Sex or Gender? An Endless question

Many authors of medical articles face difficulties when it comes to incorporating sex and gender information in their reports, particularly when discussing differences among study participants or when labeling tables in their manuscripts. Sex and gender play crucial roles in determining health and well-being. It is widely recognized that the way pharmaceutical agents are processed and their effects vary between sexes, resulting in different adverse event profiles and ultimately influencing treatment outcomes.

The most recent recommendation by the International Committee of Medical Journal Editors (ICMJE) advises authors to consult the SAGER guidelines for reporting sex and gender information in study design, data analysis, results, and interpretation of findings. According to the SAGER guidelines, it is important to use the terms “sex” and “gender” carefully to avoid confusion. Sex refers to biological characteristics in humans and animals, encompassing chromosomes, gene expression, hormone function, and reproductive/sexual anatomy. It is typically classified as female or male. On the other hand, gender refers to socially constructed roles, behaviors, and identities associated with female, male, and gender-diverse individuals. It influences self-perception, interpersonal interactions, and the distribution of power and resources in society. When referring to animals in research, the term “sex” should be used.

The SAGER guidelines are intended to promote consistent reporting of sex and gender in research. They provide researchers and authors with a framework for standardizing the inclusion of sex and gender information in scientific publications. SAGER encourages authors, editors, and referees to consider the relevance of sex and gender to the study title. In the Introduction section, authors should indicate whether sex and/or gender differences are anticipated. In the Methods section, authors should explain how they accounted for sex and gender in the study design and justify any exclusions of males or females. In the Results section, data should be presented separately for each sex and gender whenever appropriate. Sex- and gender-based analyses should be reported regardless of whether the outcomes are positive or negative. In clinical trials, information about participant withdrawals and dropouts should also be reported separately for each sex. Finally, in the Discussion section, authors should explore the potential implications of sex and gender on the study results and analyses.

Reference: Heidari, S., Babor, T.F., De Castro, P. et al. Sex and Gender Equity in Research: rationale for the SAGER guidelines and recommended use. Res Integr Peer Rev 1, 2 (2016). https://doi.org/10.1186/s41073-016-0007-6