This chapter describes the committee’s recommendations for 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, and that could supplement the current list of preventive services for women recommended under the Patient Protection and Affordable Care Act of 2010 (ACA). The committee’s recommendations regarding chronic diseases, sexual and reproductive health conditions, interpersonal and domestic violence, and well-woman visits follow.
The committee also provided interpretations for unclear USPSTF Grade A and B recommendations as described in Chapter 4; these are annotated in Table 5-1. Clarifying statements for osteoporosis screening and tobacco use have also been added. The rationale for including these two statements is presented in Appendix A.
Diabetes mellitus (DM) is a syndrome characterized by either an absolute or a relative deficiency of insulin in various organ systems of the body. The inability of these organ systems to utilize glucose thus exposes all tissues of the body to chronic excess glucose in the bloodstream, or hyperglycemia (ADA, 2011a). DM has three main types: type 1, type 2, and gestational DM. Only about 5 percent of people with diabetes in the United States have type 1 diabetes, which results from the body’s failure to produce insulin (ADA, 2011a). Type 2 diabetes, which accounts for about
TABLE 5-1 Grade A and B Recommendations with Committee Interpretations and Clarification Statements
|Topic||USPSTF Recommendation||USPSTF Grade||IOM Committee Interpretation|
|Alcohol misuse counseling||The USPSTF recommends screening and behavioral counseling interventions to reduce alcohol misuse by adults, including pregnant women, in primary care settings.||B||Annual screening with approved screening instrument.|
|Anemia screening: pregnant women||The USPSTF recommends routine screening for iron deficiency anemia in asymptomatic pregnant women.||B||Screening in each trimester.|
|Blood pressure screening||The USPSTF recommends screening for high blood pressure in adults aged 18 and older.||A||Annual screening.|
|BRCA screening, counseling about||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.||B||Referral for genetic counseling and testing, if appropriate.|
|Breast cancer preventive medication||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.||B||Medication provided if indicated.|
|Depression screening: adolescents||The USPSTF recommends screening of adolescents (12–18 years of age) for major depressive disorder when systems are in place to ensure accurate diagnosis, psychotherapy (cognitive-behavioral or interpersonal), and follow-up.||B||Annual depression screening.|
|Depression screening: adults||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.||B||Annual depression screening.|
|Diabetes screening||The USPSTF recommends screening for type 2 diabetes in asymptomatic adults with sustained blood pressure (either treated or untreated) greater than 135/80 mm Hg.||B||Annual screening.|
|Topic||USPSTF Recommendation||USPSTF Grade||IOM Committee Interpretation|
|Human immuno-deficiency virus HIV screening||The USPSTF strongly recommends that clinicians screen for HIV all adolescents and adults at increased risk for HIV infection.||A||Annual screening.|
|Obesity screening and counseling: adults||The USPSTF recommends that clinicians screen all adult patients for obesity and offer intensive counseling and behavioral interventions to promote sustained weight loss for obese adults.||B||Annual screening.|
|Osteoporosis screening: women||The USPSTF recommends that women aged 65 and older be screened routinely for osteoporosis and in younger women whose fracture risk is equal to or greater than that of a 65-year-old white woman who has not additional risk.||B||Women with previous fractures and women with secondary causes of osteoporosis are suggested to be included (see Appendix A).|
|Tobacco use counseling and interventions: nonpregnant adults||The USPSTF recommends that clinicians ask all adults about tobacco use and provide tobacco cessation interventions for those who use tobacco products.||A||Annual screening. Counseling and Food and Drug Administration (FDA)-approved and over-the-counter medications are suggested (see Appendix A).|
|Tobacco use counseling: pregnant women||The USPSTF recommends that clinicians ask all pregnant women about tobacco use and provide augmented, pregnancy-tailored counseling to those who smoke.||A||Discussion at each prenatal visit. It is appropriate for pregnant women who smoke to receive counseling that is tailored to their needs.|
|Syphilis screening: non-pregnant persons||The USPSTF strongly recommends that clinicians screen persons at increased risk for syphilis infection.||A||Annual screening.|
|Syphilis screening: pregnant women||The USPSTF recommends that clinicians screen all pregnant women for syphilis infection.||A||Screening at first prenatal visit, and as indicated if at high risk.|
90 to 95 percent of the cases of diabetes in the United States, results from the body’s inability to produce sufficient amounts of insulin as well as its resistance to insulin, which means that the body does not use insulin effectively (NIDDK, 2008).
Gestational diabetes mellitus (GDM) is diabetes that arises or is diagnosed in pregnancy, typically during the second and third trimesters of pregnancy. It accounts for about 135,000 diabetic patients annually in the United States and occurs in approximately 2 to 10 percent of pregnant women (NIDDK, 2011). Although most women recover from GDM after giving birth, they have an increased risk of developing type 2 diabetes in the future (Turok et al., 2003). Furthermore, their offspring are at significantly increased risk of being overweight and insulin resistant throughout childhood (Boerschmann et al., 2010).
Almost 25.8 million Americans, or 8.3 percent of the population, have diabetes, which is widely recognized as one of the leading causes of death and disability in the United States (CDC, 2011c). By 2050, it is estimated that the rate of adult diabetes in the United States will triple, from 1 in 10 now to 1 in 3 (Boyle et al., 2010).
No striking gender difference in the rates of diabetes exist between men and women in the United States (ADA, 2011b). However, a gender difference in the burden of this disease does appear to exist. Narayan and colleagues (2003) found that women have a significantly higher estimated lifetime risk of developing diabetes than men (38.5 percent for females versus 32.8 percent for males born in 2000). The authors further estimated that women diagnosed with diabetes at age 40 years will lose 14.3 life-years and 22 quality-adjusted life years, whereas the length of life lost for men diagnosed with diabetes at the same age are 11.6 life-years and 18.6 quality-adjusted life-years, respectively.
The consequences of diabetes appear to be more severe for women as well. In a study to assess whether trends in mortality rates among adults with diabetes had changed, Gregg and colleagues found that between the 1971 to 1986 and 1988 to 2000 survey periods for the National Health and Nutrition Examination Survey, the all-cause mortality rate for men with diabetes decreased by 18.2 deaths per 1,000 persons annually (from 42.6 to 24.4 deaths per 1,000 persons annually), whereas for diabetic women, the all-cause mortality rate more than doubled (from 8.3 to 18.2 deaths per 1,000 persons annually) (Gregg et al., 2007).
Furthermore, recent data indicate that women with diabetes are at high risk for developing cardiovascular disease. Women with diabetes were found to be four to six times more likely to develop cardiovascular disease
than women who do not have diabetes (Rivellese et al., 2010). Women with diabetes are more than three times more likely to have a stroke as women without diabetes but no prior history of a cardiovascular event. In fact, women with diabetes have a stroke risk profile similar to that of non-diabetic women who have had a prior stroke (Ho et al., 2003).
In addition to having one of the highest diabetes rates in the world (8.3 percent), the United States has the highest rates of GDM in the world, with as many as 2 to 10 percent of pregnancies being complicated by GDM each year (Danaei et al., 2011; NIDDK, 2011). This may be in part due to increased screening conducted in the United States. Although the incidence of preexisting diabetes in pregnancy has increased over the past decade, the incidence of GDM has remained relatively stable since the late 1990s because of better recognition of the disease and more aggressive intervention, according to a Southern California Kaiser Permanente study (Lawrence et al., 2008). This suggests that the complications of GDM for both mother and infant can be reduced even further by better detection and prevention and more aggressive management of this condition (Crowther et al., 2005; Langer et al., 2005).
Many women who are first diagnosed with diabetes during pregnancy are classified as having GDM. However, it is possible that many had preexisting or pregestational type 2 diabetes. Indeed, the majority of women with GDM seem to have β-cell dysfunction that appears on a background of chronic insulin resistance already present before pregnancy (Buchanan, 2001).
If a woman who has had GDM is not tested after delivery, the diabetes may have persisted and her next pregnancy may be incorrectly classified as recurrent GDM instead of preexisting diabetes. This distinction is important, because preexisting diabetes could be associated with more serious consequences for the fetus, including cardiac, neurological, and vascular anomalies, than diabetes that arises in the second and third trimesters of pregnancy (Jenkins et al., 2007; Ornoy, 2005; Sivan et al., 2004).
Cases of GDM increase with maternal age and occur 7 to 10 times more often among pregnant women age 24 and older than among women younger than 24 years old (Reece, 2010), suggesting that universal screening may be the most effective in the latter group (Marquette et al., 1985). GDM is itself a risk factor for type 2 diabetes. Women who have GDM during pregnancy have a seven-fold increased risk for the development of type 2 diabetes after delivery, which persists for their lifetime (Reece et al., 2009). One large, population-based study of 659,000 women found that 20 percent of women with GDM progressed to type 2 diabetes within nine years of pregnancy (Feig et al., 2008). Furthermore, the children of women with a history of GDM are at an increased risk for obesity and diabetes compared to other children (Reece, 2010).
Diabetes care costs the United States an estimated $174 billion annually, including both indirect and direct costs (ADA, 2011a). The United States spends more than half (54 percent) of the global expenditure on diabetes care and is expected to still be doing so by 2030, when it will spend an estimated $264 billion annually (Zhang et al., 2010).
Risk Factors for Diabetes
The primary risk factors for type 1 diabetes are genetics and family history (ADA, 2011a), diseases of the pancreas (Buxbaum and Eloubeidi, 2010), and infections or illnesses (Hober and Sane, 2010). The number one risk factor for type 2 diabetes is obesity (Chan et al., 1994; Colditz et al., 1995). Besides obesity, other risk factors for developing type 2 diabetes include impaired glucose tolerance or impaired fasting glucose, insulin resistance, ethnic background, high blood pressure, a history of gestational diabetes, a sedentary lifestyle, family history, polycystic ovary syndrome, and older age (ADA, 2011a).
A number of risk factors have been consistently linked to the development of GDM during pregnancy, including a history of GDM in a prior pregnancy, previously having had a large for gestational age (LGA) infant, obesity, a strong immediate family history of type 2 diabetes or GDM and a history of unexplained fetal death (Mayo Clinic, 2011).
Obesity is an excess amount of subcutaneous body fat in proportion to lean body mass. (CDC, 2010d). The most common measure of obesity is the body mass index (BMI). If BMI is 25 to 29.9, an individual is considered overweight; a person is considered obese when his/her BMI, is greater than 30.
The rapid increase in diabetes in recent decades has closely paralleled the increase in obesity and overweight in the general population (Wang et al., 2008). The United States currently has the highest obesity rate in the world, with more than 30 percent of adults, or 77 million, considered obese. By 2030, if the secular rate of increase continues, it is estimated that nearly 90 percent of Americans will be overweight and 51 percent will be obese (Wang et al., 2008). Obesity recently passed smoking as America’s greatest health threat, at least as measured by quality-adjusted life-years (QALYs) lost (Jia and Lubetkin, 2010). Obesity-related diseases account for nearly 10 percent of all medical spending in the United States (Finkelstein et al., 2009). Greater weight means a higher risk of insulin resistance, because fat interferes with the body’s ability to use insulin.
Overall there are a variety of factors that play a role in obesity. This makes it a complex health issue to address. The risk factors for obesity include overeating; lack of exercise; genetics; environment; and some diseases and drugs. However, experts have concluded that the two chief causes of obesity are a sedentary lifestyle and the overconsumption of high-calorie foods (Vainio and Bianchini, 2002). Thus, most obesity interventions are directed toward modifying these two lifestyle factors.
The USPSTF recommends screening for type 2 diabetes only in asymptomatic adults with a sustained blood pressure of greater than 135/80 mm Hg and found insufficient evidence to support screening in asymptomatic adults with lower blood pressure levels. Bright Futures does not specifically address screening for diabetes.
Existing Guidelines and Recommendations
The USPSTF recommends screening for type 2 diabetes in asymptomatic adults with sustained blood pressure (either treated or untreated) greater than 135/80 mm Hg. Grade B Recommendation (USPSTF, 2008b).
The USPSTF concludes that the current evidence is insufficient to assess the balance of benefits and harms of screening for type 2 diabetes in asymptomatic adults with blood pressure of 135/80 mm Hg or lower. Grade I Statement (USPSTF, 2008b).
The USPSTF concludes that the evidence is insufficient to recommend for or against routine screening for gestational diabetes. Grade I Statement (USPSTF, 2008a).
The USPSTF recommends that all clinicians screen all adult patients for obesity and offer intensive counseling and behavioral interventions to promote sustained weight loss for obese adults. Grade B Recommendation (USPSTF, 2003).
The U.S. Department of Veterans Affairs (VA) and the U.S. Department of Defense (DOD) Clinical Practice Guidelines recommend that physicians consider screening for diabetes and encourage aerobic exercise and diet to achieve weight loss and prevent the progression of pre-diabetes to diabetes (VA, 2010). Numerous health professional associations and other organizations recommend screening for diabetes as part of preventive care for women. The American Diabetes Association, for example, recommends
that physicians consider testing for diabetes in all adults who are overweight and who have additional risk factors and all adults 45 years and older not exhibiting these conditions (Zinman et al., 2010).
Guidelines for GDM Screening
Little evidence indicates that screening for GDM improves health outcomes. For this reason, the USPSTF concluded that the evidence is insufficient to recommend for or against routine screening for gestational diabetes. However, according to the USPSTF, “clinicians should discuss screening for GDM with their patients and make case-by-case decisions. Discussions should include information about the uncertainty of benefits and harms as well as the frequency of positive screening test results.” Women at increased risk include women who are obese, older than 25 years of age, have a family history of diabetes, have a history of previous GDM, or are of certain ethnic groups (Hispanic, American Indian, Asian, or African-American). There are no existing interventions to prevent GDM from occurring in pregnancy. However, some bodies have considered it important to screen pregnant women for GDM because these women are at increased risk for having infants with excessive birth weight and require operative delivery or infants with increased neonatal morbidity.
