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Appendix A
Clarifications
This appendix describes several conditions that the Committee on
Preventive Services for Women examined to determine if there may be gaps
in preventive services necessary for women’s health and well-being that are
not included in the United States Preventive Services Task Force (USPSTF)
Grade A and B recommendations, Bright Futures, and Advisory Committee
on Immunization Practices (ACIP) guidelines. The committee conducted a
full review of the following conditions and risk factors, including those re-
lating to cardiovascular disease, osteoporosis, breast cancer, mental health,
tobacco use, and diet and physical activity. For these conditions, the com-
mittee concluded that there was insufficient evidence to develop new recom-
mendations. At the same time, evidence supported by peer-reviewed studies,
federal goals, professional clinical guidelines, and existing federal practices
led the committee to suggest a clarifying statement to existing USPSTF
recommendations, or led to a suggestion that specific services should be
addressed within the context of the well-woman preventive care visit rec-
ommended by the committee. Several of the committee descriptions that
follow serve as examples of areas in which further high-quality research
is needed to understand and better address preventive services for women.
CARDIOVASCULAR DISEASE
Cardiovascular disease (CVD) is the class of diseases that involve the
heart or blood vessels and includes high blood pressure, coronary heart
disease (CHD), stroke, and heart failure (Bonow et al., 2011). Address-
ing cardiovascular disease across the life span in women, including during
171
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172 CLINICAL PREVENTIVE SERVICES FOR WOMEN
adolescence, the reproductive years, and maturity, is important. It has been
shown that risk factors experienced during pregnancy, such as hypertension
of pregnancy, gestational diabetes, and preeclampsia, place women at risk
for the development of cardiovascular disease as they age.
Prevalence/Burden
More women die annually from heart disease than men, but overall,
men have a higher burden of CVD (Roger et al., 2011). Likely because of
the obesity epidemic in the United States, rates of mortality from CHD
(CVD affecting the coronary arteries) in women aged 35 to 54 years have
increased in recent years.
CVD rates for American black females are significantly higher than those
for their white counterparts (286.1/100,000 population and 205.7/100,000
population, respectively) (Mosca et al., 2011; Roger et al., 2011). The black
female population also has a lower rate of awareness of heart disease than
white women (Ferris et al., 2005; Kleindorfer et al., 2009; Mosca et al.,
2010; Roger et al., 2011). More women die each year of stroke and stroke
constitutes a higher proportion of CVD events in women, compared with
a higher proportion of coronary heart disease in men. The majority of the
research from which preventive care recommendations are derived is based
on CHD and not stroke (Mosca et al., 2011).
Evidence shows differences in the pathology of CHD by sex, with
women having a higher prevalence of disease of the small coronary vessels
than men (Bairey Merz et al., 2006; Jacobs, 2006). Symptoms of CHD
are more likely to be atypical, including dyspnea and epigastric discom-
fort (Canto et al., 2007). Lastly, premenopausal women who suffer sud-
den death are more likely to have pathologic findings of plaque erosion
than plaque rupture, which is more common in men and postmenopausal
women (Burke et al., 1998; Oparil, 1998). Older women who suffer a
myocardial infarction are more likely than men to have plaque rupture with
thrombus (Kruk et al., 2007). The relevance of these findings is unclear but
points to biological differences in CHD in women, the full extent of which
remains unknown.
Risk Factors for CVD
Most modifiable risk factors for the primary prevention of CVD, such
as hypertension, hyperlipidemia, diabetes mellitus, smoking, obesity, meta-
bolic syndrome, and physical inactivity, are similar in women and men; but
the prevalence and impact of certain risk factors may differ by sex. Risk
factors in which there are sex differences in prevalence and impact or in
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APPENDIX A
which there are different criteria by sex are outlined below. Diabetes mel-
litus, obesity, smoking, and physical activity are addressed in other sections
of this document.
