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Clinical Research in Southampton
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Press release: Hospital staff and supporters to celebrate development of new cancer support centre
Description
Staff and supporters at Southampton's university hospitals will celebrate the development of a new £5 million support centre for cancer patients
Url
/AboutTheTrust/Newsandpublications/Latestnews/2019/February/Press-release-Hospital-staff-and-supporters-to-celebrate-development-of-new-cancer-support-centre.aspx
UHS register of interests June 2025
Description
Employee Name Aarvold, Dr Alice Beatrice Rachel Aarvold, Dr Alice Beatrice Rachel Adam, Dr Robert Dhugald (Rob) Adam, Dr Robert Dhugald (Rob) Adam, Dr Robert Dhugald (Rob) Adam, Dr Robert Dhugald (Rob) Adam, Dr Robert Dhugald (Rob) Adam, Dr Robert Dhugald (Rob) Adam, Dr Robert Dhugald (Rob) Afzal, Dr Nadeem Ahmad Afzal, Dr Nadeem Ahmad Afzal, Dr Nadeem Ahmad Afzal, Dr Nadeem Ahmad Afzal, Dr Nadeem Ahmad Afzal, Dr Nadeem Ahmad Afzal, Dr Nadeem Ahmad Afzal, Dr Nadeem Ahmad Afzal, Dr Nadeem Ahmad Afzal, Dr Nadeem Ahmad Afzal, Dr Nadeem Ahmad Akerman, Dr Catherine Mary Elizabeth Akerman, Dr Catherine Mary Elizabeth Akerman, Dr Henry (Harry) Akerman, Dr Henry (Harry) Akerman, Dr Henry (Harry) Al Rawi, Dr Samar Othman Abed Al Baki (Samar) Al Rawi, Dr Samar Othman Abed Al Baki (Samar) Al Rawi, Dr Samar Othman Abed Al Baki (Samar) Al Rawi, Dr Samar Othman Abed Al Baki (Samar) Al Rawi, Dr Samar Othman Abed Al Baki (Samar) Al-Azzawi, Dr Omar Muataz Shnasi Alderton, Dr Mark Vernon Alderton, Dr Mark Vernon Alderton, Dr Mark Vernon Allan, Dr Charlotte Georgina Allan, Dr Charlotte Georgina Allen, Dr David Charles Allen, Dr David Charles Amerasinghe, Ms. Nishani Amerasinghe, Ms. Nishani Amerasinghe, Ms. Nishani Amerasinghe, Ms. Nishani Amerasinghe, Ms. Nishani Amerasinghe, Ms. Nishani Amerasinghe, Ms. Nishani Amerasinghe, Ms. Nishani Amerasinghe, Ms. Nishani Amerasinghe, Ms. Nishani Amerasinghe, Ms. Nishani Amerasinghe, Ms. Nishani Amerasinghe, Ms. Nishani Amerasinghe, Ms. Nishani Amerasinghe, Ms. Nishani Amerasinghe, Ms. Nishani Amerasinghe, Ms. Nishani Amerasinghe, Ms. Nishani Amerasinghe, Ms. Nishani Amerasinghe, Ms. Nishani Amerasinghe, Ms. Nishani Amerasinghe, Ms. Nishani Amerasinghe, Ms. Nishani Amerasinghe, Ms. Nishani Amerasinghe, Ms. Nishani Amerasinghe, Ms. Nishani Amerasinghe, Ms. Nishani Amerasinghe, Ms. Nishani Amerasinghe, Ms. Nishani Amerasinghe, Ms. Nishani Amerasinghe, Ms. Nishani Amerasinghe, Ms. Nishani Amerasinghe, Ms. Nishani Amerasinghe, Ms. Nishani Amerasinghe, Ms. Nishani Amerasinghe, Ms. Nishani Amerasinghe, Ms. Nishani Amerasinghe, Ms. Nishani Amerasinghe, Ms. Nishani Amerasinghe, Ms. Nishani Anderson, Mr. David Frederick Anderson, Mr. David Frederick Anderson, Mr. David Frederick Anderson, Mr. David Frederick Role Consultant Consultant Consultant Consultant Consultant Consultant Consultant Consultant Consultant Consultant Consultant Consultant Consultant Consultant Consultant Consultant Consultant Consultant Consultant Consultant Consultant Consultant Consultant Consultant Consultant Consultant Consultant Consultant Consultant Consultant Consultant Consultant Consultant Consultant Consultant Consultant Consultant Consultant Consultant Consultant Consultant Consultant Consultant Consultant Consultant Consultant Consultant Consultant Consultant Consultant Consultant Consultant Consultant Consultant Consultant Consultant Consultant Consultant Consultant Consultant Consultant Consultant Consultant Consultant Consultant Consultant Consultant Consultant Consultant Consultant Consultant Consultant Consultant Consultant Consultant Consultant Consultant Consultant Consultant Consultant Consultant Consultant Interest Declared Y Y Interest Category Financial interests Financial interests Y Financial interests Y Financial interests Y Indirect interests Y Indirect interests Y Indirect interests Y Indirect interests Y Indirect interests Y Financial interests Y Financial interests Y Financial interests Y Financial interests Y Financial interests Y Financial interests Y Financial interests Y Financial interests Y Financial interests Interest Situation Clinical private practice Clinical private practice Outside employment Outside employment Hospitality Outside employment Outside employment Outside employment Sponsored events Clinical private practice Clinical private practice Clinical private practice Clinical private practice Donations Sponsored events Sponsored events Sponsored events Sponsored research Y Financial interests Sponsored research Y Financial interests Sponsored research Y Indirect interests Clinical private practice Shareholdings and other Y Indirect interests ownership interests Y Financial interests Clinical private practice Shareholdings and other Y Financial interests ownership interests Shareholdings and other Y Financial interests ownership interests Y Financial interests Clinical private practice Y Financial interests Clinical private practice Y Financial interests Clinical private practice Y Financial interests Clinical private practice Y Indirect interests Clinical private practice Shareholdings and other Y Financial interests ownership interests Y Indirect interests Clinical private practice Non-financial Y professional interest Outside employment Non-financial Y professional interest Outside employment Non-financial personal Y interests Loyalty interests Y Y Financial interests Clinical private practice Y Indirect interests Donations Y Financial interests Clinical private practice Y Financial interests Clinical private practice Y Financial interests Donations Y Financial interests Hospitality Y Financial interests Hospitality Y Financial interests Hospitality Shareholdings and other Y Financial interests ownership interests Y Financial interests Sponsored events Y Financial interests Sponsored events Y Financial interests Sponsored events Y Financial interests Sponsored events Y Financial interests Sponsored events Y Financial interests Sponsored events Y Financial interests Sponsored events Y Financial interests Sponsored events Y Financial interests Sponsored events Y Financial interests Sponsored events Y Financial interests Sponsored events Y Financial interests Sponsored events Y Financial interests Sponsored events Y Financial interests Sponsored events Y Financial interests Sponsored events Y Financial interests Sponsored events Y Financial interests Sponsored events Y Financial interests Sponsored events Y Financial interests Sponsored events Y Financial interests Sponsored events Y Financial interests Sponsored events Y Financial interests Sponsored events Y Financial interests Sponsored events Y Financial interests Sponsored events Y Financial interests Sponsored events Y Financial interests Sponsored events Y Financial interests Sponsored events Y Financial interests Sponsored research Non-financial personal Y interests Sponsored events Non-financial Y professional interest Hospitality Non-financial Y professional interest Outside employment Non-financial Y professional interest Sponsored events Non-financial Y professional interest Sponsored research Y Financial interests Outside employment Y Financial interests Clinical private practice Y Financial interests Sponsored events Y Financial interests Sponsored events Interest Description I have a private orthopaedic list once per month. I have a private list once a month . - Attended a educational event at the Abbott research facility in Sylmar, California, USA. - All travel cost, accomidation and meals were provided for by Abbott. - During the trip I provided 2.5 hours of feedback on future product development which I recieved a consultation fee for. In September 2022 I was part of the expert panel at the New Evidence based approach to Implementing the Four Pillars of HFrEF training event and I received HCP honorarium fees of £250 from AstraZeneca to participating in the event. On the 15th of November 2022 I attended a dinner/update event at the Harbour Hotel in Southampton that was sponsored by Medtronic LTD. I recieved a consultancy fee from AstraZenaza for speaking of cardiovscualar risk in COPD. I recieved a speakers fee from Astra Zeneca for apprearing at a Cardiometabolic GP Symposium. I recieved a speakers fee from Zoll for giving a presentation at EHRA. In September 2023 I attended a CRT training course in Denmark which was funded by Merit Medical. CANDOVER CLINIC BASINGSTOKE I do private work at Candover clinic, Basingstoke and North Hampshire Hospital, Aldermaston Road, Basingstoke RG24 9NA I have a private practice at Candover Clinic in Basingstoke and Spire Southampton. However, my practice at Spire Southampton is minimal, as it was intended for private endoscopies, which have not been possible due to a lack of support from the Spire hospital team. I practice at the Candover Basingstoke and the Spire A sum of 9,750 £ received from Dana Fry, a parent for purchase of a Paediatric Fibroscan probe. This is to be used for NHS practice. The moneys were deposited in Charity fund I sought sponsorship from Nutricia to organise a regional Wessex Gastroenterology meeting. The aim of this meeting is to maintain effective regional communication, discuss guidelines and standards of practice, and include presentations with key learning points for our day-to-day work. Comments This does not impact on my NHS work This is a regular list that has no impact on my NHS practice. - The trip was approved by to my line manager. - Merit funded all travel, accommodation and hospitality cost Private practice outside working hours for UHS I see patients with paediatric gastroenterology conditions in the clinic The fibroscan probe will be exceptionally useful for managing and treating children with liver fibrosis CoI Date From CoI Date To 16/09/2024 25/07/2022 25/07/2023 20/07/2022 24/09/2022 21/09/2022 21/09/2022 15/11/2022 15/11/2023 12/09/2024 12/09/2024 22/05/2024 22/05/2024 30/03/2025 30/03/2025 16/09/2023 18/09/2023 01/05/2021 04/10/2022 01/05/2021 01/12/2023 18/10/2024 01/12/2022 19/11/2021 27/02/2024 27/02/2024 Talk on national symposium sponsored by Falk, UK. However I haven't received any moneys yet. I declared my conflict of interest at the talk and the sponsorship didn't influence the content of my talk. WESSEX PAEDIATRIC GI NETWORK MEETING CI for The ACTIVE-IBD Study RHM CHI1102 Awarded 400£ for the study by CICRA - Childhood Crohns Research Association PAID TO PROVIDE LUNCH AND TEA FOR DELEGATES ATTENDING MEETING THE NETWORK MEETING IS FOR TEACHING AND DISCUSSION OF NETWORK PROTOCOLS - THIS TIME WE ARE DISCUSSING MANAGEMENT OF GI BLEEDING IN CHILDREN Ethics REC - Sep 2021 Study started - Nov 2021 35/50 recruited into study 19/10/2023 18/10/2022 18/10/2022 01/02/2022 EnablExercise in Crohns: A qualitativE study to uNderstAnd the Barriers and faciLitators to physical activity and Exercise IN children and adolescents with CROHN’S disease – perceptions of patients, caregivers and clinicians The aim of this project is to understand the barriers to and facilitators of physical activity and exercise training in children and adolescents with Crohn’s disease – incorporating the views of young people with Chrohns, their parents/guardians and doctors. Awarded 25K by GUTS UK (national bidding) Principal applicant DR Zoe Saynor - i m co-applicant SPONSORED RESEARCH My husband works as an anaesthetist in private practice moneys not awarded yet still to commence Granted 25K from GUTS UK to conduct research on Crohns in children with IBD 01/02/2022 01/11/2021 04/10/2022 30/11/2023 My husband has developed an app that allocates staff to vacancies in healthcare. Private healthcare providers are using this currently. I undertake private practice in my own at all the local private hospitals I have shares in Zelemiq Life Science Limited which is a local electronics company that helps other companies navigate through regulatory pathways. They also are creating the Ripple- a non invasive continuous glucose and lactate monitor I part own Alloc8tor that is a company linking together healthcare professionals with available outside work. We currently do no business with UHS or with the NHS. We have a contact with the Nuffield Hospital chain nationally and some other smaller contacts with other private hospitals. We have no plans to sell the company currently 30/11/2023 20/01/2022 01/01/2030 18/02/2024 26/02/2030 20/01/2022 01/04/2025 I am a member of SAS partnership and as such provide anaesthesia services locally. I work with a few surgeons closely and may pick up some as hoc sessions when offered to the group 04/01/2022 04/01/2023 I am part of SAS LLP which includes many colleagues from my trust. We provide anaesthetic services individually and as a group to local surgeons as well as other local providers such as ECT for the RSH. 04/11/2024 I have practicing privileges at both the Nuffield and Spire hospitals. In the past this included choose and book NHS patients but more recently the large majority is insured or self funding. Practicing privileges at both the Nuffield and Spire hospitals I continue to work in local private sectors and will occasionally have UHS outsourced patients on some of my lists 01/12/2020 31/12/2021 01/01/2022 01/01/2023 01/01/2023 31/12/2023 I am the sole shareholder and director of two companies. The first one is Al-Azzawi Trading Limited (Company number 13862060), which is an E-Commerce company that trades medical items such as stethoscopes, ophthalmoscopes, and consumer ECG monitors, as well as non-medical items. The suppliers are exclusively dealt with through eBay, Aliexpress, and Alibaba, while buyers are sold to through I would like to state that this is a declaration of interest rather than a declaration of conflict of interest. None of the time spent directing eBay. The second company is Al-Azzawi Businesses Limited (Company number 13829506), which is a property investment company in the form of Buy-To-Let. either of the two companies is part of my contracted time with the trust, nor does it happen on the trust premises. 28/03/2022 I have worked within the joint NHS/Private Palforzia peanut immunotherapy clinic. This is joint with Southampton NHS Trust however the immunotherapy is not offered via NHS services and it was felt best option to be able to offer this to some of our patients within the region. It does not impact on NHS duties running on a weekend and my role is very much supporting the service rather than leading it. I have not really worked in the service this year and will only support if staff sickness 18/01/2024 Designated doctor for child deaths for Hampshire, isle of Wight, Portsmouth and Southampton. Employed via HIOW ICS Potential COI but likely impact more for HIOW ICB 11/02/2020 NHSE SE Long COVID CYP lead No real conflict of interest to the hospital here 18/01/2024 Married to Mr Edward Gardner Consultant Orthopaedic Surgeon at UHS Asked to declare this at previous appraisals I undertake private clinical practice in Clinical Neurophysiology at the Sarum Road (Circle) Hospital Winchester I run one or two clinics per week, lasting 3 hrs each. We previously completed in a sponsored running event and raised money for the Smile for Wessex (Neuro) charity, which donated a few thousand pounds. We are currently potential beneficiaries of the Smile for Wessex charity, with regards to them funding equipment for a second VT bed. Continued work at Wessex Nuffield and Southampton Spire Also ad hoc work at Prema Clinic Portsmouth Do private practice at Southampton Spire and Nuffield wessex and Prema Laservision Educational Grant from Thea Pharmaceuticals £500 Attended list at Western Eye to watch Miniject insertion Moorfields international Glaucoma meeting - delegate iStent meeting - lecture given Hotel room booked by iStar Registration, dinner and hotel room for one night paid by Thea Pharmaceuticals Honorarium from Glaukos 01/11/2008 26/09/2022 26/09/2022 01/01/2010 12/03/2024 03/10/2021 12/03/2024 14/01/2024 08/02/2022 25/06/2023 02/11/2023 27/01/2024 15/09/2023 Paid a refundable deposit to buy shares in a new private non NHS hospital, where I hope to carry out private practice work in the future AbbVie Advisory Board Advisory Board on Durstyra Basic Glaucoma Course - organizer and facilitator - Alcon Basic Surgical Glaucoma Course, held at Alcon Education Centre, Barcelona Booth talk and podcast at European Society of Cataract and Refractive Surgeons Conference on Elios Chair and organiser of Corneal & Glaucoma Southern Meeting Sponsered by Thea Pharmaceuticals Chair of Wessex Glaucoma Forum Chair of Wessex Glaucoma Meeting Chaired Nguenity 1.5 meeting Chaired Southern Glaucoma and Corneal Meeting Educational Grant Elios Advisory Board Glaukos Advisory Board Honoria from Alcon for Advanced Glaucoma Surgical Course Hydrus Meeting Chaired Honorarium received Alcon Eye Care Hydrus Workshop Hydrus Workshop Course facilitator and lecturer International Glaucoma Consortium - participant Interview for Ophthalmologist magazine Interview on Gemini Study for the Ophthalmologist magazine Lecture series x 4 lectures in Singapore Speaker Lecture to Singapore Audience "More than meets the Eye" MIGS unplugged interview On advisory board for AbbVie Allergan for intracameral drugs use Preserflo User Group Meeting Chair of meeting Speaker at Cataract and Glaucoma Update meeting Wessex Glaucoma Meeting Real world data study in Glaucoma Honorarium paid by AbbVie Honoria received from AbbVie Advice on novel drug delivery to NHS Travel Hotel and dinners paid Honoria paid Course organizer and facilitator/lecturer Honorarium paid Course sponsored Accommodation, flights paid Honorarium paid by Elios Conference registration paid by Elios Hotel room & Dinner paid by Thea Pharmaceuticals Honoria paid Educational event for Wessex Glaucoma consultants Honoria received from Thea Pharmatceuticals Honoria received from Thea Pharmaceuticals Honorarium paid by Alcon Honorarium paid by Thea including hotel room for one night Educational Grant from Thea Pharmaceuticals to attend WGC Educational Event Honorarium from Elios travel , hotel and dinner paid Honoria paid Payments on 13th and 20th May 2025 Educational event for new technique being introduced to Trust Attended event registration, travel and accommodation covered by Alcon UK Honorarium paid by Alcon Honorarium paid by ICG Honorarium from Sight Sciences Honorarium paid by Sight Sciences Honorarium , flights , accommodation x 2 nights paid by AbbVie Honorarium received from AbbVie Honorarium paid by International Glaucoma Consortium Honorarium paid by Santen Hotel room booked Honoria received from Scope Chaired meeting Honoria received from Santen Educational event Sponsorship of data analysis and research methodology from AbbVie 12/05/2025 23/04/2024 01/12/2022 01/12/2022 08/01/2025 10/01/2025 17/04/2024 19/04/2024 07/09/2024 14/03/2025 14/03/2025 12/10/2022 12/10/2022 25/11/2022 25/11/2022 07/09/2024 08/12/2023 27/06/2023 01/07/2023 09/09/2023 10/04/2025 11/04/2025 23/04/2025 24/04/2025 06/07/2023 20/04/2023 21/04/2023 14/06/2024 31/05/2024 08/09/2023 07/09/2024 04/03/2024 05/03/2024 16/08/2023 02/06/2024 07/02/2022 21/11/2023 17/05/2023 17/05/2023 16/05/2023 16/05/2023 01/10/2022 Sponsorship of Charitable endeavor - Everest in the Alps to raise money for Glaucoma UK Sponsorship gained from ELIOS Vision; Santen UK; Thea Pharmaceuticals; iStar Medical Benefit to NHS - raises profile of Glaucoma 28/02/2023 03/03/2023 Sight Sciences Dinner WGC 2023 28/06/2023 28/06/2023 President-Elect UK & Eire Glaucoma Society Professional body affiliated to Glaucoma UK charity 04/05/2022 Educational event - Hydrus Workshop Registration , travel and accommodation covered by Alcon UK 20/04/2023 21/04/2023 Real world study of glaucoma data with Medisoft and research sponsored (no direct financial payment) by AbbVie Consultancy agreement between DFA and Leica Microsystems 20/04/2022 on-going private practice as detailed in Job Plan Leica Microsystems Visualization Summit October 2022 Southampton Corneal Meeting sponsored by Thea Pharmaceuticals Standard NDA and consultancy agreement for advice and presentation to Leica Microsystems from 2022Evening lecture 05/12/2021 20/04/2022 27/09/2023 24/07/2024 13/10/2022 13/10/2022 23/03/2023 23/03/2023 Anjum, Mr. Syed Neshat Anjum, Mr. Syed Neshat Anjum, Mr. Syed Neshat Ansell, Dr Gillian Lindsay (Gilly) Antonakis, Dr Serafeim Antonakis, Dr Serafeim Antonakis, Dr Serafeim Antonakis, Dr Serafeim Antony, Mrs. Shaibi Armstrong, Mr. Thomas Armstrong, Mr. Thomas Armstrong, Mr. Thomas Armstrong, Mr. Thomas Armstrong, Mr. Thomas Armstrong, Mr. Thomas Arshad, Mr. Ali Ahmed Osman Ali (Ali) Arshad, Mr. Ali Ahmed Osman Ali (Ali) Ayer, Miss Mavis Grace (Mavis) Ayer, Miss Mavis Grace (Mavis) Ayer, Miss Mavis Grace (Mavis) Ayer, Miss Mavis Grace (Mavis) Ayer, Miss Mavis Grace (Mavis) Ayer, Miss Mavis Grace (Mavis) Ayer, Miss Mavis Grace (Mavis) Ayer, Miss Mavis Grace (Mavis) Ayer, Miss Mavis Grace (Mavis) Ayer, Miss Mavis Grace (Mavis) Ayer, Miss Mavis Grace (Mavis) Ayer, Miss Mavis Grace (Mavis) Ayer, Miss Mavis Grace (Mavis) Ayer, Miss Mavis Grace (Mavis) Ayer, Miss Mavis Grace (Mavis) Ayer, Miss Mavis Grace (Mavis) Ayer, Miss Mavis Grace (Mavis) Ayer, Miss Mavis Grace (Mavis) Ayer, Miss Mavis Grace (Mavis) Ayer, Miss Mavis Grace (Mavis) Ayer, Miss Mavis Grace (Mavis) Ayer, Miss Mavis Grace (Mavis) Ayer, Miss Mavis Grace (Mavis) Ayer, Miss Mavis Grace (Mavis) Ayer, Miss Mavis Grace (Mavis) Ayer, Miss Mavis Grace (Mavis) Ayer, Miss Mavis Grace (Mavis) Ayer, Miss Mavis Grace (Mavis) Ayer, Miss Mavis Grace (Mavis) Ayer, Miss Mavis Grace (Mavis) Ayer, Miss Mavis Grace (Mavis) Ayer, Miss Mavis Grace (Mavis) Ayer, Miss Mavis Grace (Mavis) Ayer, Miss Mavis Grace (Mavis) Ayer, Miss Mavis Grace (Mavis) Ayer, Miss Mavis Grace (Mavis) Ayer, Miss Mavis Grace (Mavis) Ayer, Miss Mavis Grace (Mavis) Ayer, Miss Mavis Grace (Mavis) Ayer, Miss Mavis Grace (Mavis) Ayer, Miss Mavis Grace (Mavis) Ayer, Miss Mavis Grace (Mavis) Ayer, Miss Mavis Grace (Mavis) Ayer, Miss Mavis Grace (Mavis) Ayer, Miss Mavis Grace (Mavis) Ayer, Miss Mavis Grace (Mavis) Ayer, Miss Mavis Grace (Mavis) Ayer, Miss Mavis Grace (Mavis) Ayer, Miss Mavis Grace (Mavis) Ayer, Miss Mavis Grace (Mavis) Ayer, Miss Mavis Grace (Mavis) Ayer, Miss Mavis Grace (Mavis) Baker, Mr. Peter Stuart Balabanidou, Miss Eleni Balabanidou, Miss Eleni Barker, Dr Ruth Emily Barker, Dr Ruth Emily Barker, Dr Ruth Emily Barker, Dr Ruth Emily Barker, Dr Ruth Emily Barker, Dr Ruth Emily Barker, Dr Ruth Emily Barker, Dr Ruth Emily Barratt, Mr. James Matthew Bateman, Dr Andrew Rea Consultant Y Consultant Y Consultant Y Consultant Y Consultant Y Consultant Y Consultant Y Consultant Y Specialist Nurse Practitioner Y Consultant Y Consultant Y Consultant Y Consultant Y Consultant Y Consultant Y Consultant Y Consultant Y Nurse Manager Y Nurse Manager Y Nurse Manager Y Nurse Manager Y Nurse Manager Y Nurse Manager Y Nurse Manager Y Nurse Manager Y Nurse Manager Y Nurse Manager Y Nurse Manager Y Nurse Manager Y Nurse Manager Y Nurse Manager Y Nurse Manager Y Nurse Manager Y Nurse Manager Y Nurse Manager Y Nurse Manager Y Nurse Manager Y Nurse Manager Y Nurse Manager Y Nurse Manager Y Nurse Manager Y Nurse Manager Y Nurse Manager Y Nurse Manager Y Nurse Manager Y Nurse Manager Y Nurse Manager Y Nurse Manager Y Nurse Manager Y Nurse Manager Y Nurse Manager Y Nurse Manager Y Nurse Manager Y Nurse Manager Y Nurse Manager Y Nurse Manager Y Nurse Manager Y Nurse Manager Y Nurse Manager Y Nurse Manager Y Nurse Manager Y Nurse Manager Y Nurse Manager Y Nurse Manager Y Nurse Manager Y Nurse Manager Y Nurse Manager Y Nurse Manager Y Nurse Manager Y Manager Y Consultant Y Consultant Y Manager Y Manager Y Manager Y Manager Y Manager Y Manager Y Manager Y Manager Y Dietitian Specialist Practitioner Y Consultant Y Financial interests Financial interests Non-financial professional interest Clinical private practice Clinical private practice Clinical private practice Indirect interests Financial interests Loyalty interests Clinical private practice Financial interests Financial interests Clinical private practice Shareholdings and other ownership interests Financial interests Non-financial professional interest Financial interests Financial interests Indirect interests Non-financial personal interests Non-financial personal interests Non-financial professional interest Indirect interests Non-financial professional interest Financial interests Financial interests Financial interests Financial interests Financial interests Financial interests Financial interests Financial interests Financial interests Financial interests Financial interests Financial interests Financial interests Financial interests Financial interests Financial interests Financial interests Financial interests Financial interests Financial interests Financial interests Financial interests Financial interests Financial interests Financial interests Financial interests Financial interests Financial interests Financial interests Financial interests Financial interests Financial interests Financial interests Financial interests Financial interests Financial interests Financial interests Financial interests Financial interests Financial interests Financial interests Financial interests Financial interests Financial interests Financial interests Financial interests Non-financial personal interests Non-financial personal interests Non-financial professional interest Non-financial professional interest Non-financial professional interest Non-financial professional interest Non-financial professional interest Sponsored events Hospitality Sponsored events Sponsored events Sponsored events Loyalty interests Sponsored events Clinical private practice Clinical private practice Clinical private practice Hospitality Hospitality Outside employment Outside employment Outside employment Outside employment Outside employment Outside employment