RHRP-II Attachment 2 - USPSTF.xls

Non-Flyers

&R&D -- The USPSTF strongly recommends that clinicians screen men and women 50 years of age or older for colorectal cancer.

Rating: A recommendation.

Rationale: The USPSTF found fair to good evidence that several screening methods are effective in reducing mortality from colorectal cancer. The USPSTF concluded that the benefits from screening substantially outweigh potential harms, but the quality of evidence, magnitude of benefit, and potential harms vary with each method.

The USPSTF found good evidence that periodic fecal occult blood testing (FOBT) reduces mortality from colorectal cancer and fair evidence that sigmoidoscopy alone or in combination with FOBT reduces mortality. The USPSTF did not find direct evidence that screening colonoscopy is effective in reducing colorectal cancer mortality; efficacy of colonoscopy is supported by its integral role in trials of FOBT, extrapolation from sigmoidoscopy studies, limited case-control evidence, and the ability of colonoscopy to inspect the proximal colon. Double-contrast barium enema offers an alternative means of whole-bowel examination, but it is less sensitive than colonoscopy, and there is no direct evidence that it is effective in reducing mortality rates. The USPSTF found insufficient evidence that newer screening technologies (for example, computed tomographic colography) are effective in improving health outcomes.

There are insufficient data to determine which strategy is best in terms of the balance of benefits and potential harms or cost-effectiveness. Studies reviewed by the USPSTF indicate that colorectal cancer screening is likely to be cost-effective (less than $30,000 per additional year of life gained) regardless of the strategy chosen.

It is unclear whether the increased accuracy of colonoscopy compared with alternative screening methods (for example, the identification of lesions that FOBT and flexible sigmoidoscopy would not detect) offsets the procedure's additional complications, inconvenience, and costs.

-- The USPSTF strongly recommends screening for cervical cancer in women who have been sexually active and have a cervix.

Rating: A recommendation.

Rationale: The USPSTF found good evidence from multiple observational studies that screening with cervical cytology (Pap smears) reduces incidence of and mortality from cervical cancer. Direct evidence to determine the optimal starting and stopping age and interval for screening is limited. Indirect evidence suggests most of the benefit can be obtained by beginning screening within 3 years of onset of sexual activity or age 21 (whichever comes first) and screening at least every 3 years (go to Clinical Considerations). The USPSTF concludes that the benefits of screening substantially outweigh potential harms.

The USPSTF recommends against routinely screening women older than age 65 for cervical cancer if they have had adequate recent screening with normal Pap smears and are not otherwise at high risk for cervical cancer (go to Clinical Considerations).

-- The U.S. Preventive Services Task Force (USPSTF) recommends screening mammography, with or without clinical breast examination (CBE), every 1-2 years for women aged 40 and older.

Rating: B recommendation.

Rationale: The USPSTF found fair evidence that mammography screening every 12-33 months significantly reduces mortality from breast cancer. Evidence is strongest for women aged 50-69, the age group generally included in screening trials. For women aged 40-49, the evidence that screening mammography reduces mortality from breast cancer is weaker, and the absolute benefit of mammography is smaller, than it is for older women. Most, but not all, studies indicate a mortality benefit for women undergoing mammography at ages 40-49, but the delay in observed benefit in women younger than 50 makes it difficult to determine the incremental benefit of beginning screening at age 40 rather than at age 50.

The absolute benefit is smaller because the incidence of breast cancer is lower among women in their 40s than it is among older women. The USPSTF concluded that the evidence is also generalizable to women aged 70 and older (who face a higher absolute risk for breast cancer) if their life expectancy is not compromised by comorbid disease. The absolute probability of benefits of regular mammography increase along a continuum with age, whereas the likelihood of harms from screening (false-positive results and unnecessary anxiety, biopsies, and cost) diminish from ages 40-70. The balance of benefits and potential harms, therefore, grows more favorable as women age. The precise age at which the potential benefits of mammography justify the possible harms is a subjective choice. The USPSTF did not find sufficient evidence to specify the optimal screening interval for women aged 40-49 (see Clinical Considerations).

-- The USPSTF concludes that the evidence is insufficient to recommend for or against routine CBE alone to screen for breast cancer.

Rating: I recommendation.

