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The importance of sex and gender in medical research

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The importance of sex and gender in medical research

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The importance of sex and gender in medical research.

For many years it was widely assumed that the occurrence and outcome of disease was the same for women and men.

Our understanding was that studies involving only men would be equally relevant for women. In the last two decades however, it has been shown that this assumption is highly prejudice and can have a detrimental impact on the health of women.

It is, therefore, really important to incorporate a sex and gender research lens in to medical research.

First, Kelly makes the important distinction between sex and gender and how this can impact medical diagnosis, treatment and outcomes.

Then, she identifies how the incorporation of sex and gender into research has allowed for advancements across healthcare. Improved accuracy, avoiding misinterpretation, reduced unintentional bias and greater social equity to name a few.

In this presentation, Kelly Thompson refers to case studies to examine the differences in the interpretation of health data when examining through a sex and gender research lens.

The severity of disease, risk factors and treatment effectiveness are just a few of the reasons why this is so important.

Kelly encourages researchers to ensure gender diversity in the research team and to explain how sex and gender are accounted for in research applications moving forward.

From CodaZero Live, tune into this fascinating discussion on the importance of sex and gender in medical research by Kelly Thompson.

The importance of sex and gender in medical research.

For many years it was widely assumed that the occurrence and outcome of disease was the same for women and men.

Our understanding was that studies involving only men would be equally relevant for women. In the last two decades however, it has been shown that this assumption is highly prejudice and can have a detrimental impact on the health of women.

It is, therefore, really important to incorporate a sex and gender research lens in to medical research.

First, Kelly makes the important distinction between sex and gender and how this can impact medical diagnosis, treatment and outcomes.

Then, she identifies how the incorporation of sex and gender into research has allowed for advancements across healthcare. Improved accuracy, avoiding misinterpretation, reduced unintentional bias and greater social equity to name a few.

In this presentation, Kelly Thompson refers to case studies to examine the differences in the interpretation of health data when examining through a sex and gender research lens.

The severity of disease, risk factors and treatment effectiveness are just a few of the reasons why this is so important.

Kelly encourages researchers to ensure gender diversity in the research team and to explain how sex and gender are accounted for in research applications moving forward.

From CodaZero Live, tune into this fascinating discussion on the importance of sex and gender in medical research by Kelly Thompson.

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The importance of sex and gender in medical research

  1. 1. 1
  2. 2. Responsible science: sex and gender analyses Kelly Thompson Research Fellow / Program Manager Global Women’s Health & Critical Care
  3. 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. 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. 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. 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. 7. Case study: coronary heart disease • Differences in risk factors 7
  8. 8. + 44% Peters et al., Lancet, 2014 Peters et al., Diabetologia, 2014 Diabetes and CVD
  9. 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. 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. 11. Case study: COVID-19 • Differences in risk factors 11 Global Health 50:50, 2021
  12. 12. Global Health 50:50, 2021
  13. 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
  14. 14. Baseline characteristics 14
  15. 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. 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. 17 Case study: Sepsis and septic shock
  18. 18. Sex differences in sepsis-related deaths 18 Rudd et al, Lancet 2020
  19. 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. 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. 21
  22. 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. 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
  24. 24. @kelly_thompson_ kthompson@georgeinstitute.org.au Thank you

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