Outside employment Outside employment Outside employment Outside employment Outside employment Outside employment Outside employment Outside employment Outside employment Outside employment Outside employment Outside employment Outside employment Outside employment Outside employment Outside employment Outside employment Outside employment Outside employment Outside employment Outside employment Outside employment Outside employment Outside employment Outside employment Outside employment Outside employment Outside employment Outside employment Outside employment Outside employment Outside employment Outside employment Outside employment Outside employment Outside employment Outside employment Outside employment Hospitality Hospitality Hospitality Hospitality Sponsored events Sponsored events Outside employment Financial interests Non-financial personal interests Non-financial professional interest Non-financial professional interest Non-financial professional interest Non-financial professional interest Non-financial professional interest Non-financial professional interest Non-financial professional interest Non-financial professional interest Outside employment Loyalty interests Sponsored posts Sponsored posts Sponsored posts Sponsored posts Sponsored posts Sponsored posts Sponsored posts Sponsored posts Indirect interests Financial interests Sponsored events Clinical private practice I have got private practice privilege in Spire Southampton & Wessex Nuffield Hospitals My private practice mirrors NHS practice I do private practice in Spire & Nuffield hospital and my practice mirrors my NHS practice. I am joint owner of a LLP company with my spouse. His private practice income (HealthShare Winchester, Nuffield Hospital, Chandlers Ford) is paid directly into that company. My spouse also works in industry for a small company called OCG (orthopaedic Consulting Group) as a CMO and this income is also paid directly into the LLP. He does 1 day a week in industry and 1/2 day a week private practice. I have private practice privileges at Spire Southampton Hospital I see patients and do private Vitreoretinal and Cataract surgery through self-referral or/and insured work. Overall Time Commitment: Dedicated session on Job plan or weekends. (Information included in my previous portfolio appraisal documents) I perform cataract surgery un the ICS (NHS pathway) with the following providers: - Newmedica (since October 2020) I stopped working with the following providers: - Optegra (November 2020 - July 2022) - SpaMedica (June 2021 - June 2022) Overall time commitment: Dedicated session on job plan for private work or/and weekends with no on-call commitment or/and non-working time of NHS job plan. (already included in my previous portfolio documents) (14-6-2023: updated status) Service Contract Agreement with New Medical Systems Ltd as Shareholder and Joint Venture Partner in Newmedica Solent OJV. (Contract agreement signed - Newmedica Solent OJV will start offering its services from mid-September 2023) Sponsorship by Alimera to attend American Academy of Ophthalmology (virtual) Congress. As it is stated in the agreement document with Alimera, sponsorship does not constitute an inducement to prescribe, recommend, buy or sell any medicine or product. (Agreement document and details of sponsorship already included in my portfolio appraisal documents.) I have attended MS Trust conference from 23/03/2025 to 25/03 /2025 ENETS Honorarium paid by AAA to lecture at UKINETs symposium Ipsen paid for registration, travel and accommodation to ENETs in Vienna sponsored by AAA Committee member for UKINETs IPSEN Funded attendance at ENETS Conference 2022 and honorarium for supporting an educational event I do private practice in the same clinical sphere private practice I undertake clinical private practice at Spire Hospital Southampton Attending meeting for Merck conference Sponsorship to Conference (CMSC) Roche Ad board Sanofi Advisory Board Novartis Advisory board £420 Advisory board ( Roche) Advisory board Biogen CHARMS steering committee 5-7pm £540 Chairing an evening meeting Roche Chairing and speaking at a Biogen symposium at conference Chairing and speaking at an evening meeting/debate. Novartis Chairing national meeting Chairing sponsored symposium Charing evening meeting ( Merck) Evening Steering committee meeting with Novartis Filming for Merck Interview for market research for Roche paid £100 MS Nursing Connections ad board Meeting for an hour at 2pm Merck Advisory Board Merck Steering Committee Merck Steering committee meeting ( evening) Nursing Practice conference speaker Paid speaking engagement at REALMS Paid speaking engagement ( evening meeting with Novartis) Paid speaking engagement at Get Smart ( Novartis) Paid speaking engagement at INFORM MS Recording of podcast with Biogen Roche Steering committee Roche steering committee meeting ( paid) Roche- chairing a national meeting Roche- promotional material consultancy Roche- sponsorship to attend CMSC ( international conference) and chairing meetings Sanofi advisory board Sanofi- roundtable consultancy Speaker at an evening meeting, sponsored by Novartis Speaker conference Speaking at Biogen meeting for Saudi Nurses. Two separate days 45 mins each Speaking at a conference( Roche) Speaking at a conference, Nurse at the Limits Speaking at a meeting for Merck Speaking at a symposium ( Janssen) Speaking at an evening meeting Steering Committee meeting Steering committee 23rd of March and 27th of March £300 Virtual Advisory Board 5-8pm Biogen £452 ongoing commitment 6pm-7pm 2 hour evening meeting Sponsorship to CMSC Sponsorship to ECTRIMs Milan ( biogen) Sanofi- delegation to ECTRIMS international conference Speaker at conference and hospitality Sponsorship to International Conference Unknown amount Sponsorship to International conference unknown amount 01.05.25: Appointment as Director of YMCA Fairthorne Housing Trustee position of a local charity. I do not consider this to create a conflict of interest with my role at UHS Since the 1st of June 2021 I have started working with Practice Plus Group in Southampton as a Consultant. I hold a part time contract with the company of 20hrs a week. I treat NHS patients there as well. It currently keeps my elective operating skills up to date as my SUHT Contract is purely trauma operating. I am married to another Orthopaedic Hand Surgeon who is currently an employee of Practice Plus Group in Southampton Community Manager: Community Manager (a peer-support and forum) for ‘Healthcare Professionals in Research’ group - unpaid role. Early Career Working Group committee chair: Chair of international committee with American Thoracic Society Pulmonary Rehabilitation Assembly - unpaid role. National co-lead: National co-lead for /AHP's Everywhere’ group - unpaid role. Visiting Fellow: Visiting Fellow contract with UoS - unpaid role. Community Manager: Community Manager (a peer-support and forum) for ‘Healthcare Professionals in Research’ group - unpaid role. Early Career Working Group committee chair: Chair of international committee with American Thoracic Society Pulmonary Rehabilitation Assembly - unpaid role. National co-lead: National co-lead for /AHP's Everywhere’ group - unpaid role. Visiting Fellow: Visiting Fellow contract with UoS - unpaid role. Sponsorship of BIMDG conference by Nutricia Metabolics Private Oncology practice conduct at Spire Southampton and Genesis Southampton private clinical practice mirrors NHS practice i.e. Clinical Oncology for GI cancer Is ongoing 09/11/2024 22/06/2022 22/06/2022 22/06/2022 09/01/2020 20/09/2020 28/10/2020 09/06/2023 12/11/2021 13/11/2021 23/03/2025 25/03/2025 12/03/2024 14/03/2024 04/12/2022 04/12/2022 22/03/2023 24/05/2023 05/02/2022 05/03/2035 09/03/2022 11/03/2022 05/02/2022 16/05/2023 01/01/2021 07/02/2022 26/04/2024 26/04/2024 21/04/2023 22/04/2023 27/05/2024 02/06/2024 11/12/2024 11/12/2024 30/11/2022 30/11/2022 12/05/2022 19/06/2024 19/06/2024 01/12/2022 01/12/2022 08/11/2021 09/11/2021 21/11/2024 21/11/2024 26/03/2023 24/01/2023 24/01/2025 25/01/2025 17/09/2022 17/09/2022 03/04/2025 03/04/2025 21/02/2023 13/08/2024 13/08/2024 13/10/2021 13/10/2021 05/02/2025 05/02/2025 22/10/2024 22/10/2024 27/07/2022 27/07/2022 06/09/2022 06/09/2022 27/02/2025 27/02/2025 09/11/2022 09/11/2022 09/06/2023 09/06/2023 28/11/2023 28/11/2023 11/11/2023 11/11/2023 21/09/2023 21/09/2023 07/02/2023 18/04/2023 18/04/2023 03/10/2023 03/10/2023 20/06/2025 21/06/2025 23/04/2025 23/04/2025 26/05/2025 02/06/2025 28/02/2023 23/04/2025 23/04/2025 28/11/2023 28/12/2023 30/09/2022 01/10/2022 04/03/2023 05/03/2023 10/02/2024 10/02/2024 16/11/2024 16/11/2024 13/11/2024 13/11/2024 19/03/2024 19/03/2024 16/10/2024 16/10/2024 03/09/2024 03/09/2024 23/03/2022 25/11/2021 25/11/2021 29/05/2023 03/06/2023 11/10/2023 13/10/2023 23/09/2025 26/09/2025 17/09/2024 20/09/2024 31/05/2022 04/06/2022 31/05/2022 04/06/2022 01/05/2025 01/05/2028 01/06/2021 30/06/2022 06/05/2012 10/11/2021 01/01/2020 01/04/2022 01/07/2022 19/04/2021 01/01/2020 01/04/2022 01/07/2022 19/04/2021 11/06/2024 12/06/2024 01/10/2007 22/11/2024 Bateman, Professor Adrian Calvin Bateman, Professor Adrian Calvin Bates, Dr Andrew Tom Bates, Dr Andrew Tom Bates, Dr Andrew Tom Bates, Dr Andrew Tom Baxter, Dr Mark Alan Beck, Mr. Nicholas Edward Beecham, Mr. Ryan Christopher Beedle, Mr. Matthew Ian (Matt) Belgi, Dr Geeta Belgi, Dr Geeta Berry, Mrs. Lisa Jane Bevan, Ms. Amanda Bhargava, Dr Vidhi (Vidhi) Bhatnagar, Dr Adityanarayan Bhatnagar, Dr Adityanarayan Birch, Mr. Brian Robert Peter Birkett, Mr. Lewis Terence Blackwell, Ms. Nicola (Nicky) Blackwell, Ms. Nicola (Nicky) Blake, Mrs. Sinead Patricia (Sinead) Boswell, Dr Owen David Boulos, Mr. Nabil Adel Aziz Bowley, Mr. Adam Marcus Haydon Boyce, Dr Sara Rosalind (Sara) Boyce, Dr Sara Rosalind (Sara) Boyce, Dr Sara Rosalind (Sara) Boyce, Dr Sara Rosalind (Sara) Brain, Dr Amanda Rachel Brander, Mr. Matt Lee Breen, Dr David John Breen, Dr David John Breen, Dr David John Briant, Mr. Jason Scott (Jase) Broadbent, Miss Bethany (Beth) Broadley, Dr Rachel Jane Broadley, Dr Rachel Jane Bromby, Mr. Mark David Brooks, Mrs. Julie Bryant, Dr Timothy Bryant, Dr Timothy Bryant, Dr Timothy Bryant, Dr Timothy Bujanova, Dr Jana Bull, Mr. Colin Lawrence Bulters, Mr. Diederik Olivier Bulters, Mr. Diederik Olivier Bulters, Mr. Diederik Olivier Burke, Dr Georgina Burke, Dr Georgina Burke, Dr Hannah Burke, Mr. Martin James Burke, Mr. Martin James Burke, Mr. Martin James Butler, Mrs. Eleanor Mary (Eleanor) Byrne, Dr James Patrick Consultant Y Consultant Y Consultant Y Consultant Y Consultant Y Consultant Y Consultant Y Consultant Y Analyst Y Manager Y Consultant Y Consultant Y Nurse - Advanced Practitioner Y Pharmacist Y Consultant Y Consultant Y Consultant Y Consultant Y Manager Y Occupational Therapy Specialist Practitioner Y Occupational Therapy Specialist Practitioner Y Specialist Nurse Practitioner Y Consultant Y Pharmacist Y Physiotherapist Specialist Practitioner Y Consultant Y Consultant Y Consultant Y Consultant Y Associate Specialist (Closed to new entrants) Y Manager Y Consultant Y Consultant Y Consultant Y Analyst Y Specialist Healthcare Science Practitioner Y Consultant Y Consultant Y Specialist Healthcare Science Practitioner Y Nurse Manager Y Consultant Y Consultant Y Consultant Y Consultant Y Consultant Y Manager Y Consultant Y Consultant Y Consultant Y Consultant Y Consultant Y Consultant Y Manager Y Manager Y Manager Y Physiotherapist Manager Y Consultant Y Financial interests Financial interests Financial interests Financial interests Financial interests Indirect interests Non-financial professional interest Clinical private practice Loyalty interests Clinical private practice Hospitality Hospitality Loyalty interests Clinical private practice Financial interests Clinical private practice Financial interests Outside employment Non-financial professional interest Financial interests Financial interests Financial interests Financial interests Financial interests Financial interests Financial interests Hospitality Clinical private practice Clinical private practice Loyalty interests Sponsored events Clinical private practice Clinical private practice Outside employment Financial interests Non-financial personal interests Sponsored events Gifts Indirect interests Clinical private practice Indirect interests Outside employment Financial interests Indirect interests Outside employment Clinical private practice Non-financial professional interest Sponsored events Financial interests Financial interests Financial interests Financial interests Financial interests Non-financial personal interests Non-financial personal interests Financial interests Financial interests Non-financial professional interest Non-financial personal interests Clinical private practice Outside employment Outside employment Outside employment Sponsored events Outside employment Gifts Sponsored events Sponsored events Sponsored events Gifts Financial interests Financial interests Financial interests Financial interests Non-financial professional interest Financial interests Gifts Outside employment Shareholdings and other ownership interests Clinical private practice Loyalty interests Hospitality Financial interests Financial interests Hospitality Hospitality Financial interests Indirect interests Financial interests Financial interests Financial interests Financial interests Financial interests Non-financial professional interest Financial interests Non-financial personal interests Outside employment Sponsored events Outside employment Clinical private practice Outside employment Outside employment Sponsored events Sponsored events Sponsored events Gifts Non-financial personal interests Hospitality Non-financial personal interests Financial interests Financial interests Hospitality Clinical private practice Outside employment I undertake private practice at the Spire Southampton and Wessex Nuffield Hospitals I am registered with Source Bioscience and Backlogs - which are remote locum companies in cellular pathology I am the Editor in Chief of the journal Diagnostic Histopathology and receive an honorarium for this. Private Practice with admitting rights at UHS, Spire Southampton Hospital and Genesis Care Southampton. 3 hours per week on Wednesday am in Job Plan. Honoraria for talk to Astra Zeneca Sponsored Satellite Symposium at BTOG January 2022. £800 Hospitality from Genesis Care: Dinner Lainston House Hotel 2/12/21 Dinner Ennios Restaurant, Southampton 6/10/22 Mr wife, Claire Walsh (Bates) is a GP Partner at Stockbridge Surgery. Chemotherapy mostly delivered at UHS in Solent Suite. Radiotherapy delivered at UHS and Genesis Care. Most of my Private Practice radiotherapy is now with Genesis Care at Spire Southampton Hospital. Previously most of my Private radiotherapy was delivered at UHS, but the waits are now too long. Patients from Stockbridge Surgery are referred to UHS 05/02/2022 01/09/2024 05/02/2022 01/09/2024 01/06/2006 31/12/2025 27/01/2022 27/01/2022 02/12/2021 06/10/2022 01/01/2010 31/12/2025 I do a weekly private outpatient clinic at Spire/Nuffield. This takes about 4 hours per week This has been ongoing for many years, no change and doesn't impact my NHS practice 25/09/2022 31/03/2023 General and colorectal surgeon including outpatients, endoscopy/colonoscopy, operating. Practicing at: Spire Southampton Hospital, Chalybeate Close, Southampton SO16 6UY Nuffield Health Wessex Hospital, Winchester Road, Chandlers Ford, Eastleigh SO53 2DW Tuesday pm colonoscopy Spire hospital Tuesday evening Outpatients Nuffield hospital (variable/ad hoc surgery) Updated 04.09.24 confirmed private practice as outlined. 01/10/2004 04/09/2024 Looking to be Part Time self employed (weekend work) to be a system analyst for other UK Hospital Sites which use the same software we use in critical care (MetaVision). The skills I have built within my First time filling one of these in so i am happy to reply with more information if needed. I have set the date to a year as i am unsure how the current role within the trust would aide in my Part Time self employment i.e. analysing databases and building reporting solutions I would currently remain as a full time member of UHS. part time self employment will last for in its early stages. 11/05/2023 11/05/2024 Flights, accommodation and conference attendance at the the CPSI (TruBridge) conference in the USA in May 2024. TruBridge are the supplier we partner with to develop My Medical Record. This conference will include an in-person user group (with other TruBridge customers). It will also include meetings with the TruBridge product team, where we will discuss alignment (including potential blockers) of the TruBridge and My Medical Record product roadmaps. I notified my line manger (David Cable) as soon as I received the invite and I also have a approval from Jason Teoh (CIO). I do private work at nuffield. This work is on a wednesday and is documented in the job plan My work at Spire is in NHS hours only. I have private practice to declare I notified my line manger (David Cable) as soon as I received the invite and I also have a approval from Jason Teoh (CIO). I've added this as 'non-financial professional interest' although I'm not sure if that is the correct category? It seemed the best fit from the options. I have private practice to declare. My practice is at the nuffield and Spire hospitals 28/04/2024 03/05/2024 01/06/2022 06/06/2023 01/06/2023 07/06/2024 Advisory Board Member for: DGH Pharma (Europe) Ltd Kemp House 160 City Road London United Kingdom EC1v 2NX Payment received for education session at meeting sponsored by Chiesi. I work for Spire Southampton, Nuffield Wessex hospitals outside of NHS hours. I do remote reporting for Backlogs limited. I work in the private hospital as a consultant oncologist. Private hospitals include Spire Southampton, Genesis radiotherapy, new hall hospital Salisbury. I also undertake private patient work at UHS Southampton Working with GCUK - private radiotherapy provider. Working as a clinical oncologist for approximately 3 to 4 hours a week as MR -Linac specialist. Currently UHS does not have MR Linac therefore there is no direct conflict of interest. have either received research grants, honoraria to speak at, chair and attend meetings or liaised/received educational material from representatives of the following companies over the last 20 years: · Astellas · Pfizer · Ipsen · Glaxo Smith Kline · Sanofi · Lilly · Bayer · Amgen · Ferring · Takeda · Comvita · AstraZenecaJanssen-Cilag · Janssen The latest were from 1. Janssen to attend (as faculty) the prostate cancer summit in the UK (2020) 2. Laborie for providing a presentation to be used at the ICS meeting in Melbourne (20210) (2020) Christmas food box from a supplier - Softcat – of mostly perishable items (crisps, chocolate, cranberry sauce, biscuits, bottle of wine). The market value of the items is estimated at less than £15. Generally thee support provide has been to attend conferences or fund research. I do not hold shares (directly) in any companies providing health care resources of any kind to the NHS or other like companies. I have a Private Practice based at the Wessex Nuffield that might be considered a potential conflict of interest to my work with the NHS and UHS but I manage this along NHS and UHS guidelines and do not perform any procedures there that I do not perform on the NHS other than reversal of vasectomy as this is not generally funded by the NHS. Given the relatively low value, perishable nature, and inconvenience of returning the item to the supplier, it was deemed appropriate for the team to keep this food box. 01/06/2022 31/12/2022 01/04/2021 31/03/2022 20/02/2023 24/03/2025 01/01/2009 31/03/2025 01/04/2024 31/03/2025 07/02/2002 08/07/2022 20/12/2023 20/12/2023 Private OT consultations, on an as and when basis. This is not advertised through verbal or printed advertisements, social media or verbally mentioned, within my current role 27/03/2024 Sole Trade Home/ Mobile Beauty Therapist Case Support/ Brilliant Minds- Epilepsy Teaching (Self Employed) The Grove, North Road Dibden/ Longview, Fryern Court Road Private Epilepsy Awareness and emergency medication training sessions No committed hours/ as and when needed (approx. 4-10 hours per month) Private practice and member of SAS Received sponsorship for flight and hotel accommodation relating to a professional conference in Madrid, Spain. Sponsorship covered only the two days of the conference. Conference details: XLH international conference. Date: 18-19th April 2024. Sponsor: Kyowa Kirin. I prescribe burosumab at UHS, a biological therapy for children with a rare condition (XLH). The therapy is manufactured by Kyowa Kirin. I am an associate of MDT Rehab providing private clinical physiotherapy in an intermittent capacity. 1/ training as AstraZeneca speaker - 19/3/24 £1080 2/talk for AstraZeneca - 16/10/24 £405 Speaker fee- AstraZeneca £500 speaker fee for Sanofi - £760 Advisory board for CSL Behring Sponsorship to attend ISTH congress by Sanofi This is an ongoing Profession before i initially started my first employment at UHS Dec 2008 I will not advertise or provide information about private practice unless specifically asked. If the information is requested I will offer a number of options and not declare which company I am associated with. 17/10/2023 07/06/2022 13/07/2023 14/07/2023 17/04/2024 19/04/2024 01/11/2023 01/01/2024 01/01/2025 21/09/2023 21/09/2023 03/07/2023 03/07/2023 17/01/2023 I have my own business as a sole trader - making and selling dichroic glass jewellery. This is entirely conducted in my own time. Christmas food box from a supplier - Softcat – of mostly perishable items (crisps, chocolate, cranberry sauce, biscuits, bottle of wine). The market value of the items is estimated at less than £15. Proctor and advisory board to Neuwave/Johnson&Johnson. Proctoring for Boston Scientific on image-guided Cryoablation Given the relatively low value, perishable nature, and inconvenience of returning the item to the supplier, it was deemed appropriate for the team to keep this food box. On-site proctoring on image-guided microwave ablation. Payment made to UoS Southampton Charitable fund. Onsite proctoring- payments made to UoS Southampton charitable fund. 04/01/2024 21/12/2023 21/12/2023 07/06/2018 22/06/2022 Advisory panel to Varian/Siemens healthcare systems. Christmas food box from a supplier - Softcat – of mostly perishable items (crisps, chocolate, cranberry sauce, biscuits, bottle of wine). The market value of the items is estimated at less than £15. Technical advice. Usually consulted at conferences. Given the relatively low value, perishable nature, and inconvenience of returning the item to the supplier, it was deemed appropriate for the team to keep this food box. 01/06/2021 22/06/2022 21/12/2023 21/12/2023 One-time receipt of cheque to value of £152 payable to myself from Mortuary Fund. Mortuary fund accrues voluntary donations from various/multiple external bodies (namely funeral directors) to UHS mortuary in recognition of additional assistance provided to these companies by mortuary team outside of their contracted role (e.g. patient handling & chasing paperwork). The total amount donated to the fund in each calendar year is divided equally amongst all mortuary employees annually, with all members of team (9x staff B3-B8a) receiving an equal share. No interests as received from multiple & various different donors on a voluntary basis. No service contracts are in place between UHS mortuary & donors and so no opportunity for influence in decision making. Terema Ltd: provision of teaching for Human Factors training company. Paid daily rate on attendance. No financial stake in business. As above 01/04/2021 31/03/2022 06/02/2022 31/12/2024 Founder of REN Think Ltd Facilitation of education and training in team skills, human factors, leadership; speaker 13/04/2025 30/04/2034 Spire Southampton Hospital Chalybeate Close Southampton SO16 6UY Occasional spinal cord monitoring performed during spinal operations (usually scoliosis correction). 2-3 cases per year. 01/01/2015 Coordinator of the Wessex Branch of the Infection Prevention society Infection Prevention society Blackburn House, Redhouse Road, Seafield, Bathgate, West Lothian, EH4 7AQ BSIR 2022 attenda
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InP-LEAM
Description
