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The Flange FITS Guide for optimal comfort, efficiency and milk yield

Description: THE FLANGE FITS™ GUIDE for optimal comfort, efficiency and milk yield a results-based method for pumping Feel Intensity Tempo Supply SIDE VIEW PARENT’S VIEW ©Copyright Babies in Common 2023 Jeanette Mesite Frem, IBCLC. Reproduction permitted with attribution. April 2023. Best Fit • only nipple pulled into tunnel • sides of nipple touch walls of tunnel • nipple moves a little bit back and forth in tunnel • milk sprays during pumping • best to pump 15-20 minutes (both sides at same time) • feels like nothing or a gentle tug Too Large Much Too Large • might hurt • might get less milk or more drips than sprays • nipple might move side to side in tunnel • pumping might take a long time • more chance for nipple swelling and damage • areola goes into tunnel and can swell • outdated recommendations will indicate this as best fit; newer clinical evidence finds this too large babiesincommon.com Feel of the flange (size, shape, material) Which flange size, shape or material is the most comfortable (but also gets out the most milk)? Often, a flange that is closest to the actual size of the nipple feels best (and gets the most milk out). Start by measuring how wide the tip of each nipple is (left can be different than right). 1. Gently touch/tug the nipple to help it stick out a bit. 2. Use a tool with centimeters (cm) or millimeters (mm). Start with 0 next to one edge of the nipple tip. The tool does not need to touch the nipple. 3. Turn on the pump on a low vacuum/intensity level and try pumping with 2 or 3 hard plastic flange sizes: one a little smaller than the nipple, one about the same size, and one a little bigger than the nipple. • Best fit or optimal fit: The sides of the nipple touch the sides of the flange tunnel and the nipple gently glides a little bit back and forth. It should also be comfortable and milk should come out easily. • Too small: The nipple will not move easily in the tunnel and less/no milk comes out. • Too large: It may hurt, make the nipple get bigger than it usually is (swollen) and less milk comes out. A thin layer of coconut oil or nipple balm on the bend of the flange can increase comfort. Pumping should feel good and get plenty of milk out! Intensity of the pump (vacuum pressure/pull) How strongly does the pump pull on the nipple? The intensity of the pull of the nipple into the flange tunnel depends on the pump. Not all pumps are the same. Not all pumping parents need a strong pull when pumping. Once milk starts spraying and there is complete comfort, stay on that vacuum level and play with the pump cycle speed. Increase the intensity of the pull during the pumping session if it is comfortable and you see more milk sprays. Pumping should be comfortable from start to finish – it should not be something to "tolerate". Nipples should feel good when the pumping session is done. The size of the nipple (width) should be about the same as before pumping (but the nipple may be longer after pumping). Tempo of the pump (cycle speed, rhythm, vibration) What is the best tempo of the pump? The one that helps the most milk come out. The tempo is not only the speed, or cycle, but also the rhythm. Some pumps have simple tempos and others have options. Think of tempo like music for dance. Some tempos are faster, slower, or a combination of fast and slow. See what works best for your body with the pump you have. Some pumps have more of a pull-release rhythm and others have more of a vibration. Helpful Tips: • Start on the fastest tempo and after milk is coming out for 20-30 seconds, change to a slower tempo – more sprays should come out. • If sprays stop at some point during the pumping session, change the tempo back to faster for 1-2 minutes and then back to slower again. There are people who stay on a faster tempo the entire pumping session—play with the tempo to discover what works best to get the most milk out but with comfort. Some parents may need to find a different pump that works better for their body. A pumping session ideally would last 15-20 minutes. Supply of milk (drips, dribbles; strong sprays are ideal) How much milk should someone get when pumping? The answer depends on many factors but the goal is to see sprays of milk during pumping. Drips and dribbles are fine for part of a pumping session but, ideally, sprays would be seen/heard for most of the pumping session. Helpful Tips: • Many people find they get the most milk when they have the best flange fit. They may also get the same amount or more milk in a shorter amount of time when pumping than with flanges that are too large. • Hands-on pumping during pumping and hand expression of milk after pumping can help get more milk out. • The left breast may make more or less milk than the right • It's normal to get more milk in the morning hours. If you want to make more milk overall, it's best to seek out help from a lactation professional who specializes in pumping and milk supply. What about silicone flanges and inserts? For parents who wish to get more milk during pump sessions but who want to try silicone inserts or silicone flanges, it is best to try hard plastic flanges first to find the ideal size for each nipple. Then try silicone flanges and/or inserts and see how the comfort and amount of milk pumped compares to using the best fitting hard flange. Many people find that they get more milk with a hard flange that is the optimal size, and they are completely comfortable. Need help? Find a lactation professional who has experience observing pumping sessions with varied flange options. They can do an in-person or video meeting to help find the optimal flange size for you. If you have questions or want help finding someone near you who can help with flange fitting, email jeanette@babiesincommon.com. The Flange FITS™ Guide by Jeanette Mesite Frem MHS, IBCLC, RLC, CCE. Reproduction and distribution permitted with attribution. No editing or cropping permitted. Editing Assistance: Nikki Lee, RN, BSN, MS, IBCLC, RLC, CCE & the Washington State Dept of Health WIC Program. Stephanie Audette Connor, graphic designer. areola nipple tip Measure nipple tip before pumping to estimate which flange sizes to try. 1cm = 10mm. Flange sizes are in mm. page 2/2 | v.2, 4/2023
Url: /Media/UHS-website-2019/Docs/Services/Maternity/The-Flange-FITS-Guide-for-optimal-comfort-efficiency-and-milk-yield.pdf

Good health care for all

Description: Good health care for all What can I expect from the NHS? Alison Giraud-Saunders February 2012 1 Who helped with this book Money for this book was given by the Department of Health’s Valuing People Now programme, which ended in March 2011 Mark Bradley, Health Facilitator Network Stephan Brusch, NHS London Sue Carmichael (when she worked at the Department of Health) Janet Cobb, UK Health and Learning Disability Network Marcella Cooper and friends: people with learning disabilities and family carers from Barking and Dagenham and from Maidstone Beverley Dawkins, Mencap Hanifa Islam, Foundation for People with Learning Disabilities Allyson Kent, Access to Acute Network Hannah Rutter (when she worked at the Department of Health) Christine Towers, Foundation for People with Learning Disabilities Sue Turner, Improving Health and Lives/National Development Team for Inclusion Claire Walsh, Mental Health Foundation Richard West, Self advocate Made with Photosymbols 2 What is in this book? 05 About this book 06 What is the NHS? 09 Looking after your health 14 Making decisions about your health 15 Using the NHS 18 Going to the doctor or nurse 3 24 Going to hospital for an appointment 30 Staying in hospital 38 How to get help in a hurry 40 Who can help you? 42 Where you can get more information 44 What some of the words mean 4 About this book This book is for people with learning disabilities, family carers and anyone who supports a person with learning disabilities. This book is to help you get a good service from the National Health Service (the NHS). The book is mainly about health services for people who are aged 18 or more. It is mainly about services from your family doctor (GP) and hospitals. Some health services are just for people with learning disabilities. They are usually in the Community Learning Disability Team. You can get good information from them. You may be able to get extra help from them if you need it. You might look at the book on your own. Or you can ask someone to look at the book with you and talk about what it says. You can look at everything in the book. Or you can look at one bit that is right for you. Some words to do with health and the NHS are a bit hard. Harder words are shown like this: NHS Constitution. There is a list of these words at the back of the book to tell you what each word means. 5 What is the NHS? Some words to do with health and the NHS are a bit hard. Harder words are shown like this: NHS Constitution. There is a list of these words at the back of the book to tell you what each word means. The NHS is made up of lots of different services. For example: - your family doctor (GP) and practice nurse – where you can get health checks and treatment when you are ill - optician (optometrist) – where you get eye tests and glasses (spectacles) - dentist – where you get your teeth and mouth checked - chemist (pharmacist) – where you can ask for health advice and get some medicines like headache tablets Here are some other NHS services your doctor or nurse might arrange for you: - health promotion – where you can get advice to help you with healthy living 6 - screening services – you might get asked by your doctor to have a special check that can find an illness like cancer very early, so it can be treated - community health services like the district nurse, podiatrist (foot care), Macmillan nurse (cancer) - audiology – where you can get your hearing checked and get hearing aids - services that just work with people with learning disabilities, like the Community Learning Disability Team – the team often includes health staff like learning disability nurses, physiotherapist, occupational therapist, speech and language therapist, psychologist, psychiatrist - mental health services (psychiatrist, nurse or psychologist) – help if you have a mental health problem - hospitals – where you go to have special health tests or see different doctors. Or you might have to stay in hospital for extra help 7 - children’s health services – school nurse, children’s doctor (paediatrician), mental health services for children and young people (CAMHS) - ‘transition’ teams for young people who are nearly adults – some areas have a special transition nurse if you have lots of different health needs All these services work under the NHS Constitution. This helps to make health services better and fair for everyone. You can get more information about the Constitution from this website: http://tinyurl.com/cgveofa The NHS has to follow the laws about being fair to everyone (the Equality Act 2010). For example, the NHS must try to make it as easy for disabled people as anyone else to use health services. This is called ‘making reasonable adjustments’. You can find more information from this website: http://tinyurl.com/cpvw6gx The rest of this book has lots of ideas about reasonable adjustments you can ask for. If you need some extra help, please ask someone! 8 Looking after your health Some words to do with health and the NHS are a bit hard. Harder words are shown like this: NHS Constitution. There is a list of these words at the back of the book to tell you what each word means. There are lots of things you can do yourself to look after your health. For example: - eating healthy food (like salads and vegetables) - taking exercise (like having a walk every day) - not smoking or drinking too much alcohol - getting health checks with your doctor, dentist and optician at least once a year - looking after your feet, especially if you have a health problem called diabetes - looking after the shape of your body (posture) 9 - cleaning your teeth at least twice a day - having a good wash every day (like a bath or a shower) It is important for family carers to look after their health too, including carers who have learning disabilities You can get help from the NHS to keep healthy. Here are some ideas about things you can ask for: - information in easy read - information about groups you can join, like walking exercise groups and groups to help people lose weight - information about where people with learning disabilities can go for dentists and opticians - regular checks of your ears if you get a lot of earwax 10 - information in big print and easy read about any medicines you have to take You can get a health check every year from your family doctor and practice nurse. This is a good idea to help you keep healthy. You can ask for a health check if you have not had one. A health check includes things like: - checking how tall you are and how much you weigh - tests for common health problems like high blood pressure - checking for different illnesses - checking what medicines you take. Lots of people like to have a Health Action Plan. If you have not got one, you can ask the Community Learning Disability Team about them. A Health Action Plan holds all the things that are important about your health. It also holds information about things you might do to keep you healthy. For example, you might decide you want to lose some weight. Then you would put in your Health Action Plan how you are going to do that and who will help you. Lots of places have a person called a Primary Care Liaison Nurse. (Sometimes they are called a Health Facilitator). They may work in the Community Learning Disability Team. You can ask them to help you to think about your health. You can also ask them for help with getting health care, from your doctor or the hospital. 11 Here is an example of a Health Action Plan: Sharifa’s Health Action Plan Sharifa has a health problem called diabetes. Her plan says: - I will not eat sweets or cakes. My friend Hanifa will help me to stay away from those shelves in the shop - I will get some easy read information on healthy eating for people with diabetes. The diabetes nurse will help me with this - The diabetes nurse will make sure I get my blood, feet and eyes checked regularly - Sue, the practice nurse, will help me make all these appointments. She will text me the day before each appointment to remind me to go - The diabetes nurse will help me join a group of other people who have diabetes so we can support and learn from each other. Sharifa helps to look after her mum, who has diabetes too. So Sharifa’s plan also says: - I will make a plan with Sue, the practice nurse, for things I need to do to help my mum keep healthy - Sue will help me ask for a carer’s assessment from Social Services. 12 Websites where you can get more useful information - Lots of easy read information about health: www.easyhealth.org.uk - Information about eyes: http://www.lookupinfo.org/ - Information about healthy eating (not easy read): http://tinyurl.com/cvjr2p6 - Information about Health Action Plans: http://tinyurl.com/dymv5c6 - Information about looking after body shape (posture): http://tinyurl.com/cb898km - Lots of information about health and health care: NHS Choices website (not easy read) http://tinyurl.com/c38t54 - Information about health checks: Health Screening Template Part one http://tinyurl.com/ckzowyf 13 Making decisions about your health ‘Mental capacity’ means being able to make decisions for yourself. There is a law called the Mental Capacity Act. It says you should get help if you need it to make a decision for yourself. A doctor or another health worker might ask you to consent to some treatment for your health. This means asking you to say yes or no. You can do this if you can make the decision yourself. Sometimes it is very hard to make a decision yourself about your health. You might need a doctor or another health worker to make a decision for you. If a doctor or another health worker makes a decision for you, they must make a decision in your ‘best interests’. This means doing what is right for you. They should talk to you and to people who know and care about you to find out what is right for you. There is an easy read leaflet about the Mental Capacity Act. You can get it from this website: http://tinyurl.com/c5h9e2v 14 Using the NHS Some words to do with health and the NHS are a bit hard. Harder words are shown like this: NHS Constitution. There is a list of these words at the back of the book to tell you what each word means. There are some important things that people with learning disabilities say about using any bit of the NHS. And there are some things you can ask for that might help you! It is your right to ask for help like this. Services should try hard to make changes like these. They are called reasonable adjustments. These are just a few ideas. Maybe they will get you thinking of more things that would help. It is a good idea to tell them you have a disability, so they know you might need some extra help. You can get an easy read book called “Questions to ask when you go to the doctor or to a hospital”. You can get it from this website: http://tinyurl.com/6e4nknd Lots of family carers and carers with learning disabilities also say: - Health staff try hard to listen to the person with learning disabilities. That is good, but they need to listen to me too. Sometimes I know things about my son or daughter that the doctor needs to know. It may help to write things down before you see the doctor or nurse. 15 16 Things people say are hard I cannot understand the letters they send me Ideas that might help you Ask them to use easy read when they write to you. Or you could ask them to phone you or send a text message It is difficult to make an appointment. The phone system is too hard! And I cannot use the computer Ask if there is a phone number you can ring that goes straight to the receptionist The receptionist is not very helpful Before you go, think about what you want to say. Be polite but firm. Ask them to help or ask someone to help you write down what you want I find waiting difficult. If I come at the right time, I do not want to have to wait in a crowded room Ask if you can have the first appointment, or the last one when most people have left. Ask if there is somewhere private you can wait I sometimes miss my appointment time because I do not hear the receptionist call my name. There are lights that flash too, but I do not know what they mean Ask the receptionist to come over and tell you when to go in Things people say are hard Ideas that might help you Everyone is in too much of a hurry. I need some time to think what to say Ask for a longer appointment, maybe at the end of the day. This is called a “double appointment” They do not have the right equipment to help me in and out of my wheelchair Ask them to make sure they have the right equipment. Write down what equipment you need so they know what to have ready I have asked for help, but nothing has changed Tell them the law says they should make ‘reasonable adjustments’ for disabled people. Ask for a leaflet about ‘how to complain when you are not happy’. Remember, you can ask for this in easy read! 17 Going to the doctor or nurse Some words to do with health and the NHS are a bit hard. Harder words are shown like this: NHS Constitution. There is a list of these words at the back of the book to tell you what each word means. There are some important things that people with learning disabilities say about going to the doctor or nurse. And there are some things you can ask for that might help you! It is your right to ask for help like this. Services should try hard to make changes like these. They are called reasonable adjustments. These are just a few ideas. Maybe they will get you thinking of more things that would help. It is a good idea to tell them you have a disability, so they know you might need some extra help. You might like to look first at the ideas about using any bit of the NHS. Some of those ideas might help with going to the doctor – like making an appointment. You can get an easy read book called “Questions to ask when you go to the doctor or to a hospital”. You can get it from this website: http://tinyurl.com/6e4nknd 18 Things people say are hard It is a bit scary going to the doctor I really cannot go to the surgery. It is too difficult for me Ideas that might help you Ask if you can visit the surgery (where the doctor works) when it is quiet. You could look at the room where you will see the doctor. You could look at equipment like: - the machine that the nurse uses to check your blood pressure - scales to check your weight - the bed the doctor may ask you to lie on to look at part of your body You may be able to ask the doctor to visit you at home. It is not easy for them to do this. They will only agree if it is really difficult for you to go to them because of your health problems or disability The doctor speaks to my mum or my support worker instead of me. They do not try to understand what I have to say Before you go, think about what you want to say. You could take your Health Action Plan to show the doctor. Be polite but firm – you could say: “I am the one you need to talk to” 19 20 Things people say are hard The doctor speaks too fast and uses long words Ideas that might help you Ask them to slow down and use easy words. Ask for information in easy words to take away, so you can take it in at your own pace I need a longer time to say what I want to say and to understand what the doctor is saying Ask for a longer time (“double appointment”) when you make your appointment. Ask for information in easy words to take away, so you can take it in at your own pace Sometimes there are things I want to ask that are private. I do not want to ask while my mum is there Ask to see the doctor or nurse on your own. You can agree with them what will be kept private Every time I go, I see a different person. I have to explain all over again Ask to see the same doctor or nurse each time. You could take your Health Action Plan to show them too Here is an example of making an agreement with your doctor: Earl’s agreement with his doctor’s surgery It is important for Earl to know exactly what is happening. Earl gets very upset if he has to wait without being kept informed. Earl’s support worker helped him make an agreement with the doctor’s surgery. This helps Earl know what to expect, and also what he needs to do: - You will give me an appointment the same day or the next day if you can. If you cannot do this, I will know you have done your best - You will tell me exactly what time to come. I will be there. You will do your best to see me at that time. If you cannot do this, you will tell me how long I have to wait. I will do my best to keep calm - You will try to make sure I see the same doctor each time - You will give me time to say what I need to say or to ask questions. I may ask my support worker to say some things for me - I will bring my Health Action Plan to remind you what is important to me - If you need to talk to my mum about my health, you will ask me first and tell me why you need to do this - You will talk to me and use easy words - You will ask if I would like to take information away with me, in easy words - You will tell me what will happen next 21 Lots of family carers and carers with learning disabilities also say: - The doctor and nurse try hard to listen to the person with learning disabilities. That’s good, but they need to listen to me too. Sometimes I know things about my son or daughter that the doctor needs to know - My son or daughter can decide some things, if they are explained very carefully. Or a big decision might have to be made by the doctor, after talking to all of us who know my son or daughter well. This is called ‘best interests’. Sometimes I have to remind the doctor about the Mental Capacity Act. You can get more information about the Mental Capacity Act at this website: http://tinyurl.com/bvueljs Here is a link to a flowchart about ‘best interests’ decisions: http://tinyurl.com/cc96w4f Family carers can ask their son or daughter’s doctor or nurse to include them properly. This might mean having an appointment at a time that is right for the family carer. 