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Responsible science: sex and gender analyses
Kelly Thompson
Research Fellow / Program Manager
Global Women’s Health & Critical Care
Overview
3
• Definitions
• Importance of conducting sex and gender disaggregated analysis
• Case studies
• Heart disease
• COVID-19
• Sepsis and septic shock
• Recommendations
• Questions
Sex and Gender
4
• Sex biological attributes that distinguish organisms as male, female,
intersex and hermaphrodite
• Gender psychological, social and cultural factors that shape attitudes,
behaviours, stereotypes, technologies and knowledge.
3 dimensions:
• Gender norms - rules in culture that influence individuals
• Gender identity - how individuals and groups perceive and
present themselves within cultures
• Gender relations - power relations between individuals with
different gender roles and identities
Tannenbaum et al, Nature, 2019
Importance of sex and gendered analysis
5
• Better science
o Rigorous
o Reproducible
o Responsible
• Enables advancements
• Fosters scientific discovery
• Improves experimental efficiency
• Enables social equity
Tannenbaum et al, Nature, 2019
Case study: coronary heart disease
Using routinely collected health data, data from large-scale
studies and meta-analyses
Has identified:
• Presentation differences
Acute Myocardial Infarction
Men significantly less likely than women to complain of:
• Neck pain OR = 0.52; 95% CI: 0.35, 0.78
• Back pain OR = 0.38; 95% CI: 0.26, 0.56
• Jaw pain OR = 0.50; 95% CI: 0.31, 0.81
• Nausea OR = 0.58; 95% CI: 0.45, 0.75
6
Goldberg et al, JAHA, 1998
Case study: coronary heart disease
• Differences in risk factors
7
+ 44%
Peters et al., Lancet, 2014
Peters et al., Diabetologia, 2014
Diabetes and CVD
Peters et al, Diabetalogia 2016
Number of children
Hazard
ratio
(95%
CI)
0.8
1.0
1.2
1.4
1.6
1.8
2.0
0 1 2 3 >3
Women (No. events = 5579)
9
China Kadoorie Biobank:
7-year risk of incident diabetes
China Kadoorie Biobank:
7-year risk of incident diabetes
Peters et al, Diabetalogia 2016
Number of children
Hazard
ratio
(95%
CI)
0.8
1.0
1.2
1.4
1.6
1.8
2.0
0 1 2 3 >3
Women (No. events = 5579)
Men (No. events = 3261)
10
Case study: COVID-19
• Differences in risk factors
11
Global Health 50:50, 2021
Global Health 50:50, 2021
- Open-label trial of daily dexamethasone (6mg IV or oral), for up to 10 days vs. usual care
- Primary outcome 28 day mortality
- Subgroups by illness severity based on oxygen requirements
- 6425 participants (2104 assigned dex. vs. 4321 assigned usual care)
Conclusions: Use of dexamethasone improved mortality in severely ill COVID-19 patients
(those receiving mechanical ventilation or requiring oxygen)
RECOVERY trial Investigators, NEJM 2020
Baseline characteristics
14
Let’s break that down
15
27%=87
37%=473
- Assuming women (N=2338)
were distributed relatively
equally between
dexamethasone and usual
care groups this would
mean……
- Possibly insufficient numbers
of women to determine
whether dexamethasone
treatment was as effective in
women, particularly those who
were ventilated
Take home message
16
- Women and men may be more (or less) likely to acquire severe forms of disease
- Where treatment effects are dependent on disease severity, true effects in women and men
may be masked if;
1. Sex-disaggregated analyses are not performed in appropriate subgroups
2. Insufficient numbers of the lesser impacted sex are included
17
Case study: Sepsis and septic shock
Sex differences in sepsis-related deaths
18
Rudd et al, Lancet 2020
- Double-blind randomised controlled trial of daily 7-days IV hydrocortisone (200mg) vs. placebo in
3800 patients with septic shock
- Primary outcome 90 day mortality
- Secondary outcomes; time to resolution of shock, recurrence of shock, length of ICU stay, length of
hospital stay, frequency and duration of mechanical ventilation and RRT, onset of new
bacteraemia, receipt of blood transfusions
Conclusions: Hydrocortisone did not improve 90-day mortality, but patients assigned hydrocortisone
had faster resolution of shock, spent less time on a mechanical ventilator, had a shorter duration of
ICU stay.
Venkatesh et al, NEJM 2018
- Assessment of ADRENAL secondary outcomes separately for women and men, after
adjustments
- To compare treatment effects in women and men separately
- To assess differences between women and men; differences in mean differences,
ratio of odds ratio and ratio of hazard ratios
Thompson et al, ICM 2021
21
Conclusion: In the ADRENAL trial hydrocortisone produced beneficial effects on some
secondary outcomes in men but not women. Sex-specific treatment effects should be
examined in other critical care trials.
