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Questions & Answers
Why is the U.S. Preventive Services Task Force (Task Force) updating its breast cancer screening recommendation again now?
The Task Force bases its recommendations on the current evidence about preventive services. Recognizing that science and medicine are constantly advancing, the Task Force is committed to updating its recommendations on a regular basis. To keep its recommendations useful to health care professionals and the public, the Task Force aims to update each of its recommendations about every 5 years. (If major new studies are published, the Task Force sometimes chooses to update a recommendation earlier.) The Task Force last reviewed the evidence on screening for breast cancer in 2009. It is time for the Task Force to review the literature and update its recommendation.
Is the Task Force about to make a new recommendation on screening for breast cancer?
No. The Task Force is in the process of updating its breast cancer screening recommendation. This takes time. The first stage of its recommendation process was the development of the draft research plan, which guides the evidence to be collected and reviewed for a topic, and posting it for public comment. Now that the research plan has been finalized, the Task Force will review the evidence. Once the evidence has been reviewed, the Task Force will begin to develop an updated draft recommendation statement.
Research Plan Development
How does the research plan fit into the recommendation process?
The Task Force bases its recommendations on a rigorous, systematic review of the available scientific evidence on each topic. In order to make a recommendation, the Task Force first develops a research plan to guide which evidence will be collected and reviewed for a topic. Getting the framework and specific research questions right at the beginning of the process ensures that the Task Force has the best evidence when developing recommendations. This also helps ensure that recommendations are valid, reliable, and useful to patients, families, and clinicians.
What does a research plan contain?
The heart of the research plan is an analytic framework that describes how a clinical preventive service could lead to improved health outcomes, as well as any potential harms that could also accompany its use. The research plan also specifies the key questions that will be systematically reviewed. Finally, the research plan contains details about what types of research studies will be included and excluded from the systematic review.
What does the research plan for screening for breast cancer contain?
The research plan will examine evidence regarding the benefits and harms of screening for breast cancer in women, including:
- The benefits of breast cancer screening via mammography, magnetic resonance imaging (MRI), ultrasound, and newer technologies, such as 3-D mammography, on important outcomes, including preventing death from breast cancer, reducing rates of advanced breast cancer, and improving quality of life.
- The potential harms of breast cancer screening, such as overdiagnosis and resulting overtreatment, false-positive and false-negative test results, and adverse effects related to breast cancer treatment.
- How screening benefits and harms may vary by age, a woman's individual risk factors, and time between examinations.
- Issues surrounding the medical care of women who have a mammogram that shows they have dense breast tissue, but otherwise negative mammography results.
The review will include both randomized, controlled trials and observational studies.
Does the Task Force typically look at observational studies?
Yes. The Task Force commonly looks at observational studies as it examines the harms and benefits of a particular preventive service. In the case of the recommendation on screening for breast cancer, many trials that examine the effectiveness of mammography screening are old; by adding observational studies to its review, it helps the Task Force look at current trends and data.
Who develops the research plan?
Members of the Task Force develop the research plan with help from researchers at an Evidence-based Practice Center (EPC), a research organization that partners with the Task Force in gathering evidence for a recommendation. Once the research plan is finalized, the EPC team uses the plan to guide the systematic evidence review they conduct for the Task Force.
Process and Status of the Recommendation
How does the Task Force make a recommendation?
There are eight steps in the Task Force's process, including:
- Develop Draft Research Plan: Task Force members work with researchers from an EPC to create a draft research plan that guides the recommendation process.
- Public Comment Opportunity: The draft research plan is posted on the Task Force Web site for public comment.
- Finalize Research Plan: The Task Force and EPC review all comments, address them as appropriate, and create a final research plan.
- Develop Draft Evidence Review: Using the final research plan, the research team at the EPC independently gathers and reviews the available published evidence and creates a draft evidence review.
- Develop Draft Recommendation: Task Force members discuss the draft evidence review and deliberate on the certainty of the evidence and the benefits and harms of the service. Based on the discussion, Task Force members create a draft recommendation statement.
- Public Comment Opportunity: The draft recommendation statement and draft evidence review are posted simultaneously on the Task Force Web site for public comment.