22 Lots of doctors and nurses also say: - It’s really hard to know what to do if a person with learning disabilities can’t tell me what’s wrong and the support worker is from an agency and doesn’t know anything! - I’m not sure if I explain everything well enough, so the person will know what to do - I’m not sure how much to tell the person’s family or support workers - I’d like some help to find easy read information about common health problems Doctors and nurses can ask their local Community Learning Disability Team or Learning Disability Primary Care Liaison Nurse for help. There is easy read information about common health problems at these websites: www.easyhealth.org.uk http://tinyurl.com/5rkdcvf www.changepeople.co.uk 23 Going to hospital for an appointment Some words to do with health and the NHS are a bit hard. Harder words are shown like this: NHS Constitution. There is a list of these words at the back of the book to tell you what each word means. There are some important things that people with learning disabilities say about going to hospital for an appointment. And there are some things you can ask for that might help you! It is your right to ask for help like this. Services should try hard to make changes like these. They are called reasonable adjustments. These are just a few ideas. Maybe they will get you thinking of more things that would help. It is a good idea to tell them you have a disability, so they know you might need some extra help. You might like to have a Hospital Passport. This is a book to hold important information about you and your health. Sometimes the book is called different things (like Hospital Book or Patient Passport). You can see some Hospital Passports on this website: http://tinyurl.com/bmtzbdz You might like to look first at the ideas about using any bit of the NHS. Some of those ideas might help with going to hospital – like asking for easy read letters or extra time. You can get an easy read book called “Questions to ask when you go to the doctor or to a hospital”. You can get it from this website: http://tinyurl.com/6e4nknd 24 Things people say are hard My own doctor knows me well and knows how to make things easy for me. Will the hospital know this too? I need to have several different tests, but it is difficult for me to keep travelling to the hospital Ideas that might help you Ask your doctor to tell the hospital what help you need, before you go. You can take your Communication Passport or Hospital Passport if you have one. (Sometimes these are called different names) Ask if the hospital has an ‘acute liaison nurse’. This is a nurse who tries to make things in hospital easier for people with learning disabilities. Or you can ask for the ‘safeguarding’ nurse Talk to someone at the hospital before the day of your appointment to let them know if you need any special arrangements Ask if all the tests and appointments can be on the same day Ask if you can have help with travel to the hospital It is quite scary going to hospital and having tests Ask if you can have some information to look at before you go. This could be in easy read, or perhaps a DVD Ask someone you trust to help you look at the information and think about the questions you want to ask Ask if you can visit the hospital before you go for the proper test. You could ask to see the room where you will be seen, or the machine that might be used for a test Ask if they can advise you about how to relax. There might be exercises you can do to help you be less anxious 25 26 Things people say are hard It is quite hard to find your way around at the hospital It can be hard to understand what doctors are talking about Ideas that might help you Ask if there are ‘buddies’ (people who can help you find your way round). Or visit the hospital before your appointment day so you can figure out how to get around the hospital. Most hospitals have ‘help’ desks where you can ask for help like this. Ask them before you visit and they may be able to help you to find your way on the day of your appointment Ask them to slow down and use easy words. Ask for information in easy words to take away, so you can take it in at your own pace Ask questions about the results of the tests – what do they mean? Ask questions about the choices for treatment – what is good or bad about them? I do not understand the information they Ask for information in easy read send after I have had tests Ask to have someone explain the test results to you Here is an example about visiting hospital: Earl’s excellent visit to hospital The doctor said Earl needed to have some tests at the hospital. Earl felt quite nervous about that. His doctor talked to him about the tests and gave Earl some information in easy words and pictures. The doctor said he would write to the hospital and tell them that Earl had a learning disability and would need some extra help. Earl’s support worker, Jason, helped him look at the easy read information and they talked about what it meant. Earl asked Jason to phone the hospital to talk about the help Earl would need. Jason did this and was put through to the Acute Liaison Nurse, Ellie. Ellie said she would help make special arrangements for Earl. The hospital arranged for all Earl’s tests to be done on one day. They sent him a DVD with more information about the tests. They sent him a text the day before, to remind him what time to arrive. When Earl arrived at the hospital he was met by a ‘buddy’. This person was a volunteer at the hospital. She helped Earl get to the right places at the right times. The hospital staff who did the tests all knew that Earl needed some extra help to understand what was happening. They talked to him in easy words. They checked that he agreed to the tests. They let him look around and settle before doing the tests. The last person Earl saw for tests gave him a big card to remind Earl to make an appointment with his own doctor, to talk about the test results. After all the tests were done Earl’s ‘buddy’ helped him find his way back to the hospital entrance, where Jason was waiting for him. Earl said: “Everything worked right!” 27 Lots of family carers and carers with learning disabilities also say: - The doctor and nurse try hard to listen to the person with learning disabilities. That is good, but they need to listen to me too. Sometimes I know things about my son or daughter that the doctor needs to know - My son or daughter can decide some things, if they are explained very carefully. Or a big decision might have to be made by the doctor, after talking to all of us who know my son or daughter well. This is called ‘best interests’. Sometimes I have to remind the doctor about the Mental Capacity Act. You can get more information about the Mental Capacity Act at this website: http://tinyurl.com/bvueljs Here is a link to a flowchart about ‘best interests’ decisions: http://tinyurl.com/cc96w4f 28 Family carers can ask the hospital to include them properly. This might mean having an appointment at a time that is right for the family carer. Lots of doctors and nurses also say: - It’s really hard to know what to do if a person with learning disabilities can’t tell me what’s wrong and the support worker is from an agency and doesn’t know anything! - I’m not sure if I explain everything well enough, so the person will know what to do - I’m not sure how much to tell the person’s family or support workers - I’d like some help to find easy read information about common health problems. Doctors and nurses can ask their local Community Learning Disability Team or Learning Disability Primary Care Liaison Nurse for help. There is easy read information about common health problems at these websites: www.easyhealth.org.uk http://tinyurl.com/5rkdcvf www.changepeople.co.uk 29 Staying in hospital Some words to do with health and the NHS are a bit hard. Harder words are shown like this: NHS Constitution. There is a list of these words at the back of the book to tell you what each word means. There are some important things that people with learning disabilities say about staying in hospital. And there are some things you can ask for that might help you! It is your right to ask for help like this. Services should try hard to make changes like these. They are called reasonable adjustments. These are just a few ideas. Maybe they will get you thinking of more things that would help. It is a good idea to tell them you have a disability, so they know you might need some extra help. You might like to look first at the ideas about using any bit of the NHS, or going to hospital. Lots of things people say about going to hospital are the same as they say about staying in hospital. So you can try out some of the same ideas that might help – like asking for easy read letters or extra time. 30 Things people say are hard I am really picky about what I eat. I might get upset if I am given the wrong food I need people with me who know me well Ideas that might help you You can put this in your Hospital Passport, if you have one. (Sometimes these are called different names) It is a good idea to talk to someone at the hospital about this before you go in to stay. Ask to talk to PALS or the Acute Liaison Nurse. Or the ‘safeguarding’ nurse Take a food plan into hospital Ask if your family can stay with you in hospital, or your support worker if you have one I need help to eat and drink. If I do not get help, I might choke. Or I might not have any food or drink You can put this in your Hospital Passport, if you have one. (Sometimes these are called different names) It is a good idea to talk to someone at the hospital about this before you go in to stay. Ask to talk to PALS or the Acute Liaison Nurse. Or the ‘safeguarding’ nurse I know what is important to me, but I need a lot of help to make people understand me You can have a Hospital Passport or a Communication Passport. This can tell people about how you tell them what you want. (Sometimes these are called different names) 31 32 Things people say are hard I need a lot of help to understand what is happening Ideas that might help you You can have a Hospital Passport or a Communication Passport. This can tell people how they should give you information. (Sometimes these are called different names) I can make decisions about my health if things are explained with easy read. You need to give me time to understand I know there are some big decisions that are too hard for me You can have a Hospital Passport or a Communication Passport. This can tell people how they should give you information. (Sometimes these are called different names) You can ask people who know you well to help the hospital doctors and nurses to make good decisions for you. This is called ‘best interests’ I need a lot of help with personal care You can put this in your Hospital Passport, if you have one. (Sometimes these are called different names) It is a good idea to talk to someone at the hospital about this before you go in to stay. Ask to talk to PALS or the Acute Liaison Nurse. Or the ‘safeguarding’ nurse Things people say are hard I do not feel very safe in a ward with other people I find being in a noisy ward very difficult. I get upset Ideas that might help you It is a good idea to talk to someone at the hospital about this before you go in to stay. Ask to talk to PALS or the Acute Liaison Nurse. Or the ‘safeguarding’ nurse. They might suggest you stay in a “side ward”. This is a room off the main ward It is a good idea to talk to someone at the hospital about this before you go in to stay. Ask to talk to PALS or the Acute Liaison Nurse. Or the ‘safeguarding’ nurse. They might suggest you stay in a “side ward”. This is a room off the main ward It is important that you understand what help I will need when I leave hospital I want to know what will happen next! Ask about plans for you leaving hospital. You might need to keep taking some medicine. You might need some extra help at home for a while. You can ask the hospital staff to talk to your family or your support staff about this too. Ask for information in easy read. If you need to go for a check-up, ask for help to make the appointment 33 You can get an easy read book called “Questions to ask when you go to the doctor or to a hospital”. You can get it from this website: http://tinyurl.com/6e4nknd Here is an example about staying in hospital: Michael’s good stay in hospital Michael was born with a health problem called Tuberous Sclerosis. This means he has quite a few health problems. He has complex epilepsy (fits) and his kidneys are not working properly. Michael does not speak, but he loves to join in with whatever is going on in his noisy family! Michael lives with his family and gets support from two Personal Assistants. Michael’s family were worried when they heard he would have to go to hospital and stay there for an operation. Michael had a bad time when he had to stay in hospital before. This time the Community Learning Disability Team asked their Primary Care Liaison Nurse, Sam, to work with Michael, his family and the hospital to make a plan for his stay. Sam came to Michael’s house to meet him and his family and Personal Assistants. They talked about what had gone wrong last time, and what Michael would need this time. Sam helped them to make a Hospital Passport for Michael. They wrote down all the things that were important to Michael, like how to help him relax. They wrote down all the things that were important to keep Michael safe, like how to help him to eat without choking. Sam went to talk to the Acute Liaison Nurse at the hospital. They looked at Michael’s Hospital Passport together. They talked about all the arrangements that would be needed to make Michael’s stay a success. Staff on the ward thought Michael should go into a side room. Sam thought Michael might like the main ward better, as there was more going 34 on. Staff on the ward were worried that they would not have enough time to support Michael well at important times like mealtimes. Sam said the hospital should pay for one of Michael’s Personal Assistants to go in to support him. The hospital did not want to do this at first. The Acute Liaison Nurse talked to the Patient Advice and Liaison Service (PALS) and persuaded them to agree. On the day that Michael went into hospital the Acute Liaison Nurse met him and his family on the ward. Michael met his ‘named nurse’ from the ward team. He gave her his Hospital Book. She agreed to tell the other nurses how important it was to support Michael using all the information in his Hospital Passport. She agreed to speak to Michael’s family every day. She made a plan with Michael’s Personal Assistant, to agree who would do what. The Personal Assistant showed her how to talk to Michael while she was working with him. Before Michael’s operation all the doctors and nurses got together to make sure they had a good plan for him. They invited his family and the Acute Liaison Nurse. They made sure everyone agreed that the operation was in Michael’s best interests. They talked about how to make sure Michael was supported while he waited for the drug (anaesthetic) to put him to sleep before the operation, and while he was waking up after the operation. They talked about what would happen after the operation, and what Michael and his family would need when he went home. The operation went OK, but that night the nurses were worried about Michael. They called his family and his mum came to the hospital. They offered her a comfy chair by Michael’s bed and a cup of tea. They checked during the night to see if she wanted anything else, and made sure she knew where the toilets were. They gave her a pass for the car park. In the morning Michael was a bit better. The Acute Liaison Nurse popped in every day to make sure things were going OK. Before Michael was due to go home she got everyone together again and they went through all the plans. They agreed who would sort out some new equipment 35 Michael would need at home. They agreed who would speak to the district nurse about checking on him at home. They arranged some training for Michael’s family and Personal Assistant about the new equipment. They fixed a date for Michael to come back for a check-up. Michael’s family were really pleased with how this stay in hospital went. They said a big ‘thank you’ to all the hospital staff. Lots of family carers and carers with learning disabilities also say: - The doctor and nurse try hard to listen to the person with learning disabilities. That is good, but they need to listen to me too. Sometimes I know things about my son or daughter that the doctor needs to know - My son or daughter can decide some things, if they are explained very carefully. Or a big decision might have to be made by the doctor, after talking to all of us who know my son or daughter well. This is called ‘best interests’. Sometimes I have to remind the doctor about the Mental Capacity Act - The hospital seem to assume that I or a support worker will come and look after my son or daughter. They need to talk to us about what is possible and reasonable! - I have needs as a carer. If I need to stay with my son or daughter, the hospital should help me with parking, somewhere to rest and access to food and drinks You can get more information about the Mental Capacity Act at this website: http://tinyurl.com/c8g2bzn Here is a link to a flowchart about ‘best interests’ decisions: http://tinyurl.com/d7w4t6v 36 There is a guide for families and hospitals about supporting people with learning disabilities in hospital. You can find it at this website: http://tinyurl.com/bwocmba Lots of doctors and nurses also say: - It’s really hard to know what to do if a person with learning disabilities can’t tell me what’s wrong and the support worker is from an agency and doesn’t know anything! - I’m not sure if I explain everything well enough, so the person will know what to do - I’m not sure how much to tell the person’s family or support workers - I don’t know how much I can ask the person’s family or support workers to help them while they are in hospital - I’d like some help to find easy read information about common health problems - I’m not sure what help the person will get when they leave hospital Doctors and nurses can ask their local Community Learning Disability Team for help. There may be an Acute Liaison Nurse in the hospital. There is a guide for hospitals and families about supporting people with learning disabilities in hospital: http://tinyurl.com/bwocmba There is easy read information about common health problems at these websites: www.easyhealth.org.uk http://tinyurl.com/5rkdcvf www.changepeople.co.uk 37 How to get help in a hurry Some words to do with health and the NHS are a bit hard. Harder words are shown like this: NHS Constitution. There is a list of these words at the back of the book to tell you what each word means. Sometimes you need to get help with a health problem in a hurry. Here are some things you can do: - You might be able to get some advice from the chemist (pharmacist). They might be able to suggest some treatment if they do not think you need to see a doctor - You could ring NHS Direct to ask for advice: 0845 4647. Or look on their website: http://www.nhsdirect.nhs.uk/ (not easy read) In a few places there is a new number you can call (111). It should work everywhere by 2013 - Your doctor’s surgery might have a phone number you can call for advice even when the surgery is not open (‘out of hours’) - In some cities there are NHS ‘walk in centres’ that you can go to any time for health care - Some hospitals have ‘minor injuries units’ where you can go for treatment if you are hurt (like if you have cut your finger and it will not stop bleeding) 38 - You might have to go to a hospital Accident and Emergency Department (A&E) if you are hurt very badly - If someone has a bad accident, or a sudden bad illness like a heart attack or a stroke, you might need to phone or text 999 for an ambulance. If you need an ambulance, the staff will have to ask you lots of questions. Good ideas The London Ambulance Service uses a book called the “Pre Hospital Communication Guide” with easy read pages. You could ask your local ambulance service if they have something like this. You can give them this website address: http://tinyurl.com/cnxtwbf If you have a mobile phone, save the telephone number of someone who can be phoned in an emergency. Save the number with the name ICE. This means ‘In Case of Emergencies’. Ambulance staff and police all know what this means. Some people have health problems that are important to know about in an emergency. For example, some people must not be given a drug called penicillin. People can wear a bracelet or a pendant (‘MedicAlert’) that has details about their health problems. 39 Who can help you? Some words to do with health and the NHS are a bit hard. Harder words are shown like this: NHS Constitution. There is a list of these words at the back of the book to tell you what each word means. If you have a question about your health, you can ask a health person you know (like your doctor or nurse). You can get some advice about health from your chemist (pharmacist). And there is more from the website NHS Choices and the phone line NHS Direct. (These are not easy read). Here are some other ideas about people you can ask: - Community Learning Disability Team: you may already know some people from the Team, like a learning disability nurse. If you don’t know anyone there, you can get contact details for the Team from Social Services - Health Facilitator: this is a person who helps you think about your health. They can help you make a Health Action Plan. Sometimes they are called different things. You can usually find the right person through the Community Learning Disability Team - Patient Advice and Liaison Service (PALS): every hospital has a PALS. They can give you information about health care and the NHS 40 - Acute Liaison Nurse: this is a nurse who tries to make things in hospital easier for people with learning disabilities. Not every hospital has one. You can find out if your hospital has one through the Community Learning Disability Team or through PALS - Safeguarding Nurse: most hospitals have a nurse who is responsible for making sure that people are safe from harm while they are in hospital - HealthWatch: this service will start in 2012 (it is being tried out in some areas sooner than this). HealthWatch will help people get information about health services. They will also collect information about how good or bad local services are. If you are unhappy about your health care, some services are there specially to help: - Patient Advice and Liaison Service (PALS): every hospital has a PALS. They can help if you are unhappy with the hospital services. They can help you if you want to complain - Independent Complaints Advocacy Service: this service is completely separate from the NHS. They can help you make a complaint. You can get in touch with them through PALS - Patients Association: this is a charity that is quite separate from the NHS. They have a helpline you can call. The number is 0845 608 4455 41 Where you can get more information Books Beyond Words: books for people with learning disabilities. Some of the books are about health problems http://www.picturesbeyondwords.com CHANGE: an organisation that works for the human rights of people with learning disabilities. CHANGE has some easy read information about health www.changepeople.co.uk Easyhealth: a website with lots of easy read information about health problems and health care www.easyhealth.org.uk Foundation for People with Learning Disabilities: an organisation that works with health services to help them get better www.learningdisabilities.org.uk General Medical Council: learning disability resources launched in Spring 2012 www.gmc-uk.org/learningdisabilities Health checks: Your Say Advocacy Service are launching a DVD about health checks in Spring 2012. Email: info@yoursayadvocacy.co.uk Improving Health and Lives: a website with lots of information about the health of people with learning disabilities www.improvinghealthandlives.org.uk Leeds Animation Workshop: two DVDs and easy read books about going to the doctor and going to hospital http://www.leedsanimation.org.uk/index.html Look Up: a website with lots of information from SeeAbility about looking after your eyes http://www.lookupinfo.org 42 Mencap: an organisation that campaigns for better health care for people with learning disabilities www.mencap.org.uk NHS Choices: a website with lots of information about health and health care www.nhs.uk A picture of health: a website with easy read information about health and health care in South West England www.apictureofhealth.southwest.nhs.uk/ PRODIGY: a website with lots of information about health problems and health care www.prodigy.clarity.co.uk Postural Care Campaign: a web page about how to get better care for people who need a lot of help to protect the shape of their bodies http://tinyurl.com/cb898km Reasonable adjustments: examples of changes the NHS can make www.ihal.org.uk/adjustments Royal College of General Practitioners: learning disability resources for GPs http://tinyurl.com/d747vaz UK Health and Learning Disability Network: an email network of people all over the country who are interested in the health of people with learning disabilities www.jan-net.co.uk 43 What some of the words mean Acute liaison nurse: a nurse who works in hospital to try to make things easier for people with learning disabilities Audiology: the service that does hearing tests and can give out hearing aids Best interests: deciding what is right for a person if they cannot make the decision for themselves CAMHS (Child and Adolescent Mental Health Service): the service that helps children and young people if they have mental health problems Carer’s assessment: a check to see what help you need if you are caring for another person Communication passport: a book about how you let people know what you want, and how they should talk to you Community Learning Disability Team: a team of health workers and social workers who just work with people with learning disabilities Consent: saying yes or no to a health test or treatment District nurse: a nurse who helps people at home, like giving an injection GP: a family doctor Health Action Plan: a plan about all the things that are important for your health Health facilitator: someone who can help you think about your health 44 Health promotion: a service that teaches people about looking after their health Hospital passport: a book with important information about you and your health that you can take to hospital Learning disability nurse: a nurse who just works with people with learning disabilities Macmillan nurse: a nurse who helps people who have cancer Mental capacity: being able to make decisions for yourself Mental Capacity Act: the law about making decisions NHS Constitution: the ground rules for the NHS, to help make health services better and fair for everyone Occupational therapist: a health worker who helps people learn to do the things they want to do, at home or at work or out and about Optometrist: a health worker who does eye tests and gives out glasses (spectacles) Paediatrician: a children’s doctor PALS (Patient Advice and Liaison Service): a service that can give you information about the NHS and help you if you have problems using the NHS Pharmacist: a health worker who knows about medicines Physiotherapist: a health worker who knows about how bodies move 45 Podiatrist: a health worker who knows about looking after feet Posture: the way you sit, stand or lie. This is important for keeping healthy Primary care liaison nurse: a nurse who helps family doctors and other nurses to give good services to people with learning disabilities Psychiatrist: a doctor who knows about mental health problems Psychologist: a health worker who knows about behaviour and how people’s minds work Reasonable adjustments: changes that the NHS and other services can make, to make it easier for disabled people to use the services Safeguarding nurse: a nurse who helps NHS services think about how to keep people safe from harm Screening: tests for cancer Speech and language therapist: a health worker who helps people who have difficulty speaking or being understood. They also help people who have difficulty swallowing Transition: moving from services for children and young people to services for adults 46 47 Foundation for People with Learning Disabilities Colechurch House 1 London Bridge Walk London SE1 2SX United Kingdom Telephone 020 7803 1100 Fax 020 7803 1111 Email info@fpld.org.uk Website www.learningdisabilities.org.uk Registered Charity No. England 801130 Scotland SC039714 © Foundation for People with Learning Disabilities 2012 changing liv48 es
Url: /Media/UHS-website-2019/Docs/For-patients/Good-health-care-for-all.pdf

