A Publication of the
Jacobs Institute of Women's Health
March 1996 - Volume 4, Number 1
Steady progress and the need for active minority recruitment were the key notes sounded by Loretta Finnegan, MD, and Lucile Adams-Campbell, PhD, in "The Women's Health Initiative: Lessons Learned to Date," the fourth of the Jacobs Institute's series of breakfast seminars on women's health in the twenty-first century. Dr. Finnegan, director of the Initiative, and Dr. Adams-Campbell, director of the Howard University Cancer Center, one of the clinic sites, spoke to an intent audience on January 24 in an event postponed by the Blizzard of '96.
Citing the fact that a woman today spends one third of her life in her postmenopausal years, Dr. Finnegan outlined the need for more research into coronary heart disease (CHD), osteoporosis, and breast and endometrial cancer that led to the creation in 1991 of the Women's Health Initiative. The Initiative is a 10-year effort by the National Institutes of Health to accumulate data on women's health behaviors and the effects of certain interventions, including hormone replacement therapy, on the incidence of these four diseases in women.
The Initiative has three elements: an observational study of the health behavior of 100,000 women; a clinical trial examining hormone replacement therapy (HRT), dietary modifications, and calcium and vitamin D supplementation in 64,500 women; and a community prevention study aimed at promoting healthy behavior among minority and disadvantaged women. Initial funding established a vanguard of 16 clinic sites around the country. Since then, another 24 have been funded. The community prevention centers are operated in conjunction with the Centers for Disease Control and Prevention. To date, the Initiative has funded 7 activities in 8 of the 13 centers nationwide.
Hormone replacement therapy is a major concern. "We are off the idea of 'feminine forever,'" Dr. Finnegan said. "We are certainly going to age. But we hope to age in grace and health and with a good quality of life." She reminded the audience that early trials of estrogen effects were conducted on men. While observational studies show some cardioprotective benefit from HRT, few clinical trials have been done and questions remain about appropriate dosage, duration, and hormone combinations. Previous study populations have also had confounding factors (e.g., fewer obese, smoking, and inactive women). The HRT component of the Initiative will examine the risks and benefits of estrogen use in women who no longer have a uterus and estrogen-progestin use in women who still have a uterus, focused on CHD, fractures, and breast cancer.
The dietary modification component will examine whether a low-fat diet reduces the incidence of breast and colorectal cancer. Participants' daily caloric intake contains only 20 percent total fat and 7 percent saturated fat in a diet that includes five servings of fruits and vegetables and six servings of grains. The control group is given standard nutritional information and the intervention group is given behavior modifications.
Recruitment of women for the studies, which began in 1993, is nearly 50 percent complete. "At this point," said Dr. Finnegan, "the Initiative has screened a quarter of a million women, half of whom were interested in participating." The clinical trial has a recruitment target of 1,200 women per center, but Dr. Finnegan reported that in many sites the numbers are greater. Minority women, who represent 17 percent of the U.S. population of women aged 50 to 79, will make up 20 percent of the trial population.
Some 27,500 women are enrolled in the HRT component, 45,000 in the calcium and vitamin D supplementation component, and 48,000 in the dietary modification component. The Initiative's goal is to finish recruitment by 1998. Participants will be followed up until 2005, and data analysis is expected to take another two years. Dr. Adams-Campbell, co-investigator at her site, raised a laugh when she commented on the length of the study, "I knew I was in trouble when Dr. Finnegan asked 'What plans do you have in case one of you dies?'"
Only ten of the funded sites are minority centers (sites where 60 percent of the population must represent minorities). Dr. Adams-Campbell pointed out that traditional recruitment methods are often unsuccessful. The key to recruiting minorities, she emphasized, is to establish trust with the community, which requires continuous involvement of clinic staff in the community and of community members in clinic efforts (e.g., representation on an advisory board or a similar feedback mechanism). It also requires an understanding of the simple problems which often create barriers to participation, such as child care, work flexibility, and literacy appropriateness. Adequate representation of minorities among site staff is critical. Incentives (e.g., refrigerator magnets, T-shirts) are also important to keep the issue in the forefront of participants' thoughts and imply membership in a group effort.
At the Howard site, staff are actively and aggressively recruiting. In fact, attendee suggestions of possible influential organizational sources led to a relationship being established at the seminar and Howard recruiters spoke with attendees after the event.
Federal shutdown and budget cutbacks raised questions about the long-term sustainability of the Initiative. Dr. Finnegan pointed out that all government agencies work with year-to-year budgets but stressed that appropriate justification, evidence of progress, and congressional interest all point to the Initiatives successful completion.
As for what motivates women to enroll, both Dr. Finnegan and Dr. Adams-Campbell pointed out that what they hear most is that "Its about time." Women want answers. Interest in women's health has risen to such a point, said Dr. Finnegan, that "It would be very difficult to go back. It can only escalate."
The Jacobs Institute is pleased to announce that its official journal, Women's Health Issues, will begin bimonthly publication in 1996. The benefits of increasing publication, according to editor Warren H. Pearse, MD, are not just that members receive increased value and that subscribers get access to more articles. He points out that "The field is expanding. Six issues allow us to provide more timely publication for authors and more timely reports of conferences."
The need to shift from quarterly to bi-monthly publication, engendered by the quantity and quality of manuscripts submitted, is also an indication of the value subscribers and practitioners ascribe to the material they find in the journal.
Journal issues this year will cover several important events: the proceedings of the Jacobs Institute's July 1995 conference, "Women's Health and Managed Care: Balancing Cost, Access, and Quality"; abstracts from a National Advisory Board on Ethics in Reproduction conference on the social, legal, and ethical issues of assisted reproduction; and the results of a conference sponsored by the Uniformed Services University of Health Sciences on the health of women in the military.
Other issues will include a discussion of the opinion on end-of-life decision-making recently issued by the American College of Obstetricians and Gynecologists Ethics Committee and publication of the manuscripts on Women and Exercise submitted for the Jacobs Institute's prize award.
Studies suggest that postmenopausal estrogen therapy reduces morbidity and mortality, yet racial differences in mortality between African-American and Caucasian women persist. The 1995 Jacobs-Ortho Scholar, Barbara A. Bartman, MD, MPH, will test three hypotheses to determine whether race is independently associated with estrogen use (that is, independent of income, insurance, and other demographic and health characteristics):
Her study, "Racial Differences in Estrogen Use Among Middle-Aged and Older Women," was selected by a multidisciplinary committee from 63 applications. Dr. Bartman will be working with data from the National Medical Expenditure Survey, the National Health Interview Survey, and the National Ambulatory Medical Care Surveys.
Dr. Bartman is assistant professor of medicine in the Department of Epidemiology and Preventive Medicine at the University of Maryland School of Medicine. She has published and presented extensively on women's primary care, particularly on social, cultural, and institutional factors in women's access to care.
The Jacobs-Ortho Scholar award is aimed at finding ways to improve the delivery of women's health care through research into unmet service needs and the effects of social, cultural, and demographic factors. Last year's recipient, Janice I. French, CNM, MS, of the University of Colorado Health Sciences Center, is studying the risk of preterm birthamong African-American women with reproductive tract infections. The results of Jacobs-Ortho Scholars' studies are published in the Institute's bimonthly journal, Women's Health Issues. The application deadline for the 1998 award is October 15, 1997. For more information, call the Jacobs Institute at 202-863-4990 or .