Browse site A to Z

Search results

Go To Advanced Search

You could also try: dead body (5), body (764)

Press release: Spinal surgeons use revolutionary lifelike simulator to test operations

Description: Spinal surgeons in Southampton are using a revolutionary simulator complete with artificial bone, tissue and blood as part of a national
Url: /AboutTheTrust/Newsandpublications/Latestnews/2018/May-2018/Press-release-Spinal-surgeons-use-revolutionary-lifelike-simulator-to-test-operations.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
Url: /Media/UHS-website-2019/Docs/About-the-Trust/Trust-governance-and-corporate-docs/UHS-register-of-interests-June-2025.pdf

DH IVIg approved indications full guidance July 2011

Description: DH INFORMATION READER BOX Policy HR / Workforce Management Planning / Clinical Performance Document Purpose Gateway Reference Title Author Publication Date Target Audience Estates Commissioning IM & T Finance Social Care / Partnership Best Practice Guidance 16290 ROCR Ref: ROCR approval applied for Clinical guidelines for immunoglobulin use: update to second edition Department of Health 01 Aug 2011 PCT CEs, NHS Trust CEs, SHA CEs, Foundation Trust CEs , Medical Directors, Directors of Finance, GPs, Communications Leads, Emergency Care Leads, Chief Pharmacists Circulation List #VALUE! Description The Clinical Guidelines for Immunoglobulin Use were implemented in 2008. The Guidelines were developed utilising an evidence review and extensive consultations. This Update fulfills the commitment to undertake a biennial review from 2009. The Second Edition Guidelines remain in place and this Update should be used in conjunction with them. Cross Ref Superseded Docs Action Required Timing Contact Details Clinical Guidelines for Immunoglobulin Use (Second Edition) N/A N/A N/A Tina Lee Blood Safety & Supply Team Room 30 Wellington House 133-155 Waterloo Road London SE1 8UG 020 7972 4750 0 For Recipient's Use Clinical guidelines for IMMUNOGLOBULIN Use seCOND eDITION UPDATe second edition Update Working Group Dr Jennie Wimperis Consultant Haematologist, Norfolk and Norwich NHS Trust Dr Michael Lunn Consultant Neurologist, National Hospital for Neurology and Neurosurgery Dr Alison Jones Consultant Immunologist, Great Ormond Street Hospital Dr Richard Herriot Consultant Immunologist, NHS Grampian Dr Philip Wood Consultant Immunologist, Leeds Teaching Hospitals NHS Trust Dr Denise O'shaughnessy Blood Policy, Department of Health Mr Malcolm Qualie Pharmaceutical Advisor Department of Health CLINICAL GUIDeLINes fOR IMMUNOGLOBULIN Use Contents ...................................................................................... 2 eXeCUTIVe sUMMARY ....................................................................... 6 Selection criteria for appropriate use of immunoglobulin .................................. 6 Efficacy outcomes to assess treatment success ........................................... 6 Modification of existing indications and inclusion of new indications .................... 7 Commissioning of immunoglobulin ........................................................... 7 INTRODUCTION ................................................................................ 8 Insights from the National Immunoglobulin Database ..................................... 8 CONTeNTs Changes to the colour-coded prioritisation employed in the Demand Management Programme ...................................................................... 8 Automatic assignment of Red and Blue prioritisation ................................. 9 Grey indications ............................................................................. 9 Reclassification of diseases .............................................................. 10 11 12 12 13 14 14 14 15 16 18 26 27 27 Introduction of specific selection and outcome criteria in the Demand .................................................................... Definitions of duration of immunoglobulin treatment ..................................... Recommended dosing of immunoglobulin ................................................ Ideal body weight-adjusted dosing of immunoglobulin .................................. Western Australia pilot study ............................................................. Hospital Corporation of America ........................................................ The Ohio State University Medical Centre, Columbus, Ohio ........................ Infusion rates for intravenous immunoglobulin ............................................ Subcutaneous administration ............................................................... sUMMARY TABLes .......................................................................... sUMMARY Of GReY INDICATIONs ...................................................... Removed from Grey ........................................................................... INDICATIONs fOR WHICH IVIG Is NOT ReCOMMeNDeD .......................... Management Programme CLINICAL GUIDeLINes fOR IMMUNOGLOBULIN Use Replacement pages IMMUNOLOGY HAeMATOLOGY ............................................................................... .............................................................................. 29 35 Primary immunodeficiencies (replacing relevant content on pages 28-29) Coagulation factor inhibitors (replacing relevant content on pages 32-33) Haemolytic disease of the foetus and newborn (replacing relevant content on pages 32-33) Immune thrombocytopenic purpura (replacing relevant content on pages 34-35) NeUROLOGY ................................................................................. 40 Introduction (replacing relevant content on page 41) Chronic inflammatory demyelinating polyradiculoneuropathy (replacing relevant content on page 41) Inflammatory myopathies (replacing relevant content on page 42) TRANsPLANTATION ........................................................................ 