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Papers Trust Board - 11 March 2025

Description: Date Time Location Chair Agenda Trust Board – Open Session 11/03/2025 9:00 - 13:00 Conference Room, Heartbeat Education Centre
Url: /Media/UHS-website-2019/Docs/About-the-Trust/Trust-governance-and-corporate-docs/2025-Trust-documents/Papers-Trust-Board-11-March-2025.pdf

Press release: Cancer expert welcomes HPV vaccine for boys but warns against limited rollout

Description: A cancer expert has welcomed the introduction of the HPV vaccine for boys but warned not extending it to those over
Url: /AboutTheTrust/Newsandpublications/Latestnews/2019/September/Press-release-Cancer-expert-welcomes-HPV-vaccine-for-boys-but-warns-against-limited-rollout.aspx

Papers Trust Board - 25 July 2024

Description: Agenda Trust Board – Open Session Date 25/07/2024 Time 9:00 - 13:00 Location Anaesthetic Seminar Room (CE95/99), E Level, Centre B
Url: /Media/UHS-website-2019/Docs/About-the-Trust/Trust-governance-and-corporate-docs/2024-Trust-documents/Papers-Trust-Board-25-July-2024.pdf

NIHR BRC Imaging Network Meeting Abstract Advert

Description: NIHR BRC Imaging Network Meeting – Abstract deadline extended to 19th January National Institute for Health and Care Research (NIHR) Biomedical Research
Url: /Media/Southampton-Clinical-Research/Downloads/NIHR-BRC-Imaging-Network-Meeting-Abstract-Advert.pdf

Papers Trust Board - 5 November 2024

Description: Date Time Location Chair Apologies Agenda Trust Board – Open Session 05/11/2024 9:00 - 11:30 The Ark Conference Centre
Url: /Media/UHS-website-2019/Docs/About-the-Trust/Trust-governance-and-corporate-docs/2024-Trust-documents/Papers-Trust-Board-5-November-2024.pdf

UHS AR 23-24 Final

Description: 2023/24 Incorporating the quality account University Hospital Southampton NHS Foundation Trust Annual Report and
Url: /Media/UHS-website-2019/Docs/About-the-Trust/Annual-reports-and-quality-accounts/UHS-AR-23-24-Final.pdf

Papers Trust Board - 29 November 2022

Description: Date Time Location Chair Agenda Trust Board – Open Session 29/11/2022 9:00 - 13:20 Conference Room, Heartbeat/Microsoft Teams
Url: /Media/UHS-website-2019/Docs/About-the-Trust/Trust-governance-and-corporate-docs/2022-Trust-documents/Papers-Trust-Board-29-November-2022.pdf

