Development and Validation of a Nipple-Specific Scale for the BREAST-Q to Assess Patient-Reported Outcomes following Nipple-Sparing Mastectomy.

BACKGROUND: Nipple-sparing mastectomy and immediate reconstruction has become increasingly popular for prophylactic and therapeutic indications. Patient-reported outcomes instruments such as the BREAST-Q provide important information regarding patient satisfaction and aesthetic and functional outcomes. However, a validated patient-reported outcomes scale specifically addressing nipple-related outcomes following nipple-sparing mastectomy is not currently available. METHODS: The authors developed a new scale measuring nipple outcomes by adapting nipple reconstruction questions from the BREAST-Q breast reconstruction module. Patients completed the questions using the think-aloud method and underwent semistructured cognitive interviews to discuss their nipple-sparing mastectomy experience to elicit new concepts. Interviews were coded and additional questions were added based on this analysis after receiving additional input from a multidisciplinary group of breast cancer providers. The final scale was distributed electronically to a larger group with solicitation for any issues that were not addressed in the question set. RESULTS: Ten patients completed the initial questionnaire. Analysis of the cognitive interviews identified nipple sensation, position, projection, scarring, symmetry, and surgical expectations as key content areas. After revising the questionnaire, an additional 35 patients completed it electronically. All respondents felt the questions were clear and no additional issues needed to be addressed. Feedback was used to clarify the instructions for how to respond to the questions if bilateral nipple-sparing mastectomy had been performed. CONCLUSIONS: Through qualitative patient interviews and adaptation of existing BREAST-Q questions, appropriate nipple-focused questions were developed to assess outcomes following nipple-sparing mastectomy. Incorporating these questions into patient-reported outcomes assessment of patients undergoing nipple-sparing mastectomy can help improve future techniques and optimize outcomes.