Miss Kate Harvey
BMRF Research Fellow for 2017/18.
Research is entitled: “The Pre Bra Feasibility Study”
What changes has the research fellowship made to you personally?
I have been able to spend a period dedicated to training in high quality surgical research methodology. I had the advantage of high-quality taught courses as well as individual supervision and mentorship from experienced surgical clinical trialists and methodologists at The University of Bristol. The fellowship ultimately afforded me the luxury of several years in research, which is the amount of time it takes to see a clinical trial through from the design and set up to the data analysis and publication phase.
The Pre-BRA study forms the basis of my MD thesis, an academic qualification that will be integral to my future research career. The fellowship has also allowed me the time and opportunities to develop a national network of breast surgery clinicians whom I can call upon as future collaborators in new research projects, mentors and career advisors.
What has your research done for patient care/numbers?
The Pre-BRA Study is an important milestone in UK implant-based breast surgery research, demonstrating for the first time the high-risk nature of prepectoral breast reconstruction in a pragmatic (i.e. representative, the opposite of highly selected) group of women. Three hundred and fifty one women were recruited from 40 UK centres involving 96 surgeons, a huge feat of collaboration! This network of clinicians who took part in Pre-BRA has already begun to recruit to other breast surgery clinical trials and to an important RCT in implant reconstruction, The Best-BRA Trial.
What is the impact of your research?
I have published our study results and will continue to present outcomes to national conferences of breast surgeons and methodologists, aiming to raise awareness of the high-risk nature of implant-based breast reconstruction and advocating for further research to inform patients’ and surgeons’ choices in breast reconstruction and breast conservation surgery.
Has the award enabled you to obtain further funding or opened other doors professionally?
During the course of the award, I have developed research relationships with hospital sites across the UK, with other academic breast trainees, and surgeons from other related disciplines such as plastic surgery. I hope to rely upon many of these individuals as future collaborators and mentors. I was successful in reaching the interview stage for a fully funded MRC Clinical Research Training Fellowship. The feedback from that process was invaluable and it will inform my future grant applications.
What are the project outcomes?
The Pre-BRA Study results have informed the design of and supported the need for The Best-BRA Study, a clinical trial in breast surgery, which is currently open and recruiting.
The study website is: https://bestbra.blogs.bristol.ac.uk/home/
Has it enabled you to attend any key/prominent events/meetings?
I presented at the largest UK national meeting of breast surgeons, the ABS AGM twice in the oral prize session (2021 and 2022). I attended the Society for Clinical Trials meeting in New Orleans in May 2019 and gave an oral presentation about The Pre-BRA Study’s novel methodology. I presented at a virtual international meeting of surgical trialists and methodologists, The IDEAL Collaboration, in April 2021.
Papers published to date:
Short-term safety outcomes of mastectomy and immediate pre-pectoral implant-based breast reconstruction: The Pre-BRA prospective multicentre cohort study
KL Harvey, P Sinai, N Mills, P White, S Potter, on behalf of The Pre-BRA Study Steering Group
BJS Open 2022 Apr 5; doi:10.1093/bjs/znac077. Online ahead of print.
The Pre-BRA (Pre-pectoral Breast Reconstruction Evaluation) Feasibility Study: Protocol for a mixed-methods IDEAL 2a/2b prospective cohort study to determine the safety and effectiveness of pre-pectoral implant-based breast reconstruction
KL Harvey et al on behalf of The Pre-BRA Feasibility Study Steering Group.
BMJ Open. 2020 Jan 26;10(1):e033641.
Oral presentations at scientific conferences to date include:
Patient-reported outcomes of prepectoral implant-based breast reconstruction: Early results from the Pre-BRA prospective multi-centre cohort study
KL Harvey, P Sinai, N Mills, C Holcombe, S Potter
Due to be presented (in the prize session), ABS meeting, in person conference, May 2022, Liverpool.
Early results from the Pre-BRA IDEAL 2a/2b prospective multicentre cohort study to evaluate the safety and effectiveness of prepectoral breast reconstruction
KL Harvey, P Sinai, N Mills, C Holcombe, S Potter
Association of Breast Surgeons Annual Meeting (virtual), May 2021
Awarded first prize for best oral presentation
Is it possible to use a novel mixed-methods approach within an IDEAL 2a/2b study to determine when a procedure is sufficiently stable for formal evaluation in a randomised controlled trial (RCT)? The Pre-BRA Study
KL Harvey, P Sinai, N Mills, C Holcombe, S Potter, on behalf of the Pre-BRA Steering Group
IDEAL Collaboration Annual Meeting, Amsterdam Netherlands (virtual presentation), April 2021
Using mixed methods within an IDEAL 2a/2b study to evaluate a novel surgical technique:
The Pre-BRA study
KL Harvey, N Mills, C Holcombe, S Potter
The Society for Clinical Trials Annual General Meeting, New Orleans USA, May 2019