Chemotherapy Protocol LYMPHOMA LOMUSTINE-CYTARABINE-ETOPOSIDE (split)-MELPHALAN (LEAM) Inpatient Regimen Regimen Lymphoma – InP-LEAM (split)-Lomustine-Cytarabine-Etoposide-Melphalan Indication Conditioning for autologous peripheral blood stem cell transplant (PBSCT) / bone marrow transplant in individuals with either Non Hodgkin Lymphoma (NHL) or Hodgkin Lymphoma Toxicity Drug Lomustine Cytarabine Etoposide Adverse Effect Pulmonary toxicity CNS toxicity, conjunctivitis, flu-like syndrome, pulmonary toxicity, gastro-intestinal toxicity Hypotension on rapid infusion, hyperbilirubinaemia Melphalan Gastro-intestinal disturbances, stomatitis Patients treated with LEAM are at risk of transfusion-associated graft versus host disease (TA-GVHD). Where blood products are required these patients must receive irradiated blood products for the 1 week prior to harvest and for at least 12 weeks after the transplant has taken place. Patients with Hodgkin lymphoma carry a lifelong risk of graft versus host disease and must always receive irradiated blood products. Local blood transfusion departments must be notified as soon as a diagnosis is made and the patient must be issued with an alert card to carry with them at all times. The adverse effects listed are not exhaustive. Please refer to the relevant Summary of Product Characteristics for full details. Version 1 (September 2022) Page 1 of 10 Lymphoma- InP-LEAM (split)-Lomustine-Cytarabine-Etoposide (split)-Melphalan Monitoring Drugs FBC, LFTs (including albumin) and U&Es prior to day one of treatment EDTA or calculated creatinine clearance prior to each melphalan infusion Monitor the fluid balance during the administration of melphalan, including throughout the administration of the pre and post hydration. Ensure the urine output is more than 250ml/hour immediately prior to the administration of melphalan Dose Modifications The dose modifications listed are for haematological, liver and renal function and some limited drug specific toxicities only. Dose adjustments may be necessary for other toxicities as well. In principle all dose reductions due to adverse drug reactions should not be re-escalated 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. Haematological Treatment will be given regardless of blood results. Consider blood transfusion if patient symptomatic of anaemia or has a haemoglobin of less than 8g/dL. Irradiated blood products must be used. Hepatic Impairment Please note that the approach may be different if abnormal liver function tests are due to disease involvement. Drug Lomustine Bilirubin μmol/L N/A AST/ALT units/L N/A Dose (% of original dose) No dose adjustment necessary Cytarabine more than 34 50% The dose may be escalated dependent on toxicity Etoposide Melphalan 30-51 or more than 51 or N/A 60-180 more than 180 N/A Consider dose reducing to 50% Clinical decision No dose adjustment necessary Version 1 (September 2022) Page 2 of 10 Lymphoma- InP-LEAM (split)-Lomustine-Cytarabine-Etoposide (split)-Melphalan Renal Impairment Drug Lomustine Creatinine Clearance (ml/min) more 60 45-60 30-<45 less than 30 Dose (% of original dose) 100% 75% 50% Clinical decision Cytarabine N/A No dose adjustment necessary Etoposide more than 50 15-50 less than 15 100% 75% 50% Melphalan more than 50 30-50 less than 30 100% 75% Clinical decision Other Lomustine It may be necessary to reduce the dose of lomustine in patients with reduced pulmonary function. Lomustine dose reductions in this situation are to be made at the discretion of the consultant oncologist/haematologist only. Etoposide Where significant reductions in albumin levels occur consider reducing the dose of etoposide. Regimen 1 cycle will be set in Aria Drug Lomustine Cytarabine Etoposide Melphalan Dose 200mg/m2 200mg/m2 every 12 hours 200mg/m2 140mg/m2 Days -6 -5,-4,-3,-2 -5,-4,-3,-2 -1 Administration Oral Intravenous infusion in 100ml sodium chloride 0.9% over 30 minutes Intravenous infusion in 2000ml sodium chloride 0.9% over 120 minutes (this will be administered as two infusions of 100mg/m2 in 1000ml sodium chloride 0.9% over 60 minutes administered sequentially) Intravenous infusion in 500ml sodium chloride 0.9% over 30 minutes Dose Information Version 1 (September 2022) Page 3 of 10 Lymphoma- InP-LEAM (split)-Lomustine-Cytarabine-Etoposide (split)-Melphalan Lomustine will be dose rounded to the nearest 40mg (down if halfway) Cytarabine will be dose banded in accordance with the national dose bands (20mg/ml) Etoposide will be dose banded in accordance with the national dose bands (20mg/ml) The melphalan dose will be dose rounded to the nearest 10mg (down if halfway). The National Dose Banding Team have advised not to use dose banding tables for this product in view of the 90 minute expiry (must be made locally for individual patient), the 50mg vial size and frequent stock shortages. Administration Information Extravasation Cytarabine – non-vesicant Etoposide – irritant Melphalan – irritant Other Due to the stability of etoposide the total dose of 200mg/m2 will be split into two infusions of 100mg/m2 in 1000ml sodium chloride 0.9% over 60 minutes. The two infusions are given sequentially, the second is started as soon as the first infusion is complete. The total duration of etoposide administration is 120minutes. Ensure the urine output is more than 250ml/hour immediately prior to the administration of melphalan Additional Therapy This is an in-patient regimen. Please ensure all supportive and take home medicines are prescribed on the in-patient chart or general electronic prescribing system. Please refer to the transplant schedule for the individual patient. Antiemetics Starting 15-30 minutes prior to chemotherapy - dexamethasone 2mg twice a day for 10 days oral or intravenous starting on day -6 of the cycle - metoclopramide 10mg three times a day for 10 days oral or intravenous starting on day -6 of the cycle - ondansetron 8mg twice a day for 10 days oral or intravenous - aprepitant 125mg once only orally on the day of the melphalan infusion then 80mg once a day for the subsequent two days Version 1 (September 2022) Page 4 of 10 Lymphoma- InP-LEAM (split)-Lomustine-Cytarabine-Etoposide (split)-Melphalan Anti-infectives - aciclovir 400mg oral twice a day until day +90 - ciprofloxacin 250mg oral twice a day from day+1 (stop when neutrophils are greater than 1) - pentamidine 300mg by nebuliser prior to discharge - co-trimoxazole 960mg once a day on Monday, Wednesday and Friday (start from 28 days post discharge, if neutrophils are greater than 1 and platelets are greater than 50, and continue until day +120) - fluconazole 100mg once a day oral (stop when neutrophils are greater than 1 unless the patient remains on corticosteroids) - nystatin suspension 1ml four times a day oral (stop when neutrophils are greater than 1 unless the patient remains on corticosteroids) Thromboprophylaxis, continued until platelets are less than 50x109/L, or as directed by the consultant, according to local formulary choices; - dalteparin 5000units once a day subcutaneous injection - enoxaparin 40mg once a day subcutaneous injection - heparin 5000units twice a day subcutaneous injection Growth factors such as filgrastim biosimilar 30million units (300mcg) once a day subcutaneous from day +5 (stop when neutrophils are greater than 1x109/L for at least 24 hours, or greater than 3 on any occasion) Intravenous hydration before and after melphalan infusion The evening before melphalan infusion (to be completed by 0930 on the morning of the infusion) sodium chloride 0.9% with potassium chloride 27mmol 1000ml The day of melphalan infusion 0900hrs Start fluid chart and daily weights. Contact pharmacy to make melphalan infusion for delivery to ward at 1045hrs 0930hrs 1000ml sodium chloride 0.9% intravenous infusion over 90 minutes 1010hrs 20mg furosemide intravenous bolus 1045hrs Measure urine output since 0900hrs If more than 500ml continue with melphalan infusion If less than 500ml give second furosemide 20mg dose intravenous bolus check urine output since 0900hrs again at 1100hrs: if more than 500ml go ahead with melphalan if less than 500ml contact the prescriber. 1100hrs – give melphalan intravenous infusion over thirty minutes (This product has a short expiry so adhering to set timing is essential) Version 1 (September 2022) Page 5 of 10 Lymphoma- InP-LEAM (split)-Lomustine-Cytarabine-Etoposide (split)-Melphalan 1130hrs - 1000ml sodium chloride 0.9% intravenous infusion over 120 minutes 1330hrs - 1000ml sodium chloride 0.9% with potassium chloride 27mmol intravenous infusion over 240 minutes 1730hrs - 1000ml sodium chloride 0.9% intravenous infusion over 360 minutes 2330hrs - 1000ml sodium chloride 0.9% with potassium chloride 27mmol intravenous infusion over 480 minutes The day after melphalan infusion; 0730hrs - 1000ml sodium chloride 0.9% intravenous infusion over 480 minutes then restart routine intravenous fluids Furosemide 20mg oral or intravenous bolus to maintain fluid balance and a urine output of more than 250ml/hour immediately prior to melphalan administration In menstruating women consider norethisterone 5mg three times a day oral to prevent menstruation. This may be stopped when the platelets are more than 50x109/L. Mouthcare for the prophylaxis or treatment of mucositis in accordance with local or national guidelines Gastric protection with a proton pump inhibitor or a H2 antagonist according to local formulary choice; - esomeprazole 20mg once a day oral - omeprazole 20mg once a day oral - lansoprazole 15mg once a day oral - pantoprazole 20mg once a day oral - rabeprazole 20mg once a day oral - cimetidine 400mg twice a day oral - famotidine 20mg once a day oral - nizatidine 150mg twice a day oral - ranitidine 150mg twice a day oral Additional Information Irradiated blood products must be used Autologous stem cells/ bone marrow will be infused on day 0, at least 24 hours after the melphalan infusion Coding Version 1 (September 2022) Page 6 of 10 Lymphoma- InP-LEAM (split)-Lomustine-Cytarabine-Etoposide (split)-Melphalan Procurement – X70.5 Delivery – Not Required References 1.Mills W, Chopra R, McMillan A et al. BEAM chemotherapy and autologous bone marrow transplantation for patients with relapsed or refractory non-Hodgkin's lymphoma. J Clin Oncol (1995);13(3): 588-95 2.Kelsey P, Pearce R, Perry J et al. Substituting carmustine for lomustine is safe and effective in the treatment of relapsed or refractory Lymphoma – a retrospective study from the BSBMT (BEAM versus LEAM) Version 1 (September 2022) Page 7 of 10 Lymphoma- InP-LEAM (split)-Lomustine-Cytarabine-Etoposide (split)-Melphalan REGIMEN SUMMARY InP-LEAM (split)-Lomustine-Cytarabine-Etoposide (split)-Melphalan Other than those listed below, supportive medication for this regimen will not appear in Aria as prescribed agents. The administration instructions for each warning describes the agents which must be prescribed on the in-patient chart or general electronic prescribing system Day -6 1. Warning – Check blood transfusion status Administration Instructions Patients treated with LEAM carry a lifelong risk of transfusion associated graft versus host disease. Where blood products are required these patients must receive ONLY IRRADIATED BLOOD PRODUCTS for life. Ensure transfusion departments are notified and the patient has been issued with an alert card to carry with them at all times. 2. Warning – Check supportive medication prescribed Administration instructions Please refer to the individual transplant schedule. In general the following is required; 1. Aprepitant 125mg once a day oral on the day of melphalan administration followed by 80mg once a day for two days after melphalan administration 2. Dexamethasone 2mg twice a day, days -6 to +3 oral or intravenous 3. Metoclopramide 10mg three times a day, days -6 to +3 then as required oral or intravenous 4. Ondansetron 8mg twice a day, days -6 to +3 oral or intravenous 5. Growth factors such as biosimiliar filgrastim 30million units once a day from day +5 (stop when neutrophils are greater than 1x109/L for at least 24 hours or are greater than 3x109/L on any occasion 6. Aciclovir 400mg oral twice a day until day +90 7. Ciprofloxacin 250mg twice a day from day +1 and continued until neutrophils are greater than 1x109/L. 8. Co-trimoxazole 960mg once a day on Monday, Wednesday and Friday (start from 28 days post discharge if the neutrophils are greater than 1x109/L and platelets are greater than 50x109/L and continue until day +120) 9. Fluconazole 100mg once a day (stop when neutrophils are greater than 1x109/L) 10.Pentamidine 300mg nebuliser prior to discharge 11.Thromboprophylaxis with a low molecular weight heparin until platelets are less than 50x109/L 12.Furosemide 20mg when required oral or intravenous bolus 13.Melphalan pre and post hydration 14.Gastric protection 15.Consider mouthwashes 16.Consider norethisterone for menstruating women 3. Lomustine 200mg/m2 once a day for one day oral Administration Instructions This should be given before midday. Swallow whole with a full glass of water. Do not open or chew Day -5, -4, -3, -2 4. Warning – Cytarabine is TWICE a day (12hrs apart) Administration Instructions Cytarabine is administered TWICE a day at 12 hour intervals (0900 and 2100) 5. Cytarabine 200mg/m2 intravenous infusion in 100ml sodium chloride 0.9% over 30 minutes every 12 hours (9am and 9pm) Administration Instructions Cytarabine is administered TWICE a day at 12 hour intervals (0900 and 2100) 6. Warning – Etoposide is TWO infusions () Administration Instructions Due to the stability of etoposide the total dose of 200mg/m2 will be split into two infusions of 100mg/m2 in 1000ml sodium chloride 0.9% over 60 minutes. The two infusions are given sequentially, the second is started as soon as the first infusion is complete. The total duration of etoposide administration is 120minutes. 7. Etoposide 100mg/m2 intravenous infusion in 1000ml sodium chloride 0.9% over 60 minutes Administration Instructions Version 1 (September 2022) Page 8 of 10 Lymphoma- InP-LEAM (split)-Lomustine-Cytarabine-Etoposide (split)-Melphalan Due to the stability of etoposide the total dose of 200mg/m2 will be split into two infusions of 100mg/m2 in 1000ml sodium chloride 0.9% over 60 minutes. The two infusions are given sequentially, the second is started as soon as the first infusion is complete. The total duration of etoposide administration is 120minutes. 8. Etoposide 100mg/m2 intravenous infusion in 1000ml sodium chloride 0.9% over 60 minutes Administration Instructions Due to the stability of etoposide the total dose of 200mg/m2 will be split into two infusions of 100mg/m2 in 1000ml sodium chloride 0.9% over 60 minutes. The two infusions are given sequentially, the second is started as soon as the first infusion is complete. The total duration of etoposide administration is 120minutes Day -1 9. Warning – Check hydration and fluid balance Administration Instructions See separate fluid prescription for the pre hydration: 1. Overnight to be completed at 0930hrs on day of melphalan infusion, 1000ml sodium chloride 0.9% with potassium chloride 0.2% (27mmol) intravenous infusion The day of melphalan infusion: 2. 0900hrs on the day of melphalan start fluid chart and daily weights. Contact pharmacy to make melphalan infusion for delivery to ward at 1045hrs 3. 0930hrs 1000ml sodium chloride 0.9% intravenous infusion over 90 minutes 4. 1010hrs 20mg furosemide intravenous bolus 5. 1045hrs Measure urine output since 0900hrs If more than 500ml continue with melphalan infusion If less than 500ml give second furosemide 20mg dose intravenous bolus and recheck urine output since 0900hrs again at 1100hrs: • if more than 500ml go ahead with melphalan • if less than 500ml contact prescriber. 10. Time– Administer melphalan at 1100 11. Melphalan 140mg/m2 intravenous infusion in 500ml sodium chloride 0.9% over 30 minutes Administration Instructions - see separate fluid prescription for the post hydration requirements 1. 1100hrs – give melphalan intravenous infusion over thirty minutes 2. 1130hrs - 1000ml sodium chloride 0.9% intravenous infusion over two hours 3. 1330hrs - 1000ml sodium chloride 0.9% with potassium chloride 0.2% (27mmol) intravenous infusion over four hours 4. 1730hrs - 1000ml sodium chloride 0.9% intravenous infusion over six hours 5. 2330hrs - 1000ml sodium chloride 0.9% with potassium chloride 0.2% (27mmol) intravenous infusion over eight hours 6. The day after melphalan infusion: 0730hrs - 1000ml sodium chloride 0.9% intravenous infusion over eight hours and then restart routine intravenous fluids Version 1 (September 2022) Page 9 of 10 Lymphoma- InP-LEAM (split)-Lomustine-Cytarabine-Etoposide (split)-Melphalan Version Date DOCUMENT CONTROL Amendment Written By Approved By 1 September 2022 None Nanda Basker Pharmacist Dr Rob Lown Consultant Haematologist 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 Hospitals 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 that occur as a result of following these guidelines. These protocols should be used in conjunction with other references such as the Summary of Product Characteristics and relevant published papers. Version 1 (September 2022) 10 Page 10 of Lymphoma- InP-LEAM (split)-Lomustine-Cytarabine-Etoposide (split)-Melphalan
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InP-BEAM
Description
Chemotherapy Protocol LYMPHOMA CARMUSTINE-CYTARABINE-ETOPOSIDE (split)-MELPHALAN (BEAM) Inpatient Regimen Regimen Lymphoma – InP-BEAM (split)-Carmustine-Cytarabine-Etoposide-Melphalan Indication • Conditioning for autologous peripheral blood stem cell transplant (PBSCT) / bone marrow transplant in individuals with either Non Hodgkin Lymphoma (NHL) or Hodgkin Lymphoma Toxicity Drug Carmustine Cytarabine Etoposide Adverse Effect Pulmonary toxicity CNS toxicity, conjunctivitis, flu-like syndrome, pulmonary toxicity, gastro-intestinal toxicity Hypotension on rapid infusion, hyperbilirubinaemia Melphalan Gastro-intestinal disturbances, stomatitis Patients treated with BEAM are at risk of transfusion-associated graft versus host disease (TA-GVHD). Where blood products are required these patients must receive irradiated blood products for the 1 week prior to harvest and for at least 12 weeks after the transplant has taken place. Patients with Hodgkin lymphoma carry a lifelong risk of graft versus host disease and must always receive irradiated blood products. Local blood transfusion departments must be notified as soon as a diagnosis is made and the patient must be issued with an alert card to carry with them at all times. The adverse effects listed are not exhaustive. Please refer to the relevant Summary of Product Characteristics for full details. Version 1.1 (August 2018) Page 1 of 10 Lymphoma- InP-BEAM (split)-Carmustine-Cytarabine-Etoposide (split)-Melphalan Monitoring Drugs • FBC, LFTs (including albumin) and U&Es prior to day one of treatment • EDTA or calculated creatinine clearance prior to each melphalan infusion • Monitor the fluid balance during the administration of melphalan, including throughout the administration of the pre and post hydration. Ensure the urine output is more than 250ml/hour immediately prior to the administration of melphalan Dose Modifications The dose modifications listed are for haematological, liver and renal function and some limited drug specific toxicities only. Dose adjustments may be necessary for other toxicities as well. In principle all dose reductions due to adverse drug reactions should not be re-escalated 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. Haematological Treatment will be given regardless of blood results. Consider blood transfusion if patient symptomatic of anaemia or has a haemoglobin of less than 8g/dL. Irradiated blood products must be used. Hepatic Impairment Please note that the approach may be different if abnormal liver function tests are due to disease involvement. Drug Carmustine Bilirubin µmol/L N/A AST/ALT units/L N/A Dose (% of original dose) No dose adjustment necessary Cytarabine more than 34 50% The dose may be escalated dependent on toxicity Etoposide Melphalan 30-51 or 60-180 Consider dose reducing to 50% more than 51 or more than 180 Clinical decision N/A N/A No dose adjustment necessary Version 1.1 (August 2018) Page 2 of 10 Lymphoma- InP-BEAM (split)-Carmustine-Cytarabine-Etoposide (split)-Melphalan Renal Impairment Drug Carmustine Creatinine Clearance (ml/min) more 60 46-60 30-45 less than 30 Dose (% of original dose) 100% 80% 75% Clinical decision Cytarabine N/A No dose adjustment necessary Etoposide more than 50 15-50 less than 15 100% 75% 50% Melphalan more than 50 30-50 less than 30 100% 75% Clinical decision Other Carmustine It may be necessary to reduce the dose of carmustine in patients with reduced pulmonary function. Carmustine dose reductions in this situation are to be made at the discretion of the consultant oncologist/haematologist only. Etoposide Where significant reductions in albumin levels occur consider reducing the dose of etoposide. Regimen 1 cycle will be set in Aria Drug Carmustine Cytarabine Etoposide Melphalan Dose 300mg/m2 200mg/m2 every 12 hours 200mg/m2 140mg/m2 Days -6 -5,-4,-3,-2 -5,-4,-3,-2 -1 Administration Intravenous infusion in 500ml sodium chloride 0.9% over 60 minutes Intravenous infusion in 100ml sodium chloride 0.9% over 30 minutes Intravenous infusion in 2000ml sodium chloride 0.9% over 120 minutes (this will be administered as two infusions of 100mg/m2 in 1000ml sodium chloride 0.9% over 60 minutes administered sequentially) Intravenous infusion in 500ml sodium chloride 0.9% over 30 minutes Version 1.1 (August 2018) Page 3 of 10 Lymphoma- InP-BEAM (split)-Carmustine-Cytarabine-Etoposide (split)-Melphalan Dose Information • Carmustine will be dose rounded to the nearest 10mg (down if halfway) • Cytarabine will be dose banded in accordance with the national dose bands (20mg/ml) • Etoposide will be dose banded in accordance with the national dose bands (20mg/ml) • The melphalan dose will be dose rounded to the nearest 10mg (down if halfway). The National Dose Banding Team have advised not to use dose banding tables for this product in view of the 90 minute expiry (must be made locally for individual patient), the 50mg vial size and frequent stock shortages. Administration Information Extravasation • Carmustine – irritant • Cytarabine – non-vesicant • Etoposide – irritant • Melphalan – irritant Other • Due to the stability of etoposide the total dose of 200mg/m2 will be split into two infusions of 100mg/m2 in 1000ml sodium chloride 0.9% over 60 minutes. The two infusions are given sequentially, the second is started as soon as the first infusion is complete. The total duration of etoposide administration is 120minutes. • Ensure the urine output is more than 250ml/hour immediately prior to the administration of melphalan Additional Therapy This is an in-patient regimen. Please ensure all supportive and take home medicines are prescribed on the in-patient chart or general electronic prescribing system. Please refer to the transplant schedule for the individual patient. • Antiemetics Starting 15-30 minutes prior to chemotherapy - dexamethasone 2mg twice a day for 10 days oral or intravenous starting on day -6 of the cycle - metoclopramide 10mg three times a day for 10 days oral or intravenous starting on day -6 of the cycle - ondansetron 8mg twice a day for 10 days oral or intravenous Version 1.1 (August 2018) Page 4 of 10 Lymphoma- InP-BEAM (split)-Carmustine-Cytarabine-Etoposide (split)-Melphalan - aprepitant 125mg once only orally on the day of the melphalan infusion then 80mg once a day for the subsequent two days • Anti-infectives - aciclovir 400mg oral twice a day until day +90 - ciprofloxacin 250mg oral twice a day from day+1 (stop when neutrophils are greater than 1) - pentamidine 300mg by nebuliser prior to discharge - co-trimoxazole 960mg once a day on Monday, Wednesday and Friday (start from 28 days post discharge, if neutrophils are greater than 1 and platelets are greater than 50, and continue until day +120) - fluconazole 100mg once a day oral (stop when neutrophils are greater than 1 unless the patient remains on corticosteroids) - nystatin suspension 1ml four times a day oral (stop when neutrophils are greater than 1 unless the patient remains on corticosteroids) • Thromboprophylaxis, continued until platelets are less than 50x109/L, or as directed by the consultant, according to local formulary choices; - dalteparin 5000units once a day subcutaneous injection - enoxaparin 40mg once a day subcutaneous injection - heparin 5000units twice a day subcutaneous injection • Growth factors such as filgrastim biosimilar 30million units (300mcg) once a day subcutaneous from day +5 (stop when neutrophils are greater than 1x109/L for at least 24 hours, or greater than 3 on any occasion) • Intravenous hydration before and after melphalan infusion The evening before melphalan infusion (to be completed by 0930 on the morning of the infusion) sodium chloride 0.9% with potassium chloride 27mmol 1000ml The day of melphalan infusion 0900hrs Start fluid chart and daily weights. Contact pharmacy to make melphalan infusion for delivery to ward at 1045hrs 0930hrs 1000ml sodium chloride 0.9% intravenous infusion over 90 minutes 1010hrs 20mg furosemide intravenous bolus 1045hrs Measure urine output since 0900hrs If more than 500ml continue with melphalan infusion If less than 500ml give second furosemide 20mg dose intravenous bolus check urine output since 0900hrs again at 1100hrs: • if more than 500ml go ahead with melphalan • if less than 500ml contact the prescriber. Version 1.1 (August 2018) Page 5 of 10 Lymphoma- InP-BEAM (split)-Carmustine-Cytarabine-Etoposide (split)-Melphalan 1100hrs – give melphalan intravenous infusion over thirty minutes (This product has a short expiry so adhering to set timing is essential) 1130hrs - 1000ml sodium chloride 0.9% intravenous infusion over 120 minutes 1330hrs - 1000ml sodium chloride 0.9% with potassium chloride 27mmol intravenous infusion over 240 minutes 1730hrs - 1000ml sodium chloride 0.9% intravenous infusion over 360 minutes 2330hrs - 1000ml sodium chloride 0.9% with potassium chloride 27mmol intravenous infusion over 480 minutes • The day after melphalan infusion; 0730hrs - 1000ml sodium chloride 0.9% intravenous infusion over 480 minutes then restart routine intravenous fluids • Furosemide 20mg oral or intravenous bolus to maintain fluid balance and a urine output of more than 250ml/hour immediately prior to melphalan administration • In menstruating women consider norethisterone 5mg three times a day oral to prevent menstruation. This may be stopped when the platelets are more than 50x109/L. • Mouthcare for the prophylaxis or treatment of mucositis in accordance with local or national guidelines • Gastric protection with a proton pump inhibitor or a H2 antagonist according to local formulary choice; - esomeprazole 20mg once a day oral - omeprazole 20mg once a day oral - lansoprazole 15mg once a day oral - pantoprazole 20mg once a day oral - rabeprazole 20mg once a day oral - cimetidine 400mg twice a day oral - famotidine 20mg once a day oral - nizatidine 150mg twice a day oral - ranitidine 150mg twice a day oral Additional Information • Irradiated blood products must be used • Autologous stem cells/ bone marrow will be infused on day 0, at least 24 hours after the melphalan infusion Version 1.1 (August 2018) Page 6 of 10 Lymphoma- InP-BEAM (split)-Carmustine-Cytarabine-Etoposide (split)-Melphalan Coding • Procurement – X70.5 • Delivery – Not Required References 1.Mills W, Chopra R, McMillan A et al. BEAM chemotherapy and autologous bone marrow transplantation for patients with relapsed or refractory non-Hodgkin's lymphoma. J Clin Oncol (1995);13(3): 588-95 Version 1.1 (August 2018) Page 7 of 10 Lymphoma- InP-BEAM (split)-Carmustine-Cytarabine-Etoposide (split)-Melphalan REGIMEN SUMMARY InP-BEAM (split)-Carmustine-Cytarabine-Etoposide (split)-Melphalan Other than those listed below, supportive medication for this regimen will not appear in Aria as prescribed agents. The administration instructions for each warning describes the agents which must be prescribed on the in-patient chart or general electronic prescribing system Day -6 1. Warning – Check blood transfusion status Administration Instructions Patients treated with BEAM carry a lifelong risk of transfusion associated graft versus host disease. Where blood products are required these patients must receive ONLY IRRADIATED BLOOD PRODUCTS for life. Ensure transfusion departments are notified and the patient has been issued with an alert card to carry with them at all times. 