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Purpose A James Lind Alliance priority setting partnership was developed to identify research priorities in breast cancer surgery from individuals with lived experience, at high genetic risk of breast cancer, and healthcare professionals (HCPs). Methods ‘Uncertainties’ were collected using an online survey. Following an evidence check and development of summary questions, an interim survey asked participants to rank their top 10 research priorities from the question list. Top-ranked questions from patient/carer, high-risk and professional groups were carried forward for discussion to a final online prioritisation workshop. Results 260 participants (101 patients/carers, 156 HCPs) submitted 940 uncertainties via the initial survey. These were analysed thematically into 128 summary questions in six topic areas. Following evidence checking, 59 questions were included in the interim survey which was completed by 572 respondents. Marked differences were seen in questions prioritised by patients/carers, HCPs and women at high-risk. The top eight priorities in patient/carer and professional groups and top two priorities for high-risk women were carried forward to the online workshop at which 22 participants discussed and agreed the final top 10. Key themes included de-escalation of breast and axillary surgery, factors impacting the development/detection of locoregional recurrence and optimal provision of support for informed treatment decision-making. Conclusion The top 10 research priorities in breast cancer surgery have been agreed. However, the observed differences in research priorities identified by patients and professional groups were not anticipated. Top priorities from both groups should inform future UK breast cancer surgical research, to ensure that it addresses questions that are important to breast cancer community as a whole.

Background Breast conserving surgery with adjuvant radiotherapy (BCS+RT) and mastectomy are currently offered as oncologically equivalent options for the surgical management of early breast cancer based on findings from randomised controlled trials (RCTs) conducted over four decades ago. Since then, locoregional and systemic breast cancer treatments have improved significantly and several recent observational studies suggest a survival advantage in patients receiving BCS+RT compared to those having mastectomy. If BCS+RT is oncologically superior to mastectomy, this may dramatically impact surgical treatment recommendations. The aim of this systematic review was to identify, critically appraise and summarise the contemporary literature comparing survival following BCS+RT and mastectomy to inform surgical decision-making for patients with early breast cancer. Methods A systemic search of MEDLINE, Cochrane Central Register of Controlled Trials and Embase identified studies published between 1st January 2000 to 22nd September 2021. Included were primary research studies published in English comparing overall survival in women undergoing primary surgery with either BCS+RT or mastectomy for unilateral stage I to III breast cancer. Excluded were studies evaluating neoadjuvant chemotherapy; rare breast cancer subtypes (e.g. mucinous) or in specific patient populations (e.g. pregnancy associated breast cancer) and those that completed recruitment before 1st January 1990. We used the ROBINS-I tool to assess the risk of bias in study results and GRADE to assess the overall certainty of evidence. All papers without critical risk of bias were included in a quantitative meta-analysis. Where more than one study reported outcomes in overlapping population-based registry cohorts, the study with the most recent data on the largest cohort was selected for analysis. The primary analysis was a random effects meta-analysis with a fixed effect model undertaken as sensitivity analysis. A secondary meta-analysis was performed for studies only including triple negative breast cancers. All analyses were conducted using STATA17. Results 10,876 abstracts were screened and 157 full-text papers assessed for eligibility, of which 93 (17 multi-centre observational studies, 30 were single-centre observational studies and 46 registry-based studies) met the inclusion criteria for the review. 25 papers were excluded from meta-analysis due to an overall critical risk of confounder bias and 27 were excluded due overlapping study populations. 36 studies (34 with serious risk of bias and 2 with moderate risk of bias) reporting survival outcomes on 1,321,291 patients (729,789 undergoing BCS+RT and 591,502 undergoing mastectomy) were included in the meta-analysis. The pooled hazard ratio was 0.72 (95% CI 0.64– 0.81, p< 0.001, I2 97.6%) demonstrating improved overall survival for patients undergoing BCS+RT compared with those receiving mastectomy. The sensitivity analysis, using a fixed effect model, showed a hazard ratio of 0.88 (95% CI 0.87 – 0.89, p< 0.001, I2 97.6%) for survival in women undergoing BCS+RT compared with mastectomy. Meta-analysis of 8 studies reporting survival in 17,181 patients with triple negative breast cancer showed a hazard ratio of 0.73 (95% CI 0.68 – 0.79), p< 0.001, I2 34.7%) for those receiving BCS+RT versus mastectomy. Discussion This meta-analysis provides further, albeit very low certainty evidence, that overall survival is improved following BCS+RT compared with mastectomy in a contemporary cohort of patients treated for early-stage breast cancer. These results should be interpreted with caution due to the heterogeneity of included studies and the high risk of bias associated with observational data. As future RCTs will not be feasible, well-designed large-scale prospective observational studies are needed to provide better evidence to support surgical decision-making in early-stage breast cancer. Citation Format: Kiran Kasper Rajan, Katherine Fairhurst, Beth Birkbeck, Rebecca Wilson, Jelena savovic, Chris Holcombe, Shelley Potter. PD15-04 Overall survival following breast conserving surgery and adjuvant radiotherapy compared with mastectomy for early stage breast cancer: a systematic review and meta-analysis [abstract]. In: Proceedings of the 2022 San Antonio Breast Cancer Symposium; 2022 Dec 6-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2023;83(5 Suppl):Abstract nr PD15-04.