Rationale: No screening trial has examined the benefits of CBE alone (without accompanying mammography) compared to no screening, and design characteristics limit the generalizability of studies that have examined CBE. The USPSTF could not determine the benefits of CBE alone or the incremental benefit of adding CBE to mammography. The USPSTF therefore could not determine whether potential benefits of routine CBE outweigh the potential harms.

-- The USPSTF concludes that the evidence is insufficient to recommend for or against teaching or performing routine breast self-examination (BSE).

Rating: I recommendation.

Rationale: The USPSTF found poor evidence to determine whether BSE reduces breast cancer mortality. The USPSTF found fair evidence that BSE is associated with an increased risk for false-positive results and biopsies. Due to design limitations of published and ongoing studies of BSE, the USPSTF could not determine the balance of benefits and potential harms of BSE.

-- The U.S. Preventive Services Task Force (USPSTF) recommends screening and behavioral counseling interventions to reduce alcohol misuse (go to Clinical Considerations) by adults, including pregnant women, in primary care settings.

Rating: B Recommendation.

Rationale: The USPSTF found good evidence that screening in primary care settings can accurately identify patients whose levels or patterns of alcohol consumption do not meet criteria for alcohol dependence, but place them at risk for increased morbidity and mortality, and good evidence that brief behavioral counseling interventions with followup produce small to moderate reductions in alcohol consumption that are sustained over 6- to 12-month periods or longer. The USPSTF found some evidence that interventions lead to positive health outcomes 4 or more years post-intervention, but found limited evidence that screening and behavioral counseling reduce alcohol-related morbidity. The evidence on the effectiveness of counseling to reduce alcohol consumption during pregnancy is limited; however, studies in the general adult population show that behavioral counseling interventions are effective among women of childbearing age. The USPSTF concluded that the benefits of behavioral counseling interventions to reduce alcohol misuse by adults outweigh any potential harms.

-- The USPSTF concludes that the evidence is insufficient to recommend for or against screening and behavioral counseling interventions to prevent or reduce alcohol misuse by adolescents in primary care settings.

Rating: I Recommendation.

Rationale: The USPSTF found limited evidence evaluating the effectiveness of screening and behavioral counseling interventions in primary care settings to prevent or reduce alcohol misuse by adolescents. The USPSTF concluded that the evidence is insufficient to assess the potential benefits and harms of screening and behavioral counseling interventions in this population.

-- The U.S. Preventive Services Task Force (USPSTF) strongly recommends that clinicians screen adults aged 18 and older for high blood pressure.

Ratings: A recommendation.

Rationale: The USPSTF found good evidence that blood pressure measurement can identify adults at increased risk for cardiovascular disease due to high blood pressure, and good evidence that treatment of high blood pressure substantially decreases the incidence of cardiovascular disease and causes few major harms. The USPSTF concludes the benefits of screening for, and treating, high blood pressure in adults substantially outweigh the harms.

-- The USPSTF concludes that the evidence is insufficient to recommend for or against routine screening for high blood pressure in children and adolescents to reduce the risk of cardiovascular disease.

Ratings: I recommendation.

Rationale: The USPSTF found poor evidence that routine blood pressure measurement accurately identifies children and adolescents at increased risk for cardiovascular disease, and poor evidence to determine whether treatment of elevated blood pressure in children or adolescents decreases the incidence of cardiovascular disease. As a result, the USPSTF could not determine the balance of benefits and harms of routine screening for high blood pressure in children and adolescents.

-- The U.S. Preventive Services Task Force (USPSTF) recommends screening adults for depression in clinical practices that have systems in place to assure accurate diagnosis, effective treatment, and followup.

Rating: B recommendation.

Rationale: The USPSTF found good evidence that screening improves the accurate identification of depressed patients in primary care settings and that treatment of depressed adults identified in primary care settings decreases clinical morbidity. Trials that have directly evaluated the effect of screening on clinical outcomes have shown mixed results. Small benefits have been observed in studies that simply feed back screening results to clinicians. Larger benefits have been observed in studies in which the communication of screening results is coordinated with effective followup and treatment. The USPSTF concluded the benefits of screening are likely to outweigh any potential harms.

-- The USPSTF concludes the evidence is insufficient to recommend for or against routine screening of children or adolescents for depression.

Rating: I Recommendation.

Rationale: The USPSTF found limited evidence on the accuracy and reliability of screening tests in children and adolescents and limited evidence on the effectiveness of therapy in children and adolescents identified in primary care settings.