43 Antibody Incompatible Transplant (AIT) (replacing relevant content on page 65) Antibody-Mediated Rejection (AMR) (replacing relevant content on page 65) Viral pneumonitis (replacing relevant content on page 65) CLINICAL GUIDeLINes fOR IMMUNOGLOBULIN Use Summary table of conditions for which intravenous immunoglobulin use is appropriate Condition Primary and secondary antibody deficiency states Primary immunodeficiencies Thymoma with immunodeficiency HSCT in primary immunodeficiencies Specific antibody deficiency Secondary antibody deficiency (any cause) Haematology Acquired red cell aplasia Alloimmune thrombocytopenia (foeto-maternal/neonatal) Autoimmune haemolytic anaemia Coagulation factor inhibitors (alloantibodies and autoantibodies) Haemolytic disease of the newborn Haemophagocytic syndrome Immune thrombocytopenic purpura (acute and persistent, excluding chronic*) Post-transfusion purpura Neurology Chronic inflammatory demyelinating polyradiculoneuropathy** Guillain-Barr? syndrome Inflammatory myopathies Myasthenia gravis (including Lambert-Eaton myasthenic syndrome) Multifocal motor neuropathy Paraprotein-associated demyelinating neuropathy (IgM, IgG or IgA) Rasmussen syndrome Stiff person syndrome short duration Long duration continued * Chronic immune thrombocytopenic purpura is a grey indication ** The disease should be life-threatening to allow database entry as red CLINICAL GUIDeLINes fOR IMMUNOGLOBULIN Use Summary table of conditions for which intravenous immunoglobulin use is appropriate continued Condition Others Autoimmune congenital heart block Autoimmune uveitis Immunobullous diseases Kawasaki disease Necrotising (PVL-associated) staphylococcal sepsis Severe or recurrent Clostridium difficile colitis Staphylococcal or streptococcal toxic shock syndrome Toxic epidermal necrolysis, Stevens Johnson syndrome Transplantation (solid organ) short duration Long duration CLINICAL GUIDeLINes fOR IMMUNOGLOBULIN Use eXeCUTIVe sUMMARY The Clinical Guidelines for Immunoglobulin Use were implemented in 2008. The Guidelines were developed utilising an evidence review and extensive consultations with clinicians and other stakeholders. This update fulfils the commitment made in the Second Edition to undertake a biennial review from 2009. The Second Edition Guidelines remain in place and this update should be used in conjunction with the Second Edition. This update did not review all of the Second Edition Guidelines content, but limited its focus to three key areas: defining selection criteria for appropriate use; efficacy outcomes to assess treatment success; and reassignment of existing indications /inclusion of new indications. should be fulfilled if immunoglobulin is to be used, including particular disease characteristics, disease severity and any requirement for other treatments to have been demonstrably unsuccessful before immunoglobulin is considered. This reflects the approach taken by the National Blood Authority in Australia in defining appropriate prescribing of immunoglobulin. efficacy outcomes to assess treatment success The Guidelines did not include efficacy tracking of immunoglobulin treatment, although Immunoglobulin Assessment Panels (IAP) were encouraged to request parameters by which efficacy could be assessed. This update provides efficacy outcomes to be measured in all indications (except primary immunodeficiencies), and it is expected that all Grey indications will have efficacy parameters defined and monitored on a case by case basis. Efficacy outcomes are expected to play an important role in the IAP decision-making process for patients in whom continuation of immunoglobulin treatment is requested beyond the short- and long-term durations defined in this update. This change reflects the wider change of focus in the NHS to patient outcomes, as presented in The NHS Outcomes Framework. selection criteria for appropriate use of immunoglobulin The Guidelines did not provide explicit selection criteria for the appropriate use of immunoglobulin. Review of data in the National Immunoglobulin Database showed a considerable volume of immunoglobulin was used in patients for whom no specific diagnosis was provided. Clearly, this was less than optimal and caused concern among commissioners. This update provides criteria that CLINICAL GUIDeLINes fOR IMMUNOGLOBULIN Use Modification of existing indications and inclusion of new indications Changes to existing indications required proponents to submit new evidence to the Update Working Group for review. However, allocation of diseases to Red, Blue or Grey did not solely depend on the level of evidence presented, but included expert clinical advice and the availability of effective alternative therapies or treatment approaches. The British Transplantation Society made a strong case to change certain defined transplant cases to Blue, despite limited high-quality evidence for some of the clinical scenarios and the Update Working Group accepted the Society's view. For complex regional pain syndrome, although randomised evidence from a small study showed benefit, this was regarded by the Update Working Group as an emerging indication for refractory cases; a number of important questions concerning optimal treatment doses and duration of treatment remain unanswered. Therefore, this disease has been added to the Grey list. It remains the responsibility of the local IAP to decide with the PCT (or specialised commissioning group) if treatment with immunoglobulin is appropriate on a case by case basis. Other Grey indications have been updated and others, for which there was little or no prescribing recorded in the database, deleted. Grey indications are now listed as immune-mediated disorders with limited evidence of immunoglobulin efficacy, or presumed immune-mediated disorders with little or no evidence of efficacy. Review of Red and Blue indications identified a number of disease entities with the same underlying pathophysiology that were listed separately; these are now grouped together under single disease headings. Commissioning of immunoglobulin Ensuring immunoglobulin prescribing is consistent with the evidence-base and restricted to those patients for whom there are no alternative treatments and for those most likely to benefit is the central aim of these guidelines. But from a commissioner's viewpoint, cost-effectiveness and affordability play an important role in their discussions with IAPs regarding prescribing. The commissioning aspects of this guideline update are included in a separate document and this should be reviewed to understand the requirements of commissioners around immunoglobulin prescribing, in particular regarding National Immunoglobulin Database entry and treatment duration. CLINICAL