The U.S. Indian Health Service (IHS), VA, and the DOD Clinical Management Guideline for the Management of Pregnancy, for example, recommend routine screening of all pregnant women for GDM at 24 to 28 weeks of gestation (VA, 2009). While the American Academy of Family Physicians (AAFP) recognizes that more studies are needed to unequivocally support the benefit of universal screening for GDM, it also identifies that universal screening for GDM at 24 to 28 weeks of gestation is recommended by many experts. The recommendation is based on consensus, disease-oriented evidence, expert opinion, and case series (Serlin and Lash, 2009). In support of the recommendation, AAFP also notes that most obstetric practices employ this strategy. The American Congress of Obstetricians and Gynecologists (ACOG), in its Clinical Management Guidelines for Obstetrician-Gynecologists on gestational diabetes (ACOG, 2001), recommends screening for GDM at 24 to 28 weeks of gestation. Its recommendation is based on limited or inconsistent scientific evidence. Other organizations with guidelines include the National Collaborating Centre for Women’s and Children’s Health, the American Heart Association, the Endocrine Society, and the National Kidney Foundation.
The value of early detection of diabetes, other than type 1 diabetes, remains controversial because of the lack of an established evidence base. Randomized trials have established the benefits of interventions to prevent or delay diabetes (Knowler et al., 2002; Tuomilehto et al., 2001) and to reduce diabetes-related complications (UKPDS, 1998). However, no randomized control trial has established the benefits of early detection of diabetes. Several major studies have demonstrated that delaying and/or aggressively managing diabetes can ameliorate many of its negative consequences for women and their children.
The Diabetes Control and Complications Trial (DCCT), an almost 10-year study sponsored by the National Institutes of Health found that maintaining blood glucose levels as close to normal as possible slowed the development and progression of the eye, kidney, and nerve damage caused by diabetes (Genuth, 2006). It also found that any sustained lowering of blood glucose was beneficial. The most significant side effect of intensive treatment in the DCCT was an increase in the risk for hypoglycemia, or low blood glucose, including episodes severe enough to require additional medical assistance (Genuth, 2006).
The Diabetes Prevention Program (DPP), another intervention study, was designed to assess whether modest weight reduction through dietary changes and increased physical activity or treatment with oral diabetes medication could prevent or delay the onset of type 2 diabetes. Results from this study showed that participants who were pre-diabetic could sharply reduce their risk of developing diabetes with a modest loss of weight through dietary changes and increased physical activity (The Diabetes Prevention Program Research Group, 2000). Taking oral diabetes medication could also reduce risk, although less dramatically.
Since the conclusion of the DPP study, additional data analyses continue to provide important insights into the value of lifestyle changes in helping people prevent type 2 diabetes and its complications. One analysis found that DPP participants with specific genetic profiles had a significantly increased risk of developing diabetes and selective responses to specific interventions (Florez et al., 2007). It is possible that subgroups of individuals will not respond well to standard interventions or that some responders may respond very well to a particular treatment on the basis of their genetic profile.
Nutritional support and exercise also can have a significant impact on the incidence and severity of diabetes. The DPP found that just 30 minutes of moderate physical activity a day, coupled with a 5 to 10 percent reduction in body weight, produced a 58 percent reduction in the incidence of diabetes (Knowler et al., 2002).
The current evidence of the efficacy of obesity prevention and interven-
tions is based on a very small number of studies (Lemmens et al., 2008). Some studies showed a positive impact of the intervention on BMI or weight status, but there is too much heterogeneity in terms of study design, theoretical underpinning, and target population to be able to draw firm conclusions about which intervention approaches are more effective than others (Lemmens et al., 2008). More research is urgently needed to extend the body of evidence in this area of prevention.
The only intervention for obesity that has been shown to have great benefit for preventing other complications of obesity is surgery (Valezi et al., 2010). Gastric bypass surgery has been shown to ameliorate diabetes (Gill et al., 2011) and cardiovascular morbidity and mortality (Pontiroli and Morabito, 2011). However, this is an invasive surgical intervention, and an estimated 5 percent or more of people have serious or life-threatening complications after gastric bypass surgery (Picot et al., 2009).
The primary gaps in preventive services not already addressed by the provisions set forth in the ACA (reviewed in this section) were screening for diabetes in all women and screening for gestational diabetes among pregnant women, especially those identified to be at high risk for developing gestational diabetes. The committee found insufficient evidence to support screening for diabetes in all women.
The evidence provided to support a recommendation for gestational diabetes is based on current federal practice policy from IHS and the VA as well as current practice and clinical professional guidelines such as those set forth by AAFP and ACOG.
Recommendation 5.1: The committee recommends for consideration as a preventive service for women: screening for gestational diabetes in pregnant women between 24 and 28 weeks of gestation and at the first prenatal visit for pregnant women identified to be at high risk for diabetes.
Invasive cervical neoplasia is a low-prevalence cancer with a lengthy pre-invasive phase that is amenable to screening and early detection. Current USPSTF screening recommendations do not yet address the potential role of high-risk (oncogenic) human papillomavirus (HPV) DNA testing within practice of screening for invasive cervical neoplasia (USPSTF, 2003a). High-risk HPV DNA testing detects the viral types most commonly associated with the development of cancer.
Persistent infection with 1 of 20 high-risk HPV types is the necessary precursor for the development of squamous cell carcinoma and adenocarcinoma of the uterine cervix (Plummer et al., 2007; Walboomers et al., 1999; WHO, 2005). HPV infection is highly prevalent and is sexually acquired with the onset of sexual intercourse, typically resolving within 24 months (Insinga et al., 2007; Khan et al., 2005). Progression from persistent infection to precursor lesion (high-grade squamous intraepithelial lesion or cervical intraepithelial neoplasia [CIN] grade 2 [CIN2] or CIN3) can be a lengthy process, with the 10-year risk for the development of these lesions (even for the highest-risk viral types) being approximately 17 percent (Khan et al., 2005). Even after precursor lesions, the risk of progression to invasive disease is about 31 percent in 30 years (McCredie et al., 2008). On the basis of the current understanding of the natural history or HPV infection and cervical carcinogenesis, it is recommended that adult women with a history of sexual activity undergo periodic screening as part of their routine preventive care.
In 2010, 12,200 cases of invasive cervical cancer were diagnosed and 4,210 deaths were estimated to have occurred in the United States (CDC, 2007a), and the incidence of cervical cancer has been steadily decreasing in the United States and Western Europe since the introduction of formal and informal cytological screening programs in the 1950s. By 2007, the rate of mortality in the United States has decreased from 10.2 and 18 per 100,000 among White and non-White women, respectively, to 2.2 and 4.3 per 100,000 for White and African-American women, respectively (CDC, 1953; NCI, 2011a). Despite these tremendous gains, women with poor access to health care services and specifically women from communities of color have lagged significantly behind and currently represent a disproportionate share of cervical cancer incidence and mortality (NCI, 2011b; Saslow et al., 2002).
Although the annual incidence of death from cervical cancer is less than that of other cancers (ACS, 2010), the fact that these deaths are almost entirely preventable through primary prevention, screening and early detection, treatment of precancerous lesions, and effective therapies for invasive disease, makes cervical cancer a high-impact public health priority. Because sexually acquired persistent high-risk HPV infection is the primary causal factor associated with the development of cervical cancer, regular screening of all adult women with a history of sexual activity has been the mainstay of prevention efforts (USPSTF, 2003a). Periodic exfoliative cervical cytology-based screening (with or without high-risk HPV DNA testing) detects pre-invasive and early-stage disease, contributing to reductions in
the rate of mortality from cervical cancer. This type of screening, in combination with prophylactic (bivalent or quadrivalent) HPV vaccination of young women and girls, has made the prevention of mortality from cervical cancer an attainable public health goal.
Healthy People 2020, which sets health goals for the United States, contains specific objectives for increasing the proportion of women who receive screening for cervical cancer (HHS, 2011a). The specific targets set for this objective are increasing the rate of screening among women aged 21 to 65 years who receive a cervical cancer screen (based on the most recent guidelines) by 10 percent so that 93 percent of women are screened.
Existing Guidelines and Recommendations
The USPSTF strongly recommends screening for cervical cancer in women who have been sexually active and have a cervix. Grade A Recommendation (USPSTF, 2003a).
The USPSTF concludes that the evidence is insufficient to recommend for or against the routine use of new technologies to screen for cervical cancer. Grade I Statement (USPSTF, 2003a).
The USPSTF concludes that the evidence is insufficient to recommend for or against the routine use of human papillomavirus (HPV) testing as a primary screening test for cervical cancer. Grade I recommendation (USPSTF, 2003a).
Broad consensus exists about the need for periodic screening of adult women with a history of sexual activity. The American Cancer Society (ACS) and ACOG recommend the periodic screening of women beginning at 21 years of age (or three years after the onset of intercourse) (ACOG, 2005a, 2008, 2009; Saslow et al., 2002, 2007). Both entities also recommend the combined use of cytology with testing for high-risk HPV to improve detection and lengthen screening intervals in women 30 years of age and older. The discontinuation of cervical cancer screening in later life is also addressed by these recommendations, with ACS suggesting 70 years of age as the upper limit and ACOG mentioning 65 or 70 years as the upper limit. Both entities caution that discontinuation of screening should occur only when a woman has a documented history of negative screenings. Discontinuation is also recommended by both entities when a woman has had
a hysterectomy for benign disease. The DOD recently added the high-risk HPV DNA test to its list of covered preventive services (TRICARE, 2011).
The ACS and ACOG recommendations also largely agree with the 2003 recommendations of the USPSTF (USPSTF, 2003a). These call for the screening of all sexually active women with cervical cytology beginning at age 21 years or within years of the onset of sexual activity and at least every three years thereafter (Grade A). Like ACS and ACOG, the USPSTF recommends against the screening of women who have undergone hysterectomy for benign disease (Grade D), as well as women age 65 years and older in the setting of prior normal screening examinations (Grade D). In 2003, the USPSTF concluded that there was insufficient evidence to recommend for or against HPV testing in a routine screening setting.
On the basis of the summary of observational data, it can be concluded that the use of cytology for cervical cancer screening has contributed significantly to the reduction in the incidence of and rate of mortality from invasive cervical cancer. This has been accomplished on the basis of the substantial uptake of screening for cervical cancer. In 2008, more than 80 percent of women, aged 18–44, reported that they had undergone cytological screening during the previous three years (CDC, 2011a). The rate of screening utilization, however, varies substantially by race and ethnicity, level of educational attainment, and age, with significantly lower rates of screening being seen for Asian and American Indian/Alaska Native women, those with a high-school education or less, and those older than 64 years of age (CDC, 2011a). These considerations are critical, because more than half of all invasive cervical cancers occur among un- and underscreened women, while nearly a third occur among women with screening failures and the remainder are due to inadequate postscreening follow-up or misreadings (Janerich et al., 1995; Kinney et al., 1998; Leyden et al., 2005; Sung et al., 2000).
Cytology has also evolved with liquid-based cytology platforms now largely replacing conventional dry slide cytology in the United States (Irwin et al., 2006). The quality of liquid-based cytology has arguably been proposed to be superior to that of conventional dry slide cytology on the basis of lower rates of unsatisfactory results (Ronco et al., 2007; Siebers et al., 2009), although they are otherwise comparable on the basis of test performance characteristics (Arbyn et al., 2008; Davey et al., 2006). The shift to liquid-based cytology has been driven by practical considerations, including the advent of automated high-throughput processing, an aging cytotechnology workforce, and the advent of molecular testing. It is, however, the ability to perform high-risk HPV DNA testing and cytology on a
single patient specimen that may represent the most important contribution of this technology to overall cancer prevention.
The identification of HPV infection as the requisite etiologic precursor to cervical carcinoma has led to the development of clinically useful assays. The high-risk HPV DNA hybrid capture (HC2) assay (de Cremoux et al., 2003) is the most widely used assay for HPV detection. The HC2 assay is a pooled probe assay that detects 13 different high-risk HPV types and is approved by the Food and Drug Administration (FDA) for use for the triage of a cytology result indicating an atypical squamous cell of undetermined significance as well as for primary screening in combination with cytology for primary screening in women 30 years of age and older (FDA, 2009b,c). More recently, another pooled test (Cervista; Hologic, Bedford, MA) was approved for the same indication as the HC2 assay, as was a related type-specific probe for the detection of HPV types 16 and 18 (FDA, 2009a; Ronco et al., 2010). Although they are not FDA approved, a variety of commercially available and laboratory-specific molecular assays are currently in use under laboratory-specific internal validation standards.
Changing Screening Paradigms
A number of European trials have examined the usefulness of primary screening using high-risk HPV DNA testing compared with that of cervical cytology for the detection of cervical cancer and its precursors. A large randomized controlled trial conducted within the Italian national screening program compared the performance of the HC2 assay to that of conventional cytology among 35,471 women 35 years of age or older (Ronco et al., 2007). After 3.5 years of follow-up, the cumulative rates of detection of CIN3 and above (CIN3+) were 55 and 35 percent for cervical intraepithelial neoplasm grade 2 (HC2 assay) and cytology, respectively (relative risk [RR] = 1.57, 95 percent confidence interval [CI] = 1.03 to 2.4), although no differences in the number of invasive cancers detected in the two groups were detected (four in the HC2 assay arm compared with five in the cytology arm). In another large population-based European trial of 7,908 women aged 30 years and older, the HC2 assay was significantly more sensitive than cytology for the detection of CIN3+: 97 percent (95 percent CI = 83 to 99 percent) and 46 percent (95 percent CI = 31 to 62 percent), respectively (Petry et al., 2003). The magnitude of these findings is even greater at the lower, yet still clinically relevant, treatment threshold of CIN2 or greater (Bigras and de Marval, 2005; Cardenas-Turanzas et al., 2008; Cochand-Priollet et al., 2001; de Cremoux et al., 2003; Mayrand et al., 2006, 2007; Petry et al., 2003).
Taking a slightly different approach, a large Finnish randomized controlled trial compared the HC2 assay (with cytology triage of abnormal)
with cytology alone among 61,149 women in the national screening program (Kotaniemi-Talonen et al., 2008). On extended follow-up at 3.3 years, the rates of detection of CIN3+ and cancer in the HC2 testing arm (59 cases of CIN3+ and 11 invasive cancers) were significantly increased (RR = 1.77, 95 percent CI = 1.16 to 2.74) compared with those for the arm that used cytology only (33 cases of CIN3+ and 6 invasive cancers) (Anttila et al., 2010).
