PURPOSE: Women are under-represented in heart failure (HF) trials and the reason remains unknown. To evaluate sex differences among patients who do not participate, we analyzed non-enrollment in SUSTAIN-IT, a multi-center study comparing health-related quality of life outcomes in 60-80 year old patients implanted with left ventricular assist devices as destination therapy (DT) or who awaited heart transplantation (HT). METHODS: 238 patients were approached and not enrolled in SUSTAIN-IT. Reasons for not enrolling and for refusing were documented. Sex differences were evaluated for the cohort and then stratified by DT vs HT RESULTS: 50 women (29 DT, 21 HT) and 187 men (81 DT, 106 HT) approached did not enroll in SUSTAIN-IT. Women were more likely than men to refuse (92% vs 76%, P=0.015) and the reasons varied by sex. Women were more likely too tired, stressed, anxious, depressed, or unable to concentrate while men were mostly not interested (Table 1). When stratified by HF therapy, women were more likely to refuse when approached for HT (100% HT vs 86% DT, P=0.13), while refusal for men did not differ with HF therapy (76% HT and 77% DT). Refusal also varied by therapy with the majority of HT non-enrollers not interested (38% women, 52% men) and DT non-enrollers refusing for different reasons (women 56% symptoms; men 31% symptoms, 32% not interested). CONCLUSION: Women approached who did not enroll in SUSTAIN-IT were more likely than men to refuse to participate. Reasons for refusal varied for both women and men based on type of advanced HF therapy. Our novel findings may provide tailored guidance when recruiting men and women in clinical trials.
|Original language||English (US)|
|Journal||The Journal of heart and lung transplantation : the official publication of the International Society for Heart Transplantation|
|State||Published - Apr 1 2020|
ASJC Scopus subject areas
- Pulmonary and Respiratory Medicine
- Cardiology and Cardiovascular Medicine