title: Clinical breast examination screening by trained laywomen in Malawi integrated with other health services.
abstract: Breast cancer awareness and early detection are limited in sub-Saharan Africa. Resource limitations make screening mammography or clinical breast examination (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.
  
  
  
  Four laywomen were trained to deliver breast cancer educational talks and conduct CBE. After training, screening was implemented in diverse urban health clinics. Eligible women were ≥30 y, 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 examination were pathologically sampled. Patients with abnormal screening CBE but normal surgeon examination underwent breast ultrasound confirmation. In addition, 50 randomly selected women with normal screening CBE underwent breast ultrasound, and 45 different women with normal CBE were randomly assigned to surgeon examination.
  
  
  
  Among 1220 eligible women, 1000 (82%) agreed to CBE. Lack of time (69%) was the commonest reason for refusal. Educational talk attendance was associated with higher CBE participation (83% versus 77%, P = 0.012). Among 1000 women screened, 7% had abnormal CBE. Of 45 women with normal CBE randomized to physician examination, 43 had normal examinations 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 examination. Thirty-one women (52%) had discordant normal physician examination, all of whom also had normal breast ultrasounds. Compared with physician examination, sensitivity for CBE by laywomen was 94% (confidence interval [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.
  
  
  
  CBE uptake in Lilongwe clinics was high. CBE by laywomen compared favorably with physician examination 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.
authors.affiliation: UNC Project-Malawi, Lilongwe, Malawi. Electronic address: lily.gutnik@mail.harvard.edu.
authors.forename: Lily
authors.initials: L
authors.lastname: Gutnik
authors.affiliation: UNC Project-Malawi, Lilongwe, Malawi; University of North Carolina, Lineberger Comprehensive Cancer Center, Chapel Hill, North Carolina.
authors.forename: Clara
authors.initials: C
authors.lastname: Lee
authors.affiliation: Department of Surgery, Kamuzu Central Hospital, Lilongwe, Malawi.
authors.forename: Vanessa
authors.initials: V
authors.lastname: Msosa
authors.affiliation: UNC Project-Malawi, Lilongwe, Malawi; University of North Carolina, Lineberger Comprehensive Cancer Center, Chapel Hill, North Carolina; Department of Medicine, Kamuzu Central Hospital, Lilongwe, Malawi; University of Malawi College of Medicine, Blantyre, Malawi.
authors.forename: Agnes
authors.initials: A
authors.lastname: Moses
authors.affiliation: UNC Project-Malawi, Lilongwe, Malawi.
authors.forename: Christopher
authors.initials: C
authors.lastname: Stanley
authors.affiliation: Department or Radiology, Kamuzu Central Hospital, Lilongwe, Malawi; University of Malawi College of Medicine, Blantyre, Malawi.
authors.forename: Suzgo
authors.initials: S
authors.lastname: Mzumara
authors.affiliation: UNC Project-Malawi, Lilongwe, Malawi.
authors.forename: N George
authors.initials: NG
authors.lastname: Liomba
authors.affiliation: UNC Project-Malawi, Lilongwe, Malawi; University of North Carolina, Lineberger Comprehensive Cancer Center, Chapel Hill, North Carolina; University of Malawi College of Medicine, Blantyre, Malawi.
authors.forename: Satish
authors.initials: S
authors.lastname: Gopal
mesh_terms: D000328:Adult; D000368:Aged; D001943:Breast Neoplasms / Q000175:diagnosis*; D003150:Community Health Workers / Q000193:education / Q000458:organization & administration; D019033:Delivery of Health Care, Integrated; D055088:Early Detection of Cancer / Q000379:methods*; D005240:Feasibility Studies; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008295:Malawi; D008875:Middle Aged; D010342:Patient Acceptance of Health Care / Q000706:statistics & numerical data; D010808:Physical Examination / Q000379:methods*; D012017:Referral and Consultation; D012680:Sensitivity and Specificity
keywords: Breast cancer; Global health; Laywomen; Screening