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Editorial
November 2018

Reporting of Sex as a Variable in Research Published in Surgical Journals

Author Affiliations
  • 1Editor-in-Chief, JAMA Surgery
JAMA Surg. 2018;153(11):983. doi:10.1001/jamasurg.2018.2450

Conducting sex-inclusive biomedical and clinical research is imperative to improving the health outcomes of women and men.1 (Note that the word sex is being used rather than the term gender. Sex is the genotype that an individual is born with, and gender is the phenotype. For most research, it is the chromosomal sex of the human, animal, tissue, or cell that is important.) Recent studies have shown that most biomedical research in the field of surgery and associated topics is conducted on male animals and male cells, even when the diseases being studied are prevalent in females.2 Human clinical research is challenged by a lack of sex-based reporting and sex-based analysis of study results.3,4 Given these findings, the National Institutes of Health has asked that sex be considered as a biologic variable in all National Institutes of Health–funded research.5

The surgical journals whose editors are members of the Surgery Journals Editors Group will require this information in their journals. As such, defined reporting of the sex used for human, animal, tissue, and cell research in all articles published in JAMA Surgery is required.6 This information can be collected by self-report, administrative data, or (less commonly) genetic evaluation. If only 1 sex is studied, authors must include a justification statement as to why a single-sex study was conducted. Sex-based analysis of data for all human, animal, tissue, and cell research is also required.

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Article Information

Corresponding Author: Melina R. Kibbe, MD, Department of Surgery, the University of North Carolina at Chapel Hill, 4041 Burnett Womack, 101 Manning Dr, CB 7050, Chapel Hill, NC 27599-7050 (melina_kibbe@med.unc.edu).

Published Online: August 1, 2018. doi:10.1001/jamasurg.2018.2450

Conflict of Interest Disclosures: None reported.

Additional Information: A version of this Editorial will be published by many journals whose editors are members of the Surgery Journals Editors Group. The Surgery Journal Editors Group is composed of editors from 74 international, surgery-associated journals who meet once a year at the annual meeting of the American College of Surgeons and discuss concerns common among surgery journals.

References
1.
Clayton  JA, Tannenbaum  C.  Reporting sex, gender, or both in clinical research?  JAMA. 2016;316(18):1863-1864. doi:10.1001/jama.2016.16405PubMedGoogle ScholarCrossref
2.
Yoon  DY, Mansukhani  NA, Stubbs  VC, Helenowski  IB, Woodruff  TK, Kibbe  MR.  Sex bias exists in basic science and translational surgical research.  Surgery. 2014;156(3):508-516. doi:10.1016/j.surg.2014.07.001PubMedGoogle ScholarCrossref
3.
U.S. Government Accountability Office. National Institutes of Health: better oversight needed to help ensure continued progress including women in health research. https://www.gao.gov/products/GAO-16-13. Published October 23, 2015. Accessed June 18, 2018.
4.
Mansukhani  NA, Yoon  DY, Teter  KA,  et al.  Determining if sex bias exists in human surgical clinical research.  JAMA Surg. 2016;151(11):1022-1030. doi:10.1001/jamasurg.2016.2032PubMedGoogle ScholarCrossref
5.
National Institutes of Health. Consideration of sex as a biological variable in NIH-funded research. https://grants.nih.gov/grants/guide/notice-files/NOT-OD-15-102.html. Published June 9, 2015. Accessed June 18, 2018.
6.
JAMA Network. Reporting demographic information for study participants; JAMA Surgery instructions for authors. https://jamanetwork.com/journals/jamasurgery/pages/instructions-for-authors. Accessed June 18, 2018.
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