Wessex teenage and young adult cancer service - patient information

Description: This booklets introduces Wessex teenage and young adult (TYA) cancer service which is here to help support young people diagnosed with cancer.
Url: /Media/UHS-website-2019/Patientinformation/Cancercare/Wessex-teenage-and-young-adult-cancer-service-2796-PIL.pdf

BEACON protocol v8.0 07Mar2023 signed

Description: A randomised phase IIb trial of BE AC v izumab added to Temozolomide O ± Irin tecan for children with N refractory/relapsed euroblastoma Version 8.0 dated 07-Mar-2023 Dinutuximab beta amendment Coordinating Sponsor: Sponsor Protocol Number: CAS Code: EudraCT Number: ISRCTN Reference Number: ITCC Number: Roche Study Reference Number: Email: University of Birmingham RG_ 11-087 BN2008 2012-000072-42 40708286 032 MO28245 beacon@trials.bham.ac.uk This application is supported by the facilities funded through Birmingham Science City: Translational Medicine Clinical Research Infrastructure and Trials Platform, an Advantage West Midlands (AWM) funded project which forms part of the Science City University of Warwick and University of Birmingham Research Alliance. BEACON-Neuroblastoma Protocol_vn 8.0_vd 07Mar2023 Page1 of 157 BEACON-Neuroblastoma Trial Protocol AMENDMENTS The following amendments and/or administrative changes have been made to this protocol since the implementation of the first approved version Amendment Date of number amendment Protocol version number Type of amendment SA 1 29-Jan-2013 2.0 Substantial Amendment N/A 23-Apr-2013 2.0a Non-Substantial Amendment N/A 01-Jul-2013 2.0b Non-Substantial Amendment Summary of amendment Introduction of the recommendation of weekly monitoring of blood counts for all patients receiving irinotecan. Addition of planned vaccination with live vaccination to exclusion criteria and prohibited medications section. ITCC Number has been corrected. Roche Study Reference Number and ISRCTN Reference Number have been added. Contact details for Plasma & Tumour Angiogenesis-Related Biomarkers have been amended. Table numbers have been corrected. Addition of guidance for research bone marrow sampling in Schedule of Activities table and sections 7.4.2.2 and 7.5.2. Addition of paragraph to sections 7.2, 7.6.1 – 7.6.4 detailing arrangements for handling dose modifications for Irinotecan + Temozolomide for patients receiving Bevacizumab. Discontinuation rules for osteonecrosis of the jaw and eye disorders added to table 13 in section 7.6.4. Correction to table number references in section 7.6.3. Clarification made in section 13.4.1 concerning Planned Interim Analysis. SA 3 06-Oct-2014 4.0 Substantial Amendment Changes to the Trial Personnel section of the protocol to include the addition of contact details for Denmark and Ireland Lead Investigators. Amendments to reflect the changes in study sampling requirements to Trial Synopsis, Schedule of Activities table and sections 1.2.6, 2.1, 2.2, 5.1, 5.2, 7.3, 7.4.2 and 7.5. Amendment to exclusion criteria in Trial Synopsis and section 4.2. Changes to the Schedule of Activities table to include the addition of an echocardiogram to be performed at screening and Tanner staging at screening and yearly in follow up. Changes to the time line for measuring renal function prior to commencing treatment in the Trial Synopsis, Schedule of Activities and section 4.1. BEACON-Neuroblastoma Protocol_vn 8.0_vd _07Mar2023 Page 3 of 157 BEACON-Neuroblastoma Trial SA 4 06-Oct-2014 4.0 SA 5 30-Jul-2015 5.0 Substantial Amendment Substantial Amendment Protocol Option to fax emergency randomisation removed. Telephone only in section 6.2 Changes to guidelines in section 7.2 for dose calculation in patients whose weight exceeds the 98th centile for age. Removal of enhanced data collection for Adverse Events of Special Interest (AESI) in section 7.6 and 9.1.2. Addition of option to extend treatment delay with agreement from Sponsor in Section 7.6.1 Addition of necrotising fasciitis as an adverse event requiring bevacizumab discontinuation in section 7.6.4. Changes to section 7.10 concerning the documenting of concomitant medications in patient medical notes and administration of bisphosphonates. Changes to section 9.1 regarding reporting of laboratory adverse events. Clarification on the arrangements for Follow Up Form completion for patients who do not require further follow up visits in section 11. Changes to bevacizumab and irinotecan preparation and dispensing guidelines in sections 8.2.4 and 8.3.3. Clarification on fasting arrangements prior to temozolomide administration added to section 8.4.3. Changes to events that should be reported on an Expected SAR Form in section 9.1.3.1. Clarification on SAEs that should be reported to F.Hoffman-La Roche Ltd in section 9.2.6 Addition of Trial Management Group meeting frequency in section 14.4. Changes to the wording of irinotecan randomisation in section 13.4.2. Addition of guidelines for dose reduction and discontinuation of temozolomide for liver toxicity in tables 8, 9, 10 & 11. Reference to the National Coordinating Centres has been changed to National CoSponsor throughout. Reference to Sponsor has been changed to Coordinating Sponsor. Change of Chief Investigator to Professor Pamela Kearns. Change of Principal Investigator at Royal Marsden Hospital to Dr Sucheta Vaidya. No changes made to the Protocol version. Chief Investigator and UK Lead Investigator changed to Dr Lucas Moreno Switzerland details added Schedule of events table amended for End Of Treatment clarity BEACON-Neuroblastoma Protocol_vn 8.0_vd _07Mar2023 Page 4 of 157 BEACON-Neuroblastoma Trial N/A 23-Sep-2015 5.0a SA 6 16-Jan-2019 6.0a Protocol Topotecan added to the study as a new trial question and 2 new randomisation arms. The following sections are amended accordingly: Synopsis (Primary Objectives, sample size, Trial Duration, Trial therapy) Section 1 Background and rationale (Trial rationale) Section 3 Trial design (Randomisation) Section7.1 and 7.2 Treatment details Section7.6.1 Dose modifications Table 6 amended, Tables 11 and 12 added Section 8.4 Pharmaceutical Information Section 13 Statistical considerations The following changes were made to the Eligibility: Inclusion criteria – further details regarding birth control Exclusion criteria – Defined wash out period following prior IMP according to IMP half-life or 14 days. Lifestyle guidelines - further details regarding birth control Section 7.6 Dose modifications Figure 1 – reference to “chemo” changed to Temozolomide/Irinotecan/Topotecan” for clarity Section 8.2.4 Reference to “chemo” removed for clarity Section 7.6.4 AEs requiring Bevacizumab discontinuation – additional AEs added following Bevacizumab IB v22 Addendum Additional mRNA and exploratory sampling. Non-Substantial Amendment Substantial amendment The requirement for confirmatory scans was removed from the Schedule of Activities and Response assessment section 7.4.3. Lead Investigator for France amended to Dr Marion Gambart Minor wording corrections and clarifications Schedule of events table corrected Introduction of two new treatment arms (dinutuximab beta) for additional 64 patients Addition of eligibility criteria, schedule of events, treatment details, duration, cross over and dose modification details for new dinutuximab beta arms Adaptation of objectives, trial design, supporting treatment, pharmaceutical information and statistical consideration sections with new, relevant information. BEACON-Neuroblastoma Protocol_vn 8.0_vd _07Mar2023 Page 5 of 157 BEACON-Neuroblastoma Trial N/A 11-Apr-2019 6.0b SA 7 07-Feb-2020 7.0 SA 22 07-Mar-2023 8.0 Protocol Non-Substantial Amendment Substantial Amendment Substantial Amendment Minor wording corrections and clarifications Version amended from 6.0 to 6.0a to add. Additional rationale to update typographical errors.) Trial Synopsis: Clarification of recruitment targets Clarification of Section 10 title: “Dinutuximab beta and topotecan randomisations” Clarification that not all biological studies will be open at any one time (Section 10.2 and 15.5) Minor wording corrections and clarifications Urgent Safety Measure – implemented on 28th January 2020 Closure of Temozolomide (T) and Dinutuximab beta and Temozolomide (dBT) arms with immediate effect. Section 1.1 Background Section 1.2.3 Benefit Risk assessment Section 3.1 Randomisation Section 10 Headings changed Section 10.3 Trial therapy Update of contact details Change of definition of End of Trial (Section 21). Protocol previously defined two stages of end of trial (6 months after last patient completes treatment and 12 months after last data capture after 5 years follow up). This has been combined into one End of Trial definition: 6 months after last patient last visit (i.e. after 5 years follow up) Also addition of option to email SAE form (Section 18.2.1.2) BEACON-Neuroblastoma Protocol_vn 8.0_vd _07Mar2023 Page 6 of 157 BEACON-Neuroblastoma Trial Protocol TRIAL PERSONNEL Chief Investigator: Co-Investigators: Exploratory Biomarkers Dr Lucas Moreno Dr. Lucas Moreno, MD, PhD Director Paediatric Oncology & Haematology Division Vall d’Hebron Barcelona Hospital Campus Passeig de la Vall d’Hebron, 119-129, 08035, Barcelona, Spain  +34 93 489 3000  +34 93 489 4060  lucas.moreno@vhebron.net Professor Keith Wheatley Professor of Clinical Trials Cancer Research UK Clinical Trials Unit (CRCTU) Institute of Cancer and Genomic Sciences College of Medical and Dental Sciences University of Birmingham Birmingham, UK B15 2TT  +44 (0)121 415 9119  k.wheatley@bham.ac.uk Dr Juliet Gray Associate Professor and Consultant in Paediatric Oncology Southampton Children’s Hospital Tremona Road Southampton SO16 6YD  +44 (0) 790 1507929  juliet.gray@uhs.nhs.uk Dr Gudrun Schleiermacher Senior Scientist Institute Curie 26 rue d'Ulm 75248 Paris cedex 05 France  +33 (0)1 56 24 45 50  +33 (0)1 56 24 66 30  gudrun.schleiermacher@curie.net Professor Louis Chesler Paediatric Tumour Biology Team Institute of Cancer Research and Royal Marsden Hospital (University of London), Downs Road, Sutton Surrey, UK SM2 5PT  +44 (0) 208 722 4035 BEACON-Neuroblastoma Protocol_vn 8.0_vd _07Mar2023 Page 7 of 157 BEACON-Neuroblastoma Trial Protocol  louis.chesler@icr.ac.uk Functional Imaging Study: Professor Andrew Peet Institute of Child Health University of Birmingham Whittall Street Birmingham, UK B4 6NH  +44 (0) 121 333 8234  +44 (0) 121 333 8241  a.peet@bham.ac.uk Dr Dow-Mu Koh Consultant Radiologist in Functional Imaging Royal Marsden Hospital Downs Road, Sutton, Surrey, UK SM2 5PT  +44 (0) 208 6613857  dow-mu.koh@icr.ac.uk Professor Martin Leach Co-Director, Cancer Research UK and EPSRC Centre for Cancer Imaging, Director, NIHR Clinical Research Facility Deputy Head, Division of Radiotherapy and Imaging Institute of Cancer Research and Royal Marsden Hospital (University of London), Downs Road, Sutton Surrey, UK SM2 5PT  +44 (0 208 661 3338  Martin.Leach@icr.ac.uk Molecular Monitoring mRNA Study: Professor Sue Burchill Leeds Institute of Cancer & Pathology St. James University Hospital Beckett Street Leeds, UK LS9 7TF  +44 (0) 113 206 5873  +44 (0) 113 242 9886  S.A.Burchill@leeds.ac.uk Professor Walter Gregory Clinical Trials Research Unit (CTRU) University of Leeds Clinical Trials Research House 71-75 Clarendon Road Leeds LS2 9PH  +44 (0) 113 343 1489  +44 (0) 113 343 1471 BEACON-Neuroblastoma Protocol_vn 8.0_vd _07Mar2023 Page 8 of 157 BEACON-Neuroblastoma Trial Protocol Trial Statistician: Trial Coordinator & Trial Office: Randomisation Service: SAE Reporting:  W.M.Gregory@leeds.ac.uk Miss Grace Holt Cancer Research UK Clinical Trials Unit (CRCTU) Institute of Cancer and Genomic Sciences College of Medical and Dental Sciences University of Birmingham Birmingham, UK B15 2TT  +44 (0)121 414 8328  +44 (0)121 414 3700  G.C.Holt@bham.ac.uk Miss Punam Mistry Children’s Cancer Trials Team Cancer Research UK Clinical Trials Unit (CRCTU) Institute of Cancer and Genomic Sciences College of Medical and Dental Sciences University of Birmingham Birmingham, UK B15 2TT  +44 (0)121 414 3788  +44 (0)121 414 9520  beacon@trials.bham.ac.uk Provided by the CRCTU at the University of Birmingham Randomisation should be performed by sites online at: https://www.cancertrials.bham.ac.uk/BEACONLive In case of any problems with online randomisation, randomisation can be performed over the phone by the CRCTU on: 0800 371 969 or +44 (0)121 414 3366 SAEs should be faxed to the BEACON-Neuroblastoma Trial Office, CRCTU, University of Birmingham, UK  + 44 (0)121 414 9520 or +44 (0)121 414 3700 National Coordinating Investigators: Austria – Lead Investigator: Prof Dr Ruth Ladenstein St. Anna Children’s Hospital and CCRI /Studies and Statistics Department for Integrated Research and Projects (S²IRP) Kinderspitalgasse 6, Zimmermannplatz 10 A-1090 Vienna Austria +43-1-40470-4750  +43-1- 40470- 7430  ruth.ladenstein@ccri.at BEACON-Neuroblastoma Protocol_vn 8.0_vd _07Mar2023 Page 9 of 157 BEACON-Neuroblastoma Trial Belgium Lead Investigator: Prof Genevieve Laureys Ghent University Hospital 9000 Ghent De Pinterlaan 185 Belgium  +32 93 32 34 48  genevieve.laureys@uzgent.be Denmark – Lead Investigator: Dr Karsten Nysom Dept. of Paediatrics & Adolescent Medicine Rigshospitalet Blegdamsvej 9 DK2100 Copenhagen Denmark  +45 35 45 08 09  +45 35 45 50 55  Karsten.nysom@regionh.dk France – Lead Investigator: Dr Marion Gambart Unité d'Hémato-Oncologie Hôpital des Enfants 330, avenue de Grande Bretagne TSA 70034 31059 Toulouse Cedex France  +33 (0)5 34 55 86 11  +33 (0)5 34 55 86 12  gambart.m@chu-toulouse.fr Germany - Lead Investigator: Dr. Simone Hettmer Zentrum für Kinder- und Jugendmedizin UNIVERSITÄTSKLINIKUM FREIBURG Mathildenstr. 1, 79106 Freiburg Germany  +49 761 270-43000  +49 761 270-45180  simone.hettmer@uniklinik-freiburg.de Ireland – Lead Investigator: Dr Cormac Owens Our Lady’s Children’s Hospital Crumlin Road, Crumlin Dublin 12 Ireland  +35314096659  +35313453041  Cormac.owens@olchc.ie Protocol BEACON-Neuroblastoma Protocol_vn 8.0_vd _07Mar2023 Page 10 of 157 BEACON-Neuroblastoma Trial Protocol Italy – Lead Investigator: Dr. Aurora Castellano U.O.Oncoematologia Ospedale Pediatrico Bambino Gesù Pzza S. Onofrio 4 00165 Roma Italy +39 06 68592957-2678  +39 06 68592826  aurora.castellano@opbg.net Netherlands – Lead Investigator: Dr. C Michel Zwaan Erasmus Medical Center Sophia’s Children's Hospital Dr. Molewaterplein 60 3015 GJ Rotterdam +31 (0) 10 703 6691  +31(0) 10 703 6681  c.m.zwaan@erasmusmc.nl Spain – Lead Investigator: Dr. Victoria Castel Instituto de Investigación Sanitaria Unidad de Oncología Pediátrica Hospital Universitario La Fe Bulevar Sur, S/N 46026 Valencia Spain +34 963862758 Ext 50040  +34 963494416  castel_vic@gva.es Switzerland – Lead Investigator: Dr. Nicolas Gerber University Children’s Hospital, Steinwiesstrasse 75, CH-8032 Zurich, Switzerland +41 44 266 31 17  +41 44 266 34 61  Nicolas.gerber@kispi.uzh.ch UK – Lead Investigator: Dr Lucas Moreno Honorary Research Fellow University of Birmingham Birmingham, UK B15 2TT  +44 (0)121 414 3788  +44 (0)121 414 9520  lucas.moreno@vhebron.net, lmorenom@ext.cnio.es BEACON-Neuroblastoma Protocol_vn 8.0_vd _07Mar2023 Page 11 of 157 BEACON-Neuroblastoma Trial Protocol TRIAL SYNOPSIS Title A randomised phase IIb trial of bevacizumab added to temozolomide ± irinotecan for children with refractory/relapsed neuroblastoma – BEACON-Neuroblastoma Trial Trial Design A phase II, randomised, open label, international multicentre 3x2 factorial trial. The dinutuximab beta amendment did utilise a 2x2 factorial design it will now be a simple two-way randomisation. Objectives Primary: - To test whether bevacizumab added to a backbone chemotherapy regimen (temozolomide, irinotecan + temozolomide or temozolomide + topotecan) demonstrates activity in children with relapsed or refractory neuroblastoma - To test whether the addition of irinotecan to temozolomide increases the activity of chemotherapy in children with relapsed or refractory neuroblastoma - To test whether the addition of topotecan to temozolomide increases the activity of chemotherapy in children with relapsed or refractory neuroblastoma (“topotecan randomisation”) - To test whether dinutuximab beta added to a backbone chemotherapy regimen (temozolomide or temozolomide + topotecan) demonstrates activity in children with relapsed or refractory neuroblastoma (“dinutuximab beta randomisation”) Secondary: - To evaluate the safety of the regimens Tertiary: - To undertake preliminary evaluation of the changes in magnetic resonance imaging (MRI) derived functional imaging biomarkers of angiogenesis - To undertake preliminary evaluation of the role of circulating mRNA levels for tyrosine hydroxylase (TH), paired-like homeobox 2b (PHOX2B) and doublecortin (DCX) as prognostic/predictive biomarkers in this refractory/relapsed setting - To undertake a preliminary evaluation of the role of tumour molecular profiles in blood and archival tumour tissue profiles as prognostic and predictive biomarkers - To undertake a preliminary evaluation of biomarkers of response to anti-GD2 therapy (Fc/KIR polymorphisms, Antibody Dependant Cell-Mediated Cytotoxicity (ADCC) and Anti-Drug Antibodies (ADAs) and of dinutuximab beta pharmacokinetics (PK) Outcome Measures Primary Endpoint: - Best response (Complete Response [CR] or Partial Response [PR]) [1] at any time during the first 6 cycles of trial treatment - For the bevacizumab part 2 only: Progression-free survival (PFS) Secondary Endpoints: - Safety of the regimens: Incidence and severity of Adverse Events (AE)s - PFS - Overall survival (OS) - Event-free survival (EFS) BEACON-Neuroblastoma Protocol_vn 8.0_vd _07Mar2023 Page 12 of 157 BEACON-Neuroblastoma Trial Protocol Exploratory/Tertiary Endpoints: - Changes in (MRI) derived functional imaging biomarkers of angiogenesis measured by quantitative dynamic contrast enhanced (DCE) MRI: primary biomarkers will be the transfer constant Ktrans [min-1] and initial area under the gadolinium uptake curve from 0 to 60 seconds (IAUGC60, mM Gd min) and secondary biomarkers will be tumour apparent diffusion coefficient (ADC, 10-6 cm2 s-1), native T1 and T2 relaxation times (ms) and transverse relaxation rate R2* - Changes in circulating mRNA levels for TH, PHOX2B and DCX in bone marrow and blood samples - Pilot descriptive study of angiogenesis and neuroblastoma markers that may include O6methylguanine-methyltransferase (MGMT) status, immunohistochemistry and immunofluorescence markers on tumour samples (such as microvessel density (MVD), CD31, Ki67, NRP1, VEGFR-1, VEGFR-2, C-KIT), DNA/RNA extraction from tissue sections for tumour mutation screening and tumour expression profiling - A preliminary correlation of the different biomarkers [Fc/KIR polymorphisms, Antibody – Dependent Cellular Toxicity (ADCC), and Anti-Drug Antibodies (ADAs)] will be made with parameters of anti-tumour activity (response rate, PFS and OS). PK parameters (dinutuximab beta trough levels) for this chemo-immunotherapy regimen will be described. Patient Population Children and young adults aged 1 to 21 years of age with relapsed/refractory neuroblastoma. Sample Size Approximately 224 patients, including 160 for the bevacizumab randomisation and 64 for the dinutuximab beta amendment. Trial Duration 8 years of patient recruitment, 5 years of patient follow up BEACON-Neuroblastoma Protocol_vn 8.0_vd _07Mar2023 Page 13 of 157 BEACON-Neuroblastoma Trial Protocol Abbreviations ADA ANTI-DRUG ANTIBODIES ADCC ANTIBODY – DEPENDENT CELL-MEDIATED CYTOTOXICITY AE ADVERSE EVENT AESI ADVERSE EVENT OF SPECIAL INTEREST AFSAPPS COMPETENT AUTHORITY FOR FRANCE ALT ALANINE AMINOTRANSFERASE ANC ABSOLUTE NEUTROPHIL COUNT APPT ACTIVATED PARTIAL THROMBOPLASTIN TIME ASCT AUTOLOGOUS STEM CELL TRANSPLANTATION AST ASPARTATE AMINOTRANSFERASE AUC AREA UNDER THE CURVE AR ADVERSE REACTION BIT BEVACIZUMAB + IRINOTECAN + TEMOZOLOMIDE ARM BM BONE MARROW BP BLOOD PRESSURE BSA BODY SURFACE AREA BT BEVACIZUMAB + TEMOZOLOMIDE ARM BTTo BEVACIZUMAB + TEMOZOLOMIDE + TOPOTECAN ARM CI CHIEF INVESTIGATOR CIs CONFIDENCE INTERVALS COG CHILDREN’S ONCOLOGY GROUP CNS CENTRAL NERVOUS SYSTEM CR COMPLETE RESPONSE CRF CASE REPORT FORM CR UK CANCER RESEARCH UK CRCTU CANCER RESEARCH UK CLINICAL TRIALS UNIT (UNIVERSITY OF BIRMINGHAM) CRN CLINICAL RESEARCH NETWORK CSR CLINICAL STUDY REPORT CT COMPUTERISED TOMOGRAPHY CTC COMMON TERMINOLOGY CRITERIA CTCAE COMMON TERMINOLOGY CRITERIA FOR ADVERSE EVENTS CXR CHEST X-RAY dBT DINUTUXIMAB BETA + TEMOZOLOMIDE ARM dBTTo DINUTUXIMAB BETA + TEMOZOLOMIDE + TOPOTECAN ARM DCX DOUBLECORTIN DLT DOSE LIMITING TOXICITY DMC DATA MONITORING COMMITTEE DNA DEOXYRIBONUCLEIC ACID ECHO ECHOCARDIOGRAM ECOG EASTERN COOPERATIVE ONCOLOGY GROUP EFS EVENT FREE SURVIVAL EMA EUROPEAN MEDICINES AGENCY ERDC ELECTRONIC REMOTE DATA CAPTURE EOT END OF TREATMENT FFPE FORMALIN-FIXED PARAFFIN EMBEDDED GCP GOOD CLINICAL PRACTICE G-CSF GRANULOCYTE COLONY STIMULATING FACTOR BEACON-Neuroblastoma Protocol_vn 8.0_vd _07Mar2023 Page 14 of 157 BEACON-Neuroblastoma Trial Protocol GFR GM-CSF GGT GP GPOH HR IB ICF ICH IMP INR INRC INRG INSS IRF ISF IT ITCC IV MGMT MIBG MHRA MRD MRI MSKCC MTD MYCN NANT NCI NCS NR OS OTC PCP PD PFS PHOX2B PI PIS PK PMA PRES PO PPTP PR REC RECIST RNA GLOMERULAR FILTRATION RATE GRANULOCYTE-MONOCYTE COLONY STIMULATING FACTOR GAMMA-GLUTAMYL TRANSPEPTIDASE GENERAL PRACTITIONER GERMAN SOCIETY FOR PAEDIATRIC ONCOLOGY & HAEMATOLOGY HEART RATE INVESTIGATOR BROCHURE INFORMED CONSENT FORM INTERNATIONAL CONFERENCE ON HARMONISATION INVESTIGATIONAL MEDICINAL PRODUCT INTERNATIONAL NORMALISED RATIO INTERNATIONAL NEUROBLASTOMA RESPONSE CRITERIA INTERNATIONAL NEUROBLASTOMA RISK GROUP INTERNATIONAL NEUROBLASTOMA STAGING SYSTEM INSTITUTIONAL REVIEW BOARD INVESTIGATOR SITE FILE IRINOTECAN + TEMOZOLOMIDE ARM INNOVATIVE THERAPIES FOR CHILDREN WITH CANCER INTRAVENOUS O6-METHYGUANINE METHYLTRANSFERASE META-IODO-BENZYL-GUANIDINE MEDICINES AND HEALTHCARE PRODUCTS REGULATORY AGENCY MINIMAL RESIDUAL DISEASE MAGNETIC RESONANCE IMAGING MEMORIAL SLOAN KETTERING CANCER CENTRE MAXIMUM TOLERATED DOSE MYELOCYTOMATOSIS VIRAL RELATED ONCOGENE NEW AGENTS FOR NEUROBLASTOMA THERAPY NATIONAL COORDINATING INVESTIGATOR NATIONAL CO-SPONSOR NO RESPONSE OVERALL SURVIVAL OVER THE COUNTER PNEUMOCYSTIS CARNI PNEUMONITIS PROGRESSSIVE DISEASE PROGRESSION FREE SURVIVAL PAIRED-LIKE HOMEOBOX2B PRINCIPAL INVESTIGATOR PATIENT INFORMATION SHEET PHARMACOKINETICS POPULATION-MODELLING ANALYSIS POSTERIOR REVERSIBLE ENCEPHALOPATHY SYNDROME ORALLY PAEDIATRIC PRECLINICAL TESTING PROGRAM PARTIAL RESPONSE RESEARCH ETHICS COMMITTEE RESPONSE EVALUATION CRITERIA IN SOLID TUMOURS RIBONUCLEIC ACID BEACON-Neuroblastoma Protocol_vn 8.0_vd _07Mar2023 Page 15 of 157 BEACON-Neuroblastoma Trial Protocol RTKI RT-qPCR SAE SAR SCT SD SFOP SIOPEN SNP SPC SUSAR SWFI T TH TMA TMG TSC TTo TVD UAR UKCCSG ULN VTE VEGF VGPR WMA RECEPTOR TYROSINE KINASE INHIBITORS REVERSE TRANSCRIPTASE QUANTITATIVE POLYMERASE CHAIN REACTION SERIOUS ADVERSE EVENT SERIOUS ADVERSE REACTION STEM CELL TRANSPLANT STABLE DISEASE FRENCH SOCIETY OF PAEDIATRIC ONCOLOGY INTERNATIONAL SOCIETY PAEDIATRIC ONCOLOGY EUROPEAN NEUROBLASTOMA GROUP SINGLE NUCLEOTIDE POLYMORPHISM SUMMARY OF PRODUCT CHARACTERISTICS SUSPECTED UNEXPECTED SEVERE ADVERSE REACTION STERILE WATER FOR INJECTION TEMOZOLOMIDE ARM TYROSINE HYDROXYLASE TISSUE MICROARRAY TRIAL MANAGEMENT GROUP TRIAL STEERING COMMITTEE TEMOZOLOMIDE + TOPOTECAN ARM TOPOTECAN, VINCRISTINE & DOXORUBICIN UNEXPECTED ADVERSE REACTION UNITED KINGDOM CHILDREN’S CANCER STUDY GROUP UPPER LIMIT OF NORMAL VENOUS THROMBO-EMBOLISM VASCULAR ENDOTHELIAL GROWTH FACTOR VERY GOOD PARTIAL RESPONSE WORLD MEDICAL ASSOCIATION FORMULAE Mosteller formula: BSA (m²) = BEACON-Neuroblastoma Protocol_vn 8.0_vd _07Mar2023 Page 16 of 157 BEACON-Neuroblastoma Trial Protocol Table of Contents Trial Synopsis ...................................................................................................................................... 12 Title .................................................................................................................................................... 12 Trial Design ........................................................................................................................................ 12 Objectives .......................................................................................................................................... 12 Outcome Measures............................................................................................................................ 12 Patient Population .............................................................................................................................. 13 Sample Size ....................................................................................................................................... 13 Trial Duration...................................................................................................................................... 13 Abbreviations ..................................................................................................................................... 14 1. Background and Rationale ............................................................................................................. 22 1.1 Background............................................................................................................................ 22 1.1.1 Background for the dinutuximab beta amendment............................................................ 28 1.2 Trial Rational.......................................................................................................................... 29 1.2.1 Justification for design ....................................................................................................... 29 1.2.2 Rationale for patient population ......................................................................................... 30 1.2.3 Benefit-risk assessment .................................................................................................... 31 1.2.4 Rationale for the selected backbone schedules: Temozolomide, irinotecan + temozolomide and temozolomide + topotecan .............................................................................. 31 1.2.5 Rationale for dosing schedule of bevacizumab................................................................. 32 1.2.6 Rationale for evaluating chemo-immunotherapy in the BEACON-Neuroblastoma Trial... 32 1.2.7 Rationale for dosing schedule of dinutuximab beta........................................................... 33 1.2.8 Rationale for the use of biomarker studies ........................................................................ 34 1.3 Relevance and future importance ......................................................................................... 35 2. Objectives and Outcome Measures ............................................................................................. 36 2.1 Objectives .............................................................................................................................. 36 2.2 Outcome Measures ............................................................................................................... 37 3. Trial Design ..................................................................................................................................... 37 3.1 Randomisation....................................................................................................................... 37 3.2 Duration of treatment............................................................................................................. 38 3.3 Frequency and duration of follow-up ..................................................................................... 38 4. Eligibility.......................................................................................................................................... 39 4.1 Lifestyle guidelines ................................................................................................................ 39 5. Schedule of activities..................................................................................................................... 39 6. Screening and Consent ................................................................................................................. 40 6.1 Informed Consent .................................................................................................................. 40 6.2 Screening............................................................................................................................... 41 7. Trial Entry........................................................................................................................................ 42 7.1 Procedure for online patient randomisation........................................................................... 42 7.2 Emergency Randomisation ................................................................................................... 42 8. Treatment Details ........................................................................................................................... 43 8.1 Definition of Investigational Medicinal Products (IMPs) ........................................................ 43 9. Bevacizumab randomisation......................................................................................................... 43 9.1 Eligibility criteria for the bevacizumab randomisation............................................................ 43 9.1.1 Inclusion criteria for the bevacizumab randomisation ....................................................... 43 9.1.2 Exclusion criteria for the bevacizumab randomisation ...................................................... 44 9.2 Schedule of activities for the bevacizumab randomisation ................................................... 45 BEACON-Neuroblastoma Protocol_vn 8.0_vd _07Mar2023 Page 17 of 157 BEACON-Neuroblastoma Trial Protocol 9.3 Trial Therapy (bevacizumab randomisation) ......................................................................... 49 9.3.1 Bevacizumab randomisation trial treatment ...................................................................... 49 9.4 Treatment Schedule..................................................................................................................... 51 9.4.1 Day 1 of Cycle 1 ................................................................................................................ 51 9.4.2 Day 1 of subsequent cycles............................................................................................... 51 9.4.3 Post Cycle 6 (For patients continuing to Cycle 7-12) ........................................................ 52 9.4.4 End of Treatment ............................................................................................................... 52 9.4.5 Treatment Duration............................................................................................................ 52 9.5 Dose Modifications for the bevacizumab randomisation ....................................................... 53 9.5.1 Dose Modifications for AEs due to chemotherapy - for the bevacizumab randomisation. 56 9.5.2 Bevacizumab – Infusion-related Reaction/Infusional Site Extravasation Management Guidelines ...................................................................................................................................... 62 9.5.3 Bevacizumab - Treatment Delays ..................................................................................... 63 9.5.4 Bevacizumab - Discontinuation ........................................................................................ 64 9.5.5 Bevacizumab - Toxicity Management guidelines .............................................................. 65 9.6 Central Venous Access Device (CVAD)................................................................................ 67 10 Dinutuximab beta and topotecan randomisations...................................................................... 68 10.1 Eligibility for the dinutuximab beta randomisation ................................................................. 68 10.1.1 Inclusion criteria for the dinutuximab beta randomisation ............................................. 68 10.1.2 Exclusion criteria for the dinutuximab beta randomisation ............................................ 69 10.2 Schedule of events for the dinutuximab beta and topotecan randomisations....................... 70 10.3 Trial therapy (dinutuximab beta and topotecan randomisations) .......................................... 74 10.3.1 Dinutuximab beta and topotecan trial treatment................................................................ 75 10.4 Treatment Schedule .............................................................................................................. 76 10.4.1 Day 1 of Cycle 1 ............................................................................................................ 