Research and Innovation
Summer 2018
The GEM 3 study is looking at whether lung cancer drug gefitinib taken alongside methotrexate can stop an ectopic pregnancy developing without the need for surgery or further medication. An ectopic pregnancy is when a fertilised egg implants itself outside of the womb, usually in one of the fallopian tubes. There is no chance of this pregnancy surviving and it can be life threatening if left untreated. If picked up early, a single dose of methotrexate is given. However, if this does not terminate the pregnancy within two weeks, another dose or surgery may be needed. Women being treated with methotrexate are invited to take part in the study and are given either gefitinib or a placebo (dummy drug) to take as well. Neither researchers nor participants are told which they are getting, so they can be compared without bias One of our patients, Lorraine, was admitted to Stoke Mandeville hospital for sepsis (blood poisoning) and was given a blood test which revealed an ectopic pregnancy. The mother-of-two said: “I was in a lot of pain, but because I had sepsis at the time I couldn’t pinpoint whether it was that or the ectopic pregnancy. Had I just been dealing with the ectopic pregnancy, my symptoms may have been different.” After her sepsis was treated with antibiotics, Lorraine was discharged to the hospital’s maternity ward. She said: “The research midwives approached me and told me I could either take part in a new drug trial or have surgery. The new drug sounded like it would get everything over with quicker in the least invasive way possible, so I thought it was a great idea. I’m quite a helper. If something good can come out of something bad and help more people, it’s a great thing to do. I am also quite a curious person and I thought if the trial drug would make my life a bit easier, then why not?”
The research team, happy at work in the maternity unit
Lorraine urges others to consider taking part in research after figures showed 4,024 participants took part in 79 studies supported by the National Institute for Health Research (NIHR) at Buckinghamshire Healthcare NHS Trust. Lorraine said: “I would definitely recommend investigating research and finding out more, even if you don’t decide to go on a trial. I would consider taking part again.” Lorraine, who was eight weeks pregnant at the time of her diagnosis, said: “I hadn’t had a lot of emotional attachment to the pregnancy as I didn’t know about it before I found out it wasn’t viable. It was a bit different from having a miscarriage. This was more of a medical issue than an emotional one.” She said: “I feel very lucky, fortunate and humbled my diagnosis and treatment happened when they did and that I’m okay.”
For more information on obstetric and gynaecology studies contact the research midwife team on 01296 418160.
Where can I find out about study results? To promote transparency in research, studies are bound by the approval processes during set up to publish their results (good or bad) and share the information with peers and participants at the end. This can be via presentation to conference, publication in scientific journals and is sometimes summarized in newsletters to participants. It is considered good practice to communicate results and proposed changes in care to participants and other interested groups. The participant information sheet should include how results will be published. A good source of study results is the NIHR Dissemination Twitter feed @NIHR_DC. Clinical trials of a medicinal product are required to publish results within one year on a European database called EuDRACT. 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 You can also follow us on facebook or Twitter @BHTResearch
Raha West – A New Research Fellow at BHT My name is Dr Raha West, I'm an anaesthetist and working in the Anaesthetic and Critical care department at Stoke Mandeville Hospital. My role includes research lead for the Anaesthetic department. I am also a research fellow for the National Institute for Health Research for Thames Valley and South Midlands. I am responsible for the development and the conduct of research in the perioperative and critical care department. I believe in clinical research because it allows me to focus on improving the care, experience and outcome of patients following their anaesthetic and critical care admission. Research is fundamental to the growth and maturity of the perioperative and critical care specialty, for the development of best evidence practice, new therapy and technologies.
One of the studies we’re supporting is PQIP which stands for the Perioperative Quality Improvement Programme. “Perioperative” refers to the time before, during and after surgery. Our aim is to improve the care and treatment of patients undergoing major surgery in the United Kingdom. We do this by collecting and studying information about you, your surgery, and then your recovery afterwards How does PQIP help patients? The information collected by PQIP is used by doctors, nurses and medical researchers to: • Produce information on the quality of care received by patients undergoing major surgery in NHS hospitals • Ensure that any changes or improvements to services benefit patients • Learn about the best ways in which doctors and nurses can use patient information to improve quality of care • Better understand what happens to patients after they leave hospital after having a major operation, and whether the surgery has had a beneficial effect on their longer-term health
For more details please contact Dr Raha West via email: raha.west@nhs.net
We’re expanding our team of Patient Research Ambassadors If you have ever considered becoming involved in research and innovation, but don’t know how, then why not consider becoming a Patient Research Ambassador (PRA)? John Smith, one of our great Patient Research Ambassadors, explains why he became involved and what kind of activities he has been engaged in. “When I retired, I wanted to give something back to my community. There were a number of options, but the one that I found most appealing was a voluntary role within the NHS. A Patient Research Ambassador is someone who promotes health research from a patient point of view. They could be a patient, service user, carer or lay person. No special skills are required, just a passion to promote healthcare and research. I have enjoyed supporting the research teams by looking at Patient Information documentation from the patient’s point of view, giving talks to promote research and innovation, helping to design training courses for nurses involved in research and supporting the redesign of our research website”. In becoming a PRA, you can play to your own strengths and skill sets in support of the promotion of health research. If you want to find out more, then please contact us via: nicola.higgins5@nhs.net
BHT Most Engaged Team! Congratulations goes to the whole research workforce team who were recognised by the Trust as the most engaged out of 101 teams surveyed. The results show that the research team are the happiest at work, enjoying what they do for patients whilst contributing to the development of new treatments and improving outcomes for patients.
