Heidi D. Nelson, MD, MPH; Ellen S. O'Meara, PhD; Karla Kerlikowske, MD, MPH; Steven Balch, MA, MBA; Diana Miglioretti, PhD
Disclaimer: The findings and conclusions in this article are those of the authors, who are responsible for its content, and do not necessarily represent the views of the AHRQ. No statement in this report should be construed as an official position of the AHRQ or the U.S. Department of Health and Human Services.
Acknowledgment: The authors thank the participating women, mammography facilities, and radiologists for the data they provided for this study. A list of the BCSC investigators and procedures for requesting BCSC data for research purposes are provided at http://breastscreening.cancer.gov.
Financial Support: By the AHRQ (contract 290-2012-00015-I, Task Order 2), Rockville, Maryland, and the National Cancer Institute (P01CA154292, HHSN261201100031C, and U54 CA163303). The collection of BCSC data was also supported in part by several state public health departments and cancer registries throughout the United States. For a full description of these sources, please see http://breastscreening.cancer.gov/work/acknowledgement.html.
Disclosures: Drs. Nelson, O'Meara, Kerlikowske, and Miglioretti and Mr. Balch report grants from AHRQ during the conduct of the study. Authors not named here have disclosed no conflicts of interest. Disclosures can also be viewed at www.acponline.org/authors/icmje/ConflictOfInterestForms.do?msNum=M15-0971.
Editors' Disclosures: Christine Laine, MD, MPH, Editor in Chief, reports that she has no financial relationships or interests to disclose. Darren B. Taichman, MD, PhD, Executive Deputy Editor, reports that he has no financial relationships or interests to disclose. Cynthia D. Mulrow, MD, MSc, Senior Deputy Editor, reports that she has no relationships or interests to disclose. Deborah Cotton, MD, MPH, Deputy Editor, reports that she has no financial relationships or interest to disclose. Jaya K. Rao, MD, MHS, Deputy Editor, reports that she has stock holdings/options in Eli Lilly and Pfizer. Sankey V. Williams, MD, Deputy Editor, reports that he has no financial relationships or interests to disclose. Catharine B. Stack, PhD, MS, Deputy Editor for Statistics, reports that she has stock holdings in Pfizer.
Reproducible Research Statement:Study protocol and statistical code: Available from the statistical coordinating center of the BCSC (e-mail, SCC@ghc.org). Data set: Available with approval of the BCSC Steering Committee (http://breastscreening.cancer.gov).
Requests for Single Reprints: Heidi D. Nelson, MD, MPH, Oregon Health & Science University, 3181 SW Sam Jackson Park Road, Mail Code BICC, Portland, OR 97239; e-mail, email@example.com.
Current Author Addresses: Dr. Nelson: Oregon Health & Science University, 3181 SW Sam Jackson Park Road, Mail Code BICC, Portland, OR 97239.
Dr. O'Meara and Mr. Balch: Group Health Research Institute, 1730 Minor Avenue, Suite 1600, Seattle, WA 98101.
Dr. Kerlikowske: San Francisco VA Medical Center, VAMC (111A1), 4150 Clement Street, San Francisco, CA 94121.
Dr. Miglioretti: University of California, Davis, One Shields Avenue, Med Sci 1C, Room 145, Davis, CA 95616.
Author Contributions: Conception and design: H.D. Nelson, K. Kerlikowske, D. Miglioretti.
Analysis and interpretation of the data: H.D. Nelson, E.S. O'Meara, K. Kerlikowske, D. Miglioretti.
Drafting of the article: H.D. Nelson, E.S. O'Meara, K. Kerlikowske.
Critical revision of the article for important intellectual content: H.D. Nelson, E.S. O'Meara, K. Kerlikowske, D. Miglioretti.
Final approval of the article: H.D. Nelson, E.S. O'Meara, K. Kerlikowske, S. Balch, D. Miglioretti.
Provision of study materials or patients: H.D. Nelson, K. Kerlikowske.
Statistical expertise: H.D. Nelson, E.S. O'Meara, D. Miglioretti.
Obtaining of funding: H.D. Nelson, K. Kerlikowske, D. Miglioretti.
Administrative, technical, or logistic support: H.D. Nelson, K. Kerlikowske.
Collection and assembly of data: H.D. Nelson, E.S. O'Meara, K. Kerlikowske, S. Balch, D. Miglioretti.