2. Warning – Check supportive medication prescribed Administration instructions Please refer to the individual transplant schedule. In general the following is required; 1. Aprepitant 125mg once a day oral on the day of melphalan administration followed by 80mg once a day for two days after melphalan administration 2. Dexamethasone 2mg twice a day, days -6 to +3 oral or intravenous 3. Metoclopramide 10mg three times a day, days -6 to +3 then as required oral or intravenous 4. Ondansetron 8mg twice a day, days -6 to +3 oral or intravenous 5. Growth factors such as biosimiliar filgrastim 30million units once a day from day +5 (stop when neutrophils are greater than 1x109/L for at least 24 hours or are greater than 3x109/L on any occasion 6. Aciclovir 400mg oral twice a day until day +90 7. Ciprofloxacin 250mg twice a day from day +1 and continued until neutrophils are greater than 1x109/L. 8. Co-trimoxazole 960mg once a day on Monday, Wednesday and Friday (start from 28 days post discharge if the neutrophils are greater than 1x109/L and platelets are greater than 50x109/L and continue until day +120) 9. Fluconazole 100mg once a day (stop when neutrophils are greater than 1x109/L) 10.Pentamidine 300mg nebuliser prior to discharge 11.Thromboprophylaxis with a low molecular weight heparin until platelets are less than 50x109/L 12.Furosemide 20mg when required oral or intravenous bolus 13.Melphalan pre and post hydration 14.Gastric protection 15.Consider mouthwashes 16.Consider norethisterone for menstruating women 3. Carmustine 300mg/m2 intravenous infusion in 500ml sodium chloride 0.9% over 60 minutes Day -5, -4, -3, -2 4. Warning – Cytarabine is TWICE a day (12hrs apart) Administration Instructions Cytarabine is administered TWICE a day at 12 hour intervals (0900 and 2100) 5. Cytarabine 200mg/m2 intravenous infusion in 100ml sodium chloride 0.9% over 30 minutes every 12 hours (9am and 9pm) Administration Instructions Cytarabine is administered TWICE a day at 12 hour intervals (0900 and 2100) 6. Warning – Etoposide is TWO infusions () Administration Instructions Due to the stability of etoposide the total dose of 200mg/m2 will be split into two infusions of 100mg/m2 in 1000ml sodium chloride 0.9% over 60 minutes. The two infusions are given sequentially, the second is started as soon as the first infusion is complete. The total duration of etoposide administration is 120minutes. 7. Etoposide 100mg/m2 intravenous infusion in 1000ml sodium chloride 0.9% over 60 minutes Administration Instructions Due to the stability of etoposide the total dose of 200mg/m2 will be split into two infusions of 100mg/m2 in 1000ml sodium chloride 0.9% over 60 minutes. The two infusions are given sequentially, the second is started as soon as the first infusion Version 1.1 (August 2018) Page 8 of 10 Lymphoma- InP-BEAM (split)-Carmustine-Cytarabine-Etoposide (split)-Melphalan is complete. The total duration of etoposide administration is 120minutes. 8. Etoposide 100mg/m2 intravenous infusion in 1000ml sodium chloride 0.9% over 60 minutes Administration Instructions Due to the stability of etoposide the total dose of 200mg/m2 will be split into two infusions of 100mg/m2 in 1000ml sodium chloride 0.9% over 60 minutes. The two infusions are given sequentially, the second is started as soon as the first infusion is complete. The total duration of etoposide administration is 120minutes Day -1 9. Warning – Check hydration and fluid balance Administration Instructions See separate fluid prescription for the pre hydration: 1. Overnight to be completed at 0930hrs on day of melphalan infusion, 1000ml sodium chloride 0.9% with potassium chloride 0.2% (27mmol) intravenous infusion The day of melphalan infusion: 2. 0900hrs on the day of melphalan start fluid chart and daily weights. Contact pharmacy to make melphalan infusion for delivery to ward at 1045hrs 3. 0930hrs 1000ml sodium chloride 0.9% intravenous infusion over 90 minutes 4. 1010hrs 20mg furosemide intravenous bolus 5. 1045hrs Measure urine output since 0900hrs If more than 500ml continue with melphalan infusion If less than 500ml give second furosemide 20mg dose intravenous bolus and recheck urine output since 0900hrs again at 1100hrs: • if more than 500ml go ahead with melphalan • if less than 500ml contact prescriber. 10. Time– Administer melphalan at 1100 11. Melphalan 140mg/m2 intravenous infusion in 500ml sodium chloride 0.9% over 30 minutes Administration Instructions - see separate fluid prescription for the post hydration requirements 1. 1100hrs – give melphalan intravenous infusion over thirty minutes 2. 1130hrs - 1000ml sodium chloride 0.9% intravenous infusion over two hours 3. 1330hrs - 1000ml sodium chloride 0.9% with potassium chloride 0.2% (27mmol) intravenous infusion over four hours 4. 1730hrs - 1000ml sodium chloride 0.9% intravenous infusion over six hours 5. 2330hrs - 1000ml sodium chloride 0.9% with potassium chloride 0.2% (27mmol) intravenous infusion over eight hours 6. The day after melphalan infusion: 0730hrs - 1000ml sodium chloride 0.9% intravenous infusion over eight hours and then restart routine intravenous fluids Version 1.1 (August 2018) Page 9 of 10 Lymphoma- InP-BEAM (split)-Carmustine-Cytarabine-Etoposide (split)-Melphalan DOCUMENT CONTROL Version Date Amendment Written By Approved By Split added to regimen name. Etoposide changed to two infusions of 100mg/m2 Furosemide dose changed to 20mg Administration instructions updated to describe the two 1.1 August etoposide infusions. 2018 Warning added regarding the Dr Deborah Wright Pharmacist Harriet Launders Pharmacist two infusions Corticosteroid statement removed from fluconazole. Gastricprotection added Thromboprophylaxis change to include formulary choices Disclaimer added Rebecca Wills Dr Rob Lown 1 August 2017 None Pharmacist Dr Deborah Wright Consultant Haematologist Pharmacist 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 Hospitals 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 that occur as a result of following these guidelines. These protocols should be used in conjunction with other references such as the Summary of Product Characteristics and relevant published papers. Version 1.1 (August 2018) Page 10 of 10 Lymphoma- InP-BEAM (split)-Carmustine-Cytarabine-Etoposide (split)-Melphalan
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AmB LEAM (split)-Lomustine-Cytarabine-Etoposide-Melphalan
Description
Chemotherapy Protocol LYMPHOMA LOMUSTINE-CYTARABINE-ETOPOSIDE (split)-MELPHALAN (LEAM) Ambulatory Regimen This regimen is for AMBULATORY CARE pathway use only and will only be available to prescribe at units which carry out autograft transplantation. Regimen Lymphoma – AmB-LEAM (split)-Lomustine-Cytarabine-Etoposide-Melphalan Indication • Conditioning for autologous peripheral blood stem cell transplant (PBSCT) / bone marrow transplant in individuals with either Non Hodgkin Lymphoma (NHL) or Hodgkin Lymphoma Toxicity Drug Lomustine Cytarabine Etoposide Adverse Effect Pulmonary toxicity CNS toxicity, conjunctivitis, flu-like syndrome, pulmonary toxicity, gastro-intestinal toxicity Hypotension on rapid infusion, hyperbilirubinaemia Melphalan Gastro-intestinal disturbances, stomatitis Patients treated with LEAM are at risk of transfusion-associated graft versus host disease (TA-GVHD). Where blood products are required these patients must receive irradiated blood products for the 1 week prior to harvest and for at least 12 weeks after the transplant has taken place. Patients with Hodgkin lymphoma carry a lifelong risk of graft versus host disease and must always receive irradiated blood products. Local blood transfusion departments must be notified as soon as a diagnosis is made and the patient must be issued with an alert card to carry with them at all times. The adverse effects listed are not exhaustive. Please refer to the relevant Summary of Product Characteristics for full details. Version 1 (August 2023) Page 1 of 12 Lymphoma- AmB-LEAM (split)-Lomustine-Cytarabine-Etoposide (split)-Melphalan Monitoring Drugs • FBC, LFTs (including albumin) and U&Es prior to day one of treatment • EDTA or calculated creatinine clearance prior to each melphalan infusion • Monitor the fluid balance during the administration of melphalan, including throughout the administration of the pre and post hydration. Ensure the urine output is more than 250ml/hour immediately prior to the administration of melphalan Dose Modifications The dose modifications listed are for haematological, liver and renal function and some limited drug specific toxicities only. Dose adjustments may be necessary for other toxicities as well. In principle all dose reductions due to adverse drug reactions should not be re-escalated 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. Haematological Treatment will be given regardless of blood results. Consider blood transfusion if patient symptomatic of anaemia or has a haemoglobin of less than 8g/dL. Irradiated blood products must be used. Hepatic Impairment Please note that the approach may be different if abnormal liver function tests are due to disease involvement. Drug Lomustine Bilirubin μmol/L N/A AST/ALT units/L N/A Dose (% of original dose) No dose adjustment necessary Cytarabine more than 34 50% The dose may be escalated dependent on toxicity Etoposide Melphalan 30-51 or 60-180 more than 51 or more than 180 N/A N/A Consider dose reducing to 50% Clinical decision No dose adjustment necessary Version 1 (August 2023) Page 2 of 12 Lymphoma- AmB-LEAM (split)-Lomustine-Cytarabine-Etoposide (split)-Melphalan Renal Impairment Drug Lomustine Creatinine Clearance (ml/min) more 60 45-60 30-<45 less than 30 Dose (% of original dose) 100% 75% 50% Clinical decision Cytarabine N/A No dose adjustment necessary Etoposide more than 50 15-50 less than 15 100% 75% 50% Melphalan more than 50 30-50 less than 30 100% 75% Clinical decision Other Lomustine It may be necessary to reduce the dose of lomustine in patients with reduced pulmonary function. Lomustine dose reductions in this situation are to be made at the discretion of the consultant oncologist/haematologist only. Etoposide Where significant reductions in albumin levels occur consider reducing the dose of etoposide. Regimen 1 cycle will be set in Aria Drug Lomustine Cytarabine Etoposide Dose 200mg/m2 1600 mg/m2 (8 doses of 200mg/m2 every 12 hours) 200mg/m2 Days -6 200mg/m2 BD Every 12 hours at 9am and 9pm. -5,-4,-3,-2 (8 doses total) -5,-4,-3,-2 Administration Oral Administer via CADD Solis VIP pump. Each CADD cassette contains 8 doses (240ml total volume). Connect cassette on day -5 and disconnect on day -1 (AM) Each dose: IV infusion of 200mg/m2 in 30ml of sodium chloride 0.9% over 15 minutes at 120ml/hr. Intravenous infusion in 2000ml sodium chloride 0.9% over 120 minutes (this will be administered as two infusions of 100mg/m2 in 1000ml sodium chloride 0.9% over 60 minutes administered Version 1 (August 2023) Page 3 of 12 Lymphoma- AmB-LEAM (split)-Lomustine-Cytarabine-Etoposide (split)-Melphalan Melphalan 140mg/m2 sequentially) -1 Intravenous infusion in 500ml sodium chloride 0.9% over 30 minutes Dose Information • Lomustine will be dose rounded to the nearest 40mg (down if halfway) • Cytarabine will be dose banded in accordance with the national dose bands (100mg/ml) • Etoposide will be dose banded in accordance with the national dose bands (20mg/ml) • The melphalan dose will be dose rounded to the nearest 10mg (down if halfway). The National Dose Banding Team have advised not to use dose banding tables for this product in view of the 90 minute expiry (must be made locally for individual patient), the 50mg vial size and frequent stock shortages. Administration Information CADD pump • Total 8 doses provided as one infusion bag in cassette of CADD pump, to be administered as intermittent infusion on day -5 to -2. • Sodium chloride 0.9% 100ml to be run as continuous infusion to keep CADD infusion line patent. • Administer concurrently with cytarabine via Y-site with at 0.5 mL/hour on days -5 to 1. Extravasation • Cytarabine – non-vesicant • Etoposide – irritant • Melphalan – irritant Other • Due to the stability of etoposide the total dose of 200mg/m2 will be split into two infusions of 100mg/m2 in 1000ml sodium chloride 0.9% over 60 minutes. The two infusions are given sequentially, the second is started as soon as the first infusion is complete. The total duration of etoposide administration is 120minutes. • Ensure the urine output is more than 250ml/hour immediately prior to the administration of melphalan Version 1 (August 2023) Page 4 of 12 Lymphoma- AmB-LEAM (split)-Lomustine-Cytarabine-Etoposide (split)-Melphalan Additional Therapy This regimen is to be administered in the ambulatory setting. Please ensure all supportive and take home medicines are prescribed on the in-patient chart or general electronic prescribing system on admission. Please refer to the transplant schedule for each individual patient. • Antiemetics Starting 15-30 minutes prior to chemotherapy - dexamethasone 2mg twice a day for 10 days oral or intravenous starting on day -6 of the cycle - metoclopramide 10mg three times a day for 10 days oral or intravenous starting on day -6 of the cycle - ondansetron 8mg twice a day for 10 days oral or intravenous - aprepitant 125mg once only orally on the day of the melphalan infusion then 80mg once a day for the subsequent two days • Anti-infectives - aciclovir 400mg oral twice a day until day +180 - ciprofloxacin 250mg oral twice a day from day+1 (stop when neutrophils are greater than 1) - pentamidine 300mg by nebuliser prior to discharge - co-trimoxazole 960mg once a day on Monday, Wednesday and Friday (start from 28 days post discharge, if neutrophils are greater than 1 and platelets are greater than 50, and continue until day +180) - fluconazole 100mg once a day oral (stop when neutrophils are greater than 1 unless the patient remains on corticosteroids) - nystatin suspension 1ml four times a day oral (stop when neutrophils are greater than 1 unless the patient remains on corticosteroids) • Thromboprophylaxis, continued until platelets are less than 50x109/L, or as directed by the consultant, according to local formulary choices; - dalteparin 5000units once a day subcutaneous injection - enoxaparin 40mg once a day subcutaneous injection - heparin 5000units twice a day subcutaneous injection • Growth factors such as filgrastim biosimilar 30million units (300mcg) once a day subcutaneous from day +5 (stop when neutrophils are greater than 1x109/L for at least 24 hours, or greater than 3 on any occasion) • Hormone replacement In menstruating women consider norethisterone 5mg three times a day oral to prevent menstruation. This may be stopped when the platelets are more than 50x109/L. • Mouthcare Commence oral cryotherapy approximately 15mins prior to melphalan infusion, replenishing to cover melphalan infusion and 75 mins afterwards. Version 1 (August 2023) Page 5 of 12 Lymphoma- AmB-LEAM (split)-Lomustine-Cytarabine-Etoposide (split)-Melphalan Mouthcare for the prophylaxis or treatment of mucositis in accordance with local or national guidelines. • Gastric protection with a proton pump inhibitor or a H2 antagonist according to local formulary choice; - esomeprazole 20mg once a day oral - omeprazole 20mg once a day oral - lansoprazole 15mg once a day oral - pantoprazole 20mg once a day oral - rabeprazole 20mg once a day oral - cimetidine 400mg twice a day oral - famotidine 20mg once a day oral - nizatidine 150mg twice a day oral - ranitidine 150mg twice a day oral • Hydration - Encourage 3L oral fluids daily. If ambulatory patients are unable to maintain this (e.g. due to nausea), they should be admitted for intravenous hydration. - Intravenous hydration before and after melphalan infusion should be prescribed on inpatient prescribing system or using paper proforma (Appendix 1) Before and after melphalan infusion - Encourage oral hydration at least 1 litre between 8pm and 8am the night before melphalan infusion. 0830hrs Contact pharmacy on ext 5037 to inform them that the patient is present. Confirm that they have melphalan prescription (on ARIA). Request melphalan infusion to be on the ward by 11:30hrs. Start fluid chart and daily weights. Start fluid 1000ml sodium chloride 0.9% intravenous infusion over 90 minutes 0915hrs Administer anti-emetics and supportive medication as per ARIA prescription 0930hrs 20mg furosemide intravenous bolus Warning – Check hydration and fluid balance 1000hrs 1000ml sodium chloride 0.9% intravenous infusion over 90 minutes 1030hrs 20mg furosemide intravenous bolus Measure urine output since 0900hrs - If more than 500ml continue with melphalan infusion - If less than 500ml give second furosemide 20mg dose Version 1 (August 2023) Page 6 of 12 Lymphoma- AmB-LEAM (split)-Lomustine-Cytarabine-Etoposide (split)-Melphalan 1130hrs 1200hrs Thereafter intravenous bolus check urine output since 0900hrs again at 1100hrs: o if more than 500ml go ahead with melphalan o if less than 500ml contact the prescriber. Give melphalan intravenous infusion over thirty minutes (This product has a short expiry so adhering to set timing is essential) 1000ml sodium chloride 0.9% intravenous infusion over 120 minutes Encourage 2L oral fluid intake over subsequent 12 hours Instruct patient to take all supportive medications with particular reference to antiemetics Advise patient to drink 1000 ml of oral fluids over the evening Emergency contact details for AOS given to patient Patient and carer to return to C7 at 08:30 on day 0 • The day after melphalan infusion (Day 0): 0830hrs - 1000ml sodium chloride 0.9% intravenous infusion over 480 minutes then restart routine intravenous fluids Additional Information • Irradiated blood products must be used • Autologous stem cells/ bone marrow will be infused on day 0, at least 24 hours after the melphalan infusion References 1.Mills W, Chopra R, McMillan A et al. BEAM chemotherapy and autologous bone marrow transplantation for patients with relapsed or refractory non-Hodgkin's lymphoma. J Clin Oncol (1995);13(3): 588-95 2.Kelsey P, Pearce R, Perry J et al. Substituting carmustine for lomustine is safe and effective in the treatment of relapsed or refractory Lymphoma – a retrospective study from the BSBMT (BEAM versus LEAM) 3. Stabilis (manufacturers data) Stability of Alexan "Ebewe" infusion solutions. Ebewe Pharma 2007 from http://www.stabilis.org/ (Date accessed: 03/07/23). Version 1 (August 2023) Page 7 of 12 Lymphoma- AmB-LEAM (split)-Lomustine-Cytarabine-Etoposide (split)-Melphalan REGIMEN SUMMARY AmB-LEAM (split)-Lomustine-Cytarabine-Etoposide (split)-Melphalan Other than those listed below, supportive medication for this regimen will not appear in Aria as prescribed agents. The administration instructions for each warning describes the agents which must be prescribed on the in-patient chart or general electronic prescribing system. Supportive care should be prescribed on ARIA and given to the patient on day -6. Supportive care should be transcribed to the electronic inpatient prescribing system on admission to hospital. Day -6 1. Warning – Check blood transfusion status Administration Instructions Patients treated with LEAM carry a lifelong risk of transfusion associated graft versus host disease. Where blood products are required these patients must receive ONLY IRRADIATED BLOOD PRODUCTS for life. Ensure transfusion departments are notified and the patient has been issued with an alert card to carry with them at all times. 2. Dexamethasone 2mg oral or intravenous 3. Ondansetron 8mg oral or intravenous 4. Metoclopramide 10mg oral or intravenous 5. Lomustine 200mg/m2 once a day for one day oral Administration Instructions This should be given before midday. Swallow whole with a full glass of water. Do not open or chew 6. Warning -Ensure take home medicines are supplied Take home medicines 7. Aprepitant 80mg once a day oral for 2 days starting the day after melphalan (i.e. start day 0). 8. Dexamethasone 2mg once a day in the afternoon for 6 days starting on day -6 the day of lomustine. Then take 2mg twice a day for 4 days. 9. Ondansetron 8mg once a day in the evening for 6 days starting on day -6 the day of lomustine. Then take 8mg twice a day for 4 days. 10. Metoclopramide 10mg twice a day in the afternoon and evening for 6 days starting on day -6 the day of lomustine. Then take 10mg three times a day for 4 days. Administration instructions –Please supply 28 tablets or an original pack as appropriate 11. Aciclovir 400mg three times a day for 28 days Administration Instructions Please supply 28 days or an original pack if appropriate. 12. Ciprofloxacin 250mg twice a day starting on day +1 (2 days after melphalan administration) for 14 days Administration Instructions Please supply 14 days with no stop date 13. Fluconazole 100mg oral once a day for 14 days Administration instructions – please supply 14 days with no stop date Version 1 (August 2023) Page 8 of 12 Lymphoma- AmB-LEAM (split)-Lomustine-Cytarabine-Etoposide (split)-Melphalan 14. Nystatin 1ml four times a day Administration instructions – please supply 1 x OP 15. Gastric Protection Administration Instructions The choice of gastric protection is dependent on local formulary choice and may include; - esomeprazole 20mg once a day oral - omeprazole 20mg once a day oral - lansoprazole 15mg once a day oral - pantoprazole 20mg once a day oral - rabeprazole 20mg once a day oral - cimetidine 400mg twice a day oral - famotidine 20mg once a day oral - nizatidine 150mg twice a day oral - ranitidine 150mg twice a day oral Please supply 28 days or the nearest original pack size. 16. Sodium Chloride 0.9% oral rinse 10mL four times a day Administration instructions – pharmacy please supply 50 x 10mL pods 17. Thromboprophylaxis according to local formulary choice Continued until platelets are less than 50x109/L, or as directed by the consultant, according to local formulary choices: - dalteparin 5000units once a day subcutaneous injection - enoxaparin 40mg once a day subcutaneous injection - heparin 5000units twice a day subcutaneous injection Please supply 28 days or nearest original pack size. Day -5 18. Dexamethasone 2mg oral or intravenous 19. Ondansetron 8mg oral or intravenous 20. Metoclopramide 10mg oral or intravenous 21. Warning – Cytarabine delivered via one CADD. Administration Instructions Cytarabine is administered TWICE a day at 12 hour intervals (0900 and 2100) via CADD pump. Sodium chloride infusion must be administered concurrently. 22. Cytarabine 1600mg/m2 intravenous infusion in 240ml sodium chloride 0.9% as intermittent infusions via CADD pump. Administration Instructions One dose: Cytarabine 200mg/m2 in 30ml sodium chloride 0.9% over 15 minutes at 120ml/hour. Cytarabine is administered TWICE a day at 12 hour intervals (0900 and 2100) on days -5 to -2 (8 doses in total). Connect cassette on day -5 and disconnect on day -1 (AM). 23. Sodium Chloride 0.9% 100ml continuous infusion at 0.5ml/hr. Administration Instructions Sodium chloride 0.9% to be administered via folfusor pump at 0.5ml/hr on Days -5 to -1. To be connected via Y-site with CADD pump to maintain line patency. Disconnect folfusor at the same time as disconnecting CADD cassette 24. Warning – Etoposide is TWO infusions Administration Instructions Due to the stability of etoposide the total dose of 200mg/m2 will be split into two infusions of 100mg/m2 in 1000ml sodium chloride 0.9% over 60 minutes. The two infusions are given sequentially, the second is started as soon as the first infusion is complete. The total duration of etoposide administration is 120minutes. Version 1 (August 2023) Page 9 of 12 Lymphoma- AmB-LEAM (split)-Lomustine-Cytarabine-Etoposide (split)-Melphalan 25. Etoposide 100mg/m2 intravenous infusion in 1000ml sodium chloride 0.9% over 60 minutes Administration Instructions Due to the stability of etoposide the total dose of 200mg/m2 will be split into two infusions of 100mg/m2 in 1000ml sodium chloride 0.9% over 60 minutes. The two infusions are given sequentially, the second is started as soon as the first infusion is complete. The total duration of etoposide administration is 120minutes. 26. Etoposide 100mg/m2 intravenous infusion in 1000ml sodium chloride 0.9% over 60 minutes Administration Instructions Due to the stability of etoposide the total dose of 200mg/m2 will be split into two infusions of 100mg/m2 in 1000ml sodium chloride 0.9% over 60 minutes. The two infusions are given sequentially, the second is started as soon as the first infusion is complete. The total duration of etoposide administration is 120minutes Day -4, Day -3, Day -2 27. Dexamethasone 2mg oral or intravenous 28. Ondansetron 8mg oral or intravenous 29. Metoclopramide 10mg oral or intravenous 30. Warning – Etoposide is TWO infusions Administration Instructions Due to the stability of etoposide the total dose of 200mg/m2 will be split into two infusions of 100mg/m2 in 1000ml sodium chloride 0.9% over 60 minutes. The two infusions are given sequentially, the second is started as soon as the first infusion is complete. The total duration of etoposide administration is 120minutes. 