Download EAST KENT HOSPITALS UNIVERSITY NHS FOUNDATION TRUST

RESEARCH AND DEVELOPMENT DEPARTMENT
ANNUAL REPORT 2014-2015
Forewords
Since arriving in EKHUFT in March 2013 as Interim CEO I have been extremely impressed by the
commitment of staff towards research, development & innovation. The recently published NIHR/Guardian
league tables (http://www.ekhuft.nhs.uk/patients-and-visitors/news/news-archive-2015/east-kenthospitals-ranked-first-in-kent-for-clinical-research-studies/) show how EKHUFT has risen from 86th position
nationally in 2013-14 to 45th this year, and confirm that we continue to be the most research-active NHS
Trust in Kent.
The fact that we're so active in research means that we're able to offer our patients cutting-edge
treatments in cancer, eye & skin disease, and many other conditions that they might not otherwise be able
to receive. Moreover, because of the large number of studies we offer across a diverse range of conditions,
we're able to respond to East Kent peoples' desire to be really involved in 'local' research. In these
straightened financial times, the fact that we're able to generate modest additional income - to reinvest in
more R&D - whilst supporting the UK's biosciences industry can only be a good thing.
To conclude, I would like to reiterate my congratulations to those staff who've received national and
international recognition for their efforts, and to thank all the staff and patients - without whom all this
excellent work would not be possible - for their invaluable contributions.
Mr Chris Bown
Interim Chief Operating Officer
November 2015
This has been a truly impressive year for Research & Development in East Kent Hospitals. The numbers and
narrative contained within this report only tell part of the story, for behind those mentioned are many
other people – staff and patients – that enable all these fantastic achievements. What particularly pleased
me was the diversity of studies we now offer: people with conditions aligned to 23 out of the 30 NIHR CRN
Specialty groups are able to participate in studies relevant to their conditions. This means that EKHUFT is
really delivering for the people of East Kent of whom 87% - in our survey undertaken in May 2014 – told us
that they considered it ‘very important for their local hospital’ to be involved in research.
Colleagues who act as Principal Investigators and the teams that support them do so because they are
passionate about improving our patients’ lives through research that leads to better treatments and
outcomes. It is therefore extremely gratifying to see those colleagues achieve national recognition for their
efforts, and I offer them my heartfelt congratulations.
None of us can have failed to notice the enormous financial strain under which EKHUFT – along with much
of the NHS – is currently operating. We know that those of us committed to research will need to do more
for the same (or less). But we are also in the fortunate position of being able to generate ‘new’ income
through Industry funded- and sponsored-research. Since my appointment as Director of R&D in 2012, our
Industry income has grown 10-fold. I do not claim the credit for this – again I have our Principal
Investigators, Research Delivery Teams and R&D Department to thank – but I do believe we are now set on
a path to eventually deliver sustainable, self-funding R&D activities in the years ahead.
Dr Tim Doulton
Director of Research & Development
November 2015
EKHUFT Research & Development Annual Report 2014-15
Author: Dr Tim Doulton, Director of Research & Development
Page 2 of 40
Contents
Forewords
2
Contents
3
Executive summary
4
Key events in R&D during 2014-15 financial year
5
R&D metrics
9
Overview of research activity during 2014-15 financial year
12
Neurophysiology: Dr Jeremy Bland
Cardiology:
Dr Jane Fisher
Dr Konrad Grosser
Stroke Research
Tissue Viability: Sr Judy Elliott
12
12
13
13
14
Orthodontics: Mr Andrew DiBiase
Ophthalmology: Mr Afsar Jafree
14
15
Dermatology: Dr Susannah Baron & Dr Emilia Duarte-Williamson
Kidney Research
Haemophilia: Dr David Stephensen & Dr Gillian Evans
Solid Oncology: Dr Rakesh Raman & colleagues
Paediatric Occupational Therapy: Dr Eve Hutton
Neonatology: Dr Vimal Vasu
Child Psychology: Nicky Wood
15
16
19
22
23
24
25
Microbiology: Prof Fritz Mühlschlegel & colleagues from Kent Fungal Group
Dr Matthew Strutt
Interventional Radiology: Dr Neelan Das
Physiotherapy: Benjamin Chitambira
Helen Oakes
26
27
27
28
28
Risk and Legal: Daniel Marsden
29
Pilgrim’s Hospice: Rose Ward
29
List of peer-reviewed publications from Trust researchers (April 2013 to March 2014)
31
Appendix: Finance Report
38
EKHUFT Research & Development Annual Report 2014-15
Author: Dr Tim Doulton, Director of Research & Development
Page 3 of 40
1.
Executive Summary
1. During the year a total number of 2364 patients were recruited by East Kent Hospitals University
Foundation Trust (EKHUFT, hereinafter referred to as “the Trust”) researchers into National Institute for
Health Research (NIHR) portfolio studies. This represents a 41% increase on 2013-14.
2. During 2014-15 there were 79 studies given NHS R&D approval by the Trust of which 50 were NIHR
Portfolio studies. Of the 79 newly opening studies, 15 were clinical trials of investigation medicinal
products (CTIMPs) and 14 were industry-funded/-sponsored studies.
3. Staff achieved national recognition for their work including Dr Chris Pocock, Consultant Haematologist,
Dr Emilia Duarte-Williamson – both for their contributions towards Industry research. Dr David
Stephensen was awarded the Best Oral Presentation at the 2014 UK Haemophilia Physiotherapy
Meeting.