UHS AR 22-23-6

Description: 2022/23 Incorporating the quality account University Hospital Southampton NHS Foundation Trust Annual Report and Accounts 2022/23 Presented to Parliament pursuant to Schedule 7, paragraph 25(4)(a) of the National Health Service Act 2006 © 2023 University Hospital Southampton NHS Foundation Trust Contents Welcome from our chair and chief executive 6 Overview and performance 8 Performance report 9 Overview 10 Accountability report 33 Directors’ report 34 Remuneration report 57 Staff report 71 Annual governance statement 91 Quality account 106 Statement on quality from the chief executive 107 Priorities for improvement and statements of assurance from the board 110 Other information 188 Annual accounts 222 Statement from the chief financial officer 223 Auditor’s report 224 Foreword to the accounts 230 Statement of Comprehensive Income 231 Statement of Financial Position 232 Statement of Changes in Taxpayers’ Equity 233 Statement of Cash Flows 234 Notes to the accounts 235 5 Welcome from the Chair and Chief Executive Officer University Hospital Southampton NHS Foundation Trust (‘UHS’ or the ‘Trust’) experienced another challenging year during 2022/23. Nonetheless, the Trust and its staff have continued to deliver for patients and the wider system in which it operates. Trust highlights from 2022/23 include: • Delivering an 8% increase in activity (compared to 2019/20) under the elective recovery programme, which places us as one of the top performing trusts in England. • Being recognised in the NHS staff survey as the seventh highest trust for recommendation as a place to work nationally and the best performing trust in opportunities for career development. • Celebrating 50 years as a medical school with the University of Southampton and continuing to pioneer UK and world-first research studies. • Enhancing the reputation of our specialist care – for example our bone marrow transplant team at UHS have the best patient outcomes in Europe. However, as was the picture across the country, UHS had an extremely challenging winter with attendances at our emergency department often in excess of 400 a day. This was driven in part by high prevalence of streptococcus A (strep A) in the community along with other seasonal illnesses such as influenza and high incidences of COVID-19 at times. Moreover, the lack of availability of care home beds and other care packages in the community has resulted in challenges in discharging patients who are ready to leave hospital and therefore we have been operating at or near to capacity throughout the year. At the time of writing, there continues to be operational pressures due to industrial action by the Royal College of Nursing and British Medical Association. Throughout the disputes, we have attempted to balance the right of our staff to strike with the need to minimise the impact on the Trust’s operations and patients and ensure that safety was not compromised. Our leadership team has engaged proactively with the unions to agree, where possible, derogations (i.e. services that will continue to be staffed during strikes) to ensure that the running of our hospitals can continue and that patients remain safe. We would like to express our thanks to all staff who have gone over and above during these periods of industrial action by being willing to do different work to usual, often at anti-social times of the day. While we cannot influence national negotiations, we are focusing on what we can control within UHS. Our people strategy published last year sets out how we will grow and deploy our workforce of today and the future as part of a thriving community to deliver world-class patient care. Building on this, we have recently launched our inclusion and belonging strategy so that as a leadership team we can deliver what is required for all our workforce to feel they can belong and thrive at UHS. The Trust achieved its Cost Improvement Plan (CIP) target of £45.6m for 2022/23, the highest in our history but despite this, ended the year with a deficit of £11m. The deficit was driven by a combination of factors including a substantial increase in energy prices, higher costs of medicines and equipment and temporary staffing costs as well as changes in recent years in respect of the NHS funding infrastructure, which adversely impacted the Trust relative to others during the year. In terms of the broader context, the Hampshire and Isle of Wight Integrated Care System, in which the Trust operates, reported an overall deficit for 2022/23 driven in part by a significant increase in staffing numbers when compared to 2019/20 as well as structural factors. 6 We have continued to make progress on our estates strategy, building new theatres and carrying out improvements to existing facilities, as well as opening a new park and ride for staff at Adanac Park and progressing plans for a new innovation campus there. During 2022/23 we invested over £88m of capital expenditure to meet our ambition of increasing capacity and improving services in order to manage the increasing demand. All development is underpinned by our green plan, which sets out areas of focus for decarbonising UHS and achieving the net zero target set by the NHS. The Trust has continued to support the Hampshire and Isle of Wight Integrated Care System, which was formed on 1 July 2022 to facilitate integration and collaboration across health and social care partners in the region. In particular, UHS has worked closely with the Integrated Care Board and other providers in the development of the operating plan for 2023/24. We have also continued to work with other partners in the region, including local authorities and the University of Southampton. The 13,000 staff of UHS are our greatest asset and we would like to express our gratitude to them for continuing to go above and beyond to put patients first under very challenging circumstances. Without our staff, we would be unable to fulfil our ambition to be a world-class organisation with world-class people delivering world-class care. Jenni Douglas-Todd Chair 26 June 2023 David French Chief Executive Officer 26 June 2023 7 PERFORMANCE REPORT Performance report Introduction from the Chief Executive Officer The Trust experienced another challenging year with the need to balance the delivery of quality patient care with a significant increase in demand for the Trust’s resources and the need to do so whilst maintaining a sustainable financial position. The Trust saw the number of patients on a waiting list under the 18-week referral to treatment pathway increase to just over 55,000 patients at the end of the year. Despite this, however, the Trust was successful in reducing the number of patients waiting more than 104 weeks to nil and in reducing the number of patients waiting more than 78 weeks to 14 by the end of the year. In addition, the Trust’s performance under the elective recovery programme placed it as one of the topperforming trusts in the country. Demand for non-elective care also significantly increased during the year with the emergency department seeing more than 400 attendances per day at some points, especially during the winter months. The industrial action seen in the latter part of 2022/23 placed further pressure on the Trust and resulted in a need to cancel elective procedures and outpatients appointments. However, on balance, the Trust was able to manage these events through effective planning and the engagement and support of its staff. Although the Trust was successful in recruiting to substantive roles, especially in terms of reducing the number of Health Care Assistant vacancies, the anticipated reduction in use of bank and agency staff was not seen. This, among other factors, such as the substantial increase in energy costs and the rate of inflation, posed a significant challenge in terms of the Trust’s financial position. Despite achieving savings of £45.6m, the Trust reported a deficit of £11m for 2022/23. 9 Overview About the Trust Our services University Hospital Southampton NHS Foundation Trust is one of the largest acute teaching trusts in England with a turnover of more than £1 billion in 2022/23. It is based on the coast in southeast England and provides services to over 1.9 million people living in Southampton and south Hampshire and specialist services, including neurosciences, respiratory medicine, cancer care, cardiovascular, obstetrics and specialist children’s services, to more than 3.7 million people in central southern England and the Channel Islands. The Trust is also a designated major trauma centre, one of only two places in the south of England to offer adults and children full major trauma care provision. As a leading centre for teaching and research, the Trust has close working relationships with the University of Southampton, the Medical Research Council, National Institute for Health and Care Research (NIHR), Wellcome Trust and Cancer Research UK. The Trust is consistently one of the UK’s highest recruiting trusts of patients to clinical trials and one of the top nationally for research study volumes as ranked by the NIHR Clinical Research Network. Every year the Trust: treats around 160,000 inpatients and day patients, including about 75,000 emergency admissions sees over 650,000 people at outpatient appointments deals with around 150,000 cases in our emergency department delivers more than 100 outpatient clinics across the south of England, keeping services local for patients The Trust provides most of its services from the following locations: • Southampton General Hospital – the Trust’s largest location, where a great number of specialist services are based alongside emergency and critical care and which includes Southampton Children’s Hospital. • Princess Anne Hospital – located across the road from Southampton General Hospital and providing maternity care and specialist care for women with medical problems during pregnancy and babies who need extra care around birth across the region. • Royal South Hants Hospital – although the Trust does not operate this site near the centre of Southampton it provides a smaller number of services from this location. • New Forest Birth Centre – located at Ashurst on the edge of the New Forest and run by experienced midwives and support staff it acts as a community midwifery hub. The services provided by the Trust are commissioned and paid for by the Hampshire and Isle of Wight Integrated Care System (ICS) and, in the case of more specialised services (such as treatments for rare conditions), by NHS England. Trust services are supported by clinical income, of which 55% is paid for by NHS England and 43% by the Hampshire and Isle of Wight Integrated Care Board. These are provided under a standard NHS contract, which incorporates ongoing monitoring of the Trust and the quality of the services provided. 10 Our structure UHS gained foundation trust status on 1 October 2011. A foundation trust is a public benefit corporation providing NHS services in line with the core NHS principles: that care should be universal, comprehensive and free at the point of need. The Trust is licensed as a foundation trust to provide these services by NHS England and the healthcare services we provide are regulated by the Care Quality Commission. Since 1 July 2022, the Trust has been part of the Hampshire and Isle of Wight Integrated Care System (ICS) when this was established through the Health and Social Care Act 2022. Each ICS has two statutory elements: an integrated care partnership (ICP) and an integrated care board (ICB). The ICP is a statutory committee jointly formed between the NHS integrated care board and all uppertier local authorities that fall within the ICS area. The ICP will bring together a broad alliance of partners concerned with improving the care, health and wellbeing of the population, with membership determined locally. The ICP is responsible for producing an integrated care strategy on how to meet the health and wellbeing needs of the population in the ICS area. The ICB is a statutory NHS organisation responsible for developing a plan for meeting the health needs of the population, managing the NHS budget and arranging for the provision of health services in the ICS area. The establishment of ICBs resulted in clinical commissioning groups (CCGs) being closed down. The Trust has been a university teaching hospital since 1971. The diagram below provides an overview of the overall organisational structure of the Trust. Division A Surgery Critical Care Opthalmology Theatres and Anaesthetics Public and foundation trust members Council of Governors Board of Directors Executive Directors Division B Division C Division D Cancer Care Emergency Medicine Helicopter Emergency Medical Services Medicine and Medicine for Older People Pathology Specialist Medicine Women and Newborn Maternity Child Health Clinical Support Cardiovascular and Thoracic Neurosciences Trauma and Orthopaedics Radiology Trust Headquarters Division 11 Our values Our values describe how we do things at UHS and act as a guide to all staff working with colleagues to deliver high quality patient care and a great patient experience every day. Our values are: Patients, their families and carers are at the heart of what we do. Their experience of our services will be our measure of success. Partnership between clinicians, patients and carers is critical to achieving our vision, both within hospital teams and extending across organisational boundaries in the NHS, social care and the third sector. We will ensure we are always improving services for patients through research, education, clinical effectiveness and quality improvement. We will continue to incorporate new ideas, technologies and create greater efficiencies in the services we provide. 12 Our strategy 2021-25 The Trust’s strategy was updated during 2020/21 to take account of everything our staff had experienced during the COVID-19 pandemic and what we had learnt from this. The vision for UHS is to become an organisation of world class people delivering world class care. Our strategy is organised around five themes and for each of these it describes a number of ambitions we aim to achieve by 2025. Theme Ambitions Outstanding patient outcomes, • We will monitor clinical outcomes, safety and experience of our experience and safety patients regularly to ensure they are amongst the best in the UK By 2025 we will strengthen our and the world. national reputation for outstanding • We will reduce harm, learning from all incidents through our patient outcomes, experience and proactive patient safety culture. safety, providing high quality care • We will ensure all patients and relatives have a positive experience and treatment across an extensive of our care, as a result of the environment created by our people range of services from foetal and our facilities. medicine, through all life stages and conditions, to end-of-life care Pioneering research • We will recruit and enable people to deliver pioneering research in and innovation Southampton. We will continue to be a leading teaching hospital with a growing, reputable and innovative research and development portfolio • We will optimise access to clinical research studies for our patients. • We will enable innovation in everything we do, and ensure that ‘cutting edge’ investigations and treatments are delivered in Southampton. that attracts the best staff and efficiently delivers the best possible treatments and care for our patients. World class people • We will recruit and develop enough people with the right Supporting and nurturing our knowledge and skills to meet the needs of our patients. people through a culture that values • We will provide satisfying and fulfilling roles, growing our talent diversity and builds knowledge and through development and opportunity for progression. skills to ensure everyone reaches • We will empower our people, embracing diversity and embedding their full potential. We must provide compassion, inclusion and equity of opportunity. rewarding career paths within empowered, compassionate, and motivated teams. Integrated networks and collaboration We will deliver our services with partners through clinical networks, collaboration and integration across geographical and organisational boundaries. • We will work in partnership with key stakeholders across the Hampshire and Isle of Wight integrated care system. • We will strengthen our acute clinical networks across the region, centralising when necessary and supporting local care when appropriate. • We will foster local integration with primary and community care as well as mental health and social care services for seamless delivery across boundaries. • We will build on our successful partnership with University of Southampton (UoS), growing our reputation as a national leading university teaching hospital. 13 Theme Foundations for the future Making our enabling infrastructure (finance, digital, estate) fit for the future to support a leading university teaching hospital in the 21st century and recognising our responsibility as a major employer in the community of Southampton and our role in broader environmental sustainability. Ambitions • We will deliver best value to the taxpayer as a financially efficient and sustainable organisation. • We will support patient self-management and seamless care across organisational boundaries through our ambitious digital programme, including real time data reporting, to inform our care. • We will expand and improve our estate, increasing capacity where needed and providing modern facilities for our patients and our people. • We will strengthen our role in the community as an employer of choice, a partner in delivery of services to our population and by leading the Greener NHS agenda locally. During each year of the strategy the Trust sets out a more detailed series of objectives to achieve and progress towards the delivery of its ambitions. In 2022/23 these objectives included: Outstanding patient outcomes, experience and safety Pioneering research and innovation World class people Integrated networks and collaboration Foundations for the future • Recovery, restoration and improvement of clinical services • Introducing a robust and proactive safety culture • Empowering and developing staff to improve services for patients • Always Improving strategy • Delivering a high-quality experience of care for all • Delivery of year two of the research and innovation investment plan • Strategy and partnership working • Growing, developing and innovating our workforce • A great place to work, develop and achieve • Compassionate and inclusive workplace for all • We Work in partnership with Integrated Care System and Primary Care Networks • Integrated Networks and Collaborations • Establishing Southern Counties Pathology Network • Establishing the Wessex Imaging Network • Develop Collaborations strategy • Creating a sustainable financial infrastructure • Making our corporate infrastructure fit for the future to support a leading university teaching hospital in the 21st century • Recognising our responsibility as a major employer in the community of Southampton and our role in delivering a greener NHS Performance against these objectives will be monitored and reported to the Trust’s Board on a quarterly basis. 14 Principal risks to our strategy and objectives The Board has identified and manages the principal risks to the delivery of its strategy and objectives through its board assurance framework. The principal risks to the delivery of its strategy and objectives identified by the Trust during 2022/23 were that: • There would be a lack of capacity to appropriately respond to emergency demand, manage the increasing waiting lists for elective demand, and provide timely diagnostics, that results in avoidable harm to patients. • Due to the current challenges, the Trust fails to provide patients and their families with a high-quality experience of care and positive patient outcomes. • The Trust would not effectively plan for and implement infection prevention and control measures that reduce the number of hospital-acquired infections and limit the number of nosocomial outbreaks of infection. • The Trust is unable to meet current and planned service requirements due to unavailability of qualified staff to fulfil key roles. • The Trust fails to develop a diverse, compassionate and inclusive workforce, providing a more positive experience for all staff. • The Trust fails to create a sustainable and innovative education and development response to meet the current and future workforce needs identified in the Trust’s longer-term workforce plan. • The Trust does not implement effective models to deliver integrated and networked care, resulting in sub-optimal patient experience and outcomes, increased numbers of admissions and increases in patients’ length of stay. • The Trust is unable to deliver a financial breakeven position and support prioritised investment as identified in the Trust’s capital plan within locally available limits (capital departmental expenditure limit (CDEL)). • The Trust does not adequately maintain, improve and develop its estate to deliver its clinical services and increase capacity. • The Trust fails to introduce and implement new technology and expand the use of existing technology to transform its delivery of care through the funding and delivery of the digital strategy. • The Trust fails to prioritise green initiatives to deliver a trajectory that will reduce its direct and indirect carbon footprint by 80% by 2028-2032 (compared with a 1990 baseline) and reach net zero direct carbon emissions by 2040 and net zero indirect carbon emissions by 2045. During 2022/23, the Trust continued to experience the impact of the COVID-19 pandemic. The need to ensure a safe environment for patients through stringent infection control processes impacted the Trust’s capacity due to the need to isolate patients with COVID-19 in separate areas of the hospital. In addition, outbreaks of norovirus during the winter months placed further pressure on hospital capacity. The impact of the pandemic continued to be felt in terms of staff absence due to becoming infected with COVID-19 as well as the significant impact on staff mental health. The higher than normal (i.e. pre-COVID) levels of staff absence placed additional strain on the Trust’s operations and led to increased expenditure due to the requirement to enlist bank and/or agency staff to maintain safe staffing levels. 15 Performance overview The Trust monitors a broad range of key performance indicators within its departments, divisions, directorates and through Trust executive committees. On a monthly basis, the Board and executive committee receives a performance report containing a variety of indicators intended to provide assurance in respect of the Trust’s strategy and that the care provided is safe, caring, effective, responsive and well-led. This report also includes the Trust’s performance against the national targets set by NHS England. The performance reports include a ‘spotlight’ section, which provides more detailed analysis of a particular area. Typically, this is one of either the national targets or the Trust’s performance against the expectations set out in the NHS Constitution. The monthly performance report is also published on the Trust’s website. The Chief Executive Officer provides a regular report on performance to the Council of Governors, which includes a range of non-financial and financial performance information. Capacity The pressures of the COVID-19 pandemic led to increases in the waiting times for patients and the number of patients waiting for more than a year increased significantly. During the year, the Trust achieved its goal of no patients waiting more than 104 weeks by July 2022 and finished the year with only 14 patients waiting for more than 78 weeks. However, the length of time patients are waiting for treatment remains one of the key risks for the Trust. This situation was compounded by the sustained demand for non-elective activity, which saw attendances at the emergency department rise to over 400 patients per day during some periods of 2022/23 and was consistently higher than previously was the case. The significant increase in referrals, often requiring more complex treatment, has seen the number of patients on a waiting list under the 18-week referral to treatment pathway increase to just over 55,000 patients at the end of the year. In addition, the industrial action during the year placed further strain on the Trust’s ability to both provide urgent care and manage its elective recovery programme. Quality and compliance Furthermore, difficulties in obtaining care home beds and other care packages in the community has resulted in challenges in discharging patients who are ready to leave hospital and therefore the Trust has been operating at or near to capacity throughout the year. The Trust continued to monitor the quality of care delivered throughout 2022/23. The Trust continued its focus on infection prevention and control, which had proven successful during the COVID-19 pandemic. The Trust progressed its Always Improving strategy and successfully supported the identification and implementation of 84 quality improvement projects. In addition, the Trust continued to implement the patient safety incident response framework as well as taking other steps to drive a safety culture within the organisation. Furthermore, the Trust conducted further trials of shared decision making between clinicians and patients and is a leading site nationally for shared decision-making principles. Further information can be found in the Quality Account. 