ABSTRACT
Introduction: The offer of immediate breast reconstruction (IBR) was temporarily withdrawn for women requiring mastectomy during the COVID-19 pandemic to allow prioritisation of emergency care. Many women are now awaiting delayed breast reconstruction (DBR) surgery. This survey aimed to explore the current provision of DBR in the UK and how this had been impacted by COVID-19. Method(s): An online survey was distributed to UK breast units via the ABS/Mammary Fold newsletters and social media feeds between 10/2021 and 04/2022. Simple descriptive statistics were used to summarise the results. Result(s): Of the 42 UK breast units that completed the survey, most units reported that COVID-19 had led to increased waits for DBR. Before the pandemic over three quarters of units reported waits of less than 1 year (29% <6 months, 45% 6-12 months) whereas currently waits of 12-24 months are common with a third of units reporting waits of 24-36 months. A small number of units reported waits of >3 years or that DBR had not yet restarted (14%). Key identified challenges for DBR services included limited availability of theatre time and consultant and/or theatre/nursing staff, and a lack of in-patient capacity for post-operative recovery. Conclusion(s): Waiting times for DBR have been negatively impacted by COVID-19. As reconstruction is an integral part of women's breast cancer treatment, there is an urgent need to develop a recovery plan to address this issue, support patients and allow women to access reconstructive surgery in a timely manner.Copyright © 2023
ABSTRACT
Travel Plans are a mechanism for delivering a package of transport measures targeted at a specific site by an organization, such as an employer, school, shopping, or sports center, intended to deliver transport and wider goals to the organization and society as a whole. Introduced from the 1980s to 1990s in the United States, Netherlands, UK, Australia, New Zealand, Canada and Japan, when consistently applied, Travel Plans can usefully reduce car use. The best employer Travel Plans in the United Kingdom secured a reduction in car use of between 10% and 20% and in the United States mandatory Travel Plans have in several cases cut car use by 30%. Despite the potential promised by the concept, Travel Plans never really established themselves as a mainstream part of transport policy. They became marginalized within the traditional transport planning structures as they do not map onto the existing practices and skill sets of engineering-led transport planning approaches. By 2010, they had largely fallen into disuse. However, in recent years the growth of data generating and analytics companies led to travel becoming part of organization management. Although not labeled as "Travel Plans,” the purpose of travel planning is returning in a form that matches institutional structures. © 2021 Elsevier Ltd. All rights reserved
ABSTRACT
Background: Mammographic screening programmes reduce breast cancer mortality, but detect many small tumours with favourable biological features which may not progress during a woman's lifetime. Screen-detected cancers are treated with standard surgery and adjuvant therapies, with associated morbidities. There is a need to reduce overtreatment of good prognosis tumours and numerous studies have evaluated the omission of radiotherapy in this context. However, there is little evidence to support surgical de-escalation, although percutaneous minimally invasive treatment approaches have been described. Vacuum-assisted excision (VAE) is in widespread use for management of benign lesions and lesions of uncertain malignant potential. SMALL (ISRCTN 12240119) is designed to determine the feasibility of using this approach for treatment of small invasive tumours detected within the UK NHS Breast Screening Programme (BSP). Method(s): SMALL is a phase III multicentre randomised trial comparing standard surgery with VAE for screendetected good prognosis cancers. The main eligibility criteria are age >=47 years, unifocal grade 1 tumours with maximum diameter 15mm, which are strongly ER/PR+ve and HER2-ve, with negative clinical/radiological axillary staging. Patients are randomised 2:1 in favour of VAE or surgery;with no axillary surgery in the VAE arm. Completeness of excision is assessed radiologically, and if excision is incomplete, patients undergo open surgery. Adjuvant radiotherapy and endocrine therapy are mandated in the VAE arm but may be omitted following surgery. Co-primary end-points are: 1. Noninferiority comparison of the requirement for a second procedure following excision 2. Single arm analysis of local recurrence (LR) at 5 years following VAE Recruitment of 800 patients will permit demonstration of 10% non-inferiority of VAE for requirement of a second procedure. This ensures sufficient patients for single arm analysis of LR rates, where expected LR free survival is 99% at 5 years, with an undesirable survival probability after VAE of 97%. To ensure that the trial as a whole only has 5% alpha, the significance level for each co-primary outcome is set at 2.5% with 90% power. The Data Monitoring Committee will monitor LR events to ensure these do not exceed 3% per year. Secondary outcome measures include time to ipsilateral recurrence, overall survival, complications, quality of life and health economic analysis. A novel feature of SMALL is the integration of a QuinteT Recruitment Intervention (QRI), which aims to optimise recruitment to the study. Recruitment challenges are identified by analysing recruiter/patient interviews and audiorecordings of trial discussions, and by review of trial screening logs, eligibility and recruitment data and study documentation. Solutions to address these are developed collaboratively, including individual/group recruiter feedback and recruitment tips documents. Result(s): SMALL opened in December 2019, but recruitment halted in 2020 for 5 months due to COVID-19. At 7st July 2022, 142 patients had been randomised from 26 centres, with a randomisation rate of approximately 45%, and a per site recruitment rate of 0.4-0.5 patients/month, approaching the feasibility recruitment target of 144 patients. Drawing from preliminary QRI findings and insights from patient representatives, a recruitment tips document has been circulated (on providing balanced information about treatments, encouraging recruiters to engage with patient preferences, and explaining randomisation). Individual recruiter feedback has commenced, with wider feedback delivered across sites via recruitment training workshops. Conclusion(s): Despite pandemic-related challenges, SMALL has an excellent recruitment rate to date and is expected to have a global impact on treatment of breast cancer within mammographic screening programmes.