The impressive negative predictive value of the combination of cytology and screening for high-risk HPV was first noted in large cross-sectional studies (Cuzick et al., 2006; Kjaer et al., 2006). The combination has also subsequently been assessed in various European trials, although none used methods that reflect the current practice in the United States. In general, these trials of the combination of cytology and screening for high-risk HPV have consistently demonstrated the improved detection of cervical cancer precursors (CIN2+) over that by cytology by itself, as well as extremely high negative predictive values (Mayrand et al., 2006, 2007; Petry et al., 2003). It is this impressive predictive value of the combination of a negative cytology result and a negative result for HPV, first identified in cross-sectional studies that may permit further safe lengthening of screening intervals.
A recent U.S. study examined data from 331,818 women aged 30 and older who received care in a Kaiser Permanente Northern California from 2003 to 2005. The authors found 7.5 cervical cancers per 100,000 women/ year for all women with a normal conventional cytology test, while the rate of cervical cancer was 3.8 per 100,000 woman/years for all women who were HPV-negative. The rate was lowest among women who were HPV-negative and had a normal conventional cytology result, at 3.2 per 100,000 women/year. The study also found that HPV-positive women had a 7.6 percent risk of developing a cancerous or pre-cancerous lesion over five years, while women with an abnormal conventional test result had a 4.7 percent risk. Women with a negative HPV had a lower cancer risk than women who had a normal conventional cytology test. When both cytology and HPV were positive, women had twice the risk for cancer compared to women with a positive HPV test and a normal conventional cytology test (Katki et al., 2011).
The primary gap in preventive services not already addressed by the provisions set forth in the ACA (reviewed in this section) is that currently there is an absence of coverage for co-testing with cytology and high-risk HPV DNA testing among women 30 years of age and older as a strategy to increase screening intervals to every three years. Cervical cancer is
almost entirely preventable through early screening, detection, and treatment. Evidence to support high-risk HPV DNA testing is based on federal practice policy from the DOD. Peer-reviewed studies demonstrate that improved testing technologies, particularly combined screening using both conventional cytology and high-risk HPV DNA screening, may significantly improve the rate of detection of cervical cancer precursors and facilitate the safe lengthening of the interval for screening.
Recommendation 5.2: The committee recommends for consideration as a preventive service for women: the addition of high-risk HPV DNA testing to cytology testing in women with normal cytology results. Screening should begin at 30 years of age and should occur no more frequently than every 3 years.
Sexually transmitted infections (STIs), or sexually transmitted diseases (STDs), are diseases transmitted primarily by sexual activity. In 1997, the Institute of Medicine (IOM) labeled STDs a hidden epidemic, reflecting the knowledge that this largely unrecognized public health threat had considerable scope (IOM, 1997). The discussion that follows focuses primarily on chlamydia, gonorrhea, and syphilis.
For all STIs generally and for chlamydia, gonorrhea, and syphilis more specifically, the prevalence and number of reported cases are high among certain age groups, racial and ethnic groups and in certain geographic areas. Nevertheless, many STIs are asymptomatic and go undiagnosed; thus, current surveillance systems tend to underestimate the actual burden of disease. Significant short- and long-term morbidities are associated with these conditions, as is the risk for perinatal transmission, with its disease-specific attendant consequences. The services under consideration here include screening and counseling.
Women who contract STIs suffer from adverse reproductive health outcomes (Friedel and Lavoie, 2008). Infections in women, which are usually asymptomatic, can result in pelvic inflammatory disease, a major cause of infertility, ectopic pregnancy, and chronic pelvic pain. As with human immunodeficiency virus (HIV), women at risk for STIs often do not appreciate that they are at risk if they consider themselves in a monogamous relationship (Hodder et al., 2010).
In 2009, the overall rate of reported chlamydia infection among women (592 cases per 100,000 women) was almost three times higher than the
rate among men. Although the rates of reported chlamydia infections have been rising for several years, this could be due at least in part to increased screening and improvements in detection methods. The highest age-specific rates of reported cases in 2009 were among those aged 15 to 19 years.
In 2009, the rates of gonorrhea were 105.5 cases per 100,000 women and 91.9 per 100,000 men. Rates continue to be the highest among adolescents and young adults (CDC, 2009b; Workowski and Berman, 2010). In addition, epidemiological and biological studies provide strong evidence that gonococcal infections facilitate the transmission of HIV infection (Fleming and Wasserheit, 1999).
Syphilis is a genital ulcerative disease that causes significant complications if it is left untreated, including perinatal death in up to 40 percent of pregnant women, and can lead to infection of the fetus in 80 percent of cases, even if the infection is acquired during the four years before pregnancy (CDC, 2009b). Syphilis is also shown to facilitate the transmission of HIV infection (Fleming and Wasserheit, 1999). In 2009, the rate of syphilis was 7.8 cases per 100,000 men and 1.4 cases per 100,000 women. Consistent with other STIs, the rates are the highest for women aged 20 to 24 years (5.6 cases per 100,000) (Workowski and Berman, 2010).
Although the absolute risk factors for each disease may vary, in general, populations at increased risk for one STI are at increased risk for all STIs. The prevalence of gonorrhea and syphilis is highly dependent on the geographic area and sociodemographic factors, with increased rates occurring among Hispanics, African Americans, and lower socioeconomic groups. However, in general, in addition to sexual activity and age, other risk factors for STIs include a history of a prior STI; new, bisexual, or multiple sexual partners; inconsistent condom use; exchanging sex for money or drugs; and incarceration in adult correctional facilities. Sexually active adolescents are at higher risk of acquiring STIs, for a combination of developmental, behavioral, and biological reasons (Friedel and Lavoie, 2008). The risk factors for pregnant women are the same as those for nonpregnant women.
A 2008 Henry J. Kaiser Family Foundation survey found that only 38 percent of women, aged 18 to 44 years reported that they had discussed their sexual history with a doctor or nurse within the past three years. Furthermore, only 28 percent reported that they had discussed STIs with a doctor or nurse. Nevertheless, many women assume that they are tested routinely for STIs (Ranji and Salganicoff, 2011).
Existing Guidelines and Recommendations
The USPSTF recommends screening and counseling for STIs on the basis of the following risk factors listed in Table 5-2.
TABLE 5-2 Indicators of Increased Risk for STIs from USPSTF and Populations Excluded by the Guidelines
|Condition/Intervention||Indicators of Increased Risk Defined by the USPSTF||Populations Excluded|
|Chlamydia||Sexually active women aged 24 and younger History of STIs New or multiple sexual partners Inconsistent condom use Exchanging sex for money or drugs Incarcerated persons Military recruits Patients at public STI clinics African-American women Hispanic women||“Average risk” women older than 25|
|Gonorrhea||Women aged younger than 25 History of previous gonorrhea infection Other STIs New or multiple sexual partners Inconsistent condom use Commercial sex workers Drug use African-American women Individual risk depends on local epidemiology of disease||Sexually active and pregnant women not at increased risk|
|Syphilis||Commercial sex workers Exchanging sex for drugs Incarcerated persons||Sexually active women not at increased risk|
|STI||Sexually active adolescents||Nonsexually|
Adults/married adolescents with current STIs or infections within the past year
Adults/married adolescents with multiple current sexual partners
Sexually active patients in nonmonogamous relationships in a location with a high rate of STIs
Sexually active women not at increased risk
SOURCES: USPSTF, 2004b, 2005a, 2007, 2008a.
The USPSTF 2008 Clinical Guidelines for counseling to prevent STIs indicate that “clinicians should also consider the communities they serve. If the practice’s population has a high rate of STIs, all sexually active patients in non-monogamous relationships may be considered to be at increased risk” (Calonge et al., 2008).
The National Institute for Health and Clinical Excellence in the United Kingdom recommends identifying individuals at high risk for STIs by obtaining a sexual history and conducting one-on-one structured discussions with those at high risk of STIs. Those at risk include people who come from or who have visited areas with a high prevalence of HIV infection. Other
risk factors are misuse of alcohol or other substances, early onset of sexual activity, and unprotected sex or multiple sex partners (NICE, 2007).
The Centers for Disease Control and Prevention (CDC) recommends that all providers obtain a sexual history from each patient and engage in risk-reduction counseling. Evaluation of patients for the Five P’s (partners, prevention of pregnancy, protection from STDs, practices, and past STDs) is considered an effective strategy for this purpose (Workowski and Berman, 2010). Healthy People 2020 outlines a series of objectives for reducing STIs and STI complications, as well as addressing sexual risk behaviors (HHS, 2011a). The National Business Group on Health’s (NBGH’s) 2006 Evidence Statement also addresses the need for STI education and counseling (Campbell and Lantine, 2006). Furthermore, the Michigan Quality Improvement Consortium recommends that health maintenance exams include risk evaluation and counseling for STI prevention for all individuals aged 18 to 49 years (Michigan Quality Improvement Consortium, 2008). ACOG recommends counseling on STIs, including discussion of partner selection, barrier protection, and high-risk behaviors, as part of their recommended periodic assessments for women aged 13 and older (ACOG, 2007c). The American Medical Association (AMA) encourages physicians to educate their patients about STIs and condom use (AMA, 2003).
Bright Futures recommends that sexually active adolescents receive annual screenings for gonorrhea and chlamydia. In addition, Bright Futures provides anticipatory guidance for physicians to encourage adolescents to protect themselves from STIs and risky behaviors. Counseling on methods of safe sex and contraceptive use is recommended for sexually active adolescents (AAP, 2008).
Although many studies have focused primarily on behavioral interventions for prevention of HIV infection, interventions for prevention of STI and HIV infection are interdependent, because the risk-taking behaviors that result in an STI or HIV infection are similar. Short counseling interventions were shown to reduce risky behavior in patients at risk for HIV infection. Project RESPECT, a multicenter randomized control trial of 5,758 heterosexual individuals with STIs, showed that brief, individualized counseling increased the frequency of self-reported condom use through six months and reduced the rate of STI acquisition by 30 percent through six months and 20 percent through 12 months. It was also shown that counseling for those who had ever used drugs was effective and could be effective for current drug users (Kamb et al., 1998). Drug use, past and present, is a risk factor for HIV infection, gonorrhea, and potentially syphilis (Semaan et al., 2010). A study by Kelly et al. provides
some of the strongest evidence for the success of behavioral interventions in heterosexual women (Kelly et al., 1994). Rates of condom use increased from 26 to 56 percent after a cognitive behavioral intervention aimed at high-risk women.
The USPSTF currently recommends that physicians offer high-intensity behavioral counseling to prevent STIs for all sexually active adolescents and adults at increased risk, defined by current STI status and multiple sexual partners. High-intensity interventions that were found to be effective were delivered in multiple sessions, most often in groups, with total durations being three to nine hours (USPSTF, 2008a).
In addition to a client-centered approach, the CDC recommends that comprehensive counseling includes addressing abstinence and condom use, reducing sex partners, and types of sex practiced (Friedel and Lavoie, 2008).
The primary gap in preventive services not already addressed by the provisions set forth in the ACA is that STI counseling is limited to adults who currently have STIs or who identify themselves as having multiple sex partners. Additionally, screening for chlamydia for women aged 25 years and older is not defined by geographic risk factors.
The evidence provided to support a recommendation related to STI counseling is based on federal goals from CDC and Healthy People 2020 (CDC, 2010e; HHS, 2011a), as well as recommendations from AMA and ACOG. The committee found insufficient evidence to support a new recommendation related to screening for chlamydia or gonorrhea; instead, the evidence supported by federal priorities and clinical professional guidelines led to a suggestion for those screenings to be addressed during a well-woman visit.
Recommendation 5.3: The committee recommends for consideration as a preventive service for women: annual counseling on sexually transmitted infections for sexually active women.
HIV was addressed above in the section on STIs, as HIV infection frequently coexists with other STIs and the risk factors for HIV infection and STIs are much the same. HIV is a sexually transmitted virus that causes damage to an infected person’s CD4+ T cells, which are crucial for helping
the body defend itself against diseases. HIV is the virus that causes AIDS, a condition in humans in which progressive failure of the immune system allows life-threatening opportunistic infections and cancers to thrive. HIV can develop into AIDS within just a few years if it is left untreated (CDC, 2010a). Currently, no vaccine for HIV infection/AIDS is available (Flexner, 2007). However, to date more than 30 anti-HIV drugs have been developed and licensed. In combinations of three or more, these medications have proved extremely effective in slowing the progression of HIV if it is detected and treated early (Fauci, 2011). New HIV infections in women are found at the highest rates between ages 13 and 39 years (KFF, 2011).
Although HIV infection/AIDS is more prevalent in men, the rate of HIV infection/AIDS in women is increasing (IOM, 2010b). From 1999 to 2003, the CDC reported a 15 percent increase in AIDS cases among women but only a 1 percent increase in men (CDC, 2006). In 1985, women accounted for 8 percent of new AIDS cases, a proportion that grew to 25 percent in 2009 (CDC, 2011b; KFF, 2011). In 2009, 9,973 women were diagnosed with HIV infection.
The majority of HIV infection and AIDS cases in women are a result of high-risk heterosexual sex (CDC, 2010b; KFF, 2011). However, many women are unknowingly infected because of the risk behavior of their partners (Hader et al., 2001; IOM, 2010b; Varghese et al., 2002). In addition, an estimated 6,000 to 7,000 HIV-positive women in the United States give birth each year (Bulterys et al., 2002; CDC, 2007c; Lee and Fleming, 2001).
Women with HIV infection often have lower socioeconomic status. Family responsibilities and a lack of access to care have been identified as barriers to women managing their HIV infection and pursuing appropriate care (Bozzette et al., 1998; Cunningham et al., 1999; Fleishman et al., 2005; Shapiro et al., 1999). Although women share with men the complication of the progression of HIV infection to AIDS, they also experience gender-specific comorbidities, such as recurrent vaginal yeast infections, severe pelvic inflammatory disease, and increased risk of precancerous changes in the cervix (NIAID, 2008). In 2007, HIV infection was the fifth leading cause of death for women (aged 25 to 44 years), but it was the third leading cause of death for black women (CDC, 2011b; KFF, 2011). HIV infection was the number one cause of death for black women aged 25 to 34 years (CDC, 2008).
Women at risk for acquisition of HIV frequently do not appreciate that they are at risk (Hodder et al., 2010). Black women, in particular, report
not knowing their sexual partner’s risks, such as injection drug use, having other current sex partners, or unknown HIV status (DeCarlo and Reznick, 2009). In 2005, 80 percent of HIV-positive black woman were infected through heterosexual sex (Rose et al., 2008).
