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W A R W I C K S H I R E
WORCESTERSHIRE
H E R E F O R D S H I R E
W E S T M I D L A N D S S O U T H P R I M A RY C A R E R E S E A R C H N E W S L E T T E R
PARTICIPATE
VOLUME NO 15
AUTUMN 2014
Tangible and Intangible Benefits
from Research Activity
POINTS OF
INTEREST
Working to increase the amount of high quality commercial clinical research taking place in a
primary care setting is a national priority. This is seen as being important to the growth and
success of Life Sciences in the UK, and hence to the economy as a whole. Locally, we are aiming
to increase both the number of practices involved in recruitment and also the number and
scope of studies that are available for participation.
Current Study –
PSM COPD
New Study –
4 Fold Asthma
Local Research –
Research Awareness Morning
Local News –
One Patient’s Story
CONTENTS
Current Studies
Commercial Studies
2-4
5
New Studies
6-7
Study Update
8 -9
Raising Research Awareness
10-11
Local Research &Training
12-13
Local News
14-15
Continuing Professional Development
16
Ways of achieving this goal are being informed by a recent pilot run by the Clinical Research
Network (CRN) in West Midlands South. As part of the pilot new commercial studies are
reviewed by the CRN, after which they are sent out to GP practices for their consideration;
if interested, practices were then assisted with the paperwork and supported through the
whole application process. With our guidance, so far 80% of the practices that expressed an
interest have been chosen to run one or more commercial studies.
It is not always easy to measure the softer advantages of taking part in research, commercial
or otherwise, or to quantify the additional health benefits this can confer on an individual,
without looking at this from a personal perspective. In this publication, we hear from two
patients about their experience of ‘what has research ever done for them?’, why they got
involved and the unexpected additional assistance that followed their participation.
In this edition we feature articles on:
•a randomised controlled trial of a telephone-based self-management intervention for
patients with mild dyspnoea compared to usual care (page 4)
•a study to find out if advising patients to temporarily quadruple their inhaled corticosteroid
treatment when asthma symptoms start to deteriorate may help to prevent a more serious
asthma attack from happening (page 7)
•following up results on ESTEEM, looking at the rising demand for general practice
appointments; in an attempt to deal with this, many practices introduced systems of
telephone triage when patients are phoned by a doctor or nurse (page 9)
•‘Why I Became Involved in Clinical Research: a Patient’s Tale’ examining one person’s
experience of the benefits of engagement in research (page 11)
If you would like to contribute to Participate or for further information please contact
Jenny Oskiera, email: j.oskiera@warwick.ac.uk
Current Studies
CANDID – CANcer DIagnosis Decision rules
CANDID is a national study with
practices participating from across
the country, supported by the
relevant local Clinical Research
Network (CRN). This study is
about finding out which symptoms
and examination findings are most
accurate for early identification of
lung and colorectal cancer.
Study update
Recruitment for CANDID in West
Midlands south is underway with a total
of 23 patients recruited in our locality
to date. Five practices within our area
are currently recruiting patients and we
now have a total of 16 practices open
to recruitment. A further ten practices
are in the set-up stage and practice
expressions of interest in the study are
still being received.
Service support costs have almost
doubled per patient recruited, in order
to successfully recruit more patients in
the study time frame.
We are able to supply practices
with a range of hints and tips, study
posters etc., to support recruitment.
Practices may invite patients with a
broad spectrum of lung or bowel
symptoms, which is important for
developing future guidance that can
distinguish between people at very low
risk versus increased risk of cancer.
How can we help?
We have our research nurse Susan
Zhao working with us to offer
additional support to practices during
the start of patient recruitment.
Materials and support for recruiting
patients via monthly retrospective
searches (selecting ten eligible patients
who consulted in the previous week)
is available to practices.
Our target for case identification is
1-2 participants per month per clinician
to enable us to make a significant
contribution towards the national target
and we will be updating practices
regularly to monitor progress in this
important study.
Your local team is here to support
you and answer any questions
you may have. Please contact Julia
Roscoe, email: j.roscoe@warwick.ac.uk
or Jenny Lee, email: jennifer.lee@
warwick.ac.uk if you have any queries
about the CANDID study.
Helicobacter Eradication Aspirin Trial
Helicobacter eradication to prevent ulcer
bleeding in aspirin users: a large simple
randomised controlled trial
Principal investigator Birmingham region:
Prof Richard Hobbs.
Locations: ~400 GP practices in Birmingham
and Black Country, Worcestershire, Coventry
and Warwickshire, Shropshire, Staffordshire,
Herefordshire, Stoke, Telford and Wrekin,
Wolverhampton, Sussex & Surrey, Nottingham,
Durham, Southampton, and Oxford.
Enrolment Period: 2012 – June 2014
Participants: Men and women aged 60+, infected
with H. pylori, who are using aspirin <326mg daily
Other Information: This trial has been preceded
by a successful pilot study, funded by the MRC.
Practices will be reimbursed for their time.
Use of aspirin for cardiovascular prophylaxis is widespread and
increasing. The main hazard is ulcer bleeding. This is usually
associated with H. pylori infection. It is important to determine
whether this can be reduced or prevented by H. pylori eradication.
The trial hypothesis is that aspirin does not itself cause peptic
ulcers, but that it promotes bleeding of ulcers caused by H. pylori.
Given the scale of aspirin use, its continuing increase and its
contribution to ulcer bleeding, how to deal with this problem is
arguably the most important question with regard to current
iatrogenic medicine.
Intervention and Clinic: Suitable patients will be identified by their
surgery, using an automated search, and then asked to attend an
appointment with a University Research Nurse or Practice Nurse
(relevant training will be provided) to consent to the trial and take a
H. pylori breath test. Those with a positive result will be randomised
to receive a one week course of either eradication treatment or
placebo, supplied by the trial centre. No follow-up visits for the
patients are required, but any hospital admissions for ulcer bleeding
will be recorded over a period of 2-3 years by the trial centre.
Further information: If you would like to find out more, please contact the trial manager for your region, Rachel Iles,
phone: 0121 414 2691, email: r.iles@bham.ac.uk
Page 2
Current Studies
FADES
(Feeding and
Autoimmunity
in Down’s Syndrome Evaluation Study)
FADES is an exciting new study following babies with Down’s Syndrome from birth
to see how events in their early lives may influence certain autoimmune conditions
which children with Down’s Syndrome are at increased risk of developing. The study
is being undertaken at the University of Bristol but will be recruiting babies under the
age of 8 months from across the UK and following them until they are 5 years old.
