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 relating to cardiovascular disease, osteoporosis, breast cancer, mental health, tobacco use, and diet and physical activity. For these conditions, the committee concluded that there was insufficient evidence to develop new recommendations. 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 recommended 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 (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). Addressing cardiovascular disease across the life span in women, including during
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.
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 discomfort (Canto et al., 2007). Lastly, premenopausal women who suffer sudden 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, metabolic 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
which there are different criteria by sex are outlined below. Diabetes mellitus, 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 factors 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 metabolic syndrome are significantly higher in non-Hispanic black and Mexican American women than in their male counterparts (38.8 and 25.3 percent, respectively, for non-Hispanic black women versus men and 40.6 and 33.2 percent, 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 developing 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
(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 measurement 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 pregnancies, is often seen in women who also have gestational hypertension.
Women who experience preeclampsia have twice the risk of heart disease, 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 complications (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. Similarly, research on the etiology of these disorders and how best to prevent them before pregnancy, during pregnancy, or between pregnancies is lacking. 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).
Depression: Depression is more common in women than men and disproportionately 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 understanding 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 disproportionate 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).
Existing Guidelines and 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 potential 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 recommendation (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 throughout 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 expansive 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.
The Adult Treatment Panel III from the National Cholesterol Education Program recommends that lipids be treated according to the risk stratification obtained by use of the Framingham risk score. This system stratifies patients into three basic categories by 10-year risk (the percentage probability 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.
A large body of evidence has been amassed to support prevention strategies 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 modifiable 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 metabolic 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 complications of pregnancy, such as gestational hypertension and preeclampsia, which are risk factors for CVD. Achieving a healthy weight before pregnancy 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.
The primary gaps in preventive services not already addressed by the provisions set forth in the ACA are (1) there is no comprehensive mechanism 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 developing cardiovascular disease in the future.
The committee found insufficient evidence to support a new recommendation; 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 complications within the context of the well-woman preventive visit.
The USPSTF recommends screening for osteoporosis using bone densitometry 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 recommendation). 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 gravity 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 density 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
for subsequent fractures. Although most women can accurately recall having 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 subsequent 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 osteoporosis) 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 conditions (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 modified 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).
Low bone density, osteoporosis, and related fragility fractures are common 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 increasing 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
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 predict 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 osteoporosis 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 monitor 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
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 recommend bone density testing for individuals with osteoporosis-related fractures
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 recommendations 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 testing 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 services, whereas screening, prevention, and treatment are addressed in other contexts.
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 previous 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
some of the drugs, such as alendronate, prevention doses are smaller than treatment doses. Alendronate, raloxifene, and estrogen significantly reduced the incidence of spine fractures in clinical trials of women without previous fractures (Nelson et al., 2010a,b).
Drugs approved for treatment purposes are intended for individuals who have had previous osteoporosis-related fractures or whose T-scores are low (≤–2.5). For women, these include four bisphosphonate drugs, alendronate (Fosamax, Fosamax Plus D), ibandronate (Boniva), risedronate (Actonel, Actonel with calcium), and zoledronic acid (Reclast); calcitonin (Fortical, Miacalcin); denosumab (Prolia); raloxifene (Evista); and teriparatide (Forteo). In clinical trials of women with previous fractures, all of these drugs significantly reduced spine fractures, and all except calcitonin and raloxifene reduced fractures at other sites (MacLean et al., 2008; Nelson et al., 2010b). Trials evaluating the effectiveness of non-drug interventions alone and in combination with drugs would be clinically useful but are lacking. These interventions include functional assessment and improvement, safety evaluations, vision examinations, and nutritional analyses, among others.
The primary gap in preventive services not already addressed by the provisions set forth in the ACA (reviewed in this section) is the lack of bone densitometry testing explicitly for women below the age of 65 at high risk for osteoporosis, such as those with previous fractures and secondary causes of osteoporosis. Evidence supported by systematic evidence reviews and the National Osteoporosis Foundation guidelines support a clarification statement to the USPSTF recommendation.
The committee interprets the current USPSTF recommendation regarding osteoporosis screening for women to include screening women with previous fractures and with secondary causes of osteoporosis.
Women at high risk for breast cancer may require additional screening and surveillance services that are not included in the USPSTF screening recommendations and current legislation intended for average-risk women (Federal Register, 2010; USPSTF, 2009f). Issues surrounding the prevention of breast cancer in high-risk women are technical in nature because of the complexity of the condition.
Although several factors are associated with increased risk for breast cancer, few increase a woman’s risk to levels that are clinically significant for screening purposes. Women at high risk include those with known mutations in breast cancer susceptibility genes one and two (BRCA1 and BRCA2), with unknown mutation status but have a first-degree relative (parent, brother, sister, or child) with a BRCA1 or BRCA2 gene mutation, or have a family history of breast and related cancers regardless of mutation status. Also at increased risk are women who received radiation therapy to the chest, such as for treatment of Hodgkin’s disease (Wahner-Roedler et al., 2003); have abnormal pathology results on a previous breast biopsy (Arpino et al., 2005); or have extremely dense breasts when viewed on mammography (Kerlikowske et al., 2010).
Breast cancer is the most frequently diagnosed cancer after skin cancer and the second leading cause of cancer deaths after lung cancer among women in the United States (ACS, 2010). In 2010, an estimated 207,090 cases of invasive breast cancer and 54,010 cases of noninvasive breast cancer were diagnosed, and an estimated 39,840 women died of breast cancer (ACS, 2010). Periodic mammography screening detects early stages of breast cancer and reduces the rate of mortality from breast cancer in clinical trials, although the extent of these benefits varies by age (Nelson et al., 2009a). Because most women with breast cancer have no major risk factors and are considered to be at average risk, mammography screening is recommended for women at all levels of risk (Smith et al., 2003a; USPSTF, 2009f). However, several individual characteristics are associated with an increased risk for breast cancer in epidemiological studies. Identifying women with risk factors most strongly associated with breast cancer can lead to the use of additional screening measures to improve early breast cancer detection and reduce the burden of disease for these women.
