3/21/11 Tabar et al Lancet 2003;361:

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4 Tabar et al Lancet 2003;361:

5 Tabar et al Lancet 2003;361: Tabar Rad Clin NA 2000;38: , via R. Edward Hendrick, PhD, U. Colorado 5

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9 Screening Interval 1 year 36% 46% 44% 2 year 18% 39% 39% 3 year 4% 34% 34% Adapted from Breast-cancer screening with mammography in women aged years. Swedish Cancer Society and the Swedish National Board of Health and Welfare. Int J Cancer 1996;68:

10 Tabar L et al Lancet 2003;361: Walter LC and Covinsky KE. JAMA 2001;285:

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12 BCSC data 12

13 Kerlikowske et al. JNCI 2007; 99:

14 Interval Ca 12 months Interval Ca 24 months Age alone 2.4 (1.1, 4.8) 3.6 (2.2, 6.0) Dense breasts 1.4 (0.6, 3.3) 2.6 (1.5, 4.6) High Mitotic Figure Count 2.3 (1.1, 4.9) 3.0 (1.7, 5.3) High Ki-67 Index 2.3 (1.1, 4.9) 3.0 (1.7, 5.4) 14

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17 Age at Exposure (yrs) Lifetime Incidence of Excess Breast Cancers per 100,000 Excess Breast Cancer Mortality per 100, From BEIR-VII, via Ed Hendrick, in detailed response USPSTF Guidelines on SBI website, Berg et al

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20 The U.S. Preventive Services Task Force Breast Cancer Screening Recommendations: What Were They Thinking? Women s Health 2011: The 19th Annual Congress Arlington, Virginia April 1, 2011 Steven H. Woolf, MD, MPH Department of Family Medicine Virginia Commonwealth University Disclosures I have no conflicts of interest or financial disclosures to report.

21 History The question of when, how often, and by what means to screen for breast cancer has been the subject of heated controversy for three decades. Some have questioned the value of breast selfexaminations and clinical breast examinations For many years, critics questioned whether existing trials had proven that mammograms reduce mortality for women ages Some groups only recommended mammograms for women age 50 and older. Since 2002, all major guideline groups including the U.S. Preventive Services Task Force have agreed that periodic mammography screening from age 40 to 70 reduces the risk of death from breast cancer.

22 November 16, 2009 The USPSTF recommends against routine screening mammography in women aged 40 to 49 years. 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. Source: U.S. Preventive Services Task Force. Screening for breast cancer: U.S. Preventive Services Task Force recommendation statement. Ann Intern Med 2009;151: The Reaction As portrayed by media: a new federal panel had recommended against mammography for women age 40-49, despite evidence that it saved lives, and had advised against women examining their breasts, the method by which most breast cancers are detected. Condemned by medical organizations, breast cancer experts, and women s groups Experts discredited the panel included no radiologists or oncologists Relied on mathematical models rather than outcomes data. Potential harms of screening were characterized as ridiculous and a subterfuge for cost-cutting. USPSTF was accused of working at the behest of insurance companies. Critics warned that payers might reduce mammography coverage. Media frenzy: Newspapers, network news, talk shows, and blogs fueled the controversy. USPSTF members received hostile s DHHS distanced itself; HHS Secretary Katherine Sebelius issued clarifying statement

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24 This is How Rationing Begins This is how rationing begins This is what he had warned about. Rep. Marsha Blackburn (R-Tenn.)

25 The USPSTF What Were They Thinking?

26 Why not screen? Assuming monetary costs are not the issue If there is even the slightest possibility of benefit, albeit unproved, why shouldn t patients be offered screening and the chance to avoid adverse outcomes from undetected disease? Schwartz et al. JAMA 2004;291(1):71-8.

