The Sex and Gender Equity in The Sex and Gender Equity in Research (SAGER) guidelines: Research (SAGER) guidelines: Implementation and checklist Implementation and checklist developmentdevelopment

Understanding sex and gender differences is fundamental to rigorous and inclusive research, whether studying disease pathophysiology, sociodemographic determinants of health, or the benefits and harms of medical or social interventions. The inclusion of gender-diverse study populations has improved, but the reporting of sex and gender variables in research is still incomplete. The Sex and Gender Equity in Research (SAGER) guidelines, published in 2016, have been widely endorsed, but few scientific journals and organizations have incorporated them into formal editorial guidance and publication policies. To facilitate monitoring of and adherence to the SAGER guidelines in Lancet journals, we carried out an informal pilot study and developed a checklist to enable rapid editorial checks, promote uptake of the guidelines by other editors and journals, and raise awareness among peer reviewers and authors. By using this checklist as part of manuscript assessment and peer-review processes, journal editors can support best reporting practices when considering sex and gender as variables, improving the generalizability of the research they publish. Abstract 3a Abstract specifies sex of animals or any cells, tissues, and other material derived from these 3b In applied sciences (technology, engineering, etc.), the abstract indicates if the study model was based on one sex/gender or the application was considered for the use of one specific sex/gender


Introduction
Historically, scientific research has neglected differences between male and female organisms and has placed a disproportionate focus on male models. Since the turn of the millennium, this male bias has been increasingly recognized as both unscientific and unethical, 1,2 but the tendency to accept men as the norm in research remains a key source of gender inequity. 3 Consideration of sex and gender differences is essential to scientific research. 3,4 Underrepresentation or even exclusion of women and gender-diverse people remains a problem in both clinical and social sciences. 5,6 As such, despite increasing recognition of the importance of sex and gender as health determinants, the gender data gap remains and poses disproportionate risks to women and gender-diverse people-risks that include misdiagnosis and inappropriate treatment. 6 Sex and gender differences also affect outcomes in engineering, technology, and socio-economic research. 7,8 Many research funders now require that sex and gender be balanced among study subjects or that authors provide justification for imbalances; for example, NIH Policy on Sex as a Biological Variable, Trans-NIH Strategic Plan for Women's Health Research. 9 Regulatory agencies have issued guidance for trial sponsors 10 to include underrepresented groups in clinical trials.
There is also increasing emphasis on the need for research participants to accurately represent real-world patient populations with regard to sex and gender, racial identity, ethnicity, age, and sexual orientation, among others. 11   the publication of an editorial announcing our pilot programme. 17 We did not include a formal measure of feasibility at this stage, such as an analysis of the additional time required by editors to screen manuscripts and request data from authors, and for our production team to modify display items.
On the whole, authors were receptive to our requests and were willing to engage in a productive discussion with the editorial team about whether and how to incorporate sex/ gender-disaggregated data into their reports. As the pilot programme proceeded, we realized that implementation of the SAGER guidelines and monitoring compliance with them would be facilitated by a checklist. We therefore transformed the table from the original SAGER article 5 into a list of points following the organizational structure of the CONSORT checklist. 19 We created two checklists, one for studies including human participants (Table 1) and one for studies that do not include human participants (Table 2), such as those in the fields of applied science and cell biology.
We also included requirements that went    of the paper is useful and potentially informative.

Discussion
Our efforts to implement the SAGER guidelines into our published articles were successful, and we hope that use of the checklist as part of the peer-review process (1) will help journal editors to contribute to standardizing terminology, (2) will support best reporting practices for inclusion of sex and gender as variables to ensure that sex/ gender-specific eligibility criteria are justified, and (3)   Enforcing new requirements in study design will require the endorsement of funders, researchers, institutional review boards, and other organizations that produce data, as well as support from policymakers, advocates, and society as a whole. 18,23,24 Until intersectional research becomes the norm, we hope this checklist will facilitate reporting according to the SAGER guidelines by authors and scientific editors. Science is for everyone, and comprehensive reporting of sex and gender will highlight where studies are inadequate in their consideration of inclusivity.