Clinically significant BRCA mutations are associated with an approximately 60 percent lifetime risk of breast cancer and a 15–40 percent lifetime risk of ovarian cancer. The prevalence of deleterious BRCA mutations is estimated to be between 1 in 400 to 1 in 800 in the general population (Anglian Breast Cancer Study Group, 2000; Ford and Easton, 1995; Whittemore et al., 2004), although specific BRCA mutations are clustered among certain ethnic groups such as Ashkenazi Jews (1 in 40) (Struewing et al., 1997). Rare disease syndromes related to deleterious mutations located on different genes also increase breast cancer risk to high levels (Garber and Offit, 2005).
Women with high risk for breast cancer can also be identified by risk
assessment instruments used in genetic counseling that are based mainly on family history information (Amir et al., 2003; Claus et al., 1994; Domchek et al., 2003; Gail et al., 1989; Tyrer et al., 2004). Approximately 10 percent of women have a first-degree relative (i.e., mother, sister, or daughter) with breast cancer, which doubles their risk of having breast cancer themselves (Collaborative Group, 2001; Pharoah et al., 1997). Risks are higher if more than one relative is affected and if breast cancer in relatives was diagnosed at younger ages, especially below age 50 years (Collaborative Group, 2001; Pharoah et al., 1997). Risk assessment considers all of these factors to provide an estimate of an individual’s breast cancer risk.
Most women previously treated for breast cancer are closely monitored after treatment, and this type of surveillance generally falls outside of screening recommendations. Women who had previous biopsies that indicated abnormal lesions that were not cancer often re-enter screening programs after their biopsies. Some of these abnormal lesions can increase the breast cancer risk 4 to 10 times above average, depending on the type of lesion (Arpino et al., 2005). Approximately 16 biopsies are obtained for every 1,000 women undergoing mammography screening in the United States (Weaver et al., 2006). Of these biopsies, approximately 1 of the 16 has an abnormal lesion that increases the risk for breast cancer.
Women with extremely dense breasts when viewed by mammography have twice the five-year risk for breast cancer than women with normal breast density (Kerlikowske et al., 2010). Women with unevenly dense breasts also have elevated risks, but to a lesser degree (Kerlikowske et al., 2010). High breast density compromises the accuracy of mammography and increases susceptibility to breast cancer (Boyd et al., 2007; Kerlikowske et al., 1996; van Gils et al., 1998a,b). Women with extremely dense breasts, particularly younger women, are more likely to be diagnosed with advanced-stage disease than women with average breast density (Kerlikowske et al., 2010). A national study of mammography screening found that approximately 9 percent of women have extremely dense breasts and 37 percent have unevenly dense breasts, with the highest rates among younger women (Kerlikowske et al., 2010). The use of breast density as a risk factor in screening is currently limited, however, because it is not routinely provided with mammography results and interpretations vary widely in practice (Kerlikowske et al., 1998).
Determination of a woman’s risk of breast cancer provides important clinical information to guide appropriate screening and prevention decisions. Women with family history information indicating high risk could adopt more intensive screening regimens that begin at younger ages that are more frequent and include additional clinical examinations and imaging technologies than women at average risk (Burke et al., 1997; Kriege et
al., 2004; Lee et al., 2010; Saslow et al., 2007; Warner et al., 2004). Those with family histories suspicious for deleterious BRCA mutations could undergo genetic testing and inform their relatives of their status to benefit them as well. Women at high risk of breast cancer could consider the use of medications (i.e., tamoxifen or raloxifene) or surgeries (i.e., mastectomy or oophorectomy, or both) to reduce their risks (Nelson et al., 2005, 2009b). Conversely, women often overestimate their risk of breast cancer (Bowen et al., 1998; Lerman et al., 1991, 1996). Women initially suspected to be at high risk but determined to be at average risk after further evaluation could be spared unnecessary evaluations, procedures, and worry if they had that information available.
Screening recommendations target primary care practice as the appropriate context for initial identification of women at high risk for breast cancer; however, methods for accurately stratifying women into high-risk and average-risk groups in this setting have not been adequately demonstrated (Nelson et al., 2005, 2009c). The accuracy of family cancer history information is variable, although a report of breast cancer in a first-degree relative was reasonably accurate in one study (sensitivity = 82 percent, specificity = 91 percent) (Murff et al., 2004). The accuracy of information for a first-degree relative was better than for a second-degree relative.
Health maintenance organizations, professional organizations, cancer programs, and state and national health programs have developed referral guidelines to assist primary care clinicians with identifying women at potentially increased risk (Nelson et al., 2005). Although specific items vary, most include questions about personal and family histories of BRCA mutations and breast and ovarian cancer, age of diagnosis, bilateral breast cancer, and Ashkenazi Jewish heritage. Most guidelines are intended to lead to a referral for more extensive genetic evaluation and counseling. No consensus or gold standard about the use of guidelines currently exists, and the effectiveness of this approach has not been evaluated. Concerns about inappropriate referrals in current practice include not only too few referrals of high-risk women but also too many referrals of average-risk women (White et al., 2008).
Genetic counseling provides an assessment of risk using established risk calculation instruments and is an essential step in determining if a woman is at increased risk and requires enhanced screening and prevention services. Genetic counseling to determine cancer risk status for women without breast cancer is a new concept in practice. No study has yet determined how genetic counseling modifies cancer screening behaviors or if doing so improves early detection and mortality. Information to guide effective integration of shared decision making into this process is also lacking. Although enhanced screening is recommended by expert groups (Burke et al.,
1997) and is based on favorable results of programs designed for women with familial risk (Brekelmans et al., 2001; Burke et al., 1997; Gui et al., 2001; Kollias et al., 1998; Warner et al., 2004), no trials of its effectiveness have been conducted.