Autoimmunity and Down’s Syndrome
Most babies and children with Down’s Syndrome will not develop autoimmune
conditions but compared to their peers they are more at risk of developing
conditions where the body reacts against its own cells, including conditions such as
thyroid problems, diabetes and coeliac disease (which causes problems with the gut).
If we are able to identify factors that increase the risk of these conditions developing
then hopefully in the future we will be able to lower this risk.
What does the study involve?
Thanks to the help and support of the Down’s Syndrome Association, Down’s
Syndrome Scotland and Down’s Syndrome Medical Interest Group the study will be
advertised to new parents. If they are interested in taking part the majority of the
study can be done at home and would not require additional appointments. The
study includes detailed questionnaires which can be completed online or on paper.
These ask about their baby’s feeding, the issues that families have with feeding and
what support they receive. From this study we may be able to help families in the
future by identifying the issues with feeding, dispelling myths and identifying where
support could be improved. The questionnaires will also ask about medical conditions,
infections and a little bit about family history.
The study will also involve collecting samples including some cells, collected
by rubbing the inside of the baby’s cheek with a soft swab, these will be used to look
at the baby’s genes (little packets of information within the cells) especially those we
know are associated with autoimmune conditions. We will also collect poo samples
to look at the natural bacteria that live in the gut which is considered to have an
effect on the development of immunity. Urine samples will be collected to see if there
are any signs of any of the babies developing diabetes although we expect that very
few will develop diabetes during the 5 years that they are in the study. We will also
collect small blood samples from heel pricks which will be used to see if there are any
antibodies associated with autoimmune conditions.
A little about the research team
The study is being led by Professor Julian Hamilton-Shield, Dr Kathleen Gillespie and
Dr Georgina Williams. Professor Hamilton-Shield and Dr Gillespie both have a long
standing interest in children with Down’s Syndrome and have previously published
articles on Down’s Syndrome and Diabetes. Dr Georgina Willliams is a paediatrician
and this study will form part of her Clinical PhD in Child Health.
The study is sponsored by the University of Bristol and is funded by the National
Institute of Health Research, Bristol Biomedical Research Unit in Nutrition.
If you are interested in finding out more about this study please contact us at
fades-study@bristol.ac.uk or telephone 0117 342 1756. You can also visit our
webpage at www.bristolnutritionbru.org.uk and follow the FADES link on the
left hand side of the page which will enable you to download a participant
information sheet.
The Lipos Study:
Liraglutide in PCOS
Principal Investigator:
Dr Harpal Randeva
Location: University Hospital
Coventry and Warwickshire,
with recruitment from UHCW,
George Eliot and Warwick Hospitals
as well as NHS Community Health
Clinics and GP practices within
Coventry and Warwickshire.
Enrolment Period:
October 2013 - December 2014
Participants: Women with PCOS
Study details
The Lipos (Liraglutide
in PCOS) study has
recently begun
recruitment in the
Coventry and
Warwickshire area.
Lipos is a prospective,
randomised, double
blind, placebo controlled study investigating
the use of Liraglutide alongside Metformin
SR to improve fertility and symptom control
in women diagnosed with Polycystic Ovary
Syndrome. The study is funded by
Novonordisk, sponsored by the University
of Warwick and hosted by UHCW.
The study aims to establish whether the
combined use of Metformin SR and
Liraglutide will improve menstrual regularity
amongst women diagnosed with PCOS.
Secondary outcome measures include
improvements in other symptoms and
effects of the condition including hirsutism,
metabolic syndrome and difficulty
controlling weight and acne.
We aim to enrol 106 participants,
who will all receive Metformin SR, with
randomisation leading to 50% receiving
Liraglutide and 50% receiving a placebo.
Participants will need to attend UHCW on
a number of occasions (17) over a period
of 62 weeks, with multiple data being
collected by study clinicians at each visit to
measure a wide range of metabolic and
cardiovascular parameters. Potential
participants should be over 18 and
diagnosed with PCOS.
If you would like to be involved, or
for more information, please contact
Dr Randeva email: harpal.randeva@
warwick.ac.uk or the study nurse, Kay
Webb, email: kathryn.webb@uhcw.nhs.uk
Page 3
Current Studies
Anticoagulation Therapy in SELECTeD Cancer Patients
at Risk of Recurrence of Venous Thromboembolism
A study for cancer patients with
venous thromboembolism
Treatment
•Dalteparin (Fragmin®, Pfizer), a low molecular weight heparin,
the only licensed anticoagulant in the UK for the extended
treatment and prevention of recurrence of VTE in cancer patients.
•Rivaroxaban (Xarelto®, Bayer), an oral direct Factor Xa inhibitor, licensed for the
treatment of DVT and the prevention of recurrence of DVT and PE in adult patients.
select-d is a prospective, randomised,
open label, multicentre pilot study
comparing dalteparin vs. rivoraxaban
with a second placebo-controlled
randomisation comparing the duration
of anticoagulation therapy (6 months vs.
12 months treatment) in patients with deep
vein thrombosis [DVT] who are residual
vein thrombosis [RVT] positive (+ve).
All patients presenting with pulmonary
embolism [PE] will be invited to
participate in the second randomisation.
Many eligible patients will present to
their GP with suspected VTE; please refer
as usual practice and inform patients
of the possibility of the select-d trial.
Professor Annie Young
Chief Investigator:
Sponsor:
University of Warwick
Funder:
Educational grant from Bayer plc (Investigator Initiated Study)
Sites:
60 sites
Recruitment target: 530 patients
Recruitment period: September 2013 – September 2015
Eligible patients:Aged > 18 with active cancer and a primary presentation of
an objectively confirmed VTE; symptomatic lower extremity
proximal DVT or symptomatic or incidental PE
Update
It has been one year since we welcomed our first site (Queens Hospital, Burton
upon Trent) to start recruiting into select-d, and since then a further 34 sites have
followed, including the following sites in the Midlands: Hereford County Hospital,
Kidderminster Hospital, New Cross Hospital (Wolverhampton), Royal Shrewsbury
Hospital, Russells Hall Hospital (Dudley), and University Hospital Coventry.
