Research and Innovation
Summer 2017
Hilary’s story … Can you tell me a bit about yourself? “I used to be a Health Visitor and retired in 1998. Since retiring I keep myself busy and active, walking and birding. My favourite bird is the Long Tailed Tit.” What type of study are you taking part in? “It’s for high cholesterol levels. They think mine is familial and I just inherited it because my lifestyle and diet doesn’t justify what it was. The study’s called Odyssey Outcomes.” How did you find out about it? “I had a heart attack three and a half years ago now, 4 years in December, and had two stents put in here at Wycombe hospital. Excellent it was. I think Nicola (Research Sister) approached me on the ward after the stents were put in.” Why did you decide to take part? “Because if it’s familial then my sons and grandchildren might inherit it. That’s the sole reason really.”
Hilary in clinic with Nicola Bowers, Senior Cardiac Research Nurse
What do you have to do? “I have to inject myself every two weeks. They give us a diary to fill in with dates and times you do it. I started off coming to see the team monthly at first for four months and it’s gone gradually longer to every six months now. The drug’s now been licenced in the UK and the trial’s stopping early, I have two more visits left.” What would you say are the benefits to you? “I’m participating in something that will benefit others and that I’m monitored. When I did have a problem I could contact the team and come in. It’s been reassuring.” What would you say to anyone thinking about taking part in research? “Definitely people should take part. It’s for the benefit of everyone else in the future isn’t it.”
Odyssey Outcomes Trial This phase III trial involves 18,000 patients from 57 countries and is looking a drug called Alirocumab which lowers a type of cholesterol called LDL (low-density lipoprotein). Alirocumab was already approved for use in some countries including the USA and EU & has now been approved for use in the UK. The study aims to find out whether it can help patients who have recently suffered a heart attack prevent future cardiovascular events such as angina or stroke. Patient recruits were taught how to inject themselves under the skin every two weeks with the Alirocumab medication or a placebo for approximately 2 years. All the patients are monitored regularly by the research team at Wycombe which is led by Consultant Cardiologist, Dr Piers Clifford and Senior Cardiac Research Nurse, Nicola Bowers. The team were the 5th highest recruiting centre in the UK. For more information on cardiac research call 01494 425901.
What does Informed Consent mean? Prior to taking part in research it is essential that a person freely gives informed consent. The potential participant must be given the information to make a voluntary decision about whether to take part or not, this includes the purpose of the research, what’s involved for them and understanding the risks and benefits. The research professionals taking consent must also be trained and qualified to take it. 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
RAMPP – Respiratory Study
Study Snippets
Bucks Healthcare NHS Trust is expanding its research opportunities to patients with respiratory diseases, led by Dr Mitra Shahidi.
SILENCE
RAMPP is a University of Oxford study open to patients who come to A&E with a pneumothorax (collapsed lung) which can cause pain and breathing difficulties for approximately 3,000 patients a year in the UK. The condition usually requires treatment to remove the air from the lung space and admission to hospital while the lung is re-inflated by a chest drain.
Patients are asked to complete a short questionnaire about how they slept on one night during their stay which will be compared to the nurse questionnaire about their perception of the patient’s sleep. The study aims to reduce noise levels, promote good sleep and lower the number of patients who become confused on ICU. For information please contact:
The study is measuring how long patients are admitted for (6-8 days on average) and whether the use of a new portable drain means they can go home with the device in place and have their medical and chest x-ray assessments done as an outpatient. Patients would participate for about 12 months and be followed up with four study visits to the hospital to check for breathlessness, discomfort and the risk of a pneumothorax happening again. Contact Katarina Manso on 01296 315832 or email katarina.manso@buckshealthcare.nhs.uk.
The Intensive Care Units (ICU) at Wycombe and Stoke Mandeville hospitals are taking part in their first research study to find out how noise at night affects the sleep quality of their patients.
Sue Johnson (Wycombe) 01494 425580 Sally Scott (Stoke Mandeville) 01296 315620
Paediatrics – Cow’s Milk Allergy Our paediatric research team are celebrating their successful application to conduct their first commercial trial at the Trust. NHS hospitals are encouraged to support commercially sponsored research because of the opportunity to; participate in drug or device development; test out new medical equipment; become involved with the development of improved treatment for NHS patients; generate funds for investment into future research, facilities and patient care. The study will be looking at cow’s milk allergy diagnosed in babies between 0-6 months old. Contact the research nurse via email: chris.cleaver@buckshealthcare.nhs.uk
Meet Dr Pradeep Shanmugasundaram, Consultant Intensive Care Medicine & Anaesthesia Where and when did you do your medical training? I qualified from Imperial College School of Medicine at St Mary’s in 2003.I did my anaesthetic training in the Oxford region and intensive care training primarily at Guy’s and St Thomas’, Oxford & Reading, all highly active research units. Have you taken part in research yourself? My wife and I participated in a trial investigating pre-eclampsia in her first pregnancy. It involved a questionnaire, a few extra antenatal visits and blood tests. The whole process was well supported and we definitely felt it was worthwhile. How has research in your field resulted in changed practice? Many trials focus on clarifying how we should deliver existing treatments most effectively to prevent inadvertent harm, which is particularly important in intensive care. In recent years these trials have improved the way we manage severe respiratory failure, sepsis, anaemia and post-cardiac arrest to minimise brain injury. Intensive care is a fast moving field where one of the main challenges is keeping up with the pace of change! Why do you think research is important to the NHS? Healthcare in the UK is extremely resource limited at present, so it is of vital importance that clinical research studies determine what the most effective treatments are and how they should be delivered. What do you think are the benefits to patients of taking part? It allows patients to access new treatments or strategies that push the boundaries of medical knowledge. Do you think there are any negatives patients should consider? Participation involves a degree of commitment and should be a deliberate, informed choice. Research in the NHS can only take place using highly regulated methods that put patient safety and welfare first. Patients can choose to withdraw from a study at any time and for any reason if they wish to. What’s your favourite sport? Football, both to watch & play (with my children), but finding time to do either is a challenge! What’s your dream holiday destination? An African safari.
International Clinical Trials Day – 2017 Every year, the National Institute for Health Research (NIHR) promotes International Clinical Trials Day in May. This is a special day to celebrate clinical research activity all over the world, and highlight the important impact research has had on medicine to date. This year the day aimed to encourage patients and carers to come forward and get involved in research and to raise the awareness of research activities amongst hospital staff. Bucks Healthcare joined in the promotion of research in outpatient areas at Stoke Mandeville and Wycombe hospitals. Key messages for this year are: ● Participating in health research helps develop new treatments, improve the NHS and save lives. ● Find out about research via the UK Clinical Trials Gateways and register your interest on www.ukctg.nihr.ac.uk ● Research active trusts have better outcomes for patients
For more patient stores about how research changes lives read Bob’s story, follow the link: https://www.nihr.ac.uk/news/buckinghamshire-patient-who-suffered-three-heart-attacks-proud-to-take-part-in-research/6209
Breast Cancer Surgery versus Active Monitoring The cancer team are taking part in a study called LORIS from the University of Birmingham to find out whether annual mammogram monitoring is preferable to invasive surgery in women with low risk ductal carcinoma in situ (DCIS) of the breast. Currently DCIS accounts for approximately 20% of all breast cancers detected by screening. Contact Research Nurse Alice Ngumo for more information on 01296 315809.
Research Team with Dame Lesley Fallowfield
Breast MDT; Dr Farid Ahmed, Dr Giles Cunnick, Wendy Brazier, Dr Carol Record, Manisha Joshi, Alice Ngumo