Reporting sex and gender with SAGER

The Sex and Gender Equity in Research guidelines support systematic reporting of sex and gender in study design, analysis, results and interpretation.

Scope and terminology

Overlooking sex and gender differences in research design, implementation, reporting and general science communication limits the generalisability of findings and their clinical applicability, particularly for women but also for men. ¹ The 2016 Sex and Gender Equity in Research (SAGER) guidelines primarily guide manuscript authors and also help editors incorporate assessment of sex and gender into manuscript evaluation. ¹

The guidelines recommend three general principles. ²

1. Use sex and gender carefully to avoid confusing the terms.
2. Where organisms can be differentiated by sex, design and conduct research so that it can reveal sex-related differences, even when none were initially expected.
3. Where subjects can also be differentiated by gender, as shaped by social and cultural circumstances, conduct research at this additional level of distinction.

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Sex should classify male or female on the basis of biological distinction to the extent that this can be confirmed, and sex should be the term used in animal studies. ² Cell-biological, molecular-biological and biochemical experiments should state the origin and sex-chromosome constitution of cells or tissue cultures. ² When devices or technology are tested in humans, authors should explain whether they will be used by all genders and whether testing considered the user’s gender. ²

Recommendations by manuscript section

Many studies are not designed to analyse sex or gender differences. ²

SAGER recommends the following reporting by section. ²

Section	Recommended reporting
Title and abstract	If only one sex is included, or results apply only to one sex or gender, specify the sex of animals and derived cells, tissues or other material, and the sex and gender of human participants.
Introduction	Report, where relevant, whether sex or gender differences may be expected.
Methods	Report how sex and gender informed study design, whether representation of males and females was adequate, and the justification for any exclusion of males or females.
Results	Present data disaggregated by sex and gender where appropriate; report sex- and gender-based analyses regardless of positive or negative outcomes, and disaggregate clinical-trial withdrawals and dropouts by sex.
Discussion	Discuss potential implications of sex and gender for results and analyses; if no sex or gender analysis was conducted, give the rationale and discuss what its absence means for interpretation.

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