Frail older women's participation in a trial of hormone replacement therapy: Perceived benefits and concerns

Objective: The aim of this study was to identify the reasons that were important to frail older women's decisions to participate or not participate in a clinical trial of hormone replacement therapy (HRT). Design: We conducted a cross-sectional study of a community-based sample of physically frail women ≥ 75 years old, who were recruited to participate in an intervention trial of HRT. Participants were randomized 2:1 to either HRT or placebo, respectively. Questionnaires measured participants' reasons for participation and nonparticipants' reasons for declining. Five-point scaled responses to questionnaire items ranged from least to most important or least to most concerned. Results: Sixty-nine women participated (84% white, 16% African American) in the trial. Nonparticipants (n = 41) were older, on average, than participants (83.8 ± 4.2 vs. 82.2 ± 3.6 years; p = 0.04). Important reasons for participation were reducing risk for Alzheimer's disease and osteoporosis, having more energy, improving self-care ability, and benefiting other women. Fear of cancer from postmenopausal estrogen was the predominant concern of 46% of nonparticipants and 78% of participants (p = 0.08). Recommendation against participation or use of estrogen by a woman's personal physician was the most prevalent additional reason given for nonparticipation. Conclusions: Disease prevention and improving self-care abilities were most important to participants. Fear of cancer was not a greater concern for nonparticipants than for participants. The role of the physician in older women's decision-making about use of postmenopausal estrogen seems to be important.