- Finalize Recommendation and Evidence Review: The EPC reviews all comments on the draft evidence review, addresses them as appropriate, and creates a final evidence review. The Task Force discusses the final evidence review, including any new evidence. The Task Force then reviews all comments on the draft recommendation statement, addresses them as appropriate, and creates a final recommendation. Members vote to ratify the final recommendation.
- Publish and Disseminate Final Recommendation: The final recommendation statement and supporting final evidence review are posted on the Task Force Web site. Final recommendations are also made available through electronic tools, peer-reviewed journals, and consumer guides. In addition, a final evidence summary is published in a peer-reviewed journal, outlining the evidence the Task Force reviewed.
To learn more about the Task Force's process, you can access the “USPSTF 101” presentation at http://www.uspreventiveservicestaskforce.org/uspstf101_slides/uspstf101.htm.
Did the Task Force review the comments on the draft research plan for screening for breast cancer?
Yes. The Task Force reviewed each and every comment received on the draft research plan and used this feedback to finalize the research plan. The research plan guides the evidence review, which is then used to develop the draft recommendation statement. The final research plan has been posted on the Task Force Web site on the breast cancer topic page: http://www.uspreventiveservicestaskforce.org/breastcancer.htm.
What changed between the draft and final research plan?
In response to the comments received, the Task Force:
- Clarified the target population, risk factors, and definitions of risk.
- Clarified that although the current evidence review is primarily searching for new studies or updates of previous trials published since the last systematic evidence review, the USPSTF, in making its recommendations, always considers the totality of evidence available, not just studies published since the last time a recommendation was made.
- Refined the contextual question concerning a woman's perspective or values when considering breast cancer screening.
- Added questions about the test characteristics of newer screening techniques.
- To address the issue of the medical care of women identified to have dense breast tissue on otherwise negative screening mammograms, the Task Force expanded the scope of the review to:
- Examine the reliability and reproducibility of the Breast Image Reporting and Data System (BI-RADS), a scoring system used to describe breast density as observed on a mammogram.
- Evaluate the test characteristics and effectiveness of supplemental screening on important breast cancer outcomes.
Did the Task Force incorporate all comments into the final research plan?
The Task Force carefully reviewed and considered every comment received. Not all comments resulted in specific changes to the research plan.
Will the Task Force make the public comments available for others to see or review?
The Task Force views the primary purpose of the public comment process as helping it create the most effective and relevant research plan possible. At times, individuals submit personal stories or protected health information as a part of their comments. To protect the privacy of commenters, the Task Force maintains that all comments received will be kept confidential.
However, to help the public better understand how public comment can enhance the recommendation development process, final research plans include a summary of public comment themes. The Task Force hopes that these summaries are informative, and that the public seeks out opportunities to engage with the Task Force and its recommendations.
When will there be a draft recommendation on screening for breast cancer?
The next step after finalizing the research plan is to develop the draft evidence review and draft recommendation statement, which will both be posted for public comment. The Task Force tries to move each topic through the recommendation development process efficiently, while allowing the time necessary to come to a thoughtful, well-informed recommendation. In general, it takes a few years for the Task Force to update a major recommendation.
Will the Task Force's recommendation change?
When the Task Force revisits a topic, it always starts the process without forming any baseline hypotheses, or an idea of what its recommendation will be. The purpose of the research plan is to lay out the questions so that the public and people with an interest in the topic can provide feedback to the Task Force to help ensure that the right questions are being asked and the right studies are being reviewed. The Task Force always looks thoroughly at the existing research to help make an informed recommendation.
One of the purposes of the Task Force is to carefully review the available evidence and explain what it means as a whole to primary care professionals and their patients. Because a research plan is one of the first steps in developing a recommendation, it is too early in the process for the Task Force to know if its recommendation will change.
Current Recommendation on Breast Cancer
What did the Task Force recommend in its 2009 recommendation on screening for breast cancer?
In 2009, the Task Force recommended the use of screening mammography for breast cancer every 2 years in women ages 50 to 74 years.
For women younger than age 50 years, the Task Force stated that the decision to start regular screening mammography for breast cancer should be an individual one, and should take into account a woman's own situation and her values regarding specific benefits and harms. The Task Force did not recommend against mammography for this age group. It recognized that the benefits were smaller for younger women and the harms were potentially greater, and recommended that women make informed decisions about whether breast cancer screening for mammography was right for them.
