal of Obstetrics, Gynecology and Reproductive Biology in 2015 and retracted on August 10, went into detail:

This article has been removed: please see Elsevier’s Policy on Article Withdrawal (https://www.elsevier.com/about/our-business/policies/article-withdrawal).

This article has been removed at the request of the editor.

The editors have been alerted to the following regarding the characteristics of this trial:

The date of submission is impossible. Patients were recruited between 24 and 34 weeks (mean 31 weeks). 18% of participants gave birth after 37 weeks. Average recruitment 26 per month. Recruitment ended in September 2014 but the article was received by the journal on October 23, 2014.

The second author, Sayyed T, is co-author of related articles retracted in BJOG.

Given these concerns, we wrote to Dr. Rezk who had no satisfactory explanation and refused to share the data. So we decided to withdraw.

Some of Rezk’s papers containing allegedly fabricated data have been included in journals that influence patient care, Jezebel reported. Mol told the website:

We are talking about families who lose their mothers, who lose their babies because of this problem.

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