Recommendations
Major Recommendations
Note from the National Guideline Clearinghouse (NGC) and the U.S. Preventive Services Task Force (USPSTF):
On December 4, 2009, the USPSTF unanimously voted to update the
language of their recommendation regarding women under 50 years of age
to clarify their original and continued intent. The following
recommendations reflect that change.
The U.S. Preventive Services Task Force (USPSTF) grades its recommendations (A, B, C, D, or I) and identifies the Levels of Certainty regarding Net Benefit (High, Moderate, and Low). The definitions of these grades can be found at the end of the "Major Recommendations" field.
Summary of Recommendations and Evidence
Patient Population Under Consideration
This recommendation statement applies to women 40 years or older who are not at increased risk for breast cancer by virtue of a known underlying genetic mutation or a history of chest radiation.
Assessment of Risk
Increasing age is the most important risk factor for breast cancer for most women. Women without known deleterious genetic mutations (such as BRCA1 or BRCA2) may still have other demographic, physical, or historical risk factors for breast cancer, but none convey a clinically important absolute increased risk for cancer.
Screening Tests
In recent decades, the early detection of breast cancer has been accomplished by physical examination by a clinician (CBE), by a woman herself (BSE), or by mammography. Standardization of mammography practices enacted by the Mammography Quality Standards Act have led to improved mammography quality. Clinicians should refer patients to Mammography Quality Standards Act–certified facilities, a listing of which is available at www.fda.gov/cdrh/mammography/certified.html.
Screening Intervals
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.
Treatment
Effective treatments, including radiation, chemotherapy (including hormonal treatment), and surgery, are available for invasive carcinoma. Although the standard treatments women receive for ductal carcinoma in situ (DCIS) include surgical approaches as well as radiation and hormonal therapy, considerable debate exists about the optimal treatment strategy for this condition.
Considerations for Practice Regarding I Statements
Clinical Breast Examination
Potential Preventable Burden. The evidence for CBE, although indirect, suggests that CBE may detect a substantial proportion of cases of cancer if it is the only screening test available. In parts of the world where mammography is infeasible or unavailable (such as India), CBE is being investigated in this way.
Potential Harms. The potential harms of CBE are thought to be small but include false-positive test results, which lead to anxiety and breast cancer worry, as well as repeated visits and unwarranted imaging and biopsies.
Costs. The principal cost of CBE is the opportunity cost incurred by clinicians in the patient encounter.
Current Practice. Surveys suggest that the CBE technique used in the United States currently lacks a standard approach and reporting standards. Clinicians who are committed to spending the time on CBE would benefit their patients by considering the evidence in favor of a structured, standardized examination.
Digital Mammography
Potential Preventable Burden. Digital mammography detects some cases of cancer not identified by film mammography; film mammography detects some cases of cancer not identified by digital mammography. Overall detection is similar for many women. For women who are younger than 50 years or have dense breast tissue, overall detection is somewhat higher with digital mammography. It is not clear whether this additional detection would lead to reduced mortality from breast cancer.
Potential Harms. The possibility of false-positive test results is similar for film and digital mammography. It is uncertain whether overdiagnosis occurs more with digital mammography than with film mammography.
Costs. Digital mammography is more expensive than film mammography.
Current Practice. Some clinical practices are now switching their mammography equipment from film to digital. This may curtail the availability of film mammography in some areas.
Magnetic Resonance Imaging
Potential Preventable Burden. Studies of the use of contrast-enhanced MRI for breast cancer screening have been conducted only in very high-risk populations. In these studies, MRI detected more cases of cancer than did mammography. It is unknown whether detecting these additional cases of cancer would lead to reduced breast cancer mortality.
Potential Harms. Contrast-enhanced MRI requires the injection of contrast material. Studies of MRI screening have shown that MRI yields many more false-positive results than does mammography. Magnetic resonance imaging has the potential to be associated with a greater degree of overdiagnosis than mammography.
Costs. Magnetic resonance imaging is much more expensive than either film or digital mammography.
Current Practice. Magnetic resonance imaging is not currently used for screening women at average risk for breast cancer.