16 Partnerships The new arrangements for integrated care systems were implemented in July 2022 with the Trust becoming part of the Hampshire and Isle of Wight Integrated Care System. As such, the Trust’s senior management frequently meets with peers from across the system to consider and agree matters of wider concern across the system. In addition, the Trust worked with the Integrated Care Board in order to develop its financial and capital plans for 2023/24 and beyond. The Trust also attends the Southampton Health and Wellbeing Board at Southampton City Council and in the Hampshire and Isle of Wight Acute Provider Partnership Board. During 2022/23, the Trust continued to progress research activities and opportunities with the University of Southampton and Wessex Health Partners. Workforce In addition, work continued in the development of an elective hub at Winchester with Hampshire Hospitals NHS Foundation Trust, which will provide the Trust with additional capacity to carry out its elective programme. The Trust’s key areas of focus during 2022/23 were in respect of increasing the substantive workforce and reducing staff turnover. Although the Trust was successful in recruiting to substantive posts, the expected reduction in reliance on bank and agency staff did not materialise, which meant that the Trust was 1,068 whole-time equivalents above its plan for 2022/23. Included in this figure is the TUPE transfer of genomics staff from Salisbury. A particular area of focus was the recruitment of Health Care Assistants where the Trust was successful in reducing the number of vacancies from 27% to 18%. Whilst the Trust was successful in reducing staff turnover from 14.9% in 2021/22 to 13.5%, it remained above the 12% target. However, the Trust did experience a reduction in staff absence from 4.7% in April 2022 to 4.3% in March 2023, and initiatives to improve staff wellbeing were an area of focus during the year. Estate Innovation and technology The industrial action in late 2022 and early 2023 posed significant challenges for the Trust, including in terms of the need to engage additional temporary staff to ensure patient safety. The Trust continued to invest in and develop its estate during 2022/23 including successful completion of the Paediatric Intensive Care Unit project, which delivered single rooms and specialist accent lighting alongside delivery of a ‘twin care’ room. There were a number of other significant projects during the year, including refurbishments of wards and work on creating new theatres as well as projects to improve staff wellbeing. These were part of over £88m of capital expenditure in 2022/23 that also included equipment, digital and the backlog maintenance programme. The Trust continued to promote research and development during 2022/23, including through partnerships with the University of Southampton and Wessex Health Partners. Furthermore, the Trust continued to examine ways to make use of technology to improve its service delivery. In particular, the Trust has promoted the use of MyMedicalRecord, which gives patients the ability to co-manage their healthcare online and through an app. 17 Sustainable financial model The Trust did not achieve breakeven status at the end of 2022/23 and reported a deficit of £11.037m at year-end. This was due to a number of factors, including the Trust’s underlying deficit as well as the increase in energy prices. The Trust was more exposed than most to fluctuations in the wholesale price of gas due to its reliance on a gas-powered energy supply. In addition, the Trust’s 8% uplift in elective activity when compared to 2019/20 was not fullyfunded, which placed further pressure on the Trust’s existing financial resources, which had been used to ensure a breakeven position in 2021/22. The continued use of bank and agency staff as well as the costs of industrial action in late 2022 and early 2023 further eroded the Trust’s financial position. Notwithstanding the above, the Trust did succeed in obtaining a number of sources of nonrecurrent funding during the year, including a successful bid for £29.4m of funding through the Public Sector De-Carbonisation Fund, which will be used to fund green initiatives as part of the Trust’s capital programme. The financial outlook across the NHS continues to appear very challenging during 2023/24 and the Hampshire and Isle of Wight Integrated Care System is forecasting one of the highest deficits in England. 18 Performance analysis COVID-19 Impacts Although the pandemic has ended and serious cases of COVID-19 have reduced significantly, the Trust continued to be impacted by COVID-19 during 2022/23. Heightened infection prevention control measures in respect of patients with COVID-19 placed additional stress on the Trust’s capacity due to the need to isolate those patients and there was a consequential reduction in the Trust’s ability to make most efficient use of its available spaces. Furthermore, the ongoing impact on the Trust’s staff has led to higher staff absence than was the case prior to the pandemic, particularly due anxiety, infectious diseases and colds and flu. • The Trust experienced an average number of 98.7 patients per day who tested positive for COVID-19. During the winter months, this number increased substantially to nearly 200. • During the year, an average of 3.6 intensive care/high-dependency beds per day were occupied by COVID-19 patients. However, at times this increased to as much as ten. • Although staff sickness rates remained higher than pre-pandemic, the Trust saw a decrease in the absence rate from 4.7% at the beginning of 2022/23 to 4.3% by the end of the period. COVID-19 Cases UHS average number of confirmed COVID-19 patients in bed (08:00 census) 250 200 150 100 50 0 4/1/20225/1/2022 6/1/20227/1/2022 8/1/2022 9/1/202210/1/202211/1/202212/1/2022 1/1/2023 2/1/20233/1/2023 Intensive care/higher care beds UHS average number of confirmed COVID-19 patients in an ICU/HDU bed (08:00 census) 12 10 8 6 4 2 0 4/1/20225/1/2022 6/1/20227/1/2022 8/1/2022 9/1/202210/1/202211/1/202212/1/2022 1/1/2023 2/1/20233/1/2023 19 Number of patients Emergency access through the emergency department The Trust continued to experience high demand from patients presenting to receive care in the emergency department throughout the year above that seen prior to the COVID-19 pandemic. In particular, during the period between January and March 2023, the Trust averaged 352 attendances per day compared to 301 during the same period in 2019/20, an increase of 17%. The Trust also saw a significant increase in attendances during December due to both seasonal illnesses, but also due to the prevalence of streptococcus A in the community with attendances sometimes over 400 per day. Furthermore, the industrial action during the latter part of 2022 and early 2023 placed further pressure on the Trust’s ability to deliver services. In addition, the difficulties in discharging patients in need of care either at home or in another setting resulted in reduced flow from the emergency department to the relevant ward(s), which placed further strain on the Trust’s performance. During the year, in order to reduce emergency department attendances, the Trust trialled using General Practitioners to triage and see more straightforward patients who would otherwise have presented to the emergency department. Although this trial did result in a slight reduction in terms of number of patients and waiting times in ambulatory majors and majors, the affordability and value for money of this scheme is under review. Number of patients presenting to the emergency department 16,000 14,000 12,000 10,000 8,000 6,000 4,000 2,000 0 Apr-22 May-22 Jun-22 Jul-22 Aug-22 Sep-22 Oct-22 Nov-22 Dec-22 Jan-23 Feb-23 Mar-23 As a result of the increase in demand upon the emergency department, there continued to be a significant adverse impact on timeliness of care. The Trust failed to meet the national target of 95% of main emergency department/type 1 attendances seen within four hours, achieving 64.5% in March 2023, although this performance was above average in England. 20 % standard met Emergency access 4hr standard UHS vs NHSE average Type 1 performance 70% 0 10 60% 20 50% 30 40 40% 50 Apr-22 May-22 Jun-22 Jul-22 Aug-22 Sep-2 2 Oct-22 Nov-22 Dec-22 Jan-23 Feb-2 3 Mar-23 UH S NHSE average UHS rank amongst NHSE trusts Rank Ambulance handovers are an area of focus for NHS England, with a target of all handovers having to take place within 15 minutes and none waiting more than 30 minutes. The Trust performed well in this area with an average handover time of 17 minutes, having made the conscious decision to ensure that patients did not queue in ambulances at the expense of patients being queued within emergency department majors – thus impacting the Trust’s four-hour target, but meaning that ambulances were not queued outside the hospital as was seen in other areas of the country. Elective Waiting times Demand The year saw a continuation of the trend of increasing elective referrals experienced in 2021/22 following the pandemic, and referral rates continued to be above those seen prior to the pandemic. UHS Accepted Referrals 30,000 25,000 20,000 15,000 10,000 5,000 0 Apr-22 May-22 Jun-22 Jul-22 Aug-22 Sep-2 2 Oct-22 Nov-22 Dec-22 Jan-23 Feb-2 3 Mar-23 Number of accepted referrals 21 Activity The Trust experienced significant increases in terms of the number of hospital appointments, diagnostic tests and elective admissions during the year, exceeding levels in previous years. The Trust was one of the top performing trusts in terms of its elective recovery programme, achieving an 8% increase in its elective activity during the year when compared to 2019/20. However, performance in this area and in terms of outpatients appointments was negatively affected by the industrial action by nurses, junior doctors and other members of staff, which took place in late 2022 and early 2023 due to the need to cancel non-urgent procedures and appointments in favour of maintaining safe staffing levels in areas such as the emergency department. In addition, the continued presence of COVID-19 as well as other illnesses such as influenza and norovirus placed significant pressure at times on the Trust’s capacity due to the need to implement appropriate infection prevention control measures. Furthermore, difficulties in discharging patients fit to be discharged, but in need of a care package, placed additional strain on the Trust’s capacity. Elective admissions (including day case) Post-COVID-19 pandemic Elective (including day case) recovery (% of same month compared between March 2019 – February 2020) 105% 100% 95% 90% 85% 80% 75% Apr-22 May-22 Jun-22 Jul-22 Aug-22 Sep-22 Oct-22 Nov-22 Dec-22 Jan-23 Feb-23 % recovery Outpatient attendances Post-COVID-19 pandemic outpatient seen recovery (% of same month compared between March 2019 – February 2020) 140% 0 90% 10 20 40% 30 Apr-22 May-22 Jun-22 Jul-22 Aug-22 Sep-22 Oct-22 Nov-22 Dec-22 Jan-23 Feb-23 UH S UHS rank amongst NHSE trusts % recovery Rank 22 Diagnostics The Trust measures performance on a total of 15 frequently used diagnostic tests. In March 2023, 22% of patients were waiting more than six weeks for diagnostics compared with the national target of less than 1%. Patients waiting for a diagnostic test to be performed (sum of 15 different frequently used tests) UHS diagnostic waiting list volume 12,000 11,500 11,000 10,500 10,000 9,500 Apr-22 May-22 Jun-22 Jul-22 Aug-22 Sep-2 2 Oct-22 Nov-22 Dec-22 Jan-23 Feb-2 3 Mar-23 Diagnostic waiting list volume Percentage of patients waiting over 6 weeks for a diagnostic test to be performed Diagnostic 6 week wait performance UHS vs. NHSE average 35% 30% 25% 20% 15% 10% 5% 0% Apr-22 May-22 Jun-22 Jul-22 Aug-22 Sep-22 Oct-22 Nov-22 Dec-22 Jan-23 Feb-23 Mar-23 UH S NHSE average % standard met 23 Referral to Treatment The Trust continued to see an increase in the number of patients being referred for treatment during 2022/23 with just over 55,000 patients on a waiting list under the 18-week referral to treatment pathway at the end of the year. Averaged across the year, the volume of referrals exceeded the Trust’s theoretical capacity by around 3.5%. Due to this significant demand, the Trust only achieved 63.2% of patients being treated within 18 weeks of referral in March 2023 compared with the monthly target of more than 92%. However, despite this, the Trust remained in the top quartile when compared to other teaching hospitals, reflecting that this growth in demand continues to be a national challenge. During 2022/23, the national target was to ensure that there were no patients waiting over two years for treatment by July 2022, and that there were no patients waiting more than 78 weeks by the end of March 2023. Long-waiting patients were an area of particular focus for the Trust during the year with no reported two-year waits since November 2022 and only two between the period June-November due to patients choosing to delay their treatment. This was a significant improvement compared to the peak of 171 patients reported in December 2021. Similarly, the Trust made progress in reducing the number of patients waiting over 78 weeks for treatment. In February 2023, the Trust reported 84 patients in this category compared to the peak of over 900 patients in September 2021. By the end of March 2023, the Trust had managed to further reduce this number of patients to 14, with those in breach of the target all due to the complexity of the cases. UHS referral to treatment waiting list 56,000 54,000 52,000 50,000 48,000 46,000 44,000 Apr-22 May-22 Jun-22 Jul-22 Aug-22 Sep-22 Oct-22 Nov-22 Dec-22 Jan-23 Feb-23 Mar-23 24 Number on waiting list % standard met Percentage of patients waiting up to 18 weeks between referral and treatment RTT 18 week performance UHS vs. NHSE average 70% 65% 60% 55% 50% Apr-22 May-22 Jun-22 Jul-22 Aug-22 Sep-22 Oct-22 Nov-22 Dec-22 Jan-23 Feb-23 Mar-23 UH S NHSE average Percentage of patients waiting more than 52 weeks between referral and commencement of a treatment for their condition Number of patients Rank UHS Referral to treatment patients waiting more than 52 weeks 3,000 0 2,500 10 2,000 20 1,500 30 1,000 40 500 50 0 60 Apr-22 May-22 Jun-22 Jul-22 Aug-22 Sep-22 Oct-22 Nov-22 Dec-22 Jan-23 Feb-23 Mar-23 UH S UHS rank amongst NHSE trusts % of RTT patients RTT % of patients waiting more than 52 weeks UHS vs. NHSE average 5.0% 0 4.5% 20 40 4.0% 60 3.5% 80 Apr-22 May-22 Jun-22 Jul-22 Aug-22 Sep-22 Oct-22 Nov-22 Dec-22 Jan-23 Feb-23 Mar-23 UH S UHS rank amongst NHSE trusts Rank 25 % standard met Cancer Waiting Times The Trust is one of 12 regional cancer centres in the UK offering treatment for rare and complex cancers as well as cancer in children and brain cancer. The Trust has historically been in the upper quartile, relative to teaching hospital peers. Due to loss of key members of staff and industrial action, the Trust’s performance has slipped over the year with 72.5% of patients seen within two weeks in March 2023 following referral by a General Practitioner for suspected cancer (national target: > 93% per month). Cancer waiting times - 2 week wait performance UHS vs NHSE average 100% 0 80% 50 60% 100 40% 150 Apr-22May-22 Jun-22 Jul-22 Aug-22 Sep-22 Oct-22 Nov-22 Dec-22 Jan-23 Feb-23Mar-23 UH S NHSE average UHS rank amongst NHSE trusts Rank Referrals for January to March 2023 were at the highest for that month for the past five years and overall referral volumes in 2022/23 averaged 2,049 patients per month, 8% higher than in 2021/22 and 28% higher than in 2019/20. The national target was for 96% of patients to commence treatment within 31 days of diagnosis. However, in March 2023, the Trust only achieved 87.9%, but this figure hides considerable variation dependent on the tumour site and type of cancer with a range of 100% for haematology and children’s cancers to 71% for skin. The high rate of referrals led to a significant backlog in terms of patients waiting longer than 62 days for treatment. However, the Trust took steps to reduce this backlog by more than 50% through a dedicated recovery programme. In March 2023, the Trust treated 54.8% of patients within 62 days of referral compared to the target of more than 85%. Treatment for Cancer within 62 days of an urgent GP referral to hospital Cancer waiting times 62 day RTT performance UHS vs. NHSE average 80% 60% 40% 20% 0% Apr-22 May-22 Jun-22 Jul-22 Aug-22 Sep-22 Oct-22 Nov-22 Dec-22 Jan-23 Feb-23 Mar-23 UH S NHSE average % standard met 26 First definitive treatment for cancer within 31 days of a decision to treat % standard met Cancer waiting times 31 day RTT performance UHS vs. NHSE average 95% 90% 85% 80% 75% Apr-22 May-22 Jun-22 Jul-22 Aug-22 Sep-22 Oct-22 Nov-22 Dec-22 Jan-23 Feb-23 Mar-23 UH S NHSE average Quality priorities The Trust set eight quality priorities in 2022/23, which were aimed at ensuring it continued to deliver the highest quality of care. The quality priorities were shaped by a range of national and regional factors as well as local and Trust‐wide considerations. The Trust recognised the overriding issues of significant operational pressures being felt right across the health and social care system, including those associated with the previous two years of the COVID-19 pandemic. The challenge was to deliver the best quality care in the context of these operational pressures, and the Trust set its quality priorities accordingly. Out of the eight priories set, the Trust achieved five and partially achieved three. Priority One: Enhancing capability in Quality Improvement (QI) through our Always Improving strategy The transformation team has grown to over thirty team members including project support officers, project managers, benefit realisation managers. This has allowed the Trust to develop that systematic organisational approach to guide and support its staff in their QI projects. The Trust originally set a target of delivering fifty quality improvement projects but have successfully supported a total of 84 (55 local and 29 flow improvements). These are local change projects which were identified, proposed, led, and delivered by the people who do the work. To date over 1500 people have been trained in the Trust’s improvement approach, which exceeds the original target of 500. The Trust also developed a QI project register and held an Always Improving conference. Priority Two: Developing a culture of kindness and compassion to drive a safety culture The Trust only partially achieved this priority as plans to fully deliver training were affected by operational pressures. However, during the year a variety of communication platforms were used to make sure staff understood the Trust’s vision and were kept up to date with plans and progress. The Trust worked to develop and embed a ‘just culture’ allowing staff to speak up and ask, “what happened and how do we learn?” and developed ‘stop for safety’ staff huddles. Priority Three: We will improve mental health care across the Trust including support for staff delivering care The Trust only partially achieved this priority as several key quality improvement projects have not yet been delivered, and the mental health strategy not yet been finalised. However, a training needs analysis was completed and significant staff training and an education scheme were introduced in response to the findings of the analysis. Mental health champion training has been delivered to 153 staff and IT systems have been improved to help capture vital data to help shape the Trust’s service. 27 Priority Four: Recognising and responding to deterioration in patients During 2021/22 the Trust successfully introduced national Paediatric Early Warning System (nPEWS) into its Southampton Children’s Hospital and UHS is now part of the national test and trial of nPEWS which is assessing the usability of the scoring system. The Trust has also explored how nPEWS can be adapted for children with complex medical conditions requiring interventions (including non-invasive ventilation) as part of their normal care. A daily heat map of escalation times over a 24-hour period was piloted in 2022 and will be rolled out across all adult’s inpatient areas during 2023. The Trust has also performed well with its cardiac arrest audits, and training and education programmes have consistently been delivered. September 2022 saw the implementation of a 24-hour paediatric outreach service. There is a deteriorating patient group and several successful QI projects have been introduced. Priority Five: Improving how the organisation learns from deaths The Trust only partially achieved this priority as it has been unable to establish a learning from deaths steering group. The Trust has introduced a mortality governance coordinator/analyst and grown its bereavement care service. Priority Six: Shared Decision Making (SDM) The shared decision models started at UHS in 2021/22 and have continued to grow with investment in pilot roles to expand these models, which include several advanced nurse practitioner roles, models in paediatrics bringing Shared Decision Making to patients who are transitioning from paediatric to adult services, while in maternity we have introduced SDM in birth planning. When assessing delivery of SDM against NICE guidelines, UHS performs well, especially in targets related to Trust buy-in, governance and practices of pilot areas. This year the Trust has implemented training through key platforms and expanded patient involvement in the project. As a leading site nationally for SDM principles, UHS have worked with NHS England on creating materials for others to learn from. Priority Seven: Working with our local community to expose and address health inequalities During the year the Trust refocused its efforts on making sure that its involvement and participation activities support the health inequalities agenda, while also working to deliver responsive information and advice to patients, carers, and families. Priority Eight: Ensure patients are involved, supported, and appropriately communicated with on discharge During the year the Trust has focused on improved patient, carer and family involvement, and improved communication during the discharge process as well as prompting a more collaborative working between social and health care staff. Strong partnership working with external agencies has been developed to support a system approach to hospital discharge, develop digital solutions, develop the patient hub to support discharge and delivered education to UHS staff. More information can be found about how the Trust delivered and measured its quality priorities, including feedback from patients and staff and improvement aims and quality priorities for 2023/24, in the Trust’s Quality Account for 2022/23. 28 Financial performance The Trust delivered a deficit of £11 million from a revenue position of over £1.2 billion, once items deemed as “below the line” by NHS England, such as the financial position of the Southampton Hospitals Charity, were removed. The Trust was unable to deliver the planned breakeven position. Several material cost pressures were incurred, including unfunded high-cost drugs costs and energy prices. These were unable to be off set in full by a savings programme, despite delivery of £45.6m of efficiencies (2021/22: £15m). Trust operating income rose by £64m from the previous financial year, most notably funding the NHS pay award, as well as additional elective recovery funding. Income reduced from the prior year in relation to ending a nationally funded project regarding testing for COVID-19. The Trust has however been successful in increasing funding for research and development. Trust operating expenditure rose by £78m, incorporating funded inflationary costs as well as the cost pressures outlined above. The Trust has also continued its reinvestment of surplus cash into infrastructure for the Trust, with capital investmen
Url: /Media/UHS-website-2019/Docs/About-the-Trust/Annual-reports-and-quality-accounts/UHS-AR-22-23-6.pdf

