Background
Breast cancer awareness and early detection are limited in sub-Saharan Africa. Resource limitations make screening mammography or clinical breast exam (CBE) by physicians or nurses impractical in many settings. We aimed to assess feasibility and performance of CBE by laywomen in urban health clinics in Malawi.
Methods
Four laywomen were trained to deliver breast cancer educational talksand conduct CBE. After training, screening was implemented in diverse urbanhealth clinics. Eligible women were ≥30 years, with no prior breast cancer or breast surgery, and clinic attendance for reasons other than abreast concern. Wo men 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 underwentbreast ultrasound con firmation. 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
Among 1,220 eligible women, 1,000 (82%) agreed to CBE. Lack of time (69%) was the commonest reason for refusal. Educational talk attendance was associated with higher CBE participation (83% vs 77%, p=0.012). Among 1,000 women screened, 7% had abnormal CBE. Of 45 women with normal CBE randomized to physician exam, 43 had normal exams and two had axillary lymphadenopathy not detected by CBE. Sixty of 67 women (90%) with abnormal CBE attended the referral visit. Of these, 29 (48%) had concordant abnormal physician exam. Thirty-one women (52%) had discordant normal physician exam, all of whom also had normal breast ultrasounds. Compared to physician 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 13 women who underwent recommended pathologic sampling of a breast lesion, two had cytologic dysplasia and all others benign results.
Conclusions and relevance
CBE uptake in Lilongwe clinics was high. CBE by laywomen compared favorably with physician exam, and follow-up was good. Our intervention can serve as a model for wider implementation. Performance in rural areas, effects on cancer stage and mortality, and cost-effectiveness require evaluation.