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. Author manuscript; available in PMC: 2010 Nov 4.
Published in final edited form as: Ann Intern Med. 2009 Nov 17;151(10):727–W242. doi: 10.1059/0003-4819-151-10-200911170-00009

Table 4. Trials of Clinical Breast Examination and Breast Self Examination.

Author, Year (reference) Technique Years Setting/Population (no. screening; no. control) Ages at Enrollment (years) Study Design Intervention Primary Outcomes Secondary Outcomes USPSTF Quality Rating
Pisani et al, 2006 (53) CBE 1996-1997 Manila, Philippines; women living in the 12 central areas (151,168; controls not indicated) 35-64 RCT; block randomization of 202 health centers 5 annual CBEs vs usual care provided by nurses and midwives; CBE instruction using the MAMMACARE program Breast cancer mortality not reported *False negative: 80/133 diagnosed breast cancers
*False positive: 1182/1220 (96.9%) of those who completed follow-up		 Poor: low participation; discontinued after one round
Boulos et al, 2005 (54) CBE/BSE Pilot: 2000-2002 RCT: ongoing Cairo, Egypt; women living in area around Italian Hospital (screening phase 1= 4,116 with 1,924 at early follow-up; controls late follow-up 1,927) Phase 1: 35-64 Phase 2 and 3: 39-65 Phase 1: cohort Phase 2: RCT; block randomization CBE/BSE× (intervention) vs CBE/BSE× (control) provided by female physicians; CBE training at Italian Hospital 2 months prior to study Breast cancer incidence Benign procedures: 1.2% after one round Not rated (in progress)
Trial in progress (55) CBE/BSE 1998 and ongoing Mumbai, India; women living in area around Tata Memorial Hospital (150,000; controls not indicated) 35-64 RCT; cluster randomization CBE + BSE + breast health education every 24 months for 4 rounds vs education alone provided by trained female health workers; CBE training for 5 months prior to trial Breast cancer mortality Not available Not rated (in progress)
Thomas et al, 2002 (58) BSE 1989-2000 Shanghai, China; women working at one of 519 factories (132,979; 133,085) 31-65 RCT; factories assigned to BSE or control group BSE instruction with periodic reinforcement provided by trained former factory medical workers vs no instruction; initial BSE instruction, follow-up sessions at 1 and 3 years, medical supervised BSE every 6 months Breast cancer mortality: RR 1.03 (95% CI 0.81-1.31) Benign biopsies: RR 1.57 (95% CI 1.48-1.68) Good
Semiglazov et al, 2003 (18) BSE 1985-2001 St. Petersburg, Russia; women attending one of 28 clinics (58,985; 64,763) 40-64 RCT; cluster randomization BSE instruction with refresher every 3 years provided by trained nurses or physicians vs no instruction; providers received 3-hour training; instruction given to groups of 5 to 20 women All cause mortality: RR 1.07 (95% CI 0.88-1.29) Benign biopsies: RR 2.05 (95% CI 1.80-2.33) Fair: low adherence; inconsistent data reported
*

Risks not calculated because diagnostic follow-up for a positive CBE was 35%

Abbreviations: BSE = breast self examination; CBE = clinical breast examination; RCT = randomized controlled trial; RR = relative risk; CI = confidence interval.