BEACON protocol v8.0 07Mar2023 signed

Description: A randomised phase IIb trial of BE AC v izumab added to Temozolomide O ± Irin tecan for children with N refractory/relapsed euroblastoma Version 8.0 dated 07-Mar-2023 Dinutuximab beta amendment Coordinating Sponsor: Sponsor Protocol Number: CAS Code: EudraCT Number: ISRCTN Reference Number: ITCC Number: Roche Study Reference Number: Email: University of Birmingham RG_ 11-087 BN2008 2012-000072-42 40708286 032 MO28245 beacon@trials.bham.ac.uk This application is supported by the facilities funded through Birmingham Science City: Translational Medicine Clinical Research Infrastructure and Trials Platform, an Advantage West Midlands (AWM) funded project which forms part of the Science City University of Warwick and University of Birmingham Research Alliance. BEACON-Neuroblastoma Protocol_vn 8.0_vd 07Mar2023 Page1 of 157 BEACON-Neuroblastoma Trial Protocol AMENDMENTS The following amendments and/or administrative changes have been made to this protocol since the implementation of the first approved version Amendment Date of number amendment Protocol version number Type of amendment SA 1 29-Jan-2013 2.0 Substantial Amendment N/A 23-Apr-2013 2.0a Non-Substantial Amendment N/A 01-Jul-2013 2.0b Non-Substantial Amendment Summary of amendment Introduction of the recommendation of weekly monitoring of blood counts for all patients receiving irinotecan. Addition of planned vaccination with live vaccination to exclusion criteria and prohibited medications section. ITCC Number has been corrected. Roche Study Reference Number and ISRCTN Reference Number have been added. Contact details for Plasma & Tumour Angiogenesis-Related Biomarkers have been amended. Table numbers have been corrected. Addition of guidance for research bone marrow sampling in Schedule of Activities table and sections 7.4.2.2 and 7.5.2. Addition of paragraph to sections 7.2, 7.6.1 – 7.6.4 detailing arrangements for handling dose modifications for Irinotecan + Temozolomide for patients receiving Bevacizumab. Discontinuation rules for osteonecrosis of the jaw and eye disorders added to table 13 in section 7.6.4. Correction to table number references in section 7.6.3. Clarification made in section 13.4.1 concerning Planned Interim Analysis. SA 3 06-Oct-2014 4.0 Substantial Amendment Changes to the Trial Personnel section of the protocol to include the addition of contact details for Denmark and Ireland Lead Investigators. Amendments to reflect the changes in study sampling requirements to Trial Synopsis, Schedule of Activities table and sections 1.2.6, 2.1, 2.2, 5.1, 5.2, 7.3, 7.4.2 and 7.5. Amendment to exclusion criteria in Trial Synopsis and section 4.2. Changes to the Schedule of Activities table to include the addition of an echocardiogram to be performed at screening and Tanner staging at screening and yearly in follow up. Changes to the time line for measuring renal function prior to commencing treatment in the Trial Synopsis, Schedule of Activities and section 4.1. BEACON-Neuroblastoma Protocol_vn 8.0_vd _07Mar2023 Page 3 of 157 BEACON-Neuroblastoma Trial SA 4 06-Oct-2014 4.0 SA 5 30-Jul-2015 5.0 Substantial Amendment Substantial Amendment Protocol Option to fax emergency randomisation removed. Telephone only in section 6.2 Changes to guidelines in section 7.2 for dose calculation in patients whose weight exceeds the 98th centile for age. Removal of enhanced data collection for Adverse Events of Special Interest (AESI) in section 7.6 and 9.1.2. Addition of option to extend treatment delay with agreement from Sponsor in Section 7.6.1 Addition of necrotising fasciitis as an adverse event requiring bevacizumab discontinuation in section 7.6.4. Changes to section 7.10 concerning the documenting of concomitant medications in patient medical notes and administration of bisphosphonates. Changes to section 9.1 regarding reporting of laboratory adverse events. Clarification on the arrangements for Follow Up Form completion for patients who do not require further follow up visits in section 11. Changes to bevacizumab and irinotecan preparation and dispensing guidelines in sections 8.2.4 and 8.3.3. Clarification on fasting arrangements prior to temozolomide administration added to section 8.4.3. Changes to events that should be reported on an Expected SAR Form in section 9.1.3.1. Clarification on SAEs that should be reported to F.Hoffman-La Roche Ltd in section 9.2.6 Addition of Trial Management Group meeting frequency in section 14.4. Changes to the wording of irinotecan randomisation in section 13.4.2. Addition of guidelines for dose reduction and discontinuation of temozolomide for liver toxicity in tables 8, 9, 10 & 11. Reference to the National Coordinating Centres has been changed to National CoSponsor throughout. Reference to Sponsor has been changed to Coordinating Sponsor. Change of Chief Investigator to Professor Pamela Kearns. Change of Principal Investigator at Royal Marsden Hospital to Dr Sucheta Vaidya. No changes made to the Protocol version. Chief Investigator and UK Lead Investigator changed to Dr Lucas Moreno Switzerland details added Schedule of events table amended for End Of Treatment clarity BEACON-Neuroblastoma Protocol_vn 8.0_vd _07Mar2023 Page 4 of 157 BEACON-Neuroblastoma Trial N/A 23-Sep-2015 5.0a SA 6 16-Jan-2019 6.0a Protocol Topotecan added to the study as a new trial question and 2 new randomisation arms. The following sections are amended accordingly: Synopsis (Primary Objectives, sample size, Trial Duration, Trial therapy) Section 1 Background and rationale (Trial rationale) Section 3 Trial design (Randomisation) Section7.1 and 7.2 Treatment details Section7.6.1 Dose modifications Table 6 amended, Tables 11 and 12 added Section 8.4 Pharmaceutical Information Section 13 Statistical considerations The following changes were made to the Eligibility: Inclusion criteria – further details regarding birth control Exclusion criteria – Defined wash out period following prior IMP according to IMP half-life or 14 days. Lifestyle guidelines - further details regarding birth control Section 7.6 Dose modifications Figure 1 – reference to “chemo” changed to Temozolomide/Irinotecan/Topotecan” for clarity Section 8.2.4 Reference to “chemo” removed for clarity Section 7.6.4 AEs requiring Bevacizumab discontinuation – additional AEs added following Bevacizumab IB v22 Addendum Additional mRNA and exploratory sampling. Non-Substantial Amendment Substantial amendment The requirement for confirmatory scans was removed from the Schedule of Activities and Response assessment section 7.4.3. Lead Investigator for France amended to Dr Marion Gambart Minor wording corrections and clarifications Schedule of events table corrected Introduction of two new treatment arms (dinutuximab beta) for additional 64 patients Addition of eligibility criteria, schedule of events, treatment details, duration, cross over and dose modification details for new dinutuximab beta arms Adaptation of objectives, trial design, supporting treatment, pharmaceutical information and statistical consideration sections with new, relevant information. BEACON-Neuroblastoma Protocol_vn 8.0_vd _07Mar2023 Page 5 of 157 BEACON-Neuroblastoma Trial N/A 11-Apr-2019 6.0b SA 7 07-Feb-2020 7.0 SA 22 07-Mar-2023 8.0 Protocol Non-Substantial Amendment Substantial Amendment Substantial Amendment Minor wording corrections and clarifications Version amended from 6.0 to 6.0a to add. Additional rationale to update typographical errors.) Trial Synopsis: Clarification of recruitment targets Clarification of Section 10 title: “Dinutuximab beta and topotecan randomisations” Clarification that not all biological studies will be open at any one time (Section 10.2 and 15.5) Minor wording corrections and clarifications Urgent Safety Measure – implemented on 28th January 2020 Closure of Temozolomide (T) and Dinutuximab beta and Temozolomide (dBT) arms with immediate effect. Section 1.1 Background Section 1.2.3 Benefit Risk assessment Section 3.1 Randomisation Section 10 Headings changed Section 10.3 Trial therapy Update of contact details Change of definition of End of Trial (Section 21). Protocol previously defined two stages of end of trial (6 months after last patient completes treatment and 12 months after last data capture after 5 years follow up). This has been combined into one End of Trial definition: 6 months after last patient last visit (i.e. after 5 years follow up) Also addition of option to email SAE form (Section 18.2.1.2) BEACON-Neuroblastoma Protocol_vn 8.0_vd _07Mar2023 Page 6 of 157 BEACON-Neuroblastoma Trial Protocol TRIAL PERSONNEL Chief Investigator: Co-Investigators: Exploratory Biomarkers Dr Lucas Moreno Dr. Lucas Moreno, MD, PhD Director Paediatric Oncology & Haematology Division Vall d’Hebron Barcelona Hospital Campus Passeig de la Vall d’Hebron, 119-129, 08035, Barcelona, Spain  +34 93 489 3000  +34 93 489 4060  lucas.moreno@vhebron.net Professor Keith Wheatley Professor of Clinical Trials Cancer Research UK Clinical Trials Unit (CRCTU) Institute of Cancer and Genomic Sciences College of Medical and Dental Sciences University of Birmingham Birmingham, UK B15 2TT  +44 (0)121 415 9119  k.wheatley@bham.ac.uk Dr Juliet Gray Associate Professor and Consultant in Paediatric Oncology Southampton Children’s Hospital Tremona Road Southampton SO16 6YD  +44 (0) 790 1507929  juliet.gray@uhs.nhs.uk Dr Gudrun Schleiermacher Senior Scientist Institute Curie 26 rue d'Ulm 75248 Paris cedex 05 France  +33 (0)1 56 24 45 50  +33 (0)1 56 24 66 30  gudrun.schleiermacher@curie.net Professor Louis Chesler Paediatric Tumour Biology Team Institute of Cancer Research and Royal Marsden Hospital (University of London), Downs Road, Sutton Surrey, UK SM2 5PT  +44 (0) 208 722 4035 BEACON-Neuroblastoma Protocol_vn 8.0_vd _07Mar2023 Page 7 of 157 BEACON-Neuroblastoma Trial Protocol  louis.chesler@icr.ac.uk Functional Imaging Study: Professor Andrew Peet Institute of Child Health University of Birmingham Whittall Street Birmingham, UK B4 6NH  +44 (0) 121 333 8234  +44 (0) 121 333 8241  a.peet@bham.ac.uk Dr Dow-Mu Koh Consultant Radiologist in Functional Imaging Royal Marsden Hospital Downs Road, Sutton, Surrey, UK SM2 5PT  +44 (0) 208 6613857  dow-mu.koh@icr.ac.uk Professor Martin Leach Co-Director, Cancer Research UK and EPSRC Centre for Cancer Imaging, Director, NIHR Clinical Research Facility Deputy Head, Division of Radiotherapy and Imaging Institute of Cancer Research and Royal Marsden Hospital (University of London), Downs Road, Sutton Surrey, UK SM2 5PT  +44 (0 208 661 3338  Martin.Leach@icr.ac.uk Molecular Monitoring mRNA Study: Professor Sue Burchill Leeds Institute of Cancer & Pathology St. James University Hospital Beckett Street Leeds, UK LS9 7TF  +44 (0) 113 206 5873  +44 (0) 113 242 9886  S.A.Burchill@leeds.ac.uk Professor Walter Gregory Clinical Trials Research Unit (CTRU) University of Leeds Clinical Trials Research House 71-75 Clarendon Road Leeds LS2 9PH  +44 (0) 113 343 1489  +44 (0) 113 343 1471 BEACON-Neuroblastoma Protocol_vn 8.0_vd _07Mar2023 Page 8 of 157 BEACON-Neuroblastoma Trial Protocol Trial Statistician: Trial Coordinator & Trial Office: Randomisation Service: SAE Reporting:  W.M.Gregory@leeds.ac.uk Miss Grace Holt Cancer Research UK Clinical Trials Unit (CRCTU) Institute of Cancer and Genomic Sciences College of Medical and Dental Sciences University of Birmingham Birmingham, UK B15 2TT  +44 (0)121 414 8328  +44 (0)121 414 3700  G.C.Holt@bham.ac.uk Miss Punam Mistry Children’s Cancer Trials Team Cancer Research UK Clinical Trials Unit (CRCTU) Institute of Cancer and Genomic Sciences College of Medical and Dental Sciences University of Birmingham Birmingham, UK B15 2TT  +44 (0)121 414 3788  +44 (0)121 414 9520  beacon@trials.bham.ac.uk Provided by the CRCTU at the University of Birmingham Randomisation should be performed by sites online at: https://www.cancertrials.bham.ac.uk/BEACONLive In case of any problems with online randomisation, randomisation can be performed over the phone by the CRCTU on: 0800 371 969 or +44 (0)121 414 3366 SAEs should be faxed to the BEACON-Neuroblastoma Trial Office, CRCTU, University of Birmingham, UK  + 44 (0)121 414 9520 or +44 (0)121 414 3700 National Coordinating Investigators: Austria – Lead Investigator: Prof Dr Ruth Ladenstein St. Anna Children’s Hospital and CCRI /Studies and Statistics Department for Integrated Research and Projects (S²IRP) Kinderspitalgasse 6, Zimmermannplatz 10 A-1090 Vienna Austria +43-1-40470-4750  +43-1- 40470- 7430  ruth.ladenstein@ccri.at BEACON-Neuroblastoma Protocol_vn 8.0_vd _07Mar2023 Page 9 of 157 BEACON-Neuroblastoma Trial Belgium Lead Investigator: Prof Genevieve Laureys Ghent University Hospital 9000 Ghent De Pinterlaan 185 Belgium  +32 93 32 34 48  genevieve.laureys@uzgent.be Denmark – Lead Investigator: Dr Karsten Nysom Dept. of Paediatrics & Adolescent Medicine Rigshospitalet Blegdamsvej 9 DK2100 Copenhagen Denmark  +45 35 45 08 09  +45 35 45 50 55  Karsten.nysom@regionh.dk France – Lead Investigator: Dr Marion Gambart Unité d'Hémato-Oncologie Hôpital des Enfants 330, avenue de Grande Bretagne TSA 70034 31059 Toulouse Cedex France  +33 (0)5 34 55 86 11  +33 (0)5 34 55 86 12  gambart.m@chu-toulouse.fr Germany - Lead Investigator: Dr. Simone Hettmer Zentrum für Kinder- und Jugendmedizin UNIVERSITÄTSKLINIKUM FREIBURG Mathildenstr. 1, 79106 Freiburg Germany  +49 761 270-43000  +49 761 270-45180  simone.hettmer@uniklinik-freiburg.de Ireland – Lead Investigator: Dr Cormac Owens Our Lady’s Children’s Hospital Crumlin Road, Crumlin Dublin 12 Ireland  +35314096659  +35313453041  Cormac.owens@olchc.ie Protocol BEACON-Neuroblastoma Protocol_vn 8.0_vd _07Mar2023 Page 10 of 157 BEACON-Neuroblastoma Trial Protocol Italy – Lead Investigator: Dr. Aurora Castellano U.O.Oncoematologia Ospedale Pediatrico Bambino Gesù Pzza S. Onofrio 4 00165 Roma Italy +39 06 68592957-2678  +39 06 68592826  aurora.castellano@opbg.net Netherlands – Lead Investigator: Dr. C Michel Zwaan Erasmus Medical Center Sophia’s Children's Hospital Dr. Molewaterplein 60 3015 GJ Rotterdam +31 (0) 10 703 6691  +31(0) 10 703 6681  c.m.zwaan@erasmusmc.nl Spain – Lead Investigator: Dr. Victoria Castel Instituto de Investigación Sanitaria Unidad de Oncología Pediátrica Hospital Universitario La Fe Bulevar Sur, S/N 46026 Valencia Spain +34 963862758 Ext 50040  +34 963494416  castel_vic@gva.es Switzerland – Lead Investigator: Dr. Nicolas Gerber University Children’s Hospital, Steinwiesstrasse 75, CH-8032 Zurich, Switzerland +41 44 266 31 17  +41 44 266 34 61  Nicolas.gerber@kispi.uzh.ch UK – Lead Investigator: Dr Lucas Moreno Honorary Research Fellow University of Birmingham Birmingham, UK B15 2TT  +44 (0)121 414 3788  +44 (0)121 414 9520  lucas.moreno@vhebron.net, lmorenom@ext.cnio.es BEACON-Neuroblastoma Protocol_vn 8.0_vd _07Mar2023 Page 11 of 157 BEACON-Neuroblastoma Trial Protocol TRIAL SYNOPSIS Title A randomised phase IIb trial of bevacizumab added to temozolomide ± irinotecan for children with refractory/relapsed neuroblastoma – BEACON-Neuroblastoma Trial Trial Design A phase II, randomised, open label, international multicentre 3x2 factorial trial. The dinutuximab beta amendment did utilise a 2x2 factorial design it will now be a simple two-way randomisation. Objectives Primary: - To test whether bevacizumab added to a backbone chemotherapy regimen (temozolomide, irinotecan + temozolomide or temozolomide + topotecan) demonstrates activity in children with relapsed or refractory neuroblastoma - To test whether the addition of irinotecan to temozolomide increases the activity of chemotherapy in children with relapsed or refractory neuroblastoma - To test whether the addition of topotecan to temozolomide increases the activity of chemotherapy in children with relapsed or refractory neuroblastoma (“topotecan randomisation”) - To test whether dinutuximab beta added to a backbone chemotherapy regimen (temozolomide or temozolomide + topotecan) demonstrates activity in children with relapsed or refractory neuroblastoma (“dinutuximab beta randomisation”) Secondary: - To evaluate the safety of the regimens Tertiary: - To undertake preliminary evaluation of the changes in magnetic resonance imaging (MRI) derived functional imaging biomarkers of angiogenesis - To undertake preliminary evaluation of the role of circulating mRNA levels for tyrosine hydroxylase (TH), paired-like homeobox 2b (PHOX2B) and doublecortin (DCX) as prognostic/predictive biomarkers in this refractory/relapsed setting - To undertake a preliminary evaluation of the role of tumour molecular profiles in blood and archival