4. A number of events co-ordinated by the R&D Department took place during the year. These included: a
major awareness raising campaign & patient-public survey about attitudes to research, our annual
symposium, and a jointly hosted mini-symposium with KentHealth.
5. Total income received on behalf of R&D during the year was £2.56m. Industry-derived income
increased 18% to £823k.
6. During 2014-15 financial year the Trust received £1.62m from NIHR/DH (via Research Networks and
directly). This included £148,559 from DH Research Capability Funding compared to £109,588 in 20132014.
7. R&D oversaw distribution of funds totalling £54,581 to Trust staff via the Internal Projects Grant
Scheme and funding for consultant and AHP sessions (1x 2 years x 1 PA; 1x 8 months x 1 PA; 1x 2 years
x 0.2 WTE) via the Research Session Scheme.
8. During 2014-15 Trust researchers published 78 articles in peer-reviewed journals, the same number as
last year.
9. NHS R&D approval was granted within 30 days (from receipt of valid application) for 90% of NIHR
Portfolio studies, meaning that the Trust achieved the target set down by the NIHR/DH. The median
time to obtain NHS permission was 3 days.
EKHUFT Research & Development Annual Report 2014-15
Author: Dr Tim Doulton, Director of Research & Development
Page 4 of 40
2.
Key Events in R&D during the 2014-15 Financial Year
R&D awareness raising campaign: “Research: Good for you, Good for the NHS”
In May members of the R&D team could
be found at different sites across the Trust
promoting the importance of research
and innovation to patients and the NHS.
The campaign was launched on 6th May
at QEQM where Sandie Tapsell and Jo
Pearson from the R&D team were joined
by Nick Wells, Trust Chairman and Andrew
DiBiase, Deputy Director of R&D. The R&D
team then spent a week at each main site
talking to patients and staff, highlighting
the Trust's impressive research record and
explaining how they could help or even
get involved.
As part of the campaign a patient survey was conducted to gain patients opinions and views on research.
Over 500 questionnaires were collected from patients attending the Outpatient Departments. These
showed that patients are very supportive of research and keen to be involved. They just want to be asked!
The three week campaign culminated in an open meeting held on 23rd May 2014 in the William Harvey Hall
at K&CH celebrating International Clinical Trials Day. Patients, researchers and staff were invited along to
share their experiences and to learn how research had impacted on their lives. This was very well attended
and again showed how interested and supportive the majority of patients were in the research being
undertaken in the Trust.
Annual Symposium
The R&D Annual symposium took place on 12th June 2014
in the Harvey Hall, Postgraduate Centre, K&CH. The theme
for this year was “Imaging in Research” and over 70
attendees enjoyed a wide range of talks from invited
internal and external speakers, as well as four oral
presentations selected as the best submitted abstracts
(Caroline Judge, Renal, EKHUFT; Vanessa Abrahamson,
CCCU; Campbell Gourlay, UoK; Samira Bouyagoub,
Neurology, KCH).
Samira (left, with supervisor Professor Alan Colchester,
Consultant Neurologist, EKHUFT) won the prize for best
oral presentation and Mark Shepherd (School of
Biosciences, UoK) won best poster presentation.
EKHUFT Research & Development Annual Report 2014-15
Author: Dr Tim Doulton, Director of Research & Development
Page 5 of 40
Internal Project Grant Scheme 2014-15
Using funding from NIHR Research Capability Funding (RCF) the Internal Project Grants Scheme (IPGS) and
Research Session Scheme (RSS) were able to support the following Trust staff:
Applicant
Karen Jenkins
Title of Study
The experiences of older
people in the shared
(Consultant Nurse) decision-making process
in advanced kidney care
Dr Matthew Strutt Characterizing overactive
bladder syndrome with a
(Consultant
view to better diagnostics
Microbiologist)
and treatments; a crossinstitution basic/clinical
collaboration
Dr David
STABLE- Stability Training
Stephensen
and Balanced Locomotion
Exercises. Intervention
(Physiotherapist)
programme to reduce
falls and balanced
dysfunction in people
with haemophilia
Dr Yvonne
To design a shared
Morrissey
patient database and
advice service to GPs to
(Consultant
prevent adverse events
Geriatrician)
due to drug induced
hypotension
Dr Tom Webb
Improving Stroke
prevention in the Rapid
(Consultant
Access Neurovascular
Neurologist/Stroke Clinic – the role of
Physician)
obstructive sleep apnoea
& cerebral microbleeds
Amount
Awarded
£37,694
Duration
Start Date
IPGS/RSS
24
months
March 2014
IPGS
£16,887
1 year
March 2014
IPGS
0.2 WTE
2 years
December
2014
RSS
1 PA
8 months
Continuation
of previous
award
RSS
1 PA
2 years
June 2014
RSS
KentHealth: Symposia, Vacation & PhD Studentships
The Trust have continued to host, in partnership with the University of Kent, quarterly networking
symposia around particular health research themes, with invited speakers from both the Trust and
Universities. Stroke was the theme on 4th June 2014 where Mike Geeves from UoK presented his work on
inherited cardiomyopathies and how it could be relevant to stroke. Tom Webb and Ibrahim Balogun from
EKHUFT outlined the prevention and treatment of stroke now and in the future, discussing their research
on improving the prevention of stroke, and the treatment of strokes with unknown time of onset. Ben
Chitambira, also from EKHUFT then outlined his research using the OKCSIB protocol for upper limb recovery
in dense acute strokes. On 10th October 2014, Vimal Vasu, Consultant Neonatologist, and Nicky Wood, Child
Psychologist were two of the speakers at the Child Health themed event, along with researchers from Kent
Community Health Trust and University of Kent. Organisation of these events has again been undertaken by
Dr Julie Hedayioglu, Research & Innovation Officer, KentHealth, we remain extremely grateful to Julie for
her hard work in making these events happen.