76 10.4.2 Day 1 of subsequent cycles........................................................................................... 76 10.4.3 Post Cycle 6 (For patients continuing to Cycle 7-12 on chemotherapy only) ............... 77 10.4.4 End of Treatment ........................................................................................................... 77 10.4.5 Treatment Duration............................................................................................................ 78 10.4.6 Cross-over ......................................................................................................................... 78 10.5 Dose Modifications – dinutuximab beta and topotecan randomisations ............................... 79 10.5.1 Dose modifications for dinutuximab beta specific toxicities .......................................... 79 10.5.2 Dose modifications for haematological toxicity.............................................................. 81 10.5.3 Dose modifications for hepatic toxicity .......................................................................... 82 11 Treatment Compliance................................................................................................................... 84 12 Supportive Treatment .................................................................................................................... 84 12.1 Nausea and Vomiting ............................................................................................................ 84 12.2 Growth Factors ...................................................................................................................... 84 12.3 Fever and neutropenia .......................................................................................................... 84 12.4 Blood products....................................................................................................................... 84 12.5 Pneumocystis jirovecii pneumonia (PJP) prophylaxis ........................................................... 84 12.6 Management of side effects caused by non-selective NSAIDs as cyclooxygenase (COX) type I and II inhibitors ......................................................................................................................... 84 12.7 Supportive care during Dinutuximab beta infusion................................................................ 85 12.7.1 Pain Management.......................................................................................................... 85 12.7.2 Prevention of dinutuximab beta related infusion reactions............................................ 86 13 Concomitant Medication................................................................................................................ 87 14 Assessments .................................................................................................................................. 87 BEACON-Neuroblastoma Protocol_vn 8.0_vd _07Mar2023 Page 18 of 157 BEACON-Neuroblastoma Trial Protocol 14.1 Response assessment .......................................................................................................... 88 15 Biomarkers...................................................................................................................................... 88 15.1 Blood sampling safety ........................................................................................................... 88 15.2 MRI-derived functional imaging biomarkers of angiogenesis................................................ 90 15.3 Molecular monitoring mRNA.................................................................................................. 90 15.4 Neuroblastoma exploratory biomarker analyses ................................................................... 90 15.5 Sample Collection.................................................................................................................. 92 15.5.1 Peripheral blood samples .............................................................................................. 92 15.5.2 Bone Marrow Samples .................................................................................................. 92 15.5.3 Archival tumour samples ............................................................................................... 92 16 Patient Follow Up ........................................................................................................................... 93 16.1 Patient Withdrawal................................................................................................................. 93 17 Pharmaceutical Information .......................................................................................................... 94 17.1 Definition of Investigational Medicinal Product ...................................................................... 94 17.2 Bevacizumab ......................................................................................................................... 94 17.2.1 Bevacizumab - Drug Supply .......................................................................................... 94 17.2.2 Bevacizumab - Ordering ............................................................................................... 94 17.2.3 Bevacizumab - Formulation, Packaging and Labelling ................................................. 94 17.2.4 Bevacizumab - Preparation and Dispensing ................................................................. 95 17.2.5 Compatibility information ............................................................................................... 95 17.2.6 Bevacizumab - Administration ....................................................................................... 95 17.2.7 Bevacizumab – Accountability....................................................................................... 96 17.2.8 Bevacizumab - Destruction............................................................................................ 96 17.3 Cyclophosphamide ................................................................................................................ 96 17.4 Dinutuximab beta................................................................................................................... 96 17.5 Irinotecan ............................................................................................................................... 96 17.5.1 Irinotecan - Drug Supply ............................................................................................... 96 17.5.2 Irinotecan - Formulation, Packaging and Labelling ....................................................... 96 17.5.3 Irinotecan - Preparation and Dispensing ....................................................................... 97 17.5.4 Compatibility information ............................................................................................... 97 17.5.5 Irinotecan - Administration ............................................................................................. 97 17.6 Temozolomide ....................................................................................................................... 97 17.6.1 Temozolomide – Drug Supply ....................................................................................... 97 17.6.2 Temozolomide - Formulation, Packaging and Labelling ............................................... 97 17.6.3 Temozolomide - Administration ..................................................................................... 97 17.7 Topotecan.............................................................................................................................. 98 17.7.1 Topotecan - Drug Supply.............................................................................................. 98 17.7.2 Topotecan - Formulation, Packaging and Labelling ..................................................... 98 17.7.3 Topotecan - Preparation and Dispensing ..................................................................... 98 17.7.4 Topotecan - Compatibility information ........................................................................... 98 17.7.5 Topotecan - Administration........................................................................................... 99 18 Adverse Event Reporting .............................................................................................................. 99 18.1 Reporting Requirements........................................................................................................ 99 18.1.1 Adverse Events (AE) ..................................................................................................... 99 18.1.2 AESIs of Bevacizumab .................................................................................................. 99 18.1.3 Serious Adverse Advents (SAE).................................................................................... 99 18.1.4 Reporting period .......................................................................................................... 100 18.2 Reporting Procedure ........................................................................................................... 100 BEACON-Neuroblastoma Protocol_vn 8.0_vd _07Mar2023 Page 19 of 157 BEACON-Neuroblastoma Trial Protocol 18.2.1 Site............................................................................................................................... 100 18.2.2 Trial Office ................................................................................................................... 102 18.2.3 Reporting to the Competent Authority and main Research Ethics Committee ........... 102 18.2.4 Investigators ................................................................................................................ 102 18.2.5 Data Monitoring Committee ......................................................................................... 102 18.2.6 Manufacturer of Investigational Medicinal Product...................................................... 102 19 Data Handling and Record Keeping ........................................................................................... 103 19.1 Data Collection .................................................................................................................... 103 19.2 Archiving .............................................................................................................................. 103 20 Quality Management .................................................................................................................... 103 20.1 Site Set-up and Initiation ..................................................................................................... 103 20.2 On-site Monitoring ............................................................................................................... 104 20.3 Central Monitoring ............................................................................................................... 104 20.4 Audit and Inspection ............................................................................................................ 104 20.5 Notification of Serious Breaches ......................................................................................... 104 21 End of Trial Definition .................................................................................................................. 105 22 Statistical Considerations ........................................................................................................... 105 22.1 Trial Design.......................................................................................................................... 105 22.2 Definition of Outcome Measures ......................................................................................... 106 22.2.1 Primary ........................................................................................................................ 106 22.2.2 Secondary.................................................................................................................... 106 22.2.3 Exploratory/Tertiary ..................................................................................................... 106 22.3 Sample Size......................................................................................................................... 106 22.4 Interim and Main Analyses of Outcome Measures.............................................................. 108 22.4.1 Planned Interim Analyses ............................................................................................ 108 22.4.2 Main Analysis............................................................................................................... 108 22.5 Stopping Guidelines ............................................................................................................ 110 23 Trial Organisational Structure..................................................................................................... 110 23.1 Coordinating Sponsor .......................................................................................................... 110 23.2 Co-Sponsor Centres ........................................................................................................... 110 23.3 Relationship of trial committees........................................................................................... 112 23.4 Trial Management Group..................................................................................................... 112 23.5 Trial Steering Committee ..................................................................................................... 112 23.6 Data Monitoring Committee................................................................................................. 112 23.7 Finance ................................................................................................................................ 113 23.8 NIHR CRN Portfolio ............................................................................................................. 113 24 Ethical Considerations ................................................................................................................ 113 25 Confidentiality and Data Protection ........................................................................................... 114 26 Insurance and Indemnity ............................................................................................................. 115 27 Publication Policy ........................................................................................................................ 116 28 Reference List............................................................................................................................... 117 Appendix 1 – WMA Declaration of Helsinki .................................................................................... 124 Appendix 2 - Definition of Adverse Events ..................................................................................... 127 Appendix 3 - Common Toxicity Criteria Grading ........................................................................... 129 Appendix 4 – RECIST Criteria 1.1 .................................................................................................... 130 Appendix 5 – Tumor Response at Metastatic Soft Tissue and Bone Sites (Park et al. 2017) ... 133 Appendix 6 - CURIE & SIOPEN scoring methods for neuroblastoma ......................................... 134 Appendix 7 – Temozolomide Dosing............................................................................................... 136 BEACON-Neuroblastoma Protocol_vn 8.0_vd _07Mar2023 Page 20 of 157 BEACON-Neuroblastoma Trial Protocol Appendix 8 – Blood Pressure Levels by Age and Height Percentile for Children and Adolescents ....................................................................................................................................... 139 Appendix 9 – Height for Age Chart - Girls ...................................................................................... 144 Appendix 10 – Height for Age Chart - Boys.................................................................................... 149 Appendix 11 – Lansky and Karnofsky/ECOG Scales .................................................................... 154 Appendix 12 – Tanner Staging ......................................................................................................... 156 Appendix 13 – Clinical studies of anti-GD2 therapies in combination with chemotherapy ...... 157 LIST OF TABLES Table 1 - Second line chemotherapy regimens tested in phase II in relapsed or refractory neuroblastoma since 2000 ..........
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Description: Originally uploaded to http://cdn.flamehaus.com/Valve_Handbook_LowRes.pdf Handbook courtesy of Valve HANDBOOK FOR NEW EMPLOYEES ============================================================ HANDBOOK FOR NEW EMPLOYEES ======================================================== A fearless adventure in knowing what to do when no one’s there telling you what to do FIRST EDITION 2012 Dedicated to the families of all Valve employees. Thank you for helping us make such an incredible place. Table of Contents Preface . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . vii How to Use This Book . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . viii Part 1: Welcome to Valve . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 Your First Day Valve Facts That Matter Welcome to Flatland Part 2: Settling In . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7 Your First Month What to Work On Why do I need to pick my own projects?, But how do I decide which things to work on?, How do I find out what projects are under way?, Short-term vs. long term goals, What about all the things that I’m not getting done?, How does Valve decide what to work on? Can I be included the next time Valve is deciding X? Teams, Hours, and the Office Cabals, Team leads, Structure happens, Hours, The office Risks What if I screw up?, But what if we ALL screw up? Part 3: How Am I Doing? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25 Your Peers and Your Performance Peer reviews, Stack ranking (and compensation) Part 4: Choose Your Own Adventure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35 Your First Six Months Roles, Advancement vs. growth, Putting more tools in your toolbox Part 5: Valve Is Growing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41 Your Most Important Role Hiring, Why is hiring well so important at Valve?, How do we choose the right people to hire?, We value “T-shaped” people, We’re looking for people stronger than ourselves, Hiring is fundamentally the same across all disciplines Part 6: Epilogue . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 51 What Is Valve Not Good At? What Happens When All This Stuff Doesn’t Work? Where Will You Take Us? Glossary . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 55 © 2012 Valve Corporation. All Rights Reserved. Printed in the United States of America. This handbook does not constitute an employment contract or binding policy and is subject to change at any time. Either Valve or an employee can terminate the employment relationship at any time, with or without cause, with or without notice. Employment with Valve is at-will, and nothing in this handbook will alter that status. First edition: March 2012 Valve Corporation Bellevue, Washington USA www.valvesoftware.com Designed by Valve Typeface: ITC New Baskerville 10 9 8 7 6 5 4 3 2 1 Preface In 1996, we set out to make great games, but we knew back then that we had to first create a place that was designed to foster that greatness. A place where incredibly talented individuals are empowered to put their best work into the hands of millions of people, with very little in their way. This book is an abbreviated encapsulation of our guiding principles. As Valve continues to grow, we hope that these principles will serve each new person joining our ranks. If you are new to Valve, welcome. Although the goals in this book are important, it’s really your ideas, talent, and energy that will keep Valve shining in the years ahead. Thanks for being here. Let’s make great things. – vii – VALVE: HANDBOOK FOR NEW EMPLOYEEs How to Use This Book This book isn’t about fringe benefits or how to set up your workstation or where to find source code. Valve works in ways that might seem counterintuitive at first. This handbook is about the choices you’re going to be making and how to think about them. Mainly, it’s about how not to freak out now that you’re here. ================================================== For more nuts-and-bolts information, there’s an official Valve intranet (http://intranet). Look for stuff there like how to build a Steam depot or whether eyeglasses are covered by your Flex Spending plan. This book is on the intranet, so you can edit it. Once you’ve read it, help us make it better for other new people. Suggest new sections, or change the existing ones. Add to the Glossary. Or if you’re not all that comfortable editing it, annotate it: make comments and suggestions. We’ll collectively review the changes and fold them into future revisions. ================================================== 1 Welcome to Valve – viii – VALVE: HANDBOOK FOR NEW EMPLOYEEs Your First Day WELCOME TO VALVE Valve Facts That Matter Fig. 1-1 So you’ve gone through the interview process, you’ve signed the contracts, and you’re finally here at Valve. Congratulations, and welcome. Valve has an incredibly unique way of doing things that will make this the greatest professional experience of your life, but it can take some getting used to. This book was written by people who’ve been where you are now, and who want to make your first few months here as easy as possible. –2– Fig. 1-2 Valve is self-funded. We haven’t ever brought in outside financing. Since our earliest days this has been incredibly important in providing freedom to shape the company and its business practices. Valve owns its intellectual property. This is far from the norm, in our industry or at most entertainment contentproducing companies. We didn’t always own it all. But thanks to some legal wrangling with our first publisher after Half-Life shipped, we now do. This has freed us to make our own decisions about our products. Valve is more than a game company. We started our existence as a pretty traditional game company. And we’re still one, but with a hugely expanded focus. Which is great, because we get to make better games as a result, –3– VALVE: HANDBOOK FOR NEW EMPLOYEES and we’ve also been able to diversify. We’re an entertainment company. A software company. A platform company. But mostly, a company full of passionate people who love the products we create. Welcome to Flatland Hierarchy is great for maintaining predictability and repeatability. It simplifies planning and makes it easier to control a large group of people from the top down, which is why military organizations rely on it so heavily. But when you’re an entertainment company that’s spent the last decade going out of its way to recruit the most intelligent, innovative, talented people on Earth, telling them to sit at a desk and do what they’re told obliterates 99 percent of their value. We want innovators, and that means maintaining an environment where they’ll flourish. That’s why Valve is flat. It’s our shorthand way of saying that we don’t have any management, and nobody “reports to” anybody else. We do have a founder/president, but even he isn’t your manager. This company is yours to steer—toward opportunities and away from risks. You have the power to green-light projects. You have the power to ship products. A flat structure removes every organizational barrier –4– Fig. 1-3 VALVE: HANDBOOK FOR NEW EMPLOYEEs between your work and the customer enjoying that work. Every company will tell you that “the customer is boss,” but here that statement has weight. There’s no red tape stopping you from figuring out for yourself what our customers want, and then giving it to them. If you’re thinking to yourself, “Wow, that sounds like a lot of responsibility,” you’re right. And that’s why hiring is the single most important thing you will ever do at Valve (see “Hiring ,” on page 43). Any time you interview a potential hire, you need to ask yourself not only if they’re talented or collaborative but also if they’re capable of literally running this company, because they will be. ================================================== Why does your desk have wheels? Think of those wheels as a symbolic reminder that you should always be considering where you could move yourself to be more valuable. But also think of those wheels as literal wheels, because that’s what they are, and you’ll be able to actually move your desk with them. You’ll notice people moving frequently; often whole teams will move their desks to be closer to each other. There is no organizational structure keeping you from being in close proximity to the people who you’d help or be helped by most. The fact that everyone is always moving around within the company makes people hard to find. That’s why we have http://user—check it out. We know where you are based on where your machine is plugged in, so use this site to see a map of where everyone is right now. ================================================== –6– 2 Settling In VALVE: HANDBOOK FOR NEW EMPLOYEEs Your First Month So you’ve decided where you put your desk. You know where the coffee machine is. You’re even pretty sure you know what that one guy’s name is. You’re not freaking out anymore. In fact, you’re ready to show up to work this morning, sharpen those pencils, turn on your computer, and then what? This next section walks you through figuring out what to work on. You’ll learn about how projects work, how cabals work, and how products get out the door at Valve. What to Work On Why do I need to pick my own projects? We’ve heard that other companies have people allocate a percentage of their time to self-directed projects. At Valve, that percentage is 100. Since Valve is flat, people don’t join projects because they’re told to. Instead, you’ll decide what to work on after asking yourself the right questions (more on that later). Employees vote on projects with their feet (or desk wheels). Strong projects are ones in which people can see demonstrated value; they staff up easily. This means there are any number of internal recruiting efforts constantly under way. –8– S ettling in If you’re working here, that means you’re good at your job. People are going to want you to work with them on their projects, and they’ll try hard to get you to do so. But the decision is going to be up to you. (In fact, at times you’re going to wish for the luxury of having just one person telling you what they think you should do, rather than hundreds.) But how do I decide which things to work on? Deciding what to work on can be the hardest part of your job at Valve. This is because, as you’ve found out by now, you were not hired to fill a specific job description. You were hired to constantly be looking around for the most valuable work you could be doing. At the end of a project, you may end up well outside what you thought was your core area of expertise. There’s no rule book for choosing a project or task at Valve. But it’s useful to answer questions like these: • Of all the projects currently under way, what’s the most valuable thing I can be working on? • Which project will have the highest direct impact on our customers? How much will the work I ship benefit them? • Is Valve not doing something that it should be doing? • What’s interesting? What’s rewarding? What leverages my individual strengths the most? –9– VALVE: HANDBOOK FOR NEW EMPLOYEEs How do I find out what projects are under way? There are lists of stuff, like current projects, but by far the best way to find out is to ask people. Anyone, really. When you do, you’ll find out what’s going on around the company and your peers will also find out about you. Lots of people at Valve want and need to know what you care about, what you’re good at, what you’re worried about, what you’ve got experience with, and so on. And the way to get the word out is to start telling people all of those things. So, while you’re getting the lay of the land by learning about projects, you’re also broadcasting your own status to a relevant group of people. Got an idea for how Valve could change how we internally broadcast project/company status? Great. Do it. In the meantime, the chair next to anyone’s desk is always open, so plant yourself in it often. Short-term vs. long-term goals Because we all are responsible for prioritizing our own work, and because we are conscientious and anxious to be valuable, as individuals we tend to gravitate toward projects that have a high, measurable, and predictable return for the company. So when there’s a clear opportunity on the table to succeed at a near-term business goal with a clear return, we all want to take it. And, when we’re faced with a – 10 – S ettling in problem or a threat, and it’s one with a clear cost, it’s hard not to address it immediately. This sounds like a good thing, and it often is, but it has some downsides that are worth keeping in mind. Specifically, if we’re not careful, these traits can cause us to race back and forth between short-term opportunities and threats, being responsive rather than proactive. So our lack of a traditional structure comes with an important responsibility. It’s up to all of us to spend effort focusing on what we think the long-term goals of the company should be. Someone told me to (or not to) work on X. And they’ve been here a long time! Well, the correct response to this is to keep thinking about whether or not your colleagues are right. Broaden the conversation. Hold on to your goals if you’re convinced they’re correct. Check your assumptions. Pull more people in. Listen. Don’t believe that anyone holds authority over the decision you’re trying to make. They don’t; but they probably have valuable experience to draw from, or information/data that you don’t have, or insight that’s new. When considering the outcome, don’t believe that anyone but you is the “stakeholder”. You’re it. And Valve’s customers are who you’re serving. Do what’s right for them. – 11 – VALVE: HANDBOOK FOR NEW EMPLOYEEs ================================================== There are lots of stories about how Gabe has made important decisions by himself, e.g., hiring the whole Portal 1 team on the spot after only half of a meeting. Although there are examples, like that one, where this kind of decision making has been successful, it’s not the norm for Valve. If it were, we’d be only as smart as Gabe or management types, and they’d make our important decisions for us. Gabe is the first to say that he can’t be right nearly often enough for us to operate that way. His decisions and requests are subject to just as much scrutiny and skepticism as anyone else’s. (So if he tells you to put a favorite custom knife design into Counter-Strike, you can just say no.) ================================================== Whatever group you’re in, whether you’re building Steam servers, translating support articles, or making the tenthousandth hat for Team Fortress 2, this applies to you. It’s crucial that you believe it, so we’ll repeat it a few more times in this book. What about all the things that I’m not getting done? It’s natural in this kind of environment to constantly feel like you’re failing because for every one task you decide to work on, there will be dozens that aren’t getting your attention. Trust us, this is normal. Nobody expects you to devote time to every opportunity that comes your way. Instead, we want you to learn how to choose the most important work to do. – 12 – S ettling in How does Valve decide what to work on? The same way we make other decisions: by waiting for someone to decide that it’s the right thing to do, and then letting them recruit other people to work on it with them. We believe in each other to make these decisions, and this faith has proven to be well-founded over and over again. But rather than simply trusting each other to just be smart, we also constantly test our own decisions. Whenever we move into unknown territory, our findings defy our own predictions far more often than we would like to admit. We’ve found it vitally important to, whenever possible, not operate by using assumptions, unproven theories, or folk wisdom. This kind of testing takes place across our business, from game development to hiring, to selling games on Steam. Luckily, Steam is a fantastic platform for business learning. It exists to be an entertainment/service platform for our customers, and as such it also is a conduit for constant communication between us and them. Accepted truisms about sales, marketing, regionality, seasonality, the Internet, purchasing behavior, game design, economics, and recruiting, etc., have proven wrong surprisingly often. So we have learned that when we take nearly any action, it’s best to do so in a way that we can measure, predict outcomes, and analyze results. – 13 – VALVE: HANDBOOK FOR NEW EMPLOYEEs Recruiting can be a difficult process to instrument and measure. Although we have always tried to be highly rational about how we hire people, we’ve found much room for improvement in our approach over the years. We have made significant strides toward bringing more predictability, measurement, and analysis to recruiting. A process that many assume must be treated only as a “soft” art because it has to do with humans, personalities, language, and nuance, actually has ample room for a healthy dose of science. We’re not turning the whole thing over to robots just yet though(see “Hiring ,” on page 43). Can I be included the next time Valve is deciding X? Yes. There’s no secret decision-making cabal. No matter what project, you’re already invited. All you have to do is either (1) Start working on it, or (2) Start talking to all the people who you think might be working on it already and find out how to best be valuable. You will be welcomed— there is no approval process or red tape involved. Quite the opposite—it’s your job to insert yourself wherever you think you should be. – 14 – S ettling in Teams, Hours, and the Office Cabals Fig. 2-1 Cabals are really just multidisciplinary project teams. We’ve self-organized into these largely temporary groups since the early days of Valve. They exist to get a product or large feature shipped. Like any other group or effort at the company, they form organically. People decide to join the group based on their own belief that the group’s work is important enough for them to work on. ================================================== For reference, read the article on cabals by Ken Birdwell. It describes where cabals came from and what they meant to us early on: http://tinyurl.com/ygam86p. ================================================== – 15 – VALVE: HANDBOOK FOR NEW EMPLOYEEs Team leads Often, someone will emerge as the “lead” for a project. This person’s role is not a traditional managerial one. Most often, they’re primarily a clearinghouse of information. They’re keeping the whole project in their head at once so that people can use them as a resource to check decisions against. The leads serve the team, while acting as centers for the teams. Structure happens Project teams often have an internal structure that forms temporarily to suit the group’s needs. Although people at Valve don’t have fixed job descriptions or limitations on the scope of their responsibility, they can and often do have clarity around the definition of their “job” on any given day. They, along with their peers, effectively create a job description that fits the group’s goals. That description changes as requirements change, but the temporary structure provides a shared understanding of what to expect from each other. If someone moves to a different group or a team shifts its priorities, each person can take on a completely different role according to the new requirements. Valve is not averse to all organizational structure—it crops up in many forms all the time, temporarily. But problems show up when hierarchy or codified divisions of – 16 – S ettling in labor either haven’t been created by the group’s members or when those structures persist for long periods of time. We believe those structures inevitably begin to serve their own needs rather than those of Valve’s customers. The hierarchy will begin to reinforce its own structure by hiring people who fit its shape, adding people to fill subordinate support roles. Its members are also incented to engage in rent-seeking behaviors that take advantage of the power structure rather than focusing on simply delivering value to customers. Hours While people occasionally choose to push themselves to work some extra hours at times when something big is going out the door, for the most part working overtime for extended periods indicates a fundamental failure in planning or communication. If this happens at Valve, it’s a sign that something needs to be reevaluated and corrected. If you’re looking around wondering why people aren’t in “crunch mode,” the answer’s pretty simple. The thing we work hardest at is hiring good people, so we want them to stick around and have a good balance between work and family and the rest of the important stuff in life. If you find yourself working long hours, or just generally feel like that balance is out of whack, be sure to raise the (cont’d on page 19) – 17 – Fig. 2-2 Method to move your desk 1. 