31. Etoposide 100mg/m2 intravenous infusion in 1000ml sodium chloride 0.9% over 60 minutes Administration Instructions Due to the stability of etoposide the total dose of 200mg/m2 will be split into two infusions of 100mg/m2 in 1000ml sodium chloride 0.9% over 60 minutes. The two infusions are given sequentially, the second is started as soon as the first infusion is complete. The total duration of etoposide administration is 120minutes. 32. Etoposide 100mg/m2 intravenous infusion in 1000ml sodium chloride 0.9% over 60 minutes Administration Instructions Due to the stability of etoposide the total dose of 200mg/m2 will be split into two infusions of 100mg/m2 in 1000ml sodium chloride 0.9% over 60 minutes. The two infusions are given sequentially, the second is started as soon as the first infusion is complete. The total duration of etoposide administration is 120minutes Day -1 33. Warning – Check CADD pump and sodium chloride pump removal 34. Aprepitant 125mg oral 35. Dexamethasone 2mg oral or intravenous 36. Ondansetron 8mg oral or intravenous 37. Metoclopramide 10mg oral or intravenous 38. Furosemide 20mg injection bolus Administration instructions – to be given if required for fluid overload. Version 1 (August 2023) Page 10 of 12 Lymphoma- AmB-LEAM (split)-Lomustine-Cytarabine-Etoposide (split)-Melphalan 39. Warning – Check hydration and fluid balance Administration Instructions See separate fluid prescription for the pre hydration: The evening before melphalan infusion (to be completed by 0930 on the morning of the infusion) Sodium chloride 0.9% with potassium chloride 27mmol 1000ml The day of melphalan infusion: 0830hrs Contact Pharmacy on ext 5037 to inform them that the patient is present. Confirm that they have melphalan prescription (on ARIA) □ Request melphalan to be on the ward by 11:30 □ Start fluid balance sheet and start daily weight measurement 0915hrs Administer anti-emetics and supportive medication as per ARIA prescription 0930hrs 20mg furosemide intravenous bolus 1000hrs 1000ml sodium chloride 0.9% intravenous infusion over 90 minutes 1030hrs 20mg furosemide intravenous bolus Measure urine output since 0900hrs If more than 500ml continue with melphalan infusion If less than 500ml give second furosemide 20mg intravenous bolus dose and check urine output since 0900hrs again at 1100hrs: if more than 500ml go ahead with melphalan if less than 500ml contact the prescriber. 1130hrs – give melphalan intravenous infusion over thirty minutes (this product has a short expiry so adhering to set timing is essential) 1200hrs - 1000ml sodium chloride 0.9% intravenous infusion over 120 minutes 40. Time– Administer melphalan at 1130hrs 41. Melphalan 140mg/m2 intravenous infusion in 500ml sodium chloride 0.9% over 30 minutes Administration Instructions - see separate fluid prescription for the post hydration requirements Day 0 42. Chlorphenamine 10mg Intravenous bolus Administration instructions – to be given pre stem cell infusion 43. Paracetamol 1000mg Tablet Oral Administration instructions – to be given pre stem cell infusion 44. Stem Cell Return – see separate chart Version 1 (August 2023) Page 11 of 12 Lymphoma- AmB-LEAM (split)-Lomustine-Cytarabine-Etoposide (split)-Melphalan DOCUMENT CONTROL Version Date Amendment Written By Approved By 1 August 2023 New document Madeleine Norbury Pharmacist Hwai Jing Hiew Consultant 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; University Hospital Southampton NHS Foundation Trust -Wessex Blood and Marrow Transplant All actions have been taken to ensure these protocols are correct. However, no responsibility can be taken for errors that occur as a result of following these guidelines. These protocols should be used in conjunction with other references such as the Summary of Product Characteristics and relevant published papers. Version 1 (August 2023) Page 12 of 12 Lymphoma- AmB-LEAM (split)-Lomustine-Cytarabine-Etoposide (split)-Melphalan
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Engaging for increased research participation - full report
Description
Engaging for increased research participation Public and healthcare professionals' perceptions For further information contact: Chris Stock Head of R&D communications and strategy University Hospital Southampton NHS Foundation Trust T: 07795506319 / E: christopher.stock@uhs.nhs.uk Ben Hickman Research director Alterline Research T: 01616050862 / E: ben.hickman@alterline.co.uk This report presents independent research funded in part by the National Institute for Health Research (NIHR) Clinical Research Network: Wessex. The views expressed are those of the author(s) and not necessarily those of the NHS, the NIHR or the Department of Health. Contents 1. Executive summary 1.1. Headline findings and recommendations 1.1.1.People are positive about research and participation 1.1.2. The critical conversations are not happening 1.1.3 Healthcare professionals perceive major barriers to involvement 1.1.4 The public need information, of immediate relevance to their health 1.1.5 Time and fitting participation into life is a concern 2. Introduction and Methodology 2.1. Introduction 2.2. Key objectives 2.3. This report 2.4. Method 3. Review of the literature 3.1. General background 3.2. Why do people take part in clinical research? 3.3. What stops people from taking part in clinical research? 3.4. Why do people take part, or not take part, in related activities? 3.5. Summary 4. Likelihood to participate in clinical research 4.1. The public view clinical research as important 4.1.1. Demographic Differences 4.2. Few people have been asked to take part in clinical research 4.3. Likelihood to participate 4.3.1. Demographic differences 4.4. Likelihood to participate in various types of research 5. Motivations for taking part 5.1. Why do other people take part in clinical research? 5.2. What would motivate you to take part? 5.2.1. Demographic differences 5.3. Exploring motivations in more depth 6. Barriers to taking part 6.1. Why don't other people take part? 6.2. What stops you from taking part? 6.2.1. Demographic differences 6.3. Exploring barriers in more depth 6.4. What do people mean by the `risks' involved? 6.5. How are people forming opinions about risk? 6.6. What might reassure people? 7. The experience of taking part in clinical research 7.1.What motivated people to take part? 7.2. Would people recommend the experience? 7.3. Why would people recommend the experience? 7.4. Why would people not recommend the experience? 7.5. Knowing someone who has taken part 7.6. Why would people be more likely to take part, knowing someone who has? 7.7. Why would people be less likely to take part, having known someone who has? 4 4 4 4 4 4 5 6 6 6 7 7 8 8 9 9 10 11 12 12 12 14 15 15 16 18 18 18 19 19 22 22 22 24 24 26 27 28 29 29 29 29 31 31 31 32 Engaging for increased research participation ? key findings and recommendations 2 8. Knowledge and information 8.1. Level of understanding of clinical research 8.1.1. Demographic differences 8.2. Seeking information 8.3. What information would you need? 8.4. Media coverage 9. Healthcare professionals' perceptions of clinical research 9.1. What do healthcare professionals think of clinical research? 9.2. Who do they think are getting involved in research? 10. Motivations for getting involved in clinical research 10.1. What motivates healthcare professionals to get involved? 11. Barriers to getting involved in clinical research 11.1. What stops healthcare professionals from getting involved? 12. Research opportunities 12.1. Approaching healthcare professionals 12.2. Why are healthcare professionals approaching patients? 12.3. Why are healthcare professionals not approaching patients? 13. Availability of information 13.1. Awareness of clinical research 13.2. Finding information about clinical research 14. The future 14.1.What would make you more likely to get involved in research in the future? 14.2.What would make you more likely to get speak to patients the future? 15. Conclusions and recommendations 15.1. People are positive about research and participation 15.2. The critical conversations are not happening 15.2.1. Recommendation 1 15.3. Healthcare professionals perceive major barriers to involvement 15.3.1. Recommendation 2 15.4. The public need information, of immediate relevance to their health 15.4.1. Recommendation 3 15.5.Time and fitting participation into life is a concern 15.5.1. Recommendation 4 Appendix 1 ? Public survey demographics 33 33 33 34 34 35 37 37 38 39 39 41 41 43 43 44 44 45 45 46 47 47 48 49 49 49 49 49 49 50 50 50 51 52 Engaging for increased research participation ? key findings and recommendations 3 1. Executive summary See section 15 for summary findings and specific recommendations for increasing clinical research participation. 1.1.1 People are positive about research and participation The Wessex population views research in the NHS positively and a large proportion are open to participating: 90% of respondents think that it is important for the NHS to support research into new treatments, whilst 47% think it likely they would be willing to participate in clinical trials in the future. Those that have participated have positive perceptions, and they will likely have a significant influence on others' future participation: 80% of people who have taken part in clinical research would recommend taking part to a friend or family member, whilst around half (44%) of people who know someone who has taken part in clinical research said that they are more likely to participate now because of their experience. 1.1.2 The critical conversations are not happening Only 15% have had clinical research discussed with them by a healthcare professional in their lifetime, whilst only 5% of those who have seen healthcare professional in the last 12 months had clinical research discussed with them. Recommendation 1: Communications supporting participation in interventional trials should be focussed on enabling effective clinical conversations, with a reduced emphasis on broad public awareness approaches. 1.1.3 Healthcare professionals perceive major barriers to involvement The healthcare professionals interviewed were broadly positive about research; however they cite workload, time and lack of local trial information as constraints on discussion of research with patients. Better trial information was also identified as something that would increase the likelihood of discussing trial options with patients. Clinicians self-segregate themselves into `researchers' (an academically orientated minority) and `practitioners', with the latter positive about the benefits of clinical research and open to research referrals/facilitation but unlikely to have direct involvement in, or lead their own, research. Direct involvement in research by clinicians is limited by lack of programmed/sanctioned time within work plans, perceptions of excessive bureaucracy and lack of support. Recommendation 2: Local Clinical Research Networks, local research infrastructure and Trusts' senior leadership should support NHS clinicians' engagement with local clinical trials, and to explore management and education interventions to make communication with patients about trials a routine part of all NHS consultations. 1.1.4 The public need information, of immediate relevance to their health Public participation motivations centred on potential benefits to one's own health or that of close friends and family, whilst perceived risk of harm and receiving the `unknown' alongside concerns over time commitments and time off work were the biggest barriers to participation. Only 9% of respondents reported that they felt they understood clinical research very well, with this group the least likely to agree that risk was a significant barrier to participation. Generic online searches, condition-specific online sources of information and healthcare professionals were the primary sources of information, with a high degree of trust in the information provided by professionals. Recommendation 3: Public communications and engagement should have a greater emphasis on informing and empowering people at the point of care or enquiry, to enable discussion of trials with clinicians. Engaging for increased research participation ? key findings and recommendations 4 1.1.5 Time and fitting participation into life is a concern Concerns over time commitments needed to participate in studies, including taking time out of work and fitting such activity into daily/family life were significant barriers to participation. Recommendation 4: Changes to clinical research delivery to improve convenience and flexibility for participants, alongside interventions that lower the practical threshold to participation should be investigated and evaluated. Engaging for increased research participation ? key findings and recommendations 5 2. Introduction and Methodology 2.1 Introduction The partnership between University Hospital Southampton NHS Foundation Trust (UHS) and the University of Southampton enables clinical-academics to perform clinical research through quality assured support, facilities and resources embedded at the heart of a major teaching hospital trust. This partnership hosts, and participates in the National Institute for Health Research Clinical Research Network Wessex (NIHR CRN:Wessex), one of 15 regional CRNs that coordinate and support clinical trial activity across the UK on behalf of the NIHR. Participation in clinical research by the public, patients and clinicians is essential to advancing medicine and care, and access to such trials is a right conferred to patients under the NHS constitution1. Because of this, recruitment to trials is the primary measure by which NIHR manages performance of CRNs and their member organisations. Rapid, complete recruitment to open trials remains challenging for Trusts and CRNs nationwide, indicating a significant issue relating to public and patient engagement with trial treatment options and research participation. Against this background UHS, with match-funding from NIHR CRN:Wessex, commissioned Alterline Research Ltd. to conduct a programme of market research to better understand the perceptions, motivations and barriers to participation in clinical research across the region. This research is intended to inform more effective communication and engagement aimed at increasing participation, primarily focussed on interventional clinical research. 2.2 Key objectives The research was conducted with three audiences: ? The public (18 years and older across all demographics and geographies) ? Primary care professionals including GPs and community nurses across the region. ? Hospital clinical staff including consultants, nurses, midwives and allied health professionals across the region's trusts. The research outputs are intended to provide an evidence base to help: ? ? ? ? Shape and inform effective engagement strategies with these audiences Build an evaluation framework against which engagement can be assessed and developed for greater efficacy Ensure coherence and commonality in engagement approaches and messages across Wessex Provide a reference point and baseline data for long-term tracking and evaluation. 2.3 This report This report details findings of the research with the public and healthcare professionals, exploring their attitudes towards clinical research, their likelihood to participate and the drivers and barriers to increasing participation and recommending actions for increasing research participation. > > > 1 NHS Constitution, 2013 http://www.nhs.uk/choiceintheNHS/Rightsandpledges/NHSConstitution/Documents/2013/the-nhs-constitution-forengland-2013.pdf Engaging for increased research participation ? key findings and recommendations 6 2.4 Method Review of literature and pilot A review of the existing literature was conducted to help inform the design of research materials including the quantitative and qualitative questionnaires. Quantitative questionnaire development A questionnaire comprising predominantly closed questions and a small number of open-ends was developed in partnership with the Trust. Quantitative public survey by telephone In total 1101 interviews were completed by telephone using specialist computer assisted telephone interviewing (CATI) software and an automated dialler system. The interview sample for the telephone survey was sourced from a specialist data provider using relevant postcodes. In order to ensure a representative survey sample of the Wessex population interview completions were monitored by key demographics such as gender, age and location. See appendix one for details of the demographic sample. Public depth survey Following the quantitative survey, key emerging themes were used develop a qualitative, in-depth survey which was administered by telephone. In total, 30 people took part in in-depth interviews including a mix of men and women, different ages and geographies. Clinician depth survey To explore perceptions, motivations and barriers of clinicians, an in-depth survey was designed and administered by telephone. In total, 25 healthcare professionals took part in the survey, including 6 GPs, 10 nurses, and 9 hospital consultants. Analysis The quantitative survey data was exported to SPSS (Statistical Packages for Social Sciences) where it was quality checked. Frequencies and cross-tabulations exploring differences between respondents were produced and key questions were charted and included in this report. Demographic differences have been included in this report following the application of tests of statistical significance. Open-ended data was themed, with key verbatim quotes pulled out and included in the report. The in-depth interviews were audio recorded and transcriptions were made. Key themes were identified from the focus group transcripts and representative verbatim quotes have been pulled out and included in the report. Engaging for increased research participation ? key findings and recommendations 7 3. Review of the literature 3.1 General background Clinical research is central to advancing medicine, developing and evaluating medications, treatments, and practices. The purpose of this review is to examine perceptions of clinical research, willingness to participate and motivations and barriers to taking part. As the research in the area is limited, it will also look at motivations and barriers to taking part in related, voluntary activities (i.e. giving blood and organ donation) in order to identify any commonalities. Generally, reports in the literature show support for clinical research to be high. The Wellcome Trust notes that 95% of adults and 93% of 13-18 year olds think that medical research should be supported2. Further 88% of those surveyed by the National Institutes of Health3 in the USA think that clinical trials are important for advancing knowledge about treating disease. A 2011 UK national survey of 990 adults by IPSOS-MORI, commissioned by the Association of Medical Research Charities, reported similarly strong public support for research with 97% believing the NHS should support research into new treatments, whilst 93% wanted their local NHS to be encouraged or required to support research. These figures are corroborated by a 2014 national survey of 3,000 adults commissioned by the National Institute for Health research, indicating that 95% of people said it was important to them that the NHS carries out clinical research4.5. Reported willingness to participate in research is also strong. In a monitor of people's views on science and research, 60% said they would be willing to take part in clinical trials6. 72% of those polled in the 2011 AMRC survey would want to be offered opportunities to be involved in trials of new medicines or treatments if they suffered from a health condition that affects their day-to-day life; 80% would consider allowing a researcher confidential access to their medical records, and 88% would be happy to be asked to talk to researchers about their family history or give a sample of their blood for laboratory testing. 89% of people surveyed in the 2014 NIHR national survey would be willing to take part in clinical research if they were diagnosed with a medical condition or disease, with only 3% saying they would not consider it at all5. Comis et al7 report that, in relation to cancer trials, 32% of adults would be willing to take part and 38% would potentially be interested, but would hold some reservations. Further, willingness to participate is not static and much depends on the nature of the trial. For example, 74% of people would be willing to allow access to their medical records, whereas only 30% would be willing to test a new drug2. These figures showing positive perception and willingness to participate are however in stark contrast to reported and actual participation rates. In two monitors by the Wellcome Trust, lifetime participation varied from 10%6 to 23%2, whilst a further 10% of people have a family member who has taken part6. These findings support National Institute for Health Research official figures indicating that annual recruitment to clinical trials in the English NHS stands at 0.94% of the English population (2013-14 figures)8, with CRN Wessex reporting recruitment of 1.15% of the regional population in the same period9. > > > Butt, S., Clery, E., Abeywardana, V., Phillips, M. (National Centre for Social Research). Wellcome Trust Monitor 1. London: Wellcome Trust; 2010 National Institutes of Health, National Cancer Institute. (1997). Results from Quarterly Omnibus Survey: Clinical Trials Questions-April 22, 1997. Bethesda: National Cancer Institute. 4 IPSOS-MORI / Association of Medical research Cahrities J11-02572 Public support for research in the NHS, http://www.ipsos-mori.com/ researchpublications/researcharchive/2811/Public-support-for-research-in-the-NHS.aspx 5 National Institute for Health Research, 2014, http://www.crn.nihr.ac.uk/blog/news/nine-out-of-ten-people-would-be-willing-to-take-part-inclinical-research/ 6 Clemence, M., Gilby, N., Shah, J., Swiecicka, J., Warren, D. (2013). Wellcome Trust Monitor Wave 2: Tracking public views on science, biomedical research and science education. London: Wellcome Trust. 7 Comis, R.L., Miller, J.D., Aldige, C.R., Krebs, L. and Stoval, E. (2003). Attitudes toward participation in cancer clinical trials. Journal of Clinical Oncology. 21: 830-835. 2 3 Engaging for increased research participation ? key findings and recommendations 8 3.2 Why do people take part in clinical research? By far, the most reported reason for taking part in clinical research in the literature was a sense of altruism and helping others. Mattson et al10, found that 65% of participants took part for altruistic reasons. Rosenbaum et al11 noted that 46% of people who participated in clinical research reported altruism as the reasons for doing so. Of those people, just under half (45%) provided an altruistic reason as their only motivation. Those who gave altruistic reasons were more likely to have higher levels of social support, have a college education, and were less likely to say they had a disability. Specifically in cancer trials, altruism is often reported as a reason for taking part12. Jenkins et al13 report that 23% of those who consented to take part in clinical research did so because others would benefit from their participation. Many people also said that they took part because of healthcare professionals. Some report that this was because of a recommendation from their doctor3 and others report that it was through the doctor's influence that they decided to take part14. Jenkins et al13 looked solely at people who had decided to take part after being asked by their doctor. Of those who were asked, 72% decided to take part, of which 21% said it was because they trust their doctor. Further, it is apparent that some people also take part in clinical research because of the benefit that it will have to them. Such motivations include a hoping that there will be a therapeutic benefit or because there is no other treatment available12. Further, in Mattson et al10 74% of participants for aspirin and beta-blocker trials said they were motivated by non-altruistic motivations. These motivations included better medical monitoring and reassurance, physical improvement and preventions of further illness. 3.3 What stops people from taking part in clinical research? A concern about side effects and risks present a significant barrier to participation in the literature. Looking into cancer trials, a fear of making the cancer worse presented a significant barrier when being asked to participate15. Further, when testing a new drug, 93% of those with concerns in the Wellcome Trust study said they were worried about the possible risk to their own health from participating2. As with many factors, concerns about the side effects and risks of a trial are not stable across all groups. Basche et al16 spoke to seniors who were asked to participate in cancer trials. They found that those ages 65?75 were more likely to participate in the trial when the side effects were likely, than those aged over 75. Further, many studies report that issues related to the time commitment of clinical research and logistical difficulties also present a significant constraint on participation. A quarter of people asked about their attitudes to participation in clinical research said that they did not have the time to participate17. Further, a third of people in Basche et al16 said that they were concerned about the time commitment and other issues, such as getting to the trial facility. Many other barriers have been reported in the literature. These include: a dislike of randomisation13 and the potential to be in a placebo group; lack of knowledge of both the processes involved in clinical research19 and the trials that are available18, and a lack of trust in medical research19. > > > NIHR Clinical Research Network Annual Report 2013/14 http://www.crn.nihr.ac.uk/wp-content/uploads/About%20the%20CRN/13_14%20Annual%20Performance%20Report_PUBLIC_FV.pdf 9 CRN Wessex Performance Report May2014, www.odp.nihr.ac.uk/default.htm 10 Mattson, M.E., Curb, J.D., and McArdle, R. (1985). Participation in a clinical trial: The patients' point of view. Controlled Clinical Trials. 