Improving Evidence-Based Care

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Two new studies delve into sex-based differences in patient outcomes and quality of life.
Posted On: January 16, 2025
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Response to treatment can vary by sex, and men’s and women’s experience of disease can impact factors such as disease burden and quality of life. Understanding these differences is critical to developing personalized treatment plans that address the unique needs of men and women. (Image: iStock)

Two recent studies from UHN’s Toronto General Hospital Research Institute (TGHRI) have advanced our understanding of best practices in care. These studies examined whether health outcomes, such as stroke recurrence, disease burden, and quality of life differ between men and women.

A research team led by Dr. Eric Horlick, Clinician Investigator at TGHRI, and Dr. Lusine Abrahamyan, Scientist at TGHRI, investigated whether there were sex-based differences in stroke recurrence following patent foramen ovale (PFO) closure for stroke. Limited clinical data had suggested men were more likely than women to benefit from the procedure.

A PFO is a small congenital hole in the heart, present in 25% of the population, that is a recognized risk factor for stroke. Evidence from trials suggests that an outpatient, catheter-based procedure under local anesthesia, called PFO closure, yields better outcomes than medical therapy alone. However, real-world data on long-term differences in outcomes for men and women after PFO closure is not available.  

To determine whether outcomes differ, Dr. Horlick’s team analyzed the long-term results of PFO closure in men and women. They reviewed the detailed medical charts of patients from their practice at Toronto General Hospital who had undergone the PFO procedure, one of the largest programs internationally in the region.

Out of 783 patients in the study, 349 (44.5%) were women, and 434 (55.5%) were men. Results showed that women were generally younger and more likely to experience migraines, while men had more risk factors for heart disease. There were no differences between men and women in the success of the procedure or outcomes within 30 days and over a median follow-up period of 14 years (e.g., repeat stroke risk, survival, and atrial fibrillation).

This underscores the importance of updating clinical trial data with robust longitudinal data disaggregated by sex and demonstrates how sex-based analyses can enable more personalized, evidence-based care decisions. The researchers recommend further studies include sex-based analyses to further advance care which will enhance the reproducibility of findings, benefit women’s health, and help support guideline development. Many future trials will be designed from the outset focussing on the relative benefits of new and existing therapies for men and women.

In another study from TGHRI, a North American team led by Dr. Florence Wong, Affiliate Scientist, looked at sex differences in how patients perceive the burden of ascites from cirrhosis of the liver—fluid collecting in spaces of the abdomen—and how it impacts their quality of life.

Ascites develops in about 31% of patients within the first year after being diagnosed with cirrhosis—scarring of the liver. As cirrhosis progresses, the ascites become increasingly difficult to control and treat. Due to factors such as physical discomfort, changes in body appearance, dietary restrictions, and increased stress, patients typically experience a reduced quality of life.

Research suggests that women with liver disease may experience a poorer quality of life, possibly due to a greater disease burden or a stronger impact from the same disease severity. As individualized care is becoming increasingly important in cirrhosis, this study aimed to explore whether men and women with advanced liver disease and ascites experience differences in quality of life, what factors contribute to these differences, and how they affect daily functioning.

Researchers studied 392 men and 184 women with cirrhosis and severe ascites, comparing symptoms, mental health, physical activity, and overall quality of life between men and women using various tests and questionnaires.

Results showed that women with cirrhosis and ascites had more severe symptoms than men at the same stage of the disease, which affected their quality of life, even though their physical functioning remained similar. Women reported lower mental well-being, than men. Despite the negative emotional impact, women were able to conduct their daily activities as adequately as men. Interestingly, women who were referred for transplants exhibited reduced physical function compared to men. This difference was not present in the patients not referred for transplant.

This study highlights the differences in the lived experience of women and men and the importance of using both clinical and patient-reported data to provide better, more personalized care.

By examining whether certain conditions, treatments, and disease burdens affect men and women in distinct ways, both studies contribute to a more nuanced body of knowledge that promotes better outcomes for all patients.

UHN is committed to producing high-quality research that reports on sex and gender in treatment efficacy, health outcomes, and experience of disease. Research that addresses these knowledge gaps illuminates the path to reducing health disparities based on sex and gender. Studies like these build knowledge in under-explored areas and contribute to UHN’s reputation as a leading research hospital.

Dr. Eric Horlick is senior author of the Flores-Umanzor et al., 2024 study. Dr. Horlick is a Clinician Investigator at TGHRI, Professor of Medicine at the University of Toronto (U of T) and the Peter Munk Chair in Structural Heart Disease at Toronto General Hospital; Dr. Lusine Abrahamyan is a co-first author of the study, Scientist at TGHRI, and an Associate Professor at the Institute of Health Policy, Management and Evaluation at U of T; Dr. Eduardo Flores-Umanzor is co-first author of this study, Interventional Cardiology Specialist at Hospital Clínic de Barcelona, and former Interventional Cardiology fellow working with Dr. Horlick at Toronto General Hospital.

Dr. Florence Wong is first and corresponding author of Wong et al., 2024. Dr. Wong is an Affiliate Scientist at TGHRI and Professor in the Division of Gastroenterology at U of T.

Flores-Umanzor et al., 2024 was supported by the Peter Munk Cardiac Centre, the Ontario Ministry of Health and the Ministry of Long-Term Care, and UHN Foundation.

Dr. Horlick is a consultant for Abbott, Edwards, and Medtronic and has received research grants from Abbott and Occlutech for other projects. Dr. Horlick is supported by the Peter Munk Chair in Structural Heart Disease.

Wong et al., 2024 was part of the North American Consortium for the Study of End-Stage Liver Disease project. The study was supported by UHN Foundation.

Dr. Wong is a consultant for Sequana Medical and has received research grants from Grifols, and Mallinckrodt for other projects.

#Flores-Umanzor E, #Abrahamyan L, Asghar A, Schrutka L, Everett K, Lee DS, Osten M, Benson L, Horlick E. Sex-Based Differences in Long-Term Outcomes Following Transcatheter Closure of Patent Foramen Ovale for Cryptogenic Stroke. Circ Cardiovasc Interv. 2024 Nov;17(11):e014467. doi: 10.1161/CIRCINTERVENTIONS.124.014467. Epub 2024 Nov 19.

# Contributed equally

Wong F, Reddy KR, Tandon P, Lai JC, Garcia-Tsao G, O'Leary JG, Biggins SW, Vagas HE, Thacker L, Kamath PS, Bajaj JS; NACSELD III Study Group. Sex differences in patient-reported outcomes and perception of ascites burden amongst outpatients with decompensated cirrhosis and ascites.: Sex Differences in Ascites Burden Perception. Am J Gastroenterol. 2024 Nov 27. doi: 10.14309/ajg.0000000000003251. Epub ahead of print.