2. 3. 4. step 1. Unplug cords from wall step 2. Move your desk step 3. Plug cords back into wall step 4. Get back to work VALVE METHOD DIAG. 1 A Timeline of Valve’s History 1996 1997 Valve is formed in Kirkland, WA, by Gabe Newell and Mike Harrington. Formation papers are signed on the same day as Gabe’s wedding. Quake engine license is acquired from id Software. Production commences on the game soon to be known as Half-Life (HL). Production commences on Valve’s second game, Prospero. Valve recruits and hires two game teams, including the ﬁrst international employee from the UK. Gabe promises that if HL becomes the #1- selling game, the company will take everyone on vacation. After internal review, HL deemed not good enough to ship. HL team returns to the drawing board and essentially starts over. Prospero permanently shelved. – 19 – HFNE:96:97::01 VALVE 19 9 8 Half-Life: Day One OEM demo is released. Released as a demo bundled with the Voodoo Banshee graphics card, the OEM release circulates far beyond its original intended audience. Valve realizes the level of anticipation for the full game. Half-Life is released. Following a certain Black Mesa Incident, the world is never the same again. TeamFortress Software Pty. Ltd. is acquired. Creators of Team Fortress (TF) join Valve and commence work on Team Fortress Classic. Valve’s ﬁrst company vacation to Cabo San Lucas, Mexico. # of employees: 30 # of children: 0 VALVE HFNE:98::02 1999 2000 2001 Valve establishes a pattern of supporting the best mods and occasionally acquiring them. Mike Harrington amicably dissolves his partnership with Gabe Newell, leaving Newell as the sole head of Valve Corporation. Half-Life: Opposing Force is released. Expansion pack follows events in Black Mesa from the viewpoint of an invading soldier. Counter-Strike (CS) is released. CS soon becomes the world’s #1 premier online action game. Team Fortress Classic is released. Ricochet is released. Robin Walker demonstrates to the mod community how a game can be created quickly and easily with Valve’s SDK. Half-Life: Deathmatch Classic is released. Half-Life: Blue Shift is released. HFNE:99:00:01::03 VALVE 2002 2003 Valve outgrows its original Kirkland ofﬁce space and moves to downtown Bellevue, WA. Steam is announced at GDC. Valve’s Steam offers to third parties its new suite of tools and services, which it had originally built to service its own games like HL and CS. Valve Anti-Cheat (VAC) is released. In a ﬁeld where rampant online cheating ruins the experience for many customers, Valve aggressively addresses the issue. Half-Life 2 (HL2) source code is stolen. A thief inﬁltrates Valve’s network to steal and disperse the code base for the still-in-production HL2. Years of speculation regarding the Borealis and Kraken Base begin… Steam is released. CS is released as Valve’s first Xbox title. Day of Defeat is released. A popular mod gets full Valve support, becoming one of its stalwart products. VALVE HFNE:02:03::04 2004 Source engine is unveiled. Half-Life 2 (HL2) is released. The world’s ﬁrst (legal) look at the Source engine, along with the game it powers: HL2. HL2 appears as the ﬁrst game available both through Steam and in retail locations. HL2 also becomes Valve’s second Xbox title. Counter-Strike: Source (CSS) is released. Years of work on Valve’s new Source engine technology ﬁnally come to light. Counter-Strike: Condition Zero is released. Half-Life: Source is released. The original HL gets a visual upgrade. HFNE:04::05 VALVE 2005 2006 2007 First third-party games are released on Steam. A landmark in digital distribution, Steam gives PC developers an alternative to retail for their games. Half-Life 2: Episode One is released. Valve’s ﬁrst experiment in episodic storytelling. The Orange Box is released with two previously-released titles and three new products: Half-Life 2: Lost Coast tech demo is released. Supported by the ﬁrst version of Valve’s popular developer commentary. Day of Defeat: Source is released. Valve hires six students from DigiPen Institute of Technology after seeing their demo of the game, Narbacular Drop. Half-Life Deathmatch: Source is released. Team Fortress 2 (TF2), the long-awaited sequel to the classic multiplayer game. Half Life 2: Episode Two— raising the bar for emotional storytelling. Portal—hailed worldwide as an instant classic. Steam Community is released with the first wave of features designed to help friends connect and socialize via the Steam platform. Steam reaches 15 million active users, playing over 200 games. VALVE HFNE:05:06:07::06 2008 Left 4 Dead is released. 2009 LEFT 4 DEAD 2 is released. Presale numbers are the biggest yet for a Valve game. Steamworks is unveiled, making the business and technical tools of the Steam platform available to thirdparty developers free of charge. Steam hits over 20 million users and over 500 games. TF2 gets major class updates for Medic, Pyro, and Heavy characters. These updates are delivered via Steam to all TF2 customers. Steam ships its ﬁrst downloadable content update for indie game The Maw. Steam Cloud is released, offering seamless online storage of any ﬁle types, including saved games, conﬁguration ﬁles, etc. Steam hits over 25 million users and over 1,000 games. TF2 releases The Sniper vs Spy Update, followed by outright WAR! After this release, the TF2 updates increase rapidly: more than 280 have shipped in total. TF2 ships its ﬁrst hat. HFNE:08:09::07 VALVE 2010 2011 2012 Portal 2 debuts on multiple platforms to critical acclaim. Valve’s 44th international hire clears immigration—this time from Germany. Valve moves to a more expansive location in Bellevue, WA. Valve announces that Steam and Source will be available for Macintosh. Dota 2 premieres at Gamescom in Cologne, Germany, with the first annual Dota 2 championship. In 2012, Valve heads to the Big Island of Hawaii for its 10th company vacation. # of employees: 293 # of children: 185 Valve announces Portal 2 is launching in 2011. Valve begins development of Dota 2. VALVE HFNE:10:11:12::08 Q1: New employee handbook rolls off press. What’s next? You tell us… S ettling in issue with whomever you feel would help. Dina loves to force people to take vacations, so you can make her your first stop. The office Sometimes things around the office can seem a little too good to be true. If you find yourself walking down the hall one morning with a bowl of fresh fruit and Stumptown-roasted espresso, dropping off your laundry to be washed, and heading into one of the massage rooms, don’t freak out. All these things are here for you to actually use. And don’t worry that somebody’s going to judge you for taking advantage of it—relax! And if you stop on the way back from your massage to play darts or work out in the Valve gym or whatever, it’s not a sign that this place is going to come crumbling down like some 1999-era dot-com startup. If we ever institute caviar-catered lunches, though, then maybe something’s wrong. Definitely panic if there’s caviar. – 19 – VALVE: HANDBOOK FOR NEW EMPLOYEEs Risks What if I screw up? Nobody has ever been fired at Valve for making a mistake. It wouldn’t make sense for us to operate that way. Providing the freedom to fail is an important trait of the company— we couldn’t expect so much of individuals if we also penalized people for errors. Even expensive mistakes, or ones which result in a very public failure, are genuinely looked at as opportunities to learn. We can always repair the mistake or make up for it. Screwing up is a great way to find out that your assumptions were wrong or that your model of the world was a little bit off. As long as you update your model and move forward with a better picture, you’re doing it right. Look for ways to test your beliefs. Never be afraid to run an experiment or to collect more data. It helps to make predictions and anticipate nasty outcomes. Ask yourself “what would I expect to see if I’m right?” Ask yourself “what would I expect to see if I’m wrong?” Then ask yourself “what do I see?” If something totally unexpected happens, try to figure out why. There are still some bad ways to fail. Repeating the same mistake over and over is one. Not listening to customers or peers before or after a failure is another. Never ignore the evidence; particularly when it says you’re wrong. – 20 – S ettling in Fig. 2-3 – 21 – Fig. 2-4 Methods to find out what’s going on 1. 2. S ettling in But what if we ALL screw up? 3. 4. step 1. Talk to someone in a meeting step 2. Talk to someone in the elevator step 3. Talk to someone in the kitchen step 4. Talk to someone in the bathroom VALVE METHOD DIAG. 2 Fig. 2-5 So if every employee is autonomously making his or her own decisions, how is that not chaos? How does Valve make sure that the company is heading in the right direction? When everyone is sharing the steering wheel, it seems natural to fear that one of us is going to veer Valve’s car off the road. Over time, we have learned that our collective ability to meet challenges, take advantage of opportunity, and respond to threats is far greater when the responsibility for doing so is distributed as widely as possible. Namely, to every individual at the company. We are all stewards of our long-term relationship with our customers. They watch us, sometimes very publicly, – 23 – VALVE: HANDBOOK FOR NEW EMPLOYEEs make mistakes. Sometimes they get angry with us. But because we always have their best interests at heart, there’s faith that we’re going to make things better, and that if we’ve screwed up today, it wasn’t because we were trying to take advantage of anyone. 3 How Am I Doing? – 24 – VALVE: HANDBOOK FOR NEW EMPLOYEES Your Peers and Your Performance We have two formalized methods of evaluating each other: peer reviews and stack ranking. Peer reviews are done in order to give each other useful feedback on how to best grow as individual contributors. Stack ranking is done primarily as a method of adjusting compensation. Both processes are driven by information gathered from each other—your peers. Peer reviews We all need feedback about our performance—in order to improve, and in order to know we’re not failing. Once a year we all give each other feedback about our work. Outside of these formalized peer reviews, the expectation is that we’ll just pull feedback from those around us whenever we need to. There is a framework for how we give this feedback to each other. A set of people (the set changes each time) interviews everyone in the whole company, asking who each person has worked with since the last round of peer reviews and how the experience of working with each person was. The purpose of the feedback is to provide people with information that will help them grow. That means that the best quality feedback is directive and – 26 – H ow am I doing ? prescriptive, and designed to be put to use by the person you’re talking about. The feedback is then gathered, collated, anonymized, and delivered to each reviewee. Making the feedback anonymous definitely has pros and cons, but we think it’s the best way to get the most useful information to each person. There’s no reason to keep your feedback about someone to yourself until peer review time if you’d like to deliver it sooner. In fact, it’s much better if you do so often, and outside the constraints of official peer reviews. When delivering peer review feedback, it’s useful to keep in mind the same categories used in stack ranking because they concretely measure how valuable we think someone is. Stack ranking (and compensation) The other evaluation we do annually is to rank each other against our peers. Unlike peer reviews, which generate information for each individual, stack ranking is done in order to gain insight into who’s providing the most value at the company and to thereby adjust each person’s compensation to be commensurate with his or her actual value. Valve pays people very well compared to industry norms. Our profitability per employee is higher than that of Google or Amazon or Microsoft, and we believe strongly that the right thing to do in that case is to put a maximum – 27 – Fig. 3-1 Method to working without a boss 1. 2. 3. 4. step 1. Come up with a bright idea step 2. Tell a coworker about it step 3. Work on it together step 4. Ship it! VALVE METHOD DIAG. 3 H ow am I doing ? amount of money back into each employee’s pocket. Valve does not win if you’re paid less than the value you create. And people who work here ultimately don’t win if they get paid more than the value they create. So Valve’s goal is to get your compensation to be “correct.” We tend to be very flexible when new employees are joining the company, listening to their salary requirements and doing what we can for them. Over time, compensation gets adjusted to fit an employee’s internal peer-driven valuation. That’s what we mean by “correct”—paying someone what they’re worth (as best we can tell using the opinions of peers). ================================================== If you think your compensation isn’t right for the work you do, then you should raise the issue. At Valve, these conversations are surprisingly easy and straightforward. Adjustments to compensation usually occur within the process described here. But talking about it is always the right thing if there’s any issue. Fretting about your level of compensation without any outside information about how it got set is expensive for you and for Valve. ================================================== The removal of bias is of the utmost importance to Valve in this process. We believe that our peers are the best judges of our value as individuals. Our flat structure eliminates some of the bias that would be present in a peer-ranking system elsewhere. The design of our stack-ranking process is meant to eliminate as much as possible of the remainder. – 29 – VALVE: HANDBOOK FOR NEW EMPLOYEEs Each project/product group is asked to rank its own members. (People are not asked to rank themselves, so we split groups into parts, and then each part ranks people other than themselves.) The ranking itself is based on the following four metrics: 1. Skill Level/Technical Ability How difficult and valuable are the kinds of problems you solve? How important/critical of a problem can you be given? Are you uniquely capable (in the company? industry?) of solving a certain class of problem, delivering a certain type of art asset, contributing to design, writing, or music, etc.? 2. Productivity/Output How much shippable (not necessarily shipped to outside customers), valuable, finished work did you get done? Working a lot of hours is generally not related to productivity and, after a certain point, indicates inefficiency. It is more valuable if you are able to maintain a sensible work/life balance and use your time in the office efficiently, rather than working around the clock. – 30 – Fig. 3-2 VALVE: HANDBOOK FOR NEW EMPLOYEEs 3. Group Contribution How much do you contribute to studio process, hiring, integrating people into the team, improving workflow, amplifying your colleagues, or writing tools used by others? Generally, being a group contributor means that you are making a tradeoff versus an individual contribution. Stepping up and acting in a leadership role can be good for your group contribution score, but being a leader does not impart or guarantee a higher stack rank. It is just a role that people adopt from time to time. 4. Product Contribution How much do you contribute at a larger scope than your core skill? How much of your work matters to the product? How much did you influence correct prioritization of work or resource trade-offs by others? Are you good at predicting how customers are going to react to decisions we’re making? Things like being a good playtester or bug finder during the shipping cycle would fall into this category. – 32 – H ow am I doing ? By choosing these categories and basing the stack ranking on them, the company is explicitly stating, “This is what is valuable.” We think that these categories offer a broad range of ways you can contribute value to the company. Once the intra-group ranking is done, the information gets pooled to be company-wide. We won’t go into that methodology here. There is a wiki page about peer feedback and stack ranking with some more detail on each process. – 33 – Fig. 3-3 Method to taking the company trip 1. 2. 3. 4. step 1. Find someone to watch your cats step 2. Board our chartered flight step 3. Relax by the pool step 4. Relax by the pool some more VALVE METHOD DIAG. 4 4 Choose Your Own Adventure VALVE: HANDBOOK FOR NEW EMPLOYEEs Your First Six Months You’ve solved the nuts-and-bolts issues. Now you’re moving beyond wanting to just be productive day to day—you’re ready to help shape your future, and Valve’s. Your own professional development and Valve’s growth are both now under your control. Here are some thoughts on steering both toward success. Roles Fig. 4-1 By now it’s obvious that roles at Valve are fluid. Traditionally at Valve, nobody has an actual title. This is by design, to remove organizational constraints. Instead we have things we call ourselves, for convenience. In particular, people – 36 – CHOOSE YOUR OWN ADVENTURE who interact with others outside the company call themselves by various titles because doing so makes it easier to get their jobs done. Inside the company, though, we all take on the role that suits the work in front of us. Everyone is a designer. Everyone can question each other’s work. Anyone can recruit someone onto his or her project. Everyone has to function as a “strategist,” which really means figuring out how to do what’s right for our customers. We all engage in analysis, measurement, predictions, evaluations. One outward expression of these ideals is the list of credits that we put in our games—it’s simply a long list of names, sorted alphabetically. That’s it. This was intentional when we shipped Half-Life, and we’re proud to continue the tradition today. Advancement vs. growth Because Valve doesn’t have a traditional hierarchical structure, it can be confusing to figure out how Valve fits into your career plans. “Before Valve, I was an assistant technical second animation director in Hollywood. I had planned to be a director in five years. How am I supposed to keep moving forward here?” Working at Valve provides an opportunity for extremely efficient and, in many cases, very accelerated, career – 37 – VALVE: HANDBOOK FOR NEW EMPLOYEEs growth. In particular, it provides an opportunity to broaden one’s skill set well outside of the narrow constraints that careers can have at most other companies. So the “growth ladder” is tailored to you. It operates exactly as fast as you can manage to grow. You’re in charge Fig. 4-2 of your track, and you can elicit help with it anytime from those around you. F Y I , we usually don’t do any formalized employee “development” (course work, mentor assignment), because for senior people it’s mostly not effective. We believe that high-performance people are generally self-improving. – 38 – CHOOSE YOUR OWN ADVENTURE Most people who fit well at Valve will be betterpositioned after their time spent here than they could have been if they’d spent their time pretty much anywhere else. Putting more tools in your toolbox The most successful people at Valve are both (1) highly skilled at a broad set of things and (2) world-class experts within a more narrow discipline. (See “T-shaped” people on page 46.) Because of the talent diversity here at Valve, it’s often easier to become stronger at things that aren’t your core skill set. Engineers: code is only the beginning If you were hired as a software engineer, you’re now surrounded by a multidisciplinary group of experts in all kinds of fields—creative, legal, financial, even psychological. Many of these people are probably sitting in the same room as you every day, so the opportunities for learning are huge. Take advantage of this fact whenever possible: the more you can learn about the mechanics, vocabulary, and analysis within other disciplines, the more valuable you become. Non-Engineers: program or be programmed Valve’s core competency is making software. Obviously, – 39 – VALVE: HANDBOOK FOR NEW EMPLOYEES different disciplines are part of making our products, but we’re still an engineering-centric company. That’s because the core of the software-building process is engineering. As in, writing code. If your expertise is not in writing code, then every bit of energy you put into understanding the code-writing part of making software is to your (and Valve’s) benefit. You don’t need to become an engineer, and there’s nothing that says an engineer is more valuable than you. But broadening your awareness in a highly technical direction is never a bad thing. It’ll either increase the quality or quantity of bits you can put “into boxes,” which means affecting customers more, which means you’re valuable. 5 Valve Is Growing – 40 – VALVE: HANDBOOK FOR NEW EMPLOYEEs Your Most Important Role Concepts discussed in this book sound like they might work well at a tiny start-up, but not at a hundreds-of-people-plusbillions-in-revenue company. The big question is: Does all this stuff scale? Well, so far, yes. And we believe that if we’re careful, it will work better and better the larger we get. This might seem counterintuitive, but it’s a direct consequence of hiring great, accomplished, capable people. Getting this to work right is a tricky proposition, though, and depends highly on our continued vigilance in recruiting/hiring. If we start adding people to the company who aren’t as capable as we are at operating as high-powered, selfdirected, senior decision makers, then lots of the stuff discussed in this book will stop working. One thing that’s changing as we grow is that we’re not great at disseminating information to everyone anymore (see “What is Valve not good at?,” on page 52). On the positive side, our profitability per employee is going up, so by that measure, we’re certainly scaling correctly. Our rate of hiring growth hovered between 10 and 15 percent per year, for years. In 2010, we sped up, but only to about 20 percent per year. 2011 kept up this new pace, largely due to a wave of hiring in Support. – 42 – Valve is growing We do not have a growth goal. We intend to continue hiring the best people as fast as we can, and to continue scaling up our business as fast as we can, given our existing staff. Fortunately, we don’t have to make growth decisions based on any external pressures—only our own business goals. And we’re always free to temper those goals with the long-term vision for our success as a company. Ultimately, we win by keeping the hiring bar very high. Hiring Fig. 5-1 – 43 – VALVE: HANDBOOK FOR NEW EMPLOYEEs Hiring well is the most important thing in the universe. Nothing else comes close. It’s more important than breathing. So when you’re working on hiring—participating in an interview loop or innovating in the general area of recruiting—everything else you could be doing is stupid and should be ignored! When you’re new to Valve, it’s super valuable to start being involved in the interview process. Ride shotgun with people who’ve been doing it a long time. In some ways, our interview process is similar to those of other companies, but we have our own take on the process that requires practice to learn. We won’t go into all the nuts and bolts in this book—ask others for details, and start being included in interview loops. Why is hiring well so important at Valve? At Valve, adding individuals to the organization can influence our success far more than it does at other companies —either in a positive or negative direction. Since there’s no organizational compartmentalization of people here, ================================================== Bring your friends. One of the most valuable things you can do as a new employee is tell us who else you think we should hire. Assuming that you agree with us that Valve is the best place to work on Earth, then tell us about who the best people are on Earth, so we can bring them here. If you don’t agree yet, then wait six months and ask yourself this question again. ================================================== – 44 – Valve is growing adding a great person can create value across the whole company. Missing out on hiring that great person is likely the most expensive kind of mistake we can make. Usually, it’s immediately obvious whether or not we’ve done a great job hiring someone. However, we don’t have the usual checks and balances that come with having managers, so occasionally it can take a while to understand whether a new person is fitting in. This is one downside of the organic design of the company—a poor hiring decision can cause lots of damage, and can sometimes go unchecked for too long. Ultimately, people who cause damage always get weeded out, but the harm they do can still be significant. How do we choose the right people to hire? An exhaustive how-to on hiring would be a handbook of its own. Probably one worth writing. It’d be tough for us to capture because we feel like we’re constantly learning really important things about how we hire people. In the meantime, here are some questions we always ask ourselves when evaluating candidates: • Would I want this person to be my boss? • Would I learn a significant amount from him or her? • What if this person went to work for our competition? Across the board, we value highly collaborative people. That means people who are skilled in all the things that are – 45 – VALVE: HANDBOOK FOR NEW EMPLOYEEs integral to high-bandwidth collaboration—people who can deconstruct problems on the fly, and talk to others as they do so, simultaneously being inventive, iterative, creative, talkative, and reactive. These things actually matter far more than deep domain-specific knowledge or highly developed skills in narrow areas. This is why we’ll often pass on candidates who, narrowly defined, are the “best” at their chosen discipline. Of course it’s not quite enough to say that a candidate should collaborate well—we also refer to the same four metrics that we rely on when evaluating each other to evaluate potential employees (See “Stack ranking,” on page 27). We value “T-shaped” people. That is, people who are both generalists (highly skilled at a broad set of valuable things—the top of the T) and also experts (among the best in their field within a narrow discipline—the vertical leg of the T). This recipe is important for success at Valve. We often have to pass on people who are very strong generalists without expertise, or vice versa. An expert who is too narrow has difficulty collaborating. A generalist who doesn’t go deep enough in a single area ends up on the margins, not really contributing as an individual. – 46 – Valve is growing Fig. 5-2 We’re looking for people stronger than ourselves. When unchecked, people have a tendency to hire others who are lower-powered than themselves. The questions listed above are designed to help ensure that we don’t start hiring people who are useful but not as powerful as we are. We should hire people more capable than ourselves, not less. In some ways, hiring lower-powered people is a natural response to having so much work to get done. In these conditions, hiring someone who is at least capable seems (in the short term) to be smarter than not hiring anyone at all. But that’s actually a huge mistake. We can always bring – 47 – VALVE: HANDBOOK FOR NEW EMPLOYEES on temporary/contract help to get us through tough spots, but we should never lower the hiring bar. The other reason people start to hire “downhill” is a political one. At most organizations, it’s beneficial to have an army of people doing your bidding. At Valve, though, it’s not. You’d damage the company and saddle yourself with a broken organization. Good times! Hiring is fundamentally the same across all disciplines. There are not different sets of rules or criteria for engineers, artists, animators, and accountants. Some details are different—like, artists and writers show us some of their work before coming in for an interview. But the actual interview process is fundamentally the same no matter who we’re talking to. “With the bar this high, would I be hired today?” That’s a good question. The answer might be no, but that’s actually aw
Url: /Media/UHS-website-2019/Docs/Zengenti-Mock/PDF-document.pdf

