Title: The BRIghteR study – Breast Reconstruction: InvestigatinG long-term clinical and cost-effectiveness in tHe National MasTectomy and BrEast Reconstruction Audit cohort
Funder: Department of Health and Social Care

Abstract: The BRIghteR study&ndash;Breast Reconstruction: InvestigatinG long-term clinical and cost-effectiveness in tHe National MasTectomy and BrEast Reconstruction Audit cohort Research Question What are the comparative long-term outcomes and cost-effectiveness of implant-based and autologous (tissue-based) breast reconstruction (BR)? Background Almost 80% of the 55,000 women diagnosed with breast cancer in the UK each year will survive 10-years or more following their diagnosis but despite advances in treatment, up to 40% will still require a mastectomy. The loss of a breast may profoundly affect women s well-being and breast reconstruction (BR) is routinely offered to improve quality-of-life. Decision-making for BR is complex. Reconstruction can be performed using implants or the patient s own tissue (autologous BR) taken from the back, abdomen or buttocks, either at the time of mastectomy or as a delayed procedure. Each technique has different risks and benefits including the duration of post-operative recovery and surgical complications. Patients and surgeons need to be able to balance these short-term considerations against the long-term outcomes of surgery to make fully-informed decisions. As different techniques vary considerably in cost, policymakers also require high-quality cost-effectiveness evidence to inform care. Evidence for the long-term clinical and cost-effectiveness of BR, however, is lacking. The National Mastectomy and Breast Reconstruction Audit (NMBRA) cohort which includes over 18,000 women who underwent mastectomy+/-BR between 2008 and 2009 represents a unique opportunity to explore long-term outcomes of different approaches to BR in a time and cost-effective way. Aims and objectives The overall aim of the study is to use the unique NMBRA-cohort to compare the long-term clinical and cost-effectiveness of implant-based and autologous BR to help patients, professionals and commissioners make more informed-decisions about reconstructive breast-surgery. Specific objectives are to Compare the long-term clinical outcomes of implant-based and autologous-BR using hospital episode statistics(HES) Explore the long-term patient-reported outcomes (PROs) of different approaches to BR using validated measures Establish the cost-effectiveness of implant-based and autologous-techniques Methods The study will have 3 parts: A clinical outcome data-linkage study using HES-data to compare revision-surgery and secondary reconstruction rates following implant-based and autologous-BR A PRO cohort-study to explore the long-term PROs of different approaches to BR using validated-measures (BREAST-Q/EQ-5D-5L/ICECAP-A) A cost-effectiveness analysis using the results from parts 1 and 2 and evidence in the literature to develop a decision-analysis model to compare the cost-effectiveness of implant-based and autologous-techniques. Timelines for delivery Months 0-6 will focus on study set-up. HES data-analysis and the PRO study will run concurrently from months 7-12 with the decision-analysis modelling planned for months13-18. Report-writing and active dissemination to key-stakeholders will occur months19-24. Anticipated Impact and Dissemination This work will establish the long-term clinical and cost-effectiveness of different approaches to BR. It will benefit patients and the NHS by promoting evidence-based practice, improving outcomes through more informed decision-making. 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 and produce updated patient information materials and policy-makers to promote evidence-based provision of reconstructive services in the UK.

Lay abstract: Aims To compare the long-term outcomes and cost-effectiveness(value-for-money) of implant and tissue-based breast reconstruction to help patients and healthcare-providers make more informed-decisions about reconstructive surgery. Background The majority of the 55,000 women diagnosed with breast cancer each year will be long-term cancer survivors but up to 40% will still require a mastectomy(removal of the breast). The loss of a breast may affect women s well-being and breast reconstruction is offered to improve quality-of-life. Decision-making for breast reconstruction is complex. Reconstruction can be performed using implants or the patient s own tissue from the back,abdomen or buttocks either at the time of mastectomy or at a later date,often after necessary cancer treatments have been completed.Each technique has different short-term risks and benefits such as the duration of recovery, number and position of scars and surgical complications.Patients and surgeons need to balance these factors against the long-term outcomes of different procedures to make fully-informed decisions about surgery. Between 2008-9,over 18,000 patients took part in a national breast reconstruction study(The National Mastectomy and Breast Reconstruction Audit,NMBRA).Some of these patients had mastectomy only,others had reconstruction using implants or their own tissue.This study hopes to go back to the same women to find out how effective their treatment has been 10-years on. Design and methods The study will have 3parts: 1.Combining patient data from the NMBRA and hospital records to determine if and when patients undergoing breast reconstruction needed further surgery to improve the appearance of their reconstruction or to remedy any problems that had occurred. 2.Asking patients who were included in the NMBRA to complete questionnaire at approximately 10-years following their surgery to explore their quality-of-life and factors that may influence this. 3.Combining the results from parts 1and2 to explore which approaches to breast reconstruction offer the best benefit to patients. Patient and public involvement This study addresses an area of research called for by patients taking part in the recent Association of Breast Surgery research Gap Analysis . Patients have advised on study design to make sure it is acceptable to potential participants.They have helped design study information and will comment on the study results as they are produced.Patient involvement will ensure that the costs and benefits included in the cost-effectiveness model are important to women undergoing breast reconstruction. Patients will help to put together information packs explaining the results of the study to the public. Dissemination Results will be presented at national meetings and published in scientific journals. We will work with patient groups;national charities including Breast Cancer Care and professional associations to produce advice booklets and digital information for patients.Together we will also brief the professionals involved in breast reconstruction to make sure patients in the UK are offered the best-options based on this research.

Research activity codes: 7.3 MANAGEMENT AND DECISION MAKING
Health categories: CANCER AND NEOPLASMS