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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,
    Addressing gender inequality in science: The multifaceted challenge of assessing impact Open PDF 
    (2017)
    Schmidt, E.K.
    ;
    Cacace, M.
    The analysis of the reasons behind the persistent under-representation of women in senior positions in science is well-developed. In contrast, the assessment of the impact of policies addressing the problem suffers from a lack of evidence and an oversimplification of approaches. Based on the assessment of 125 programs for gender equality implemented in research organizations in Europe, North America, and Australia, we argue that holistic approaches and multidimensional frames of reference are needed for impact assessment, also to improve program design and policy. Our analysis shows that the problem of gender inequality is rooted in so many and interrelated factors that program impact assessment has to be multidimensional and complex. Having a conceptual approach grounded in the notion of complexity as a point of departure, the article presents an innovative impact assessment tool, pointing to effective ways to assess the impact of gender equality programs. © The Author 2017. Published by Oxford University Press. All rights reserved.
  • 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.