EKHUFT Research & Development Annual Report 2014-15
Author: Dr Tim Doulton, Director of Research & Development
Page 6 of 40
This is the fifth year of the jointly funded EKHUFT-KentHealth student vacation scheme. Trust clinicians are
invited to submit proposals for projects that are suitable to be undertaken by a second-year undergraduate
student during their summer vacation. The scheme provides students with an insight (and hopefully
encouragement) into working in healthcare & one of the area’s largest employers and further builds
excellent relations (and sometimes collaboration) between the University and the Trust. As in previous
years students blogged on the KentHealth website about their experiences. To read the blogs go to
KentHealth at http://www.kent.ac.uk/health/student-placements/index.html. This year Emily Betts will be
looking at the stability of 5-hydroxyindoleacetic acid – used to diagnosed carcinoid syndrome – in urine and
will be supervised by Dr Alan Dodd from the Department of Biochemistry, EKHUFT.
As was the case in 2013/14, EKHUFT clinicians have been successful in collaborative bids with University of
Kent academics in bidding for KentHealth PhD studentships: Dr Mohamed Sakel (Consultant in
Neurorehabilitation) and University co-applicant Dr David Wilkinson (Reader in Psychology) are
investigating “Neuropsychological outcomes in military veterans with traumatic brain injury”.
National recognition for our researchers
Dr Chris Pocock, Consultant Haematologist, has received recognition for his work as Principal Investigator
on a number of Industry trials in blood cancer. He received a personal invitation from Professor Dame Sally
Davies, Chief Medical Officer for England, to attend a meeting held by the NIHR Clinical Research
Network to recognise leading Industry study PIs. The meeting, held at BMA house on February 4th 2015,
celebrated the greatly improved recruitment performance by PIs and their teams into Industry trials over
the last five years. Dr Pocock was invited under the banner “Always delivers to time and target” recognizing
the four completed Industry trials for which East Kent has been the leading centre in the UK.
Dr Emilia Duarte Williamson and colleagues in Dermatology, supported by Janine Musselwhite, James Rand
and Anthea Potter from the East Kent Research Delivery Team received recognition from the national
dermatology Specialty Group Lead for their work in recruiting to the Signature study (CCRN 2278). Dr Nick
Levell, wrote: “Very well done on your excellent recruitment so far into this study. Your site has been
highlighted by Novartis as performing excellently and this has been recognised and is appreciated. When
Novartis originally outlined the Signature study at one of our National Dermatology Specialty Group
meetings we agreed that the Network could make a real difference to recruitment and your outstanding
performance is helping us to prove this to Novartis”.
Other notable events during the year
Funding to Dr Eve Hutton for “A postural care training package: feasibility study for commercialisation”
Eve Hutton, Head Paediatric Occupational Therapist, was successful in securing Higher Education
Innovation Funding (HEIF) which will enable her along with researchers based at University of Kent and
Canterbury Christ Church University to explore the feasibility for commercialising an innovative training
package designed to improve the confidence of parents and teachers who care for children with postural
care needs. The training package was originally developed and rigorously evaluated as part of a National
Institute of Health Research, Research for Patient Benefit Study (PB-PG-0110-21045) that concluded in
2013.
Award to Dr David Stephensen for Best Oral Presentation
At the 2014 Annual UK Haemophilia Physiotherapy Meeting, Dr David Stephensen, Physiotherapist at the
Haemophilia & Thrombosis Centre was awarded the Best Oral Presentation for his presentation on "Gait
deviations in adolescent boys following ankle joint haemarthrosis". The work was undertaken by a doctoral
EKHUFT Research & Development Annual Report 2014-15
Author: Dr Tim Doulton, Director of Research & Development
Page 7 of 40
physiotherapist as part of an NIHR internship awarded to Dr Stephensen in 2013. In this multi-centre UKwide study Dr Stephensen's team completed a comparative analysis of boys with haemophilia aged 11-18
years and age- and maturity-matched typically developing children using a three-dimensional motion
capture system to identify any changes in motor performance. In the haemophilia children, they found
that in addition to changes in ankle joint motion as bleeding frequencies increased, the boys walked with
more extended knees. This study is part of a much larger research programme co-ordinated by Dr
Stephensen quantifying muscle and joint characteristics and functional abilities of boys with haemophilia in
order to develop a clinical classification tool of early haemophilic arthropathy.
Appointment of Lead Research Nurse
We were delighted to welcome Ruth Hulbert as Lead Research Nurse for
EKHUFT in March 2015. Ruth has spent much of her 30 year nursing
career in research. Initially she worked as a clinical research nurse within
the pharmaceutical industry, working mainly on Phase 1 clinical trials. In
2003 she returned to the NHS when the Cancer Research Network was
set up in Kent & Medway and was appointed as Team Leader for the
then new solid tumour cancer research team in EKHUFT. She then joined
the Kent & Medway CLRN in 2008 and worked as Lead Research Nurse
until April of this year, when the NIHR Clinical Research Networks across
England were restructured and the CRN: Kent, Surrey & Sussex was
formed. Since then Ruth has worked as one of the Research Delivery
Managers and the Workforce Development Lead.
