背景:基于植入物的乳房重建(IBBR)是英国最常用的重建程序。增加胸下口袋的技术的引入彻底改变了该程序,但缺乏高质量的结果数据来描述这些技术的安全性或有效性.随机对照试验(RCT)是比较治疗方法的最佳方法,但手术随机对照试验具有挑战性.iBRA(植入物乳房重建评估)研究旨在确定可行性,设计和实施实用的RCT,以检查IBBR方法的有效性。
方法:iBRA研究是受训人员主导的研究合作项目,分为四个阶段:第一阶段-国家实践问卷(NPQ),以调查当前的实践。第二阶段-多中心前瞻性队列研究接受IBBR治疗的患者评估临床和患者报告的结果阶段3-IBBR-RCT可接受性调查和定性工作,以探索患者和外科医生对拟议试验的设计和观点。第4阶段-第1至第3阶段将为未来RCT的设计和实施提供信息乳腺和整形外科专业协会(乳腺外科协会和英国整形外科医师协会)鼓励所有提供IBBR的中心参加。收集的数据将通过定义当前实践和探索围绕招聘的问题来告知进行RCT的可行性,比较器臂的选择,主要结果的选择,样本量,选择标准,审判行为,数据收集方法和使用受训者协作模式招募患者和收集数据的可行性。
结论:iBRA研究中进行的初步工作将确定可行性,IBBR中确定的RCT的设计和实施。它将与受训者合作,通过建立研究活跃的乳房和整形外科医生的基础设施来建设能力,这将促进未来的高质量研究,最终改善所有寻求重建手术的妇女的结果。
背景:ISRCTN37664281。
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.