Papers Trust Board 27 May 2021

Description: Date Time Location Chair Agenda Trust Board – Open Session 27/05/2021 9:00 - 13:00 Microsoft Teams Peter Hollins 1 Chair’s Welcome, Apo
Url: /Media/UHS-website-2019/Docs/About-the-Trust/Trust-governance-and-corporate-docs/2021-Trust-document/TB-papers/Papers-Trust-Board-27-May-2021.pdf

Recipe book - For babies who need to make the most of every mouthful

Description: RECIPE BOOK For babies who need to get the most out of every mouthful Contents 04 06 11 14 15 16 18 20 22 Acknowled
Url: /Media/UHS-website-2019/Docs/Services/Child-health/DietaryAdvice/Recipe-book-For-babies-who-need-to-make-the-most-of-every-mouthful.pdf

Eating and drinking with a high output stoma - patient information

Description: This factsheet provides information on how to manage your high output stoma.
Url: /Media/UHS-website-2019/Patientinformation/Digestionandurinaryhealth/Eating-and-drinking-with-a-high-output-stoma-2412-PIL.pdf

Annual report 20-21

Description: 2020/21 Incorporating the quality report University Hospital Southampton NHS Foundation Trust Annual Report and Accounts 2020/21 Presented to Parliament pursuant to Schedule 7, paragraph 25(4)(a) of the National Health Service Act 2006 © 2021 University Hospital Southampton NHS Foundation Trust Table of contents Welcome from our chair and chief executive 6 Overview and performance 8 Performance report 9 Overview 10 Accountability report 29 Directors’ report 30 Remuneration report 53 Staff report 65 NHS Foundation Trust Code of Governance 81 NHS Oversight Framework 81 Annual governance statement 84 Quality report 95 Statement on quality from the chief executive 96 Priorities for improvement and statements of assurance from the board 99 Other information 153 Annual accounts 180 Statement from the chief financial officer 181 Auditor’s report 182 Foreword to the accounts 188 Statement of Comprehensive Income 189 Statement of Financial Position 190 Statement of Changes in Taxpayers’ Equity 191 Statement of Cash Flows 192 Notes to the accounts 193 5 Welcome from our chair and chief executive 2020/21 was undoubtedly the most challenging year in the history of the NHS, and we have felt the impact of the COVID-19 pandemic here at University Hospital Southampton NHS Foundation Trust (UHS) in full. Responding to this has meant there isn’t a single part of our organisation that hasn’t changed in some way over the last year and we have all had to adapt to a rapidly changing environment. Our staff have been unwavering in their dedication, hard work and commitment to keeping our hospitals running, our patients cared for, and their colleagues supported. Every single member of the UHS family has played their part. The loss of life from COVID-19 has been devastating, and at UHS we stand shoulder-to-shoulder with everyone affected by this tragedy, including the families of staff members whom we lost. We must recognise the incredible work of Southampton Hospital Charity, which has funded boost boxes, wellness rooms, a helpline and so much more to support staff at a time when their wellbeing is more important than ever. As the nationwide vaccination programme continues to offer hope of life more like pre-pandemic times, we are proud to have been at the forefront of these efforts - from being part of early research for the Oxford-AstraZeneca vaccine, to the opening of one of the largest vaccination hubs in the region on our site in December 2020. We will continue to play a key role in vaccination development by leading the world’s first clinical trial into the effectiveness of COVID-19 booster vaccines, as well as taking part in a study involving pregnant people. Our response to COVID-19 has prompted innovation and new ways of working across the Trust, to the benefit of patient experience. At the start of the pandemic we faced real challenges of capacity and increases in waiting times, which led to us working with Spire Southampton so cancer treatment and surgery could continue for patients at highest risk. We also increased the number of outpatient attendances which took place by telephone or video call, and our patient support hub was set up to provide a single point of support for patients who had been advised to shield. We are immensely proud of the record of the Trust during the pandemic, exemplified by the number of patients we were able to take into our care from well outside the local area. The Trust is in a strong financial position as a result of careful spending and efficiencies, which has allowed us to invest significantly in upgrading our estate. These improvements have seen the opening of the general intensive care unit, and the new cancer ward, which was built in just six months. These formed part of overall capital expenditure of £80 million during the year. The last year has seen us say goodbye to two members of our executive leadership team. Paula Head left the chief executive officer role in November to join the national response to COVID-19, before becoming a senior fellow at The King’s Fund. Derek Sandeman moved on from being our chief medical officer to take the same position at the Hampshire and Isle of Wight Integrated Care System. We are grateful to both for their efforts on the Trust leadership team during the most challenging of years. One of our non-executive directors, Jenni Douglas-Todd, also left the Trust to take on the important role of director of equality and inclusion with NHS England and NHS Improvement. 6 Looking ahead to the future, UHS will play a key role in the Hampshire and Isle of Wight Integrated Care System. Our commitment is to deliver services with partners through clinical networks, collaboration and integration across geographical and organisational boundaries for seamless patient care. We as a Trust board are looking forward to implementing our own five year strategy, which sets out ambitions for what we want the hospital to be in 2025, for both patients and staff. Our focus will always be on enabling world class people to deliver world class care. Peter Hollins David French Chair Chief Executive Officer 7 OVERVIEW AND PERFORMANCE Performance report Introduction from our chief executive Over the last year, the way in which the Trust has worked and performance it has achieved, has been transformed by the COVID-19 pandemic. • UHS saw a number of large surges in demand for inpatient care, and for intensive respiratory support in particular, due to COVID-19 infection rates. Our capacity to deliver intensive care had to be increased, and many of our staff moved from other services such as our elective theatres in order to meet this need for care. • We have introduced and continue to maintain a number of changes to reduce the risk of COVID-19 being transmitted, or adversely affecting patient outcomes, within the Trust. Changes have included the wearing of additional personal protective equipment by our staff (especially when caring for patients who might have COVID-19 or undertaking higher risk procedures), reducing the number of patients coming to our outpatient departments and increasing the number of telephone and video consultations, separating elective and emergency patients within our departments and regular testing of our staff and all patients on or prior to their admission to hospital for treatment. • Public concerns about safety, government restrictions and the efforts of community services actually contributed to reductions in the total number of patients who sought hospital care this year. • Treatment plans have been modified by a number of services, in partnership with patients, to reduce the risk posed by COVID-19 to those patients. This was often appropriate in those circumstances in which the normal treatment would significantly reduce the patient’s own resistance to infections. Our performance has, in many cases, been strongly influenced by these profound changes. We have responded well to the need to provide the most urgent care, and the adverse impacts on elective care have been slightly less than the average across the NHS. However, we remain very concerned by the significant increase in the numbers of patients waiting longer than they should for elective care. It will take concerted and sustained action within both the Trust and the wider NHS in order to return elective performance to levels achieved before the pandemic whilst also continuing to meet urgent care needs as the restrictions that have been implemented within our society are progressively relaxed. 9 Overview About the Trust Our services University Hospital Southampton NHS Foundation Trust is one of the largest acute teaching trusts in England with a turnover of more than £1 billion in 2020/21. It is based on the coast in south east England and provides services to over 1.9 million people living in Southampton and south Hampshire and specialist services, including neurosciences, respiratory medicine, cancer care, cardiovascular, obstetrics and specialist children’s services, to more than 3.7 million people in central southern England and the Channel Islands. The Trust is also a designated major trauma centre, one of only two places in the south of England to offer adults and children full major trauma care provision. As a leading centre for teaching and research, the Trust has close working relationships with the University of Southampton, the Medical Research Council, National Institute for Health Research (NIHR), Wellcome Trust and Cancer Research UK. UHS is consistently one of the UK’s highest recruiting trusts of patients to clinical trials and in the top ten nationally for research study volume as ranked by the NIHR Clinical Research Network. 12,000 Every year over staff at UHS: treat around 160,000 inpatients and day patients, including about 75,000 emergency admissions see over 650,000 people at outpatient appointments deal with around 150,000 cases in our emergency department deliver more than 100 outpatient clinics across the south of England, keeping services local for patients The Trust provides most of its services from the following locations: • Southampton General Hospital – the Trust’s largest location, where a great number of specialist services are based alongside emergency and critical care and which includes Southampton Children’s Hospital. • Princess Anne Hospital – located across the road from Southampton General Hospital and providing maternity care and specialist care for women with medical problems during pregnancy and babies who need extra care around birth across the region. • Royal South Hants Hospital – although the Trust does not operate this site near the centre of Southampton it provides a smaller number of services from this location. • New Forest Birth Centre – located at Ashurst on the edge of the New Forest and run by experienced midwives and support staff it offers a safe, ‘home away from home’ environment for women having a healthy pregnancy and expecting a straightforward birth. The services provided by the Trust are commissioned and paid for by local clinical commissioning groups (CCGs) and, in the case of more specialised services (such as treatments for rare conditions), by NHS England. Over 50% of UHS services are paid for by CCGs and approximately 48% by NHS England. We provide these under a standard NHS contract, which incorporates ongoing monitoring of the Trust and the quality of the services provided. 10 Our structure UHS gained foundation trust status on 1 October 2011. A foundation trust is a public benefit corporation providing NHS services in line with the core NHS principles: that care should be universal, comprehensive and free at the point of need. The Trust is licensed as a foundation trust to provide these services by Monitor (the independent regulator, now part of NHS England and NHS Improvement) and the healthcare services we provide are regulated by the Care Quality Commission. Being a foundation trust has enabled greater local accountability and greater financial freedom and has supported the delivery of the Trust’s mission and strategy over a number of years. The diagram below provides an overview of the overall organisational structure of the Trust. Public and foundation trust members Council of Governors Board of Directors Executive Directors Division A Surgery Critical Care Opthalmology Theatres and Anaesthetics Division B Division C Cancer Care Emergency Medicine Helicopter Emergency Medical Services Medicine and Medicine for Older People Pathology Specialist Medicine Women and Newborn Maternity Child Health Clinical Support Division D Trust Headquarters Division Cardiovascular and Thoracic Neurosciences Trauma and Orthopaedics Radiology Corporate Affairs Communications Estates, Facilities and Capital Development Finance Human Resources Informatics Patient Support Services Procurement and Supply Transformation and Improvement (‘Always Improving’) Research and Development Strategy and Business Development 11 The Trust is also part of an integrated care system in Hampshire and the Isle of Wight, which is a partnership of NHS and local government organisations working together to improve the health and wellbeing of the population across Hampshire and the Isle of Wight. Our values Our values describe how we do things at UHS and act as a guide to all staff working with colleagues to deliver high quality patient care and a great patient experience every day. Our values are: Patients, their families and carers are at the heart of what we do. Their experience of our services will be our measure of success. Partnership between clinicians, patients and carers is critical to achieving our vision, both within hospital teams and extending across organisational boundaries in the NHS, social care and the third sector. We will ensure we are always improving services for patients through research, education, clinical effectiveness and quality improvement. We will continue to incorporate new ideas, technologies and create greater efficiencies in the services we provide. 12 Our strategy 2021-25 The Trust’s strategy was updated during 2020/2021 to take account of everything our staff had experienced during the COVID-19 pandemic and what we had learnt from this. The vision for UHS is to continue on its journey to become an organisation of world class people delivering world class care. Our strategy is organised around five themes and for each of these describes a number ambitions we aim to achieve by 2025. Theme Ambitions Outstanding patient outcomes, • We will monitor clinical outcomes, safety and experience of our experience and safety patients regularly to ensure they are amongst the best in the UK By 2025 we will strengthen our and the world. national reputation for outstanding • We will reduce harm, learning from all incidents through our patient outcomes, experience and proactive patient safety culture. safety, providing high quality care • We will ensure all patients and relatives have a positive experience and treatment across an extensive of our care, as a result of the environment created by our people range of services from foetal and our facilities. medicine, through all life stages and conditions, to end-of-life care. Pioneering research • We will recruit and enable people to deliver pioneering research and innovation in Southampton. We will continue to be a leading teaching hospital with a growing, reputable and innovative research and development portfolio • We will optimise access to clinical research studies for our patients. • We will enable innovation in everything we do, and ensure that ‘cutting edge’ investigations and treatments are delivered in Southampton. that attracts the best staff and efficiently delivers the best possible treatments and care for our patients. World class people • We will recruit and develop enough people with the right Supporting and nurturing our knowledge and skills to meet the needs of our patients. people through a culture that values • We will provide satisfying and fulfilling roles, growing our talent diversity and builds knowledge and through development and opportunity for progression. skills to ensure everyone reaches • We will empower our people, embracing diversity and embedding their full potential. We must provide compassion, inclusion and equity of opportunity. rewarding career paths within empowered, compassionate, and motivated teams. Integrated networks and collaboration We will deliver our services with partners through clinical networks, collaboration and integration across geographical and organisational boundaries. • We will work in partnership with key stakeholders across the Hampshire and Isle of Wight integrated care system. • We will strengthen our acute clinical networks across the region, centralising when necessary and supporting local care when appropriate. • We will foster local integration with primary and community care as well as mental health and social care services for seamless delivery across boundaries. • We will build on our successful partnership with University of Southampton (UoS), growing our reputation as a national leading university teaching hospital. 13 Theme Foundations for the future Making our enabling infrastructure (finance, digital, estate) fit for the future to support a leading university teaching hospital in the 21st century and recognising our responsibility as a major employer in the community of Southampton and our role in broader environmental sustainability. Ambitions • We will deliver best value to the tax payer as a financially efficient and sustainable organisation. • We will support patient self-management and seamless care across organisational boundaries through our ambitious digital programme, including real time data reporting, to inform our care. • We will expand and improve our estate, increasing capacity where needed and providing modern facilities for our patients and our people. • We will strengthen our role in the community as an employer of choice, a partner in delivery of services to our population and by leading the Greener NHS agenda locally. During each year of the strategy the Trust will set out a more detailed series of objectives to achieve and progress towards the delivery of its ambitions. In 2020/21 these objectives included: • Recovery, restoration and improvement of clinical services • Implementing the ‘Always Improving’ strategy • Restoring a full research portfolio • Continuing our focus on staff wellbeing including the long-term effects of coronavirus (long COVID) • Working in partnership with the newly established integrated care system • Creating a sustainable financial infrastructure • Making our corporate infrastructure (digital, estate) fit for the future to support a leading university teaching hospital in the 21st century, including an estates masterplan. Performance against these objectives will be monitored and reported to the Trust’s board of directors on a quarterly basis. Principal risks to our strategy and objectives The board of directors has identified and manages the principal risks to the delivery of its strategy and objectives through its board assurance framework. The principal risks to the delivery of its strategy and objectives identified by the Trust during 2020/21 were that: • it would be unable to form effective partnerships that achieve networked care for patients; • it could not develop the estate in line with the ambitions set out in the strategy; • it would fail to restore and increase capacity following the COVID-19 pandemic to meet waiting times for elective care and cancer care needs; • it would fail to introduce and implement new technology for the transformation of care; • it would be unable to retain, recruit, develop and train a diverse and inclusive workforce necessary to meet the strategic goals; • it could not develop a sustainable model within the new financial regime that preserves quality care; • it would fail to provide vulnerable service users with timely and high quality and appropriate care; • it would not reach the ambition of outstanding compliance and quality standards; • it could not sufficiently engage with key stakeholders and system partners to support effective interventions and maintain the health of the local population; • it would be unable to respond to the needs of the NHS in order to deliver our strategy; • it would fail to capitalise on its relationship with the universities in Southampton and other health education providers in line with our strategy; • it would not develop innovative education and training approaches. 14 While the COVID-19 pandemic presented the Trust with new risks as it introduced more stringent infection control processes, stopped certain types of activity and responded quickly to care for large numbers of seriously ill patients who had tested positive for COVID-19, it also prompted innovation across a wide range of areas. However the ongoing impact of the pandemic on both our staff, patients who have had COVID-19 and patients who have waited longer than expected for treatment as a result, added to the risks facing the Trust. National targets for performance have not been amended as a result of the pandemic, although the national plan has focussed on the recovery of activity levels as the first stage in a restoration of elective services. Capacity – The initial and subsequent waves of the COVID-19 pandemic have led to increases in the waiting times for patients and the number of patients waiting more than 52 and 78 weeks has increased significantly. While the Trust was able to recover capacity quickly between waves of the pandemic, its ability to reduce the overall waiting list and the length of time patients are waiting for treatment remains one of the key risks for the Trust. This may be compounded by the reduction in the number of referrals from GPs during the pandemic, leading to a potential future increase in the number of patients being referred as people visit their GPs for the first time with more advanced disease. During the pandemic the Trust utilised the support available from the independent sector to continue cancer treatment and surgery for those patients at highest risk. It also increased the number of outpatient attendances which took place by telephone or video call. The Trust developed a clinical assurance framework during the year to better assess the risk of harm to patients as a result of delays in treatment and this has been utilised in decision-making around the allocation of resources to those areas where there is the greatest risk of potential harm to patients. In addition to opening additional capacity during 2020/21 (described in the Estates section below), the Trust also committed expenditure and commenced construction works in 2020/21 in order to be in a position to open an additional endoscopy room and four further operating theatres during 2021/22 and prepared plans for a significant expansion in ophthalmology outpatient capacity. These initiatives will contribute to improvements in elective waiting times that needed following the pandemic. Quality and compliance – The Trust continued to monitor the quality of care delivered throughout 2020/21. During the COVID-19 pandemic the primary focus became infection prevention and control, with the launch of a successful COVID ZERO campaign that saw the Trust reduce the transmission of the virus in hospital (nosocomial transmission). The Trust also achieved its annual target for reduction in Clostridium Difficile infections, however, there was one MRSA Bacteraemia during March 2021, the only such event in 2020/21. The Trust continued to develop its proactive patient safety culture during 2020/21 with changes to the way in which patient safety incidents are investigated and the approval of its Always Improving strategy, which will be launched in 2021. Reporting and investigation of incidents continued during 2020/21. Partnerships – During 2020/21, the Trust and its partners worked together very effectively to discharge patients safely and provide ongoing support to patients who had tested positive for COVID-19, to ensure patients requiring urgent cancer treatment and surgery were able to continue their treatment in the independent sector and to develop a COVID-19 saliva testing pilot with the University of Southampton and local authorities. Work to respond to the COVID-19 pandemic, however, meant that as a system we were unable to progress the Hampshire and Isle of Wight strategic plan delivery at the pace we would have wanted or had set out to achieve, particularly the development of networks. Nonetheless the application for Hampshire and Isle of Wight to become an integrated care system was approved with effect from 1 April 2021. 15 Existing networks continued to develop and improve. The Trust also became the Wessex Cancer Surgical Hub during 2020 as a result of a national initiative with the aim of maximising the number of patients receiving curative surgery. Both the Wessex Cancer Alliance and the Trust ended the year as the second highest performing among their respective peers for cancer treatment. Workforce – While additional staff were recruited to specifically assist the Trust during the pandemic, the Trust continued to recruit nurses from overseas during 2020/21 meaning that the number of vacancies has reduced compared to the position prior to the pandemic. Changes to recruitment processes were approved in 2020/21 to improve the fairness, transparency and quality of these. The Trust also continued to work with its staff networks and specific focus groups to increase diversity in leadership roles. While workforce capacity continues to be one of the biggest challenges faced by the Trust, during 2020/21 our main focus has been on supporting our staff to respond to the COVID-19 pandemic and providing both the tools and time to help staff recovery. We are incredibly proud of the way that staff responded to the pandemic and continue to recognise this in whatever ways we can, however, we also want to ensure that staff continue to be able to contribute to patient care at their best and want to stay and develop with the Trust. Technology was also used at levels not previously achieved to continue to deliver training to staff and enable staff to work from home where possible, ensuring a safer environment for patients and staff in the hospitals. Estate – The Trust continued to invest in and develop its estate during 2020/21 including the opening a new general intensive care unit (GICU), a new operating theatre and a new cancer care ward, built in just six months. These were part of £80 million of capital expenditure in 2020/21. The Trust has also established a programme to reduce backlog maintenance in addition to continuing to add to and improve the environment in which services are provided to patients and the working environment for staff. Innovation and technology – There have been exceptional levels of achievement in relation to COVID-19 related research activity, including in partnership with the universities. You can read more about these from page 167 of the quality report. The board of directors also supported the funding of an expansion of research and innovation activity to allow the continued delivery of the Trust’s ambitions to innovate and improve and transform its services. Sustainable financial model – The Trust achieved its forecast breakeven position in 2020/21. Income was more predictable in 2020/21 as block contract arrangements were put in place in response to the COVID-19 pandemic and ensured that costs were covered. The Trust continues to maintain a strong cash position and to implement improvements and efficiency savings, allowing it to continue to invest in its services. 16 Summary of performance COVID-19 bed occupancy UHS has experienced two distinct peaks in inpatient care for patients with COVID-19 infection, with smaller numbers of patients continuing to receive care outside these peak times. Bed occupancy reached a maximum of 173 in the first peak in April 2020, and 322 in the second peak in January 2021. All bed types Intensive care/higher care beds 17 Emergency access through our emergency and eye casualty departments Public concerns about safety, government restrictions on the activities people were able to do, and the efforts of community services contributed to significant reductions in the total number of patients who presented to our departments. All patients presenting to the emergency department Many changes were introduced within our departments in the course of the year to ensure that emergency assessment and treatment could be provided safely, including wearing of protective equipment by staff and patients, providing care in separate areas for patients suspected or known to have COVID-19, and using rapid laboratory tests to identify infection and confirm/exclude COVID-19 as a cause. Emergency access performance (measured as the percentage of patients discharged from emergency department care or admitted to a hospital bed within four hours of arrival to the department) improved significantly in 2020/21 compared to previous years. The national target of 95% was not achieved, however, the performance of our departments compared favourably with the average for acute trusts in England. 18 Emergency access four hour performance 19 Elective Waiting times Demand We saw a significant reduction in the number of elective referrals to hospital in the early part 2020/21, though they had returned close to pre-pandemic levels by the end of the year. It is likely that this pattern relates to a range of factors including reluctance from members of the public to attend healthcare facilities at that time, changes to the ways in which primary care was accessed, and efforts made within primary and community to avoid hospital referrals needing to be made. Accepted referrals The number of patients referred to hospital with suspected cancer also reduced during 2020/21; 7% fewer patients were seen across the year as a whole, though referrals returned to pre-pandemic levels or higher from July 2020 onwards. Patients seen following ‘Two week wait’ urgent referral for suspected cancer 20 Activity UHS hospital appointments, diagnostic tests and elective admissions were all significantly reduced during 2020/21 due to the impact of COVID-19. • During periods of higher bed occupancy with COVID-19 it was necessary to significantly reduce the number of elective admissions undertaken in order that additional staff could work in intensive care. Less clinically urgent and therefore longer waiting patients were primarily those affected. • Throughout the year, additional infection prevention measures have reduced the number of patients that can be seen in each session, particularly when higher risk ‘aerosol generating’ procedures are planned, but also as a result of additional PPE being worn or to enable greater distancing of patients attending outpatient departments. UHS was offered additional capacity at local independent sector hospitals and used this effectively to minimise these adverse impacts. Approximately 30% of outpatient appointments are now undertaken by telephone or video, helping to maintain the capacity for patient care whilst reducing the infection risk for those patients and helping to maintain distancing measures for those patients still attending our outpatient departments. The graphs below show 2020/21 activity levels as a percentage of those achieved in the previous year. Elective admissions (including daycase) 21 Outpatient attendances Performance The average waiting time for first outpatient appointments has remained close to nine weeks for the majority of the year. UHS has however experienced very significant deteriorations in the waiting times our patients experience for diagnostic tests to be undertaken and elective treatment to be provided. The reduced number of new patients referred to hospital early in 2020/21 has moderated the extent of the growth in the total numbers of patients waiting, and the greatest rate of growth has unfortunately been amongst those groups of patients already waiting longest. 22 Diagnostics Our performance measures for diagnostics report on a total of 15 different frequently used tests. The waiting list is approximately 50% bigger than it was before the pandemic and stable through the second half of the year. At the end of the year 28% of patients were waiting more than six weeks to receive their investigation compared to the national target of 1%. The tests with the largest numbers of longer waiting patients include non-obstetric ultrasound, MRI and endoscopies, and further recovery will be driven through a combination of recruitment, independent sector capacity and an additional endoscopy room which opened at the start of April 2021. Patients waiting for a diagnostic test to be performed (sum of 15 different frequently used tests) Percentage of patients waiting over 6 weeks for a diagnostic test to be performed 23 Referral to Treatment Our waiting list from referral to treatment increased in size by 6% (2,220 patients) during 2020/21, rising when the recovery in referral numbers exceeded the recovery in clinical activity, the total increase in waiting list size would have been significantly higher had it not been for the significant reduction in the referrals received by the hospital especially during the early months of the pandemic. Looking forward, we anticipate referrals numbers returning to pre-pandemic levels, and being able to maintain the total size of our waiting list by delivering an equivalent number of treatments each month. Number of patients waiting between referral and commencement of a treatment for their condition The national target is that at least 92% of patients should be waiting for treatment no more than 18 weeks from their referral to hospital. Our performance against this measure is now 12% worse than one year ago, at 66%. Our performance continues to be typical of the major teaching hospital trusts that we benchmark with and the trend has been similar to that experienced across trusts in England. Percentage of patients waiting up to 18 weeks between referral and treatment 24 Unfortunately, the number of patients waiting significantly longer than the 18 week target has increased at a faster rate than the size of the waiting list as a whole. The graph below shows how the percentage of patients who have waited more 52 weeks increased. The number of patients who have waited more 52 weeks increased from 40 in March 2020 to 3,419 by March 2021 (of these 445 patients had waited more than 78 weeks). Such patients often require surgical treatment, particularly in the orthopaedic, ear nose and throat and oral surgery specialities. The impact on surgical care has been greater than that in outpatients during the pandemic, and it is also more challenging to increase capacity due to the need for additional operating theatres and a combination of different healthcare professionals to work within them. UHS opened an additional operating theatre in 2020/21, and has a further four theatres scheduled to open during 2021/22, which will make a significant contribution to our capacity to treat more patients. Unfortunately, the number of patients waiting significantly longer than the 18 week target is likely to continue to grow further in the short term, due to diagnostic investigations having been progressed less quickly than usual during the pandemic, the need to prioritise our increased treatment capacity according to the clinical urgency of conditions and because our scheduled capacity increases will not be completed before the autumn of 2021. Percentage of patients waiting more than 52 weeks, between referral and commencement of a treatment for their condition 25 Cancer Waiting Times UHS has been mostly successful in maintaining the timeliness of urgent services for patients with suspected cancer through the pandemic, and our performance has been amongst the best in both the south-east and nationally. UHS prioritised the theatre and intensive care capacity we were able to provide during the pandemic in order to meet the needs of those patients with the greatest clinical urgency, used capacity offered by independent sector hospitals to supplement that available within NHS, and operated a hub through which hospitals in Wessex were able to collaborate to continue critical cancer surgery during periods of peak COVID-19 demand. The national target is to provide the first definitive treatment to at least 85% of patients with cancer with 62 days of referral to hospital. Whilst UHS performance remained below this level in the majority of months, our performance has been significantly better than the national average, and has improved relative to other trusts. Treatment for Cancer within 62 days of an urgent GP referral to hospital 26 The national target is to provide the first definitive treatment to at least 96% of patients within 31 days of a decision to treat being made and agreed with the patients; both for the first and any subsequent treatments for cancer. UHS achieved this level on average across the year, and in the majority of months. The treatments provided are typically by means of surgery, chemotherapy/immunotherapy or radiotherapy. The most significant performance challenge this year has been in radiotherapy, where more sophisticated treatment plans improve patient outcomes but take longer to prepare, and there was also reduced treatment capacity whilst we replaced one of our ‘Linear Accelerator’ treatment machines with a new model. First definitive treatment for cancer within 31 days of a decision to treat Equality in service delivery Identifying and addressing health inequalities have been the central part of the Trust’s approach to improving the experience of care for our patients, families and carers. Over the past year, new initiatives have augmented progress on existing work to ensure there is appropriate support, due regard and recognition of those patients and their families and carers who are most at risk of poor experiences, outcomes and access to services. In 2020 we added two questions to our patient surveys, asking first if patients felt themselves to have a disability or require a reasonable adjustment, and, if yes, whether the Trust met this need. In 2020/21, the results were: TOTAL Had a disability / required a reasonable adjustment 27% Had this need met by the Trust (positive response) 95% This question was added to our major Friends and Family Test surveys as well as our local service-specific patient surveys. In June 2020 the Trust launched the sunflower lanyard scheme for hidden disabilities, participating in the national initiative to ensure that people whose disabilities are not visible are able to access further support and reasonable adjustments by means of a nationally recognised indicator (the sunflower). In 2020/21, 618 lanyards were issued with those needs recorded to ensure future reasonable adjustments are made for those individuals. 27 Carers have always been essential partners in the care that we provide, and having introduced a new post at the end of 2019 to focus solely on carer experience, this work has culminated in a Trust strategy for improving the involvement, support and experience carers have of our services. We have, over the past year, introduced carers cards, virtual peer support and carer-specific information about services while actively participating in local and regional work on carers. In January 2021 we realised our ambition of becoming an accredited ‘Veterans Aware’ hospital, with our submission of evidence being recognised as ‘strong’ and indicative of an organisation that has made great progress in helping to provide enhanced support for the armed forces community. Towards the end of 2019 we worked with the disability organisation AccessAble to produce accessibility guides for all of our services and estate. These online guides allow patients and visitors with disabilities to plan their journey and identify potential challenges to the environment. In 2020/21 our guides had 5,000 unique visits per month. One of our COVID-19 initiatives, a patient support hub, was set up in May 2020 to provide a single point of support for our patients who had been advised to shield. The service has grown and now offers support to patients and carers who are vulnerable, disabled or with additional needs. This includes coordinating community transport, arranging companions to assist with attending appointments, hosting a technology library to support those who are digitally excluded in accessing virtual appointments and information, and most recently receiving funding to pilot volunteer-led support for diabetes patients. Across the Trust, we continue to actively promote the importance of asking patients and carers about disabilities and reasonable adjustments, flagging needs on our patient administrative system to prompt our services to take proactive steps to ensure that any needs or adjustments are met on each and every visit. This has been of vital importance for meeting accessible information and communication needs. We are currently one of first trusts to pilot a new translation app that provides immediate interpretation into different languages, and we have worked closely with our communication support partners to ensure that where virtual appointments are needed, people with communication needs (BSL, foreign language) are supported to access care virtually. Our specialist nursing liaison teams continued to support access to services throughout the pandemic, ensuring that patients with dementia, with learning disabilities and autism, were supported to attend hospital where necessary. Further information about the Trust’s work in relation to equality, diversity and inclusion can be found on page 69 and pages 106 and 160 in the quality report. Going concern After making enquiries, the directors have a reasonable expectation that the services provided by the Trust will continue to be provided by the public sector for the foreseeable future. For this reason, the directors have adopted the going concern basis in preparing the accounts, following the definition of going concern in the public sector adopted by HM Treasury’s Financial Reporting Manual. David French Chief Executive Officer 28 June 2021 28 Accountability report Directors’ report Board of directors The board of directors is usually made up of six executive directors and seven non-executive directors, including the chair. Since 1 January 2021 the number of non-executive directors has been reduced by one as Jane Bailey’s reappointment as a non-executive director was deferred to allow her to lead the Hampshire and Isle of Wight saliva mass testing programme. Jane is expected to return to the board of directors in her non-executive director role by 1 July 2021. Paragraph B.1.2 of the NHS foundation trust code of governance provides that at least half the board of directors, excluding the chair, should comprise non-executive directors determined by the board to be independent. Pending the reappointment of Jane Bailey as a non-executive director, the Trust has been operating with one fewer non-executive directors than is required by the Trust’s constitution and the Trust has been non-compliant with this paragraph of the code. During this period the provisions of the Trust’s constitution that a quorum for meetings of the board of directors requires at least one non-executive director and one executive director to be present and for the chair to have a second and casting vote in the case of an equal vote continued to apply. The board of directors has given careful consideration to the range of skills and experience it requires to run the Trust. Together the members of the board of directors bring a wide range of skills and experience to the Trust, such that the Board achieves balance and completeness at the highest level. The chair was determined to be independent on his appointment and the other non-executive directors have been determined to be independent in both character and judgement. This included specific consideration of Jane Bailey’s continued independence following her role leading the Hampshire and Isle of Wight saliva mass testing programme. The chair, executive directors and non-executive directors have declared any business interests that they have. Each director has declared their interests at public meetings of the board of directors. The register of interests is available on the Trust’s website. 30 The current members of the board of directors are: Non-executive directors Peter Hollins Chair Peter graduated in chemistry from Hertford College, Oxford. Joining Imperial Chemical Industries in 1973, he undertook a series of increasingly senior roles in marketing and then general management. Following three years in the Netherlands as general manager of ICI Resins BV, in 1992 he was appointed as chief operating officer of EVC in Brussels – a joint venture between ICI and Enichem of Italy. He played a key role in the flotation of the company in 1994, before returning in 1998 to the UK as chief executive officer of British Energy where he remained until 2001. From 2001, he held various chairmanships and non-executive directorships. In 2003, he decided to return to an executive role as chief executive of the British Heart Foundation in which post he remained until retirement in March 2013. He joined Southampton University Hospital Trust as a non-executive director in 2010, became senior independent director and deputy chairman of UHS in 2014 and was appointed chair in April 2016. Trust roles: • Chair of remuneration and appointment committee • Chair of governors’ nomination committee Jane Bailey Non-executive director In 1985, Jane joined the pharmaceutical company Glaxo as a management trainee, having graduated from London University with a degree in environmental science and pharmacology. Here she rose to senior commercial vice-president, gaining experience of a broad range of disease areas across different regions of the world. She specialised in leading global research and development teams in the formation of strategies to bring new medicines to patients. She also worked to ensure that the medicines developed were supported by robust evidence demonstrating their clinical and cost-effectiveness. In delivering this she gained extensive experience of leading large diverse teams across a complex global organisation. For five years, Jane ran her own strategy development consultancy, working across a breadth of healthcare organisations. In 2017 Jane gained an MSc in public health, with distinction, at King’s College, London University. Her studies focused on how to ensure the public are engaged in development of healthcare services and how social theories can help inform effective disease prevention and management. Jane is a director of Wessex NHS Procurement Limited, a joint venture between the Trust and Hampshire Hospitals NHS Foundation Trust and a director of Healthwatch Portsmouth. Trust roles: • Deputy chair and senior independent director • Chair of finance and investment committee • Audit and risk committee member • Charitable funds committee member • People and organisational development committee member • Remuneration and appointment committee member • Wellbeing Guardian 31 Non-executive directors Dave Bennett Non-executive director Dave graduated in chemistry from the University of Southampton before entering management consulting, becoming a partner in Accenture’s strategy practice. In 2003 he joined Exel Logistics (later acquired by DHL), managing the company’s healthcare business across Europe and the Middle East. During this time, he established NHS Supply Chain, a UK organisation responsible for procuring and delivering medical consumables for the NHS in England, as well as sourcing capital equipment. Dave joined the board of Cable & Wireless as sales director in 2008. He later set up his own strategy consulting practice serving the healthcare sector, completing numerous projects in the UK and the US. Dave has also served as a non-executive director at The Royal Bournemouth and Christchurch Hospitals NHS Foundation Trust between 2009 and 2016, where he chaired the Trust’s quality committee. Dave is a non-executive director at the Faculty of Leadership and Medical Management and a director of Royal College of General Practitioners (RCGP) Enterprises Ltd and RCGP Conferences Ltd. Trust roles: • Chair of charitable funds committee • Chair of finance and investment committee (from 1 January 2021) • Audit and risk committee member (from 9 February 2021) • Quality committee member • Remuneration and appointment committee member • Chair of Trust’s organ donation committee 32 Non-executive directors Cyrus Cooper Non-executive director Cyrus Cooper is professor of rheumatology and director of the MRC Lifecourse Epidemiology Unit. He is also vice-dean of the faculty of medicine at the University of Southampton and professor of epidemiology at the Nuffield Department of Orthopaedics (rheumatology and musculoskeletal sciences, University of Oxford). He leads an internationally competitive programme of research into the epidemiology of musculoskeletal disorders, most notably osteoporosis. His key research contributions have been: • discovery of the developmental influences which contribute to the risk of osteoporosis and hip fracture in late adulthood • demonstration that maternal vitamin D insufficiency is associated with sub-optimal bone mineral accrual in childhood • characterisation of the definition and incidence rates of vertebral fractures • leadership of large pragmatic randomised controlled trials of calcium and vitamin D supplementation in the elderly as immediate preventative strategies against hip fracture. He is president of the International Osteoporosis Foundation, chair of the BHF Project Grants Committee, an emeritus NIHR senior investigator, a director of The Rank Prize Funds and associate editor of Osteoporosis International. He has previously served as chairman of the Scientific Advisors Committee (International Osteoporosis Foundation), the MRC Population Health Sciences Research Network and the National Osteoporosis Society of Great Britain. He has also been president of the Bone Research Society of Great Britain and has worked on numerous Department of Health, European Community and World Health Organisation committees and working groups. Cyrus has published extensively on osteoporosis and rheumatic disorders and pioneered clinical studies on the developmental origins of peak bone mass. In 2015, he was awarded an OBE for services to medical research. Trust roles: • Quality committee member • Remunerati
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Institutional information_2024-25