tumour tissue profiles as prognostic and predictive biomarkers - To undertake a preliminary evaluation of biomarkers of response to anti-GD2 therapy (Fc/KIR polymorphisms, Antibody Dependant Cell-Mediated Cytotoxicity (ADCC) and Anti-Drug Antibodies (ADAs) and of dinutuximab beta pharmacokinetics (PK) Outcome Measures Primary Endpoint: - Best response (Complete Response [CR] or Partial Response [PR]) [1] at any time during the first 6 cycles of trial treatment - For the bevacizumab part 2 only: Progression-free survival (PFS) Secondary Endpoints: - Safety of the regimens: Incidence and severity of Adverse Events (AE)s - PFS - Overall survival (OS) - Event-free survival (EFS) BEACON-Neuroblastoma Protocol_vn 8.0_vd _07Mar2023 Page 12 of 157 BEACON-Neuroblastoma Trial Protocol Exploratory/Tertiary Endpoints: - Changes in (MRI) derived functional imaging biomarkers of angiogenesis measured by quantitative dynamic contrast enhanced (DCE) MRI: primary biomarkers will be the transfer constant Ktrans [min-1] and initial area under the gadolinium uptake curve from 0 to 60 seconds (IAUGC60, mM Gd min) and secondary biomarkers will be tumour apparent diffusion coefficient (ADC, 10-6 cm2 s-1), native T1 and T2 relaxation times (ms) and transverse relaxation rate R2* - Changes in circulating mRNA levels for TH, PHOX2B and DCX in bone marrow and blood samples - Pilot descriptive study of angiogenesis and neuroblastoma markers that may include O6methylguanine-methyltransferase (MGMT) status, immunohistochemistry and immunofluorescence markers on tumour samples (such as microvessel density (MVD), CD31, Ki67, NRP1, VEGFR-1, VEGFR-2, C-KIT), DNA/RNA extraction from tissue sections for tumour mutation screening and tumour expression profiling - A preliminary correlation of the different biomarkers [Fc/KIR polymorphisms, Antibody – Dependent Cellular Toxicity (ADCC), and Anti-Drug Antibodies (ADAs)] will be made with parameters of anti-tumour activity (response rate, PFS and OS). PK parameters (dinutuximab beta trough levels) for this chemo-immunotherapy regimen will be described. Patient Population Children and young adults aged 1 to 21 years of age with relapsed/refractory neuroblastoma. Sample Size Approximately 224 patients, including 160 for the bevacizumab randomisation and 64 for the dinutuximab beta amendment. Trial Duration 8 years of patient recruitment, 5 years of patient follow up BEACON-Neuroblastoma Protocol_vn 8.0_vd _07Mar2023 Page 13 of 157 BEACON-Neuroblastoma Trial Protocol Abbreviations ADA ANTI-DRUG ANTIBODIES ADCC ANTIBODY – DEPENDENT CELL-MEDIATED CYTOTOXICITY AE ADVERSE EVENT AESI ADVERSE EVENT OF SPECIAL INTEREST AFSAPPS COMPETENT AUTHORITY FOR FRANCE ALT ALANINE AMINOTRANSFERASE ANC ABSOLUTE NEUTROPHIL COUNT APPT ACTIVATED PARTIAL THROMBOPLASTIN TIME ASCT AUTOLOGOUS STEM CELL TRANSPLANTATION AST ASPARTATE AMINOTRANSFERASE AUC AREA UNDER THE CURVE AR ADVERSE REACTION BIT BEVACIZUMAB + IRINOTECAN + TEMOZOLOMIDE ARM BM BONE MARROW BP BLOOD PRESSURE BSA BODY SURFACE AREA BT BEVACIZUMAB + TEMOZOLOMIDE ARM BTTo BEVACIZUMAB + TEMOZOLOMIDE + TOPOTECAN ARM CI CHIEF INVESTIGATOR CIs CONFIDENCE INTERVALS COG CHILDREN’S ONCOLOGY GROUP CNS CENTRAL NERVOUS SYSTEM CR COMPLETE RESPONSE CRF CASE REPORT FORM CR UK CANCER RESEARCH UK CRCTU CANCER RESEARCH UK CLINICAL TRIALS UNIT (UNIVERSITY OF BIRMINGHAM) CRN CLINICAL RESEARCH NETWORK CSR CLINICAL STUDY REPORT CT COMPUTERISED TOMOGRAPHY CTC COMMON TERMINOLOGY CRITERIA CTCAE COMMON TERMINOLOGY CRITERIA FOR ADVERSE EVENTS CXR CHEST X-RAY dBT DINUTUXIMAB BETA + TEMOZOLOMIDE ARM dBTTo DINUTUXIMAB BETA + TEMOZOLOMIDE + TOPOTECAN ARM DCX DOUBLECORTIN DLT DOSE LIMITING TOXICITY DMC DATA MONITORING COMMITTEE DNA DEOXYRIBONUCLEIC ACID ECHO ECHOCARDIOGRAM ECOG EASTERN COOPERATIVE ONCOLOGY GROUP EFS EVENT FREE SURVIVAL EMA EUROPEAN MEDICINES AGENCY ERDC ELECTRONIC REMOTE DATA CAPTURE EOT END OF TREATMENT FFPE FORMALIN-FIXED PARAFFIN EMBEDDED GCP GOOD CLINICAL PRACTICE G-CSF GRANULOCYTE COLONY STIMULATING FACTOR BEACON-Neuroblastoma Protocol_vn 8.0_vd _07Mar2023 Page 14 of 157 BEACON-Neuroblastoma Trial Protocol GFR GM-CSF GGT GP GPOH HR IB ICF ICH IMP INR INRC INRG INSS IRF ISF IT ITCC IV MGMT MIBG MHRA MRD MRI MSKCC MTD MYCN NANT NCI NCS NR OS OTC PCP PD PFS PHOX2B PI PIS PK PMA PRES PO PPTP PR REC RECIST RNA GLOMERULAR FILTRATION RATE GRANULOCYTE-MONOCYTE COLONY STIMULATING FACTOR GAMMA-GLUTAMYL TRANSPEPTIDASE GENERAL PRACTITIONER GERMAN SOCIETY FOR PAEDIATRIC ONCOLOGY & HAEMATOLOGY HEART RATE INVESTIGATOR BROCHURE INFORMED CONSENT FORM INTERNATIONAL CONFERENCE ON HARMONISATION INVESTIGATIONAL MEDICINAL PRODUCT INTERNATIONAL NORMALISED RATIO INTERNATIONAL NEUROBLASTOMA RESPONSE CRITERIA INTERNATIONAL NEUROBLASTOMA RISK GROUP INTERNATIONAL NEUROBLASTOMA STAGING SYSTEM INSTITUTIONAL REVIEW BOARD INVESTIGATOR SITE FILE IRINOTECAN + TEMOZOLOMIDE ARM INNOVATIVE THERAPIES FOR CHILDREN WITH CANCER INTRAVENOUS O6-METHYGUANINE METHYLTRANSFERASE META-IODO-BENZYL-GUANIDINE MEDICINES AND HEALTHCARE PRODUCTS REGULATORY AGENCY MINIMAL RESIDUAL DISEASE MAGNETIC RESONANCE IMAGING MEMORIAL SLOAN KETTERING CANCER CENTRE MAXIMUM TOLERATED DOSE MYELOCYTOMATOSIS VIRAL RELATED ONCOGENE NEW AGENTS FOR NEUROBLASTOMA THERAPY NATIONAL COORDINATING INVESTIGATOR NATIONAL CO-SPONSOR NO RESPONSE OVERALL SURVIVAL OVER THE COUNTER PNEUMOCYSTIS CARNI PNEUMONITIS PROGRESSSIVE DISEASE PROGRESSION FREE SURVIVAL PAIRED-LIKE HOMEOBOX2B PRINCIPAL INVESTIGATOR PATIENT INFORMATION SHEET PHARMACOKINETICS POPULATION-MODELLING ANALYSIS POSTERIOR REVERSIBLE ENCEPHALOPATHY SYNDROME ORALLY PAEDIATRIC PRECLINICAL TESTING PROGRAM PARTIAL RESPONSE RESEARCH ETHICS COMMITTEE RESPONSE EVALUATION CRITERIA IN SOLID TUMOURS RIBONUCLEIC ACID BEACON-Neuroblastoma Protocol_vn 8.0_vd _07Mar2023 Page 15 of 157 BEACON-Neuroblastoma Trial Protocol RTKI RT-qPCR SAE SAR SCT SD SFOP SIOPEN SNP SPC SUSAR SWFI T TH TMA TMG TSC TTo TVD UAR UKCCSG ULN VTE VEGF VGPR WMA RECEPTOR TYROSINE KINASE INHIBITORS REVERSE TRANSCRIPTASE QUANTITATIVE POLYMERASE CHAIN REACTION SERIOUS ADVERSE EVENT SERIOUS ADVERSE REACTION STEM CELL TRANSPLANT STABLE DISEASE FRENCH SOCIETY OF PAEDIATRIC ONCOLOGY INTERNATIONAL SOCIETY PAEDIATRIC ONCOLOGY EUROPEAN NEUROBLASTOMA GROUP SINGLE NUCLEOTIDE POLYMORPHISM SUMMARY OF PRODUCT CHARACTERISTICS SUSPECTED UNEXPECTED SEVERE ADVERSE REACTION STERILE WATER FOR INJECTION TEMOZOLOMIDE ARM TYROSINE HYDROXYLASE TISSUE MICROARRAY TRIAL MANAGEMENT GROUP TRIAL STEERING COMMITTEE TEMOZOLOMIDE + TOPOTECAN ARM TOPOTECAN, VINCRISTINE & DOXORUBICIN UNEXPECTED ADVERSE REACTION UNITED KINGDOM CHILDREN’S CANCER STUDY GROUP UPPER LIMIT OF NORMAL VENOUS THROMBO-EMBOLISM VASCULAR ENDOTHELIAL GROWTH FACTOR VERY GOOD PARTIAL RESPONSE WORLD MEDICAL ASSOCIATION FORMULAE Mosteller formula: BSA (m²) = BEACON-Neuroblastoma Protocol_vn 8.0_vd _07Mar2023 Page 16 of 157 BEACON-Neuroblastoma Trial Protocol Table of Contents Trial Synopsis ...................................................................................................................................... 12 Title .................................................................................................................................................... 12 Trial Design ........................................................................................................................................ 12 Objectives .......................................................................................................................................... 12 Outcome Measures............................................................................................................................ 12 Patient Population .............................................................................................................................. 13 Sample Size ....................................................................................................................................... 13 Trial Duration...................................................................................................................................... 13 Abbreviations ..................................................................................................................................... 14 1. Background and Rationale ............................................................................................................. 22 1.1 Background............................................................................................................................ 22 1.1.1 Background for the dinutuximab beta amendment............................................................ 28 1.2 Trial Rational.......................................................................................................................... 29 1.2.1 Justification for design ....................................................................................................... 29 1.2.2 Rationale for patient population ......................................................................................... 30 1.2.3 Benefit-risk assessment .................................................................................................... 31 1.2.4 Rationale for the selected backbone schedules: Temozolomide, irinotecan + temozolomide and temozolomide + topotecan .............................................................................. 31 1.2.5 Rationale for dosing schedule of bevacizumab................................................................. 32 1.2.6 Rationale for evaluating chemo-immunotherapy in the BEACON-Neuroblastoma Trial... 32 1.2.7 Rationale for dosing schedule of dinutuximab beta........................................................... 33 1.2.8 Rationale for the use of biomarker studies ........................................................................ 34 1.3 Relevance and future importance ......................................................................................... 35 2. Objectives and Outcome Measures ............................................................................................. 36 2.1 Objectives .............................................................................................................................. 36 2.2 Outcome Measures ............................................................................................................... 37 3. Trial Design ..................................................................................................................................... 37 3.1 Randomisation....................................................................................................................... 37 3.2 Duration of treatment............................................................................................................. 38 3.3 Frequency and duration of follow-up ..................................................................................... 38 4. Eligibility.......................................................................................................................................... 39 4.1 Lifestyle guidelines ................................................................................................................ 39 5. Schedule of activities..................................................................................................................... 39 6. Screening and Consent ................................................................................................................. 40 6.1 Informed Consent .................................................................................................................. 40 6.2 Screening............................................................................................................................... 41 7. Trial Entry........................................................................................................................................ 42 7.1 Procedure for online patient randomisation........................................................................... 42 7.2 Emergency Randomisation ................................................................................................... 42 8. Treatment Details ........................................................................................................................... 43 8.1 Definition of Investigational Medicinal Products (IMPs) ........................................................ 43 9. Bevacizumab randomisation......................................................................................................... 43 9.1 Eligibility criteria for the bevacizumab randomisation............................................................ 43 9.1.1 Inclusion criteria for the bevacizumab randomisation ....................................................... 43 9.1.2 Exclusion criteria for the bevacizumab randomisation ...................................................... 44 9.2 Schedule of activities for the bevacizumab randomisation ................................................... 45 BEACON-Neuroblastoma Protocol_vn 8.0_vd _07Mar2023 Page 17 of 157 BEACON-Neuroblastoma Trial Protocol 9.3 Trial Therapy (bevacizumab randomisation) ......................................................................... 49 9.3.1 Bevacizumab randomisation trial treatment ...................................................................... 49 9.4 Treatment Schedule..................................................................................................................... 51 9.4.1 Day 1 of Cycle 1 ................................................................................................................ 51 9.4.2 Day 1 of subsequent cycles............................................................................................... 51 9.4.3 Post Cycle 6 (For patients continuing to Cycle 7-12) ........................................................ 52 9.4.4 End of Treatment ............................................................................................................... 52 9.4.5 Treatment Duration............................................................................................................ 52 9.5 Dose Modifications for the bevacizumab randomisation ....................................................... 53 9.5.1 Dose Modifications for AEs due to chemotherapy - for the bevacizumab randomisation. 56 9.5.2 Bevacizumab – Infusion-related Reaction/Infusional Site Extravasation Management Guidelines ...................................................................................................................................... 62 9.5.3 Bevacizumab - Treatment Delays ..................................................................................... 63 9.5.4 Bevacizumab - Discontinuation ........................................................................................ 64 9.5.5 Bevacizumab - Toxicity Management guidelines .............................................................. 65 9.6 Central Venous Access Device (CVAD)................................................................................ 67 10 Dinutuximab beta and topotecan randomisations...................................................................... 68 10.1 Eligibility for the dinutuximab beta randomisation ................................................................. 68 10.1.1 Inclusion criteria for the dinutuximab beta randomisation ............................................. 68 10.1.2 Exclusion criteria for the dinutuximab beta randomisation ............................................ 69 10.2 Schedule of events for the dinutuximab beta and topotecan randomisations....................... 70 10.3 Trial therapy (dinutuximab beta and topotecan randomisations) .......................................... 74 10.3.1 Dinutuximab beta and topotecan trial treatment................................................................ 75 10.4 Treatment Schedule .............................................................................................................. 76 10.4.1 Day 1 of Cycle 1 ............................................................................................................ 76 10.4.2 Day 1 of subsequent cycles........................................................................................... 76 10.4.3 Post Cycle 6 (For patients continuing to Cycle 7-12 on chemotherapy only) ............... 77 10.4.4 End of Treatment ........................................................................................................... 