US Preventive Services Task Force Recommendations for Adults March, 2014 Recommendation Key Insufficient evidence/No recommendation (I or C Grade) Recommended (A or B Grade) Preventive Service Screening Body Measurement Blood Pressure1 Height/Weight/BMI2 Bone Densitometry3 General Population High Risk Population ? periodicity ? periodicity No specific recommendation No specific recommendation F, >65, ? periodicity F <65 with fracture risk is equal to or greater than that of a 65-year-old white woman who has no additional risk factors. M, 65-75 who have ever smoked, one time only Insufficient evidence for intermediate and high risk Insufficient evidence M, insufficient evidence 4 Abdominal Aortic Aneurysm Coronary Heart Disease (ECG, ETT)5 Non-traditional (hs-CRP, ABI, leukocyte count, fasting blood glucose level, periodontal disease, carotid IMT, CAC on EBCT, homocysteine level, and lipoprotein(a) level. 5 Peripheral Arterial Disease (Doppler)6 Carotid Artery Stenosis (US)7 COPD (spirometry)8 Metabolic Lipid Disorders (total cholesterol and HDL)9 Diabetes Mellitus10 Thyroid Disease11 Anemia (iron deficiency)12 Chronic Kidney Disease13 Cancer Breast (mammogram, clinical breast exam, genetic testing)14 Prostate (PSA)15 Recommend Against (D Grade) F, recommend against. Recommend against Insufficient evidence M, no recommendation Recommend against Recommend against Recommend against No specific recommendation No specific recommendation No specific recommendation M, >35, F, >45, ? periodicity M, <35, F <45 Insufficient evidence Insufficient evidence Insufficient evidence Insufficient evidence M & F, >20, ? periodicity if at increased coronary heart disease risk BP > 135/80, ? periodicity. F > 24 weeks gestation No specific recommendation F, pregnant Insufficient evidence Mammogram: F, 50-75 q 2 yrs. Mammogram: F, 40-49, >75, clinical exam, MRI Genetic testing: Recommend against Recommend against Family history breast, ovarian, tubal or peritoneal cancer. Assess for risk with validated screening tool and refer for genetic counseling if positive. Recommend against Preventive Service General Population High Risk Population <50 may be reasonable for those with 1o relatives who developed cancer at a younger age or those with multiple affected 1o relatives q <3 yrs Ovarian (CA-125, ultrasound, BRCA)18 50-75 76-85 > 86 F, 21-65 q 3 yrs. 30-65 q 5 (PAP and HPV) <21, >65 if history normal screening, or post hysterectomy without high grade cervical lesion Recommend against Oral (exam)19 Thyroid (exam or ultrasound)20 Skin (exam)21 Testicular (exam, self-exam)22 Pancreatic (exam, US, serology)23 Lung (low dose CT)24 Insufficient evidence Recommend against Insufficient evidence. Recommend against Recommend against No recommendation Bladder (UA, cytology, BTA)25 Sensory Hearing Impairment (questioning)26 Visual Impairment (eye chart)27 Glaucoma (intraocular pressure)28 Infectious Diseases Tuberculosis (PPD)29 Recommend against Family history breast, ovarian, tubal or peritoneal cancer. Assess for risk with validated screening tool and refer for genetic counseling if positive. Insufficient evidence Insufficient evidence Insufficient evidence. Familial not reviewed. No specific recommentation No specific recommendation q 1 yr, 55-80 yrs if 30 pack year history and current smoker or quit <15 yrs ago No specific recommendation Insufficient evidence Insufficient evidence Insufficient evidence Insufficient evidence No specific recommendation Insufficient evidence Insufficient evidence Medically underserved, low income, foreign born (Asia, Africa, Latin America), alcoholic, IVDA, residents of institutions, close contact with TB, and HIV, diabetes, renal failure. ? periodicity F, pregnant at first prenatal visit Periodically if ongoing risk (ie. IV drug users) F, high risk sexual activity, ? periodicity M, insufficient evidence High risk sexual activity/ IV drug use. F., pregnant High risk sexual activity. F, pregnant F, high risk sexual activity, ? periodicity M, insufficient evidence F, pregnant, 12-16 weeks gestation F, pregnant, pre-term high risk insufficient evidence Colorectal (High-sensitivity FOB yearly, colonoscopy q 10 yrs, or sigmoidoscopy and high-sensitivity FOB q 3 yrs) 16 Cervical (PAP, HPV)17 Hepatitis B30 Hepatitis C31 Chlamydia32 HIV33 Syphilis34 Gonorrhea (culture, nucleic acid tests)35 Recommend against All born between 1945-1965—one time screening F, <24, sexually active or pregnant, ? periodicity, M, insufficient evidence No recommendation Recommend against Recommend against Bacteriuria36 Bacterial Vaginosis37 Recommend against F, pregnant, pre-term low risk Recommend against Preventive Service General Population High Risk Population When staff-assisted depression care supports are in place to assure accurate diagnosis, effective treatment, and follow-up Insufficient evidence Insufficient evidence F, childbearing age Insufficient evidence No specific recommendation Hormone Replacement (osteoporosis)43 Aspirin (coronary heart disease)44 (ischemic stroke)44 Aspirin (colorectal cancer)44 Tamoxifen/Raloxifen (breast cancer)45 Iron (anemia)46 Recommend against M, 45-79* W, 55-79 Recommend against for <45 Recommend against Recommend against Recommend against No specific recommendation >3% risk in 5 years B-Carotene (cancer or CHD)47 Vitamins. A, C, E, or multivit with folate (cancer or CHD)48 Vitamin D (fall prevention)49 (fracture prevention)49 50 Folic Acid Recommend against Insufficient evidence No specific recommendation F, 40-50 with uterus, 40-60 without uterus F, pregnant anemic F, pregnant non-anemic--insufficient evidence No specific recommendation No specific recommendation No specific recommendation Insufficient evidence F, capable of or planning pregnancy* >65 at increased risk of falls No specific recommendation No specific recommendation Physical Activity51 Insufficient evidence Healthy Diet52 Insufficient evidence Tobacco Use53 All tobacco users Ask, Advise, Assess, Assist, Arrange All > 18. Screen for misuse. If positive provide brief behavioral counseling interventions Obese (BMI >30)—as part of high intensity counseling Overweight (BMI >25<30)—insufficient evidence >65 at increased risk of falls—physical exercise or physical therapy Hyperlipidemia or other diet-related risk factors— as part of intensive counseling F, pregnant smokers—pregnancy-tailored counseling No specific recommendation Mental Health Depression38 Dementia39 Suicide40 Elderly and Intimate Partner Violence41 Illicit Drug Use42 No specific recommendation No specific recommendation Elderly—insufficient evidence No specific recommendation Chemoprevention Counseling Alcohol Misuse54 Skin Cancer Prevention55 Motor Vehicle Occupant Restraint56 Sexually Transmitted Infections (STIs)57 M,F > 24 or not fair complexion Insufficient evidence Insufficient evidence M, F < 24 with fair complexion No specific recommendation High risk for STIs Rationale 1 Blood Pressure. The USPSTF found good evidence that treatment of high blood pressure in adults substantially decreases the incidence of cardiovascular events. The USPSTF found good evidence that screening and treatment for high blood pressure causes few major harms. The USPSTF concluded that there is high certainty that the net benefit of screening for high blood pressure in adults is substantial. (2007) 2 Height/Weight/BMI. The USPSTF found good evidence that body mass index (BMI), calculated as weight in kilograms divided by height in meters squared, is reliable and valid for identifying adults at increased risk for mortality and morbidity due to overweight and obesity. (2003) 3 Bone Densitometry. By 2012, approximately 12 million Americans older than 50 years are expected to have osteoporosis. One half of all postmenopausal women will have an osteoporosis-related fracture during their lifetime; 25% of these women will develop a vertebral deformity, and 15% will experience a hip fracture. Osteoporotic fractures, particularly hip fractures, are associated with chronic pain and disability, loss of independence, decreased quality of life, and increased mortality. Although hip fractures are less common in men than in women, more than one third of men who experience a hip fracture die within 1 year. The USPSTF found convincing evidence that bone measurement tests predict short-term risk for osteoporotic fractures in women and men. The most commonly used tests are dual-energy x-ray absorptiometry (DXA) of the hip and lumbar spine and quantitative ultrasonography of the calcaneus. Adequate evidence indicates that clinical risk assessment instruments have only modest predictive value for low bone density or fractures. No controlled studies have evaluated the effect of screening for osteoporosis on fracture rates or fracture-related morbidity or mortality. In postmenopausal women who have no previous osteoporotic fractures, the USPSTF found convincing evidence that drug therapies reduce the risk for fractures. In women aged 65 years or older and in younger women whose fracture risk is equal to or greater than that of a 65-year-old white woman who has no additional risk factors, the USPSTF judged that the benefit of treating screening-detected osteoporosis is at least moderate. Because of the lack of relevant studies, the USPSTF found inadequate evidence that drug therapies reduce the risk for fractures in men who have no previous osteoporotic fractures. The USPSTF identified the absence of randomized trials of primary fracture prevention in men who have osteoporosis as a critical gap in the evidence. The USPSTF found no new studies that described harms of screening for osteoporosis in men or women. Screening with DXA is associated with opportunity costs (time and effort required by patients and the health care system). Harms of drug therapies for osteoporosis depend on the specific medication used. The USPSTF found adequate evidence that the harms of bisphosphonates, the most commonly prescribed therapies, are no greater than small. Convincing evidence indicates that the harms of estrogen and selective estrogen receptor modulators are small to moderate. The USPSTF concluded that for women aged 65 years or older and younger women whose fracture risk is equal to or greater than that of a 65-yearold white woman who has no additional risk factors, there is moderate certainty that the net benefit of screening for osteoporosis by using DXA is at least moderate. The USPSTF concluded that, for men, evidence of the benefits of screening for osteoporosis is lacking and the balance of benefits and harms cannot be determined. (2011) 4 Abdominal Aortic Aneurysm. The USPSTF found good evidence that screening for AAA and surgical repair of large AAAs (5.5 cm or more) in men aged 65 to 75 who have ever smoked (current and former smokers) leads to decreased AAA-specific mortality. There is good evidence that abdominal ultrasonography, performed in a setting with adequate quality assurance (i.e., in an accredited facility with credentialed technologists), is an accurate screening test for AAA. There is also good evidence of important harms of screening and early treatment, including an increased number of surgeries with associated clinicallysignificant morbidity and mortality, and short-term psychological harms. Based on the moderate magnitude of net benefit, the USPSTF concluded that the benefits of screening for AAA in men aged 65 to 75 who have ever smoked outweigh the harms. The USPSTF found good evidence that screening for AAA in men aged 65 to 75 who have never smoked leads to decreased AAA-specific mortality. There is, however, a lower prevalence of large AAAs in men who have never smoked compared with men who have ever smoked; thus, the potential benefit from screening men who have never smoked is small. There is good evidence that screening and early treatment leads to important harms, including an increased number of surgeries with associated clinically-significant morbidity and mortality, and short-term psychological harms. The USPSTF concluded that the balance between the benefits and harms of screening for AAA is too close to make a general recommendation in this population. Because of the low prevalence of large AAAs in women, the number of AAA-related deaths that can be prevented by screening this population is small. There is good evidence that screening and early treatment result in important harms, including an increased number of surgeries with associated morbidity and mortality, and psychological harms. The USPSTF concluded that the harms of screening women for AAA outweigh the benefits. (2004) 5 Coronary Heart Disease. For asymptomatic adults at low risk for CHD events, the USPSTF found adequate evidence that the incremental information offered by resting or exercise ECG (beyond that obtained with conventional CHD risk factors) is highly unlikely to result in changes in risk stratification that would prompt interventions and ultimately reduce CHD-related events. The USPSTF based this conclusion on the epidemiology of CHD, the natural history of CHD, and established treatment strategies based on risk stratification. For asymptomatic adults at intermediate or high risk for CHD events, the USPSTF found inadequate evidence to determine the extent to which the incremental information offered by resting or exercise ECG (beyond that obtained with conventional CHD risk factors) results in changes in risk stratification that would prompt interventions and ultimately reduce CHD-related events. There is adequate evidence that screening asymptomatic adults with resting or exercise ECG leads to harms that are at least small, including unnecessary invasive procedures, overtreatment, and labeling. The USPSTF concluded with moderate certainty that the potential harms of screening for CHD with exercise or resting ECG equal or exceed the potential benefits in asymptomatic adults at low risk for CHD events. The USPSTF concluded that evidence is lacking and the balance of benefits and harms of screening for CHD with exercise or resting ECG in asymptomatic adults at intermediate or high risk for CHD events cannot be determined. For asymptomatic adults at low risk for CHD events, a resting or exercise ECG is unlikely to provide additional information about CHD risk beyond that obtained with conventional CHD risk factors (that is, Framingham risk factors) and result in changes in risk stratification that would prompt interventions and ultimately reduce CHD-related events. False-positive results may cause harms in low-risk asymptomatic adults. (2012) There is insufficient evidence to determine the percentage of persons with an intermediate CHD risk who would be reclassified by screening with nontraditional risk factors other than hs-CRP and ABI. About 11% of men with an intermediate CHD risk would be reclassified into the high-risk category by hs-CRP screening, and about 12% of men would be reclassified into the low-risk category. National estimates of the number of women who would be reclassified by hsCRP screening are not reliable because of small study samples. The available meta-analysis of individual data on ABI does not yield a clear picture on the proportion of intermediate-risk men who would be reclassified but does suggest that approximately 10% of women would be reclassified from intermediate to high risk for CHD. The evidence is insufficient to determine the magnitude of any reduction in CHD events and CHD-related deaths obtained by using nontraditional risk factors in CHD screening. This constitutes a critical gap in the evidence