title: The iBRA-2 (immediate breast reconstruction and adjuvant therapy audit) study: protocol for a prospective national multicentre cohort study to evaluate the impact of immediate breast reconstruction on the delivery of adjuvant therapy.
abstract: Immediate breast reconstruction (IBR) is routinely offered to improve quality of life for women with breast cancer requiring a mastectomy, but there are concerns that more complex surgery may delay the delivery of adjuvant oncological treatments and compromise long-term oncological outcomes. High-quality evidence, however, is lacking. iBRA-2 is a national prospective multicentre cohort study that aims to investigate the effect of IBR on the delivery of adjuvant therapy.
  
  
  
  Breast and plastic surgery centres in the UK performing mastectomy with or without (±) IBR will be invited to participate in the study through the trainee research collaborative network. All women undergoing mastectomy ± IBR for breast cancer between 1 July and 31 December 2016 will be included. Patient demographics, operative, oncological and complication data will be collected. Time from last definitive cancer surgery to first adjuvant treatment for patients undergoing mastectomy ± IBR will be compared to determine the impact that IBR has on the time of delivery of adjuvant therapy. Prospective data on 3000 patients from ∼50 centres are anticipated.
  
  
  
  Research ethics approval is not required for this study. This has been confirmed using the online Health Research Authority decision tool. This novel study will explore whether IBR impacts the time to delivery of adjuvant therapy. The study will provide valuable information to help patients and surgeons make more informed decisions about their surgical options. Dissemination of the study protocol will be via the Mammary Fold Academic and Research Collaborative (MFAC) and the Reconstructive Surgery Trials Network (RSTN), the Association of Breast Surgery (ABS) and the British Association of Plastic, Reconstructive and Aesthetic Surgeons (BAPRAS). Participating units will have access to their own data and collective results will be presented at relevant surgical conferences and published in appropriate peer-reviewed journals.
authors.affiliation: Nightingale Breast Unit, University Hospital of South Manchester NHS Foundation Trust, Manchester, UK.
authors.forename: Rajiv
authors.initials: R
authors.lastname: Dave
authors.affiliation: Department of Breast Surgery, The Royal Marsden NHS Foundation Trust, Sutton, UK.
authors.forename: Rachel
authors.initials: R
authors.lastname: O'Connell
authors.affiliation: Department of Cancer Studies, Clinical Sciences Building, University of Leicester, Leicester, UK.
authors.forename: Tim
authors.initials: T
authors.lastname: Rattay
authors.affiliation: Bristol Centre for Surgical Research, School of Social and Community Medicine, University of Bristol, Bristol, UK.
authors.forename: Zoe
authors.initials: Z
authors.lastname: Tolkien
authors.affiliation: Department of Breast Surgery, The Royal Marsden NHS Foundation Trust, Sutton, UK.
authors.forename: Nicola
authors.initials: N
authors.lastname: Barnes
authors.affiliation: Department of Plastic Surgery, University Hospitals Coventry and Warwickshire NHS Trust, Coventry, UK.
authors.forename: Joanna
authors.initials: J
authors.lastname: Skillman
authors.affiliation: Department of Biostatistics, Clinical Trials Research Centre, University of Liverpool MRC North West Hub for Trials Methodology Research, University of Liverpool, Liverpool, UK.
authors.forename: Paula
authors.initials: P
authors.lastname: Williamson
authors.affiliation: Department of Biostatistics, Clinical Trials Research Centre, University of Liverpool MRC North West Hub for Trials Methodology Research, University of Liverpool, Liverpool, UK.
authors.forename: Elizabeth
authors.initials: E
authors.lastname: Conroy
authors.affiliation: Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Nuffield Orthopaedic Centre, Oxford, UK.|Department of Surgery and Cancer, Imperial College London, London, UK.
authors.forename: Matthew
authors.initials: M
authors.lastname: Gardiner
authors.affiliation: Norfolk and Norwich Hospital, Norwich, UK.
authors.forename: Adrian
authors.initials: A
authors.lastname: Harnett
authors.affiliation: The Christie NHS Foundation Trust, Manchester, UK.
authors.forename: Ciara
authors.initials: C
authors.lastname: O'Brien
authors.affiliation: Bristol Centre for Surgical Research, School of Social and Community Medicine, University of Bristol, Bristol, UK.
authors.forename: Jane
authors.initials: J
authors.lastname: Blazeby
authors.affiliation: Bristol Centre for Surgical Research, School of Social and Community Medicine, University of Bristol, Bristol, UK.
authors.forename: Shelley
authors.identifier: 0000-0002-6977-312X
authors.initials: S
authors.lastname: Potter
authors.affiliation: Linda McCartney Centre, Royal Liverpool and Broadgreen University Hospital, Liverpool, UK.
authors.forename: Chris
authors.initials: C
authors.lastname: Holcombe
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001691:Biological Therapy; D001940:Breast / Q000601:surgery*; D001943:Breast Neoplasms / Q000601:surgery / Q000628:therapy*; D017024:Chemotherapy, Adjuvant; D002985:Clinical Protocols; D005260:Female; D006801:Humans; D016462:Mammaplasty; D008408:Mastectomy; D008875:Middle Aged; D011446:Prospective Studies; D011788:Quality of Life; D018714:Radiotherapy, Adjuvant; D012107:Research Design; D013997:Time Factors; D006113:United Kingdom; D055815:Young Adult
keywords: adjuvant therapy; cohort study; immediate breast reconstruction; trainee collaboratives