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Health
Systems
Proposed
Care Management for Women with Estrogen Deficiency: Identification,
Risk Stratification, and Treatment
By
Philip
J. Tuso, MD, FACP
Introduction
For years, we have understood the importance of managing the care of women
with estrogen deficiency: Women's risk for death from hip fracture and
ischemic heart disease increase significantly after menopause.1
Population care management programs have been developed to improve quality
of life and to reduce utilization of expensive resources for patients
who have preventable diseases.2 Newly developed information
technology systems within Kaiser Permanente (KP) make it possible to identify
and stratify risks for chronic illnesses such as congestive heart failure,
diabetes mellitus, and asthma. Using this technology, we have the potential
to identify and manage the care of all women who have estrogen deficiency:
Selection algorithms can be integrated into current data systems to educate
and improve the overall care of menopausal women who are at risk for complications
of estrogen deficiency (eg, coronary artery disease, and osteoporosis).
This article
describes a proposed model of care that has been developed to help manage
the care of estrogen-deficient menopausal women.
Management
of Estrogen Deficiency: The Problem
In general, estrogen deficiency among women is poorly managed: Fewer than
20% of US women over age 50 years are adequately treated for estrogen
deficiency. This statistic suggests that we have substantial room for
improvement. Moreover, as our adult population ages, the number of women
who become estrogen-deficient will increase. There is a growing concern
that many of these women will not be treated for estrogen deficiency.
Management
of estrogen deficiency is a subject of interest to many clinicians who
care for women who have had hysterectomy or who become menopausal. Clinicians
are aware that hormone replacement therapy (HRT) in women decreases symptoms
of menopause and decreases their risk for death associated with hip fracture
and heart disease; indeed, mortality among women who use postmenopausal
hormones is lower than among nonusers. However, the survival benefit of
HRT use diminishes with longer duration because prolonged HRT use is associated
with a slightly increased risk of breast cancer.3.4 In the
United States, hip fracture kills approximately 65,000 women per year,
heart disease kills about 233,000 women per year, and breast cancer kills
about 43,000 women per year.5 Some authors1,6 have
suggested that the decrease in risk of heart disease outweighs the risk
of breast cancer.
Despite
the known benefits of HRT, however, many women choose to not take estrogen
replacement. In one study,7 current use of HRT was reported
by 58.7% of women who had hysterectomy and by 19.6% of women who did not
have hysterectomy. Most women either do not fill prescriptions for HRT
or discontinue treatment within one year after starting HRT.8
Recent
and Proposed Ways to Improve Identification and Management of Estrogen
Deficiency
In general, women are not well informed about the risks and benefits of
HRT. The Health Plan Employer Data and Information Set (HEDIS), which
is maintained by the National Committee for Quality Assurance (NCQA),
now uses a set of standardized performance measures to assure purchasers
and consumers of health care that their managed care organizations are
informing women who may have estrogen deficiency about the risks and benefits
of HRT as well as alternatives to this therapy. Specifically, HEDIS will
be sending to members of managed care organizations a questionnaire which
focuses on exposure to counseling, breadth of counseling, and personalization
of counseling. In addition, the American Association of Clinical Endocrinologists
(AACE) has outlined educational guidelines10 to help clinicians
manage their patients' menopausal symptoms (Table
1).
As a managed
care organization, we must be held accountable for our management of the
care of women with estrogen deficiency. By using tracking systems to screen
women for estrogen deficiency, by educating women about estrogen deficiency,
and by improving compliance with prescribed treatment regimens, treatment
programs could decrease the incidence of osteoporotic fracture and coronary
artery disease in women with estrogen deficiency. Successful preventive
therapy for these women could then have a dramatic impact on health care
expenditures over the next two decades. A care management program is therefore
needed and should include population identification, risk stratification,
and models of care for estrogen-deficient menopausal women.
Proposed
Population-Based Care Management Model
Women should start receiving counseling in their mid- to late forties,
when most women are perimenopausal or menopausal. These Health Plan members
could receive counseling by a case manager with or without attending classes
that review the risks and benefits of managing estrogen deficiency as
well as alternative methods of managing this condition. Members seen in
primary care clinics for routine examination or for cancer screening (mammography,
Pap smear) or who attend the counseling sessions or classes can be asked
to complete a simple self-examination tool (Table
2). Responses to the questionnaire can be used to identify members
as being at low, medium, or high risk for complications associated with
untreated estrogen deficiency. Feedback to primary care providers on percentage
of impaneled women aged >45 years who are receiving HRT may increase
the percentage of women who are appropriately counseled on the risks and
benefits of HRT as well as on alternatives to this method of managing
estrogen deficiency. Models of care (Table
3) could help guide members, staff, care managers, and clinicians
in developing the best management plan for each Health Plan member.
Women who
decide to take HRT should have easy access to clinics or practitioners
who can provide education on the most appropriate treatment plan and who
can arrange for follow-up consultation to answer any questions and, if
necessary, to adjust therapy. For women who have not had hysterectomy,
HRT should include estrogen and progestin agents because unopposed estrogen
therapy in women with a uterus has been associated with endometrial cancer.
Women who have had hysterectomy need only estrogen replacement. Multiple
HRT regimens have been developed.10 For women with a uterus,
these regimens commonly prescribe 0.625 mg equine estrogen taken orally
every day with daily or cycled medroxyprogesterone at a dosage of 5 mg
to 10 mg per day.