September 2014 was marked with celebrations for the recruitment of the 100th
select-d patient, a huge thank you to everyone involved for making this happen,
and congratulations to Hereford County Hospital who recruited the 100th patient.
Many thanks also go to Russells Hall Hospital in Dudley, who are currently the
highest recruiting select-d site in the Midlands.
For further information please contact Jenny Phillips (Trial Coordinator),
phone: 024 7657 3315 or email: j.phillips@warwick.ac.uk
Patient Self-Management in primary care patients with
Chronic Obstructive Pulmonary Disease (PSM-COPD)
A randomised controlled trial of a telephone-based self-management intervention for patients with mild dyspnoea
The PSM-COPD trial is a NIHR funded
study that aims to assess the effectiveness
of a telephone-based self-management
intervention as a treatment for patients
with COPD who have mild dyspnoea
compared to usual care. Patients will be
recruited across four sites (Birmingham,
Keele, Manchester, and Oxford). Eligible
patients will be randomised to receive
the telephone-based self-management
care that is delivered by a study research
nurse or they will be randomised to
usual care. The telephone calls will cover
the areas of: smoking cessation advice;
encouragement to become physically
active; support for medication adherence;
and action planning. At present, we are
undertaking a feasibility study along with
focus groups to assess the acceptability
Page 4
of the intervention. The main trial began
in January 2014.
Therefore, we would like to invite
interested GP practices to contact us
to take part in our trial. The additional
workload, if you decide to take part,
is minimal. We will ask you to generate
a list of patients who have mild dyspnoea
(MRC grades 1 and 2) and mail a study
invitation letter. Those patients wishing
to take part in our study will be asked
to return a reply slip or contact the
University of Birmingham research team.
Practices will need to provide clinic
space so our research nurse can confirm
eligibility and take consent from patients.
We will pay a set-up fee and reimburse
practices for additional activities
completed as part of our trial.
Principal Investigator: Professor Kate Jolly
If your practice would like to take
part or would like more information,
please contact: Dr Manbinder Sidhu,
Research Fellow, phone: 0121 414
7895 email: m.s.sidhu@bham.ac.uk
Commercial Studies
1. What is an Industry Research Site?
Health on a Cork Board by artur84 @ FreeDigitalPhotos.net
Any GP practice acting as a host for
industry clinical trials where a nominated
GP acts as principal investigator (PI) during
the trial, liaising directly with the
pharmaceutical company to recruit patients
from their list, and to deliver the
intervention according to the research
protocol. Practice staff undertake the set-up
and running of the trial.
What is involved?
The Clinical Research Network (CRN)
sends summaries of industry clinical trials
adopted onto the NHS National Institute
of Health Research (NIHR) Portfolio.
You will be asked to review the summary
and, without commitment, if you would
like further information, complete and
return the Expression of Interest (EoI)
within the specified time. If your EoI is
accepted, you will liaise with the
pharmaceutical company directly.
It is essential that anyone involved in
these clinical trials is Good Clinical Practice
(GCP) trained.
What are the benefits?
•Patients have access to treatments not
routinely be available to them
•You can contribute to the development
of treatments which may improve patient
outcomes
•Delivering industry clinical trials can
provide a significant additional income
stream for your practice
•Patients will be reimbursed for any
related travel costs
Your local CRN Primary Care industry
contact can provide guidance on accessing
GCP training, help to identify potential
studies for your practice and provide
support on research management and
governance issues.
2. What is a GP Participant
Identification Centre? (PIC)
A PIC is any organisation responsible for
identifying and informing potential patients
about a trial taking place in another
organisation.
What is involved?
The CRN will send details of an ethically
approved co-adopted industry clinical trial
taking place in a local research site. A search
of your clinical system will identify potentially
eligible patients – the CRN can assist with
this – prior to GP screening of the list.
A patient invite, using your GP letterhead
will be sent to potentially eligible patients to
inform them of a clinical trial taking place
which may be of interest to them. Patients
need to contact the team at the research
site for further information if they wish to
be involved.
A PIC is not:
7A research site
7Responsible for subsequent assessment
of potential patients and their possible
recruitment into the trial
7Responsible for the delivery of procedures
specified in the research protocol
What are the benefits?
•Patients have access to treatments not
routinely available and will have any travel
costs reimbursed
•Acting as PIC site will provides an additional
practice income stream
GP practices acting as a PIC site will be paid
per trial to cover stationery and postage for
patient invite letters, for the time taken to
search and screen the patient list and, after
patient consent, for providing a brief medical
history. In addition a further reimbursement
will be made for any patient randomised
into a trial.
If you would like further information, please contact Lauren Thakrar, Assistant RM&G Project Manager email: lauren.thakrar@uhcw.nhs.uk
Working with Industry: a Commercial Pilot Scheme
Supporting high-quality commercial clinical
research across all therapeutic areas is a
high priority for the Clinical Research
Network. In primary care we are aiming to
increase the number of studies that we can
offer our practices and also the number of
practices recruiting to commercial studies.
At the start of 2014, with the aid of
dedicated support from members of the
CRN team, a pilot scheme was started,
initially involving five practices that had all
previously expressed an interest in taking on
commercial work and already had a history
of recruiting well to several research studies.
Leading this work is Lauren Thakrar who
has worked closely with the primary care
team to support practices.
Next steps
Meetings were held at all the practices to
discuss in detail:
•Expectations of commercial studies
•What the practices needed to
consider and put in place at the
start of the process.
After this, information on demographics
and previous study recruitment was
collated, and all the staff involved had to
undertake Good Clinical Practice training.
A commercial trials workshop was also
offered to participating practices.
CRN assistance
New commercial studies were reviewed
by the delivery team to ensure that the
sponsors would accept “green shoot sites”
and then a study would be sent out to the
practices for consideration.
Lauren Thakrar helped with the completion
of Expression of Interest forms, maximising
the chances of a practice being chosen for the
study. To date 20 studies have been offered
to our five surgeries new to commercial
studies with four of these sites chosen for
three new studies – a great success.
