Browse site A to Z

Search results

Go To Simple Search

Search Type: Criteria:

Papers Trust Board - 11 November 2025

Description: Date Time Location Chair Agenda Trust Board – Open Session 11/11/2025 9:00 - 13:00 Conference Room, Heartbeat Education Centre Jenni Douglas-Todd 1 Chair’s Welcome, Apologies and Declarations of Interest 9:00 Note apologies for absence, and to hear any declarations of interest relating to any item on the Agenda. 2 Patient Story (item deferred) The patient story provides an opportunity for the Board to reflect on the experiences of patients and staff within the Trust and understand what the Trust could do better. 3 Minutes of Previous Meeting held on 9 September 2025 Approve the minutes of the previous meeting held on 9 September 2025 4 Matters Arising and Summary of Agreed Actions To discuss any matters arising from the minutes, and to agree on the status of any actions assigned at the previous meeting. 5 QUALITY, PERFORMANCE and FINANCE Quality includes: clinical effectiveness, patient safety, and patient experience 5.1 Briefing from the Chair of the Audit and Risk Committee 9:05 Keith Evans, Chair 5.2 Briefing from the Chair of the Finance, Investment & Cash Committee 9:10 David Liverseidge, Chair 5.3 Briefing from the Chair of the People and Organisational Development 9:15 Committee Jane Harwood, Chair 5.4 Briefing from the Chair of the Quality Committee 9:20 Tim Peachey, Chair 5.5 Chief Executive Officer's Report 9:25 Receive and note the report Sponsor: David French, Chief Executive Officer 5.6 Performance KPI Report for Month 6 10:00 Review and discuss the report Sponsor: Andy Hyett, Chief Operating Officer 5.7 Break 10:40 5.8 Finance Report for Month 6 10:55 Review and discuss the report Sponsor: Ian Howard, Chief Financial Officer 5.9 ICB System Report for Month 6 11:05 Receive and discuss the report Sponsor: Ian Howard, Chief Financial Officer 5.10 11:10 People Report for Month 6 Review and discuss the report Sponsor: Steve Harris, Chief People Officer 5.11 NHSE Audit and review of 'Developing Workforce Safeguards' including 11:20 UHS Self-Assessment Return Review and approve the self-assessment return Sponsor: Natasha Watts, Acting Chief Nursing Officer 5.12 11:30 Guardian of Safe Working Hours Quarterly Report and Update on 10-Point Plan Review and discuss the report and update Sponsor: Paul Grundy, Chief Medical Officer Attendee: Diana Hulbert, Guardian of Safe Working Hours and Emergency Department Consultant 5.13 Annual Clinical Outcomes Summary Report 11:45 Review and discuss the report Sponsor: Paul Grundy, Chief Medical Officer Attendees: Lucinda Hood, Head of Medical Directorate/Kate Pryde, Clinical Director for Improvement and Clinical Effectiveness 6 STRATEGY and BUSINESS PLANNING 6.1 Corporate Objectives 2025-26 Quarter 2 Review 11:55 Review and feedback on the corporate objectives Sponsor: David French, Chief Executive Officer Attendee: Martin de Sousa, Director of Strategy and Partnerships 6.2 Board Assurance Framework (BAF) Update 12:05 Review and discuss the update Sponsor: Natasha Watts, Acting Chief Nursing Officer Attendees: Craig Machell, Associate Director of Corporate Affairs and Company Secretary/Lauren Anderson, Corporate Governance and Risk Manager Page 2 7 CORPORATE GOVERNANCE, RISK and INTERNAL CONTROL 7.1 Feedback from the Council of Governors' (CoG) meeting 28 October 2025 12:15 (Oral) Sponsor: Jenni Douglas-Todd, Trust Chair 7.2 Register of Seals and Chair's Actions Report 12:25 Receive and ratify In compliance with the Trust Standing Orders, Financial Instructions, and the Scheme of Reservation and Delegation. Sponsor: Jenni Douglas-Todd, Trust Chair 7.3 Health and Safety Services Annual Report 2024-25 12:30 Receive and discuss Sponsor: Natasha Watts, Acting Chief Nursing Officer Attendees: Vickie Purdie, Head of Patient Safety/Scott Spencer, Health and Safety Adviser 8 Any other business 12:40 Raise any relevant or urgent matters that are not on the agenda 9 Note the date of the next meeting: 13 January 2026 10 Items circulated to the Board for reading 12:45 10.1 South Central Regional Research Delivery Network (SC RRDN) 2025-26 Q2 Performance Report Note the report Sponsor: Paul Grundy, Chief Medical Officer 11 Resolution regarding the Press, Public and Others Sponsor: Jenni Douglas-Todd, Trust Chair To agree, as permitted by the National Health Service Act 2006 (as amended), the Trust's Constitution and the Standing Orders of the Board of Directors, that representatives of the press, members of the public and others not invited to attend to the next part of the meeting be excluded due to the confidential nature of the business to be transacted. 12 Follow-up discussion with governors 12:45 Page 3 Agenda links to the Board Assurance Framework (BAF) 11 November 2025 – Open Session Overview of the BAF Risk 1a: 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. 1b: Due to the current challenges, we fail to provide patients and their families / carers with a high-quality experience of care and positive patient outcomes. 1c: We do 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. 2a: We do not take full advantage of our position as a leading University teaching hospital with a growing, reputable, and innovative research and development portfolio, attracting the best staff and efficiently delivering the best possible treatments and care for our patients. 3a: We are unable to meet current and planned service requirements due to the unavailability of staff to fulfil key roles. 3b: We fail to develop a diverse, compassionate, and inclusive workforce, providing a more positive staff experience for all staff. 3c: We fail 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. 4a: We do 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. 5a: We are unable to deliver a financial breakeven position, resulting in: inability to move out of the NHS England Recovery Support Programme, NHS England imposing additional controls/undertakings, and a reducing cash balance impacting the Trust’s ability to invest in line with its capital plan, estates/digital strategies, and in transformation initiatives. 5b: We do not adequately maintain, improve and develop our estate to deliver our clinical services and increase capacity. 5c: Our digital technology or infrastructure fails to the extent that it impacts our ability to deliver care effectively and safely within the organisation, 5d: We fail to prioritise green initiatives to deliver a trajectory that will reduce our 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. Agenda links to the BAF No Item Linked BAF risk(s) 5.6 Performance KPI Report for Month 6 5.8 Finance Report for Month 6 5.9 ICB System Report for Month 6 5.10 People Report for Month 6 5.11 Workforce Safeguards Self-Assessment 5.12 Guardian of Safe Working Hours Quarterly Report 5.13 Clinical Outcomes Summary Report 1a, 1b, 1c 5a 5a 3a, 3b, 3c 1a, 3a 3a, 3b 1a, 1b Appetite (Category) Minimal (Safety) Current risk rating 4x5 20 Cautious (Experience) Minimal (Safety) 4x4 16 4x4 16 Open (Technology & Innovation) 3x4 12 Open (workforce) Open (workforce) Open (workforce) 4x5 20 4x3 12 4x4 16 Cautious (Effectiveness) 3x3 9 Cautious (Finance) 5x5 25 Target risk rating 4 x 2 Apr 6 27 3 x 2 Apr 6 27 2 x 3 Apr 6 27 3 x 2 Mar 6 27 4 x 3 Mar 12 30 4 x 2 Mar 8 30 3 x 2 Mar 6 29 3 x 2 Dec 6 25 3 x 3 Apr 9 30 Cautious (Effectiveness) Open (Technology & Innovation) Open (Technology & Innovation) 4x5 20 3x4 12 2x4 8 4 x 2 Apr 8 30 3 x 2 Apr 6 27 2 x 2 Dec 4 27 Does this item facilitate movement towards or away from the intended target risk score and appetite? Towards Away Neither x x x x x x x Minutes Trust Board – Open Session Date 09/09/2025 Time 9:00 – 13:00 Location Conference Room, Heartbeat/Microsoft Teams Chair Jenni Douglas-Todd (JD-T) Present Diana Eccles, NED (DE) Keith Evans, Deputy Chair and NED (KE) Paul Grundy, Chief Medical Officer (PG) Steve Harris, Chief People Officer (SH) Jane Harwood, NED/Senior Independent Director (JH) Ian Howard, Chief Financial Officer (IH) Andy Hyett, Chief Operating Officer (AH) David Liverseidge, NED (DL) Alison Tattersall, NED (AT) In attendance Craig Machell, Associate Director of Corporate Affairs and Company Secretary (CM) Lauren Anderson, Corporate Governance and Risk Manager (LA) (item 6.1) Danielle Honey, Named Nurse for Safeguarding Children (DH) (item 5.14) Lucinda Hood, Head of Medical Directorate (LH) (item 5.15) Duncan Linning-Karp, Deputy Chief Operating Officer (DL-K) (item 5.6) Corinne Miller, Named Nurse for Safeguarding Adults (CMi) (item 5.14) Jenny Milner, Associate Director of Patient Experience (JM) (items 5.11-5.12) 1 member of the public (item 2) 30 members of staff (observing) 6 members of the public (observing) Apologies Gail Byrne, Chief Nursing Officer (GB) David French, Chief Executive Officer (DAF) Tim Peachey, NED (TP) 1. Chair’s Welcome, Apologies and Declarations of Interest The Chair welcomed attendees to the meeting. There were no interests to declare in the business to be transacted at the meeting. It was noted that apologies had been received from Gail Byrne, David French and Tim Peachey. The Chair provided an overview of meetings she had held and events that she had attended since the previous Board meeting. 2. Patient Story Aelwen Emmett, a volunteer at the Trust and former patient was invited to present her experience, focusing particularly on her work to improve the standard of food offered to patients. 3. Minutes of the Previous Meeting held on 15 July 2025 The draft minutes tabled to the meeting were agreed to be an accurate record of the meeting held on 15 July 2025. Page 1 4. Matters Arising and Summary of Agreed Actions The matters arising and actions were noted. In respect of action 1246, it was noted that virtual outpatient appointments had now been built into the Trust’s programme. Furthermore, meetings were to be held with commissioners and the cancer network to improve the quality of referrals. It was noted that action 1246 could be closed. 5. QUALITY, PERFORMANCE and FINANCE 5.1 Briefing from the Chair of the Finance and Investment Committee David Liverseidge was invited to present the Committee Chair’s Reports in respect of the meetings held on 21 July and 2 September 2025, the content of which was noted. It was further noted that: • In July 2025, the Trust had reported that it was £1.1m adverse to its plan, but that the underlying trajectory was improving. • The committee received an update from Wessex NHS Procurement Limited, noting that the company was on track in terms of its Cost Improvement Programme target. • The committee had received an update in respect of both the proposed Hampshire and Isle of Wight elective hub and a possible Urgent Treatment Centre at Southampton. • The committee reviewed the Finance Report for Month 4 (item 5.8), noting that the Trust had reported a year-to-date deficit of £19.5m, which was £5.8m adverse to plan. Key drivers for the Trust’s financial position included the lack of improvement in the number of patients having no criteria to reside and mental health patients, the continued difference between funded and actual activity under block contracts, lower than anticipated income, and higher than planned workforce numbers. • The Trust was ahead of its plan on Cost Improvement Programme delivery. • The committee reviewed the Trust’s proposed Financial Recovery Plan and noted the need to ensure that the long-term impact of decisions needed to be taken into account. • The committee reviewed the Trust’s cash position and noted that cash support would be required in the Autumn and that the committee would be amending its terms of reference to expand its role in terms of cash monitoring and oversight. • The committee reviewed the Board Assurance Framework risks within its remit, noting that Risk 5a had increased to 25 due to the risk associated with the Trust’s cash position (item 6.1). 5.2 Briefing from the Chair of the People and Organisational Development Committee Jane Harwood was invited to present the Committee Chair’s Reports in respect of the meetings held on 21 July and 1 September 2025, the content of which was noted. It was further noted that: • The committee reviewed the People Report for Month 4 (item 5.10), noting that there continued to be significant demands on the Trust’s workforce, especially due to the number of patients having no criteria to reside and patients with a primary mental health need. Whilst the Trust’s substantive workforce had reduced, there had been an increase in the number of temporary staff resulting in the Trust reporting that it was 55 whole-time- equivalents above its plan. Page 2 • The committee considered the impact of the recruitment controls on the administrative and clerical workforce and the potential for shortages in these areas causing issues elsewhere. • The committee received an update in respect of the Mutually Agreed Resignation Scheme (MARS), noting that 65 applications had been approved. • The committee received an update on the recruitment of newly qualified nurses, noting that the Trust had pre-empted the announcement of a ‘guarantee’ by the Secretary of State. • The committee reviewed the workforce related elements of the Trust’s Financial Recovery Plan, noting the challenges in delivering what was required and the Trust’s reliance on improvements in patients having no criteria to reside and mental health patients. • The committee reviewed its terms of reference, proposing to make only minor changes (item 7.2). 5.3 Briefing from the Chair of the Quality Committee Diana Eccles was invited to present the Committee Chair’s Report in respect of the meeting held on 18 August 2025, the content of which was noted. It was further noted that: • The committee considered the proposal to revise enhanced rates paid to temporary staff in certain areas to remove the enhancement and bring rates into line with Agenda for Change rates. The committee noted the impact on staff and the concerns expressed by staff members. However, it was further noted that the enhancements were not intended to be permanent. • The committee received the Experience of Care report and noted a continuation in the trend observed during Quarter 4 of staff attitudes featuring as a reason for complaint. It was considered likely that this was indicative of the pressures on staff. • The committee reviewed the Maternity and Neonatal Safety 2025-26 Quarter 1 Report, noting that an action plan was in place in respect of the Maternity Triage Line to address some shortcomings identified in the process. • The committee received the Learning from Deaths 2025-26 Quarter 1 Report (item 5.11), noting that the Trust was one of only 11 trusts out of 119 with a lower-than-expected death rate during the period. • The committee reviewed the Safeguarding Annual Report 2024-25 and Strategy 2025-26 (item 5.14), noting that activity levels remained consistent with prior years, but the complexity of cases had increased. 5.4 Chief Executive Officer’s Report Paul Grundy was invited to present the Chief Executive Officer’s Report, the content of which was noted. It was further noted that: • The NHS league tables for 2025 had been published on 9 September 2025. The Trust had ranked 48th out of 134 and had been placed in segment 3 of the NHS Oversight Framework due to the effect of the ‘financial override’. The Trust was temporarily in segment 5 due to being in the Recovery Support Programme. • Trusts were required to submit self-assessments for the Provider Capability Assessment during October 2025. This would inform decisions relating to which organisations to place in the Performance Improvement Programme. • Resident doctors undertook strike action between 25 and 30 July 2025. Approximately one-third of those eligible at the Trust took part in the industrial action and the Trust had performed well in terms of mitigating the impact on activity. Page 3 • The Royal College of Nursing had published results of its analysis of violence and aggression against nursing staff in emergency departments, noting that the number of incidents had increased from 2,093 in 2019 to 4,054 in 2024. • NHS England had published a series of urgent and emergency care improvement guides to assist organisations with managing the winter period. • A number of changes to the organisation of local councils in Hampshire and Southampton were proposed as part of national plans to create unitary councils in place of existing county and district/borough councils. 5.5 Performance KPI Report for Month 4 Andy Hyett was invited to present the Performance KPI Report for Month 4, the content of which was noted. It was further noted that: • The Trust had reported an increase in the number of patients waiting over 52, 65 and 78 weeks alongside an increase in the overall waiting list. The Trust had entered Tier 2 escalation for Referral To Treatment performance. • The Trust had been placed in Tier 1 escalation due to the gap between its current Emergency Department performance and its performance plan for 2025/26. However, indicative data for August and September 2025 showed improved performance. • Work was ongoing to improve flow with task and finish groups established to review the discharge process and to implement rapid improvements. • The number of patients having no criteria to reside and those with a primary mental health need remained high. A workshop had been set up with Hampshire and Isle of Wight Healthcare NHS Foundation Trust in respect of mental health patients. • Steps were being undertaken to reduce the number of inappropriate attendances in the Emergency Department with patients potentially redirected to other areas. However, an Urgent Treatment Centre would be key to alleviating pressure on the Emergency Department in the longer term. The Board discussed the Trust’s performance against national standards. This discussion is summarised below: • Performance against the 62-day standard for cancer waiting times was an area of focus to ensure more consistent performance. • Work was ongoing to extend shared decision-making in order to involve patients in decisions about their care and treatment, noting however that this was more of a challenge with inpatients. • There was a challenge in terms of managing the demand for patients requiring diagnostic services. It was noted that there had been issues with availability of equipment over the summer period. It was acknowledged that diagnostics performance also impacted other areas such as cancer and Emergency Department metrics. • The percentage of over 65s attending the Emergency Department was expected to be a key metric to monitor over the winter period. Actions Andy Hyett agreed to look at the roll out of Pharmacy First. Andy Hyett agreed to carry out a deep-dive into Diagnostics to be either provided as a ‘Spotlight’ in the Performance KPI Report or via a Trust Board Study Session. Page 4 5.6 UHS Operating Plan 2025-26 and Board Assurance Statement Andy Hyett was invited to present the Operating Plan 2025-26 and Board Assurance Statement, the content of which was noted. It was further noted that: • The Operating Plan provided a summary of plans from October 2025 to September 2026, sitting alongside other key policies such as those relating to infection prevention control, major incidents, and influenza. • The Operating Plan would also serve as the Trust’s winter plan, which was recognised as a period of increased pressure. The Board discussed the proposed Operating Plan for 2025/26, this discussion is summarised below: • It was considered likely that, even with delivery of the demand management schemes being led by the Integrated Care Board (ICB), there would be a gap between demand and capacity over the winter period in particular. Therefore, further interventions to improve discharge rates and to reduce the number of patients having no criteria to reside would be necessary. In addition, the Trust would be required to make potentially difficult decisions in respect of prioritisation of patients and possible cancellation of elective procedures. • Concerns were expressed in relation to the trend of low uptakes of seasonal vaccinations, such as that against influenza, which had been seen since the COVID-19 pandemic. This situation would likely create further challenges due to patients with seasonal illnesses requiring additional infection prevention control measures. Furthermore, low uptake by staff members would likely result in increased rates of staff sickness and, accordingly, reduced capacity and/or increased expenditure on temporary staffing. • It was understood that there was a NHS campaign to encourage staff in particular to be vaccinated against influenza, and that plans were in place for senior leaders to visibly support this campaign through being vaccinated. • The Board challenged whether the Trust could meet the targets set out in the Operating Plan given the financial and other pressures currently experienced. • It was additionally noted that the Trust was reliant on external support and delivery of external demand management programmes led by the ICB in order to be able to meet the performance targets, especially in terms of management of the number of patients having no criteria to reside and those with a primary mental health need. • Furthermore, the Trust’s financial position was such that it was required to produce a financial recovery plan, which would require additional financial savings to be made. • It was agreed that the Board should fully consider whether to approve the Operating Plan once it had considered the Trust’s financial recovery plan in the Closed Session of the meeting. [Note: the matters below forming part of item 5.6 were discussed following the approval of the Trust’s financial recovery plan in the Closed Session.] Noting that the Board had discussed and supported the Trust’s financial recovery plan, subject to certain caveats, the Board again discussed the proposed Operating Plan for 2025/26. This discussion is summarised below: • The Trust’s financial recovery plan would need to be supported by NHS England and would also need to deliver in order for the Trust to be able to meet the performance targets set out in the Operating Plan. • The Trust continued to have significant dependence on third parties, especially other providers, the Integrated Care Board, and local authorities, to be able to successfully reduce the number of patients having no criteria to Page 5 reside or number of mental health patients. Without these reductions, the Trust would face significant capacity constraints, which would impact its performance, especially during periods of high demand. Decision Noting the discussions in the Closed Session in respect of the financial recovery plan, and having reviewed the proposed Operating Plan 2025-26 and accompanying Board Assurance Statement, the Board approved the Operating Plan 2025-26 and its submission, subject to the following: • delivery of system-wide programmes to manage demand and reduce numbers of non-criteria to reside and mental health patients, • appropriate support being provided by third parties, including local providers, the Integrated Care Board, and local authorities, especially in terms of supporting discharges and managing numbers of non-criteria to reside and mental health patients, and • support from NHS England for and delivery of the Trust’s financial recovery plan. In addition, the Board authorised the Chair and Chief Executive Officer to sign the Board Assurance Statement. 5.7 Break 5.8 Finance Report for Month 4 Ian Howard was invited to present the Finance Report for Month 4, the content of which was noted. It was further noted that: • The Trust had reported an in-month deficit of £6.8m (£4.8m above plan), although the underlying deficit was showing improvement, reducing to £6.6m. However, this trajectory was not sufficient to deliver the plan. • The Trust was carrying out approximately £2.5m of unfunded activity per month. In order to tackle some of this amount, the Trust had conducted negotiations with other providers and systems to address underfunding on contracts. • There were concerns about whether the Trust’s elective over-performance during the first half of the year would be fully funded. Whilst agreement had been reached in respect of funding three months of over-performance, it was not clear whether this would be replicated in the future. • The Trust would be seeking an activity management plan, which would detail which activities to cease to perform on the basis that the Trust continuing to over-perform against agreed funded activity levels was financially unsustainable and that it was not reasonable that the Trust should be criticised for falling performance in areas such as waiting lists as it sought to manage its finances. • The Trust’s cash position remained an area of concern with cash support to be requested from NHS England. • There appeared to be an emerging risk of slippage against the Trust’s capital programme, which was to be discussed at the Finance and Investment Committee. 5.9 ICS Operational Delivery Report for Month 4 Ian Howard was invited to present the ICS Operational Delivery Report for Month 4, the content of which was noted. It was further noted that: • The Trust was the only organisation within the system currently reporting being off plan. However, there were indicators from other providers with Page 6 significant risks being highlighted about organisations’ abilities to meet their 2025/26 plans. • There was an error in the report in respect of the Trust’s workforce numbers. A correction to the report had been requested. • The Hampshire and Isle of Wight ICS plan was for a breakeven position at the end of 2025/26. However, this was reliant on receipt of £60m of deficit support funding from NHS England, which was at risk because the Trust was no longer reporting being on plan. 5.10 People Report for Month 4 It was noted that two questions had been received from members of the public prior to the meeting (see Annex A), both of which related to the decision to remove the enhancement from NHS Professionals rates paid to staff in certain areas of the Trust such as in Theatres and in the Emergency Department. It was further noted that: • A discussion had also been held with staff prior to the Board meeting, at which a number of other questions had been raised. In particular, staff had expressed concerns about their feeling valued by the organisation. • The reasoning behind the decision to remove the enhancement previously paid on temporary staffing rates was explained as being to provide consistency with other staffing groups and with other providers by aligning rates paid with Agenda for Change rates. This change was part of a package of measures to improve the financial position of the Trust. • The decision to remove the enhancement was supported by an Equality and Quality Impact Assessment as part of the Trust’s process for making decisions of this nature. [Post meeting note: Following the meeting, the Royal College of Nursing, on behalf of its members in the affected areas, submitted a collective dispute. The questions raised in advance of the meeting, together with other related points, were to be addressed as part of the collective dispute process.] Steve Harris was invited to present the People Report for Month 4, the content of which was noted. It was further noted that: • The Trust’s plan for 2025/26 was for a reduction in whole-time-equivalents (WTE) by 765. Whilst the Trust had reduced the size of its workforce, it was still 55 WTE off-plan. • The Trust had reduced the number of divisions from four to three and had implemented recruitment controls whereby only 70% of clinical posts would be recruited to and a prohibition on recruitment to non-clinical posts. • The Trust had also carried out a Mutually Agreed Resignation Scheme (MARS) and had made some redundancies in discrete areas. It was noted, however, that there was a lack of funding for severance payments, which limited the Trust’s options with respect to steps it could take to reduce its workforce. • Temporary staffing was a particular area of focus, both in terms of numbers of temporary staff but also in terms of the cost paid for such staff. This aligned with the work of the South East temporary staffing collaborative which aimed to reduce the price of temporary labour in both bank and agency. Page 7 • Despite its challenges during 2025/26, the Trust had proactively offered roles to newly-qualified nurses ahead of the Secretary of State’s announcement of a ‘graduate guarantee’ on the basis that, from a strategic perspective, the Trust needed to take into account its future workforce requirements. Action Steve Harris and Andy Hyett agreed to respond to the questions and points raised at the meeting held with staff in respect of the NHS Professionals rates matter. 5.11 Learning from Deaths 2025-26 Quarter 1 Report Jenny Milner was invited to present the Learning from Deaths 2025/26 Quarter 1 Report, the content of which was noted. It was further noted that: • The Trust’s summary hospital-level mortality indicator (SHMI) score continued its downward trajectory and was the lowest value recorded since 2018. As such, the Trust was one of only 11 trusts nationally to achieve a lower-thanexpected mortality rate. • Work was ongoing to disseminate lessons from end-of-life care and an additional module for the Ulysses system had been purchased to facilitate data capture and standardisation for Morbidity and Mortality meetings. Action Jenny Milner was to provide further information to the Board in respect of why the Trust’s SHMI score remained low. 5.12 Annual Complaints Report 2024-25 Jenny Milner was invited to present the Annual Complaints Report 2024/25, the content of which was noted. It was further noted that: • The report provided details of complaints received between 1 April 2024 and 31 March 2025 and was the first full year of reporting against the new standard introduced by the Parliamentary and Health Service Ombudsman (PHSO). • Complaints activity had increased by 40% and the Trust was not currently meeting response targets. • The Trust benchmarked higher than others in terms of complaints not upheld. The Board discussed the Trust’s approach to complaints handling and, in particular, whether the Trust was an outlier in terms of the number of complaints not upheld. The Board challenged whether complaints deemed as ‘not upheld’ ought, in some instances, to be considered ‘partially upheld’. Consideration should therefore be given to reviewing the Trust’s complaints against PHSO referrals and outcomes. Action Jenny Milner was to provide further information regarding how the Trust was planning to meet complaints response times. Page 8 5.13 Medical Appraisal and Revalidation Annual Report including Board Statement of Compliance Paul Grundy was invited to present the Medical Appraisal and Revalidation Annual Report, the content of which was noted. It was further noted that: • The framework published by NHS England was designed to allow the Trust to provide assurance that its professional standards processes meet the relevant statutory requirements and support quality improvement. • Feedback in respect of the appraisals process had been largely positive. • Appraisal compliance rates had continued to rise across the year with a current average of 88.8%. • The Board was required to approve a Statement of Compliance confirming that the Trust was compliant with the Medical Profession (Responsible Officers) Regulations 2010 (as amended). Decision Having considered the Medical Appraisal and Revalidation Annual Report tabled to the meeting, the Board authorised the Chair or Chief Executive Officer to sign the Statement of Compliance. 5.14 Safeguarding Annual Report 2024-25 and Strategy 2025-26 Danielle Honey was invited to present the Safeguarding Annual Report 2024/25 and Strategy for 2025/26, the content of which was noted. It was further noted that: • The report summarised the activity of the Trust’s safeguarding service in 2024/25. It was noted that the service had contributed to reviews of 56 patients where a statutory review had been considered. • The number of referrals under section 42 of the Care Act 2014 caused by Southampton City Council had reduced following the implementation of the council’s new processes. This was not reflective of a reduction in the number of UHS referrals or the complexity of the referrals responded to. • There had been an increase in the number of open cases with Southampton City Council and there had been a 13% increase in the number of patients subject to Deprivation of Liberty Safeguards (DoLS) under the Mental Capacity Act 2005. • There had also been an increase in the number of scoping reviews compared to prior years, although fewer were progressing to formal reviews. • Following a survey of staff, work was underway to improve the visibility of the team and there was a focus on team wellbeing with support from the psychology team. • The situation in respect of expected changes in the role of integrated care boards was being monitored due to the potential for changes in the team’s scope and remit. Page 9 6. STRATEGY and BUSINESS PLANNING 6.1 Board Assurance Framework (BAF) Update Lauren Anderson was invited to present the Board Assurance Framework update, the content of which was noted. It was further noted that: • All risks had been reviewed by the relevant executive directors since July 2025. • The revised risk appetites agreed by the Board in July 2025 were being embedded. • The rating of Risk 5a had increased from 20 to 25 due to the lack of agreement for cash support. However, once this agreement had been obtained and the Financial Recovery Plan was in place, it was expected that this risk would again reduce to 20. • An audit of the Trust’s risk management maturity by the Trust’s internal auditors was near to completion. 7. CORPORATE GOVERNANCE, RISK and INTERNAL CONTROL 7.1 Feedback from the Council of Governors’ (COG) Meeting 16 July 2025 The Chair presented a summary of the Council of Governors’ meeting held on 16 July 2025. It was noted that the meeting had considered the following matters: • Chief Executive Officer’s Performance Report • The Trust’s 2025/26 Operating Plan • Council of Governors’ Terms of Reference • Membership Engagement • Feedback from the Governors’ Nomination Committee Furthermore, the Council of Governors approved the extension of the appointment of Tim Peachey as a non-executive director for a period of 12 months. 7.2 People and Organisational Development Committee Terms of Reference Craig Machell was invited to present the proposed changes to the People and Organisational Development Committee’s Terms of Reference, the content of which was noted. It was further noted that: • The People and Organisational Development Committee had reviewed its terms of reference at its meeting on 1 September 2025. • It was proposed to make only minor changes to remove reference to the Charitable Funds Committee, which no longer existed. Decision Having considered the proposed amendments to the People and Organisational Development Committee’s Terms of Reference, the Board approved the changes. Page 10 8. Any other business It was noted that it was organ donation week during 22-28 September 2025. Action Craig Machell agreed to add organ donation to the agenda of a future Trust Board Study Session. 9. Note the date of the next meeting: 11 November 2025 10. Items circulated to the Board for reading The item circulated to the Board for reading was noted. There being no further business, the meeting concluded. 11. Resolution regarding the Press, Public and Others Decision: The Board resolved that, as permitted by the National Health Service Act 2006 (as amended), the Trust’s Constitution and the Standing Orders of the board of directors, that representatives of the press, members of the public and others not invited to attend to the next part of the meeting be excluded due to the confidential nature of the business to be transacted. The meeting was adjourned. Page 11 Annex A Questions: 1. The Board has agreed a cut in bank pay rates for nursing staff, resulting in local staff being unlikely to maintain their bank roles in this organisation, (based on a survey of over 450 nurses within the affected areas). Currently these roles provide staffing in areas such as theatres and other specialised areas, the impact being these departments can use local skills and knowledge to provide seamless operational delivery. How can the board provide assurance that, a) this will not impact on safety for patients, and b) they truly value nurses for the professional skills they provide for this Trust. 2. Our Emergency Department has recently been placed under Tier 1 monitoring by NHS England, reflecting serious national concerns about safety and performance. The department is already regularly understaffed, with patient care frequently delayed as a result. In light of this, how can the Trust justify reducing NHSP pay rates for Emergency Department nurses — a decision that risks deterring skilled staff from covering shifts and further compromising patient safety and the delivery of safe, timely care? What specific steps will the Trust take to mitigate these risks to patients and staff if the changes go ahead? Page 12 List of action items Agenda item Assigned to Deadline Status Trust Board – Open Session 15/07/2025 - 5.11 Freedom to Speak Up Report 1267. Data Mbabazi, Christine Watts, Natasha 13/01/2026 Pending Explanation action item Christine Mbabazi to include data from other mechanisms for reporting concerns in future Freedom to Speak Up reports. Trust Board – Open Session 09/09/2025 - 5.5 Performance KPI Report for Month 4 1281. Pharmacy First Hyett, Andy 11/11/2025 Pending Explanation action item Andy Hyett agreed to look at the roll out of Pharmacy First. 1282. Diagnostics Hyett, Andy 11/11/2025 Pending Explanation action item Andy Hyett agreed to carry out a deep-dive into Diagnostics to be either provided as a ‘Spotlight’ in the Performance KPI Report or via a Trust Board Study Session. Trust Board – Open Session 09/09/2025 - 5.10 People Report for Month 4 1283. NHS Professionals rates Harris, Steve Hyett, Andy 11/11/2025 Pending Explanation action item Steve Harris and Andy Hyett agreed to respond to the questions and points raised at the meeting held with staff in respect of the NHS Professionals rates matter. Page 1 of 2 Agenda item Assigned to Deadline Status Trust Board – Open Session 09/09/2025 - 5.11 Learning from Deaths 2025-26 Quarter 1 Report 1284. SHMI score Milner, Jenny Watts, Natasha 11/11/2025 Pending Explanation action item Jenny Milner was to provide further information to the Board in respect of why the Trust’s SHMI score remained low. Trust Board – Open Session 09/09/2025 - 5.12 Annual Complaints Report 2024-25 1285. Response times Milner, Jenny Watts, Natasha 11/11/2025 Pending Explanation action item Jenny Milner was to provide further information regarding how the Trust was planning to meet complaints response times. Trust Board – Open Session 09/09/2025 - 8 Any other business 1286. Organ donation Machell, Craig 18/12/2025 Pending Explanation action item Craig Machell agreed to add organ donation to the agenda of a future Trust Board Study Session. Update: To be scheduled 18/12/25 or 03/02/26. Page 2 of 2 Agenda Item 5.1 Committee Chair’s Report to the Trust Board of Directors 11 November 2025 Committee: Audit & Risk Committee Meeting Date: 13 October 2025 Key Messages: • • • • • • • • • The committee reviewed and discussed the outputs of a ‘lessons learned’ activity following the late publication of the Trust’s annual report and accounts. It was noted that a number of actions had been agreed and that a trial run would be conducted at Month 9. The committee noted the proposal to tender for new valuers for 2025/26 and the review of the Modern Equivalent Asset estimation methodology that would be carried out during the year. The committee agreed with a proposal to write off historical debt from private (mostly overseas) patients on the basis that it was irrecoverable. There had been 68 waivers of competitive tendering during the first half of 2025/26, most of which related to continued service provision. It was noted that the submission as part of the National Cost Collection exercise had been completed in July 2025 and that the Trust was 7% more efficient than the average based on the data. An update was received in respect of Information Governance. The Trust’s Data Security and Protection Toolkit was now rated as ‘approaching standards’ and progress had been made in respect of the backlog in subject access requests. The committee received an update in respect of legal expenditure and claims during 2024/25. The committee reviewed the internal audit reports on the Data Security and Protection Toolkit, CQC Readiness, and risk maturity. The committee received an update on the progress of the Trust’s local counter-fraud team against the plan for 2025/26, noting that imposter fraud was an area of focus. Assurance: (Reports/Papers reviewed by the Committee also appearing on the Board agenda) 6.2 Board Assurance Framework (BAF) Update Assurance Rating: Risk Rating: Substantial N/A • The committee had last reviewed the BAF in March 2025, and there had been a definite increase in the level of risk with the ratings of four of the risks having increased since then. • Approximately 25% of the risks on the Trust’s operational risk register were rated ‘critical’ (i.e. 15 or above). • The internal audit of risk management had been positive and the Trust’s risk management framework was considered as being mature. Any Other N/A Matters: Page 1 of 2 Assurance Rating: Substantial There is a robust series of suitably designed internal controls in place upon Assurance which the organisation relies to manage the risk of failure of the continuous and effective achievement of the objectives of the process, which at the time of our review were being consistently applied. Reasonable There is a series of controls in place, however there are potential risks that Assurance may not be sufficient to ensure that the individual objectives of the process are achieved in a continuous and effective manner. Improvements are required to enhance the adequacy and effectiveness of the controls to mitigate these risks. Limited Assurance Controls in place are not sufficient to ensure that the organisation can rely upon them to manage the risks to the continuous and effective achievement of the objectives of the process. Significant improvements are required to improve the adequacy and effectiveness of the controls. No Assurance There is a fundamental breakdown or absence of core internal controls such that the organisation cannot rely upon them to manage the risks to the continuous and effective achievement of the objectives of the process. Immediate action is required to improve the adequacy and effectiveness of controls. Not Applicable Where assurance is not required and/or relevant. Risk Rating: Low Medium High Not Applicable Based on the report considered by the committee, there is little or no concern that the Trust will be unable to meet its stated objectives and/or plans. There is some concern that the Trust might not be able to fully meet its stated objectives and/or plans based on the information contained in the report considered by the committee. There is a significant risk that the Trust will not be able to meet its stated objectives and/or plans based on the information contained in the report considered by the committee. Where risk rating is not relevant. Page 2 of 2 Agenda Item 5.2 i) Committee Chair’s Report to the Trust Board of Directors 11 November 2025 Committee: Finance and Investment Committee Meeting Date: 22 September 2025 Key Messages: • • • • • • • • • The committee reviewed the Finance Report for Month 5. The Trust had reported an in-month deficit of £5.9m and £25.4m deficit year-todate. The in-month deficit was £4.2m above the original plan, but was in line with the trajectory in the Financial Recovery Plan. The Trust’s underlying deficit had continued to improve, reducing to £6.2m, although this improvement was not yet at the pace required. The main drivers of the variance to plan were variances in income compared with what had been expected during 2025/26 and variances in terms of pay costs. The Trust was expecting to be 95 whole-timeequivalents above plan at year end based on current assumptions. It was noted that the Trust had identified 100% of Cost Improvement Programme savings at Month 5 and 76% of schemes were fully developed. Approximately £37m of savings had been delivered between Months 1 and 5, although higher than anticipated levels of non-recurrent savings had been delivered. The committee reviewed the Trust’s capital forecast, noting that there was a risk of a shortfall against the Trust’s internal CDEL. An update was received regarding the Urgent and Emergency Care transformation programme. The committee received the annual assurance report from UHS Pharmacy Limited, noting the company’s performance during the year and the work being done to expand services internally and externally. The committee considered the Trust’s cash forecast for Month 5, noting that the Trust’s underlying deficit was steadily eroding the Trust’s cash balance. The Trust had introduced strict treasury management measures and had previously received advance payments from the ICB as a means to mitigate the cash position. However, it had been necessary to submit a request for revenue support from NHS England in September 2025 and further such applications would be required from November 2025 onwards. In order to increase the focus on and governance of cash-related matters, the committee reviewed its terms of reference to strengthen the cash-related provisions and agreed to recommend to the Board that the committee be re-constituted as the Finance, Investment and Cash Committee with an Operating Cash Group reporting into the committee. Assurance: (Reports/Papers reviewed by the Committee also appearing on the Board agenda) N/A Any Other Matters: The revised terms of reference for the committee were reviewed and approved at the Board meeting held on 7 October 2025. Page 1 of 2 Assurance Rating: Substantial There is a robust series of suitably designed internal controls in place upon Assurance which the organisation relies to manage the risk of failure of the continuous and effective achievement of the objectives of the process, which at the time of our review were being consistently applied. Reasonable There is a series of controls in place, however there are potential risks that Assurance may not be sufficient to ensure that the individual objectives of the process are achieved in a continuous and effective manner. Improvements are required to enhance the adequacy and effectiveness of the controls to mitigate these risks. Limited Assurance Controls in place are not sufficient to ensure that the organisation can rely upon them to manage the risks to the continuous and effective achievement of the objectives of the process. Significant improvements are required to improve the adequacy and effectiveness of the controls. No Assurance There is a fundamental breakdown or absence of core internal controls such that the organisation cannot rely upon them to manage the risks to the continuous and effective achievement of the objectives of the process. Immediate action is required to improve the adequacy and effectiveness of controls. Not Applicable Where assurance is not required and/or relevant. Risk Rating: Low Medium High Not Applicable Based on the report considered by the committee, there is little or no concern that the Trust will be unable to meet its stated objectives and/or plans. There is some concern that the Trust might not be able to fully meet its stated objectives and/or plans based on the information contained in the report considered by the committee. There is a significant risk that the Trust will not be able to meet its stated objectives and/or plans based on the information contained in the report considered by the committee. Where risk rating is not relevant. Page 2 of 2 Agenda Item 5.2 ii) Committee Chair’s Report to the Trust Board of Directors 11 November 2025 Committee: Finance, Investment and Cash Committee Meeting Date: 3 November 2025 Key Messages: • • • • • • • • The committee reviewed the Finance Report for Month 6 (see below). The committee received an update in respect of the Trust’s performance against its Financial Recovery Plan, noting that progress had been made in terms of putting plans in place regarding patients with no criteria to reside and mental health patients. Good progress had also been made in respect of the ‘grip and control’ measures. At Month 6, the Trust remained on track with the Financial Recovery Plan. An overview of the recently published Medium Term Planning framework was provided. It was noted that the first submission of the Trust’s three-year plan was due before
Url: /Media/UHS-website-2019/Docs/About-the-Trust/Trust-governance-and-corporate-docs/2025-Trust-documents/Papers-Trust-Board-11-November-2025.pdf