GUIDeLINes fOR IMMUNOGLOBULIN Use INTRODUCTION This update of the Department of Health's (DH) immunoglobulin guidelines fulfils the commitment made in the Second Edition to undertake a biennial review from 2009. This review was informed by changes in the clinical evidence base for immunoglobulin, the findings of the National Immunoglobulin Database (Reference number ROCR/ OR/0221), and a change of focus in the NHS to patient outcomes, as presented in The NHS Outcomes Framework. The DH has consulted widely in this review and the changes have been discussed at length with clinicians and commissioners involved in the demand management of immunoglobulin. National Immunoglobulin Database was launched on 2nd June 2008. These documents and the National Immunoglobulin Database are accessible through the immunoglobulin website www.ivig.org.uk. The first data review from the National Immunoglobulin Database, published in January 2010, contained data on immunoglobulin prescribing in 5119 patients, and offered a unique, detailed view of prescribing practice of immunoglobulin in England as well as providing, for the first time, a baseline of immunoglobulin use. This was a major step forward in establishing the Demand Management Programme and, in particular, gave insights into the appropriate use of this treatment across all indications. Generally, the data demonstrated appropriate and controlled prescribing of immunoglobulin for a wide range of conditions, most of which was evidence based. The review also identified a number of issues regarding the Demand Management Programme, which are addressed in this guideline update. Insights from the National Immunoglobulin Database The DH's Demand Management Programme for Immunoglobulin was a key output from the 2006 review that assessed the opportunities available to secure the supply of immunoglobulin. The review recommended two complementary work streams, one based on securing supply and the other giving structure to the process of fulfilling demand (the Demand Management Programme). The Demand Management Programme was fully launched in late May 2008, when DH published the Second Edition of `Clinical Guidelines for Immunoglobulin Use' and the `Demand Management Plan for Immunoglobulin Use' (Gateway reference 10012 and 10013). The Changes to the colour-coded prioritisation employed in the Demand Management Programme Automatic assignment of Red and Blue prioritisation The Demand Management Programme introduced colour coding to reflect the prioritisation of immunoglobulin treatment CLINICAL GUIDeLINes fOR IMMUNOGLOBULIN Use in times of shortage, based on the availability of alternative treatments and strength of clinical evidence. The database review showed many cases for which diseases were mis-assigned to an incorrect prioritisation. In particular, there were many cases of misassignment of diseases to Red and Blue. `Red' indicates conditions for which treatment is considered the highest priority because of a risk to life without treatment. The intention remains that Trusts will protect supply for these high-priority diseases in times of immunoglobulin shortage, particularly for patients with primary immunodeficiencies. To ensure accurate prioritisation assignment, the database will now automatically assign the colour coding upon patient entry on the basis of patient characteristics. The Immunoglobulin Assessment Panels (IAP) at Trusts should continue to manage local demand for immunoglobulin; in times of shortage, local panels should continue to identify Red indications as those of most clinical need. The database will automatically assign diseases to `Blue', but prescribing of immunoglobulin in Blue indications will continue to require prior approval of the IAP . because the disease is rare. Approval from both the local IAP and the Primary Care Trust (PCT) (or specialised commissioning group) is required for immunoglobulin treatment. As previously specified in the Demand Management Plan for Immunoglobulin Use, treatment should be considered on a caseby-case basis, and prioritised against other competing demands for immunoglobulin, especially in times of shortage. It is not possible or desirable to list every disease that could potentially be prescribed immunoglobulin. In cases of `unlisted' diseases, it is important to restate that those not listed in the guidelines are to be considered as Grey. The database review showed a considerable volume of immunoglobulin prescribed without a specific diagnosis being provided. Even if the disease is unlisted, the diagnosis and agreed efficacy criteria are to be recorded in the database. Grey indications are now listed as immune-mediated disorders with limited evidence of immunoglobulin efficacy, or presumed immune-mediated disorders with little or no evidence of efficacy. It is accepted that the lack of an evidence base may reflect the rarity of these diseases; it remains the responsibility of the local IAP to decide with the PCT (or specialised commissioning group) if treatment with immunoglobulin is appropriate on a caseby case basis. Grey indications `Grey' indications are those diseases for which the evidence is weak, in many cases 10 CLINICAL GUIDeLINes fOR IMMUNOGLOBULIN Use Reclassification of diseases 1. Grey to Blue The database review identified two of the top 10 immunoglobulin-using indications as Grey (secondary antibody deficiencies and antibody-mediated rejection following solid organ transplantation). In many Trusts, commissioners have permitted pre-approval of immunoglobulin use for these indications despite the limited evidence base. Therefore, these indications were reviewed in detail and the evidence base was reassessed. Secondary antibody deficiencies were identi- Acquired von Willebrand disease has now been included with acquired haemophilia, in the general disease grouping of `Coagulation factor inhibitors', which is listed under appropriate use of immunoglobulin. Immunoglobulin use carries selection criteria, including that these rare and severe bleeding disorders are managed in a comprehensive care centre for haemophilia. Polymyositis and Inclusion body myositis have now been grouped with dermatomyositis under the general disease grouping of inflammatory myopathies, with strict selection criteria. Post-transfusion hyperhaemolysis has now been fied by a number of stakeholders as a key area for revision. In the previous edition, they were listed under immunosuppressive pharmacotherapy, and separately under some of the haematological malignancies such as CLL, without listing other mature B-cell malignancies such as non-Hodgkin's lymphoma. These have been revised into a single indication. The outcome of this review is that use of immunoglobulin for these indications is appropriate and is now listed as Blue (see replacement page 30). Antibody-mediated rejection following solid grouped under the more general heading of haemolytic anaemia. SLE with secondary immunocytopenias should be considered under the relevant immune cytopenia. 