Gender in Clinical Research: A Review of Prins et al Susan Phillips Gender Basic, Jan. 2007

Sex Differences genetic similarity phenotypic difference

Sex differences in Research Failure to include women or to disaggregate data: –Valid? –Biased?

Question #1 When do ‘ between ’ group differences (with the groups being men and women) matter enough to validate using scarce resources to identify them?

What is clinical research? Research conducted with human subjects... for which an investigator (or colleague) directly interacts with human subjects.

What about gender? Prins et al: –useful concept for interpreting findings but not part of research design

Epidemiology - cautions Subdividing Tx & control groups by sex –Sex as a confounder rather than a variable in the pathway from input to outcome

A solution...comment #1 Sex stratification of study population (?)

Comment #2 Assumption of homogeneity within group The risk: missing an effect modifier that changes the measured outcome –An example

Randomization- strengths & shortcomings: comment #3 Equalizes unmeasured factors across groups Makes the contribution of unmeasured factors invisible What about gender?

Background data: comment #4 Age, co-morbidities, smoking, drug use, etc What about sexual abuse,control at home or in workplace What about a gender index?

Gender bias in variables: comment #5 Does gender create bias in variables representing social determinants? Examples: -Gini coefficient -household income measure -self reported health

Measuring gender’s effect: comment #6 Only an interpretive lens? An independent variable? What about a gender index?

Measuring gender’s effect: comment #7 A contextual level effect A cross level effect What about a gender index?

Gender and individual level analyses: comment #8 Some examples: -inventory re acceptance of sex roles -Acceptance of gender stereotypes

The bottom line Sex - individual level variable Gender - ecological variable Sex disaggregated data - good design Gender - describes the social climate Can we create a gender index to import group level info into individual or multi level analyses?

Thank you...