Existing Guidelines and Recommendations
The USPSTF recommends biennial screening mammography for women aged 50 to 74 years. Grade B recommendation (USPSTF, 2009e).
The decision to start regular, biennial screening mammography before the age of 50 years should be an individual one and take patient context into account, including the patient’s values regarding specific benefits and harms. Grade C recommendation (USPSTF, 2009e).
The USPSTF concludes that the current evidence is insufficient to assess the additional benefits and harms of screening mammography in women 75 years or older. Grade I Statement (USPSTF, 2009e).
The USPSTF concludes that the current evidence is insufficient to assess the additional benefits and harms of clinical breast examination (CBE) beyond screening mammography in women 40 years or older. Grade I statement (USPSTF, 2009e).
The USPSTF concludes that the current evidence is insufficient to assess the additional benefits and harms of either digital mammography or magnetic resonance imaging (MRI) instead of film mammography as screening modalities for breast cancer Grade I statement (USPSTF 2009e)
The USPSTF recommends that women whose family history is associated with an increased risk for deleterious mutations in BRCA1 or BRCA2 genes be referred for genetic counseling and evaluation for BRCA testing. Grade B recommendation (USPSTF, 2005a).
The USPSTF recommends that clinicians discuss chemoprevention with women at high risk for breast cancer and at low risk for adverse effects of chemoprevention. Clinicians should inform patients of the potential benefits and harms of chemoprevention. Grade B recommendation (USPSTF, 2002b).
The American Cancer Society recommends yearly magnetic resonance imaging (MRI) screening, in addition to mammography screening, and that clinicians consider starting screening at age 30 years for women with lifetime risks for breast cancer of >20 percent (ACS, 2011; Saslow et al., 2007). Expert groups also advise that women with BRCA mutations or with
strong family histories of early age of breast cancer onset begin screening at younger ages (e.g., five years younger than the age of diagnosis) (Burke et al., 1997). The Society of Breast Imaging and the American College of Radiology recently published guidelines on the use of mammography, breast MRI, breast ultrasound, and other technologies for the detection of clinically occult breast cancer, recommending for women at high risk earlier screening and additional technologies that vary depending on the risk factor (Lee et al., 2010).
Assessment of breast cancer risk status and use of enhanced screening services are highly variable in practice. Ideally, an initial risk assessment based on personal characteristics and family cancer history would occur for all women as part of routine prevention in primary care. Currently, referrals to risk and genetic counseling for women without existing breast cancer are most commonly offered to relatives of women diagnosed with cancer and with strong family histories. As a result, enhanced screening is being provided to only some women who have been appropriately identified to be at high risk, as well as to others whose risk status may have been inadequately determined.
The efficacy of MRI in detecting breast cancer for screening purposes was demonstrated in a study of women with either deleterious BRCA mutations or a family history of breast cancer indicting a lifetime risk of 15 percent or greater (Kriege et al., 2004). Women were screened every six months by clinical breast examination and yearly by mammography and MRI. The sensitivity and specificity for detecting invasive breast cancer were 18 and 98 percent, respectively, for clinical breast examination; 33 and 95 percent, respectively, for mammography; and 79.5 and 90 percent, respectively, for MRI. The results were compared with those for two age-matched control groups undergoing usual screening (yearly mammography and clinical breast examination). One control group had a lifetime risk of 15 percent or greater, and the other had average risk. Women screened with clinical breast examination, mammography, and MRI had significantly smaller tumors at diagnosis and fewer cases of cancer spreading beyond the breast than women in either control group. Use of MRI also led to twice as many unneeded additional examinations as mammography and three times as many unneeded biopsies.
A comparison of four intensive screening approaches in BRCA mutation carriers included yearly MRI, mammography, and ultrasound and clinical breast examinations provided every 6 months (Warner et al., 2004). MRI was more sensitive in detecting breast cancers (sensitivity = 77 percent, specificity = 95 percent) than mammography (sensitivity = 36 percent, specificity = 99.8 percent), ultrasound (sensitivity = 33 percent, specificity = 96 percent), or clinical breast examination alone (sensitivity = 9 percent, speci-
ficity = 99 percent). Use of MRI, ultrasound, clinical breast examination, and mammography together had a sensitivity of 95 percent. In this study, 14 percent of women had a biopsy that proved to be benign. Additional clinical outcomes, including mortality, were not reported in either study.
The primary gap in preventive services not already addressed by the provisions set forth in the ACA (reviewed in this section) is the lack of enhanced breast cancer screening services for high-risk women who may require earlier and/or more frequent examinations and imaging, as well as additional imaging technologies beyond mammography.
The committee believes that the evidence is insufficient to recommend coverage for additional breast cancer screening services for high-risk women at this time. The committee recognizes the complexity of appropriately identifying women with high levels of breast cancer risk to determine eligibility for services and the limitations of research on the potential benefits of the services. Considerations for increasing use of screening services are coupled with the acknowledgment of the harms that can also occur, including increasing the rates of false-positive results and benign biopsies and the adverse impact these experiences have on women. Nonetheless, the committee feels that with rapidly evolving scientific inquiry, such consideration should be reevaluated given evidence that may alter this assessment.
Depression is a widespread mental disorder that affects approximately 121 million people worldwide and has been identified to be one of the top 10 leading causes of disease burden (Lopez et al., 2006; WHO, 2011). Symptoms include depressed mood, loss of interest or pleasure, feelings of guilt or low self-worth, fatigue, insomnia, and disturbed appetite. Depression may also lead to suicidal ideation and actions (NIMH, 2011b; WHO, 2011). In addition, postpartum depression is a condition specific to new mothers. Depression can occur throughout the life course, from childhood to late in life.
