Mammography Follow-up Rates

Transcription

1 Mammography Follow-up Rates Methodology A targeted literature review was designed using relevant breast cancer and mammography search terms. The search strategy was developed using Medical Subject Headings (MeSH) related to mammography and breast cancer as well as other relevant text words identified in a primary literature scan. Results were limited to studies written in English and conducted in humans in the past ten years. The search was developed to answer the following evidence questions: 1. What is the evidence surrounding mammography recall rates? 2. To what extent does the diagnostic mammogram accurately detect breast cancer in patients who are recalled? 3. Of the patients who received a diagnostic mammography/mammary ultrasound, what is the evidence of improved outcomes? 4. What is the evidence that recall rates differ by patient characteristics? Profile of Evidence Brief Review and Discussion of Literature in National Quality Measures Clearinghouse, National Guideline Clearinghouse, PubMed, and Cochrane Databases National Quality Measures Clearinghouse Our search of the National Quality Measures Clearinghouse (NQMC), using the search term mammography, returned five relevant documents that were unique to the NQMC. National Guideline Clearinghouse Our search of the National Guideline Clearinghouse (NGC), using the search term mammography, returned six relevant documents that were unique to the NGC. PubMed A combination of search strategies including MeSH terms and text words was employed to identify the full range of literature for each of the key questions. The MeSH terms included breast neoplasms; mammography; ultrasonography; mammary; mass screening; time factors; follow-up studies; diagnostic errors; sensitivity and specificity; quality of life; outcome assessment (health care); prognosis; morbidity; mortality; healthcare disparities; minority health; risk factors; age factors; comorbidity; poverty; and social class. Our searches in PubMed returned a total of 71 relevant studies. 1

2 Cochrane Review Databases For our review of the Cochrane Review Databases, including the Cochrane Database of Systematic Reviews, the Health Technology Assessment Database, and the National Health Service (NHS) Economic Evaluation Database, we used the following MeSH search terms: breast neoplasms and mammography. We were unable to identify any studies that were relevant to the key questions and unique to Cochrane (i.e., not included in the literature found in PubMed). Magnitude and/or Importance of the Problem Mammographies and Breast Cancer The outlook for women with breast cancer has improved in recent years. Due to the combination of improved treatments and the benefits of mammography screening, breast cancer mortality has decreased steadily since Yet breast cancer is the leading non-skin cancer among U.S. women and the second leading cause of cancer death among U.S. women. 1 Experience and studies have shown that treatments are most effective when a cancer is detected early, before it has spread to other tissues. This suggests that the most effective way to continue reducing mortality from breast cancer is improved early detection and diagnosis. 2 So far the regular breast cancer detection practice is conducted through semi-annual mammographies. Generally speaking, detection can consist of two mammographies the initial screening and the diagnostic screening. The initial screening mammogram is an x-ray of the breast used to detect breast changes in patients with no signs or symptoms of breast cancer. Women are recommended to get a screening mammogram on an annual or biannual basis. A diagnostic mammogram is an x-ray used to check for breast cancer after a symptom of breast cancer has been found. The diagnostic mammogram often follows a screening mammogram if an abnormality has been found and the patient is recalled. A diagnostic mammogram involves more x-rays and different angles for the breast than a screening mammogram. 3 Regarding the outcomes of mammographies, several trials have tried to assess whether mammography reduces mortality and morbidity from breast cancer in women aged 39 and over. In a meta-analysis of seven trials to test mammography s ability to reduce breast cancer mortality and morbidity, it was found that mammographies had a summary relative risk reduction of 0.84 after 14 years of observation (95% confidence, 1 Screening for Breast Cancer, Systematic Evidence Review, Prepared for: Agency for Healthcare Research and Quality, U.S. Department of Health and Human Services. Portland, OR: Oregon Health Sciences University, Accessed May 10, 2009 at 2 Joy J, Penhoet E, Petitti D (Eds.) Saving Women s Lives: Strategies for Improving Breast Cancer Detection and Diagnosis. Washington, DC: National Academies Press - Committee on New Approaches to Early Detection and Diagnosis of Breast Cancer, Institute of Medicine and National Research Council. 3 Screening Mammograms: Questions and Answers. Bethesda, MD: National Cancer Institute, National Institutes of Health. Accessed May 20, 2009, at 2

3 ). 4 When the meta-analysis was limited to only studies that had women over age 50, it found that mammography had a summary relative risk of.81 (95% confidence, ). However, a number of factors may change mammography s performance. These factors include age of the woman, breast density, use of hormone replacement therapy, and family history of breast cancer. There is no consensus on criteria for recalling a woman from a screening mammography for a follow-up diagnostic. Although the Mammography Quality Standards Acts of 1992, 1998, and 2004 establish national quality standards of images and image interpretations, 5 mammography practice is still reliant on subjective physician observation and interpretation. As a result, recall rate variability is common. 6 There are several negative consequences of too many false positive recalls. There is a small risk of radiation-induced breast cancer. False positives can also result in overdiagnosis and over-treatment of ductal carcinoma in situ, a Stage 0 cancer. 7 Ductal carcinoma in situ is not regarded as an emergency situation, and almost all diagnosed women are cured. 8 Younger women, women who have previously had biopsies, women with a family history of breast cancer, and women on hormone replacement therapy are more likely to have a false positive. 9 There are also negative consequences of inappropriately low recall rates. Inappropriately low recall rates may lead to false negatives. A false negative occurs when a person with breast cancer is not recalled for a diagnostic screening and is not told that they have breast cancer. As breast cancer treatments are most effective when used early on in the cancer progression, a false negative and delayed treatment can result in serious negative health trajectories. Mammography Cost Considerations 4 Screening for Breast Cancer, Systematic Evidence Review, Prepared for: Agency for Healthcare Research and Quality, U.S. Department of Health and Human Services. Protland, OR: Oregon Health Sciences University, Accessed May 10, 2009 at 5 Report to Congressional Requestors: Mammography: Current Nationwide Capacity is Adequate, but Access Problems May Exist in Certain Locations. Washington, DC: United States Government Accountability Office, Nass S. and Ball J (Eds). Improving Breast Imaging Quality Standards. Washington, DC: National Academies Press - Committee on Improving Mammography Quality Standards, National Research Council Screening for Breast Cancer, Systematic Evidence Review, Prepared for: Agency for Healthcare Research and Quality, U.S. Department of Health and Human Services. Protland, OR: Oregon Health Sciences University, Accessed May 10, 2009 at 8 What is Breast Cancer? Washington, DC: American Cancer Society, Accessed May 20, 2009 at 9 Screening Mammograms: Questions and Answers. Bethesda, MD: National Cancer Institute, National Institutes of Health. Accessed May 20, 2009, at 3