EKHUFT Research & Development Annual Report 2014-15
Author: Dr Tim Doulton, Director of Research & Development
Page 8 of 40
3.
R&D Metrics
Study activity
During 2014-15 the Trust had 299 active research studies including 190 NIHR Portfolio studies that were
open to new participants, with the remaining 109 studies being non-Portfolio studies or “own account”
studies. Included within our active studies were 68 clinical trials of investigation medicinal products
(CTIMPs). Currently, the Trust has 40 industry-funded and/or -sponsored studies active of which 34 are
Portfolio and 6 non-Portfolio studies.
The Trust R&D Department issued approval for 79 new studies between 1st April 2014 and 31st March
2015 (50 NIHR Portfolio and 29 non-Portfolio), of which 19 were “Grey Area Projects”, 15 were CTIMPs and
14 were industry-funded/sponsored studies.
Participant Accrual
During the year there has been 41% increase in recruitment into NIHR portfolio studies. The Trust recruited
2364 participants compared to 1670 participants in 2013-14. We have maintained a healthy balance with
complex interventional (usually randomized controlled) and more straightforward observational and largescale studies (see figure 1).
NHS Permission
From April 2014, the NIHR set NHS organisations are an aspirational target of achieving NHS permission for
a research study to open with 15 days of a valid application for 80% of studies. In 2014-15 we approved 50
new NIHR Portfolio studies, of which 45 (90%) were within 15 days. Our mean and median times to
permission were 8 days and 3 days respectively.
Research Income
Research-related income to the Trust was similar to that seen last year (£2.56m vs. £2.44m in 2013-14) with
Industry related income up 16% to £823k (see figure 3). During the year the Trust was allocated £148,559
by the NIHR for its Research Capability Funding, and this supported NIHR faculty members (present and
future) directly and via the Trust’s Internal Project Grants Scheme (IPGS) and Research Sessions Scheme
(RSS).
GCP & R&D training for staff
Training session
GCP Introduction and refresher
session
R&D Workshop
R&D ‘Meet the Governor’ session
IRAS training session
GCP refresher training
GCP Introduction and refresher
training session
Date
24th June 2014
Venue
Kent and Canterbury Hospital
10th June 2014
17th July 2014
17th September 2014
22nd September 2014
15th December 2014
William Harvey Hospital
William Harvey Hospital
Kent and Canterbury Hospital
QEQM Margate
Kent and Canterbury Hospital
EKHUFT Research & Development Annual Report 2014-15
Author: Dr Tim Doulton, Director of Research & Development
Participants
Intro – 16
Refresher - 31
9
Intro – 28
Refresher - 33
Page 9 of 40
Statistical Advice
Statistical advice was provided by Paul Bassett (StatsConsultancy Ltd) to 19 Trust researchers by phone, email and in face-to-face meetings.
Figure 1. Recruitment to NIHR Portfolio studies by financial year and type of study.
Figure 2. Industry-funded and/or -sponsored studies opened in each financial year
EKHUFT Research & Development Annual Report 2014-15
Author: Dr Tim Doulton, Director of Research & Development
Page 10 of 40
Figure 3. Research income by financial year to NIHR Portfolio studies, by funding source
EKHUFT Research & Development Annual Report 2014-15
Author: Dr Tim Doulton, Director of Research & Development
Page 11 of 40
4.
Overview of Research Activity during 2014-15 Financial Year
URGENT CARE & LONG TERM CONDITIONS DIVISION
Dr Jeremy Bland, Neurophysiology/Neurosciences, K&CH
The department has continued to add new cases, and follow-up data on existing cases, to the East Kent
Carpal Tunnel Syndrome database, adding 1632 new subjects during the year and bringing the total
number of cases on the register to over 40,000. The database forms the substrate for a variety of research
studies. This year we have published a prospective study of the accuracy of our online questionnaire for the
self-diagnosis of carpal tunnel syndrome by patients, confirming that the web-based questionnaire is a
usefully accurate diagnostic tool. This publically available instrument now offers a tool which can be used to
reduce unnecessary referrals for nerve conduction studies for suspected CTS by approximately 25%. CTS
services locally, in Lambeth and Southwark, and Lancashire are looking at formally incorporating use of the
web questionnaire into their local management pathways for carpal tunnel syndrome. A study of whether
local steroid injection prejudices the outcome of subsequent carpal tunnel decompression has just been
completed (in press), and we are currently developing prognostic models for surgical and non-surgical
treatment of CTS which promise to improve decision making in choosing an appropriate treatment for
individual cases. We have also participated in basic research into the aetiology and physiology of carpal
tunnel syndrome and are planning further studies in association with the National Amyloidosis Centre.
Other research output (conference proceedings, abstracts, poster & oral presentations; invited lectures;
invited contributions to books etc.):
Invited lectures and research presentations have been given to the British Society for Clinical
Neurophysiology, British Society for Hand Surgery Manchester training course, Association of Chartered
Physiotherapists in Orthopaedic Medicine/Injection Therapy and the East Kent annual research symposium.
We also arranged the first UK one day course in peripheral nerve ultrasound imaging in March which was
substantially oversubscribed.
Dr Jane Fisher, Cardiology
Study: The use of a self-paced VO2max protocol for assessing maximal oxygen uptake in post myocardial
infarction and pre- operative care of patients with cardiovascular disease.