Existing Guidelines and Recommendations
The USPSTF strongly recommends that clinicians screen for human immunodeficiency virus (HIV) all adolescents and adults at increased risk for HIV infection. Grade A Recommendation (USPSTF, 2005b).
The USPSTF makes no recommendation for or against routinely screening for HIV adolescents and adults who are not at increased risk for HIV infection. Grade C Recommendation (USPSTF, 2005b).
Increased risk for HIV is defined by the following factors:
- Receives health care in a high-prevalence or high-risk clinical setting;
- Women having unprotected sex with multiple partners;
- Past or present injection drug users;
- Women who exchange sex for money or drugs or have sex partners who do;
- Individuals whose past or present sex partners were HIV-infected, bisexual, or injection drug users;
- Persons being treated for STDs;
- Persons with a history of blood transfusion between 1978 and 1985; and
- Persons who request an HIV test (USPSTF, 2005b).
The USPSTF also recommends that all pregnant women receive screening for HIV infection as part of prenatal care. Screening of adults and adolescent women who are not pregnant or who are not considered to be at increased risk for HIV infection is a USPSTF Grade C recommendation, implying that screening should not be routinely done but, rather, should be done on an individualized case-specific basis. Bright Futures recommends that all sexually active and at risk adolescents aged 11 to 21 years be screened for HIV infection annually (AAP, 2008).
The CDC, the American College of Physicians (ACP), the Infectious
Diseases Society of America (IDSA), AMA, ACOG, the American College of Nurse-Midwives, as well as the IOM recommend broader screening for HIV infection to include adolescents and sexually active adults to age 65 years (CDC, 2006; IOM, 2010a). The CDC qualifies its recommendation, stating that screening may not be warranted if the prevalence rate is <0.1 percent or the diagnostic yield is <1/1,000 screened. The CDC recommends opt-out screening and instructs physicians to offer counseling on HIV infection and test results before the patient is tested if the patient does not decline the screening. Preventive counseling regarding HIV infection is still recommended by the CDC, but the revised guidelines recommend separation of testing from screening for high-risk individuals as a way to eliminate one potential barrier to testing. For patients with a positive test result, the CDC recommends the provision of access to care, prevention counseling, and support services.
Risk-based screening has been shown in large health care networks to be an ineffective means of identifying individuals with HIV infection. Identified risk factors such as a current sexually transmitted disease or substance abuse have not been shown to be reliably used by physicians as reasons to screen, even within a health care system in which access to care is not a barrier (Gandhi et al., 2007; Owens et al., 2007). A review of Medicaid claims from 1998 revealed that of all cohort patients diagnosed with a non-blood-borne STI (gonorrhea, chlamydia, or pelvic inflammatory disease, strong risk factors for co-infection with HIV), only 10 percent were subsequently screened for HIV infection, despite the evidence that these are known risk factors for HIV infection (Rust et al., 2003). Additionally, among people who tested positive for HIV, approximately 25 percent did not report high-risk behaviors that would have led a physician to perform risk-based screening (Chou et al., 2005). As referenced earlier, many women do not believe themselves to be at risk, so it is unlikely that they will ask to be tested.
Opt-out screening was shown to be very effective in prenatal screening for HIV. In a retrospective cohort study of 12,221 pregnancies resulting in delivery, only 221 women declined the screening (Breese et al., 2004). This type of screening has been accepted by women and is now widely implemented (Schuman et al., 2004).
Early screening for HIV infection is crucial to afford patients effective treatment and also for the benefit of the patients’ sexual partners. In a recent worldwide clinical trial, researchers found that HIV-infected men and women who were able to start oral antiretroviral medicines early in
the stage of HIV progression actually reduced their risk of transmitting the virus to their partners by 96 percent (NIAID, 2011).
The primary gap in preventive services not already addressed by the provisions set forth in the ACA (reviewed in this section) is that current screening recommendations by the USPSTF are limited in scope; that is, they are limited to pregnant women and high-risk adolescents and adults.
The evidence provided to support a recommendation for expanding screening is based on federal goals from the CDC, as well as clinical professional guidelines, such as those from the ACP, IDSA, AMA, and ACOG.
Recommendation 5.4: The committee recommends for consideration as a preventive service for women: counseling and screening for HIV infection on an annual basis for sexually active women.
Unintended pregnancy is defined as a pregnancy that is either unwanted or mistimed at the time of conception (Finer and Henshaw, 2006) and affects women with reproductive capacity, that is, from the time of menarche to menopause. Family planning services that are provided to prevent unintended pregnancies include contraception (i.e., all FDA-approved contraceptive drugs and devices, sterilization procedures) as well as patient education and counseling.
Unintended pregnancy is highly prevalent in the United States. In 2001, an estimated 49 percent of all pregnancies in the United States were unintended—defined as unwanted or mistimed at the time of conception—according to the National Survey of Family Growth (Finer and Henshaw, 2006). The unintended pregnancy rate is much lower in other developed countries (Trussell and Wynn, 2008). In 2001, 42 percent of U.S. unintended pregnancies ended in abortion (Finer and Henshaw, 2006). Although 1 in 20 American women has an unintended pregnancy each year, unintended pregnancy is more likely among women who are aged 18 to 24 years and unmarried, who have a low income, who are not high school graduates, and who are members of a racial or ethnic minority group (Finer and Henshaw, 2006).
The consequences of an unintended pregnancy for the mother and the baby have been documented, although for some outcomes, research is limited. Because women experiencing an unintended pregnancy may not immediately be aware that they are pregnant; their entry into prenatal care may be delayed, they may not be motivated to discontinue behaviors that present risks for the developing fetus; and they may experience depression, anxiety, or other conditions. According to the IOM Committee on Unintended Pregnancy, women with unintended pregnancies are more likely than those with intended pregnancies to receive later or no prenatal care, to smoke and consume alcohol during pregnancy, to be depressed during pregnancy, and to experience domestic violence during pregnancy (IOM, 1995).
A more recent literature review found that U.S. children born as the result of unintended pregnancies are less likely to be breastfed or are breastfed for a shorter duration than children born as the result of intended pregnancies and that mothers who have experienced any unwanted birth report higher levels of depression and lower levels of happiness (Gipson et al., 2008). Finally, a recent systematic literature review found significantly increased odds of preterm birth and low birth weight among unintended pregnancies ending in live births compared with pregnancies that were intended (Shah et al., 2008).
The risk factors for unintended pregnancy are female gender and reproductive capacity. Although certain subgroups of women are at greater risk for unintended pregnancy than others (e.g., women aged 18 to 24 years, unmarried women, women with low incomes, women who are not high school graduates, and women who are members of a racial or ethnic minority group), all sexually active women with reproductive capacity are at risk for unintended pregnancy. In 2008, approximately 36 million U.S. women of reproductive age (usually defined as ages 15 to 44 years) were estimated to be in need of family planning services because they were sexually active, able to get pregnant, and not trying to get pregnant (Frost et al., 2010). More than 99 percent of U.S. women aged 15 to 44 years who have ever had sexual intercourse with a male have used at least one contraceptive method (Mosher and Jones, 2010).
Pregnancy spacing is important because of the increased risk of adverse pregnancy outcomes for pregnancies that are too closely spaced (within 18 months of a prior pregnancy). Short interpregnancy intervals in particular have been associated with low birth weight, prematurity, and small for gestational age births (Conde-Agudelo et al., 2006; Fuentes-Afflick and Hessol, 2000; Zhu, 2005). In addition, women with certain chronic medical conditions (e.g., diabetes and obesity) may need to postpone pregnancy until appropriate weight loss or glycemic control has been achieved (ADA, 2004; Johnson et al., 2006). Finally, pregnancy may be contraindicated for women with serious medical conditions such as pulmonary hyper-
tension (etiologies can include idiopathic pulmonary arterial hypertension and others) and cyanotic heart disease, and for women with the Marfan Syndrome (Meijboom et al., 2005; Regitz-Zagrosek et al., 2008; Warnes, 2004).
Existing Guidelines and Recommendations
Numerous health care professional associations and other organizations recommend the use of family planning services as part of preventive care for women, including ACOG, AAFP, the American Academy of Pediatrics (AAP), the Society of Adolescent Medicine, the AMA, the American Public Health Association, the Association of Women’s Health, Obstetric and Neonatal Nurses, and the March of Dimes. In addition, the CDC recommends family planning services as part of preventive visits for preconception health (Johnson et al., 2006).
The USPSTF does not address prevention of unintended pregnancy. Bright Futures recommends that information about contraception be offered to all sexually active adolescents and those who plan to become sexually active (AAP, 2008).
The IOM Committee on Women’s Health Research recently identified unintended pregnancy to be a health condition of women for which little progress in prevention has been made, despite the availability of safe and effective preventive methods (IOM, 2010b). This report also found that progress in reducing the rate of unintended pregnancy would be possible by “making contraceptives more available, accessible, and acceptable through improved services (IOM, 2010b). Another IOM report on unintended pregnancy recommended that “all pregnancies should be intended” at the time of conception and set a goal to increase access to contraception in the United States (IOM, 1995). Healthy People 2020 (HHS, 2011a), which sets health goals for the United States, includes a national objective of increasing the proportion of pregnancies that are intended from 51 to 56 percent. In addition, Healthy People 2020 sets goals to increase the number of insurance plans that offer contraceptive supplies and services, to reduce the proportion of pregnancies conceived within 18 months of a previous birth, and to increase the proportion of females or their partners at risk of unintended pregnancy who used contraception during the most recent sexual intercourse (HHS, 2011a).
Family planning services are preventive services that enable women and couples to avoid an unwanted pregnancy and to space their pregnancies to promote optimal birth outcomes. A wide array of safe and highly
effective FDA-approved methods of contraception is available, including barrier methods, hormonal methods, emergency contraception, and implanted devices; sterilization is also available for women and for men (FDA, 2010). This range of methods provides options for women depending upon their life stage, sexual practices, and health status. Some methods, such as condoms, spermicides, and emergency contraceptives, are available without a prescription, whereas the more effective hormonal and long-acting reversible methods, such as oral contraceptives and intrauterine devices, are available by prescription or require insertion by a medical professional. Sterilization is a surgical procedure. For women with certain medical conditions or risk factors, some contraceptive methods may be contraindicated. These can be assessed clinically so that an appropriate method can be selected for the individual (CDC, 2010; Dragoman et al., 2010).
The effectiveness of contraceptives is determined by studying the rate of failure (i.e., having an unintended pregnancy) in the first year of use (Table 5-3). The failure rates of all FDA-approved methods in both U.S. and international populations have been well documented and are negligible with proper use (Amy and Tripathi, 2009; Hatcher et al., 2007; Kost et al., 2008; Mansour et al., 2010). Female sterilization, the intrauterine device, and the contraceptive implant have failure rates of 1 percent or less in the first 12 months of use (Fu et al., 1999; Hatcher et al., 2007). Injectable and oral contraceptives have use failure rates of seven and 9 percent, respectively, because some women miss or delay an injection or pill (Kost et al., 2008). Failure rates for both male and female condoms and other barrier methods are higher (e.g., 15 percent for the male condom) (Amy and Tripathi, 2009). These rates compare with an 85 percent chance of an unintended pregnancy within 12 months among couples using no method of contraception (Hatcher et al., 2007; Trussell and Kost, 1987).
In addition to this evidence of method effectiveness, evidence exists that greater use of contraception within the population produces lower unintended pregnancy and abortion rates nationally. Studies show that as the rate of contraceptive use by unmarried women increased in the United States between 1982 and 2002, rates of unintended pregnancy and abortion for unmarried women also declined (Boonstra et al., 2006). Other studies show that increased rates of contraceptive use by adolescents from the early 1990s to the early 2000s was associated with a decline in teen pregnancies and that periodic increases in the teen pregnancy rate are associated with lower rates of contraceptive use (Santelli and Melnikas, 2010).
As with all pharmaceuticals and medical procedures, contraceptive methods have both risks and benefits. Side effects are generally considered minimal (ACOG, 2011a,b,c; Burkman et al., 2004). Death rates associated with contraceptive use are low and, except for oral contraceptive users who
TABLE 5-3 Percentage of U.S. Women Experiencing an Unintended Pregnancy During First Year of Typical Use and First Year of Perfect Use, by Contraceptive Method
|% Experiencing Unintended Pregnancy in First Year of|
|Method||Typical Usea||Perfect Useb|
|Spermicides (foams, creams, gels, vaginal suppositories, and vaginal film)||29||18|
|Fertility awareness-based methodsc||25|
|Standard days method||5|
|Ovulation method Sponge||3|
|Diaphragm (with spermicidal cream or jelly) Condom (without spermicides)||16||6|
|Combined pill and progestin-only pill||8||0.30|
|Depro-Provera Intrauterine Device||3||0.30|
|ParaGard (copper T)||0.80||0.60|
a Among typical couples who initiate use of a method (not necessarily for the first time), the percentage who experience an accidental pregnancy during the first year if they do not stop use for any other reason.
b Among couples who initiate use of a method (not necessarily for the first time) and who use it perfectly (both consistently and correctly), the percentage who experience an accidental pregnancy during the first year if they do not stop use for any other reason.
c The ovulation and 2-day methods are based on evaluation of cervical mucus. The standard day method avoids intercourse on cycle days 8 through 19.
SOURCE: © 2007 by Contraceptive Technology Communications Reprinted by permission of Ardent Media, Inc.
smoke, lower than the U.S. maternal mortality rate (Hatcher et al., 1998). For example, the oral contraceptive death rate per 100,000 users under the age of 35 years who are nonsmokers was 1.5 per 100,000 live births (Hatcher et al., 1998), compared with 11.2 maternal deaths per 100,000 live births in 2006 (age adjusted) (CDC, 2010c).
Contraceptive methods often have benefits separate from the ability to plan one’s family and attain optimal birth spacing. For example, the non-contraceptive benefits of hormonal contraception include treatment of menstrual disorders, acne or hirsutism, and pelvic pain (ACOG, 2010a). Long-term use of oral contraceptives has been shown to reduce a woman’s risk of endometrial cancer, as well as protect against pelvic inflammatory disease and some benign breast diseases (PRB, 1998). The Agency for Healthcare Research and Quality (AHRQ) is currently undertaking a systematic evidence review to evaluate the effectiveness of oral contraceptives as primary prevention for ovarian cancer (AHRQ, 2011).