Lipids: Elevated levels of low-density lipoprotein (LDL) present equivalent
risks to women and men but a high-density lipoprotein (HDL) level of
<50 mg/dL is considered a risk in women and an HDL level of <40 mg/dL is
considered a risk in men (National Cholesterol Education Program Expert
Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol
in Adults, 2002; Mosca et al., 2011). Currently, interventions to improve
HDL mainly focus on lifestyle and control of traditional risk factors. No
sex-specific interventions for increasing HDL levels currently exist.
Metabolic Syndrome: Metabolic syndrome is a constellation of risk fac-
tors that are associated with the development of CVD and type 2 diabetes
mellitus. The diagnosis is made when three of the following five findings
are present: (1) elevated waist circumference (≥40 in. [102 cm] in men and
≥35 in. [88 cm] in women), (2) elevated triglyceride levels (≥150 mg/dL
[1.7 mmol/L]) or drug treatment for elevated triglyceride levels, (3) reduced
HDL cholesterol levels (<40 mg/dL [1.03 mmol/L] in men and <50 mg/dL
[1.3 mmol/L] in women or drug treatment for reduced HDL cholesterol
levels, (4) elevated blood pressure (≥130 mm Hg systolic blood pressure or
≥85 mm Hg diastolic blood pressure) or antihypertensive drug treatment,
and (5) elevated fasting glucose level of ≥100 mg/dL or drug treatment for
elevated glucose levels (Grundy et al., 2005).
The prevalence of the metabolic syndrome is increasing and varies by age
in women and men, with the prevalence being higher in men up to the age of
60 years, after which the rates are higher in women (51.5 percent in men
versus 54.4 percent in women) (Ervin, 2009). Importantly, the rates of meta-
bolic syndrome are significantly higher in non-Hispanic black and Mexican
American women than in their male counterparts (38.8 and 25.3 percent, re-
spectively, for non-Hispanic black women versus men and 40.6 and 33.2 per-
cent, respectively, for Mexican American women versus men) (Ervin, 2009).
Meta-analyses of studies evaluating the metabolic syndrome showed
an association of metabolic syndrome with an increased risk of develop-
ing CVD and death from CVD (relative risk = 1.78; 95 percent confidence
interval = 1.58 to 2.00), with the association between metabolic syndrome
and an increased risk of CVD being stronger in women than in men in the
smaller number of studies that provide data by sex (relative risk = 2.63
versus 1.98, P = 0.09) (Gami et al., 2007).
Women with metabolic syndrome have a three times higher risk of
dying from a heart attack or stroke than women who do not have it
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174 CLINICAL PREVENTIVE SERVICES FOR WOMEN
(Cleveland Clinic, 2011), and they have a significantly elevated risk for
developing type 2 diabetes (Lorenzo et al., 2007). Furthermore, women
diagnosed with metabolic syndrome in early pregnancy have a significantly
greater risk of developing gestational diabetes mellitus. An accurate mea-
surement of the waist circumference must be obtained to make a diagnosis
of metabolic syndrome.
Pregnancy-Related Risk Factors: Pregnancy-related risk factors such as
preeclampsia, gestational hypertension, and gestational diabetes mellitus
are specific to women and are risk factors for the development of CVD and
CVD events in women as they age. These pregnancy-related disorders are
highly prevalent, with approximately 5 percent of pregnancies complicated
by preeclampsia. Gestational diabetes, which complicates 5 percent of preg-
nancies, is often seen in women who also have gestational hypertension.
Women who experience preeclampsia have twice the risk of heart dis-
ease, stroke, and venous thromboembolism as they age and are twice as
likely to die of cardiovascular disease (Bellamy et al., 2007; McDonald et
al., 2008; Rich-Edwards et al., 2010). In a Canadian population, women
who have preeclampsia and preterm birth (<37 weeks of gestation) have
been found to have an eight-fold higher risk of mortality from CVD than
women who do not have preeclampsia and who give birth at term (Irgens
et al., 2001).
Approximately 50 percent of the women who experience gestational
diabetes mellitus will go on to develop type 2 diabetes mellitus and also
experience a 70 percent increase in the risk of CVD, much of which can be
attributed to the development of type 2 diabetes mellitus (Shah et al., 2008).