BackgroundImplant-based breast reconstruction (IBBR) is the most commonly performed reconstructive procedure following mastectomy. IBBR techniques are evolving rapidly, with mesh-assisted subpectoral reconstruction becoming the standard of care and more recently, prepectoral techniques being introduced. These muscle-sparing techniques may reduce postoperative pain, avoid implant animation and improve cosmetic outcomes and have been widely adopted into practice. Although small observational studies have failed to demonstrate any differences in the clinical or patient-reported outcomes of prepectoral or subpectoral reconstruction, high-quality comparative evidence of clinical or cost-effectiveness is lacking. A well-designed, adequately powered randomised controlled trial (RCT) is needed to compare the techniques, but breast reconstruction RCTs are challenging. We, therefore, aim to undertake an external pilot RCT (Best-BRA) with an embedded QuinteT Recruitment Intervention (QRI) to determine the feasibility of undertaking a trial comparing prepectoral and subpectoral techniques.Methods and analysisBest-BRA is a pragmatic, two-arm, external pilot RCT with an embedded QRI and economic scoping for resource use. Women who require a mastectomy for either breast cancer or risk reduction, elect to have an IBBR and are considered suitable for both prepectoral and subpectoral reconstruction will be recruited and randomised 1:1 between the techniques.The QRI will be implemented in two phases: phase 1, in which sources of recruitment difficulties are rapidly investigated to inform the delivery in phase 2 of tailored interventions to optimise recruitment of patients.Primary outcomes will be (1) recruitment of patients, (2) adherence to trial allocation and (3) outcome completion rates. Outcomes will be reviewed at 12 months to determine the feasibility of a definitive trial.Ethics and disseminationThe study has been approved by the National Health Service (NHS) Wales REC 6 (20/WA/0338). Findings will be presented at conferences and in peer-reviewed journals.Trial registration numberISRCTN10081873.

Breast cancer liver metastases have traditionally been considered incurable and any treatment given therefore palliative. Liver resections for breast cancer metastases are being performed, despite there being no robust evidence for which patients benefit. This review aims to determine the safety and effectiveness of liver resection for breast cancer metastases. A systematic literature review was performed and resulted in 33 papers being assembled for analysis. All papers were case series and data extracted was heterogeneous so a meta-analysis was not possible. Safety outcomes were mortality and morbidity (in hospital and 30-day). Effectiveness outcomes were local recurrence, re-hepatectomy, survival (months), 1-, 2-, 3-, 5- year overall survival rate (%), disease free survival (months) and 1-, 2-, 3-, 5- year disease free survival rate (%). Overall median figures were calculated using unweighted median data given in each paper. Results demonstrated that mortality was low across all studies with a median of 0% and a maximum of 5.9%. The median morbidity rate was 15%. Overall survival was a median of 35.1 months and a median 1-, 2-, 3- and 5-year survival of 84.55%, 71.4%, 52.85% and 33% respectively. Median disease free survival was 21.5 months with a 3- and 5-year median disease free survival of 36% and 18%. Whilst the results demonstrate seemingly satisfactory levels of overall survival and disease free survival, the data are of poor quality with multiple confounding variables and small study populations. Recommendations are for extensive pilot and feasibility work with the ultimate aim of conducting a large pragmatic randomised control trial to accurately determine which patients benefit from liver resection for breast cancer liver metastases.

