Clinical Research Today - Winter (RBCH Research Newsletter)
Clinical Research Today - Winter 15/16 (RBCH Research Newsletter)
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Rheumatology<br />
research in<br />
Christchurch<br />
Patient<br />
interview with<br />
Shirley<br />
International<br />
clinical trials day<br />
MSc in <strong>Clinical</strong><br />
<strong>Research</strong><br />
Promising trials<br />
at <strong>RBCH</strong><br />
Your feedback is invited<br />
Please send any comments<br />
about this newsletter to<br />
Neal Beamish at<br />
neal.beamish@rbch.nhs.uk
Welcome to the first issue of <strong>Clinical</strong> <strong>Research</strong> <strong>Today</strong> from the<br />
Royal Bournemouth and Christchurch Hospital<br />
We aim to inform patients, public and staff about research in the hospital.<br />
<strong>Research</strong> into new medicines and healthcare practices is vital in the discovery of<br />
treatments for diseases such as cancer, heart disease, arthritis and diabetes.<br />
<strong>Clinical</strong> research is growing in <strong>RBCH</strong> and we now have more than 50 staff<br />
dedicated to research, attending to over 300 research studies. In fact over 10,000<br />
patients have joined a research study at the hospital since 2008, and each of these<br />
patients is showing that they care about the development of new medicines and<br />
practices in the fight against disease.<br />
We hope this newsletter that reaches out to as many people as possible. Dr<br />
Jonathan Marks, Consultant Rheumatologist, writes about some of the Rheumatoid<br />
Arthritis research at Christchurch Hospital and the future for rheumatology<br />
research in the NHS. The spotlight on staff describes the important new role of<br />
<strong>Clinical</strong> trials assistant at the hospital through the eyes of Christine Clarke. There<br />
is a focus on patients with Shirley talking about what it is like to be on a clinical<br />
trial. There is news about significant new research studies in various therapeutic<br />
areas in the hospital. We develop close relationships with our partners, and Lisa<br />
Gale-Andrews reviews the activities of Bournemouth University <strong>Clinical</strong> <strong>Research</strong><br />
Unit. International <strong>Clinical</strong> Trials day was held on the 20 th May, and Lucy Thomas,<br />
Data manager, keeps us up to date with the feedback from this publicity event.<br />
There are also reflections from some of our new staff. Education is very important<br />
to us in research and Hannah Dewhurst, Gastroenterology research nurse, speaks<br />
about her Masters in <strong>Clinical</strong> <strong>Research</strong> at Southampton University.<br />
So, if you’ve been given a copy of this newsletter, or simply picked one up in a<br />
clinic waiting room, please browse through the articles because there is a strong<br />
chance you’ll find something interesting and relevant.<br />
Please read on.<br />
INSIDE THIS ISSUE<br />
Rheumatology research in<br />
Christchurch Hospital………,...,...3/4<br />
Spotlight on staff: the role<br />
of the CTA………………………….…....4<br />
Patient interview……..............…..5/6<br />
Promising trials at <strong>RBCH</strong> …….…..7/8<br />
BU <strong>Clinical</strong> <strong>Research</strong> Unit………..….9<br />
Achievements in cancer trials…....10<br />
International <strong>Clinical</strong> Trials<br />
day……………………….........…….....10<br />
Trials monitor physical exercise<br />
and surgery …………………….….....11<br />
Data Office workshop……….…......12<br />
New staff………..……….……….......13<br />
Education in Focus: the MSc in<br />
<strong>Clinical</strong> <strong>Research</strong>………………........14<br />
Latest events and courses……..….15<br />
<strong>Research</strong> word search….……....….15<br />
ON THE COVER<br />
Ian Leadbitter, <strong>Research</strong> nurse, takes<br />
measurements from an orthopaedic<br />
patient.<br />
Sally Sawyer, Senior research nurse, attends to<br />
one of her patients at Christchurch Hospital<br />
@<strong>RBCH</strong>_<strong>Research</strong> www.Dorset<strong>Research</strong>.org 2
New Approaches to Old Problems: Using<br />
<strong>Clinical</strong> <strong>Research</strong> Tools to Improve NHS Care<br />
By Dr Jonathan Marks, Consultant Rheumatologist, <strong>RBCH</strong>.<br />
The management of rheumatoid arthritis (RA), an inflammatory disease of the<br />
joints, has undergone a transformational change over the last decade with<br />
more than a dozen new drug agents available to treat what was historically a<br />
progressive disabling condition. Even with highly effective medications now<br />
available, there are still many unanswered questions: When should we use<br />
them? For how long? What are the long-term consequences? And why do<br />
treatments help some symptoms but not others?<br />
At Christchurch Hospital, the rheumatology department are engaging in a<br />
number of non-commercial research studies to try and fill in the missing<br />
pieces of this treatment puzzle. These studies sit comfortably alongside a<br />
research trials portfolio that also includes phase III and IV clinical drug trials<br />
that aim to establish the effectiveness and long-term safety of new<br />
