Abstract: |
Introduction: While ultrasound-guided breast biopsy (UGBB) performed by a radiologist is the standard of care in high-income countries for diagnosing breast cancer, blind or surgical biopsy has been the norm in low-and middle-income countries (LMIC) in part because LMIC radiologists lack the skill to perform UGBB. We present the study protocol of a competency-based UGBB training program for LMIC Nigerian radiologists that leverages mobile health technology. Methods: This institutional review board-approved prospective multi-institutional single-arm clinical trial (ClinicalTrials.gov identifier: NCT04501419) involves 13 Nigerian radiologists from eight tertiary hospitals in South West and South East Nigeria. Our training program is unique because it uses a competency-based curriculum developed specifically for LMIC radiologists. The competency-based curriculum incorporates blended learning (e-learning and trainer-led), simulation (supervised and unsupervised), and patient biopsy (supervised and unsupervised) components. The study time frame is two years: 1 year for the trainees to complete active training and patient recruitment and another 1 year for patient follow-up. Primary outcome measures include trainees' competency (measured using the Ottawa Surgical Competency Operating Room Evaluation (O-SCORE)), the radiology-pathology concordance rate, and the complication rate. Secondary outcome measures include the diagnostic interval and the positive predictive value of UGBB. Conclusion: Building capacity for UGBB in Nigeria and other LMIC can potentially improve breast cancer outcomes through early diagnosis. This training program is part of an implementation multi-component strategy package in Nigeria to improve breast cancer outcomes. This training program can also be adapted for other image-guided procedures that could impact global cancer control through diagnosis, therapeutic intervention, and/or palliation. |