Representation of Women in Stroke Clinical Trials

Abstract

Objective:Women have been under-represented in clinical trials areas of cardiovascular disease but there is less certainty over the level of disparity specifically in stroke. We examined the participation of women in trials according to stroke prevalence in the population.Methods:Published randomized controlled trials with ≥100 participants enrolled between 1990 and 2020 were identified from ClinicalTrials.gov. To quantify sex disparites in enrolment we calculated the participation to prevalence ratio (PPR), defined as the percentage of women participating in a trial against the prevalence of women in the disease population.Results:There were 281 stroke trials eligible for analyses with a total of 588,887 participants, of whom 37.4 % were women. Overall, women were represented at a lower proportion relative to their prevalence in the underlying population (mean PPR 0.84; 95% confidence interval [CI] (0.81 to 0.87)). The greatest differences were observed in trials of intracerebral hemorrhage (PPR 0.73; 95% CI 0.71 to 0.74), trials with a mean age of participants <70 years (PPR 0.81; 95% CI (0.78 to 0.84)), non-acute interventions (PPR 0.80; 95% CI (0.76 to 0.84)) and rehabilitation trials (PPR 0.77; 95% CI 0.71 to 0.83)). These findings did not significantly change over the period from 1990 to 2020 (p for trend = 0.201).Conclusion:Women are disproportionately underrepresented in stroke trials relative to the burden of disease in the population. Clear guidance and effective implementation strategies are required to improve the inclusion of women and thus broader knowledge of the impact of interventions in clinical trials.

Integration and Validation of a Natural Language Processing Machine Learning Suicide Risk Prediction Model Based on Open-Ended Interview Language in the Emergency Department

“…Nevertheless, as with all screening and diagnostic tools, there will always be variables that can impact results, and how a tool was developed should be considered when interpreting results. For example, there have been gender imbalances in clinical research (55,56), so caution must be taken when generalizing results across the underrepresented gender. Similarly, clinicians using a language-based tool to identify suicide risk should be trained to understand its limitations, such as this model's inability to recognize language related to COVID-19.…”

Sex-Specific Differences in Cardiovascular Risk, Risk Factors and Risk Management in the Peripheral Arterial Disease Population

“…Despite women making up roughly 50% of the world's population, and even in the face of some journals and funding bodies requiring women to be well represented in research, the reporting of sex-disaggregated data is by no means regular and women continue to be under-represented in cardiovascular randomised controlled trials [18,85]. This not only inhibits research to identify sex differences for the benefit of both sexes, such as the current article, but also contributes to inadequate care for women, and ultimately costs disability-adjusted life years.…”

“…Despite this, cardiovascular risk in the PAD population is underrecognised by clinicians and the public. As a result, those with PAD are significantly less likely to receive secondary preventative treatment than those following an MI [17,18].…”

“…Data from the Vascular Quality Initiative between 2010 and 2013 report that women with PAD were less likely to receive statin therapy (64% vs. 70%, p < 0.001) [87]. This may be due to a lack of recognition, discontinuation, or refusal, and a greater prevalence of statin intolerance has been reported amongst women [18]. Indeed, a study in the USA found that women who met the criteria of the American Heart Association Cholesterol Guideline to be recommended statin therapy were also less likely to receive treatment (67% vs. 78.4%, p < 0.001) or to receive the recommended dose (36.7% vs. 45.2%, p < 0.001).…”

Digital Health–Enabled Clinical Trials in Stroke: Ready for Prime Time?

“…An effective implementation of guidance strategies are required to improve the inclusion of women and thus broader knowledge of the impact of interventions in clinical trials. 16 Racial and ethnic gaps are also particularly disturbing. Several RCTs fail to include enough participants from the racial and ethnic groups that are disproportionately affected by the condition being studied.…”