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  • Item type:Publication,
    Trial characteristics associated with under-enrolment of females in randomized controlled trials of heart failure with reduced ejection fraction: a systematic review Open PDF 
    (2021)
    Whitelaw, Sera
    ;
    Sullivan, Kristen
    ;
    Eliya, Yousif
    ;
    Alruwayeh, Mohammad
    ;
    Thabane, Lehana
    AIMS: To evaluate temporal trends in the enrolment of females in randomized controlled trials (RCTs) of heart failure with reduced ejection fraction (HFrEF) published in high-impact journals, and assess RCT characteristics associated with under-enrolment. METHODS AND RESULTS: We searched MEDLINE, EMBASE and CINAHL for studies published from January 2000 to May 2019 in journals with impact factor ≥10. We included RCTs that recruited adults with HFrEF. We used a 20% threshold below the sex distribution of HFrEF to define under-enrolment. We used multivariable logistic regression to assess trial characteristics independently associated with under-enrolment. We included 317 RCTs. Among the 183 097 participants, mean (standard deviation) age was 63.0 (7.0) years and 25.5% were female. Females were under-enrolled in 71.6% [95% confidence interval (CI) 66.6-76.6%] of the RCTs; enrolment did not increase significantly between 2000-2019. Sex-related eligibility criteria [odds ratio (OR) 2.05, 95% CI 1.01-4.16; P = 0.046]; recruitment in ambulatory settings (OR 2.56, 95% CI 1.37-4.81; P = 0.003); trial coordination in North America (OR 4.44, 95% CI 1.09-18.07; P = 0.037), Europe (OR 6.79, 95% CI 1.63-27.39; P = 0.018) and Asia (OR 9.33, 95% CI 1.40-12.40; P = 0.033); drug (OR 1.76, 95% CI 1.96-7.36; P < 0.001) and device/surgical interventions (OR 1.69, 95% CI 1.16-9.43; P = 0.002); and men in first and last authorship position (OR 1.32, 95% CI 1.12-3.54; P = 0.047) were associated with under-enrolment of females. CONCLUSIONS: Females were under-enrolled relative to disease distribution in a majority of high-impact HFrEF RCTs, with no change in temporal trends between 2000 and 2019. Trial characteristics and gender of trial leaders were associated with under-enrolment.
  • Item type:Publication,
    Analysis of Authorship in Hepatopancreaticobiliary Surgery: Women Remain Underrepresented Open PDF 
    (2020)
    Farooq, Ayesha
    ;
    Sahara, Kota
    ;
    Muneeb, Aeman
    ;
    Farooq, Khadija
    ;
    Tsilimigras, Diamantis I.
    INTRODUCTION: Given the need to increase female representation in hepatopancreatobiliary (HPB) surgery, as well as the need to increase the academic pipeline of women in this subspecialty, we sought to characterize the prevalence of female authorship in the HPB literature. In particular, the objective of the current study was to determine the proportion of women who published HPB research articles as first, second, or last author over the last decade. METHODS: All articles pertaining to hepatopancreaticobiliary (HPB) surgery appearing in seven surgical journals (Annals of Surgery, British Journal of Surgery, JAMA Surgery, Annals of Surgical Oncology, HPB (Oxford), Surgery, and Journal of Gastrointestinal Surgery) were reviewed for the years 2008 and 2018. Information on sex of author, country of author's institution, and article type was collected and entered into a computerized database. RESULTS: Among the 1473 index articles included in the final analytic cohort, 414 (28%) publications had a woman as the first or last author, while the vast majority (n = 1,059, 72%) had a man as the first or last author. The number of female first authors increased from 15.6% (n = 92/591) in 2008 to 25.7% (n = 227/882) in 2018 (p < 0.001). There were no differences in the proportion of second (n = 123/536, 23.0% vs n = 214/869, 24.6%, p = 0.47) or last (n = 44/564, 7.8% vs n = 88/875, 10.1%, p = 0.15) authors. Women were more likely to publish papers appearing in medium-impact journals (OR 1.40, 95% CI 1.04-1.88) and articles with a female author were more likely to be from a North American institution (referent: North America, Asia OR 0.43, 95% CI 0.31-0.59 vs Europe OR 0.67, 95% CI 0.51-0.87). CONCLUSION: Women first/last authors in HPB research articles have increased over the past 10 years from 22 to 32%. Women as last authors remain low, however, as only 1 in 10 papers had a senior woman author. These data should prompt HPB leaders to find solutions to the gap in female authorship including mentorship of young female researchers and surgeons.
  • 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.