Adolescence is perhaps the most critical time period for recognizing mental health issues. Half of all mental disorders diagnosed in adulthood develop in puberty, by age 14 years (Merikangas et al., 2010). Data from the Behavioral Risk Factor Surveillance System (BRFSS) survey from 2008 revealed that young adults aged 18 to 24 years experienced the highest rates of current depression at 10.9 percent. The 45- to 64-year-old adult age
group experienced the next highest rates at 10 percent (CDC, 2010a). Adolescents and young adults also have high rates of suicide, which accounts for 12.2 percent of deaths among 15- to 24-year-olds annually (CDC, 2010b). In 2009, one in seven U.S. high school students reported that he/ she had seriously considered attempting suicide over the past 12 months, and 6.3 percent reported that they had made at least one attempt during this time period. Suicide rates in women are highest over the age range of 45 to 54 years (CDC, 2010b). Across the life course, women may develop depression more often or more prominently around the time of certain reproductive events, such as menstruation, pregnancy, loss of a baby, birth of a baby, infertility, and menopause (ACOG, 2008).
Women are consistently rated as a high-risk group for depression (Kessler, 2003; Kessler et al., 2003) because depression is significantly more prevalent in women than in men at almost twice the rate. According to data from the BRFSS survey from 2008, 4 percent of women currently fit the criteria for major depression, whereas the rate was 2.7 percent among the surveyed men (CDC, 2010a). This disproportionate ratio emerges in adolescence, between ages 10 and 15 years (Angold et al., 1998). A lifetime experience of abuse, which women experience at higher rates, contributes to the development of depression, as well as suicide ideation and suicide (NIMH, 2011a,b; Tjaden and Thoennes, 1998).
Although death rates by suicide are higher among men, women attempt suicide two to three times more often (WHO, 2002). Existing mental disorders, particularly mood disorders like depression, are often seen as a precursor to a suicide attempt (Bertolote et al., 2003; Henriksson et al., 1993; Mann et al., 2005; Robins et al., 1959). Data from psychological autopsy studies have revealed that diagnoses of clinical mental disorders were found in nearly all suicide victims. The most prevalent disorders were depression and alcohol dependence or abuse. A diagnosis of major depression was documented in 46 percent of female suicide victims (of 26 percent of male suicide victims) (Henriksson et al., 1993). Minority sexual orientation and disclosure of sexuality are associated with various rates of suicidal ideation in women. In a U.S. survey of women, lesbians and bisexual women who were not “out” were more likely to have attempted suicide than heterosexual women (Koh and Ross, 2006).
Between 10 and 20 percent of mothers experience postpartum depression within the first year after giving birth, which has significant consequences for both the child’s development and the mother’s well-being (Chaudron et al., 2004; Freeman et al., 2005; Mishina and Takayama, 2009). Although it is common for new mothers to experience feelings of sadness, anxiety, and mood swings after giving birth, these “baby blues” last for a short period of time and are not severe. Postpartum depression symptoms are markedly more severe, last longer than two weeks, and require treatment from a trained professional (womenshealth.gov). Women
with postpartum depression are at risk for future depression, including recurrent postpartum depression. Like other instances of depression, postpartum depression can lead to suicidal ideation. One in five postpartum maternal deaths is a result of suicide (Lindahl et al., 2005). Mothers with postpartum depression may have difficulty with mother-infant bonding or have thoughts of harming their infant. They may also have impaired attention to pediatric preventive practices, like the use of care safety seats and pediatric health care utilization (Chaudron et al., 2004).
Diagnosis of postpartum depression is challenging for a number of reasons. Women who did not receive their pregnancy care from a family physician may be confused about who to turn to, if they are not scheduled to visit their obstetrician-gynecologist until a year later or if they view their pediatrician as purely their child’s doctor. Symptoms of postpartum depression such as sleep disturbance, loss of energy, weight loss, and diminished concentration may be seen as normal sequelae of childbirth and not recognized as a marker of illness (Epperson, 1999).
Existing Guidelines and Recommendations
The USPSTF recommends screening adults for depression when staff-assisted depression care supports are in place to assure accurate diagnosis, effective treatment, and follow-up. Grade B recommendation (USPSTF, 2009g).
The USPSTF recommends against routinely screening adults for depression when staff-assisted depression care supports are not in place. There may be considerations that support screening for depression in an individual patient. Grade C recommendation (USPSTF, 2009g).
The USPSTF recommends screening of adolescents (12–18 years of age) for major depressive disorder (MDD) when systems are in place to ensure accurate diagnosis, psychotherapy (cognitive-behavioral or interpersonal), and follow-up. Grade B recommendation (USPSTF, 2009d).
The USPSTF concludes that the current evidence is insufficient to assess the balance of benefits and harms of screening of children (7–11 years of age). Grade I statement (USPSTF, 2009d).
The USPSTF concludes that the evidence is insufficient to recommend for or against routine screening by primary care clinicians to detect suicide risk in the general population. Grade I Statement (USPSTF, 2004).
Bright Futures identifies emotional well-being and mental health to be priority screening areas for adolescents from ages 11 to 21 years and directs physicians to screen for depression and suicidal thoughts through the use of sample questions and anticipatory guidance. Bright Futures also recommends that mothers be screened for postpartum depression during the first- and second-month infant visits (AAP, 2008).
To help bring awareness to and combat the high rates of depression, the Institute of Medicine’s (IOM’s) report Leading Health Indicators recommended that Healthy People 2020 (HHS, 2011) adopt a reduction in the proportion of people who experience major depressive episodes as one of its objectives (IOM, 2011). Healthy People 2020 has already set a goal of increasing rates of screening for depression in primary care (HHS, 2011). In 1999, the U.S. Surgeon General identified suicide to be a major public health issue in the report Call to Action to Prevent Suicide, and current Healthy People 2020 goals are to reduce the suicide rate overall, particularly for adolescents (HHS, 1999, 2011).