treatments prior to them becoming available in the NHS. We also work closely<br />
with our research colleagues at Poole hospital, enabling us to provide a<br />
balanced research programme for patients across the region.<br />
“At Christchurch<br />
Hospital the<br />
rheumatology<br />
department are<br />
engaging in a number<br />
of research studies to<br />
try and fill in the<br />
missing pieces of this<br />
treatment puzzle.”<br />
Dr Jonathan Marks<br />
Some of the current Rheumatoid Arthritis trials at Christchurch Hospital<br />
TITRATE (Treatment Intensities and Targets in Rheumatoid Arthritis Therapy)<br />
This treatment study for patients with established RA and aims to answer a<br />
number of key questions:<br />
<br />
<br />
<br />
How should patients with established moderately active disease be<br />
managed?<br />
Will they benefit from receiving more intensive treatment or will it<br />
increase the side effects they experience?<br />
Can self-management improvement outcomes and how can patients be<br />
supported in this?<br />
The findings from this study have the potential to dramatically change the<br />
way we treat and engage with patients in the NHS.<br />
FeeTURA (Foot and Ankle Ultrasound studies in Rheumatoid Arthritis)<br />
This imaging study is helping researchers to understand how the foot is<br />
affected in patients with RA and why foot symptoms often occur despite other<br />
joints improving dramatically with treatment. This information will help<br />
researchers assess foot disease more accurately and tailor future trials to<br />
address this area of unmet need.<br />
RAMS (Rheumatoid Arthritis Medications Study)<br />
This observational study is helping researchers to identify why some patients<br />
respond well to commonly used RA treatments whilst others do not improve<br />
or develop side effects.<br />
BSRBR (British Society of Rheumatology Biologics Registry)<br />
This is a long-term national research project that Christchurch have been<br />
contributing to for more than a decade aimed at identifying long-term<br />
outcomes with newer ‘biologic’ medications used in RA. This project has<br />
already produced several important pieces of research that have helped<br />
doctors and patients better understand the risk and benefits associated with<br />
biologic therapies.<br />
@<strong>RBCH</strong>_<strong>Research</strong> www.Dorset<strong>Research</strong>.org 3
As well RA-related research, we also have interventional trials running in more common conditions such as<br />
osteoporosis including the ‘PROVE’ study which is assessing the role of physiotherapy in the management of<br />
osteoporotic fractures.<br />
What does the future hold for rheumatology research? New drug development and a greater understanding of<br />
the causes of disease will enable healthcare providers to move towards an era of stratified medicine: targeting<br />
the right drug for right patient at the right time. But in conjunction with drug development, trials such as<br />
TITRATE and FeeTURA in RA and PROVE in osteoporosis will be vital to helping address the unanswered<br />
questions that still exist. The information these studies provide will help medical teams to manage patients in a<br />
holistic manner and consider how best to treat specific symptoms which may not respond to medications.<br />
For us in Christchurch, the aim is not only to offer every NHS patient the opportunity to be involved in<br />
research, but additionally to help translate the findings of that research back into our everyday clinical practice<br />
for the benefit of all patients.<br />
Spotlight on staff: What is the role of CTA in clinical research?<br />
By Christine Clarke, <strong>Clinical</strong> trials assistant, <strong>RBCH</strong><br />
CTA stands for ‘<strong>Clinical</strong> Trials Assistant’ and we have been part of the research team since 2013 when the first<br />
CTA was appointed. Indeed, that appointment was so successful there are now five CTAs working in research<br />
in <strong>RBCH</strong>.<br />
<strong>Clinical</strong> trials involve a lot of administration and co-ordination, and the role of the CTA is to take some of this<br />
workload off the research nurses to allow them to spend more time with their patients.<br />
Our typical day starts in the morning clinic. One of our roles in the clinics is receiving ‘consent’ from the new<br />
patients: I’ll explain what this means. Before patients are asked if they wish to join a research study their<br />
medical records are looked at to see if they meet the strict criteria for inclusion on a study. If the patient is<br />
eligible to join a research study it is the CTA’s job to help the patient decide if they want to join the trial, and<br />
we do this by introducing information and answering any questions they have about the trial. We call this<br />
process ‘consent’ and we are trained very thoroughly to take on this important role.<br />
At other times in the morning clinic we see patients<br />
who have already joined a research study and are<br />
attending for assessment of their progress. After these<br />
clinics we often take the first steps in the analysis of<br />
patient samples such as blood. This means either<br />