2. Blue to Red Specific antibody deficiency, as a recognised primary antibody deficiency disorder, has been reclassified as a Red indication (for those cases where immunoglobulin replacement therapy is required). Haemolytic disease of the newborn has been organ transplantation and antibody-incompatible transplantation were reviewed, and a single grouping of `Transplantation (solid organ)' has been introduced and listed as Blue. updated to reflect recommendations in NICE clinical guideline 98 on neonatal jaundice [1]. CLINICAL GUIDeLINes fOR IMMUNOGLOBULIN Use 11 Introduction of specific selection and outcome criteria in the Demand Management Programme Selection criteria The database review also raised an important issue over patient diagnosis ? a considerable volume of immunoglobulin was used in patients in which there was no specific diagnosis listed (13% of total recorded immunoglobulin use). Clearly, this was less than optimal and caused concern among commissioners. In addition, this showed that improvements were required before the database was sufficiently robust to be able to link to payments by use. Further feedback from commissioners indicated widespread approval of the system used in Australia, with each indication for immunoglobulin carrying specific selection criteria for use, in particular, the need to use immunoglobulin as second- or third-line treatment in diseases for which there are a number of alternative treatment options. This approach, with selection criteria for each approved indication for immunoglobulin, has now been adopted in this guideline update. The need to employ selection criteria before prescribing will largely remove the need for panel decisions on prescribing, reducing the burden on IAPs and increasing focus on assessing patient outcome. Efficacy outcomes The database was not successful in the capture of data regarding the efficacy of immunoglobulin. Panels were encouraged to request up to three parameters by which efficacy could be determined in each patient [e.g., platelet count in patients with immune thrombocytopenic purpura (ITP)]. The purpose of this exercise was both to obtain preliminary data about efficacy in various conditions (fully accepting that lack of diagnostic criteria and other issues would make this a very crude analysis) and to provide feedback to individual Panels about the quality of their decision making. For example, if Panels repeatedly approved indications prioritised as Grey by the Demand Management Programme and the treatment was largely ineffective, review of these findings would improve IAP decision making. The decision has been taken to introduce efficacy outcomes for most indications. Monitoring of efficacy outcomes by commissioners may result in withholding payments to Trusts if efficacy outcomes have not been recorded in the database. Efficacy outcomes are expected to play an important role in the decision-making process of IAPs in cases in which continuation of immunoglobulin treatment is requested beyond the short- and long-term durations defined in the next section. 1 CLINICAL GUIDeLINes fOR IMMUNOGLOBULIN Use Definitions of duration of immunoglobulin treatment The definitions of short-term and longterm treatment durations are refined in this update, with each approved indication for immunoglobulin now approved on the basis of short-term (3 months) and long-term (3 months) treatment needs. The definitions of duration of treatment are included in the table below. IAPs and commissioners together will make decisions on treatment extensions. short-term treatment Three prescribed doses of up to 2 g/kg, given at appropriate clinical intervals 3 months The treatment episode ends at 3 months. The National Immunoglobulin Database will record treatment re-initiation as a new treatment episode based on a new panel decision. It is expected that the IAP decision will be influenced by the outcome measures recorded on the database. 3 months Treatment reviews should be conducted annually. The National Immunoglobulin Database will record treatment re-initiation as a new treatment episode based on a new panel decision. It is expected that the IAP decision will be influenced by the outcome measures recorded on the database.* Long-term treatment *The primary immunodeficiencies are exempt from funding termination at 1 year. Recommended dosing of immunoglobulin The Second Edition of the Clinical Guidelines did not provide specific dosing recommendations; it is widely accepted that the standard immunomodulatory dose of 2 g/kg is usually divided into five daily infusions of 0.4 g/kg, although some physicians prefer to use two daily doses of 1 g/kg each. The database infusion records were incomplete and, therefore, it was not possible to fully interpret the data and decipher the dosing that had been used. This update to the guidelines now provides specific dosing recommendations for each of the conditions for which prescribing is regarded as appropriate. Immunoglobulin users are expected to record the dosing employed in the national database. CLINICAL GUIDeLINes fOR IMMUNOGLOBULIN Use 1 An ongoing issue for diseases that require long-term immunoglobulin treatment is that once responsiveness to intravenous immunoglobulin (IVIg) is proven for a patient using standard immunomodulatory dosing, the `maintenance' dosing required to maintain the therapeutic response is not well characterised. In this update, the dosing recommendations for some neurological indications include `time to relapse' as the interval between doses. This approach is supported by recent evidence from The Oxford Programme for Immunomodulatory Immunoglobulin Therapy, which was set up to review multifocal