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Viewpoint
November 8, 2016

Reporting Sex, Gender, or Both in Clinical Research?

Author Affiliations
  • 1Office of Research on Women’s Health, National Institutes of Health, Bethesda, Maryland
  • 2Institute of Gender and Health, Canadian Institute of Health Research, Montréal
JAMA. 2016;316(18):1863-1864. doi:10.1001/jama.2016.16405

Virtually every clinical research report includes basic demographic characteristics about the study participants, such as age, and how many participants were male/men or female/women. Some research articles refer to this latter variable as sex, others refer to it as gender. As one of the first pieces of data reported, the importance of including sex appears undisputed. But what does the sex-gender category really entail, and how should it be reported?

With emerging evidence that both sex and gender have an effect, for instance, on how an individual selects, responds to, metabolizes, and adheres to a particular drug regimen,1 there is an ethical and scientific imperative to report to whom research results apply. This Viewpoint explains the contexts in which sex and gender are relevant and provides suggestions for improving reporting of this characteristic.

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