Enhancing diversity in endometriosis clinical trials: Application of the clinical diversity scoring framework

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This paper applies the clinical diversity scoring framework to evaluate and enhance participant diversity in endometriosis clinical trials.

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This paper applies an existing clinical diversity scoring framework to endometriosis clinical trial designs, evaluating how trial characteristics and eligibility or enrollment factors map to measures of participant diversity. Using a structured framework approach, the authors report how the scoring system can be implemented for endometriosis studies to identify diversity-related gaps at the design level, while emphasizing that the evaluation depends on what diversity-relevant information is available in the trial descriptions. A key limitation explicitly acknowledged in such framework-based work is that the assessment reflects recorded trial parameters rather than confirmed participant demographics once the study is completed. This paper is centrally about endometriosis — it uses the clinical diversity scoring framework to enhance and quantify diversity considerations in endometriosis clinical trials.

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Enhancing diversity in endometriosis clinical trials: Application of the clinical diversity scoring framework Corresponding Author Klaire Irwin Office of Medical Student Research, Oklahoma State University Center for Health Sciences, Tulsa, Oklahoma, USA Correspondence Klaire Irwin, Office of Medical Student Research, Oklahoma State University Center for Health Sciences, 1111 W 17th St., Tulsa, OK 74107, USA. Email: [email protected] Search for more papers by this authorAbigail Dennis Office of Medical Student Research, Oklahoma State University Center for Health Sciences, Tulsa, Oklahoma, USA Search for more papers by this authorHaley Howard Office of Medical Student Research, Oklahoma State University Center for Health Sciences, Tulsa, Oklahoma, USA Search for more papers by this authorGarrett Jones Office of Medical Student Research, Oklahoma State University Center for Health Sciences, Tulsa, Oklahoma, USA Search for more papers by this authorChristian Hemmerich Office of Medical Student Research, Oklahoma State University Center for Health Sciences, Tulsa, Oklahoma, USA Search for more papers by this authorJ. Tyler Babek Office of Medical Student Research, Oklahoma State University Center for Health Sciences, Tulsa, Oklahoma, USA Search for more papers by this authorMackenzie Moody Department of Obstetrics and Gynecology, Oklahoma State University Medical Center, Tulsa, Oklahoma, USA Search for more papers by this authorAlicia Ito Ford Office of Medical Student Research, Oklahoma State University Center for Health Sciences, Tulsa, Oklahoma, USA Department of Psychiatry and Behavioral Sciences, Oklahoma State University Center for Health Sciences, Tulsa, Oklahoma, USA Search for more papers by this authorMatt Vassar Office of Medical Student Research, Oklahoma State University Center for Health Sciences, Tulsa, Oklahoma, USA Department of Psychiatry and Behavioral Sciences, Oklahoma State University Center for Health Sciences, Tulsa, Oklahoma, USA Search for more papers by this authorCorresponding Author Klaire Irwin Office of Medical Student Research, Oklahoma State University Center for Health Sciences, Tulsa, Oklahoma, USA Correspondence Klaire Irwin, Office of Medical Student Research, Oklahoma State University Center for Health Sciences, 1111 W 17th St., Tulsa, OK 74107, USA. Email: [email protected] Search for more papers by this authorAbigail Dennis Office of Medical Student Research, Oklahoma State University Center for Health Sciences, Tulsa, Oklahoma, USA Search for more papers by this authorHaley Howard Office of Medical Student Research, Oklahoma State University Center for Health Sciences, Tulsa, Oklahoma, USA Search for more papers by this authorGarrett Jones Office of Medical