Follow-up versus tissue diagnosis in BI-RADS category 3 solid breast lesions at US: a cost-consequence analysis.

PURPOSE The aim of this study was to compare the economic effect of a proposed follow-up strategy for managing category 3 breast masses. The strategy incorporated direct tissue diagnosis at the patient's discretion for masses that had been assessed only based on ultrasonography (US) and for which mammography made no diagnostic contribution. MATERIALS AND METHODS This prospective cohort study was conducted between 2003 and 2006 and included 174 patients. We used a two-year short-term follow-up protocol composed of five steps. A biopsy was recommended for masses that were increasing in size and changing in nature. The long-term results were available at the end of 2010. The mean and total costs were calculated for the women who preferred our follow-up protocol and for those who preferred direct tissue diagnosis. The cost savings were calculated by comparing the costs of the current study protocol to the costs of two different scenarios. RESULTS Two malignancies were found among the 18 women who underwent tissue diagnosis on the recommendation of the radiologist during follow-up. Thirteen of these women underwent biopsy at the request of the patient or surgeon, and these biopsies all revealed benign tumors. The overall negative predictive value was 99.2% (95% confidence interval, 98.46%-100%). There was a statistically significant difference between the mean costs for the women who chose our follow- up regimen (147.57±106.7 TL) and those who preferred direct tissue diagnosis (426.89±149.8 TL) (P = 0.0001). The use of our follow-up protocol decreased the cost of diagnosis by 60% compared with the cost of using direct tissue diagnosis as the initial procedure. CONCLUSION Our long-term results indicate that following-up solid category 3 masses detected only by US for at least two years at short intervals is a cost-effective alternative to direct breast biopsy.