Reconceptualizing Patient-reported Outcomes Measures in the Australian Breast Device Registry.

Background: The Australian Breast Device Registry (ABDR) is a clinical quality registry that monitors the long-term safety and performance of breast devices, including breast implants, tissue expanders, and matrix/mesh. A 5-question BREAST-Q Implant Surveillance questionnaire was captured with the primary aim of identifying poorly performing devices in women undergoing cosmetic or reconstructive breast procedures from 2017 to 2021. Poor response rates limited the ability to achieve this aim. Higher patient-reported outcome measure (PROM) completion rates were seen with reconstructive procedures. In light of this, we decided to reconceptualize the ABDR PROM program. The aim of this study was to determine the most acceptable scales for inclusion for reconstructive patients in the ABDR. Methods: A qualitative acceptability study was undertaken to seek the views of women and surgeons regarding appropriate scales from a selection of BREAST-Q instruments for a new PROM program that focused on reconstructive procedures. Data were collected via semistructured interviews, and interview transcripts were reviewed and coded thematically. Results: Eleven women who had undergone breast reconstruction surgery and 5 surgeons were interviewed. The overall preferred BREAST-Q scales were "psychosocial well-being" and "satisfaction with breasts," with recommendations to be initially administered at 6, 12, and 24 months following breast reconstruction surgery. Conclusions: The reconceptualized PROM program addresses outcomes important to women following breast reconstruction surgery. By changing to a more targeted, reliable cohort and broadening the ABDR PROM outcomes, the new program will be better able to inform enhancements in clinical care.