Thompson et al, ICM 2021
Recommendations
Researchers: ensure gender diversity in the research team
Journals: adopt the SAGER guidelines & create a mechanism to be
accountable
Funders: require applicants to explain how sex and gender is
accounted for
@kelly_thompson_
kthompson@georgeinstitute.org.au
Thank you

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The importance of sex and gender in medical research

  • 1. 1
  • 2. Responsible science: sex and gender analyses Kelly Thompson Research Fellow / Program Manager Global Women’s Health & Critical Care
  • 3. Overview 3 • Definitions • Importance of conducting sex and gender disaggregated analysis • Case studies • Heart disease • COVID-19 • Sepsis and septic shock • Recommendations • Questions
  • 4. Sex and Gender 4 • Sex biological attributes that distinguish organisms as male, female, intersex and hermaphrodite • Gender psychological, social and cultural factors that shape attitudes, behaviours, stereotypes, technologies and knowledge. 3 dimensions: • Gender norms - rules in culture that influence individuals • Gender identity - how individuals and groups perceive and present themselves within cultures • Gender relations - power relations between individuals with different gender roles and identities Tannenbaum et al, Nature, 2019
  • 5. Importance of sex and gendered analysis 5 • Better science o Rigorous o Reproducible o Responsible • Enables advancements • Fosters scientific discovery • Improves experimental efficiency • Enables social equity Tannenbaum et al, Nature, 2019
  • 6. Case study: coronary heart disease Using routinely collected health data, data from large-scale studies and meta-analyses Has identified: • Presentation differences Acute Myocardial Infarction Men significantly less likely than women to complain of: • Neck pain OR = 0.52; 95% CI: 0.35, 0.78 • Back pain OR = 0.38; 95% CI: 0.26, 0.56 • Jaw pain OR = 0.50; 95% CI: 0.31, 0.81 • Nausea OR = 0.58; 95% CI: 0.45, 0.75 6 Goldberg et al, JAHA, 1998
  • 7. Case study: coronary heart disease • Differences in risk factors 7
  • 8. + 44% Peters et al., Lancet, 2014 Peters et al., Diabetologia, 2014 Diabetes and CVD
  • 9. Peters et al, Diabetalogia 2016 Number of children Hazard ratio (95% CI) 0.8 1.0 1.2 1.4 1.6 1.8 2.0 0 1 2 3 >3 Women (No. events = 5579) 9 China Kadoorie Biobank: 7-year risk of incident diabetes
  • 10. China Kadoorie Biobank: 7-year risk of incident diabetes Peters et al, Diabetalogia 2016 Number of children Hazard ratio (95% CI) 0.8 1.0 1.2 1.4 1.6 1.8 2.0 0 1 2 3 >3 Women (No. events = 5579) Men (No. events = 3261) 10
  • 11. Case study: COVID-19 • Differences in risk factors 11 Global Health 50:50, 2021
  • 13. - Open-label trial of daily dexamethasone (6mg IV or oral), for up to 10 days vs. usual care - Primary outcome 28 day mortality - Subgroups by illness severity based on oxygen requirements - 6425 participants (2104 assigned dex. vs. 4321 assigned usual care) Conclusions: Use of dexamethasone improved mortality in severely ill COVID-19 patients (those receiving mechanical ventilation or requiring oxygen) RECOVERY trial Investigators, NEJM 2020
  • 15. Let’s break that down 15 27%=87 37%=473 - Assuming women (N=2338) were distributed relatively equally between dexamethasone and usual care groups this would mean…… - Possibly insufficient numbers of women to determine whether dexamethasone treatment was as effective in women, particularly those who were ventilated
  • 16. Take home message 16 - Women and men may be more (or less) likely to acquire severe forms of disease - Where treatment effects are dependent on disease severity, true effects in women and men may be masked if; 1. Sex-disaggregated analyses are not performed in appropriate subgroups 2. Insufficient numbers of the lesser impacted sex are included
  • 17. 17 Case study: Sepsis and septic shock
  • 18. Sex differences in sepsis-related deaths 18 Rudd et al, Lancet 2020
  • 19. - Double-blind randomised controlled trial of daily 7-days IV hydrocortisone (200mg) vs. placebo in 3800 patients with septic shock - Primary outcome 90 day mortality - Secondary outcomes; time to resolution of shock, recurrence of shock, length of ICU stay, length of hospital stay, frequency and duration of mechanical ventilation and RRT, onset of new bacteraemia, receipt of blood transfusions Conclusions: Hydrocortisone did not improve 90-day mortality, but patients assigned hydrocortisone had faster resolution of shock, spent less time on a mechanical ventilator, had a shorter duration of ICU stay. Venkatesh et al, NEJM 2018
  • 20. - Assessment of ADRENAL secondary outcomes separately for women and men, after adjustments - To compare treatment effects in women and men separately - To assess differences between women and men; differences in mean differences, ratio of odds ratio and ratio of hazard ratios Thompson et al, ICM 2021
  • 21. 21
  • 22. Conclusion: In the ADRENAL trial hydrocortisone produced beneficial effects on some secondary outcomes in men but not women. Sex-specific treatment effects should be examined in other critical care trials. Thompson et al, ICM 2021
  • 23. Recommendations Researchers: ensure gender diversity in the research team Journals: adopt the SAGER guidelines & create a mechanism to be accountable Funders: require applicants to explain how sex and gender is accounted for