Gender in Clinical Research: A response to Prins et al

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Transcript Gender in Clinical Research: A response to Prins et al

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.
www.nih.gov/news/crp/97report/index.htm
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
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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 . . .