-- The USPSTF recommends that clinicians screen all adult patients for obesity and offer intensive counseling and behavioral interventions to promote sustained weight loss for obese adults.

Rating: B Recommendation.

Rationale: 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. There is fair to good evidence that high-intensity counseling—about diet, exercise, or both—together with behavioral interventions aimed at skill development, motivation, and support strategies produces modest, sustained weight loss (typically 3-5 kg for 1 year or more) in adults who are obese (as defined by BMI > 30 kg/m2). Although the USPSTF did not find direct evidence that behavioral interventions lower mortality or morbidity from obesity, the USPSTF concluded that changes in intermediate outcomes, such as improved glucose metabolism, lipid levels, and blood pressure, from modest weight loss provide indirect evidence of health benefits. No evidence was found that addressed the harms of counseling and behavioral interventions. The USPSTF concluded that the benefits of screening and behavioral interventions outweigh potential harms.

-- The USPSTF concludes that the evidence is insufficient to recommend for or against the use of moderate- or low-intensity counseling together with behavioral interventions to promote sustained weight loss in obese adults.

Rating: I Recommendation.

Rationale: The USPSTF found limited evidence to determine whether moderate- or low-intensity counseling with behavioral interventions produces sustained weight loss in obese (as defined by BMI > 30 kg/m2) adults. The relevant studies were of fair to good quality but showed mixed results. In addition, studies were limited by small sample sizes, high drop-out rates, potential for selection bias, and reporting the average weight change instead of the frequency of response to the intervention. As a result, the USPSTF could not determine the balance of benefits and potential harms of these types of interventions.

-- The USPSTF concludes that the evidence is insufficient to recommend for or against the use of counseling of any intensity and behavioral interventions to promote sustained weight loss in overweight adults.

Rating: I Recommendation.

Rationale: The USPSTF found limited data that addressed the efficacy of counseling-based interventions in overweight adults (as defined by BMI from 25-29.9 kg/m2). As a result, the USPSTF could not determine the balance of benefits and potential harms of counseling to promote sustained weight loss in overweight adults.

-- The U.S. Preventive Services Task Force (USPSTF) strongly recommends that clinicians routinely screen men aged 35 years and older and women aged 45 years and older for lipid disorders and treat abnormal lipids in people who are at increased risk of coronary heart disease.

Rating: A recommendation.

Rationale: The USPSTF found good evidence that lipid measurement can identify asymptomatic middle-aged people at increased risk of coronary heart disease and good evidence that lipid-lowering drug therapy substantially decreases the incidence of coronary heart disease in such people with abnormal lipids and causes few major harms. The USPSTF concludes that the benefits of screening for and treating lipid disorders in middle-aged and older people substantially outweigh harms.

-- The USPSTF recommends that clinicians routinely screen younger adults (men aged 20 to 35 and women aged 20 to 45) for lipid disorders if they have other risk factors for coronary heart disease. (Go to Clinical Considerations for discussion of risk factors.)

Rating: B recommendation.

Rationale: The USPSTF found good evidence that lipid measurement can identify younger people at increased risk for coronary heart disease, that risk is highest in those with other risk factors, and that the absolute benefits of lipid-lowering treatment depend on a person's underlying risk of coronary heart disease. The USPSTF concludes that benefits of screening for and treating high-risk young adults outweigh harms.

-- The USPSTF makes no recommendation for or against routine screening for lipid disorders in younger adults (men aged 20 to 35 or women aged 20 to 45) in the absence of known risk factors for coronary heart disease.

Rating: C recommendation.

Rationale: The USPSTF found good evidence that lipid measurement in low-risk young adults can detect some individuals at increased long-term risk of heart disease, but the absolute reduction in risk as a result of treating dyslipidemia in most people is small before middle age. Fair evidence suggests that a substantial proportion of the benefits of treatment may be realized within 5 years of initiating therapy. The USPSTF concludes the net benefits of screening for lipid disorders in low-risk young people are not sufficient to make a general recommendation.

-- The USPSTF recommends that screening for lipid disorders include measurement of total cholesterol (TC) and high-density lipoprotein cholesterol (HDL-C).

Rating: B recommendation.

Rationale: The USPSTF found good evidence that measurement of HDL-C along with TC improves the identification of people at increased risk of cardiovascular disease. Good evidence from randomized trials demonstrates that people with low HDL-C without high TC benefit from treatment.