4 The National Health Interview Survey estimates that 33 million women aged 40 and older received a screening mammogram in The survey also estimates that 2 million diagnostic mammograms were performed in In general, screening mammograms cost $50 to $ A study of a New Hampshire mammography registry found that mean total direct medical costs (imaging and consult) for women who only received a screening mammogram was $99. For women who also underwent a diagnostic mammogram, mean total direct costs was $ Combining national mammography statistics with estimated individual costs results in rough estimates for national mammography costs (screening and diagnostic mammograms, consultation and intervention) of up to $3.9 billion. 12 The same study found that 87 percent of women underwent a screening mammography only and were responsible for 79 percent of total costs. The 13 percent of women who received a diagnostic mammogram and other consultation and interventional procedures (including ultrasounds and biopsies) were responsible for 21 percent of total costs. Increases in Imaging Spending From 2000 through 2006, Medicare Part B spending for imaging services more than doubled and increased to about $14 billion. 13 While most of the growth in spending can be attributed to complex procedures like CT scans, MRIs, and nuclear medicine, spending on simpler procedures including x-ray mammographies grew at an average of 9 percent annually. Mammographies, along with some other imaging procedures, occur predominantly in physician offices and independent radiology offices. Medicare Part B imaging spending that took place in physician offices and diagnostic testing facilities rose from 65 percent ($4.5 billion) of all imaging spending in 2000 to 75 percent ($10.6 billion) in During the six year period, physician imaging spending per beneficiary varied substantially across geographic regions of the country, suggesting that not all utilization was necessary or appropriate. For example, in 2006, physician spending on imaging per beneficiary varied from $62 in Vermont to $472 in Florida. 14,15 Nationwide Mammography Capacity The U.S. General Accounting Office (GAO) found that key capacity elements of mammographies decreased between 2001 and More specifically, the numbers of facilities, machines, radiologic technologists, and interpreting physicians declined; and 10 Ibid. 11 Poplack, S. P., Carney, P. A., Weiss, J. E., Titus-Ernstoff, L., Goodrich, M. E., & Tosteson, A. N. A. Screening mammography: Costs and use of screening-related services. Radiology, 2005;234(1), Costs are from mammographies performed in , and the NHIS national estimates are from Report to Congressional Requesters: Medicare Part B Imaging Services. Washington, D.C.: United States Government Accountability Office, Ibid. 15 Readers should keep in mind that costs apply to imaging services overall and should not be regarded as mammography costs. 4

5 facility closures outpaced openings. 16 The GAO also estimated that as the number of women over 40 increased, there would be an increased demand for mammographies. But despite the fact that capacity was down and demand projected to go up, the GAO concluded that nationwide mammography capacity is adequate. Estimates of capacity found that the number of mammograms performed by U.S. machines was substantially lower than the number that could be performed. Screening mammograms accounted for 94 percent of the mammograms provided in 2003, and there was still excess capacity. The excess capacity for performing screening mammograms in 2003 would have been more than adequate for the estimated 2 million diagnostic mammograms that were performed that year. However, the GAO cautions that while there is nationwide excess capacity, some locales may be underserved. Some women may have to go lengthy distances or have significant wait times for mammographies. Some of these women may be medically underserved in general. Overview of Existing Related Measures Our search of the NQMC yielded five sets of quality measures relevant to mammography screening for breast cancer. In this section we provide an overview of our measure including the numerator, denominator, and exclusion criteria used to calculate the measure. We then provide an overview of the five quality measures identified through the NQMC. Outpatient Imaging Efficiency Measure Mammography Follow-up Rates The purpose of this measure is to estimate the percentage of patients with mammography screenings that are followed by a diagnostic mammogram or ultrasound of the breast in an outpatient or office setting. An abnormally high rate of call-backs from indeterminate screenings may be an indication of the inability of the reader to adequately determine when additional imaging is necessary (high false positive rate). This points to the experience and confidence of the interpreting physician and indicates both quality and efficiency. Recall rates for follow-up diagnostic mammography studies greater than 10 to 14 percent are generally felt to be unusually high unless explained by the morbidity of the underlying population. At the same time, recall rates below a certain threshold may indicate an underuse of appropriate diagnostic mammography studies and may be a cause for concern. Numerator: The number of patients who had a diagnostic mammography study or an ultrasound of the breast study following a screening mammography study (within 45 days). Denominator: The number of patients who had received a screening mammography study. 16 Report to Congressional Requestors: Mammography: Current Nationwide Capacity is Adequate, but Access Problems May Exist in Certain Locations. Washington, DC: United States Government Accountability Office,

