Sex and Gender in Urological Research

You have accessJournal of UrologyJU Forum1 Apr 2024Sex and Gender in Urological Research Kiera Liblik and D. Robert Siemens Kiera LiblikKiera Liblik https://orcid.org/0000-0003-1385-9298 and D. Robert SiemensD. Robert Siemens Corresponding Author: D. Robert Siemens, MD, FRCSC, Department of Urology, Queen's University, Kingston Health Science Center, 76 Stuart St, Kingston, Ontario , CanadaK7L 1B9 ([email protected]) https://orcid.org/0000-0002-3203-6468 View All Author Informationhttps://doi.org/10.1097/JU.0000000000003852AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookTwitterLinked InEmail In 1977, the Food and Drug Administration released a guideline recommending the exclusion of women of childbearing age as research participants in phase 1/2 clinical trials.1 Though the guideline was reversed in 1993, it is part of a complex history of the exclusion of female participants in clinical research.2 This is reflected by a paucity of sex- and gender-based analysis (SGBA) in biomedical publications. This is both a societal and scientific oversight, as SGBA plays a critical role in understanding disease pathophysiology, treatment response, and disparities in the delivery of care. More recently, research advocacy groups and funding organizations have made efforts to counter these disparities in SGBA. The Sex and Gender Equity in Research (SAGER) guidelines were released in 2016 to guide SGBA and assess its effective implementation.3 It is unclear to what degree SGBA is currently implemented in urological research, given its expanding role in assessing disease processes and treatments that include sex- and gender-diverse participants.4 We therefore undertook an analysis of all interventional and observational studies published from January 2019 to July 2023 in a diverse number of urological research publications including The Journal of Urology®, Canadian Urological Association Journal, BJU International, Urology, European Urology, and BMC Urology. Articles published in 2022 and 2023 were further assessed based on the SAGER guidelines checklist following its release in 2022.5 The checklist provides guidance for researchers and journal reviewers/editors to enhance the consideration of SGBA in publications. In this assessment of sex-based analysis, articles were included if the topic applied to both female and male patients.4 A total of 4702 original research articles were analyzed for eligibility, and the included articles (n = 1704) had a pooled 23,333,793 participants (50% male, 42% female, 8% sex not reported). Topics with the highest proportion of articles that did not report sex/gender were urethroplasty (73%), congenital anomalies (50%), and urolithiasis (22%). Topics with the highest percentages of male participants included cystectomy (75%), urological trauma (63%), and pyeloplasty (59%). Conversely, topics with the greatest proportion of female patients were urological infections (86%), pelvic pain syndromes (69%), and overactive bladder/incontinence (60%). The proportion of female participants by year was the highest in 2020 (53%) and the lowest in 2019 (27%), with no temporal trends identified. In those studies that reported sex, inclusion of male vs female participants has generally been representative of the target populations. It is important to note, however, that 8% of studies did not report sex, which would seem to be unacceptably high given that articles included in this subanalysis were only selected if the condition studied applied to male and female patients. This speaks to a need for journals to continue to advocate for inclusion of this information during the review process, requiring sex- and gender-based reporting where applicable. It was unclear to what degree gender was assessed in the majority of articles, given that only 42% of articles used sex and gender terminology appropriately. Assessment of the inclusion of gender-based analysis was based on the methodology description of how patient demographics were extracted. Accordingly, most articles discussing "gender" differences were, based on our observations, analyzing sex differences. Most articles that analyzed patient gender (n = 64) did so in the context of gender-affirming and transgender care (n = 58). It is crucial to note that gender is a social determinant of health in all realms of urology, not just gender-affirming care. The exclusion of patient gender in clinical research as well as the misuse of sex/gender terminology implies a lack of understanding of the importance of gender as a part of patient identity and as a social determinant of health. From a research standpoint, it should be an expectation that accurate terminology is used when reporting patient demographics as it substantially limits the ability to compare sex and gender outcomes when it is unclear which is being reported. This, then, becomes a barrier to analyses such as a systematic review that relies on the accuracy of previously published data. The SAGER checklist was next applied to all articles published in the past 2 years since its release. The purpose of this checklist is to provide a reference document for the proper implementation of SGBA in biomedical research, as well as a tool for editorial teams to assess submissions for