Protocol for a national cohort study to explore the long-term clinical and patient-reported outcomes and cost-effectiveness of implant-based and autologous breast reconstruction after mastectomy for breast cancer: The Brighter Study

Introduction: Breast reconstruction (BR) is offered to improve quality of life for women with breast cancer undergoing mastectomy. As most women will be long-term breast cancer survivors, high-quality information regarding the long-term outcomes of different breast reconstruction procedures is essential to support informed decision-making. As different techniques vary considerably in cost, policymakers also require high-quality cost-effectiveness evidence to inform care. The Brighter study aims to explore the long-term clinical and patient-reported outcomes (PROs) of implant-based and autologous BR and use health economic modelling to compare the long-term cost-effectiveness of different reconstructive techniques.
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.