PUBBLICAZIONE/PUBLICATION

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  • Item type:Publication,
    Gender gap in cardiothoracic surgery randomized controlled trial and post-hoc analysis of randomized controlled trial authorship from 2014 to 2020 Open PDF 
    (2024)
    Shariff, Mariam
    ;
    Kumar, Ashish
    ;
    Stulak, John
    ;
    Naumann, Kathryn E.
    ;
    Blackmon, Shanda H.
    OBJECTIVES: To estimate gender disparities among first and last authorships in cardiothoracic randomized controlled trials (RCTs) and association of gender with publications in high-impact journals. METHODS: PubMed/MEDLINE database was searched from 1 January 2014 to 31 December 2020 using R statistical software via the 'easyPubMed' package to retrieve pertinent data. The 'gender' package was utilized to determine gender using the United States Social Security Administration Baby Name Data. The percentage of female first and last authors were computed along with determining the uniqueness of the names. The association of gender and publication in high-impact peer-reviewed journals was delineated. Jonckheere's trend was computed. RESULTS: The database search retrieved a total of 4820 RCTs, of which gender was encoded for the first author in 3247 (67%) RCTs, among which 911 (28%) studies had women as first authors, with a similar trend across 7 years (P = 0.23). Gender was encoded for the last author of 3204 (66%) RCTs, of which 622 (19%) studies had women as last authors, with a similar trend across 7 years (P = 0.45). A total of 627 studies were published in high-impact-factor journals, among which 79 (16%) studies had female first authors and 67 (13%) studies had female last authors. CONCLUSIONS: There is an obvious gender disparity of first and last authors in cardiothoracic surgery-related RCTs, with a similar trend across 7 years. However, the post-hoc analysis did demonstrate a positive trend with an increase in the number of female first authors, demonstrating progress.
  • Item type:Publication,
    The Persistence of Sex Bias in High-Impact Clinical Research Open PDF 
    (2022)
    Barlek, Mark H.
    ;
    Rouan, Jessica R.
    ;
    Wyatt, Thomas G.
    ;
    Helenowski, Irene
    ;
    Kibbe, Melina R.
    INTRODUCTION: Sex bias is present in clinical research resulting in disparities in the treatment of women. Our objective was to identify the prevalence of sex inclusiveness of participants in human clinical trials after the passage of National Institutes of Health (NIH) and United States Congress policies in 2015 and 2016 to increase female enrollment in clinical research. METHODS: We performed an observational analysis of data from registered clinical trials published in three high-impact biomedical journals from January 1, 2015 to December 31, 2019. RESULTS: One thousand four hundred and forty two manuscripts with 4,765,783 human subjects were included for analysis. Significantly more males (56%) than females (44%) were included in all three journals (P < 0.0001). Sex matching ≥ 80% was found in 24.6% of publications. Industry funded 43.7% of all studies enrolling significantly more males than females (60.8% versus 39.2%, P < 0.0001). NIH funded 10.2% of studies enrolling significantly more females than males (52.7% versus 47.3%, P < 0.0001). North America and Europe contributed 82.6% of the studies with each enrolling significantly more males than females (P < 0.0001). The United States was the country contributing the most studies (36.1%), enrolling significantly more males than females (55.5% versus 45.5%, P < 0.0001). Cardiovascular disease was the subject area of the most manuscripts among medical specialties (19%), enrolling significantly more males than females (64.9% versus 35.1%, P < 0.0001). Studies analyzed by clinical trial phase, type, trial, and allocation enrolled significantly more males than females (P < 0.0001). CONCLUSIONS: Sex bias remains prevalent in human clinical research trials. Improvements have been made in NIH-funded clinical trials; however, this constitutes a small percentage of overall studies.