freezing the blood plasma samples in the laboratory for<br />
later collection, or separating the components of the<br />
sample by ‘spinning’ in a machine called a centrifuge.<br />
You can see that the role of a CTA takes us from the<br />
clinic to the laboratory.<br />
We take the chance of some quiet time in the<br />
afternoon to work on our ‘observational’ research<br />
studies. As their name suggests, ‘observational’ studies<br />
require the collection and inputting of patient data and,<br />
like much of our role, we do this task to help with the<br />
workload of the research nurses.<br />
Christine Clarke,<br />
<strong>Clinical</strong> trials assistant<br />
All of this work – the research clinic, the laboratory<br />
duties and the computer work – is vital to the research<br />
studies as it helps to build the bigger picture of what is happening to the patients. We enjoy our work,<br />
especially the contact with the patients, and fulfil an important role in advancing research studies and<br />
improving patient care in the NHS.<br />
@<strong>RBCH</strong>_<strong>Research</strong> www.Dorset<strong>Research</strong>.org 4
Focus on Patients:<br />
Shirley tells us how she became a patient in a clinical research trial<br />
and what is was like to take part<br />
Shirley, an active retired lady from Poole, was diagnosed with Chronic Lymphocytic Leukaemia and subsequently received<br />
treatment in a clinical trial at the Royal Bournemouth Hospital. In this interview Shirley describes how she came to join a<br />
clinical trial and her feelings about what it was like to be on a trial.<br />
How did you hear about taking part in research?<br />
I was playing tennis, representing Great Britain in Croatia. In the evening – we had to dress up one evening – I was<br />
trying to fix a necklace and I couldn’t get the clasp to fix so I looked in the mirror. I saw a bulge on my shoulder and I<br />
looked at the other shoulder and thought it was probably a muscle from tennis or something like that, but I thought I<br />
would tell the doctor when I got home. So I went to the doctor and he sent me off for tests and they came back with the<br />
result that I had Chronic Lymphocytic Leukaemia. This was completely new to me… and almost within days he sent me to<br />
Poole Hospital …and they said they were going to watch this situation for a while. (During my visits) I peered towards<br />
the computer and I saw these graphs. After some months I noted that the graph had gone up looking like Mount Everest<br />
and the doctor said, “We’re going to start treatment today, Shirley.”<br />
A few days prior to that a magazine (Hartley News) came through the post<br />
from Southampton University, addressed to my daughter who was there 25<br />
years ago. I looked at the cover and it said “Personalising cancer treatment:<br />
more control over cancer for millions of patients.” I thought, well I’ll open<br />
this… I read the article and I took this magazine to the consultant at Poole<br />
Hospital and said, “I do apologise but this has come through the door - am I<br />
any use on this trial? Am I appropriate?” The consultant said, “You go<br />
upstairs and have a blood test and I’ll ring up the hospital.” So I went upstairs<br />
and I remember that that day they filled 17 little vials with my blood which<br />
seemed an awful lot to me but anyway I went downstairs again and he said,<br />
“You fulfil all the criteria for coming on this trial, one of which is that we<br />
should not have started any treatment.” That was going to start that very<br />
afternoon – that was a narrow squeak wasn’t it! So he said, “I’m going to<br />
transfer you over to Bournemouth Hospital because of this treatment”<br />
What made you decide to take part?<br />
Shirley reads the magazine<br />
from Southampton University<br />
which led her to ask<br />
her doctor about<br />
clinical trials<br />
I could only think that I would benefit from it and perhaps other people<br />
would. There was never any doubt once I was given the opportunity. I didn’t<br />
waiver. Go for it girl because there’s nothing else!<br />
Did you feel you had sufficient information about the study to decide to take part?<br />
Without any question it’s there. I thought look I’m going to leave all the<br />
administration and the clinical details to them, I’ll just get on with my life. I’m<br />
never going to be able to absorb all their (information) in half an hour. It’s all<br />
there but it’s double-dutch to me…just sign up and go for it. Yes there was plenty<br />
of information.<br />
@<strong>RBCH</strong>_<strong>Research</strong> www.Dorset<strong>Research</strong>.org 5
What was it like to take part?<br />
It gave me confidence that there was a future. I was itching to get on with some treatment because I thought, “look this isn’t<br />
good”. I saw this chart which had got a sort of a ginger bread biscuit man and it had 29 little black blobs on it and I thought it<br />
was about time we were moving. It was a terrific relief because I knew something was going to be done.<br />
What made it such a good experience for you?<br />
The care. The help with so much heart, you know. Cared for like a new born baby really I was. Everything was answered…<br />