6: 156-167 11 Rosenbaum, J.R., Wells, C.K., Viscoli, C.M., Brass, L.M., Kernan, W.N., and Horwitz, R.I. (2005). Altruism as a reason for participation in clinical trials was independently associated with adherence. Journal of Clinical Epidemiology. 58: 1109-1114. 12 National Institutes of Health, National Cancer Institute, Working Group on Enhancing Recruitment to Early Phase Cancer Clinical Trials. (2004). Enhancing Recruitment to Early Phase Cancer Clinical Trials: Literature Review. Bethesda: National Cancer Institute. 13 Jenkins, V. and Fallowfield, L. (2000). Reasons for accepting or declining to participate in randomised clinical trials for cancer therapy. British Journal of Cancer. 82(11): 1783-1788. 14 Chu, S.H., Jeong, S.H., Kim, E.J., Park, M.S., Park, K., Nam, M., Shim, J.Y., and Yoon, Y. (2012). The views of patients and healthy volunteers on participation in clinical trials: An exploratory survey study. Contemporary Clinical Trial. 33: 611-619 15 Solomon, M.J., Pager, C.K., Young, J.M., Roberts, R., and Butow, P. (2003). Patient entry into randomized controlled trials of colorectal cancer treatment: Factors influencing participation. Surgery. 133(6): 608-613. 16 Basche, M., Baron, A.E., Eckhardt, S.G., Balducci, L., Persky, M., Levin, A., Jackson, N., Zeng, C., Brna, P., and Steiner, J.F. (2008). Barriers to enrollement of elderly adults in early-phase cancer clinical trials. American Society of Clinical Oncology. 4(4): 162-168 8 Engaging for increased research participation ? key findings and recommendations 9 Although little literature looks into healthcare professionals' motivations regarding clinical research, several have looked at the barriers to getting involved. The research suggests that concerns for patients represent significant barriers to participation. In in-depth interviews with clinicians in South-west England, clinicians suggested that concerns for individual patients and respect for patients' preferences for different treatments prevented them from approaching patients and getting involved20. Further, concern for patients and a worry about the impact on the doctor-patient relationship was shown to be a significant barrier in Ross et al's meta-analysis21. 3.4 Why do people take part, or not take part, in related activities? Many reasons, both similar and dissimilar to those expressed above, are noted in the literature that motivate blood and organ donation. Coad et al22 found that those who knew someone who had donated or received an organ were more likely to agree with donating an organ to a family member or friend. Further, Wildman and Hollingsworth23 note that those who have donated blood before are more likely to donate again. Further, Cohen and Hoffner24 note that self-interest explains motivations to become an organ donor. 40% said they would be willing to sign a blood donor card. Self-interest motivations were the most important predictor of willingness to sign the card, including pride and satisfaction with the decision, otherwise known as the `warm glow' feeling. A questionnaire of university students in Japan showed that being in good health, having time to donate, being given opportunity to donate and helping others were the most important motivations for those who both had given blood before and those who had not25. The same study also looked at barriers to taking part. These were very much the opposite of the motivators, and included having time to donate, not knowing when and where to donate and not being given the opportunity to donate were considered barriers to taking part25. Lack of knowing where to go and it not being in a convenient place was corroborated by a further study of American adults, as well as a fear of needles and pain26. 3.5 Summary In summary, although many people believe that clinical research is important and are willing to take part, this is not reflected in rates of participation. Reasons why people take part in clinical research include altruism, the influence of a healthcare professional and a benefit to themselves. Major barriers to participation include the risk to themselves and time commitments. Clinician barriers generally revolve around a concern for their patients. Significantly different motivators and barriers to taking part in related activities include knowing someone who has taken part, taking part before and knowing what opportunities were available. > > > Bevan, E.G., Chee, L.C., McGhee, S.M. and McInnes, G.T. (1993). Patients' attitudes to participation in clinical trails. British Journal of Clinical Pharmacology. 35(2): 204-207 18 Mills, E.J., Seely, D., Rachlis, B., Griffith, L., Wu, P., Wilson, K., Ellis, P., and Wright, J.R. (2006). Barriers to participation in clinical trials of cancer: a meta-analysis and systematic review of patient-reported factors. Lancet Oncol. 7: 141-148 19 Lovato, L.C. and Kristin, H. (1997). Recruitment for controlled clinical trials: Literature summary and annotate bibliography. Controlled Clinical Trials. 18: 328-357 20 Langley, C., Gray, S., Selley, S., Bowie, C., and Price, C. (2000). Clinicians' attitudes to recruitment to randomised trials in cancer care: A qualitative study. Journal of Health Services Research and Policy. 5(3): 164-169 21 Ross, S., Grant, A., Counsell, C., Gillespie, W., Russell, I., and Prescott, R. (1999). Barriers to participation in randomised controlled trials: A systematic review. J Clin Epidemiol. 52(12): 1143-1156 22 Coad, L., Carter, N., and Ling, J. (2013). Attitudes of young adults from the UK towards organ donation and transplantation. Transplantation Research. 2: 9-14 23 Wildman, J., and Hollingsworth, B. (2009). Blood donation and the nature of altruism. Journal of Health Economics. 28: 492-503 24 Cohen, E.L. and Hoffner, C. (2012). Gifts of giving: The role of empathy and perceived benefits to others and self in young adults' decisions to become organ donors. Journal of Health Psychology. 18(1): 128-138 25 Ngoma, A.M., Goto, A., Yamazaki, S., Machida, M., Kanno, T., Nollet, K.E., Ohto, H. and Yasumura, S. (2013) Barriers and motivators to blood donation among university students in Japan: Development of a measurement tool. Vox Sanguinis 105(3): 219-224 26 Adelbert, J.B., Schreiber, G.B., Hillyer, C.D., and Shaz, B.H. (2013). Blood donations motivators and barriers: A descriptive study of African American and white voters. Transfusion and Aphresis Science. 48(1): 87-93 17 Engaging for increased research participation ? key findings and recommendations 10 4. Likelihood to participate in clinical research 4.1 The public view clinical research as important To provide a background to people's perceptions of clinical research, we asked respondents to tell us how important they thought it was for the NHS to support research into new treatments. As figure 1 below shows, the overwhelming majority of people (90%) think that it is either important or very important. However, of those who responded to the survey, only 10% have actually taken part in clinical research. There is a clear gap between how important the area is seen to be, and how many people are taking part. Figure 1 g1 How important do you think it is, if at all, for the NHS to support research into new treatments for patients? Base: 1101 3% 6% 13% 77% Very unimportant g3 unimportant Neither important nor unimportant Important Very important 4.1.1 Demographic Differences Age Belief that supporting research is important is lowest in 18-24 year olds (73%). As people get older, they are more likely to believe that it is important, peaking at 96% for 75-84 year olds. Gender Females (95%) a more likely to say supporting research is important than males (85%). Educational attainment Those who have qualifications other than a degree are the most likely to view research as important (97%). Those who have no educational qualifications are least likely (80%). Employment status Students (90%), retired people (83%) and those who are employed (76%) are more likely to see clinical research as important, compared to those who are self-employed (69%), home-makers (67%), or gout of work and not looking for work (55%). 7 Dependents Those with dependents (96%) are more likely to view clinical research as important than those without dependents (90%). Health Those with good (80%) or very good health (80%) are more likely than those with fair (70%) or very bad (54%) to view research as very important. Previous participation Those who have participated in clinical research (99%) are more likely to say supporting research is important than those who have not (89%). g8 Knowing someone who has taken part Those who know someone who has taken part in clinical research (97%) are more likely to see supporting research as important, compared to those who don't (89%). > > > Engaging for increased research participation ? key findings and recommendations 11 g7 g7 4.2 Few people have been asked to take part in clinical research g8 g8 Importantly, of those surveyed, only 15% recalled a time when a healthcare professional had discussed involvement in clinical research with them. Further, of the 43% who had seen a healthcare professional in the last month, only 5% had clinical research discussed with them (Figure 2, below). Figure 2 Did the healthcare professional you saw discuss involvement in clinical research with you? Base: 367 5% Do you recall a time at any point in your life when a healthcare professional has discussed clinical research with you? 15% Base: 799 Yes No 95% Yes No 85% Increasing the number of conversations taking place between clinicians and their patients about clinical research is likely to increase the number of people who take part. In the in-depth interviews, people often said they reason they had not taken part before was because no-one had ever asked. "I just haven't been asked." "No-one's ever asked me." Further, previous research has shown that trust in healthcare professionals is high, with 72% of adults saying that they trust a medical professional to provide them with information about clinical research27. This was also seen in the in-depth interviews, where many respondents expressed a great deal of trust for their doctor. "So if they said `blardy blardy blah', would you take part? Then I probably would have done, because we gained that much trust." g1 "Yes I would trust them if they talked about clinical research because the consultant I've been under for four years now, my GP I've known for over 20 years now so they're people that I've known long enough to trust." 4.3 Likelihood to participate Although only 10% of people have taken part in clinical research, the results would show appetite for participation is higher than this. When respondents were asked if they would consider taking part in clinical research, just under half (47%) agreed that they would be likely or very likely to (Figure 3, below). Figure 3 How likely is it that you would be willing to participate in clinical research in the future? g3 Base: 1101 15% 16% 22% 31% 16% Very unlikely 27 unlikely Neither likely nor unlikely likely Very likely Butt, S., Clery, E., Abeywardana, V., Phillips, M. (National Centre for Social Research). Wellcome Trust Monitor 1. London: Wellcome Trust; 2010 g7 > > > 12 Engaging for increased research participation ? key findings and recommendations 4.3.1 Demographic differences The demographic differences below explore whether some people are more likely than others to participate. Characteristics of people who are more likely to participate include: ? ? ? ? ? ? ? ? ? Having previously participated (64%) or knowing someone who has (63%) Having a good understanding of clinical research (63%) Students (58%) and those unable to work (63%) Having a degree or equivalent level of education (58%) Registered organ donors (58%) People in very good health (57%) People who do regular volunteer work (55%) People who have given blood (54%) People aged 35-64 (52%). Age People aged 35-64 (52%) are most likely to agree that they would be willing to take part in clinical research, this decreases amongst 25-34s (48%), 16-24s (46%), 65-74s (49%) and in particular 75-84s (32%) and 85+ (12%). Understanding of clinical research Those who have a very good understanding of clinical research (63%) are the most likely to say they would take part in clinical research, followed by those that have some (54%), little (40%) or none (39%). Previous participation Those who have participated before (68%) are more likely to say they would be willing to take part than those who have not (45%). Knowing someone who has taken part People who know someone who has participated in clinical research (63%) are more likely to say that they are willing to take part than those who don't (44%). Educational attainment Those with a degree or a degree equivalent (58%) and those who have other qualifications (52%) are more likely than those with no qualifications (35%) to say they would take part. Employment status Students (66%), those who are unable to work (62%), and those who are employed for wages (52%) are more likely to say they are willing to take part than those who are those who are retired (37%) and out of work and looking (26%). Volunteers Those who give help as a volunteer to clubs or organisations weekly (55%), monthly (53%) or occasionally (54%) are more likely to say they are willing take part than those have volunteered in the last year (46%) and those who give unpaid help on an individual basis (36%). Giving blood People who have previously given blood (54%) are more likely to say they would participate than those who have not given blood (45%). Organ donors Those who are registered as organ donors (58%) are more likely to say they would participate than those who are not (42%). Health Those who have very good (57%), good (49%) and bad health (47%) are more likely to say they are would take part than those who have very fair (35%) or bad health (32%). > > > Engaging for increased research participation ? key findings and recommendations 13 4.4 Likelihood to participate in various types of research To expand on people's likelihood to take part, we asked people about different scenarios they would be willing to take part in. As shown in Figure 4 (below), the scenarios that might improve their own health or care are those in which people were most willing to participate . Likelihood to participate extends to 61% in the scenario where it may help prolong a respondents' own life, or where it is looking at new forms of care and exercise to regain movement after a knee injury. In contrast, the scenarios which people were least willing to take part reflected those which were at earlier stages of the research process. This may be because research into new medications or treatments is seen as riskier. Figure 4 How likely is it you would be willing to take part in clinical research if...? Base: 1101 The study might help prolong or improve your life because you have a condition, significant illness or injury The study is looking at a new form of care and exercises to regain movement after knee injury The study is observing how your condition, illness or injury develops or responds to current treatments, over time The study is looking at how the way care is given affects you and your health (e.g. care at home versus staying in hospital) The study is looking at a new medical device 9% 6% 9% 9% 9% 10% 8% 11% 12% 11% 11% 9% 9% 11% 12% 15% 17% 18% 24% 19% 22% 23% 21% 23% 24% 22% 22% 40% 42% 43% 44% 44% 39% 39% 40% 39% 21% 19% 17% 15% 14% 17% 12% 9% 10% The study is looking at a treatment at a very advanced stage of development The study is looking for healthy volunteers The study is looking at a new vaccination The study is looking at a new drug The study is looking at a treatment in the very early stages of development 11% 19% 25% 35% 10% Very unlikely Unlikely Neither likely nor unlikely Likely Very likely Engaging for increased research participation ? key findings and recommendations 14 5. Motivations for taking part 5.1 Why do other people take part in clinical research? In order to understand what motivates people to take part in clinical research, we asked respondents to tell us what they thought motivated other people to take part. The most commonly cited reasons were: ? Helping others/altruism ? A positive impact on their own health ? A personal interest in a particular disease/condition. 5.2 What would motivate you to take part? To look into motivations further, we asked people what would motivate them (rather than others) to take part in clinical research. When people are speaking about their own motivations, they tend to agree more with statements which are related to personal motivations, i.e. helping to improve their own, or a close relative's, health. However, altruistic motivations are still important, with 72% agreeing that they would be motivated by helping others. Respondents also indicated that other things would motivate them, beyond those factors seen earlier. Knowing that aftercare would be available (67%) and an interest in a particular disease (67%) are both seen as important to respondents. Just 32% of respondents said that money would motivate them to take part. Figure 5 To what extent do you agree or disagree that the following would motivate you to take part in a clinical trial? Base: 1101 g5 Supporting research into a condition a close family member suffers from A positive impact on my own health Getting access to the latest treatments for a condition I have Helping others by helping to find new treatments Knowing that there would be continued aftercare and follow-up A personal interest in a particular disease / condition I would find the process of being involved interesting Money / financial gain 6% 5% 12% 6% 5% 6% 5% 6% 7% 7% 6% 7% 8% 8% 10% 13% 15% 15% 19% 17% 22% 36% 42% 48% 44% 51% 45% 44% 47% 15% 35% 28% 30% 21% 22% 23% 14% 25% 7% 17% Strongly disagree Disagree g6 Neither agree nor disagree Agree Strongly agree > > > Engaging for increased research participation ? key findings and recommendations 15 5.2.1 Demographic differences Understanding of clinical research Those who have no understanding of clinical research (58%) are the least likely to agree that they would be motivated by getting the latest access to treatment for a condition they have. Age 35-44 year olds (76%) are more likely to agree that they would be motivated by helping others by finding new treatments than 16-24 (70%) and 25-34 (64%) year olds. 34-44 (86%), 44-54 (85%) and 55-64 (84%) years olds are more likely to agree that they would be motivated by a positive impact on their own health than 16-24 (64%), 25-34 (70%) and 75-84 (64%) year olds. 35-44 (77%), 45-54 (80%) and 55-64 (78%) year olds are more likely to agree that they would be motivated by getting access to the latest treatment for a condition they have than 16-24 (64%), 25-34 (67%), 75-84 (70%) and 85+ (53%) year olds. Gender Women (80%) are more likely than men (75%) to agree that supporting research into a condition a close family member suffers from would motivate them to take part. Educational attainment Those with a degree of degree equivalent and those with other qualifications are more likely than those who have no qualifications to say they are motivated by helping others by helping to find new treatments, a positive impact on their own health, getting access to the latest treatment for a condition they have and supporting research into a condition a close family member suffers from. Employment status Students (90%) are more likely to agree that they are motivated by helping others by helping to find new treatments than those who are employed (76%), self-employed (70%), retired (66%) and out of work and looking (50%). Employed persons (77%) are more likely to be motived by getting access to the latest treatment for a condition they have than those who are retired (71%). Students (96%) are more likely than any other group to strongly agree that they are motivated by supporting research into a condition a close family member suffers from. 5.3 Exploring motivations in more depth When exploring what would motivate people to take part some clear themes emerged from both the open survey questions and the in-depth interviews,. The key motivations are summarised below. It would have a positive impact on my own health Many felt that they would be motivated to participate because it may have a positive impact on their own health. "I've got a few health problems so I would like to take part to see if there any treatments or information in regards to arthritis that would help me" "I have arthritis - anything new to improve life or find a cure." "Finding a drug that helps me." "If anybody could help me with my lifestyle and my health, I'm in a lot of pain, I'm overweight, so that would help." Although some people who responded did not currently suffer from a condition, they suggested they would be motivated to take part if they did and it would help that condition. "I still think the key motivation for me to do it would be if there was something detrimental to my health or something for my health and well-being to improve my lifestyle." "Of course I would, if I had a condition that required treatment and was offered something that would alleviate that." > > > Engaging for increased research participation ? key findings and recommendations 16 Further, some suggested that they would take part as a last resort if nothing else would help their condition. "If I had something that was as of yet untreatable I'd give it a go, but otherwise no." "If I was in an unfortunate situation of having a life threatening illness then I tend to think you grasp at anything." Altruistic motivations and helping the people around me A willingness to help with clinical research relating to a condition that those close to them suffer from was evident in people's responses. "Because my mother has dementia." "In recent years a lot of people I know have suffered from cancer and arthritis." "I suppose its family history, we have had a run in with cancer so I suppose we would be interested in getting involved." "My son's diabetic, anything that would help." Respondents also suggested that they were motivated by a more general altruistic sense of helping others. "Because I want to help people." "If it helps give people a better life." "It's being out there trying to help somebody that is unable to help themselves." It will help advance medical science Some respondents expressed that they would be likely to take part because it may help improve medicine and medical science. "Because it is interesting and it helps the process of medical science." "I feel if people don't participate then science will not advance, for everyone's benefit." "It is important to help the development of medicine and if people aren't helping then there would be no progress and it wouldn't get anywhere." I would find it interesting Respondents said that they would be motivated to take part in various types of trials because they found it interesting. "I find that really quite interesting, I quite like a bit of psychology myself, I'd like to see what goes on in their heads to make it go one way or the other." "Yeah that's a fascinating thing, it's just so clever!" "I'm quite interested in exercise and diet." "Because it would be interesting to see how your health can be affected by those types of things." > > > Engaging for increased research participation ? key findings and recommendations 17 Because I've taken part before Those who had already taken part in clinical research suggested they would again because of their previous experience. "Previous experience in a clinical trial." "Already have been part of a clinical trial for cancer. So far it is a beneficial experience." "I have already taken part and thought it helped." "I have previously been part of a clinical trial and had a good experience." Money Earning money through participating was a clear motivation for a minority of people. "Depending on what the cash incentive was. I wouldn't participate in it if there was no financial gain because of the dangers behind it." "It would depend what it was in aid of and if it was for money." "If there was a large pay out I would take part." Engaging for increased research participation ? key findings and recommendations 18 6. Barriers to taking part 6.1 Why don't other people take part? We also looked into the barriers to taking part in clinical research. When asked what may stop other people from taking part, respondents mentioned: ? Being worried about the risks ? Lack of knowledge/information ? Lack of time to be involved. 6.2 What stops you from taking part? In order to explore this further, respondents were asked what would stop them personally (rather than others) from taking part. Respondents' answers reflected concerns about the risks involved in clinical research, a lack of knowledge and information, and practical issues with time and having to take time off work. When prompted, it was clear that there were other issues which concerned respondents. For some, the involvement of private drug companies (33%) and stories they have seen in the media (31%) would stop them from taking part in clinical research. Figure 6 To what extent do you agree or disagree that the following would stop you from taking part in a clinical trial? Base: 1101 g6 I'm worried about the risks g5 4% 11% 8% 7% 10% 12% 10% 20% 24% 28% 27% 32% 19% 19% 19% 28% 25% 42% 32% 35% 32% 25% 25% 19% 16% 32% 46% 14% 15% 14% 10% 6% 8% 6% 6% 5% 5% I might need to take time off work I don't have time to participate I don't know enough about clinical trials The involvement of a private drug company Stories I have seen in the media I wouldn't pass the medical screening test 37% 32% 44% 34% 20% 34% My family and friends would disapprove I'm not the type of person the NHS want to participate in clinical trials My religious or moral beliefs 18% 12% 25% 17% 16% 11% 5% Strongly disagree Disagree g9 Neither agree nor disagree Agree Strongly agree > > > Engaging for increased research participation ? key findings and recommendations 19 6.2.1 Demographic differences Understanding of clinical research Those who have a very good understanding (41%) are the least likely to agree they are worried about the risks, rising with some understanding (55%), little understanding (60%) and no understanding (62%). Those who have no (50%) or little understanding (48%) are more likely to agree that they don't have the time to take part than those with some (40%) or very good understanding (37%). Age Those aged 85+ (70%) are the most likely to say that not knowing enough about clinical research stops them from taking part. Those ages 75-84 (43%) and 85+ (59%) are the most likely to think that they are not the type of people the NHS want to take part. Gender Women (62%) are more likely to say that a worry about the risks would stop them from participating than men (52%). Women (48%) are also more likely to worry about needing time of work than men (43%). Educational attainment Those with no qualifications are least likely to agree that they are worried about the risks of participating (50%), that they don't have the time to participate (39%), and that they may need to take time off work (33%). However, this group are the most likely to agree (27%) that they are not the type of person the NHS wants to participate. Employment status Those who are unable to work are least likely to agre
