BACKGROUND: Objective measurement of benign non-discrete lumpy breasts is not performed routinely that would lead to disease measurement, inter-physician communication, therapeutic response assessment and a normative function of reducing unnecessary biopsies. A schematic 5-point ordinal visual analogue scale was developed. METHODS: Two blinded experienced clinicians graded breast nodularity on a pre-determined five point analogue scale (grades 0-4) to determine its inter-observer reliability after its face validity that excluded inflammatory, nipple, areola and discrete lump problems. RESULTS: 784 Women (hospital 384; community 400) aged between 20 and 70 years (mean 31.9) underwent physical breast examination by 2 experienced clinicians. Inter-observer matched nodularity grading in women attending hospital were Grade 0 in 123 (32.03%), grade 1 in 67 (17.44%), grade 2 in 54 (14.06%), grade 3 in 52 (13.54%) and grade 4 in 23 (5.99%) and in community it was grade 0 in 172 (43%), grade 1 in 88 (22%), grade 2 in 60 (15%), grade 3 in 28 (7%) and grade 4 in 14 (3.5%) women. There was very good agreement (kappa = 0.7798) across all grades in hospital subjects and excellent agreement (kappa = 0.8659) in community subjects. Both estimates of kappa coefficients were highly significant from population kappa coefficient of zero (p < 0.001). Overall, 1/3rd normal women have absolutely smooth textured breasts. CONCLUSION: User-friendly tool developed for objective evaluation of non-discrete lumpy breasts showed excellent reliability and validity. This tool should be useful for clinical drug trials in benign breast disorders and for wide routine clinical recording of patients. Copyright (c) 2010 Elsevier Ltd. All rights reserved.
BACKGROUND: Objective measurement of benign non-discrete lumpy breasts is not performed routinely that would lead to disease measurement, inter-physician communication, therapeutic response assessment and a normative function of reducing unnecessary biopsies. A schematic 5-point ordinal visual analogue scale was developed. METHODS: Two blinded experienced clinicians graded breast nodularity on a pre-determined five point analogue scale (grades 0-4) to determine its inter-observer reliability after its face validity that excluded inflammatory, nipple, areola and discrete lump problems. RESULTS: 784 Women (hospital 384; community 400) aged between 20 and 70 years (mean 31.9) underwent physical breast examination by 2 experienced clinicians. Inter-observer matched nodularity grading in women attending hospital were Grade 0 in 123 (32.03%), grade 1 in 67 (17.44%), grade 2 in 54 (14.06%), grade 3 in 52 (13.54%) and grade 4 in 23 (5.99%) and in community it was grade 0 in 172 (43%), grade 1 in 88 (22%), grade 2 in 60 (15%), grade 3 in 28 (7%) and grade 4 in 14 (3.5%) women. There was very good agreement (kappa = 0.7798) across all grades in hospital subjects and excellent agreement (kappa = 0.8659) in community subjects. Both estimates of kappa coefficients were highly significant from population kappa coefficient of zero (p < 0.001). Overall, 1/3rd normal women have absolutely smooth textured breasts. CONCLUSION: User-friendly tool developed for objective evaluation of non-discrete lumpy breasts showed excellent reliability and validity. This tool should be useful for clinical drug trials in benign breast disorders and for wide routine clinical recording of patients. Copyright (c) 2010 Elsevier Ltd. All rights reserved.
Authors: Robert E Mansel; Tapas Das; Geraldine E Baggs; Michael J Noss; William P Jennings; Jay Cohen; David Portman; Mario Cohen; Anne Coble Voss Journal: J Womens Health (Larchmt) Date: 2017-12-13 Impact factor: 2.681