appropriate inclusion of sex and gender reporting. The checklist is subdivided by article section, including article abstracts.3 Based on the included articles that did assess sex and/or gender, 13% of titles/abstracts, 6% of introductions, 8% of methods, 28% of results, and 18% of discussions/conclusions met checklist criteria (Table). Observational studies were more likely to adhere to SAGER guidelines than interventional studies for all article sections. It is clear from the application of the SAGER checklist that principles of SGBA are suboptimally implemented in the current urological literature. This likely reflects both a lack of historical emphasis on the importance of SGBA, as well as limited awareness of standards of sex- and gender-based reporting. Though organizations such as the Food and Drug Administration began to call for sex/gender equity in research in the early 1990s, it is a relatively new area of focus in mainstream clinical research, with funding organizations and journals only beginning to implement SGBA analysis standards. Table. Sex and Gender Equity in Research Guideline Compliance for 2022 and 2023 Articles 2022 2023 Interventional studies Observational studies Interventional studies Observational studies Total studies assessed 62 284 34 143 SAGER guideline compliance, No. (%)a Title/abstract 5 (8) 35 (12) 5 (15) 21 (15) Introduction 2 (3) 22 (8) 1 (3) 5 (3) Methods 3 (5) 22 (8) 2 (6) 13 (9) Results 4 (6) 97 (34) 4 (12) 43 (30) Discussion/conclusion 5 (8) 59 (21) 2 (6) 28 (20) Sex/gender used appropriately 29 (47) 118 (42) 14 (41) 64 (45) Abbreviations: SAGER, Sex and Gender Equity in Research. Based on the 2022 SAGER guidelines checklist. The present study is the first to investigate the representation of female participants as well as SGBA in urology research.4 Despite increasing understanding of the social and scientific benefits of these more inclusive research guidelines, there remains substantial heterogeneity in SGBA in urology. It is the responsibility of researchers, editorial teams, reviewers, publishers, and funding organizations alike to collaborate to expedite the adoption of these standards with the goal of improved patient care, scientific knowledge, accurate data reporting, and the development of an equity-focused research culture (Figure). Figure. Practical advice to enhance sex- and gender-based analysis in urological publications. Download PPT REFERENCES 1. Food and Drug Administration. General Considerations for the Clinical Evaluation of Drugs. Vol 77. Publication No. (FDA) 77-3040. Department of Health, Education, and Welfare; 1977. Google Scholar 2. Food and Drug Administration. Guideline for the study and evaluation of gender differences in the clinical evaluation of drugs; notice. Fed Regist. 1993; 58(139):39406-39416. Medline, Google Scholar 3. . Sex and Gender Equity in Research: rationale for the SAGER guidelines and recommended use. Res Integr Peer Rev. 2016; 1:2. Crossref, Medline, Google Scholar 4. . The Sex and Gender Equity in Research (SAGER) guidelines: implementation and checklist development. Eur Sci Ed. 2022; 48:e86910. Crossref, Google Scholar 5. . COVID, cancer and sexual dimorphism. J Urol. 2022; 207(1):12-13. Link, Google Scholar Recusal: Dr Siemens is the editor of The Journal of Urology® and was recused from the editorial and peer review processes. Funding/Support: None. Conflict of Interest Disclosures: The Authors have no conflicts of interest to disclose. Ethics Statement: This study was deemed exempt from Institutional Review Board review as it assessed only publicly available data. Author Contributions:Conception and design: Siemens, Liblik. Data analysis and interpretation: Liblik. Data acquisition: Siemens, Liblik. Drafting the manuscript: Siemens, Liblik. Statistical analysis: Siemens, Liblik. Submission History: This manuscript has not been previously published and is not under consideration in the same or substantially similar form in any other journal. © 2024 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 211Issue 4April 2024Page: 617-619 Advertisement Copyright & Permissions© 2024 by American Urological Association Education and Research, Inc.Metrics Author Information Kiera Liblik More articles by this author D. Robert Siemens Corresponding Author: D. Robert Siemens, MD, FRCSC, Department of Urology, Queen's University, Kingston Health Science Center, 76 Stuart St, Kingston, Ontario , CanadaK7L 1B9 ([email protected]) More articles by this author Expand All Recusal: Dr Siemens is the editor of The Journal of Urology® and was recused from the editorial and peer review processes. Funding/Support: None. Conflict of Interest Disclosures: The Authors have no conflicts of interest to disclose. Ethics Statement: This study was deemed exempt from Institutional Review Board review as it assessed only publicly available data. Author Contributions:Conception and design: Siemens, Liblik. Data analysis and interpretation: Liblik. Data acquisition: Siemens, Liblik. Drafting the manuscript: Siemens, Liblik. Statistical analysis: Siemens, Liblik. Submission History: This manuscript has not been previously published and is not under consideration in the same or substantially similar form in any other journal. 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