Hormone
replacement therapy is contraindicated in women who have a history of
breast or uterine cancer, thromboembolism, undiagnosed genital bleeding,
gallbladder disease, or undiagnosed headache with or without hypertension.10,11
For women in whom HRT is not well tolerated or for whom HRT is contraindicated
or not selected, alternative therapy for preventing osteoporosis includes
vitamin D and calcium supplementation, selective estrogen receptor modulators
(raloxifene), biphosphonates (alendronate), phytoestrogens, and calcitonin.10
In addition to having protective effects on bone, raloxifene may also
lower LDL cholesterol levels. Alendronate has been shown to have no effect
on reduction of symptoms associated with menopause but has been approved
for both prevention and treatment of osteoporosis. Alendronate has not
been shown to reduce cardiac mortality associated with estrogen deficiency.12
The effects
of HRT, alendronate, and raloxifene on bone disease, coronary artery disease,
menopausal symptoms, breast cancer, and thromboembolism are summarized
in Table
4. As stated above, HRT, alendronate, and raloxifene all help to prevent
osteoporosis. The cardioprotective effects of HRT have been well documented.13
Of all 3 treatmentsHRT, alendronate, and raloxifeneHRT is best for managing
menopausal symptoms. Raloxifene and HRT may cause thromboembolic disease.
Menopausal
symptoms are easily managed with HRT but are difficult to treat without
estrogen replacement. Flaxseed, soy products, and certain herb products
contain phytoestrogen, which may inhibit release of leutinizing hormone
and subsequently help women with hot flushes and mood irregularity.14
Vaginal dryness can be managed with phytoestrogen creams or with nonprescription,
water-based lubricants.15 Use of herbal remedies is not without
risk (Table
1), and members should review their use of herbal supplements with
their health care practitioners.16
All Health
Plan members should be screened for diabetes mellitus, hypertension, and
hyperlipidemia, and appropriate treatment should be initiated according
to KP Regional guidelines. Women at risk for coronary artery disease should
be screened carefully to ensure that optimum LDL levels have been achieved.
After receiving dietary counseling, Health Plan members at very high risk
for coronary artery disease may be considered candidates for "statin"
therapy.17 All members who smoke should be advised to stop.
Education classes and individual counseling should emphasize the importance
of exercise as well as vitamin D and calcium supplementation.18
Care of women in the high-risk group should be managed aggressively by
these members' primary care practitioner or referred to a specialist,
as appropriate. Some medical centers may consider developing clinics to
manage the care of female members who are at risk for complications associated
with estrogen deficiency. Teams may consist of representatives from the
adult medicine and obstetrics-gynecology departments and use a care management
strategy that includes long-term continuity of care as well as special
expertise in managing multiple risk factors.
The Problem
of Noncompliance
Two important reasons exist for noncompliance with HRT: 1) side effects
resulting from initiation of HRT and 2) belief that an increased risk
of breast cancer is associated with estrogen replacement. An estimated
20%-30% of women who initiate HRT discontinue it within one year after
starting treatment.8 Many women are concerned about associated
problems, ie, abnormal uterine bleeding and the inconvenience of taking
hormones for the rest of their lives. Well-organized education programs
and access to counselors should be made available to women who have questions
about HRT before they consider stopping treatment.
Many women
avoid HRT because of the fear that by taking estrogen replacement they
will increase their risk of developing breast cancer. In 1997, the
results of a collaborative reanalysis of the effects of HRT on women were
reported from 51 epidemiologic studies of 52,705 women with breast cancer
and 108,411 women without breast cancer.19 The results demonstrated
that an increased risk of breast cancer in estrogen users might not be
conclusive. Women should know that multiple studies published over the
past 20 years fail to show that estrogen use increases women's risk for
breast cancer.10 To ensure that all members receive counseling
and comply with prescribed treatment regimensand to assess the program's
overall successmeasurable outcomes such as those proposed (Table
5) should be monitored continuously.
Conclusion
Information technology is revolutionizing the way we care for patients.
Specifically, we now have the tools to identify and stratify risks for
many chronic illnesses and to manage the care of large numbers of Health
Plan members with these chronic illnesses. Over the next few years, we
will therefore shift many of our resources form disease treatment to disease
prevention. In this context, population-based care management for women
represents the next phase of care management: after individual Health
Plan members are stratified according to their health risks, long-term
medical complications in these members can be prevented through routine
medical evaluations given by health care practitioners, yearly reminder
letters, and recommended participation in health education programs or
seminars. Population-based care management of women with estrogen deficiency
can be modeled after highly successful care management programs currently
used by KP for management of asthma, congestive heart failure, and diabetes
mellitus.
Considering
these emerging needs and capabilities, a goal of our health maintenance
organization should be to inform all women of the risks and benefits of
hormone replacement therapy as well as its alternatives.
References
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H, Wang-Dheng R, Nattinger AB. Postmenopausal hormone replacement: are
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medicines in the treatment of chronic vaginal symptoms. Obstet Gynecol
1997 Jul;90(1):50-3.
16. Tuso PJ. The herbal medicine pharmacy: what Kaiser Permanente providers
need to know. Permanente J 1999 Winter;3(1):33-7.
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19. Breast cancer and hormone replacement therapy: collaborative reanalysis
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