for benefit from screening. Little evidence is available to determine the harms of using nontraditional risk factors in CHD screening. Harms include lifelong use of medications without proof of benefit but with expense and potential side effects. Statins are the class of medication most commonly used; these medications have been demonstrated to be safe but are associated with the rare but serious side effect of rhabdomyolysis.1 Psychological and other harms may result from being put into a higher risk category for CHD events. The USPSTF concluded that the evidence is insufficient to determine the balance between benefits and harms of using nontraditional risk factors in screening for CHD risk. Although using hs-CRP and ABI to screen men and women with intermediate Framingham CHD risk would reclassify some into the low-risk group and others into the high-risk group, the evidence is insufficient to determine the ultimate effect on the occurrence of CHD events and CHD-related deaths. (2009) 6 Peripheral Arterial Disease. The USPSTF found no evidence that screening for and treatment of PAD in asymptomatic patients leads to clinically important benefits. It also reviewed the potential benefits of adding the ABI to the Framingham Risk Score (FRS) and found evidence that this results in some patient risk reclassification; however, how often the reclassification is appropriate or whether it results in improved clinical outcomes is not known. Determining the overall benefit of ABI testing requires not only evidence on appropriate risk reclassification but also evidence that this reclassification leads to treatments shown to improve clinical outcomes. One randomized trial found that aspirin did not reduce CVD events in patients with a low ABI (2). No studies assessed the effect of lipid-lowering therapy or other cardiovascular risk reduction interventions in patients with asymptomatic PAD and no known diagnosis of CVD or diabetes. The USPSTF found inadequate evidence that early treatment of screen-detected PAD leads to improvement in clinical outcomes. The USPSTF found no studies addressing the magnitude of harms of screening for PAD with the ABI; however, the direct harms to the patient of screening itself, beyond the time needed for the test, are probably minimal. Other harms resulting from testing may include false-positive results, exposure to gadolinium or contrast dye if magnetic resonance angiography (MRA) or computed tomography angiography (CTA) is used to confirm diagnosis, anxiety, labeling, and opportunity costs. The USPSTF found inadequate evidence on the harms of early treatment of screen-detected PAD. One study showed that low-dose aspirin treatment in asymptomatic patients with a low ABI may increase bleeding. Additional harms associated with treatment include use of unnecessary medications (or higher doses) and their resulting adverse effects and discontinuation of medications known to be effective in patients with established coronary artery disease (CAD) if the patient is reclassified to a lower risk category on the basis of a normal ABI. The USPSTF concludes that the evidence on screening for PAD with the ABI in asymptomatic adults with no known diagnosis of CVD or diabetes is insufficient and that the balance of benefits and harms therefore cannot be determined. (2013) 7 Carotid Artery Stenosis. Good evidence indicates that in selected, high-risk trial participants with asymptomatic severe CAS, carotid endarterectomy by selected surgeons reduces the 5-year absolute incidence of all strokes or perioperative death by approximately 5%. These benefits would be less among asymptomatic people in the general population. For the general primary care population, the benefits are judged to be no greater than small. Good evidence indicates that both the testing strategy and the treatment with carotid endarterectomy can cause harms. A testing strategy that includes angiography will itself cause some strokes. A testing strategy that does not include angiography will cause some strokes by leading to carotid endarterectomy in people who do not have severe CAS. In excellent centers, carotid endarterectomy is associated with a 30-day stroke or mortality rate of about 3%; some areas have higher rates. These harms are judged to be no less than small. The USPSTF concluded that for individuals with asymptomatic CAS there is moderate certainty that the benefits of screening do not outweigh the harms. (2007) 8 COPD. Good evidence suggests that pharmacologic therapy prevents exacerbations (worsening of symptoms, requiring medical care) but does not affect hospitalizations or all-cause mortality among symptomatic individuals who have been smokers in the past ("ever smokers"), who are 40 years of age or older, and who have severe or very severe COPD (FEV1 <50% of predicted). Fair evidence shows that both pharmacologic therapy and pulmonary rehabilitation improve respiratory-related health status measures, but the relationship of these measures to clinically meaningful functional outcomes is not well established. Fair evidence also shows that supplemental oxygen reduces mortality in individuals with resting hypoxia. Whether individuals who do not recognize or report symptoms but meet spirometric criteria for a diagnosis of severe to very severe COPD would benefit from pharmacologic treatment to the same degree as symptomatic individuals, or at all, is not known. Benefits experienced by individuals who do not recognize or report symptoms are unlikely to be greater than those in symptomatic individuals. The evidence suggests that the potential benefit of spirometry-based screening for COPD is the prevention of 1 exacerbation or more by treating patients with previously undetected airflow obstruction. By definition, an exacerbation requires medical care. Although an unknown proportion of patients who present with clinical symptoms of an exacerbation does not receive a COPD diagnosis, the incremental benefit of early detection over clinical diagnosis for the remainder of patients would, at most, be a deferral of the first exacerbation. These incremental benefits are judged to be no greater than small. The opportunity costs (time and effort required by both patients and the health care system) associated with screening for COPD using spirometry are large even in populations at higher risk. The physical performance of spirometry has not been associated with adverse effects. Fair evidence indicates that spirometry can lead to substantial overdiagnosis of COPD in "never smokers" older than age 70 years, and that it produces fewer false-positive results in other healthy adults. Good evidence suggests that pharmacologic therapies are associated with adverse effects, including oropharyngeal candidiasis, easy bruising, dry mouth, urinary retention, and sinus tachycardia. These harms are judged to be no less than small. The USPSTF concluded that there is at least moderate certainty that screening for COPD using spirometry has no net benefit. (2008) 9 Lipid Disorders. There is good evidence that high levels of total cholesterol and low density lipoprotein-cholesterol (LDL-C) and low levels of high density lipoprotein-cholesterol (HDL-C) are important risk factors for coronary heart disease. The risk for coronary heart disease is highest in those with a combination of risk factors. The 10-year risk for coronary heart disease is lowest in young men and in women who do not have other risk factors, even in the presence of abnormal lipids. The USPSTF found good evidence that lipid measurement can identify asymptomatic men and women who are eligible for preventive therapy. There is good evidence that lipid-lowering drug therapy substantially decreases the incidence of coronary heart disease in persons with abnormal lipids. The absolute benefits of lipid-lowering treatment depend on a person's underlying risk for coronary heart disease. Men over the age of 35 and women over the age of 45 who are at increased risk will realize a substantial benefit from treatment; younger adults with multiple risk factors for coronary disease, including dyslipidemia, will realize a moderate benefit from treatment; and younger men and women without risk factors for coronary heart disease will realize a small benefit from treatment, as seen in the risk reduction in 10-year CHD event rate. There is good evidence that the harms from screening and treatment are small and include possible labeling and the adverse effects associated with lipid-lowering therapy (e.g., rhabdomyolysis). The USPSTF concludes that the benefits of screening for and treating lipid disorders in all men aged 35 and older and women aged 45 and older at increased risk for coronary heart disease substantially outweigh the potential harms. The USPSTF concludes that the benefits of screening for and treating lipid disorders in young adults at increased risk for coronary heart disease moderately outweigh the potential harms. The USPSTF concludes that the net benefits of screening for lipid disorders in young adults not at increased risk for coronary heart disease are not sufficient to make a general recommendation. (2008) 10 Diabetes Mellitus. The USPSTF found convincing evidence that available screening tests accurately detect type 2 diabetes during an early, asymptomatic phase. The USPSTF found adequate evidence that, in adults who have hypertension and diabetes, lowering blood pressure below conventional target values reduces the incidence of cardiovascular events and cardiovascular mortality. The USPSTF found convincing evidence that intensive glycemic control in persons with clinically detected (as opposed to screening-detected) diabetes can reduce progression of microvascular disease. However, the benefits of tight glycemic control on microvascular clinical outcomes, such as severe visual impairment or end-stage renal disease, take years to become apparent. There is inadequate evidence that early diabetes control as a result of screening provides an incremental benefit for microvascular clinical outcomes compared with initiating treatment after clinical diagnosis. There is inadequate evidence that tight glycemic control significantly reduces macrovascular complications, such as myocardial infarction and stroke. The USPSTF found adequate evidence that the short-term harms of screening for diabetes, such as anxiety, are small. However, the longer-term effects of labeling a large proportion of the adult U.S. population as abnormal are unknown. The USPSTF concluded that for adults with sustained blood pressure greater than 135/80 mm Hg, there is moderate certainty that the net benefit of screening for diabetes is substantial. The USPSTF concluded that for adults with blood pressure of 135/80 mm Hg or less, evidence of the value of screening for diabetes is lacking, and the balance of benefits and harms cannot be determined. (2008) The USPSTF found adequate evidence that treatment of screen-detected GDM with dietary modifications, glucose monitoring, and insulin (if needed) can significantly reduce the risk of preeclampsia, fetal macrosomia, and shoulder dystocia. When these outcomes are considered collectively, there is a moderate net benefit for both mother and infant. The benefit of treatment on long-term metabolic outcomes in women who are treated for GDM compared with those who are not treated is uncertain. The USPSTF found inadequate evidence to determine whether there are benefits to screening for GDM in women before 24 weeks of gestation. Overall, the USPSTF found adequate evidence that the magnitude of the harms of screening and treatment is small to none. Randomized, controlled trials (RCTs) demonstrated an increase in the number of prenatal visits in screen-detected women who were treated for GDM compared with screen-detected women who were not treated. There was conflicting evidence on the risk for an increase in the induction of labor associated with treatment. No significant differences were reported for cesarean delivery or neonatal intensive care unit admissions between women who were treated and women who were not treated for GDM in the overall pooled meta-analysis. Trials also demonstrated no significant differences in the incidence of small-for-gestational-age infants or episodes of neonatal hypoglycemia, but the trials were not adequately powered to detect meaningful differences in these outcomes. The USPSTF concluded with moderate certainty that there is a moderate net benefit to screening for gestational diabetes after 24 weeks of gestation to reduce maternal and fetal complications (the collective outcomes of preeclampsia, macrosomia, and shoulder dystocia). The USPSTF concluded that the evidence on screening for gestational diabetes before 24 weeks of gestation is insufficient, and the balance of benefits and harms of screening cannot be determined. (2014) 11 Thyroid Disease. The USPSTF found fair evidence that the thyroid stimulating hormone (TSH) test can detect subclinical thyroid disease in people without symptoms of thyroid dysfunction, but poor evidence that treatment improves clinically important outcomes in adults with screen-detected thyroid disease. Although the yield of screening is greater in certain high-risk groups (e.g., postpartum women, people with Down syndrome, and the elderly), the USPSTF found poor evidence that screening these groups leads to clinically important benefits. There is the potential for harm caused by false positive screening tests; however, the magnitude of harm is not known. There is good evidence that over-treatment with levothyroxine occurs in a substantial proportion of patients, but the longterm harmful effects of over-treatment are not known. As a result, the USPSTF could not determine the balance of benefits and harms of screening asymptomatic adults for thyroid disease. (2004) 12 Anemia. Iron deficiency anemia during pregnancy has been associated with increased risk for low birth weight, preterm delivery, and perinatal mortality. Recent studies suggest that maternal iron deficiency anemia may be associated with postpartum depression and poor performance on mental and psychomotor tests in offspring. The USPSTF found insufficient evidence (no studies) that specifically addressed the accuracy of screening tests in asymptomatic pregnant women. The USPSTF found fair evidence that treating asymptomatic pregnant women who have iron deficiency anemia results in moderate benefits in health outcomes. The USPSTF found no evidence addressing the harms of screening pregnant women for iron deficiency anemia. Potential harms include false-positive results, anxiety, and cost; the small potential harms of treatment with oral iron include gastrointestinal symptoms and unintentional overdose. The USPSTF concludes that the benefits of routine screening for iron deficiency anemia in asymptomatic pregnant women outweigh the potential harms. (2006) There is also insufficient evidence to recommend for or against routine testing for anemia in other asymptomatic persons, but recommendations against such screening may be made on the grounds of low prevalence, cost, and potential adverse effects of iron therapy. (1996) 13 Chronic Kidney Disease. Approximately 11% of U.S. adults have CKD, many of whom are elderly. The condition is usually asymptomatic until its advanced stages. Most cases of CKD are associated with diabetes or hypertension. Chronic kidney disease is defined as decreased kidney function or kidney damage that persists for at least 3 months. No studies assess the