The aims of this project are to assess the reliability, validity and acceptability of a novel self-paced cardiopulmonary exercise test (CPET) in the:
- Phase 1: Assessment of VO2max in post-myocardial infarction patients
- Phase 2: Assessment of patient pre-operative cardiovascular fitness to determine suitability for surgery
and help predict post-surgery outcome
Phase 1: We have recruited and tested 28 patients. We need another 2 in order to complete the study.
Phase 2: Data collection was started January 2015. we have now recruited 22 patients and will continue to
recruit up until Easter 2016. We aim to have a manuscript completed for phase 1 by October 2016 which
we will then submit for publication.
Other research output (conference proceedings, abstracts, poster & oral presentations; invited lectures;
invited contributions to books etc.):
Preliminary data from phase 1 was presented at the EBPOM CPET conference July 4th 2014.
EKHUFT Research & Development Annual Report 2014-15
Author: Dr Tim Doulton, Director of Research & Development
Page 12 of 40
Dr Konrad Grosser, Cardiology
EMMACE 4 is a prospective longitudinal observational study of routine clinical care in 6,000 inpatients
hospitalised with an acute coronary syndrome. The aim of the study is to use regional data about heart
attacks, to identify and measure the effects of hospital care. This research will identify hospital qualities
that promote improved patient care. In doing so, best practice will be highlighted and healthcare policy
changed so that all patients will have an equal chance of surviving a heart attack. Recruitment closed in
June as target was met globally and we achieved 154 participants.
Drs Hargroves, Balogun, Gunathilagan, Baht, Webb and colleagues, Stroke Research
The last year in stroke medicine research has been an exciting time, with many innovative research
developments in both the NIHR Portfolio and locally driven initiatives. The group’s past success in
recruitment has encouraged us to set challenging targets, remaining, as we do, the single largest recruiter
as a trust into Stroke Research in Kent, Surrey & Sussex. We take a collaborative approach with regard to
other specialities, facilitating their portfolios by acting as PIs in some cardiovascular / thrombosis
preventative studies (e.g. the GLORIA-AF study on stroke reduction in AF). There are now some exciting
new studies on the horizon in hyper-acute treatment and secondary prevention (PRACTISE and Navigate
ESUS along with others) which will significantly increase the range of patients we can offer the chance to be
involved in improving stroke treatment through research.
Work on ‘home grown’ Stroke research is also progressing. Tom Webb is taking the lead on work
collaborating with David Werring’s group at University College London to look at the numbers of patients in
the Rapid Access Neurovascular (TIA) Clinic who have tiny amounts of bleeding evident on their brain scans
(so-called cerebral microbleeds). Work on the incidence of Obstructive Sleep Apnoea in patients attending
this same clinic is also continuing. Both of these studies are part of a project to make use of the unique
resource of MRI brain imaging in this patient group in order to set up future projects to further understand
risk factors for cerebrovascular disease and how it can be prevented. We have received permission to
recruit an undergraduate student from Kent University to help with this work. Previously this has only been
possible as part of the EKHUFT-KentHealth summer vacation scheme. While this has been very fruitful, we
hope that having a student working with us for a day a week over a whole year will be more productive still
and enable them and us to get the most out of the experience. This will be taking place on a pilot basis
initially but we hope if successful it can be continued in the future.
EKHUFT has been an early adopter of CT perfusion (CTP) brain scans in people with stroke of unknown time
of onset. Ibrahim Balogun has been analysing our outcomes in patients with stroke of unknown time of
onset treated with IV thrombolysis after having CTP. This has been using our stroke research registry
database, one of the largest in the UK. Without the use of this technology this patient group would not
have stood to benefit from this treatment. Furthermore, the use of multimodal imaging to select patients
for thrombolysis, rather than the crude (and often inaccurate) time of symptom onset is increasingly seen
as a way forward to improve hyperacute stroke care. This work is shortly to be submitted for publication
and we hope it will form an important part of the emerging bedrock of evidence to support this approach
and achieve better outcomes for our patients with safer, more effective therapy.
The group continues its interest in real world solutions for practical challenges: David Hargroves recently
co-authored a peer review of magnetic feeding tubes (see Smithard et al. in publication list) and initiated
the ‘Coast’ study, a multi-centre cluster observational studying aiming to understand whether magnetic
feeding tube insertion reduces time to feed and complications in a specific subset of patients with stroke.
The stroke department in East Kent were one of the first in the country to demonstrate the safety of
horizontal telemedicine in the delivery of hyperacute stroke intravenous thrombolysis care and are now in
receipt of an NHS innovation grant to place video cameras in the back of SECAMB ambulances in the hope
EKHUFT Research & Development Annual Report 2014-15
Author: Dr Tim Doulton, Director of Research & Development
Page 13 of 40
of demonstrating a reduction in door to treatment times. The proof of concept trial is complete and roll
out of the project is planned for later in the year.
Encouragement of stroke research at the undergraduate level continues with another King’s College
medical student presenting their work at the premier UK stroke Forum conference this summer. We are
also piloting, with KentHealth’s Julie Hedayioglu, a new quarterly research meeting to work on building on
existing connections with the University and foster current and future research programmes by sharing
experience and expertise between the academic and clinical arenas.
Finally, we are also pleased to have Vanessa Abrahamson with us who is working towards a PhD using
qualitative research focused on the review process of patients after Stroke, a crucial and under-studied
time in the recovery journey of our patients.