motor neuropathy (MMN) and chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) treatment with immunoglobulin. In view of the uncertainty of both remission and disease progression in CIDP and MMN, The Oxford Programme reviewed the dose and infusion frequency of patients on a regular basis and showed that increasing the infusion interval proved successful in some patients and resulted in treatment discontinuation [2]. The study also indicated that the precise dose and infusion interval to keep each patient asymptomatic was not predictable, but the authors suggested a rough guide: patients in whom responses last 20% more than IBW, prescribers should consider using adjusted-bodyweight dosing of immunoglobulin. Infusion rates for intravenous immunoglobulin Initial intravenous infusion rates are low, and if well tolerated, the rate of administration may be increased, as specified in the products' Summary of Product Characteristics (SPC). For certain products, the SPC indicates that if the higher rate is tolerated, the rate may be further increased in primary immunodeficiency (PID) patients to the maximum infusion rate. Higher infusion rates may lead to improved convenience for patients and may reduce nursing time and the need for hospital resources. Infusion rates for each of the licensed immunoglobulins are provided in the table below. Immunoglobulin should be administered according to the manufacturers' recommendations. The table below gives the infusion rates, and the infusion time at maximum infusion rate of 1 g/kg dose in a 70 kg person. Infusion rates Infusion time of 0 g in minutes at max. rate 100 250 500 640 125 200 125 241 83 Product Baxter Kiovig BPL Gammaplex BPL Vigam Biotest Intratect CsL Privigen Grifols flebogamma Grifols flebogamma 10 Octapharma Octagam Octapharma Octagam 10 Initial 0.5 mL/kg/h for 30 mins 0.01?0.02 mL/kg/min for 15 mins 0.01?0.02 mL/kg/min for 30 mins 1.4 mL/kg/h for 30 mins 0.3 mL/kg/h 0.01?0.02 mL/kg/min for 30 mins 0.01 mL/kg/min for 30 mins 1 mL/kg/h for 30 mins 0.01?0.02 ml/kg/min for 30 mins Maximum 6 mL/kg/h (8 ml/kg/h in PID) 0.04?0.08 mL/kg/min 0.04 mL/kg/min (max. 3mL/min) 1.9 mL/kg/h 4.8 mL/kg/h (7.2 mL/kg/h in PID) 0.1 mL/kg/min 0.08 mL/kg/min 5 mL/kg/h 0.12 ml/kg/min 1 CLINICAL GUIDeLINes fOR IMMUNOGLOBULIN Use subcutaneous administration Subcutaneous immunoglobulin (SCIg) as replacement therapy for primary immune deficiency disease and as immunomodulatory therapy for some autoimmune diseases, including peripheral neuropathies, can be a safe, effective, and convenient alternative to intravenous therapy. Subcutaneous administration can offer advantages that may be important for many patients [3]. Although SCIg is typically administered weekly by infusion pump, administration by a rapid push technique may provide a greater degree of convenience, and recent evidence suggests it is a safe and effective method. Seventy-four patients with primary immune deficiency disease received an average SCIg dose of 32 g/month split into an average of three times per week. Volume per site ranged from 3 to 20 mL, typically administered over 5?20 min. Mean serum IgG levels did not differ significantly compared with those receiving infusion and only two patients discontinued therapy because of an adverse event [4]. Recent evidence suggests that individualising the dosage based on measured serum IgG levels and the clinical response is preferable to using mean pharmacokinetic parameters [5]. Findings from the Oxford Self Infusion at Home Programme for CIDP and MMN also suggest that the dose of immunoglobulin and the serum IgG trough level are individual to each patient [2]. Recommendation Prescribers should consider the comparative advantages of intravenous and subcutaneous administration for individual patients requiring immunoglobulin treatment where this is clinically appropriate. Table. Subcutaneous immunoglobulin products licensed in the UK CSL Vivaglobin Baxter Subcuvia Octapharma Gammanorm BPL Subgam CLINICAL GUIDeLINes fOR IMMUNOGLOBULIN Use 1 RefeReNCes 1. NICE clinical guideline 98. Neonatal Jaundice. Nice, 2010. 2. Lucas M, Hugh-Jones K, Welby A, et al. Immunomodulatory therapy to achieve maximum efficacy: doses, monitoring, compliance, and self-infusion at home. J Clin Immunol 2010;30 Suppl 1:S84?9. 3. Berger M. Subcutaneous immunoglobulin replacement in primary immunodeficiencies. Clin Immunol 2004;112:1?7. 4. Shapiro R. Subcutaneous immunoglobulin therapy by rapid push is preferred to infusion by pump: a retrospective analysis. J Clin Immunol 2010;30:301?7. 5. Berger M, Rojavin M, Kiessling P, Zenker O. Pharmacokinetics of subcutaneous immunoglobulin and their use in dosing of replacement therapy in patients with primary immunodeficiencies. Clin Immunol 2011;139:133?41. 1 sUMMARY TABLes PRIMARY AND seCONDARY ANTIBODY DefICIeNCY sTATes selection criteria A specific PID diagnosis must be established by a clinical immunologist Outcome measures are not required Condition s L Outcomes for review Dosing Initiate at 0.4?0.6 g/kg/month; dose requirements may increase and should be based on clinical outcome Initiate at 0.4?0.6 g/kg/month; dose requirements may increase and should be based on clinical outcome Initiate at 0.4?0.6 g/kg/month; dose requirements may increase and should be based on clinical outcome Initiate at 0.4?0.6 g/kg/month; dose requirements may increase and should be based on clinical outcome Primary immunodeficiencies (associated with significant antibody defects) Profound B cell depletion and/or significant antibody deficiency Outcome measures are not required Thymoma with immunodeficiency HSCT in primary immunodeficiencies PID patients undergoing HSCT Outcome measures are not required CLINICAL GUIDeLINes fOR IMMUNOGLOBULIN Use Specific antibody deficiency Approval by a clinical immunologist, AND Severe, persistent, opportunistic or recurrent bacterial infections despite continuous oral antibiotic therapy for 3 months, AND Documented failure of serum antibody response to unconjugated pneumococcal or other polysaccharide vaccine challenge Underlying cause of hypogammaglobulinaemia cannot be reversed or reversal is contraindicated; OR Hypogammaglobulinaemia associated with NHL, CLL, MM or other relevant B-cell malignancy confirmed by haematologist; AND ? Recurrent or severe bacterial infection despite continuous oral antibiotic