sensitivity and specificity of screening for CKD with tests for estimated GFR, microalbuminuria, or macroalbuminuria. Evidence that routine screening for CKD improves clinical outcomes for asymptomatic adults is inadequate. Evidence on the harms of screening for CKD is inadequate. However, convincing evidence shows that medications used to treat early CKD may have adverse effects.The USPSTF concludes that the evidence on routine screening for CKD in asymptomatic adults is lacking, and that the balance of benefits and harms cannot be determined. (2012) 14 Breast Cancer. Mammography--Breast cancer is the second-leading cause of cancer death among women in the United States. Widespread use of screening, along with treatment advances in recent years, have been credited with significant reductions in breast cancer mortality. Mammography, as well as physical examination of the breasts (CBE and BSE), can detect presymptomatic breast cancer. Because of its demonstrated effectiveness in randomized, controlled trials of screening, film mammography is the standard for detecting breast cancer; in 2002, the USPSTF found convincing evidence of its adequate sensitivity and specificity. There is convincing evidence that screening with film mammography reduces breast cancer mortality, with a greater absolute reduction for women aged 50 to 74 years than for women aged 40 to 49 years. The strongest evidence for the greatest benefit is among women aged 60 to 69 years. Among women 75 years or older, evidence of benefits of mammography is lacking. Adequate evidence suggests that teaching BSE does not reduce breast cancer mortality. The evidence for additional effects of CBE beyond mammography on breast cancer mortality is inadequate. The evidence for benefits of digital mammography and MRI of the breast, as a substitute for film mammography, is also lacking. In trials that demonstrated the effectiveness of mammography in decreasing breast cancer mortality, screening was performed every 12 to 33 months. The evidence reviewed by the USPSTF indicates that a large proportion of the benefit of screening mammography is maintained by biennial screening, and changing from annual to biennial screening is likely to reduce the harms of mammography screening by nearly half. At the same time, benefit may be reduced when extending the interval beyond 24 months; therefore the USPSTF recommends biennial screening. (2009) Genetic Testing--The cancer types related to potentially harmful mutations of the BRCA genes are predominantly breast, ovarian, and fallopian tube cancer, although other types are also associated (1). In the general population, 12.3% of women will develop breast cancer during their lifetime and 2.74% will die of the disease, whereas 1.4% of women will develop ovarian cancer and 1.0% will die of the disease. A woman's risk for breast cancer increases to 45% to 65% by age 70 years if there are clinically significant mutations in either BRCA gene. Mutations in the BRCA1 gene increase ovarian cancer risk to 39% by age 70 years, and BRCA2 mutations increase ovarian cancer risk to 10% to 17% by age 70 years. In the general population, these mutations occur in an estimated 1 in 300 to 500 women (0.2% to 0.3%). In a meta-analysis conducted for the USPSTF, the combined prevalence of BRCA1 and BRCA2 mutations was 2.1% in a general population of Ashkenazi Jewish women. Genetic risk assessment and BRCA mutation testing is generally a multistep process involving identification of individuals who may be at increased risk for potentially harmful mutations, followed by genetic counseling from suitably trained health care providers and genetic testing of selected high-risk individuals when indicated. Several familial risk stratification tools are clinically useful for selecting patients who should be offered genetic counseling to further determine their candidacy for possible BRCA mutation testing. For women whose family history is associated with an increased risk for potentially harmful mutations in the BRCA1 or BRCA2 genes, adequate evidence suggests that the benefits of testing for potentially harmful BRCA mutations are moderate. For women whose family history is not associated with an increased risk for potentially harmful mutations in the BRCA1 or BRCA2 genes, there is adequate evidence that the benefits of testing for potentially harmful BRCA mutations are few to none. Adequate evidence suggests that the overall harms of detection of and early intervention for potentially harmful BRCA mutations are small to moderate. For women whose family history is associated with an increased risk for potentially harmful mutations in the BRCA1 or BRCA2 genes, there is moderate certainty that the net benefit of testing for potentially harmful BRCA mutations and early intervention is moderate. For women whose family history is not associated with an increased risk for potentially harmful mutations in the BRCA1 or BRCA2 genes, there is moderate certainty that the net benefit of testing for potentially harmful BRCA mutations and early intervention ranges from minimal to potentially harmful. This recommendation applies to asymptomatic women who have not been diagnosed with BRCArelated cancer. Women who have 1 or more family members with a known potentially harmful mutation in the BRCA1 or BRCA2 genes should be offered genetic counseling and testing. The USPSTF recognizes the potential importance of further evaluating women who have a diagnosis of breast or ovarian cancer. Some women receive genetic testing as part of a cancer evaluation at the time of diagnosis of breast cancer. The USPSTF did not review the appropriate use of BRCA testing in the evaluation of women who are newly diagnosed with breast cancer. That assessment is part of disease management and is beyond the scope of this recommendation. Women who have been diagnosed with breast cancer in the past and who did not receive BRCA testing as part of their cancer care but have a family history of breast or ovarian cancer should be encouraged to discuss further evaluation with their clinician. These recommendations do not apply to men, although male family members may be identified for testing during evaluation. (2013) 15 Prostate Cancer. Although the precise, long-term effect of PSA screening on prostate cancer–specific mortality remains uncertain, existing studies adequately demonstrate that the reduction in prostate cancer mortality after 10 to 14 years is, at most, very small, even for men in what seems to be the optimal age range of 55 to 69 years. There is no apparent reduction in all-cause mortality. In contrast, the harms associated with the diagnosis and treatment of screendetected cancer are common, occur early, often persist, and include a small but real risk for premature death. Many more men in a screened population will experience the harms of screening and treatment of screen-detected disease than will experience the benefit. The inevitability of overdiagnosis and overtreatment of prostate cancer as a result of screening means that many men will experience the adverse effects of diagnosis and treatment of a disease that would have remained asymptomatic throughout their lives. Assessing the balance of benefits and harms requires weighing a moderate to high probability of early and persistent harm from treatment against the very low probability of preventing a death from prostate cancer in the long term. The USPSTF concluded that there is moderate certainty that the benefits of PSA-based screening for prostate cancer do not outweigh the harms. Although the USPSTF discourages the use of screening tests for which the benefits do not outweigh the harms in the target population, it recognizes the common use of PSA screening in practice today and understands that some men will continue to request screening and some physicians will continue to offer it. The decision to initiate or continue PSA screening should reflect an explicit understanding of the possible benefits and harms and respect patients' preferences. Physicians should not offer or order PSA screening unless they are prepared to engage in shared decision making that enables an informed choice by patients. Similarly, patients requesting PSA screening should be provided with the opportunity to make informed choices to be screened that reflect their values about specific benefits and harms. Community- and employerbased screening should be discontinued. (2012) 16 Colorectal Cancer. Colorectal cancer is the third most common type of cancer and the second leading cause of cancer death in the United States. Current levels of screening in this country lag behind those of other effective cancer screening tests; it has been estimated that attainment of goals for population colorectal cancer screening could save 18,800 lives per year. Colorectal cancer incidence and mortality show health disparities, with a disproportionate burden occurring in certain minority populations, including African Americans and Alaska Natives. The evidence is convincing that screening for colorectal cancer with fecal occult blood testing, sigmoidoscopy, or colonoscopy detects early-stage cancer and adenomatous polyps. Although colonoscopy is considered to be the reference standard against which the sensitivity of other colorectal cancer screening tests are compared, it is not perfect. Two types of studies to assess the sensitivity of colonoscopy—tandem colonoscopy studies, in which the same patient is studied twice, and studies comparing colonoscopy and CT colonography— show that colonoscopy may miss even polyps larger than 10 mm and colorectal cancer. In addition, most of the evidence about the sensitivity of colonoscopy comes from experienced examiners in research settings. The evidence is inadequate to estimate the sensitivity in community practice; however, it is likely to be lower than in research settings. Although single test performance is an important issue in the detection of colorectal neoplasia, the sensitivity of the test over time is more important in an ongoing screening program. Unfortunately, data that permit assessment and comparison of screening methods to detect colorectal neoplasia in a testing program over time from a population perspective are limited to data from analytic modeling. There is convincing evidence that screening with any of the 3 recommended tests reduces colorectal cancer mortality in adults age 50 to 75 years. Follow-up of positive screening test results requires colonoscopy regardless of the screening test used. Because of the harms of colonoscopy described below, the chief benefit of less invasive screening tests is that they may reduce the number of colonoscopies required and their attendant risks. There is adequate evidence that the benefits of detection and early intervention decline after age 75 years. The lead time between the detection and treatment of colorectal neoplasia and a mortality benefit is substantial, and competing causes of mortality make it progressively less likely that this benefit will be realized with advancing age. The primary established harms of colorectal cancer screening are due to the use of invasive procedures initially or in the evaluation sequence. Harms may arise from the preparation the patient undergoes to have the procedure, the sedation used during the procedure, and the procedure itself. Evidence is adequate to estimate the harms of colonoscopy. In the United States, perforation of the colon occurs in an estimated 3.8 per 10,000 procedures. Serious complications—defined as deaths attributable to colonoscopy or adverse events requiring hospital admission, including perforation, major bleeding, diverticulitis, severe abdominal pain, and cardiovascular events—are significantly more common, occurring in an estimated 25 per 10,000 procedures. The USPSTF concludes that, for fecal occult blood testing, flexible sigmoidoscopy, and colonoscopy to screen for colorectal cancer, there is high certainty that the net benefit is substantial for adults age 50 to 75 years. The USPSTF concludes that, for adults age 76 to 85 years, there is moderate certainty that the net benefits of screening are small. The USPSTF concludes that, for adults older than age 85 years, there is moderate certainty that the benefits of screening do not outweigh the harms. The USPSTF concludes that there is insufficient evidence to assess the sensitivity and specificity of fecal DNA testing for colorectal neoplasia, and that therefore the balance of benefits and harms cannot be determined for this test. The USPSTF concludes that, for CT colonography, evidence to assess the harms related to extracolonic findings is insufficient, and the balance of benefits and harms cannot be determined. (2008) 17 Cervical Cancer. There is convincing evidence that screening women age 21 to 65 years with cytology every 3 years substantially reduces cervical cancer incidence and mortality. Among women age 30 to 65 years, there is adequate evidence that screening with a combination of cytology and HPV testing (cotesting) every 5 years provides benefits similar to those seen with cytology screening alone every 3 years. Among women younger than age 30 years, there is adequate evidence that screening with HPV testing (alone or in combination with cytology) confers little to no benefit. There is adequate evidence that screening women younger than age 21 years (regardless of sexual history) does not reduce cervical cancer incidence and mortality compared with beginning screening at age 21 years. There is adequate evidence that screening women older than age 65 years who have had adequate prior screening and are not otherwise at high risk provides little to no benefits. There is convincing evidence that continued screening after hysterectomy with removal of the cervix for indications other than a high-grade precancerous lesion or cervical cancer provides no benefits. Screening with cervical cytology or HPV testing can lead to harms, and the harms of screening can take many forms. Abnormal test results can lead to more frequent testing and invasive diagnostic procedures, such as colposcopy and cervical biopsy. Evidence from randomized, controlled trials and observational studies indicates that harms from these diagnostic procedures include vaginal bleeding, pain, infection, and failure to diagnose (due to inadequate sampling). Abnormal screening test results are also associated with mild psychological harms; shortterm increases in anxiety, distress, and concern about health have been reported with cytology and HPV testing. The harms of treatment include risks from the treatment procedure itself and the potential downstream consequences of treatment. Summary evidence from observational studies indicates that some treatments for precancerous lesions (such as cold-knife conization and loop excision) are associated with adverse pregnancy outcomes, such as preterm delivery, that can lead to low birthweight in infants and perinatal death (2). Evidence is convincing that many precancerous cervical lesions will regress and that other lesions are so indolent and slow-growing that they will not become clinically important over a woman's lifetime; identification and treatment of these lesions constitute overdiagnosis. It is difficult to estimate the precise magnitude of overdiagnosis associated with any screening or treatment strategy, but it is of concern because it confers no benefit and leads to unnecessary surveillance, diagnostic tests, and treatments with the associated harms. There