Underrepresentation of women in cardiovascular disease clinical Trials—What’s in a Name?

Background: Cardiovascular disease is the leading cause of death in women worldwide. Yet, women are often underrepresented in cardiovascular clinical trials. Trial characteristics may influence the participation of women. For instance, trials are often entitled with an acronym, which might be percei...

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Main Authors: A.E. Spiering, A.M.L.N. van Ommen, J.E. Roeters van Lennep, Y. Appelman, K. Reue, N.C. Onland-Moret, H.M. den Ruijter
Format: Article
Language:English
Published: Elsevier 2024-12-01
Series:International Journal of Cardiology: Heart & Vasculature
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Online Access:http://www.sciencedirect.com/science/article/pii/S2352906724002136
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author A.E. Spiering
A.M.L.N. van Ommen
J.E. Roeters van Lennep
Y. Appelman
K. Reue
N.C. Onland-Moret
H.M. den Ruijter
author_facet A.E. Spiering
A.M.L.N. van Ommen
J.E. Roeters van Lennep
Y. Appelman
K. Reue
N.C. Onland-Moret
H.M. den Ruijter
author_sort A.E. Spiering
collection DOAJ
description Background: Cardiovascular disease is the leading cause of death in women worldwide. Yet, women are often underrepresented in cardiovascular clinical trials. Trial characteristics may influence the participation of women. For instance, trials are often entitled with an acronym, which might be perceived as gendered. We aimed to investigate if the perceived gender of the acronym and other trial characteristics affect the representation of female patients in cardiovascular trials. Methods: We searched ClinicalTrials.gov for randomized controlled trials in cardiovascular disease named with an acronym. Cardiovascular patients (n = 148) scored the perceived gender of the acronym of 148 identified trials. Prevalence ratios (PR) were calculated with Poisson regression to link trial characteristics to representation of female patients in the trials. Results: In 62 % of trials, female patients were underrepresented relative to the disease population. There was no improvement over time in proportion of trials with adequate representation. A third of acronyms was classified as gendered. The perceived gender did not affect representation of female patients (PR 1.01; 95% CI 0.95 – 1.08; P = 0.68). A woman as first and/or last author (PR 1.22; 95% CI 1.07 – 1.38; P = 0.002) and recruitment in an outpatient setting (PR 1.15; 95% CI 1.02 – 1.29; P = 0.01) were associated with a higher prevalence of adequate representation of female patients. Conclusions: Representation of female patients in cardiovascular trials does not depend on the perceived gender of the trial acronym but is improved in trials under female leadership in out-patient settings. Our findings may direct efforts towards increasing representation of female patients in cardiovascular trials.
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spelling doaj-art-af8b17648b3746a5ae6232bc4b91083c2025-08-20T01:54:12ZengElsevierInternational Journal of Cardiology: Heart & Vasculature2352-90672024-12-015510154710.1016/j.ijcha.2024.101547Underrepresentation of women in cardiovascular disease clinical Trials—What’s in a Name?A.E. Spiering0A.M.L.N. van Ommen1J.E. Roeters van Lennep2Y. Appelman3K. Reue4N.C. Onland-Moret5H.M. den Ruijter6Laboratory of Experimental Cardiology, University Medical Center Utrecht, Utrecht University, Utrecht, the Netherlands; Department of Human Genetics, David Geffen School of Medicine, University of California Los Angeles, Los Angeles, United StatesLaboratory of Experimental Cardiology, University Medical Center Utrecht, Utrecht University, Utrecht, the NetherlandsDepartment of Internal Medicine, Erasmus Medical Center, Rotterdam, the NetherlandsDepartment of Cardiology, Heart Center, Amsterdam UMC – Vrije Universiteit Amsterdam, Amsterdam Cardiovascular Sciences, Amsterdam, the NetherlandsDepartment of Human Genetics, David Geffen School of Medicine, University of California Los Angeles, Los Angeles, United StatesDepartment of Epidemiology, Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University, Utrecht, the NetherlandsLaboratory of Experimental Cardiology, University Medical Center Utrecht, Utrecht University, Utrecht, the Netherlands; Corresponding author.Background: Cardiovascular disease is the leading cause of death in women worldwide. Yet, women are often underrepresented in cardiovascular clinical trials. Trial characteristics may influence the participation of women. For instance, trials are often entitled with an acronym, which might be perceived as gendered. We aimed to investigate if the perceived gender of the acronym and other trial characteristics affect the representation of female patients in cardiovascular trials. Methods: We searched ClinicalTrials.gov for randomized controlled trials in cardiovascular disease named with an acronym. Cardiovascular patients (n = 148) scored the perceived gender of the acronym of 148 identified trials. Prevalence ratios (PR) were calculated with Poisson regression to link trial characteristics to representation of female patients in the trials. Results: In 62 % of trials, female patients were underrepresented relative to the disease population. There was no improvement over time in proportion of trials with adequate representation. A third of acronyms was classified as gendered. The perceived gender did not affect representation of female patients (PR 1.01; 95% CI 0.95 – 1.08; P = 0.68). A woman as first and/or last author (PR 1.22; 95% CI 1.07 – 1.38; P = 0.002) and recruitment in an outpatient setting (PR 1.15; 95% CI 1.02 – 1.29; P = 0.01) were associated with a higher prevalence of adequate representation of female patients. Conclusions: Representation of female patients in cardiovascular trials does not depend on the perceived gender of the trial acronym but is improved in trials under female leadership in out-patient settings. Our findings may direct efforts towards increasing representation of female patients in cardiovascular trials.http://www.sciencedirect.com/science/article/pii/S2352906724002136Cardiovascular diseaseClinical trialsFemale representationTrial acronymFemale authorshipPerceived gender
spellingShingle A.E. Spiering
A.M.L.N. van Ommen
J.E. Roeters van Lennep
Y. Appelman
K. Reue
N.C. Onland-Moret
H.M. den Ruijter
Underrepresentation of women in cardiovascular disease clinical Trials—What’s in a Name?
International Journal of Cardiology: Heart & Vasculature
Cardiovascular disease
Clinical trials
Female representation
Trial acronym
Female authorship
Perceived gender
title Underrepresentation of women in cardiovascular disease clinical Trials—What’s in a Name?
title_full Underrepresentation of women in cardiovascular disease clinical Trials—What’s in a Name?
title_fullStr Underrepresentation of women in cardiovascular disease clinical Trials—What’s in a Name?
title_full_unstemmed Underrepresentation of women in cardiovascular disease clinical Trials—What’s in a Name?
title_short Underrepresentation of women in cardiovascular disease clinical Trials—What’s in a Name?
title_sort underrepresentation of women in cardiovascular disease clinical trials what s in a name
topic Cardiovascular disease
Clinical trials
Female representation
Trial acronym
Female authorship
Perceived gender
url http://www.sciencedirect.com/science/article/pii/S2352906724002136
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