77 10.4.5 Treatment Duration............................................................................................................ 78 10.4.6 Cross-over ......................................................................................................................... 78 10.5 Dose Modifications – dinutuximab beta and topotecan randomisations ............................... 79 10.5.1 Dose modifications for dinutuximab beta specific toxicities .......................................... 79 10.5.2 Dose modifications for haematological toxicity.............................................................. 81 10.5.3 Dose modifications for hepatic toxicity .......................................................................... 82 11 Treatment Compliance................................................................................................................... 84 12 Supportive Treatment .................................................................................................................... 84 12.1 Nausea and Vomiting ............................................................................................................ 84 12.2 Growth Factors ...................................................................................................................... 84 12.3 Fever and neutropenia .......................................................................................................... 84 12.4 Blood products....................................................................................................................... 84 12.5 Pneumocystis jirovecii pneumonia (PJP) prophylaxis ........................................................... 84 12.6 Management of side effects caused by non-selective NSAIDs as cyclooxygenase (COX) type I and II inhibitors ......................................................................................................................... 84 12.7 Supportive care during Dinutuximab beta infusion................................................................ 85 12.7.1 Pain Management.......................................................................................................... 85 12.7.2 Prevention of dinutuximab beta related infusion reactions............................................ 86 13 Concomitant Medication................................................................................................................ 87 14 Assessments .................................................................................................................................. 87 BEACON-Neuroblastoma Protocol_vn 8.0_vd _07Mar2023 Page 18 of 157 BEACON-Neuroblastoma Trial Protocol 14.1 Response assessment .......................................................................................................... 88 15 Biomarkers...................................................................................................................................... 88 15.1 Blood sampling safety ........................................................................................................... 88 15.2 MRI-derived functional imaging biomarkers of angiogenesis................................................ 90 15.3 Molecular monitoring mRNA.................................................................................................. 90 15.4 Neuroblastoma exploratory biomarker analyses ................................................................... 90 15.5 Sample Collection.................................................................................................................. 92 15.5.1 Peripheral blood samples .............................................................................................. 92 15.5.2 Bone Marrow Samples .................................................................................................. 92 15.5.3 Archival tumour samples ............................................................................................... 92 16 Patient Follow Up ........................................................................................................................... 93 16.1 Patient Withdrawal................................................................................................................. 93 17 Pharmaceutical Information .......................................................................................................... 94 17.1 Definition of Investigational Medicinal Product ...................................................................... 94 17.2 Bevacizumab ......................................................................................................................... 94 17.2.1 Bevacizumab - Drug Supply .......................................................................................... 94 17.2.2 Bevacizumab - Ordering ............................................................................................... 94 17.2.3 Bevacizumab - Formulation, Packaging and Labelling ................................................. 94 17.2.4 Bevacizumab - Preparation and Dispensing ................................................................. 95 17.2.5 Compatibility information ............................................................................................... 95 17.2.6 Bevacizumab - Administration ....................................................................................... 95 17.2.7 Bevacizumab – Accountability....................................................................................... 96 17.2.8 Bevacizumab - Destruction............................................................................................ 96 17.3 Cyclophosphamide ................................................................................................................ 96 17.4 Dinutuximab beta................................................................................................................... 96 17.5 Irinotecan ............................................................................................................................... 96 17.5.1 Irinotecan - Drug Supply ............................................................................................... 96 17.5.2 Irinotecan - Formulation, Packaging and Labelling ....................................................... 96 17.5.3 Irinotecan - Preparation and Dispensing ....................................................................... 97 17.5.4 Compatibility information ............................................................................................... 97 17.5.5 Irinotecan - Administration ............................................................................................. 97 17.6 Temozolomide ....................................................................................................................... 97 17.6.1 Temozolomide – Drug Supply ....................................................................................... 97 17.6.2 Temozolomide - Formulation, Packaging and Labelling ............................................... 97 17.6.3 Temozolomide - Administration ..................................................................................... 97 17.7 Topotecan.............................................................................................................................. 98 17.7.1 Topotecan - Drug Supply.............................................................................................. 98 17.7.2 Topotecan - Formulation, Packaging and Labelling ..................................................... 98 17.7.3 Topotecan - Preparation and Dispensing ..................................................................... 98 17.7.4 Topotecan - Compatibility information ........................................................................... 98 17.7.5 Topotecan - Administration........................................................................................... 99 18 Adverse Event Reporting .............................................................................................................. 99 18.1 Reporting Requirements........................................................................................................ 99 18.1.1 Adverse Events (AE) ..................................................................................................... 99 18.1.2 AESIs of Bevacizumab .................................................................................................. 99 18.1.3 Serious Adverse Advents (SAE).................................................................................... 99 18.1.4 Reporting period .......................................................................................................... 100 18.2 Reporting Procedure ........................................................................................................... 100 BEACON-Neuroblastoma Protocol_vn 8.0_vd _07Mar2023 Page 19 of 157 BEACON-Neuroblastoma Trial Protocol 18.2.1 Site............................................................................................................................... 100 18.2.2 Trial Office ................................................................................................................... 102 18.2.3 Reporting to the Competent Authority and main Research Ethics Committee ........... 102 18.2.4 Investigators ................................................................................................................ 102 18.2.5 Data Monitoring Committee ......................................................................................... 102 18.2.6 Manufacturer of Investigational Medicinal Product...................................................... 102 19 Data Handling and Record Keeping ........................................................................................... 103 19.1 Data Collection .................................................................................................................... 103 19.2 Archiving .............................................................................................................................. 103 20 Quality Management .................................................................................................................... 103 20.1 Site Set-up and Initiation ..................................................................................................... 103 20.2 On-site Monitoring ............................................................................................................... 104 20.3 Central Monitoring ............................................................................................................... 104 20.4 Audit and Inspection ............................................................................................................ 104 20.5 Notification of Serious Breaches ......................................................................................... 104 21 End of Trial Definition .................................................................................................................. 105 22 Statistical Considerations ........................................................................................................... 105 22.1 Trial Design.......................................................................................................................... 105 22.2 Definition of Outcome Measures ......................................................................................... 106 22.2.1 Primary ........................................................................................................................ 106 22.2.2 Secondary.................................................................................................................... 106 22.2.3 Exploratory/Tertiary ..................................................................................................... 106 22.3 Sample Size......................................................................................................................... 106 22.4 Interim and Main Analyses of Outcome Measures.............................................................. 108 22.4.1 Planned Interim Analyses ............................................................................................ 108 22.4.2 Main Analysis............................................................................................................... 108 22.5 Stopping Guidelines ............................................................................................................ 110 23 Trial Organisational Structure..................................................................................................... 110 23.1 Coordinating Sponsor .......................................................................................................... 110 23.2 Co-Sponsor Centres ........................................................................................................... 110 23.3 Relationship of trial committees........................................................................................... 112 23.4 Trial Management Group..................................................................................................... 112 23.5 Trial Steering Committee ..................................................................................................... 112 23.6 Data Monitoring Committee................................................................................................. 112 23.7 Finance ................................................................................................................................ 113 23.8 NIHR CRN Portfolio ............................................................................................................. 113 24 Ethical Considerations ................................................................................................................ 113 25 Confidentiality and Data Protection ........................................................................................... 114 26 Insurance and Indemnity ............................................................................................................. 115 27 Publication Policy ........................................................................................................................ 116 28 Reference List............................................................................................................................... 117 Appendix 1 – WMA Declaration of Helsinki .................................................................................... 124 Appendix 2 - Definition of Adverse Events ..................................................................................... 127 Appendix 3 - Common Toxicity Criteria Grading ........................................................................... 129 Appendix 4 – RECIST Criteria 1.1 .................................................................................................... 130 Appendix 5 – Tumor Response at Metastatic Soft Tissue and Bone Sites (Park et al. 2017) ... 133 Appendix 6 - CURIE & SIOPEN scoring methods for neuroblastoma ......................................... 134 Appendix 7 – Temozolomide Dosing............................................................................................... 136 BEACON-Neuroblastoma Protocol_vn 8.0_vd _07Mar2023 Page 20 of 157 BEACON-Neuroblastoma Trial Protocol Appendix 8 – Blood Pressure Levels by Age and Height Percentile for Children and Adolescents ....................................................................................................................................... 139 Appendix 9 – Height for Age Chart - Girls ...................................................................................... 144 Appendix 10 – Height for Age Chart - Boys.................................................................................... 149 Appendix 11 – Lansky and Karnofsky/ECOG Scales .................................................................... 154 Appendix 12 – Tanner Staging ......................................................................................................... 156 Appendix 13 – Clinical studies of anti-GD2 therapies in combination with chemotherapy ...... 157 LIST OF TABLES Table 1 - Second line chemotherapy regimens tested in phase II in relapsed or refractory neuroblastoma since 2000 ..........
Url: /Media/UHS-website-2019/Docs/PaediatricOncology/beacon-protocol-v8.0-07mar2023-signed.pdf