is adequate evidence that the harms of screening for cervical cancer with cytology alone or in combination with HPV testing in women age 30 to 65 years are moderate. Positive screening results are more common with strategies that include HPV testing than with strategies that use cytology alone. Therefore, the likelihood of prolonged surveillance and overtreatment may increase with strategies that incorporate HPV testing. Cervical treatments may increase the risk for adverse pregnancy outcomes (for example, cervical insufficiency and preterm delivery) in women who have not yet completed childbearing. There is adequate evidence that the harms of HPV testing (alone or in combination with cytology) in women younger than age 30 years are moderate. There is adequate evidence that the harms of screening in women younger than age 21 years are moderate. There is adequate evidence that the harms of screening in women older than age 65 years who have had adequate prior screening and are not otherwise at high risk are at least small. There is adequate evidence that screening after hysterectomy among women who do not have a history of a high-grade precancerous lesion or cervical cancer is associated with harms. The USPSTF concluded that for women age 21 to 65 years, there is high certainty that the benefits of screening with cytology every 3 years substantially outweigh the harms. For women age 30 to 65 years, there is high certainty that the benefits of screening with a combination of cytology and HPV testing (co-testing) every 5 years outweigh the harms. For women younger than age 21 years, regardless of sexual history, there is moderate certainty that the harms of screening outweigh the benefits. For women older than age 65 years who have had adequate prior screening and are not otherwise at high risk for cervical cancer, there is moderate certainty that the benefits of screening do not outweigh the potential harms. For women who have had a hysterectomy with removal of the cervix for indications other than a high-grade precancerous lesion or cancer, there is high certainty that the harms of screening outweigh the benefits. For women younger than age 30 years, there is moderate certainty that the potential harms of screening with HPV testing (alone or in combination with cytology) outweigh the potential benefits (2012). 18 Ovarian Cancer. Although the mortality rate associated with ovarian cancer is high, the disease occurs infrequently in the general U.S. population, with an age-adjusted incidence of 13 cases per 100,000 women. As a result, the positive predictive value of screening for ovarian cancer—which directly depends on the prevalence of the disease—is low, and most women with a positive screening test result will have a false-positive result. The USPSTF found adequate evidence that annual screening with transvaginal ultrasonography and testing for a serum tumor marker, cancer antigen (CA)–125, in women does not reduce the number of ovarian cancer deaths. Adequate evidence shows that screening for ovarian cancer can lead to important harms, including major surgical interventions in women who do not have cancer. The USPSTF concluded that there is at least moderate certainty that the harms of screening for ovarian cancer outweigh the benefits. (2012) Genetic Testing--The cancer types related to potentially harmful mutations of the BRCA genes are predominantly breast, ovarian, and fallopian tube cancer, although other types are also associated (1). In the general population, 12.3% of women will develop breast cancer during their lifetime and 2.74% will die of the disease, whereas 1.4% of women will develop ovarian cancer and 1.0% will die of the disease. A woman's risk for breast cancer increases to 45% to 65% by age 70 years if there are clinically significant mutations in either BRCA gene. Mutations in the BRCA1 gene increase ovarian cancer risk to 39% by age 70 years, and BRCA2 mutations increase ovarian cancer risk to 10% to 17% by age 70 years. In the general population, these mutations occur in an estimated 1 in 300 to 500 women (0.2% to 0.3%). In a meta-analysis conducted for the USPSTF, the combined prevalence of BRCA1 and BRCA2 mutations was 2.1% in a general population of Ashkenazi Jewish women. Genetic risk assessment and BRCA mutation testing is generally a multistep process involving identification of individuals who may be at increased risk for potentially harmful mutations, followed by genetic counseling from suitably trained health care providers and genetic testing of selected high-risk individuals when indicated. Several familial risk stratification tools are clinically useful for selecting patients who should be offered genetic counseling to further determine their candidacy for possible BRCA mutation testing. For women whose family history is associated with an increased risk for potentially harmful mutations in the BRCA1 or BRCA2 genes, adequate evidence suggests that the benefits of testing for potentially harmful BRCA mutations are moderate. For women whose family history is not associated with an increased risk for potentially harmful mutations in the BRCA1 or BRCA2 genes, there is adequate evidence that the benefits of testing for potentially harmful BRCA mutations are few to none. Adequate evidence suggests that the overall harms of detection of and early intervention for potentially harmful BRCA mutations are small to moderate. For women whose family history is associated with an increased risk for potentially harmful mutations in the BRCA1 or BRCA2 genes, there is moderate certainty that the net benefit of testing for potentially harmful BRCA mutations and early intervention is moderate. For women whose family history is not associated with an increased risk for potentially harmful mutations in the BRCA1 or BRCA2 genes, there is moderate certainty that the net benefit of testing for potentially harmful BRCA mutations and early intervention ranges from minimal to potentially harmful. This recommendation applies to asymptomatic women who have not been diagnosed with BRCArelated cancer. Women who have 1 or more family members with a known potentially harmful mutation in the BRCA1 or BRCA2 genes should be offered genetic counseling and testing. The USPSTF recognizes the potential importance of further evaluating women who have a diagnosis of breast or ovarian cancer. Some women receive genetic testing as part of a cancer evaluation at the time of diagnosis of breast cancer. The USPSTF did not review the appropriate use of BRCA testing in the evaluation of women who are newly diagnosed with breast cancer. That assessment is part of disease management and is beyond the scope of this recommendation. Women who have been diagnosed with breast cancer in the past and who did not receive BRCA testing as part of their cancer care but have a family history of breast or ovarian cancer should be encouraged to discuss further evaluation with their clinician. These recommendations do not apply to men, although male family members may be identified for testing during evaluation. (2013) 19 Oral Cancer. The USPSTF found inadequate evidence that the oral screening examination accurately detects oral cancer. The USPSTF found inadequate evidence that screening for oral cancer and treatment of screen-detected oral cancer improves morbidity or mortality. The USPSTF found inadequate evidence on the harms of screening. No study reported on harms from the screening test or from false-positive or false-negative results. Potential diagnostic harms are primarily related to the harms of biopsy for suspected oral cancer or its potential precursors. Harms of treatment for screen-detected oral cancer and its potentially malignant precursors (leukoplakia and erythroplakia) may result from complications of surgery (first-line treatment), radiation, and chemotherapy. The natural history of screen-detected oral cancer or potentially malignant disorders is unclear; thus, the magnitude of overdiagnosis due to screening is unknown. The USPSTF concludes that the evidence is insufficient to determine the balance of benefits and harms of screening for oral cancer in asymptomatic adults by primary care providers. (2013) 20 Thyroid Cancer. Screening asymptomatic adults or children for thyroid cancer using either neck palpation or ultrasonography is not recommended. Although there is insufficient evidence to recommend for or against such screening in asymptomatic persons with a history of external upper body (primarily head and neck) irradiation in infancy or childhood, recommendations for periodic palpation of the thyroid gland in such persons may be made on other grounds, including patient preference or anxiety regarding their increased risk of cancer. (1996) 21 Skin Cancer. Skin cancer—basal cell carcinoma, squamous cell carcinoma, and melanoma—is the most commonly diagnosed cancer. Although melanoma accounts for about 5% to 6% of skin cancer diagnoses, it accounts for approximately 75% of the mortality from skin cancer.There is fair evidence that screening by clinicians is moderately accurate in detecting melanoma. The evidence is insufficient to determine the extent to which screening by patient self-examination accurately detects skin cancer. The evidence is insufficient (lack of studies) to determine whether early detection of skin cancer reduces mortality or morbidity from skin cancer. This is a critical gap in the evidence. The evidence is insufficient (lack of studies) to determine the magnitude of harms from screening for skin cancer. Potential harms of screening for skin cancer include misdiagnosis, overdiagnosis, and the resultant harms from biopsies and overtreatment. This is a critical gap in the evidence. The USPSTF concluded that the current evidence is insufficient to assess the balance of benefits and harms of screening for skin cancer by primary care clinicians or by patient skin self-examination. If this service is used, patients should be made aware of the uncertainty about the balance of benefits and harms (2009). 22 Testicular Cancer. Testicular cancer (a primary germ-cell tumor of the testis) is the most common cancer among males aged 15 to 34 years. However, with an annual incidence rate of 5.4 cases per 100,000 males, testicular cancer is relatively rare compared with other types of cancer. Most cases of testicular cancer are discovered accidentally by patients or their partners. There is inadequate evidence that screening by clinician examination or patient self-examination has a higher yield or greater accuracy for detecting testicular cancer at earlier (and more curable) stages. Based on the low incidence of this condition and favorable outcomes of treatment, even in cases of advanced disease, there is adequate evidence that the benefits of screening for testicular cancer are small to none. Potential harms associated with screening for testicular cancer include false-positive results, anxiety, and harms from diagnostic tests or procedures. The USPSTF found no new evidence on potential harms of screening and concluded that these harms are no greater than small. The USPSTF concluded that there is moderate certainty that screening for testicular cancer has no net benefit. (2011) 23 Pancreatic Cancer. The USPSTF found no evidence that screening for pancreatic cancer is effective in reducing mortality. There is a potential for significant harm due to the very low prevalence of pancreatic cancer, limited accuracy of available screening tests, the invasive nature of diagnostic tests, and the poor outcomes of treatment. As a result, the USPSTF concluded that the harms of screening for pancreatic cancer exceed any potential benefits. (2004) 24 Lung Cancer. Although lung cancer screening is not an alternative to smoking cessation, the USPSTF found adequate evidence that annual screening for lung cancer with LDCT in a defined population of high-risk persons can prevent a substantial number of lung cancer–related deaths. Direct evidence from a large, well-conducted, randomized, controlled trial (RCT) provides moderate certainty of the benefit of lung cancer screening with LDCT in this population (4). The magnitude of benefit to the person depends on that person's risk for lung cancer because those who are at highest risk are most likely to benefit. Screening cannot prevent most lung cancer–related deaths, and smoking cessation remains essential. The harms associated with LDCT screening include false-negative and falsepositive results, incidental findings, overdiagnosis, and radiation exposure. False-positive LDCT results occur in a substantial proportion of screened persons; 95% of all positive results do not lead to a diagnosis of cancer. In a high-quality screening program, further imaging can resolve most false-positive results; however, some patients may require invasive procedures. The USPSTF found insufficient evidence on the harms associated with incidental findings. Overdiagnosis of lung cancer occurs, but its precise magnitude is uncertain. A modeling study performed for the USPSTF estimated that 10% to 12% of screendetected cancer cases are overdiagnosed—that is, they would not have been detected in the patient's lifetime without screening. Radiation harms, including cancer resulting from cumulative exposure to radiation, vary depending on the age at the start of screening; the number of scans received; and the person's exposure to other sources of radiation, particularly other medical imaging. The USPSTF concluded with moderate certainty that annual screening for lung cancer with LDCT is of moderate net benefit in asymptomatic persons who are at high risk for lung cancer based on age, total cumulative exposure to tobacco smoke, and years since quitting smoking. The moderate net benefit of screening depends on limiting screening to persons who are at high risk, the accuracy of image interpretation being similar to that found in the NLST (National Lung Screening Trial), and the resolution of most false-positive results without invasive procedures. (2013) 25 Bladder Cancer. The USPSTF found fair evidence that screening with available tests can detect bladder cancer in asymptomatic individuals. The potential benefit of screening would be small, at best, for the following reasons: there is fair evidence that many of the cancers detected by screening have a low tendency to progress to invasive disease; there is a relatively low overall prevalence of asymptomatic bladder cancer that would eventually lead to important clinical consequences; and there is limited evidence that early treatment of bladder cancer detected through screening improves long-term health outcomes. The potential harms of screening are at least small: screening tests have a low positive predictive value and yield many false positive results, leading to unnecessary invasive procedures. As a result, the USPSTF concluded that the potential harms of screening for bladder cancer outweigh any potential benefits. (2004) 26 Hearing Impairment. Age-related sensorineural hearing loss is a common health problem among adults aged 50 years or older. Hearing loss can affect social functioning and quality of life. Convincing evidence shows that screening tools can reliably and accurately identify adults with objective hearing loss. Clinical tests used to screen for hearing impairment include testing whether a person can hear a whispered voice, a finger rub, or a watch tick at a specific distance. Perceived hearing loss can be assessed by asking a single question (for example, “Do