Budget impact analysis of a breast rapid diagnostic unit.

BACKGROUND: The Odette Cancer Centre's recent implementation of a rapid diagnostic unit (rdu) for breast lesions has significantly decreased wait times to diagnosis. However, the economic impact of the unit remains unknown. This project defined the development and implementation costs and the operational costs of a breast rdu in a tertiary care facility. METHODS: From an institutional perspective, a budget impact analysis identified the direct costs associated with the breast rdu. A base-case model was also used to calculate the cost per patient to achieve a diagnosis. Sensitivity analyses computed costs based on variations in key components. Costs are adjusted to 2015 valuations using health care-specific consumer price indices and are reported in Canadian dollars. RESULTS: Initiation cost for the rdu was $366,243. The annual operational cost for support staff was $111,803. The average per-patient clinical cost for achieving a diagnosis was $770. Sensitivity analyses revealed that, if running at maximal institutional capacity, the total annual clinical cost for achieving a diagnosis could range between $136,080 and $702,675. CONCLUSIONS: Establishment and maintenance of a breast rdu requires significant investment to achieve reductions in time to diagnosis. Expenditures ought to be interpreted in the context of institutional patient volumes and trade-offs in patient-centred outcomes, including lessened patient anxiety and possibly shorter times to definitive treatment. Our study can be used as a resource-planning tool for future rdus in health care systems wishing to improve diagnostic efficiency.

Long-term results of screening with magnetic resonance imaging in women with BRCA mutations.

BACKGROUND: The addition of breast magnetic resonance imaging (MRI) to screening mammography for women with BRCA mutations significantly increases sensitivity, but there is little data on clinical outcomes. We report screening performance, cancer stage, distant recurrence rate, and breast cancer-specific mortality in our screening study. METHODS: From 1997 to 2009, 496 women aged 25 to 65 years with a known BRCA1/2 mutation, of whom 380 had no previous cancer history, were enrolled in a prospective screening trial that included annual MRI and mammography. RESULTS: In 1847 screening rounds, 57 cancers were identified (53 screen-detected, 1 interval, and 3 incidental at prophylactic mastectomy), of which 37 (65%) were invasive. Sensitivity of MRI vs mammography was 86% vs 19% over the entire study period (P<0.0001), but was 74% vs 35% from 1997 to 2002 (P=0.02) and 94% vs 9% from 2003 to 2009 (P<0.0001), respectively. The relative sensitivities of MRI and mammography did not differ by mutation, age, or invasive vs non-invasive disease. Of the incident cancers, 97% were Stage 0 or 1. Of 28 previously unaffected women diagnosed with invasive cancer, 1 BRCA1 mutation carrier died following relapse of a 3 cm, node-positive breast cancer diagnosed on her first screen at age 48 (annual breast cancer mortality rate=0.5%). Three patients died of other causes. None of the 24 survivors has had a distant recurrence at a median follow-up of 8.4 years since diagnosis. CONCLUSION: Magnetic resonance imaging surveillance of women with BRCA1/2 mutations will detect the majority of breast cancers at a very early stage. The absence of distant recurrences of incident cancers to date is encouraging. However, longer follow-up is needed to confirm the safety of breast surveillance.

Level of suspicion of a mammographic lesion: use of features defined by BI-RADS lexicon and correlation with large-core breast biopsy.

OBJECTIVE: To determine whether the categories defined in the Breast Imaging Reporting and Data System (BI-RADS) are useful predictors of malignancy and to assess their positive predictive value. PATIENTS AND METHODS: A retrospective study was undertaken from July 1, 1994, to June 30, 1995. Of 568 abnormal mammograms for which largecore biopsy was recommended, 495 were available for review. The mammographic features of the lesions, as defined by the BI-RADS lexicon, were used to assess the level of suspicion. The lesions were classified as "probably benign," "suspicious" or "highly suggestive of malignancy." These diagnostic impressions were then correlated with the histologic diagnosis made after core biopsy. RESULTS: The diagnostic impressions before core biopsy were as followed: 16 (3%) benign lesions, 397 (80%) suspicious lesions and 82 (17%) lesions highly suggestive of malignancy. All benign lesions remained in the same category after core biopsy, whereas, of the suspicious lesions, 91% were diagnosed as benign, only 4% as malignant, and the other 5% as atypical hyperplasia. Among the lesions highly suggestive of malignancy according to the BI-RADS lexicon, 54% were found to be malignant at core biopsy. CONCLUSION: The BI-RADS lexicon is helpful in discriminating between lesions that are probably benign and probably malignant from the mammographic features. However, the rate of malignancy in the "suspicious" category is low.