Papers Trust Board - 9 September 2025

Description: Date Time Location Chair Apologies Agenda Trust Board – Open Session 09/09/2025 9:00 - 13:00 Conference Room, Heartbeat Education Centre Jenni Douglas-Todd David French, Tim Peachey 1 Chair’s Welcome, Apologies and Declarations of Interest 9:00 Note apologies for absence, and to hear any declarations of interest relating to any item on the Agenda. 2 Patient Story The patient story provides an opportunity for the Board to reflect on the experiences of patients and staff within the Trust and understand what the Trust could do better. 3 Minutes of Previous Meeting held on 15 July 2025 9:15 Approve the minutes of the previous meeting held on 15 July 2025 4 Matters Arising and Summary of Agreed Actions To discuss any matters arising from the minutes, and to agree on the status of any actions assigned at the previous meeting. 5 QUALITY, PERFORMANCE and FINANCE Quality includes: clinical effectiveness, patient safety, and patient experience 5.1 Briefing from the Chair of the Finance and Investment Committee 9:20 David Liverseidge, Chair 5.2 Briefing from the Chair of the People and Organisational Development 9:25 Committee Jane Harwood, Chair 5.3 Briefing from the Chair of the Quality Committee 9:30 including Maternity and Neonatal Safety 2025-26 Quarter 1 Report Tim Peachey, Chair 5.4 Chief Executive Officer's Report 9:35 Receive and note the report Sponsor: David French, Chief Executive Officer 5.5 Performance KPI Report for Month 4 10:00 Review and discuss the report Sponsor: David French, Chief Executive Officer 5.6 UHS Operating Plan 2025-26 and Board Assurance Statement 10:30 Receive and approve the Plan Sponsor: Andy Hyett, Chief Operating Officer Attendee: Duncan Linning-Karp, Deputy Chief Operating Officer 5.7 Break 10:40 5.8 Finance Report for Month 4 10:55 Review and discuss the report Sponsor: Ian Howard, Chief Financial Officer 5.9 ICS Operational Delivery Report for Month 4 11:05 Receive and discuss the report Sponsor: Ian Howard, Chief Financial Officer 5.10 11:10 People Report for Month 4 Review and discuss the report Sponsor: Steve Harris, Chief People Officer 5.11 Learning from Deaths 2025-26 Quarter 1 Report 11:20 Review and discuss the report Sponsor: Paul Grundy, Chief Medical Officer Attendee: Jenny Milner, Associate Director of Patient Experience 5.12 Annual Complaints Report 2024-25 11:30 Receive and discuss the report Sponsor: Gail Byrne, Chief Nursing Officer Attendee: Jenny Milner, Associate Director of Patient Experience 5.13 11:40 Medical Appraisal and Revalidation Annual Report including Board Statement of Compliance Receive and note the Annual Report. Approve the Statement of Compliance. Sponsor: Paul Grundy, Chief Medical Officer 5.14 Safeguarding Annual Report 2024-25 and Strategy 2025-26 11:50 Receive and discuss the report and strategy Sponsor: Gail Byrne, Chief Nursing Officer Attendees: Corinne Miller, Named Nurse for Safeguarding Adults/ Dannielle Honey, Named Nurse for Safeguarding Children 6 STRATEGY and BUSINESS PLANNING 6.1 Board Assurance Framework (BAF) Update 12:05 Review and discuss the update Sponsor: Gail Byrne, Chief Nursing Officer Attendees: Craig Machell, Associate Director of Corporate Affairs and Company Secretary/Lauren Anderson, Corporate Governance and Risk Manager Page 2 7 CORPORATE GOVERNANCE, RISK and INTERNAL CONTROL 7.1 Feedback from the Council of Governors' (CoG) Meeting 16 July 2025 12:20 (Oral) Sponsor: Jenni Douglas-Todd, Trust Chair 7.2 People and Organisational Development Committee Terms of Reference 12:30 Review and approve Sponsor: Steve Harris, Chief People Officer 8 Any other business 12:35 Raise any relevant or urgent matters that are not on the agenda 9 Note the date of the next meeting: 11 November 2025 10 Items circulated to the Board for reading 10.1 South Central Regional Research Delivery Network (SC RRDN) 2025-26 Quarter 1 Performance Report Note the report Sponsor: Paul Grundy, Chief Medical Officer 11 Resolution regarding the Press, Public and Others Sponsor: Jenni Douglas-Todd, Trust Chair To agree, as permitted by the National Health Service Act 2006 (as amended), the Trust's Constitution and the Standing Orders of the Board of Directors, that representatives of the press, members of the public and others not invited to attend to the next part of the meeting be excluded due to the confidential nature of the business to be transacted. 12 Follow-up discussion with governors 12:45 Page 3 Agenda links to the Board Assurance Framework (BAF) 9 September 2025 – Open Session Overview of the BAF Risk 1a: 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. 1b: Due to the current challenges, we fail to provide patients and their families / carers with a high-quality experience of care and positive patient outcomes. 1c: We do 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. 2a: We do not take full advantage of our position as a leading University teaching hospital with a growing, reputable, and innovative research and development portfolio, attracting the best staff and efficiently delivering the best possible treatments and care for our patients. 3a: We are unable to meet current and planned service requirements due to the unavailability of staff to fulfil key roles. 3b: We fail to develop a diverse, compassionate, and inclusive workforce, providing a more positive staff experience for all staff. 3c: We fail 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. 4a: We do 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. 5a: We are unable to deliver a financial breakeven position, resulting in: inability to move out of the NHS England Recovery Support Programme, NHS England imposing additional controls/undertakings, and a reducing cash balance impacting the Trust’s ability to invest in line with its capital plan, estates/digital strategies, and in transformation initiatives. 5b: We do not adequately maintain, improve and develop our estate to deliver our clinical services and increase capacity. 5c: Our digital technology or infrastructure fails to the extent that it impacts our ability to deliver care effectively and safely within the organisation, 5d: We fail to prioritise green initiatives to deliver a trajectory that will reduce our 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. Agenda links to the BAF No Item Linked BAF risk(s) 5.5 Performance KPI Report for Month 4 5.6 Operating Plan October 2025 – September 2026 5.8 Finance Report for Month 4 5.9 ICS Operational Delivery Report for Month 4 5.10 People Report for Month 4 5.11 Learning from Deaths 2025-26 Quarter 1 Report 5.12 Annual Complaints Report 2024-25 5.13 Medical Appraisal and Revalidation Annual Report including Board Statement of Compliance 5.14 Safeguarding Annual Report 2024-25 and Strategy 2025-26 1a, 1b, 1c 1a, 1b, 1c 5a 5a 3a, 3b, 3c 1b, 3b 1b, 3b 3b, 3c 1b Appetite (Category) Minimal (Safety) Current risk rating 4x5 20 Cautious (Experience) Minimal (Safety) 4x4 16 4x4 16 Open (Technology & Innovation) 3x4 12 Open (workforce) Open (workforce) Open (workforce) 4x5 20 4x3 12 4x4 16 Cautious (Effectiveness) 3x3 9 Cautious (Finance) 5x5 25 Target risk rating 4 x 2 Apr 6 27 3 x 2 Apr 6 27 2 x 3 Apr 6 27 3 x 2 Mar 6 27 4 x 3 Mar 12 30 4 x 2 Mar 8 30 3 x 2 Mar 6 29 3 x 2 Dec 6 25 3 x 3 Apr 9 30 Cautious (Effectiveness) Open (Technology & Innovation) Open (Technology & Innovation) 4x5 20 3x4 12 2x4 8 4 x 2 Apr 8 30 3 x 2 Apr 6 27 2 x 2 Dec 4 27 Does this item facilitate movement towards or away from the intended target risk score and appetite? Towards Away Neither x x x x x x x x x Minutes Trust Board – Open Session Date Time 15/07/2025 9:00 – 13:00 Location Chair Conference Room, Heartbeat/Microsoft Teams Jenni Douglas-Todd (JD-T) Present Gail Byrne, Chief Nursing Officer (GB) Keith Evans, Deputy Chair and NED (KE) David French, Chief Executive Officer (DAF) Paul Grundy, Chief Medical Officer (PG) Steve Harris, Chief People Officer (SH) Jane Harwood, NED/Senior Independent Director (JH) Ian Howard, Chief Financial Officer (IH) Duncan Linning-Karp, Interim Chief Operating Officer (DL-K) David Liverseidge, NED (DL) Tim Peachey, NED (TP) Alison Tattersall, NED (AT) In attendance Craig Machell, Associate Director of Corporate Affairs and Company Secretary (CM) Lauren Anderson, Corporate Governance and Risk Manager (LA) (shadowing CM) Julie Brooks, Deputy Director of Infection Prevention and Control) (JB) (item 5.12) Phil Bunting, Director of Operational Finance (PB) (item 7.2) Martin De Sousa, Director of Strategy and Partnerships (MDeS) (item 6.1) Christopher Kipps, Clinical Director of R&D (CK) (item 6.2) Christine Mbabazi, Equality & Inclusion Adviser/Freedom to Speak Up Guardian (CMb) (item 5.11) Laura Purandare, Deputy Director of R&D (LP) (item 6.2) Julian Sutton, Clinical Lead, Department of Infection (JS) (item 5.12) Karen Underwood, Director of R&D (KU) (item 6.2) 1 members of the public (item 2) 4 governors (observing) 3 members of staff (observing) 1 members of the public (observing) Apologies Diana Eccles, NED (DE) 1. Chair’s Welcome, Apologies and Declarations of Interest The Chair welcomed attendees to the meeting. There were no interests to declare in the business to be transacted at the meeting. It was noted that apologies had been received from Diana Eccles. 2. Patient Story Verity Elbro-White was invited to present her experience of the birth of her second child at Princess Anne Hospital. The mother was diabetic, and the pregnancy was complex. It was noted that: Page 1 • Both the community midwife and diabetic team had been excellent. The midwife had advised that the patient go to hospital because she was feeling unwell, following which she underwent a caesarean section. • The patient felt valued and listened to, with the care patient-centred. • The surgical and neonatal intensive care teams were also excellent and compassionate. • Attention was also paid to family members. 3. Minutes of the Previous Meeting held on 13 May 2025 The draft minutes tabled to the meeting were agreed to be an accurate record of the meeting held on 13 May 2025. 4. Matters Arising and Summary of Agreed Actions The matters arising and actions were noted. It was noted that action 1247 could be closed. 5. QUALITY, PERFORMANCE and FINANCE 5.1 Briefing from the Chair of the Audit and Risk Committee Keith Evans was invited to present the Committee Chair’s Report in respect of the meeting held on 9 June 2025, the content of which was noted. It was further noted that: • There had been a delay in the production of the Trust’s Annual Report and Accounts due to issues with reconciling information from the Trust’s ledgers into the accounts. NHS England had been notified, and it had been agreed that the Trust would submit its accounts by 21 July 2025. • The committee had reviewed the internal auditor’s report for 2024/25 and noted that out of the six reviews undertaken during the year, the results were good overall. • The committee received an update from the Trust’s external auditor and noted that it was necessary for the Trust to simplify its processes in order to prevent a repeat of the delay in producing end-of-year accounts. 5.2 Briefing from the Chair of the Finance and Investment Committee David Liverseidge was invited to present the Committee Chair’s Reports in respect of the meetings held on 2 June 2025 and 23 June 2025, the content of which was noted. It was further noted that: • The committee reviewed the Finance Reports for Month 1 and Month 2 (item 5.8), noting that the Trust’s reported deficit remained in line with its plan. • The Trust’s underlying deficit remained at c.£7m per month. • The committee reviewed the Trust’s Cost Improvement Programme, noting that the Trust was targeting £110m of savings for 2025/26. It was further noted that even with full delivery of the Trust’s workforce plans, there would still be a shortfall. • The committee received an update on the contracting process for 2025/26, noting that there was a risk that there would be £20-30m of unfunded activity during the year based on the current position. • The committee also continued to monitor the Trust’s cash position. Page 2 5.3 Briefing from the Chair of the People and Organisational Development Committee Jane Harwood was invited to present the Committee Chair’s Report in respect of the meeting held on 25 June 2025, the content of which was noted. It was further noted that: • The committee reviewed the People Report for Month 2 (item 5.10), noting that the Trust was on track in terms of its plan to reduce its workforce by c.700 and had received more than 220 applications under the Mutually Agreed Resignation Scheme. • The committee received an update on organisational change and the support being given to staff on managing change. • An update was provided in respect of the Trust’s education programmes, noting that there was a risk due to a lack of resource. • The committee would be reviewing the recently published 10-Year Plan in detail, particularly in terms of the organisational development elements and the plan’s implications for the Trust. 5.4 Briefing from the Chair of the Quality Committee Tim Peachey was invited to present the Committee Chair’s Report in respect of the meeting held on 2 June 2025 and to provide an update following the meeting held on 14 July 2025, the content of which was noted. It was further noted that: • There had been a further never event, although no harm had resulted. • The committee received a report on pressure ulcers and noted some concerns with respect to the regular turning of patients. • An update on the Fundamentals of Care programme was received and it was noted that improvement in general standards was limited in the absence of sufficient staff. • The committee noted an update in respect of job planning and that this provided good assurance of the process. • The committee reviewed the Maternity and Neonatal Safety Report for Quarter 4 and confirmed that there was nothing requiring escalation to the Board. Tim Peachey was invited to present the Maternity and Neonatal Workforce Report, the content of which was noted. It was further noted that: • The Trust expected to be compliant with the requirements of the NHS Resolution Maternity Incentive Scheme for 2025/26. • Although the Birthrate Plus assessment indicated a reduction in the birth rate, the acuity was, however, higher. • According to assessment, the Trust was approximately nine midwives below the required level. However, there was a plan in place to address this shortfall using the existing workforce. • There was a national shortage of neonatal nurses, although the Trust was attempting to address this issue through its in-house training programme. • In terms of the obstetrics workforce, there remained an issue with the number of trainees. 5.5 Chief Executive Officer’s Report David French was invited to present the Chief Executive Officer’s Report, the content of which was noted. It was further noted that: • The Trust had opened a new Neonatal ICU facility on 11 July 2025 as part of its work to improve the quality of the environment in the department. • The Government had published its 10-Year Health Plan for the NHS in England, which was based on reforming the NHS through three shifts: hospitals to community; analogue to digital; and sickness to prevention. Page 3 • NHS England had published the NHS Oversight Framework for 2025/26 under which organisations would be segmented based on their performance against a range of metrics. Whilst the Trust was one of the best performing trusts, the impact of a financial override and being in the Recovery Support Programme meant that the Trust would be placed in segment 5, the lowest category of performance. • Whilst the NHS waiting list nationally had fallen, the Trust’s waiting list has continued to grow. This was partially due to the impact of the cap on elective funding which had caused the Trust to cease outsourcing some procedures on the basis that it was not financially viable. • Notification had been received from the British Medical Association that resident doctors would embark on a five-day strike commencing on 25 July 2025. There was a risk of industrial action by other staffing groups, as both the Royal College of Nursing and Unite were conducting consultative ballots in respect of the 2025/26 pay award and other matters. 5.6 Performance KPI Report for Month 2 Duncan Linning-Karp was invited to present the Performance KPI Report for Month 2, the content of which was noted. It was further noted that: • In the spotlight on Referral To Treatment, despite the Trust treating more patients, its waiting list had grown by 1%. Certain services accounted for much of this growth, with other services seeing flat or reducing waiting lists. The increase had also been driven by the decision to cease outsourcing some specialities due to the impact of the elective recovery funding cap. • There were three ways to address the increasing size of the waiting list: refusing referrals, validation, and treating more. The ‘patient choice’ agenda made refusing out-of-area referrals difficult. • The Trust’s performance across the constitutional standards indicated that the Trust was operating in a challenging environment and was delivering at activity levels far in excess of pre-COVID-19 levels. • Attendances at the Emergency Department remained high, averaging 433 attendances per day across March, April and May 2025. The Trust’s performance against the four-hour standard was 56.2%, a reduction of 4.5% compared to April 2025. • There had also been a reported increase in the number of Category 2 Pressure Ulcers (per 1,000 bed days) to 0.37 in May 2025, above the target of 0.3. • The Trust continued to benchmark in the top quartile when compared to peer teaching organisations against the national cancer performance targets. • Pressure on flow had caused an increase in overnight ward moves. 5.7 Break 5.8 Finance Report for Month 2 Ian Howard was invited to present the Finance Report for Month 2, the content of which was noted. It was further noted that: • The Trust had reported an in-month deficit of £3.8m, which was consistent with the Trust’s annual plan. The underlying monthly deficit remained at £7.2m. • There had been a number of ‘one-offs’ during the month which had reduced the underlying deficit to meet the planned level of deficit. The Trust continued to target recurrent savings. • Whilst the Trust remained on an improving trajectory, there was some concern regarding the pace of improvement. Page 4 • The Trust was involved in a number of contractual disputes in respect of currently unfunded or insufficiently funded services. • The Trust’s cash position remained an area of concern and continued to be closely monitored. The Trust had five operating days of expenditure, although this was supported in month by holding c.£13m of payments. There remained a significant risk that the Trust’s cash balance would reduce to close to zero in the first half of 2025/26. 5.9 ICS Operational Delivery Report for Month 2 Ian Howard was invited the present the ICS Operational Delivery Report for Month 2, the content of which was noted. It was further noted that: • The previous ICB Finance Report had been expanded to now include operational and performance information across the system. • The Hampshire and Isle of Wight Integrated Care System had reported that it was on plan for Month 2 with a reported deficit year-to-date of £18.25m against a planned deficit of £18.3m. • All organisations in the system would receive deficit support funding for Quarter 1 and Quarter 2. Whilst there was no clear national picture, it was believed that other organisations were in a similar position. • The South East region’s plan for 2025/26 was for a deficit of £95m at Month 2. 5.10 People Report for Month 2 Steve Harris was invited to present the People Report for Month 2, the content of which was noted. It was further noted that: • In May 2025, the workforce grew by 19 whole-time-equivalents (WTE), although was still below plan by 107 WTE. In addition, in June 2025, there had been a reduction in the overall workforce size of 99 WTE driven by the closure of surge capacity and higher turnover during the month. • There had been a freeze on hiring for administrative and clerical roles since March 2025 and only 70% of clinical leavers were being replaced. However, patient demand was not reducing. • The Trust had carried out a divisional restructure, reducing its clinical divisions from four to three. • Even full delivery of the Trust’s Cost Improvement Programme workforce reduction schemes would still produce a shortfall in terms of the Trust’s achievement of its 2025/26 plan. Whilst the Trust was currently on plan in terms of its workforce numbers, it was expected that it would deviate from this later in the year. • The Trust had accepted 42 applications under the Mutually Agreed Resignation Scheme and a number of others were under consideration. The majority of accepted applicants were from clinical administration teams, • The Trust was carrying out work to benchmark its temporary pay rates against others. • Transparency about the changes was key to mitigate against the anxiety in the workforce. A number of engagement activities were taking place, including regular ‘Talk To David’ sessions. • An Equality and Quality Impact Assessment process was in place and was undertaken in respect of decisions. The impact of decisions would be monitored through the Quality Governance Steering Group. It was also Page 5 necessary to ensure that there was a strategic view of decisions rather than just individual cases. The Board discussed the controls on recruitment. The content of the discussion is summarised below: • It was questioned whether a complete freeze on non-clinical recruitment could be sustained for the full year, and that shortages in administrative staff were already having an impact. It was noted that there had already been restrictions on recruitment for these staff groups during the previous year. • It was noted that decisions made by providers in isolation could impact other providers. However, chief medical officers across the system had agreed to discuss plans collectively. 5.11 Freedom to Speak Up Report Christine Mbabazi was invited to present the Freedom to Speak Up Report, the content of which was noted. It was further noted that: • The Trust had received 37 Freedom to Speak Up cases between December 2024 and June 2025, compared to 64 cases during the same period in 2023/24. There had also been a lower number of patient safety and health and safety reports. • Although there had been fewer reports via Freedom To Speak Up, there were other routes for raising concerns and Freedom To Speak Up was meant to provide a route where other options were unavailable or not possible. • It had been reported that the National Guardian Office function was to be abolished. The Board discussed the report, the key points from which are summarised below: • The Freedom to Speak Up framework was designed to facilitate reporting of patient safety related concerns. However, there had been few such reports through this route, with the mechanism being used more as a conventional ‘speak up’ method to report matters such as bullying and harassment. • Moreover, it was not clear whether the lack of such reports via Freedom to Speak Up was an indicator whether the more conventional reporting mechanisms were working effectively and hence there was no requirement to use Freedom to Speak Up. • It was agreed that it would be helpful to have data from the other means of reporting patient safety concerns included in the report in order to provide greater assurance. Action Christine Mbabazi to include data from other mechanisms for reporting concerns in future Freedom to Speak Up reports. 5.12 Infection Prevention and Control 2024-25 Annual Report Julian Sutton and Julie Brooks were invited to present the Infection Prevention and Control 2024/25 Annual Report, the content of which was noted. It was further noted that: Page 6 • The Trust had exceeded the threshold for Clostridioides Difficile and Methicillin-resistant Staphylococcus aureus (MRSA) cases during the year. However, the Trust had been successful in improving antimicrobial stewardship by 1%. • There had been a surge in respiratory infections in early 2025, which the Trust had managed well due to the use of its rapid testing diagnostic tool. The Trust had also successfully mitigated outbreaks of norovirus. • The measures taken to prevent the spread of Candida auris had been successful with only four acquisitions since September 2024. • Only 59% of areas had achieved the accreditation scheme standard, but there were actions in place to address this and improve standards as well as support through the Fundamentals of Care programme. 5.13 Guardian of Safe Working Hours Quarterly Report Paul Grundy was invited to present the Guardian of Safe Working Hours Quarterly Report, the content of which was noted. It was further noted that: • There was a resident doctor vacancy rate of 8%, which was good compared with others. • Exception reports had decreased since the winter months. 711 exception reports had been received over the past 12 months, an average of 59 per month. • The People and Organisational Development Committee would continue to receive updates in respect of work being carried out to improve the lives of resident doctors. • The main challenge in terms of steps required to improve working conditions remained the Trust’s estate and the limited options for providing office space. 6. STRATEGY and BUSINESS PLANNING 6.1 Corporate Objectives 2025-26 Quarter 1 Review Martin de Sousa and Kelly Kent were invited to present the Corporate Objectives 2025/26 Quarter 1 Review, the content of which was noted. It was further noted that: • Twelve objectives had been agreed for 2025/26. • The Trust was on track with 75% of objectives recorded as ‘green’ and the balance being ‘amber’. • The main risks to achieving the Trust’s objectives related to availability of people and financial constraints. 6.2 Research and Development Plan 2025-26 Karen Underwood and Chris Kipps were invited to present the Research and Development Plan 2025/26, the content of which was noted. It was further noted that: • 2024/25 had been a challenging year, but despite this there had been a number of significant successes. These included an award to host a new Commercial Research Delivery Centre, launch of the South Central Regional Page 7 Research Delivery Network, and securing funding for a secure data environment. • There remained challenges in terms of available capacity to set up and deliver studies. • Key Performance Indicators were to be focused on national priorities. • The plan for 2025/26 would focus on efficiency and working regionally. • The Trust had increased the size of its commercial portfolio. However, there needed to be a balance with non-commercial studies to support the Trust’s wider strategy. Decision Having considered the proposed Research and Development Plan for 2025/26, the Board approved the plan. 6.3 Board Assurance Framework (BAF) Update and Risk Appetite Statement Lauren Anderson was invited to present the Board Assurance Framework (BAF) Update, the content of which was noted. It was further noted that: • All risks had been reviewed by the relevant executive(s) and by the Board’s committees since the Board Assurance Framework was last presented to the Board. • The risk ratings had been increased for three risks. This was broadly due to the tension between the Trust’s finances and increasing demand. As a result, 60% of BAF risks were now at the ‘critical’ level. • The risk descriptions indicated crossover in terms of mitigations, demonstrating a holistic approach to risk management. Lauren Anderson was invited to present the Trust’s Risk Appetite Statement, the content of which was noted. It was further noted that: • The Trust’s Risk Appetite Statement had been updated following the Trust Board Study Session held on 3 June 2025. • Due to the current environment, the Trust was required to tolerate a higher level of risk. • The main changes in terms of risk appetite were to reflect the need to make decisions that might adversely impact patient experience and a lower appetite for financial risk. Decision: The Board agreed the Risk Appetite Statement tabled to the meeting. 7. CORPORATE GOVERNANCE, RISK and INTERNAL CONTROL 7.1 Register of Seals and Chair’s Actions Report The paper ‘Register of Seals and Chair’s Actions Report’ was presented to the meeting, the content of which was noted. Page 8 Decision: The Board agreed to ratify the application of the Trust Seal to the documents listed in the ‘Register of Seals and Chair’s Actions Report’. 7.2 Review of Standing Financial Instructions 2025 Ian Howard was invited to present the review of the Standing Financial Instructions, the content of which was noted. It was further noted that: • There were two main changes proposed: an additional section on employee expenses and reducing non-pay approval limits for certain bands. • The Standing Financial Instructions had been benchmarked against others to address differences of approach. • The proposed changes had been reviewed and supported by the Audit and Risk Committee at its meeting held on 9 June 2025. Decision: The Board approved the proposed changes to the Standing Financial Instructions tabled to the meeting. 8. Any other business There was no other business. 9. Note the date of the next meeting: 9 September 2025 10. Resolution regarding the Press, Public and Others Decision: The Board resolved that, as permitted by the National Health Service Act 2006 (as amended), the Trust’s Constitution and the Standing Orders of the board of directors, that representatives of the press, members of the public and others not invited to attend to the next part of the meeting be excluded due to the confidential nature of the business to be transacted. The meeting was adjourned. Page 9 List of action items Agenda item Assigned to Deadline Status Trust Board – Open Session 13/05/2025 - 5.6 Performance KPI Report for Month 12 1246. Virtual outpatients appointments Linning-Karp, Duncan 09/09/2025 Pending Explanation action item Duncan Linning-Karp agreed to investigate why the number of virtual outpatients appointments had reduced. Trust Board – Open Session 15/07/2025 - 5.11 Freedom to Speak Up Report 1267. Data Mbabazi, Christine 13/01/2026 Pending Explanation action item Christine Mbabazi to include data from other mechanisms for reporting concerns in future Freedom to Speak Up reports. Page 1 of 1 Agenda Item 5.1 i) Committee Chair’s Report to the Trust Board of Directors 9 September 2025 Committee: Finance and Investment Committee Meeting Date: 21 July 2025 Key Messages: • • • • • • • • • The committee reviewed the Finance Report for Month 3, noting that the Trust had reported a £4.5m in-month deficit. This was £1.1m above the plan submitted to NHS England. The Trust’s underlying deficit was £6.5m in month and income had been lower than expected. Whilst the Trust’s financial trajectory was improving, it was not improving at the rate required to deliver the plan. The committee received an update in respect of the Trust’s cash position, noting that the Trust had received additional cash from the ICB during the month. However, the Trust expected to record a negative cash balance in December 2025. Accordingly, the Trust was investigating further measures to manage its cash position. There was also a risk due to any unfunded elements of the pay award and additional costs due to industrial action. The committee reviewed the Trust’s CIP performance, noting that whilst the Trust was close to full achievement, there had been fewer recurrent schemes delivered than anticipated with a greater proportion of savings being delivered through non-recurrent savings. The committee received an update in respect of the Trust’s productivity, noting that this would be one of the metrics to be included in the new NHS Oversight Framework. The committee received an update regarding the Outpatient Transformation Programme. The committee reviewed Wessex NHS Procurement Limited’s performance, including its delivery of CIP. The committee received the quarterly UHS Digital report. The committee received an update on the proposed Hampshire and Isle of Wight elective hub and on a possible Urgent Treatment Centre at Southampton General Hospital. Assurance: N/A (Reports/Papers reviewed by the Committee also appearing on the Board agenda) Any Other N/A Matters: Assurance Rating: Substantial There is a robust series of suitably designed internal controls in place upon Assurance which the organisation relies to manage the risk of failure of the continuous and effective achievement of the objectives of the process, which at the time of our review were being consistently applied. Reasonable There is a series of controls in place, however there are potential risks that Assurance may not be sufficient to ensure that the individual objectives of the process are achieved in a continuous and effective manner. Improvements are required to enhance the adequacy and effectiveness of the controls to mitigate these risks. Page 1 of 2 Limited Assurance No Assurance Not Applicable Controls in place are not sufficient to ensure that the organisation can rely upon them to manage the risks to the continuous and effective achievement of the objectives of the process. Significant improvements are required to improve the adequacy and effectiveness of the controls. There is a fundamental breakdown or absence of core internal controls such that the organisation cannot rely upon them to manage the risks to the continuous and effective achievement of the objectives of the process. Immediate action is required to improve the adequacy and effectiveness of controls. Where assurance is not required and/or relevant. Risk Rating: Low Medium High Not Applicable Based on the report considered by the committee, there is little or no concern that the Trust will be unable to meet its stated objectives and/or plans. There is some concern that the Trust might not be able to fully meet its stated objectives and/or plans based on the information contained in the report considered by the committee. There is a significant risk that the Trust will not be able to meet its stated objectives and/or plans based on the information contained in the report considered by the committee. Where risk rating is not relevant. Page 2 of 2 Agenda Item 5.1 ii) Committee Chair’s Report to the Trust Board of Directors 9 September 2025 Committee: Finance and Investment Committee Meeting Date: 2 September 2025 Key Messages: • • • • • • The committee reviewed the Finance Report for Month 4 (see below). The committee reviewed and discussed a draft of the Trust’s Financial Recovery Plan, which was to be reviewed by the Board on 9 September 2025. The committee requested some clarifications and proposed some additions to ensure that long-term implications were understood. These changes would be incorporated into the paper to go to the Board. Suggestions for further action were also raised, but some of these had been discounted due to the impact on operations and detriment to the short-term position. The committee received an update in respect of the Trust’s cash position, noting that the Trust had received cash advances in June and July and that the ICB had agreed to provide additional cash in August and September. In addition, the process for requesting cash support from NHS England had now been published, although this would likely require some adjustments to the Trust’s governance to establish a ‘cash committee’ – it was considered appropriate to review the terms of reference for the Finance and Investment Committee and possibly to separate out the cash monitoring activities. It was further noted that NHS England had published guidance which suggested that trusts should have a minimum of four days’ operating expenditure in cash. The committee supported the submission of a request for cash support from NHS England, noting that the consequences of not receiving such support would be extremely serious (see also BAF review below). The committee received an update in respect of ongoing and recent contracting disputes, noting that a number of significant disputes had been closed and two remain in dispute and have been escalated. Assurance: (Reports/Papers reviewed by the Committee also appearing on the Board agenda) 5.8 Finance Report for Month 4 Assurance Rating: Risk Rating: Substantial High • The Trust had recorded a year-to-date deficit of £19.5m, which was £5.8m above its 2025/26 plan. • There had not been the one-off benefits seen in previous months during Month 4, which meant that the Trust’s position had worsened. However, its underlying month-on-month deficit was improving with £6.5m being recorded in month (previous months had been c.£7m). • The Trust had also received less income than anticipated from areas such as the Channel Islands, genomics, pathology, and CAR(T). There was also a risk that the Trust would not be fully paid for its over performance in terms of elective work, but this was being pursued with the relevant commissioners. • The Trust was also above its workforce plan by 55 whole-timeequivalents and the unfunded element of the pay award amounted to £2.4m per annum, of which £1.4m related to the training and Page 1 of 2 Any Other Matters: education contract and the balance being as a result of the settlement not accurately reflecting the Trust’s staffing mix. • However, the Trust was on track in terms of its CIP delivery, albeit there had been higher non-recurrent delivery than expected. 6.1 Board Assurance Framework (BAF) Update Assurance Rating: Risk Rating: Substantial N/A • Risks 5a, 5b and 5c have been updated, following discussions with the respective Executive Director(s). • It had been agreed to increase the rating of risk 5a from 20 to 25 on the basis that the Trust did not, currently, have an agreement for the provision of cash support, and that the Trust was reliant on third parties to resolve many of the underlying issues. It was also noted that the need to reduce activity and spending now would likely require increased expenditure in future years in order to recover the Trust’s position. • It was agreed that the target risk ratings should be amended to show a rating of 20 at April 2026 and 15 at April 2027. The committee noted new guidance in respect of strengthening financial management and supporting delivery in 2025/26. Assurance Rating: Substantial There is a robust series of suitably designed internal controls in place upon Assurance which the organisation relies to manage the risk of failure of the continuous and effective achievement of the objectives of the process, which at the time of our review were being consistently applied. Reasonable There is a series of controls in place, however there are potential risks that Assurance may not be sufficient to ensure that the individual objectives of the process are achieved in a continuous and effective manner. Improvements are required to enhance the adequacy and effectiveness of the controls to mitigate these risks. Limited Assurance Controls in place are not sufficient to ensure that the organisation can rely upon them to manage the risks to the continuous and effective achievement of the objectives of the process. Significant improvements are required to improve the adequacy and effectiveness of the controls. No Assurance There is a fundamental breakdown or absence of core internal controls such that the organisation cannot rely upon them to manage the risks to the continuous and effective achievement of the objectives of the process. Immediate action is required to improve the adequacy and effectiveness of controls. Not Applicable Where assurance is not required and/or relevant. Risk Rating: Low Medium High Not Applicable Based on the report considered by the committee, there is little or no concern that the Trust will be unable to meet its stated objectives and/or plans. There is some concern that the Trust might not be able to fully meet its stated objectives and/or plans based on the information contained in the report considered by the committee. There is a significant risk that the Trust will not be able to meet its stated objectives and/or plans based on the information contained in the report considered by the committee. Where risk rating is not relevant. Page 2 of 2 Agenda Item 5.2 i) Committee Chair’s Report to the Trust Board of Directors 9 September 2025 Committee: People and Organisational Development Committee Meeting Date: 21 July 2025 Key Messages: • • • • • • • The committee reviewed the People Report for Month 3 and noted that the size of the workforce had reduced during June 2025. There had been 110 whole-time-equivalent (WTE) staff who left during the month and the Trust was phasing new starters. In addition, the Trust had been able to close surge capacity and was closing wards, which had led to a reduction in bank staff use. Based on the forecast, the Trust expected to be c.350 WTE short of its 2025/26 plan based on the delivery of the ‘green’ and ‘amber’ rated CIP programmes. The Trust continued to experience increased demand and there had been an increase in the number of patients having no criteria to reside. In addition, new resident doctors and newly qualified nurses would impact the Trust’s workforce numbers and the forecast made no assumptions regarding industrial action. The committee noted that administrative and clerical staff had been hardest hit by the recruitment restrictions over the past two years, which was causing difficulties in some areas. The committee discussed the potential intake of newly qualified nurses, noting the difficulty of balancing the Trust’s short-term concerns of needing to reduce its workforce with the longer term need for qualified staff. The committee received an update on the organisational change activities underway, including the proposed divisional restructure and MARS programme. The committee received an update in respect of the planned industrial action by resident doctors. The committee reviewed the National Education and Training Survey for 2024, which covered all staff in training posts in the NHS. Assurance: N/A (Reports/Papers reviewed by the Committee also appearing on the Board agenda) Any Other Matters: • The committee reviewed five draft Equality and Quality Impact Assessments relating to the measures required to deliver the Trust’s 2025/26 plan. Assurance Rating: Substantial There is a robust series of suitably designed internal controls in place upon Assurance which the organisation relies to manage the risk of failure of the continuous and effective achievement of the objectives of the process, which at the time of our review were being consistently applied. Reasonable There is a series of controls in place, however there are potential risks that Assurance may not be sufficient to ensure that the individual objectives of the process are achieved in a continuous and effective manner. Improvements are required to enhance the adequacy and effectiveness of the controls to mitigate these risks. Page 1 of 2 Limited Assurance No Assurance Not Applicable Controls in place are not sufficient to ensure that the organisation can rely upon them to manage the risks to the continuous and effective achievement of the objectives of the process. Significant improvements are required to improve the adequacy and effectiveness of the controls. There is a fundamental breakdown or absence of core internal controls such that the organisation cannot rely upon them to manage the risks to the continuous and effective achievement of the objectives of the process. Immediate action is required to improve the adequacy and effectiveness of controls. Where assurance is not required and/or relevant. Risk Rating: Low Medium High Not Applicable Based on the report considered by the committee, there is little or no concern that the Trust will be unable to meet its stated objectives and/or plans. There is some concern that the Trust might not be able to fully meet its stated objectives and/or plans based on the information contained in the report considered by the committee. There is a significant risk that the Trust will not be able to meet its stated objectives and/or plans based on the information contained in the report considered by the committee. Where risk rating is not relevant. Page 2 of 2 Agenda Item 5.2 ii) Committee Chair’s Report to the Trust Board of Directors 9 September 2025 Committee: People and Organisational Development Committee Meeting Date: 1 September 2025 Key Messages: • • • • • • The committee reviewed the People Report for Month 4 (see below). The committee noted the recent announcement by the Government of a ‘graduate guarantee’ for nurses. It was noted that, prior to this announcement, the Trust had decided to increase the level of offers to newly qualified nurses, but to phase start dates in line with predicted turnover and anticipated vacancies in nursing posts. The committee noted that there were significant challenges across the organisation with staff impacted by multiple factors, including: increased car parking rates, building work requiring temporary relocation of 300-400 car park users to Adanac (Park and Ride), a reduction in enhanced bank rates back to standard Agenda for Change levels, and a decision to no longer offer free tea and coffee in theatres for staff (in line with other areas of the Trust). This coupled with the ongoing financial environment and workforce controls would impact staff engagement and satisfaction with the Staff Survey due to launch at the end of September 2025. The committee also expressed its concern for staff – particularly those from overseas – in view of the recent political climate regarding immigration. The committee reviewed the workforce related elements of the Trust’s proposed recovery plan, noting that the Trust was dependent on a number of material assumptions in order to be able to meet its 2025/26 plan. These included: availability of funding for further restructuring, reductions in mental health and no criteria to reside numbers, and reduction in overall activity levels. The committee received an update in respect of the industrial action undertaken by resident doctors in July 2025 and noted that about one third of staff eligible took part in the strike and that most clinical activity continued. It was also noted that F1 doctors were to be balloted separately by the BMA with the focus more on pay and availability of training places. The Trust has been required to produce a selfassessment of ten actions relating to doctors’ working conditions and to determine how to achieve these actions which will be presented to committee and to Board through the update by the Guardian of Safe Working at UHS. Assurance: (Reports/Papers reviewed by the Committee also appearing on the Board agenda) 5.10 People Report for Month 4 Assurance Rating: Risk Rating: Substantial High • The overall workforce had increased by 10 whole-time-equivalents (WTE) in July 2025. Whilst the substantive workforce had decreased by 18 WTE, increased numbers of mental health cases, coupled with industrial action, had led to an increase in use of temporary staff. • Accordingly, the Trust was above the NHSE 2025/26 workforce plan by 55 WTE. • 65 applications under the Mutual Agreed Resignation Scheme (MARS) had been approved with all successful applicants due to leave Page 1 of 2 Any Other Matters: by the end of November 2025. This would deliver a recurrent saving of £2.2m based on the whole-year saving, albeit at a one-off cost of £1.1m, which meant that it was broadly cost neutral for 2025/26. • The Trust completed its divisional restructure on 1 July 2025, which was expected to deliver a saving of £700k and 12 WTE 7.2 People and Organisational Assurance Rating: Risk Rating: Development Committee Terms N/A N/A of Reference • The committee reviewed its terms of reference and recommended that the Board approve the updated terms of reference. • Only one minor change was proposed – to remove reference to the Charitable Funds Committee on the basis that this committee no longer existed. N/A Assurance Rating: Substantial There is a robust series of suitably designed internal controls in place upon Assurance which the organisation relies to manage the risk of failure of the continuous and effective achievement of the objectives of the process, which at the time of our review were being consistently applied. Reasonable There is a series of controls in place, however there are potential risks that Assurance may not be sufficient to ensure that the individual objectives of the process are achieved in a continuous and effective manner. Improvements are required to enhance the adequacy and effectiveness of the controls to mitigate these risks. Limited Assurance Controls in place are not sufficient to ensure that
Url: /Media/UHS-website-2019/Docs/About-the-Trust/Trust-governance-and-corporate-docs/2025-Trust-documents/Papers-Trust-Board-9-September-2025.pdf