We aim to expand the pilot scheme to
include other interested GP practises, so if
you would like to explore this in more detail,
please contact Lauren Thakrar, Assistant
RM&G Project Manager email: lauren.
thakrar@uhcw.nhs.uk phone: 01564 711600
Page 5
Benefits Word by Stuart Miles @ FreeDigitalPhotos.net
Working with Pharmaceutical Companies
to Deliver Industry Interventional Clinical Trials
New Studies
TASMINH4:
Telemonitoring And/or
Self-Monitoring IN Hypertension
What is the TASMINH4 trial?
This research is a patient randomised controlled trial to
evaluate the management of hypertension in primary care
using self-monitored blood pressure values, with or without
tele-monitoring, compared to that using clinic monitored
blood pressure. It will also consider the effect of selfmonitoring and tele-monitoring on adherence, side effects,
quality of life, adverse events and costs. This study is being run
by the Universities of Birmingham and Oxford underpinning
key work from previous blood pressure surveys and
TASMINH trials (TASMINH, TASMINH2, TASMIN-SR).
We are looking to recruit approximately 110
practices nationally from now until August 2015
What is involved for practices?
•Practices will identify potential participants (patients with
coded hypertension with a BP ≥140 (systolic) and/or
90 (diastolic) mmHg)
•Room hire for holding baseline and follow-up clinics
(6 and 12 months)
•Mail study invitation letters to trial participants
• Full training will be provided
Practices undertaking this study will be eligible to receive
payment via service support costs to cover the time spent
recruiting patients.
If your practice would like to take part or would like
more information please contact: Mrs Siobhan Milner,
Project Officer, phone: 0121 414 2954, fax: 0121 414 8616,
email: s.l.milner@bham.ac.uk
FAST
(Febuxostat
versus Allopurinol
Streamlined Trial)
Page 6
New Studies
Four-Fold Asthma (FAST) Study
– can a new approach to managing asthma
help to prevent a bad attack?
Now recruiting locally
Recruitment for Four-Fold Asthma is about
to start in West Midlands south and we
are looking for additional GP practices to
recruit 10 patients per practice.
GPs or nurses are asked to identify
patients who have asthma, use an inhaled
steroid or combination inhaler and have
had at least one asthma attack requiring
prednisolone tablets in the last 12 months.
Image courtesy of marin ID-100112438 @ FreeDigitalPhotos.net
In a national
study led
by Dr Tim
Harrison at
the University
of Nottingham and funded by the National
Institute for Health Research, researchers
are inviting people with asthma to
participate in a clinical trial exploring
whether a new approach to managing
asthma could prevent an attack.
The researchers aim to find out if
advising patients to temporarily quadruple
their inhaled corticosteroid treatment
when asthma symptoms start to
deteriorate may help to prevent a more
serious asthma attack from happening.
If found to be effective, this advice could
be incorporated into standard asthma
management guidelines.
Trial intervention
Enrolled participants will be randomised
and taught how to use one of two asthma
action plans that will contain advice on how
to manage asthma. One of the action plans
will contain standard advice on how to
manage asthma whilst the other will include
information on the new approach.
Participants will then be invited to attend
at least two follow-up visits at their own GP
practice over the next 12 months with an
additional visit if their asthma control
deteriorates.This is a multi-centre pragmatic,
randomised, normal care-controlled clinical
trial, where the primary outcome is 'time to
first asthma exacerbation', defined as: the
need for systemic corticosteroids and/or
unscheduled health care consultation for
asthma (i.e. reaching zone 3 or 4 of the
Asthma UK self-management plan).
If your practice would like to take part or like more information, please contact Julia Roscoe, CRN Research Facilitator,
email: j.roscoe@warwick.ac.uk or Linda Field, CRN Research Nurse, email: linda.field@warwick.ac.uk
FAST is a major multicentre clinical trial
evaluating long term cardiovascular safety of
febuxostat in comparison with allopurinol
in patients with chronic symptomatic
hyperuricaemia (gout). This trial is
sponsored by the University of Dundee, and
is part of the NIHR portfolio of studies.
Suitable patients are identified in primary
care by their GPs; those that respond
favourably attend an appointment with our
research nurse to be fully informed and
consented and enter a pre-randomised
phase where their urate levels are optimised
on allopurinol. Once optimised, patients will
be randomised to either allopurinol or
febuxostat, and are followed up every 2
months by our research nurses. Urate levels
will be checked annually as part of the trial.
Participating practices will receive a £500
fee for completing the database search, in
addition to £5 per month per patient for
follow-up. All medication will be prescribed
by the trial sponsor, and so there will be no
prescribing costs to GP practices.
Why participate?
•Research involvement at very little time
cost to you
•Opportunity for developing research in
your practice (GCP training available)
•Pragmatic simple trial to answer
important questions
•Practice will be reimbursed:
– for setting up the trial and inviting
potential participants
– a monthly fee per patient
– for room hire in your practice
If your practice would be interested in finding out more, then please get in touch. The Trial Coordinator is Jen Dumbleton,
contact email: jennifer.dumbleton@nottingham.ac.uk phone: 0115 823 1053. Further details can also be found on the trial website:
www.fast-study.co.uk
Page 7
Study Update
GNOME:
A double-blind randomised
placebo-controlled trial of
topical nasal steroids in 4-11
year old children with
persistent bilateral Otitis
Media with Effusion
(OME) in primary care
Otitis media with effusion is a
common condition of childhood, but
there are is some confusion about
treatment, particularly from within
primary care settings. This trial sought
to find out if topical nasal steroids
was an effective treatment amongst
affected children aged 4-11 years.
217 children were recruited to
the trial from general practices
around the UK, including the West
Midlands. They were randomised to
either a steroid (mometasone
furoate 50 µg) or placebo spray
given once a day for three months.
The percentage of children who
were cured after three months was
similar between the placebo and
intervention groups. Diaries of
symptoms also showed no
difference. The authors concluded
that steroids were unlikely to be
effective against otitis media. However,
a high proportion of cases (>50%)
resolved naturally within 1-3 months.
The original findings were reported
in the British Medical Journal:
Williamson, Ian, Benge, Sarah,
Barton, Sheila, Petrou, Stavros, Letley,
Louise, Fasey, Nicky, Haggard, Mark
and Little, Paul (2009) Topical
intranasal corticosteroids in 4-11
year old children with persistent
bilateral otitis media with effusion in
primary care: double blind
randomised placebo controlled trial.
British Medical Journal, 339, (b4984),
1-8. (doi:10.1136/bmj.b4984).