Professional organizations have also published guidelines on screening for suicide and postpartum depression, in addition to the depression screening that is already recommended by the USPSTF. The American College of Obstetricians and Gynecologists (ACOG) recommends a psychosocial evaluation that includes asking about suicide and depressive symptoms in patients aged 13 through 18 years (ACOG, 2007b). The American Medical Association (AMA) advises physicians with adolescent patients to ask about behaviors or emotions that indicate severe depression or suicidal thoughts on an annual basis (AMA, 1997). ACOG recommends that women be counseled about postpartum depression during the third trimester of pregnancy and that obstetricians-gynecologists consult with their patients about their risk of psychiatric illness during the postpartum period (ACOG, 2007a). ACOG also recommends that postpartum counseling take place as part of preconception care (ACOG, 2007b). In recognition of the underdiagnosis of postpartum depression, the U.S. Department of Veterans Affairs (VA) Clinical Practice Guideline for the Management of Major Depressive Disorder states that women receiving care through the VA be screened for depression at first contact with health care services in the antenatal and postnatal periods, separate from its guidelines on screening for depression in the general patient population (VA, 2009).
Depression is a condition commonly encountered in primary care because people with major depression utilize health care at high rates. A review of the evidence of rates of primary care and mental health specialist contact rates in select developed countries revealed that 45 percent
of suicide victims visit their primary care provider within one month of the suicide (Luoma et al., 2002). Moreover, increased rates of physician education and recognition of depression in primary care are associated with a reduction in the accompanying suicide rates (Mann et al., 2005). This evidence points to the utility of screening for depression in a primary care setting as a method of suicide prevention. However, the most recent systematic review of the evidence by the USPSTF, which was in 2004, found insufficient evidence to routinely screen for suicide risk in the general population (Gaynes et al., 2004).
Postpartum depression can be screened for and detected in the context of a well-child visit, as Bright Futures already recommends (AAP, 2008; Chaudron et al., 2004; Freeman et al., 2005; Mishina and Takayama, 2009). Six states (Illinois, Iowa, Kentucky, Pennsylvania, Louisiana, and Massachusetts) have implemented projects funded by the Health Resources and Services Administration to increase rates of screening for postpartum depression by increasing awareness, assessment, and treatment and joining the maternal and infant health care systems (Shade et al., 2011). The USPSTF recommendation for screening for depression does not address postpartum depression or denotes new mothers to be a high-risk group.
Mental health issues are increasingly becoming a part of primary care, in part because of increased physician education (Kessler et al., 2007). Although the numbers of patients who receive outpatient treatment for depression have increased, most individuals with depression receive inadequate care for their symptoms (Olfson et al., 2002). Among those receiving mental health services, more than one-fifth of patients received their treatment from a general medical provider (Wang et al., 2005). Psychotherapy treatment has decreased, whereas prescriptions for antidepressants have increased, including in children and adolescents, in part because of managed care plan support of pharmaceuticals over specialty care and also the challenges of providing psychotherapy in a physician’s office, including but not limited to time constraints (Ma et al., 2005; Olfson et al., 2002; Pignone et al., 2002). Under the Mental Health Parity and Addiction Equity Act of 2008, group health plans and health insurance issuers must not place dollar limits on mental health benefits that are any lower than limits for medical and surgical benefits (DOL, 2011). Mental health benefits for depression would include ongoing psychotherapy and pharmacotherapy treatments.
The primary gap in preventive services not already addressed by the provisions set forth in the ACA (reviewed in this section) is that the current
recommendation for depression screening and follow-up does not address suicide and postpartum depression as related conditions to be evaluated. The committee found insufficient evidence to support a new recommendation; instead, evidence supported by systematic reviews, federal agendas from Healthy People 2020 (HHS, 2011), and the U.S. Surgeon General, as well as clinical professional guidelines and federal practice guidelines support the reasonableness of including screening for suicide ideation and postpartum depression in women who are pregnant and/or who have recently given birth during the context of a well-woman visit.
Tobacco use in the form of cigarette smoking is the leading cause of preventable morbidity and mortality in the United States. Quitting smoking with the help of cessation aids such as counseling and pharmacotherapy greatly improves a woman’s health and well-being. Women of all ages should be encouraged and aided in their efforts to quit smoking, although pharmacotherapy is currently approved only for those over 18 years.
From 2000 to 2004, there were approximately 270,000 smoking-attributable deaths annually among males and approximately 174,000 smoking-attributable deaths annually among females (CDC, 2008a). Approximately 90 percent of lung cancer deaths are due to smoking (Stewart et al., 2008). Almost all tobacco use in women consists of cigarette smoking (SAMHSA, 2004). Although trends in the prevalence of smoking show that it is lower among women than men, between 1955 and 1995 the prevalence of smoking decreased more rapidly among men (Chilcoat, 2009). After 1995, a gradual decrease in the incidence of cigarette smoking occurred for both men and women. Data from the 2009 National Health Interview Survey show that in 1997, 27.6 percent of men and 22.1 percent of women reported being current smokers (CDC, 1999), whereas in 2009, 23.5 percent of men and 17.9 percent of women reported being current smokers (CDC, 2010c). Although the gap in smoking prevalence between men and women has narrowed considerably over time, these trends differ across levels of educational attainment. Women with less education appear to be a group at particularly high risk (Chilcoat, 2009).
In addition to lung cancer, smoking increases women’s risk of developing uterine, cervix, and other cancers, including cancers of the head and neck, pancreas, kidney, and bladder. Smoking doubles a woman’s risk of developing coronary heart disease (HHS, 2001). Women who smoke and
concurrently use oral contraceptives are at a 30-fold increased risk for myocardial infarction and a 3-fold increased risk of stroke compared with nonsmokers (Burkman et al., 2004). Postmenopausal women who smoke have lower bone density than women who never smoked, and they have an increased risk for hip fracture than woman who never smoked (HHS, 2001; Law et al., 1997). Cigarette smoking also increases the risk for infertility, and smoking during pregnancy may result in negative reproductive and developmental effects, including premature birth, stillbirth, low birth weight, intrauterine growth retardation, and sudden infant death syndrome (Ashford et al., 2010; Behm et al., 2011; IOM, 2011; Khader et al., 2011; Ye et al., 2010).