Papers Trust Board - 7 January 2025

Description: Date Time Location Chair Observing Agenda Trust Board – Open Session 07/01/2025 9:00 - 13:00 Conference Room, Heartbeat/Microsoft Teams Jenni Douglas-Todd Fatemeh Jenabi, Specialty Registrar (shadowing Joe Teape) 1 Chair’s Welcome, Apologies and Declarations of Interest 9:00 Note apologies for absence, and to hear any declarations of interest relating to any item on the Agenda. 2 Patient Story The patient story provides an opportunity for the Board to reflect on the experiences of patients and staff within the Trust and understand what the Trust could do better. 3 Minutes of Previous Meeting held on 5 November 2024 9:15 Approve the minutes of the previous meeting held on 5 November 2024 4 Matters Arising and Summary of Agreed Actions To discuss any matters arising from the minutes, and to agree on the status of any actions assigned at the previous meeting. 5 QUALITY, PERFORMANCE and FINANCE Quality includes: clinical effectiveness, patient safety, and patient experience 5.1 Briefing from the Chair of the Finance and Investment Committee 9:20 Dave Bennett, Chair 5.2 Briefing from the Chair of the People and Organisational Development 9:25 Committee Jane Harwood, Chair 5.3 Briefing from the Chair of the Quality Committee 9:30 Tim Peachey, Chair including Maternity and Neonatal Safety 2024-25 Quarter 2 Report 5.4 Chief Executive Officer's Report 9:40 Receive and note the report Sponsor: David French, Chief Executive Officer 5.5 Performance KPI Report for Month 8 10:00 Review and discuss the report Sponsor: David French, Chief Executive Officer 5.6 Break 10:35 5.7 Finance Report for Month 8 10:45 Review and discuss the report Sponsor: Ian Howard, Chief Financial Officer 5.8 ICB Finance Report for Month 8 10:55 Receive and discuss the report Sponsor: David French, Chief Executive Officer 5.9 People Report for Month 8 11:05 Review and discuss the report Sponsor: Steve Harris, Chief People Officer 5.10 Freedom to Speak Up Report 11:15 Review and discuss the report Sponsor: Gail Byrne, Chief Nursing Officer Attendee: Christine Mbabazi, Equality & Inclusion Adviser/Freedom to Speak Up Guardian 5.11 Guardian of Safe Working Hours Quarterly Report 11:25 Receive and discuss the report Sponsor: Paul Grundy, Chief Medical Officer Attendee: Diana Hulbert, Guardian of Safe Working Hours and Emergency Department Consultant 5.12 Learning from Deaths 2024-25 Quarter 2 Report 11:35 Review and discuss the report Sponsor: Paul Grundy, Chief Medical Officer Attendees: Natasha Watts, Deputy Chief Nursing Officer/Jenny Milner, Associate Director of Patient Experience 5.13 Infection Prevention and Control 2024-25 Quarter 2 Report 11:45 Review and discuss the report Sponsor: Gail Byrne, Chief Nursing Officer Attendees: Julian Sutton, Lead Infection Control Director/Julie Brooks, Deputy Director of Infection Prevention & Control 5.14 Annual Medicines Management 2023-24 Report 11:55 Receive and discuss the report Sponsor: Paul Grundy, Chief Medical Officer Attendee: James Allen, Chief Pharmacist 5.15 Annual Ward Staffing Nursing Establishment Review 2024 12:05 Discuss and approve the review Sponsor: Gail Byrne, Chief Nursing Officer Attendee: Rosemary Chable, Head of Nursing for Education, Practice and Staffing Page 2 6 STRATEGY and BUSINESS PLANNING 6.1 Board Assurance Framework (BAF) Update 12:15 Review and discuss the update Sponsor: Gail Byrne, Chief Nursing Officer Attendees: Craig Machell, Associate Director of Corporate Affairs and Company Secretary/Lauren Anderson, Corporate Governance and Risk Manager 7 CORPORATE GOVERNANCE, RISK and INTERNAL CONTROL 7.1 Annual Assurance for the NHS England Core Standards for Emergency 12:25 Preparedness, Resilience and Response (EPRR) Review and discuss the report Sponsor: Joe Teape, Chief Operating Officer Attendees: John Mcgonigle, Emergency Planning & Resilience Manager/ Danielle Sinclair, Deputy Emergency Planner 7.2 Register of Seals and Chair's Actions Report 12:30 Receive and ratify In compliance with the Trust Standing Orders, Financial Instructions, and the Scheme of Reservation and Delegation. Sponsor: Jenni Douglas-Todd, Trust Chair 8 Any other business 12:35 Raise any relevant or urgent matters that are not on the agenda 9 Note the date of the next meeting: 11 March 2025 10 Resolution regarding the Press, Public and Others Sponsor: Jenni Douglas-Todd, Trust Chair To agree, as permitted by the National Health Service Act 2006 (as amended), the Trust's Constitution and the Standing Orders of the Board of Directors, that representatives of the press, members of the public and others not invited to attend to the next part of the meeting be excluded due to the confidential nature of the business to be transacted. 11 Follow-up discussion with governors 12:45 Page 3 Agenda links to the Board Assurance Framework (BAF) 7 January 2025 – Open Session Overview of the BAF Risk 1a: 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. 1b: Due to the current challenges, we fail to provide patients and their families / carers with a high-quality experience of care and positive patient outcomes. 1c: We do 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. 2a: We do not take full advantage of our position as a leading University teaching hospital with a growing, reputable, and innovative research and development portfolio, attracting the best staff and efficiently delivering the best possible treatments and care for our patients. 3a: We are unable to meet current and planned service requirements due to the unavailability of staff to fulfil key roles. 3b: We fail to develop a diverse, compassionate, and inclusive workforce, providing a more positive staff experience for all staff. 3c: We fail 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. 4a: We do 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. 5a: We are unable to deliver a financial breakeven position, resulting in: inability to move out of the NHS England Recovery Support Programme, NHS England imposing additional controls/undertakings, and a reducing cash balance impacting the Trust’s ability to invest in line with its capital plan, estates/digital strategies, and in transformation initiatives. 5b: We do not adequately maintain, improve and develop our estate to deliver our clinical services and increase capacity. 5c: Our digital technology or infrastructure fails to the extent that it impacts our ability to deliver care effectively and safely within the organisation, 5d: We fail to prioritise green initiatives to deliver a trajectory that will reduce our 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. Agenda links to the BAF No Item Linked BAF risk(s) 5.5 Performance KPI Report for Month 8 5.7 Finance Report for Month 8 5.8 ICB Finance Report for Month 8 5.9 People Report for Month 8 5.10 Freedom to Speak Up Report 5.11 Guardian of Safe Working Hours Quarterly Report 5.12 Learning from Deaths 2024-25 Quarter 2 Report 5.13 Infection Prevention Control 2024-25 Quarter 2 Report 5.14 Annual Medicines Management 2023-24 Report 5.15 Annual Ward Staffing Nursing Establishment Review 2024 7.1 Annual Assurance for the NHS England Core Standards for Emergency Preparedness, Resilience and Response (EPPR) 1a, 1b, 1c 5a 5a 3a, 3b, 3c 3b 3a, 3b 1b 1c All 1b, 3a 1a, 3a, 5b, 5c Appetite (Category) Minimal (Safety) Current risk rating 4x5 20 Cautious (Experience) Minimal (Safety) 3x3 9 4x4 16 Open (Technology & Innovation) 3x3 9 Open (workforce) Open (workforce) Open (workforce) 4x5 20 4 x3 12 4x3 12 Cautious (Effectiveness) 3x3 9 Cautious (Finance) 3x5 15 Target risk rating 4 x 2 Apr 6 27 3 x 2 Mar 6 26 2 x 3 Apr 6 27 3 x 2 Mar 6 25 4 x 3 Mar 12 26 4 x 2 Mar 8 27 3 x 2 Mar 6 25 3 x 2 Apr 6 25 3 x 3 Apr 9 25 Cautious (Effectiveness) Open (Technology & Innovation) Open (Technology & Innovation) 4x5 20 3x4 12 2x3 6 4 x 2 Apr 8 27 3 x 2 Apr 6 27 2 x 2 Dec 4 24 Does this item facilitate movement towards or away from the intended target risk score and appetite? Towards Away Neither x x x x x x x x x x x Minutes Trust Board – Open Session Date 05/11/2024 Time 9:00 – 11:30 Location The Ark Conference Centre, HHFT/Microsoft Teams Chair Jenni Douglas-Todd (JD-T) Present Dave Bennett, NED (DB) Gail Byrne, Chief Nursing Officer (GB) Keith Evans, Deputy Chair and NED (KE) David French, Chief Executive Officer (DAF) Paul Grundy, Chief Medical Officer (PG) Steve Harris, Chief People Officer (SH) Jane Harwood, NED/Senior Independent Director (JH) Ian Howard, Chief Financial Officer (IH) Tim Peachey, NED (TP) Joe Teape, Chief Operating Officer (JT) Alison Tattersall, NED (AT) In attendance Martin De Sousa, Director of Strategy and Partnerships (MDeS) (item 5.1) Craig Machell, Associate Director of Corporate Affairs and Company Secretary (CM) Ali Keen, Head of Cancer Nursing (AK) (item 4.11) Kelly Kent, Head of Strategy and Partnerships (KK) (item 5.1) 4 governors (observing) 2 members of staff (observing) 2 members of the public (observing) Apologies Diana Eccles, NED (DE) 1. Chair’s Welcome, Apologies and Declarations of Interest The Chair welcomed attendees to the meeting. There were no interests to declare in the business to be transacted at the meeting. It was noted that apologies had been received from Diana Eccles. The Chair provided an overview of her activities since September 2024, including visits to hospital departments, meetings with peers and other key stakeholders. 2. Minutes of the Previous Meeting held on 10 September 2024 The draft minutes tabled to the meeting were agreed to be an accurate record of the meeting held on 10 September 2024. 3. Matters Arising and Summary of Agreed Actions In respect of action 1175, it was noted that there had been an increase in the number of incidents of delays in giving of medication or pain relief, missed symptoms, and insufficient staffing numbers. However, in part the increase in numbers of incidents was considered to be due to efforts to encourage reporting of such incidents, and the situation had improved more recently. It was agreed to close this action. Page 1 It was noted that there were no other matters arising or overdue actions. 4. QUALITY, PERFORMANCE and FINANCE 4.1 Briefing from the Chair of the Audit and Risk Committee The chair of the Audit and Risk Committee was invited to present the Committee Chair’s Report in respect of the meeting held on 14 October 2024, the content of which was noted. It was further noted that: • The committee reviewed the lessons learned from the 2023/24 annual accounts, and noted that the issues encountered should be resolved in time for the 2024/25 accounts due, largely, to the implementation of a new finance system. • The committee also received a report in respect of the risk of impersonation fraud for bank/agency staff and the procedures that had been put in place to mitigate this risk. 4.2 Briefing from the Chair of the Finance and Investment Committee The chair of the Finance and Investment Committee was invited to present the Committee Chair’s Report in respect of the meeting held on 21 October 2024, the content of which was noted. It was further noted that: • The committee had reviewed the Finance Report for Month 6 (item 4.7) and discussed the Trust’s re-commitment to its 2024/25 plan in support of its request for deficit support funding from NHS England. • The position in respect of cash was challenging and the committee discussed what the Trust should do in the final quarter of 2024/25. It was noted that the rules on when and how much cash support could be requested were somewhat unclear. • The committee discussed a potential expansion of the activities of UHS Pharmacy Limited, although it was subsequently noted that the specific potential opportunity had since failed to materialise. • The committee also discussed the Trust’s financial recovery programme. 4.3 Briefing from the Chair of the People and Organisational Development Committee The chair of the People and Organisational Development Committee was invited to present the Committee Chair’s Report in respect of the meeting held on 21 October 2024, the content of which was noted. It was further noted that: • The Trust had been below its plan in terms of whole-time-equivalent (WTE) numbers, although this position would change from October 2024 onward due to the onboarding of newly qualified nurses and the failure of the Integrated Care System transformation plans to deliver in terms of reduction in patients having no criteria to reside and mental health support. • The committee noted the cumulative impact on staff of having to balance staff numbers, performance, and patient experience. • Whilst noting that the annual appraisal rate remained low, it was suspected that more appraisals than recorded had taken place, but that these had not been recorded on the Electronic Staff Record. 4.4 Briefing from the Chair of the Quality Committee The chair of the Quality Committee was invited to present the Committee Chair’s Report in respect of the meeting held on 14 October 2024, the content of which was noted. It was further noted that: Page 2 • Patients’ access to a rehabilitation and recovery service during and after intensive care unit (ICU) admission was limited due to a lack of service provision. The Trust was non-compliant with national guidance in this area. • Due to resource constraints the Trust was unable to systematically roll out the National Safety Standards for Invasive Procedures (NatSSIPS) 2. However, it was noted that a solution to this issue was being considered. • There had been no significant improvement in terms of the Trust’s system partners in respect of supporting the Trust with mental health admissions. • The committee also reviewed the Maternity and Neonatal Safety Report, based on data available at September 2024, and including the NHS Resolution Maternity Incentive Scheme Year 6 progress update, the local response to the Care Quality Commission’s National Report Review of Maternity Services in England 2022-2024, and the Antenatal and Newborn Screening Annual Report 2023/24. 4.5 Chief Executive Officer’s Report David French was invited to present the Chief Executive Officer’s Report, the content of which was noted. It was further noted that: • Whilst the commitment in the Autumn Statement to additional funding for the NHS was welcomed, it was unclear at this stage what this additional funding will mean in practice and how it would be allocated. • There had been recent media coverage of the Trust’s ongoing dispute with its porters following a press release by the UNITE union. • Arbitration proceedings were expected to commence in respect of a long- running dispute with BAM Construction relating to the construction of the east wing annex building. • Significant changes in employment legislation were anticipated between now and 2026, although, due to the nature of employment conditions in the NHS, it was not anticipated that these changes would have a significant impact on the Trust. • The new combined community provider, Hampshire and Isle of Wight Healthcare NHS Foundation Trust was launched on 1 October 2024. • A meeting had been held with the now independent hospital charity to discuss priorities over the medium term. • The national NHS staff survey had launched on 20 September 2024 and would run until 28 November 2024. It was noted that the participation rate thus far had been below that seen in previous years. • The Trust’s quality and patient safety partners programme had won the ‘Patient Involvement in Safety’ award at the Health Service Journal’s Patient Safety Awards on 16 September 2024. • There was a concern that the Government’s intended 10-Year Plan for the NHS, which was expected to redirect focus on prevention and community healthcare, could result in an immediate loss of funding for acute providers, i.e. before the longer-term preventative measures had had an opportunity to take effect. 4.6 Performance KPI Report for Month 6 Joe Teape was invited to present the Performance KPI Report for Month 6, the content of which was noted. It was further noted that: • The Trust’s overall performance was good compared to other teaching hospitals. In August 2024, the Trust was first for its 65-week wait performance, and second for the 60-day cancer metric. Page 3 • The month of October was proving to be challenging with increased bed occupancy and surge capacity having to be opened. Type 1 Emergency Department attendance was over 400 per day. • Whilst there had been improvements in the length of stay, the impact of this had largely been negated by the high demand being experienced. • The ‘W-45’ initiative was to be implemented at the end of November 2024, whereby ambulances would automatically hand over patients to emergency departments after 45 minutes. It was noted that this policy would potentially put strain the relationship between the Emergency Department and the South Central Ambulance Service (SCAS). • It was noted that there were potential issues with the data presented in terms of the number of virtual appointments and use of MyMedicalRecord. The Board discussed the high levels of attendance in the Emergency Department. It was noted that: • The Trust’s winter plans did not assume 400 attendances per day. • Attendances were typically of higher acuity, and did not appear to be as a result of patients being unable to access GP services. • The Trust had a number of projects underway in order to direct patients to alternative routes into the hospital, such as through the Same-Day Emergency Care service. • The importance of ensuring the wellbeing of staff during such a period of sustained demand was also noted. • In addition, the Trust had requested funding for GPs in the Emergency Department as had occurred in previous years as a means of reducing demand on the Emergency Department. Action: Joe Teape agreed to investigate the data in respect of virtual appointment and MyMedicalRecord numbers presented for Month 6. 4.7 Finance Report for Month 6 Ian Howard was invited to present the Finance Report for Month 6, the content of which was noted. It was further noted that: • The Trust had received additional funding in respect of 2023/24 Elective Recovery Fund (ERF) performance, funding for industrial action costs, and deficit support funding from NHS England. As a result, the Trust had recorded a year-to-date deficit of £8m, a variance of -£4.7m against plan. • The Trust’s underlying deficit continued to be £5-6m per month. • The Trust had 200-220 patients with no criteria to reside at any one time, and expected reductions in mental health demand had not been realised due to non-delivery of system programmes. • The Trust had also undertaken £17m of unpaid activity in the first half of 2024/25. • The Trust had recorded 130% ERF performance in month and 128% year-to- date. It also continued to maintain low bank and agency use, and had delivered £32m of Cost Improvement Programme benefits. • There was significant financial pressure throughout the NHS in England. 4.8 ICB Finance Report for Month 6 Ian Howard was invited to present the ICB Finance Report for Month 6, the content of which was noted. It was further noted that: • The report tabled to the meeting had been prepared by the Hampshire and Isle of Wight Integrated Care Board (ICB) for all providers in the system. Page 4 • The system’s 2024/25 plan targeted a deficit of £70m. • During the first half of 2024/25, the system had received £55m in deficit support funding from NHS England and a surplus of £20m would be required during the second half of the year in order to be able to meet its 2024/25 target. • Meeting the 2024/25 target would likely be challenging. • The system had yet to see any significant benefit from the six transformation programmes. • It was noted that the ICB report would benefit from additional information in respect of workforce and equality, diversity and inclusion. 4.9 Recovery Support Programme (RSP) Undertakings – Self Assessment Ian Howard was invited to present the paper ‘Recovery Support Programme (RSP) Undertakings – Self-Assessment’, the content of which was noted. It was further noted that: • In June 2024, the Trust, along with all other organisations in the Hampshire and Isle of Wight Integrated Care System (ICS) under the Recovery Support Programme had submitted a self-assessment in respect of the undertakings entered into in 2023. NHS England had provided feedback in respect of these self-assessments in August 2024. • All providers had been asked to provide a further self-assessment, which would then be incorporated into a system-wide response in January 2025. • The evidence supplied by the Trust in support of its self-assessment indicated significant engagement by the Trust’s Board with the organisation’s undertakings under the RSP as well as progress against these undertakings since the previous submission. • Factors such as the number of patients having no criteria to reside and other matters beyond the Trust’s control remained a concern in terms of the Trust’s ability to fully meet the undertakings. • The action plans for the ICS transformation programmes should be included as part of the Trust’s response to the request for a self-assessment. Decision Having discussed the proposed response by the Trust, the Board agreed the proposed self-assessment, and authorised David French and Ian Howard to submit it to the Hampshire and Isle of Wight Integrated Care Board, subject to there being no material changes prior to submission. 4.10 People Report for Month 6 Steve Harris was invited to present the People Report for Month 6, the content of which was noted. It was further noted that: • The Trust was currently under its 2024/25 plan by 249 whole-time-equivalents (WTE). However, this situation was expected to change in October 2024 due to the impact of onboarding of newly qualified nurses and midwives, and also due to non-delivery of ICS transformation programmes in non-criteria to reside and mental health, which assumed a reduction of 167 WTE. • The Trust benchmarked well in terms of its sickness absence rate and turnover. • The Trust had plans to transfer recording of appraisals from the Electronic Staff Record to the Visual Learning Environment platform, which was considered to be more ‘user friendly’ and was therefore expected to improve recorded appraisal numbers. Page 5 • The Trust was in active negotiations with Unison in respect of the Band 2/3 pay dispute. • The People and Organisational Development Committee was to examine the overall workforce picture in more detail. 4.11 Cancer Patient Experience Survey Results 2023 Ali Keen was invited to present the Cancer Patient Experience Survey Results 2023, the content of which was noted. It was further noted that: • The survey involved 132 trusts, and had a 58% response rate at UHS (1,064 patients). • At the Trust 15 out of 59 questions scored above the expected range, which indicated that the Trust was a positive outlier when compared to trusts of a similar size and demographic. • Patients with longer-term health conditions and women tended to have worse experiences than other groups. • The care by and quality of staff at the Trust were rated highly. • There were opportunities for improvement in some areas such as administration and communication around appointments. 5. STRATEGY and BUSINESS PLANNING 5.1 Corporate Objectives 2024-25 Quarter 2 Review Martin De Sousa and Kelly Kent were invited to present the Corporate Objectives 2024/25 Quarter 2 review, the content of which was noted. It was further noted that: • The report now incorporated a forecast for the end of year. • The overall picture was positive with 12 objectives shown as ‘green’, two as ‘amber’, and two as ‘red’. • The main areas of risk in terms of the objectives concerned the deliverability of a stretching financial plan. • The completion of year two of the Public Sector Decarbonisation Scheme was also at risk due to the state of steam duct tunnels, which required substantial remediation ahead of work commencing on the low temperature hot water system. 5.2 Board Assurance Framework (BAF) Update Craig Machell was invited to present the Board Assurance Framework Update, the content of which was noted. It was further noted that: • In September and October 2024, the Board’s committees had reviewed the BAF risks assigned to them, and the Audit and Risk Committee had reviewed the entire BAF. • As a result of these reviews, it had been agreed to increase the risk rating for Risk 1c (Infection Prevention Control) and to extend the target date. In addition, the target dates for all risks were to be reviewed to ensure that they were realistic. • The Board agenda now included an annex, which indicated where papers were linked to a BAF risk and the impact of any decision by the Board on the Trust’s achievement of its target risk rating. Furthermore, Board papers now Page 6 had a clear link to any relevant BAF risk included as part of the new cover sheet. 6. CORPORATE GOVERNANCE, RISK and INTERNAL CONTROL 6.1 Feedback from the Council of Governors’ (CoG) Meeting 23 October 2024 The Chair provided an overview of the meeting of the Council of Governors held on 23 October 2024. It was noted that the meeting had addressed the following matters: • Attendance at Council of Governors meetings • Appointment of a member of the Governors’ Nomination Committee • Planning for the Governors’ strategy session in December 2024 • Membership engagement • Feedback from the Working Groups • The external auditor’s report on the Annual Accounts In addition, on 31 October 2024, the Council of Governors had met with the Hampshire and Isle of Wight ICB to discuss future plans for the system and opportunities for collaboration between providers. 6.2 Register of Seals and Chair’s Actions Report The paper ‘Register of Seals and Chair’s Actions Report’ was presented to the meeting, the content of which was noted. Decision: The Board agreed to ratify the application of the Trust Seal to the documents listed in the ‘Register of Seals and Chair’s Actions Report’. 7. Any other business There was no other business. 8. Note the date of the next meeting: 7 January 2025 9. Items circulated to the Board for reading The item circulated to the Board for reading was noted. There being no further business, the meeting concluded. 10. Resolution regarding the Press, Public and Others Decision: The Board resolved that, as permitted by the National Health Service Act 2006 (as amended), the Trust’s Constitution and the Standing Orders of the board of directors, that representatives of the press, members of the public and others not invited to attend to the next part of the meeting be excluded due to the confidential nature of the business to be transacted. The meeting was adjourned. Page 7 List of action items Agenda item Assigned to Deadline Status Trust Board – Open Session 06/06/2024 5.6 Performance KPI Report for Month 1 1152. Digital Teape, Joe Explanation action item JT agreed to include Digital as an agenda item at a future Trust Board Study Session. 27/02/2025 Pending Update: Item tentatively scheduled for TBSS on 27/02/2025 Trust Board – Open Session 25/07/2024 5.4 Briefing from the Chair of the Quality Committee (Oral) 1163. Impact of technology Machell, Craig 27/02/2025 Pending Explanation action item Craig Machell agreed to add an item covering the impact of technology over the next 5-10 years to a future Trust Board Study Session agenda. Update: Item tentatively scheduled for 27/02/25 Study Session. Trust Board – Open Session 05/11/2024 4.6 Performance KPI Report for Month 6 1181. MyMedicalRecord (MMR) Teape, Joe 07/01/2025 Completed Explanation action item Joe Teape agreed to investigate the data in respect of virtual appointment and MyMedicalRecord numbers presented for Month 6. Update: The issue was related to the MMR – drop-in logins in month and the increase in the previous month which was noted in the Month 6 report, as oncology had been added to the system and all patients notified in that month driving a surge in logins. Page 1 of 1 Agenda Item 5.1 i) Committee Chair’s Report to the Trust Board of Directors 7 January 2025 Committee: Finance & Investment Committee Meeting Date: 25 November 2024 Key Messages: • • • • • • • • For month 7, the Trust had reported an in-month deficit of £4.5m and a £12.5m year-to-date deficit. The Trust was £9.2m behind plan. The non-delivery of system-wide transformation programmes represented approximately half of the overall deficit. The recent pay awards resulted in an additional £2m cost pressure. Elective Recovery performance was 125%, which was lower than previously due to operational challenges in October 2024, high levels of annual leave, and the performance achieved in October 2019 on which in-month performance was based. The Trust’s workforce numbers were beginning to increase as anticipated as newly qualified staff members were onboarded. The ongoing discussions with Unison in respect of the Band 2/3 pay dispute would likely lead to additional one-off costs as well as recurring costs if any pay increase were agreed. It was expected that the Trust would be below the NHS England minimum cash holding during Quarter 4. It was forecast that the Trust would deliver £67.7m of CIP for 2024/25 against £84.9m of identified schemes. The Trust’s Always Improving programme had succeeded in delivering a 3.6% reduction in length of stay. Assurance: (Reports/Papers reviewed by the Committee also appearing on the Board agenda) Not applicable. Any Other Matters: • The committee received a quarterly update from Estates, Facilities and Capital Development. • The committee supported the Trust’s bid for external funding in support of the Southampton Elective Hub. Assurance Rating: Substantial There is a robust series of suitably designed internal controls in place upon Assurance which the organisation relies to manage the risk of failure of the continuous and effective achievement of the objectives of the process, which at the time of our review were being consistently applied. Reasonable There is a series of controls in place, however there are potential risks that Assurance may not be sufficient to ensure that the individual objectives of the process are achieved in a continuous and effective manner. Improvements are required to enhance the adequacy and effectiveness of the controls to mitigate these risks. Limited Assurance Controls in place are not sufficient to ensure that the organisation can rely upon them to manage the risks to the continuous and effective achievement of the objectives of the process. Significant improvements are required to improve the adequacy and effectiveness of the controls. Page 1 of 2 No Assurance Not Applicable Risk Rating: Low Medium High Not Applicable There is a fundamental breakdown or absence of core internal controls such that the organisation cannot rely upon them to manage the risks to the continuous and effective achievement of the objectives of the process. Immediate action is required to improve the adequacy and effectiveness of controls. Where assurance is not required and/or relevant. Based on the report considered by the committee, there is little or no concern that the Trust will be unable to meet its stated objectives and/or plans. There is some concern that the Trust might not be able to fully meet its stated objectives and/or plans based on the information contained in the report considered by the committee. There is a significant risk that the Trust will not be able to meet its stated objectives and/or plans based on the information contained in the report considered by the committee. Where risk rating is not relevant. Page 2 of 2 Agenda Item 5.1 ii) Committee Chair’s Report to the Trust Board of Directors 7 January 2025 Committee: Finance & Investment Committee Meeting Date: 16 December 2024 Key Messages: • • • • The Trust’s financial position remains difficult despite significant levels of savings being delivered in areas such as patient flow, theatres, and outpatients. The main contributor to the Trust’s deficit continues to be non-delivery of system-wide transformation programmes, especially those concerning patients having no criteria to reside. The Trust was forecasting to achieve c.£67m of its cost improvement programme target for 2024/25, a shortfall of £17m against the identified opportunities. However, much of the unachieved amount assumed delivery of system transformation programmes. The Trust’s cash balance was initially expected to fall below the NHS England minimum holding level during Quarter 4. However, the Trust has received £12m of additional cash, which now means that the Trust’s cash balance should not fall below minimum required levels until Quarter 1 of 2025/26. Assurance: (Reports/Papers reviewed by the Committee also appearing on the Board agenda) 5.7 Finance Report for Month 8 Assurance Rating: Risk Rating: Substantial High • The Trust’s in-month deficit was £5.7m and a year-to-date deficit of £18.2m, £14.8m behind plan year-to-date. • The Trust has carried out £21m of unfunded activity during the year. • The Trust continues to benchmark well in terms of value for money, and continues to apply measures to ensure financial grip and governance with strong controls in place. 6.1 Board Assurance Framework (BAF) Update Assurance Rating: Risk Rating: Substantial N/A • Risks 5a, 5b and 5c have been updated, following discussions with the respective Executive Director(s). • The risk rating for Risk 5a has been increased from 15 to 20 due to the deteriorating cash balance and the ongoing financial pressures. Any Other Matters: • The committee reviewed the outputs of the review of non-pay expenditure carried out by Deloitte. • The committee supported the outline strategy for a possible private patient unit. • The committee gave its support in principle for the Trust to bid for £1.75m of funding in support of the Trust’s Same-Day Emergency Care service. Assurance Rating: Substantial There is a robust series of suitably designed internal controls in place upon Assurance which the organisation relies to manage the risk of failure of the continuous and effective achievement of the objectives of the process, which at the time of our review were being consistently applied. Reasonable There is a series of controls in place, however there are potential risks that Assurance may not be sufficient to ensure that the individual objectives of the process are achieved in a continuous and effective manner. Improvements are required to enhance the adequacy and effectiveness of the controls to mitigate these risks. Page 1 of 2 Limited Assurance No Assurance Not Applicable Controls in place are not sufficient to ensure that the organisation can rely upon them to manage the risks to the continuous and effective achievement of the objectives of the process. Significant improvements are required to improve the adequacy and effectiveness of the controls. There is a fundamental breakdown or absence of core internal controls such that the organisation cannot rely upon them to manage the risks to the continuous and effective achievement of the objectives of the process. Immediate action is required to improve the adequacy and effectiveness of controls. Where assurance is not required and/or relevant. Risk Rating: Low Medium High Not Applicable Based on the report considered by the committee, there is little or no concern that the Trust will be unable to meet its stated objectives and/or plans. There is some concern that the Trust might not be able to fully meet its stated objectives and/or plans based on the information contained in the report considered by the committee. There is a significant risk that the Trust will not be able to meet its stated objectives and/or plans based on the information contained in the report considered by the committee. Where risk rating is not relevant. Page 2 of 2 Agenda item 5.2 Committee Chair’s Report to the Trust Board of Directors 7 January 2025 Committee: People & Organisational Development Committee Meeting Date: 13 December 2024 Key Messages: • • • • • The Trust’s substantive workforce grew by 7 whole-time-equivalents (WTE) during November 2024 in line with forecast. However, an adjustment has also been made to the substantive numbers being reported due to the status of a hosted network (the CRN), which expanded following a TUPE transfer of staff. The rate of bank staff usage had increased in November 2024 due to the need to open surge capacity. This was expected to continue during the remainder of the year. Reduction in bank benefit has been assumed though, commencing in January linked to NQNs exiting supernumerary periods. The non-delivery of system-wide transformation programmes continues to pose a significant risk to the Trust’s delivery of its 2024/25 workforce plan. A Mutually Agreed Resignation Scheme (MARS) has been approved by NHS England, which was expected to deliver a reduction in workforce of c.20 WTE by March 2025. The Trust was forecasting a total workforce of 13,464 WTE at the end of the year – broadly flat compared with the end of 2023/24. Increases in substantive workforce has been forecasted during December and January. Due to the volatility of predicting start dates during the Christmas period, a reforecast may take place in January. Assurance: (Reports/Papers reviewed by the Committee also appearing on the Board agenda) 5.9 People Report for Month 8 Assurance Rating: Risk Rating: Substantial High • The Trust is above its 2024/25 workforce plan by 77 WTE due to a combination of the planned increases in substantive staff as newly qualified employees are onboarded, and the assumed reduction in workforce requirements due to delivery of system-wide transformation programmes. • The system-wide transformation programmes assumed a reduction in workforce of 218 WTE. Non-delivery of these programmes therefore poses a significant risk to the Trust’s achievement of its overall 2024/25 workforce plan. • The Trust’s sickness absence rate was 3.3% against the target of 3.9%, and turnover was lower than expected. • The response rate to the Staff Survey was low compared to the national average. 6.1 Board Assurance Framework (BAF) Update Assurance Rating: Risk Rating: Substantial N/A • Risks 3a, 3b and 3c have been updated, following discussions with the respective Executive Director(s). • The financial situation and uncertainty in respect of the NHS long-term workforce plan poses a significant underlying risk, and it was suggested that increasing the rating of risk 3c should be considered to reflect this. Any Other Matters: • A detailed update was provided in respect of the ongoing industrial dispute with the porters and in respect of the Band 2/3 pay dispute. Page 1 of 2 • The need to manage ongoing industrial disputes was impacting the Trust’s People team’s capacity to make progress on other areas, such as those relating to transformation. Assurance Rating: Substantial There is a robust series of suitably designed internal controls in place upon Assurance which the organisation relies to manage the risk of failure of the continuous and effective achievement of the objectives of the process, which at the time of our review were being consistently applied. Reasonable There is a series of controls in place, however there are potential risks that Assurance may not be sufficient to ensure that the individual objectives of the process are achieved in a continuous and effective manner. Improvements are required to enhance the adequacy and effectiveness of the controls to mitigate these risks. Limited Assurance Controls in place are not sufficient to ensure that the organisation can rely upon them to manage the risks to the continuous and effective achievement of the objectives of the process. Significant improvements are required to improve the adequacy and effectiveness of the controls. No Assurance There is a fundamental breakdown or absence of core internal controls such that the organisation cannot rely upon them to manage the risks to the continuous and effective achievement of the objectives of the process. Immediate action is required to improve the adequacy and effectiveness of controls. Not Applicable Where assurance is not required and/or relevant. Risk Rating: Low Medium High Not Applicable Based on the report considered by the committee, there is little or no concern that the Trust will be unable to meet its stated objectives and/or plans. There is some concern that the Trust might not be able to fully meet its stated objectives and/or plans based on the information contained in the report considered by the committee. There is a significant risk that the Trust will not be able to meet its stated objectives and/or plans based on the information contained in the report considered by the committee. Where risk rating is not relevant. Page 2 of 2 Agenda item 5.3 Committee Chair’s Report to the Trust Board of Directors 7 January 2025 Committee: Quality Committee Meeting Date: 25 November 2024 Key Messages: • • • • • • • There had been seven never events reported during 2024/25. There had been a decrease in the number of category 2 pressure ulcers, which was possibly due to increased training rates. Three prostate patients had been lost to follow up, and there were concerns in respect of capacity within the prostate service. Overall, the Quality Indicators show a system under pressure. There were also concerns in respect of cardiac surgery services due to staffing levels and culture within the team, which had led to cancellations and increased waiting lists. The PALS/complaints service had had 2,135 interactions during Quarter 2. The top themes related to clinical treatment, patient care, and communication. The number of Inquests was increasing, which was putting pressure on services. Assurance: (Reports/Papers reviewed by the Committee also appearing on the Board agenda) 5.12 Learning from Deaths 2024-25 Quarter 2 Report Assurance Rating: Risk Rating: Substantial Medium • Whilst the overall death rate had increased, this was in line with national trends. The Trust was performing well, and was one of 13 trusts scoring below the expected figure. • A mobile application to share the outputs of mortality and morbidity meetings was being reviewed. • The lack of available side rooms was leading to an increasing number of patients dying on wards rather than in a private environment. 5.13 Infection Prevention and Control 2024-25 Quarter 2 Report Assurance Rating: Risk Rating: Substantial High • The Trust was expected to miss most bacteraemia targets for 2024/25. • The Trust was mid-table compared with other teaching hospitals. • The rate of MRSA had increased to 4-5 cases per annum from 2020 onwards, compared with 0-2 per annum between 2015 and 2020. • An audit of hand washing had raised concerns about the compliance rate. • The loss of experienced staff since the COVID-19 pandemic was considered to be a significant contributor to the decline in performance. Any Other Matters: The committee reviewed the Maternity and Neonatal Safety 2024-25 Quarter 2 Report and noted the following: • Caesarean section rates remained high. • The Trust’s post-partum haemorrhage rate remained above the national expectations, but no key themes had been identified following review of this matter. • In a review of third- and fourth-degree tears, no key themes had been identified. • One maternal death was under investigation. Page 1 of 43 Assurance Rating: Substantial There is a robust series of suitably designed internal controls in place upon Assurance which the organisation relies to manage the risk of failure of the continuous and effective achievement of the objectives of the process, which at the time of our review were being consistently applied. Reasonable There is a series of controls in place, however there are potential risks that Assurance may not be sufficient to ensure that the individual objectives of the process are achieved in a continuous and effective manner. Improvements are required to enhance the adequacy and effectiveness of the controls to mitigate these risks. Limited Assurance Controls in place are not sufficient to ensure that the organisation can rely upon them to manage the risks to the continuous and effective achievement of the objectives of the process. Significant improvements are required to improve the adequacy and effectiveness of the controls. No Assurance There is a fundamental breakdown or absence of core internal controls such that the organisation cannot rely upon them to manage the risks to the continuous and effective achievement of the objectives of the process. Immediate action is required to improve the adequacy and effectiveness of controls. Not Applicable Where assurance is not required and/or relevant. Risk Rating: Low Medium High Not Applicable Based on the report considered by the committee, there is little or no concern that the Trust will be unable to meet its stated objectives and/or plans. There is some concern that the Trust might not be able to fully meet its stated objectives and/or plans based on the information contained in the report considered by the committee. There is a significant risk that the Trust will not be able to meet its stated objectives and/or plans based on the information contained in the report considered by the committee. Where risk rating is not relevant. Page 2 of 43 Agenda Item 4.6 Report to the Quality Committee, 25 November 2024 Title: Sponsor: Author: Purpose Maternity and Neonatal Safety 2024-25 Quarter 2 Report Gail Byrne, Chief Nursing Officer Alison Millman, Quality Assurance and Safety Midwifery Matron Jessica Bown, Quality Assurance and Safety Midwifery Matron Hannah Mallon, Quality Assurance and Safety Neonatal Matron Marie Cann, Maternity and Neonatal Safety Lead Emma Northover, Director of Midwifery (Re)Assurance Approval Ratification Information x x x Strategic Theme Outstanding patient outcomes, safety and experience Pioneering research and innovation World class people Integrated networks Foundations for the and collaboration future x Executive Summary: NHS Resolution (NHSR) requires that the Maternity & Neonatal (MatNeo) service reports to our Trust Quality Committee each time it meets. This Quarter 2 (Q2) 24-25 MatNeo services safety report will continue to be adapted and responsive to safety concerns or issues within our service providing assurance around safety improvements impacting our families, services, and staff. The information provided is for assurance and reassurance, whilst meeting the requirements of NHSR Maternity Incentive Scheme (MIS)Year 6 and highlights the safety improvement work and learning from all aspects of the services. We ask members to continue to support the MatNeo Services and provide monitoring and scrutiny as required. Contents: This report provides an update in relation to the following areas for Quarter 2 2024/25: 1. Perinatal Quality Surveillance – Maternity & Neonatal Dashboard (Appendix 1) 1.1. Scheduled Caesarean Section Capacity 1.2. Post Partum Haemorrhage (PPHs) 1.3. Episiotomy 1.4. 3rd and 4th degree tears 1.5. ITU transfers 1.6. Apgars 500ms (43.58%) NMPA target is 1500mls (5.8%) NMPA target is 35% Global majority booked CoC Model – Q2 compliance 19.5%, National target is > 35% The most vulnerable families are still supported by our Needing Extra Support Teams (NEST) and as we progress workstreams around future workforce plans, the service aspires to develop new and more sustainable CoC models of care. To give assurance we monitor and audit outcomes to ensure that groups most likely to be offered a CoC model are not showing as exceptions in our data or when clinically reviewing adverse outcomes. 1.9 FFT recommenders as % of responders Current compliance: 83.9% of responders would recommend our service. This has fallen slightly from Q1 (87.4%). As mentioned in the previous Committee report, the % of responders who would recommend our postnatal ward dropped to 67% in September 2024. This was escalated to the inpatient matrons and an improvement plan focusing on two areas has been developed (Appendix 2). These areas are: • Partner or someone else involved in service users care being allowed to stay with them as much as the service user wanted during their stay in hospital. • After the birth, ensure that women and birthing people are given the opportunity to ask any questions they may have about their labour and birth. 1.10 Maternity Opel 4 Diverts There has been an increase in the number of occasions when the Maternity Service has moved through escalation and ultimately declared OPEL 4. There are escalation processes and policies in place that aim to ensure appropriate decision making and the safety of our families and workforce. This issue has been widely monitored through Birthrate Plus reporting and reviewed within safety incident investigations and is on our Risk Register (Risk 259 High Red). As per the Trust’s PSIRF plan, harm tools are completed for each Opel 4 exceeding 24 hours to review the wider impact and harm associated with the service being on
Url: /Media/UHS-website-2019/Docs/About-the-Trust/Trust-governance-and-corporate-docs/2025-Trust-documents/Papers-Trust-Board-7-January-2025.pdf

