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

Johnson, Leigh; Holcombe, Chris; O’Donoghue, Joe M; Jeevan, Ranjeet; Browne, John; Fairbrother, Patricia; MacKenzie, Mairead; Gulliver-Clarke, Carmel; White, Paul; Mohiuddin, Syed; Hollingworth, Will; Potter, Shelley

Abstract

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 BR 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 1 January 2008 and 31 March 2009 will be identified from hospital episode statistics (HES). Surviving women will be contacted and invited to complete validated PRO measures 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 comorbidities, 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.

• Journal Article Type: Article
• Acceptance Date: Jul 29, 2021
• Online Publication Date: Aug 18, 2021
• Publication Date: 2021
• Deposit Date: Aug 1, 2021
• Publicly Available Date: Aug 19, 2021
• Journal: BMJ Open
• Electronic ISSN: 2044-6055
• Publisher: BMJ Publishing Group
• Peer Reviewed: Peer Reviewed
• Volume: 11
• Issue: 8
• Article Number: e054055
• DOI: https://doi.org/10.1136/bmjopen-2021-054055
• Public URL: https://uwe-repository.worktribe.com/output/7597215