Page 8
Study Update
Primary care telephone triage does not
save money or reduce practice workload
Demand for general practice
appointments is rising rapidly,
and in an attempt to deal with this,
many practices have introduced
systems of telephone triage.
Patients are phoned by a doctor
or nurse who either manages the
problem on the phone, or agrees
with the patient whether and how
urgently they need to be seen.
A new large study, published in The
Lancet on 4 August 2014 and funded by
the UK National Institute for Health
Research (NIHR), has investigated the
potential value of telephone triage for
patients and for the NHS. It concluded that
patients who receive a telephone call-back
from a doctor or a nurse following their
request for a same-day consultation with a
GP are more likely to require further
support or advice when compared to
patients who see a doctor in person.
The research concluded that ‘telephone
triage’ systems did not reduce overall
practice workload.
These findings, from a team led by the
University of Exeter Medical School, are
important as telephone triage is becoming
increasingly popular in general practice as a
response to managing patient care. Overall,
the ESTEEM study – one of the first robust
investigations in this field – concluded that
telephone triage by a doctor or a nurse
only results in a redistribution of practice
workload, not a reduction. It also discovered
that telephone triage is no more expensive
or cheaper than care provided via
traditional face-to-face appointments.
The ESTEEM trial involved more than
20,000 patients across 42 doctor surgeries
in England. Practices were randomly
assigned to continue delivering care in their
usual way, or to change to a system using a
doctor or nurse to call the patient back to
offer help or advice following the patient’s
request for a consultation with a GP ‘that
same day’ in the practice. The research
lasted for around 2-3 months in each
practice. The researchers examined patients’
consulting patterns in the 28 days following
their initial same-day consultation request.
Practices offering triage by a GP saw an
increase of 33% in the total number of
patient contacts amongst patients who
had requested a same-day appointment
compared to patients seen under usual
care. For practices offering nurse triage
the increase in the total number of
contacts was 48%.
The researchers identified that there was
a redistribution of GP workload associated
with introducing triage. In practices
providing GP triage, GPs had 39% fewer
face-to-face consultations, whilst in practices
providing nurse triage, GPs had 16% fewer
face-to-face consultations. Thus introducing
GP triage was associated with a
redistribution of GP workload from face-to
face consultations to telephone
consultations, and introducing nurse triage
was associated with a redistribution of
workload from doctors to nurses.
Around half of the patients seen in ‘usual
care’ had no further contact with the
health care system in the 28 days following
their initial consultation. However, 75% of
patients seen in practices operating a GP
telephone triage systems did make further
contact, and where nurse telephone triage
was in operation, 88% of patients made
further contact.
Overall, patients reported a good
experience of care provided by the
study practices, although patients from
practices providing nurse triage were
slightly less satisfied than those from
the other practices.
Lead author Professor John Campbell, of the University of Exeter Medical School, said:
“Up to now, it has been widely thought that introducing a triage system
might be an efficient way of providing same-day access to healthcare
advice. However, our study suggests that introducing triage may not
represent the most efficient use of doctor or nurse time. Patients who
receive over-the-phone support are more likely to seek follow-up
advice, meaning that the workload is only redistributed, whilst the costs
are the same.
Practices thinking about introducing triage might benefit from looking
at our findings carefully, and considering whether introducing triage is
really likely to be of benefit to their patients, or to the primary care
practice team. Healthcare managers should consider the implications
across the whole system of introducing triage on a wider scale, especially
given the staffing constraints and challenges faced by the NHS ”
The study also involved collaborators from the University of Oxford, the University of
East Anglia, the University of Bristol, and the University of Warwick. It was funded by the
National Institute for Health Research Health Technology Assessment Programme.
Page 9
Raising Research Awareness
Impact of PCPIE (Patient Carer Pubic Involvement
Engagement) Research Awareness Coffee Mornings
This year the local National Institute for Health Research:
Clinical Research Network Primary Care team marked
International Clinical Trials day in host practices in Coventry
and Redditch by celebrating and spreading the message that
it is “OK to Ask” about clinical research.
As reported in a previous edition of Participate [summer
2014], four coffee mornings were held during the months of
May – July 2014 at Winyates Surgery in Redditch, Broad
Street Surgery and Jubilee Health Centre in Coventry and
Castle Medical Centre in Kenilworth, as part of International
Clinical Trials day and we are now pleased to be able to
provide a detailed breakdown of results.
The aims of these events were to raise awareness about
research happening at the practice amongst patients, and to
encourage patients that it is ‘OK to Ask’ their health
professionals about research that may be relevant to them.
Interested patients were given the opportunity to discuss
local research opportunities and complete a short survey to
gauge existing awareness and possibilities for further involvement.
There was an excellent response to the questionnaires
(170+) enabling us to identify:
•existing research awareness and compare
socio-demographic profiles of respondents,
•types of research studies and disease areas of interest,
•how patients prefer to receive information
•other ideas for ways to encourage patient participation
Table 1 summary results of responses per practice
BROAD STREET
/ JUBILEE
(COVENTRY)
WINYATES
(REDDITCH)
CASTLE
(KENILWORTH)
2,888
2,974
21,572
Deprivation Level (according to
English Indices of Deprivation 2010)
Number of respondents
52
66
54
% aware of research
21.2
16.7
42.6
% interested in research
75.0
71.2
68.5
% willing to take part in:
Questionnaires
59.6
66.7
68.5
Blood tests
36.5
48.5
55.6
New drug/treatment
34.6
28.8
35.2
Extra examinations (health checks)
63.5
65.2
53.7
Extra appointments
38.5
34.8
46.3
% would like to hear about research via:
GP/nurse at appointment
38.5
21.2
35.2
Letter from GP
55.8
51.5
48.1
Leaflet or email
23.1
37.9
18.5
Other
9.6
0
3.7 (email)
Age group
<29
7.7
10.6
5.8
30-49
55.8
33.3
15.4
50-69
21.2
30.3
32.7
>70
7.7
22.2
46.2
Ethnicity
White
40.4
89.4
87.0
Black
1.9
3.0
0
Asian
40.4
0
0
Mixed
1.9
3.0
0
Other
1.9
0
0
The Indices of Deprivation 2010 combines a number of indicators, chosen to cover a range of economic,
social and housing issues, into a single deprivation score for each small area in England. This allows
each area to be ranked relative to one another according to their level of deprivation. The Indices of
Deprivation 2010 have been produced at Lower Super Output Area level, of which there are 32,482
in the country (Department for Communities and Local Government, Published March 24 2011)
Page 10
This will enable us to investigate ways of increasing awareness
in practices and getting information to patients.