EC-PPH Cyclophosphamide Epirubicin Paclitaxel Pertuzumab Trastuzumab

Description: Chemotherapy Protocol BREAST CANCER CYCLOPHOSPHAMIDE-EPIRUBICIN-PACLITAXEL-PERTUZUMABTRASTUZUMAB (EC-PPH) Regimen • Breast Cancer – Cyclophosphamide-Epirubicin-Paclitaxel-PertuzumabTrastuzumab (EC-PPH) Indication • Neo-adjuvant / adjuvant therapy of breast cancer • WHO Performance status 0, 1, 2 Toxicity Drug Cyclophosphamide Epirubicin Paclitaxel Pertuzumab Trastuzumab Adverse Effect Dysuria, haemorrhagic cystitis, taste disturbances Cardio-toxicity, urinary discolouration (red) Hypersensitivity, hypotension, bradycardia, peripheral neuropathy, myalgia and back pain on administration Diarrhoea, hypersensitivity reactions, headache, reduced appetite, dyspnoea, cough, vomiting, nausea, constipation, rash, pain, oedema, fatigue, asthenia, cardiotoxicity Cardio toxicity, acute respiratory distress syndrome, infusion related effects The adverse effects listed are not exhaustive. Please refer to the relevant Summary of Product Characteristics for full details. The diarrhoea can be severe in patients treated with pertuzumab. It is important to ensure patients are given appropriate therapy for the treatment of diarrhoea. This is not included in the regimen on Aria and must be added from the support folder. Monitoring Regimen • FBC, U&E’s and LFT’s prior to day 1 for cycles containing cyclophosphamide, epirubicin and paclitaxel. A full blood count should also be conducted before days 8 and 15 of paclitaxel administration. During the administration of trastuzumab with pertuzumab alone this may be reduced to once every three months. • Ensure adequate cardiac function before and at regular intervals during treatment. Baseline LVEF should be measured, particularly in patients with a history of cardiac problems or in the elderly. An echocardiogram should be Version 1 (Feb 2021) Page 1 of 15 Breast–Cyclophosphamide-Epirubicin-Paclitaxel-Pertuzumab-Trastuzumab (EC-PPH) conducted before cycle four and then three monthly thereafter. • HER2 status before initiating therapy Dose Modifications The dose modifications listed are for haematological, liver and renal function only. Dose adjustments may be necessary for other toxicities as well. In principle all dose reductions due to adverse drug reactions should not be reescalated in subsequent cycles without consultant approval. It is also a general rule for chemotherapy that if a third dose reduction is necessary treatment should be stopped. The following guidelines apply to chemotherapy only. Please discuss all dose reductions / delays with the relevant consultant before prescribing if appropriate. The approach may be different depending on the clinical circumstances. The following is a general guide only. Haematological Prior to prescribing the following treatment criteria must be met on day 1 of treatment. Criteria Neutrophils Platelets Eligible Level equal to or more than 1x109/L equal to or more than 100x109/L Consider blood transfusion if patient symptomatic of anaemia or has a haemoglobin of less than 8g/dL (80g/l) In the adjuvant / neo-adjuvant setting always check with the relevant consultant before delaying or reducing the dose in response to a toxicity. If counts on day one are below these criteria for neutrophils and platelets then delay treatment for seven days. Treatment should only be re-started when these levels are reached. Treatment may be resumed at the original dose or reduce the dose of cyclophosphamide and epirubicin to 80% of the original dose where a NCI-CTC grade 3 or above haematological event has occurred. Consider stopping the paclitaxel. If a second episode of neutropenia and / or thrombocytopenia occurs, despite dose reduction or the time to reach the eligible level is longer than seven days consider changing or stopping therapy. No dose modifications for haematological toxicity are necessary for pertuzumab or trastuzumab. If treatment is not tolerated it should be stopped. Version 1 (Feb 2021) Page 2 of 15 Breast–Cyclophosphamide-Epirubicin-Paclitaxel-Pertuzumab-Trastuzumab (EC-PPH) Kidney Impairment Drug Creatinine Clearance (ml/min) more than 20 Cyclophosphamide 10-20 Less than 10 Dose (% of original dose) 100 75 50 Paclitaxel No dose adjustment necessary Epirubicin Dose reduce in severe impairment only Pertuzumab The safety and efficacy of pertuzumab has not been established in renal impairment Trastuzumab No dose adjustment necessary Liver Impairment Drug Cyclophosphamide Epirubicin Paclitaxel Pertuzumab Trastuzumab Recommendation Dose reduction may not be necessary Bilirubin (umol/L) Dose (% of original) 24-51 50 52-85 25 85 or greater Contra-indicated If AST 2-4 x ULN and bilirubin 21-51μmol/L give 50% dose , if the AST greater than 4 x ULN or bilirubin greater than 51μmol/L then give 25% dose less than 26 90mg/m² 27-51 75mg/m² greater than 51 50mg/m² If bilirubin less than 1.25xULN and transaminase less than 10xULN then prescribe the last dose otherwise consider a dose reduction or stopping treatment. The safety and efficacy of pertuzumab has not been established in hepatic impairment No dose adjustment necessary Other Dose reductions or interruptions in therapy are not necessary for those toxicities that are considered unlikely to be serious or life threatening. For example, alopecia, altered taste or nail changes. Version 1 (Feb 2021) Page 3 of 15 Breast–Cyclophosphamide-Epirubicin-Paclitaxel-Pertuzumab-Trastuzumab (EC-PPH) Epirubicin Discontinue epirubicin if cardiac failure develops. Paclitaxel NCI-CTC grade 2 peripheral neuropathy withhold paclitaxel only until the neuropathy recovers to NCI-CTC grade 1 then dose reduce to 75% of the original dose. Where the peripheral neuropathy is NCI-CTC grade 3 again withhold the paclitaxel until it resolves to NCI-CTC grade 1 and then reduce the dose of paclitaxel to 50% of the original dose. Paclitaxel should be discontinued if the neuropathy does not resolve to NCI-CTC grade 1. Pertuzumab The diarrhoea can be severe in patients treated with pertuzumab. It is important to ensure patients are given appropriate therapy for the treatment of diarrhoea. This is not included in the regimen on Aria and must be added from the support folder. Pertuzumab and Trastuzumab Cardiac The LVEF should be fifty or above before starting cycle one of pertuzumab and trastuzumab. Subsequent Echocardiograms The flow chart below describes the process to be followed if there is an asymptomatic decline in LVEF during pertuzumab and trastuzumab treatment. This is taken from the study protocol as used in the reference section. Study treatment refers to pertuzumab and trastuzumab. Version 1 (Feb 2021) Page 4 of 15 Breast–Cyclophosphamide-Epirubicin-Paclitaxel-Pertuzumab-Trastuzumab (EC-PPH) In general patients who develop symptomatic cardiac dysfunction should have pertuzumab and trastuzumab discontinued, be commenced on ACE inhibitor therapy and be referred to a cardiologist. Further treatment should be discussed with the relevant oncology consultant. Version 1 (Feb 2021) Page 5 of 15 Breast–Cyclophosphamide-Epirubicin-Paclitaxel-Pertuzumab-Trastuzumab (EC-PPH) Regimen Cyclophosphamide-Epirubicin (EC) 21 day cycle for 4 cycles (cycles 1, 2, 3, 4) Drug Dose Days Administration Cyclophosphamide 500mg/m2 1 Intravenous bolus Epirubicin 90mg/m² 1 Intravenous bolus Followed by; Paclitaxel-Pertuzumab-Trastuzumab 21 day cycle for 4 cycles Cycle 5 Drug Paclitaxel Pertuzumab Trastuzumab Dose 80mg/m2 840mg 8mg/kg Days 1, 8, 15 1 1 Administration Intravenous infusion in 250ml sodium chloride 0.9% over 60 minutes Intravenous infusion in 250ml sodium chloride 0.9% over 60 minutes Intravenous infusion in 250ml sodium chloride 0.9% over 90 minutes Followed by; Cycle 6, 7, 8 Drug Paclitaxel Pertuzumab Trastuzumab Dose 80mg/m2 420mg 6mg/kg Days 1, 8, 15 1 1 Administration Intravenous infusion in 250ml sodium chloride 0.9% over 60 minutes Intravenous infusion in 250ml sodium chloride 0.9% over 30 minutes Intravenous infusion in 250ml sodium chloride 0.9% over 30 minutes Cycles 9-22 inclusive Drug Pertuzumab Trastuzumab Dose 420mg 6mg/kg Days 1 1 Administration Intravenous infusion in 250ml sodium chloride 0.9% over 30 minutes Intravenous infusion in 250ml sodium chloride 0.9% over 30 minutes Version 2 (July 2024) Page 6 of 15 Breast–Cyclophosphamide-Epirubicin-Paclitaxel--Pertuzumab-Trastuzumab (EC-PPH) Dose Information • Cyclophosphamide will be dose banded in accordance with the national dose bands (20PM). • Epirubicin will be dose banded in accordance with the national dose bands (2PM). • The maximum lifetime cumulative dose of epirubicin is 900mg/m². • Paclitaxel will be dosed banded in accordance with the national dose bands (6mg/mL) • If the time between two sequential infusions of pertuzumab is less than six weeks, the 420mg dose should be administered as soon as possible without regard to the next planned dose. If the time between two sequential infusions is 6 weeks or more, the initial loading dose of 840mg should be readministered as a 60 minute intravenous infusion followed every 3 weeks thereafter by a maintenance dose of 420 mg administered over a period of 30 to 60 minutes. • Trastuzumab will be dose banded in accordance with national dose bands (21mg/ml) • If the patient misses a dose of trastuzumab by seven days or less, then the usual maintenance dose of 6mg/kg should be given as soon as possible. Do not wait until the next planned cycle. Subsequent maintenance doses should be given according to the previous schedule • If the patient misses a dose of trastuzumab by more than seven days, a reloading dose of 8mg/kg should be given over 90 minutes. Subsequent maintenance doses should then be given every 21 days from that point Administration Information • Hypersensitivity reactions tend to occur with the first or second infusion of paclitaxel. Paclitaxel infusions should be interrupted for minor symptoms such as flushing or localised rashes. If these resolve promptly (within 5 minutes) the infusion may be restarted at a lower rate with intensive monitoring. Immediately discontinue the infusion for severe reactions which include profound hypotension, bronchospasm and generalised erythema. • Paclitaxel must be administered via a non-PVC administration set containing an in-line 0.22 micron filter. • Pertuzumab has been associated with hypersensitivity and infusion related reactions. Patients should be observed for 60 minutes after the first infusion and for 30 – 60 minutes after subsequent infusions. If patients have tolerated the first two infusions with no infusion related reactions consideration can be given to reducing this observation period. • Trastuzumab is associated with hypersensitivity reactions. The SPC recommends patients should be observed for six hours following the start of Version 2 (July 2024) Page 7 of 15 Breast–Cyclophosphamide-Epirubicin-Paclitaxel--Pertuzumab-Trastuzumab (EC-PPH) the first infusion of trastuzumab and for two hours following the start of subsequent infusions. In practice these times have been reduced. If the patient has tolerated the first two infusions with no infusion related effects consideration can be given to reducing or stopping this observation period. Extravasation • Cyclophosphamide – neutral • Epirubicin – vesicant • Paclitaxel - vesicant • Pertuzumab – neutral • Trastuzumab - neutral Additional Therapy • EC EC antiemetics day 1 15-30 minutes prior to chemotherapy; - aprepitant 125mg oral - dexamethasone 4mg oral or intravenous - ondansetron 8mg oral or intravenous As take home medication - aprepitant 80mg once a day for 2 days - dexamethasone 2mg twice a day for 3 days oral - metoclopramide 10mg three times a day when required oral - ondansetron 8mg twice a day for 3 days oral Growth factor according to local formulary choice. For example; - filgrastim or bioequivalent 30 million units once a day subcutaneous for five days starting on day five of the cycle - lenograstim or bioequivalent 33.6 million units once a day subcutaneous for five days starting on day five of the cycle - pegfilgrastim or bioequivalent 6mg once a day subcutaneous on day two of the cycle • Paclitaxel 15-30 minutes prior to chemotherapy with paclitaxel − metoclopramide 10mg oral or intravenous As take home medication Version 2 (July 2024) Page 8 of 15 Breast–Cyclophosphamide-Epirubicin-Paclitaxel--Pertuzumab-Trastuzumab (EC-PPH) − metoclopramide 10mg three times a day when required oral • Premedication to reduce of risk of paclitaxel hypersensitivity reaction 30 minutes prior to chemotherapy with paclitaxel − chlorphenamine 10mg intravenous − dexamethasone 10mg intravenous − H2 antagonist according to local formulary choice and availability • For treatment of pertuzumab or trastuzumab infusion reactions ‘once only when required’ doses of the following should be prescribed; - chlorphenamine 10mg intravenous - hydrocortisone 100mg intravenous - paracetamol 1000mg once oral • Mouthwashes according to local or national policy on the treatment of mucositis • Gastric protection with a proton pump inhibitor or a H2 antagonist may be considered in patients considered at high risk of GI ulceration or bleed. References 1.von Minckwitz G, Proctor M, de Azambuja et al. Adjuvant pertuzumab and trastuzumab in early HER 2 positive breast cancer. N Engl J Med 2017; 377 (2): 122-131. 2. Ramshorst M, van der Voot A, van Werkhoven E et al. Neoadjuvant chemotherapy with or without anthracyclines in the presence of dual HER2 blockade for HER2-positive breast cancer (TRAIN-2): a multicentre, open-label, randomised, phase 3 trial. Lancet Oncology 2018: 19 (12); 1630-1640 Version 2 (July 2024) Page 9 of 15 Breast–Cyclophosphamide-Epirubicin-Paclitaxel--Pertuzumab-Trastuzumab (EC-PPH) REGIMEN SUMMARY Cyclophosphamide-Epirubicin-Paclitaxel-Pertuzumab-Trastuzumab (EC-PPH) Cycle 1, 2, 3, 4 1. Aprepitant 125mg oral 2. Dexamethasone 4mg oral or intravenous 3. Ondansetron 8mg oral or intravenous 4. Epirubicin 90mg/m² intravenous bolus over 10 minutes 5. Cyclophosphamide 500mg/m² intravenous bolus over 10 minutes Take Home Medicines 6. Aprepitant 80mg once a day oral for 2 days starting on day 2 of the cycle Administration Instructions Take 80mg once a day for 2 days starting on day 2 of the cycle 7. Dexamethasone 2mg twice a day for 3 days oral starting on day two of the cycle Administration Instructions Take 2mg twice a day (morning and lunch) for 3 days starting on day two of the cycle 8. Metoclopramide 10mg three times a day when required oral Administration Instructions When required for nausea. Please supply five days or an original pack if appropriate. 9. Ondansetron 8mg twice a day for 3 days oral starting on the evening of day one of the cycle Administration Instructions Take 8mg twice a day for three days starting on the evening of day one of the cycle 10. Growth factor according to local formulary choice. Administration Instructions Dispense according to local formulary choices; - filgrastim or bioequivalent 30 million units once a day subcutaneous for 5 days starting on day 5 of the cycle - lenograstim or bioequivalent 33.6million units once a day subcutaneous for 5 days starting on day 5 of the cycle - pegfilgrastim or bioequivalent 6mg once a day subcutaneous on day 2 of the cycle Paclitaxel-Pertuzumab-Trastuzumab Cycle 5 Day 1 11. Pertuzumab 840mg intravenous infusion in 250ml sodium chloride 0.9% over 60 minutes Administration Instructions The first infusion of pertuzumab should be given over 60 minutes. If this is well tolerated subsequent infusions may be given over 30 minutes Version 2 (July 2024) Page 10 of 15 Breast–Cyclophosphamide-Epirubicin-Paclitaxel--Pertuzumab-Trastuzumab (EC-PPH) 12. Trastuzumab 8mg/kg intravenous infusion in 250ml sodium chloride 0.9% over 90 minutes Administration Instructions The first infusion of trastuzumab must be administered over 90 minutes. If this is well tolerated administer subsequent infusions over 30 minutes 13. Chlorphenamine 10mg intravenous 14. Dexamethasone 10mg intravenous 15. H2 antagonist according to local formulary choice and availability Administration Instructions: Administer according to local formulary choice and availability one of the following 30 minutes prior to chemotherapy; - ranitidine 50mg intravenous once only - famotidine 20mg oral once only - nizatidine 150mg oral once only - ranitidine 150mg oral once only If there is no stock of these products due to national shortages treatment may proceed without the H2 antagonist provided there is no instruction in the ARIA journal indication the patient must have H2 antagonist treatment. All infusion related reactions must be recorded in the ARIA journal and reported to the appropriate consultant. Many Trusts do not administer an H2 antagonist from cycle three onwards. They have been left in the ARIA protocols so that decisions can be made on an individual Trust and patient basis. 16. Metoclopramide 10mg oral or intravenous 17. Paclitaxel 80mg/m² intravenous infusion in 250ml sodium chloride 0.9% over 60 minutes 18. Chlorphenamine 10mg intravenous when required for infusion related reactions 19. Hydrocortisone 100mg intravenous when required for infusion related reactions 20. Paracetamol 1000mg oral when required for infusion related reactions Administration Instructions Please check if the patient has taken paracetamol. Maximum dose is 4g per 24 hours. There should be 4 hours between doses Day 8, 15 1. Chlorphenamine 10mg intravenous 2. Dexamethasone 10mg intravenous 3. H2 antagonist according to formulary choice and availability. Administration Instructions Administer according to local formulary choice and availability one of the following 30 minutes prior to chemotherapy; - ranitidine 50mg intravenous once only - famotidine 20mg oral once only - nizatidine 150mg oral once only - ranitidine 150mg oral once only If there is no stock of these products due to national shortages treatment may proceed without the H2 antagonist provided there is no instruction in the ARIA journal indication the patient must have H2 antagonist treatment. All infusion related reactions must be recorded in the ARIA journal and reported to the appropriate consultant. Many Trusts do not administer an H2 antagonist from cycle three onwards. They have been left in the ARIA protocols so that decisions can be made on an individual Trust and patient basis. Version 2 (July 2024) Page 11 of 15 Breast–Cyclophosphamide-Epirubicin-Paclitaxel--Pertuzumab-Trastuzumab (EC-PPH) 4. Metoclopramide 10mg oral or intravenous 5. Paclitaxel 80mg/m² intravenous infusion in 250ml sodium chloride 0.9% over 60 minutes Administration Instructions Paclitaxel must be administered via a non-PVC administration set containing an in-line 0.22 micron filter Take Home Medicines (Day 1 only) 21. Metoclopramide 10mg three times a day when required oral 22. Loperamide 4mg after the first loose stool and 2mg after each subsequent loose stool to a maximum of 16mg in 24 hours Administration Instructions Take 4mg after the first loose stool and then 2mg after each subsequent loose stool to a maximum of 16mg in 24 hours. Please supply one original pack size Cycle 6, 7, 8 Day 1 23. Pertuzumab 420mg intravenous infusion in 250ml sodium chloride 0.9% over 60 minutes Administration Instructions The first infusion of pertuzumab should be given over 60 minutes. If this is well tolerated subsequent infusions may be given over 30 minutes 24. Trastuzumab 6mg/kg intravenous infusion in 250ml sodium chloride 0.9% over 90 minutes Administration Instructions The first infusion of trastuzumab must be administered over 90 minutes. If this is well tolerated administer subsequent infusions over 30 minutes 25. Chlorphenamine 10mg intravenous 26. Dexamethasone 10mg intravenous 27. H2 antagonist according to local formulary choice and availability Administration Instructions: Administer according to local formulary choice and availability one of the following 30 minutes prior to chemotherapy; - ranitidine 50mg intravenous once only - famotidine 20mg oral once only - nizatidine 150mg oral once only - ranitidine 150mg oral once only If there is no stock of these products due to national shortages treatment may proceed without the H2 antagonist provided there is no instruction in the ARIA journal indication the patient must have H2 antagonist treatment. All infusion related reactions must be recorded in the ARIA journal and reported to the appropriate consultant. Many Trusts do not administer an H2 antagonist from cycle three onwards. They have been left in the ARIA protocols so that decisions can be made on an individual Trust and patient basis. 28. Metoclopramide 10mg oral or intravenous 29. Paclitaxel 80mg/m² intravenous infusion in 250ml sodium chloride 0.9% over 60 minutes Version 2 (July 2024) Page 12 of 15 Breast–Cyclophosphamide-Epirubicin-Paclitaxel--Pertuzumab-Trastuzumab (EC-PPH) 30. Chlorphenamine 10mg intravenous when required for infusion related reactions 31. Hydrocortisone 100mg intravenous when required for infusion related reactions 32. Paracetamol 1000mg oral when required for infusion related reactions Administration Instructions Please check if the patient has taken paracetamol. Maximum dose is 4g per 24 hours. There should be 4 hours between doses Day 8, 15 32. Chlorphenamine 10mg intravenous 33. Dexamethasone 10mg intravenous 34. H2 antagonist according to formulary choice and availability. Administration Instructions Administer according to local formulary choice and availability one of the following 30 minutes prior to chemotherapy; - ranitidine 50mg intravenous once only - famotidine 20mg oral once only - nizatidine 150mg oral once only - ranitidine 150mg oral once only If there is no stock of these products due to national shortages treatment may proceed without the H2 antagonist provided there is no instruction in the ARIA journal indication the patient must have H2 antagonist treatment. All infusion related reactions must be recorded in the ARIA journal and reported to the appropriate consultant. Many Trusts do not administer an H2 antagonist from cycle three onwards. They have been left in the ARIA protocols so that decisions can be made on an individual Trust and patient basis. 35. Metoclopramide 10mg oral or intravenous 36. Paclitaxel 80mg/m² intravenous infusion in 250ml sodium chloride 0.9% over 60 minutes Administration Instructions Paclitaxel must be administered via a non-PVC administration set containing an in-line 0.22 micron filter Take Home Medicines (Day 1 only) 37.Metoclopramide 10mg three times a day when required oral Cycles 9 – 22 Day 1 33. Pertuzumab 420mg intravenous infusion in 250ml sodium chloride 0.9% over 60 minutes Administration Instructions The first infusion of pertuzumab should be given over 60 minutes. If this is well tolerated subsequent infusions may be given over 30 minutes 34. Trastuzumab 6mg/kg intravenous infusion in 250ml sodium chloride 0.9% over 90 minutes Administration Instructions The first infusion of trastuzumab must be administered over 90 minutes. If this is well tolerated administer subsequent infusions over 30 minutes Version 2 (July 2024) Page 13 of 15 Breast–Cyclophosphamide-Epirubicin-Paclitaxel--Pertuzumab-Trastuzumab (EC-PPH) 35. Chlorphenamine 10mg intravenous when required for infusion related reactions 36. Hydrocortisone 100mg intravenous when required for infusion related reactions 37. Paracetamol 1000mg oral when required for infusion related reactions Administration Instructions Please check if the patient has taken paracetamol. Maximum dose is 4g per 24 hours. There should be 4 hours between doses Version 2 (July 2024) Page 14 of 15 Breast–Cyclophosphamide-Epirubicin-Paclitaxel--Pertuzumab-Trastuzumab (EC-PPH) DOCUMENT CONTROL Version Date Amendment Written By Approved By 2 July 2024 Trastuzumab updated with national dose bands Alexandra Pritchard Pharmacist Nanda Basker Pharmacist 1 Feb 2021 None Dr Deborah Wright Pharmacist Dr Sanjay Raj Consultant Clinical Oncologist This chemotherapy protocol has been developed as part of the chemotherapy electronic prescribing project. This was and remains a collaborative project that originated from the former CSCCN. These documents have been approved on behalf of the following Trusts; Hampshire Hospitals NHS Foundation Trust NHS Isle of Wight Portsmouth Hospitals NHS Trust Salisbury NHS Foundation Trust University Hospital Southampton NHS Foundation Trust Western Sussex Hospitals NHS Foundation Trust All actions have been taken to ensure these protocols are correct. However, no responsibility can be taken for errors which occur as a result of following these guidelines. Version 2 (July 2024) Page 15 of 15 Breast–Cyclophosphamide-Epirubicin-Paclitaxel--Pertuzumab-Trastuzumab (EC-PPH)
Url: /Media/UHS-website-2019/Docs/Chemotherapy-SOPs1/Breastcancer/EC-PPH-Cyclophosphamide-Epirubicin-Paclitaxel-Pertuzumab-Trastuzumab.pdf

