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Clinical Research Today - Winter (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

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