BACKGROUND: The overriding goal of breast surgery is to satisfy the patient regarding her own assessment of the results of surgery. While many questionnaires have been used in cosmetic and reconstructive breast surgery, few have undergone adequate development and validation. The objective of this study was therefore, to rigorously develop a new questionnaire that could be used to measure satisfaction and quality of life following breast surgery and be easily incorporated into clinical practice.
METHODS: This measure was developed with strict adherence to internationally accepted guidelines. In Phase I, the conceptual model and item list were developed from patient interviews (n=48) and focus groups (n=12). The preliminary questionnaire was pilot tested with cognitive debriefing interviews (n=47) and further modified. Field-testing was preformed at 5 centers in the US and Canada (total n=1950, test-retest n=491, response rate 72%). Item response theory (Rasch) analysis was used for item reduction and scale development.
RESULTS: A conceptual model for the impact of breast surgery was developed with scales that examine: (1) psychosocial well-being, (2) physical well-being, (3) sexual well-being, (4) satisfaction with breasts, (5) satisfaction with overall outcome and (6) satisfaction with care. The process of item generation led to a separate module for each surgery type: 1) breast augmentation, 2) reconstruction, and 3) reduction. In the item reduction analysis, 48% of field-test items were eliminated.  All preoperative items are repeated in the postoperative questionnaires. Cronbach’s alphas for the scales (3 modules with 6 scales) ranged from 0.87 to 0.98.  Test-retest reliability, as measured by intraclass correlation coefficients, ranged from 0.85 to 0.98. 
CONCLUSIONS: This new patient-reported outcome measure, the BREAST-Q ©, will provide essential information about the impact and effectiveness of breast surgery from the patients' perspective. It has a procedure-specific, modular structure and addresses multiple aspects of the patient's experience. It will support multi-center prospective studies and facilitate an evidence-based approach to the management of breast surgery patients.