Screening Mammography in Women 75 Years or Older
Potential Preventable Burden. No women 75 years or older have been included in the multiple randomized clinical trials of breast cancer screening. Breast cancer is a leading cause of death in older women, which might suggest that the benefits of screening could be important at this age. However, 3 facts suggest that benefits from screening would probably be smaller for this age group than for women aged 60 to 69 years and probably decrease with increasing age: 1) the benefits of screening only occur several years after the actual screening test, whereas the percentage of women who survive long enough to benefit decreases with age; 2) a higher percentage of the type of breast cancer detected in this age group is the more easily treated estrogen receptor–positive type; and 3) women of this age are at much greater risk for dying of other conditions that would not be affected by breast cancer screening.
Potential Harms. Screening detects not only cancer that could lead to a woman’s death but also cancer that will not shorten a woman's life. Women cannot benefit from—but can be harmed by—the discovery and treatment of this second type of cancer, which includes both cancer that might someday become clinically apparent and cancer that never will. Detection of cancer that would never have become clinically apparent is called overdiagnosis, and it is usually followed by overtreatment. Because of a shortened life span among women 75 years or older, the probability of overdiagnosis and unnecessary earlier treatment increases dramatically after about age 70 or 75 years. Overdiagnosis and unnecessary earlier treatment are important potential harms from screening women in this age group.
Current Practice. Studies show that many women 75 years or older are currently being screened.
Useful Resources
Other USPSTF recommendations on screening for genetic susceptibility for breast cancer and chemoprevention of breast cancer are available on the Agency for Healthcare Research and Quality Web site (www.preventiveservices.ahrq.gov).
Definitions:
What the United States Preventive Services Task Force (USPSTF) Grades Mean and Suggestions for Practice
USPSTF Levels of Certainty Regarding Net Benefit
Definition: The U.S. Preventive Services Task Force defines certainty as "likelihood that the USPSTF assessment of the net benefit of a preventive service is correct." The net benefit is defined as benefit minus harm of the preventive service as implemented in a general, primary care population. The USPSTF assigns a certainty level based on the nature of the overall evidence available to assess the net benefit of a preventive service.
The U.S. Preventive Services Task Force (USPSTF) grades its recommendations (A, B, C, D, or I) and identifies the Levels of Certainty regarding Net Benefit (High, Moderate, and Low). The definitions of these grades can be found at the end of the "Major Recommendations" field.
Summary of Recommendations and Evidence
- The USPSTF recommends biennial screening mammography for women aged 50 to 74 years. This is a B recommendation.
- The decision to start regular, biennial screening mammography before the age of 50 years should be an individual one and take patient context into account, including the patient’s values regarding specific benefits and harms. This is a C recommendation.
- The USPSTF concludes that the current evidence is insufficient to assess the additional benefits and harms of screening mammography in women 75 years or older. This is an I statement.
- The USPSTF recommends against teaching breast self-examination (BSE). This is a D recommendation.
- The USPSTF concludes that the current evidence is insufficient to assess the additional benefits and harms of clinical breast examination (CBE) beyond screening mammography in women 40 years or older. This is an I statement.
- The USPSTF concludes that the current evidence is insufficient to assess the additional benefits and harms of either digital mammography or magnetic resonance imaging (MRI) instead of film mammography as screening modalities for breast cancer. This is an I statement.
Patient Population Under Consideration
This recommendation statement applies to women 40 years or older who are not at increased risk for breast cancer by virtue of a known underlying genetic mutation or a history of chest radiation.
Assessment of Risk
Increasing age is the most important risk factor for breast cancer for most women. Women without known deleterious genetic mutations (such as BRCA1 or BRCA2) may still have other demographic, physical, or historical risk factors for breast cancer, but none convey a clinically important absolute increased risk for cancer.
Screening Tests
In recent decades, the early detection of breast cancer has been accomplished by physical examination by a clinician (CBE), by a woman herself (BSE), or by mammography. Standardization of mammography practices enacted by the Mammography Quality Standards Act have led to improved mammography quality. Clinicians should refer patients to Mammography Quality Standards Act–certified facilities, a listing of which is available at www.fda.gov/cdrh/mammography/certified.html.