The Task Force concluded that there was not enough evidence available to draw reliable conclusions about the additional benefits and harms of screening mammography for breast cancer in women age 75 years or older.
The Task Force also concluded that that there was not enough evidence available to draw reliable conclusions about any additional benefits and harms of using either digital mammography or MRI instead of film mammography as screening tests for breast cancer.
The Task Force's recommendation on screening for breast cancer included several additional recommendations. The Task Force recommended that primary care clinicians not teach breast self-examination to women; this recommendation applied specifically to health care professionals providing formal instruction in breast self-examination to patients, and did not mean that women should not be generally aware of their bodies. The Task Force concluded there was not enough evidence available to draw reliable conclusions about the additional benefits and harms of clinical breast examination beyond screening mammography for breast cancer in women age 40 years or older.
These recommendations applied to women without a history of breast cancer and without factors placing them at high risk for developing breast cancer.
To read the full 2009 Task Force recommendation statement on screening for breast cancer, please visit: http://www.uspreventiveservicestaskforce.org/uspstf/uspsbrca.htm.
What did the “C grade” recommendation for women younger than age 50 years really mean?
In 2009, the Task Force gave mammography screening a “C grade” recommendation for women younger than age 50 years. A “grade C” recommendation meant that the Task Force found a small net benefit for this population of women. The Task Force found that while there were benefits to screening, there were also important harms for individual women to consider. The Task Force found that most women in this age range would not benefit from mammography screening, some would, and others would be harmed. The Task Force therefore recommended that women talk with their doctors and nurses and make an individualized, informed decision based on their own health history, values, and personal preferences. The “grade C” recommendation does not mean the Task Force recommended against mammography for women ages 40 to 49 years.
What are the potential harms of screening for breast cancer?
Harms of screening for breast cancer may include overdiagnosis and overtreatment (that is, being diagnosed with and treated for a slow or nongrowing cancer that would not otherwise have become apparent or life-threatening during a woman's lifetime). Harms may also include false-positive test results that lead to unnecessary imaging tests, biopsies, surgeries, and anxiety; false-negative tests and resulting false reassurance; and radiation exposure.
How has the Task Force's recommendation development process changed since the 2009 recommendation?
Since 2009, the Task Force has taken several steps to increase the transparency of its work and continues to pursue opportunities to engage the public in a meaningful way. The Task Force shares draft research plans, draft evidence reviews, and draft recommendations on its Web site for public comment to help make its recommendation statements clearer and more useful for patients and primary care clinicians.
The public is encouraged to read the draft recommendation statements and offer comments on both the findings and the way in which the findings are communicated. Each draft and final recommendation has a consumer fact sheet that explains the draft or final recommendation in plain language. Anyone can sign up for the Task Force's email list to receive email updates and announcements from the Task Force, including when draft recommendations are posted for public comment.
What about the Affordable Care Act and insurance coverage for screening for breast cancer?
Research plans created by the Task Force do not affect coverage requirements for preventive services.
The Task Force's primary concern is the health of Americans, and its recommendations are based on an assessment of the evidence of both the benefits and harms of the service. The Task Force recognizes that insurance coverage decisions involve considerations beyond the clinical benefit.
If you would like more information on health insurance and coverage of preventive services, please visit www.healthcare.gov.
About the Task Force
Who are the Task Force members?
The Task Force has 16 volunteer members who are experts in prevention and evidence-based medicine. They include family physicians, internal medicine physicians, nurses, obstetricians/gynecologists, and pediatricians. They are practicing doctors and nurses, medical directors, deans, professors, and researchers. They are led by a chair and two vice chairs.
For biographies of the current Task Force members, visit: www.uspreventiveservicestaskforce.org/members.htm.
If you have any more questions about the Task Force or its processes, please submit them via this form: http://www.uspreventiveservicestaskforce.org/contact-uspstf/.
Current as of July 2014
Screening for Breast Cancer: Questions & Answers. U.S. Preventive Services Task Force. http://www.uspreventiveservicestaskforce.org/uspstf14/breastcancer/breastcancerfaq.htm