ObjectivesTo examine the design and findings of recruitment studies in randomised controlled trials (RCTs) involving patients with an unscheduled hospital admission (UHA), to consider how to optimise recruitment in future RCTs of this nature.DesignStudies within the ORRCA database (Online Resource for Recruitment Research in Clinical TriAls;www.orrca.org.uk) that reported on recruitment to RCTs involving UHAs in patients >18 years were included. Extracted data included trial clinical details, and the rationale and main findings of the recruitment study.ResultsOf 3114 articles populating ORRCA, 39 recruitment studies were eligible, focusing on 68 real and 13 hypothetical host RCTs. Four studies were prospectively planned investigations of recruitment interventions, one of which was a nested RCT. Most recruitment papers were reports of recruitment experiences from one or more ‘real’ RCTs (n=24) or studies using hypothetical RCTs (n=11). Rationales for conducting recruitment studies included limited time for informed consent (IC) and patients being too unwell to provide IC. Methods to optimise recruitment included providing patients with trial information in the prehospital setting, technology to allow recruiters to cover multiple sites, screening logs to uncover recruitment barriers, and verbal rather than written information and consent.ConclusionThere is a paucity of high-quality research into recruitment in RCTs involving UHAs with only one nested randomised study evaluating a recruitment intervention. Among the remaining studies, methods to optimise recruitment focused on how to improve information provision in the prehospital setting and use of screening logs. Future research in this setting should focus on the prospective evaluation of the well-developed interventions to optimise recruitment.

Background Medical Research Council guidance for evaluating complex interventions like surgery, recommends that pilot work should precede randomised controlled trials (RCTs). Methodological considerations pilot work could address include intervention complexity and adherence, education of surgeons on research methodology and recruitment, logistics of co-ordination and feasibility of collaboration. Presented are findings of an ongoing literature review exploring how pilot work may optimally inform surgical RCTs.

The concept of using simulation to gain and improve practical skills in a safe and low-risk environment has been employed extensively in the airline industry to train pilots for many years now. The use of simulation techniques to train surgeons, however, is a new but rapidly expanding and developing area of surgical education. The introduction of simulation to surgical training curricula has inevitably led to a plethora of simulation technology entering the commercial market, as well as the introduction of new terminology used to describe both the equipment itself, and the methods used to test and validate it for use in the training of surgeons. The terminology has its basis mostly in statistical methodology, and the terms are used throughout the surgical literature, often interchangeably and with multiple meanings. In our experience, this terminology is where most confusion arises. Interpreting the literature is difficult for those not directly involved in the field. This article aims to define the statistical terms used to describe the many forms of validity testing and types of surgical simulator, and consequently to act as a reference guide for those unfamiliar with this rapidly evolving field of technology and surgical training.

The acquisition of technical skills using surgical simulators is an area of active research and rapidly evolving technology. The LapSim is a virtual reality simulator that currently allows practice of basic laparoscopic skills and some procedures. To date, no reviews have been published with reference to a single virtual reality simulator. A PubMed search was performed using the keyword “LapSim,” with further papers identified from the citations of original search articles. Use of the LapSim to develop surgical skills has yielded overall results, although inconsistencies exist. Data regarding the transferability of learned skills to the operative environment are encouraging as is the validation work, particularly the use of a combination of measured parameters to produce an overall comparative performance score. Although the LapSim currently does not have any proven significant advantages over video trainers in terms of basic skills instruction and although the results of validation studies are variable, the potential for such technology to have a huge impact on surgical training is apparent. Work to determine standardized learning curves and proficiency criteria for different levels of trainees is incomplete. Moreover, defining which performance parameters measured by the LapSim accurately determine laparoscopic skill is complex. Further technological advances will undoubtedly improve the efficacy of the LapSim, and the results of large multicenter trials are anticipated.

The number of patients who have undergone laparoscopic liver surgery has increased in the last 15 years. It is technically challenging surgery, requiring both advanced laparoscopic and liver resection skills. Surgeons often require familiarisation with much of the equipment and techniques used in this type of surgery. No ex vivo model currently exists for laparoscopic liver resection (LLR). The aim of this study was to develop a model for acquiring the technical skills involved in LLR that was also able to assess and measure surgical performance.The ProMIS augmented reality surgical simulator was selected because performance data other than time could be obtained, and the simulator was adapted to create the laparoscopic trainer. Twenty candidates with differing laparoscopic surgical experience tested the model. Three groups were identified, novice, intermediate, and expert, according to previous exposure to the laparoscopic tasks. Candidates were required to identify a tumour ultrasonographically, mark and transect ex vivo liver, and perform two laparoscopic stitches with intracorporeal knots. The ProMIS recorded the performance data, including instrument path lengths and time.Measurements taken from the ProMIS simulator were analysed for statistical differences between the groups. Expert surgeons showed a statistically significant difference in the time taken to identify the liver lesion and transect the organ. The results also demonstrate that the more difficult tasks such as laparoscopic suturing are completed by the expert surgeons with statistically significant shorter times and path lengths compared to the less experienced surgeons.The adapted ProMIS augmented reality simulator provided junior surgeons with a realistic learning environment in which to familiarise themselves with the equipment and techniques required for LLR. The model also allows assessment of the performance of individuals over time and within a peer group. Construct validity is proven for the suturing component of the model.