Screening Intervals
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.
Treatment
Effective treatments, including radiation, chemotherapy (including hormonal treatment), and surgery, are available for invasive carcinoma. Although the standard treatments women receive for ductal carcinoma in situ (DCIS) include surgical approaches as well as radiation and hormonal therapy, considerable debate exists about the optimal treatment strategy for this condition.
Considerations for Practice Regarding I Statements
Clinical Breast Examination
Potential Preventable Burden. The evidence for CBE, although indirect, suggests that CBE may detect a substantial proportion of cases of cancer if it is the only screening test available. In parts of the world where mammography is infeasible or unavailable (such as India), CBE is being investigated in this way.
Potential Harms. The potential harms of CBE are thought to be small but include false-positive test results, which lead to anxiety and breast cancer worry, as well as repeated visits and unwarranted imaging and biopsies.
Costs. The principal cost of CBE is the opportunity cost incurred by clinicians in the patient encounter.
Current Practice. Surveys suggest that the CBE technique used in the United States currently lacks a standard approach and reporting standards. Clinicians who are committed to spending the time on CBE would benefit their patients by considering the evidence in favor of a structured, standardized examination.
Digital Mammography
Potential Preventable Burden. Digital mammography detects some cases of cancer not identified by film mammography; film mammography detects some cases of cancer not identified by digital mammography. Overall detection is similar for many women. For women who are younger than 50 years or have dense breast tissue, overall detection is somewhat higher with digital mammography. It is not clear whether this additional detection would lead to reduced mortality from breast cancer.
Potential Harms. The possibility of false-positive test results is similar for film and digital mammography. It is uncertain whether overdiagnosis occurs more with digital mammography than with film mammography.
Costs. Digital mammography is more expensive than film mammography.
Current Practice. Some clinical practices are now switching their mammography equipment from film to digital. This may curtail the availability of film mammography in some areas.
Magnetic Resonance Imaging
Potential Preventable Burden. Studies of the use of contrast-enhanced MRI for breast cancer screening have been conducted only in very high-risk populations. In these studies, MRI detected more cases of cancer than did mammography. It is unknown whether detecting these additional cases of cancer would lead to reduced breast cancer mortality.
Potential Harms. Contrast-enhanced MRI requires the injection of contrast material. Studies of MRI screening have shown that MRI yields many more false-positive results than does mammography. Magnetic resonance imaging has the potential to be associated with a greater degree of overdiagnosis than mammography.
Costs. Magnetic resonance imaging is much more expensive than either film or digital mammography.
Current Practice. Magnetic resonance imaging is not currently used for screening women at average risk for breast cancer.
Screening Mammography in Women 75 Years or Older
Potential Preventable Burden. No women 75 years or older have been included in the multiple randomized clinical trials of breast cancer screening. Breast cancer is a leading cause of death in older women, which might suggest that the benefits of screening could be important at this age. However, 3 facts suggest that benefits from screening would probably be smaller for this age group than for women aged 60 to 69 years and probably decrease with increasing age: 1) the benefits of screening only occur several years after the actual screening test, whereas the percentage of women who survive long enough to benefit decreases with age; 2) a higher percentage of the type of breast cancer detected in this age group is the more easily treated estrogen receptor–positive type; and 3) women of this age are at much greater risk for dying of other conditions that would not be affected by breast cancer screening.
Potential Harms. Screening detects not only cancer that could lead to a woman’s death but also cancer that will not shorten a woman's life. Women cannot benefit from—but can be harmed by—the discovery and treatment of this second type of cancer, which includes both cancer that might someday become clinically apparent and cancer that never will. Detection of cancer that would never have become clinically apparent is called overdiagnosis, and it is usually followed by overtreatment. Because of a shortened life span among women 75 years or older, the probability of overdiagnosis and unnecessary earlier treatment increases dramatically after about age 70 or 75 years. Overdiagnosis and unnecessary earlier treatment are important potential harms from screening women in this age group.
Current Practice. Studies show that many women 75 years or older are currently being screened.
Useful Resources
Other USPSTF recommendations on screening for genetic susceptibility for breast cancer and chemoprevention of breast cancer are available on the Agency for Healthcare Research and Quality Web site (www.preventiveservices.ahrq.gov).