Whilst around only 26% of respondents were
previously aware that their surgery was involved
in research, over 70% of respondents said they
would be willing to be involved in research that
was relevant to them.
Therefore our aim is to narrow this gap and increase
awareness, so that many more of the 70% willing to be
involved are aware of research taking place at their practice.
With each increasing age category, the percentage
of patients willing to participate in research was lower,
indicating that older adults may be less inclined to participate.
However, even in the 70-79 age group, over half (52.2%) were
keen to be involved. There were no associations between age
and the types of research activities that patients were willing
to do, so there is not a particular activity that older adults are
less willing to participate in.
Disease areas patients are interested in included diabetes,
fertility, coughs, women’s health and weight loss. Encouragingly
in these areas we have had, or currently have, studies running.
Common themes encouraging research participation included
altruism, money, payment of transport costs, relevant /
interesting / readily available research, a better understanding
of research in general and research feedback.
Direct improvements from the events resulted in an
increase in research material presented inside practices,
increased expressions of interest for
studies and increased research
awareness amongst practice staff.
Patient feedback has enabled us to
identify further opportunities to
involve patients and members of the
public in research. Furthermore,
patients have shared success stories,
encouraged others to become
involved and highlighted other
potential health questions.
In summary, whilst a majority of
patients would be interested in participating in clinical
research, only a minority were aware that their practice was
involved in research studies. Therefore, as a CRN: Primary
Care team, we are committed to continually raising awareness
and promoting engagement with patients and members of
the public through a continuous improvement programme.
Raising Research Awareness
Raising Awareness:
“Ask about Clinical Research”
A ribbon to help raise awareness about
clinical research for International Clinical
Trials Day has been designed and used
at research awareness events held within
host practices in Coventry, Warwickshire
and Worcestershire which were supported
by the Clinical Research Network:
West Midlands. GPs and receptionists were
asked to wear the ribbons to encourage
patients to ask about opportunities for taking
part in clinical research.
Research nurses and research facilitators
working with the CRN also wore the
ribbons and encouraged reception staff and
GPs to advise patients by handing out contact details of their local research nurse.
Although the impact of the ribbons has proved difficult to measure, national
recognition was received from Simon Denegri, Chair of INVOLVE – the UK's national
advisory group on public involvement – and NIHR National Director for Public
Participation and Engagement in Research,
and Tracey Johns, the Patient Public Involvement Manager. The ribbon was also
highlighted in the CRN Newsletter www.crn.nihr.ac.uk/wpcontent/uploads/West%20
Midlands/CRN%20WM%20Newsletter%20Launch%20Special%20Edition%20v02.pdf
and on the NIHR Facebook page.
Eleanor Hoverd research nurse CRN: Primary Care presented the idea to the local
Patient and Public Advisory Group (PPAG) at University Hospital Coventry and
Warwickshire NHS Trust, led by Patient Public Involvement Officer, Mohammed Shaikh,
to gather their views on the ribbon.
Comments from the group included:
Some people may view the ribbons as being more geared towards
females and using a badge or coloured wrist bands may be inclusive
of all the population.
It may not be clear to some patients/members of the public what
is meant by “clinical research” on the ribbon. There is confusion
as much research in the NHS is undertaken on mental health issues
which is by nature social research.
The ribbons would be ideal as part of an information pack as
the “Ok to ask” campaign is not clear to all patients and public
members such as ribbons used for Breast Cancer Awareness and
poppies used for Remembrance Day
A simple slogan such as NHS Research: Ok to ask would be ideal
as most people are aware of the NHS institution.
Accompanying information packs or material may help support
the ribbons target specific groups such as research professionals,
NHS staff and patients and public members. General information
from the newly established NIHR/ CRN website could be used,
which defines what research is and how patients and public
members can find out more information and take part in research.
This accompanying information would be important as not all trusts
and practices in the region are research active or have the capacity
and resources to promote clinical research.
The group shared excellent feedback and would be keen to work together to further
develop it as part of a patient education project on health research for practices.
If you would like further information on any aspect of research awareness raising,
please contact Eleanor Hoverd, email: e.j.hoverd@warwick.ac.uk
Why I Became
Involved in
Clinical Research:
a Patient’s Tale
Based on an
original handwritten account
by Joyce Cunliffe,
a patient at Castle
Medical Centre
How and Why I became
involved in clinical research
I had started to feel guilty about the
extensive help I had received for numerous
problems over the past 20 years or so:
• Breast cancer
• Heart disease
•Eye problems (detached retina
in both eyes and cataracts)
• High blood pressure
• Broken arm in fall
Taking part in research studies seemed
a good way to give something back.
The letter from my GP surgery gave me
the opportunity to join the PreFIT study
(University of Warwick)
Self Interest: I had read about the concerns
relating to aspirin possibly causing stomach
ulcers. The HEAT study at University of
Birmingham offered an opportunity to check
out my position on this as I take aspirin daily.
Unexpected benefits to
participating in a study
1.The exercise programme included in the
PreFIT study under the supervision of a
physiotherapist was exactly what had
been recommended by the GP to help
to treat my chronic heart disease (CHD).
This had all round benefits. I felt fitter and
stronger and more confident to tackle
tasks I thought I could not do.
2.The completion of the diaries and record
of exercise gave a structure to my day and
a sense of achievement. This has continued
as I still do the exercise programme.
3.Being involved in a study along with
many other people gives some sense
of belonging. It is good to know in the
Million Women Study (Oxford) that the
very detailed questionnaires are being
completed by 999,999 other women
at around the same time and that I am
contributing to knowledge which might
help cancer research.
Note: Original handwritten story by patient filed at Castle MC. (Typed and
submitted 12/8/14 by E Hoverd Research Nurse with permission from patient.)
Page 11
Local Research and Training
Worcestershire Allergy and Asthma
Research Collaboration
The Worcestershire Allergy
and Asthma Research
Collaboration or (WAARC)
have held their first meeting
at the National Pollen and
Aerobiology Research Unit
(NPARU) at the University
of Worcester.