6 For full technical specifications of the measure please visit the QualityNet website: Percentage of patients undergoing screening mammograms whose assessment category is entered into an internal database that will, at a minimum, allow analysis of abnormal interpretation (recall) rate. The American Medical Association, on behalf of the American College of Radiology, the Physician Consortium for Performance Improvement and the National Committee for Quality Assurance, developed a measure to assess the percentage of patients undergoing screening mammograms whose assessment category was entered into an internal database that will allow analysis of abnormal recall rates. Relevant assessment categories included the Mammography Quality Standards Act (MQSA), Breast Imaging Reporting and Data System (BI-RADS), or Food and Drug Administration (FDA) approved equivalent categories. This measure applies to ambulatory care, ancillary services, hospitals, and physician group practices/clinics. While radiologists surpass recommendations for mammography services, the recall rate for almost half of radiologists is higher than recommended. The measure developers assert that collecting the data elements required to allow for internal calculation of recall rate is a first step in encouraging quality improvement activities. The measure uses the assessment categories of several bodies, including the MQSA, BI-RADS, and the FDA, to create an accountability measure for the abnormal interpretation (recall) rate. 17 Numerator: Any screening mammograms that receive an MQSA assessment category of incomplete, probably benign, suspicious or highly suggestive of malignancy, BI-RADS category of 0, 3, 4, or 5, or FDA-approved equivalent assessment categories Denominator: All patients undergoing screening mammograms Radiology: percentage of final reports for screening mammograms that are classified probably benign. The American Medical Association, on behalf of the American College of Radiology, Physician Consortium for Performance Improvement, and National Committee for Quality Assurance developed a measure to determine the percentage of final reports for screening mammograms that are classified probably benign. This measure applies to ambulatory care, ancillary services, hospitals, and physician group practices/clinics. The mammogram assessment category of probably benign is associated with up to 11 percent of screening mammograms and accounts for over 40 to 50 percent of abnormal screening mammograms; however, the designation of probably benign, is reserved for 17 American College of Radiology, Physician Consortium for Performance Improvement, National Committee for Quality Assurance. Radiology physician performance measurement set. Chicago, IL: American Medical Association, National Committee for Quality Assurance Accessed May 10, 2009 at 6

7 findings that are almost certainly benign according to ACR guidelines. 18 The guidelines further emphasize that probably benign is not an indeterminate category for malignancy, but one that, for mammography, has a less than 2 percent chance of malignancy (i.e. is almost certainly benign). The guidelines also state that the diagnosis comes with a recommendation for short-interval follow-up (typically 6 months) and can result in economic and emotional consequences. 19 For the purposes of this measure, the definition of probably benign classification includes MQSA assessment category of probably benign; BI-RADS category 3; or FDA-approved equivalent assessment category. Numerator: Final reports classified as "probably benign" Denominator: All final reports for screening mammograms Radiology: percentage of patients undergoing diagnostic mammograms that are classified as "suspicious" or "highly suggestive of malignancy" with documentation of direct communication of findings from the diagnostic mammogram to the patient within 5 business days of exam interpretation. The American Medical Association, on behalf of the American College of Radiology, Physician Consortium for Performance Improvement, and National Committee for Quality Assurance developed a measure to determine the percentage of patients undergoing diagnostic mammograms that are classified as suspicious or highly suggestive of malignancy with documentation of direct communication of findings from the diagnostic mammogram to the patient within 5 business days of exam interpretation. This measure applies to ambulatory care, ancillary services, hospitals, and physician group practices/clinics. Failure to appropriately communicate findings is a common complaint against radiologists and 28 percent of breast cancer malpractice claims result from a delay in diagnosis stemming from some type of communication breakdown. Of those claims, no direct contact was made for urgent or significant unexpected findings 71 percent of the time and there was a failure to document attempts to communicate 90 percent of the time. In order to prevent delays in patient care, this measure calls for direct communication within 5 business days American College of Radiology Appropriateness Criteria: Nonpalpable breast masses. Reston, VA: American College of Radiology Accessed May 10, 2009 at mensimagingbreastworkgroup.aspx 19 American College of Radiology, Physician Consortium for Performance Improvement, National Committee for Quality Assurance. Radiology physician performance measurement set. Chicago, IL: American Medical Association, National Committee for Quality Assurance Accessed May 10, 2009 at 20 American College of Radiology, Physician Consortium for Performance Improvement, National Committee for Quality Assurance. Radiology physician performance measurement set. Chicago, IL: American Medical Association, National Committee for Quality Assurance Accessed May 10, 2009 at 7

8 Numerator: Patients with documentation of direct communication of findings from the diagnostic mammogram to the patient within 5 business days of exam interpretation Denominator: All patients undergoing diagnostic mammograms that are classified as suspicious or highly suggestive of malignancy Breast cancer screening: percentage of women years of age who had one or more mammograms during the measurement year or the year prior to the measurement year. As a part of the Healthcare Effectiveness Data and Information Set (HEDIS ) 2008, the National Committee for Quality Assurance (NCQA) developed a measure to calculate the percentage of women years of age who had one or more mammograms during the measurement year or the year prior to the measurement year. This measure applies to managed care plans and is used for accreditation; decision-making by businesses about health-plan purchasing; decision-making by consumers about health plan and provider choice; external oversight of the Medicaid program; external oversight of the Medicare program; external oversight of State government programs; internal quality improvement; and national reporting purposes. This measure excludes women with biopsies, breast ultrasounds or other diagnostic mammograms from the numerator and women who have had a bilateral mastectomy from the denominator. 21 Numerator: Women with one or more screening mammograms during the measurement year or the year prior to the measurement year. Denominator: Women 42 through 69 years of age as of December 31 of the measurement year Diagnosis of breast disease: percentage of class 4 or 5 abnormal mammograms that are followed with biopsy within 7 to 10 days. The Institute for Clinical Systems Improvement developed a measure to assess the percentage of class 4 or 5 abnormal mammograms that are followed with biopsy within 7 to 10 days in women 74 years or younger. This measure applies to physician group practices and clinics. The rationale for this measure is to reduce the length of time between first knowledge of a breast abnormality and diagnostic resolution. 22 Numerator: Total number of patients within 7 to 10 days between the first documentation of a mammogram abnormality and a complete biopsy for all records reviewed Denominator: Total number of patients with an abnormal mammogram undergoing biopsy 21 National Committee for Quality Assurance (NCQA). HEDIS 2008: Healthcare Effectiveness Data & Information Set. Vol. 2, Technical Specifications. Washington (DC): National Committee for Quality Assurance (NCQA); 2007 Jul. 22 Institute for Clinical Systems Improvement (ICSI). Diagnosis of breast disease. Bloomington (MN): Institute for Clinical Systems Improvement (ICSI); 2008 Jan. 8