time was spent explaining things, doing things, keeping me informed and particular attention to detail. I mean every little<br />
thing has to be worked out and it was the confidence that they inspired in me…I got on with my life and took the pills. All I’m<br />
doing is taking 3 of these funny little pills a day. That’s all I have to do. I’m not the hero, they are the ones, the scientists,<br />
the doctors and the people doing the research - they are doing all the hard work.<br />
I do my gardening, I play tennis sometimes four, sometimes five times a week. I’ve got local grandchildren and I just get on<br />
with my life…I’ve just come back from Costa Rica with the Scientific Exploration Society.<br />
Did you manage to fit your clinic visits around your normal routine?<br />
Absolutely, because I was asked, “What would be convenient?” So I said I’d come to the hospital earlier on Tuesdays because<br />
I was not playing tennis that day.<br />
What would you say to other patients who might be considering taking part in a study?<br />
I would say keep a very optimistic attitude. I would say you can depend on the team to give you advice. You won’t be a<br />
specialist overnight, so really, if they recommend something to you and they say that you are eligible and fulfil the criteria, go<br />
for it!<br />
Is there anything else you would like to say?<br />
I feel really in wonderfully good health, touch wood, but I feel wonderfully well and full of energy…What else could I possibly<br />
say? Bournemouth hospital from top to bottom is full of incredible people and you see other people with worries – it puts you<br />
on your back foot when you see what other people go through and the worries that they have. The care from the moment<br />
you walk in…the Pathology department gets through 300 people a day! I cannot speak too highly of this place.<br />
Shirley would like to take this opportunity to thank all the staff at the hospital, including the ‘unseen’ research<br />
teams, for the care she has received. “You are wonderful.”<br />
How to join a clinical trial<br />
To find out if there is research you<br />
can participate in ask your hospital<br />
doctor / consultant or your GP<br />
@<strong>RBCH</strong>_<strong>Research</strong> www.Dorset<strong>Research</strong>.org 6
SPICE III Trial: encouraging signs for ‘light’<br />
sedation in critical care<br />
Sally Pitts, <strong>Research</strong> nurse in Critical Care, is managing an exciting new<br />
international clinical trial at Royal Bournemouth Hospital called the Sedation<br />
Practice in Intensive Care Evaluation trial (or ‘SPICE III’). The use of sedative<br />
(calming) drugs in intensive care is widespread. Currently, there is no<br />
agreement among doctors around the world about the best choice of drugs<br />
or the best way to manage sedation. The purpose of the SPICE III trial is to<br />
understand whether early ‘light’ sedation, where a patient is kept comfortable<br />
but responsive, might shorten the time on the ventilator (breathing machine),<br />
shorten the intensive care stay and result in less side effects. Sally Pitts says<br />
that the findings of this trial could have widespread influence on medical<br />
practice.<br />
Sally Pitts,<br />
<strong>Research</strong> nurse<br />
A phase IV Renal study in patients with<br />
‘treatment naïve’ HIV-1 has 150% recruitment<br />
Currently, there is no<br />
agreement among<br />
doctors around the<br />
world about the best<br />
choice of drugs or the<br />
best way to manage<br />
sedation.<br />
SPICE III Trial<br />
The Department of Sexual Health at Royal Bournemouth Hospital are involved<br />
in a clinical research study that looks at kidney function in HIV-1 patients<br />
treated with antiretroviral medication. The original target for recruitment was<br />
3 patients, however Joss Ablorde, <strong>Research</strong> nurse, has recruited 5 patients to<br />
the study. The trial is being undertaken at 30 sites across Europe including<br />
Spain, Belgium and Ireland. Specifically the study is looking into the effects<br />
of six antiretroviral medications in HIV-1 patients who have not previously<br />
received this type of treatment. Previous medications have been known to<br />
have a potentially detrimental effect to kidney function and the medications<br />
which these patients are receiving in this trial might not be so detrimental.<br />
Joss Ablorde says that it is too early in the study to discuss results, however<br />
the trial could enable clinicians to decide which medications to use in the<br />
future.<br />
@<strong>RBCH</strong>_<strong>Research</strong> www.Dorset<strong>Research</strong>.org 7
TOPAZ – 1 Trial: promising early signs in a clinical trial for<br />
Hepatitis C viral infection<br />
Emma Gunter, <strong>Research</strong> nurse at Bournemouth, is overseeing the running of an exciting new trial which aims to<br />
give one of the latest treatments to patients with Hepatitis C viral infection. The trial is being undertaken in 21<br />
countries.<br />
Infection with Hepatitis C virus (HCV) leads to a debilitating condition which can cause liver inflammation leading<br />
to fibrosis and then cirrhosis and eventually liver failure and/or liver cancer. This disease process can take time<br />