therapy for 3 months ? IgG 1 dose required if thrombocytopenia persists Clinical suspicion in antenatal or neonatal setting based on clinical and laboratory features: Thrombocytopenia or spontaneous haemorrhage in the foetus; OR Thrombocytopenia with or without haemorrhage in the neonate; OR Unexplained foetal death in a previous pregnancy and the presence of maternal platelet-specific allo-antibodies that are known or suspected to cause this condition (most commonly HPA-1a or HPA-5b) Symptomatic or severe anaemia (Hb 15, acute rising Any significant clearance of C. diff. creatinine and/or signs/symptoms Duration of hospital in-patient stay of colitis) not responding to oral vancomycin 125 mg qds, highdosage oral vancomycin +/- iv metronidazole 500 mg tds is recommended; the addition of oral rifampicin (300 mg bd) or IVIg may be considered. If multiple recurrences, especially if evidence of malnutrition, wasting etc., consider IVIg Severe or recurrent Clostridium difficile colitis 0.4 g/kg, one dose, and consider repeating continued Other selection criteria Diagnosis of streptococcal or staphylococcal TSS, preferably with isolation of organism; AND Failure to achieve rapid improvement with antibiotic therapy and other supportive measures; AND Life-threatening Diagnosis by a dermatologist; AND Involved body surface area > 10%; AND When other treatments are contraindicated; OR The condition is life-threatening Resolution of the disease 2 g/kg, preferably as a single dose, or divided over 3 consecutive days Improvement of FBC, ALK, CPK Reduction in hospital inpatient stay Survival (yes/no) 2 g/kg as a single dose continued Outcomes for review Dosing Condition s L Staphylococcal or streptococcal toxic shock syndrome Toxic epidermal necrolysis, Stevens Johnson syndrome Transplantation (solid organ) AIT Up to 2 g/kg to be repeated as per DSA, in renal desensitisation at 0.1 g/kg for 8?12 doses AMR Up to 2 g/kg to be repeated for 2?3 doses Viral pneumonitis 0.5 g/kg for 5 days CLINICAL GUIDeLINes fOR IMMUNOGLOBULIN Use Antibody Incompatible Transplant AIT and AMR* (AIT) Renal Patients in whom renal, heart or Type of renal transplant lung transplant is prevented HLA class DSA because of antibodies Rejection episodes Patient survival Antibody Mediated Rejection Graft survival (AMR) Renal function = eGFR (MDRD) Patients experiencing steroid Cardiothoracic resistant rejection or where other DSA therapies are contraindicated after Patient survival renal, heart and/or lung transplant Length of ITU and hospital stay Graft function (heart = ejection Viral pneumonitis fraction; lung = spirometry) Patients experiencing viral pneumonitis following heart and/or Viral pneumonitis* lung transplant (viruses to include Cardiothoracic HSV, VZV, CMV, RSV, but excluding Virus type influenza virus) Reversal of radiological infiltrates Length of hospital stay Survival *These parameters will be reviewed after one year, at which time specific outcome criteria will be formulated. CLINICAL GUIDeLINes fOR IMMUNOGLOBULIN Use sUMMARY Of GReY INDICATIONs Grey indications are those diseases for which the evidence is weak, in many cases because the disease is rare. Approval from both the local IAP and the PCT is required for immunoglobulin treatment. In cases of `unlisted' diseases, those not listed in the guidelines are to be considered as Grey. Even if the disease is unlisted, the diagnosis and locally agreed efficacy criteria are to be recorded in the database. Immune-mediated disorders with limited evidence of immunoglobulin efficacy Acute disseminated encephalomyelitis (if high-dose steroids have failed) Autoimmune encephalitis (including NMDA and VGKC antibodies, among others) Catastrophic antiphospholipid syndrome Cerebral infarction with antiphospholipid antibodies Chronic ITP Complex regional pain syndrome CNS vasculitis Intractable childhood epilepsy Neuromyotonia Opsoclonus Myoclonus Post-exposure prophylaxis for viral or pathogenic infection if intramuscular injection is contraindicated, or treatment when hyperimmune immunoglobulins are unavailable Pyoderma gangrenosum Systemic juvenile idiopathic arthritis Systemic vasculitides and ANCA disorders Urticaria (severe, intractable) Presumed immune-mediated disorders with little or no evidence of efficacy Acquired red cell aplasia NOT due to parvovirus B19 Acute idiopathic dysautonomia Aplastic anaemia/pancytopenia Atopic dermatitis/eczema Autoimmune neutropenia Chronic facial pain Diabetic proximal neuropathy Haemolytic uraemic syndrome PANDAS Paraneoplastic disorders that are known not to be B- or T-cell mediated POEMS SLE without secondary immunocytopenias (including juvenile) CLINICAL GUIDeLINes fOR IMMUNOGLOBULIN Use Removed from Grey: ? Secondary antibody deficiencies INDICATIONs fOR WHICH IVIG Is NOT ReCOMMeNDeD (now Blue) ? Acquired vWd (now Blue) ? Post-transfusion hyperhaemolysis (now with haemolytic anaemia) ? Graft versus host disease (delete) ? SLE with secondary immunocytopenias (included in the relevant cytopenias) ? Infection following BMT or HSCT (included in Blue) ? Polymyositis (now Blue) ? Transplantation indications (now Blue) ? Immunodeficiency secondary to paediatric HIV infection ? Autologous BMT ? Adrenoleukodystrophy ? Alzheimer's disease ? Amyotrophic lateral sclerosis ? Chronic fatigue syndrome ? Critical illness neuropathy ? Multiple sclerosis ? Rheumatoid arthritis ? Neonatal sepsis (prevention or treatment) ? Sepsis in the intensive care unit not related to specific toxins or C. difficile ? Asthma ? Graves' ophthalmopathy ? IVF failure ? Recurrent spontaneous pregnancy loss CLINICAL GUIDeLINes fOR IMMUNOGLOBULIN Use Next section contains the replacement pages of second edition CLINICAL GUIDeLINes fOR IMMUNOGLOBULIN Use Update for pages 28?30 IMMUNOLOGY Primary immunodeficiency disorders (associated with significant antibody defects) Antibody deficiencies may arise as primary disorders with a known or suspected genetic basis or secondary to a variety of other diseases, drugs and environmental or iatrogenic factors. They may occur in isolation or in association with defects in other effector components of the immune system (combined defects). Significant primary antibody deficiencies collectively account for the majority of primary immunodeficiency syndromes encountered in clinical practice [1,2]. The hallmark clinical