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ORIGINAL RESEARCH article

Front. Psychiatry
Sec. Public Mental Health
Volume 15 - 2024 | doi: 10.3389/fpsyt.2024.1448487
This article is part of the Research Topic New Approaches for Improving Equity in Mental Health Research, Treatment, and Policy View all 17 articles

An expert perspective on diversity-oriented standards for assessing sex and gender in clinical research

Provisionally accepted
Hannah R. Hambruch Hannah R. Hambruch 1Nora M. Laskowski Nora M. Laskowski 1*Robert-Paul Juster Robert-Paul Juster 2Georg Halbeisen Georg Halbeisen 1Georgios Paslakis Georgios Paslakis 1
  • 1 University Clinic for Psychosomatic Medicine and Psychotherapy, Medical Faculty, Campus East-Westphalia, Ruhr-University Bochum, Luebbecke, Germany
  • 2 Research Center, Montreal University Institute of Mental Health, Montreal, Canada

The final, formatted version of the article will be published soon.

    Introduction: Randomized controlled trials require diverse patient groups to ensure broad applicability of results. However, gender minorities are often not included, which affects the generalizability and equity of healthcare outcomes. Inclusive research must consider the diversity of sex and gender to eliminate inequalities and improve health outcomes.Methods: A two-stage expert survey was conducted using a self-developed questionnaire in which the constructs of sex, gender, and gender expression were considered. Experts rated the importance and practicality of assessing these concepts in clinical trials and evaluated terms for suitability and comprehension. In addition, existing definitions were refined. Consensus was defined as 70% agreement or disagreement.Results: 14 out of 17 participating experts agreed on the importance to independently assess sex assigned at birth, and 9 out of 16 emphasized this for gender identity in clinical trials. Sex should be assessed with "Please specify your sex assigned at birth" and the answer categories "female", "male", "intersex". Gender identity should be assessed with "I identify as…" and the answer categories "woman", "man", "nonbinary", "trans woman", "trans man", "genderqueer", "genderfluid", "agender", "two spirit". Assessment of gender expression depends on the research question and may not be relevant for every study.Discussion: Our findings emphasize inclusivity by providing multiple gender options and improve data accuracy by allowing individuals to accurately report their gender identity. The results emphasize the importance of distinguishing between sex assigned at birth, gender identity, and gender expression in research. This ensures that gender diversity is accurately represented and considered, improving the relevance and inclusivity of clinical trials.

    Keywords: expert study1, diversity2, guidelines3, LGTB+4, LGBTQ+5, gender6, survey7

    Received: 13 Jun 2024; Accepted: 25 Nov 2024.

    Copyright: © 2024 Hambruch, Laskowski, Juster, Halbeisen and Paslakis. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.

    * Correspondence: Nora M. Laskowski, University Clinic for Psychosomatic Medicine and Psychotherapy, Medical Faculty, Campus East-Westphalia, Ruhr-University Bochum, Luebbecke, Germany

    Disclaimer: All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article or claim that may be made by its manufacturer is not guaranteed or endorsed by the publisher.