Background: Implant-based breast reconstruction (IBBR) is the most commonly performed reconstructive\nprocedure in the UK. The introduction of techniques to augment the subpectoral pocket has revolutionised the\nprocedure, but there is a lack of high-quality outcome data to describe the safety or effectiveness of these\ntechniques. Randomised controlled trials (RCTs) are the best way of comparing treatments, but surgical RCTs are\nchallenging. The iBRA (implant breast reconstruction evaluation) study aims to determine the feasibility, design\nand conduct of a pragmatic RCT to examine the effectiveness of approaches to IBBR.\nMethods/design: The iBRA study is a trainee-led research collaborative project with four phases:\nPhase 1 ââ?¬â?? a national practice questionnaire (NPQ) to survey current practice\nPhase 2 ââ?¬â?? a multi-centre prospective cohort study of patients undergoing IBBR to evaluate the clinical and\npatient-reported outcomes\nPhase 3ââ?¬â?? an IBBR-RCT acceptability survey and qualitative work to explore patientsââ?¬â?¢ and surgeonsââ?¬â?¢ views of\nproposed trial designs and candidate outcomes.\nPhase 4 ââ?¬â?? 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\nassociations (Association of Breast Surgery and British Association of Plastic Reconstructive and Aesthetic Surgeons).\nData collected will inform the feasibility of undertaking an RCT by defining current practice and exploring issues\nsurrounding recruitment, selection of comparator arms, choice of primary outcome, sample size, selection criteria,\ntrial conduct, methods of data collection and feasibility of using the trainee collaborative model to recruit patients\nand collect data.\nDiscussion: The preliminary work undertaken within the iBRA study will determine the feasibility, design and\nconduct of a definitive RCT in IBBR. It will work with the trainee collaborative to build capacity by creating an\ninfrastructure of research-active breast and plastic surgeons which will facilitat
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