Capecitabine-Carboplatin(AUC5)-Cetuximab

Description: Chemotherapy Protocol HEAD AND NECK CANCER CAPECITABINE-CARBOPLATIN (AUC5)-CETUXIMAB Regimen • Head and Neck Cancer – Capecitabine-Carboplatin-Cetuximab Indication • The treatment of advanced head and neck cancer that has not been previously treated with cetuximab • WHO performance status 0, 1 Toxicity Drug Capecitabine Carboplatin Cetuximab Adverse Effect Palmar-plantar erythrodysesthesia, diarrhoea, mucositis, chest pain Neuropathy, hypersensitivity Infusion related reactions, interstitial lung disease, skin reactions, electrolyte abnormalities, fatigue, abdominal pain, constipation The adverse effects listed are not exhaustive. Please refer to the relevant Summary of Product Characteristics for full details. Monitoring Regimen • FBC, LFT’s and U&E’s prior to day one of treatment • Monitor for hypersensitivity reactions for 60 minutes after the end of the cetuximab infusion • Patients with complete or partial dihydropyrimidine dehydrogenase (DPD) deficiency are at increased risk of severe and fatal toxicity during treatment with capecitabine. All patients should be tested for DPD deficiency before initiation (cycle 1) to minimise the risk of these reactions Dose Modifications The dose modifications listed are for haematological, liver and renal function only. Dose adjustments may be necessary for other toxicities as well. In principle all dose reductions due to adverse drug reactions should not be reescalated in subsequent cycles without consultant approval. It is also a general rule for chemotherapy that if a third dose reduction is necessary treatment should be stopped. Version 1.2 (August 2022) Page 1 of 12 Head and Neck–Capecitabine-Carboplatin (AUC5)-Cetuximab Please discuss all dose reductions / delays with the relevant consultant before prescribing if appropriate. The approach may be different depending on the clinical circumstances. The following is a general guide only. Haematological Prior to prescribing the following criteria must be met. Criteria Neutrophil Platelets Eligible Level equal to or more than 1.5x109/L equal to or more than 100x109/L Consider blood transfusion if patient symptomatic of anaemia or has a haemoglobin of less than 8g/dL There is little need to adjust the dose of cetuximab for haematological toxicity. The following applies to capecitabine and carboplatin only. On day one if the neutrophils are less than 1.5x109/L in the first instance delay treatment for 7 days. If counts recover at this point continue at the initial dose. If counts remain low continue with treatment using a 20% dose reduction. If the myelosuppression recurs despite this dose reduction stop treatment. On day one if the platelets are less than 100x109/L in the first instance delay treatment for 7 days. If the counts recover at this point continue at the initial dose. If the counts still fall within this range continue using a 20% dose reduction. If the platelet level falls below 50x109/L reduce the dose by 50%. Hepatic / Renal Impairment Deteriorating liver or kidney function may be a sign of disease progression or drug toxicity. Hepatic Impairment Drug Capecitabine Carboplatin Cetuximab Dose (% of original dose) There is little published information available. No dose reductions are necessary for those with mild to moderate hepatic dysfunction due to liver metastasis No adjustment necessary Administer only when the transaminases are 5xULN or below and the bilirubin is 1.5xULN or below Version 1.2 (August 2022) Page 2 of 12 Head and Neck–Capecitabine-Carboplatin (AUC5)-Cetuximab Renal Impairment Drug Capecitabine Carboplatin Cetuximab Creatinine Clearance (ml/min) Dose (% of original dose) More than 51 30-50 less than 30 Less than 20 100 75 Do not use Do not use Changes in the GFR of more than 10% between cycles may require dose adjustment If the creatinine is more than 180 (1.5xULN), do not use Other Dose reductions or interruptions in therapy are not necessary for those toxicities that are considered unlikely to be serious or life threatening. For example, alopecia, altered taste or nail changes. Dose limiting toxicities include diarrhoea, abdominal pain, emesis, stomatitis, palmar-plantar erythrodysesthesia and neurosensory toxicities among others. If any NCI-CTC grade 1toxicity occurs treatment should be continued, without interruption, at the full dose. For toxicities NCI-CTC grade 3 or above in general treatment should be withheld until recovery to at least NCI-CTC grade 1 then re-started if medically appropriate. If recovery takes twenty-one days or longer then stop treatment. Capecitabine NCI-CTC Grade 2 Interrupt treatment until the toxicity resolves to NCI-CTC grade 0-1 then continue at the same dose. If the toxicity recurs for a second time again interrupt treatment until it resolves to NCI-CTC grade 0-1 then resume therapy at 75% of the original dose. If the same adverse effect develops on a third occasion once more interrupt treatment until it resolves to NCI-CTC grade 0-1 then continue at 50% of the original dose. Stop treatment if the toxicity re-appears on a fourth instance. NCI-CTC Grade 3 Interrupt treatment until the toxicity resolves to NCI-CTC grade 0-1 then continue treatment using 75% of the original dose with prophylaxis if appropriate. If the toxicity recurs for a second time again interrupt treatment until it resolves to NCI-CTC grade 0-1 and then resume therapy at 50% of the original dose. If the same adverse effect develops on a third occasion discontinue capecitabine. Version 1.2 (August 2022) Page 3 of 12 Head and Neck–Capecitabine-Carboplatin (AUC5)-Cetuximab NCI-CTC Grade 4 Discontinue treatment unless the responsible consultant considers it to be in the best interest of the patient to continue at 50% of the original dose once the toxicity has resolved to NCI-CTC grade 0-1. When capecitabine is stopped for toxicity the doses are omitted, not delayed. Consider stopping capecitabine therapy if chest pain occurs. Cetuximab Allergic or hypersensitivity reactions have occurred during the administration of cetuximab. For a NCI-CTC grade 1 reaction reduce the infusion rate by 50%. For a NCI-CTC grade 2 reaction, stop the infusion and administer supportive therapies as indicated. When the reaction has resolved to NCI-CTC grade 1 or below resume the infusion at 50% of the previous rate. For a NCI-CTC grade 3 or 4 toxicity stop the infusion immediately and disconnect the tubing from the patient. Administer appropriate supportive therapies. Once recovered, patients should not receive cetuximab again. Once the rate has been reduced it should not be increased on subsequent infusions. If a second reaction occurs on the slower infusion rate the infusion should be stopped and no further treatment given. An acneiform skin rash occurs in over 70% of those receiving cetuximab. The onset is normally within three weeks of starting therapy and often resolves after week twelve. For a NCI-CTC grade 1-2 reaction use symptomatic treatments such as topical or oral antibiotics and continue with the cetuximab. For a NCI-CTC grade 3 toxicity delay treatment until the toxicity resolves to NCI-CTC grade 2 or below. If this occurs within fourteen days resume cetuximab at the same dose. If more than fourteen days is required stop treatment. If the NCI-CTC grade 3 toxicity occurs for a second and third time the cetuximab may again be delayed for up to and including fourteen days with concomitant dose reductions to 200mg/m2 and 150mg/m2 respectively. Cetuximab dose reductions are permanent. The cetuximab must be discontinued if more than two consecutive infusions are withheld or a fourth episode of a NCI-CTC grade 3 skin toxicity develops or a NCI-CTC grade 4 toxicity at any time. UV radiation may worsen skin reactions. Sun safety practices should be followed during and for up to two months after the end of treatment. Stop treatment if there is a confirmed pneumonitis. Regimen The starting dose of carboplatin AUC5 is used with calculated GFR. AUC4 may be considered with EDTA clearance, seek advice from the appropriate consultant before prescribing. The recommended maximum dose when using a calculated creatinine clearance at AUC5 is 750mg. If you have an obese patient or an individual with a calculated creatinine clearance above 125ml/min please seek advice from the relevant consultant. Consider a dose reduction in poor performance patients. Version 1.2 (August 2022) Page 4 of 12 Head and Neck–Capecitabine-Carboplatin (AUC5)-Cetuximab It should be noted that the dose of carboplatin may need to be altered if there is a change (improvement or reduction) in renal function of more than 10% from the previous cycle. 21 day cycle for 6 cycles The starting dose of carboplatin AUC 5 is used with calculated GFR. AUC 4 may be considered with EDTA clearance, seek advice from the appropriate consultant before prescribing. The recommended maximum dose when using a calculated creatinine clearance at AUC5 is 750mg (creatinine clearance 125ml/min). This is not a dose included in the national dose banding table. The maximum dose has been set at 790mg in ARIA. Please check if this dose is appropriate. If you have an obese patient or an individual with a calculated creatinine clearance above 125ml/min please seek advice from the relevant consultant. It should be noted that the dose of carboplatin may need to be altered if there is a change (improvement or reduction) in renal function of more than 10% from the previous cycle. The cetuximab may be continued if the disease is at least stable at the end of six cycles until disease progression or toxicity occurs. Cycle One Drug Capecitabine Carboplatin Cetuximab Dose 1000mg/m2 twice a day AUC5 (max dose) 400mg/m2 Cetuximab 250mg/m2 Days 1-10 incl 1 1 8, 15 Route Oral Intravenous infusion in 500ml glucose 5% over 60 minutes Intravenous infusion (see administration) Intravenous infusion (see administration) Cycle Two Onwards Drug Capecitabine Carboplatin Cetuximab Dose 1000mg/m2 twice a day AUC5 (max dose) 250mg/m2 Days Route 1-10 incl Oral 1 1, 8, 15 Intravenous infusion in 500ml glucose 5% over 60 minutes Intravenous infusion (see administration) Dose Information • Capecitabine will be dose banded in accordance with the national dose bands • Carboplatin will be dose banded in accordance with the national dose bands (10mg/ml) Version 1.2 (August 2022) Page 5 of 12 Head and Neck–Capecitabine-Carboplatin (AUC5)-Cetuximab • The maximum dose of carboplatin for AUC 5 is 750mg. This will be set as 790mg in ARIA to comply with national dose bands. • It should be noted that the dose of carboplatin may need to be altered if there is a change (improvement or reduction) in renal function of more than 10% from the previous cycle. • Cetuximab will be dose banded in accordance with the national dose bands (5mg/ml) Administration Information Extravasation • Carboplatin - irritant • Cetuximab - neutral Other • Capecitabine should start on the evening of day 1 • Capecitabine should be taken with or after food • Individuals should be monitored for hypersensitivity reactions for sixty minutes after finishing the cetuximab infusion. Do not administer other chemotherapy during this period. • The rate of administration of cetuximab must not exceed 5mg/min for the first infusion (minimum 120 minutes). If well tolerated subsequent infusions may be given at a rate of 10mg/min (minimum 60 minutes). Additional Therapy • Antiemetics 15-30 minutes prior to chemotherapy on day one only; - dexamethasone 8mg oral or intravenous or equivalent dose - ondansetron 8mg oral or intravenous As take home medication; - dexamethasone 4mg twice a day oral for 3 days - metoclopramide 10mg three times a day when required oral - 30 minutes prior to cetuximab infusion; - chlorphenamine 10mg intravenous - dexamethasone 8mg oral or intravenous (given as part of antiemetic regimen on day 1) - H2 antagonist according to local formulary choice and availability - paracetamol 1000mg oral Version 1.2 (August 2022) Page 6 of 12 Head and Neck–Capecitabine-Carboplatin (AUC5)-Cetuximab • Oral loperamide 4mg after the first loose stool then 2-4mg four times a day when required for the relief of diarrhoea (maximum 16mg/24 hours). • Mouthwashes according to local or national policy on the treatment of mucositis • Gastric protection with a proton pump inhibitor or a H2 antagonist may be considered in patients considered at high risk of GI ulceration or bleed Additional Information • The National Patient Safety Agency alert NPSA/2008/RRR001 must be followed when prescribing, dispensing or administering oral chemotherapy. • Ensure the total daily dose of capecitabine is divided into two doses given twelve hours apart (the first should be administered in the evening of day one of the cycle), Serious toxicity has occurred where the total daily dose has been given twice a day. • It must be made clear to all staff, including those in the community, that this is a short course of oral chemotherapy that must not be continued. Referen c es 1. Vermorken JB, Mesia R, Rivera F et al. Platinum based chemotherapy plus cetuximab in head and neck cancer. N Engl Med 2008; 359 (11): 1116-1126. Version 1.2 (August 2022) Page 7 of 12 Head and Neck–Capecitabine-Carboplatin (AUC5)-Cetuximab REGIMEN SUMMARY Capecitabine-Carboplatin(AUC5)-Cetuximab Day One Cycle One 1. Chlorphenamine 10mg intravenous 2. Dexamethasone 8mg oral or intravenous or equivalent dose 3. Paracetamol 1000mg oral Administration Instructions Please check if the patient has taken paracetamol. The maximum dose is 4000mg in every 24 hours 4. H2 antagonist according to local formulary choice and availability Administration Instructions: Administer according to local formulary choice and availability one of the following 30 minutes prior to SACT; - famotidine 20mg oral once only - nizatidine 150mg oral once only - ranitidine 150mg oral once only - ranitidine 50mg intravenous once only If there is no stock of these products due to national shortages treatment may proceed without the H2 antagonist provided there is no instruction in the ARIA journal indication the patient must have H2 antagonist treatment. All infusion related reactions must be recorded in the ARIA journal and reported to the appropriate consultant. Many Trusts do not administer an H2 antagonist from cyclethree onwards. They have been left in the ARIA protocols so that decisions can be made on an individual Trust and patient basis. 5. Cetuximab 400mg/m2 intravenous infusion An interval of 60 minutes should be left between administration of cetuximab and carboplatin 6. Ondansetron 8mg oral or intravenous Administration Instructions Administer 15-30 minutes prior to SACT. This may be given as ondansetron 8mg intravenous if required 7. Warning - Carboplatin Maximum Dose Administration Instructions The dose of carboplatin is capped at a creatinine clearance of 125ml/min. The internationally recommended maximum dose of carboplatin for AUC 5 is 750mg . The national dose bands do not contain this dose so the cap has been set at 790mg in ARIA. Please check this dose is appropriate for your patient. 8. Carboplatin AUC 5 intravenous infusion in 500ml glucose 5% over 60 minutes Administration Instructions The dose of carboplatin is capped at a creatinine clearance of 125ml/min. The internationally recommended maximum dose of carboplatin for AUC 5 is 750mg . The national dose bands do not contain this dose so the cap has been set at 790mg in ARIA. Please ch eck this dose is appropriate for your patient Take Home Medicines (day 1 only) 9. Capecitabine 1000mg/m2 twice a day for 10 days starting on the evening of day one of the cycle oral Administration Instructions Oral SACT Start on the evening of day 1 of the cycle 10. Dexamethasone 4mg twice a day for 3 days oral starting on day two of the cycle Administration Instructions Take 4mg twice a day (morning and lunch) for 3 days starting on day 2 of the cycle Version 1.2 (August 2022) Page 8 of 12 Head and Neck–Capecitabine-Carboplatin (AUC5)-Cetuximab 11. Metoclopramide 10mg three times a day when required oral Administration Instructions Please supply 28 tablets or an original pack as appropriate Day Eight and Fifteen Cycle One 12. Chlorphenamine 10mg intravenous 13. Dexamethasone 8mg oral or intravenous or equivalent dose Administration Instructions Administer 15-30 minutes prior to SACT. This may be administered as dexamethasone 8mg intravenous 14. Paracetamol 1000mg oral Administration Instructions Please check if the patient has taken paracetamol. The maximum dose is 4000mg in every 24 hours 15. H2 antagonist according to local formulary choice and availability Administration Instructions: Administer according to local formulary choice and availability one of the following 30 minutes prior to SACT; - famotidine 20mg oral once only - nizatidine 150mg oral once only - ranitidine 150mg oral once only - ranitidine 50mg intravenous once only If there is no stock of these products due to national shortages treatment may proceed without the H2 antagonist provided there is no instruction in the ARIA journal indication the patient must have H2 antagonist treatment. All infusion related reactions must be recorded in the ARIA journal and reported to the appropriate consultant. Many Trusts do not administer an H2 antagonist from cycle th ree onwards. They have been left in the ARIA protocols so that decisions can be made on an individual Trust and patient basis. 16. Cetuximab 250mg/m2 intravenous infusion Day One Cycle Two Onwards 17. Chlorphenamine 10mg intravenous 18. Dexamethasone 8mg oral or intravenous or equivalent dose Administration Instructions Administer 15-30 minutes prior to SACT. This may be administered as dexamethasone 8mg intravenous 19. Paracetamol 1000mg oral Administration Instructions Please check if the patient has taken paracetamol. The maximum dose is 4000mg in every 24 hours 20. H2 antagonist according to local formulary choice and availability Administration Instructions: Administer according to local formulary choice and availability one of the foll owing 30 minutes prior to c h emo th erap y ; - famotidine 20mg oral once only - nizatidine 150mg oral once only - ranitidine 150mg oral once only - ranitidine 50mg intravenous once only If there is no stock of these products due to national shortages treatment may proceed without the H2 antagonist provided there is no instruction in the ARIA journal indication the patient must have H2 antagonist treatment. All infusion related reactions must be recorded in the ARIA journal and reported to the appropriate consultant. Many Trusts do not administer an H2 antagonist from cycle three onwards. They have been left in the ARIA protocols so that decisions can be made on an individual Trust and patient basis. 21. Cetuximab 250mg/m2 intravenous infusion Version 1.2 (August 2022) Page 9 of 12 Head and Neck–Capecitabine-Carboplatin (AUC5)-Cetuximab 22. Ondansetron 8mg oral or intravenous Administration Instructions Administer 15-30 minutes prior to SACT. This may be given as ondansetron 8mg intravenous if required An interval of 60 minutes should be left between administration of cetuximab and carboplatin 23. Warning - Carboplatin Maximum Dose Administration Instructions The dose of carboplatin is capped at a creatinine clearance of 125ml/min. The internationally recommended maximum dose of carboplatin for AUC 5 is 750mg . The national dose bands do not contain this dose so the cap has been set at 790mg in ARIA. Please check this dose is appropriate for your patient. 24. Carboplatin AUC 5 intravenous infusion in 500ml glucose 5% over 60 minutes Administration Instructions The doseof carboplatin is capped at a creatinine clearance of 125ml/min. The internationally recommended maximum dose of carboplatin for AUC 5 is 750mg . The national dose bands do not contain this dose so the cap has been set at 790mg in ARIA. Please ch eck this dose is appropriate for your patient Take Home Medicines 25. Capecitabine 1000mg/m2 twice a day for 10 days oral Administration Instructions Oral SACT Start on the evening of day 1 of the cycle 26. Dexamethasone 4mg twice a day for 3 days oral starting on day two of the cycle Administration Instructions Take 4mg twice a day (morning and lunch) for 3 days starting on day 2 of the cycle 27. Metoclopramide 10mg three times a day when required oral Administration Instructions Please supply 28 tablets or an original pack as appropriate Day Eight and Fifteen Cycle Two Onwards 28. Chlorphenamine 10mg intravenous 29. Dexamethasone 8mg oral or intravenous or equivalent dose Administration Instructions Administer 15-30 minutes prior to SACT. This may be administered as dexamethasone 8mg intravenous 30. Paracetamol 1000mg oral Administration Instructions Please check if the patient has taken paracetamol. The maximum dose is 4000mg in every 24 hours 31. H2 antagonist according to local formulary choice and availability Administration Instructions: Administer according to local formulary choice and availability one of the following 30 minutes prior to c h emo th erap y ; - famotidine 20mg oral once only - nizatidine 150mg oral once only - ranitidine 150mg oral once only - ranitidine 50mg intravenous once only If there is no stock of these products due to national shortages treatment may proceed without the H2 antagonist provided there is no instruction in the ARIA journal indication the patient must have H2 antagonist treatment. All infusion related reactions must be recorded in the ARIA journal and reported to the appropriate consultant. Many Trusts do not administer an H2 antagonist from cycle three onwards. Th ey have been left in the ARIA protocols so that decisions can be made on an individual Trust and patient basis. Version 1.2 (August 2022) Page 10 of 12 Head and Neck–Capecitabine-Carboplatin (AUC5)-Cetuximab 32. Cetuximab 250mg/m2 intravenous infusion Version 1.2 (August 2022) Page 11 of 12 Head and Neck–Capecitabine-Carboplatin (AUC5)-Cetuximab DOCUMENT CONTROL Version Date Amendment Written By Approved By Carboplatin national dose bands added 1.2 Aug 2022 Administration instructions added in summary Dr Deborah Wright Donna Kimber Pharmacist Pharmacy Technician Warning added in summary Update of premedication due to shortage of IV ranitidine. IV ranitidine changed to H2 antagonist according to local formulary choice and availability Coding removed 1.1 Nov 2020 Dose banding statement updated Donna Kimber Pharmacy Technician Rebecca Wills Pharmacist Monitoring updated with DPD testing Carboplatin max dose added Paracetamol admin instructions updated 1 Dec 2014 None Dr Debbie Wright Dr S Ramkumar Pharmacist Consultant Clinical Oncologist This chemotherapy protocol has been developed as part of the chemotherapy electronic prescribing project. This was and remains a collaborative project that originated from the former CSCCN. These documents have been approved on behalf of the following Trusts; Hampshire Hospitals NHS Foundation Trust NHS Isle of Wight Portsmouth Hospitals NHS Trust Salisbury Hospital NHS Foundation Trust University Hospital Southampton NHS Foundation Trust Western Sussex Hospitals NHS Foundation Trust All actions have been taken to ensure these protocols are correct. However, no responsibility can be taken for errors which occur as a result of following these guidelines. Version 1.2 (August 2022) Page 12 of 12 Head and Neck–Capecitabine-Carboplatin (AUC5)-Cetuximab
Url: /Media/UHS-website-2019/Docs/Chemotherapy-SOPs1/Headandneckcancer/Capecitabine-Carboplatin-Cetuximab.pdf

