A female acronym is not enough: underrepresentation of women in cardiovascular trials

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Abstract Introduction Cardiovascular disease is the leading cause of death for women worldwide. Yet, women are often underrepresented in clinical trials of cardiovascular disease compared to population prevalence. Reasons for underrepresentation are multifactorial, and often attributed to trial criteria. Yet, women may also decide not to participate for more subconscious reasons, such as the perception of the trial acronym. Trial acronyms are used in patient communication and are often chosen to have a certain meaning, which can be perceived as gendered. We hypothesize that masculine trial names are associated with underrepresentation of women in clinical trials. Purpose To investigate if the perceived gender of the trial acronym, and other study characteristics affect the representation of women in cardiovascular clinical trials. Methods We performed a systematic search of ClinicalTrials.gov to collect information on randomized clinical trials testing drug interventions for cardiovascular disease. We extracted trial characteristics and acronyms from primary outcome publications. We conducted a survey among 148 cardiovascular patients (both women and men) recruited via an online patient forum and asked them whether they perceived trial acronyms names as more masculine, feminine or neutral. We defined female underrepresentation as those trials where the proportion of included women divided by the proportion of women in the disease population was below 0.8. We analyzed female underrepresentation and study setting, participant characteristics, and female first and last authorship. Results We identified 148 eligible clinical trials of which 29.9% of participants were women. Women were underrepresented in 61.5% of trials (Figure 1). Only 45.3% of publications reported sex-stratified results. The proportion of trials in which women were underrepresented increased between 1992 and 2022 from 48.3% to 70.5%. A total of 148 patients (67.6% women, mean age 61 y) evaluated the trial acronyms for their perceived gender. The majority (70.9%) of trial names was perceived as neutral, 17.6% as masculine and 11.5% as feminine. Female representation was not associated with the perceived gender of the trial name (OR 0.92, 95% CI 0.63 – 1.35) (Figure 2A). Trials had a higher odds of female underrepresentation if they recruited at an in-patient setting (OR 2.47, 95% CI 1.14 – 5.58), or if their participants were in the second-highest age group between 64.0 and 66.3 years (OR 3.93, 95% CI 1.25 – 14.18). Trials had lower odds of female underrepresentation if the last author was a woman (OR 0.10, 95% CI 0.01 – 0.49). Conclusion Female representation in cardiovascular clinical trials remains poor but is not depending on the perceived gender of the trial acronym. Female representation varies with recruitment type, participant age and last author gender, which are important starting points to improve participation rates of women.