Black women experience significantly higher rates of these pregnancy com-
plications (Rich-Edwards et al., 2010).
Little is currently understood about the possible vascular abnormalities
caused by these disorders or the time course of the increase in risk. Simi-
larly, research on the etiology of these disorders and how best to prevent
them before pregnancy, during pregnancy, or between pregnancies is lack-
ing. Given the association of preeclampsia, gestational hypertension, and
gestational diabetes with an increased risk of CVD in women as they age,
the 2011 American Heart Association (AHA) guidelines for prevention of
CVD in women recommends that a history of pregnancy complications be
obtained as part of the evaluation of CVD risk in women (Mosca et al.,
2011).
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APPENDIX A
Depression: Depression is more common in women than men and dis-
proportionately affects the outcomes of women who have experienced a
myocardial infarction. Screening for depression is recommended for women
with CVD, but no evidence suggests that screening affects the outcomes
for these women. Research to understand the role of depression on the
development of CVD and how sex and gender influence this relationship is
emerging (Mosca et al., 2011).
Social Determinants of Health: Evidence shows that the risk for CVD is
influenced by social determinants of health, such as socioeconomic status,
geographic location, chronic stress, poverty, and racism. The intersection
of race/ethnicity, gender, and economic status complicates the understand-
ing of who is at risk for metabolic syndrome, but understanding this social
patterning is important for the development of targeted interventions. In
an analysis of data from the National Health and Nutrition Examination
Survey III, economic status was found to have an impact on the incidence
of metabolic syndrome for women but not for men. Women in the lowest
economic group were more likely to be at risk than women in the highest
economic group (Salsberry et al., 2007). Results such as these underscore
the potential clinical significance of socioeconomic position, particularly for
women (Loucks et al., 2007). Black women are at greater risk for CVD than
white women of comparable socioeconomic status, and the age-adjusted
rates of death from CVD for black women exceed those for white women
(Hayes et al., 2006). Black women in the southern rural United States have
among the highest rates of mortality from CVD, especially stroke (Casper
et al., 2011).
These studies demonstrate that social determinants may have dispro-
portionate impacts on the development of CVD in women, but more high-
quality evidence is needed in this area.
High-Sensitivity C-Reactive Protein: High-sensitivity C-reactive protein is
a nonspecific biomarker of increased risk for CVD. The role of the high-
sensitivity C-reactive protein levels in the assessment of risk and in defining
preventive strategies remains unclear. The Jupiter study, which is often cited
as the rationale to use high-sensitivity C-reactive protein for screening, did
not include women with low high-sensitivity C-reactive protein levels, and
therefore, no definitive statement about the use of this biomarker to screen
women in the general population can be made (Mosca et al., 2011; Ridker
et al., 2010).
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176 CLINICAL PREVENTIVE SERVICES FOR WOMEN
Existing Guidelines and Recommendations
USPSTF Recommendations
The USPSTF recommends the use of aspirin for women aged 55 to 79 years
when the potential benefit of a reduction in ischemic strokes outweighs the poten-
tial harm of an increase in gastrointestinal hemorrhage. Grade A recommendation
(USPSTF, 2009a).
The USPSTF recommends screening for high blood pressure in adults aged 18
and older. Grade A recommendation (USPSTF, 2007a).
The USPSTF strongly recommends screening women aged 45 and older for lipid
disorders if they are at increased risk for coronary heart disease. Grade A recom-
mendation (USPSTF, 2008).
The USPSTF recommends screening women aged 20 to 45 for lipid disorders if
they are at increased risk for coronary heart disease. Grade B recommendation
(USPSTF, 2008).
The USPSTF makes no recommendation for or against routine screening for lipid
disorders in men aged 20 to 35 or in women aged 20 and older who are not at
increased risk for CHD. Grade C recommendation (USPSTF, 2008).
The USPSTF concludes that the evidence is insufficient to recommend for or
against routine screening for lipid disorders in infants, children, adolescents, or
young adults (up to age 20). Grade I statement (USPSTF, 2007b).
