Methods and analysis: Women undergoing mastectomy and/or BR following a diagnosis of breast cancer between 1st January 2008 and 31st March 2009 will be identified from Hospital Episode Statistics (HES). Surviving women will be contacted and invited to complete validated patient-reported outcome measures (PROMs) including the BREAST-Q, EQ-5D-5L and ICECAP-A, or opt out of having their data included in the HES analysis.
Long-term clinical outcomes will be explored using HES data. The primary outcome will be rates of revisional surgery between implant-based and autologous procedures. Secondary outcomes will include rates of secondary reconstruction and reconstruction failure.
The long-term PROs of implant-based and autologous reconstruction will be compared using BREAST-Q; EQ-5D-5L and ICECAP-A scores. Multivariable regression will be used to examine the relationship between long-term outcomes, patient co-morbidities, sociodemographic and treatment factors.
A Markov model will be developed using HES and PRO data and published literature to compare the relative long-term cost-effectiveness of implant-based and autologous BR.
Ethics and dissemination: The Brighter study has been approved by the South-West - Central Bristol Research Ethics Committee (20/SW/0020), and the Confidentiality Advisory Group (20/CAG/0021).
Results will be published in peer-reviewed journals and presented at national meetings. We will work with the professional associations, charities and patient groups to disseminate the results.
|Publication status||Accepted/In press - 29 Jul 2021|
- Breast reconstruction
- patient-reported outcomes