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/Media/Southampton-Clinical-Research/Marketresearch/Engaging-for-increased-research-participation-full-report-v2.pdf
UHS AR 23-24 Final
Description
2023/24 Incorporating the quality account University Hospital Southampton NHS Foundation Trust Annual Report and Accounts 2023/24 Presented to Parliament pursuant to Schedule 7, paragraph 25(4)(a) of the National Health Service Act 2006 © 2024 University Hospital Southampton NHS Foundation Trust Contents Welcome from our chair and chief executive 6 Overview and performance 8 Performance report 9 Overview 10 Accountability report 37 Directors’ report 38 Remuneration report 62 Staff report 75 Annual governance statement 95 Quality account 111 Statement on quality from the chief executive 112 Priorities for improvement and statements of assurance from the board 115 Other information 180 Annual accounts 207 Statement from the chief financial officer 208 Auditor’s report 210 Foreword to the accounts 217 Statement of Comprehensive Income 218 Statement of Financial Position 219 Statement of Changes in Taxpayers’ Equity 220 Statement of Cash Flows 221 Notes to the accounts 222 5 Welcome from the Chair and Chief Executive Officer This has been another busy and undoubtedly challenging year across the NHS and UK health and social care system, and much of what has impacted the national picture has been reflected in the operational focuses and patient and people priorities for University Hospital Southampton NHS Foundation Trust (‘UHS’ or the ‘Trust’) over the last year. Meeting and continuing to overcome the challenges we have faced has required an organisation-wide team effort, and looking back at the successes we feel incredibly proud of the achievements of our 13,000 staff. Particular highlights include: • In the top ten in the country (7th) against government targets for elective recovery performance with 118% of activity compared with 2019. • Top-quartile performance against most performance metrics compared to similar sized teaching hospitals, including Emergency Department access, long-waiting patients on Referral to Treatment pathways, Diagnostics and Cancer performance. • Significant investment in new capacity through building new wards and theatres and refurbishing existing areas of the hospital. • Delivery of our highest ever Cost Improvement Programme saving. These achievements place us among the best performing trusts in England in several areas and are even more remarkable against a backdrop of continued periods of industrial action and increasing demand for our services, with many people coming to us with higher levels of acuity than ever before. The Trust’s performance in terms of elective recovery places it as one of the best-performing trusts in England and demonstrates the impact of the Trust’s decision to invest in additional capacity in prior years by building new wards and theatres. The Trust’s Emergency Department performance in respect of its four-hour waiting target at the end of March 2024 has attracted additional capital funding as part of an incentive scheme. Some of this funding will be used to increase the department’s same-day emergency care capacity during 2024/25. From a financial perspective, balancing the complexities of today’s challenges alongside the need to protect and ensure the long-term stability and quality of our service provision, has required the Board to take a number of considered and crucial efficiency improvement actions this year. Whilst challenging, the Trust has seen significant progress in delivering on both its forecasted finance position for 2023/24 and productivity targets. Achieving long-term financial stability is key to us continuing to invest in much needed upgrades and improvements to the parts of our estate that are ageing, and to developing new state-of-the-art facilities and infrastructure that increases our capabilities and capacity into the future. In the last year parts of the hospital have been transformed, with the opening of new wards, theatres and a skybridge to link the estate. Construction of a sterile services and aseptics facility has begun at Adanac Park and the expansion of our neonatal department, where we treat and care for some of our most vulnerable babies and their families, is underway. The development of a new aseptic facility at Adanac Park will have capacity to serve other hospitals within the region and is a significant opportunity for improved system-wide working. 6 We have also worked with our people to design spaces where they can rest, relax and recharge - including a new wellbeing hub and rooftop garden on the Princess Anne Hospital site. In addition, 40 staff rooms across the site have been refurbished thanks to funding from Southampton Hospitals Charity. During the year, the Trust worked to establish the Southampton Hospitals Charity as a separate charitable company to improve its ability to both raise and spend funds. This process completed on 1 April 2024. Work was carried out to refurbish a children’s ward during the year in partnership with the charity. Our people are our greatest asset, and we are pleased to see improvements from the annual staff survey in several areas - such as how people can work more flexibly, access to learning and development and improved satisfaction in support from line managers. We recognise the pressures and demands that come with working in this environment and will continue to ensure everyone working here feels heard, encouraged and supported when raising concerns. At UHS, every opportunity is taken to recognise and celebrate the incredible things our people do here every day, including the return of our in-person annual awards ceremony, monthly staff recognition events and the first ever ‘We Are UHS Week’. These occasions are an important reminder that, even when faced with challenges, there is so much to be proud of and celebrate across the whole Trust. Working together, both within the Trust and across organisational boundaries, remains one of our core values. The partnership between UHS and the University of Southampton is as strong as it has ever been, with more than 250,000 individuals having now taken part in research studies in Southampton. As the lead partner member for Acute Hospital Services on the Hampshire and Isle of Wight Integrated Care Board, we are proactively working with other trusts and healthcare providers in the region to improve the health of the community we serve. In addition, the Trust has continued to work in partnership with other providers across the system to build a shared elective orthopaedic hub in Winchester. It is anticipated that the health and social care system will continue to be a challenging environment in 2024/25. We recognise that many of the big challenges we face can only be solved in partnership with wider local partners, and we are committed to actively playing our part in delivering system-wide solutions. Equally, we will continue to focus on improving whatever is within our internal control, and to work collaboratively with our people to ensure our patients’ experience, safety and outcomes remain central to our decision-making and the actions of everyone at UHS. Jenni Douglas-Todd Chair 19 July 2024 David French Chief Executive Officer 19 July 2024 7 PERFORMANCE REPORT Performance report Introduction from the Chief Executive Officer As with 2022/23, this was another challenging year with continued increasing demand for the Trust’s resources and the need to balance this with the need to deliver quality patient care and at the same time maintain a sustainable financial position. Demand for non-elective care continued to increase with an average of 375 attendances per day to our main Emergency Department. In addition, the number of patients on the 18-week Referral to Treatment pathway rose to 58,000. Patients having no clinical criteria to reside in hospital, but unable to be discharged due to the lack of funded care in a more suitable location, posed and continues to pose a significant challenge for the Trust. The number of patients within this category was as high as 270 at times and was consistently higher throughout the year when compared to 2022/23. Despite this the Trust continued to perform well when compared to other comparable organisations, achieving some of the best Emergency Department and elective recovery fund performance in England. The Trust’s financial position continued to be difficult, which required some difficult decisions in respect of spending controls and controls on recruitment. The Trust focused in particular on controlling spending on temporary and agency staff, but in view of the overall workforce numbers compared to the 2023/24 plan, further controls were implemented in respect of substantive recruitment. Due to the additional controls and the Trust’s best delivery to date on its Cost Improvement Programme (£63.4m), the Trust achieved an end of year deficit of £4.5m, compared to the deficit of £26m anticipated in its 2023/24 plan. 9 Overview About the Trust Our services University Hospital Southampton NHS Foundation Trust is one of the largest acute teaching trusts in England with a turnover of more than £1.3 billion in 2023/24. It is based on the coast in south east England and provides services to over 1.9 million people living in Southampton and south Hampshire and specialist services, including neurosciences, respiratory medicine, cancer care, cardiovascular, obstetrics and specialist children’s services, to nearly four million people in central southern England and the Channel Islands. The Trust is also a designated major trauma centre, one of only two places in the south of England to offer adults and children full major trauma care provision. As a leading centre for teaching and research, the Trust has close working relationships with the University of Southampton, the Medical Research Council, National Institute for Health and Care Research (NIHR), Wellcome Trust and Cancer Research UK. The Trust is consistently one of the UK’s highest recruiting trusts of patients to clinical trials and one of the top nationally for research study volumes as ranked by the NIHR Clinical Research Network. Every year the Trust: treats around 155,000 inpatients and day patients, including about 70,000 emergency admissions sees over 750,000 people at outpatient appointments deals with around 150,000 cases in our emergency department The Trust provides most of its services from the following locations: • Southampton General Hospital – the Trust’s largest location, where a great number of specialist services are based alongside emergency and critical care and which includes Southampton Children’s Hospital. • Princess Anne Hospital – located across the road from Southampton General Hospital and providing maternity care and specialist care for women with medical problems during pregnancy and babies who need extra care around birth across the region. • Royal South Hants Hospital – although the Trust does not operate this site near the centre of Southampton it provides a smaller number of services from this location. • New Forest Birth Centre – located at Ashurst on the edge of the New Forest and run by experienced midwives and support staff it acts as a community midwifery hub. The services provided by the Trust are commissioned and paid for by the Hampshire and Isle of Wight Integrated Care System (ICS) and, in the case of more specialised services (such as treatments for rare conditions), by NHS England. Trust services are supported by clinical income, of which 54% is paid for by NHS England and 43% by integrated care boards, predominantly the Hampshire and Isle of Wight Integrated Care Board (ICB). These are provided under a standard NHS contract, which incorporates ongoing monitoring of the Trust and the quality of the services provided. 10 Our structure UHS gained foundation trust status on 1 October 2011. A foundation trust is a public benefit corporation providing NHS services in line with the core NHS principles: that care should be universal, comprehensive and free at the point of need. The Trust is licensed as a foundation trust to provide these services by NHS England and the healthcare services we provide are regulated by the Care Quality Commission. Since 1 July 2022, the Trust has been part of the Hampshire and Isle of Wight Integrated Care System when this was established through the Health and Social Care Act 2022. Each ICS has two statutory elements: an integrated care partnership (ICP) and an integrated care board. The ICP is a statutory committee jointly formed between the NHS integrated care board and all upper-tier local authorities that fall within the ICS area. The ICP brings together a broad alliance of partners concerned with improving the care, health and wellbeing of the population, with membership determined locally. The ICP is responsible for producing an integrated care strategy on how to meet the health and wellbeing needs of the population in the ICS area. The ICB is a statutory NHS organisation responsible for developing a plan for meeting the health needs of the population, managing the NHS budget and arranging for the provision of health services in the ICS area. The Trust has been a university teaching hospital since 1971. The diagram below provides an overview of the overall organisational structure of the Trust. Public and foundation trust members Council of Governors Board of Directors Executive Directors Division A Division B Division C Division D Surgery Critical Care Opthalmology Theatres and Anaesthetics Cancer Care Emergency Medicine Helicopter Emergency Medical Services Medicine and Medicine for Older People Pathology Specialist Medicine Women and Newborn Maternity Child Health Clinical Support Cardiovascular and Thoracic Neurosciences Trauma and Orthopaedics Radiology Trust Headquarters Division 11 Our values The Trust’s values describe how things are done at UHS and act as a guide to all staff working with colleagues to deliver high quality patient care and a great patient experience every day. These values are: Patients, their families and carers are at the heart of what we do. Their experience of our services will be our measure of success. Partnership between clinicians, patients and carers is critical to achieving our vision, both within hospital teams and extending across organisational boundaries in the NHS, social care and the third sector. We will ensure we are always improving services for patients through research, education, clinical effectiveness and quality improvement. We will continue to incorporate new ideas, technologies and create greater efficiencies in the services we provide. 12 Our strategy 2021-25 The Trust’s strategy was updated during 2020/21 to take account of everything its staff had experienced during the COVID-19 pandemic and what had been learnt from this. The vision for UHS is to become an organisation of world class people delivering world class care. The Trust’s strategy is organised around five themes and for each of these it describes a number of ambitions UHS aims to achieve by 2025. Theme Ambitions Outstanding patient outcomes, • We will monitor clinical outcomes, safety and experience of our experience and safety patients regularly to ensure they are amongst the best in the UK By 2025 we will strengthen our and the world. national reputation for outstanding • We will reduce harm, learning from all incidents through our patient outcomes, experience and proactive patient safety culture. safety, providing high quality care • We will ensure all patients and relatives have a positive experience and treatment across an extensive of our care, as a result of the environment created by our people range of services from foetal and our facilities. medicine, through all life stages and conditions, to end-of-life care. Pioneering research • We will recruit and enable people to deliver pioneering research in and innovation Southampton. We will continue to be a leading teaching hospital with a growing, reputable and innovative research and development portfolio • We will optimise access to clinical research studies for our patients. • We will enable innovation in everything we do, and ensure that ‘cutting edge’ investigations and treatments are delivered in Southampton. that attracts the best staff and efficiently delivers the best possible treatments and care for our patients. World class people • We will recruit and develop enough people with the right Supporting and nurturing our knowledge and skills to meet the needs of our patients. people through a culture that values • We will provide satisfying and fulfilling roles, growing our talent diversity and builds knowledge and through development and opportunity for progression. skills to ensure everyone reaches • We will empower our people, embracing diversity and embedding their full potential. We must provide compassion, inclusion and equity of opportunity. rewarding career paths within empowered, compassionate, and motivated teams. Integrated networks and collaboration We will deliver our services with partners through clinical networks, collaboration and integration across geographical and organisational boundaries. • We will work in partnership with key stakeholders across the Hampshire and Isle of Wight integrated care system. • We will strengthen our acute clinical networks across the region, centralising when necessary and supporting local care when appropriate. • We will foster local integration with primary and community care as well as mental health and social care services for seamless delivery across boundaries. • We will build on our successful partnership with University of Southampton (UoS), growing our reputation as a national leading university teaching hospital. 13 Theme Foundations for the future Making our enabling infrastructure (finance, digital, estate) fit for the future to support a leading university teaching hospital in the 21st century and recognising our responsibility as a major employer in the community of Southampton and our role in broader environmental sustainability. Ambitions • We will deliver best value to the taxpayer as a financially efficient and sustainable organisation. • We will support patient self-management and seamless care across organisational boundaries through our ambitious digital programme, including real time data reporting, to inform our care. • We will expand and improve our estate, increasing capacity where needed and providing modern facilities for our patients and our people. • We will strengthen our role in the community as an employer of choice, a partner in delivery of services to our population and by leading the Greener NHS agenda locally. During each year of the strategy the Trust sets out a more detailed series of objectives to achieve and progress towards the delivery of its ambitions. In 2023/24 these objectives included: Outstanding patient outcomes, experience and safety Pioneering research and innovation World class people Integrated networks and collaboration Foundations for the future • Increasing the number of reported Shared Decision-Making conversations. • Increasing the number of specialities reporting outcomes that matter to patients. • Rolling out the Patient Safety Incident Reporting Framework across the Trust. • Working with patients as partners to improve patient satisfaction. • Treating patients according to need but aiming for no patient to wait, other than through patient choice, more than 65 weeks for treatment. • Delivering national metrics for site set-up time to target for clinical research studies. • Improving the Trust’s position against peers. • Delivering year three of the Trust’s research and innovation investment plan. • Developing the five-year research and development strategy implementation plan and delivery of the first year. • Strengthening and broadening the partnership between the Trust and the University of Southampton. • Supporting delivery of the Trust’s workforce plan for 2023/24. • Reducing turnover and sickness absence rates. • Increasing overall participation in the NHS staff survey and maintaining overall staff engagement score. • Increasing the proportion of appraisals completed. • Delivering the first year objectives of the Inclusion and Belonging strategy. • Working in partnership with acute trusts to agree and implement the acute services strategy. • Producing and embedding an internal framework for network development. • Working with the local delivery system on vertical integration to reduce the number of patients without criteria to reside. • Working with system partners to open a surgical elective hub. • For the Trust to be seen as an ‘anchor institution’ in the local area. • Delivering the Trust’s financial plan for 2023/24. • Engaging the organisation in the challenge to manage demand so that capacity and demand are in equilibrium. • Delivery of the Always Improving strategy priorities. • Delivering the Trust’s capital programme in full. • Entering into a new energy performance contract and delivering the first year of the Public Sector Decarbonisation Scheme. Performance against these objectives was monitored and reported to the Trust’s Board on a quarterly basis. 14 At the end of 2023/24, the Trust had met the objectives set as follows: Corporate Ambition Outstanding patient outcomes, safety and experience Pioneering research and innovation World class people Integrated networks and collaboration Foundations for the future Totals Number of Objectives 5 5 5 5 5 25 Achieved in full 4 3 2 3 2 14 Partially achieved 1 2 2 1 3 9 Not achieved 0 0 1 1 0 2 Particular areas to highlight where the Trust has achieved strong delivery during the year include: • Delivery of quality priorities in Shared Decision-Making and the roll out of the Patient Safety Incident Response Framework. • Achieving the Trust’s 65-week waiter glide path. • Successful delivery of a number of research and development priorities, including work with the University of Southampton. • Maintaining sickness absence and turnover well below the targets set at the beginning of the year, and successfully delivering the first year of the Trust’s Inclusion and Belonging strategy. • Delivery of the Trust’s full available capital budget and completion of the first year of the Trust’s decarbonisation scheme. 