The USPSTF recommends that clinicians ask all adults about tobacco use and
provide tobacco cessation interventions for those who use tobacco products.
Grade A recommendation (USPSTF, 2009b).
The USPSTF concludes that the evidence is insufficient to recommend for or
against routine screening for tobacco use or interventions to prevent and treat
tobacco use and dependence among children or adolescents. Grade I statement
(USPSTF, 2003c).
Bright Futures recommends screening for high blood pressure through-
out adolescence and annual screening for dyslipidemia. Otherwise, Bright
Futures provides only anticipatory guidance on this subject (AAP, 2008).
Numerous organizations such as the AHA provide a wealth of ex-
pansive and specific guidelines for preventing CVD in women. The AHA
alone recently published an updated list of more than 20 guidelines. These
recommendations are commonly in agreement with those of the USPSTF.
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APPENDIX A
The Adult Treatment Panel III from the National Cholesterol Education
Program recommends that lipids be treated according to the risk stratifica-
tion obtained by use of the Framingham risk score. This system stratifies
patients into three basic categories by 10-year risk (the percentage prob-
ability of experiencing an event in the next 10 years): >20 percent, 10 to 20
percent, and <10 percent. However, these recommendations do not differ
by sex.
Effective Interventions
A large body of evidence has been amassed to support prevention strat-
egies for CVD in women and men. Even though CVD-related conditions are
often grouped together, most evidence is based on trials that do not include
stroke as the primary outcome, which is particularly important, given that
stroke is more prevalent in women than men (Mosca et al., 2011). CVD is
primarily prevented through adequate treatment of modifiable risk factors,
including hypertension, diabetes mellitus, hyperlipidemia, and obesity, and
achievement of a healthy lifestyle, including smoking cessation, physical
activity, a healthy diet, and maintaining a healthy weight.
Metabolic syndrome is a significant risk factor for CVD in women,
and the major focus is on preventing or treating the underlying modifi-
able risk factors, such as central obesity, hypertension, increased LDL and
triglyceride levels, and diabetes mellitus. Lifestyle modification, including
weight loss, physical activity, and a healthy diet, decreases all of the meta-
bolic risk factors (Grundy et al., 2005). Although good data that link the
modification of each risk factor that comprises metabolic syndrome to a
decrease in cardiovascular risk are available, the data on preventing or
treating metabolic syndrome are lacking. No data directly link screening
for metabolic syndrome and prevention of CVD, although the syndrome
must be recognized to accurately define women’s risk.
Few data are available on effective interventions to prevent the compli-
cations of pregnancy, such as gestational hypertension and preeclampsia,
which are risk factors for CVD. Achieving a healthy weight before preg-
nancy has been linked with decreased rates of these complications (IOM,
2009). Much remains to be learned about the mechanisms underlying these
disorders, in particular, preeclampsia. Knowledge of these mechanisms
might lead to effective preventive strategies (Rich-Edwards et al., 2010).
Finally, identification of these disorders when a woman’s medical history is
obtained is important and will help to more accurately define overall risk
for CVD.
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178 CLINICAL PREVENTIVE SERVICES FOR WOMEN
Identified Gaps
The primary gaps in preventive services not already addressed by the
provisions set forth in the ACA are (1) there is no comprehensive mecha-
nism for the prevention or screening of metabolic syndrome in all women,
and (2) there is no comprehensive mechanism in place to collect pregnancy
complication histories to better predict the risk level of a woman for devel-
oping cardiovascular disease in the future.
The committee found insufficient evidence to support a new recom-
mendation; instead, evidence supported by professional clinical guidelines
led to committee support for the reasonableness of including screening for
metabolic syndrome in women and obtaining a history of pregnancy com-
plications within the context of the well-woman preventive visit.
BONE/SKELETAL DISEASE
The USPSTF recommends screening for osteoporosis using bone densi-
tometry testing for women aged 65 years and older and in younger women
whose fracture risk is equal to or greater than that of a 65-year-old white
woman who has no additional risk factors (USPSTF Grade B recommenda-
tion). This recommendation was based on the age and personal risk factors
of average-risk women with no previous fragility fractures and does not
explicitly address women with secondary causes of osteoporosis or previous
fractures (USPSTF, 2011d).