Education and counseling are important components of family planning services because they provide information about the availability of contraceptive options, elucidate method-specific risks and benefits for the individual woman, and provide instruction in effective use of the chosen method (NBGH, 2005; Shulman, 2006). Research on the effectiveness of structured contraceptive counseling is limited (Halpern et al., 2006; Lopez et al., 2010b; Moos et al., 2003). However, studies show that postpartum contraceptive counseling increases contraceptive use and decreases unplanned pregnancy (Lopez et al., 2010a), that counseling increases method use among adolescents in family planning clinics (Kirby, 2007), that counseling decreases nonuse of contraception in older women of reproductive age (35 to 44 years) who do not want a future baby (Upson et al., 2010), and that counseling of adult women in primary care settings is associated with greater contraceptive use and the use of more effective methods (Lee et al., 2011; Weisman et al., 2002).
Although it is beyond the scope of the committee’s consideration, it should be noted that contraception is highly cost-effective. The direct medical cost of unintended pregnancy in the United States was estimated to be nearly $5 billion in 2002, with the cost savings due to contraceptive use estimated to be $19.3 billion (Trussell, 2007). The cost-effectiveness of family planning is also documented in an evaluation of FamilyPact, California’s 1115 Medicaid Family Planning Waiver Program. The unintended pregnancies averted in this program in 2002 would have cost the state $1.1 billion within two years, and $2.2 billion within five years, for public-sector health and social services that otherwise would have been needed (Amaral et al., 2007).
In a study of the cost-effectiveness of specific contraceptive methods, all contraceptive methods were found to be more cost-effective than no
method, and the most cost-effective methods were long-acting contraceptives that do not rely on user compliance (Trussell et al., 2009). The most common contraceptive methods used in the United States are the oral contraceptive pill and female sterilization. It is thought that greater use of long-acting, reversible contraceptive methods—including intrauterine devices and contraceptive implants that require less action by the woman and therefore have lower use failure rates—might help further reduce unintended pregnancy rates (Blumenthal et al., 2011). Cost barriers to use of the most effective contraceptive methods are important because long-acting, reversible contraceptive methods and sterilization have high up-front costs (Trussell et al., 2009).
Contraceptive coverage has become standard practice for most private insurance and federally funded insurance programs. For example, contraceptive services are covered for all federal employees and individuals who obtain their care through federally financed programs, such as VA, TRICARE for active-duty military and their dependents, and IHS. Federal programs provide funding for family planning services in community health centers through the Public Health Service Act, in family planning centers through Title X [Population Research and Voluntary Family Planning Programs (P.L. 91-572)], through the Maternal and Child Health Block Grant, and through the Medicaid program.
Since 1972, Medicaid, the state-federal program for certain low-income individuals, has required coverage for family planning in all state programs and has exempted family planning services and supplies from cost-sharing requirements. In addition, 26 states currently operate special Medicaid-funded family planning programs for low-income women who either no longer qualify for Medicaid or do not meet the program’s categorical requirements. In Massachusetts, family planning services with no copayments will be included as part of the preventive benefits offered to members of Commonwealth Care, a program of subsidized health insurance for low- and moderate-income people (Personal communication, Stephanie Chrobak and Nancy Turnbull, Massachusetts Health Connector, May 10, 2011).
Private employers have also expanded their coverage of contraceptives as part of the basic benefits packages of most policies. This expansion has occurred in response to state and federal policies. Twenty-eight states now have regulations requiring private insurers to cover contraceptives, and 17 of these states also require that insurance cover the associated outpatient visit costs (Guttmacher Institute, 2011) (see Chapter 3). A federal court ruling issued in 2000 by the Equal Employment Opportunity Commission found an employer’s failure to cover prescription contraceptive drugs and devices in a health plan that covers other drugs, devices, and preventive care to be discrimination against women in violation of Title VII of the Civil Rights Act (EEOC, 2000).
In 2007, NBGH recommended that employer-sponsored health plans include coverage of family planning services, without cost sharing, as part of a minimum set of benefits for preventive care. The Guttmacher Institute also calls comprehensive coverage of contraceptive services and supplies “the current insurance industry standard,” with more than 89 percent of insurance plans covering contraceptive methods in 2002 (Camp, 2011). A more recent 2010 survey of employers found that 85 percent of large employers and 62 of small employers offered coverage of FDA-approved contraceptives (Claxton et al., 2010).
Despite increases in private health insurance coverage of contraception since the 1990s, many women do not have insurance coverage or are in health plans in which copayments for visits and for prescriptions have increased in recent years. In fact, a review of the research on the impact of cost sharing on the use of health care services found that cost-sharing requirements, such as deductibles and copayments, can pose barriers to care and result in reduced use of preventive and primary care services, particularly for low-income populations (Hudman and O’Malley, 2003). Even small increments in cost sharing have been shown to reduce the use of preventive services, such as mammograms (Trivedi et al., 2008). The elimination of cost sharing for contraception therefore could greatly increase its use, including use of the more effective and longer-acting methods, especially among poor and low-income women most at risk for unintended pregnancy. A recent study conducted by Kaiser Permanente found that when out-of-pocket costs for contraceptives were eliminated or reduced, women were more likely to rely on more effective long-acting contraceptive methods (Postlethwaite et al., 2007).
Contraception and contraceptive counseling are not currently in the array of preventive services available to women under the ACA.
Systematic evidence reviews and other peer-reviewed studies provide evidence that contraception and contraceptive counseling are effective at reducing unintended pregnancies. Current federal reimbursement policies provide coverage for contraception and contraceptive counseling and most private insurers also cover contraception in their health plans. Numerous health professional associations recommend family planning services as part of preventive care for women. Furthermore, a reduction in unintended pregnancies has been identified as a specific goal in Healthy People 2010 and Healthy People 2020 (HHS, 2000, 2011a).
Recommendation 5.5: The committee recommends for consideration as a preventive service for women: the full range of Food and Drug
Administration-approved contraceptive methods, sterilization procedures, and patient education and counseling for women with reproductive capacity.
Breastfeeding benefits the mother, the child, and society. The challenge is to ensure that the majority of mothers initiate breastfeeding and exclusively breastfeed their children during the first six months, with breastfeeding continuing to a year or beyond for every child (Gartner et al., 1997).
An AHRQ report from 2007 includes a summary of systematic reviews and meta-analyses on breastfeeding and maternal and infant health outcomes (Ip et al., 2007). The evidence is clear that breastfeeding reduces Sudden Infant Death Syndrome, gastrointestinal infections, upper and lower respiratory diseases, childhood leukemia, asthma, ear infections, childhood obesity, and diabetes mellitus type 2 risk for children, as well as rates of hospitalization (Table 5-4). They also concluded that sufficient results are available to be able to state that breastfeeding significantly lowers the maternal risk of breast and ovarian cancers (Table 5-4). Breastfeeding soon after birth may reduce the risk of maternal blood loss and enhance maternal-infant bonding (ACNM, 2004). A recent study concluded that if 90 percent of all children were exclusively breastfeed during the first six months of life, the United States would save $13 billion per year and prevent an excess of 911 deaths (Bartick and Reinhold, 2010). If only 80 percent of U.S. families complied, $10.5 billion would be saved and 741 deaths would be prevented each year.
In the United States, the majority of pregnant women plan to breastfeed (DiGirolamo et al., 2005), and yet there is a clear gap between the proportion of women who prenatally intend to breastfeed and those who actually do so by the time they are discharged after a brief hospital stay (California WIC Association and U.C. Davis Human Lactation Center, 2008; CDC, 2007b). The National Immunization Survey found that among the mothers of children born in 2007, 75 percent of mothers initiated breastfeeding, 43 percent were breastfeeding at six months, and 22 percent were breastfeeding at 12 months (CDC, 2007b). Although considerable progress has been made through overall promotion of breastfeeding in the United States, gains in breastfeeding rates have not been made equally across geographic, racial, and socioeconomic groups (Table 5-5).
Contrary to popular conception, breastfeeding appears to be a learned skill and the mother must be supported to be successful. Nevertheless,
TABLE 5-4 Impact of Breastfeeding on Infant and Maternal Health Outcomes from the Surgeon General’s Call to Action to Support Breastfeeding
|Outcome||Excess Risk (%) (95% CI)||Comparison Groups|
|Among full-term infants|
Acute ear infections (otitis media)
|100 (56, 233)||EFF vs. EBF for 3 or 6 mos|
Eczema (atopic dermatitis)
|47 (14, 92)||EBF <3 mos vs. EBF ≥3 mos|
Diarrhea and vomiting (gastrointestinal infection)
|178 (144, 213)||Never BF vs. ever BF|
Hospitalization for lower respiratory tract diseases in the first year
|257 (85, 614)||Never BF vs. EBF ≥4 mos|
Asthma, with family history
|67 (22, 133)||BF <3 mos vs. ≥3 mos|
Asthma, no family history
|35 (9, 67)||BF <3 mos vs. ≥3 mos|
|32 (16, 49)||Never BF vs. ever BF|
Type 2 diabetes mellitus
|64 (18, 127)||Never BF vs. ever BF|
Acute lymphocytic leukemia
|23 (10, 41)||Never BF vs. >6 mos|
Acute myelogenous leukemia
|18 (2, 37)||Never BF vs. >6 mos|
Sudden infant death syndrome
|56 (23, 96)||Never BF vs. ever BF|
|Among preterm infants|
|138 (22, 2400)||Never BF vs. ever BF|
|4 (3, 6)||Never BF vs. ever BF (per year of breastfeeding)|
|27 (10, 47)||Never BF vs. ever BF|
ABBREVIATIONS: BF = breastfeeding; CI = confidence interval; EBF = exclusive breastfeeding; EFF = exclusive formula feeding.
SOURCE: HHS, 2011b.
a large gap exists in the area of providers discussing breastfeeding with patients prenatally and assisting with breastfeeding issues postnatally. Mothers’ experiences as they receive this care have an influence on their intention to breastfeed (Howard et al., 1997), the establishment of breastfeeding (Dewey et al., 2003), and the duration of breastfeeding (DiGirolamo et al., 2003). The duration of breastfeeding is dependent on several factors. Two of these are confidence and commitment. Blyth et al. (2002) identified confidence to be a modifiable variable that may be “amenable to supportive interventions,” rather than nonmodifiable demographic risk factors that are associated with feeding choices. Another review concluded that mothers often wean their babies before six months of age because of perceived difficulties with breastfeeding rather than because of choice, thus suggesting that a mother’s lack of confidence in her ability to breastfeed may have a
TABLE 5-5 Provisional Breastfeeding Rates Among Children Born in 2007a
|Sociodemographic Factor||Ever Breastfed (%)||Breastfeeding at 6 Months (%)||Breastfeeding at 12 Months (%)|
|American Indian or Alaska Native||73.8||42.4||20.7|
|Asian or Pacific Islander||83.0||56.4||32.8|
|Hispanic or Latino||80.6||46.0||24.7|
|Non-Hispanic Black or African American||58.1||27.5||12.5|
|No, but eligible||77.5||48.2||30.7|
|Not a high school graduate||67.0||37.0||21.9|
|High school graduate||66.1||31.4||15.1|
a Survey limited to children aged 19–35 months at the time of data collection. The lag between birth and collection of data allows for tracking of breastfeeding initiation as well as calculating the duration of breastfeeding.
ABBREVIATION: WIC = Special Supplemental Nutrition Program for Women, Infants, and Children; U.S. Department of Agriculture.
SOURCE: From the Surgeon General’s Call to Action to Support Breastfeeding (HHS, 2011b).
greater impact on breastfeeding success than her intent or desire to breastfeed (Dennis, 2002).
Mothers’ experiences as patients during the maternity stay influence future feeding behaviors (Taveras et al., 2004); however, the quality of prenatal, postpartum, and pediatric medical care in the United States is inconsistent (DiGirolamo et al., 2008; Stark and Lannon, 2009). The CDC survey of Maternity Practices in Infant Nutrition and Care biannually assesses breastfeeding-related maternity practices in hospitals and birth centers across the United States. This survey discloses that policies and practices in U.S. maternity care facilities that are unsupportive and even harmful to breastfeeding, are pervasive throughout labor, delivery, and postpartum care, as well as in hospital discharge planning (CDC, 2011d).
Examples of these unsupportive policies and practices include placement of the stable, healthy, full-term newborn on an infant warmer immediately upon delivery rather than skin to skin with the mother, provision of infant formula or water to breastfed newborns without a medical indica-
tion, removal of the newborn from the mother’s room at night, inadequate assurance of postdischarge follow-up for lactation support, and provision of promotional samples of infant formula from manufacturers (Bystrova et al., 2007; Chung et al., 2008; Moore et al., 2007; Rosenberg et al., 2008; Wight et al., 2009). Studies have shown that practices such as these are associated with a shorter duration of breastfeeding (DiGirolamo et al., 2008; Fairbank et al., 2000).
After being discharged from the hospital, mothers may have no means of identifying or obtaining the skilled support needed to address their concerns about lactation and breastfeeding; furthermore, barriers to reimbursement for needed lactation support and services may exist (Salem-Schatz et al., 2004). In addition, limited communication between providers across health care settings (Cherouny et al., 2005) and between providers and mothers may also make mothers less likely to comply with recommended postpartum health care visits than they were during the prenatal period (Stark and Lannon, 2009).
Several studies have found gaps between providers’ intentions surrounding breastfeeding counseling and their training, experience, and practice in supporting patients with breastfeeding. Taveras and colleagues (2004) found that clinicians’ perceptions of the counseling they provided on breastfeeding did not match their patients’ perceptions of the counseling received. When clinicians’ and patients’ reports on the counseling were linked, it was found that among mothers whose prenatal clinicians stated that they always or usually discussed breastfeeding with their patients, only 16 percent of mothers indicated that breastfeeding had been discussed during their prenatal visits.