ABSTRACT
Background: Mammographic screening programmes reduce breast cancer mortality but detect many small tumours with favourable biology which may not progress. These are treated with surgery and adjuvant therapies, but associated morbidities mean there is a need to reduce overtreatment. Minimally invasive treatments such as vacuum-assisted excision (VAE) have been described but there is no prospective randomised evidence to support their routine use. SMALL (ISRCTN 12240119) is designed to establish the feasibility of using VAE to treat small tumours detected within the UK NHS Breast Screening Programme (BSP). Methods: Phase III multicenter randomized trial comparing surgery with VAE for screen-detected good prognosis cancers. Eligibility criteria are age ≥47 years, unifocal grade 1 tumors (maximum diameter 15mm), strongly ER/PR+ve and HER2-ve, with negative axillary staging. Patients are randomized 2:1 to VAE or surgery, with no axillary surgery in the VAE arm. Excision is assessed radiologically, and if incomplete, patients undergo surgery. Adjuvant radiotherapy and endocrine therapy are mandated in the VAE arm. Coprimary end-points are: (1) Non-inferiority comparison of the requirement for a second procedure. (2) Single-arm analysis of local recurrence (LR) at 5 years after VAE. Recruitment of 800 patients will permit demonstration of 10% non-inferiority of VAE for requirement of a second procedure, ensuring sufficient patients for single arm analysis of LR rates, where expected LR free survival is 99% at 5 years, with an undesirable survival probability after VAE of 97%. The DMC will monitor LR events to ensure these do not exceed 3% per year. Secondary outcome measures include time to ipsilateral recurrence, overall survival, complications, quality of life and health economic analysis. A QuinteT Recruitment Intervention (QRI) is integrated throughout SMALL to optimize recruitment and informed consent. Recruitment challenges are identified by analyzing recruiter/ patient interviews, audio-recordings of trial discussions, and by review of screening, eligibility and recruitment data and study documentation. Solutions are developed collaboratively, including recruiter feedback and recruitment tips documents. Results: SMALL opened in December 2019, but recruitment halted for 5 months due to COVID-19. At 11th February 2022, 91 patients had been recruited from 22 centers, with an approached/consented ration of 50%. Drawing from preliminary QRI findings, a recruitment tips document has been circulated (on discussing SMALL, providing balanced information on treatment options and explaining randomization). Individual recruiter feedback has commenced, with wider feedback planned shortly. Conclusion: Despite pandemic-related challenges, SMALL has excellent recruitment to date and is expected to have a global impact on treatment of screen-detected breast cancer.
ABSTRACT
Introduction: Prepectoral breast reconstruction (PPBR) has been widely adopted due to a perceived reduction in post-operative pain and improved patient satisfaction but high-quality evidence to support these benefits is lacking. The Pre-BRA prospective multicentre cohort study aimed to explore the safety and effectiveness of PPBR prior to definitive evaluation in an RCT. Here we report the 1st analysis of the 18-month patient-reported outcome (PRO) data. Methods: Consecutive women undergoing PPBR at 40 UK centres were recruited to the Pre-BRA study between July 2019 and Dec 2020 with a 4 month pause to recruitment (March-July 2020) due to the COVID-19 pandemic. Demographic, operative, oncological, and 3-month safety data were collected. Women were asked to complete the BREAST-Q© (V2.0) at baseline, 3 and 18-months. Questionnaires were scored according to the developers' instructions and compared with the 18-month PRO results from the iBRA study which included mainly subpectoral mesh-assisted reconstruction. Results: 347 women underwent PPBR in the Pre-BRA study. Of these, 221 patients recruited pre-COVID have reached 18-month follow-up and 164 (74%) have completed the 18-month questionnaire. The median Satisfaction with Breasts score was 60 (48.5-71;0-100) [inter-quartile range;range] compared to 59 (48-71;0-100) in the UK iBRA study. Conclusions: Satisfaction with breasts at 18-months following surgery appears to be equivalent following pre and subpectoral breast reconstruction. Further analysis is needed, but this study supports the need for an RCT to definitively compare techniques and establish best practice for implant-based reconstruction.