Description: Institutional information – key facts for inclusion as appropriate Support statements must be personal to your application to avoid the same document being submitted for different people from the same source. The NIHR have fed back that they expect tailored and personal statements of organisational support so, if you use some of the text below, it needs to be refined to connect with your own situation, context, focus of project, career to date and plans for the future. You should also check with the relevant NIHR infrastructure in advance of submission that they are happy to support you and/or be mentioned in your submission as in some cases the NIHR (and other funders) will email the infrastructure director following your submission to confirm they support your application. Brief information that describes research excellence of both organisations pertinent to your proposal is generally required. Start with your substantive employer, and then weave in the honorary organisation. Work up as a Word document in conjunction with your supervisor. Submit to relevant School, Faculty and/or Trust division/care group/department to the named person who will confirm participation on the system and may, for some schemes, have to make the final submission on behalf of the host institution. This might be the Faculty Associate Dean for Research, Deputy Head of School (Research) or relevant Head of Department or Care Group. They should review, augment and discuss the text with you, as necessary. University – generic information You are not expected to use all of this generic information. Recent feedback from the NIHR says they really don’t want reams of text extolling the virtues of the institution, but rather it should be personalised to the applicant and the project. Think carefully how you demonstrate the excellence of your chosen academic partner in your chosen area of research. The University of Southampton’s outstanding research and impact has been recognised in the Research Excellence Framework (REF 2021) results. Research by 1,412 Southampton academics – comprising 3,227 research outputs, 104 impact case studies, and 25 environment statement. Ninety-two per cent of the University’s research has been classed as ‘world leading’ (4*) or ‘internationally excellent’ (3*), placing Southampton in the top 10 per cent of submitting institution and ranked seventh among universities that submitted to more than one Unit of Assessment (‘non-specialist’ universities) across the sector. The University of Southampton is a founding signatory of the Athena SWAN Charter. The University has held a Silver Athena SWAN award since 2016. The University of Southampton Doctoral College provides a focal point for the training and development of researchers across the university who are enrolled on a PhD programme. In addition, the Centre for Higher Education Practice (CHEP) provides opportunities for the academic professional development of all staff, (research, education and enterprise) and works collaboratively with colleagues across the University, promoting professional development sessions via Staffbook, the online booking system. CHEP is notable for offering the PGCAP programme and fellowship accreditation with Advance HE, the funding intensive programme, writing retreats, and CPD sessions. CHEP hosts communities of practice including the KEE-CoP for knowledge exchange and enterprise, and signposts to relevant resources for research staff at all career levels via the Researcher Development Hub. UK league table rankings ➢ 20th overall and 2nd for Physiotherapy with 11 subject areas in the top 10 in The Complete University Guide 2025 ➢ 19th in The Times and The Sunday Times Good University Guide 2025 ➢ 22nd overall and 1st for Midwifery - with a total of 7 of subject areas in the top 10 in The Guardian University Guide 2025 International league table rankings ➢ 80th in the QS World University Rankings (2025), and joint 12th in the UK. Institutional information_2024-25 -1- ➢ 6 subjects in the global top 50, according to QS World University Rankings by Subject 2024: Nursing (11), Archaeology (36), Earth and Marine Sciences (38), Geophysics (42), Geology (46) and Statistics and Operational Research (4) ➢ Also in the top 100 globally, according to QS World University Rankings by Subject 2024: Civil & Structural Engineering; Physics and Astronomy; Electrical & Electronic Engineering; Mechanical, Aeronautical & Manufacturing Engineering; Medicine; Accounting and Finance. ➢ 115th in the Times Higher Education (THE) World University Rankings 2025 and 14th among UK universities listed. Explore the full World University Rankings and UK Best Universities: World University Rankings 2025 | Times Higher Education (THE) Student satisfaction The National Student Survey (NSS) gathers feedback from mainly final-year undergraduates about their time in UK universities. Highlights from the NSS 2024 results include: ➢ 85% of our students were satisfied with the teaching on their course ➢ 87% of our students were satisfied with the learning resources provided by the University ➢ 90% of our students agreed that staff were good at explaining things ➢ 87% of our students agreed that their course was intellectually stimulating Knowledge Exchange Framework (KEF) The University of Southampton’s outstanding business and public engagement activities have been recognised as among the best in England in the 2024 Knowledge Exchange Framework (KEF). The University received top ratings in several categories, including in public engagement, IP and commercialisation, working with the public and third sector, and working with business. The second highest rating ('high engagement’) was awarded for the University’s research partnerships, local growth and regeneration and CPD and graduate start-ups. These results place Southampton at or above the average in all areas when compared to other similarly large, research-intensive and broad-discipline English universities. In partnership with University Hospital Southampton A foundation of its success has been the strong partnership between the University of Southampton and University Hospital Southampton. The relationship draws strength from the very best of Southampton’s basic science research in biomedicine, psychology, social sciences, electronics and computer science and mathematics and allows us to continually pursue excellence in health and social care research, education and professional practice. Institutional information_2024-25 -2- University Research group This is by far the most important bit. Describe the research group/department and key people in it who will support the fellowship holder, how the research project and person will be aligned with this focus and expertise, describe any facilities and resources available and what ‘support’ you will get from group, e.g. seminars, departmental meetings, being part of doctoral and post-doctoral community. School of Health Sciences Generic information The School of Health Sciences in the Faculty of Environmental and Life Sciences is internationally acknowledged as the leading centre for research in Nursing, Allied Health Professions, and Health Sciences in the UK. The School is ranked 11th in World for Nursing (QS ranking 2025), 1st in UK for Midwifery (Guardian 2025), 9th in UK Mental Health Nursing (Guardian 2025), 3rd in UK for Physiotherapy (Guardian 2025), and 4th in UK for Occupational Therapy (Complete University Guide 2025). The School delivers world-leading health and care research to improve the health and wellbeing of the people of Wessex, the UK and beyond. All aspects of the School’s research environment were judged in REF 2021 to be conducive to producing research of world-leading quality and enabling outstanding impact in terms of its vitality and sustainability. The panel noted clear and concise strategic direction of research, particularly in clinical partnerships, sustainability and ongoing development of international collaborations. 93% of our research outputs were judged to be of internationally excellent or world-leading quality in terms of originality, significance and rigour. 80% of research impact case studies submitted were judged to have led to outstanding impact in terms of their reach and significance. These excellent results confirm our position as a leading research-intensive School. The School’s research strategy is based on strong links with the NHS and other healthcare organisations in collaboration with leading figures from a range of clinical professions, and research. Our research also helps to prepare the healthcare leaders of the future feeding into the School’s educational and enterprise programmes, and vice versa, giving our students the opportunity to work with cutting-edge research teams, in research groups: Health Workforce & System, Centre for Psychosocial Research in Cancer (Centric+), Child & Adolescent Health, Ageing and Dementia, Long-term Conditions, Active Living for Health, Medicine Management, Bladder & Bowel, and Skin Health. We are proud to host research infrastructures which are fully integrated within the School and our strategy, particularly NIHR Applied Research Centre (ARC) Wessex. We are also embedded in the NIHR Southampton Biomedical Research Centre (BRC), delivering on specific research objectives. Clinical academic development Our Health Sciences academics have a long history and leading track record in nurturing and supporting nurses, midwives and AHPs (NMAHPs) across the entire career trajectory from pre-doctoral to senior investigator, within a strong culture of inter-disciplinary research. We have a leading role with the NIHR ARC Wessex and within the School of Health Sciences are strongly committed to supporting a range of fellowships (e.g. NIHR, Diabetes UK, Versus Arthritis UK, UKRI, ESRC). From 2014, we have extended and expanded our post-doctoral clinical academic capacity for NMAHPs (56 awards: Senior Investigators, Senior Fellowships, Advanced Fellowships, Senior Clinical Lectureship, Clinical Lectureship) and 68 NIHR, ARC and School/Trust partnership funded clinical academic PGR students have been awarded. Since 2006, we have supported many internships and NIHR funded MRes studentships (119 awards), successfully building capacity in research knowledge as a pre doctoral pipeline. XXX will benefit from career development support specific to non-medical clinical academic career pathways. They will participate as part of our larger clinical academic team of senior researchers, Early Career Researchers and PhD students in additional activities that focus career development. They will also work alongside the established multidisciplinary researchers housed in the clinical academic facility, funded through URKI and EU projects e.g. EU Marie Curie Integrated Training Network ‘STINTS’. The purpose-built facility provides open plan research space, conference rooms and specialist laboratories to support research (including a biomechanics laboratory, imaging facilities and a CAT2 biochemistry lab). Institutional information_2024-25 -3- For inclusion in Doctoral fellowship applications: In addition to the Doctoral College training focused on transferable skills and employability, we offer a Health Sciences doctoral training programme. This consists of the taught component of the MRes, with modules focused on clinical and health research, specifically design & methods, conducting research, planning research, quantitative and qualitative methods from the clinical and health research perspective. In addition, we run regular PGR student forum sessions which provide more in-depth discussion on topics requested by the students, for example ethics and approvals, patient and public involvement. Finally, students are invited to attend the Health Sciences seminar series and have opportunities to present via their research groups. Faculty of Medicine Generic information The Faculty of Medicine leads innovative learning and discovery for better health across the life course. The Faculty aims to establish its reputation as an internationally recognised Medical School (placed =81st in the 2024 QS global subject rankings), and to secure its place as one of the UK’s leading Medical Schools, building upon three distinctive features: our strong partnership with the local NHS (particularly University Hospital Southampton NHS Foundation Trust - UHS) to deliver translational research and equip the next generation of doctors to work in a rapidly‐changing environment; collaborations at the life sciences interface with engineering, mathematics, computing, chemistry and nanotechnology; and exploitation of the enterprise agenda to maximise the impact of our education and research. Our research will focus on four key approaches: • Combining basic mechanistic and clinical research to deliver internationally-leading research and resultant outputs • Early clinical translation, utilising and fostering links with the NHS • Interdisciplinary collaborations, through the UoS Institute for Life Sciences (IfLS) • Enterprise and innovation Our research falls within five key themes: • Cancer Sciences • Healthy Ageing and Multi-Morbidity • Infection and Microbial Science • Developmental Sciences and Regenerative Medicine • Population Science Supporting these themes are five cross-cutting research methodology platforms that guide investment in equipment, core facilities and technical support: • Cell Biology & Chemistry of Life • Immunology • Clinical Trials & Experimental Medicine • Systems Biology • Data Science We are proud to host research centres/units which are fully integrated within the Faculty and our strategy. Institutional information_2024-25 -4- The Centre for Cancer Immunology. We undertake interdisciplinary research involving scientists and clinicians. Through worldwide collaborations, we combine our expertise to understand and develop potential new treatments for cancer. Centre for Cancer Immunology | University of Southampton Southampton Experimental Cancer Medicine Centre (ECMC) delivers access to world class experimental cancer medicine for the population of southern England and beyond. Experimental Cancer Medicine Centre | University of Southampton The NIHR Southampton Biomedical Research Centre takes new discoveries, treatments and technologies into the clinic, using unique tools, facilities and world-changing expertise. NIHR Southampton Biomedical Research Centre | University of Southampton The NIHR Southampton Clinical Research Facility is an extensive, dedicated space for early-stage clinical research located at Southampton General Hospital. NIHR Southampton Clinical Research Facility | University of Southampton The NIHR Applied Research Collaboration (ARC) Wessex conduct applied health research with our partners and others in the health and care sector, alongside patients and members of the public. Applied health research aims to address the immediate issues facing the health and social care system. We also help bring research evidence into practice and provide training for the local workforce. National Institute for Health and Care Research (NIHR) Applied Research Collaboration Wessex | University of Southampton The Southampton NIHR School for Primary Care Research is one of nine in a partnership of leading academic centres for primary care research in England. We work to increase the evidence base for primary care practice through high quality research and strategic leadership, and to build capacity in primary care with a well established training programme NIHR School for Primary Care Research The Southampton Clinical Trials Unit (SCTU) delivers world-leading clinical trials of innovative new treatments and diagnostic tools. Our trials directly influence routine clinical practice for the benefit of patients. Southampton Clinical Trials Unit (SCTU) | University of Southampton The MRC Lifecourse Epidemiology Centre (Director, Professor Nicholas Harvey) was established in 2021, following reconfiguration from the forerunning MRC Lifecourse Epidemiology Unit. At the MRC LEC, we study the determinants of musculoskeletal and metabolic disease throughout the lifecourse. MRC Lifecourse Epidemiology Centre | University of Southampton i-NutriLife is a Diet and Health Open Innovation Research Club (OIRC) Innovation Hub. OIRC is a network funded by the UK Research and Innovation Biotechnology and Biological Sciences Research Council that promotes collaborations between academia and industry in the diet, nutrition and health space. Innovative Nutrition Solutions for Lifecourse Health | University of Southampton Institutional information_2024-25 -5- The Faculty hosts the NIHR Research Support Service (RSS) Hub delivered by University of Southampton and Partners. The Hub provides support in all areas of applied health and care research, especially in public health research conducted outside of the NHS, and other under-researched areas. Research Support Service Hub delivered by University of Southampton and Partners | NIHR The Clinical Informatics Research Unit (CIRU) operates as an applied research and enterprise unit within the Faculty of Medicine at the University of Southampton. We have over 20 years of experience in providing clinical research solutions and services across the globe, advancing data excellence, quality, management, and improving research conduct. CIRU works across the 7 continents including Europe, North America, South America, Oceania, Australasia, Asia, and Africa. CIRU The School of Healthcare Enterprise and Innovation (SHEI) is home to research-focused businesses tackling major issues in healthcare. We also provide a consultancy service and run a purpose-built teaching lab to improve health outcomes for young people. Healthcare Enterprise & Innovation | University of Southampton SHEI knowledge exchange and enterprise units include: EViR advances the practices of health-related research and research funding Member organisations from around the world collaborate in EViR to develop new approaches to increase the value of health-related research. Ensuring value in research - EViR Hatch use their expertise and extensive network of researchers and partners to access the best minds and the latest thinking to drive meaningful change home - hatch Southampton Health Technology Assessments Centre (SHTAC) is a leading centre for health technology assessment and health services research in the UK. Our expertise in evidence synthesis, health economics and information science informs timely policy decisions on the use of new healthcare technology and services, directly benefitting patients and ensuring good value for money for our healt Southampton Health Technology Assessments Centre | University of Southampton LifeLab is a unique initiative created by the University of Southampton in collaboration with the National Institute for Health Research (NIHR), Southampton Biomedical Research Centre (BRC) and University Hospital Southampton. At a purpose built ‘lab’ in University Hospital Southampton, young people take part in fun and engaging sessions, conduct experiments, meet scientists, and learn first-hand why and how to lead healthier lives. LifeLab Online Institutional information_2024-25 -6- Clinical academic development The Southampton Clinical Academic Training Scheme (SoCATS) brings together the Faculty of Medicine and Health Education England-Wessex (HEE-W) to support the development our Specialised Foundation Programme (SFP) trainees, Academic Clinical Fellows (ACFs) and Clinical Lecturers (CLs). SFP trainees involved with research are provided with monthly training throughout year 1 on research methods. There is a four-month rotation in year 2 for an academic placement with hands-on research and weekly academic training sessions throughout the post. ACFs and CLs can access funding to undertake a wide range of training opportunities (research methodology, epidemiology, statistics, etc.) to support their development. Trainees can also access workshops on scientific writing, abstract writing, poster presentations, supervisory skills and research impact. Professional development workshops include time management, leadership skills, building/managing research teams, public engagement, and teaching skills. Mentoring for clinical academic trainees is facilitated via the Faculty Mentoring Scheme. ACFs and CLs can access funding to attend conferences to disseminate their research findings, as well as other research related events. Financial support is available to fund training to support academic development. As a result of the rigorous scientific training received many of our former or current ACFs and CLs have made significant discoveries in their field of research and have published these findings in international journals. This includes publications in Lancet, Nature Medicine, Nature Genetics, British Medical Journal, Lancet Oncology, Lancet Infectious Diseases, Lancet Diabetes and Endocrinology, Proceedings of the National Academy of Sciences USA, Gut, American Journal of Respiratory and Critical Care Medicine, Journal of Allergy and Clinical Immunology, Journal of the National Cancer Institute, Cancer Research, Clinical Cancer Research, Brain, Blood, and many other reputable journals. Career progression through fellowships is supported via three Fellowship Champions and six Fellowship Mentors based within the Faculty. The University Research and Innovation Services team provide bespoke advice and assistance with fellowship and grant applications. Since the inception of our Integrated Academic Training programme over 120 NIHR funded ACFs have completed their ACF with the majority continuing research once their post has come to an end. We have an excellent track record of CLs being awarded intermediate or advanced fellowships, including Career Development Fellowships (NIHR, MRC, Pathological Society, Fulbright Scholarship), Postdoctoral Fellowships (NIHR, Wellcome Trust) and Clinician Scientist/Advanced Clinician Scientist Fellowships (CRUK, MRC). SoCATS has a network of Academic Leads who can provide information specific to their specialty. Details are available on the SoCATS website. (https://www.southampton.ac.uk/socats/index.page). NOTE – Further information on SoCATS can be found on our website and Intranet site (UoS login required). Support for Early Career Researchers and Technical Staff The Postdoctoral Association (PDA) The Faculty of Medicine PDA aims to enhance the development of early career staff, nurturing careers and helping each individual to achieve their professional goals. FoM Postdoctoral Association The PDA has a Steering Committee with at least postdoctoral researcher and one academic member from each of the Faculty’s Schools to ensure the association works in partnership with our postdoctoral researchers to provide what they need. Postdoctoral research staff are automatically members of the association and are encouraged to take part in the events facilitated through the PDA. Activities include our annual PDA Christmas Lecture delivered by a distinguished speaker and events to highlight career opportunities. The PDA advertise teaching opportunities for ECRs within the Faculty and relevant funding awards that are available. Institutional information_2024-25 -7- Seminars and workshops on topics requested by early career staff are provided through our ‘Transferable skills programme. Topics include Starting a family in academia; getting the most from your appraisal; Fellowships: A path to independence; Work:life balance; and Academic promotion. Additional ECR training opportunities include session on abstract writing; oral presentation skills; excellent poster presentations; and narrative CVs. All research related staff can access sessions on more general topics including research integrity, open research, and trusted research, delivered by The University Centre for Higher Education Practice or the Faculty Research Support Office. We coordinate our Faculty Dean’s Awards which recognise the work performed by the early career staff outside of their academic achievements. Excellent supervision is also recognised through the Dean's Award for Most Supportive PI (for postdoctoral researchers) and Dean's Award for Most Supportive Supervisor (PGRs). Dean's Awards Peer support within the postdoctoral researcher community is facilitated via a dedicated Microsoft Teams channel where exchanges between postdocs ECRs can take place. The Teams channel is also used to advertise relevant events. Researcher Development Concordat We uphold the Researcher Development Concordat and proactively worked to raise both postdoctoral research staff (postdocs) and PI awareness of the Concordat and embed appropriate behaviours across the Faculty. A strong focus is on postdoc training and development and the commitment to enable all postdocs to have access to 10 days of