This is the first study to date that measures outcomes in addition to cancer diagnoses in women with breast pain. Our results indicate that initial imaging in the evaluation of breast pain increases subsequent clinical utilization, regardless of clinical breast exam findings. Women who received initial imaging were significantly more likely to undergo additional diagnostic evaluation. Most importantly, women with normal clinical breast exams had increased odds of clinical utilization if they received initial imaging, with no benefit of increased cancer detection. The findings did not change when the data was stratified by age as a proxy for menopausal status, or stratified by one provider with higher rates of initial imaging.
These results support existing data demonstrating a low probability of malignancy in women presenting with breast pain as a primary complaint.9–11
The number of cancers diagnosed represents 0.6% of the study population, within the range of 0-3% previously documented in the medical literature.7–9
Three of the 6 cancers were detected with initial imaging showing a lesion that corresponded with a mass at the site of breast pain; one had a negative initial mammogram with imaging three months later finding a contralateral DCIS, while two were detected through screening mammography (not considered diagnostic imaging in analyses) Diagnostic imaging in women with breast pain and normal clinical exams yielded no cancer diagnoses.
Previous studies in women with breast pain have sought to describe the causes, prevalence, and treatment of breast pain. Studies analyzing imaging in evaluation of breast pain have focused on cancer diagnosis as the outcome, and have demonstrated low yield of imaging in the setting of normal findings on clinical examinations.8–11,14,22
Nevertheless, imaging has been recommended for reassurance purposes,9
with no data describing its effect on the management of breast pain. By looking at clinical utilization outcomes, we measured the effect imaging has on clinical management of breast pain. Our data show that imaging in the initial evaluation of breast pain leads to increased clinical utilization without increased breast cancer detection. While initial imaging in women with breast pain has been recommended for reassurance purposes, there is significant increased subsequent utilization in women who receive initial imaging, without increased diagnostic yield.
Overutilization of diagnostic imaging is a concern, particularly as healthcare reform demands efforts to curtail overutilization.23,24
In addition, normal test results do not necessarily lead to reassurance, and in some cases can increase anxiety levels and do harm.25–27
With efforts to improve health care quality while decreasing costs, it is important to determine if imaging for patients with breast pain is of value in reassuring patients and providers, as reflected in subsequent utilization. The fact that individual provider behaviors vary within the same clinic in the management of women with breast pain and normal clinical breast exams (this variation was absent in women with mass on clinical breast exam), suggests a need for establishment of guidelines for women with breast pain.
Past studies have posited that the goal of imaging in breast pain is to provide reassurance of benign etiology to the patient and provider. This implies that diagnostic certainty of non-malignancy should increase. Previous research has demonstrated a link between diagnostic certainty and provider clinical actions, such that reduced test-ordering behaviors are directly influenced by providers’ increased certainty regarding diagnoses.28–30
Applying this association to our study, with reassurance and diagnostic certainty, subsequent testing should decrease. The increased utilization observed in this study suggests the opposite, that initial imaging does not provide reassurance or increase diagnostic certainty.
Several limitations should be considered when interpreting study findings. Study data did not allow for breast cancer risk adjustment. Using a tool such as the Modified Gail Model31
was not age-appropriate for all women and there was incomplete data for variables in the tool, including age at first pregnancy, menarche, and menopause. Clinical services provided outside of the institution were not included in analyses. Systematic data to categorize non-malignant diagnoses (i.e. fibroadenoma, cyst) were not available and therefore not included in analyses. Clinical services and additional visits during 12 months of follow-up attributed to complaints other than breast pain could not be ascertained, and therefore we were not able to exclude these visits from analyses.
A potential referral bias exists in this population in that only women with breast pain referred to a specialty practice were included. Providers in this practice have expertise in clinical breast exams and are likely to have a higher sensitivity and specificity of their exams than most primary care providers. Markers of patient concern or anxiety were not collected and therefore could not be controlled for in analyses. Using clinical utilization as a proxy for diagnostic certainty does not elucidate whether the patient or provider is driving increased utilization. Patients who received diagnostic imaging following initial provider visit may have demonstrated a higher level of anxiety or concern than patients who did not. Similarly, providers themselves may be uncertain about the underlying etiology of breast pain and therefore order additional diagnostic tests. Future studies that prospectively assess anxiety and reasoning for subsequent imaging are needed to address these concerns.
While past studies have indicated the main value of breast imaging in women with painful breasts to be that of reassurance, our results show that initial imaging leads to additional evaluation. Our results support previous research demonstrating that the prevalence of cancer in patients with breast pain is low and suggest that following normal clinical exam, diagnostic imaging is not required to either rule out cancer or provide reassurance in ruling out cancer. As importantly, these results support the critical role of clinical breast exam skills in the evaluation of breast pain.