Sr Judy Elliott, Tissue Viability
PRESSURE-2 is a national-wide multicentre randomised, double triangular group sequential trial led by the
Clinical Trial Research Unit (CTRU) at the University of Leeds. The EKHUFT PI is Judy Elliott, Lead Tissue
Viability Nurse. The aim of this study is to determine the clinical and cost effectiveness of High
Specification Foam (HSF) and Alternating Pressure Mattresses (APM) when both are used in conjunction
with an electric profiling bed frame for the prevention of Category 2 (and above) pressure ulcers.
The treatment phase begins from randomisation to HSF or APM until the patient is discharged, deemed no
longer at risk of developing a pressure ulcer, or up to a maximum of 60 days (whichever of these occurs
first). Skin assessments are completed during the treatment phase twice-weekly by a trained research
nurse from day 0-30 and once-weekly from day 31-60. A final follow up visit 30 days post-treatment phase
is conducted at either home or hospital.
Recruitment has been difficult nationally due to the nature of the study (ward-based, equipment required)
and the conviction of many nurses that APM are more effective for the prevention of pressure damage,
despite there being no evidence to prove this. As a Trust, we have been praised by the study centre for
continuing to recruit patients regularly when many Trusts are failing to recruit.
SURGICAL SERVICES DIVISION
Mr Andrew DiBiase, Orthodontics
Research in the Orthodontic Department focuses on innovation and novel treatments. Recruitment was
completed and the preliminary results presented nationally of a randomized controlled trial investigating
the use of vibrational forces to accelerate tooth movement. We have just started recruitment on a national
Portfolio study investigating use of bone anchored plates in early treatment of facial skeletal problems,
being one of the few centres in the UK to undertake this procedure. We also undertake research on the
psychosocial impact of malocclusion and completed a study looking at the social perceptions made for
individuals with overtly disfiguring malocclusion and the benefits of treatment. Ongoing research will
investigate how peer relations are affected by the presence of a malocclusion in school children and the
impact this has on the psychosocial well-being. Our research is showing the huge benefits of orthodontic
treatment for well-being and health.
Other research output (conference proceedings, abstracts, poster & oral presentations; invited lectures;
invited contributions to books etc.):
British Dental Association Conference Manchester April 2014 “Malocclusion, orthodontics and bullying”
EKHUFT Research & Development Annual Report 2014-15
Author: Dr Tim Doulton, Director of Research & Development
Page 14 of 40
British Orthodontic Conference Edinburgh September 2014 – “Better, stronger, faster; can we move teeth
any quicker?”
New higher degree supervision:
MSc in Orthodontics Kings College London
Mr Afsar Jafree, Ophthalmology
The CLEOPATRA trial is an ophthalmology trial which is being conducted at the William Harvey Hospital, and
is supported by the East Kent Research (Delivery) Team. The trial is looking at “The clinical efficacy and
safety of light masks at preventing dark adaptation in the treatment of early diabetic macular oedema”. It is
an interventional trial looking at whether the use of a light mask worn during sleep prevents the
progression of early diabetic changes in the eye. Patients that entered onto the trial were randomised to
either light or dark masks, and then followed up for 2 years in 4 monthly intervals.
The trial is led by Kings College Hospital and there are 20 sites taking part nationally. Each site was asked to
recruit 25 patients to the trial. East Kent Hospitals – led by Mr Jafree’s proactive approach to participant
identification – managed to recruit 21 patients which was just short of target! Patients are now being
followed up and study will close in June 2017.
SPECIALIST SERVICES DIVISION
Dr Susannah Baron & Dr Emilia Duarte-Williamson, Dermatology
A new position of Dermatology Research Lead was created from 1st November 2014. Since this date we
have rapidly expanded our NIHR research portfolio.
Current open studies:
1. Identification of Major Susceptibility Genes for Eczema and Food Allergy 118 – top recruiters in the UK
2. British Association of Dermatology Biologics Intervention Registration (BADBIR) – currently 67 recruited
3. A World-wide Antihistamine Refractory chronic urticaria patient Evaluation (AWARE) - 9 recruited (over
target)
4. IMAP – Investigating Medication Adherence in Psoriasis – opened July 15
Recently completed studies:
1. Signature study – a new biologic Secukinimab: we over recruited 8 patients and had a letter of
recognition from Dr Nick Levell, national Specialty Group Lead for Dermatology for our excellent
recruitment. In addition an article was published in the NIHR newsletter written by one of the Signature
patients about his excellent experience.
2. Accrue – measuring the societal impact of psoriasis
Involvement in new NIHR Portfolio trials:
1. B-STOP – Biomarkers for systemic treatment outcomes in psoriasis
2. MUSE – Mirvaso Utilization and Patient Satisfaction Study; site has been selected and in set-up phase
3. We have been pre-selected for Secukinimab follow-up study; Long term clear skin maintenance
treatment optimization in patients with moderate to severe chronic plaque psoriasis: A randomized,
multicenter, open-label with blinded-assessment, comparative, 52 week study to evaluate the efficacy,
safety and tolerability of secukinumab 300 mg s.c. OPTIMISE STUDY
4. Hi-Light for vitiligo – site visit being planned
5. Site visit planned with LEO for further Phase III studies on 7 August 2015
EKHUFT Research & Development Annual Report 2014-15
Author: Dr Tim Doulton, Director of Research & Development
Page 15 of 40
Other research output (conference proceedings, abstracts, poster & oral presentations; invited lectures;
invited contributions to books etc.):
1. July 2014 - C. Duhovic, M. Mohsin, E. Duarte-Williamson and S. Baron. ‘The effectiveness of a written
treatment plan in the management of children with atopic eczema East Kent Hospitals University NHS
Foundation Trust, Canterbury.’ British Society for Paediatric Dermatology Oral Presentation at the BAD
annual meeting.
