Brian L. Sprague, PhD; Natasha K. Stout, PhD; Clyde Schechter, MD, MA; Nicolien T. van Ravesteyn, PhD; Mucahit Cevik, MS; Oguzhan Alagoz, PhD; Christoph I. Lee, MD, MSHS; Jeroen J. van den Broek, MS; Diana L. Miglioretti, PhD; Jeanne S. Mandelblatt, MD, MPH; Harry J. de Koning, MD, PhD; Karla Kerlikowske, MD, MS; Constance D. Lehman, MD, PhD; Anna N.A. Tosteson, ScD
Acknowledgment: The authors thank the BCSC investigators, participating women, mammography facilities, and radiologists for the data they have 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.
Grant Support: By the National Cancer Institute–funded BCSC (P01 CA154292, HHSN261201100031C) and the National Cancer Institute (U01 CA152958, U54 CA163303, and U54 CA163307). The collection of BCSC cancer and vital status data used in this study was supported in part by several state public health departments and cancer registries throughout the United States. For a full description of these sources, visit http://breastscreening.cancer.gov/work/acknowledgement.html.
Disclosures: Disclosures can be viewed at www.acponline.org/authors/icmje/ConflictOfInterestForms.do?msNum=M14-0692.
Reproducible Research Statement:Study protocol: Not available. Statistical code: Available at http://cisnet.cancer.gov/breast/profiles.html. Data set: Available from Dr. Sprague (e-mail, firstname.lastname@example.org).
Requests for Single Reprints: Brian L. Sprague, PhD, Office of Health Promotion Research, 1 South Prospect Street, University Health Campus Room 4425, University of Vermont, Burlington, VT 05401; e-mail, Brian.Sprague@uvm.edu.
Current Author Addresses: Dr. Sprague: Office of Health Promotion Research, 1 South Prospect Street, University Health Campus Room 4425, University of Vermont, Burlington, VT 05401.
Dr. Stout: Department of Population Medicine, Harvard Medical School and Harvard Pilgrim Health Care Institute, 133 Brookline Avenue, 6th Floor, Boston, MA 02215.
Dr. Schechter: Department of Family & Social Medicine, Albert Einstein College of Medicine, 1300 Morris Park Avenue, Block Building 406, Bronx, NY 10461.
Drs. van Ravesteyn and de Koning and Mr. van den Broek: Department of Public Health, Erasmus Medical Center, PO Box 2040, 3000 CA, Rotterdam, the Netherlands.
Mr. Cevik and Dr. Alagoz: University of Wisconsin–Madison, 3242 Mechanical Engineering Building, 1513 University Avenue, Madison, WI 53706.
Drs. Lee and Lehman: Department of Radiology, University of Washington, Seattle Cancer Care Alliance, 825 Eastlake Avenue East, G2-600 Seattle, WA 98109.
Dr. Miglioretti: Department of Public Health Sciences, University of California–Davis School of Medicine, 1 Shields Ave, Medical Sciences 1C, Room 145, Davis, CA 95616.
Dr. Mandelblatt: Lombardi Comprehensive Cancer Center, 3300 Whitehaven Street Northwest, Suite 4100, Washington, DC 20007.
Dr. Kerlikowske: University of California, San Francisco, 4150 Clement Street, Veterans Affairs Medical Center (111A1), San Francisco, CA 94121.
Dr. Tosteson: Dartmouth Institute for Health Policy and Clinical Practice, Geisel School of Medicine at Dartmouth, 1 Medical Center Drive (HB7505), Lebanon, NH 03756.
Author Contributions: Conception and design: B.L. Sprague, N.K. Stout, C. Schechter, N.T. van Ravesteyn, M. Cevik, O. Alagoz, D.L. Miglioretti, J.S. Mandelblatt, K. Kerlikowske, C.D. Lehman, A.N.A. Tosteson.
