Factors Associated With Rates of False-Positive and False-Negative Results From Digital Mammography Screening: An Analysis of Registry Data

Ann Intern Med. 2016 Feb 16;164(4):226-35. doi: 10.7326/M15-0971. Epub 2016 Jan 12.


Background: 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.

Objective: 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.

Design: Analysis of registry data.

Setting: Participating facilities at 5 U.S. Breast Cancer Surveillance Consortium breast imaging registries with linkages to pathology databases and tumor registries.

Patients: 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.

Measurements: 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.

Results: 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.

Limitations: 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.

Conclusion: 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.

Primary funding source: Agency for Healthcare Research and Quality and National Cancer Institute.

Publication types

  • Research Support, N.I.H., Extramural

MeSH terms

  • Adult
  • Age Factors
  • Aged
  • Aged, 80 and over
  • Biopsy
  • Body Mass Index
  • Breast / anatomy & histology
  • Breast Density
  • Breast Neoplasms / diagnostic imaging*
  • Breast Neoplasms / epidemiology
  • Early Detection of Cancer / adverse effects*
  • Early Detection of Cancer / methods
  • False Negative Reactions
  • False Positive Reactions
  • Female
  • Genetic Predisposition to Disease
  • Humans
  • Mammary Glands, Human / abnormalities
  • Mammography / adverse effects*
  • Mammography / methods
  • Mass Screening / adverse effects*
  • Mass Screening / methods
  • Middle Aged
  • Registries
  • Risk Factors
  • Time Factors
  • United States / epidemiology