Uptake and Performance of Clinical Breast Exam Screening Program by Trained Laywomen in Malawi

Abstract

Abstract 2 Background: Breast cancer mortality is high in sub-Saharan Africa (SSA) partly due to limited breast cancer awareness and challenges in early detection. We trained laywomen to promote breast cancer awareness and perform screening - clinical breast exam (CBE) - in urban clinics. This is the first breast cancer screening study in Malawi, and the first study in SSA to assess CBE delivered by laywomen with other health services. Methods: Four laywomen were trained to deliver breast cancer educational talks and conduct CBE. After training, screening was implemented in diverse urban health clinics. Women eligible to undergo CBE were ≥30 years, with no prior breast cancer or breast surgery, and clinic attendance for reasons other than a breast concern. Women with abnormal CBE were referred to a study surgeon. All palpable masses confirmed by surgeon exam were pathologically sampled. Patients with abnormal screening CBE but normal surgeon exam underwent breast ultrasound confirmation. Additionally, 50 randomly selected women with normal screening CBE underwent breast ultrasound, and 45 different women with normal CBE were randomly assigned to surgeon exam. Results: 175 educational talks were delivered to 4,295 people across 5 clinics. Among 1,220 eligible women, 1,000 (82%) agreed to CBE. Lack of time (68%) was the most common reason for refusal. CBE agreement varied across clinics from 71% to 86% (p=0.001). Women who attended the talk were more likely to accept CBE than women who did not (83% vs 77%, p=0.012). Among 1,000 women screened, 7% had abnormal CBE. All 50 women with normal CBE randomized to ultrasound had normal findings. Of 45 women with normal CBE randomized to surgeon exam, 43 had normal surgeon exams and 2 had axillary lymphadenopathy not detected by screening CBE. Sixty of 67 women (90%) with abnormal CBE attended the referral visit. Of these, 29 (48%) had concordant abnormal surgeon exam, and 15 were recommended to have pathologic sampling. Fourteen women had nipple discharge or breast pain identified by both CBE and surgeon exam, which did not require further work-up after surgeon review. Thirty-one women (52%) had discordant normal surgeon exam, all of whom had normal breast ultrasounds. Compared to surgeon exam, sensitivity for CBE by laywomen was 94% (CI 79-99%), specificity 58% (CI 46-70%), positive predictive value 48% (CI 35-62%), and negative predictive value 96% (CI 85-100%). Of 15 women who underwent pathologic sampling, 2 had cytologic dysplasia and are awaiting surgical excision, 7 had fibroadenomas, 2 normal tissue, 1 galactocele, 1 abscess, 1 lymph node with Kaposi sarcoma, and 1 tumoral calcinosis. Conclusions: Uptake of CBE screening in Lilongwe clinics was high. CBE by laywomen compared favorably with surgeon exam, and follow-up was good. Our intervention can serve as a model for wider implementation. Performance in rural areas, effects on breast cancer stage distribution and mortality, and cost-effectiveness require further evaluation. AUTHORS' DISCLOSURES OF POTENTIAL CONFLICTS OF INTEREST: No COIs from the authors.