Nelson HD, O'Meara ES, Kerlikowske K, Balch S, Miglioretti D. Factors Associated With Rates of False-Positive and False-Negative Results From Digital Mammography Screening: An Analysis of Registry Data. Ann Intern Med. 2016;164:226-235. doi: 10.7326/M15-0971
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Published: Ann Intern Med. 2016;164(4):226-235.
Published at www.annals.org on 12 January 2016
Women screened with digital mammography may receive false-positive and false-negative results and subsequent imaging and biopsies. How these outcomes vary by age, time since the last screening, and individual risk factors is unclear.
To determine factors associated with false-positive and false-negative digital mammography results, additional imaging, and biopsies among a general population of women screened for breast cancer.
Analysis of registry data.
Participating facilities at 5 U.S. Breast Cancer Surveillance Consortium breast imaging registries with linkages to pathology databases and tumor registries.
405 191 women aged 40 to 89 years screened with digital mammography between 2003 and 2011. A total of 2963 were diagnosed with invasive cancer or ductal carcinoma in situ within 12 months of screening.
Rates of false-positive and false-negative results and recommendations for additional imaging and biopsies from a single screening round; comparisons by age, time since the last screening, and risk factors.
Rates of false-positive results (121.2 per 1000 women [95% CI, 105.6 to 138.7]) and recommendations for additional imaging (124.9 per 1000 women [CI, 109.3 to 142.3]) were highest among women aged 40 to 49 years and decreased with increasing age. Rates of false-negative results (1.0 to 1.5 per 1000 women) and recommendations for biopsy (15.6 to 17.5 per 1000 women) did not differ greatly by age. Results did not differ by time since the last screening. False-positive rates were higher for women with risk factors, particularly family history of breast cancer; previous benign breast biopsy result; high breast density; and, for younger women, low body mass index.
Confounding by variation in patient-level characteristics and outcomes across registries and regions may have been present. Some factors, such as numbers of first- and second-degree relatives with breast cancer and diagnoses associated with previous benign biopsy results, were not examined.
False-positive mammography results and additional imaging are common, particularly for younger women and those with risk factors, whereas biopsies occur less often. Rates of false-negative results are low.
Agency for Healthcare Research and Quality and National Cancer Institute.
Screening mammography can produce false-positive or false-negative results.
This analysis of registry data describes rates of false-positive and false-negative results among women aged 40 to 89 years screened with digital mammography. False-positives and recommendations for additional imaging were highest among women aged 40 to 49 years. Rates of false-negative results were generally low. Positive family history, previous biopsy, high breast density, and low body mass index for younger women were associated with higher risk for a false-positive result.
Variation in patient characteristics and screening protocols across registries could have confounded estimates.
False-positive results and additional imaging are common, particularly for younger women and those with risk factors.
Description of BCSC data sources for the study.
Mammograms were included if they were designated by the radiologist or radiology technologist as performed for screening purposes and if they occurred >9 mo after a previous imaging examination in women with no history of breast cancer, breast augmentation, or mastectomy. Routine screening required ≥1 mammogram within the previous 30 mo. BCSC = Breast Cancer Surveillance Consortium; DCIS = ductal carcinoma in situ.
* Carolina Mammography Registry, Group Health (Washington State), New Hampshire Mammography Network, San Francisco Mammography Registry, and Vermont Breast Cancer Surveillance System.
Appendix Table 1. Rates of Missing Data for Outcome and Risk Factor Measures for 405 191 Women Screened*
Table 1. Age-Specific Rates of False-Positive and False-Negative Digital Mammography Results and Recommendations for Additional Imaging and Biopsies From a Single Screening Round in the BCSC*
Appendix Table 2. Rates of False-Positive and False-Negative Digital Mammography Results and Recommendations for Additional Imaging and Biopsies Based on Time Since Last Mammography Examination*
Table 2. Rates of False-Positive Results After Screening With Digital Mammography, by Risk Factor*
Appendix Table 3. Rates of False-Negative Results After Screening With Digital Mammography, by Risk Factors*
Appendix Table 4. Rates of Recommendations for Additional Imaging After Screening With Digital Mammography, by Risk Factors*
Table 3. Rates of Recommendations for Biopsy After Screening With Digital Mammography, by Risk Factor*
Appendix Table 5. Rates of False-Positive and False-Negative Digital Mammography Results and Recommendations for Additional Imaging and Biopsies, by Different Breast Density Categories*
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