-- The USPSTF concludes that the evidence is insufficient to recommend for or against triglyceride measurement as a part of routine screening for lipid disorders.

Rating: I recommendation.

Rationale: Evidence that elevated triglyceride level is an independent risk factor for heart disease is conflicting, and prospective data are lacking to determine whether including triglyceride is more effective for screening than simply measuring TC and HDL-C.

-- The USPSTF strongly recommends that clinicians screen all adults for tobacco use and provide tobacco cessation interventions for those who use tobacco products.

Rating: A Recommendation.

Rationale: The USPSTF found good evidence that brief smoking cessation interventions, including screening, brief behavioral counseling (less than 3 minutes), and pharmacotherapy delivered in primary care settings, are effective in increasing the proportion of smokers who successfully quit smoking and remain abstinent after 1 year. Although most smoking cessation trials do not provide direct evidence of health benefits, the USPSTF found good evidence that smoking cessation lowers the risk for heart disease, stroke, and lung disease. The USPSTF concluded that there is good indirect evidence that even small increases in the quit rates from tobacco cessation counseling would produce important health benefits, and that the benefits of counseling interventions substantially outweigh any potential harms.

Summary of Recommendations

* The U.S. Preventive Services Task Force (USPSTF) recommends that women aged 65 and older be screened routinely for osteoporosis. The USPSTF recommends that routine screening begin at age 60 for women at increased risk for osteoporotic fractures (select Clinical Considerations for discussion of women at increased risk).

Rating: B Recommendation.

Rationale: The USPSTF found good evidence that the risk for osteoporosis and fracture increases with age and other factors, that bone density measurements accurately predict the risk for fractures in the short-term, and that treating asymptomatic women with osteoporosis reduces their risk for fracture. The USPSTF concludes that the benefits of screening and treatment are of at least moderate magnitude for women at increased risk by virtue of age or presence of other risk factors.

* The USPSTF makes no recommendation for or against routine osteoporosis screening in postmenopausal women who are younger than 60 or in women aged 60-64 who are not at increased risk for osteoporotic fractures.

Rating: C Recommendation.

Rationale: The USPSTF found fair evidence that screening women at lower risk for osteoporosis or fracture can identify additional women who may be eligible for treatment for osteoporosis, but it would prevent a small number of fractures. The USPSTF concludes that the balance of benefits and harms of screening and treatment is too close to make a general recommendation for this age group.

The U.S. Preventive Services Task Force (USPSTF) strongly recommends that clinicians discuss aspirin chemoprevention with adults who are at increased risk for coronary heart disease (CHD) (go to Clinical Considerations). Discussions with patients should address both the potential benefits and harms of aspirin therapy.

Rating: A recommendation.

Rationale: The USPSTF found good evidence that aspirin decreases the incidence of coronary heart disease in adults who are at increased risk for heart disease. They also 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 the balance of benefits and harms is most favorable in patients at high risk of CHD (5-year risk of greater than or equal to 3 percent) but is also influenced by patient preferences.

Although the optimal timing and frequency of discussions related to aspirin therapy are unknown, reasonable options include every 5 years in middle-aged and older people or when other cardiovascular risk factors are detected.

Clinical Considerations

* Decisions about aspirin therapy should take into account overall risk for coronary heart disease. Risk assessment should include asking about the presence and severity of the following risk factors: age, sex, diabetes, elevated total cholesterol levels, low levels of high-density lipoprotein (HDL) cholesterol, elevated blood pressure, family history (in younger adults), and smoking. Tools that incorporate specific information on multiple risk factors provide more accurate estimation of cardiovascular risk than categorizations based simply on counting the numbers of risk factors (http://www.intmed.mcw.edu/clincalc/heartrisk.html).2

* Men older than 40 years, postmenopausal women, and younger people with risk factors for coronary heart disease (eg, hypertension, diabetes, or smoking) are at increased risk for heart disease and may wish to consider aspirin therapy. Table 1 shows how estimates of the type and magnitude of benefits and harms associated with aspirin therapy vary with an individual's underlying risk for coronary heart disease. Although balance of benefits and harms is most favorable in high-risk people (5-year risk greater than 3 percent), some people at lower risk may consider the potential benefits of aspirin to be sufficient to outweigh the potential harms.