2 July 2014 - Invited Guest Speaker Dr Susannah Baron at the British Society for Paediatric Dermatology
at the BAD annual meeting. ‘Paediatric Dermatology at the Regional Dermatology Training Centre at Moshi,
Tanzania’
3. Oct 2014 - Duhovic. C and Duarte-Williamson E. 'A case of necrobiotic xanthogranuloma treated with
prednisolone'. Poster at the EADV Annual Congress, Amsterdam, The Netherlands, October 8-12, 2014.
4. Jan 2015 - Duhovic C and Birnie A. 'A giant fungating tumour on the buttock'. Presentation at the CPC
Meeting, Royal Society of Medicine - Dermatology Section.
5. Jan 2015 – Invited Guest Speaker Dr Susannah Baron at the UK Psychodermatology Meeting at the
Royal College of Physicians .‘A pilot study of hypnotherapy to treat adults and children with moderate to
severe atopic eczema’.
6. Mar 2015 - Duhovic. C and Duarte-Williamson E. 'A case of necrobiotic xanthogranuloma treated with
prednisolone'. Poster at the AAD Annual Congress, San Francisco, California, March 20-24, 2015.
7. Two invited book chapters by Susannah Baron: Systemic therapy in children and Propanolol chapters in
2nd Edition of Handbook of Systemic Drug Treatment in Dermatology, edited by Sarah Wakelin, Howard
Maibach and Clive Archer. CRC Press, published 2015.
Kent Kidney Research Group
The Kent Kidney Research Group has a research strategy linked to the understanding and prevention of
chronic kidney disease (CKD) and acute kidney injury (AKI), resistant hypertension and the better
management of established renal failure. The group contributes to many studies in the UK CRN Portfolio
and is the lead centre for several UK-wide studies.
A key priority has been investigation of the value of a novel marker of renal function, serum cystatin C, as
part of the HTA/NIHR funded eGFR-C study. We are the lead centre (and leading recruiter) for this multicentre study which has recruited >500 patients in the past year towards its target of 1320. The group
continues to analyse data and publish results generated from the RfPB/NIHR-funded study investigating the
validity of equations for estimating GFR in older people. We have completed an RfPB/NIHR-funded study
investigating the biological variability of markers of acute kidney injury, including neutrophil gelatinase
associated lipocalin (NGAL), kidney injury molecule-1 (KIM-1), cystatin C and others, and this project is
being prepared for publication. A British Renal Society funded study investigating the value of bone alkaline
phosphatase as a predictor of outcome in haemodialysis patients opened to recruitment in March 2014 and
has recruited >1300 haemodialysis patients. A variety of other projects have been undertaken and
published in collaboration with clinical biochemistry.
Studies investigating the utility of clinical decision support systems in the fields of both CKD and AKI are
ongoing, funded by NIHR (11/200428). This work is being carried out in collaboration with The University of
Kent (Department of Statistics) and Canterbury Christchurch University and is due to complete in mid-2014.
EKHUFT Research & Development Annual Report 2014-15
Author: Dr Tim Doulton, Director of Research & Development
Page 16 of 40
The group are actively collaborating with the University of Kent (Medway School of Pharmacy) using in vitro
models to assess the mechanism of nephrotoxicity seen with some common drugs, and investigating more
accurate methods of identifying urinary tract infection in kidney transplant recipients.
The KKRG group is one of two renal research groups within the Kent, Surrey and Sussex Clinical Research
Network (CRN). The Renal Research Nursing Team is supported by the NIHR (HTA grant, supporting Gillian
Eaglestone – Team Leader), the BiCARB and PIVOTAL studies (supporting Elizabeth Clarke, Research Nurse)
and CRN: KSS (2.8 WTE posts: Research Nurses Sarah Knight & Frances Morris and CTA Zara Garratt). A
research scientist, Aisling Potter, also supports many of the studies.
The team work incredibly hard to deliver at least 15 NIHR Portfolio studies in a wide range of conditions, of
which examples. PRED4 is a large gastroenterology study looking at prevention of proton pump inhibitor
induced nephritis. The BiCARB study addresses the question of whether there are benefits to treating
acidotic CKD3/4 patients with sodium bicarbonate.
In addition, Dr Tim Doulton is PI for a number of open NIHR Portfolio studies – with outstanding support
from Elizabeth, Frances and the rest of the team:
 PYRENEES – an Industry-funded study (Astellas) – is looking at the efficacy and safety of
Roxadustat, a novel agent used to treat anaemia in people with CKD. We are well on track to hit our
recruitment target.
 PIVOTAL – an RCT looking at high vs. lose dose IV iron in people on haemodialysis. This is the largest
RCT ever undertaken by the UK renal community and EKHUFT is the third highest recruiting centre
(from over 50) in the UK.
 PEXIVAS – a globally-recruiting RCT (2x2 factorial) comparing standard vs. lower dose
glucocorticoids and plasma exchange (PLEX) vs. no PLEX in patients with life/organ-threatening
systemic vasculitis. Since opening in early 2013 we’ve recruited 7 patients.