Definitions:
What the United States Preventive Services Task Force (USPSTF) Grades Mean and Suggestions for Practice
| Grade | Grade Definitions | Suggestions for Practice |
|---|---|---|
| A | The USPSTF recommends the service. There is high certainty that the net benefit is substantial. | Offer or provide this service. |
| B | The USPSTF recommends the service. There is high certainty that the net benefit is moderate or there is moderate certainty that the net benefit is moderate to substantial. | Offer or provide this service. |
| C | The USPSTF recommends against routinely providing the service. There may be considerations that support providing the service in an individual patient. There is moderate or high certainty that the net benefit is small. | Offer or provide this service only if other considerations support offering or providing the service in an individual patient. |
| D | The USPSTF recommends against the service. There is moderate or high certainty that the service has no net benefit or that the harms outweigh the benefits. | Discourage the use of this service. |
| I Statement |
The USPSTF concludes that the current evidence is insufficient to assess the balance of benefits and harms of the service. Evidence is lacking, of poor quality, or conflicting, and the balance of benefits and harms cannot be determined. | Read "Clinical Considerations" section of USPSTF Recommendation Statement (see "Major Recommendations" field). If this service is offered, patients should understand the uncertainty about the balance of benefits and harms. |
Definition: The U.S. Preventive Services Task Force defines certainty as "likelihood that the USPSTF assessment of the net benefit of a preventive service is correct." The net benefit is defined as benefit minus harm of the preventive service as implemented in a general, primary care population. The USPSTF assigns a certainty level based on the nature of the overall evidence available to assess the net benefit of a preventive service.
| Level of Certainty | Description |
|---|---|
| High | The available evidence usually includes consistent results from well-designed, well-conducted studies in representative primary care populations. These studies assess the effects of the preventive service on health outcomes. This conclusion is therefore unlikely to be strongly affected by the results of future studies. |
| Moderate | The available evidence is sufficient to
determine the effects of the preventive service on health outcomes, but
confidence in the estimate is constrained by factors such as:
|
| Low | The available evidence is insufficient to assess effects on health outcomes. Evidence is insufficient because of:
|
Clinical Algorithm(s)
None available
Evidence Supporting the Recommendations
Type of Evidence Supporting the Recommendations
The type of supporting evidence is not specifically stated for each recommendation.
Benefits/Harms of Implementing the Guideline Recommendations
Potential Benefits
Benefits of Detection and Early Intervention
- 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 breast self-examination (BSE) does not reduce breast cancer mortality.
- The evidence for additional effects of clinical breast examination (CBE) beyond mammography on breast cancer mortality is inadequate.
- The evidence for benefits of digital mammography and magnetic resonance imaging (MRI) of the breast, as a substitute for film mammography, is also lacking.
Potential Harms
Harms of Detection and Early Intervention
- The harms resulting from screening for breast cancer include psychological harms, unnecessary imaging tests and biopsies in women without cancer, and inconvenience due to false-positive screening results. Furthermore, one must also consider the harms associated with treatment of cancer that would not become clinically apparent during a woman's lifetime (overdiagnosis), as well as the harms of unnecessary earlier treatment of breast cancer that would have become clinically apparent but would not have shortened a woman’s life. Radiation exposure (from radiologic tests), although a minor concern, is also a consideration.
- Adequate evidence suggests that the overall harms associated with mammography are moderate for every age group considered, although the main components of the harms shift over time. Although false-positive test results, overdiagnosis, and unnecessary earlier treatment are problems for all age groups, false positive results are more common for women aged 40 to 49 years, whereas overdiagnosis is a greater concern for women in the older age groups.
- There is adequate evidence that teaching breast self-examination (BSE) is associated with harms that are at least small. There is inadequate evidence concerning harms of clinical breast examination (CBE).
Qualifying Statements
Qualifying Statements
- The U.S. Preventive Services Task Force (USPSTF) makes recommendations about preventive care services for patients without recognized signs or symptoms of the target condition.
- Recommendations are based on a systematic review of the evidence of the benefits and harms and an assessment of the net benefit of the service.