personal development time. Concordat Technical Staff support and development The University is a signatory to the Technician Commitment to ensure visibility, recognition and career development for technicians working in the Faculty. We have expanded eligibility to ECR training programmes and provide opportunities to present at PGR/ECR research conferences to technical staff to recognise their contribution to the research environment. The Technician Commitment Our Faculty promotes recognition of the contribution our technical staff make to research. We highlight the importance of recognising this through appropriate co-authorship or direct acknowledgement, in accordance with the University Guidance on Technicians and Publication Attribution. Technicians and Publications Fair Attribution Guidance_FINAL_v1.0_190321.pdf Mentoring for all staff Mentoring involves meeting with someone who has no connection with your day-to-day work life, providing you with safe space to explore your thoughts and options. Mentoring has been shown to have real value for diverse early career staff, for those who mentor them, and for the institution in terms of improving research success, recruitment and retention of staff1. Mentoring is also valued by funding bodies and Athena Swan committees. The Faculty has a well-established Mentoring Scheme facilitated thorough our Faculty Mentoring Committee. The Committee run a Language of Mentoring workshop every year to explain what mentoring is and to develop confidence in mentoring techniques. A database of mentors is available to help individuals identify a suitable mentor. Regular ‘find me a mentor’ sessions are offered where members of the Mentoring Committee help match mentees with potential mentors. Specific mentoring options highlighted to our staff include; • Maternity, paternity, adoption and family mentoring • Academic Intersectionality Mentoring in Medical Schools • Public-patient engagement and mentoring Institutional information_2024-25 -8- • PGCAP and PREP mentoring • Peer mentoring, including peer mentoring for promotion Medicine Mentoring - Home Fellowship Mentoring The Faculty of Medicine has fellowship mentors in each School of the Faculty who offer advice and support for those wishing to apply for a fellowship in their School. A dedicated intranet (SharePoint) site highlights both our Fellowship Mentors and various other options for support and advise this is available. We work closely with colleagues across the University and our key partner University Hospital Southampton to ensure anyone interested in taking up a fellowship is appropriately supported. Faculty of Medicine Fellowship Support - Home Annual Research Conference The Faculty hosts an annual two-day research conference which provides the opportunity for PGR students, postdocs, clinical academic trainees and technical staff involved in medicine related research to present their work and network with colleagues from across the University and our local NHS partners. Annual Faculty of Medicine Research Conference 2024 Faculty of Medicine Resource Library Applicants may also wish to review the ‘FoM Resource Library’ which includes a Faculty Infographic and Faculty presentation slides. FoM Resource Library Institutional information_2024-25 -9- UHS Trust – generic information Again you don’t have to use all of this – refer to relevant areas as needed and specific to context of your own research and situation. So if you are doing research that aligns with expertise and focus of the BRC for example, mention that, and what the BRC will offer in terms of support and development. University Hospital Southampton NHS Foundation Trust is one of the largest acute teaching trusts in England, with a staff of 13,000 with a turnover of more than £1bn (2020-21). It provides hospital services for 1.9 million people living in Southampton and southern Hampshire and specialist services including neurosciences, respiratory medicine, cancer, cardiovascular, obstetrics and specialist children’s services to more than 3.7 million people in central southern England and the Channel Islands. The Trust is also a designated major trauma centre, one of only two places in the south of England to offer adults and children full major trauma care provision. UHS gained foundation trust status on 1 October 2011. Every year, our staff see more than 650,000 people at outpatient appointments, deal with 150,000 attendances in the emergency department, and treat around 160,000 inpatients and day patients, including over 75,000 emergency admissions. In addition, the Trust delivers more than 100 outpatient clinics across the south of England to keep services local for patients. Research is an integral part of University Hospital Southampton’s mission to constantly improve and be able to offer better care to our patients. The Trust’s Research Strategy (2017-2022) “Research for All”, and UHS Clinical Strategy (2020-2025) lay out the Trust vision that research is fundamental to everything we do, embedded in the delivery of care. One of the UK’s largest University Hospitals, between 19/20 and 2023/24 UHS recruited a total of 68,245 participants into NIHR portfolio studies. 3,670 was commercial and 14,501 was interventional. At the end of 2023/24 UHS ranked 15 out of acute Trusts for recruitment/11 for complexity weighted recruitment/10 for commercial recruitment. 75% of studies closed in 2023/24 met time to target. 64% of studies set-up in 2023/24 met 40 days from date site selection to site confirmation of capacity and capability. The University of Southampton (UoS) and University Hospital Southampton NHS Foundation Trust’s (UHS) research partnership extends from fundamental laboratory based science, through joint management of large-scale, externally funded translational research infrastructure, to collaborative implementation of research interventions into practice. The partnership has in place a strategic agreement and robust governance designed to govern and contract for their frequent research collaboration. The partnership is realised through a combination of joint strategic investment, a physical University presence within the Trust at Southampton General Hospital and a collaborative approach to working. This essential base for the University at the heart of the NHS ensures it is positioned to undertake timely and relevant research into service provision and intervention, informed by collaboration with clinical colleagues at the forefront of NHS practice. The two institutions seek to foster a collaborative approach to research, through joint working arrangements, the sharing of best practice, and regular operational and strategic steering groups, in an administrative, academic and clinical context. UHS is committed to developing a culture of inclusion, diversity and belonging. The ‘Actionable Allyship’ programme is being rolled out across all staff, encouraging confidence to have positive discussions around all aspects of inclusion and belonging, and to challenge microaggressions and inequalities in the moment. Additional health and wellbeing support measures for staff were implemented in response to the COVID-19 pandemic, including designation of a wellbeing guardian on the board of directors. The Clinical Informatics Research Unit has achieved much in the field of health service data research and has developed the EDGE Clinical Research Management system enabling investigators nationwide to manage their clinical research data optimally. The Trust has a dedicated grants team who can provide advice and support on aspects such as managing the research grant, looking after the budget and developing an annual report of progress. Institutional information_2024-25 - 10 - Material on your clinical department Ask your supervisors and other senior academics who are in the dept and clinical mentors to support this section. Describe the ethos, culture and research and innovation strengths of particular dept and the Trust as a clinical centre of excellence. Mention if, for example, there are seminars or research group meetings that you can access. Also, the presence of medical academic clinical fellows, other nurse/AHP clinical academics and medical senior investigators who will support and encourage. Southampton NIHR infrastructure – generic information If your research is aligned with the BRC or the NIHR ARC Wessex make sure you talk to the training lead of the relevant bit of BRC (Nutrition – Mark Johnson, Respiratory and Allergy, and Perioperative and Critical Care – Malcolm West, and Microbiology, Immunology and Infection, and Data, Health and Society TBC), or NIHR ARC (Richard Trowbridge or Kinda Ibrahim, deputy directors of NIHR ARC Wessex) and they can help you add text about ‘trainee’ support as relevant to your area of focus. Embedded in the heart of the hospital is the NIHR Clinical Research Facility (CRF) (2022-2027 award £10.5m) which facilitates over 500+ active studies each year and consistently recruits a high number of participants with the CRF hosting > 16,800 visits on average each financial year. In 2023/24 the CRF had 585 active studies with 6888 research participants and > 16,800 participant visits (including vaccine hub) in over 19 different health categories, including early phase cancer trials. The satellite CRF Vaccine Hub, part of the Wessex Vaccine Research Hub Model (covering Southampton, Portsmouth, Bournemouth and Weymouth) continues to support the CRF with participant vaccine study visits recorded as > 630 in 2023/24. The CRF had 24 active First in Human studies during 2023/2024 across the health categories of Cancer, Infection, Neurological, Metabolic and Endocrine, Musculoskeletal and cardiovascular health. The CRF facilitates early phase industry and non-commercial studies to phase 1 standards, industry funded academic-led translational research and engagement with industry including SMEs and experimental medicine. The Southampton Clinical Trials Unit (SCTU) delivers world-leading clinical trials of innovative new treatments and diagnostic tools. We work in partnership with investigators to deliver high-quality trials that will directly influence routine clinical practice for the benefit of patients. We work at the forefront of innovative clinical research, taking discoveries from the laboratory into the clinic to provide the treatments and medical interventions of the future. Our team has expertise in the design, conduct and analysis of multicentre, interventional clinical trials and other well-designed studies. We are a UK Clinical Research Collaboration registered CTU that receives core funding from Cancer Research UK with additional funding from the NIHR Southampton Biomedical Research Centre (BRC), and we are part of the South Central NIHR Research Support Service (RSS). For an informal chat about how we might be able to help you, email Professor Gareth Griffiths at ctuadmin@soton.ac.uk. Wessex Investigational Sciences Hub (WISH) laboratory is a Good Laboratory Practice regulated immunology laboratory with genomics and molecular microbiology facilities. Part NIHR funded, it is a quality-regulated research environment and is approved by several external governance bodies. It hosts the CR UK Experimental Cancer Medicine Centre, unique in the UK for its focus on immunotherapy and immunomonitoring, in addition to the Wessex NHS Genomic Medicine Centre. The NIHR Southampton Biomedical Research Centre (BRC) (£25m award 2022-2027) brings together five themes (Nutrition, Lifecourse and Metabolism, Respiratory and Allergy, Data health and Society, Microbiology, Immunology and Infection and Perioperative and Critical Care), two core partners (University Hospital Southampton and University of Southampton) and a network of collaborations across Wessex, the UK and internationally. Our vision is to enhance health and quality-of-life by improving resilience to disease, injury and the consequences of ageing across the lifecourse through translation of world-class experimental medicine combined with our seven foundational principles of focus, integration, democratisation, personcentredness, inclusivity, collaboration and efficiency. NIHR Applied Research Collaboration Wessex (ARC) - Oct 2019 to March 2026 NIHR awarded ARC Core funding of £11.9m, with further NIHR additional funding of £6.2m, in total £18m+. In addition, NIHR ARC Wessex secures supplementary income from NHS partners, and NHS England to co-fund Projects and Capacity Building opportunities. NIHR ARC Wessex is a partnership between the NHS, Local authorities, Hampshire and Isle of Wight and Dorset Integrated Care Boards, four Universities, charities, local authorities, Institutional information_2024-25 - 11 - and other organisations across the Wessex region. The ARC Wessex programme of research addresses four areas related to the health and social care needs of our community: Ageing & Dementia, Healthy Communities, Long term Conditions, Workforce & Health Systems, alongside a Mental Health hub. Academic career development forms a central component of the ARC Wessex strategy to develop the research skills and talents of the ARC Wessex community and make a substantial contribution to fostering a world class research environment in applied health and social care research. XXX will become a member of our Academy (200+ members) which offers a diverse and collaborative network by which we pool resources to support a variety of events, regular ‘check-in’ meetings and have set up on-line resources and top tips for Academy members to remain connected throughout the course of their awards and beyond. In January 2025, University Hospital Southampton NHS Foundation Trust who host the ARC, will make an application for further NIHR funding. If successful this will cover a five year term from April 2026 to March 2031. Outcome expected Oct 2025. The University of Southampton’s Primary Care Research Centre is a member of the NIHR School for Primary Care Research (SPCR). NIHR research schools are national collaborations between leading academic centres that fund research in primary care, public health and social care. This new phase of the SPCR has an explicit aim to strengthen the primary care research sector more broadly, covering sectors such as community nursing and pharmacy as well as general practice. Funding of £22 million started in April 2021 for five years. The NIHR Research Support Service (RSS-SC) provides research design and methodological support to researchers, including qualitative research, health economics and PPI capabilities. The RSS also delivers training including an annual NIHR focussed grant application workshop. Sited at Southampton General Hospital, the hub is a collaboration between 15 units in Southampton, Portsmouth and Oxford. These centres amount to significant NIHR investment and come together to form the supporting pillars of the Southampton clinical research partnership. Southampton Academy of Research (SoAR) - generic information Operating across the Trust/University partnership, SoAR is University Hospital Southampton’s pan professional hub for health-related research career training and development. The creation of the Academy is evidence of the Trust’s serious commitment to research capacity building. SoAR supports the development of policies relevant to researcher career development across the Trust/University partnership to ensure both institutions work in ways that meet the principles and obligation statements of NIHR. SoAR benefits The applicant (name) may take advantage of the resources and support offered by the Academy, including: • Engagement with other researchers across all stages of career path and across professions and disciplines, through events and networking opportunities. • Access to a multidisciplinary research career development team for career advice, support and information, including participation in regular one-to-one clinics. • Short, free training courses addressing practical researcher development skills such as writing Pathways to Impact statements, writing quality papers, networking and influencing strategies. • Access to information and advice about internship and fellowship funding calls for healthcare professionals (HCP) and medical doctors, including the Research Leaders Programme. • A Spring School featuring topics such as impact, collaboration and researcher well-being. • A regular SoAR update in the weekly UHS R&D newsletter, including training information, fellowship and development opportunities. • Support to source an appropriate mentor. • Support to navigate and problem solve any challenges that might arise in working across the Trust/University interface. Institutional information_2024-25 - 12 - APPENDIX Example support statements 1. With kind permission of Alasdair Munro: I am delighted to support Alasdair Munro’s application for a Clinical Research Training Fellowship and will provide senior mentorship during the duration of the award. Alasdair is an ideal candidate for an NIHR training fellowship which will be conducted using equipment provided by the new £2.8 M. NIHR antimicrobial resistance capital award to Southampton. He gained a first-class honours degree from the University of Southampton and was an outstanding student. Alasdair has progressed rapidly and seamlessly through the clinical training pathway, gaining a national training number in paediatric medicine and his MRCPCH. He has demonstrated a clear interest in clinical academic medicine since his medical student project where he excelled in a project requiring complex data analysis. He has been self-motivated in conducting clinical research projects that he has published while in clinical training posts, including in the area of real-world diagnostics. He was appointed against strong competition for his current post as NIHR Clinical Research Facility fellow, and has impressed us greatly. In his current post, Alasdair has shown great energy and ability, leading on the set up of complex noncommercial and commercial phase 1 trials of antibiotics and new vaccines. He has taken an interest in biofilm infections and diagnostic technologies, writing a review and working across Faculties to put his Fellowship proposal together. This clinical feasibility study will translate a new imaging solution for diagnosing resistant bacteria in biofilms, which fits very well with his clinical training and interest in diagnostics. Alasdair has developed the proposal himself, working with his supervisors to carry out a PhD aligning with both the current national/global priority area of preventing antimicrobial resistance and to current expertise and interfaculty work at the University of Southampton, Southampton BRC/CRF and National Biofilm Innovation Centre. Alasdair will be supported by an excellent supervisory team at the University of Southampton, each an emerging leader in their respective fields. Saul Faust is Director of the NIHR Clinical Research Facility who leads the Faculty of Medicine and BRC input to the National Biofilm Innovation Centre (NBIC). Jeremy Webb is an international authority on pseudomonal biofilms who is co-chief investigator NBIC, itself hosted by the University of Southampton. Sumeet Mahajan is a global academic leader in Raman spectroscopy and engineering. This Fellowship will give Alasdair an excellent training in cutting edge technologies and interdisciplinary research that can be widely applied to address human disease. We clearly need to mentor and develop such translational clinical scientists to harness the potential of emerging technologies. Alasdair’s strong academic background and stage in his clinical training makes him an ideal candidate for an NIHR Clinical Doctoral Fellowship to develop such skills. 2. With kind permission of Andrew Bates: We first became aware of Andrew during his work at Royal Bournemouth Hospital. He took responsibility for delivering our Fit4Surgery portfolio, recruiting significant participant numbers with exceptional commitment, desire and dedication. Andrew secured an HEE/NIHR Internship award, further establishing our partnership as we hosted his research placement during this successful and productive programme. We quickly understood his potential and valuing his contributions, we developed a 12-month secondment. He has become an integral member of the Critical Care Research team, so we have been delighted to appoint him on a permanent basis, as research manager. This is a Clinical Academic Post. He is developing a translational Institutional information_2024-25 - 13 - clinical service and managing a team of junior research staff. We are committed to supporting a 50:50 clinical: fellowship role. With our support, we feel he has the attributes and desire to forge a leading clinical academic career within this exemplar service. Given his extensive experience of research delivery and management, we gave serious consideration to steering Andrew towards a doctoral training programme. On reflection, we felt that developing Andrew’s individual research identity and relevant methodological skills would be better served through the PCAF level award. Andrew’s PCAF programme will be hosted by a partnership between University Hospital Southampton and University of Southampton. This established research partnership has enabled the Southampton Academy of Research to harness the potential of our health-related research workforce, driving the next generation of clinical discoveries and supporting them to advance knowledge and improve care. While keeping his primary hospital contract, Andrew will gain access to training, facilities and networking opportunities at the University, via an extension of his established honorary contract. The Faculty of Medicine and School of Health Sciences will collaborate with the NIHR Southampton Biomedical Research Centre, Critical Care Research Area, to ensure that he receives the highest quality of support. The School of Health Sciences is internationally acknowledged as the leading centre for research in Nursing, Allied Health Professions, and Health Sciences in the UK, with a strong track record with NIHR personal awards. The School’s aim is to build and sustain world-leading applied health research that will lead to real improvements in health care. Research environment and research impact were both rated world-leading (4*) in REF 2014. The School has an excellent reputation for cutting edge multidisciplinary research based on strong links with the NHS and other healthcare organisations. The research strategy is aimed at generating the highest quality research and making a real difference to people’s lives. The Faculty of Medicine leads innovative learning and discovery for better health across the life course and is an internationally recognised Medical School (placed in the top 100 in 2014 in the QS global subject rankings). To secure our place as one of the UK’s leading Medical Schools, we are building upon three distinctive features: our strong partnership with the local NHS providers, to deliver translational research and equip the next generation of healthcare professionals to work in a rapidly-changing environment; collaborations at the life sciences interface with technology; and exploitation of the enterprise agenda to maximise the impact of our education and research. The Faculty’s transferable skills programme will provide a wide range of training opportunities for Andrew. The programme has been developed in-line with the Vitae Researcher Development Framework. It includes a range of workshops including scientific writing, presentation skills, mentoring and interview skills. The Critical Care Research team is a group of clinicians and clinical scientists engaged in research to meet key unmet needs in critical illness across the life-course, with particular attention to the acute patient pathway, of which Andrew has vast clinical, teaching and now research experience. Fit4Surgery is a world-leading clinical and research programme, aiming to improve patient outcome throughout their surgical journey. Leadership from internationally renowned Professors, Mike Grocott, Sandy Jack and Denny Levett with whom Andrew already has close working relationships, will provide a fertile environment for his PCAF and subsequent research career development, in this, his chosen field for research. We believe that the quality of his clinical academic support is assured, not just by our institutional track record in delivering research and supporting clinical academic development, but also by the quality of his confirmed supervisor/ mentorship team. Andrew’s principal academic mentor is Associate Professor Steve Wootton. Dr Wootton is the infrastructure and training lead of NIHR Southampton Biomedical Research Centre and a member of the NIHR Trainees Coordinating Centre. He has played a lea
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