Papers Trust Board 27 May 2021

Description: Date Time Location Chair Agenda Trust Board – Open Session 27/05/2021 9:00 - 13:00 Microsoft Teams Peter Hollins 1 Chair’s Welcome, Apologies and Declarations of Interest 9:00 To note apologies for absence, and to hear any declarations of interest relating to any item on the Agenda. 2 Staff Story The patient or staff story provides an opportunity for the Board to reflect on the experiences of patients and staff within the Trust and understand what the Trust could do better. 3 Minutes of Previous Meeting held on 30 March 2021 9:15 4 Matters Arising and Summary of Agreed Actions To discuss any matters arising from the minutes, and to agree on the status of any actions assigned at the previous meeting. 5 QUALITY, PERFORMANCE and FINANCE Quality includes: clinical effectiveness, patient safety, and patient experience 5.1 Briefing from the Chair of the Charitable Funds Committee (Oral) 9:25 Dave Bennett, Chair 5.2 Briefing from the Chair of the Finance and Investment Committee (Oral) 9:30 Dave Bennett, Chair 5.3 Briefing from the Chair of the Quality Committee (Oral) 9:35 Tim Peachey, Chair 5.4 Chief Executive Officer's Update (Oral) 9:40 Sponsor: David French, Chief Executive Officer 5.5 Integrated Performance Report for Month 1 10:00 To review the Trust's performance as reported in the Integrated Performance Report Sponsor: David French, Chief Executive Officer 5.6 Equality and Diversity Update (WRES and WDES) 10:45 Sponsor: Steve Harris, Chief People Officer Attendee: Gemma Genco, Head of Equality, Diversity & Inclusivity 5.7 Gender Pay Gap Reporting 2020 11:05 Sponsor: Steve Harris, Chief People Officer Attendee: Kirsty Durrant, Strategic HR Projects Manager 5.8 Freedom to Speak Up Report 11:25 Sponsor: Gail Byrne, Chief Nursing Officer Attendee: Christine Mbabazi, Equality & Inclusion Adviser/Freedom to Speak Up Guardian 5.9 Finance Report for Month 1 11:45 Sponsor: Ian Howard, Interim Chief Financial Officer 6 STRATEGY and BUSINESS PLANNING 6.1 CRN: Wessex 2020/21 Annual Report and 2021/22 Annual Plan 11:55 Sponsor: Paul Grundy, Chief Medical Officer Attendees: Rebecca McKay, Chief Operating Officer, CRN: Wessex/Clare Rook, Deputy COO, CRN: Wessex 7 CORPORATE GOVERNANCE, RISK and INTERNAL CONTROL 7.1 Register of Seals and Chair's Actions 12:15 In compliance with the Trust Standing Orders, Standing Financial Instructions, and the Scheme of Reservation and Delegation. Sponsor: Peter Hollins, Trust Chair 7.2 Emergency Planning and Business Continuity Annual Report 2020/21 12:20 Sponsor: Joe Teape, Chief Operating Officer 7.3 Charitable Funds Committee Terms of Reference 12:30 Sponsor: Peter Hollins, Trust Chair Attendee: Karen Flaherty, Associate Director of Corporate Affairs and Company Secretary 7.4 Trust Executive Committee Terms of Reference 12:35 Sponsor: David French, Chief Executive Officer Attendee: Karen Flaherty, Associate Director of Corporate Affairs and Company Secretary 8 Any Other Business 12:40 To raise any relevant or urgent matters that are not on the agenda 9 To note the date of the next meeting: 29 July 2021 Page 2 10 Resolution regarding the Press, Public and Others Sponsor: Peter Hollins, Chair To agree, as permitted by the National Health Service Act 2006 (as amended), the Trust's Constitution and the Standing Orders of the Board of Directors, that representatives of the press, members of the public and others not invited to attend to the next part of the meeting be excluded due to the confidential nature of the business to be transacted. 11 Follow-up discussion with governors 12:45 Page 3 3 Minutes of Previous Meeting held on 30 March 2021 1 Minutes TB 30 March 2021 OS Minutes Trust Board – Open Session Date Time Location Chair Present 30/03/2021 9:00 - 12:05 Microsoft Teams Peter Hollins (PH) Dave Bennett (DB), Non-Executive Director (NED) Gail Byrne (GB), Chief Nursing Officer Cyrus Cooper (CC), NED Keith Evans (KE), NED David French (DAF), Interim Chief Executive Officer Paul Grundy (PG), Interim Chief Medical Officer Steve Harris (SH), Chief People Officer Jane Harwood (JH), NED (until item 5.10) Ian Howard (IH), Interim Chief Financial Officer Tim Peachey (TP), NED and Senior Independent Director/Deputy Chair Joe Teape (JT), Chief Operating Officer In attendance Brenda Carter (BC), Assistant Director of People (for item 5.8) Ellen Copson (EC), Associate Professor of Medical Oncology, University of Southampton and Honorary Medical Oncology Consultant (for item 2) Kirsty Durrant (KD), Strategic HR Projects Manager (for item 5.8) Karen Flaherty (KF), Associate Director or Corporate Affairs and Company Secretary Sarah Herbert (SHe), Divisional Head of Nursing and Professions, Division B (for item 5.9) Sandra Hodgkyns (SHo), Head of Emergency Planning Response and Resilience/Security (for item 5.9) Stephanie Ramsey (SR), Director of Quality and Integration (Chief Quality Officer and Chief Nurse), NHS Southampton City CCG (for item 5.6) 3 governors (observing) 3 members of the public (observing) 5 members of staff (observing) 1 member of the public (for item 2) 1 Chair’s Welcome, Apologies and Declarations of Interest The Chairman welcomed all those attending to the meeting. The following declaration of interests for GB were reported to the Board: • Chair of the Directors of Nursing Group, University Hospital Association; • Chair of the Wessex Patient Safety Collaborative; and • Member of the Policy Board, NHS Employers. The Board also noted that DB was no longer a director of Davox Consulting Limited. 2 Patient Story The patient story was told by the husband of a patient who sadly died in early 2020 following treatment for cancer at the Trust. As a result of the treatment she had received at the Trust following a diagnosis in April 2017, her life had been extended by over three years. In terms of areas for improvement, better communication of his wife’s initial diagnosis would have helped her and her family to come to terms with the diagnosis more quickly. Following their arrival at hospital, they were being asked lots of questions and his wife was being sent for tests and scans without being given information about what concerns the clinicians had or potential diagnoses. The diagnosis was also delivered on the ward just prior to a visit from a relative and with better planning this could have been done more sensitively by providing a better environment in which to have the conversation and more time for his wife to absorb the information. Once his wife met the specialist team, including the specialist nurse, she felt more reassured and was given hope by the availability of different treatment options. The Trust’s appointment of a dedicated specialist nurse for his wife’s particular cancer shortly after her diagnosis made a huge difference. The specialist nurse was always present when his wife met the consultants and would check if there was anything he or his wife needed and provided practical advice and support, which meant that he and his wife were able to spend more time together. GB reiterated the importance of specialist nurses across different patient pathways and the Trust continued to invest in more specialist nurses. While acknowledging that there was a shortage of private spaces to speak with patients and their families, through its End of Life Care Steering Group the Trust had identified a number of rooms across the hospitals to enable clinicians to go somewhere private in situations like these. The cancer service also continued to adapt to changes in cancer care and the needs of patients, with patients now living longer. Maggie’s Southampton had recently opened at the Southampton General Hospital site to provide help and support for those living with cancer, although the services it offered were currently reduced as a result of the Covid-19 pandemic. The Board expressed its gratitude for sharing the story with such strength and dignity. 3 Minutes of Previous Meeting held on 28 January 2021 The minutes of the meeting held on 28 January 2021 were approved as an accurate record of that meeting. 4 Matters Arising and Summary of Agreed Actions The updates on the actions were noted. The action relating to cancelled appointments in ophthalmology (reference 354) had been followed up and could be closed, as could the actions relating to patients medically optimised for discharge (reference 351 and 393) and the Ockenden report (reference 395), which were included as items on the agenda later in the meeting. The action relating to patient nutrition (reference 394) would be reviewed at the next meeting of the Quality Committee, which would then report to the Board. The Board agreed that the actions relating to specialty outcomes (reference 350 and reference 326) should be combined, with the paper due to be presented to the Board at its meeting in April 2021. Page 2 5 QUALITY, PERFORMANCE and FINANCE 5.1 Briefing from the Chair of the Audit and Risk Committee KE updated the Board on the meeting of the Audit and Risk Committee held on 15 March 2021: • the external audit work had commenced and there were no issues to report at this early stage; • the internal auditors had reviewed referral to treatment (RTT) data quality and while data inaccuracies had been identified in the sample testing, these had not impacted on patients clinical treatment or on Trust’s the overall performance against the RTT target, and in most instances had resulted in the Trust overreporting on pathways; and • updates had been provided on progress against the recommendations in the board governance review and the ongoing review of the data security and protection toolkit. 5.2 Briefing from the Chair of the Finance and Investment Committee DB provided an overview of the Finance and Investment Committee meeting the previous day, highlighting: • that funding for the loss of other income and additional accruals of annual leave that staff had been unable to take due to the Covid-19 pandemic had been received; • the update on the planning process for 2021/22 following the publication of new national guidance that sought to achieve a balance between restoring services and reducing backlogs while supporting staff recovery; • the review of the most recent operational productivity dashboard, from which it had been difficult to draw any meaningful conclusions given the impact of the Trust’s response to the most recent wave of the Covid-19 pandemic in the previous months; and • the business case for the expansion of the outpatients area in ophthalmology, which would be considered by the Board later in the meeting. 5.3 Briefing from the Chair of the Quality Committee TP provided an update on the meeting of the Quality Committee held on 15 March 2021 focusing on the following areas: • the increase in waiting times for diagnostics and plans to recover performance, with a review of patient harm to be completed once patients who had waited longer than six weeks had been seen; • the review of a ‘never event’ relating to a retained swab including the recommendations for a number of sensible actions that had already been implemented; • the latest update on experience of care including the Trust’s accreditation as a Veteran Aware NHS trust; • the recommendations for reporting on maternity safety following the Ockenden review of maternity services at Shrewsbury and Telford Hospital NHS Trust, which would be considered by the Board later in the meeting; • the urgent investigation of aspergillus infections in the intensive care unit to establish whether there was a link to an earlier leak in a pipe above the ceiling in that area; • the latest report on clinical outcomes, with the Board to receive a full Page 3 report at its meeting in April 2021; and • the review of the committee’s effectiveness. 5.4 Chief Executive Officer’s Update The Trust had taken part in the national day of reflection and one minute’s silence on 23 March 2021 to commemorate the anniversary of the first national lockdown due to the Covid-19 pandemic. This had given staff an opportunity to pause and reflect on the loss of life over the previous year, including patients and staff. There were currently 20 patients in the hospital who had tested positive for Covid-19, three of which were in intensive care. An average of three or four patients with Covid-19 were being admitted daily, which highlighted the importance of continuing to follow the rules as lockdown measures were eased. Staff were being encouraged to take annual leave and wellbeing conversations were taking place with every member of staff. Second doses of the Covid-19 vaccine were being administered to Trust staff and staff at health and social care partners. 92% of frontline staff and 90% of all staff had received at least one dose of the vaccine, including 88% of BAME (Black and Minority Ethnic) staff. Staff who had not yet received the vaccination were being contacted individually to understand the reasons for this and provide additional information where appropriate. As well as planning for the recovery of services in the short term, the Trust was carrying out long-term modelling of future demand and capacity supported by external consultants and architects, which would form the basis of the Trust’s estates masterplan for the main hospital site. In advance of this work, the corporate objectives for 2021/22 would be presented to the Board at its meeting in April 2021. The Trust had performed exceptionally well in its recent external accreditation of endoscopy by the Joint Advisory Group on GI Endoscopy (JAG), providing one of the best submissions reviewed by JAG. Each of the executive directors provided an update in turn, covering the following areas: • reopening of theatres in Southampton General and Princess Anne Hospitals, replacing the current additional capacity in the independent sector from 1 April 2021; • four ‘Always Improving’ quality improvement projects relating to the emergency department (ED), discharge of patients medically optimised for discharge (MOFD), theatres and outpatients; • the launch of the ‘Always Improving’ strategy with staff in June 2021; • the review of patients who had been waiting for surgery, in particular those in priority level 2 (surgery that can be deferred for up to four weeks); • modelling of the potential impact on the waiting list of GP referrals returning to more normal levels and patients potentially presenting with more advanced disease than if they had seen their GP earlier; • the business intelligence programme to improve prospective as well as retrospective reporting; • allowing time for teams to readjust to working together as part of the recovery process with additional support from the Trust for those teams experiencing challenges; • plans to safely reopen the hospitals to visitors, particularly while the Page 4 Trust continued to admit patients with Covid-19; • re-energising the COVID ZERO campaign to ensure that the infection control measures continued to be followed rigorously even as the number of cases reduced, with a nosocomial infection the previous week acting as a timely reminder of the risk; • the successful renegotiation of the limit on expenditure (CDEL) for 2020/21 through which the Trust had been able to access additional capital and the negotiation of the allocation of CDEL across the integrated care system (ICS) for 2021/22; and • the current projects in development including theatres, the private patient unit, ophthalmology and the pathology laboratory information system. The Board noted that that the Trust would need to establish how it would balance the needs of those patients who had been waiting longest for treatment with the clinical prioritisation process already in place as it planned for the recovery of activity. 5.5 Integrated Performance Report for Month 11 The integrated performance report (IPR) for month 11 was noted. During February 2021 the direct impact of Covid-19 infections upon the Trust continued to be significant. There were 263 patients in the hospital with Covid19 at the start of February and 129 at the end of the month. The number of patients in intensive care reduced from 67 at the beginning of the month to 39 by the end of February. This compared to the first wave of Covid-19 pandemic, when the number of patients with Covid-19 in the hospital peaked at 173 and 38 in intensive care. This also had an impact on elective activity within the Trust, which was 42% of the level in February 2020. The Board discussed the following areas: Responsive • while the Trust’s ED was performing well comparatively, it was not meeting the performance target on the length of time patients spent in ED, despite attendances at 71% of the normal level; • this was principally due to patients presenting with mental health conditions and surges of high acuity patients, however, new junior doctors had also joined ED in February who were not used to the level of attendances; • leadership in ED was central to managing the department in these situations particularly the effective operation of the consultant of the day model to ensure that decisions regarding patients were made in a timely manner; • performance in ED had improved overall as 87% of patients were currently seen within four hours with an average daily attendance of 345 patients compared to 78% of patients two years ago when the average daily attendance was 350 patients; • to continue to improve performance and the flow of patients through ED the Trust was ensuring that specialties adhered to the one hour standard for referrals; • infection control measures remained in place, including respiratory assessment and rapid testing in ED and the acute medical unit, although it was difficult to establish whether this had a material impact on performance as ED had performed consistently well during the Page 5 period of the pandemic; • activity in ED had increased in March 2021 as lockdown restrictions had eased; • while the number of non-face-to-face outpatient appointments had increased following the first wave of the pandemic, some of these had not been full appointments but rather an opportunity to check in with patients; • the use of non-face-to face outpatient appointments varied by condition and specialty and was more appropriate for some of these than others, however, the Trust was seeking to learn from those clinicians who had used these types of appointment successfully as part of its quality improvement work in outpatients; • feedback from patients non-face-to face appointments had been positive on the basis that their care was continuing, however, limited work had been done to assess effectiveness in terms of the experience and outcome of these appointments; and • although cancer performance measures remained stable, both the Trust and the Wessex Cancer Alliance had performed well comparatively and ranked as second highest performing in their respective peer groups. Safe • • the unusually high number of medication incidents reported with moderate or severe harm in February and the actions taken in response to these; and ensuring that staff continued to report incidents, particularly as they returned to their normal areas of work following the pandemic. Caring • the number of overnight ward moves for non-clinical reasons given that most patient moves during this period would be related to patients admitted with Covid-19; • the percentage of patients with a disability or additional needs reporting that those needs were met had reduced and there were resource challenges in this area currently with a vacancy in one of the two adult learning disabilities nursing roles, although the recruitment process was underway; and • increasing the number of vulnerable women on a continuity of carer pathway given the benefit to all these women in terms of the quality of oversight in maternity. ACTIONS: (1) GB would review the non-clinical reasons for overnight ward moves and provide an overview to the Quality Committee. (2) The Quality Committee would review the resourcing required to increase the percentage of vulnerable women on a continuity of carer pathway and update the Board. Well-led • the impact of research activity on outcomes, more detail of which would be provided in the report on clinical outcomes at the meeting of the Board in April 2021. The Board’s review of the IPR, led by TP, would report to the Board in May 2021 with a candidate IPR. Page 6 5.6 Inpatient Flow - Medically Optimised for Discharge Update SR joined the meeting for this item. The Board noted the current performance against the process improvement trajectories and key performance indicators agreed by the system, system plans in the light of current performance and the Trust’s internal work programme for MOFD. The Board was interested to learn what the Trust could be doing differently or better in order to help improve performance as a system. The work to date had made a significant impact as the system responded to discharge an increased number of patients with more complex needs such as stroke patients, patients with challenging behaviours, patients requiring more intensive therapy and homeless patients. There was a specific issue with discharging to care homes at weekends and providing the necessary clinical support to these care homes to enable discharge. The main areas of focus for the Trust were to speed up processes and ensure patients MOFD were ready to be discharged earlier in the day as this would make it easier for services in the community to respond. While there was a target to get to 40-60 patients MOFD in hospital, no specific timescales had been set. ACTION: JT agreed to include a trajectory for MOFD patients in the regular reports to the Finance and Investment Committee. Funding was also likely to be an issue in the future as additional national funding provided during the Covid-19 pandemic to support the discharge of patients would be withdrawn at the end of June 2021. The Board recognised that system partners were aligned in their aim to address the delays in discharging patients MOFD and prevent potential patient harm as a result. However, the Board suggested a more holistic view of the issue would be beneficial when reviewing future resourcing, taking into account the revenue and capital implications and the consequences in terms of hospital capacity and addressing the current backlog of patients waiting for treatment. This analysis may identify where investment was needed to support discharge, including additional capacity, albeit that the ambition remained ‘home first’ when discharging patients in order to assess ongoing needs more accurately and reduce dependency. The meeting was adjourned briefly to allow for a break. 5.7 Ockenden Review of Maternity Services The Board noted the update on progress on the emerging findings and recommendations of the independent review of maternity services at the Shrewsbury and Telford Hospital NHS Trust released on 10 December 2020. The Trust had rated its progress against two of the recommendations as red, with no actions currently in place, and nine of the recommendations as amber, where actions were still in progress. Completion of these recommendations was dependent the Trust’s submission to NHS Resolution’s maternity incentive scheme which would be made by mid-July 2021 and therefore other trusts would be in a similar position. The Trust had received feedback on the information submitted to NHS England and NHS Improvement, which had been positive overall. A template had been designed to report to the Board and the local maternity Page 7 service (LMS) on maternity safety, which would incorporate a summary of serious incidents (SIs) and moderate harm incidents. This report would be submitted to the Board maternity safety champions and LMS on a monthly basis. The Board maternity safety champions would also meet with complainants before the referral of a complaint to the Parliamentary and Health Service Ombudsman. It was proposed that reporting to the Board on maternity safety issues including SIs and moderate harm incidents, the perinatal mortality report tool, early notification scheme, red flag incidents, staff concerns and evidence of listening to families including complaints would take place quarterly following review of the information by the Quality Committee. The frequency of reporting to the Board was in line with the recommendations in the Ockenden review although not with the guidance issued subsequently. The Board was keen to ensure it maintained a good understanding of the culture and patient experience in the maternity service given the impact of each on the quality of the service. Proposals to regularly survey staff would be considered later in the meeting. In addition the Board requested that the regular patient story should include maternity at least once annually. ACTION: KF to arrange a patient story from a patient using the maternity service at least once annually. DECISION: The Board agreed: • to receive a quarterly report on maternity safety issues; and • that all SIs and moderate harm incidents would be provided to the Board maternity safety champions and LMS. 5.8 UHS Staff Survey Results 2020 Report BC and KD joined the meeting for this item. The results of the NHS staff survey 2020 were noted by the Board. The survey had been completed by staff between September and November 2020. Overall the Trust’s results were at or above the acute trust average in nine out of ten themes. 77% of staff would recommend the Trust as a place to work and 87% of staff agreed that care of patients was the top priority for the Trust. Performance on health and wellbeing had significantly increased compared to 2019. However, the survey had also identified some areas for improvement. The areas with statistically significant decreases in performance compared to the 2019 staff survey results were: • Equality, diversity and inclusion; • Immediate managers; • Violence; and • Team working. In response to a question from a NED, it was clarified that only a small number of incidents of violence against staff from managers and colleagues reflected in the staff survey results were reported leading to an investigation. The reporting through the Trust’s Freedom to Speak Up processes had identified incidents involving microaggressions rather than acts of violence. Work was also ongoing to improve leadership skills within the organisation, which would set out expectations regarding values and behaviours. Over 1,000 free text comments had been submitted from staff as part of the survey and a national analysis of themes was being prepared, which would Page 8 provide further insight into how staff were feeling following the first wave of the pandemic. The Board supported more regular surveying of staff, particularly around the areas of improvement identified, recognising that things had changed since the survey was carried out six months ago and would continue to change. 5.9 Plan to Address Violence and Aggression against Staff SHe and SHo joined the meeting for this item. The Board noted the update on the progress made since the previous update in September 2020. This included closer working with Hampshire Constabulary, proposed changes to security arrangements, staff training and staff support. These plans aimed to reduce incidents of violence and aggression against staff and provide support to staff in the management of violence and aggression and following any incidents. The Board recognised that violence and aggression against staff would never be eliminated entirely as the Trust provided care to individuals with mental health issues, brain injuries, dementia and who lacked capacity who may find it difficult to control their behaviour. It was important, however, that violent and aggressive behaviour was challenged consistently when appropriate. The Board supported the approach to exclude violent and aggressive individuals from the Trust when they repeatedly displayed unacceptable behaviour that it was not possible to manage through de-escalation, anticipatory care planning and the challenging behaviour protocol. While not formally approving the funding for the plans set out in the paper, the Board noted the importance of investment in this area in order to support staff. A further update on progress would be provided in December 2021. 5.10 Finance Report for Month 11 The finance report for month 11 was noted. The following areas were highlighted: • the Trust has received the payments for the loss of other income, additional accruals of annual leave that staff had been unable to take due to the Covid-19 pandemic and the elective incentive scheme; • the Trust remained on track to achieve a breakeven position for 2020/21 as did the other trusts in the Hampshire and Isle of Wight ICS; and • the Trust’s balance sheet position remained strong, which placed the Trust in a good position to address likely pressures in 2021/22. 6 CORPORATE GOVERNANCE, RISK and INTERNAL CONTROL 6.1 Register of Seals and Chair's Actions for ratification DECISION: The Board ratified the application of the Trust seal and the Chair’s actions set out in the report. ACTION: IH would follow up on the Wessex Clinical Research Network and the assisted conception service items in the paper as these were not single tender actions required to be reported in accordance with the Trust’s Standing Financial Instructions. 6.2 Amendment to Constitution for CCG Merger With effect from 1 April 2021, the individual Clinical Commissioning Groups Page 9 (CCGs) within Hampshire and the Isle of Wight were to merge to create a new NHS Hampshire, Southampton and Isle of Wight CCG. The Council of Governors (CoG) included an appointed governor from each of NHS Southampton City CCG and NHS West Hampshire CCG and as a result of the merger these two organisations would cease to exist. It was proposed that the Trust should reflect the merger in the composition of the CoG, by amending the composition of the CoG in Annex 3 of the Trust’s constitution to remove the Appointed Governor from each of NHS Southampton City CCG and NHS West Hampshire CCG and include an Appointed Governor from NHS Hampshire, Southampton and Isle of Wight CCG in their place. A separate review of the composition of the CoG would be undertaken as part of the annual review of the Trust’s constitution to ensure that the overall composition of the CoG remains representative and reflected the changes to NHS governance structures. DECISION: The Board approved the amendment to the Trust’s constitution with effect from 1 April 2021, subject to the approval of the CoG at its meeting on 31 March 2021. 7 Any Other Business There was no other business. 8 To note the date of the next meeting: 27 May 2021 9 Resolution regarding the Press, Public and Others DECISION: The Board resolved that, as permitted by the National Health Service Act 2006 (as amended), the Trust's Constitution and the Standing Orders for the Practice and Procedure of the Board of Directors, representatives of the press, members of the public and others not invited to attend to the next part of the meeting be excluded due to the confidential nature of the business to be transacted. The meeting was adjourned. Page 10 4 Matters Arising and Summary of Agreed Actions 1 List of Action Items List of action items Agenda item Assigned to Deadline Status Trust Board – Open Session 30/03/2021 5.5 Integrated Performance Report for Month 11 426. Caring - overnight ward moves Byrne, Gail Peachey, Tim 27/05/2021 Pending Explanation action item GB would review the non-clinical reasons for overnight ward moves and provide an overview to the Quality Committee. 427. Caring - vulnerable women Byrne, Gail Peachey, Tim 27/05/2021 Pending Explanation action item The Quality Committee would review the resourcing required to increase the percentage of vulnerable women on a continuity of carer pathway and update the Board. Trust Board – Open Session 30/03/2021 5.6 Inpatient Flow - Medically Optimised for Discharge Update 428. Trajectory for MOFD patients Teape, Joe 27/05/2021 Pending Explanation action item JT agreed to include a trajectory for MOFD patients in the regular reports to the Finance and Investment Committee. Trust Board – Open Session 30/03/2021 5.7 Ockenden Review of Maternity Services 429. Patient story Flaherty, Karen 31/03/2022 Pending Explanation action item KF to arrange a patient story from a patient using the maternity service at least once annually. Page 1 of 2 Agenda item Assigned to Deadline Status Trust Board – Open Session 30/03/2021 6.1 Register of Seals and Chair's Actions for ratification 430. Follow up Howard, Ian 27/05/2021 Pending Explanation action item IH would follow up on the Wessex Clinical Research Network and the assisted conception service items in the paper as these were not single tender actions required to be reported in accordance with the Trust’s Standing Financial Instructions. Page 2 of 2 Report to the Trust Board of Directors Title: Agenda item: Sponsor: Date: Purpose Issue to be addressed: Integrated Performance Report 2021/22 Month 1 5.5 David French, Chief Executive Officer 27 May 2021 Assurance Approval or reassurance Y Ratification Information This report is intended to support the Trust Board in assuring that: • the care we provide is safe, caring, effective, responsive and well led in the context of the COVID-19 pandemic • at the same time we continue our journey toward our vision of World Class Care for Everyone. Response to the issue: The Integrated Performance Report reflects the current operating environment and is aligned with the Care Quality Commission Key Lines of Enquiry. Implications: This report covers a broad range of trust services and activities. It is (Clinical, Organisational, intended to assist the Board in assuring that the Trust meets regulatory Governance, Legal?) requirements and corporate objectives. Risks: (Top 3) of carrying This report is provided for the purpose of assurance. out the change / or not: Summary: Conclusion This report is provided for the purpose of assurance. and/or recommendation Page 1 of 1 Integrated KPI Board Report covering up to April 2021 Sponsor - Andrew Asquith, Director of Planning, Performance and Productivity, andrew.asquith@uhs.nhs.uk Chart Type Cumulative Column Example Cumulative Column Year on Year Line Benchmarked Line & bar Benchmarked Control Chart 100% 0% 66.8% Variance from Target Report Guide Explanation A cumulative column chart is used to represent a total count of the variable and shows how the total count increases over time. This example shows quarterly updates. A cumulative year on year column chart is used to represent a total count of the variable throughout the year. The variable value is reset to zero at the start of the year because the target for the metric is yearly. The line benchmarked chart shows our performance compared to the average performance of a peer group. The number at the bottom of the chart shows where we are ranked in the group (1 would mean ranked 1st that month). 66.49% The line shows our performance and the bar underneath represents the range of performance of benchmarked trusts (bottom = lowest performance, top = highest performance) A control chart shows movement of a variable in relation to its control limits (the 3 lines = Upper control limit, Mean and Lower control limit). When the value shows special variation (not expected) then it is highlighted green (leading to a good outcome) or red (leading to a bad outcome). Values are considered to show special variation if they -Go outside control limits -Have 6 points in a row above or below the mean, -Trend for 6 points, -Have 2 out of 3 points past 2/3 of the control limit, -Show a significant movement (greater than the average moving range). Variance from target charts are used to show how far away a variable is from its target each month. Green bars represent the value the metric is achieving better than target and the red bars represent the distance a metric is away from achieving its target. 2 Report to Trust Board in May 2021 Introduction The Integrated Performance Report is presented to the Trust Board each month. The report aims to: • Provide assurance that the care we provide is safe, caring, effective, responsive and well led in the context of the COVID-19 pandemic • Ensure that at the same time we continue our journey toward our vision of World Class Care for Everyone. We adjust / add to these indicators – informing the Board and keeping a comparative narrative – as the situation changes as we work through these unusual circumstances. The structure of the report is currently being reviewed in order that it can better reflect the ambitions within ‘Our Strategy 2025’, and to support the strategic discussions of the Board. April 2021 Summary During April the direct impact of COVID-19 infections upon the Trust reduced further. Patients with a confirmed COVID-19 diagnosis during their admission: • Started the month at 48 (11 of which were in intensive care / high care) • Finished the month at 24 (5 of which were in intensive care / high care) The phased resumption of the elective admissions continued within NHS facilities, and the additional access to independent sector theatres and beds that had been secured by NHS England during the pandemic terminated at the end March. 3 Report to Trust Board in May 2021 Key aspects of performance for consideration this month include: • The total number of patients on the RTT waiting list increased by over 1,000 patients to 37,613 in April. There are over 3,000 patients waiting over 52 weeks for treatment and over 500 patients waiting over 78 weeks. Our benchmarking confirms that we are continuing to perform well in comparison to our peer group. • The crude mortality rate and Hospital Standardised Mortality Ratio (HSMR) both increased significantly in January (though HSMR remained significantly better than would be expected on average in the NHS). Patient details have been requested in order that the recorded diagnosis can be checked as a first step in investigation. It may be relevant that January saw a peak in COVID-19 occupancy. • UHS 62 day performance (RE 23) improved to 86.5% (better than our local target and the national target applying to the majority of 62 day pathways). UHS was the best performing trust amongst our 10 ‘peer’ teaching hospitals in March. 4 Report to Trust Board in May 2021 RESPONSIVE • Emergency Department timeliness deteriorated slightly to 87% (RE 9) whilst remaining 3rd best amongst 8 benchmark trusts. Attendance numbers increased further to the highest levels since the COVID-19 pandemic started (RE 8). • Elective spell volumes (excluding daycases, at SGH/PAH only) (RE 13) recovered further, yet remained below those in Autumn 2020. Two SGH theatres are currently closed due to building works and are due to reopen in June. • The total number of patients on the RTT waiting list increased by over 1,000 patients this month. The cohort of patients who have waited over 52 weeks (RE 16) reduced by over 300 patients, whilst those waiting over 78 weeks (RE 17) increased by over 100 patients. We remain concerned by this situation and are focussed on improving the situation as soon as possible for our patients. Our benchmarking (in a group of 20 Teaching hospitals) confirms that we are continuing to perform well in comparison to our peer group. • Cancer performance measures for March indicate continued improvement in performance: o UHS 62 day performance (RE 23) improved to 86.5% (better than our local target and the national target applying to the majority of 62 day pathways). UHS was the best performing trust amongst our 10 ‘peer’ teaching hospitals again this month. o 31 day performance (RE 24) was maintained above the target at 97.6%. 5 Report to Trust Board in May 2021 RESPONSIVE RE1 Non-elective Spells (discharged, including CDU) Non Elective LOS RE2-L Rolling 12 months (Solid) Monthly (Dashed) Number of inpatients that were RE3 medically optimised for discharge (monthly average) Monthly Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec Jan Feb Mar Apr target 6,800 6,292 4,000 7.5 6.0 4,128 6.49 - 5.45 - 4.5 250 76 0 122 - Longer LOS Census average RE4-N (Patients with LOS > =21days) 203.38 160.86 118.33 73 145 - RE5-l RE6 RE7 Adult midday bed occupancy Last minute cancelled operations not readmitted within 28 days Last minute cancelled operations 100% 98.2% 84.6% 71.1% 82.6% 40% 55 40 0 150 5 0 79.0% 90-95% - 6 35 - 6 Report to Trust Board in May 2021 RESPONSIVE Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec Jan Feb Mar Apr QTD 12,000 10663 RE8 Total ED Attendances - 5735 5,000 RE9-N Patients spending less than 4hrs in ED SGH Main ED (Type 1 and UCH) 92% 84% Major Trauma Centres (Type 1) 76% 90.2% 87.2% 81.30% 87.2% Rank of 8-> RE10-N Patients spending less than 4hrs in ED UHS Total (includes SGH all types) - 532533422111233 92.22% 85.5% 78.82% 91.1% 91.1% 88.0% 88.0% Q target - 95% 95% RE11-N Total time Total spent in ED - Percentiles UHS RE12 27,000 Accepted Referrals (excluding -initiated by consultant responsible) 0 RE13 2,000 Elective spells (excluding daycase, onsite SGH/PAH only) 0 90th, 4:00 Mean, 2:45 8,013 446 90th, 4:59 - - Mean, 3:04 19,100 - - 1,438 - - 7 Report to Trust Board in May 2021 RESPONSIVE Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec Jan 100% % Patients on an open 18 week pathway 66.8% RE14-N (within 18 weeks ) with teaching hospital min-max range and rank (of 20) 18 12 14 14 7 6 7 7 10 10 10 9 30% 38,000 Total number of patients on a waiting RE15-N list (18 week referral to treatment 33106 pathway) 30,000 Patients on an open 18 week pathway 9,000 RE16-N (waiting 52 weeks+ ) with teaching hospital min-max range and rank (of 20) 0 15 154 13 13 13 11 11 11 10 9 6 6 6 1000 RE17 Patients on an open 18 week pathway (waiting 78 weeks+ ) 500 0 0 65,000 RE18 Face to face outpatient attendances 40,105 Feb Mar Apr 66.5% 9 8 37613 3108 5 4 553 34,415 Target > =92% - 0 65,000 RE19 Non-face to face outpatient attendances 15,703 0 RE19 - Latest month is awaiting approx ~3k outpatient attendances to be reported 18,748 - RE20-N Average weeks waited for first outpatient appointment 12.00 10.47 8.89 10.3 7.00 7.30 8.5 - 8 Report to Trust Board in May 2021 7.00 7.30 RESPONSIVE Target Patients to Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec Jan Feb Mar /Apr recover target QTD 11,000 9563 RE21-N Patients waiting for diagnostics - 4317 4,000 80% % of Patients waiting over 6 weeks for RE22-N diagnostics with teaching hospital min- 45.2% 27.2% 90% N = 7 L= L=> 0 of 197 80% 85% 69.1% UHS Total ………………….Rank(of 10)-> 6 5 3 1 1 1 1 1 5 7 4 2 1 1 0.5 31 day cancer wait performance RE24-N (Latest data held by UHS, Combined measure – First and Subsequent Treatments of Cancer) 97.1% 93.2% 89.4% 92.2% 97.6% N=> 96% N=0 of 948 97.41% RE25-N Snapshot of waits > 104 days (from referral on a 62 day pathway) 36 27 29 25 11 17 9 11 25 24 17 13 16 22 - - - RE26-N 28 Day Faster Diagnosis 100% 70% 82.7% 87.5% => 75 % - 84.16% 9 Report to Trust Board in May 2021 RESPONSIVE RE27 My Medical Record - UHS patient logins Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec Jan Feb Mar Apr Monthly target 20,000 18,182 10,000 5,566 - 0 2,500 RE28 Number of Estates Help desk requests 900 and percentage completed on time 100% 85% 997 89.6% 1,592 - 84.7% > 85% 50% Elective inpatient activity - % of same month pre COVID-19 100% RE29 UHS Corporate peer average ------------------------------Rank--> 20% Non-elective inpatient activity - % of same month pre COVID-19 100% RE30 UHS Corporate peer average ------------------------------Rank--> 50% 1st outpatient attendances - % of same month pre COVID-19 100% RE31 UHS Corporate peer average ------------------------------Rank--> 30% Follow up outpatient attendances - 110% % of same month pre COVID-19 RE32 UHS Corporate peer average ------------------------------Rank--> 50% RE29-32 corporate peers group size = 7 90.4% 85.1% 35.23% 3 2 2 2 2 2 1 1 4 4 2 95.0% 66.6% 95.42% 534422232254 96.2% 51.7% 93.77% 47.20%2 2 2 2 2 2 2 2 2 2 2 3 70.3% 108.9% 102.8% - 63.6% 6 3 2 2 1 1 2 2 1 1 4 5 QTD - 86.2% - 10 Report to Trust Board in May 2021 SAFE • Only a single case of probable hospital associated COVID-19 acquisition > 7 days occurred in April (SA 6). • Our measure related to pressure ulcers was amended this month to distinguish between category 2 and 3 ulcers, regardless of level of ‘harm’ (SA 7/8). Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec Jan Feb Mar Apr Target YTD SA1-N Cumulative Clostridium difficile 2 SA2 MRSA bacteraemia 0 100 SA3 Clinical cleaning scores for very high risk areas 95 100 SA4 Serco cleaning scores for very high risk areas 95 Healthcare-acquired COVID 35 SA5 infection: COVID-positive sample taken > 14days after admission (validated) 0 Probable hospital-associated 80 SA6 COVID infection: COVID-positive sample taken > 7 days and 95% - 93.4% YTD target 95% 12 Report to Trust Board in May 2021 CARING • Inpatient feedback (CA 1) continues to be good and significantly better than target. • Maternity patient negative feedback (CA 2) continues to be worse than target; 6.6% compared to the target of =70% 41.5% 65.6% 14 Report to Trust Board in May 2021 0% CARING Monthly Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec Jan Feb Mar Apr target Total vulnerable women (living 100% CA8 within 10% most deprived decile) booked onto a continuity of carer 40.0% pathway 0% 100% % Patients reporting being CA9 involved in decisions about care and treatment 50% 86.0% 85.0% > =90% CA10 100% % Patients reporting finding somebody to talk to about worries and fears 50% 97.0% % Patients with a disability/ 100% additional needs reporting those 81.0% CA11 needs/adjustments were met (total number questioned included at chart base) 30 165 39 50% 57 153 215 133 164 174 178 240 77 CA11 - Performance is a scored metric with a "Yes" response scoring 1, "Yes, to some extent" receiving 0.5 score and other responses scoring 0. Overnight ward moves with a 100 CA12 reason marked as non-clinical (excludes moves from admitting 75.58 44.08 10 wards with LOS =90% 89.0% > =90% 63 110 289 29 - 10.8 - 15 Report to Trust Board in May 2021 EFFECTIVE • The crude mortality rate (EF 4) and Hospital Standardised Mortality Ratio (HSMR) (EF 3), both increased significantly in January (though HSMR remained significantly better than would be expected on average in the NHS). More deaths than ‘expected’ are reported in General Medicine, Respiratory Medicine and Medicine for Older People, with a primary diagnosis of ‘viral infection’. Information for 97 patients has been requested in order that the recorded diagnosis can be checked as a first step in investigation. • Measures relating to patients screened for smoking and harmful alcohol consumption (EF 5), with those found to smoke and given brief advice or a medication offer (EF 7), stalled in their recovery following the COVID-19 peak in January and are currently slightly below target. EF1-L Cumulative Specialities with Outcome Measures Developed EF2 Developed Outcomes RAG ratings EF3-N HSMR - UHS HSMR - SGH EF4 HSMR - Crude Mortality Rate Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec Jan Feb Mar Apr 53 54 56 56 57 255 260 285 305 332 100% 75% 80% 81% 79% 77% 76% 50% 85 82.2 81.5 75 3.5% 3.0% 2.5% Monthly target +1 - 80% EF6-N % patients screened & found to 100% have either moderate or high alcohol dependence given advice or referral 80% 96.7% 95.7% > 90% 100% % patients screened & found to EF7-N smoke given brief advice or a medication offer 60% 83.6% 88.9% > 90% 17 Report to Trust Board in May 2021 WELL LED • Non-medical appraisal rates (WL 2) have continued their modest rate of recovery to 81%, but still remain significantly below the target of 92%. • Overall sickness absence (WL 6) reduced to 3%, which is within target, whilst COVID-19 related absence (WL 7) reduced to 1% of employed time during the month of April. WL1-L Substantive Staff - Turnover Monthly Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec Jan Feb Mar Apr Target 13.63% 12.92% 12.22% 13.4% 12.3% 92% 95.0% 3.4% 12.4% =76% WL9-N Response rate of - staff recommend UHS 60% as a place to work: UHS Quarterly staff FFT National NHS Staff Survey 20% 50.0% 30% 11% WL10-L % of Band 7+ staff who are Black and Minority Ethnic 9.2% 10.0% 15% by 2023 7% WL11 14% % of Band 7+ Staff who have declared a disability or long term health condition 13.3% 13.6% - 12% WL12- QI training programme, and reporting, is currently temporarily suspended as team members support urgent change programmes as part of our Covid 19 response and recovery WL12-L Statutory & Mandatory Training Achieving Target 7 7 7 6 6 6 6 6 6 6 6 6 6 6 6 - 5 5 5 6 6 6 6 6 6 6 6 6 6 6 6 100 WL13-L Number of Apprenticeship Starts 44 49 59 23 - 0 19 Report to Trust Board in May 2021 0 WELL LED Monthly Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec Jan Feb Mar Apr target WL14-L Comparative CRN Recruitment Performance by clinical specialty 56% 52% 28% 36% 40% > =70.0% WL15-L Comparative CRN Recruitment Performance - weighted WL16-L Comparative CRN Recruitment - contract commercial WL17-L Proportion of studies closing in FY on time and to recruitment target non-commercial WL18 NIHR CRF & BRC cumulative quarterly publications 2 5 13 88% 13 50% 600 137 120 0 2 17 43% 246 261 7 7 45% 424 329 Top 5 8 2 Top 10 42% 452 562 > =80% 20 Report to Trust Board in May 2021 Changes and Corrections Section Responsive Safe Safe Caring Caring KPI KPI Name Type RE29-32 Activity metrics - % of same month pre COVID-19, UHS and corporate peer average change SA7 Pressure ulcers category 2 per 1000 bed days change SA8 Pressure ulcers category 3 and above per 1000 bed days change CA11 % Patients with a disability/ additional needs reporting those needs/adjustments were met correction (total number questioned included at
Url: /Media/UHS-website-2019/Docs/About-the-Trust/Trust-governance-and-corporate-docs/2021-Trust-document/TB-papers/Papers-Trust-Board-27-May-2021.pdf