9 Overview of Existing Guidelines In addition to established quality measures for mammography for breast cancer screening, our search identified six practice guidelines and appropriateness criterion related to recall rates in screening mammography in NGC. American College of Radiology Guidelines (2008) and Appropriateness Criteria (2005) The 2008 American College of Radiology Practice Guideline for the Performance of Screening and Diagnostic Mammography advises that all mammographies must be performed in accordance with the Mammography Quality Standards Act (MSQA) final rule as published by the FDA. 23 The guideline further explains the difference between a screening and a diagnostic mammogram, specifying that a screening mammogram is performed to detect unsuspected breast cancer in asymptomatic women while diagnostic mammography is performed to evaluate patients who have signs and/or symptoms of breast disease, imaging findings of concern, or prior imaging findings requiring specific follow-up. 24 Patients eligible for screening mammography include asymptomatic women aged 40 years or older with or without breast implants who are either self-referred or self-requested. The guidelines specify that diagnostic mammography is appropriate for patients with the following characteristics: 25 a specific focus of clinical concern including, but not limited to, mass, induration, axillary lymphadenopathy, some types of nipple discharge, skin changes, or persistent focal areas of pain or tenderness; a possible radiographic abnormality detected on screening mammography. recommended for short-interval follow-up (e.g., less than 1 year) for probably benign radiographic findings as defined by the ACR Breast Imaging Reporting and Data System (BI-RADS ); whose examination requires direct involvement of the radiologist for special views, physical breast examination, or consultation; and who have been treated for breast cancer in the past. Further, for patients arriving for a screening mammogram with an indication of a clinical problem, the facility should have a mechanism in place to convert these patients to diagnostic mammography. 26 The ACR guidelines provide an overview of the BI-RADS assessment categories for mammography including the recommended action (Table 1). Further imaging is 23 ACR practice guideline for the performance of screening and diagnostic mammography. Reston, VA: American College of Radiology Accessed May 10, 2009 at ostic.aspx 24 Ibid. 25 Ibid. 26 Ibid. 9

10 indicated for categories 0, 3, 4, and Mammographic Assessment Table 1 ACR Overview of BI-RADS Assessment Categories BI-RADS Assessment Category Description Incomplete 0 Need additional imaging evaluation and/or prior mammograms for comparison Complete 1 Negative Complete 2 Benign findings Complete 3 Probably benign finding initial short-interval follow-up suggested Complete 4 Suspicious abnormality biopsy should be considered Complete 5 Highly suggestive of malignancy appropriate action should be taken Complete 6 Known biopsy proven malignancy appropriate action should be taken. The guideline also provides information on the time-frame for communication of screening and diagnostic mammography results to patients. Regardless of the result, a facility must provide a written report of the mammography examination to the patient s healthcare provider within 30 days of the exam. In cases of BI-RADS category 4 and 5 results, the facility must communicate results to the healthcare provider and patient within 3 and 5 working days, respectively. 28 In a related document, the ACR identifies its appropriateness criteria for screening for nonpalpable masses including mammography and mammary ultrasound. 29 The criteria differentiate variations of nonpalpable masses into seven categories. Below, we summarize the appropriateness rating of mammography and mammary ultrasound use by nonpalpable mass variation (Table 2). 30 Note that the appropriateness score ranges from 1 (least appropriate) to 9 (most appropriate). Table 2 27 Ibid. 28 Ibid. 29 D'Orsi CJ, Bassett LW, Berg WA, Bohm-Velez M, Evans WP III, Farria DM, Lee C, Mendelson EB, Goldstein S. Nonpalpable breast masses. Reston, VA: American College of Radiology Accessed May 10, 2009 at aphy 30 D'Orsi CJ, Bassett LW, Berg WA, Bohm-Velez M, Evans WP III, Farria DM, Lee C, Mendelson EB, Goldstein S. Nonpalpable breast masses. Reston, VA: American College of Radiology Accessed May 10, 2009 at aphy 10

11 ACR Appropriateness Rating for Mammography and Mammary Ultrasound by Nonpalpable Mass Variation Variant Focal asymmetries Round, oval or lobular mass with circumscribed, partially obscured margin on baseline screening mammogram Spiculated and/or ill-defined masses Circumscribed (> 75%), partially obscured mass with coarse, dystrophic and/or "popcorn" calcification Circumscribed/partially obscured mass with pleomorphic/amorphous and/or heterogeneous calcifications Irregular spiculated/indistinct mass with coarse/dystrophic and/or "popcorn" calcification Irregular spiculated/indistinct mass with pleomorphic/amorphous and/or heterogeneous calcification X-ray, breast diagnostic mammography (out of a possible score of 9) 9 (with supplemental views) Ultrasound, breast (out of a possible score of 9) Shortinterval Follow-up (diagnostic) (diagnostic) American College of Obstetricians and Gynecologists (2003) In a 2003 guideline released by the American College of Obstetricians and Gynecologists (ACOG), recommendations for the use of breast cancer screening techniques are provided, including: Mammography screening Clinical breast examination and breast self-examination Ultrasonography Biopsy Referral to a professional experienced in the diagnosis of cancer 11

