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
Objective The impact of the COVID-19 pandemic on the English National Health Service (NHS) has been profound. Those who commission health services face questions and pressures around addressing growing waiting lists and ensuring patients receive appropriate and timely treatment. In 2019, NHS England launched the Evidence-Based Interventions (EBI) programme, a national initiative that intends to reduce provision of medical and surgical interventions found to have insufficient evidence of effectiveness - either in general, or in select patient groups. The EBI programme originally produced treatment policy recommendations for 17 interventions across several surgical specialties. Reducing provision of treatments already embedded in practice has been historically challenging for health services worldwide. Our ongoing NIHR-funded mixed methods study seeks to evaluate the impact and acceptability of the EBI programme. As part of this work, a key objective is to investigate national policy-makers' experiences of implementing the EBI programme during the COVID-19 pandemic, and its role in the COVID recovery programme. Methods Semi-structured interviews with informants working within English Clinical Commissioning Groups (CCGs) and at a national level. Data are being analysed thematically, using the constant comparison approach. Data collection and analysis are ongoing, with 10 interviews having been undertaken with informants from 6 geographically spread CCGs. Results Emerging findings indicate that although the pandemic impacted how informants were able to implement evidencebased treatment policies, these were perceived to be potentially useful in supporting healthcare providers to manage waiting lists in a clinically appropriate manner. Discussion This research will provide early empirical insights into informants' experiences of priority setting during and in the wake of COVID-19. Early findings suggest that historically challenging priority setting processes may be easier to implement, from informants' perspectives, under the auspices of waiting list management following the pandemic. More developed findings and implications will be reported at the conference.
ABSTRACT
Introduction The onset of the COVID-19 pandemic in early 2020 triggered reorganisation of hospital departments around the world as resources were configured to prioritise critical care. In spring 2020, NHS England issued national guidance proposing acceptable time intervals for postponing different types of surgical procedures for patients with cancer and other conditions. The 'Consider-19' study sought to investigate prioritisation decisions in practice, with in-depth examination of colorectal cancer surgery as a case-study, given recommendations that these procedures could be delayed by up to 12 weeks. Methods Twenty-seven semi-structured interviews were conducted with healthcare professionals between June - November 2020. A key informant sampling approach was used, followed by snowballing to achieve maximum regional variation across the UK. Data were analysed thematically using the constant comparison approach. Results Interviewees reported a spectrum of perceived disruption to colorectal cancer surgery services in the early phase of the pandemic, with some services reporting greater scarcity of resources than others. Nonetheless, all reported a need to prioritise patients based on local judgments. Prioritisation was framed by many as unfamiliar territory, requiring significant deliberation and emotional effort. Whilst national guidance provided a framework for prioritising, it was largely left to local teams to devise processes for prioritising within surgical specialities and then between different specialities, resulting in much local variation in practice. Discussion The pandemic necessitated a significant change in practice as surgeons, in a tense and uncertain situation, found themselves having to navigate clinically, emotionally, and ethically- charged decisions about how best to use limited surgical resources. Whilst unavoidable, many felt uncomfortable with the task and the consequences for their patients. The findings point to a need to better support surgeons tasked with prioritising patients and raise questions about who should be involved in this activity.
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.