Capecitabine-Cetuximab-Oxaliplatin

Description: Chemotherapy Protocol COLORECTAL CANCER CAPECITABINE-CETUXIMAB-OXALIPLATIN (21 day) This regimen may require funding Regimen • Colorectal Cancer – Capecitabine-Cetuximab-Oxaliplatin (21 day) Indication • Cetuximab in combination with fluoropyrimidine and oxaliplatin chemotherapy is recommended as a possible first or second line treatment for people with metastatic colorectal cancer when: - surgery to remove the cancer in the colon or rectum has been carried out or is possible - the metastases are only in the liver and cannot be removed surgically before treatment - the person is fit enough to have surgery to remove the cancer in the colon or rectum and to have liver surgery if it becomes possible to remove the metastases after cetuximab treatment • The tumour is positive for the wild type KRAS genotype • WHO performance status 0, 1, 2 Toxicity Drug Capecitabine Cetuximab Oxaliplatin Adverse Effect Palmar-plantar erythrodysesthesia, diarrhoea, mucositis, chest pain Infusion related reactions, interstitial lung disease, skin reactions, electrolyte abnormalities, fatigue, abdominal pain, constipation Peripheral neuropathy (cumulative), acute laryngopharyngeal dysasthesia (increase duration of infusion) The adverse effects listed are not exhaustive. Please refer to the relevant Summary of Product Characteristics for full details. Monitoring Regimen Version 1.3 (October 2020) Page 1 of 12 Colorectal – Capecitabine-Cetuximab-Oxaliplatin (21 day) • Prior to starting therapy confirm a positive KRAS status • FBC, LFT’s and U&E’s prior to day one of treatment • Monitor for hypersensitivity reactions for 60 minutes after the end of the cetuximab infusion • Patients with complete or partial dihydropyrimidine dehydrogenase (DPD) deficiency are at increased risk of severe and fatal toxicity during treatment with capecitabine. All patients should be tested for DPD deficiency before initiation (cycle 1) to minimise the risk of these reactions Dose Modifications The dose modifications listed are for haematological, liver and renal function only. Dose adjustments may be necessary for other toxicities as well. In principle all dose reductions due to adverse drug reactions should not be reescalated in subsequent cycles without consultant approval. It is also a general rule for chemotherapy that if a third dose reduction is necessary treatment should be stopped. Please discuss all dose reductions / delays with the relevant consultant before prescribing if appropriate. The approach may be different depending on the clinical circumstances. The following is a general guide only. Haematological Prior to prescribing the following criteria must be met. Criteria Neutrophil Platelets Eligible Level equal to or more than 1.5x109/L equal to or more than 100x109/L Consider blood transfusion if patient symptomatic of anaemia or has a haemoglobin of less than 8g/dL For haematological toxicity, if the neutrophil count is less than 1.5 109/L or the platelet count is less than 75 109/L, delay treatment until these levels are achieved. Re-initiate therapy at the full dose for a seven day delay or with 75% of the original dose for a fourteen day delay (consider re-starting with 100%). If the delay is more than 20 days stop therapy. There is little need to adjust the dose of cetuximab for haematological toxicity. Hepatic / Renal Impairment Deteriorating liver or kidney function may be a sign of disease progression or drug toxicity. Version 1.3 (October 2020) Page 2 of 12 Colorectal – Capecitabine-Cetuximab-Oxaliplatin (21 day) Hepatic Impairment Drug Capecitabine Cetuximab Oxaliplatin Dose (% of original dose) There is little published information available. No dose reductions are necessary for those with mild to moderate hepatic dysfunction due to liver metastasis Administer only when the transaminases are 5xULN or below and the bilirubin is 1.5xULN or below There is little published information available. No dose reductions are probably necessary. Renal Impairment Drug Capecitabine Cetuximab Creatinine Clearance (ml/min) Dose (% of original dose) More than 51 30-50 less than 30 more than 180 (1.5xULN) 100 75 Do not use Do not use Oxaliplatin Less than 20 Dose reduce and adjust according to toxicity Other Dose reductions or interruptions in therapy are not necessary for those toxicities that are considered unlikely to be serious or life threatening. For example, alopecia, altered taste or nail changes. Dose limiting toxicities include diarrhoea, abdominal pain, emesis, stomatitis, palmar-plantar erythrodysesthesia and neurosensory toxicities among others. If any NCI-CTC grade 1 toxicity occurs treatment should be continued, without interruption, at the full dose. For toxicities NCI-CTC grade 3 or above in general treatment should be withheld until recovery to at least NCI-CTC grade 1 then re-started if medically appropriate. If recovery takes twenty-one days or longer then stop treatment. Capecitabine NCI-CTC Grade 2 Interrupt treatment until the toxicity resolves to NCI-CTC grade 0-1 then continue at the same dose. If the toxicity recurs for a second time again interrupt treatment until it resolves to NCI-CTC grade 0-1 then resume therapy at 75% of the original dose. If the same adverse effect develops on a third occasion once more interrupt treatment until it resolves to NCI-CTC grade 0-1 then continue at 50% of the original dose. Stop treatment if the toxicity re-appears on a fourth instance. Version 1.3 (October 2020) Page 3 of 12 Colorectal – Capecitabine-Cetuximab-Oxaliplatin (21 day) NCI-CTC Grade 3 Interrupt treatment until the toxicity resolves to NCI-CTC grade 0-1 then continue treatment using 75% of the original dose with prophylaxis if appropriate. If the toxicity recurs for a second time again interrupt treatment until it resolves to NCI-CTC grade 0-1 and then resume therapy at 50% of the original dose. If the same adverse effect develops on a third occasion discontinue capecitabine. NCI-CTC Grade 4 Discontinue treatment unless the responsible consultant considers it to be in the best interest of the patient to continue at 50% of the original dose once the toxicity has resolved to NCI-CTC grade 0-1. When capecitabine is stopped for toxicity the doses are omitted, not delayed. Consider stopping capecitabine therapy if chest pain occurs. Cetuximab Allergic or hypersensitivity reactions have occurred during the administration of cetuximab. For a NCI-CTC grade 1 reaction reduce the infusion rate by 50%. For a NCI-CTC grade 2 reaction, stop the infusion and administer supportive therapies as indicated. Once the reaction has resolved to NCI-CTC grade 1 or below resume the infusion at 50% of the previous rate. For a NCI-CTC grade 3 or 4 toxicity stop the infusion immediately and disconnect the tubing from the patient. Administer appropriate supportive therapies. Once recovered, patients should not receive cetuximab again. Once the rate has been reduced it should not be increased on subsequent infusions. If a second reaction occurs on the slower infusion rate the infusion should be stopped and no further treatment given. An acniform skin rash occurs in over 70% of those receiving cetuximab. The onset is normally within three weeks of starting therapy and often resolves after week twelve. For a NCI-CTC grade 1-2 reaction use symptomatic treatments such as topical or oral antibiotics and continue with the cetuximab. For a NCI-CTC grade 3 toxicity delay treatment until the toxicity resolves to NCI-CTC grade 2 or below. If this occurs within fourteen days resume cetuximab at the same dose. If more than fourteen days is required stop treatment. If the NCI-CTC grade 3 toxicity occurs for a second and third time the cetuximab may again be delayed for up to and including fourteen days with concomitant dose reductions to 200mg/m2 and 150mg/m2 respectively. Cetuximab dose reductions are permanent. The cetuximab must be discontinued if more than two consecutive infusions are withheld or a fourth episode of a NCI-CTC grade 3 skin toxicity develops or a NCI-CTC grade 4 toxicity at any time. UV radiation may worsen skin reactions. Sun safety practices should be followed during and for up to two months after the end of treatment. Stop treatment if there is a confirmed pneumonitis. Version 1.3 (October 2020) Page 4 of 12 Colorectal – Capecitabine-Cetuximab-Oxaliplatin (21 day) Oxaliplatin For cold related dysaesthesia or paresthesia without pain there is no need to dose delay or reduce unless it persists between cycles. In this instance withhold the oxaliplatin until recovery and then re-start treatment using 100mg/m2. Only omit the oxaliplatin if it recurs. For paresthesia with pain or functional impairment that lasts up to seven days no dose modification is necessary. If it persists beyond seven days or is NCI-CTC grade 3 and above, in the first instance reduce the dose to 100mg/m2. If the painful paresthesia recurs or persists between cycles omit the oxaliplatin. If NCI-CTC grade 3-4 diarrhoea or stomatitis recurs despite appropriate reduction in the capecitabine dose the oxaliplatin dose should be reduced to 100mg/m2. There are rare case reports of acute interstitial lung disease or lung fibrosis in association with oxaliplatin. Where an unexplained respiratory symptom occurs stop treatment until pulmonary investigations have been conducted to exclude an interstitial cause. Regimen 21 day cycle for 6 cycles Cycle One Drug Capecitabine Cetuximab Cetuximab Oxaliplatin Dose 800mg/m2 twice a day 400mg/m2 250mg/m2 130mg/m2 Days Route 1-14 incl Oral 1 8, 15 1 Intravenous infusion (see administration) Intravenous infusion (see administration) Intravenous infusion in 500ml glucose 5% over 120 minutes Cycle Two Onwards Drug Dose Capecitabine 800mg/m2 twice a day Cetuximab 250mg/m2 Oxaliplatin 130mg/m2 Days 1-14 incl 1, 8, 15 1 Route Oral Intravenous infusion (see administration) Intravenous infusion in 500ml glucose 5% over 120 minutes Dose Information • Capecitabine will be dose banded in accordance with the national dose bands • Cetuximab will be dose banded in accordance with the national dose bands (5mg/ml) Version 1.3 (October 2020) Page 5 of 12 Colorectal – Capecitabine-Cetuximab-Oxaliplatin (21 day) • Oxaliplatin will be dose banded in accordance with the national dose bands (5mg/ml) Administration Information Extravasation • Cetuximab - neutral • Oxaliplatin – exfoliant Other • Capecitabine should start on the evening of day 1 • Capecitabine should be taken with or after food • Individuals should be monitored for hypersensitivity reactions for sixty minutes after finishing the cetuximab infusion. Do not administer other chemotherapy during this period. • The rate of administration of cetuximab must not exceed 5mg/min for the first infusion (minimum 120 minutes). If well tolerated subsequent infusions may be given at a rate of 10mg/min (minimum 60 minutes). • Oxaliplatin must never come into contact with sodium chloride 0.9%. Ensure the line is flushed with glucose 5% before and after each oxaliplatin infusion Additional Therapy • Antiemetics 15-30 minutes prior to chemotherapy on day one only; - dexamethasone 8mg oral or intravenous - ondansetron 8mg oral or intravenous As take home medication; - dexamethasone 4mg twice a day oral for 3 days - metoclopramide 10mg three times a day when required oral • 30 minutes prior to cetuximab infusion; - chlorphenamine 10mg intravenous - dexamethasone 8mg oral or intravenous (given as part of antiemetic regimen on day 1) - H2 antagonist according to local formulary choice and availability - paracetamol 1000mg oral Version 1.3 (October 2020) Page 6 of 12 Colorectal – Capecitabine-Cetuximab-Oxaliplatin (21 day) • Oral loperamide 4mg after the first loose stool then 2-4mg four times a day when required for the relief of diarrhoea (maximum 16mg/24 hours). • Mouthwashes according to local or national policy on the treatment of mucositis • Gastric protection with a proton pump inhibitor or a H2 antagonist may be considered in patients considered at high risk of GI ulceration or bleed Additional Information • The National Patient Safety Agency alert NPSA/2008/RRR001 must be followed when prescribing, dispensing or administering oral chemotherapy. • Ensure the total daily dose of capecitabine is divided into two doses given twelve hours apart (the first should be administered in the evening of day one of the cycle) Serious toxicity has occurred where the total daily dose has been given twice a day. • It must be made clear to all staff, including those in the community, that this is a short course of oral chemotherapy that must not be continued. References 1. Moosnann N, von Weikersthal LF, Vehling-Kaiser U et al. Cetuximab plus capecitabine and irinotecan compared with cetuximab plus capecitabine and oxaliplatin as first line treatment for patients with metastatic colorectal cancer. AIO KRK-0104 – a randomised trial of the German AIO CRC study group. JCO 2011; 29 (8): 1050-1058. 2. Maughan TS, Adams RS, Smith CG et al. Addition of cetuximab to oxaliplatin based first line combination chemotherapy for the treatment of advanced colorectal cancer; results of the randomised phase III MRC COIN trial. Lancet 2011; 377 (9783); 2103-2114. Version 1.3 (October 2020) Page 7 of 12 Colorectal – Capecitabine-Cetuximab-Oxaliplatin (21 day) REGIMEN SUMMARY Capecitabine-Cetuximab-Oxaliplatin (21 day) Day One Cycle One 1. Chlorphenamine 10mg intravenous 2. Dexamethasone 8mg oral or intravenous 3. Paracetamol 1000mg oral Administration Instructions Please check if the patient has taken paracetamol. The maximum dose is 4000mg in every 24 hours 4. H2 antagonist according to local formulary choice and availability Administration Instructions: Administer according to local formulary choice and availability one of the following 30 minutes prior to chemotherapy; - Ranitidine 50mg intravenous once only - Famotidine 20mg oral once only - Nizatidine 150mg oral once only - Ranitidine 150mg oral once only If there is no stock of these products due to national shortages treatment may proceed without the H2 antagonist provided there is no instruction in the ARIA journal indication the patient must have H2 antagonist treatment. All infusion related reactions must be recorded in the ARIA journal and reported to the appropriate consultant. Many Trusts do not administer an H2 antagonist from cycle three onwards. They have been left in the ARIA protocols so that decisions can be made on an individual Trust and patient basis. 5. Cetuximab 400mg/m2 intravenous infusion An interval of 60 minutes should be left between administration of cetuximab and oxaliplatin 6. Ondansetron 8mg oral or intravenous 7. Oxaliplatin 130mg/m2 intravenous infusion in 500ml glucose 5% over 120 minutes Take Home Medicines 8. Capecitabine 800mg/m2 twice a day for 14 days oral 9. Dexamethasone 4mg twice a day for 3 days oral starting the day after oxaliplatin 10. Metoclopramide 10mg three times a day when required oral Day Eight and Fifteen Cycle One 1. Chlorphenamine 10mg intravenous 2. Dexamethasone 8mg oral or intravenous 3. Paracetamol 1000mg oral Administration Instructions Please check if the patient has taken paracetamol. The maximum dose is 4000mg in every 24 hours Version 1.3 (October 2020) Page 8 of 12 Colorectal – Capecitabine-Cetuximab-Oxaliplatin (21 day) 4. H2 antagonist according to local formulary choice and availability Administration Instructions: Administer according to local formulary choice and availability one of the following 30 minutes prior to chemotherapy; - Ranitidine 50mg intravenous once only - Famotidine 20mg oral once only - Nizatidine 150mg oral once only - Ranitidine 150mg oral once only If there is no stock of these products due to national shortages treatment may proceed without the H2 antagonist provided there is no instruction in the ARIA journal indication the patient must have H2 antagonist treatment. All infusion related reactions must be recorded in the ARIA journal and reported to the appropriate consultant. Many Trusts do not administer an H2 antagonist from cycle three onwards. They have been left in the ARIA protocols so that decisions can be made on an individual Trust and patient basis. 5. Cetuximab 250mg/m2 intravenous infusion Day One Cycle Two Onwards 1. Chlorphenamine 10mg intravenous 2. Dexamethasone 8mg oral or intravenous 3. Paracetamol 1000mg oral Administration Instructions Please check if the patient has taken paracetamol. The maximum dose is 4000mg in every 24 hours 4. H2 antagonist according to local formulary choice and availability Administration Instructions: Administer according to local formulary choice and availability one of the following 30 minutes prior to chemotherapy; - Ranitidine 50mg intravenous once only - Famotidine 20mg oral once only - Nizatidine 150mg oral once only - Ranitidine 150mg oral once only If there is no stock of these products due to national shortages treatment may proceed without the H2 antagonist provided there is no instruction in the ARIA journal indication the patient must have H2 antagonist treatment. All infusion related reactions must be recorded in the ARIA journal and reported to the appropriate consultant. Many Trusts do not administer an H2 antagonist from cycle three onwards. They have been left in the ARIA protocols so that decisions can be made on an individual Trust and patient basis. 5. Cetuximab 250mg/m2 intravenous infusion 6. Ondansetron 8mg oral or intravenous 7. Oxaliplatin 130mg/m2 intravenous infusion in 500ml glucose 5% over 120 minutes Take Home Medicines 8. Capecitabine 800mg/m2 twice a day for 14 days oral 9. Dexamethasone 4mg twice a day for 3 days oral starting the day after oxaliplatin 10. Metoclopramide 10mg three times a day when required oral Version 1.3 (October 2020) Page 9 of 12 Colorectal – Capecitabine-Cetuximab-Oxaliplatin (21 day) Day Eight and Fifteen Cycle Two Onwards 1. Chlorphenamine 10mg intravenous 2. Dexamethasone 8mg oral or intravenous 3. Paracetamol 1000mg oral Administration Instructions Please check if the patient has taken paracetamol. The maximum dose is 4000mg in every 24 hours 4. H2 antagonist according to local formulary choice and availability Administration Instructions: Administer according to local formulary choice and availability one of the following 30 minutes prior to chemotherapy; - Ranitidine 50mg intravenous once only - Famotidine 20mg oral once only - Nizatidine 150mg oral once only - Ranitidine 150mg oral once only If there is no stock of these products due to national shortages treatment may proceed without the H2 antagonist provided there is no instruction in the ARIA journal indication the patient must have H2 antagonist treatment. All infusion related reactions must be recorded in the ARIA journal and reported to the appropriate consultant. Many Trusts do not administer an H2 antagonist from cycle three onwards. They have been left in the ARIA protocols so that decisions can be made on an individual Trust and patient basis. 5. Cetuximab 250mg/m2 intravenous infusion Version 1.3 (October 2020) Page 10 of 12 Colorectal – Capecitabine-Cetuximab-Oxaliplatin (21 day) DOCUMENT CONTROL Version Date Amendment Written By Approved By 1.3 October Update of premedication due to Arum Shortland Dr Debbie Wright 2020 shortage of IV ranitidine. Pharmacist Pharmacist IV ranitidine changed to H2 antagonist according to local formulary choice and availability Coding removed Monitoring updated with DPD testing 1.2 May 2014 Header changed Dr Debbie Wright Donna Kimber Metoclopramide dose changed Pharmacist Pharmacy Technician to 10mg Cetuximab administration changed to reflect SPC Mucositis recommendation changed Bolus removed from supportive therapies Coding updated Disclaimer added 1.1 Nov 2011 In the “Additional Therapy” section, dexamethasone added to the cetuximab premedication Dr Debbie Wright Becky Wills with statement regarding anti- Pharmacist Pharmacist emetic on day 1. Ondansetron moved in the regimen summary to be given after the cetuximab. In the regimen summary spelling of chlorpheniramine changed to chlorphenamine Spelling mistakes in dose modifications corrected (with out to without and paresthesiae to paresthesia) 1 Sept 2011 None Dr Debbie Wright Dr Tim Iveson Pharmacist Consultant Medical Oncologist This chemotherapy protocol has been developed as part of the chemotherapy electronic prescribing project. This was and remains a collaborative project that originated from the former CSCCN. These documents have been approved on behalf of the following Trusts; Hampshire Hospitals NHS Foundation Trust NHS Isle of Wight Portsmouth Hospitals NHS Trust Salisbury Hospital NHS Foundation Trust Version 1.3 (October 2020) Page 11 of 12 Colorectal – Capecitabine-Cetuximab-Oxaliplatin (21 day) University Hospital Southampton NHS Foundation Trust Western Sussex Hospitals NHS Foundation Trust All actions have been taken to ensure these protocols are correct. However, no responsibility can be taken for errors which occur as a result of following these guidelines. Version 1.3 (October 2020) Page 12 of 12 Colorectal – Capecitabine-Cetuximab-Oxaliplatin (21 day)
Url: /Media/UHS-website-2019/Docs/Chemotherapy-SOPs1/Colorectal/Capecitabine-Cetuximab-Oxaliplatin.pdf