Another factor affecting the duration of breastfeeding is whether the mother works. The percentage of women in the U.S. workforce has increased dramatically over the past century, particularly in the past 50 years. One outcome of this is that working mothers, particularly those who work full time, breastfeed for a shorter duration, but it has been found that longer maternity leave and part-time work increase the rates of breastfeeding initiation and duration. A breastfeeding support program in the workplace is also important in helping to increase the breastfeeding duration. By 2009, 15 U.S. states required that employers support breastfeeding employees when they return to work (CDC, 2009a). For the continuation of breastfeeding, it is important that mothers have access to breast pumps to maintain their milk supply (Meek, 2001). Buying or renting a pump without insurance coverage is out of the economic reach of many low-income women, leaving them with few options for maintaining breastfeeding. Further, Chamberlain and colleagues (Chamberlain et al., 2006) found that providing access to breast pumps increases overall breastfeeding rates. Despite the recognition of the importance of breastfeeding in improving
women’s and infant’s health, coverage of breastfeeding support services differs significantly across the United States. In an analysis of state Medicaid provisions, the Henry J. Kaiser Family Foundation found that 25 states cover breastfeeding education services, 15 states cover individual lactation consultations, and 31 states cover equipment rentals, such as breast pumps (Ranji and Salganicoff, 2009).
Existing Guidelines and Recommendations
The USPSTF recommends interventions during pregnancy and after birth to promote and support breastfeeding. Grade B recommendation (USPSTF, 2008b).
The USPSTF gives a Grade B to promoting and supporting breastfeeding, and a systematic review of the published literature on the effectiveness of primary care-based interventions encouraging breastfeeding concluded that breastfeeding interventions are more effective than usual care in increasing short- and long-term breastfeeding rates. Specifically, combined pre- and postnatal interventions and inclusion of lay support (such as peer counseling) in a multicomponent intervention are most likely to be effective (Chung et al., 2010).
The USPSTF concluded that promotion and support of breastfeeding are effective when they are integrated into systems of care that include training of clinicians and other health care team members and policy development. The Task Force noted that breastfeeding interventions should be designed and implemented in ways that do not make women feel guilty when they make an informed choice not to breastfeed (Chung et al., 2010).
The AAP Bright Futures program provides a framework for breastfeeding support that covers topics from counseling to prevention of breastfeeding problems (AAP, 2008). In January 2011, the U.S. Surgeon General, Dr. Regina Benjamin, released The Surgeon General’s Call to Action to Support Breastfeeding, a comprehensive report that identifies specific steps that can be taken at the micro- and macrolevels to support breastfeeding mothers (HHS, 2011b). Included among these steps are ensuring that maternity care practices throughout the United States are fully supportive of breastfeeding and including basic support for breastfeeding as a standard of care for obstetricians, family physicians, and pediatricians. The steps also include accelerating the implementation of the Baby-Friendly Hospital
Initiative (WHO and UNICEF, 1999), which was established by the World Health Organization (WHO) and the United Nations Children’s Fund (UNICEF) in 1991 and which includes the use of evidence-based maternity practices, which are summarized in the Ten Steps to Successful Breastfeeding (Box 5-1).
The Joint Commission, the major accrediting organization for health care organizations in the United States, has identified the concept of bundles of care, such as those in the Ten Steps to Successful Breastfeeding (Box 5-1), as a promising strategy to improve the care provided to patients (Joint Commission on Accrediation of Healthcare Organizations, 2006). Researchers in California have found that hospitals that have attained a Baby-Friendly Hospital designation of Baby-Friendly Hospital Initiative do not have the disparities in the rates of exclusive breastfeeding that other hospitals in the same geographic region show (California WIC Association and U.C. Davis Human Lacation Center, 2008). Despite evidence of improved rates of breastfeeding, as of May 2011 only 110 hospitals in the United States were designated Baby-Friendly Hospitals (Kramer et al., 2001).
The Health Resources and Services Administration (HRSA) recently developed a model for implementing support for lactation and direct breastfeeding in the workplace, which is described in The Business Case for
Baby-Friendly Hospital Initiative Ten Steps
- Have a written breastfeeding policy that is routinely communicated to all health care staff.
- Train all health care staff in skills necessary to implement this policy.
- Inform all pregnant women about the benefits and management of breastfeeding.
- Help mothers initiate breastfeeding within a half hour of birth.
- Show mothers how to breastfeed and how to maintain lactation, even if they should be separated from their infants.
- Give newborn infants no food or drink other than breast milk, unless medically indicated.
- Practice “rooming in”—allow mothers and infants to remain together 24 hours a day.
- Encourage breastfeeding on demand.
- WHO and UNICEF, 1989.
- Give no artificial teats or pacifiers (also called dummies or soothers) to breastfeeding infants.
- Foster the establishment of breastfeeding support groups and refer mothers to them on discharge from the hospital or clinic.
SOURCE: WHO and UNICEF, 1989.
Breastfeeding: Steps for Creating a Breastfeeding Friendly Worksite (HHS, 2008). The program components outlined in the model include flexible breaks and work schedules, a sanitary and private place to express milk, education for pregnant and lactating women, and support from supervisors and coworkers. In addition, Section 4207 of the ACA amends the Fair Labor Standards Act of 1938 by requiring employers with more than 50 employees to provide reasonable break time for a mother to express milk and to provide a place, other than a restroom, that is private and clean where she can express her milk (111th U.S. Congress, 2010).
Healthy People 2020 contains specific objectives for improving maternal, infant, and child health (HHS, 2011a). Among these objectives is increasing the proportion of infants who are breastfed. The specific targets set for this objective are increasing the proportions of infants ever breastfed to 81.9 percent, the proportions of infants breastfed at six months to 60.6 percent, and the proportions of infants breastfed at one year to 34.1 percent. It also sets targets for increasing the proportion of infants exclusively breastfed through three months to 46.2 percent and exclusively breastfed through six months to 25.5 percent (HHS, 2011a). One of the recommendations from the National Prevention Council’s (NPC’s) June 2011 National Prevention Strategy report includes the support of policies and programs that promote breastfeeding (National Prevention Council, 2011).
A number of professional organizations have guidance or supportive statements indicating that they find breastfeeding to be the preferred method of feeding newborns and infants. AAFP (2005) and AAP (2005) have developed guidelines and recommendations that mothers breastfeed their infants. In 2007, ACOG issued a committee opinion stating strong support for breastfeeding and urging obstetricians and gynecologists, other health care professionals, hospitals, and employers to support women in choosing to breastfeed their infants (ACOG, 2007a).
Although the ACA ensures that counseling on breastfeeding is included, the committee recognizes that interpretation of this varies. The primary gap in preventive services not already addressed by the provisions set forth in the ACA (reviewed in this section) is that comprehensive prenatal and postnatal lactation support, counseling, and supplies are not currently included.
The evidence provided to support the inclusion of these services is based on systematic evidence reviews, federal and international goals (such as the U.S. Surgeon General, HRSA, Healthy People 2020 [HHS, 2011a], WHO and UNICEF), and clinical professional guidelines such as those set forth by AAFP, AAP, and ACOG.
Recommendation 5.6: The committee recommends for consideration as a preventive service for women: comprehensive lactation support and counseling and costs of renting breastfeeding equipment. A trained provider should provide counseling services to all pregnant women and to those in the postpartum period to ensure the successful initiation and duration of breastfeeding. (The ACA ensures that breastfeeding counseling is covered; however, the committee recognizes that interpretation of this varies.)
Interpersonal and domestic violence, including intimate partner violence and childhood abuse, is a pattern of coercive behaviors that may include progressive social isolation, deprivation, intimidation, psychological abuse, childhood physical abuse, childhood sexual abuse, sexual assault, and repeated battering and injury. These behaviors are perpetrated by someone who is or was involved in a familial or intimate relationship with the victim. Women and adolescent girls of all ages experience interpersonal and domestic violence.
The CDC recognizes four categories of violence: physical violence, sexual violence, threat of physical or sexual violence, and psychological or emotional abuse (CDC, 2010c). Each year, as many as 1 million to 5 million women are physically, sexually, or emotionally abused by their intimate partners in the United States (Black and Breiding, 2008; The Commonwealth Fund, 1993; National Center for Injury Prevention and Control, 2003; Tjaden and Thoennes, 1998, 2000), and 39 percent of all women report intimate partner violence in their lifetimes (The Commonwealth Fund, 1999).
Prevalence rates of abuse measured in health care settings range from 4 to 44 percent within the year prior to being asked about abuse and from 21 to 55 percent over a lifetime (Abbott, 1995; Dearwater et al., 1998; Gin et al., 1991; Hamberger et al., 1992; Martins et al., 1992; Mccauley et al., 1995; Richardson et al., 2002). Approximately 20 percent of female public high school students in Massachusetts reported that they had been physically or sexually abused by a dating partner (Silverman et al., 2001). In the United States, approximately 35 percent of emergency room visits, 50 percent of all acute injuries, and 21 percent of all injuries in women requiring urgent surgery were the result of partner violence (Guth and Pachter, 2000).
The CDC estimates that intimate partner rape, stalking, and assault cost the United States more than $5.8 billion yearly, of which $4.1 billion goes to direct medical and mental health care services (National Center for Injury Prevention and Control, 2003). Women experiencing intimate partner violence have medical care costs 60 percent higher than women not experiencing abuse (Ulrich et al., 2003).
The prevalence of childhood physical and sexual abuse is not known. Prevalence estimates from population-based studies of women reporting histories of childhood physical and sexual abuse range between 20 and 38 percent (Finkelhor, 1994; Schoen et al., 1997, 1998). For adolescents, an analysis of self-reported abuse and neglect from the National Longitudinal Study of Adolescent Health indicated that 28 percent of 15,197 respondents experienced physical assault, 12 percent experienced physical neglect, 5 percent experienced contact sexual abuse, and 42 percent experienced supervision neglect (Hussey et al., 2006). Variations in estimates across studies are due to differences in the methodologies used to assess prevalence, a lack of standardized and accepted research instruments, and gaps in knowledge about how abuse victims frame and define their experiences (Hulme, 2004).
Interpersonal and domestic violence committed against adolescent girls may also meet definitions of child abuse. The 2003 Keeping Children and Families Safe Act amendment to the 1996 Federal Child Abuse Prevention and Treatment Act (CAPTA; 42 U.S.C.A. §5106g) defines “child abuse and neglect” as any recent act or failure to act on the part of a parent or caretaker which results in death, serious physical or emotional harm, sexual abuse or exploitation; or an act or failure to act which presents an imminent risk of serious harm (104th U.S. Congress, 1996; HHS, 2003, 2010). Individual states are required to define child abuse and neglect using the minimum standards in the federal law according to CAPTA; however, state definitions vary (HHS, 2009).
The immediate health consequences of interpersonal and domestic violence include injuries (Corrigan et al., 2003) and death from sexual assault (Broch, 2003), as well as sexually transmitted infections, including HIV infection (Wingood et al., 2001), pelvic inflammatory disease (Letourneau et al., 1999), pregnancy (Hathaway et al., 2000), and adverse psychological responses. Several chronic mental health conditions are related to interpersonal and domestic violence (Campbell, 2002), including posttraumatic stress disorder, depression, anxiety disorders, substance abuse, and suicide (Campbell and Lewandowski, 1997; Golding, 1999; Lehmann, 2000). Long-term physical conditions include chronic pain; neurological disorders resulting from injuries; gastrointestinal disorders, such as irritable bowel syndrome; migraine headaches; and various disabilities (Campbell and Lewandowski, 1997; Coker et al., 2000, 2002).
Although childhood sexual abuse is predominantly a prepubertal phenomenon (Finkelhor et al., 2009), the impact and consequences of this form of abuse are usually expressed in adolescence and persist into adulthood (Trickett et al., 2005). These include disability, suffering, and limitations in the quality of life that can be serious and often severe (Sickel et al., 2002). Women with childhood sexual abuse histories report more problems during pregnancy (Lukasse et al., 2009). Physical and sexual abuse in adolescence and young adulthood have been associated with poor self-esteem, alcohol and drug abuse, eating disorders, obesity, risky sexual behaviors, teen pregnancy, depression, trauma, anxiety, suicidality, and other conditions (Sickel et al., 2002; Trickett et al., 2005).
Asking women and adolescent girls about their interpersonal and domestic violence experiences could identify abuse not otherwise detected, help prevent future abuse, lessen disability, and improve future functioning and success in life (Battaglia et al., 2003; Coker et al., 2009; Martin et al., 2008; National Center for Injury Prevention, 2003; Svavarsdottir and Orlygsdottir, 2009). Women may not disclose abuse unless directly questioned under safe and respectful conditions (Dienemann et al., 2005), although there is no consensus about the most acceptable approach (Feder et al., 2009). Surveys indicate that 43 to 85 percent of female respondents consider screening for abuse acceptable, although only one-third of physicians and approximately half of emergency department nurses favored screening (Ramsay et al., 2002). Most women who have been screened for abuse report no adverse effects from the screening process (MacMillan et al., 2009; Spangaro et al., 2010).
Victims of abuse have frequent encounters with clinicians and health care services because adult victims of childhood abuse have poorer health than nonvictims and higher rates of health services utilization (Felitti, 1991; Fillingim et al., 1999; Valente, 2005). Physicians are in a unique position to identify women and adolescents experiencing abuse or neglect, and many physicians consider screening for abuse to be one of their important roles (Flaherty and Stirling, 2010). In practice, however, physicians rarely screen their patients or screen only selected patients, such as patients who have physical injuries (Bair-Merritt et al., 2004; Borowsky and Ireland, 2002; Chamberlain and Perhma-Hester, 2000, 2002; Erickson et al., 2000; Glass et al., 2001; Lapidus et al., 2002; Rodriguez et al., 2001). Barriers to screening include a lack of experience, training, time, and confidence in handling abuse cases (Bair-Merritt et al., 2004; Flaherty et al., 2006; Lane and Dubowitz, 2009; Starling et al., 2009).
Existing Guidelines and Recommendations
The USPSTF found insufficient evidence to recommend for or against routine screening of parents or guardians for the physical abuse or neglect of children, of women for intimate partner violence, or of older adults or their caregivers for elder abuse. Grade I Statement (USPSTF, 2004b).
