Research and Innovation
October 2016
Pete’s story … Can you tell me a bit about yourself? Pete: “I’m Aylesbury born and bred, married to Sheena and have two children. I worked for BT as an underground engineer but now I’m desk based. I’m a marathon runner and was about to compete in my 30th marathon when it happened.”
What type of study are you taking part in? Pete: “It’s called NAVIGATE and trials a drug called Rivaroxaban. You don’t know whether you’re on it or a placebo.
How did you find out about the trial? Pete: “Dr Burn told me about it on the ward.”
Why did you decide to take part? Pete: “I do it because I’m fit and healthy and suddenly had a stroke. If it can happen to me it can happen to anyone. If we can have a drug out there that can stop it happening again to me or anyone else that would be brilliant. If we didn’t try things we’d never get the new things to help anybody and what if it’s hereditary, you could be helping your own children.”
What do you have to do? Pete: “I have two bottles of tablets, one marked Rivaroxaban and one marked aspirin, but one or other is a placebo, for two years. I see Adrienne every 3-4 months with a yearly review. Also I can call her anytime I have a problem or need help with anything. I keep them informed of if anything happens. They look after my whole health.”
What are the benefits of taking part to you? Pete: “It gives you two years of being assessed and looked after really. I can only describe it as having a crutch. I’ve been looked after and monitored while I’m feeling like a rabbit in the headlights. I think if I hadn’t been seeing Adrienne (stroke research nurse) they wouldn’t have diagnosed my heart condition. I see that as real pay back for taking part in the study.”
What would you say to anyone thinking about taking part in research? Pete: “Definitely do it. I see no negative. If it helps somebody else after me all well and good. You’re closely monitored so you feel you’re well looked after.”
Dr Matthew Burn with Pete in clinic.
Pete is helping the NAVIGATE clinical trial. This is a study in patients who recently had a brain attack (stroke) and in whom no clear cause of the stroke could be identified. These strokes are likely due to a blood clot and therefore, can be called Embolic Stroke of Undetermined Source. The abbreviation is ESUS. The study will compare two blood thinners. Patients will be randomly assigned to either Rivaroxaban 15 mg or Aspirin 100 mg and the study is intended to show, if patients given Rivaroxaban have fewer blood clots in the brain (stroke) or in other blood vessels. Up to 7,000 patients are being enrolled worldwide. We have a target of 20 patients and with 15 already enrolled we are currently the highest recruiting Trust in the UK.
What’s a placebo? A placebo (or dummy pill) is a tablet or liquid that does not contain any active drug substance but either starch, sugar or saline. In some clinical drug trials patients with specific conditions are given standard treatment plus a placebo or standard treatment plus the new drug. Their responses to treatment and any side effects are monitored and compared. For further information about research opportunities at Bucks Healthcare NHS Trust please contact the Research and Innovation Department at Stoke Mandeville hospital on 01296 316065 or see the website at www.buckshealthcare.nhs.uk/research
Double Winners at the Thames Valley Health Research Awards The Trust is celebrating two wins at the Thames Valley Health Research Awards, held on Wednesday 12 October at Oxford University. The awards recognise those who have made a significant contribution to make sure that health research is delivered in Berkshire, Buckinghamshire, Oxfordshire and Milton Keynes.
Study Snippets HEPATITIS C Study Publication We have been recruiting patients to this large UK wide study of 10,000 people since 2012. A recently published article in the Journal of Hepatology looked at the impact of the new Direct Acting Antiviral (DAA) treatments in patients with advanced liver disease. It found that 381 out of 467 patients receiving the new drugs were cured of the viral infection. Clearing the virus was also associated with improvement in their liver function within six months compared to untreated patients. © European Association for the Study of the Liver We’d like to thank all our patients contributing to this on-going research project.
Copeptin PRO Core Registry
The Ophthalmology Research Team received the ‘Best Green Shoots Development’ award. The award recognises the work undertaken over the last two years to establish a portfolio of commercial and non-commercial Ophthalmology research studies led by Mr Mandeep Bindra and Research Nurse Judith Abrams. The studies have recruited over 300 patients so far with the support of Outpatient Matron, Steph Hartley. They have recently established a new research (AMD) clinic at the Amersham hospital and have four new studies on the way.