and patients can live with the infection for many years. Until recently treatments which sought to eliminate the<br />
virus showed varying efficacy and came with side effects which were difficult to tolerate. Emma and the liver<br />
nursing team took their expertise onto the streets of Bournemouth earlier in the year, where their suspicions<br />
about attitudes toward current HCV treatment were confirmed: they met people infected with HCV who believed<br />
that treatment could be ineffective and hard to tolerate.<br />
Emma Gunter,<br />
<strong>Research</strong> nurse<br />
The TOPAZ-1 trial is treating HCV patients with the latest ‘direct<br />
acting antiviral’ (DAA) medication and the early signs are very<br />
promising. The trial at the Royal Bournemouth Hospital has enrolled<br />
its target of 7 patients and they are receiving the DAA treatment for<br />
12 weeks, with a five year follow up. By week 12 of the treatment<br />
regimen the virus had been ‘undetected’ in all of our patients.<br />
Obviously it remains to be seen if this response is maintained and<br />
the efficacy of the drugs will only be known after the full five year<br />
follow-up period. Although the trial treatment is accompanied with<br />
side effects such as anaemia and fatigue, these are thought to be<br />
better tolerated that those caused by previous treatments, and good<br />
communication with patients can lead to open dialogue and support<br />
from nursing staff.<br />
According to Emma the early signs for the success of the new drug<br />
regimen for HCV infection are very promising, and it looks like there is a ‘seed change’ coming in terms of the<br />
treatment options of infected people. Staff at the Trust are particularly pleased with the results of the TOPAZ-1<br />
study, not least because the success of the trial and the energy and competency of the staff has been noted by<br />
Abbvie, the sponsor company, and they are hoping this will lead to similar trial opportunities in the hospital.<br />
@<strong>RBCH</strong>_<strong>Research</strong> www.Dorset<strong>Research</strong>.org 8
Bournemouth University <strong>Clinical</strong> <strong>Research</strong> Unit<br />
Bournemouth University <strong>Clinical</strong> <strong>Research</strong> Unit (BUCRU) is a model for supporting and<br />
conducting health related research in Dorset. It supports researchers in improving the quality,<br />
quantity and efficiency of research across local National Health Service (NHS) Trusts and<br />
Bournemouth University (BU). It does this by:<br />
helping researchers from the NHS and BU develop high quality applications for external<br />
research funding (including small grants) free of charge<br />
ongoing involvement in funded research projects<br />
<br />
<br />
<br />
a “pay-as-you-go” research consultation service for other projects<br />
developing its own research programme<br />
BUCRU can provide help with:<br />
Developing research questions and study design<br />
<br />
<br />
<br />
<br />
<br />
<br />
<br />
Quantitative and qualitative research methods<br />
Statistics, data management and data analysis<br />
Patient and public involvement in research<br />
Trial management<br />
Ethics, governance and other regulatory issues<br />
Linking University and NHS researchers<br />
BUCRU focuses on health research that has relevance to the NHS.<br />
The Unit is available to people working locally in the NHS and there<br />
are no restrictions on topic area or professional background of the<br />
researcher. BUCRU is partly funded by the National Institute for<br />
Health <strong>Research</strong> (NIHR) and incorporates the Dorset office of the<br />
NIHR <strong>Research</strong> Design Service South West (http://www.rdssw.nihr.ac.uk/).<br />
BUCRU includes researchers, clinicians, psychologists,<br />
methodologists, epidemiologists and statisticians, administrators and<br />
facilitators. BUCRU has a track record of collaborating with Royal<br />
Bournemouth and Christchurch Hospitals NHS Foundation trust,<br />
including on a project using an Arts for Health intervention to<br />
improve psychological well-being and confidence following a stroke.<br />
If you have an idea for a research project, or would like support<br />
please contact us to discuss further.<br />
Professor Peter<br />
Thomas, Director<br />
Professor Tamas<br />
Hickish, Director<br />
Contact us on:<br />
Email: BUCRU@bournemouth.ac.uk<br />
Twitter: @BU_CRU<br />
Tel: 01202 961939<br />
Website: www.bournemouth.ac.uk/bucru<br />
@<strong>RBCH</strong>_<strong>Research</strong> www.Dorset<strong>Research</strong>.org 9
Achievements in clinical trials in cancer at <strong>RBCH</strong><br />
Staff at the Oncology department at <strong>RBCH</strong> have been working very hard to advance the standing of their<br />
cancer trials, and two trials are especially worthy of mention.<br />
Bournemouth was the first UK site to recruit a patient to the Xilonix trial. This trial seeks to assess how<br />
effective Xilonix is in the treatment of patients with symptomatic colorectal cancer. Xilonix can be<br />
effective in blocking a substance that helps tumours grow and spread, and can also improve symptoms of<br />
