title: The iBRA (implant breast reconstruction evaluation) study: protocol for a prospective multi-centre cohort study to inform the feasibility, design and conduct of a pragmatic randomised clinical trial comparing new techniques of implant-based breast reconstruction.
abstract: BACKGROUND
  Implant-based breast reconstruction (IBBR) is the most commonly performed reconstructive procedure in the UK. The introduction of techniques to augment the subpectoral pocket has revolutionised the procedure, but there is a lack of high-quality outcome data to describe the safety or effectiveness of these techniques. Randomised controlled trials (RCTs) are the best way of comparing treatments, but surgical RCTs are challenging. The iBRA (implant breast reconstruction evaluation) study aims to determine the feasibility, design and conduct of a pragmatic RCT to examine the effectiveness of approaches to IBBR.
  
  
  METHODS
  The iBRA study is a trainee-led research collaborative project with four phases:Phase 1 - a national practice questionnaire (NPQ) to survey current practicePhase 2 - a multi-centre prospective cohort study of patients undergoing IBBR to evaluate the clinical and patient-reported outcomesPhase 3- an IBBR-RCT acceptability survey and qualitative work to explore patients' and surgeons' views of proposed trial designs and candidate outcomes.Phase 4 - phases 1 to 3 will inform the design and conduct of the future RCT All centres offering IBBR will be encouraged to participate by the breast and plastic surgical professional associations (Association of Breast Surgery and British Association of Plastic Reconstructive and Aesthetic Surgeons). Data collected will inform the feasibility of undertaking an RCT by defining current practice and exploring issues surrounding recruitment, selection of comparator arms, choice of primary outcome, sample size, selection criteria, trial conduct, methods of data collection and feasibility of using the trainee collaborative model to recruit patients and collect data.
  
  
  CONCLUSIONS
  The preliminary work undertaken within the iBRA study will determine the feasibility, design and conduct of a definitive RCT in IBBR. It will work with the trainee collaborative to build capacity by creating an infrastructure of research-active breast and plastic surgeons which will facilitate future high-quality research that will ultimately improve outcomes for all women seeking reconstructive surgery.
  
  
  BACKGROUND
  ISRCTN37664281.
authors.affiliation: Bristol Centre for Surgical Research, School of Social and Community Medicine, University of Bristol, Room 3.12 Canynge Hall, 39 Whatley Road, Bristol, BS8 2PS UK.
authors.forename: Shelley
authors.identifier: 0000-0002-6977-312X
authors.initials: S
authors.lastname: Potter
authors.affiliation: MRC North West Hub for Trials Methodology Research, Department of Biostatistics, Clinical Trials Research Centre, University of Liverpool, Liverpool, L69 3GS UK.
authors.forename: Elizabeth J
authors.initials: EJ
authors.lastname: Conroy
authors.affiliation: MRC North West Hub for Trials Methodology Research, Department of Biostatistics, Clinical Trials Research Centre, University of Liverpool, Liverpool, L69 3GS UK.
authors.forename: Paula R
authors.initials: PR
authors.lastname: Williamson
authors.affiliation: Breast Unit, Worcester Royal Hospital. Charles Hastings Way, Worcester, WR5 1DD UK.
authors.forename: Steven
authors.initials: S
authors.lastname: Thrush
authors.affiliation: Breast Institute, Nottingham University Hospitals NHS Trust, Hucknall Road, Nottingham, NG5 1PB UK.
authors.forename: Lisa J
authors.initials: LJ
authors.lastname: Whisker
authors.affiliation: Department of Plastic Surgery, University Hospitals Coventry and Warwickshire NHS Trust, Clifford Bridge Road, Coventry, CV2 2DX UK.
authors.forename: Joanna M
authors.initials: JM
authors.lastname: Skillman
authors.affiliation: The Nightingale Centre Breast Unit, University Hospital of South Manchester NHS Foundation Trust, Southmoor Road, Manchester, M23 9LT UK.
authors.forename: Nicola L P
authors.initials: NL
authors.lastname: Barnes
authors.affiliation: Breast Unit, University Hospital Southampton, Tremona Road, Southampton, Hampshire SO16 6YD UK ; Faculty of Medicine, University of Southampton, University Road, Southampton, SO17 1BJ UK.
authors.forename: Ramsey I
authors.initials: RI
authors.lastname: Cutress
authors.affiliation: Linda McCartney Centre, Royal Liverpool and Broadgreen University Hospital, Prescot Street, Liverpool, L7 8XP UK.
authors.forename: Elizabeth M
authors.initials: EM
authors.lastname: Teasdale
authors.affiliation: Bristol Centre for Surgical Research, School of Social and Community Medicine, University of Bristol, Room 3.12 Canynge Hall, 39 Whatley Road, Bristol, BS8 2PS UK.
authors.forename: Nicola
authors.initials: N
authors.lastname: Mills
authors.affiliation: New Cross Hospital, Royal Wolverhampton Hospitals NHS Trust, Wednesfield Way, Wolverhampton, WV10 0QP UK.
authors.forename: Senthurun
authors.initials: S
authors.lastname: Mylvaganam
authors.affiliation: Department of Plastic Surgery, The Royal Marsden NHS Foundation Trust, Fulham Road, London, SW3 6JJ UK.
authors.forename: Olivier A
authors.initials: OA
authors.lastname: Branford
authors.affiliation: City Hospital, Dudley Road, West Midlands, B18 7QH UK.
authors.forename: Katherina
authors.initials: K
authors.lastname: McEvoy
authors.affiliation: Imperial College London NHS Trust, London, SW7 2AZ UK ; Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Nuffield Orthopaedic Centre, Windmill Road, Headington, Oxford OX3 7HE UK.
authors.forename: Abhilash
authors.initials: A
authors.lastname: Jain
authors.affiliation: Imperial College London NHS Trust, London, SW7 2AZ UK ; Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Nuffield Orthopaedic Centre, Windmill Road, Headington, Oxford OX3 7HE UK.
authors.forename: Matthew D
authors.initials: MD
authors.lastname: Gardiner
authors.affiliation: Bristol Centre for Surgical Research, School of Social and Community Medicine, University of Bristol, Room 3.12 Canynge Hall, 39 Whatley Road, Bristol, BS8 2PS UK.
authors.forename: Jane M
authors.initials: JM
authors.lastname: Blazeby
authors.affiliation: Linda McCartney Centre, Royal Liverpool and Broadgreen University Hospital, Prescot Street, Liverpool, L7 8XP UK.
authors.forename: Christopher
authors.initials: C
authors.lastname: Holcombe
keywords: ADM; Breast reconstruction; Dermal sling; Feasibility study; Implant; Methodology; Randomised clinical trial; Trainee collaboratives