Barriers and motivations for women to participate in cardiovascular trials.

ABSTRACT

BACKGROUND: Cardiovascular disease is one of the major causes of mortality in Canadian women. However, the number of women recruited into cardiovascular clinical trials continues to be low relative to the prevalence of cardiovascular disease. To determine why the recruitment of women into cardiovascular trials continues to be problematic, we prospectively examined the barriers and motivations of women contacted for the Raloxifene Use for The Heart (RUTH) study. METHODS: Two hundred seventy postmenopausal women were surveyed. Regardless of study eligibility, women were asked to comment on their reasons for participating or not participating in cardiovascular trials in an open-ended single question format. All answers were recorded and grouped accordingly. RESULTS: Fifty-four percent of women surveyed indicated they would not participate in clinical research, and 46% indicated that they would. Motivations reported for participating in a cardiovascular clinical trial included personal health benefits (82.2%), interest in research (44.1%), and the possibility of benefiting society (29.1%). Reasons for declining participation included personal illness (24.8%), transportation issues (17.9%), reluctance to increase medication (15.2%), and concern about adverse health effects (13.1%). CONCLUSION: As reported by our cohort of postmenopausal women, the major barrier to entering a randomized controlled trial related to cardiovascular disease was the perception that participation would present an increased burden on health and time. Our experience suggests that researchers need to educate women on the importance of clinical trials and that they also need to provide practical solutions to barriers such as transportation.