muscle loss, fatigue, appetite loss and pain in patients with colorectal cancer. Preliminary evidence<br />
suggests that Xilonix treatment can improve the quality of life of patients, to the point that some patients<br />
have managed a return to a working life.<br />
Bournemouth was also the first site in the UK to recruit a patient to the AB12005 trial which seeks to<br />
evaluate the effectiveness and safety of an experimental drug, Masitinib, in advanced/metastatic<br />
pancreatic cancer. Masitinib is a new experimental drug which is currently under clinical development to<br />
treat patients with various conditions. In certain diseases, such as metastatic pancreatic cancer,<br />
particular enzymes do not function correctly. Masitinib is one of a type of drugs which can block the<br />
malfunctioning of these enzymes and can therefore help in treating such diseases.<br />
International <strong>Clinical</strong> Trials Day 20th May at the<br />
Royal Bournemouth Hospital<br />
By Lucy Thomas Data Manager, <strong>RBCH</strong><br />
On the 20 th May we celebrated International <strong>Clinical</strong> Trials Day. The day served as an excellent<br />
opportunity for us to tell the public and staff about all the wonderful things happening in research. We<br />
had the backing of the National Institute of Health <strong>Research</strong> ‘Ok to Ask’ campaign and managed to get<br />
Trust director involvement on the day. Bournemouth ECHO covered IT Director Peter Gill’s efforts on<br />
the CPEX bike, helping to raise awareness of the opportunities research offers.<br />
Throughout the day we had lots of people stopping, asking questions and participating in our mini<br />
sweet trial and smell test. We were really interested in attaining feedback and undertook a small voting<br />
survey on the day to find out how people rated both the importance of research and their<br />
understanding of research. “It<br />
was heart-warming to see how<br />
keen people are to support<br />
research.”<br />
The staff members that got<br />
involved also found the<br />
experience useful. Steven<br />
Williams, Project co-ordinator<br />
for division 6 said about the<br />
day, “It was wonderful to see<br />
everyone from across research<br />
come together to put on such<br />
a diverse and informative<br />
display” and described the day<br />
itself as, “an excellent<br />
opportunity to meet new<br />
people and showcase the work<br />
going on behind the scenes”.<br />
Lucy Thomas, Data manager, celebrates<br />
International <strong>Clinical</strong> Trials Day<br />
@<strong>RBCH</strong>_<strong>Research</strong> www.Dorset<strong>Research</strong>.org 10
Trials aim to show that physical exercise before surgery can aid<br />
recovery and rehabilitation<br />
Doctors are aware that surgery can place considerable stress on the body. In the past, patients undergoing<br />
surgery were referred to post-operative physiotherapy programmes to aid with their recovery and rehabilitation.<br />
However, three trails at the hospital are introducing tailored exercise programmes before the patients undergo<br />
surgery. The idea is that raising physical fitness levels in these patients can reduce the stress of surgery and<br />
improve rehabilitation.<br />
One of these trials, called ‘Empower’, is being managed at the hospital by Andy Bates, Senior research nurse. It<br />
is usual, before having major rectal surgery for cancer, to have a course of chemo-radiotherapy to reduce the<br />
tumour size and make it easier for the surgeon to remove it during the operation. This study aims to find out if a<br />
tailored exercise training programme after chemo-radiotherapy can improve physical fitness before undergoing<br />
major rectal surgery and, moreover, improve the quality of life and outcome after surgery.<br />
Patients who volunteer for this study, and are also selected for the exercise intervention group, undergo a Cardio<br />
Pulmonary Exercise test (CPET) to assess fitness before and after having chemo-radiotherapy. After this<br />
treatment, but before surgery, the CPET test results are used to design a carefully monitored programme of<br />
exercise using an exercise cycle in the hospital facilities. The subsequent training sessions aim to raise fitness<br />
levels prior to surgery.<br />
Andy Bates, Senior research nurse, says of the Empower study, “It is looking at the link between lifestyle and<br />
health, investigating the degree of control which people have over their medical outcome.” Empower, along with<br />
related studies in the hospital such as ‘Embrace’ and EDICT, opens up a long standing argument on the benefits<br />
of patient health and fitness and, broadly speaking, shows the importance that a ‘cultural’ change could have on<br />
public health.<br />
@<strong>RBCH</strong>_<strong>Research</strong> www.Dorset<strong>Research</strong>.org 11
Data Office workshop at Bournemouth University Business Centre<br />
The Data managers and Project co-ordinators make the <strong>Clinical</strong> Trials Data Office at the hospital a vibrant place of<br />
work. The office is always very active which means that various research issues arise which need to be properly<br />
monitored and addressed. So, periodically time is put aside for focussed discussions about work procedures and<br />
