An expert perspective on diversity-oriented standards for assessing sex and gender in clinical research
IntroductionRandomized 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...
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Frontiers Media S.A.
2025-01-01
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| Series: | Frontiers in Psychiatry |
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| Online Access: | https://www.frontiersin.org/articles/10.3389/fpsyt.2024.1448487/full |
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| author | Hannah R. Hambruch Nora M. Laskowski Robert-Paul Juster Georg Halbeisen Georgios Paslakis |
| author_facet | Hannah R. Hambruch Nora M. Laskowski Robert-Paul Juster Georg Halbeisen Georgios Paslakis |
| author_sort | Hannah R. Hambruch |
| collection | DOAJ |
| description | IntroductionRandomized 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.MethodsA 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.Results14 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.DiscussionOur 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. |
| format | Article |
| id | doaj-art-49e62178643b45faa0eb950b631c0558 |
| institution | Kabale University |
| issn | 1664-0640 |
| language | English |
| publishDate | 2025-01-01 |
| publisher | Frontiers Media S.A. |
| record_format | Article |
| series | Frontiers in Psychiatry |
| spelling | doaj-art-49e62178643b45faa0eb950b631c05582025-01-29T06:46:18ZengFrontiers Media S.A.Frontiers in Psychiatry1664-06402025-01-011510.3389/fpsyt.2024.14484871448487An expert perspective on diversity-oriented standards for assessing sex and gender in clinical researchHannah R. Hambruch0Nora M. Laskowski1Robert-Paul Juster2Georg Halbeisen3Georgios Paslakis4University Clinic for Psychosomatic Medicine and Psychotherapy, Medical Faculty, Ruhr-University Bochum, Luebbecke, GermanyUniversity Clinic for Psychosomatic Medicine and Psychotherapy, Medical Faculty, Ruhr-University Bochum, Luebbecke, GermanyResearch Center of the Institut Universitaire en Santé Mentale de Montréal, Department of Psychiatry and Addiction, Université de Montréal, Montréal, QC, CanadaUniversity Clinic for Psychosomatic Medicine and Psychotherapy, Medical Faculty, Ruhr-University Bochum, Luebbecke, GermanyUniversity Clinic for Psychosomatic Medicine and Psychotherapy, Medical Faculty, Ruhr-University Bochum, Luebbecke, GermanyIntroductionRandomized 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.MethodsA 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.Results14 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.DiscussionOur 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.https://www.frontiersin.org/articles/10.3389/fpsyt.2024.1448487/fullexpert studydiversityguidelinesLGTB+LGBTQ+gender |
| spellingShingle | Hannah R. Hambruch Nora M. Laskowski Robert-Paul Juster Georg Halbeisen Georgios Paslakis An expert perspective on diversity-oriented standards for assessing sex and gender in clinical research Frontiers in Psychiatry expert study diversity guidelines LGTB+ LGBTQ+ gender |
| title | An expert perspective on diversity-oriented standards for assessing sex and gender in clinical research |
| title_full | An expert perspective on diversity-oriented standards for assessing sex and gender in clinical research |
| title_fullStr | An expert perspective on diversity-oriented standards for assessing sex and gender in clinical research |
| title_full_unstemmed | An expert perspective on diversity-oriented standards for assessing sex and gender in clinical research |
| title_short | An expert perspective on diversity-oriented standards for assessing sex and gender in clinical research |
| title_sort | expert perspective on diversity oriented standards for assessing sex and gender in clinical research |
| topic | expert study diversity guidelines LGTB+ LGBTQ+ gender |
| url | https://www.frontiersin.org/articles/10.3389/fpsyt.2024.1448487/full |
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