- The USPSTF recognizes that clinical or policy decisions involve more considerations than this body of evidence alone. Clinicians and policy-makers should understand the evidence but individualize decision making to the specific patient or situation.
Implementation of the Guideline
Description of Implementation Strategy
The
experiences of the first and second U.S. Preventive Services Task Force
(USPSTF), as well as that of other evidence-based guideline efforts,
have highlighted the importance of identifying effective ways to
implement clinical recommendations. Practice guidelines are relatively
weak tools for changing clinical practice when used in isolation. To
effect change, guidelines must be coupled with strategies to improve
their acceptance and feasibility. Such strategies include enlisting the
support of local opinion leaders, using reminder systems for clinicians
and patients, adopting standing orders, and audit and feedback of
information to clinicians about their compliance with recommended
practice.
In the case of preventive services guidelines, implementation needs to go beyond traditional dissemination and promotion efforts to recognize the added patient and clinician barriers that affect preventive care. These include clinicians' ambivalence about whether preventive medicine is part of their job, the psychological and practical challenges that patients face in changing behaviors, lack of access to health care or of insurance coverage for preventive services for some patients, competing pressures within the context of shorter office visits, and the lack of organized systems in most practices to ensure the delivery of recommended preventive care.
Dissemination strategies have changed dramatically in this age of electronic information. While recognizing the continuing value of journals and other print formats for dissemination, the Agency for Healthcare Research and Quality will make all U.S. Preventive Services Task Force (USPSTF) products available through its Web site. The combination of electronic access and extensive material in the public domain should make it easier for a broad audience of users to access U.S. Preventive Services Task Force materials and adapt them for their local needs. Online access to U.S. Preventive Services Task Force products also opens up new possibilities for the appearance of the annual, pocket-size Guide to Clinical Preventive Services.
To be successful, approaches for implementing prevention have to be tailored to the local level and deal with the specific barriers at a given site, typically requiring the redesign of systems of care. Such a systems approach to prevention has had notable success in established staff-model health maintenance organizations, by addressing organization of care, emphasizing a philosophy of prevention, and altering the training and incentives for clinicians. Staff-model plans also benefit from integrated information systems that can track the use of needed services and generate automatic reminders aimed at patients and clinicians, some of the most consistently successful interventions. Information systems remain a major challenge for individual clinicians' offices, however, as well as for looser affiliations of practices in network-model managed care and independent practice associations, where data on patient visits, referrals, and test results are not always centralized.
In the case of preventive services guidelines, implementation needs to go beyond traditional dissemination and promotion efforts to recognize the added patient and clinician barriers that affect preventive care. These include clinicians' ambivalence about whether preventive medicine is part of their job, the psychological and practical challenges that patients face in changing behaviors, lack of access to health care or of insurance coverage for preventive services for some patients, competing pressures within the context of shorter office visits, and the lack of organized systems in most practices to ensure the delivery of recommended preventive care.
Dissemination strategies have changed dramatically in this age of electronic information. While recognizing the continuing value of journals and other print formats for dissemination, the Agency for Healthcare Research and Quality will make all U.S. Preventive Services Task Force (USPSTF) products available through its Web site. The combination of electronic access and extensive material in the public domain should make it easier for a broad audience of users to access U.S. Preventive Services Task Force materials and adapt them for their local needs. Online access to U.S. Preventive Services Task Force products also opens up new possibilities for the appearance of the annual, pocket-size Guide to Clinical Preventive Services.
To be successful, approaches for implementing prevention have to be tailored to the local level and deal with the specific barriers at a given site, typically requiring the redesign of systems of care. Such a systems approach to prevention has had notable success in established staff-model health maintenance organizations, by addressing organization of care, emphasizing a philosophy of prevention, and altering the training and incentives for clinicians. Staff-model plans also benefit from integrated information systems that can track the use of needed services and generate automatic reminders aimed at patients and clinicians, some of the most consistently successful interventions. Information systems remain a major challenge for individual clinicians' offices, however, as well as for looser affiliations of practices in network-model managed care and independent practice associations, where data on patient visits, referrals, and test results are not always centralized.
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