ABSTRACT
Microsurgery is a highly skillful component of Plastic and Reconstructive surgery with a steep learning curve. Due to COVID-19, reduced access to technical courses and hands-on theatre time has created significant challenges in microsurgical education . Trainees must therefore engage in self-education and be adept at accurate self-assessment to overcome this. The aim of this study was to assess the ability of trainees to self-assess technical performance while performing a simulated microvascular anastomosis. Novice and intermediate Plastic surgery trainees were recruited. All participants performed a simulated microvascular anastomosis using a high fidelity chicken femoral vessel model. Each participant objectively rated their anastomosis using the Anastomosis Lapse Index (ALI)[1]. Each anastomosis was then blindly rated by two expert microsurgeons. Selfscores and expert scores were compared using a Wilcoxon-Signed Rank Test. Thirteen surgical trainees completed the simulated procedure. Mean time to completion (TTC) was 22.2 minutes (range 14.2-31.9 minutes). Mean ALI self-score was 3.8 (range 3-5) whilemean ALI expert score was 5.27 (range 4.5-6). There was a significant difference between ALI self-score and expert score (p=0.001) with expert assessors consistently assigning a higher ALI score to the same anastomosis. There was no significant difference between male and female trainees or between novice and intermediate trainees in relation to TTC or ALI self-score. These findings suggest that while the ALI is an excellent training tool, surgical trainees tend to overestimate their technical performance. This emphasises the importance of expert feedback to accurately self-assess progress in the early stages of training.
ABSTRACT
Background:. Mammographic screening programmes have been shown to reduce breast cancer mortality. However, they detect many small tumours with favourable biological features which may not progress during a woman's lifetime. These are treated with standard surgery and adjuvant therapies, which have associated morbidities. Thus, there is a need to reduce overtreatment of good prognosis tumours found by screening. Minimally invasive treatment approaches have been described but there is no prospective randomised evidence to support their routine use. Vacuum-assisted excision (VAE) is in widespread use for management of benign lesions and lesions of uncertain malignant potential. SMALL (ISRCTN 12240119) is designed to determine the feasibility of using this approach for treatment of small invasive tumours detected within the UK NHS Breast Screening Programme (BSP). Methods:. SMALL is a phase III multicentre randomised trial comparing standard surgery with VAE for screen-detected good prognosis breast cancers. The main eligibility criteria are age ≥47 years, screen-detected unifocal grade 1 tumours with maximum diameter 15mm, which are strongly ER/PR+ve and HER2-ve, with negative clinical/radiological axillary staging. Patients are randomised 2:1 in favour of VAE or surgery;with no axillary surgery in S the VAE arm. Completeness of excision is assessed radiologically, and if excision is incomplete, patients undergo open surgery. Adjuvant radiotherapy and endocrine therapy are mandated in the VAE arm but may be omitted following surgery. Co-primary end-points are:1.Non-inferiority comparison of the requirement for a second procedure following excision2.Single arm analysis of local recurrence (LR) at 5 years following VAE. Recruitment of 800 patients over 4 years will permit demonstration of 10% non-inferiority of VAE for requirement of a second procedure. This ensures sufficient patients for single arm analysis of LR rates, where expected LR free survival is 99% at 5 years, with an undesirable survival probability after VAE of 97%. To ensure that the trial as a whole only has 5% alpha, the significance level for each co-primary outcome is set at 2.5% with 90% power. The Data Monitoring Committee will monitor LR events to ensure these do not exceed 3% per year. Secondary outcome measures include time to ipsilateral recurrence, overall survival, complications, quality of life and health economic analysis. A QuinteT Recruitment Intervention (QRI) is integrated throughout SMALL to optimise recruitment and informed consent. Recruitment challenges are identified by analysing recruiter/patient interviews and audio-recordings of trial discussions, and by review of screening, eligibility and recruitment data and study documentation. Solutions to address these are developed collaboratively, including individual/group recruiter feedback and recruitment tips documents. Results:. SMALL opened in December 2019, but recruitment halted in 2020 due to suspension of the NHS BSP for 5 months due to COVID-19. As of 1st July 2021, 55 patients had been approached in 10 centres, with 33 patients randomised (randomisation rate 60%). A further 23 centres are in set-up, with 8 suspended due to the pandemic. Drawing from preliminary QRI findings and insights from patient representatives, a recruitment tips document has been circulated (on introducing and discussing SMALL, providing balanced information. on treatment options and explaining randomisation). individual recruiter feedback has commenced, with wider feedback planned shortly. Conclusion:. Despite pandemic-related challenges, SMALL has an excellent recruitment rate to date and is expected to have a global impact on treatment of breast cancer within mammographic screening programmes. SMALL is funded by the UK NIHR HTA programme, award 17/42/32.
ABSTRACT
In 2018 "Starship"grocery delivery robots were first introduced in Milton Keynes (MK), a new town in England, to automate a task that is difficult to perform in a cost-effective manner by humans - that of on-demand grocery delivery. Two years later the Covid-19 pandemic rendered routine activities such as delivering groceries or visiting the supermarket unexpectedly unsafe. The ability of robots to operate in environments that are dangerous for humans was brought into sharp relief by the Covid-19 pandemic but it may also be relevant in other crisis situations such as those that may be caused by heat waves, blizzards and other extreme events associated with climate change. Drawing on a case study of Starship robots in MK, this contribution investigates the potential of robotic and autonomous systems to provide cities with tools for coping with such unexpected situations. © 2021 IEEE.