Analysis and interpretation of the data: B.L. Sprague, N.K. Stout, C. Schechter, N.T. van Ravesteyn, M. Cevik, O. Alagoz, C.I. Lee, D.L. Miglioretti, J.S. Mandelblatt, H.J. de Koning, K. Kerlikowske, C.D. Lehman, A.N.A. Tosteson.
Drafting of the article: B.L. Sprague, N.K. Stout, O. Alagoz, C.I. Lee, D.L. Miglioretti, J.S. Mandelblatt, A.N.A. Tosteson.
Critical revision of the article for important intellectual content: N.K. Stout, C. Schechter, N.T. van Ravesteyn, O. Alagoz, C.I. Lee, D.L. Miglioretti, J.S. Mandelblatt, H.J. de Koning, K. Kerlikowske, C.D. Lehman, A.N.A. Tosteson.
Final approval of the article: B.L. Sprague, N.K. Stout, C. Schechter, N.T. van Ravesteyn, O. Alagoz, C.I. Lee, D.L. Miglioretti, J.S. Mandelblatt, H.J. de Koning, K. Kerlikowske, C.D. Lehman, A.N.A. Tosteson.
Provision of study materials or patients: C.I. Lee, K. Kerlikowske.
Statistical expertise: C. Schechter, O. Alagoz, J.J. van den Broek, D.L. Miglioretti, H.J. de Koning, A.N.A. Tosteson.
Obtaining of funding: B.L. Sprague, D.L. Miglioretti, J.S. Mandelblatt, K. Kerlikowske, A.N.A. Tosteson.
Administrative, technical, or logistic support: J.S. Mandelblatt, K. Kerlikowske.
Collection and assembly of data: B.L. Sprague, N.K. Stout, J.J. van den Broek, D.L. Miglioretti, K. Kerlikowske.
Sprague BL, Stout NK, Schechter C, van Ravesteyn NT, Cevik M, Alagoz O, et al. Benefits, Harms, and Cost-Effectiveness of Supplemental Ultrasonography Screening for Women With Dense Breasts. Ann Intern Med. 2015;162:157-166. doi: 10.7326/M14-0692
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Published: Ann Intern Med. 2015;162(3):157-166.
Many states have laws requiring mammography facilities to tell women with dense breasts and negative results on screening mammography to discuss supplemental screening tests with their providers. The most readily available supplemental screening method is ultrasonography, but little is known about its effectiveness.
To evaluate the benefits, harms, and cost-effectiveness of supplemental ultrasonography screening for women with dense breasts.
Comparative modeling with 3 validated simulation models.
Surveillance, Epidemiology, and End Results Program; Breast Cancer Surveillance Consortium; and medical literature.
Contemporary cohort of women eligible for routine screening.
Supplemental ultrasonography screening for women with dense breasts after a negative screening mammography result.
Breast cancer deaths averted, quality-adjusted life-years (QALYs) gained, biopsies recommended after a false-positive ultrasonography result, and costs.
Supplemental ultrasonography screening after a negative mammography result for women aged 50 to 74 years with heterogeneously or extremely dense breasts averted 0.36 additional breast cancer deaths (range across models, 0.14 to 0.75), gained 1.7 QALYs (range, 0.9 to 4.7), and resulted in 354 biopsy recommendations after a false-positive ultrasonography result (range, 345 to 421) per 1000 women with dense breasts compared with biennial screening by mammography alone. The cost-effectiveness ratio was $325 000 per QALY gained (range, $112 000 to $766 000). Supplemental ultrasonography screening for only women with extremely dense breasts cost $246 000 per QALY gained (range, $74 000 to $535 000).
The conclusions were not sensitive to ultrasonography performance characteristics, screening frequency, or starting age.
Provider costs for coordinating supplemental ultrasonography were not considered.
Supplemental ultrasonography screening for women with dense breasts would substantially increase costs while producing relatively small benefits.
National Cancer Institute.
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Hematology/Oncology, Breast Cancer, Cancer Screening/Prevention.
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