Dr Tom Dawson, consultant
paediatrician at Worcestershire
Acute Hospitals NHS Trust and
WAARC secretary, reports “It was a very exciting and
interesting meeting and
revealed a number of
ways of that WAARC can
address new research
projects in Worcestershire
through collaboration”
The next meeting will be held on November 21st and there are potential projects
looking at relationships between pollen and asthma admissions; the allergic potential
of new allergens in asthma and allergic rhinitis and the effects of climate and
pressure on allergen exposure. On-going projects with adrenaline needle length
and psychological implications of anaphylaxis were reviewed. Exploring the best
approach to recruitment was also discussed and there are plans to look into the
availability of data from cohorts elsewhere.
Research Design
Service (RDS)
If you would like any further information,
please contact us on rds@warwick.ac.
uk or via www.rds-wm.nihr.ac.uk
Page 12
Do you have a good research idea that
you’d like to develop further into a
grant application? The RDS can help by
providing methodological expertise and
advice on all aspects of research design.
The RDS exists to provide help and
advice to NHS researchers and others
working in partnership with the NHS in
preparing research proposals for
submission to peer reviewed funding
competitions. As the RDS is funded by the
NIHR such help is provided free of charge.
Anyone wanting to get involved
in the collaboration or who is
interested in allergy or asthma
research should contact
Louise Robertson, email:
l.robertson@worc.ac.uk
Here are some of the ways we can help:
• F ormulating research questions
•B
uilding an appropriate research team
• Involving patients and the public
•D
esigning a Study
• Appropriate methodologies for
quantitative and qualitative research
• Identifying suitable funding sources
•R
egulatory issues
• Writing lay summaries
• Identifying the resources required
for a successful project
Local Research and Training
Validation of Home Blood
Pressure Monitors in Patients
with Atrial Fibrillation
This research aims to determine if automatic blood pressure (BP)
monitors, already independently validated to take measurements
in the home environment and shown to be amongst the most
accurate in the general population, can be reliably used in patients
with Atrial Fibrillation (AF).
No automatic BP monitors are currently validated for use in AF. If
monitors are shown to take accurate blood pressure readings in
patients with AF, the use of home BP monitoring could be
recommended in this high risk group to improve the effectiveness
of hypertension diagnosis and management. Home BP monitoring
allows many more BP readings to be taken, and therefore might
help provide a more accurate picture of the true underlying BP
levels in AF patients.
The proposed research will assess the potential of home BP
monitoring in AF through validation studies of different home BP
monitors in patients with AF to assess their accuracy in this population,
including additional analysis of the minimum number of measurements
required before we can be confident in the accuracy of the
obtained BP values for AF patients. Devices will be validated against
standardised protocols to ensure consistent and reliable assessment.
Eligible patients, recorded as having permanent chronic AF, will be
invited to participate. The validation studies will follow the standard
British Hypertension Society (BHS) and European Society of
Hypertension International Protocol (ESH-IP) protocols, and will
take place in the NIHR Wellcome Trust Clinical Research Facility in
Birmingham, which is accredited by the BHS as a site for monitor
validation, and where validation studies are regularly conducted.
We are looking to recruit up to 10 practices through 2014, and would
like to invite interested practices to contact us to take part or for
further information.The additional workload is minimal and service
support costs to cover time recruiting patients will be reimbursed.
Study participation involves:
•Identification and screening of eligible patients
• Mail-out of study invitation letter
•Eligible patients will be seen at the Wellcome Trust Clinical
Research Facility in Birmingham
For more information, please contact Dr James Hodgkinson, phone: 0121 414 8842 or email: j.a.hodgkinson@bham.ac.uk
PreFIT – Prevention of Falls Injury Trial
We are delighted to report that the
PreFIT Study has completed recruitment.
9,821 participants have been recruited
from general practices across various regions
of the country, including several practices in
Warwickshire, Herefordshire and
Worcestershire. PreFIT has been designed to
determine the comparative effectiveness of
advice, exercise and a multi-factorial fall
prevention programme on peripheral
factures among older people living in the
GCP Schedule 2014
community; an area of substantial public
health significance. PreFIT has recruited the
participants, who are all aged over 70 years
and living in the community, from general
practices. Some participants are still receiving
treatment as part of the trial and all
participants are being followed up for
18 months. The PreFIT Team would like
to thank the practices in Warwickshire,
Herefordshire and Worcestershire who
are taking part in the study and for the
support provided by the primary care
team of the Clinical Research Network,
and will be sure to let Participate know
when the results of the study are available.
For further information please visit
www.warwick.ac.uk/go/prefit or email
the trial team at prefit@warwick.ac.uk
A variety of Good Clinical Practice (GCP) and Informed Consent courses are delivered
across the region. Places on any of the courses listed below can be booked via the NIHR
Clinical Research Network Learning Management System (LMS) at http://learning.nihr.ac.uk
DATE
COURSE TITLE
TIME
VENUE
21st October 2014
Informed Consent
09:30-13:00
University Hospital Coventry
30th October 2014
GCP Refresher
09:00-12:15
South Warwick Hospital
November
6th November 2014
Introduction to GCP
08:45-15:45
University Hospital Coventry
December
17th November 2014
Informed Consent
09:30-13:00
University Hospital Coventry
October
Page 13
News from the Local Team
A Patient’s Experience of the Benefits of
Participating in Research as told to Sarah Joshi, research nurse
Background
I am relatively new to the Clinical Research
Network, and as the number of health benefits
for patients wishing to be involved in research
has come as a surprise, I wanted to share with
you a recent experience assisting the study
team and GP surgery team by carrying out falls
assessments, whilst working on a study looking
at falls in the elderly.
Patient experience
The participant was a gentleman over 90 who
was eager to be involved and delighted to be
offered an assessment. It transpired that he was
housebound, but keen not to exclude such a
motivated participant we offered to carry out
the assessment at home.
We arrived to an unlocked, open door and a
voice shouting for us to come to in. This very
articulate and well organised gentleman had
been a soldier in WW2, had worked all his life
and had been widowed many years previously.
His children all lived overseas but maintained
regular phone contact. His medications were laid
out with notes to remind himself when to take them,
his kitchen table was set ready for supper and a
basket of fresh vegetables was ready to be peeled.
During the assessment when we asked about
falls we were told of a number of occasions when
he had fallen in the night, including his last fall
which had left him unable to get up for a number
of hours, leaving him very cold and shaken.