The comparative value of mammographic screening for women 40-49 years old versus women 50-64 years old.

OBJECTIVE: The purpose of our study was to compare the major prognostic factors (tumor size, axillary lymph node status, and tumor stage) of breast cancers detected at mammographic screening in women ages 40-49 years old with those in women ages 50-64 years old. MATERIALS AND METHODS: Study subjects were women ages 40-64 years old who participated in our mobile van mammographic screening program from April 1985 to June 1994. We retrospectively reviewed the clinical and pathology records of women in whom breast cancer was detected at mammographic screening. All examinations were performed with dedicated equipment using screen-film technique. RESULTS: A total of 44,301 screening examinations were done during the study period. Seventy-five cancers were detected in women ages 40-49 years old, and 128 cancers were detected in women ages 50-64 years old. The cancer detection rate was 3.0 per 1000 examinations in the younger age group compared with 5.5 per 1000 examinations in the older age group. The median size of breast cancers was 10 mm for women ages 40-49 versus 11 mm for women ages 50-64. Eighty-eight percent of the patients in both age groups had no evidence of metastasis to axillary lymph nodes. Nineteen percent of women in the younger age group had advanced breast cancer (stage II or higher) compared with 26% of women ages 50-64 (p = .25). No statistically significant differences were noted between the two age groups in the size, lymph node status, or stage of breast cancers detected at mammographic screening. However, the cancers found in younger women had slightly more favorable prognoses. CONCLUSION: The major prognostic factors of cancers detected with modern mammographic equipment appear to be at least as favorable for women ages 40-49 years old as for women ages 50-64 years old. As mammographic screening has already been shown to be beneficial for women ages 50-64 years old, screening should also be beneficial for women ages 40-49 years old.

Initial versus subsequent screening mammography: comparison of findings and their prognostic significance.

OBJECTIVE: The goal of this study was to compare findings on initial and subsequent screening mammograms to determine the prognostic significance of screening-detected abnormalities. MATERIALS AND METHODS: All 3386 abnormal examinations from a 9-year mammographic screening program were studied. An initial examination was defined as one for which there were no prior films available for comparison (even if one or more prior examinations had been performed); the remainder were called subsequent examinations. The principal mammographic feature of each abnormality was recorded, as well as whether a biopsy was performed. For all screening-detected cancers, we also determined several surrogate markers of prognosis (tumor size, presence of axillary lymph node metastasis, and tumor stage). These various parameters were analyzed as a function of initial versus subsequent screening. RESULTS: The frequency of abnormal examinations was more than 2 times greater for initial examinations (7%) than for subsequent examinations (3%). Only minor differences were noted between initial and subsequent screenings when comparing the principal mammographic features of the abnormalities. However, the number of cancers found per number of biopsies performed was significantly greater (p = .02) for subsequent screenings (41%) than for initial screenings (32%). Among the 333 cancers detected, tumor size was significantly smaller for subsequent screenings (p = .0076). Node-negative status and early tumor stage (stage 0 or 1) also were found more frequently for subsequently screened cancers, but these differences were not statistically significant. CONCLUSION: Substantially fewer abnormal screening interpretations are made when mammography has been performed previously and when the prior films are available for comparison. This results in cost savings and reduced morbidity at subsequent screening (no further work-up, less patient anxiety, fewer benign biopsies). Surrogate markers of prognosis also appear to be more favorable for cancers detected at subsequent screening.