ACCORD-2 master protocol

Description: CONFIDENTIAL ACCORD-2-001 – Master Protocol TITLE PAGE Protocol Title: ACCORD-2: A Multicentre, Seamless, Phase 2 Adaptive Randomisation Platform Study to Assess the Efficacy and Safety of Multiple Candidate Agents for the Treatment of COVID-19 in Hospitalised Patients Master Protocol Number: ACCORD-2-001 Product: Multiple candidate agents Study Phase: 2 Sponsor Name: University Hospital Southampton NHS Foundation Trust Legal Registered Address: Southampton General Hospital Level E, Laboratory & Pathology Block, SCBR - MP138 Tremona Road Southampton SO16 6YD, UK Regulatory Agency Identifying Number(s): IRAS Number: RHM Number: EudraCT 2020-001736-95 282769 Date of Protocol: 22 April 2020 Version: Final Final, 22 April 2020 1 CONFIDENTIAL Chief Investigator Signatory: ACCORD-2-001 – Master Protocol I have read this protocol in its entirety and agree to conduct the study accordingly: Professor Tom Wilkinson MA Cantab MBBS PhD FRCP Professor of Respiratory Medicine and Honorary NHS Consultant Physician 22/04/2020 Date Final, 22 April 2020 2 CONFIDENTIAL ACCORD-2-001 – Master Protocol TABLE OF CONTENTS TABLE OF TABLES...............................................................................................................6 TABLE OF FIGURES.............................................................................................................7 1.0 PROTOCOL SUMMARY ..........................................................................................8 1.1 Synopsis.............................................................................................................8 1.2 Schema ............................................................................................................13 1.3 Example Schedule of Activities.....................................................................14 2.0 INTRODUCTION......................................................................................................18 2.1 Study Rationale ..............................................................................................18 2.2 Background ....................................................................................................18 2.3 Benefit/Risk Assessment ................................................................................19 3.0 OBJECTIVES AND ENDPOINTS ..........................................................................20 4.0 STUDY DESIGN........................................................................................................22 4.1 Overall Design ................................................................................................22 4.2 Scientific Rationale for Study Design...........................................................24 4.3 Justification for Dose .....................................................................................24 4.4 End of Study Definition .................................................................................24 5.0 STUDY POPULATION ............................................................................................25 5.1 Inclusion Criteria ...........................................................................................25 5.2 Exclusion Criteria ..........................................................................................25 5.3 Lifestyle Considerations ................................................................................26 5.4 Screen Failures ...............................................................................................26 6.0 STUDY TREATMENT .............................................................................................27 6.1 Study Treatment(s) Administered................................................................27 6.2 Preparation/Handling/Storage/Accountability ...........................................27 6.3 Measures to Minimise Bias: Randomisation and Blinding ........................28 6.4 Study Treatment Compliance.......................................................................28 6.5 Concomitant Therapy....................................................................................28 6.5.1 Rescue Medicine ...............................................................................29 6.6 Dose Modification ..........................................................................................29 6.7 Treatment after the End of the Study ..........................................................29 7.0 DISCONTINUATION OF STUDY TREATMENT AND PATIENT DISCONTINUATION/WITHDRAWAL ................................................................30 7.1 Discontinuation of Study Treatment ............................................................30 Final, 22 April 2020 3 CONFIDENTIAL ACCORD-2-001 – Master Protocol 7.2 Patient Discontinuation/Withdrawal from the Study.................................30 7.3 Lost to Follow-up ...........................................................................................30 8.0 STUDY ASSESSMENTS AND PROCEDURES ....................................................32 8.1 Efficacy Assessments .....................................................................................33 8.1.1 Improvement on the 9-Point Scale ....................................................33 8.1.2 Other Efficacy Assessments ..............................................................34 8.2 Safety Assessments.........................................................................................34 8.2.1 Physical Examinations.......................................................................34 8.2.2 Vital Signs and Blood Gases .............................................................34 8.2.3 Clinical Safety Laboratory Assessments ...........................................35 8.3 Virologic Load ................................................................................................35 8.4 Adverse Events ...............................................................................................35 8.4.1 Time Period and Frequency for Collecting AE and SAE Information ........................................................................................35 8.4.2 Method of Detecting AEs and SAEs .................................................36 8.4.3 Follow-up of AEs and SAEs .............................................................36 8.4.4 Regulatory Reporting Requirements for SAEs .................................36 8.4.5 Pregnancy ..........................................................................................37 8.4.6 Adverse Events of Special Interest ....................................................37 8.4.7 Disease-Related Events and/or Disease-Related Outcomes Not Qualifying as Adverse Events or Serious Adverse Events.........37 8.5 Treatment of Overdose..................................................................................37 8.6 Pharmacokinetics ...........................................................................................37 8.7 Pharmacodynamics........................................................................................38 8.8 Immunology....................................................................................................38 8.9 Genomics.........................................................................................................38 8.10 Serology Research (Host Response) .............................................................39 9.0 STATISTICAL CONSIDERATIONS .....................................................................39 9.1 Design Overview.............................................................................................39 9.2 Statistical Hypotheses ....................................................................................39 9.3 Sample Size Determination ...........................................................................40 9.4 Populations for Analyses ...............................................................................42 9.5 Statistical Analyses.........................................................................................42 9.5.1 Efficacy Analyses ..............................................................................43 9.5.2 Safety Analyses .................................................................................43 9.5.3 Other Analyses ..................................................................................44 9.5.4 Missing Data......................................................................................44 9.6 Interim Analyses ............................................................................................45 9.7 Review Committees........................................................................................45 9.7.1 Steering Committee (Scientific Review Committee) ........................45 9.7.2 Independent Data and Safety Monitoring Committee.......................45 Final, 22 April 2020 4 CONFIDENTIAL ACCORD-2-001 – Master Protocol 10.0 REFERENCES...........................................................................................................47 11.0 APPENDICES ............................................................................................................48 Appendix 1 Abbreviations ...................................................................................49 Appendix 2 Regulatory, Ethical, and Study Oversight Considerations..........51 Protocol Compliance........................................................................................51 Regulatory and Ethical Considerations............................................................51 Financial Disclosure.........................................................................................52 Indemnity .........................................................................................................52 Informed Consent Process ...............................................................................52 Data Protection.................................................................................................53 Administrative Structure ..................................................................................54 Dissemination of Clinical Study Data..............................................................54 Data Quality Assurance ...................................................................................54 Source Documents ...........................................................................................55 Study and Study Centre Closure ......................................................................55 Publication Policy ............................................................................................56 Appendix 3 Clinical Laboratory Tests ...............................................................57 Appendix 4 Adverse Events: Definitions and Procedures for Recording, Evaluating, Follow-up, and Reporting .....................................59 Appendix 5 Collection of Pregnancy Information ............................................63 Appendix 6 Genetics ............................................................................................65 Appendix 7 Signature of Investigator ................................................................66 Final, 22 April 2020 5 CONFIDENTIAL ACCORD-2-001 – Master Protocol Table 1 Table 2 Table 3 Table 4 Table 5 TABLE OF TABLES Study Objectives and Endpoints ......................................................................20 Sample Size for 80% and 90% Power for Time to Improvement, Discharge from Hospital, or Fit for Discharge Using Log-rank Test for a Hazard Ratio of 1.6 in Treatment Arm to Standard of Care ...................41 Analysis Sets ....................................................................................................42 Efficacy Analyses ............................................................................................43 Protocol-required Safety Laboratory Assessments..........................................58 Final, 22 April 2020 6 CONFIDENTIAL ACCORD-2-001 – Master Protocol Figure 1 TABLE OF FIGURES Study Schema...................................................................................................13 Final, 22 April 2020 7 CONFIDENTIAL ACCORD-2-001 – Master Protocol 1.0 PROTOCOL SUMMARY 1.1 Synopsis Protocol Title: ACCORD-2: A Multicentre, Seamless, Phase 2 Adaptive Randomisation Platform Study to Assess the Efficacy and Safety of Multiple Candidate Agents for the Treatment of COVID-19 in Hospitalised Patients Rationale: There are currently no approved therapeutic agents available to treat coronaviruses such as severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the causative agent of COVID-19 disease, and there is an urgent public health need for rapid development of such interventions. This adaptive platform study is designed to rapidly assess multiple candidate agents as treatments for COVID-19. Candidate drugs that are initially assessed as being efficacious will be moved from an evaluation (pilot) stage to a confirmatory stage, with candidate agents being added to and removed from the study on an ongoing basis, depending on the results of their evaluation. Patients to be included in the study will be hospitalised and may require either supplemental oxygen, noninvasive ventilation or high-flow oxygen devices. Objectives and Endpoints Objectives Primary • Stage 1: To evaluate the efficacy of candidate agents as add-on therapies to standard of care (SoC) in patients hospitalised with COVID-19 in a screening stage. • Stage 2: To confirm the efficacy of identified efficacious candidate agents in patients hospitalised with COVID-19 in an expansion stage. Endpoints • Time to clinical improvement of at least 2 points (from randomisation) on a 9-point category ordinal scale, live discharge from the hospital, or considered fit for discharge (a score of 0, 1, or 2 on the ordinal scale), whichever comes first, by Day 29 (this will also define the “responder” for the response rate analyses). 9-point category ordinal scale: 0. Uninfected, no clinical or virological evidence of infection 1. Ambulatory, no limitation of activities 2. Ambulatory, limitation of activities 3. Hospitalised – mild disease, no oxygen therapy 4. Hospitalised – mild disease, oxygen by mask or nasal prongs 5. Hospitalised – severe disease, noninvasive ventilation or high-flow oxygen 6. Hospitalised – severe disease, intubation and mechanical ventilation 7. Hospitalised – severe disease, ventilation and additional organ support – vasopressors, renal replacement therapy (RRT), extracorporeal membrane oxygenation (ECMO) 8. Death Final, 22 April 2020 8 CONFIDENTIAL ACCORD-2-001 – Master Protocol Secondary • To evaluate the ability to prevent deterioration according to the ordinal scale by 1, 2, or 3 points • The proportion of patients not deteriorating according to the ordinal scale by 1, 2, or 3 points on Days 2, 8, 15, 22, and 29. • To evaluate the number of oxygen-free days. • Duration (days) of oxygen use and oxygen-free days. • To evaluate ventilator-free days and incidence and • Duration (days) of ventilation and ventilation-free duration of any form of new ventilation use. days. • Incidence of any form of new ventilation use and duration (days) of new ventilation use. • To evaluate SARS-CoV-2 viral load. • Qualitative and quantitative polymerase chain reaction (PCR) determination of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in oropharyngeal/nasal swab while hospitalised on Days 1, 3, 5, 8, 11, 15, and (optional) Day 29 • To evaluate response rate (see primary endpoint for definition of responder). • Response rate (number and %) by treatment arm at Days 2, 8, 15, 22, and 29. • To evaluate time to discharge. • Time to live discharge from the hospital. • To evaluate overall mortality. • Mortality at Days 15, 29, and 60. • Time from treatment start date to death. • Change in the ratio of the oxygen saturation to fraction of inspired oxygen concentration (SpO2/FiO2), • SpO2/FiO2, measured daily from randomisation to Day 15, hospital discharge, or death • To evaluate the safety of candidate agents as • Physical examination. add-on therapy to SoC in patients with COVID-19. • Clinical laboratory examinations. • Vital signs (blood pressure/heart rate/temperature/respiratory rate). • Adverse events. • To evaluate intensive care unit (ICU) and hospitalisation length. • Duration (days) of ICU and hospitalisation. • To evaluate National Early Warning Score 2 (NEWS2). • NEWS2 assessed daily while hospitalised and on Days 15 and 29. • Time to a NEWS2 of ≤2, maintained for at least 24 hours. Final, 22 April 2020 9 CONFIDENTIAL ACCORD-2-001 – Master Protocol Exploratory • To evaluate SARS-CoV-2 viral load. • Qualitative and quantitative PCR determination of SARS-CoV-2 in blood and saliva (while hospitalised) on Days 1, 3, 5, 8, 11, 15, and (optional) Day 29 (may be become a secondary endpoint once the assays are available). • To collect samples for translational research on • Analysis of samples collected at baseline prior to host and viral genomics, serum antibody treatment and at specific time points. production, COVID-19 diagnostics, and validation of laboratory testing methods. Overall Design: ACCORD-2 is a seamless, Phase 2, adaptive, randomisation platform study, designed to rapidly test candidate agents in the treatment of COVID-19 disease. The study will include hospitalised adult patients (≥18 years) who have infection with SARS-CoV-2, the virus that causes COVID-19, as confirmed by laboratory tests and/or point of care tests. For inclusion, patients will need to have clinical status of Grade 3 (hospitalised – mild disease, no oxygen therapy) to Grade 5 (hospitalised – severe disease, noninvasive ventilation or high-flow oxygen), as defined by a 9-point ordinal scale. This study will aim to identify efficacious candidate agents for treatment of COVID-19 disease. These candidate agents may include, but will not be limited to, anti-virals, human plasma-derived agents, or immunomodulatory agents. Experimental (first-in-human) agents will not be considered as candidate agents for ACCORD-2, but will instead be considered for inclusion in the separate, but linked, ACCORD-1 Phase 1/2 platform study, which will first determine the dose and assess early activity and safety signals for later consideration for inclusion into ACCORD-2. The ACCORD-2 candidate agents evaluated will include those intended as a treatment for SARS-CoV-2 infection; the study design and/or inclusion and exclusion criteria may subsequently be revised (using a protocol amendment) or a separate protocol may be initiated to include agents intended to prevent COVID-19 disease. This Master Protocol outlines the overall structure of the study, including the population, inclusion and exclusion criteria, randomisation scheme, primary, secondary, and exploratory outcomes, study design, statistical methodology, and planned analyses that are common for all candidate agents to be tested. The Master Protocol is structured such that multiple candidate agents from different pharmaceutical companies can be evaluated simultaneously. The plan is to add candidate agents as they are identified, and to remove therapies once they have completed their evaluation, with the control group for a candidate agent including only patients randomised during the period in which the candidate agent group was randomised, with patients being randomised equally (ie, 1:1:1…) to the sub-protocols with inclusion/exclusion criteria that they meet. Sub-protocols will outline the scientific rationale, eligibility, treatment schema, and other specifics for each candidate agent. The sub-protocols may define adverse events of special interest (AESIs), and can include pharmacokinetic and/or pharmacodynamic assessments that are appropriate for the specific candidate agent (pharmacodynamic assessments may require equivalent blood samples from controls). The study consists of 2 stages: • Stage 1 of the study (evaluation/pilot) will evaluate the candidate agents as an add-on to the standard of care (SoC) to assess preliminary safety and efficacy. A patient will be considered to be a responder if they show an improvement of at least 2 points (from randomisation) on a 9-point category ordinal scale, are discharged from hospital, or are considered fit for discharge (a score of 0, 1, or 2 on the ordinal scale), whichever comes first, by Day 29. The time to response will be analysed on Day 29 and used to evaluate if an agent should proceed to Stage 2 of the Final, 22 April 2020 10 CONFIDENTIAL ACCORD-2-001 – Master Protocol study. Stage 1 data will additionally be used to determine optimal study endpoints, and the number of patients to enrol into Stage 2 of the study. • Stage 2 of the study (confirmation) is intended to provide confirmatory data of the identified candidate agents from Stage 1, to fully evaluate disease outcomes, including severe adverse events (AEs), overall AEs, disease-related co-infection complications (eg, pneumonia, septic shock), and overall mortality in an expansion stage. Patients and outcomes from Stage 1 will not form part of Stage 2. Some candidate agents will still be in Stage 1 of the study at the point where other candidate agents have progressed to Stage 2. Patients will be randomised to receive one of the candidate agents that is being evaluated at the time of randomisation and whose inclusion/exclusion criteria they meet (as an add-on to SoC) or to a control arm where only SoC is administered. Enrolment of patients will be continuous throughout the study for each candidate agent until the total randomisation number of planned patients for Stage 1 and Stage 2 is achieved. Enrolment under a sub-protocol for a specific candidate agent may also be stopped in the event of success or failure of the candidate agent. The Master Protocol will continue enrolling patients as long as there are candidate agents that are enrolling. Number of Investigators and Study Centres: Study centres will be located in the United Kingdom. Overall, it is estimated that approximately 18 centres and investigators will initially take part in the study. Number of Patients: The expected number of patients for each treatment arm is presented as part of the sample size determination below. It is estimated that up to 1800 patients will participate in the overall study. Treatment Groups and Duration: In each stage of the study, patients will be screened on Day -1 or Day 1, and will remain in the clinic from Day 1 until fit for discharge. Dosing with the candidate agent (as an add-on to SoC) will commence on Day 1. The last day of assessments while hospitalised will be on Day 29. An outpatient visit will be conducted on Day 60 (±4 days), with an end-of-study visit conducted on Day 90 (±6 days). Statistical methods: Sample size determination: Stage 1: Based on the chosen endpoint, a preliminary analysis will be carried out when an estimated 81 events have been observed across each agent treatment and SoC or 28 days after the last patient has been randomised, whichever occurs sooner, as determined by the Independent Data and Safety Monitoring Committee (IDMC). In order to achieve this number of events, it is expected that 54 patients are needed per arm, which will provide 80% power to detect a hazard ratio of 1.6 for the occurrence of the event, when comparing each candidate agent with SoC. To allow for uncertainty in the recruitment rates, it is expected that up to 60 patients will be randomised to each arm in order to achieve the required number of events for the preliminary analysis. Stage 2: The number of patients will be determined more precisely at the end of Stage 1, but approximately 126 patients will be randomised to each arm. Analysis sets: • Intention to Treat (ITT): All patients who are randomised and match the inclusion/exclusion criteria of the Master Protocol and relevant sub-protocol will be included in the ITT. • Safety Set: All patients who are randomised and take at least 1 dose of study medication will be included in the safety set. Final, 22 April 2020 11 CONFIDENTIAL ACCORD-2-001 – Master Protocol • Pharmacokinetic Analysis Set (PKS): All patients who are randomised and take at least 1 dose of the candidate agent and have quantifiable candidate agent concentrations postdose without protocol deviations or events affecting the pharmacokinetic results will be included in the PKS. • Pharmacodynamic Analysis Set (PDS): All patients who are randomised and take at least 1 dose of study medication (candidate agent or SoC) and have evaluable results for at least 1 pharmacodynamic endpoint postdose. All analyses of the PDS will be based on each patient’s randomised assigned treatment (not actual treatment received). Efficacy, safety, pharmacokinetic, and pharmacodynamic results will be listed and summarised by stage, dose, and scheduled time for the respective analysis sets, where appropriate. Candidate agent concentration versus response variables may be graphically displayed for selected endpoints. Exposure-response data obtained from this study may be combined with data from other studies and used for modelling and simulations. Data Monitoring Committee: A Steering Committee will evaluate interim analysis data to make decisions on further progression of the candidate agents within the study, and will provide guidance, advice, and recommendations to the ACCORD program on relevant clinical issues related to the strategy, implementation, and conduct of the study. An IDMC will objectively monitor safety data throughout the study to make recommendations to the Steering Committee regarding study conduct. Final, 22 April 2020 12 CONFIDENTIAL 1.2 Schema Figure 1 Study Schema ACCORD-2-001 – Master Protocol IA=interim analysis; SARS-CoV-2=severe acute respiratory syndrome coronavirus 2; SoC=standard of care. Note: This figure shows a hypothetical situation, where in Stage 1 of the study there are 4 candidate agents being compared with the SoC, of which 2 candidate agents progress to Stage 2. Final, 22 April 2020 13 CONFIDENTIAL ACCORD-2-001 – Master Protocol 1.3 Example Schedule of Activities Screening Baseline Day (± Window) ELIGIBILITY Informed consent Demographics Relevant medical historyb Review of SARS-CoV-2 diagnostic tests Inclusion and exclusion criteria 12-lead Electrocardiogram STUDY INTERVENTION Randomisation Administration of candidate agent Treatment with SoC STUDY PROCEDURES Clinical frailty score Diagnostic imaging (X-ray and/or computed tomography) Physical examination (including presenting symptoms, height, weight) Targeted physical examination (focused on lung auscultation) Vital signs, including oral temperature, pulse rate, blood pressure, respiratory rate, SpO2 Day -1 or Day 1 X X X X X X X X X Day 1 X X Xc Daily Until Hospital Discharge Day 15a (±2 days) Defined in subprotocol X X X X Day 29a (±3 days) X Day 60a Day 90a (±4 days) (±6 days) (Follow-up) (End of Study) Final, 22 April 2020 14 CONFIDENTIAL ACCORD-2-001 – Master Protocol Screening Baseline Day (± Window) Clinical assessmentsd Targeted medication review (including use of vasopressors) Adverse event evaluation Disease-related co-infection evaluation (including microbiologic/infectious agent assessment/results; bacteria, viral, fungi) Survival status Blood gases and FiO2 at worst PO2e SAFETY LABORATORY Haematology, chemistry, liver function tests, coagulationf Day -1 or Day 1 X Xg Day 1 Xc Xc X X X X Xc,h Pregnancy test for females of childbearing potential Xg RESEARCH LABORATORY Blood (SST) for exploratory inflammatory cytokine analysis X (others to be defined in sub-protocols) Blood (sodium heparin tube) for PBMC phenotypingi X Blood (EDTA) for SARS-CoV-2 PCR (qualitative and quantitative) X Daily Until Hospital Discharge X X X X X X Days 3, 5, 8, 11 (all ±1 day) while hospitalised Day 8 Day 8 Days 3, 5, 8, 11 (all ±1 day) while hospitalised Day 15a (±2 days) X X X X X X X X Day 29a (±3 days) X X X Day 60a Day 90a (±4 days) (±6 days) (Follow-up) (End of Study) X X X X X X X X Final, 22 April 2020 15 CONFIDENTIAL ACCORD-2-001 – Master Protocol Screening Baseline Day (± Window) Day -1 or Day 1 Day 1 Daily Until Hospital Discharge Day 15a (±2 days) Day 29a (±3 days) Day 60a Day 90a (±4 days) (±6 days) (Follow-up) (End of Study) Oropharyngeal/nasal swab for SARS-CoV-2 PCR (qualitative and quantitative) Days 3, 5, 8, 11 (all X ±1 day) while X X hospitalised Saliva for SARS-CoV-2 PCR (qualitative and quantitative) Days 3, 5, 8, 11 (all X ±1 day) while X X hospitalised Blood (SST) for SARS-CoV-2 serology research (host response) X Day 8 X X X Blood (PAXGENE) for transcriptome analysis (host genome)j X Day 8 X Blood (EDTA) host genome (host DNA)j X Mid-turbinate nasal swab viral genomej X EDTA=ethylenediaminetetraacetic acid; FiO2=fraction of inspired oxygen; PBMC=peripheral blood mononuclear cell; PCR=polymerase chain reaction; PO2=partial pressure of oxygen; RT PCR=reverse transcription polymerase chain reaction; SARS-CoV-2= severe acute respiratory syndrome coronavirus 2; SoC=standard of care; SpO2=oxygen saturation; SST=serum separator tube. Note: Additional assessments, if required, will be defined in the sub-protocol. a These visits will be performed even if a patient has already been discharged. If discharged prior to scheduled visit, in-person visits are preferred, but recognising that quarantine and other factors may limit the patient’s ability to return to the clinic, these visits may be conducted by telephone or with a home visit by study staff. For visits conducted by telephone, it will not be possible to perform some scheduled assessments (eg, vital signs). The Day 29 assessments will also be performed, where possible, for patients who discontinue the study prematurely. b Medical history includes estimated date and time of first symptoms and number of co-morbidities (eg, respiratory, cardiovascular, metabolic, malignancy, endocrine, gastrointestinal, immunologic, renal). c Baseline assessments should be performed prior to study drug administration. d Includes ordinal score, National Early Warning Score 2 (NEWS2), oxygen requirement, noninvasive or invasive ventilator requirement, including start and stop of low- or high-flow oxygen supply or of any form of ventilation etc. e If done as part of SoC, blood gases results to be fully recorded with date and time. f For parameters, see Table 5. Final, 22 April 2020 16 CONFIDENTIAL ACCORD-2-001 – Master Protocol g Laboratory tests performed in the 48 hours prior to enrolment will be accepted for determination of eligibility. h Any laboratory tests performed as part of routine clinical care within the specified visit window can be used for safety laboratory testing. i Samples collected for immediate laboratory processing and frozen storage. j Samples collected dependent on capacity of study centre, need for reduced study burden on staff, and potentially limited access to patients. Final, 22 April 2020 17 CONFIDENTIAL ACCORD-2-001 – Master Protocol 2.0 INTRODUCTION 2.1 Study Rationale There are currently no approved therapeutic agents available to treat coronaviruses such as severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the causative agent of COVID-19 disease, and there is an urgent public health need for rapid development of such interventions. This adaptive platform study is designed to rapidly assess multiple candidate agents as treatments for COVID-19. Candidate drugs that are initially assessed as being efficacious will be moved from an evaluation (pilot) stage to a confirmatory stage, with candidate agents being added to and removed from the study on an ongoing basis, depending on the results of their evaluation. Patients to be included in the study will be hospitalised and may require either supplemental oxygen, noninvasive ventilation or high-flow oxygen devices. 2.2 Background Coronaviruses are single-stranded RNA viruses, capable of causing life-threatening disease in humans and animals. The novel coronavirus SARS-CoV-2 was initially identified during an outbreak of viral pneumonia cases of unknown cause in China. Most of the initial infections outside of China were travel associated (ie, from people who had travelled from the infected regions of China to other countries), although person-to-person transmission in other countries was quickly established. The disease caused by the SARS-CoV-2 virus has been designated COVID-19. SARS-CoV-2 binds via the angiotensin-converting enzyme (ACE) receptor located on alveolar cells and intestinal epithelia.1 The virus is mutating, indicating that virulence and transmission will shift over time, and showing diversity in critical surface protein. New evidence suggests there are 2 groups of SARS-CoV-2; L-type and S-type.2 S-type is the less aggressive (30%); the L-type is now the most prevalent version (70%) and is more aggressive. Additionally, individuals appear to be affected to different degree with varying symptoms and outcomes. These findings strongly support an urgent need for immediate comprehensive studies and robust validation of testing methods that combine genomic data, chart records and clinical symptoms, to help better understand the disease, enable risk assessment, triage and support public health resource planning. Due to the rapid global widespread of SARS-CoV-2, there is an urgent need to develop efficacious treatments for the disease. Current clinical studies involve the use of already approved medications for other indications (repurposing) where it is thought that they might also be effective in the treatment of COVID-19 disease, as well as development of antibody-based therapies against the virus. Final, 22 April 2020 18 CONFIDENTIAL ACCORD-2-001 – Master Protocol This platform study will test multiple candidate agents, with the aim of identifying potentially efficacious treatments in the shortest timeframe possible. In addition, it will support secondary research objectives that are critical for understanding the disease, spread of infection and robust tests to track it. 2.3 Benefit/Risk Assessment There are currently no approved therapeutic agents available to treat coronaviruses such as SARS-CoV-2, and so while there may not be benefits for an individual patient participating in this study, there may be benefits to society if a safe and efficacious therapeutic agent can be identified during the global COVID-19 outbreak. Detailed information about the known and expected risks and reasonably expected adverse events (AEs) of each candidate agent may be found in the corresponding sub-protocol for that agent. Final, 22 April 2020 19 CONFIDENTIAL ACCORD-2-001 – Master Protocol 3.0 OBJECTIVES AND ENDPOINTS Table 1 Study Objectives and Endpoints Objectives Primary • Stage 1: To evaluate the efficacy of candidate agents as add-on therapies to standard of care (SoC) in patients hospitalised with COVID-19 in a screening stage. • Stage 2: To confirm the efficacy of identified efficacious candidate agents in patients hospitalised with COVID-19 in an expansion stage. Secondary • To evaluate the ability to prevent deterioration according to the ordinal scale by 1, 2, or 3 points • To evaluate the number of oxygen-free days. • To evaluate ventilator-free days and incidence and duration of any form of new ventilation use. • To evaluate SARS-CoV-2 viral load. Endpoints • Time to clinical improvement of at least 2 points (from randomisation) on a 9-point category ordinal scale, live discharge from the hospital, or considered fit for discharge (a score of 0, 1, or 2 on the ordinal scale), whichever comes first, by Day 29 (this will also define the “responder” for the response rate analyses). 9-point category ordinal scale: 0. Uninfected, no clinical or virological evidence of infection 1. Ambulatory, no limitation of activities 2. Ambulatory, limitation of activities 3. Hospitalised – mild disease, no oxygen therapy 4. Hospitalised – mild disease, oxygen by mask or nasal prongs 5. Hospitalised – severe disease, noninvasive ventilation or high-flow oxygen 6. Hospitalised – severe disease, intubation and mechanical ventilation 7. Hospitalised – severe disease, ventilation and additional organ support – vasopressors, renal replacement therapy (RRT), extracorporeal membrane oxygenation (ECMO) 8. Death • The proportion of patients not deteriorating according to the ordinal scale by 1, 2, or 3 points on Days 2, 8, 15, 22, and 29. • Duration (days) of oxygen use and oxygen-free days. • Duration (days) of ventilation and ventilation-free days. • Incidence of any form of new ventilation use and duration (days) of new ventilation use. • Qualitative and quantitative polymerase chain reaction (PCR) determination of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in oropharyngeal/nasal swab while hospitalised on Days 1, 3, 5, 8, 11, 15, and (optional) Day 29 Final, 22 April 2020 20 CONFIDENTIAL ACCORD-2-001 – Master Protocol • To evaluate response rate (see primary endpoint for definition of responder). • Response rate (number and %) by treatment arm at Days 2, 8, 15, and 29. • To evaluate time to discharge. • Time to live discharge from the hospital. • To evaluate overall mortality. • Mortality at Days 15, 29, and 60. • Time from treatment start date to death. • Change in the ratio of the oxygen saturation to fraction of inspired oxygen concentration (SpO2/FiO2), • SpO2/FiO2, measured daily from randomisation to Day 15, hospital discharge, or death • To evaluate the safety of candidate agents as • Physical examination. add-on therapy to SoC in patients with COVID-19. • Clinical laboratory examinations. • Vital signs (blood pressure/heart rate/temperature/respiratory rate). • Adverse events. • To evaluate intensive care unit (ICU) and hospitalisation length. • Duration (days) of ICU and hospitalisation. • To evaluate National Early Warning Score 2 (NEWS2). • NEWS2 assessed daily while hospitalised and on Days 15 and 29. • Time to a NEWS2 of ≤2, maintained for at least 24 hours. Exploratory • To evaluate SARS-CoV-2 viral load. • Qualitative and quantitative PCR determination of SARS-CoV-2 in blood and saliva (while hospitalised) on Days 1, 3, 5, 8, 11, 15, and (optional) Day 29 (may be become a secondary endpoint once the assays are available). • To collect samples for translational research on • Analysis of samples collected at baseline prior to host and viral genomics, serum antibody treatment and at specific time points. production, COVID-19 diagnostics, and validation of laboratory testing methods. Final, 22 April 2020 21 CONFIDENTIAL ACCORD-2-001 – Master Protocol 4.0 STUDY DESIGN 4.1 Overall Design ACCORD-2 is a seamless, Phase 2, adaptive, randomisation platform study, designed to rapidly test candidate agents in the treatment of COVID-19 disease. The study will include hospitalised adult patients (≥18 years) who have infection with SARS-CoV-2, the virus that causes COVID-19, as confirmed by laboratory tests and/or validated point of care tests. For inclusion, patients will need to have clinical status of Grade 3 (hospitalised - mild disease, no oxygen therapy) to Grade 5 (hospitalised – severe disease, noninvasive ventilation or high-flow oxygen), as defined by a 9-point ordinal scale, which was detailed in the World Health Organization R&D Blueprint “Novel Coronavirus - COVID-19 Therapeutic Trial Synopsis” (February 2020). Medical history will record the estimated date and time of first symptoms. This study will aim to identify efficacious candidate agents for treatment of COVID-19 disease. These candidate agents may include, but will not be limited to, anti-virals, human plasma-derived agents, or immunomodulatory agents. Experimental (first-in-human) agents will not be considered as candidate agents for ACCORD-2, but will instead be considered for inclusion in the separate, but linked, ACCORD-1 Phase 1/2 platform study, which will first determine the dose and assess early activity and safety signals for later consideration for inclusion into ACCORD-2. The ACCORD-2 candidate agents evaluated will include those intended as a treatment for SARS-CoV-2 infection; the study design and/or inclusion and exclusion criteria may subsequently be revised (using a protocol amendment) or a separate protocol may be initiated to include agents intended to prevent COVID-19 disease. A Steering Committee will evaluate candidate agents for progression in the study (see Section 9.7.1). This Master Protocol outlines the overall structure of the study, including the population, inclusion and exclusion criteria, randomisation scheme, primary, secondary, and exploratory outcomes, study design, statistical methodology, and planned analyses that are common for all candidate agents to be tested. The Master Protocol is structured such that multiple candidate agents from different pharmaceutical companies can be evaluated simultaneously. The plan is to add candidate agents as they are identified, and to remove therapies once they have completed their evaluation, with the control group for a candidate agent including only patients randomised during the period in which the candidate agent group was randomised, with patients being randomised equally (ie, 1:1:1…) to the sub protocols with inclusion/exclusion criteria that they meet. Sub-protocols will outline the scientific rationale, eligibility, treatment schema, and other specifics for each candidate agent. The sub-protocols may define adverse events of special interest (AESIs), and can include pharmacokinetic and/or pharmacodynamic assessments that are appropriate for the specific candidate agent (pharmacodynamic assessments may require Final, 22 April 2020 22 CONFIDENTIAL ACCORD-2-001 – Master Protocol equivalent blood samples from controls). Additional patients will be recruited into the study each time a new sub-protocol (candidate agent) is added. The study consists of 2 stages: • Stage 1 of the study (evaluation/pilot) will evaluate the candidate agents as an add-on to the standard of care (SoC) to assess preliminary safety and efficacy. A patient will be considered to be a responder if they show an improvement of at least 2 points (from randomisation) on a 9-point category ordinal scale, are discharged from hospital, or are considered fit for discharge (a score of 0, 1, or 2 on the ordinal scale), whichever comes first, by Day 29. The time to response will be analysed on Day 29 and used to evaluate if an agent should proceed to Stage 2 of the study. Stage 1 data will additionally be used to determine optimal study endpoints, and the number of patients to enrol into Stage 2 of the study. • Stage 2 of the study (confirmation) is intended to provide confirmatory data of the identified candidate agents from Stage 1, to fully evaluate disease outcomes, including severe AEs, overall AEs, disease-related co-infection complications (eg, pneumonia, septic shock), and overall mortality in an expansion stage. Patients and outcomes from Stage 1 will not form part of Stage 2. Some candidate agents will still be in Stage 1 of the study at the point where other candidate agents have progressed to Stage 2. Patients will be randomised to receive one of the candidate agents that is being evaluated at the time of randomisation and whose inclusion/exclusion criteria they meet (as an add-on to SoC) or to a control arm where only SoC is administered. In each stage of the study, patients will be screened on Day -1 or Day 1, and will remain in the clinic from Day 1 until fit for discharge. Dosing with the candidate agent (as an add-on to SoC) will commence on Day 1. The last day of assessments while hospitalised will be on Day 29. An outpatient visit will be conducted on Day 60 (±4 days), with an end-of-study visit conducted on Day 90 (±6 days). Enrolment of patients will be continuous throughout the study for each candidate agent until the total randomisation number of planned patients for Stage 1 and Stage 2 is achieved. Enrolment under a sub-protocol for a specific candidate agent may also be stopped in the event of success or failure of the candidate agent. The Master Protocol will continue enrolling patients as long as there are candidate agents that are enrolling. It is estimated that up to 1800 patients will participate in the overall study. Study centres will be located in the United Kingdom. Overall, it is estimated that approximately 18 centres and investigators will initially take part in the study. Final, 22 April 2020 23 CONFIDENTIAL ACCORD-2-001 – Master Protocol 4.2 Scientific Rationale for Study Design There are currently no approved therapeutic agents available to treat coronaviruses such SARS-CoV-2, the causative agent of as COVID-19 disease, and there is an urgent public health need for rapid development of such interventions. This adaptive platform study is designed to rapidly assess multiple candidate agents as treatments for COVID-19. Candidate drugs that are initially assessed as being efficacious will be moved from an evaluation (pilot) stage to a confirmatory stage, with candidate agents being added to and removed from the study on an ongoing basis, depending on the results of their evaluation. Patients to be included in the study will be hospitalised and may require either supplemental oxygen, noninvasive ventilation or high-flow oxygen devices. This study utilises an adaptive design that maximises efficiency in identifying a safe and efficacious therapeutic agent for COVID-19. Some candidate agents may be in limited supply and this study design enables continuation of the study even if an agent becomes unavailable. In addition, the adaptive design allows for the evaluation of new candidate agents as they are identified. 4.3 Justification for Dose Justification for the dose of each candidate agent will be included in the corresponding sub-protocol. 4.4 End of Study Definition For each sub-protocol, the end of the study for that candidate agent will be defined as the date on which the last patient completes the last visit for that sub-protocol. For the overall study, the end of the study will be defined as the date on which the last patient completes the last visit for the final sub-protocol to be concluded. Once a patient has completed this study, there are no restrictions on them entering another study, subject to the eligibility criteria of that subsequent study. Final, 22 April 2020 24 CONFIDENTIAL ACCORD-2-001 – Master Protocol 5.0 STUDY POPULATION Prospective approval of protocol deviations to recruitment and enrolment criteria, also known as protocol waivers or exemptions, is not permitted. The inclusion and exclusion criteria listed below may be supplemented by additional criteria stipulated in the sub-protocols that are specific to the target candidate being tested (eg, criteria related to prohibited medications). In order to enrol, a patient or legally authorised representative must sign an informed consent form (ICF) and meet all entry criteria for both the Master Protocol and at least 1 respective sub-protocol. 5.1 Inclusion Criteria Patients are eligible to be included in the study only if all of the following criteria apply (as well as all criteria from the appropriate sub-protocol): 1. Adults (≥18 years) with SARS-CoV-2 infection confirmed by laboratory tests and/or point of care tests. 2. A score of Grade 3 to 5 on the 9-point ordinal scale. 3. Is a woman who is not of childbearing potential (as defined in Appendix 5) or The patient, and their partner(s), agree to use medically-accepted double-barrier methods of contraception (eg, barrier methods, including male condom, female condom or diaphragm with spermicidal gel) during the study and for at least 6 weeks after termination of study therapy. 4. Ability to provide informed consent signed by the study patient or legally authorised representative. 5.2 Exclusion Criteria Patients are excluded from the study if any of the following criteria apply (or any of the criteria from the appropriate sub-protocol): 1. Patients who have previously had a score of 6 or 7 on the 9-point ordinal scale. 2. Any patient whose interests are not best served by study participation, as determined by a senior attending clinician. 3. Alanine aminotransferase (ALT)/aspartate aminotransferase (AST) > 5 × the upper limit of normal (ULN). 4. Known active infection with HIV or hepatitis B or C. 5. Stage 4 severe chronic kidney disease or requiring dialysis (ie, estimated glomerular filtration rate 500 ms. 8. Anticipated transfer to another hospital that is not a study centre within 72 hours. 9. Allergy to any study medication. 10. Experimental off-label usage of medicinal products as treatments for COVID-19. 11. Patients participating in another clinical study of an investigational medicinal product. 5.3 Lifestyle Considerations Any lifestyle considerations that are specific to the candidate agent will be defined in the corresponding sub-protocol. Female patients are advised to avoid becoming pregnant during the study. 5.4 Screen Failures Screen failures are defined as patients who consent to participate in the clinical study but are not subsequently randomly assigned to study treatment. A minimal set of screen failure information is required to ensure transparent reporting of screen failure patients to meet the Consolidated Standards of Reporting Trials (CONSORT) publishing requirements and to respond to queries from regulatory authorities. Minimal information includes demography, screen failure details, eligibility criteria, and any serious adverse event (SAE). Individuals who do not meet the criteria for participation in this study (screen failure) due to hypokalaemia, hypomagnese
Url: /Media/Southampton-Clinical-Research/COVID-19/ACCORD/ACCORD-2-master-protocol.pdf

Distinguishing mental disorder from mental incapacity: a brief guide

Description: Distinguishing mental disorder from mental incapacity poses a problem for clinicians.
Url: /HealthProfessionals/Clinical-law-updates/Distinguishing-mental-disorder-from-mental-incapacity.aspx

Press release: Doctors develop comic sequel for diabetes patients

Description: A sequel to a comic developed by diabetes experts in Southampton and Portsmouth to help young patients' understanding of the condition is set to be released on World Diabetes Day (14 November).
Url: /AboutTheTrust/Newsandpublications/Latestnews/2018/November-2018/Press-release-Doctors-develop-comic-sequel-for-diabetes-patients.aspx

1 to 10 of 322

Previous 1 2 3 4 5 … Next

Browse site A to Z

Search results

Papers Trust Board - 11 November 2025

Papers Trust Board - 9 September 2025

Papers Trust Board - 7 January 2025

EC-PPH Cyclophosphamide Epirubicin Paclitaxel Pertuzumab Trastuzumab

Capecitabine-Carboplatin(AUC5)-Cetuximab

Papers Trust Board 27 May 2021

Capecitabine-Cetuximab-Oxaliplatin

ACCORD-2 master protocol

Distinguishing mental disorder from mental incapacity: a brief guide

Press release: Doctors develop comic sequel for diabetes patients

Site policies

Contact details

Useful links