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Data Integrity Concerns in 130 Women's Health Studies - All co-authored
A team of scientists discovered data integrity problems by a researcher in 130 publications on women's health.
Data Integrity Concerns in 130 Women's Health Studies - All co-authored
A team of scientists has discovered data integrity concerns in 130 studies conducted by the same biomedical researcher, a specialist in Gynecology and gynecology, as well as his colleagues. The investigators published their findings in a peer-reviewed publication earlier this year 1.
Some of the studies identified as potentially problematic were cited by other researchers or included in analyzes that could influence clinical practices. The number of papers questioned is among the highest among life scientists who are still active, say experts.
The 130 studies were published between 2014 and 2023 and report the results of clinical trials and other research on maternal and gynecology. Issues identified include irregularities in reported statistics, unrealistic results and text identical to other publications. Ahmed Abbas, an obstetrician and gynecologist at Assiut University in Egypt, is listed as a co-author or corresponding author on all 130 articles. Abbas did not respond to Nature's request for comment.
Some of the works remain part of the specialist literature. Eleven were withdrawn. One of the withdrawn works was part of one before the withdrawal 2019 meta-analysis of treatment to prevent miscarriage. The retractions of the paper by Abbas and his team, as well as another unrelated paper, are likely to change the conclusion of the analysis, says one of the authors of the 2019 paper.
The inclusion of a potentially unreliable study in one systematic review can have harmful consequences because "it can immediately affect how a surgeon or an [obstetrician-gynecologist] does their job," says James Heathers, a forensic meta-scientist at Linnaeus University in Växjö, Sweden, who was not involved in the research that identified the data integrity concerns.
Women's health professionals are actively developing strategies to avoid publishing questionable data. However, they say that it is difficult to exclude such works from the literature once they have been published to remove.
Alaa Mohamed Ahmed Attia, the dean of Assiut University's Faculty of Medicine, where Abbas is a member, did not respond to Nature's query regarding concerns about Abbas' publications in this year's peer-reviewed article.
The 130 flagged studies were described in an article published in May 1 was published in the Journal of Gynecology, Obstetrics and Human Reproduction by obstetrician and gynecologist Ben Mol of Monash University in Clayton, Australia, and his colleagues.
In 2016, Mol reviewed an unpublished manuscript written by Abbas on the prevention of miscarriages by the hormone progesterone. Mol noticed discrepancies in the work and informed the magazine. The magazine dismissed the work of Abbas and his team. But in 2017, another journal, The Journal of Maternal-Fetal & Neonatal Medicine, published a version 2 of the manuscript, which included changes in the sections indicated by Mol. The magazine ultimately retracted the article in December 2019.
According to the retraction notice, the journal's editorial board learned that previous versions of the manuscript "included significant changes in the underlying data." The statement also said that when contacted, the authors could not provide the original data to verify the results. According to the magazine's publisher, Taylor & Francis, concerns about the work were first raised in February 2019. The resulting investigation led to the article being withdrawn in the same year, according to the publisher. Abbas did not respond to Nature's request for retraction.
Mol and his team decided to examine all of Abbas' articles except literature reviews, case reports and studies conducted as part of an international collaboration. They identified 263 articles where Abbas is listed as an author. These studies included a total of more than 74,000 participants between 2009 and 2022.
Of the 263 studies analyzed in the paper, 130 - almost half - raised investigators' concerns. Some of the studies had statistics that seemed unrealistic. One study used wording similar to that of a previously published paper. The articles marked as problematic appeared in journals published by several publishers, including Taylor & Francis and Springer Nature, which also publishes Nature. Nature's news team is independent of its publisher. Springer Nature did not respond to a request for comment from the news team.
The sheer number of studies said to have been produced in such a short period of time caught the attention of Mol’s team. According to the registered and published timeline of work, as of May 2017, Abbas had 88 concurrent clinical trials underway. Catherine Cluver, a gynecologist and obstetrician who heads the preeclampsia research unit at Stellenbosch University in South Africa, agrees with Mol's team that it seems unrealistic to conduct so many studies at once. “All the regulatory work, the ethics approvals, making sure the trials are done correctly... I think it's not possible to do more than four or five, and even that is a challenge,” she says.
A common problem Mol and his colleagues identified was statistical anomalies. One of the papers flagged as problematic, published in the Proceedings in Obstetrics and Gynecology 3, evaluated the effect of the drug esomeprazole in women with the pregnancy complication preeclampsia. The investigators determined that the last digit of 31 of the 32 values in Tables 2 and 3, including means and standard deviations, are even numbers. In scientific data, the digits of such measurements and statistical results tend to be evenly distributed between odd and even numbers, so the probability of having so many even-numbered values would be small. The numbers represent a “problem,” according to the publication by Mol and his team.