you have difficulty with your hearing?”) or with a more detailed questionnaire, such as the Hearing Handicap Inventory for the Elderly–Screening Version (HHIE-S). A handheld screening instrument consisting of an otoscope with a built-in audiometer can also be used. Because of a paucity of directly applicable trials, evidence is inadequate to determine whether screening for hearing loss improves health outcomes in persons who are unaware of hearing loss or have perceived hearing loss but have not sought care. One good-quality study showed that hearing aids can improve self-reported hearing, communication, and social functioning for some adults with age-related hearing loss. This study nearly exclusively evaluated white male veterans with moderate hearing loss and moderate to severe perceived hearing impairment, more than one third of whom had been referred for evaluation of hearing problems; as such, these findings were of limited applicability to a hypothetical asymptomatic, screened population. The only randomized trial that directly evaluated the effect of screening for hearing impairment—rather than the effect of treatment alone—was not primarily designed nor had sufficient statistical power to detect differences in hearing-related function. The USPSTF concludes that the evidence is inadequate to assess the benefit of screening and early treatment in an unselected screening population. (2012) 27 Visual Impairment. There is insufficient evidence to recommend for or against routine screening for diminished visual acuity among nonelderly adults. Recommendations against such screening may be made on other grounds, including the inconvenience and cost of routine screening, and the fact that refractive errors can be readily corrected when they produce symptoms (1996). Impairment of visual acuity—best corrected vision worse than 20/50—is a serious public health problem in older adults. The prevalence in adults older than 60 years is approximately 9%. There is adequate evidence that visual acuity testing does not accurately identify early age-related macular degeneration (AMD). Evidence that screening with a visual acuity test accurately identifies persons with cataracts is inadequate. There is convincing evidence that screening with a visual acuity test identifies persons with refractive error. The USPSTF found convincing evidence that screening questions are not as accurate as visual acuity testing for assessing visual acuity. There is inadequate direct evidence that screening and early interventions for impairment of visual acuity by primary care physicians improve functional outcomes in older adults. The USPSTF found adequate evidence that early treatment of refractive error, cataracts, and AMD improves or prevents loss of visual acuity. Although the USPSTF found adequate evidence that treatment of refractive error improves visual acuity, there was inadequate evidence that these improvements improve functional outcomes. There is adequate evidence that early treatment of refractive error, cataracts, and AMD may lead to harms that are small. The USPSTF concluded that the evidence is insufficient on whether screening older adults for visual impairment improves functional outcomes. The balance of benefits and harms cannot be determined (2009). 28 Glaucoma. The USPSTF found no direct evidence on the benefits of screening. The USPSTF found convincing evidence that treatment of increased intraocular pressure (IOP) and early glaucoma reduces the number of persons who develop small, clinically unnoticeable visual field defects and that treatment of early asymptomatic POAG decreases the number of persons whose visual field defects worsen. However, the USPSTF found inadequate evidence that screening for or treatment of increased IOP or early asymptomatic POAG reduces the number of persons who will develop impaired vision or quality of life. The USPSTF found no direct evidence on the harms of screening. It found convincing evidence that treatment results in numerous harms, including local eye irritation from medications and risk for complications from surgery, such as early formation of cataracts. The magnitude of these harms for most persons is small. Screening is associated with a risk for false-positive and false-negative results, but the magnitude of this risk is unknown, given the considerable variability in reported test sensitivity and specificity. Screening and treatment are associated with risk for overdiagnosis and overtreatment because some evidence shows that many persons with increased IOP or early POAG have an indolent long-term course yet still receive treatment. The USPSTF concludes that the evidence of effectiveness of screening for glaucoma on clinical outcomes is lacking and that the balance of benefits and harms therefore cannot be determined. (2013) 29 Tuberculosis. Screening for tuberculous infection by tuberculin skin testing is recommended for all persons at increased risk of developing tuberculosis (TB). Asymptomatic persons at increased risk include persons infected with HIV, close contacts of persons with known or suspected TB (including health care workers), persons with medical risk factors associated with TB, immigrants from countries with high TB prevalence (e.g., most countries in Africa, Asia, and Latin America), medically underserved low-income populations (including high-risk racial or ethnic minority populations), alcoholics, injection drug users, and residents of long-term care facilities (e.g., correctional institutions, mental institutions, nursing homes). (1996) 30 Hepatitis B. The USPSTF found no evidence that screening the general population for HBV infection improves long-term health outcomes such as cirrhosis, hepatocellular carcinoma, or mortality. The prevalence of HBV infection is low; the majority of infected individuals do not develop chronic infection, cirrhosis, or HBV-related liver disease. Potential harms of screening include labeling, although there is limited evidence to determine the magnitude of this harm. As a result, the USPSTF concluded that the potential harms of screening for HBV infection in the general population are likely to exceed any potential benefits. The current practice of vaccinating all infants against HBV infection and postexposure prophylaxis with hepatitis B immune globulin administered at birth to infants of HBV-infected mothers substantially reduces the risk for acquiring HBV infection. (2004) The USPSTF found convincing evidence that universal prenatal screening for HBV infection substantially reduces perinatal transmission of HBV and the subsequent development of chronic HBV infection. The current practice of vaccinating all infants against HBV infection and providing postexposure prophylaxis with hepatitis B immune globulin administered at birth to infants of mothers infected with HBV substantially reduces the risk for acquiring HBV infection. The USPSTF found no published studies that describe harms of screening for HBV infection in pregnant women. The USPSTF concluded that the potential harms of screening are no greater than small. The USPSTF concluded that there is high certainty that the net benefit of screening pregnant women for HBV infection is substantial. This recommendation applies to all pregnant women. Screening for HBV infection by testing for HBsAg should be performed in each pregnancy, regardless of previous hepatitis B vaccination or previous negative HBsAg test results. A test for HBsAg should be ordered at the first prenatal visit with other recommended screening tests. At the time of admission to a hospital, birth center, or other delivery setting, women with unknown HBsAg status or with new or continuing risk factors for HBV infection (such as injection drug use or evaluation or treatment for a sexually transmitted disease) should receive screening. (2009) 31 Hepatitis C. The USPSTF found adequate evidence that anti–HCV antibody testing followed by confirmatory polymerase chain reaction testing accurately detects chronic HCV infection. In screening strategies targeting persons with risk factors for HCV infection (such as past or present injection drug use, sex with an injection drug user, or blood transfusion before 1992), anti–HCV antibody testing is associated with high sensitivity (>90%) and small numbers needed to screen to identify 1 case of HCV infection (<20 persons) (1). Anti–HCV antibody testing remains highly accurate in low-prevalence populations, although the numbers needed to screen to detect 1 case of HCV infection are higher. The USPSTF also found adequate evidence that various noninvasive tests have good to very good diagnostic accuracy in diagnosing fibrosis or cirrhosis. The USPSTF found no direct evidence on the benefit of screening for HCV infection in asymptomatic adults in reducing morbidity and mortality. However, the USPSTF found adequate evidence that antiviral regimens result in sustained virologic response (SVR) and improved clinical outcomes. The USPSTF found inadequate evidence that counseling or immunization of patients with HCV infection against other infections improves health outcomes, reduces transmission of HCV, or changes high-risk behaviors. The USPSTF found inadequate evidence that knowledge of positive status for HCV infection reduces high-risk behaviors. The USPSTF also found inadequate evidence that labor management and breastfeeding strategies in HCV-positive women are effective at reducing risk for mother-to-child transmission. Given the accuracy of the screening test and the availability of effective interventions for HCV infection, the USPSTF concludes that screening is of moderate benefit for populations at high risk for infection. The USPSTF concludes that 1-time screening in all adults in the United States born between 1945 and 1965 is also of moderate benefit. The USPSTF found limited evidence on the harms of screening for HCV. Potential harms of screening include anxiety, patient labeling, and feelings of stigmatization. The USPSTF found adequate evidence on the harms associated with the diagnostic evaluation used to guide treatment decisions (liver biopsy). These harms include bleeding, infection, and severe pain in approximately 1% of persons who had a liver biopsy and death in less than 0.2%. However, the use of liver biopsy to guide treatment decisions is declining, and noninvasive tests have sufficient accuracy to diagnose fibrosis and cirrhosis. Thus, the absolute risk to persons who currently receive a diagnosis of HCV infection and subsequent treatment is probably declining. The USPSTF found adequate evidence that antiviral therapy regimens are associated with a high rate of harms, such as fatigue, headache, flu-like symptoms, hematologic events, and rash. However, antiviral therapy is given for a defined duration, serious adverse events are uncommon, and adverse events are self-limited and typically resolve after treatment is discontinued. The USPSTF found adequate evidence that these harms of treatment are small. The USPSTF concluded with moderate certainty that screening for HCV infection in adults at increased risk for infection and 1-time screening in adults in the 1945–1965 birth cohort has moderate net benefits. (2013) 32 Chlamydia. There is good evidence that screening for chlamydial infection in women who are at increased risk can reduce the incidence of PID. The USPSTF concluded that the benefits of screening women at increased risk are substantial. There are no studies evaluating the effectiveness of screening for chlamydial infection in pregnant women who are at increased risk. The USPSTF, however, found that there is fair evidence that screening identifies infection in asymptomatic pregnant women. There is a relatively high prevalence of infection among pregnant women who are at increased risk. There is fair evidence of improved pregnancy and birth outcomes for women who are treated for chlamydial infection. The USPSTF concluded that the benefits of screening pregnant women who are at increased risk are substantial. The USPSTF identified no studies documenting the benefits of screening women, including pregnant women, who are not at increased risk for chlamydial infection. While recognizing the potential benefit to women identified through screening, the USPSTF concluded the overall benefit of screening would be small, given the low prevalence of infection among women not at increased risk. While concluding that the direct benefit to men of screening was likely to be small, the USPSTF noted that screening for chlamydial infection in men may be beneficial if it were to lead to a decreased incidence of chlamydial infection in women. The USPSTF did not, however, find evidence to support this outcome, and therefore concluded that the benefits of screening men are unknown. The USPSTF identified this as a critical gap in the evidence. The USPSTF concluded that the harms of screening for chlamydial infection are no greater than small, although few studies have been published on this subject. Potential harms include anxiety and relationship problems arising from false positive results and over-treatment. The USPSTF identified the lack of evidence related to potential harms of screening as a gap in the evidence. (2007) 33 HIV. The USPSTF found good evidence that both standard and U.S. Food and Drug Administration (FDA)-approved rapid screening tests accurately detect HIV infection. The USPSTF also found good evidence that appropriately timed interventions, particularly highly active antiretroviral therapy (HAART), lead to improved health outcomes for many of those screened, including reduced risk for clinical progression and reduced mortality. Since false-positive test results are rare, harms associated with HIV screening are minimal. Potential harms of true-positive test results include increased anxiety, labeling, and effects on close relationships. Most adverse events associated with HAART, including metabolic disturbances associated with an increased risk for cardiovascular events, may be ameliorated by changes in regimen or appropriate treatment. The USPSTF concluded that the benefits of screening individuals at increased risk substantially outweigh potential harms. The USPSTF found fair evidence that screening adolescents and adults not known to be at increased risk for HIV can detect additional individuals with HIV, and good evidence that appropriately timed interventions, especially HAART, lead to improved health outcomes for some of these individuals. However, the yield of screening persons without risk factors would be low, and potential harms associated with screening have been noted (above). The USPSTF concluded that the benefit of screening adolescents and adults without risk factors for HIV is too small relative to potential harms to justify a general recommendation. The USPSTF found good evidence that both standard and FDA-approved rapid screening tests accurately detect HIV infection in pregnant women and fair evidence that introduction of universal prenatal counseling and voluntary testing increases the proportion of HIV-infected women who are diagnosed and are treated before delivery. There is good evidence that recommended regimens of HAART are acceptable to pregnant women and lead to significantly reduced rates of mother-tochild transmission. Early detection of maternal HIV infection also allows for discussion of elective cesarean section and avoidance of breastfeeding, both of which are associated with lower HIV transmission rates. There is no evidence of