27 Benefits vs Harms Criteria for Evaluating Screening Tests Burden of suffering Accuracy and reliability Effectiveness of early detection Harms Balance of benefits and harms

28 Harms of Screening Test procedure Anxiety and labeling effects False-positive results Harms of treatment Positive Predictive Value and Prevalence Prevalence = 0.07% Sensitivity=100%, Specificity=98%

29 Relative vs Absolute Benefit Number needed to screen to prevent a death from breast cancer after 14 years Age ( ) Age (764-10,540) Humphrey et al. Ann Intern Med 2002;137: Elmore et al., mammograms over 10 years 24% of women had at least one false positive 49% cumulative probability over 10 mammograms Consequences of false positives 870 outpatient appointments 539 diagnostic mammograms 186 ultrasound examinations 188 biopsies 19% probability of biopsy over 10 mammograms N Engl J Med 1998; 338:

30 Benefits vs Harms Rationale of USPSTF, 2002 Breast cancer is an age-dependent disease Mammography reduces mortality, but the absolute magnitude of benefit is a continuum, increasing from age 40 to age 70 Potential harms exist at all ages Balance of benefits and harms therefore becomes more favorable with age Precise age at which benefits justify harms is subjective Should take into account patient preferences

31 Am J Prev Med 2004;26(1): USPSTF Recommendations, 2002 B: Mammography, with or without CBE, every 1-2 yrs age 40 and older I: CBE alone I: Teaching/performing routine BSE Clinicians should inform women about the potential benefits (reduced chance of dying from breast cancer), potential harms (e.g., false-positive results, unnecessary biopsies), and limitations of the test that apply to women their age. Clinicians should tell women that the balance of benefits and potential harms of mammography improves with increasing age for women between the ages of 40 and 70 USPSTF, 2002

32 2007 Grading Scheme Grade A B C D I Definition The USPSTF recommends the service. There is high certainty that the net benefit is substantial. 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. The USPSTF recommends against routinely providing the service. There may be considerations that support providing the service in an individual patient. There is at least moderate certainty that the net benefit is small. 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. 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. November 16, 2009 The USPSTF recommends against routine screening mammography in women aged 40 to 49 years. 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. Source: U.S. Preventive Services Task Force. Screening for breast cancer: U.S. Preventive Services Task Force recommendation statement. Ann Intern Med 2009;151:

33 vs 2009 USPSTF Recommendations 2009 B: Mammography, with or without CBE, every 1-2 yrs age 40 and older I: CBE alone I: Teaching/performing routine BSE B: Mammography every 1-2 yrs age C: Mammography every 1-2 years age I: Mammography in women age 75 and older. I: CBE alone D: Teaching BSE I: Digital mammography or magnetic resonance imaging instead of film mammography The Bottom Line The USPSTF recommendation was poorly worded and the resulting PR crisis was mishandled The USPSTF did not recommend against mammography, it recommended against routine mammography (rote testing) It was a recommendation for empowering women to make informed choices about screening with their physician It was a recommendation against physicians ordering mammograms without informing women about the tradeoffs

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35 Many members of the public were confused by the report. It was a shame that the report was ever published, and I think the public ought to ignore the findings, said Dr. Charles R. Smart, chief of the early detection branch, division of cancer prevention and control, of the National Cancer Institute in Bethesda, Md. New York Times, May 4, 1987 The data currently available do not warrant a universal recommendation for mammography for all women in their forties. Each woman should decide for herself whether to undergo mammography. Her decision may be based not only on an objective analysis of the scientific evidence and consideration of her individual medical history, but also on how she perceives and weighs each potential risk and benefit, the values she places on each, and how she deals with uncertainty. J Natl Cancer Inst 1997;89:

36 Dispute Builds Over Value of Mammography Circling the Mammography Wagons Expert Panel Cites Doubts On Mammogram's Mammography Review Shatters the Status Quo Doubts About Its Value Alarm Many New mammography questions raised

37 What s the Takeaway for Your Patients? For any screening test, consider the benefits and harms Don t order tests by rote, especially when there are close tradeoffs Engage in shared decisionmaking empower patients to make informed choices Take advantage of resources to facilitate informed decision-making