He spoke of being frightened of dying and not
being found for a long time. His only outside
contact is a three weekly internet shopping
delivery. At this point he became emotional about
his daily struggles to maintain independence.
Patient benefits
Our assessment also highlighted other health
issues, such as a skin condition, a significant
postural hypotension and antihypertensive
medication that could be reviewed.
We spoke in detail about the services that
were available, including a key safe for his front
door, a panic alarm in case he falls, assistance
with personal care and an occupational therapy
assessment of his home. Even though we felt
he would require little support to maintain his
independence and safety, prior to our visit he
was unaware of the services available. With his
permission we were able to communicate this
to his GP to raise awareness of his situation and
offer our recommendations.
This every day, true story demonstrates the
health benefits of participating in research and
how this can become a conduit for many other
benefits and types of care.
Page 14
News from the Local Team
Medical Scientists Day:
Berkswell Church of England Primary School
Research nurse Eleanor Hoverd and Research Facilitator
Aman Johal from the CRN: Primary Care team at Warwick
Medical School recently had the opportunity to visit Berkswell
Church of England Primary School to talk to children in Key
Stage 2 about the role of the research nurse, the discovery
and testing of medicines and keeping medicines safe at their
Medical Scientists Day, organised by Science Co-ordinator
Kate Wragg. The sessions were interactive and the children
worked in groups to brainstorm and draw pictures of what
skills and qualities they felt would be essential to be a nurse.
The children shared their ideas and pictures and many of the
skills they identified were also applicable to other jobs in
medical science. Some of the skills and qualities they described
were: compassion, calmness, generosity, knowledge, good at
maths, being reliable, not squeamish and many more. Images
of bacteria under a microscope and Alexander Fleming’s
discovery of penicillin were presented with the opportunity
for children to look through some basic microscopes with
prepared slides of blood cells and plants cells later on in the
day. This was followed by a discussion of health research,
animal testing and what clinical trials are. The children were
shown props of specimen containers, which they enjoyed
guessing what went in them. This helped to illustrate how
information is sometimes gathered for clinical trials.
The children then identified a variety of medicines that
they may have had some experience in taking and recorded
information about usage, safe dosage, and storage,
highlighting a rule for each medicine, such as “always check
the expiry date”.
Aman Johal announced a competition for the children in
Year4/5 to draw a picture of what they thought would make
them want to participate in health research. The winners from
both year groups were chosen by Professor Jeremy Dale,
Clinical Lead CRN: Primary Care and the winning entries are
printed in this issue of Participate. Congratulations to Lily in
Year 5 and Sophie in Year 4 from the CRN: Primary Care team.
At the end of the session the children watched a brief
video on clinical trials filmed at Great Ormond Street Hospital
www.youtube.com/watch?v=69TgjeJnOSs
“The children were particularly excited about looking
into the microscopes and enjoyed working together on
the group task they were given. Everything was explained
very clearly and all children came away from the session
with an increased understanding of what it can take to
work in the medical sector. Thanks again for your hard
work and time. The children loved having you in.”
Matthew Penn, Year 4 teacher
“Having the opportunity to engage with young,
inquisitive minds about potential careers in the Medical
Sciences and to raise awareness about health research
proved an invaluable and rewarding experience. The
children were energetic and enthusiastic about the group
work and reflective activities, helping to promote a
culture of thought and expression of their views.
The curiosity and creativity of the children is key to the
continuous development of new knowledge in the field of
health research and it would be great to continue to raise
awareness and engage with school children, exploring the
significance and benefits of the medical sciences and how
they may be able to impact on this in the future, which I
feel is paramount to discovery and innovation.”
Eleanor Hoverd, research nurse
“I thought the activities were really fun because you got
to work together as a group.”
Year 5 pupil
“The children and I enjoyed the session and found it very
interesting. I think it’s a good idea to have visits and
sessions like this because children need to see Science
presented in a real-life context.”
Caroline Penn, Year 5 teacher
Page 15
Continuing Professional Development
Masters and Continuing
Professional Development
Health Sciences
Postgraduate Study: Certificate/Diploma/Masters (MSc)
Warwick Medical School’s postgraduate level courses have been
developed in response to changes in continuing professional
development and are ideal for busy healthcare professionals who
require the flexibility to study at a pace and level that suits their needs.
The Health Sciences MSc provides an innovative and highly flexible framework in
which modules can be chosen from a wide range of healthcare specialisms and
themes, and can be combined to meet the professional development needs of the
individual. Using the personal development planning process in negotiation with the
course director, the course can be specifically tailored to meet the career goals of the
individual. It offers flexibility for part-time study over 2-5 years, with the option to take
an MSc, Diploma or PG Certificate. You can also take modules by distance learning.
The course provides participants with invaluable skills and ensures they leave the
programme with the confidence and knowledge needed to progress their career.
Masters Graduate Review
I would certainly
recommend part-time
postgraduate study...
It enabled me to reenter education after a
number of years.
Liz Corrigan, MSc,
January 2014
For further information please contact:
T: +44 (0)24 765 72958
E: cpdenquiries@warwick.ac.uk
Warwick Medical School
The University of Warwick,
Coventry, CV4 7AL
www.warwick.ac.uk/wms
Page 16
Liz Corrigan graduated from the University of Warwick with a Masters in Health
Sciences in January 2014. She originally undertook Post Graduate Awards in Cardio
Vascular Risk and Chronic Kidney Disease. Following these two awards she decided to
embark on a part time Masters programme in Health Sciences.
Liz already had an undergraduate degree and was working in public health having
been a nurse for a number of years. She felt that by undertaking a post graduate
award prior to tackling the Masters programme, she was able to ascertain the level of
study and commitment required as well as continuing with full time employment and
a family.
“I found that the mode of study enabled me to pace my learning around family and
work. It gave me flexibility. I took a combination of face to face and on-line modules
which worked really well. The Masters programme, and particularly the professional
project has helped me to think critically, consider research and evidence, and has
ultimately helped me improve my practice.
Meeting different healthcare professionals on the course was valuable in terms of
networking and sharing ideas. I found the support and advice from tutors really
helpful. I would certainly recommend part-time postgraduate study and undertaking
it as I did through first embarking on a post graduate award. It enabled me to re-enter
education after a number of years.”