The USPSTF recommendation applies to women without apparent injuries or symptoms of abuse and is based on the lack of evidence that screening for intimate partner violence in primary care settings reduces adverse health outcomes, including premature death (USPSTF, 2004). The Canadian Task Force on Preventive Health Care also found insufficient evidence to recommend for or against screening women for intimate partner violence (Wathen and MacMillan, 2003). A report by the Health Technology Assessment Program in the United Kingdom also concluded that evidence is insufficient to implement a screening program for partner violence against women either in health services generally or in specific clinical settings (Feder et al., 2009).
WHO states that better awareness among health workers of violence and its consequences and wider knowledge of available resources for abused women can lessen the consequences of violence (WHO, 2010). AMA recommends that physicians regularly inquire about sexual, physical, and psychological abuse when taking a medical history. Furthermore, as interpersonal abuse or violence may adversely affect a patient’s health status, physicians are advised to consider abuse to be a factor in the presentation of medical complaints (AMA, 2008). ACOG recommends that physicians screen all patients for intimate partner violence and that screening should occur during routine visits and over the course of pregnancy (ACOG, 2010b). AAP also recommends screening, stating that pediatricians are in a position to recognize abused women in pediatric settings (Thackeray et al., 2010). Other groups, such as the American Nurses Association (ANA, 2000) and the Futures Without Violence (formerly the Family Violence Prevention Fund) (Family Violence Prevention Fund, 2004), also recommend that health care providers screen patients for intimate partner violence. Finally, VA covers women for health services related to intimate partner violence.
Bright Futures guidelines for adolescents include the provision of anticipatory guidance through discussions about developing healthy dating
relationships, managing conflict nonviolently, avoiding risky situations and people, and seeking help when in danger (AAP, 2008). Recommendations of other groups relevant to adolescents fall under more broadly defined statements about child abuse and neglect.
AAP advocates a prominent role for pediatricians in preventing child abuse and neglect and provides specific guidelines and information on specific risk factors and protective factors (Flaherty and Sterling, 2010). AMA recommends routine inquiry about child abuse or neglect (AMA, 2008). Other organizations do not specifically recommend universal screening but recommend that pediatricians and family practice clinicians remain alert for indications of abuse or neglect (AAFP, 2009; ENA, 2006).
All U.S. states have laws that require physicians and other health care workers, as well as other professionals who interact with children, to report suspected child abuse and neglect to Child Protective Services (CPS) (HHS, 2010b). In 2009, teachers, law enforcement and legal personnel, and social services staff made three-fifths of the reports to CPS, whereas anonymous sources, family members, friends, and neighbors made the remaining reports (HHS, 2010a). It is not clear how many reports originated from health care clinicians specifically. Some states also require physicians to report cases of adult intimate partner violence to legal authorities, and most states require reporting of injuries resulting from firearms, knives, or other weapons.
Although numerous community-based programs to safeguard victims of interpersonal and domestic violence exist, including counseling, hotlines, shelters, and advocacy groups, they are usually not directly associated with health care delivery systems. Few studies have evaluated the effectiveness of screening for abuse in health care settings by demonstrating subsequent reductions in abuse or improvement in health as a result of screening (Feder et al., 2009; Ramsay et al., 2009; Trabold, 2007; Wathen and MacMillan, 2003). Existing research has been limited by many factors, including the lack of integration of screening with services such as counseling, inadequate definitions and measurement of outcomes, loss to follow-up, insufficient study designs, patient privacy, stigma and repercussions of disclosure, and variability of individual cases, among others (Feder, 2009; MacMillan, 2006, 2009; Nelson, 2004; Rabin, 2009; Ramsay et al., 2004 Wathen and MacMillan, 2003). The 2004 IOM study Advancing the Federal Research Agenda on Violence Against Women reiterated the importance of strengthening the data and research infrastructure, especially the need for better prevalence and longitudinal data to determine the causes of violent victimization of women and the impact of interventions (IOM, 2004).
In the context of these issues, new research on screening and interventions for women identified with abuse in health care settings has been published since the previous 2004 USPSTF recommendation. These include evaluations of methods of identifying women who have been abused (Basile, et al. 2007; Feder et al., 2009; Rabin et al., 2009). Standardized questions and scales designed for screening purposes generally include from one to five items that may be scored in various ways to determine if abuse is present. The diagnostic accuracy of these questions varies, but five different sets of questions have been found to be suitably accurate (i.e., sensitivity and specificity >80 percent) (Chen et al., 2005 et al.; Ernst, 2004; Sohal, 2007; Thombs et al., 2007; Wathen et al., 2008; Weiss et al., 2003).
A large randomized trial compared women who were screened for abuse versus not screened in primary care and acute care settings in Canada. Results indicated improvements in rates of abuse and quality of life several months later, but there were no significant differences between screened and unscreened women (MacMillan et al., 2009). However, for ethical reasons, women randomized to the unscreened comparison group were also asked questions about abuse, received information about intimate partner violence, and were offered services if needed, reducing measureable differences between screened and unscreened women. This study also collected information on the potential harms of screening and reported no harms.
A randomized trial of counseling that included intimate partner violence as well as other health risks during pregnancy and postpartum reported less violence and better infant outcomes among women receiving counseling compared to those who did not (Kiely et al., 2010). Women in the counseling group had significantly fewer very preterm (<33 weeks) and very low birth weight (<1,500 grams) newborns, and increased gestational age (38.2 versus 36.9 weeks) (Kiely et al., 2010). Randomized trials of home visitation for new mothers at risk for abuse showed reduced measures of abuse compared to women not receiving these services (Bair-Merritt et al., 2010; Taft et al., 2011). In other trials, women reporting abuse who were randomized to counseling adopted more safety behaviors than women not receiving counseling (Gillum et al., 2009; McFarlane et al., 2002). Many additional observational and descriptive studies supporting screening and intervention have also been published, but the designs of these studies limit conclusions regarding their effectiveness.
The primary gap in preventive services not already addressed by the provisions set forth in the ACA (reviewed in this section) is that interpersonal and domestic violence detection and counseling are not included.
The evidence provided to support a recommendation related to increasing detection of and counseling for interpersonal and domestic violence is based on peer-reviewed studies and federal and international policies, in addition to clinical professional guidelines from organizations, such as the AMA and ACOG.
Recommendation 5.7: The committee recommends for consideration as a preventive service for women: screening and counseling for interpersonal and domestic violence. Screening and counseling involve elicitation of information from women and adolescents about current and past violence and abuse in a culturally sensitive and supportive manner to address current health concerns about safety and other current or future health problems.
Provision of Preventive Services
The committee examined existing guidelines, available evidence, and current clinical best practices to identify effective provision of services that, when provided to women through dedicated clinical encounters, have been shown to promote optimal well-being. Primary care office visits that are dedicated to preventive care may facilitate increased access to health care services that are shown to identify chronic disease risk factors, promote well-being, and/or decrease the likelihood or delay the onset of a targeted disease or condition. Box 5-2 contains examples of terms that are commonly used to label the prevention-oriented clinical encounter; this report
Common Terms Used for Well Visits
Preventive pediatric health care visit (AAP/Bright Futures)
Well-child checkup (Early Periodic Screening, Diagnosis, and Treatment program and Medicaid)
Well-adult checkup (Medicaid)
Health risk assessment (Medicaid)
“Welcome to Medicare” visit (Medicare)
Annual wellness examination (Medicare)
Health maintenance visit (MHQP)
uses the term “well-woman preventive visit” to describe the provision of prevention services in an office visit or clinical encounter.
Well-woman preventive care visits apply to women of all ages (and according to the committee’s charge, women from 10 through 64 years) and stages of life. Stages of womanhood are defined by age groupings, which are in general alignment with published frameworks and practice guidelines (AAP, 2008). These include adolescence (subdivided into two subgroups ages 10 to 14 years and 15 to 19 years), early adulthood (ages 20 to 24 years), middle adulthood (ages 25 to 49 years), and later adulthood (after age 50 years).
Justification of Well-Woman Visits for Provision of Preventive Services
Women’s Preventive Care Is Fragmented
Although “well” visits for adults are not explicitly recommended by the USPSTF, they provide an opportunity for delivering prevention services recommended by a number of government and nongovernment health care agencies (GAO, 2009). In the U.S. health care system, for women, the tendency is to separate reproductive health care services from other components of primary care (Weisman, 1998). Because many preventive services for women are for reproductive health (e.g., screening for cervical cancer and sexually transmitted infections and contraception services), many women may see obstetrician-gynecologists for those services and a generalist physician (a family physician or a general internist) for other components of their routine health care. For example, a national survey of the U.S. female population in 1998 showed that 29 to 49 percent of women, depending of type of health plan, see both a generalist and an obstetrician-gynecologist for their regular health care (Weisman and Henderson, 2001). In another study of women aged 18 to 64 years, 58 percent of women in all stages of life saw an obstetrician-gynecologist in addition to a generalist physician (Henderson et al., 2002). In the 2008 Kaiser Women’s Health Survey, 44 percent of women aged 18 to 64 years reported seeing two or more regular providers (Ranji and Salganicoff, 2011). Given these patterns of physician use, it is likely that women make more than one visit and use more than a single provider to attain needed preventive services in a given year. Thus, no single type of provider can be identified as the sole primary care provider for women.
Women have greater health care needs than men and require a broader array of health services, but not all providers are equipped or able to
provide the full range of preventive services for women. A consequence of women obtaining preventive health care from more than one provider is that women’s primary care is often fragmented.
Cost as a Major Barrier to Services and Visits
Although the preventive services detailed in Table 5-6 will be covered with no cost sharing under the ACA, insurance plans are permitted to require copayments for office visits (Federal Register, 2010). Increased health care costs, combined with the fact that most Americans have seen too little or no gains in income in recent years, can be seen as a threat to the health and financial status of women across the country (Collins et al., 2011). Furthermore, evidence suggests that these issues are adversely affecting women disproportionately compared to men. In 2010, for example, 44 percent of women but only 35 percent of men indicated that they were experiencing difficulty paying medical bills or were paying off medical debt. Furthermore, almost a third of women stated that they did not visit a doctor or clinic when they were faced with a medical problem because of cost, whereas less than a quarter of men reported the same experience (Robertson and Collins, 2011).
Gaps in Well Visits for Women
Clinical guidelines and mandated coverage for well visits exist for children and adolescents (until age 21 years), for some adults, and into maturity (for individuals aged 65 years and older) in public-sector health plans (Medicaid and Medicare) as well as some private-sector health plans (see below and Chapter 3). However, public programs may be incomplete in providing coverage in early, middle, and later adulthood. According to a Government Accountability Office analysis of responses to a survey of state Medicaid directors conducted between October 2008 and February 2009, only 39 states cover health maintenance visits to adults under their Medicaid programs (GAO, 2009). This significant gap in coverage places a disproportionate burden on women of childbearing age, putting them at a greater risk for disease and illness in their most active reproductive years.
Existing Guidelines and Recommendations
Clinical preventive services guidelines for adolescents issued by governmental agencies and nonprofit medical organizations (e.g., HRSA, the Maternal and Child Health Bureau, AAP, AMA, and AAFP) have long recommended annual well-child visits as part of a unified package of preventive health care services for children and adolescents (AAP, 1995; Elster, 1998; Elster and Kuznets, 1994).
