Women recovering from mastectomy face a stark lack of high-quality evidence to guide which breast reconstruction procedure works best—or costs the NHS least. This Fellowship aims to fix that by developing the tools needed to run a definitive clinical trial comparing different reconstruction techniques. The problem is twofold: surgeons are often sceptical of randomised trials, and there is no agreed-upon way to measure outcomes or costs consistently. Without standardised measurements, studies cannot be compared, and policymakers cannot make informed decisions. The research will create a core measurement set—a minimum list of outcomes that every future trial must report—and a micro-costing framework to capture the true cost of each surgical step, from operating time to materials. If successful, this work will transform a fragmented field into one where evidence drives practice. Surgeons will have clear data on which techniques improve quality of life, patients can make informed choices, and NHS commissioners can allocate resources based on cost-effectiveness rather than tradition. The pilot trial will also test whether women and surgeons are willing to accept random assignment to different implant types—a critical step before any large-scale study can begin.
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Background Breast reconstruction (BR) may improve outcomes for women following mastectomy for breast cancer, but there is currently a lack of high-quality evidence of the clinical or cost-effectiveness of different procedures to inform decision-making for patients or policy-makers. Randomised clinical trials (RCTs) are ideally-needed, but BR trials are challenging. In addition to the methodological difficulties, reconstructive surgeons are generally unfamiliar with evidence-based practice and often sceptical about RCTs. Recent methodological advances and changes in surgical research culture as evidenced by the success of collaborative projects such as the NIHR-funded iBRA study in implant-based breast reconstruction (IBBR), suggest that RCTs in BR may now be possible. Before a large-scale BR trial can be proposed, however, further work is needed to develop better methods for assessing the clinical and cost-effectiveness of BR and to explore whether randomisation to different techniques is acceptable to patients and professionals. Aims and objectives The aim of this Fellowship is inform the design of a definitive RCT in BR by developing methods to optimally measure the outcomes and costs of reconstructive breast surgery and determine whether it is possible to randomise patients into a trial comparing two types of implant-based BR. Specific objectives are to Improve the quality and consistency of outcome-reporting in BR by developing a core measurement set and consensus regarding standardised time-points when key outcomes should be measured Improve the use and value of economic evaluation of BR by developing a novel micro-costing framework for use in future studies Determine the feasibility of conducting an RCT in IBBR by conducting an external pilot-RCT. Engage and work with breast and plastic surgeons to design a multi-centre pragmatic RCT. Plan of investigation Work package 1 will build on my core outcome set work to develop and implement a core measurement set (CMS) for BR. This will involve systematic reviews (SRs), Delphi surveys with patients and healthcare professionals and consensus meetings to determine the final CMS. Uptake of the CMS will be promoted through active dissemination to funding-bodies, journal editors and patient advocacy groups. Work package 2 will use a SR of micro-costing in economic evaluations of surgical interventions and a real-time micro-costing study of the three main types of BR to identify the main cost-drivers for surgical procedures. These will be used to develop a framework for the use of micro-costing as a preferred method for resource-use assessment in future surgical RCTs. Work package 3 will determine the feasibility of undertaking a pragmatic large-scale RCT comparing the effectiveness and cost-effectiveness of two approaches to IBBR. This will build on the non-randomised feasibility work in iBRA to determine whether randomisation is acceptable to patients and professionals and whether the interventions identified by iBRA are sufficiently stable for formal evaluation in the context of an RCT. The pilot-RCT will take place in three centres and will include the Quintet recruitment intervention to allow anticipated issues around recruitment to be explored, understood and addressed to optimise participation. Consensus among professionals and patients will be used to establish the feasibility of a large-scale RCT and key aspects of study design. Summary of potential benefits to patients and the NHS This Fellowship will inform high-quality collaborative research in BR and educate, engage and empower the reconstructive community in the need for the creation of evidence such that future practice will be based on the results of well-designed and delivered trials. This will benefit patients and the NHS by promoting evidence-based practice, improving outcomes through more informed decision-making and supporting commissioners in making high-quality decisions about the provision of BR in a financially-constrained NHS.
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