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Sex-and-Gender-Based Considerations in Exercise-Based Randomized Controlled Trials in Individuals with Stroke: A Road of Opportunities Ahead
Author: Elise Wiley, Ph.D. Student, McMaster University
There is a growing body of research focused on the biological differences between males and females in pharmaceuticals, risk factors, pathology, severity, and prognosis of different diseases . In contrast to this large body of evidence related to sex-based differences, we know far less about how gender impacts the risk of disease. For example, how does the risk for stroke or heart attack differ in a heterosexual man versus a transgender non-binary individual? While more research is accounting for sex differences, this is not the case for gender identity. The lack of sex and gender considerations are causing a significant gap in knowledge for many health conditions.
Stroke is a leading cause of disability and death worldwide . Over the past 20 years, there has been a growing body of literature showing that exercise-based interventions are beneficial in improving physiological and psychosocial health markers in individuals with stroke . However, the extent to which sex-and gender-based considerations were implemented into exercise trials in individuals with stroke has not been previously reviewed.
In this blog post, I will share results from a study that I conducted, which aimed to examine the extent to which stroke researchers include sex-and gender-based considerations in their exercise trials. In this study, we surveyed publications of exercise trials in stroke and applied the Sex and Gender Equity in Research (SAGER) tool as a framework to determine whether sex and gender considerations were implemented in each section of a study (i.e., introduction, study design/methods, results and discussion) . We were also interested in examining whether the incorporation of sex- and gender-based considerations had increased since the publication of the SAGER guidelines in 2016.
I will preface the summary of the results by stating that we have a long way to go in addressing sex-and gender-based considerations in exercise-based trials in individuals with stroke. Over the past ten years, sex-and gender-based considerations have gained recognition for their importance in health research. This is thanks to the pioneer Canadian researchers in the field of sex and gender research who advocated for more inclusive research practices. Unsurprisingly, before 2016, the vast majority of stroke and exercise studies did not include any sex or gender considerations in any section of the research article. After 2016, we found a slight increase in the proportion of studies incorporating sex-based considerations since the publication of the SAGER guidelines. However, we also noted that researchers continued to use terminology related to “sex” and “gender” interchangeably.
Of note, there were no exercise-based studies in stroke that included gender-based considerations. While this is unsurprising, I do wonder why we, as researchers in the field of exercise and stroke, have neglected gender in our studies? Is it that there isn’t enough awareness of the available gender-based resources to guide its inclusion or assessment? Or is the reason more deep-seated? It is important to acknowledge that it is indeed challenging to incorporate gender-based considerations into research studies when self-reported gender measures are unavailable, and there is no firm consensus on how various constructs of gender are to be measured .
We hope that our research findings will serve as a call to action for researchers in the field of exercise and stroke to acknowledge the opportunities that lie ahead in being able to address the knowledge gaps related to sex-and gender-based considerations in exercise trials in individuals with stroke. We must continue to reinforce the idea that although sex and gender are interrelated, they are not interchangeable. I urge researchers to consult the resources that I’ve provided to ensure that their participants are being addressed properly. It may also be that there is a greater onus on journal editors to ensure that, at minimum, authors submitting to their journal are incorporating proper sex and gender terminology.
Stroke researchers are well-equipped to move forward in the area of sex and gender research. We have access to resources such as the SAGER guidelines, the CIHR e-learning modules Integrating Sex and Gender in Health Research, and the Gender-based Analysis Plus course [4,6,7].
As an advocate for sex and gender implementation in health research, the findings from this work suggest that we have a long way to go, but the positive trend is encouraging. I am optimistic for the years to come and continue to be inspired by my fellow researchers who advocate for enhanced sex and gender implementation in health research.
1. Melloni Chiara, Berger Jeffrey S., Wang Tracy Y., et al. Representation of Women in Randomized Clinical Trials of Cardiovascular Disease Prevention. Circulation: Cardiovascular Quality and Outcomes. 2010;3(2):135-142. doi:10.1161/CIRCOUTCOMES.110.868307
2. Campbell BCV, De Silva DA, Macleod MR, et al. Ischaemic stroke. Nature Reviews Disease Primers. 2019;5(1):1-22. doi:10.1038/s41572-019-0118-8
3. Saunders DH, Sanderson M, Hayes S, et al. Physical fitness training for stroke patients. Cochrane Database of Systematic Reviews. 2020;(3). doi:10.1002/14651858.CD003316.pub7
4. Heidari S, Babor TF, De Castro P, Tort S, Curno M. Sex and Gender Equity in Research: rationale for the SAGER guidelines and recommended use. Research Integrity and Peer Review. 2016;1(1):2. doi:10.1186/s41073-016-0007-6
5. Lacasse A, Pagé MG, Choinière M, et al. Conducting gender-based analysis of existing databases when self-reported gender data are unavailable: the GENDER Index in a working population. Can J Public Health. 2020;111(2):155-168. doi:10.17269/s41997-019-00277-2
6. Government of Canada CI of HR. IGH Learning - CIHR. Published September 2, 2015. Accessed February 25, 2021. https://cihr-irsc.gc.ca/e/49347.html
7. Government of Canada CI of HR. Gender-Based Analysis Plus (GBA+) at CIHR - CIHR. Published May 15, 2018. Accessed June 5, 2020. https://cihr-irsc.gc.ca/e/50968.html