TABLE 5-6 List of Preventive Services to Be Obtained During Well-Woman Preventive Visits Under Recommendation 8
|USPSTF Grade A and B Recommended Services|
|Alcohol misuse counseling||The USPSTF recommends screening and behavioral counseling interventions to reduce alcohol misuse by adults, including pregnant women, in primary care settings.||B|
|Anemia screening: pregnant women||The USPSTF recommends routine screening for iron deficiency anemia in asymptomatic pregnant women.||B|
|Bacteriuria screening: pregnant women||The USPSTF recommends screening for asymptomatic bacteriuria with urine culture for pregnant women at 12 to 16 weeks’ gestation or at the first prenatal visit, if later.||A|
|Blood pressure screening||The USPSTF recommends screening for high blood pressure in adults aged 18 and older.||A|
|BRCA screening, counseling about||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.||B|
|Breast cancer preventive medication||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.||B|
|Breast cancer screening||The USPSTF recommends screening mammography for women, with or without clinical breast examination, every 1–2 years for women aged 40 and older.||B|
|Breastfeeding counseling||The USPSTF recommends interventions during pregnancy and after birth to promote and support breastfeeding.||B|
|Cervical cancer screening||The USPSTF strongly recommends screening for cervical cancer in women who have been sexually active and have a cervix.||A|
|Chlamydial infection screening: non-pregnant women||The USPSTF recommends screening for chlamydial infection for all sexually active nonpregnant young women aged 24 and younger and for older nonpregnant women who are at increased risk.||A|
|Chlamydial infection screening: pregnant women||The USPSTF recommends screening for chlamydial infection for all pregnant women aged 24 and younger and for older pregnant women who are at increased risk.||B|
|Cholesterol abnormalities screening: women 45 and older||The USPSTF strongly recommends screening women aged 45 and older for lipid disorders if they are at increased risk for coronary heart disease.||A|
|Cholesterol abnormalities screening: women 45 and older||The USPSTF strongly recommends screening women aged 45 and older for lipid disorders if they are at increased risk for coronary heart disease.||A|
|Cholesterol abnormalities screening: women younger than 45||The USPSTF recommends screening women aged 20 to 45 for lipid disorders if they are at increased risk for coronary heart disease.||B|
|Colorectal cancer screening||The USPSTF recommends screening for colorectal cancer using fecal occult blood testing, sigmoidoscopy, or colonoscopy, in adults, beginning at age 50 years and continuing until age 75 years. The risks and benefits of these screening methods vary.||A|
|Depression screening: adolescents||The USPSTF recommends screening of adolescents (12–18 years of age) for major depressive disorder when systems are in place to ensure accurate diagnosis, psychotherapy (cognitive-behavioral or interpersonal), and follow-up.||B|
|Depression screening: adults||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.||B|
|Diabetes screening||The USPSTF recommends screening for type 2 diabetes in asymptomatic adults with sustained blood pressure (either treated or untreated) greater than 135/80 mm Hg.||B|
|Folic acid supplementation||The USPSTF recommends that all women planning or capable of pregnancy take a daily supplement containing 0.4 to 0.8 mg (400 to 800 µg) of folic acid.||A|
|Gonorrhea screening: women||The USPSTF recommends that clinicians screen all sexually active women, including those who are pregnant, for gonorrhea infection if they are at increased risk for infection (that is, if they are young or have other individual or population risk factors).||B|
|Healthy diet counseling||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.||B|
|Hepatitis B screening: pregnant women||The USPSTF strongly recommends screening for hepatitis B virus infection in pregnant women at their first prenatal visit.||A|
|Human immunodeficiency virus (HIV) screening||The USPSTF strongly recommends that clinicians screen for HIV all adolescents and adults at increased risk for HIV infection.||A|
|Obesity screening and counseling: adults||The USPSTF recommends that clinicians screen all adult patients for obesity and offer intensive counseling and behavioral interventions to promote sustained weight loss for obese adults.||B|
|Osteoporosis screening: women||The USPSTF recommends that women aged 65 and older be screened routinely for osteoporosis. The USPSTF recommends that routine screening begin at age 60 for women at increased risk for osteoporotic fractures.||B|
|Rh incompatibility screening: first pregnancy visit||The USPSTF strongly recommends Rh (D) blood typing and antibody testing for all pregnant women during their first visit for pregnancy-related care.||A|
|Rh incompatibility screening: 24–28 weeks gestation||The USPSTF recommends repeated Rh (D) antibody testing for all unsensitized Rh (D)-negative women at 24–28 weeks’ gestation, unless the biological father is known to be Rh (D)-negative.||B|
|Sexually transmitted infections (STIs) counseling||The USPSTF recommends high-intensity behavioral counseling to prevent STIs for all sexually active adolescents and for adults at increased risk for STIs.||B|
|Syphilis screening: non-pregnant persons||The USPSTF strongly recommends that clinicians screen persons at increased risk for syphilis infection.||A|
|Syphilis screening: pregnant women||The USPSTF recommends that clinicians screen all pregnant women for syphilis infection.||A|
|Tobacco use counseling and interventions: nonpregnant adults||The USPSTF recommends that clinicians ask all adults about tobacco use and provide tobacco cessation interventions for those who use tobacco products.||A|
|Tobacco use counseling: pregnant women||The USPSTF recommends that clinicians ask all pregnant women about tobacco use and provide augmented, pregnancy-tailored counseling to those who smoke.||A|
|Services Suggested by the Institute of Medicinea|
|Diet and physical activity||Determine current levels of physical activity and eating behaviors in all adolescent and adult women and make referrals to appropriate services.|
|Establishing pregnancy history of CVD-related conditions||Obtain a history of pregnancy complications, including preeclampsia, gestational hypertension, and gestational diabetes mellitus, from all women who have had at least one pregnancy.|
|Mental health||Screen for suicide ideation and postpartum depression in women who are pregnant or who have recently given birth.|
|Metabolic syndrome||Obtain a waist circumference as an essential component of screening for metabolic syndrome.|
|Preconception care||Provide evidence-based tests, procedures, and screening for nonpregnant women to optimize reproductive outcomes and prevent or optimize treatment for chronic conditions, as well as topics for counseling and guidance for preconception health.|
|Prenatal care||Provide evidence-based tests, procedures, and screening for pregnant women to optimize birth outcomes and future chronic conditions, as well as topics for counseling and guidance for prenatal care.|
|STIs||Screen for chlamydia and gonorrhea for women above age 25 years with risk factors outlined by the USPSTF or if local rates of infections are high. High-prevalence settings are defined by the Centers for Disease Control and Prevention as those known to have a one percent or greater prevalence of infection among the patient population being served.|
recommended annual well-child visits as part of a unified package of preventive health care services for children and adolescents (AAP, 1995; Elster, 1998; Elster and Kuznets, 1994).
Most recently, the Bright Futures Health Initiative, which was launched by HRSA’s Maternal and Child Health Bureau in 1990, recommended a schedule of preventive services beginning in the prenatal period (for an initial history and anticipatory guidance) and running through 21 years of age for “children who are receiving competent parenting, have no manifestations of any important health problems, and are growing and developing in satisfactory fashion” (AAP, 1995, 2008). Bright Futures recommends preventive pediatric health care visits for children annually from ages 3 through age 21 years, including initial/interval medical histories, measurements, sensory screening, developmental/behavioral assessments, physical examination, age-appropriate procedures, oral health, and anticipatory guidance. Although the content of well care is tailored by gender to females and males, the recommended frequency or timing of well-care visits for girls and young women does not vary.
Under federal law, state Medicaid programs generally must cover a package of prevention services for children under age 21 years through the Early Periodic Screening, Diagnosis, and Treatment (EPSDT) program (GAO, 2009). A key component of the EPSDT services is that it entitles
children to coverage of well-child checkups, which include a comprehensive health and developmental history, a comprehensive unclothed physical examination, appropriate immunizations and laboratory tests, and health education. The EPSDT program also covers other preventive services for children, such as height and weight measurement, nutritional assessment and counseling, immunizations, blood pressure screening, and cholesterol and other appropriate laboratory tests. State Medicaid programs must provide EPSDT program services at intervals that meet reasonable standards of medical and dental practice, as determined by the state and as medically necessary to determine the existence of a suspected illness or condition. Accordingly, either states must develop their own periodicity schedules (i.e., age-specific timetables that identify when EPSDT well-child checkups and other EPSDT services should occur), or they may adopt a nationally recognized schedule, such as that of AAP, which recommends well-child checkups once each year or more frequently, depending on age. The Omnibus Budget Reconciliation Act of 1989 (OBRA 89) required the Secretary of HHS to set annual goals for children’s receipt of EPSDT services, and the Centers for Medicare and Medicaid Services (CMS) established a yearly goal that each state must provide EPSDT well-child checkups to at least 80 percent of the children enrolled in the Medicaid program in their state.
For adults, the USPSTF clinical preventive services recommendations do not address how, when, where, or by whom prevention services are to be provided. For adolescents and adults, ACIP recommends age-specific timing of a full array of immunizations but does not explicitly mention their preferred provision in the context of the well-care office visit. As noted in Chapter 3, states and health insurance plans in the public and private sectors vary widely in the preventive services that they cover, including the payment for designated office visits and extended coverage for specific prevention services.
For persons 65 years and older, well visits are generally covered. All new Medicare beneficiaries have been eligible to receive a welcome to Medicare visit that is similar in scope to a wellness visit (GAO, 2009). The ACA broadens this benefit for beneficiaries to include a new annual wellness examination for all beneficiaries with no copayment. At this visit, medical and family health histories are reviewed, along with the collection of basic health measurements, screening for preventive services, and the identification of risk factors and treatment options.
State Health Plan Example
In recent years, the Commonwealth of Massachusetts has been at the forefront in establishing a core set of clinical guidelines for the well care of average-risk adults 18 years of age and older from the general population (MHQP, 2007). These guidelines include health maintenance visits that were recommended annually for people age 18 to 21 years; every one to three years, depending on risk factors, from ages 22 to 49 years; and then annually for all adults 50 years of age and older. The health maintenance visit includes an individual and family history, an age-appropriate physical examination, indicated preventive screenings and counseling, and ACIP-based immunization updates. General counseling and guidance at every age include screening for alcohol and substance abuse, depression, physical activity, tobacco use, and violence or abuse in the home, as well as safety and injury and violence prevention
Statewide health care reform in Massachusetts established minimum creditable coverage regulations, which apply for purposes of the individual mandate and to all Commonwealth Care policies. These require that health plans cover at least three preventive care visits per year for an individual (six visits under a family policy) before any deductible is applied. However, preventive care visits require the normal copayment. After the enactment of the ACA, as of July 1, 2011, no copayments for preventive services, including both preventive service visits and the well office visit (Current Procedural Terminology Codes 99381 to 99397), will be charged for any patient (Personal communication, Stephanie Chrobak and Nancy Turnbull, Massachusetts Health Connector, May 10, 2011).
Private-Sector Coverage of Well-Visits
Private health maintenance plans, such as Kaiser Permanente, cover and encourage the utilization of a wide array of prevention services in the context of ongoing primary care for beneficiaries of all ages. They do not, however, promote a specific periodicity of prevention visits (Kaiser Permanente, 2011). Although detailed coverage and benefit information about the scope of preventive services covered by insurance plans is difficult to obtain, Chapter 3 addresses more examples of current private insurance practices.
Special Considerations for Reproductive Health Care
Provision of Preconception Health Care
The preconception period (before the first pregnancy) and the interconception period (between all subsequent pregnancies) have been identi-
fied as opportune times for the provision of focused well-woman preventive care visits to identify and modify biomedical, behavioral, and social risks to a woman’s health and/or pregnancy outcomes. In 2006, the CDC developed recommendations for preconception care on the basis of a review of published research and the opinions of specialists from the CDC Agency for Toxic Substances and Disease Registry Preconception Care Work Group and the Select Panel on Preconception Care. The recommendations of the CDC were aimed at achieving four primary goals:
1) improving the knowledge and attitudes and behaviors of men and women related to preconception health; 2) assuring that all women of childbearing age in the United States receive preconception care services (i.e., evidence-based risk screening, health promotion, and interventions) that will enable them to enter pregnancy in optimal health; 3) reducing risks indicated by a previous adverse pregnancy outcome through interventions during the interconception period; and 4) reducing the racial disparities in adverse pregnancy outcomes. (Johnson et al., 2006)
However, the report did not recommend a specific suite of interventions to be included in routine preconception care. Strong evidence suggests that a number of components of preconception care are effective in improving health outcomes for women and children, in particular, screening of women who are seeking family planning services to identify and treat preconception risk conditions, the provision of nutrition services for women affected by particular metabolic conditions such as hyperphenylalanemia and diabetes, the use of dietary folate supplements by women of reproductive age who are sexually active (Korenbrot et al., 2002), and screening for depression. Furthermore, better pregnancy outcomes have been demonstrated as the result of preconception interventions for alcohol and smoking cessation (Lumley et al., 2004).
The CDC Select Panel on Preconception Care considers all women of reproductive age and potential presenting to primary care as candidates for preconception care. Its 2006 recommendations include the provision of a prepregnancy visit for couples and individuals planning a pregnancy and, as part of primary care preventive care visits, risk assessment and educational and health counseling for all women of childbearing age for improving reproductive outcomes and reducing the sequelae of future chronic diseases among women and their offspring. In 2011 the NPC issued the National Prevention Strategy. Recommendations include increasing use of preconception and prenatal care (National Prevention Council, 2011).
Prenatal Care for the Provision of Preventive Services
Another type of well-woman preventive care visit is the routine prenatal care visit for pregnant women. AAP and ACOG currently recommend
the following visit schedule for women with an uncomplicated pregnancy: a visit every 4 weeks for the first 28 weeks of pregnancy, a visit every 2 weeks until 36 weeks of pregnancy, and weekly visits thereafter (ACOG, 2007c). Women with high-risk pregnancies may need more frequent visits. The recommended content of the visit includes specific tests and procedures (e.g., blood pressure, weight, urine test, uterine size and fetal heart rate assessment, glucose tolerance testing, and screening for specific sexually transmitted infections and genetic or developmental conditions), as well as topics for counseling and guidance (e.g., tobacco avoidance and nutrition). The U.S. Public Health Service Expert Panel on the Content of Prenatal Care (USPHS, 1989) recommends less frequent visits, and some studies have supported the safety and efficacy of visits at a reduced frequency for multiparous and low-risk women. Regardless of the periodicity, pregnant women are likely to make more well-woman preventive care visits than nonpregnant women.
Additional Considerations to Assure Access to Well-Visits
Adolescence and Early Adulthood
Although an array of clinical guidelines recommend an annual well-child visit through age 21 years for the provision of preventive services, evidence on the rates of compliance with the recommendations are mixed. Only 38 percent of adolescents received a preventive care visit in the previous year, and black, Hispanic, and lower-income adolescents were the least likely to have had a preventive care visit (Irwin, 2009). Evidence of the efficacy of preventive services delivered to adolescents is stronger for increasing knowledge and awareness than for changing risky behaviors (Ozer et al., 2004).
As the ACA expands access to private and public health insurance for adolescents and young adults, it may also raise challenges for ensuring that confidential care is delivered to a newly insured segment of the adolescent and young adult population. Adolescents and young adults are likely to forgo health care when they feel that they lack access to confidential care. Time alone with the provider can enhance the client’s sense of confidentiality, and it has been shown that adolescents attending a preventive care visit are more likely to have time alone with their provider than with those with a non-preventive care visit (40 and 28 percent, respectively) (Edman et al., 2010). However, the overall proportion of young people accessing confidential care remains relatively low, particularly for adolescents from low-income and ethnically diverse populations.
Children enrolled in Medicaid are generally eligible for a well-child check up at least once every one to two years, but according to Medical Expenditure Panel Survey data from 2003 to 2006, an estimated 41 percent of children in Medicaid aged 2 through 20 years had not received a well-child checkup during the previous 2-year period. The estimated proportions of privately insured children who had received a well-child checkup were generally similar. CMS collects data and reports from states on the provision of EPSDT services, and reports from fiscal years 2000 through 2007 show that most states are not achieving the yearly goal of CMS that each state provide EPSDT well-child visits to at least 80 percent of the children enrolled in Medicaid in their state who should receive such care. State reports for 2007 showed that, on average, 58 percent of children enrolled in Medicaid received at least one EPSDT well-child visit for which they were eligible; the rates in individual states varied from 25 to 79 percent (GAO, 2009). As noted earlier for adults, only 39 states cover health maintenance visits to adults under Medicaid (GAO, 2009). Additional outreach to foster optimal utilization of preventive services may be necessary to overcome nonclinical barriers (e.g., transportation, literacy, and translation services).
The primary gap in preventive services not already addressed by the provisions set forth in the ACA (reviewed in this section) is lack of inclusion of well-woman preventive visits for women 21 to 64 years of age, which are used for providing recommended preventive services.
The evidence provided to support the inclusion of this service is based on federal and state policies (such as included in Medicaid, Medicare, and the Commonwealth of Massachusetts), clinical professional guidelines (such as those of AMA and AAFP), and private health plan policies (such as those of Kaiser Permanente).
Recommendation 5.8: The committee recommends for consideration as a preventive service for women: at least one well-woman preventive care visit annually for adult women to obtain the recommended preventive services, including preconception and prenatal care. The committee also recognizes that several visits may be needed to obtain all necessary recommended preventive services, depending on a woman’s health status, health needs, and other risk factors.
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