SAGER Guidelines Explained: Reporting Sex and Gender in an Original Research Article, Item by Item

The SAGER guidelines (Sex and Gender Equity in Research) are reporting standards that tell authors how to describe sex and gender in a scientific paper. A working group of the European Association of Science Editors developed them and published them in 2016, which is why they are sometimes called the EASE guidelines for sex and gender [1]. For decades, much research either ignored sex and gender or assumed that findings in one group applied to everyone. That gap in equity in research limits how far results can be generalised and can hide differences in safety and effect [1].

The guidelines rest on one distinction: sex refers to biological attributes, while gender refers to socially constructed roles, behaviours and identities. Use the two terms carefully and do not swap one for the other [1]. Ten years on, EASE estimates that around 9,000 journals have adopted SAGER, including the Lancet, BMJ, Nature and Cell [5]. Having the SAGER guidelines explained item by item shows exactly where sex and gender belong in a manuscript.

SAGER begins at the top of the paper. If a study includes only one sex, or its results apply to only one sex or gender, the title and abstract should say so. That means the sex of animals, cells or tissues, and the sex and gender of human participants [1]. Write “a cohort of postmenopausal women”, not a neutral label that hides the restriction. A good test: could a reader tell from your abstract alone which population your results apply to?

The introduction sets expectations. SAGER asks authors to report, where relevant, whether sex and/or gender differences may be expected in the condition under study [1]. Ground that expectation in prior evidence. If differences are plausible, the general principle applies: design the research so that it can reveal them [1]. This item makes sex and gender scientific variables from the outset, which strengthens the rationale for any planned gender analysis.

The methods section carries the heaviest SAGER load. Report how sex and gender were taken into account in the study design and inclusion criteria, whether both sexes were adequately represented, and the reasons for excluding males or females [1]. State how sex and gender were determined: self-reported, taken from records or biologically measured. Single-sex studies are allowed, but they must be justified. Add enough detail for another team to reproduce the sampling and see who was represented.

Funders push the same way. Since the 25 January 2016 application deadline, the NIH has expected applicants to factor sex as a biological variable into the design, analysis and reporting of vertebrate animal and human studies [3].

Here SAGER makes its most concrete demand. Where appropriate, routinely present sex-disaggregated data, split by sex and, where relevant, by gender. Report sex- and gender-based analyses whether the outcome was positive or negative, so a null subgroup analysis is not quietly dropped. In clinical trials, report withdrawals and dropouts by sex too [1].

Disaggregation does not mean every paper needs a formal interaction test. It means the counts and rates are visible so that others can reuse them in pooled analyses. Journals are increasingly enforcing this: in 2024, editors of leading orthopaedic journals published a joint editorial on reporting outcomes by sex and gender [4].

The discussion should interpret what the sex and gender findings mean for the results and analyses. If no sex or gender analysis was done, give the reason and discuss how its absence affects interpretation [1]. A small or single-sex sample limits generalisability, and that belongs in the limitations paragraph, not buried or left out. Honest reporting stops readers extending results to populations that were never studied.

Walk your draft section by section against the SAGER checklist before you submit. Editors can do the same: a checklist piloted in Lancet journals turns the guidelines into a quick editorial check during assessment and peer review [2]. If every section passes, your paper meets current reporting standards and gives readers the transparent sex-disaggregated data that good science depends on.