an increase in fetal anomalies or other fetal harm associated with currently recommended antiretroviral regimens (with the exception of efavirenz). Serious or fatal maternal events are rare using currently recommended combination therapies. The USPSTF concluded that the benefits of screening all pregnant women substantially outweigh potential harms. (2005) 34 Syphilis. Although the USPSTF found no new direct evidence that screening for syphilis infection leads to improved health outcomes in persons at increased risk, there is adequate evidence that screening tests can accurately detect syphilis infection and that antibiotics can cure syphilis. Screening may result in potential harms (such as clinical evaluation of false-positive results, unnecessary anxiety to the patient, and harms of antibiotic use). The USPSTF concluded that the benefits of screening persons at increased risk for syphilis infection substantially outweigh the potential harms. The USPSTF found observational evidence that the universal screening of pregnant women decreases the proportion of infants with clinical manifestations of syphilis infection and those with positive serologies. The USPSTF concluded that the benefits of screening all pregnant women for syphilis infection substantially outweigh potential harms. Given the low incidence of syphilis infection in the general population and the consequent low yield of such screening, the USPSTF concluded that potential harms of screening (i.e., opportunity cost, false-positive tests, and labeling) in a low-incident population outweigh the benefits. (2004) Untreated syphilis during pregnancy is associated with stillbirth, neonatal death, bone deformities, and neurologic impairment. There is adequate evidence that screening tests can accurately detect syphilis infection. The USPSTF found convincing observational evidence that the universal screening of pregnant women decreases the proportion of infants with clinical manifestations of syphilis infection. Screening and treatment may result in potential harms, including falsepositive results that require clinical evaluation, unnecessary anxiety to the patient, and harms of antibiotic use. However, the USPSTF concluded that the harm from screening is no greater than small. The USPSTF concluded with high certainty that the net benefit of screening is substantial for pregnant women. (2009) 35 Gonorrhea. Women with asymptomatic gonorrhea infection have high morbidity due to pelvic inflammatory disease, ectopic pregnancy, and chronic pelvic pain. Pregnant women with gonorrhea infection are at risk for preterm rupture of membranes, preterm labor, and chorioamnionitis. There is fair evidence that screening tests can accurately detect gonorrhea infection and good evience that antibiotics can cure gonorrhea infection. There is fair evidence that screening pregnant women at high risk for gonorrhea, including women at high risk because of younger age, may prevent other complications associated with gonococcal infection during pregnancy, such as preterm delivery and chorioamnionitis. Potential harms of screening and treatment for gonorrhea include false-positive test results, anxiety, and unnecessary antibiotic use. There is insufficient evidence (due to a lack of studies) to quantify the magnitude of these potential harms. The USPSTF judges the magnitide of the potential harms to be small. The USPSTF concludes that the benefits of screening women at increased risk for gonorrhea infection outweigh the potential harms. The morbidity from undiagnosed and untreated genital gonorrhea infection is lower in men than in women. Clinical symptoms are more likely to lead to diagnosis and treatment in men; thus, the prevalence of asymptomatic infection in men is lower. There is fair evidence that non-invasive screening tests can accurately detect gonorrhea infection and good evidence that antibiotics cure gonorrhea infection. The USPSTF judges the magnitide of the potential harms of screening men for gonorrhea to be small. Given the low prevalence of asymptomatic infection in men, the USPSTF could not determine the balance of benefits and harms of screening for gonorrhea infection in men at increased risk for infection. There is a low prevalence of gonorrhea infection in the general population and consequently a low yield from screening. Thus, the USPSTF concludes that potential harms of screening (ie, false-positive test results and labeling) in low-prevalence populations outweigh the benefits. The prevalence of gonorrhea infection in pregnant women who are not at increased risk for infection is low. The USPSTF could not determine the balance between benefits and harms of screening for gonorrhea in pregnant women who are not at increased risk for infection. (2005) 36 Bacteriurea. The USPSTF found fair evidence that screening men and non-pregnant women for asymptomatic bacteriuria is ineffective in improving clinical outcomes. In the absence of evidence of benefit, the potential harms associated with overuse of antibiotics are especially significant. The USPSTF found good evidence that screening pregnant women for asymptomatic bacteriuria with urine culture significantly reduces symptomatic urinary tract infections, low birth weight, and preterm delivery. The benefits of screening and treatment substantially outweigh any potential harms. (2004) 37 Bacterial Vaginosis. No direct evidence indicates that screening for bacterial vaginosis reduces adverse health outcomes in asymptomatic pregnant women at low risk for preterm delivery. Good evidence indicates that treatment of bacterial vaginosis in these women lacks benefit. No direct evidence indicates that screening for bacterial vaginosis reduces adverse health outcomes in asymptomatic pregnant women at high risk for preterm delivery. Evidence from goodquality studies is conflicting with respect to the benefits of treating bacterial vaginosis. Evidence is poor (because studies are lacking) for harms of screening for bacterial vaginosis in asymptomatic pregnant women at low risk for preterm delivery. Evidence is fair that false-positive results from screening lead to harms due to treatment. Evidence is poor (because studies are lacking) for harms of screening for bacterial vaginosis in asymptomatic pregnant women at high risk for preterm delivery. Studies on the harms of treatment have conflicting results. The USPSTF concluded that for asymptomatic pregnant women at low risk for preterm delivery, there is moderate certainty that screening for bacterial vaginosis has no net benefit. The USPSTF concluded that for asymptomatic pregnant women at high risk for preterm delivery, the evidence is conflicting and the balance of benefits and harms cannot be determined. (2008) Depression. Depression is among the leading causes of disability in persons 15 years or older. It affects individuals, families, businesses, and society. It is common in primary care patients. The USPSTF found good evidence that screening improves the accurate identification of depressed patients in primary care settings. The USPSTF found good evidence that treating depressed adults and older adults identified through screening in primary care settings with antidepressants, psychotherapy, or both decreases clinical morbidity. The USPSTF found good evidence that programs combining depression screening and feedback with staff assisted depression care supports improve clinical outcomes in adults and older adults. The USPSTF found fair evidence that screening and feedback alone without staff-assisted care supports do not improve clinical outcomes in adults and older adults. The USPSTF found no evidence of harms of 38 screening for depression in adults or older adults. The USPSTF found at least fair-quality evidence that second-generation antidepressants (mostly selective serotonin reuptake inhibitors [SSRIs]) increase suicidal behaviors in adults aged 18 to 29 years, especially those with major depressive disorder (MDD) and those who receive paroxetine. The USPSTF found at least fair-quality evidence that SSRI use is associated with an increased risk for upper gastrointestinal (UGI) bleeding in adults older than 70 years, with risk increasing with age. The USPSTF concluded that for adults who receive care in clinical practices that have staffassisted depression care supports in place, there is at least moderate certainty that the net benefit of screening for depression is at least moderate. The USPSTF concluded that for adults who receive care in clinical practices without staff-assisted depression care supports in place, there is at least moderate certainty that the net benefit of screening adults for depression is small. (2009) 39 Dementia. The USPSTF found good evidence that some screening tests have good sensitivity but only fair specificity in detecting cognitive impairment and dementia. There is fair to good evidence that several drug therapies have a beneficial effect on cognitive function (equivalent to delaying the natural progression of Alzheimer's disease from 2 to 7 months), but the evidence of their beneficial effects on instrumental activities of daily living is mixed, with the benefit being small, at best. There is insufficient evidence to determine whether the benefits observed in drug trials are generalizable to patients whose disease would be detected by screening in primary care settings. The accuracy of diagnosis, the feasibility of screening and treatment in routine clinical practice, and the potential harms of screening (e.g., labeling effects) are also unknown. The Task Force therefore could not determine whether the benefits of screening for dementia outweigh the harms. (2003) 40 Suicide. The USPSTF found no evidence that screening for suicide risk reduces suicide attempts or mortality. There is limited evidence on the accuracy of screening tools to identify suicide risk in the primary care setting, including tools to identify those at high risk. The USPSTF found insufficient evidence that treatment of those at high risk reduces suicide attempts or mortality. The USPSTF found no studies that directly address the harms of screening and treatment for suicide risk. As a result, the USPSTF could not determine the balance of benefits and harms of screening for suicide risk in the primary care setting. (2004) 41 Elderly and Intimate Partner Violence (IPV). The USPSTF found inadequate evidence on the accuracy of screening instruments for elderly or vulnerable adults. The USPSTF found inadequate evidence that screening or early detection reduces exposure to abuse or reduces physical or mental harms or mortality for elderly and vulnerable adults. For elderly and vulnerable adults, the USPSTF found inadequate evidence on the harms of screening or intervention. The USPSTF concluded that the benefits and harms of screening elderly or vulnerable adults for abuse are uncertain, and that the balance of benefits and harms cannot be determined. For IPV, there is adequate evidence that available screening instruments can identify current and past abuse or increased risk for abuse. Several instruments used in more than 1 study were highly sensitive and specific. The USPSTF found adequate evidence that effective interventions can reduce violence, abuse, and physical or mental harms for women of reproductive age. For IPV, the USPSTF found adequate evidence that the risk for harm to the individual from screening or interventions is no greater than small. The USPSTF concluded with moderate certainty that screening women of childbearing age for IPV has a moderate net benefit. (2013) 42 Illicit Drug Use. There is good evidence that various treatments are effective in reducing illicit drug use in the short term. Evidence is insufficient, however, either to demonstrate that treatment reliably improves social and legal outcomes for patients, or to link treatment directly to longer term improvements in morbidity or mortality. Since all but one published clinical trial of treatment interventions involved individuals who had already developed problems due to their drug use, it is not known whether the findings are generalizabe to asymptomatic individuals whose illicit drug use is detected through screening. There is fair evidence that, regardless of the patient's history of treatment, reducing or stopping drug use is associated with improvement in some health outcomes. There is little evidence of harms associated with either screening for illicit drug use or behavioral interventions used in treatment. Several clinical trials of pharmacotherapy for drug misuse have reported mild to serious adverse events, although some of these events were likely related to underlying drug use. The specific adverse events noted to occur more frequently in the treatment arm of trials (compared to placebo) have been previously recognized as potential side effects of the treatment medication and cited on its product label. The USPSTF concludes that for adolescents, adults, and pregnant women, the evidence is insufficient to determine the benefits and harms of screening for illicit drug use. (2008) 43 Hormone Replacement. Combined estrogen and progestin. Many health outcomes potentially associated with the use of hormone therapy in postmenopausal women have been examined. The USPSTF found convincing evidence that estrogen and progestin therapy (specifically, oral conjugated equine estrogen, 0.625 mg/d, plus medroxyprogesterone acetate, 2.5 mg/d) is of moderate benefit in reducing the risk for fractures in postmenopausal women. However, the USPSTF found adequate evidence that its use is also associated with moderate harms, including an increase in the risk for stroke, dementia, gallbladder disease, and urinary incontinence. There is convincing evidence of a small increase in the incidence of invasive breast cancer and adequate evidence of a small increase in breast cancer deaths. There is also convincing evidence that estrogen and progestin therapy is associated with a small increased risk for deep venous thrombosis (DVT) and pulmonary embolism. Convincing evidence shows that the use of estrogen and progestin therapy does not have a beneficial effect on CHD and probably increases the risk for its occurrence. Estrogen alone. The use of estrogen without progestin has generally been restricted to women who have had a hysterectomy because unopposed estrogen use increases the risk for endometrial cancer in women with an intact uterus. The USPSTF found convincing evidence that estrogen (specifically, oral conjugated equine estrogen, 0.625 mg/d) is of moderate benefit in reducing the incidence of fractures. There is adequate evidence that the use of estrogen alone results in a small reduction in the risk for developing or dying of invasive breast cancer. However, the USPSTF found adequate evidence that its use is also associated with moderate harms, including the risk for stroke, gallbladder disease, and urinary incontinence, as well as a small increase in the risk for DVT. There is convincing evidence that estrogen does not have a beneficial effect on CHD. Table 2 provides absolute risk difference estimates for the benefits and harms of estrogen therapy. The USPSTF concluded with high certainty that the chronic disease prevention benefits of combined estrogen and progestin do not outweigh the harms in most postmenopausal women. The USPSTF concludes with moderate certainty that the chronic disease prevention benefits of estrogen are unlikely to outweigh the harms in most postmenopausal women who have had a hysterectomy. (2012) 