12 Genetic counseling and testing In the development of these guidelines, ACOG considered breast cancer survival and mortality rates, risks and benefits of mammography screening, sensitivity and specificity of clinical breast examination, and risk factors for breast cancer. While the guidelines provide no recommendations directly relevant to the measure for recall rates for mammography screening, the ACOG does recommend women aged years should have screening mammography every 1 to 2 years, and women aged 50 years and older should have annual screening mammography. 31 American College of Physicians (2007) The American College of Physicians (ACP) released a clinical practice guideline in 2007 for screening mammography for women 40 to 49 years of age including four specific recommendations: In women 40 to 49 years of age, clinicians should periodically perform individualized assessment of risk for breast cancer to help guide decisions about screening mammography 2. Clinicians should inform women 40 to 49 years of age about the potential benefits and harms of screening mammography 3. For women years of age, clinicians should base screening mammography decisions on benefits and harms of screening, as well as on a woman s preferences and breast cancer risk profile 4. Further research on the net benefits and harms of breast cancer screening modalities for women 40 to 49 years of age is recommended Recommendations 1 and 2 are of greatest relevance to the mammography follow-up rate measure. In reference to the rationale for recommendation (1), the ACP notes that the 5- year breast cancer risk can vary from 0.4 percent in women age 40 years with no risk factors to 6.0 percent in women age 49 years with several risk factors. These risk factors include older age, family history of breast cancer, older age at time of first birth, younger age and menarche, and history of breast biopsy. 33 The rationale for recommendation (2) states that the most important benefit of screening mammography every one to two years for women 40 to 49 years of age is a potential decrease in breast cancer mortality. The guidelines cite a recent meta-analysis that concluded relative reduction in the breast cancer mortality rate is 15 percent after 14 years of follow-up. 34 False-positives were cited as the greatest potential harm. 31 American College of Obstetricians and Gynecologists (ACOG). Breast cancer screening. Washington, DC: American College of Obstetricians and Gynecologists Accessed May 10, 2009 at Qaseem A, Snow V, Sherif K, et al. Screening mammography for women 40 to 49 years of age: A clinical practice guideline from the American College of Physicians. Annals of Internal Medicine 2007;146: Ibid. 34 Humphrey LL, Helfand M, Chan BK, Woolf SH. Breast cancer screening: a summary of the evidence for the U.S. Preventive Services Task Force. Annals of Internal Medicine 2002;137:

13 American Cancer Society (2007) In 2002, the American Cancer Society (ACS) convened an expert panel to review the existing guidelines and develop recommendations regarding: Mammography 2. Physical examination 3. Screening of older women 4. Screening of high-risk women 5. Screening with new technologies Of particular relevance to the mammography follow-up rate measure are recommendations (1), (3), and (4). Specific to mammography, the ACS recommends: 36 Women with average risk of breast cancer should have an opportunity to become informed about the benefits, limitations, and potential harms associated with regular screening. Screening detections in older women should be individualized by considering the potential benefits and risks of mammography in the context of current health status and estimated life expectancy. As long as a woman is in reasonably good health and would be a candidate for treatment, she should continue to be screened with mammography. Women at increased risk of breast cancer might benefit from additional screening strategies beyond those offered to women of average risk, such as earlier initiation of screening, shorter screening intervals, or the addition of screening modalities other than mammography and physical examination, such as ultrasound or magnetic resonance imaging. However, the evidence currently available is insufficient to justify recommendations for any of these screening approaches. The ACS cites a number of studies demonstrating the percent mortality reduction achieved through screening mammography. In all trials combined, the average percent breast cancer mortality reduction was 24 percent with 95 percent of studies falling within percent mortality reduction for women at average risk. 37 In older women, there is limited data and the guidelines cite only one randomized control trial including women over the age of 69. Among women 65 and older, mammography sensitivity was found to be 81 percent, significantly more sensitive than for women aged 50-64, 40-49, or less than 40 years of age. 38 Additional factors to consider in older populations include hormone replacement therapy, breast density, life 35 Smith RA, Saslow D, Sawyer KA, et al. American Cancer Society guidelines for breast cancer screening: update CA: A cancer journal for clinicians 2003;53: Ibid. 37 Ibid. 38 Rosenberg RD, Yankaskas BC, Abraham LA, et al. Performance benchmarks for screening mammography. Radiology 2006;241(1):

14 expectancy, and comorbidities (e.g., diabetes, renal failure, stroke, liver disease, and previous cancer). 39 A number of risk factors have been identified over the years for breast cancer. Of these risk factors, age and sex are the most important. For the purposes of this guideline, increased risk factors for breast cancer include: 40 Two or more relatives with breast or ovarian cancer; Breast cancer occurring before age 50 in a relative; Relatives with both breast and ovarian cancer; breast and ovarian cancer; or two independent breast cancers; Male relatives with breast cancer; A family history of breast or ovarian cancer and Ashkenazi Jewish heritage The guideline concludes that there is a general need for further research to truly validate the recommendations for screening of women at increased risk for breast cancer. Institute for Clinical Systems Improvement (2008) A final set of guidelines from the Institute for Clinical Systems Improvement released in 2008 provides a recommendation in the instance of an abnormal screening or diagnostic mammogram, specifically: an abnormal finding on routine mammography should be evaluated under the direction of a radiologist in order that a full characterization of the lesion be provided back to the primary care physician ordering the original study. 41 The guidelines further specify individuals at increased risk for breast cancer as those who have: 42 Previous breast biopsy demonstrating ductal hyperplasia with atypia Family history of breast or ovarian cancer in the patient's mother, sister or daughter under age 50, or breast cancer in male family member Past, personal history of breast cancer A breast cancer gene Previous radiation to the chest (i.e., Hodgkin's Disease) Evidence Questions Key Question 1: What is the evidence surrounding mammography recall rate? Our search returned 11 articles that provided information regarding the evidence surrounding mammography recall rates. 39 Smith RA, Saslow D, Sawyer KA, et al. American Cancer Society guidelines for breast cancer screening: update CA: A cancer journal for clinicians 2003;53: Ibid. 41 Institute for Clinical Systems Improvement (ICSI). Diagnosis of breast disease. Bloomington, MN: Institute for Clinical Systems Improvement Accessed May 11, 2009 at 42 Ibid. 14

