More women are needed to participate in heart disease research to ensure treatment recommendations meet their specific health needs, according to a new Dutch report.
Writing in the European Heart Journal, the authors from the Amsterdam University Medical Centre said treatment regimes are based on data collected from studies that predominantly include white men.
“Although there have been significant advances in reducing CVD-related morbidity and mortality in both sexes, the current guideline-directed therapies are based on data that predominantly include male patients,” they write.
“Consequently, in CVD management women patients might currently be treated equally (the same), however, they are not treated based on equity (i.e. based on their health needs).”
Author Dr Jeske van Diemen, of Amsterdam University Medical Centre, said it was usual practice that studies on heart disease primarily included white men and it was assumed the results were relevant to women and other races.
She added: “Evidence is emerging that this is not the case. For instance, female heart patients have a greater risk of adverse drug reactions compared with male patients, and these reactions are generally more serious. Similarly, it has been suggested that women with heart failure may need lower doses of medications than their male counterparts.”
Dr van Diemen said her research group examined the reasons why people agree or decline to be part of cardiovascular trials to devise solutions to increase gender balance.
She and her team completed an extensive literature search for articles addressing the motivators, facilitators and barriers to enrolment and continued participation and found six studies that included 846 men and 1,122 women.
They found motivation for both and women in participating was the possibility of accessing better and more continuous care, as well as altruistic values such as the desire to promote science.
None of the studies reported on facilitators to improve sign-up rates in women, but the authors noted that women in a high socioeconomic position were more likely to sign up.
This, they write, may marginalise women with a lower socioeconomic position, who stand to benefit the most from better representation.
Barriers to participation included time constraints, apprehension of an experimental design or therapy, and the potential for an unfavourable outcome or risk of harm.
However, women declined more often because they perceived a higher risk of harm from trial participation than men, and they also reported transport problems.
The authors call for more research into the reasons why women agree or decline to take part in cardiovascular studies so that appropriate interventions can be developed to boost attendance.
Dr van Diemen said: “It was an eye opener for me that women seem to have a different assessment of the risks involved in participating in trials and consider it riskier than men do. In addition, women more often have barriers which make it difficult to attend follow-up appointments – such as not holding a driving licence or caring for grandchildren.
“We are now firm believers in participatory research, which means involving patients in the design and conduct of a trial including what is manageable for those taking part.”
van Diemen J, Verdonk P, Chieffo A, et al. The importance of achieving sex- and gender-based equity in clinical trials: a call to action. Eur Heart J 6 August 2021. doi:10.1093/eurheartj/ehab457
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