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editorial
. 2022 Jan 14;322(3):H350–H354. doi: 10.1152/ajpheart.00605.2021

Table 1.

Quick guide to incorporating sex (and gender) as a biological variable

Basic Research Clinical Research
Literature
  • Perform quick literature search on sex difference research in your area and understand limitations therein.

  • Perform quick literature search on sex/gender difference research from clinical groups in your area and understand limitations therein.

Sample
  • Use both male and female cells, animals, and humans unless scientifically justifiable not to.

  • Enroll both women and men unless there is a sound scientifical justification not to.

Enrollment (for human studies)
  • Ensure recruitment strategies address barriers that may preclude participation of one sex vs. another.

  • Work with the clinical team to ensure recruitment strategies address barriers that may preclude participation of one sex/gender vs. another.

Data collection
  • Collect data from similar number of male and female subjects.

  • Consider collecting data on variables that would influence sex differences.

  • Monitor data collection for sex/gender balance so enrollment strategies can be pivoted (population dependent).

  • Consider collecting data on confounding factors that would influence sex/gender differences.

Data analysis
  • Break out male vs. female data to check for any differences.

  • Use design-appropriate statistical approaches to make sex/gender comparisons.

Reporting
  • Report number of male/female animals/subjects and any sex differences.

  • Consider confounding variables and biological plausibility of any sex differences.

  • Report number of male/female subjects and any sex/gender differences.

  • Consider moving beyond reporting sex/gender and integrating sex/gender into primary aims.