Better gender representation in stroke trials will help improve evidence and subsequent guideline recommendations for management of stroke in women, Australian researchers say.
Their study, published in Neurology, examined 281 stroke trials conducted between 1990 and 2020. It found 37.4% of the 588,887 participants in the trials were women while the prevalence of stroke in women was 48%.
More than three quarters of the trials enrolled less women than the expected proportion that experience stroke in the community, the authors noted.
The greatest gender differences were seen in trials involving intracerebral haemorrhage, those with younger participants <70 years, and those related to post-stroke supportive care and rehabilitation.
Lead author Dr Cheryl Carcel, from The George Institute for Global Health and a Heart Foundation Fellow, said that while both women and men had the same one-in-four risk of experiencing a stroke in their lifetime, women were much older and in worse health at the time they have a stroke.
“These findings have implications for how women with stroke may be treated in the future, as women typically have worse functional outcomes after stroke and require more supportive care,” said Dr Carcel.
“Our previous research indicated that how women were treated in hospital and whether they had been on the right medications before their stroke, could be responsible for their poorer outcomes.”
More to do
Dr Carcel said that the reasons for under-representation of women were complex and most likely due to a number of factors, including recruitment criteria that unintentionally exclude women.
“Patient attitudes and beliefs can also be a factor, and there can even be a potential bias among the clinical staff conducting the study,” she said.
While the United States, Canada and some European countries adopted policies to boost the number of women in clinical trials over the course of the study, the results showed no change over this time.
The Heart Foundation’s Director of Heart Health Strategy, Julie Anne Mitchell, said it was concerning to see the Asia-Pacific region faring worse than Europe in this study.
“There is clearly still more to do before women are properly represented in clinical trials on stroke and other cardiovascular diseases,” she said.
“Women share common risk factors with men, such as high cholesterol and blood pressure, but they also have sex-specific risk factors, including pregnancy-related conditions such as pre-eclampsia and gestational diabetes. We need to understand more about all of these risk factors so we can improve prevention and treatment options for women.”