Target 900 patients - 450 patients to be recruited into the active group at Wycombe Hospital and 450 patients to be consented retrospectively from Stoke Mandeville Hospital. Does the use of a Copeptin blood sample together with the current troponin blood test allow cardiologists to safely rule out an acute heart attack? Does this strategy allow patients to be discharged from the emergency department earlier than current standard practice? Contact Nicola Bowers on 01494 425901
MS Register With an estimated 100,000 people living with MS in the UK, it’s time we increased our knowledge and understanding. MS Register researchers are working to find out more about MS and the impact it has on the lives of those it affects. If you are over the age of 18 and living in the UK, with a confirmed diagnosis of Multiple Sclerosis made by a consultant neurologist, you are eligible to take part in this ground breaking study. Contact Christine Parker on 01296 315832.
The Cardiology Team received the award for “All-round High Performing Team”. Since it was set up six years ago the team has become an outstanding recruiter in NIHR portfolio trials. The nursing team, led by Nicola Bowers and supported by Dr Piers Clifford, were praised for actively engaging with patients across the spectrum of cardiovascular disease. To date they have enrolled more than 1,500 patients into a wide range of studies, both observational and interventional. This has allowed patients to gain access to novel drug therapies or cardiac pathways and feedback has always been hugely positive.
EDNA The letters stand for Early Detection of Neovascular AMD. We are collecting information on how good certain tests are in detecting the first signs of development of “wet” (or neovascular) age-related macular degeneration. Wet AMD can cause irreversible sight loss if not treated promptly, therefore detecting it early is important to help prevent sight loss. Contact Judith Abrams on 01296 315832
LuCID – Lung Cancer Detection 44,000 people are diagnosed with lung cancer each year in the UK. The majority of patients present with advanced disease but for those diagnosed with stage 1 disease, the chance of cure is up to 75%. Researchers would like to develop a test to pick up lung cancer at an earlier stage. This way, more people could have a chance of successful treatment. This study will look at the chemicals in a person’s breath, these biomarkers are substances in the body that can be measured and may be different in a person with lung cancer. Some biomarkers can help doctors to diagnose cancer, predict whether a treatment will work and show whether treatment is working. A maximum of 600 patients across the UK will be recruited to the study and asked to provide a breath sample prior to any diagnostic tests. This is a non-invasive procedure that will require the patient to breathe normally into a facemask to collect 2.5L of breath amounting to approximately 10 minutes of breathing. The aim of the study is to develop a chemical sensor kit that can be used in doctors surgeries to determine whether a high risk patient should be referred to hospital for further tests. Improved rates of screening and early diagnosis will save 1,000s of lives and £245 million for the NHS. To find out more about taking part in Bucks call Kate Herbert, Cancer Research Nurse, on 01494 426233 Watch this BBC news clip on Youtube: https://youtu.be/4HhlxBKBpGI for more information.
Meet Julie Tebbutt, our Research Midwife Where did you do your midwifery training? “I trained as a nurse in 1986 at Amersham & Wycombe hospitals and later as a midwife at Wycombe.”
Research in the NHS
What were you doing before you started work in research? “After my training I worked in the Middle East for 5 years then at Stoke Mandeville on the labour ward, the antenatal & postnatal wards. I also worked for 10 years as a community midwife throughout the county.” What types of research projects have you worked on? “We’ve done a variety of trials looking at foetal monitoring, progesterone treatment for endometriosis, retained placenta & pain relief in labour . We’re currently taking part in an award winning trial called NCSS. This is the largest recruiting, non commercial trial in the Thames Valley & South Midlands area this year. We are the top recruiting Trust in the area with 12,500 patients so far.”
What do you enjoy about research nursing? “I enjoy the variety of work. We work in a friendly atmosphere that is very conducive to providing high quality care. I particularly enjoy meeting patients and their families, hearing their stories about what brings them into our care.” Describe a typical working day “There is no typical day! Some days I can be recruiting to trials, some days teaching colleagues, some days data entry.” Why do you think research is important to the NHS? “In short, research is the fundamental that underpins everything that we do in practice.” What’s your favourite ice-cream flavour? “The only ice cream I eat is a Mr Whippy 99 when my dad buys me one.” Do you have a pet? “I pet share a miniature Jack Russell called Doris. I also have a pond with 10 fish at the last count.” What’s your dream holiday destination? “Cornwall.”
All 240 NHS Trusts are now actively involved in research. Patients cared for in research-active acute NHS trusts have better patient outcomes, as supported by a study published in 2015.
Research provides evidence about “what works” so that treatments for patients can be improved. Last year alone, 606,596 people took part in clinical research studies via the NHS.
The National Institute for Health Research (NIHR) annual performance report 2015/2016.