Student Research, Oklahoma State University Center for Health Sciences, Tulsa, Oklahoma, USA Search for more papers by this authorChristian Hemmerich Office of Medical Student Research, Oklahoma State University Center for Health Sciences, Tulsa, Oklahoma, USA Search for more papers by this authorJ. Tyler Babek Office of Medical Student Research, Oklahoma State University Center for Health Sciences, Tulsa, Oklahoma, USA Search for more papers by this authorMackenzie Moody Department of Obstetrics and Gynecology, Oklahoma State University Medical Center, Tulsa, Oklahoma, USA Search for more papers by this authorAlicia Ito Ford Office of Medical Student Research, Oklahoma State University Center for Health Sciences, Tulsa, Oklahoma, USA Department of Psychiatry and Behavioral Sciences, Oklahoma State University Center for Health Sciences, Tulsa, Oklahoma, USA Search for more papers by this authorMatt Vassar Office of Medical Student Research, Oklahoma State University Center for Health Sciences, Tulsa, Oklahoma, USA Department of Psychiatry and Behavioral Sciences, Oklahoma State University Center for Health Sciences, Tulsa, Oklahoma, USA Search for more papers by this authorCONFLICT OF INTEREST STATEMENT The authors have no conflicts of interest to declare. DATA AVAILABILITY STATEMENT This study was registered on Open Science Framework. https://osf.io/cm72h/?view_only=be5e2b0022074dc687ff5824044eb1a1. Supporting Information | Filename | Description | |---|---| | ijgo70590-sup-0001-Supinfo.docxWord 2007 document , 31.7 KB | Data S1. | Please note: The publisher is not responsible for the content or functionality of any supporting information supplied by the authors. Any queries (other than missing content) should be directed to the corresponding author for the article. REFERENCES - 1Bougie O, Nwosu I, Warshafsky C. Revisiting the impact of race/ethnicity in endometriosis. Reprod Fertil Dev. 2022; 3(2): R34-R41. 10.1530/RAF-21-0106Google Scholar - 2Jacoby VL, Fujimoto VY, Giudice LC, Kuppermann M, Washington AE. Racial and ethnic disparities in benign gynecologic conditions and associated surgeries. Am J Obstet Gynecol. 2010; 202(6): 514-521. - 3Agboola F, Wright AC. A framework for evaluating the diversity of clinical trials. J Clin Epidemiol. 2024; 169:111299. - 4DiVasta AD, Stamoulis C, Gallagher JS, Laufer MR, Anchan R, Hornstein MD. Nonhormonal therapy for endometriosis: a randomized, placebo-controlled, pilot study of cabergoline versus norethindrone acetate. Field Staff Rep. 2021; 2(4): 454-461. - 5Nodler JL, DiVasta AD, Vitonis AF, et al. Supplementation with vitamin D or ω-3 fatty acids in adolescent girls and young women with endometriosis (SAGE): a double-blind, randomized, placebo-controlled trial. Am J Clin Nutr. 2020; 112(1): 229-236. - 6Riley KA, Benton AS, Deimling TA, Kunselman AR, Harkins GJ. Surgical excision versus ablation for superficial endometriosis-associated pain: a randomized controlled trial. J Minim Invasive Gynecol. 2019; 26(1): 71-77. - 7Tandon HK, Stratton P, Sinaii N, Shah J, Karp BI. Botulinum toxin for chronic pelvic pain in women with endometriosis: a cohort study of a pain-focused treatment. Reg Anesth Pain Med. 2019; 44(9): 886-892. - 8Sweterlitsch KM, Meyer R, Ohayon A, et al. Clinical trial racial and ethnic disparities in minimally invasive gynecologic surgery. J Minim Invasive Gynecol. 2024; 31(5): 414-422. Article Metrics Total unique accesses to an article’s full text in HTML or PDF/ePDF format.More metric information Scite metrics Explore this article's citation statements on scite.ai Share QR Code Generating QR code QR code copied to clipboard! Something went wrong while generating your QR code. Please try again in a moment. If the issue persists, refresh the page or contact support. Export citation Unable to load citation data. Please try again in a moment. How to cite Elkins, L. J., & Spiegelman, M. (2021). pyUserCalc: A revised Jupyter notebook calculator for uranium-series disequilibria in basalts. 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