Smoking cessation may be more difficult for women for a number of reasons. Women metabolize nicotine faster than men, and oral contraceptives lead to an even faster rate of metabolization of nicotine (Benowitz, 2008; Benowitz et al., 2006). The faster rate of metabolism found in women may contribute to a higher level of nicotine addiction. In addition, smoking and depression are strongly linked, and women suffer higher rates of depression, which may make quitting smoking more difficult (Smith et al., 2003b). Women may be motivated to quit for different reasons than men, such as improving fertility and reproductive health, pregnancy outcomes, physical appearance, and health problems that occur predominantly in women, such as osteoporosis (Smith et al., 2003b).
Most cases of tobacco dependence begin during childhood and adolescence (Fiore et al., 2008). The younger that a person is when he or she starts smoking, the more likely it is that the person will become dependent on nicotine and the more difficult it will be to quit (IOM, 1994). Only about 4 percent of young smokers are successful in quitting each year. Between 1991 and 2009, the prevalence rates of current cigarette smoking in high school students were similar in males and females and have shown a gradual decline over the past decade (Latimer and Zur, 2010). During this period, the prevalence of smoking decreased from 27.3 to 19.1 percent in females and from 27.6 to 19.8 percent in males (Garrett et al., 2011). Among adolescents 12 to 17 years of age, the prevalence of tobacco use is 11.4 percent (CDC, 2010e), and it has been found that tobacco use during adolescence is associated with risky sexual behavior and use of alcohol and other drugs (Latimer and Zur, 2010).
Existing Guidelines and Recommendations
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 recommends that clinicians ask all pregnant women about tobacco use and provide augmented, pregnancy-tailored counseling for those who smoke. 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).
The 2008 Public Health Service Guideline Update Panel (Fiore et al., 2008) made 10 recommendations regarding effective interventions delivered in health care settings. The updated guidelines were sponsored by eight federal government and private nonprofit organizations, including the Adolescent Health Research Program, the Centers for Disease Control and Prevention (CDC), the National Cancer Institute (NCI), the National Heart, Lung, and Blood Institute (NHLBI), the National Institute on Drug Abuse (NIDA), the American Legacy Foundation, the Robert Wood Johnson Foundation, and the University of Wisconsin Center for Tobacco Research and Intervention. These recommendations go beyond those of the USPSTF, in that they provide in detail the specific types of behavioral interventions and pharmacological treatments that clinicians can recommend to patients. The guideline panel noted that providing coverage for these treatments increased quit rates, and it recommended that all insurance plans include coverage for the strategies that it identified to be effective. The Partnership for Prevention supports the more detailed recommendations of the panel on the tobacco cessation services that should be covered by health insurance, including recognition that quitting often requires multiple or repeated interventions (Richland, 2011).
The panel emphasized that tobacco cessation interventions be interpreted to include both counseling and FDA-approved and over-the-counter medications. These recommendations have been echoed by numerous federal agencies and national medical and health associations and are consistent with the mandates of the Affordable Care Act (ACA) and the Centers
for Medicare and Medicaid Services to provide expanded coverage for tobacco screening and cessation services delivered in health care settings (Morris et al., 2011).
A number of organizations have made recommendations regarding screening for and counseling about tobacco use in adolescents (ACOG, 2010; Binns et al., 2009; Fiore et al., 2008; Gostin et al., 1997; Marwick, 1997). The 2008 guideline panel made specific recommendations for children and adolescents. It recommended that clinicians (1) ask their pediatric and adolescent patients about tobacco use and provide a strong message about abstaining from tobacco use (strength of evidence C); (2) provide counseling interventions to facilitate cessation (strength of evidence B); and (3) ask parents about tobacco use and offer cessation advice and assistance to quit (strength of evidence B).
A number of intervention strategies, including behavioral counseling and pharmacotherapies, have been shown to be effective for tobacco cessation when they are delivered in a primary care setting to nonpregnant adults aged 18 years and over (USPSTF, 2009c). The USPSTF concluded that a dose-response relation between quit rates and the intensity of counseling exists. Providing more sessions or increasing the length of sessions increased quit rates. Components of counseling strategies that were effective included instruction in problem solving and coping techniques, goal setting, developing a plan for quitting, motivational interviewing, telephone quit lines, and referrals. Combining counseling with pharmacotherapy was more effective than either approach alone. Although women appear to benefit from the same interventions as men, the data are inconsistent as to whether they benefit as much and what types of interventions are the most effective for women (Fiore et al., 2008; Munafo et al., 2004; Perkins and Scott, 2008). One meta-analysis found that the efficacy of nicotine replacement therapy was less effective in women than in men (Perkins and Scott, 2008); however, other meta-analyses have shown equivalent benefits in men and women (Baker et al., 2011; Killen et al., 2002). Behavioral interventions, such as tailored educational messages and self-help materials, were found to increase abstinence from smoking during pregnancy, but the USPSTF found inadequate evidence to evaluate the safety or efficacy of pharmacotherapy during pregnancy (USPSTF, 2009c).
In a systematic review conducted by the National Commission on Prevention Priorities for the Partnership for Prevention, screening for tobacco use and brief intervention counseling with an offer of pharmacotherapy ranked third of 25 clinical preventive services in terms of the most beneficial services to offer patients (Maciosek et al., 2009, 2010). The percent-
age of adult smokers who visited a clinician within the past year and who reported that they received advice to quit was about 68 percent, but only about 35 percent of smokers received brief counseling in which medication and cessation strategies recommended by the USPSTF were discussed (CDC, 2003; NCQA, 2005). Likewise, identifying and counseling adolescent smokers are estimated to occur in only 33 to 42 percent of physician visits and about 20 percent of dental visits (Alfano et al., 2002; Shelley et al., 2005).