presentation is recurrent or persistent bacterial infection, but these disorders are also associated with a heterogeneous variety of other infectious and non-infectious complications and with a high incidence of chronic, structural tissue damage, particularly in the respiratory tract. Clinical recognition of primary antibody deficiency is frequently delayed with consequent acute and chronic ill health, diminished Common Common variable immunodeficiency group (CVID) X-linked agammaglobulinaemia quality of life, and decreased life expectancy. Primary antibody deficiency can present at any age. Taken together, the primary antibody deficiency disorders account for at least half of all primary immunodeficiency syndromes. For some conditions, internationally-agreed diagnostic criteria have been established [3], but in other disorders formal case-definition criteria are lacking. The evidence base for current practice in the recognition, diagnosis and management of antibody deficiency has recently been reviewed [4]. Disorders which generally require immunoglobulin replacement as a central component of their management are presented below. Diagnosis, particularly of primary deficiencies, is frequently delayed or overlooked [1,5]. Many patients present with established structural tissue damage, especially in the lungs, which is essentially irreversible even with optimal treatment. Diagnostic aims are to a) identify, or exclude, significant antibody deficiency, b) differentiate primary from secondary disease and c) delineate, where possible, a precise diagnosis. Less common Germinal centre class switch recombination defects (`Hyper-IgM syndromes') Other primary antibody deficiency (XLA) (including unclassifiable disorders) Combined immunodeficiencies (including severe combined immunodeficiency (SCID) and unclassifiable disorders) 0 CLINICAL GUIDeLINes fOR IMMUNOGLOBULIN Use The goals of management are to prevent complications or retard their progression, optimise quality of life, working capacity and life expectancy and, in children, ensure optimal growth and development [6]. Replacement therapy with polyclonal human normal immunoglobulin is the cornerstone of management for significant primary antibody deficiency disorders. No viable alternatives exist to this essential, basic component of treatment, particularly in the context of severe, persistent or recurrent bacterial infections. For most patients, replacement therapy is a lifelong requirement. Existing formulations replace deficient IgG only and are given by either intravenous or subcutaneous infusion in a hospital setting or, increasingly, within domestically-based programmes. Subcutaneous and intravenous preparations are therapeutically equivalent [7]. All preparations carry risks of adverse, infusion-related reactions and both real (hepatitis C) and theoretical (vCJD) risks of transmissible disease. Replacement therapy increases life expectancy and reduces the frequency and severity of infections, antibiotic usage and hospital admissions [4]; however, patients remain susceptible to sporadic breakthrough infections [8]. Optimal dosing and target levels for IgG are not known but higher doses are more effective than low-dose regimens in reducing infection rates and risk of chronic tissue damage. However, even apparently adequate treatment may fail to completely retard progression of established disease complications such as bronchiectasis [9]. Replacement therapy is frequently targeted at achieving a sustained or pre-infusion trough serum IgG level within the normal range (6?16 g/L). There is evidence that improved outcomes, particularly in respect of respiratory infection, are associated with higher serum IgG levels up to at least 10 g/L [10]. Dosage should generally be initiated at 0.4?0.6 g/kg/month, but individual patients may require higher doses in the long term. The goal of therapy in individual cases should be to improve clinical outcome rather than achieve a minimum target level of serum IgG [11]. Dose requirements are commonly increased in the context of secondary structural tissue damage (especially in the respiratory tract) or co-existent chronic inflammatory conditions. Risk assessments for ongoing therapy with immunoglobulin should be carried out regularly (including the need to continue with active treatment). Recommendation Replacement immunoglobulin therapy in patients with significant, symptomatic primary defects of antibody production or function should be tailored to individual patient outcomes with the minimum aim of maintaining serum IgG levels within the age-related normal range (grade B recommendation, level IIb evidence). CLINICAL GUIDeLINes fOR IMMUNOGLOBULIN Use 1 Other specific Disorders Thymoma with immunodeficiency (Good's Syndrome) Good's syndrome is a complex CVID-like condition where thymoma is found in association with profound B cell lymphopenia and quantitative or functional antibody deficiency. Infection frequencies correlate better with numerical B-cell depletion than with hypogammaglobulinemia. Thymectomy rarely results in normalisation of immunoglobulin levels and the syndrome may therefore constitute, and be classified as, a primary rather than secondary defect and, in respect of any antibody deficiency, be treated as for other primary antibody defects [2,12]. diagnosis is established. Pre-existing infection in the high-risk situation of a combined primary immunodeficiency reduces the chances of a successful outcome from a haemopoietic stem cell transplant. Treatment with immunoglobulin should be continued following transplantation until reconstitution of B cells and antibody production has been achieved. In some cases, prolonged immunoglobulin replacement therapy is required. Recommendation Immunoglobulin replacement therapy should be considered an important adjunct to haemopoietic stem cell transplantation in the management of some primary immunodeficiency disorders. Duration of treatment should be based on individual reconstitution of B-cell function post-transplantation (grade C recommendation, level III evidence). Recommendation Immunoglobulin replacement is recommended for patients with thymoma associated with profound B-cell depletion and/or significant antibody deficiency (grade C recommendation, level III evidence). specific antibody deficiency Specific antibody deficiency