Paramedic2 – The Adrenaline Trial - Results published BHT cardiac research team supported the first large scale study to examine whether adrenaline is helpful or harmful as a treatment for cardiac arrest outside hospital. 8,016 patients took part across the UK with an average age of 69. The published trial results show that there was a small improvement in survival to 30 days, adrenaline made no difference to the number of patients who survived to go home from hospital with good recovery. However, surviving patients who received adrenaline were nearly twice as likely to have severe brain damage following the cardiac arrest (31% versus 18%). The public should continue to prioritise evidence based treatments – high quality CPR and prompt defibrillation. Six out of ten people in the study received CPR from bystanders or family before the ambulance arrived. See the website for more info https://warwick.ac.uk/fac/sci/med/research/ctu/trials/critical/paramedic2
Tich2 Stroke Research Results Published Thank you to all our patients who took part in the Tich2 trial of Tranexamic acid use to control bleeding after a stroke. The results were published in the Lancet on 14 May 2018.Follow this link to read a summary of the findings: http://tich2.org/documents/90-Post-publication%20documents/TICH-2_lay_results_summary_20180515_v1.0.pdf
Research Star Award Moncy Mathews, Clinical Trials Pharmacist Where did you train as a pharmacist? I qualified at the University of Sunderland & subsequently started as a pre-registration pharmacist with North Tees and Hartlepool NHS Foundation Trust. What is the role of pharmacy in clinical trials? Pharmacy has a vital role to play in clinical research by safeguarding Participant’s rights & protecting their health in line with various EU & international regulations. As part of setting-up new Clinical Studies, from a very early stage, Pharmacy engages with a range of internal and external stakeholders. In this process, Pharmacy supports the Trust R&I dept, Principal Investigators & research nurses in setting-up and running clinical studies safely & efficiently. Pharmacy ensures the study medications are stored appropriately & is correctly dispensed to the patients in line with study protocols. Pharmacy has the capabilities to handle and manufacture a range of advanced molecules currently studied in Cardiology and Cancer cohorts. Pharmacists and Technicians who are specialised in advanced pharmacotherapies and various clinical specialities assist us on decision making. To the Trust Research Teams, Pharmacy offers expert advice on a range of study specific challenges including review of study protocol, IMP procurement, storage challenges and on various regulatory barriers that hinders research. What do you enjoy about working with clinical trials? On a day to day basis, I do get opportunities to engage and collaborate with a range of internal study team members and external study Sponsors, often dealing with study management challenges & resolving problems. As a team we work towards successfully setting-up, running & closing a study with optimum regulatory compliance. It gives me confidence, strength and adaptability to manage challenges
Nursing Times Award Nomination News!
Senior cardiac nurse, Nicola Bowers, is shortlisted for the 2018 Clinical Research Nursing Award. A glittering evening of celebration and recognition will take place on 31st October 2018 at the prestigious Grosvenor House Hotel, London.
and be positive towards problems. Moreover, when studies produce positive outcomes, it gives me the feeling of being part of improving patients’ health and their wellbeing. What are the benefits to patients of taking part? Clinical Research is fundamental to finding new treatments and disease management strategies. Progressive improvements in public health indicators can be achieved through advanced research and translation. When researchers get better insights in to diseases and therapies, Patients benefit from advanced treatments and better health outcomes. Why do you think research is important to the NHS? The NHS is one of the largest public health providers in the world; Clinical Research is fundamental to its progression and sustainability. Department of Health invest billions of pounds through its research arm National Institute of Health Research (NIHR). NHS brings together researchers from academia, health authorities and pharmaceutical companies, giving them solutions and opportunities to conduct studies seamlessly. Millions of patients benefit from these research innovations and achieve better health outcomes. Research fundamentally prepares the NHS for the future and to be a modern healthcare provider meeting public demands and expectations. Have you ever been a research participant? No, I have never been a research participant but I will be keen to join, if there is one right for me available.
(Moncy has now moved to Norfolk and we wish him every success in his new role there.)
Moncy receiving his award from Dr Mandeep Bindra
Around 55,200 people are diagnosed with breast cancer in the UK each year. About 15 out of every 100 women (around 15%) with early breast cancer have HER2 positive cancer. For women with HER2 positive early-stage breast cancer taking Herceptin for six months could be as effective as 12 months in preventing relapse and death, and can reduce side effects, finds new research. The PERSEPHONE trial, a £2.6 million study funded by the NIHR with translational research funded by Cancer Research UK, recruited over 4,000 women and compared a six month course of treatment of Herceptin with the current standard of 12 months for women with HER2-positive early-stage breast cancer. This is the largest trial of its kind examining the impact of shortening the duration of Herceptin treatment. Professor Hywel Williams, Director of the NIHR Health Technology Assessment Programme that funded the PERSEPHONE study said: “This is a hugely important clinical trial that shows that more is not always better. Women will now have the potential to avoid unnecessary side effects of longer treatment without losing any benefit. In turn, this should help save vital funds for the NHS and prompt more studies in other situations where the optimum duration of treatment is not known. For more information about the PERSEPHONE trial, please visit: https://www.journalslibrary.nihr.ac.uk/programmes/hta/0630398/#/ http://www.cancerresearchuk.org/about-cancer/find-a-clinical-trial/a-trial-comparing6-months-and-12-months-of-trastuzumab-for-early-breast-cancer
INGRID OR INGR1D? Type 1 diabetes is the most common metabolic disease in children which requires daily treatment and can have serious long term consequences. We want a world without type 1 diabetes. We are launching INGR1D, a large screening study to identify young children at the risk of type 1 diabetes. For more information contact the study team. Telephone: 01296 418160 Email: bht.og.research@nhs.net Website: www.gpadd.org
GPPAD-INGR1D; OVG 2017/09; Poster 2; IRAS ID 234377; REC REF 18/SC/0005; V2.0, dated 06-March-2018