Most behavior change intervention studies of smoking cessation and prevention in youth and adolescents have been conducted in school or community settings. Scant data on intervention strategies delivered in clinical settings are available, and the existing data are inconsistent (Fiore et al., 2008; Grimshaw and Stanton, 2006). In an analysis of seven studies comparing counseling with usual care or no treatment, the long-term abstinence rate doubled for the groups receiving counseling; however, the absolute abstinence rate was low (Fiore et al., 2008). Effective strategies varied in content, format, and intensity and included brief advice, educational pamphlets, self-help materials, and/or referrals. No data were available on whether these strategies were equally effective in boys and girls when they were offered in clinical settings. An update of the Surgeon General’s report on preventing tobacco use among young people is expected to be released by December 2011 (in press).
The primary gap in preventive services not already addressed by the provisions set forth in the ACA (reviewed in this section) is that while tobacco cessation aids and counseling are recommended, the potential need for multiple interventions defined by the Public Health Service Guidelines, which include pharmacotherapy, in helping women to quit smoking are not addressed. The committee found insufficient evidence to develop a new recommendation; instead, the evidence supported by high-quality systematic reviews, supportive systematic reviews, federal agendas from the CDC, NCI, NHLBI, and NIDA, as well as clinical professional guidelines, led to a clarifying statement, which was added to the USPSTF recommendation.
In recognizing that women may need more than one type of intervention for successful tobacco cessation, the committee interprets the current USPSTF recommendation regarding tobacco use screening and cessation to consider including both counseling and FDA-approved and over-the-
counter medications. Additionally, it is appropriate for pregnant women who smoke to receive counseling that is tailored to their needs.
An unhealthy diet and physical inactivity are associated with the leading causes of morbidity and mortality among women in the United States. Counseling patients in a clinical setting offers an opportunity to motivate women to adopt healthy dietary and physical activity behaviors. The target populations for diet and physical activity counseling are adult women 18 years of age and older, pregnant women of any age, and adolescent females.
Physical inactivity is associated with increased risk of all-cause mortality, coronary heart disease, high blood pressure, stroke, type 2 diabetes, metabolic syndrome, colon cancer, breast cancer, osteoporotic fractures, falls, and depression. Regular physical activity during pregnancy may reduce the risk of preterm birth, low birth weight, early pregnancy loss, and chronic health problems in the offspring; and moderate-intensity physical activity may increase cardiorespiratory and metabolic fitness (Physical Activity Guidelines Advisory Committee, 2008).
The benefits of physical activity in children and adolescents have been less studied; however, data support the findings that important health and fitness benefits accrue to children and adolescents who participate in 60 or more minutes of moderate to vigorous physical activity daily. Regular exercise helps control weight and build and maintain strong bones and confers positive psychological benefits (CDC, 2008b; Physical Activity Guidelines Advisory Committee, 2008).
Data from the 2008 National Health Interview Survey show that women are less likely than men to be highly active and are more likely to be insufficiently active and inactive (Carlson et al., 2010). Every year from 1998 through 2008, women were less likely to be aerobically active, according to Healthy People 2010 criteria (Carlson et al., 2010; HHS, 2011). In 2008, 33 percent of men but only 24 percent of women were highly active. Data from the BRFSS also show that women are less active than men for every measure of physical activity (e.g., recommended physical activity, insufficient physical activity, inactivity, and no leisure-time physical activity), and this pattern was consistent from 2001 through 2008 (CDC, 2008c).
As the prevalence of physical activity has decreased, the prevalence of
unhealthy eating behaviors has increased, contributing to an epidemic of obesity in the United States. Men and women appear to be equally at risk for obesity. In the 2009 BRFSS survey, 27.4 percent of men and 26 percent of women were obese, as measured from the body mass index (CDC, 2010d). Data from the first National Health and Nutrition Examination Survey (NHANES I) for the period from 1971 to 1975 compared with data from the 2005 and 2006 NHANES show that the percentage of overweight and obese men and women has increased substantially. For women, the proportion who were overweight or obese increased from 40.7 to 61.5 percent; for men, the increase was from 52.9 to 73.6 percent (Austin et al., 2011).
In contrast to the male-female differences in physical activity, women are more likely than men to report that they eat a healthier diet. In the 2009 BRFSS survey, 36.1 percent of women and 28.7 percent of men reported eating fruit two or more times a day (2010). Women were also more likely than men to report eating vegetables three or more times a day: 30.9 and 21.4 percent for women and men, respectively. This pattern has been consistent since 1996 (CDC, 1996; Serdula et al., 2004). Despite these differences, the average intake of carbohydrates, protein, total fat, and saturated fat as a percentage of total kilocalories was similar for men and women (Wright and Wang, 2010).
Healthy diet and physical activity during pregnancy have health benefits for the woman and her child (Physical Activity Guidelines Advisory Committee, 2008). Moreover, 20 percent of women are obese when they become pregnant (Van Horn, 2010), indicating that they may not be receiving appropriate nutrients or maintaining a healthy diet. Many women put on excess weight during pregnancy and have difficulty losing it afterwards, but during the postpartum period, physical activity alone will not produce weight loss unless it is coupled with dietary changes. The importance of proper nutritional intake and proper eating behavior during pregnancy was underscored by the 2010 Dietary Guidelines Advisory Committee, which recommended that future reports include dietary recommendations from birth (Van Horn, 2010).
Similar to the pattern for adult females, data from the Youth Risk Behavioral Surveillance System show that the self-reported prevalence of physical activity is substantially lower in girls than in boys and remained so from 1993 to 2009 (CDC, 2011). During that period, there was a marked decrease in the percentage of adolescents who met the recommended physical activity levels. In 1993, 75 percent of boys and 56 percent of girls met the recommended levels. In 2009, only 46 percent of boys and 28 percent of girls met the recommended activity levels (CDC, 2011).
