Background: Diagnostic breast ultrasound (US) could be an important tool for early detection of breast cancer in low-resource settings, where efficient strategies to refine the likelihood of malignancy among palpable breast masses are needed. However, the feasibility and clinical role of diagnostic ultrasound in such settings has not been described. We trained 4 general practitioner doctors (GPs) and 5 nurses in diagnostic breast US at a rural district hospital in Rwanda that serves as a cancer referral facility. Aim: Assess management plans, biopsy rates and patient diagnoses after nurse- and GP-performed breast ultrasounds to determine the impact of diagnostic US on clinical care. Methods: We reviewed outcomes from trainees' ultrasounds during 21 months of in-person and electronic training and mentorship by Boston-based radiologists. Trainees' US assessments and management plans were recorded on structured clinical forms. Patient diagnoses and follow-up were extracted from medical records using a standardized data collection form. Among patients who received breast US, we examined a) clinicians' management plans; b) biopsy rate; c) cancer detection rate; c) rate of benign diagnoses; d) cancers diagnosed among patients who were sent home after initial evaluation. Results: Between January 1, 2016 and September 30, 2017, 307 patients with breast concerns had a diagnostic breast US and a documented trainee US assessment. Of these, following their initial US, 158 (51%) were recommended to receive a biopsy, 30 (10%) were recommended to have aspiration/drainage, 49 (16%) were recommended for clinical or US surveillance, 1 (0.3%) was referred to another facility, 65 (21%) were discharged, and 4 (all with no abnormalities on US) had missing recommendations. Of those recommended for biopsy at initial presentation, 151 (96%) had a biopsy at that time. 56 (37%) were diagnosed with breast cancer, 37 (25%) with fibroadenoma, 7 (5%) with lactating adenoma, and 50 (33%) with other benign diagnoses. Among those with breast masses on US (n=255), 149 (58%) received a biopsy and 55 (22%) were diagnosed with cancer. As of November 23, 2017, all patients ultimately diagnosed with cancer had had a biopsy at their initial visit, and no patients who had been discharged or recommended for clinical or radiographic surveillance had been subsequently diagnosed with cancer. Conclusion: Diagnostic breast US by GPs and nurses has been a useful tool in the evaluation of breast lesions, including palpable masses, at a rural cancer facility in Rwanda. Early findings suggest that it has allowed avoidance of biopsy for 42% of patients with breast masses noted on US. Clinical follow-up and evaluation are ongoing to assess longer-term patient outcomes, cancer detection rates among patients who are not initially biopsied, and rates of follow-up among patients recommended to have clinical or radiographic surveillance.
Automated versus handheld breast ultrasound examinations of suspicious breast masses: methodological errors in the reliability analysis