44 Aspirin. Cardiovascular disease, including heart attack and stroke, is the leading cause of death in the United States. For many groups, available risk calculators can provide an accurate estimate of the risk for coronary heart disease events and strokes based on information about cardiovascular risk factors that include sex. The USPSTF found good evidence that aspirin decreases the incidence of myocardial infarction in men and ischemic strokes in women. The USPSTF found good evidence that aspirin increases the incidence of gastrointestinal bleeding and fair evidence that aspirin increases the incidence of hemorrhagic strokes. The USPSTF concluded that, for men age 45 to 79 years whose benefit due to a reduction in myocardial infarctions exceeds the harm because of an increase in gastrointestinal bleeding, there is high certainty that the net benefit is substantial. The USPSTF concluded that, for women age 55 to 79 years whose benefit due to a reduction in ischemic stroke exceeds the harm because of gastrointestinal bleeding, there is high certainty that the net benefit is substantial. The USPSTF concluded that, for men and women 80 years or older, the evidence is insufficient to assess the balance of benefits and harms. The USPSTF concluded that, for men 44 years or younger and women 54 years or younger, the potential benefits of reducing myocardial infarction in men or ischemic stroke in women are small, and there is moderate certainty that the benefits do not outweigh the risks. (2009) Colorectal cancer represents the third most common type of cancer in both men and women and is the second leading cause of cancer-related deaths in the United States. The vast majority of cases of colorectal cancer arise from adenomatous polyps in average-risk individuals older than 50 years of age. There is fair to good evidence that aspirin and NSAIDs, taken in higher doses for longer periods, reduces the incidence of adenomatous polyps. There is good evidence that low-dose aspirin does not lead to a reduction in the incidence of colorectal cancer. There is fair evidence that aspirin used in doses higher than those recommended for prevention of cardiovascular disease and NSAIDs may be associated with a reduction in the incidence of colorectal cancer. There is fair evidence that aspirin used over longer periods may be associated with a reduction in the incidence of colorectal cancer. There is poor-quality evidence that aspirin and NSAID use leads to a reduction in colorectal cancer-associated mortality. There is good evidence that aspirin increases the incidence of gastrointestinal bleeding in a doserelated manner and fair evidence that aspirin increases the incidence of hemorrhagic stroke. There is good evidence that NSAIDs increase the incidence of gastrointestinal bleeding and renal impairment, especially in the elderly. There is good evidence that cyclooxygenase-2 inhibitors, a class of NSAID, increase the incidence of renal impairment. Cyclooxygenase-2 inhibitors appear to be associated with an increased risk for cardiovascular events. Overall, there is good evidence of at least moderate harms associated with aspirin and NSAIDs. Overall, the USPSTF concluded that harms outweigh the benefits of aspirin and NSAID use for the prevention of colorectal cancer.(2007) 45 Tamoxifen/Raloxifen. Important risk factors for breast cancer include increasing age, family history of breast or ovarian cancer (especially among first-degree relatives and onset before age 50 years), history of atypical hyperplasia or other nonmalignant high-risk breast lesions, previous breast biopsy, and extremely dense breast tissue. A history of these or other risk factors may prompt clinicians to conduct a formal breast cancer risk assessment. Available risk assessment models can accurately estimate the number of breast cancer cases that may arise in certain study populations, but their ability to accurately predict which women will (and will not) develop the disease is modest. Only a small fraction of women are at increased risk for breast cancer; moreover, only a subset of those women will derive benefit from risk-reducing medications. Information about the validity, feasibility, and effect of using risk assessment models to identify appropriate candidates for risk-reducing medications in primary care settings is limited . The USPSTF found adequate evidence that treatment with tamoxifen or raloxifene can significantly reduce the relative risk (RR) for invasive ER-positive breast cancer in postmenopausal women who are at increased risk for breast cancer.A systematic review of clinical trials found that tamoxifen and raloxifene reduced the incidence of invasive breast cancer by 7 to 9 events per 1000 women over 5 years and that tamoxifen reduced breast cancer incidence more than raloxifen. Tamoxifen also reduces the incidence of invasive breast cancer in premenopausal women who are at increased risk for the disease. Women who are at increased risk for breast cancer are more likely to benefit from risk-reducing medications. In general, women with an estimated 5-year risk of 3% or greater are, on the basis of model estimates, are more likely to benefit from tamoxifen or raloxifene. The USPSTF found that the benefits of tamoxifen and raloxifene for breast cancer risk reduction are no greater than small in women who are not at increased risk for the disease. In addition to breast cancer risk reduction, the USPSTF found adequate evidence that tamoxifen and raloxifene reduce the risk for nonvertebral or vertebral fractures, respectively, in postmenopausal women. The USPSTF found adequate evidence that tamoxifen and raloxifene increase risk for venous thromboembolic events (VTEs) by 4 to 7 events per 1000 women over 5 years and that tamoxifen increases risk more than raloxifene. The USPSTF found that potential harms from thromboembolic events are small to moderate, with increased potential for harms in older women. The USPSTF also found adequate evidence that tamoxifen but not raloxifene increases risk for endometrial cancer (4 more cases per 1000 women). Potential harms from tamoxifen-related endometrial cancer are small to moderate and depend on hysterectomy status and age. The potential risks for tamoxifen-related harms are higher in women older than 50 years and in women with a uterus. Tamoxifen may also increase the incidence of cataracts. Vasomotor symptoms (hot flashes) are a common adverse effect of both medications that is not typically classified as serious, but these symptoms may affect a patient's quality of life and willingness to use or adhere to these medications. The USPSTF concluded with moderate certainty that there is a moderate net benefit from use of tamoxifen and raloxifene to reduce the incidence of invbreast cancer in women who are at increased risk for the disease. The USPSTF concluded with moderate certainty that the potential harms of tamoxifen and raloxifene outweigh the potential benefits for breast cancer risk reduction in women who are not at increased risk for the disease. (2013) 46 Iron. Iron deficiency anemia in pregnancy has been associated with increased risk for low birth weight, preterm delivery, and perinatal mortality. Recent studies suggest that maternal iron deficiency anemia may be associated with postpartum depression and poor performance on mental and psychomotor tests in offspring. The prevalence of iron-deficiency anemia has remained stable over the last decade in the general U.S. population and continues to be greatest among minority and poor children. A validated risk assessment tool to guide primary care physicians in identifying individuals who would benefit from iron supplementation has not been developed. The USPSTF found poor evidence (poor quality studies) that iron supplementation may improve health outcomes in non-anemic pregnant women. The USPSTF found fair evidence that oral iron supplementation increases the risk for unintentional overdose and gastrointestinal symptoms. Given appropriate protection against overdose, these harms are small. There is poor evidence (poor quality studies) that iron supplementation for nonanemic pregnant women results an increased risk for harms. The USPSTF was unable to determine the balance between the benefits and harms of iron supplementation of iron supplementation in non-anemic pregnant women. (2006) 47 B-Carotene. The USPSTF found good evidence that beta-carotene supplementation provides no benefit in the prevention of cancer or cardiovascular disease in middle-aged and older adults. In 2 trials restricted to heavy smokers, beta-carotene supplementation was associated with higher incidence of lung cancer and higher all-cause mortality. The USPSTF concludes that beta-carotene supplements are unlikely to provide important benefits and might cause harm in some groups. (2003) 48 Vitamins. A, C, E, or multivitamins with folate. The USPSTF found poor evidence to determine whether supplementation with these vitamins reduces the risk for cardiovascular disease or cancer. The available evidence from randomized trials is either inadequate or conflicting, and the influence of confounding variables on observed outcomes in observational studies cannot be determined. As a result, the USPSTF could not determine the balance of benefits and harms of routine use of supplements of vitamins A, C or E; multivitamins with folic acid; or antioxidant combinations for the prevention of cancer or cardiovascular disease. (2003) 49 Vitamin D. The USPSTF concluded with moderate certainty that vitamin D supplementation has moderate net benefit in preventing falls in older adults. The USPSTF found convincing evidence that the harms of vitamin D supplementation are no greater than small. (2012) In premenopausal women and in men, there is inadequate evidence to determine the effect of combined vitamin D 3 and calcium supplementation on the incidence of fractures. In postmenopausal women, there is adequate evidence that daily supplementation with 400 IU of vitamin D 3 combined with 1,000 mg of calcium has no effect on the incidence of fractures. However, there is inadequate evidence regarding the effect of higher doses of combined vitamin D and calcium supplementation on fracture incidence in noninstitutionalized postmenopausal women. Adequate evidence indicates that supplementation with 400 IU or less of vitamin D3 and 1,000 mg or less of calcium increases the incidence of renal stones. The USPSTF assessed the magnitude of this harm as small. Noninstitutionalized, community-dwelling postmenopausal women. The USPSTF concludes that evidence is lacking about the benefit of daily supplementation with greater than 400 IU of vitamin D3 and greater than 1,000 mg of calcium for the primary prevention of fractures, and the balance of benefits and harms cannot be determined. The USPSTF concludes with moderate certainty that daily supplementation with 400 IU or less of vitamin D3 and 1,000 mg or less of calcium has no net benefit for the primary prevention of fractures. Men and premenopausal women. The USPSTF concludes that evidence is lacking about the benefit of vitamin D supplementation with or without calcium for the primary prevention of fractures, and the balance of benefits and harms cannot be determined. 50 Folic Acid. USPSTF found convincing evidence that supplements containing 0.4 to 0.8 mg (400 to 800 µg) of folic acid in the periconceptional period reduce the risk for neural tube defects. Adequate evidence suggests that folic acid from supplementation at usual doses is not associated with serious harms. The USPSTF concluded that, for women who are planning or capable of pregnancy, there is high certainty that the net benefit is substantial. This recommendation applies to women who are planning or capable of pregnancy, but it does not apply to women who have had a previous pregnancy affected by neural tube defects or women taking certain antiseizure medicines. Most organizations recommend that these women take higher doses of folic acid. The use of certain antiseizure medicines and a personal or family history of neural tube defects are well-established risk factors. Other reported risk factors include mutations in folate-related enzymes, maternal diabetes, and obesity. Most studies indicate the need to start folic acid supplementation at least 1 month before conception and to continue daily supplements through the first 2 to 3 months of pregnancy. Studies also indicate that 50% of pregnancies in the United States are unplanned, and clinicians should therefore advise all women who are capable of pregnancy to take folic acid supplements. Good evidence from randomized trials in settings without fortification of food suggests that a multivitamin with 0.8 mg (800 µg) of folic acid reduces the risk for neural tube defects. Observational studies done before fortification report a reduction of neural tube defects in women taking a supplement with 0.4 mg (400 µg) of folic acid (the generally available dose). Evidence indicates that most women in the United States are not ingesting fortified foods at a level thought to provide optimal benefit. In a setting in which food is fortified with folic acid, the effective amount of additional folic acid supplementation is unclear. (2009) 51 Physical Activity. The USPSTF found insufficient evidence to determine whether counseling patients in primary care settings to promote physical activity leads to sustained increases in physical activity among adult patients. Controlled trials of physical activity counseling in adult primary care patients were of variable quality and had mixed results. There were no completed trials with children or adolescents that compared counseling with usual care practices. Data on the feasibility and potential harms of routine physical activity counseling in primary care settings are limited. As a result, the USPSTF could not determine the balance of potential benefits and harms of routine counseling to promote physical activity in adults. The USPSTF reviewed only the literature on the effectiveness of primary care counseling to promote physical activity. It did not review the evidence for the effectiveness of physical activity to reduce chronic disease morbidity and mortality, which has been well documented in other recent reviews, or review evidence of counseling in other settings. (2002) The USPSTF found convincing evidence that exercise or physical therapy has moderate benefit in preventing falls in older adults. The USPSTF found that adequate evidence indicates that the harms of physical therapy or exercise are small. These harms include a paradoxical increase in falls and an increase in physician visits. The USPSTF concluded with high certainty that exercise or physical therapy has moderate net benefit in preventing falls in older adults. (2012) In adult patients without known hypertension, diabetes, hyperlipidemia, or CVD, there is adequate evidence that the benefits of medium- to high-intensity behavioral counseling interventions to improve diet and increase physical activity are small to moderate. There is adequate evidence that the benefits of mediumto high-intensity behavioral counseling interventions to improve intermediate health outcomes (that is, decreased blood pressure, decreased blood lipid levels, and improved glucose tolerance) are small in the short term (up to 1 year). There is inadequate evidence that medium- to high-intensity behavioral counseling interventions directly decrease rates of mortality or CVD events. There is