Existing Guidelines and Recommendations
The USPSTF concludes that the evidence is insufficient to recommend for or against routine behavioral counseling to promote a healthy diet in unselected patients in primary care settings. Grade I statement (USPSTF, 2003a).
The USPSTF recommends intensive behavioral dietary counseling for adult patients with hyperlipidemia and other known risk factors for cardiovascular and diet-related chronic disease. Intensive counseling can be delivered by primary care clinicians or by referral to other specialists, such as nutritionists or dietitians. Grade B recommendation (USPSTF, 2003a).
The USPSTF concludes that the evidence is insufficient to recommend for or against behavioral counseling in primary care settings to promote physical activity. Grade I statement (USPSTF, 2002a).
The USPSTF is in the process of updating its 2002 recommendation on behavioral counseling to promote physical activity (Berg et al., 2002) and its 2003 recommendation on behavioral counseling to promote a healthy diet in adults (USPSTF, 2003b). The earlier systematic reviews found insufficient evidence to recommend for or against behavioral counseling in primary care settings to promote either physical activity or healthy dietary behaviors in adults without preexisting cardiovascular disease or its risk factors (2003; Berg et al., 2002). An updated draft recommendation statement was available for comment from February 22 to March 22, 2011 (USPSTF, 2011b). This recommendation (Lin et al., 2010) will replace the USPSTF’s previous separate recommendations on behavioral counseling to promote a healthful diet (USPSTF, 2003b) and physical activity (Berg et al., 2002).
Although the 2003 recommendation on dietary counseling included a positive recommendation for counseling adults with risk factors for cardiovascular disease (Grade B recommendation) (USPSTF, 2003b), the updated statement does not include a recommendation for this subgroup (Lin et al., 2010). On the basis of the updated systematic review, the USPSTF concluded that “the average benefit of primary care behavioral counseling interventions to promote a healthful diet and/or physical activity for cardiovascular disease prevention is small. Clinicians may consider selectively providing or referring individual patients for medium- or high-intensity behavioral counseling interventions” (Grade C recommendation) (USPSTF, 2011b).
Bright Futures recommends that physicians calculate the body mass
index for patients ages 10 to 21 years and discuss healthy diet and physical activity through the provision of anticipatory guidance (AAP, 2008). The AMA also advises physicians to provide adolescents with annual guidance about healthy dietary habits and the benefits of engaging in physical activity on a regular basis (Copperman, 1997).
Counseling about diet and physical activity in the primary care setting provides an opportunity to mitigate the negative health outcomes associated with poor dietary behaviors and physical inactivity. The systematic review conducted for the USPSTF (Lin et al., 2010) identified 66 trials of counseling to promote physical activity, a healthy diet, or both. The outcomes measured in these trials included morbidity and mortality related to cardiovascular disease, risk factors for cardiovascular disease, and self-reported dietary and physical activity behaviors. High-intensity counseling about a healthy diet with or without counseling about physical activity resulted in positive changes in body mass index (adiposity), systolic and diastolic blood pressure, and total and low-density lipoprotein cholesterol levels. Medium- and high-intensity physical activity counseling interventions resulted in small increases in physical activity levels, although data for low-intensity interventions were inconsistent. Reductions in self-reported fat intake were observed at all levels of intervention intensity, but high-intensity interventions resulted in larger reductions. Increased fruit and vegetable consumption was observed at all levels of intervention intensity. Very few trials had periods of follow-up beyond 12 months, thus the long-term effects of the counseling interventions about dietary patterns is unknown.
Although all of the trials were conducted in health care settings or recruited participants from health care settings, the role of the primary care provider was minimal in some of the studies.
Virtually all of the trials included women; however, very few provided gender-specific comparisons of the impact of the interventions on health-related outcomes, and very few studies included women during pregnancy or the postpartum period (Lin et al., 2010). An earlier review examined diet and physical activity interventions delivered in health care settings only to women (Wilcox et al., 2001). Findings from these earlier studies were consistent with the positive results of the USPSTF review for body mass index; systolic and diastolic blood pressure; and total cholesterol, low-density lipoprotein cholesterol, dietary fat, and physical activity levels. Although effect size estimates, as measured by the mean correlation coefficient, were small, they were statistically significant. Results for dietary fiber, energy in-
take, general dietary factors, and high-density lipoprotein cholesterol were not statistically significant (Wilcox et al., 2001).
The AHA recently reviewed interventions to promote physical activity and dietary changes and issued recommendations for counseling people to increase their levels of physical activity and make healthy dietary changes. Although the review was not limited to interventions delivered in a clinical setting, the group made recommendations about strategies that clinicians could use in primary care settings to assist adults in adopting and maintaining health dietary and physical activity behaviors, including the use of cognitive-behavioral strategies and modifying interventions to be appropriate to the patient’s social and cultural context (Artinian et al., 2010).
Most intervention studies to promote a healthy diet or physical activity in children and adolescents have been conducted in school or community settings. Interventions conducted in clinical settings have targeted overweight and obese children (Summerbell et al., 2003; Whitlock et al., 2010). A 2006 report of the USPSTF on screening and interventions that targeted overweight children and adolescents found insufficient evidence for the effectiveness of behavioral counseling or other preventive interventions that could be conducted in primary care settings or to which primary care clinicians could make referrals. However, some reviews of interventions for preventing obesity in children and adolescents have been conducted (Summerbell et al., 2003; Whitlock et al., 2010).
The primary gaps in preventive services not already addressed by the provisions set forth in the ACA (reviewed in this section) are the lack of interventions in primary care practice that address healthy diet and physical activity. The committee found insufficient evidence to develop a new recommendation; instead, the evidence supported by high-quality systematic evidence reviews and clinical practice guidelines, as well as the draft recommendation statement from the USPSTF (indicating that medium- to high-intensity interventions for diet and physical activity led to small benefits toward prevention of cardiovascular disease), led to support for the reasonableness of including diet and physical activity counseling during a well-woman visit.
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