Background
Millions of women receive clinical breast examination (CBE) each year, as either a breast cancer screening test or a diagnostic test for breast symptoms. While screening CBE had moderately high specificity (∼94%) in clinical trials, community clinicians may be comparatively inexperienced and may conduct relatively brief examinations, resulting in even higher specificity but lower sensitivity.
Objective
To estimate the specificity of screening and diagnostic CBE in clinical practice and identify patient factors associated with specificity.
Design
Retrospective cohort study.
Subjects
Breast-cancer-free female health plan enrollees in 5 states (WA, OR, CA, MA, and MN) who received CBE (N = 1,484).
Measurements
Medical charts were abstracted to ascertain breast cancer risk factors, examination purpose (screening vs diagnostic), and results (true-negative vs false-positive). Women were considered “average-risk” if they had neither a family history of breast cancer nor a prior breast biopsy and “increased-risk” otherwise.
Results
Among average- and increased-risk women, respectively, the specificity (true-negative proportion) of screening CBE was 99.4% [95% confidence interval (CI): 98.8–99.7%] and 97.1% (95% CI: 95.7–98.0%), and the specificity of diagnostic CBE was 68.7% (95% CI: 59.7–76.5%) and 57.1% (95% CI: 51.1–63.0%). The odds of a true-negative screening CBE (specificity) were significantly lower among women at increased risk of breast cancer (adjusted odds ratio 0.21; 95% CI: 0.10–0.46).
Conclusions
Screening CBE likely has higher specificity among community clinicians compared to examiners in clinical trials of breast cancer screening, even among women at increased breast cancer risk. Highly specific examinations, however, may have relatively low sensitivity for breast cancer. Diagnostic CBE, meanwhile, is relatively nonspecific.
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Acknowledgements
The Cancer Research Network (CRN) consists of the research programs, enrollee populations, and databases of 11 health maintenance organizations (HMOs) that are members of the HMO Research Network. The health care delivery systems participating in the CRN are Group Health Cooperative, Harvard Pilgrim Health Care, Henry Ford Health System, HealthPartners Research Foundation, the Meyers Primary Care Institute of the Fallon Healthcare System/University of Massachusetts, and Kaiser Permanente in 6 regions: Colorado, Georgia, Hawaii, Northwest (Oregon and Washington), northern California, and southern California. The authors thank Sarah Greene, Kevin Beverly, Gene Hart, and the data abstractors for their efforts on this project.
Financial Support
Supported by the American Cancer Society (Grant #MRSGT-05-214-01-CPPB to Dr. Fenton) and the National Cancer Institute (Grants U19CA79689 to Dr. Edward H. Wagner and 1 K05 CA104699-02 to Dr. Elmore). During early phases of the project, Dr. Geiger was with the Southern California Kaiser Permanente, Research and Evaluation Department.
Potential Financial Conflicts of Interest
None disclosed.
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Fenton, J.J., Rolnick, S.J., Harris, E.L. et al. Specificity of Clinical Breast Examination in Community Practice. J GEN INTERN MED 22, 332–337 (2007). https://doi.org/10.1007/s11606-006-0062-7
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DOI: https://doi.org/10.1007/s11606-006-0062-7