UHS adult major trauma guidelines

Description: Adult Major Trauma Guidelines University Hospital Southampton NHS Foundation Trust Dr Mark Baxter Director of Major Trauma, Consultant in Older Persons Medicine Prof Rob Crouch Deputy Director of Major Trauma, Consultant Nurse in Emergency Medicine Emma Bowyer Major Trauma Centre and Wessex Trauma Network Manager Amendment’s log No. Amendments 1. Update Wessex Trauma Network Automatic acceptance tool 2. Hyperlinks added from contents page Page No. 22 4 3. Updated Guideline on the management of chest 107 injuries and chest decompression 4. Burns Operational Guidance added 55 5. Adult Major Trauma: Prophylactic Antibiotics guideline 81 Flowchart added to section 3 6. Adult Major Trauma; Prophylactic Antibiotic guideline 124 added to section 4 Date Sept 2021 Oct 2021 (v7.1) Apr 2022 (v7.2) Apr 2022 (v7.2) May 2022 (v7.3) May 2022 (v7.3) 2 NOTE: These guidelines are regularly updated. Check the intranet for the latest version. DO NOT PRINT HARD COPIES Please note these Major Trauma Guidelines are for UHS Adult Major Trauma Patients. The Wessex Children’s Major Trauma Guidelines may be found at http://staffnet/TrustDocsMedia/DocsForAllStaff/Clinical/WessexChildre nsMajorTraumaGuideline/WessexChildrensMajorTraumaGuidelines.pdf NOTE: If you are concerned about a patient under the age of 16 please contact SORT (02380 775502) who will give valuable clinical advice and assistance by phone to the Trauma Unit and coordinate any transfer required. http://www.sort.nhs.uk/home.aspx Please note current versions of individual University Hospital Southampton Major Trauma guidelines can be found by following the link below. http://staffnet/TrustDocuments/Departmentanddivisionspecificdocuments/Major-trauma-centre/Major-trauma-centre.aspx 3 Table of Contents (Hyperlinked) 1 SECTION 1: PREPARATION FOR MAJOR TRAUMA ADMISSIONS ................................................................................ 7 1.1 PRE-HOSPITAL TRIAGE & TRAUMA UNIT BYPASS TOOL ............................................................................................................ 7 1.2 ATMIST....................................................................................................................................................................... 10 1.3 ADULT MAJOR TRAUMA TEAM ACTIVATION ........................................................................................................................ 11 1.4 ADULT MAJOR TRAUMA TEAM COMPOSITION ..................................................................................................................... 12 1.5 RESPONSIBILITIES & ROLES OF TRAUMA TEAM MEMBERS ...................................................................................................... 13 1.6 HANDS-OFF HANDOVER................................................................................................................................................... 19 1.7 TRAUMA TEAM LEADER: EXECUTIVE ROLE ........................................................................................................................... 20 1.8 SITE MANAGER .............................................................................................................................................................. 21 1.9 SECONDARY TRAUMA TRANSFERS ...................................................................................................................................... 22 2 SECTION 2: TRAUMA RESUSCITATION ( ABCDE) ................................................................................................. 25 2.1 CATASTROPHIC HAEMORRHAGE......................................................................................................................................... 25 2.2 AIRWAY ........................................................................................................................................................................ 35 2.3 BREATHING ................................................................................................................................................................... 38 2.4 CIRCULATION ................................................................................................................................................................. 41 2.5 DISABILITY..................................................................................................................................................................... 46 2.6 EXPOSURE & ENVIRONMENT ............................................................................................................................................ 54 2.7 TRAUMA IMAGING.......................................................................................................................................................... 55 2.8 BURNS – OPERATIONAL GUIDANCE .................................................................................................................................... 56 2.9 ADMISSION DESTINATION ................................................................................................................................................ 57 3 TRAUMA RESUSCITATION SUPPORTING DOCUMENTS............................................................................................ 58 3.1 APPLICATION OF CELOXTM GAUZE .................................................................................................................................... 58 3.2 BELMONT RAPID INFUSER ................................................................................................................................................ 59 3.3 RESUSCITATIVE THORACOTOMY......................................................................................................................................... 60 3.4 MAJOR TRAUMA AIRWAY ALGORITHM ............................................................................................................................... 63 3.5 FRONT OF NECK ACCESS PROCEDURE ................................................................................................................................. 65 3.6 PRE-RSI CHECKLIST......................................................................................................................................................... 66 3.7 IMMEDIATE RSI CHECKLIST............................................................................................................................................... 67 3.8 TRAUMA BAY CHECKLIST.................................................................................................................................................. 68 3.9 RSI PACK LIST ................................................................................................................................................................ 71 3.10 RIB FRACTURE PATHWAY ................................................................................................................................................. 73 3.11 SCOOP STRETCHERS ........................................................................................................................................................ 77 3.12 MAJOR TRAUMA CT HOT REPORT ..................................................................................................................................... 79 3.13 ADULT MAJOR TRAUMA: PROPHYLACTIC ANTIBIOTICS GUIDELINE - FLOWCHART ......................................................................... 81 4 STANDARD OPERATING PROCEDURES .................................................................................................................... 83 4.1 UHS MANAGEMENT OF EXTREMITY BLEEDING & TOURNIQUET SOP........................................................................................ 83 4.2 UHS MAJOR HAEMORRHAGE PROTOCOL............................................................................................................................ 92 4.3 UHS GUIDELINE FOR THE MANAGEMENT OF CHEST INJURIES AND CHEST DECOMPRESSION IN ADULT MAJOR TRAUMA ................... 107 4.3.1 Executive Summary ........................................................................................................................................ 107 4.3.2 Introduction.................................................................................................................................................... 108 4.3.3 Scope .............................................................................................................................................................. 108 4.3.4 Aim/purpose................................................................................................................................................... 108 4.3.5 Definitions ...................................................................................................................................................... 109 4.3.6 Guideline for the management chest injuries and chest decompression in Adult Major Trauma ................. 109 4.3.7 Implementation.............................................................................................................................................. 112 4.3.8 Roles and responsibilities ............................................................................................................................... 112 4.3.9 Document review ........................................................................................................................................... 112 4.3.10 Process for monitoring compliance ........................................................................................................... 112 4.3.11 Appendices ................................................................................................................................................ 113 4.3.12 References ................................................................................................................................................. 113 4.4 UHS MAJOR TRAUMA TEAM SOP................................................................................................................................... 114 4.5 ADULT MAJOR TRAUMA: PROPHYLACTIC ANTIBIOTIC GUIDELINE............................................................................................ 124 4.5.1 Version control ............................................................................................................................................... 124 4 4.5.2 4.5.3 4.5.4 4.5.5 4.5.6 4.5.7 4.5.8 4.5.9 4.5.10 4.5.11 4.5.12 4.5.13 Index............................................................................................................................................................... 125 Introduction.................................................................................................................................................... 126 Scope .............................................................................................................................................................. 126 Aim/purpose................................................................................................................................................... 126 Definitions (if necessary) ................................................................................................................................ 126 Adult Major Trauma Antibiotic Flowchart ..................................................................................................... 127 Implementation.............................................................................................................................................. 128 Roles and responsibilities ............................................................................................................................... 128 Document review....................................................................................................................................... 128 Process for monitoring compliance ........................................................................................................... 129 Appendices ................................................................................................................................................ 129 References ................................................................................................................................................. 129 5 Introduction ‘These guidelines are the current policies and practice for the management of adult major trauma patients at University Hospital Southampton. They have been designed to provide a day to day framework for the management of patients; including the roles and responsibilities of clinical teams and their members. The guidelines were produced to try and ensure timely, consistent, high-quality care for all patients whatever day or time of day they present, recognising that these are challenging and often stressful cases. There will be situations when it is appropriate to deviate from the guidelines or where the guidelines do not cover the specific circumstances. In these cases it is essential that care of the patient is the foremost consideration, that senior staff are directly involved and that documentation is clear. If in doubt, seek senior advice and document their involvement. This second edition of the guidelines reflects the changes in practice in major trauma over the last 6 years together with changing national guidance and policy. My personal thanks to all members of the clinical and support teams who have contributed to the development of excellent practice at UHS and who have contributed to this revision. Thanks in particular to Dr Liz Shewry and Dr Simon Hughes, who begun these revisions and to Major Alan Weir who continued with this unenviable task. In addition, this second edition would not be possible without such a comprehensive first edition. Thanks for the first edition go to Dr Andy Eynon, Dr Liz Shewry and Dr Simon Hughes, who authored the first edition of these guidelines in 2012. The first edition has guided Major Trauma Care across Wessex and further afield for nearly a decade.’ Dr. Mark Baxter Director of Major Trauma, University Hospital Southampton, 6 1 Section 1: Preparation for Major Trauma Admissions 1.1 Pre-hospital Triage & Trauma Unit Bypass Tool The pre-hospital triage & trauma unit bypass tool was developed by the Wessex Trauma Network (WTN) to identify patients who have or are at high risk of having sustained major trauma. Patients who are within a 60 minute travel time of UHS may be transferred direct to UHS as the Major Trauma Centre (MTC), bypassing hospitals closer to the scene of the accident. The rationale for this is that it is time to definitive treatment rather than time to arrival in hospital that makes the biggest difference in outcomes. UHS was chosen as the MTC as it has all major trauma services on site. The pre-hospital team (Ambulance Service, BASICS, HIOWAA) will alert the ED that a patient with major trauma is en route. It is expected that a basic ATMIST (see p9) handover will be received with details of the mode and likely time of arrival of the patient. Patients who are outside a 60 minute travel time or who are deemed to be at risk of imminent airway compromise or have catastrophic haemorrhage will go initially to their nearest trauma unit (TU) for resuscitation. Once resuscitated, if the TU feel that the patient’s injuries are beyond their local facilities, the patient will be transferred on to either the MTC or another TU with specialist facilities (see Section 1.09 Secondary Trauma Transfers, p22). Certain hospitals have been designated as local receiving hospitals (LRH) by the Wessex Trauma Network. Trauma patients will only go to these hospitals if there is an imminent cardiac arrest or immediate airway problem. Patients will be expected to have only these immediate life-threatening conditions controlled before onward transfer to a TU or MTC. 7 8 Figure 1. Trauma Triage Tool (2021) 9 1.2 ATMIST Ambulance services, including the air ambulance service, are using the ATMIST handover tool. This gives basic information to enable preparations to be made to receive the patients. The sticker below is completed by the team leader and then it is stuck into the trauma booklet on arrival in ED resus. Figure 2. Pre-hospital alert ATMIST sheet 10 1.3 Adult Major Trauma Team Activation A two-tier response to trauma has been developed at UHS. A full trauma team response (Level 1 trauma call) should be instigated by the ED Consultant where a patient triggers a pre-hospital major trauma call and there is concern by the ED team that a full trauma team response is required. For less severe trauma it may be appropriate to activate the ED trauma team alone (Level 2 trauma call), which can be escalated if more significant injury is found. Criteria for activating a Level 1 trauma call (Figure 3) are based on physiology, anatomical injury, and mechanism of injury, however, this is not an exhaustive list and full trauma team activation is at the discretion of the receiving clinicians. To activate a Level 1 trauma call, contact Switchboard on 2222 and request “Adult Trauma Team, ED Resus” Physiological Respiratory rate 29 Or Pre hospital Sp02 o 110 GCS Motor Score of 4 or less Or Pre- hospital GCS of 1 fractured long bone Suspected major pelvic injury Trauma Triage Tool Activation (Trauma Unit Bypass) Other Considerations Pre-hospital intubation (Mandates Level 1 Call) Senior Clinician Concern (including mechanism) Gunshot wounds, stabbing, impaling Falls > 6 metres High impact RTC (Ejection, death of vehicle occupant, pedestrian struck by vehicle > 30mph) For the ≥ 65 age group consider • Systolic BP of ≤ 110 mmgHg • Heart Rate of ≥ 100 bpm • Fall with GCS of ≤ 12 • Taking Anticoagulants • Co-morbidities; Liver disease, renal failure, heart failure, COPD Figure 3. Criteria for Level 1 Trauma Response (December 2020) 11 1.4 Adult Major Trauma Team Composition Level 2 Trauma Team ED Consultant or ED ST4+ ED Doctor/ACP ED Nurse in charge ED Nurse x 2 HCA Level 1 Trauma Team Level 2 Trauma Team Members plus: ED Consultant Trauma Orthopaedic Consultant Major Trauma Anaesthetist Named Anaesthetist (Day) GICU SpR ODP / tech General Surgery SpR / Cons Orthopaedic Surgery SpR Site manager (if helipad arrival) Radiographer Major Trauma Clinical Coordinator (Daytime) bleep 1780 (Daytime) bleep 1783 bleep 1646 bleep 2110 bleep 1784 bleep 9990 bleep 2702 bleep 2238 bleep 1781 bleep 1963 There is agreement that the Neurosurgical SpR (bleep 2877) and Cardiothoracic SpR (bleep 9211) will not be part of unselected Level 1 calls. They may be contacted at the discretion of the Trauma Team if the pre-alert suggests their presence may be of benefit. Other specialists (eg ENT and MaxFax) may be contacted in a similar fashion. 12 1.5 Responsibilities & Roles of Trauma Team Members On receiving a major trauma alert, all members of the major trauma team should assemble in the ED Resus area to be briefed on the nature of the patient expected. This information should be written on a board or flipchart for the team to view throughout the trauma call. The Trauma Team Leader (TTL) will lead a team briefing and allocate roles in advance of the patient’s arrival. If a member of the team cannot attend within the given timeframe they should notify the ED immediately (x3807). If a specialty SpR cannot attend, the duty specialty Consultant must be informed and attend. CT CT should be informed that a potential major trauma patient will be arriving so that the scanner can be cleared and be on stand-by to perform a trauma series CT. The default emergency CT is the C level scanner adjacent to the ED (x6108 / x4999). Transfer equipment should be made ready in the expectation that the patient will be moving from resus to CT. Trauma mattresses are NOT to be used for Level 1 trauma cases. They should managed in the initial resuscitation phase on scoop, and transferred to CT/ Theatre / ITU on this scoop. If the patient remains in ED for a period of time following resuscitation then they may be transferred to a trauma mattress at this point. There is an agreed protocol for requesting a trauma series CT +/- limb angiography. The request is made electronically and then a single telephone call is made to the CT Radiographer to inform them of the request. The CT Radiographer will then inform the duty Radiology SpR who will approve request and provide the Hot Report to the trauma team. Major Haemorrhage (Code Red) If the pre-hospital information suggests that the patient has severe, life-threatening haemorrhage a ‘CODE RED’ should be called. This facilitates prompt requests for blood products from Blood Bank and allows the major trauma team to make adequate preparations for management e.g. preparation of tourniquet, preparation of rapid infuser. There is an allocated ‘Code Red Nurse’ for every shift. They should be identified when the trauma team assembles and if required prime the rapid infuser. A team of two is required for effective major haemorrhage management – a transfusion assist will be allocated to work with the ‘Code Red Nurse’ from the ED team. Consider allocation of ‘T’ (Transfusion) number for patients who have Code Red declared prehospital. A number of patient note folders and ‘T’ numbers have been pre-assigned. Blood Bank must be informed if a ‘T’ number is used, and they can issue FFP using a ‘T’ number. If a 13 ‘T’ number has already been allocated by HIOWAA then this must continue to be used on arrival at UHS. Most of the Air Ambulances carry blood for prehospital use. If HIOWAA has given blood please inform blood bank before their arrival as the Air Ambulance will need restocking. Helicopter Transfers If the patient is being transferred by helicopter, switchboard will be informed and asked to alert the helipad team (Site Manager, Portering staff). The Trauma Team is far more effective looking after major trauma patients in ED Resus rather than on the Helipad. Therefore, the priority is to transfer the patient from the Helipad to Resus before Hospital resuscitation commences. NOTE: Aside from the helipad team, no members of UHS staff are to attend the helipad even if the patient is critical 14 Trauma Team Roles Trauma Team Leader • Controls and manages the trauma team resuscitation • Makes decisions in conjunction with specialists • Priorities investigations and treatments • Is responsible for the handover and transfer • Undertakes the trauma transfer checklist, prior to departure from ED Before patient arrival • Ensures trauma team activated (consider additional specialties andseniority) • Liaises with Scribe • Ensures team members are booked in with Scribe • Introductions and roles assigned • Activates Code Red (if required). Consider plain film (CXR/PXR) if toounstable for CT • Ensures tranexamic acid is available • Briefs team. Rehearse emergency plan • Ensures Airway Assistant has started clock on patient arrival NOTE: It is imperative that the Trauma Team Leader maintains control and insists on MINIMUM noise from the Trauma Team members NOTE: The Team Leader will read aloud the Checklist for actions prior to leaving ED – the main indication for this is transfer to the CT Scanner. 