adequate evidence that intense physical activity is only rarely associated with adverse cardiovascular events. None of the studies reviewed was designed to detect adverse effects of interventions to promote a healthful diet. The USPSTF determined that little to no potential harms are associated with these behavioral counseling interventions. The USPSTF concludes with moderate certainty that medium- or high-intensity behavioral counseling interventions in the primary care setting to promote a healthful diet and physical activity have a small net benefit in adult patients without CVD, hypertension, hyperlipidemia, or diabetes. (2012) 52 Healthy Diet. The USPSTF found fair evidence that brief, low- to medium-intensity behavioral dietary counseling in the primary care setting can produce small-to-medium changes in average daily intake of core components of an overall healthy diet (especially saturated fat and fruit and vegetables) in unselected patients. The strength of this evidence, however, is limited by reliance on self-reported diet outcomes, limited use of measures corroborating reported changes in diet, limited followup data beyond 6 to 12 months, and enrollment of study participants who may not be fully representative of primary care patients. In addition, there is limited evidence to assess possible harms. As a result, the USPSTF concluded that there is insufficient evidence to determine the significance and magnitude of the benefit of routine counseling to promote a healthy diet in adults. Although community-based studies have evaluated measures to reduce dietary fat intake in children, no controlled trials of routine behavioral dietary counseling for children or adolescents in the primary care setting were identified. The USPSTF found good evidence that medium- to high-intensity counseling interventions can produce medium-to-large changes in average daily intake of core components of a healthy diet (including saturated fat, fiber, fruit, and vegetables) among adult patients at increased risk for diet-related chronic disease. Intensive counseling interventions that have been examined in controlled trials among at-risk adult patients have combined nutrition education with behavioral dietary counseling provided by a nutritionist, dietitian, or specially trained primary care clinician (e.g., physician, nurse, or nurse practitioner). The USPSTF concluded that such counseling is likely to improve important health outcomes and that benefits outweigh potential harms. (2003) In adult patients without known hypertension, diabetes, hyperlipidemia, or CVD, there is adequate evidence that the benefits of medium- to high-intensity behavioral counseling interventions to improve diet and increase physical activity are small to moderate. There is adequate evidence that the benefits of mediumto high-intensity behavioral counseling interventions to improve intermediate health outcomes (that is, decreased blood pressure, decreased blood lipid levels, and improved glucose tolerance) are small in the short term (up to 1 year). There is inadequate evidence that medium- to high-intensity behavioral counseling interventions directly decrease rates of mortality or CVD events. There is adequate evidence that intense physical activity is only rarely associated with adverse cardiovascular events. None of the studies reviewed was designed to detect adverse effects of interventions to promote a healthful diet. The USPSTF determined that little to no potential harms are associated with these behavioral counseling interventions. The USPSTF concludes with moderate certainty that medium- or high-intensity behavioral counseling interventions in the primary care setting to promote a healthful diet and physical activity have a small net benefit in adult patients without CVD, hypertension, hyperlipidemia, or diabetes. (2012) 53 Tobacco Use. Tobacco use, cigarette smoking in particular, is the leading preventable cause of death in the United States. Tobacco use results in more than 400,000 deaths annually from cardiovascular disease, respiratory disease, and cancer. Smoking during pregnancy results in the deaths of about 1000 infants annually and is associated with an increased risk for premature birth and intrauterine growth retardation. Environmental tobacco smoke contributes to death in an estimated 38,000 people annually. The "5-A" behavioral counseling framework provides a useful strategy for engaging patients in smoking cessation discussions: 1) Ask about tobacco use; 2) Advise to quit through clear personalized messages; 3) Assess willingness to quit; 4) Assist to quit; and 5) Arrange follow-up and support. In nonpregnant adults, the USPSTF found convincing evidence that smoking cessation interventions, including brief behavioral counseling sessions (<10 minutes) and pharmacotherapy delivered in primary care settings, are effective in increasing the proportion of smokers who successfully quit and remain abstinent for 1 year. Although less effective than longer interventions, even minimal interventions (<3 minutes) have been found to increase quit rates. The USPSTF found convincing evidence that smoking cessation decreases the risk for heart disease, stroke, and lung disease. In pregnant women, the USPSTF found convincing evidence that smoking cessation counseling sessions, augmented with messages and self-help materials tailored for pregnant smokers, increases abstinence rates during pregnancy compared with brief, generic counseling interventions alone. Tobacco cessation at any point during pregnancy yields substantial health benefits for the expectant mother and baby. The USPSTF found inadequate evidence to evaluate the safety or efficacy of pharmacotherapy during pregnancy. Finding no published studies that describe harms of counseling to prevent tobacco use in adults or pregnant women, the USPSTF judged the magnitude of these harms to be no greater than small. Harms of pharmacotherapy are dependent on the specific medication used. In nonpregnant adults, the USPSTF judged these harms to be small. The USPSTF concluded that there is high certainty that the net benefit of tobacco cessation interventions in adults is substantial. The USPSTF also concluded that there is high certainty that the net benefit of augmented, pregnancy-tailored counseling in pregnant women is substantial. (2009) 54 Alcohol Misuse. The USPSTF found adequate evidence that numerous screening instruments can detect alcohol misuse in adults with acceptable sensitivity and specificity. The USPSTF found adequate evidence that brief behavioral counseling interventions are effective in reducing heavy drinking episodes in adults engaging in risky or hazardous drinking. These interventions also reduce weekly alcohol consumption rates and increase adherence to recommended drinking limits. Direct evidence about the effectiveness of brief behavioral counseling interventions in pregnant women engaging in alcohol use is more limited. However, studies in the general adult population show that such interventions reduce alcohol consumption and increase adherence to recommended drinking limits among women of childbearing age. The USPSTF found insufficient evidence on the effect of screening for alcohol misuse and brief behavioral counseling interventions on outcomes in adolescents. There are minimal data to assess the magnitude of harms of screening for alcohol misuse or of consequent brief behavioral counseling interventions in any population. However, no studies have identified direct evidence of harms. Thus, given the noninvasive nature of the screening process and behavioral counseling interventions, the related harms are probably small to none. The USPSTF concluded with moderate certainty that there is a moderate net benefit to screening for alcohol misuse and brief behavioral counseling interventions in the primary care setting for adults aged 18 years or older. The evidence on screening for alcohol misuse and brief behavioral counseling interventions in the primary care setting for adolescents is insufficient, and the balance of benefits and harms cannot be determined. The USPSTF considers 3 tools as the instruments of choice for screening for alcohol misuse in the primary care setting: the Alcohol Use Disorders Identification Test (AUDIT), the abbreviated AUDIT-Consumption (AUDIT-C), and single-question screening (for example, the NIAAA recommends asking, “How many times in the past year have you had 5 [for men] or 4 [for women and all adults older than 65 years] or more drinks in a day?”). Of available screening tools, AUDIT is the most widely studied for detecting alcohol misuse in primary care settings; both AUDIT and the abbreviated AUDIT-C have good sensitivity and specificity for detecting the full spectrum of alcohol misuse across multiple populations. AUDIT comprises 10 questions and requires approximately 2 to 5 minutes to administer; AUDIT-C comprises 3 questions and takes 1 to 2 minutes to complete. Single-question screening also has adequate sensitivity and specificity across the alcohol-misuse spectrum and requires less than 1 minute to administer. Behavioral counseling interventions for alcohol misuse vary in their specific components, administration, length, and number of interactions. They may include cognitive behavioral strategies, such as action plans, drinking diaries, stress management, or problem solving. Interventions may be delivered by face-to-face sessions, written selfhelp materials, computer- or Web-based programs, or telephone counseling. For the purposes of this recommendation statement, the USPSTF uses the following definitions of intervention intensity: very brief single contact (≤5 minutes), brief single contact (6 to 15 minutes), brief multicontact (each contact is 6 to 15 minutes), and extended multicontact (≥1 contact, each >15 minutes). Brief multicontact behavioral counseling seems to have the best evidence of effectiveness; very brief behavioral counseling has limited effect. The USPSTF found that counseling interventions in the primary care setting can positively affect unhealthy drinking behaviors in adults engaging in risky or hazardous drinking. Positive outcomes include reducing weekly alcohol consumption and long-term adherence to recommended drinking limits. Because brief behavioral counseling interventions decrease the proportion of persons who engage in episodes of heavy drinking (which results in high blood alcohol concentration [BAC]), indirect evidence supports the effect of screening and brief behavioral counseling interventions on important health outcomes, such as the probability of traumatic injury or death, especially that related to motor vehicles. Although screening detects persons along the entire spectrum of alcohol misuse, trials of behavioral counseling interventions in primary care settings largely focused on risky or hazardous drinking rather than alcohol abuse or dependence. Limited evidence suggests that brief behavioral counseling interventions are generally ineffective as singular treatments for alcohol abuse or dependence. The USPSTF did not formally evaluate other interventions (such as pharmacotherapy or outpatient treatment programs) for alcohol abuse or dependence, but the benefits of specialty treatment are well-established and recommended for persons meeting the diagnostic criteria for alcohol dependence. Evidence is lacking to determine the optimal interval for screening for alcohol misuse in adults. (2013) 55 Skin Cancer Prevention. Behavior change interventions are aimed at techniques shown to be effective in reducing ultraviolet (UV) radiation exposure. Ultraviolet radiation comes from exposure to the sun during midday hours and from artificial sources of UV light (such as indoor tanning). Sun-protective behaviors include the use of broad-spectrum sunscreen with a sun-protection factor of 15 or greater, wearing hats or other shade-protective clothing, avoiding the outdoors during midday hours (10 a.m. to 3 p.m.), and avoiding indoor tanning. Utilizing all behaviors is important to minimizing risk. Epidemiologic evidence (3) links ultraviolet radiation exposure with incidence of all three types of skin cancer. The USPSTF found convincing evidence linking UV radiation exposure during childhood and youth to a moderately increased risk for skin cancer later in life; for adults, adequate evidence links UV radiation exposure to a small increase in risk for skin cancer. Persons with fair skin, light hair and eye color, or freckles or who sunburn easily are at increased risk for skin cancer (1). Most studies of interventions to increase sun-protective behaviors have been limited to populations with a fair skin type. For children, adolescents, and young adults (persons aged 10 to 24 years), the USPSTF found adequate evidence that counseling interventions that are available in a primary care setting or are referable from primary care can moderately increase the use of sun-protective behaviors. For adults older than 24 years, the USPSTF found inadequate evidence to determine the effect of counseling on the use of sun-protective behaviors. The USPSTF found adequate evidence that no appreciable harms are related to counseling or sun-protective behaviors in young persons or adults. Theoretical concerns about sun-protective behaviors include the risk for vitamin D deficiency in adults living in northern latitudes, but little evidence supports this hypothesis. The USPSTF concluded that for children, adolescents, and young adults aged 10 to 24 years with fair skin, there is moderate certainty that counseling has a moderate net benefit. The USPSTF concluded that for adults older than 24 years, evidence of the benefits of counseling is sparse and of unknown clinical significance; therefore, the balance of benefits and harms cannot be determined. (2012) 56 Motor Vehicle Occupant Restraint. There is no evidence addressing the harms of counseling; however, these potential harms are estimated to be none or minimal in magnitude. The USPSTF concluded that current evidence is insufficient to assess the net benefit of counseling interventions in primary care settings to increase proper use of motor vehicle occupant restraints to reduce MVOIs in children, adolescents, and adults. (2007) 57 Sexually Transmitted Infections. Primary care clinicians and teams can identify adolescents and adults who are at increased risk. There is convincing evidence that high-intensity behavioral counseling interventions targeted to sexually active adolescents and adults at increased risk for STIs reduce the incidence of STIs. These results were found 6 and 12 months after counseling took place. The USPSTF has identified the absence of studies and evidence on behavioral counseling interventions directed towards adults not at increased risk for STIs and non-sexually-active adolescents as a critical gap in the literature. No evidence of significant behavioral or biological harms resulting from behavioral counseling about risk reduction has been found. The USPSTF concluded that the potential harms of counseling are no greater than small. The USPSTF concluded that there is moderate certainty that high-intensity behavioral counseling has a moderate net benefit for sexually active adolescents and for adults who are at increased risk for STIs. The USPSTF concluded that the evidence is currently insufficient to assess the balance of benefits and harms of behavioral counseling for non-sexually active adolescents and for adults who are not at increased risk for STIs. (2008)