15 Recall Rates One retrospective study evaluated a range of radiologist performance outcomes, including positive predictive value, recall rate, cancer detection rate, mean cancer size, and cancer stage. As radiologists were evaluated, they were placed in performance ranges. The middle 50 percent of radiologists had an average recall rate of 9.8 percent on average, and rates ranged from 6.4 to 13.3 percent (n=2,580,151). 43 In another study, recall rates of 10 percent for first mammograms (n=1,872,687) and 6.7 percent for subsequent (n=171,104) mammograms are recommended targets on the basis of their AW/ACD (additional work-ups per additional cancer detected). 44 Alternatively, another article (n=215,665) found that practices with recall rates between 4.9 percent and 5.5 percent achieve the best trade-off of sensitivity and positive predictive value. 45 Similarly, in a prospective observational study of a Swiss mammography screening pilot program, the recall rate for the screening mammogram was 4.6 percent, and the recall rate for the diagnostic mammogram was 2.3 percent. 46 Lastly, a study that evaluated the false positive recall rate of a Norwegian program that administered biannual screening mammographies found that the first screening mammography of the year had a false positive recall rate of 4.6 percent, and second screening mammography of the year had a false positive recall rate of 2.6 percent. 47 While these last three studies report recall rates substantially lower than the first few studies, it should be noted that these studies are performed in foreign countries and may be comparable to studies conducted in the United States. Recall Waiting Periods Three articles addressed recall waiting periods. The recall waiting period is the number of days between the screening mammography and the diagnostic mammography. One pilot study (n=1,137) found process change can significantly decrease the waiting time to diagnosis after an abnormal breast screen. It found that facilitating the referral process had the greatest impact in reducing the median time to diagnosis for women without a biopsy. With facilitated referrals, median time to diagnosis was reduced from 23 days to 7 days. 48 Another article (n=10,314) evaluated the timeliness of diagnosis after an abnormal screening in the Screening Mammography Program of British Columbia (SMPBC) and found the median time from abnormal screening to diagnosis was 3.4 weeks with regional variation of 2 to 4.7 weeks, and 10 percent of women had to wait 8.7 weeks or more. For women proceeding to biopsy, the median diagnostic interval was Rosenberg RD, Yankaskas BC, Abraham LA, et al. Performance benchmarks for screening mammography. Radiology 2006;241(1): Schell MJ, Yankaskas BC, Ballard-Barbash R, et al. Evidence-based target recall rates for screening mammography. Radiology 2007;243(3): Yankaskas BC, Taplin SH, Ichikawa L, et al. Association between mammography timing and measures of screening performance in the United States. Radiology 2005;234(2): Bulliard JL, De Landtsheer JP, Levi F. Results from the Swiss mammography screening pilot programme. European Journal of Cancer 2003;39(12): Hofvind S, Vacek PM, Skelly J, Weaver DL, Geller BM. Comparing screening mammography for early breast cancer detection in Vermont and Norway. Journal of the National Cancer Institute 2008;100(15): Olivotto IA, Borugian MJ, Kan L, et al. Improving the time to diagnosis after an abnormal screening mammogram. Canadian Journal of Public Health 2001;92(5):

16 weeks with regional variation of 4.6 to 9.3 weeks. 49 One study (n=8,698) found that immediate interpretation of screening mammograms resulted in statistically significant increases in recalls and additional clinical work-ups of perceived abnormalities. 50 Immediate interpretations occur when the radiologist evaluates the results immediately after the mammogram. The results are communicated with the patient and any additional diagnostic imaging is also performed in the initial visit. Recall waiting periods for immediate interpretations are therefore zero days. Batch interpretations are performed after the patient has left the care setting, and patients are notified of results at a later time. Recall waiting periods for batch interpretations are therefore at least 1 day. The group of immediate interpretation mammograms had a recall rate of 18 percent, while the batch interpretation group had a recall rate of 14 percent. International Comparisons of Mammography Recall Rates A retrospective observational study compared mammography cases in Vermont and Norway (n=239,480). There was a 9.8 percent recall rate for screening mammographies in Vermont and a 2.7 percent recall rate in Norway. Cancer detection rate was 2.77 per 1000 screening mammographies in Vermont and 2.57 in Norway. Prognostic characteristics were similar between locations. 51 Another retrospective observational study compared 5.5 million screening mammography cases between the U.S. and the United Kingdom. It found that recall rates were approximately twice as high in the US than in the UK. The study found recall rates of 14.4 percent in the Breast Cancer Surveillance Consortium (U.S.), 12.5 percent in the National Breast and Cervical Cancer Early Detection Program (U.S.), and 7.6 percent in National Health Service Breast Screening Programme (U.K.). 52 Key Question 2: To what extent does the diagnostic mammogram accurately detect breast cancer in patients that are recalled? Our search returned 28 articles that provided information regarding the cancer detection rate using mammography, with seven of those specifically about cancer detection rates of the diagnostic mammogram. Breast Cancer Detection Rates Findings in two studies surrounding breast cancer detection rates were contradictory. 49 Olivotto IA, Kan L, King S. Waiting for a diagnosis after an abnormal screening mammogram. SMPBC diagnostic process workgroup. Screening Mammography Program of British Columbia. Canadian Journal of Public Health 2000;91(2): Ghate SV, Soo MS, Baker JA, Walsh R, Gimenez EI, Rosen EL. Comparison of recall and cancer detection rates for immediate versus batch interpretation of screening mammograms. Radiology 2005;235(1): Hofvind S, Geller B, Vacek PM, Thoresen S, Skaane P. Using the European guidelines to evaluate the Norwegian Breast Cancer Screening Program. European Journal of Epidemiology 2007;22(7): Smith-Bindman R, Chu PW, Miglioretti DL, et al. Comparison of screening mammography in the United States and the United kingdom. Journal of the American Medical Association 2003;290(16):