Osteoporosis is a systemic skeletal condition associated with aging
that is characterized by low bone density and deterioration of bone tissue
that weakens bones and leads to fractures (USDHS, 2004). Osteoporosis-
related fragility fractures result from forces that would not normally cause
fractures, such as hip or wrist fractures from falling from standing height
or a spine fracture resulting from compression of the vertebra from grav-
ity alone. Although some types of fractures are more commonly related to
osteoporosis (e.g., spine, hip, and wrist fractures), osteoporotic fractures
can occur at nearly all sites.
In the absence of a fracture, osteoporosis can also be diagnosed by
measuring bone density, or the thickness of bone. Results are expressed
as the T-score, which is the difference between an individual’s bone den-
sity measurement and normal values. The World Health Organization
developed definitions for levels of bone density based on T-scores (Kanis,
1994). T-scores identify only one aspect of the condition, however. Other
important components, such as rate of bone loss and quality of bone, are
not currently measured in clinical practice.
Women with previous osteoporosis-related fractures are at high risk
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APPENDIX A
for subsequent fractures. Although most women can accurately recall hav-
ing had a previous fracture that required medical attention and fractures
are usually well documented in medical records, tracking of women for
follow-up care is usually difficult. As a result, evaluations for osteoporosis
are often missed, drug treatments are not prescribed, and rates of subse-
quent fractures are high. Fractures that do not require immediate medical
attention are often not recognized, such as spine fractures with mild or no
symptoms. Nonetheless, asymptomatic spine fractures are also important
in establishing the diagnosis of osteoporosis and determining needs for
drug therapy.
Osteoporosis may occur without a known cause (primary osteoporo-
sis) or occur as the result of another condition (secondary osteoporosis).
Common secondary causes include dietary deficiencies in calcium or
vitamin D; use of certain medications (aluminum antacids, anticoagulants,
anticonvulsants, aromatize inhibitors, barbiturates, cancer chemotherapeutic
drugs, depo-medroxyprogesterone, glucocorticoids, gonadotropin-releasing
hormone agonists, lithium, and others); and the presence of health condi-
tions (rheumatoid arthritis, diabetes, hyperparathyroidism, gastric bypass
and other gastrointestinal surgery, malabsorption, inflammatory bowel
disease, hemophilia, lupus, rheumatoid arthritis, kidney disease, depression,
multiple sclerosis, emphysema, and others).
Several additional risk factors for osteoporosis and fractures have been
determined from large population studies. Risk factors that cannot be mod-
ified include age, menopause, low body mass index, and a family history
of osteoporosis and fractures. Modifiable risk factors include immobility,
falls, tobacco use, and excessive alcohol intake (three or more drinks daily).
Prevalence/Burden
Low bone density, osteoporosis, and related fragility fractures are com-
mon in older adults. Estimates indicate that as many as 50 percent of
Americans over age 50 years, or 14 million individuals by 2020, will be
at risk for osteoporotic fractures during their lifetimes (USDHS, 2004).
Fracture rates are higher and ages of incidence are younger for women than
for men. Rates are highest in whites than in other racial groups, although
osteoporosis is common in all groups (George et al., 2003; Looker et al.,
1997; Nelson et al., 1995). Older individuals have much higher fracture
rates than younger individuals with the same bone density because of in-
creasing risks from other important contributors, such as falling (Heaney,
1998). All types of fractures are associated with higher rates of death (Bliuc
et al., 2009; Center et al., 1999; Leibson et al., 2002). Nonfatal fractures
at any site can impair function and quality of life, cause chronic pain and
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180 CLINICAL PREVENTIVE SERVICES FOR WOMEN
disability, and result in high costs for health care and lost productivity
(HHS, 2004).