15 Anaesthetist • Ensures equipment and anaesthetic drugs (Blue/Red CD pack and yellow fridge Pack) are available on patients arrival • Verbalises airway and anaesthetic plan to team leader and airway assistant • Communicates airway patency and issues to team leader and scribe on arrival • Communicates with team leader airway decision making following assessment. Ensure cervical spine immobilisation • Assess pupil size and reactivity • If indicated, RSI and ongoing sedation and ventilation • Provide ongoing assessment of GCS. Reassures patient on arrival, takes AMPLE history: A- Allergies M- Medications P- Past medical history L- Last meal E- Everything else relevant • Ensures neuro protective measures are undertaken for significant head injuries (30 degree trolley tilt, sedation, muscle relaxation, avoid tube ties and tight cspinecollar, avoid hypercapnia) • Arterial lines are rarely indicated. To avoid delay to CT this can usually be done after CT or in the operating theatre • Ensures theatres are informed as appropriate (bleep 2894 or named consultanton 1646) • Ensures CD book is signed NOTE: Insertion of invasive lines should not delay transfer to CT or theatre Airway Assistant • Completes airway check list prior to patients arrival and that difficultairway trolley is accessible if required (ask if c-mac is required) • Ensures Blue/ Red CD pack and yellow fridge pack are readily available with appropriate anaesthetic drugs drawn up in conjunctionwith Anaesthetist • Confirm airway plan • Start the clock on patient arrival • May assist with removing patients clothing, have scissors to hand • Assists anaesthetist in all airway interventions • Ensure time of intubation is recorded by scribe • Takes emergency airway equipment / drugs on any transfer(CT, Theatre, ICU) • Assists in the preparation patient for transfer to CT/theatres ASAP • Ensures CD book is signed 16 Primary Survey • Undertakes primary survey ABCDE. Clearly states findingsto Team leader and scribe • Performs procedures depending on skill levels and training. Confirmsskill level with team leader prior to patient arrival • If thoracostomies are present, re-finger to ensure patency.Is lung up or down? Delegate opposite side, if necessary • FAST scan if accredited and does not delay CT • Neurological exam needed before paralysing anaesthetic agent given • Ensure patient is kept warm • Ensures CT notified. Where indicated convey urgency of completingthe CT. Order any other radiology in discussion with the team leader,should this be appropriate Circulation • Ensures patient has two patent peripheral lines in situ (IV/IO • Ensures bloods are taken: FBC U&E LFT Crossmatch Coagulation Screen Venous Gases • Requests bloods and ensures these are sent to the lab • Performs procedures depending on skill levels and training. Confirms skill level with team leader prior to patient arrival • Administer drugs in conjunction with Drugs role • Undertakes secondary survey • Ensure patient is kept warm Monitoring/Packaging • Prepares for trauma call with warming devices • Removes all patient clothes including underwear and stored securely • Checks that all monitoring equipment is available • Connects patient monitoring on arrival • Ensures Bair Hugger / blankets are covering patient at all time • Ensures temperature is taken • Prepares patient for transfer to CT/theatres ASAP • Checks transfer stack as per the checklist • Helps with any procedures as identified e.g. catheter, chest drainand ART line 17 Drugs • Manages any external major haemorrhage if present on arrival • Assists Monitoring/Packaging with clothes removal • Liaise with Airway specialist and airway assistant to support a promptanaesthetic if required • Draws up drugs and administers them as prescribed • Helps with getting IV/IO access in conjunction with Circulation • Helps with any procedures as identified e.g. catheter, chest drainand ART line • Assists Monitoring/Packaging to prepare for transfer Scribe • Ensures correct PPE and identification worn • Use ED documentation • Records names, grades and specialities of all clinical staff attending plus time of arrival • Ensures clock is started when patient arrives • Records primary survey findings • Records all observations (including time of intubation). • Records all findings and interventions • Ensures wrist bands are applied including allergy • Observe for abnormal observation and signs indicatingpotential reactions to blood products Relative Liaison • Identify any relatives on their arrival to the department and take tothe relatives room • Ensure that relatives are kept up to date with information,where possible • To assist medical team in the delivery of patient updates and to stay with the family for further questions • If CPR is in progress discuss with team leader regarding witnessedresuscitation and if suitable offer to the relatives • Where appropriate accompany the relatives/important others to the area where the patient is to be care for next (or make sure theyare escorted) • If relatives/important others are not present whilst the patient is in theED resus room – ensure that a named individual is responsible for greeting them and passing on the necessary information 18 Code Red Prior to Arrival • Inform transfusion of code red being called and ask for MajorHaemorrhage Pack 1 • Ensure you are wearing the correct PPE and designated label • Remove x2 units of Emergency blood and scan into BloodTrak On Patient Arrival • Ensure blood products have been prescribed on the transfusion chart • Contact transfusion if major haemorrhage pack 2 is required andinform them of the requirements • Ensure the transfusion are aware of the patients destination andwhere further blood products are required to be sent Code Red Infuser Prior to Arrival • Ensure you are wearing the correct PPE and designated label • If appropriate prime the Belmont ready to infuse • Ensure Tranexamic acid 1g is available and consider second dose in massive haemorrhage On Patient Arrival • Administer blood products, under the direction of the team leaderas per the trust policy • Inform team leader when boluses have been delivered • Monitors compliance with 1:1 transfusion ratio (RBC:FFP) • Ensure the scribe has documented the number of boluses administered Code Red HCA Prior to Arrival • Ensure you are wearing the correct PPE and designated label On Patient Arrival • Takes crossmatch blood sample directly to the lab & waits for the Major haemorrhage pack 1 and bring back to ED resuscitation room • Brings blood products to ED resuscitation room and scans unitson arrival 1.6 Hands-off Handover Generally unless CPR is in progress, or there is airway compromise or concern over catastrophic haemorrhage, an ATMIST handover will be given by the ambulance staff whilst UHS staff stand-off the patient. The trauma team leader will first ask where the pre-hospital team are happy to give a 'hands off handover'. Ambulance staff assisted by UHS staff will transfer the patient from the stretcher to the trolley in resus. Patients should remain on the scoop-stretcher. 19 The ATMIST handover should be completed within 30 seconds and is designed to give ALL members of the trauma team the information necessary to proceed with the immediate care of the patient. Further information regarding the patient can be relayed to the Trauma team leader following the ATMIST handover. 1.7 Trauma Team Leader: Executive Role The ED Consultant has authority from the Chief Executive and Medical Director to request any specialty Consultant to attend. All UHS Consultants have a statutory duty to be able to respond in an emergency within 30 minutes of request. The Trauma Team Leader will: • Determine and arrange the appropriate destination for the patient i.e. theatre, ICU, ward • Ensure that medical staff of the appropriate seniority are involved in the care of the patient • Ensure that only essential imaging is performed • Ensure that necessary documentation has been completed a. Major trauma activation b. Trauma team attendance (including time of arrival and grade of doctor) c. The extent of examination performed in the ED and whether a further secondary examination is required d. The secondary survey must be signed off as complete at the earliest opportunity. The team leader is responsible for ensuring the survey is performed and documented. The default specialty to complete the secondary survey is the T&O Doctor e. Ensure spinal precautions are applied throughout where indicated f. Ensure that handover of a multi-trauma patient to a specialty service is formally documented. Until this has occurred, the patient will remain under the care of the Trauma Team Leader g. Handover between the Trauma Team Leader and the receiving team Doctor should always be done in person with a written handover of all admissions and any necessary actions NOTE: The MTC Consultant or Trauma Team Leader must always attend the CT scanner and liaise with the Anaesthetist as to the patient’s injuries and planned destination after CT. In exceptional circumstances the TTL can delegate escorting the patient to CT to an appropriately senior Doctor from outside ED – e.g. the T&O Consultant. Their principal role is not to guide resuscitation (typically this will be performed by the anaesthetist) but to ensure prompt liaison with other teams (e.g. Neurosurgery) as required. 20 1.8 Site Manager It is essential that patients can move as swiftly as possible from the ED to their place of definitive care. Patients may require immediate theatre / ICU bed / ward bed. Patients requiring immediate theatre: • Coordination of theatre will be done by the TTL with the Named Anaesthetic Consultant • Patients with isolated head / spinal cord injury requiring immediate theatre should be managed in the appropriate specialist theatre • The duty Anaesthetic Consultant will be responsible for coordinating the ongoing resuscitation NOTE: F Level Theatres recovery can be used for patients requiring ongoing resuscitation after CT whilst theatre is being prepared. Patient requiring ICU bed In principle, patients with a primary neurological diagnosis (head or spinal cord injury) should be managed on Neuro ICU with the proviso that there are very limited resuscitation facilities available in the Wessex Neurological Centre. As such, patients with ongoing resuscitation needs or with significant cardiovascular injury are best managed initially on General ICU. Patient requiring Ward bed Patients with single system injury are best managed on wards with experience of managing that injury. Patients with multi-system injury requiring a ward bed should by default go to the Major Trauma Ward (F1). Patients with isolated thoracic injuries will be admitted to the thoracic ward under the care of Thoracic surgery. NOTE: The Trauma & Orthopaedics Consultant is responsible for polytrauma patients where there is no clear single specialty. 21 1.9 Secondary Trauma Transfers The secondary transfer tool has been developed by the Wessex Trauma Network to ensure that patients with certain categories of major injury, who are managed initially in a trauma unit or local receiving hospital, are rapidly transferred to the Major Trauma Centre without delay. The categories of patient to which this applies are: a. Injuries exceed Trauma Unit capabilities b. Pre intubation GCS Motor Score 4 or Less AND evidence from CT of intracranial bleeding (any variant) c. Life threatening haemorrhage not amenable to control at Trauma Unit d. Successful resuscitative thoracotomy at Trauma Unit These patients fulfill automatic acceptance criteria for transfer to the MTC. At the Trauma Unit the senior doctor will call the Ambulance Service and state that they have a “Time Critical Trauma Transfer”. The Trauma Unit Team Leader will then inform the Major Trauma Centre via the red phone in the Emergency Department and state that there is a “Secondary Trauma Transfer”. When prompted the Trauma Team Leader will give an extended ATMIST summary of patient. • NOTE: Do not negotiate terms of admission to UHS with the Trauma Unit. The transfer tool has been specifically written to ensure automatic acceptance by the MTC. The phone call from the Trauma Unit is purely to alert the MTC rather than to seek permission for the transfer. NOTE: Any paediatric secondary transfer referrals must go via SORT (02380 775502) who will not only coordinate the transfer but also give valuable clinical advice and assistance by phone to the Trauma Unit. http://www.sort.nhs.uk/home.aspx 22 Figure 4. Major Trauma Automatic Acceptance Tool (2020) 23 After receiving a secondary trauma transfer pre-alert, the optimum response is to activate a full Level 1 Trauma Call when the patient arrives. It is expected that these patients will have a management plan in place before arrival at UHS and should move swiftly from ED to their destination. Secondary Transfer due to Pre-intubation Motor Score 4 or less • Contact Neurosurgery SpR and Site Manager • Obtain plan from Neurosurgery – Critical Care bed or direct to Theatre • Site manager to arrange Level 3 Bed - Preference NICU > GICU > CICU • Site Manager to discuss with NICU Consultant regarding patient moves if NICU is full • Site Manager to ensure relevant ICU resident medical team and Neurosurgical registrar aware of location of bed if going direct to ICU Secondary Transfer due to Life Threatening Haemorrhage • When Trauma Team arrive, brief that this is a secondary transfer, review imaging with relevant teams and plan for patient’s arrival. This may include activating Theatre or Interventional Radiology teams • Patient will go to ED Resus on arrival unless exact cause of haemorrhage known and time to prepare theatre/Interventional Radiology prior to arrival • Any decision to Bypass ED Resus is only to be made by a Consultant Team Leader Secondary Transfer due to Successful Resuscitative Thoracotomy • Inform Cardiothoracic SpR (Bleep 9211) and Site Manager • Cardiothoracic team should prepare to receive patient in Theatre. Cardiothoracic SpR to inform Consultant, activate theatres and Anaesthetist/ Perfusionist • Site manager to arrange Level 3 Bed, preference Cardiac > General > Neuro • The initial destination in UHS, ED Resus versus cardiac/thoracic theatres may need to be decided on a case by case basis by the TTL. 24 2 Section 2: Trauma Resuscitation ( ABCDE) 2.1 Catastrophic Haemorrhage Recognition and management of catastrophic haemorrhage is the first priority in trauma resuscitation. Catastrophic haemorrhage is poorly defined and simply describes bleeding that is imminently life threatening. Major haemorrhage is variously defined as: • Loss of more than one blood volume in 24 hours • Loss of 50% total blood volume in less than 3 hours • Bleeding in excess of 150ml/min A clinical based approach to defining major haemorrhage is any bleeding which results in a systolic BP 110 bpm. Pre-hospital management focuses primarily on the prevention of further blood loss and the active management of hypothermia and hypoperfusion to prevent Trauma Induced Coagulopathy (TIC). • Tranexamic Acid (TXA) should be given within three hours of injury • Minimal non-haematological fluids should be administered to maintain a central pulse • Blood is available in the pre-hospital setting via HEMS and the Air Ambulances • Tourniquets may be applied in the pre-hospital setting for the management of catastrophic limb haemorrhage 25 Non-torso Catastrophic Haemorrhage Figure 5. Management of Non-torso Catastrophic Haemorrhage 1. Direct signs of vascular injury – pulsatile haemorrhage, expanding haematoma, absence of pulse / ischaemic limb, bruit, palpable thrill, Indirect signs of vascular injury – observed pulsatile bleeding, decreased pulse, nonexpanding haematoma, injury to adjacent nerve, anatomical location of injury near vessel 2. Vascular surgery input should be obtained prior to any imaging if there are direct signs of vascular injury. This can be via the registrar bleep (1322) between 0800 and 1900 and via switch for the on-call consultant after 1900. 3. CT angiography should be undertaken in all cases of suspected vascular injury unless a. There is active haemorrhage b. There is a tourniquet in situ c. Management of other injuries have taken precedence over a controlled vascular injury Discussion with vascular surgery should follow if there is injury to a named vessel which requires surgical management i. Isolated vascular injuries at or distant to the antecubital fossa (ACF) should be referred to Plastic Surgery at Salisbury District Hospital ii. Polytrauma patients with vascular injury at or distant to the ACF should be discussed with Plastic Surgery at UHS 8am – 6pm seven days a week; 6pm – 8am seven days a week these cases should be discussed with Plastic Surgery at Salisbury 4. Pressure should be applied for at least 10 minutes but ideally 20 directly over the wound using sterile gauze. If the bleeding clearly has no prospect of being controlled in the context of a junctional injury then proceed immediately to theatre 5. CeloxTM gauze (Section 4.1) 26 6. Trauma team to transfer patient to theatre for ongoing resuscitation Tourniquets Tourniquets may be required to control life threatening limb haemorrhage. The Wessex Major Trauma Network has an agreed SOP for the use of tourniquets in the pre-hospital and hospital setting (Section 5.1). Apply direct pressure and elevate Apply haemostatic dressing and blast / Oleas bandage and keep direct No pressure on for 5 minutes Successful? Yes Successful? No Observe wound closely for Yes recurrence of bleeding and continue assessment of the patient Apply Tourniquet 5cm proximal to the bleeding wound, if pneumatic, inflate up to 180mmhg – 200mmhg Time tourniquet applied indicated on the label if available. Clearly document in the patient record the time and application of the tourniquet Refer to TUB tool and transfer appropriately Pre alert receiving hospital and advise patient with Tourniquet applied being transferred On arrival at hospital clearly inform the receiving team of the presence of the tourniquet and the time of application Figure 6. Pre-hospital Tourniquet Use 27 A TOURNIQUET INSITU IS NOT A STABLE SITUATION AND REQUIRES URGENT INTERVENTION Advised by Pre hospital team to expect a transfer with tourniquet in situ Yes Position Pneumatic tourniquet, if available (box 1), take down pre hospital dressing, reassess wound. No Can Tourniquet be released? Yes Is Bleeding No controlled? No Apply celox gauze and blast / Oleas bandage Yes Level 1Trauma call raised Are patients ABC stable on Primary Survey? No Inflate Pneumatic tourniquet if available if not reapply tourniquet Ensure a robust plan is in place to release tourniquet for 10 mins every 2hours to allow limb to re-perfuse (box 2) Contact Theatre coordinator on bleep 2894 to obtain pneumatic Tourniquet Consider early activation on Major Hameorrhage protocol Optimise patients Coagulation • 1g TXA bolus • 1g TXA infusion over 8 hours • Reverse Anticoagulation • Keep Ionised Calcium > 1mmol//l • Warm patient to normothermia • TEG to guide coagulation (if available) • Resuscitate to permissive hypotension • Activate and transfuse in accordance with the major hemorrhage protocol Plan to take patient from resus directly to theatre for surgery – Consider Vascular Surgery input Is Bleeding controlled? Yes Observe wound closely for recurrence of bleeding and continue assessment of the patient Box 1 Pneumatic Tourniquet should be placed above the CAT before removing the CAT. Remove the CAT, if bleeding recurs and cannot be controlled by direct pressure, inflate the pneumatic tourniquet. If no longer bleeding, leave pneumatic tourniquet in place, but deflated until definitive decision made about destination of patient Figure 7. In-hospital Tourniquet Use Box 2 –Release of Tourniquet Limb is acutely ischaemic as soon as the tourniquet is applied and ATP stores deplete. Tourniquet should be released for a minimum of 10 mins every 2 hours to allow period of reperfusion. This is in order to reduce the risk of irreversible microvascular injury. Risks with release of tourniquet. • Potentially fatal arrhythmia • Increased PaCO2 and lactate • Increased intracranial pressure • Severe pain • Compartment syndrome • Rhabdomyolysis 28 Cavity Catastrophic Haemorrhage Evidence of cavity catastrophic haemorrhage (persistent hypotension and/or tachycardia presumed secondary to cavity blood loss) that cannot be stabilized in ED Resus requires urgent definitive control via Surgical or Interventional Radiology means. This requires a timely discussion between the TTL, Interventional Radiologist, and relevant Surgical Consultants. Further detail can be found in Section 2.4 Circulation. Massive haemorrhage in the presence of haemodynamic instability should prompt consideration of calling in the oncall Consultant for the cavity of concern. This should be done as soon as possible, and may be considered based on the pre-hospital information received. The decision to go straight to Theatre, either bypassing Resus on arrival or bypassing CT, carries great risk, particularly as the Theatre Suite is not located in close proximity to the ED. This decision must only be taken after consultation between the Team Leader and the relevant Surgical and Anaesthetic Teams. CODE RED Patients with life threatening haemorrhage require urgent replacement of lost circulating volume with blood products. Code Red refers to the activation of the UHS massive transfusion policy (Figure 8 & Section 4.2). Rapid transfusion of blood products is achieved via the Belmont Rapid Infuser (Section 3.2). This is an extremely powerful rapid transfuser which, left unchecked, can deliver huge volumes of blood/fluids within an extremely short period of time e.g. 750ml/minute. The default is to administer repeated boluses (e.g. 250 ml) with regular reassessment of the patient. The CODE RED nurse will be in charge of the Belmont and is also responsible for ensuring an accurate running total of the volume and type of fluids / blood products administered. They should regularly liaise with the Anaesthetist and Team Leader as to ongoing requirements. The benefits of the Belmont include the ability to transfuse when disconnected from a power source but the Belmont will not heat fluids whilst running on battery power and the rate will be reduced to 50ml/minute. 29 Suspected Major Haemorrhage (MH) Action Send G+S to transfusion lab Activate CODE RED (pick up the MH red phone OR call 2222 and state ‘Major Haemorrhage’) Request Pack 1 Allocate staff member/ Code Red practitioner to coordinate transfusion activity Make plan to stop bleeding: Consider splinting, tourniquets, contacting on-call Surgeons (general surgeon bleep 9990) Endoscopist or Interventional Radiologist via switchboard Give Tranexamic acid 1g IV stat bolus dose, followed by 1g over 8 hours infusion. Ensure reversal of anti-coagulants: Warfarin: Octaplex 30iu/kg + give Vit K 10mg IV Heparin: Protamine 6U Blood: Major Haemorrhage Pack 1 Group O from nearest fridge (O-ve for women, O+ve for men) or type specific/cross matched blood from lab (dictated by urgency) Pre-thawed (type A until group specific available) available in ED for ED patients or from the Blood Transfusion Laboratory Request Major Haemorrhage Pack 2 Aims of Transfusion Haemodynamic Stabilisation Hb > 80g/l Platelet count > 75x109/l (> 150x109/l in CNS trauma) INR and APTT ratio 2 Keep iCa2+ above 1.1mmol/l with calcium chloride (starting adult dose 10ml of 10%) Temp > 36oC pH > 7.2 Lactate 13kPa Aim PaCO2 4.5-5kPa Aim MAP > 90mmHg (CPP > 60mmHg if ICP monitored) Maintain normothermia Loading with 1g IV Phenytoin should be considered In addition, the patient’s neck should be in a neutral position and the cervical collar checked to ensure venous outflow is not obstructed. Loosen cervical collar in intubated patients while keeping the head immobilised (e.g sand bags and tape). NOTE: In the absence of hypotension the whole bed should be placed on a 300 head up tilt for patients with severe head injury. This simple manoeuvre47 can significantly help in reducing raised intracranial pressure. Scoop stretchers are for extrication of patients and are used to facilitate transfers. They are uncomfortable and present a significant risk of pressure damage for all patients but particularly those with spinal cord injuries. NOTE: It is the responsibility of the team leader to ensure that the scoop stretcher or spinal boards are removed as soon as possible. Mannitol & Hypertonic Saline The European Brain Injury Consortium and the Brain Trauma Foundation recommend the use of mannitol as the osmotic drug of choice in brain injured patients. Mannitol reduces intracranial pressure within a few minutes. Patients with 1 or 2 fixed & dilated pupils, which is felt to be due to raised intracranial pressure, should receive an IV bolus of either • 10% Mannitol 1g/kg (10ml/kg 10% Mannitol), or • 2.7% saline 6ml/kg Traumatic Brain Injury: Ventilated Patients www.neuroicu.org.uk for up to date guidance. Rapid assessment including pupils and monitoring parameters. Airway Breathing Circulation Disability Environment ET tube type & length at lips; EtCO2 monitoring FiO2; RR; Tidal Volume; Bilateral air entry & SpO2 > 97% HR; BP (MAP > 90mmHg); Presence and positioning of arterial line Pupils (remove contact lenses); Sedation; ?Muscle relaxation Temperature; Glucose Ensure adequate sedation and determine level of pre-existing neuromuscular blockade using a Nerve stimulator/ TOF device. All patients should be assumed to have an unstable spinal injury unless the spinal algorithm (Figure 16) has been completed and Consultant Radiologist report confirms the absence of any acute spinal injury. Transfer patient onto Neuro ICU bed maintaining spinal alignment. • Patient should be placed in a hard cervical collar • Transfer of patient will require spinal turns or the use of a scoop stretcher • 30o head up tilt of whole bed Follow Intracranial Injury Pre-transfer Checklist (Figure 15). 48 Figure 15. Intracranial Injury Pre-transfer Checklist 49 Traumatic Brain Injury: Self-ventilating Patients www.neuroicu.org.uk for up to date guidance. Rapid assessment including pupils and monitoring parameters. Airway Breathing Circulation Disability Maintained and clear; No signs of upper airway obstruction Adequate rate and depth of respiration with Sp
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