Among the ten prescription pharmaceuticals withdrawn from the US market between 19, eight caused greater harm to women than men. The underrepresentation of women in research can result in adverse consequences. More than 79 % of animal studies published in Pain over a 10-year period included male subjects only, and only 4 % studied sex differences. More importantly, among trials recruiting both men and women, only one third reported a gender-based analysis.
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A review of cardiovascular treatment trials included in Cochrane Reviews reveals that only 27 % of the total trial participants in the 258 clinical trials were women. The gap in the representation of women in studies on human subjects has been well-documented. Sex and gender bias in the conduct of researchĭespite recognition of the importance of sex and gender in most areas of research, important knowledge gaps persist owing to the general orientation of scientific attention to one sex or gender category and because of a misconception that disaggregation of sex does not apply to other living organisms that can be classified by sex. Thus, sex and gender are critical determinants of health. In addition, it is well-known that pharmacokinetics and pharmacodynamics of pharmaceutical agents differ between sexes, resulting in differential adverse event profiles and further impacting treatment outcomes. They both impact environmental and occupational risks, risk-taking behaviours, access to health care, health-seeking behaviour, health care utilization, and perceived experience with health care, and thus disease prevalence and treatment outcome. Sex and gender interactions influence health and well-being in a variety of ways. A glossary of terms is provided in Appendix 1 to define the meaning of sex, gender and related terms. In reality, there is a spectrum of gender identities and expressions defining how individuals identify themselves and express their gender. Gender is usually incorrectly conceptualized as a binary (female/male) factor. It influences how people perceive themselves and each other, how they behave and interact and the distribution of power and resources in society. Gender refers to the socially constructed roles, behaviours and identities of female, male and gender-diverse people. Sex is usually categorized as female or male, although there is variation in the biological attributes that constitute sex and how those attributes are expressed. Sex refers to a set of biological attributes in humans and animals that are associated with physical and physiological features including chromosomes, gene expression, hormone function and reproductive/sexual anatomy.
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Sex and gender are important determinants of health and well-being. The SAGER guidelines are designed primarily to guide authors in preparing their manuscripts, but they are also useful for editors, as gatekeepers of science, to integrate assessment of sex and gender into all manuscripts as an integral part of the editorial process.
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The Sex and Gender Equity in Research (SAGER) guidelines are a comprehensive procedure for reporting of sex and gender information in study design, data analyses, results and interpretation of findings. An internet survey of 716 journal editors, scientists and other members of the international publishing community was conducted as well as a literature search on sex and gender policies in scientific publishing.
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MethodsĪ panel of 13 experts representing nine countries developed the guidelines through a series of teleconferences, conference presentations and a 2-day workshop. This article describes the rationale for an international set of guidelines to encourage a more systematic approach to the reporting of sex and gender in research across disciplines. This oversight limits the generalizability of research findings and their applicability to clinical practice, in particular for women but also for men. Sex and gender differences are often overlooked in research design, study implementation and scientific reporting, as well as in general science communication.