Research and Innovation
Spring 2017
Jan’s story … Can you tell me a bit about yourself? Jan: I live in Hemel Hempstead & was it’s first lady bus driver but I’m retired now. I’ve got a white German Shepherd dog called Ice, he’s my diabetic dog. He supports my diabetes at night & wakes me up when I’m having a hypo (low blood sugar). What type of study are you taking part in? Jan: It’s an eye study called Cleopatra looking at diabetic retinopathy. How did you find out about the trial? Jan: I read it on the wall, on a poster and then Mr Smith told me about it. He said I’d be a good candidate. Why did you decide to take part? Jan: I thought I can do that so why not. Got to help out if I can. I’ve had a ball, two years have gone by so quickly and I’ve told Mr Smith and Judith that if there’s any more studies to do I’ll be there.
Jan with Judith Abrams, Ophthalmology Research Nurse
What do you have to do? Jan: Wear a blindfold! It’s like a mask & you have to drop a plastic thing in it which takes some getting used to. Mine was non-light but some had lights, green lights. I had to wear it every night for two years but I still wear it because the car headlights shine in to my bedroom & it keeps the lights out of my eyes, but I’ve taken the plastic thing out now.
What are the benefits of taking part to you? Jan: I’ve had my eyes so well looked after by the staff at Stoke Mandeville. It’s been second to none and I’ve had extra research appointments where I’ve been seen really quickly. I have to have laser treatment on little bleeds behind the eye and they can do that straight away here as part of my appointment but if I went to Hemel I’d have to have a second appointment and come to Stoke for the treatment anyway.
What would you say to anyone thinking about taking part in research? Jan: Do it, don’t think about it. If you don’t benefit others will. The treatment and staff in this hospital have been brilliant. It’s not scary, it’s been good fun and I’ve been so well looked after by Judith and all the staff here. Fantastic!
Patients More Likely to Survive in Research Active Hospitals A study supported by the National Institute for Health Research (NIHR) reported in October 2016 that bowel cancer patients are more likely to survive in research-active hospitals. Even patients not involved in the trials themselves benefit from being in hospitals where a large amount of clinical research is taking place. Bucks Healthcare didn’t take part in this particular study but the researchers concluded that, “by getting involved in research trials, hospitals may “up their game” and provide better care for all the patients they treat even in the short term long before the results of those trials are known.” http://gut.bmj.com/content/early/2016/10/14/gutjnl-2015-311308.full
What’s a blinded clinical trial? There is a risk in research that the investigators’ conclusions might be influenced by their opinions. To eliminate that risk some trials are designed so that the investigators and/or patients don’t know which treatment is allocated to each recruit. This makes the patients and investigators “blinded” and prevents assumptions being made about the benefits or sideeffects. Sometimes patients and investigators are unblinded at the end of the trial. 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
COPEPTIN PRO core Registry This Buckinghamshire Healthcare NHS Trust study is recruiting 900 patients suspected of having a heart attack on admission to Wycombe and Stoke Mandeville hospitals. The cardiac team are investigating the current standard care of assessing a single biomarker/blood protein called Troponin in patients at Stoke Mandeville against the testing of Troponin in combination with a new biomarker/blood protein called Copeptin in patients at High Wycombe. By assessing both proteins from a single blood sample, diagnosis of a heart attack can be made much more quickly and avoids the three hour wait for a second Troponin test. Patients reliably diagnosed with a heart attack can be given vital treatment much earlier. Other patients where a heart attack is ruled-out may need alternative investigations and treatment or be able to go home sooner. Patients agreeing to take part give a routine blood sample in A&E as part of standard care and are followed up one month later with health review phone call from one of the cardiac research nurses. For more information contact the cardiac research team: Dr Piers Clifford 01494 425004 Nicola Bowers 01494 425901
Patient Research Experience Feedback During 2016 we handed research feedback questionnaires to local participants. This is what we found out: 92% felt their participation was definitely valued. 89% felt the study information given was easy to understand. 100% understood that participation was entirely voluntary. 76% felt they understood what was going to happen at each visit. 61% felt that patients should routinely be offered the opportunity to participate in research. 39% thought that should not be the case in sensitive situations. 62% would definitely take part in future research if the opportunity arose, the remaining 38% consider it likely. When asked to give the reasons why they took part, 92% of patients said it was to help others and 68% said it was also for their own benefit. The comments we received included: “I felt that there was concern for me” “Great to have extra care” “Felt good to help in any way possible” “Very informative at a stressful time” “Felt that the treatment was the best possible with latest drugs available and close monitoring” To improve the experience we were asked whether study drugs could be collected via the GP and whether a heart monitor could be fitted at the GP surgery. Plenty of food for thought as we develop patient research opportunities at Bucks Healthcare NHS Trust.