15 Principal risks to our strategy and objectives The Board has identified and manages the principal risks to the delivery of its strategy and objectives through its board assurance framework. The principal risks to the delivery of its strategy and objectives identified by the Trust during 2023/24 were that: • There would be a lack of capacity to appropriately respond to emergency demand, manage the increasing waiting lists for elective demand, and provide timely diagnostics, that results in avoidable harm to patients. • Due to the current challenges, the Trust fails to provide patients and their families or carers with a highquality experience of care and positive patient outcomes. • The Trust would not effectively plan for and implement infection prevention and control measures that reduce the number of hospital-acquired infections and limit the number of nosocomial outbreaks of infection. • The Trust does not take full advantage of its 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 its patients. • The Trust is unable to meet current and planned service requirements due to unavailability of qualified staff to fulfil key roles. • The Trust fails to develop a diverse, compassionate and inclusive workforce, providing a more positive experience for all staff. • The Trust fails to create a sustainable and innovative education and development response to meet the current and future workforce needs identified in the Trust’s longer-term workforce plan. • The Trust does not implement effective models to deliver integrated and networked care, resulting in sub-optimal patient experience and outcomes, increased numbers of admissions and increases in patients’ length of stay. • The Trust is unable to deliver a financial breakeven position, 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 and digital strategies and in transformation initiatives. • The Trust does not adequately maintain, improve and develop its estate to deliver its clinical services and increase capacity. • The Trust fails to introduce and implement new technology and expand the use of existing technology to transform its delivery of care through the funding and delivery of the digital strategy. • The Trust fails to prioritise green initiatives to deliver a trajectory that will reduce its direct and indirect carbon footprint by 80% by 2028-2032 (compared with a 1990 baseline) and reach net zero direct carbon emissions by 2040 and net zero indirect carbon emissions by 2045. During 2023/24, the Trust saw continued increased demand for its services, particularly in the Emergency Department In addition, the number of patients having no clinical criteria to reside in hospital, but unable to be discharged due to a lack of appropriate care packages was higher than anticipated and spiked during winter, which significantly impacted patient flow through the hospital and required the Trust to engage additional temporary staff. The number of patients in this category peaked at 270 during the winter. There were particular challenges in respect of those patients with a primary mental health care need who would be better cared for in a more suitable alternative setting. 16 Performance overview The Trust monitors a broad range of key performance indicators within its departments, divisions, directorates and through Trust executive committees. On a monthly basis, the Board and executive committee receives a performance report containing a variety of indicators intended to provide assurance in respect of the Trust’s strategy and that the care provided is safe, caring, effective, responsive and well-led. This report also includes the Trust’s performance against the national targets set by NHS England. The performance reports include a ‘spotlight’ section, which provides more detailed analysis of a particular area. Typically, this is one of either the national targets or the Trust’s performance against the expectations set out in the NHS Constitution. The monthly performance report is also published on the Trust’s website. The Chief Executive Officer provides a regular report on performance to the Council of Governors, which includes a range of non-financial and financial performance information. Capacity The Trust continued to experience high demand for its services, especially in the Emergency Department, with average demand during the year being around 375 patients presenting per day in the main adult and children’s emergency department. In addition, the Trust experienced a significant impact on flow within the hospital due to a high number of patients having no clinical criteria to reside in hospital but unable to be discharged. This number was as high as 270 at times during winter: an increase of around 50 patients when compared to the prior year. The Trust also saw an increase in the number of referrals with the number of patients on a waiting list under the 18-week Referral to Treatment pathway rising from approximately 55,000 to 58,000 by the end of the year. In common with other trusts, the ongoing industrial action also impacted the Trust’s ability to provide urgent care and deliver on its elective recovery programme. Quality and compliance Despite the challenges, the Trust’s Emergency Department performance was one of the highest in England in March 2024, which resulted in additional capital funding being awarded. In addition, the Trust’s elective recovery performance was one of the best in England at 118% compared to 2019. The Trust continued to monitor the quality of care delivered throughout 2023/24 through a number of established quality assurance programmes. Clinical leaders monitored key quality, safety and patient experience indicators such as falls, pressure ulcers and venous thromboembolisms. Quality peer reviews were carried out, most significantly through Matron-led Quality Walkabouts every week in and out of hours focusing on the five key CQC questions – safe, effective, responsive, caring, and well-led. The Trust’s Clinical Accreditation Scheme builds on this intelligence, with clinical areas completing self-assessments of performance and review teams completing onsite visits. Patient representatives were included in these review teams. Learning was shared at the Clinical Leaders’ Group and via quarterly reports. The Trust was an active partner in a South-East accreditation network, offering advice and a steer to providers who are just setting up or looking to develop their own scheme, and extended that advice and support to other providers in England. 17 On 15 May 2023, the CQC inspected the maternity and midwifery service at Princess Anne Hospital as part of their national maternity inspection programme. The inspection report was published 11 August 2023, and the Trust retained its overall rating of ‘good’. This year UHS introduced its Fundamentals of Care (FOC) initiative. Whilst this is not a new concept, there were concerns that missed fundamental care had been amplified during the COVID- 19 pandemic. This initiative aims to empower and educate staff at all levels to ensure fundamental care is at the heart of what the Trust does. The Trust completed its transition to the Patient Safety Incident Response Framework (PSIRF) and collaborated with the ICB to develop a PSIRF plan and policy to underpin the change. The Trust implemented the requirements in respect of ‘Martha’s Rule’ where patients, relatives and carers have a legal right to a rapid review by a critical care outreach team during an acute deterioration episode in and out of hours. The Trust continued its focus on infection prevention and control, responding rapidly to rises in infection over the winter, and successfully flexing initiatives and innovations to achieve successful management in a responsive manner. The Trust progressed its Always Improving strategy and successfully supported the identification and implementation of further quality improvement projects. This included improvements across theatres, inpatient flow and outpatient programmes. During the year, average length of stay was reduced by 1.64%, day theatre cancellations were reduced by 200, and 42,350 patients were placed onto Patient Initiated Follow Up (PIFU) pathways. Further information can be found in the Quality Account. Partnerships The Trust works within the Hampshire and Isle of Wight Integrated Care System, and is an active member of a number of partner groups including the Acute Provider Collaborative Board and the Health and Wellbeing Board. The Trust develops and agrees its annual financial plans with the Integrated Care Board. The Trust is a member of a number of specific partnership groups for particular services, including the Central and South Genomics Medicine Service, the Children’s Hospital Alliance and the Southern Counties Pathology Network. The Trust works actively as a partner with other provider organisations around clinical networks, particularly with acute Trusts within the Integrated Care System and others closely located geographically. The Trust also links closely with the University of Southampton on a number of topics including research, commercial development and education and has a developed meeting structure to oversee this. 18 Workforce The Trust’s key areas of focus during 2023/24 were in respect of increasing the substantive workforce whilst also reducing reliance on bank and agency usage, and reducing staff turnover and sickness. Although the Trust was successful in recruiting to substantive posts, the expected reduction in reliance on bank and agency staff did not materialise, which meant that the Trust was 331 whole-time equivalents above its plan for 2023/24. The Trust was successful in reducing staff turnover from 13.5% in 2022/23 to 11.4%, achieving the local target of . Cancer Waiting Times - 2 Week Wait Performance Cancer Waiting Times - 2 Week Wait Performance 100% 90% 80% 70% 60% 50% 40% Apr-23 May-23 Jun-23 Jul-23 Aug-23 Sep-23 Oct-23 Nov-23 Dec-23 Jan-24 Feb-24 Mar-24 Performance % standard met The national target was for 96% of patients to commence treatment within 31 days of diagnosis. In March 2024, the Trust achieved 92% and performed in the range of 86%-94% throughout the year. The Trust has continued to make progress against the target for treatment of cancer within 62 days of an urgent GP referral, improving performance from 64% in April 2023 to 76% in March 2024 (NHS average: 69%). First definitive treatment for cancer within 31 days of a decision to treat % standard met Cancer waiting times 31 day RTT performanceUHS vs. NHSE average Cancer waiting times 31 day RTT performance UHS vs. NHSE average 96% 94% 92% 90% 88% 86% 84% 82% 80% 78% 76% Apr-23 May-23 Jun-2 3 Jul-2 3 Aug-23 Sep-2 3 Oct-23 Nov-2 3 Dec-23 Jan-24 Feb-2 4 Mar-24 Performance NHS Average 27 Treatment for Cancer within 62 days of an urgent GP referral to hospital Cancer Waiting Times 62 Day RTT Performance UHS vs NHSE Average Cancer Waiting Times 62 Day RTT Performance UHS vs NHSE Average % standard met 1 00% 80% 60% 40% 20% 0% Apr-23 May-23 Jun-23 Jul-23 Aug-23 Sep-23 Oct-23 Nov-23 Dec-23 Jan-24 Feb-24 Mar-24 Performance NHS Average 28 Quality priorities Priorities for improvement 2023/24 Last year the Trust continued its ambition to deliver the highest quality care shaped by a range of national, regional, local, and Trust-wide factors. During the year the Trust continued to experience unprecedented demand on its services, with flow, capacity, infection prevention and safety all presenting challenges. However, the Trust was confident in its ability to keep a focus on its quality priorities, and its teams worked hard to achieve their goals even in these difficult circumstances. Priorities are aligned to the three core dimensions of quality: • Patient experience – how patients experience the care they receive. • Patient safety – keeping patients safe from harm. • Clinical effectiveness – how successful is the care provided? Out of the six priories set, the Trust achieved five and partially achieved one. Overview of success Quality Priority One Improving care for people with learning disabilities and autistic (LDA) people across the Trust. Supporting staff delivering this care. Outcome against goals: achieved Key achievements: • LDA working group reestablished. • Development of an improvement plan using the NHS Learning Disability Improvement standards. • The LDA team has moved to the virtual enhanced care group in Division B where operational and governance support, leadership, and peer support/learning opportunities has been strengthened. • Sensory Boxes have been introduced for all clinical areas, funded by the Hampshire and Isle of Wight (HIOW) Integrated care board (ICB). These boxes include noise cancelling headphones, fidget toys, communication books and visual cards to support patients and wards. • Recruited additional Learning Disability Champions. • Established links with the parent carer forum (PCF) for the local area and are now attending regular events. A representative from the PCF sits on the LDA working group. The LDA team are working with the Trust lead for patient experience to develop this aspect of the LDA workplan over the next year. Quality Priority Two Supporting patients, service users and staff to overcome their tobacco dependence via a smoking cessation programme. Outcome against goals: achieved Key achievements: • Package of support available to patients who may be smokers and who need to be supported not to smoke during their treatment. • Fully trained team of tobacco advisors working in the hospital and an advisor working in the outpatient setting supporting the patients once they have returned home. • Devised the IT changes the Trust would like to implement to improve its service and referral process. • Recruited 30 smoke-free champions. • Successfully supported 1,131 patients with a self-confirmed quit rate of 45.6% at 28 days. • Supported 109 outpatients who have successfully achieved a 60% quit rate. • On track to achieve the goal to go smoke-free by April 2024 including the removal of smoking shelters. 29 Quality Priority Three Ensure carers are fully supported, involved, and valued across all our services by developing the carers support service across the Trust in partnership with Southampton Hospitals. Outcome against goals: partially achieved Key achievements: • Carers now have a more comprehensive package of concessions and vouchers to help support their cared-for person (e.g. free parking available onsite for blue badge owners is now available). • Listening events were held to put patients at the centre of transforming the way we deliver care is delivered, enabling their voices to improve the quality of care and outcomes for all. • Developed joint working with local partners (e.g. Children’s Society and No Limits to support young carers). Not yet achieved: • The ‘pathway to support, has not yet been developed. Work is ongoing to develop a new strategy. • A charity-funded carers’ support worker has not yet been appointed. • The carers’ training package has not yet been relaunched. Quality Priority Four Put patients at the centre of transforming the way care is delivered, enabling their voices to improve the quality of care and outcomes for all. Outcome against goals: achieved Key achievements: • Work has continued to work across corporate and divisional services to embed patients and carers into quality and service improvement, creating new patient groups (e.g. Mesh Support Group). • Successfully developed our engagement with various local communities, working to ensure that a range of care experiences are considered ( e.g. there is now a Gypsy, Roma, and Irish Traveller community health liaison officer to ensure that these communities are engaged with and brought into work to improve the inclusivity of our services). • Attending multiple public engagement opportunities (Young Carers’ Festival, Mela, University Freshers’ Fayres, Carers’ Listening Lunch, Hoglands Park Play Day, visits to local temples and ‘Love Where You Live’). • Youth and Young Adult Ambassador involvement has increased, including attendance toat meetings of the Council of Governors, and supporting hospital projects. • A Celebration of Carers Week and Volunteers Week were run. • The Trust has analysed its reported outcome measures to identify health inequalities in its services. This information has been used to set a new quality priority for 2024/25. • An SMS friends and family test text survey has been introduced to improve the response rate on patient feedback from the Emergency Department. In the first three months following the survey launch, responses increased from 24 to 424. 30 Quality Priority Five To develop the Trust’s clinical effectiveness process, connecting to the Trust’s Always Improving approach to measuring, understanding, and using outcomes to improve patient care. Outcome against goals: achieved Key achievements: • The Trust has developed its clinical effectiveness process across the Trust with involvement of informatics, governance and management teams, clinical effectiveness leads as well as reporting committees. • Patient representation onhas been included in the clinical assurance meeting for effectiveness and outcomes (CAMEO) to ensure conversations focus on what matters to patients. • The CAMEO template has been changed to focus discussions on areas the specialty is proud of (strong or improving outcomes), areas for improvement (poorly benchmarked or worsening outcomes) and planned actions. • The Trust encourages the use of run and/or statistical process control charts along with benchmarking where available. • Details of NICE and quality standards and national and regional reviews are included to cover breadth of clinical effectiveness. • How the clinical effectiveness team works has been reorganised, aligning each of them to each division giving a named link which helps to deepen understanding and improve links with governance and improvement activities locally. • Working with informatics to establish a core set of clinical outcome measures which are meaningful to patients, which can be reported centrally (starting with surgical specialities). • Starting to develop an education strategy and platform to support staff with a number of tools used in clinical effectiveness as well as clarity on where and how to record and evidence audit and service improvement. • A revised strategy has been drafted. Quality Priority Six Developing a culture where all clinical staff have a basic knowledge of diabetes. Outcome against goals: achieved Key achievements: • Launch of the ‘Start with the Diabasics’ Initiative, designed to help give diabetes visibility across UHS. • Delivered an extensive education programme to clinical staff across the professions and bands, including the introduction of some e-learning and a Diabasics introductory video has been shown at all trust staff inductions since July 2023. • Supported the development of 45 diabetes link nurses, resulting in all ward areas now having a named diabetes link nurse. • Improved triage for referrals. • Established processes for ‘lessons learned’. • Developed IT solutions to improvingimprove alerts and guidance. • A ‘Ketone Wednesdays’ initiative has been created in response to overuse of blood ketone testing (estimated waste cost of £100,000 per year). • The Trust’s lead diabetes specialist nurse and the Diabasics Initiative were both shortlisted for National Quality in the Care Diabetes Awards (October 2023). • The Diabasics Initiative was mentioned as a case study on the Diabetes UK charity website as an example of good practice that could be reproduced elsewhere. More information can be found about how the Trust delivered and measured its quality priorities, including feedback from patients and staff and improvement aims and quality priorities for 2024/25, in the Trust’s Quality Account for 2023/24. 31 Financial performance The Trust delivered a deficit of £4.5m from a revenue position of over £1.3bn, following receipt of £24.6m one-off cash support from NHS England. UHS started the year with an underlying deficit as a result of a number of cost pressures, notably demand for services being above block contract levels and the cost of national pay awards being above funded levels. The Trust has also continued to face a number of pressures, including high numbers of patients who no longer meet the criteria to reside in the hospital, and high demand for patients with a primary mental health need. In 2023/24, the Trust delivered a record savings level of £63.4m (5%) across a range of programmes. Trust operating income rose by £107m from the previous financial year, most notably funding the NHS pay award, as well as additional elective recovery funding. Trust operating expenses rose by £89m, incorporating funded inflationary costs as well as costs relating to the cost pressures outlined above. The Trust has also continued its reinvestment of surplus cash into infrastructure for the Trust, with capital investment of over £75m, including investment in new wards, theatres, decarbonisation, digital infrastructure, neonatal expansion and backlog maintenance. Trust cash and cash equivalents finished the year at £79m, a reduction of £24m from the previous year due to the operating loss and capital investment outlined above. Whilst liquidity remained strong in 2023/24 supported by NHS England cash support, the underlying financial deficit means it is likely to decline further in 2024/25. The Trust is continuing to monitor its cash position closely and is considering whether additional cash support may be required in 2024/25. Sustainability The Trust recognises that everyone has a part to play in responding to the climate crisis. In March 2022, the Trust agreed its own green plan in response to the challenge of the NHS becoming the world’s first health service to reach carbon net zero. Now in its third year, the plan identifies the Trust’s key areas of focus and its ambitions and has seen progress across all areas of the plan. The plan sets out the scale of the challenge, the Trust’s commitment to reducing the impact on the environment and the steps to be taken across the following categories: • Estates and facilities • Clinical and medicines • Digital transformation • Supply chain and procurement • Travel and transport • Waste and resources • Food and nutrition • Adaptation • Biodiversity • Wider sustainability The Trust continues to progress through its green plan and has completed the ‘Greener NHS’ reporting tool for several quarters, which has demonstrated good progress. In addition, the Trust is planning to launch its ‘Our Sustainable UHS’ app for staff, which will give tips on sustainability and create personalised travel plans, including identifying potential contacts for car sharing. In addition, the Trust is considering proposals to implement additional solar power, smart metering and expanding the use of LED lighting. 32 In 2022/23, the Trust was successful in bidding for £29.4m of funding through the Public Sector DeCarbonisation Fund, which will be used to fund green initiatives as part of the Trust’s capital programme. During the year the Trust successfully bid for £823k in National Energy Efficiency Funding which has been used to upgrade the lighting at Princess Anne Hospital. Social, community, anti-bribery and human rights issues The Trust recognises its responsibilities under the European Convention on Human Rights (included in the Human Rights Act 1998 in the UK). These rights include: • right to life • right not to be subjected to inhuman or degrading treatment or punishment • right to liberty and freedom • right to respect for privacy and family life. These are reflected in the duty, set out in the NHS Constitution, to each and every individual that the NHS serves, to respect their human rights and the individual’s right to be treated with dignity and respect. The Trust is committed to ensuring it fully takes into account all aspects of human rights in its work. An equality impact assessment is completed for each Trust policy. For patients, the Trust’s safeguarding policies protect and support the right to live in safety, free from abuse and neglect and other policies and standards are designed to optimise privacy and dignity in all aspects of patient care. Feedback from patients and the review of complaints, concerns, claims, incidents and audit help to monitor how the Trust is achieving these objectives. The Trust’s green plan, approved by the board of directors in March 2022, recognises the Trust’s broader role and responsibility to address the issues of climate change, air pollution, waste and environmental decline present to the city of Southampton and the impact that these issues have on the health and wellbeing of the local population served. Although the Modern Slavery Act 2015 does not apply to the Trust, its green plan sets out an ambition to stop modern slavery. The Trust is also committed to maintaining an honest and open culture within the Trust; ensuring all concerns involving potential fraud, bribery and corruption are identified and rigorously investigated. The Trust has a Fraud, Bribery and Corruption Policy, a Standards of Business Conduct Policy and a Raising Concerns (Whistleblowing) Policy. These apply to all staff and to individuals and organisations who act on behalf of UHS. Anti-bribery is part of the Trust’s work to counter fraud. This work is overseen by the Audit and Risk Committee, which receives regular reports from the local counter fraud specialist on the effectiveness of these policies through its monitoring and reviews, providing recommendations for improvement, as well as an annual report from the freedom to speak up guardian. You can read more about the work of the Audit and Risk Committee and the Trust’s approach to counter fraud in the Accountability Report. Events since the end of the financial year There have been no important events since the end of the financial year affecting the Trust. Overseas operations The Trust does not have any overseas operations. 33 Equality in service delivery NHS trusts have an essential role in tackling health inequalities, both as part of the services they provide, but also through work with the wider system. By working with those in integrated care systems, local authorities and third sector organisations, the Trust can have a significant impact on the health of the local population. The national focus on health inequalities is growing. This comes with new legal duties around reporting information and expectations to report on improvement programmes. In September 2023, a health inequalities steering group was initiated, under the leadership of the Chief Medical Officer, with representation from clinical, operational, transformation, patient experience, research, organisational development and culture, informatics, public health and the Integrated Care Board. The group focused on scoping future priorities aligned to national guidelines, contractual obligations and priorities, regional priorities, feedback from clinical teams and patients, understanding where action is already being taken, and what the data is showing. Overall, the group
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Last updated: 14 September 2019
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