processes, and one such workshop was held in October in the Bournemouth University Executive Business Centre<br />
at Lansdowne.<br />
It is important to identify roles and responsibilities within the research directorate as well as expectations of each<br />
other, and this was how the meeting started. The next debate focussed on staff training and job description, not<br />
least because newly recruited Data managers have a lot to learn about their roles, and expectations of research<br />
can be different from the reality of the job. The team progressed to discuss research processes during the course<br />
of a study. A stakeholder mapping exercise was undertaken which provided the opportunity to identify internal and<br />
external stakeholders involved in successful collaborative research and the different pressures faced by those<br />
parties. Communication strategies were discussed and the emphasis on idea generation re-enforced the culture of<br />
innovation amongst the staff. Indeed, the nature of the talks demonstrated that the management centre was the<br />
most appropriate building to hold the workshop!<br />
Data managers and Project co-ordinators agreed that meetings like this are vital to their work. Rosey Bedford,<br />
Data manager said, “It was refreshing to step outside the office for a day and get all divisions’ data staff together<br />
as one big team. It’s a great opportunity to raise questions and share your thoughts.” Monica Serrano, Project coordinator<br />
said of the day, “It was very good to get to know everyone’s opinion about the different processes in<br />
research.”<br />
Workshop participants<br />
Front table from left: Monica Serrano, Emily Cross, Taslima Rabbi, Lucy Thomas, Rosey Bedford, Oliver Hopper<br />
Standing: Laura Purandare<br />
Rear table from left: Steve Williams, Tina Stoycheva, Gail Hann, Luke Vamplew, Alex Tealdi, Carla Dimitriu<br />
@<strong>RBCH</strong>_<strong>Research</strong> www.Dorset<strong>Research</strong>.org 12
Mary Smolen, <strong>Research</strong> nurse at the Parkin<br />
Suite, Christchurch Hospital, talks about her new<br />
appointment in Parkinson’s research<br />
“Christchurch<br />
Hospital is a very<br />
friendly place to work<br />
and although the<br />
<strong>Research</strong> Team<br />
is very small,<br />
everyone is helpful.”<br />
Mary Smolen<br />
I was recruited to the research team for Parkinson’s Disease in July, after ten years<br />
as an advisor in Occupational Health. It has been a very steep learning curve for<br />
me, but I am enjoying the challenge and getting to understand so much about the<br />
condition, and about research and clinical trials. Christchurch Hospital is a very<br />
friendly place to work and although the <strong>Research</strong> Team is very small, everyone is<br />
helpful.<br />
I am currently trying to keep up with the caseload of trials already in place, and<br />
planning for a new trial looking at the potential role of statins as a neuroprotective<br />
agent for patients with Parkinson’s Disease. I also recently attended training at<br />
Moorgreen Hospital to enable me to become a Rater for dementia research in the<br />
future, which looks very interesting. I have also recently completed an online exam<br />
with the Movement Disorders Society in the United States which was challenging but<br />
really worth the effort.<br />
I suspect it will take a few more months yet before I really feel I am on top of the<br />
job. Emma Gunter has been an invaluable support in handing over and showing me<br />
the ropes, so many thanks are due to her.<br />
We welcome Katie Molloy, <strong>Research</strong> nurse in Critical<br />
Care, Anaesthetics & Emergency Medicine at <strong>RBCH</strong><br />
I have had 8 years wonderful experience working in Intensive Care and was ready<br />
for a new challenge. I have always loved research and found it to be at the heart of<br />
everything we as nurses do. So to be part of the <strong>Research</strong> Team at the Royal<br />
Bournemouth Hospital is a real honour, that we are making a real difference and<br />
able to change practice so that patients and their relatives experience the very best,<br />
most up to date health care.<br />
As part of the <strong>Research</strong> Team for Critical Care, Emergency Medicine and<br />
Anaesthetics, I am able to support and care for patients in a different and often<br />
challenging environment, keeping them and their families at the centre of everything<br />
we do. There is so much to learn in my new role, and have found the support from<br />
other team members invaluable.<br />
@<strong>RBCH</strong>_<strong>Research</strong> www.Dorset<strong>Research</strong>.org 13
Education in Focus: My experience of a part-time Master’s degree<br />
in <strong>Clinical</strong> <strong>Research</strong><br />
By Hannah Dewhurst, Gastroenterology research nurse, <strong>RBCH</strong><br />
Since I qualified as a nurse in 2007 I had an interest in clinical research, and this culminated in 2011 with my appointment<br />
as a Gastroenterology research nurse. I now maintain responsibility for a range of clinical trials focussed on Inflammatory<br />
Bowel Disease, a long-term condition that involves inflammation of the gut.<br />