* Discussions about aspirin therapy should focus on potential coronary heart disease benefits, such as prevention of myocardial infarction, and potential harms, such as gastrointestinal and intracranial bleeding. Discussions should take into account individual preferences and risk aversions concerning myocardial infarction, stroke, and gastrointestinal bleeding.

* Although the optimal timing and frequency of discussions related to aspirin therapy are unknown, reasonable options include every 5 years in middle-aged and older people or when other cardiovascular risk factors are detected.

* Most participants in the primary prevention trials of aspirin therapy have been men between 40 and 75 years of age. Current estimates of benefits and harms may not be as reliable for women and older men.

* Although older patients may derive greater benefits because they are at higher risk for CHD and stroke, their risk for bleeding may be higher.

* Uncontrolled hypertension may attenuate the benefits of aspirin in reducing CHD.

* The optimum dose of aspirin for chemoprevention is not known. Primary and secondary prevention trials have demonstrated benefits with a variety of regimens, including 75 mg per day, 100 mg per day, and 325 mg every other day. Doses of approximately 75 mg per day appear as effective as higher doses; whether doses below 75 mg per day are effective has not been established. Enteric-coated or buffered preparations do not clearly reduce adverse gastrointestinal effects of aspirin. Uncontrolled hypertension and concomitant use of other nonsteroidal anti-inflammatory agents or anticoagulants increase risk for serious bleeding.

Although the optimal timing and frequency of discussions related to aspirin therapy are unknown, reasonable options include every 5 years in middle-aged and older people or when other cardiovascular risk factors are detected.

No studies have evaluated the optimal intervals for repeated screening. Because of limitations in the precision of testing, a minimum of 2 years may be needed to reliably measure a change in bone mineral density; however, longer intervals may be adequate for repeated screening to identify new cases of osteoporosis. Yield of repeated screening will be higher in older women, those with lower BMD at baseline, and those with other risk factors for fracture.

There are no data to determine the appropriate age to stop screening and few data on osteoporosis treatment in women older than 85. Patients who receive a diagnosis of osteoporosis fall outside the context of screening but may require additional testing for diagnostic purposes or to monitor response to treatment.

Routine vision screening with Snellen acuity testing is recommended for elderly persons ("B" recommendation). The optimal frequency for screening is not known and is left to clinical discretion. Selected questions about vision may also be helpful in detecting vision problems in elderly persons, but they do not appear as sensitive or specific as direct assessment of acuity. There is insufficient evidence to recommend for or against routine screening with ophthalmoscopy by the primary care physician in asymptomatic elderly patients ("C" recommendation).

Screening for older adults for hearing impairment is recommended through:

* Periodically questioning them about their hearing.

* Counseling them about the availability of hearing aid devices.

* Making referrals for abnormalities when appropriate.

There is insufficient evidence to recommend for or against routinely screening asymptomatic adolescents and working-age adults for hearing impairment. Recommendations against such screening, except for those exposed to excessive occupational noise levels, may be made on other grounds.

-- The U.S. Preventive Services Task Force (USPSTF) strongly recommends that clinicians routinely screen all sexually active women aged 25 years and younger, and other asymptomatic women at increased risk for infection, for chlamydial infection (see Clinical Considerations for discussion of risk factors).

Rating: A recommendation.

Rationale: The USPSTF found good evidence that screening women at risk for chlamydial infection reduces the incidence of pelvic inflammatory disease and fair evidence that community-based screening reduces prevalence of chlamydial infection. The USPSTF concludes that the benefits of screening substantially outweigh the potential harms. (select Potential Adverse Effects of Screening for discussion of potential harms.)

-- The USPSTF concludes that the evidence is insufficient to recommend for or against routinely screening asymptomatic men for chlamydial infection.

Rating: I recommendation.

Rationale: No direct evidence was found to determine whether screening asymptomatic men for chlamydial infection is effective for reducing the incidence of new infections in women. The benefits and harms of screening men cannot be determined, but the potential magnitude of benefits could be large if the effectiveness of screening men can be demonstrated.

-- Routine screening for Neisseria gonorrhoeae is recommended for:

Asymptomatic women at high risk of infection.

All high-risk women should be screened during pregnancy.

There is insufficient evidence to recommend for or against screening all pregnant women, or screening asymptomatic men. Recommendations to screen selected high-risk young men may be made on other grounds.

Routine screening is not recommended for the general adult population U.S. Preventive Services Task Force Recommendation.

USPSTF Chart of Normal-Risk Adult Recommendations