Study Snippets Predicting Serious Side-Effects Gastroenterology’s Inflammatory Bowel Disease patients have been helping a study called PRED4 in association with Exeter University and the UK IBD Genetics Consortium since 2012. The study is looking at why some patients experience rare serious side-effects to commonly used medicines.
The study has already started to publish its first findings and has now extended recruitment to the end of 2017. For more information contact Research Nurse, Ruth Penn on 01494 426588 www.ibdresearch.co.uk
Stroke Investigation Network – Understanding Mechanisms By increasing the understanding of different stroke subtypes this study run by University College, London hopes to help reduce the cost of stroke care to the NHS (currently £8.2 billion a year) and improve the quality of life outcomes for patients. It is open to all patients over 18 who come into the hospital stroke service. Contact adrienne.benford@buckshealthcare.nhs.uk
QUIDS Preterm labour is when labour starts before 37 weeks of pregnancy. Diagnosing it is difficult and many women who have signs of preterm labour may still be pregnant a week or longer after diagnosis. Possible treatment includes steroids, magnesium sulphate or maybe, transferring the mother to another unit – all of these being stressful and costly measures. A test called fetal Fibronectin (fFN) may help to improve the diagnosis of preterm labour. It involves the measurement of fFN in a swab as part of the routine assessment of a woman presenting with potential signs and symptoms of preterm labour. The current test gives a positive or negative result but measuring the exact amount of fibronectin is new and has the potential to rule out preterm labour. This study is looking at the results of the quantitative fFN test obtained from women who are showing signs of pre-term labour. The information gathered will be used to develop a tool to help doctors interpret tests such as fFN and ultrasound scans, allowing doctors to decide how best to care for women who may give birth to their babies early. Julie Tebbutt 01296 418160 www.quids.org.uk
Meet Consultant Hepatologist, Dr James Maggs Q Where and when did you do your medical training? A I qualified from University College London (UCL) in 2001 and moved to Oxford in 2005 to take up a registrar post in General Medicine. I undertook specialist training in Hepatology at King’s College Hospital, London and the John Radcliffe in Oxford. Q Have you taken part in research yourself? A As an undergraduate I took part in a basic physiology study at UCL. It involved receiving an aspirin infusion into my arm whilst having a tourniquet on to stop the blood supply for ten minutes at a time. It was an interesting experience but not something I would rush into again. Q How has research in your field resulted in changed practice? A There has been a revolution in the treatment of chronic Hepatitis C in the past few years with the introduction of many new drug combinations improving cure rates and reducing treatment side effects. Research has been key to this change in clinical practice, and demonstrates how an understanding of the basic science of virus replication cycles can be used to create novel therapeutic agents. These new agents are then tested in clinical trials to determine the most effective drug combination for specific patient groups. Q Why do you think research is important to the NHS? A I believe that clinical research allows patients managed by the NHS to have access to treatments that they might not otherwise be able to have, whilst also potentially saving the NHS money! This is clearly important given the current circumstances.
Q What do you think are the benefits to patients of taking part? A Participating in research allows patients to make a positive contribution to medical science and the care of fellow patients. Q Do you think there are any negatives patients should consider? A Of course … nothing is free. All research (whether interventional or observational) requires the collection of data about and from the patient. Participants in research at the very least have to commit their time to achieve this.
Myeloma XI Trial Results Between 2010 and March 2016, 60 Bucks patients with Myeloma took part in a randomised clinical trial of Lenalidomide. It is a new oral drug treatment that was being tested to find out how effective it is at keeping patients in remission. It was the largest trial in Myeloma conducted anywhere in the world and approximately 20% of all newly diagnosed patients were enrolled across 110 NHS hospitals (over 4,400 patients). Currently there is no maintenance treatment available for patients once they are in remission. The trial results have shown that Lenalidomide could double the length of time that patients remain in remission by up to two years and so improve the current standard of care. The trial was funded by Cancer Research UK.
Receiving recognition in 2016 for the development of Hepatitis C referral services in the community.
Further information is available on the website: www.myeloma.org.uk
The NIHR (National Institute of Health Research) league table of delivering research ranked us 23rd out of over 400 trusts. 19 trusts that ranked higher than us are large teaching hospitals which demonstrated how well we are doing as a medium size acute trust, the ranking is based on how many people participated in NIHR portfolio studies. The tables also reported that the number of studies we have open for patients to participate in increased by 11%. In 2015/16 over 5,000 patients participated in research studies at our trust, we are ever grateful for our patients, families and carers who support our research activity. We have had really positive feedback from some of our patients on the benefit they have felt in participating in research, this is testament to the relationships our research nurses build with patients during their research journey. We are also required to meet national targets to: Open a study within 15 days of approval. Achieved in almost 100% of studies with an average of two days to open a study on receipt of all documentation. Recruit the first patient within 70 days of study application. We met the target in 80% of studies. Recruit the agreed number of patients. Achieved in 80% of closed studies.
The Cardiac Research Team Ward 3B, Wycombe Hospital 01494 425901