is characterised by an inability to mount adequate humoral responses to polysaccharide antigens, with otherwise normal immunoglobulins [13]. Robust case definition is currently hampered by a lack of consensus on in-vitro diagnostic criteria. Consequently, uniform recommendations for treatment are yet to be developed. Most cases appear to have a relatively mild clinical phenotype (encompassing mainly respiratory infections) which Combined immunodeficiencies requiring haemopoietic stem cell transplantation In this group of disorders, including Severe Combined Immunodeficiency and occurring predominantly in children, immunoglobulin therapy is required as a central measure to protect against infection and should be implemented as soon as possible after the CLINICAL GUIDeLINes fOR IMMUNOGLOBULIN Use can be managed with prophylactic antibiotics and acute treatment of breakthrough infections. Immunoglobulin replacement is reserved for those cases where prophylactic antibiotics fail to control either the frequency or severity of breakthrough infections. Recommendation Immunoglobulin replacement therapy may be required in a proportion of infants with prolonged physiological delay of native immunoglobulin production. Where required, the planned duration of therapy should be defined prior to initiation of active treatment (grade C recommendation, level III evidence). Recommendation Immunoglobulin replacement therapy is recommended in specific antibody deficiency in cases of failure of prophylactic antibiotic treatment where severe, persistent, opportunistic or recurrent breakthrough infections are encountered (grade C recommendation, level III evidence). secondary antibody deficiency Secondary antibody defects are found in a wide range of circumstances (in association with drugs, malignant disease, chronic infections, protein-losing states, systemic inflammatory diseases, trauma and iatrogenic factors such as splenectomy). Infections associated with low measured antibody levels appear to be relatively uncommon in secondary deficiencies, with the exceptions of hypogammaglobulinaemia linked with haematological malignant disease, occasional cases of drug-associated deficiency and rare cases of nephrotic syndrome [15]. Dosage and treatment duration are important factors in drug-associated deficiencies. The deficit may, or may not, be reversible on cessation of therapy. The selection criteria for IVIg to treat hypogammaglobulinaemia linked with haematological malignancy includes the requirement to document failure of serum antibody response to Transient hypogammaglobulinaemia of infancy Hypogammaglobulinaemia in young children is often transient, reflecting delayed maturation of the immune system. In the majority of such children, immunoglobulin levels normalise by the age of around 4 years, but in a minority this can be delayed until 11 or 12 years of age. Most of these children are affected by frequent, minor infections, which can be managed with early, acute antibiotic usage or antibiotic prophylaxis [14]. However, in a small minority, infections are more severe and cannot be controlled or prevented with antibiotics alone. In such circumstances, immunoglobulin replacement is required until normalisation of endogenous antibody production. CLINICAL GUIDeLINes fOR IMMUNOGLOBULIN Use unconjugated pneumococcal or other polysaccharide vaccine challenge. Although this may sound onerous from a practical point of view, the intention is simply to ensure that a patient's response to polysaccharide vaccination is included as a component of the evaluation for IVIg therapy. For example, if a patient received pneumococcal polysaccharide vaccine 3 months previously and their specific antibody levels are low, it would seem reasonable to prescribe immunoglobulin. However, if the patient was vaccinated many years previously, it would be reasonable to vaccinate again and assess the functional antibody response before immunoglobulin was prescribed. Recommendation Immunoglobulin replacement therapy is recommended in secondary antibody deficiency if the underlying cause of hypogammaglobulinaemia cannot be reversed or reversal is contraindicated, or is associated with B-cell malignancy where severe infections with encapsulated bacteria are persistent despite prophylactic antibiotic therapy (grade C recommendation, level III evidence). RefeReNCes 1. Eadles-Perner A-M, Gathmann B, Knerr V, et al. The European internet-based patient and research database for primary immunodeficiencies: results 2004-06. Clin Exp Immunol 2007;177:306?12. 2. Geha RS, Notarangelo LD, Casanova JL, et al. for the International Union of Immunological Societies Primary Immunodeficiency Diseases Classification Committee. Primary immunodeficiency diseases: an update from the International Union of Immunological Societies Primary Immunodeficiency Diseases Classification Committee. J Allergy Clin Immunol 2007;120:776?94. 3. Conley ME, Notarangelo LD, Etzioni A. Diagnostic criteria for primary immunodeficiencies. Clin Immunol 1999;93:190?7. 4. Wood P, Stanworth S, Burton J, et al. Recognition, clinical diagnosis and management of patients with primary antibody deficiencies: a systematic review. Clin Exp Immunol 2007;149:410?23. 5. Seymour B, Miles J, Haeney MR. Primary antibody deficiency and diagnostic delay. J Clin Pathol 2005;58:546?7. 6. Folds JD, Schmitz JL. Clinical and laboratory assessment of immunity. J Allergy Clin Immunol 2003;111(Suppl. 2):S702?11. 7. Chapel HM, Spickett GP, Ericson D, et al. The comparison of the efficacy and safety of intravenous versus subcutaneous immunoglobulin therapy. J Clin Immunol 2000;20:94?100. 8. Pettit SJ, Bourne H, Spickett GP. Survey of infection in patients receiving antibody replacement treatment for immune deficiency. J Clin Pathol 2002;55:577?80. CLINICAL GUIDeLINes fOR IMMUNOGLOBULIN Use 9. Kainulainen L, Varpula M, Liippo K, et al. Pulmonary abnormalities in patients with primary hypogammaglobulinemia. J Allerg
Url: /Media/SUHTExtranet/TrustMedicinesFormulary/Forms/DH-IVIg-approved-indications-Full-Guidance-July-2011.pdf

1 to 3 of 3

Browse site A to Z

Search results

Press release: Spinal surgeons use revolutionary lifelike simulator to test operations

UHS register of interests June 2025

DH IVIg approved indications full guidance July 2011

Site policies

Contact details

Useful links