17 One study (n=556) reported that the diagnostic mammogram s accuracy is very high and had a sensitivity of 86.8 percent, a specificity of 98.6 percent, with a positive predictive value of 68.8 percent and a negative predictive value of 99.5 percent. 53 Another study (n=332,926 diagnostic mammographies) had an abnormal interpretation rate of 8 percent, a positive predictive value for recommended biopsy of 31.4 percent, and a 39.5 percent cancer diagnosis rate. 54 Due to differences in the methodological approach, it is not possible to make comparisons between these two studies as to why the rates are so different. Another retrospective study (n=495) examined how cancer detection was influenced by screening mammography recall rate. It found that increasing the recall rate to 2 percent would increase the detection rate from 4.2 per 1,000 to 4.52 per 1,000. At recall rates of 3 percent and 4 percent the detection would increase to 4.58 per 1000 and 4.63 per 1000, respectively. Breast cancer can be detected earlier by lowering the threshold for recall, especially for recall rates of one to four percent. With further recall rate increases, cancer detection levels off with a disproportionate increase of false-positive rates. 55 Screening vs. Diagnostic Mammography Cancer Detection Rates One study (n=1,171,792) found that the cancer detection yield for short-interval followup based on first screening examination is lower than that with diagnostic work-up prior to short-interval follow-up recommendation. 56 Another study (n=7,506) found that detection rates were very different for screening and diagnostic mammographies: the screening cancer detection rate was 6.1 per thousand cases, while the diagnostic detection rate was much higher, at 86.4 per thousand. 57 A third study found that diagnostic mammographies had abnormal findings 14.4 percent of the time and screenings had abnormal findings 5.2 percent of the time; and cancer detection was 55 per 1000 for diagnostics and 5 per 1000 for screenings (n=46,857). 58 Another study found that women who undergo a screening mammography followed by a diagnostic mammography and sonography on the same day have a higher probability of undergoing a biopsy (n=584,470 women). They also had a higher probability of having that biopsy indicate cancer. About 20.1 percent of those who have the diagnostic mammography and sonography on the same day as the screening mammography 53 Sidhartha, Thapa B, Singh Y, Sayami P, Khanal U. Mammographic diagnosis of breast carcinoma: an institutional experience. Journal of Nepal Medical Association 2008;47(170): Sickles EA, Miglioretti DL, Ballard-Barbash R, et al. Performance benchmarks for diagnostic mammography. Radiology 2005;235(3): Otten JD, Karssemeijer N, Hendriks JH, et al. Effect of recall rate on earlier screen detection of breast cancers based on the Dutch performance indicators. Journal of the National Cancer Institute 2005;97(10): Kerlikowske K, Smith-Bindman R, Abraham LA, et al. Breast cancer yield for screening mammographic examinations with recommendation for short-interval follow-up. Radiology 2005;234(3): Tuncbilek I, Ozdemir A, Gultekin S, Ogur T, Erman R, Yuce C. Clinical outcome assessment in mammography: an audit of 7,506 screening and diagnostic mammography examinations. Diagnostic and Interventioanl Radiology 2007;13(4): Dee KE, Sickles EA. Medical audit of diagnostic mammography examinations: comparison with screening outcomes obtained concurrently. American Journal of Roentgenology 2001;176(3):

18 undergo a biopsy, compared to 18.9 percent of those who had the screening and diagnostic mammographies on different days. About 37 percent of biopsies performed after same-day screening and diagnostic mammographies turned out to have cancer. In comparison, biopsies performed after sonographies in the absence of a diagnostic mammography had a lower yield of breast cancer detection 12 to 17 percent. 59 Cancer Detection Variation by Technology Differences Another study looked at the use of ultrasounds when breasts were too dense for mammographies. The incremental cancer detection rate was 0.40 percent. About 65 percent of ultrasound-only detected cancers were detected at an earlier, more favorable stage than mammography-only detected cancers (35.5 percent). 60 International Comparisons of Cancer Detection Rates Looking at international studies can show how cancer detection varies by country. In one observational study of Swiss mammography screening pilot program, the recall rate for the initial mammography was 4.6 percent. About 84.7 percent of these women did not have breast cancer. There was a 2.3 percent recall rate in the subsequent round and 75.6 percent of recalled women did not have breast cancer. 61 Key Question 3: Of the patients who received a diagnostic mammography/mammary ultrasound, what is the evidence of improved outcomes? Our search yielded 8 studies that provided information regarding the relationship between mammography and evidence of improved outcomes. Of these studies, there were two modeling/simulation studies, three prospective studies, and two retrospective studies. Some of the studies address improved outcomes in relation to screening mammographies rather than diagnostic mammographies. Mammographies and Mortality Rates Most of the studies used breast cancer mortality as the main performance outcome of screening. Many (but not all) studies found that screening was associated with reduced breast cancer mortality. In one modeling study (n = 2 million), posterior mean reduction in breast cancer mortality (BCM) due to screening mammography was 10.6 percent (with an error of margin of 5.7 percent). Despite this uncertainty, the study concluded with high probability that screening contributed to the reduction in BCM observed in 59 Carney PA, Abraham LA, Miglioretti DL, et al. Factors associated with imaging and procedural events used to detect breast cancer after screening mammography. American Journal of Roentgenology 2007;188(2): Corsetti V, Houssami N, Ferrari A, et al. Breast screening with ultrasound in women with mammographynegative dense breasts: evidence on incremental cancer detection and false positives, and associated cost. European Journal of Cancer 2008;44(4): Bulliard JL, De Landtsheer JP, Levi F. Results from the Swiss mammography screening pilot programme. European Journal of Cancer 2003;39(12):