In 2013 I realised that the part time Masters course in <strong>Clinical</strong> <strong>Research</strong> at<br />
Southampton University was applicable to my work and the design of the course<br />
enabled me to continue with my clinical practice. So I registered to study!<br />
The programme at Southampton contains a range of taught modules which have<br />
taught me a variety of new research skills, such as the use of databases to review<br />
quantitative (number) data, interview skills and the impact of research on the NHS.<br />
However what has really caught my attention has been the dissertation which has<br />
required me to undertake my own research study. So, for the last year I have been<br />
researching how living with ulcerative colitis can affect personal relationships.<br />
(Ulcerative colitis is a condition of inflammatory bowel disease). In order to get a<br />
good understanding of how having Ulcerative colitis affects relationships, patients and<br />
Hannah Dewhurst,<br />
their partners that agree to<br />
take part are being<br />
<strong>Research</strong> nurse<br />
interviewed separately on a<br />
one to one basis. These<br />
interviews are then analysed<br />
to see if there are any common feelings or themes among the<br />
participants. I am very enthusiastic about this study because<br />
there is currently a lack of information we can provide patients<br />
on this topic and hopefully I can address this situation. The<br />
ultimate goal is to publish my findings.<br />
Needless to say, I have found the course to be very worthwhile<br />
and vital to the development of my research skills.<br />
This newsletter has been produced by the <strong>Research</strong> and Innovation<br />
Directorate, Royal Bournemouth and Christchurch Hospital.<br />
Any feedback about the contents of this newsletter would be welcome.<br />
Please address your messages to Neal Beamish at<br />
neal.beamish@rbch.nhs.uk<br />
@<strong>RBCH</strong>_<strong>Research</strong> www.Dorset<strong>Research</strong>.org 14
Latest events and courses<br />
<strong>RBCH</strong> <strong>Research</strong> Forum.<br />
The next <strong>Research</strong> Forum will be held in December 2015. Participants will be notified of the details in due course.<br />
‘Improving Healthcare through <strong>Clinical</strong> <strong>Research</strong>’ – Free online course to be launched on 2 nd November 2015.<br />
The course has been developed by NIHR <strong>Clinical</strong> <strong>Research</strong> Network in partnership with the University of Leeds. The<br />
course is available to everyone. Further details are available at https://www.futurelearn.com/courses/clinical-research/1<br />
PharmaTimes International <strong>Clinical</strong> <strong>Research</strong>er Awards launched.<br />
The awards are designed to recognise and reward the talent and passion of industry and academic researchers. <strong>Clinical</strong><br />
researchers at all levels of career can enter the competition. The awards include the NIHR-sponsored ‘NHS <strong>Clinical</strong><br />
<strong>Research</strong> Site’ category. Further details are available at https://www.pharmatimes.com/INTCR<br />
HSJ <strong>Clinical</strong> <strong>Research</strong> Impact Award 2015 shortlist revealed.<br />
The full list can be found at https://www.crn.nihr.ac.uk/wessex/. The finalists will be invited to the HSJ offices in<br />
London to give a short presentation to the judging panel in October, and the winner will be announced in November.<br />
Forthcoming Good <strong>Clinical</strong> Practice training courses for the Wessex region.<br />
For full information and details on how to join see: https//www.crn.nihr.ac.uk/Wessex/about/training/.<br />
Date<br />
Location<br />
20 th October Royal Hampshire County Hospital, Winchester<br />
26 th October Southampton General Hospital, Southampton<br />
17 th November Southampton General Hospital, Southampton<br />
23 rd November Basingstoke and North Hampshire Hospital, Basingstoke<br />
26 th November Bournemouth University, Bournemouth<br />
<strong>Research</strong> word search<br />
F H X L S D B C C F I M N D B<br />
E N P N O O R D F N A O U K W<br />
A T R A X C D X D O I P J O Y<br />
S K E U R P O E T T M X I R P<br />
I R B L X T M T A Q D C K Z U<br />
B O F A L N I S O T L K H K J<br />
I S J N I Q I C B R D R Y Y F<br />
L N R T T M Q F I V P X S H D<br />
I O Y N O P E W O P K L J R E<br />
T P Q D P U B L I C A T I O N<br />
Y S N T L E W K R I J N W X Z<br />
D A O H X I I A R S L V T D P<br />
R A O Z I F A T U U U B S W C<br />
N F W S Y M W V S E H I H N B<br />
H C R A E S E R T A O R X R P<br />
FEASIBILITY - INDEMNITY - PARTICIPANT - PROTOCOL - PUBLICATION<br />
RANDOMISATION - RESEARCH - SPONSOR - TRIALS<br />
@<strong>RBCH</strong>_<strong>Research</strong> www.Dorset<strong>Research</strong>.org 15
@<strong>RBCH</strong>_<strong>Research</strong><br />
www.Dorset<strong>Research</strong>.org<br />
The Royal Bournemouth and Christchurch Hospital NHS Foundation Trust<br />
<strong>Research</strong> & Innovation Directorate<br />
5 th Floor, R501, @<strong>RBCH</strong>_<strong>Research</strong> Royal London House, Christchurch Road, www.Dorset<strong>Research</strong>.org Bournemouth, BH1 3LT 16