The tables also have numerous pairs of numbers that contain identical digits after the decimal point, for example 0.76. Some of the repeating values are in the same table; some are scattered across the tables. This is also concerning, say Mol and his team.
These unusual numbers should prompt the authors to present their raw data, says Nicholas Brown, a psychologist and research quality specialist at Linnaeus University.
Proceedings in Obstetrics and Gynecology Editor-in-Chief Donna Santillan said in a statement that all inquiries about research or publication errors are investigated by the journal. Santillan, a researcher in reproductive sciences at the University of Iowa in Iowa City, declined to comment on whether this study is currently under investigation, citing privacy concerns.
Other studies flagged by Mol’s team describe seemingly unlikely results. In a 2020 survey 4 For example, in the European Journal of Contraception & Reproductive Health Care, which assessed attitudes toward abortion among gynecologists and obstetricians in Egypt, the average age of doctors surveyed was 42.6 years and their average professional experience was 26.4 years. For these numbers to be accurate, the average age at which these physicians began practicing would have to be 16.2 years. The same paper contains phrases identical to those of a study 5 from 2009 by other authors.
The journal's publisher, Taylor & Francis, says the work is currently under investigation after concerns were raised in December 2023. Abbas did not respond to a request for comment regarding the investigation.
Mol says he does not accuse the authors of falsifying data and it is possible that the discrepancies result from unintentional errors. “We simply present the facts and then others can come to a conclusion.”
Some journals specializing in women's health told Nature that they are actively working to prevent problematic research publications. For example, a group of journal editors is fighting data falsification in the field of obstetrics and gynecology by sharing information about potentially inaccurate papers. The group also created a checklist of seven requirements that randomized controlled trials must meet in order to be published, such as approval by an ethics committee. If the authors of a study don't meet these requirements, "we won't publish it," says Vincenzo Berghella, editor-in-chief of the American Journal of Obstetrics & Gynecology Maternal-Fetal Medicine and a specialist in maternal and fetal health at Thomas Jefferson University in Philadelphia, Pennsylvania.
When problematic studies do appear in journals, follow-up after publication can be a "painstakingly difficult" process, says Žarko Alfirević, a specialist in fetal and maternal medicine at the University of Liverpool, UK. “The burden of proof has to be extremely high” for magazines to admit fraud has been committed, he says.
In order to reduce the damage caused by problematic studies in the medical literature, Alfirević, the editor, is committed Cochrane, a group that reviews medical evidence, for the introduction of trustworthiness assessments of randomized controlled trials as a prerequisite for authors to include them in systematic reviews.
The risk of faulty work compromising medical care is real, says Mol. An example is the 2017 study by Abbas and his colleagues on the use of progesterone to prevent miscarriages and the 2019 systematic review that incorporated that study. This same Cochrane review also incorporated a second study authored by a different group, which was also later retracted. Both papers contributed to the review's conclusion that progesterone supplements could reduce the risk of miscarriages in women who have had recurrent miscarriages. The review was cited in ten clinical guidelines.
It is now clear that, despite suggestions from the retracted studies, the additives are not effective for all women who have had recurrent miscarriages 6. The review's corresponding author, David Haas, an obstetrician-gynecologist at Indiana University in Indianapolis, says it is "very likely" that the two retractions will change the review's conclusion. He and his colleagues are now working to publish an updated version of the review that removes the retracted studies. A note on the current online version of the review says that the review authors have been informed that the study by Abbas and his colleagues is under investigation and that the review team has moved the study from the 'included studies' to the 'studies for classification'.
Another review, which included work by Abbas and his colleagues, is also being updated. The meta-analysis 7, published in 2023, analyzed work on a strategy that combines progesterone and cervical surgery to prevent preterm birth and concluded that the combination could be successful. There was also a study among the works analyzed 8 by Abbas and his co-authors, published in the International Journal of Gynecology & Obstetrics in 2020.
The journal retracted the paper in late 2023, noting that “inconsistencies were found within the dataset that call into question the validity of the data.” The authors of the meta-analysis say they are aware that Abbas' work has been retracted, and they are close to submitting an amended version that excludes the retracted paper. “Fortunately, removing this article from our meta-analysis did not affect the main result,” says corresponding author Craig Pennell, an obstetrician and gynecologist at the University of Newcastle in Australia.
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Ali, M. K., Ahmed, S. E., Sayed, G. H., Badran, E. Y. & Abbas, A. M. Int. J. Gynecol. Obstet. 149, 370-376 (2020).