19 the US between Another simulation study found that breast screening mammographies from the age of years reduced the overall number of deaths from breast cancer by 5.7 to 8 percent. 63 One prospective observational study also found that mortality risk was reduced for those who received screening mammographies, and mortality risk was even reduced for those who received mammographies and had a more severe, late-stage form of cancer. The study (n = 36,000 women) found that screening had a beneficial effect even in women whose cancer had already spread into the axillary lymph nodes. 64 Another prospective observational research paper found that 5-year overall observed survival rates were 94 percent for the 372 patients with cancers that were detected by mammography alone. Survival rates were 87 percent for the 677 whose cancers were detectable by palpation. 65 One retrospective observational study used both mortality and stage of diagnosis as the outcome measure. It found that women who undergo regular screening mammographies are about half as likely as women who do not to be diagnosed at a late stage (n = 247). 66 Another study, a meta-analysis of seven randomized control trials, found that mammographies did not reduce risk of breast cancer mortality (It is unclear whether the studies were in reference to the screening mammography, diagnostic mammography, or both). The highest-quality trials failed to show a significant reduction in breast cancer mortality with a relative risk of With all data considered, the meta-analysis found the relative risk for breast cancer mortality after 13 years to be The evidence did not show a survival benefit of mass mammography screening. 67 Breast Cancer Outcomes and Patient Characteristics One case-control study (n=4,569) examined how the relationship between mammography and breast cancer outcomes differed by age. It found that the screening mammography s efficacy for reducing the rate of death within five years after diagnosis was greater at ages and for postmenopausal women than for women aged The odds ratio between those who received a screening mammography and those who did not for breast cancer death within 5 years of diagnosis was 0.47 for women ages 50-64, and 0.45 for post-menopausal women. The odds ratio of breast cancer death within 5 years of diagnosis was 0.89 for women aged and 0.74 for premenopausal women. 62 Berry DA, Inoue L, Shen Y, et al. Modeling the impact of treatment and screening on U.S. breast cancer mortality: a Bayesian approach. Journal of the National Cancer Institute Monographs 2006;(36): Cox B. The effect of service screening on breast cancer mortality rates. Eur J Cancer Prev 2008;17(4): Klemi PJ, Parvinen I, Pylkkanen L, et al. Significant improvement in breast cancer survival through population-based mammography screening. Breast 2003;12(5): Sener SF, Winchester DJ, Winchester DP, et al. Survival rates for breast cancers detected in a community service screening mammogram program. American Journal of Surgery 2006;191(3): Buseman S, Mouchawar J, Calonge N, Byers T. Mammography screening matters for young women with breast carcinoma: evidence of downstaging among year-old women with a history of previous mammography screening. Cancer 2003;97(2): Gotzsche PC. Screening for breast cancer. Annals of Internal Medicine 2003;138(9): Norman SA, Russell LA, Weber AL, et al. Protection of mammography screening against death from breast cancer in women aged years. Cancer Causes & Control 2007;18(9):

20 Another modeling study had different findings. It found that breast screening from the age of years reduced breast cancer mortality by percent. It also found that starting screening at age 40 with a five to ten year delay in effect compared with starting screening at age 50 produced a breast cancer mortality reduction of up to 10.6 percent. 69 Key Question 4: What is the evidence that recall rates differ by patient characteristic? Twenty-three studies addressed the question of whether recall rates differ by patient characteristics. There were 14 retrospective observational studies, five prospective observational, one case control, one modeling, one cohort, and one retrospective crosssectional. The studies looked at recall rates and mammography outcomes by several different patient characteristics race and ethnicity, socioeconomic status, age, geography, hormone therapy replacement use, and physiological traits. Some studies focused on how patient characteristics influenced mammography cancer detection rates rather than recall rates. Race & Ethnicity One retrospective cohort study (n = 6,722) examined differences in time to diagnostic follow-up for women of different races with abnormal initial mammograms. It found that African American and Hispanic women had longer times to follow-up (20 and 21 days, respectively) compared with non-hispanic white women (14 days). 70 One study looked at how the woman s socioeconomic status was related to breast cancer and recall rates. The retrospective observational study (n = 1,901) found that women with less than a high school education were less likely to report follow-up after an abnormal mammogram than were women who had at least completed college. 71 The odds of a woman with less than a high school education reporting follow-up were 0.56 compared to a woman who had at least completed college. Age and Recall Rates One retrospective observational study (n = 1,900) looked at differences in diagnostic follow-up from screening mammographies by age. It found that younger women were less likely to report diagnostic follow-up than older women. 72 Another modeling study reported that recall rates for screening mammography remains relatively stable at per 1000 across age groups over 40. Overall, recall rates ranged from 73 per 1000 to 69 Cox B. The effect of service screening on breast cancer mortality rates. European Journal of Cancer Prevention 2008;17(4): Press R, Carrasquillo O, Sciacca RR, Giardina EG. Racial/ethnic disparities in time to follow-up after an abnormal mammogram. Journal of Women s Health 2008;17(6): Yabroff KR, Breen N, Vernon SW, Meissner HI, Freedman AN, Ballard-Barbash R. What factors are associated with diagnostic follow-up after abnormal mammograms? Findings from a U.S. National Survey. Cancer Epidemiology Biomarkers & Prevention 2004;13(5): Yabroff KR, Breen N, Vernon SW, Meissner HI, Freedman AN, Ballard-Barbash R. What factors are associated with diagnostic follow-up after abnormal mammograms? Findings from a U.S. National Survey. Cancer Epidemiology Biomarkers & Prevention 2004;13(5):