Bone densitometry measures the mass of bone and can be used to pre-
dict the risk of future fractures, although it is an imperfect measure. Among
bone measurement tests at various sites, the result of dual-energy X-ray
absorptiometry (DXA) of the hip is the strongest predictor of hip fracture
(Marshall et al., 1996). Several peripheral bone measurement tests have also
been developed, including quantitative ultrasound (QUS) of the calcaneus
(heel), which can predict fractures, as well as DXA, although variation
exists across studies (Nelson et al., 2010b). QUS measures bone qualities
differently from DXA, and correlates only modestly. Therefore, it is not
clear how the results of QUS can be used clinically to select individuals who
should receive drug therapies that were proven effective in clinical trials on
the basis of DXA criteria.
Measurement of the bone density of appropriate candidates is essential
before initiation of drug therapy because all of the drugs approved by the
Food and Drug Administration (FDA) to treat low bone density and osteo-
porosis work by increasing bone density. Obtaining a bone density measure
before therapy also provides an opportunity to monitor a response to the
drug, if needed.
Identification of secondary causes and modifiable risk factors can lead
to decisions to treat the underlying cause or risk factor specifically; to moni-
tor bone density and treat osteoporosis if bone density is low or a fracture
occurs; or to treat osteoporosis, in addition to the secondary cause or risk
factor. Actual management depends on the secondary cause or risk factor,
the severity of osteoporosis, additional health considerations, and patient
preferences.
Existing Guidelines and Recommendations
USPSTF Recommendations
The USPSTF recommends screening for osteoporosis in women aged 65 years
or older and in younger women whose fracture risk is equal to or greater than
that of a 65-year-old white woman who has no additional risk factors. Grade B
recommendation (USPSTF, 2011c).
Clinical guidelines from the National Osteoporosis Foundation recom-
mend bone density testing for individuals with osteoporosis-related fractures
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APPENDIX A
or secondary causes of osteoporosis, all women aged 65 years and older, and
younger postmenopausal women with key risk factors (NOF, 2010).
Despite the increased awareness of osteoporosis and recommenda-
tions for screening and treatment from multiple groups, osteoporosis is
underdetected and inappropriately treated in the United States (Kiebzak,
2002; Wilkins and Goldfeder, 2004). The reasons for this are unclear,
although the different recommendations for identifying candidates for test-
ing and treatment and confusion in interpreting the results of testing may
be contributors (Morris et al., 2004). In addition, current medical practice
in the United States is commonly fragmented for individuals experiencing
osteoporosis-related fractures. The fracture itself is usually treated by an
acute care team in hospital emergency departments and orthopedic ser-
vices, whereas screening, prevention, and treatment are addressed in other
contexts.
Effective Interventions
Primary prevention of osteoporosis and fractures begins early in life,
while bone undergoes development. Attainment of peak bone mass and its
maintenance require optimal nutrition and physical activity throughout
the life span and avoidance of tobacco, alcohol, and other exposures that
contribute to osteoporosis. All women require adequate calcium (1,200 mg
daily) and vitamin D (800 to 1,000 international units daily) intake to avoid
deficiencies and prevent osteoporosis and fractures (Standing Committee,
1997). Those with secondary causes of osteoporosis may require treatment
of their specific underlying conditions to reduce their risks for osteoporosis
and fractures. Women using medications causing osteoporosis may require
adjustments in their medications and serial measures of bone densitometry
to monitor effects on their bones.
The FDA has approved several drugs for prevention or treatment of
osteoporosis (FDA, 2011) that reduce the risk for osteoporosis-related
fractures by increasing bone density. Women with the lowest levels of bone
density or with previous osteoporosis-related fractures are the most likely
to benefit (Cummings et al., 1998). These drugs differ by their mechanisms
of action, effectiveness in reducing fractures, routes of administration, and
adverse effects.
Drugs for prevention are intended for individuals who have no previ-
ous fractures and whose bone density levels are not in the osteoporotic
range (i.e., T-score ≥–2.5). For women, these include four bisphosphonate
drugs, alendronate (Fosamax), ibandronate (Boniva), risedronate (Actonel,
Actonel with calcium), and zoledronic acid (Reclast); several forms of
estrogen with or without a progestin hormone; and raloxifene (Evista). For
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