 PSV Genetics – a genome-wide association study (GWAS) in people with vasculitis
 RaDaR – a registry study in people with rare renal diseases
Other NIHR Portfolio studies which we have recruited to in the last year include UK calciphylaxis, Pred4,
aHUS, Direct, STOP-ACEI, and FEPOD.
Other research output (conference proceedings, abstracts, poster & oral presentations; invited lectures;
invited contributions to books etc.):
Alshaer I, Stevens PE, Kilbride HS, Eaglestone G, Knight S, Carter JL, Delaney MP, Farmer CKT, Irving J,
O'Riordan SE, Dalton N, Lamb EJ. External validation of the Berlin equations for estimation of GFR in the
elderly. Poster presentation at: Kidney Week, Joint Meeting of British Renal Society and Renal Association,
Glasgow, May 2014.
Carter JL, Stevens PE, Knight S, Eaglestone G, Farmer CKT, Lamb EJ. Biological variation of neutrophil
gelatinase-associated lipocalin (NGAL) and kidney injury molecule (KIM-1) in chronic kidney disease (CKD)
patients. Poster presentation at: Kidney Week, Joint Meeting of British Renal Society and Renal Association,
Glasgow, May 2014.
Charter C, Thomsett K. Accuracy of Body Mass Index used in Renal Association Guidelines for
undernutrition: The importance of patient height measurement. Poster presentation at Kidney Week, Joint
Meeting of British Renal Society and Renal Association, Glasgow, May 2014.
Lamb EJ. Biological variation – implications for renal medicine. Oral presentation (invited speaker) at IFCCWorldLab, 22nd International Congress of Clinical Chemistry and Laboratory Medicine, Istanbul, Turkey, June
2014.
EKHUFT Research & Development Annual Report 2014-15
Author: Dr Tim Doulton, Director of Research & Development
Page 17 of 40
Lamb EJ. The updated KDIGO guideline for chronic kidney disease. Oral presentation (invited speaker) at
IFCC-WorldLab, 22nd International Congress of Clinical Chemistry and Laboratory Medicine, Istanbul, Turkey,
June 2014.
Lamb EJ. Biological variation and kidney disease. Oral presentation (invited speaker) at ACB Wales Autumn
Regional Meeting, Newport, Wales, November 2014.
Lamb EJ, Brettell EA, Cockwell P, Dalton RN, Deeks JJ, Harris K, Higgins T, Kalra PA, Khunti K, Loud F, Ottridge
RS, Sitch AJ, Sharp CC, Stevens PE, Sutton AJ, Taal M. The eGFR-C Study. Accuracy of glomerular filtration
rate (GFR) estimation using creatinine and cystatin C and albuminuria for monitoring disease progression in
patients with stage 3 chronic kidney disease: prospective longitudinal study in a multiethnic population
(study registration number ISRCTN42955626). Poster presentation at: Kidney Week, Joint Meeting of British
Renal Society and Renal Association, Glasgow, May 2014.
Stevens PE. Integrating Multiple Guidelines: Geriatric Perspective. Distinguished International Award
Lecture, Spring Meeting of the US National Kidney Foundation, Las Vegas, April 2014.
Stevens PE. KDIGO Clinical Practice Guideline on Evaluation and Management of CKD. International Lecture
by Webcast in 3 Indian Cities, Mumbai, Hyderabad, Delhi and Chennai, May 2014
Stevens PE. CKD Epidemiology: Views From Outside Japan. Invited guest lecture, 57th Annual Meeting of
the Japanese Society of Nephrology, Yokohama, July 2014.
Stevens PE. NICE Clinical Guideline On Acute Kidney Injury (CG169). Oral presentation (invited speaker) at
the 2014 EDTNA/ERCA UK Seminar, Ashford, November 2014.
Stevens PE. Detection and Management of Chronic Kidney Disease. Oral presentation (invited speaker) at
the Acute & General Medicine Conference, London, November 2014.
Stevens PE. NICE Chronic Kidney Disease. Invited lecture to GP Update Meeting, Maidstone, December
2014.
Thomsett K, Judge C, Head C, Lam M, Wells K, Greenfield L, Willey J, Pendleton S. Establishing a
Diabetes:Kidney Care Working Group Poster presentation at Diabetes UK annual conference, March 2015
Higher degree supervision during 2014-15:
Christopher Parker, MSc Clinical Biochemistry, University of Manchester, research project on biological
variability of TIMP-2 and IL-18.
EKHUFT Research & Development Annual Report 2014-15
Author: Dr Tim Doulton, Director of Research & Development
Page 18 of 40
Dr David Stephensen & Dr Gillian Evans, Kent Haemophilia and Thrombosis Centre
Investigator initiated research
Haemophilia: Investigating Physical Performance Outcomes (HIPPO): This study linked to an NIHR Clinical
Lectureship award by Dr David Stephensen indicates that in children aged 6-11 years greater frequencies of
bleeds into the knee were significantly associated with reduced muscle strength of ankle plantarflexors,
walking distance and ability to stand on one leg. Additionally, increased incidents of bleeding into the ankle
were significantly associated with reduced knee extensor strength and time taken ascending and
descending stairs, with close relationships between age at first bleed and strength. (UKCRN ID 13597)
Stability Training And Balanced Locomotion Exercise intervention programme to reduce falls and balance
dysfunction in people with haemophilia (STABLE): Dr David Stephensen in collaboration with colleagues
from Canterbury Christchurch University is exploring if falls or the fear of falling is a problem for people
with haemophilia and to see if this has any effect on mobility and balance. If a problem exists we plan to
develop a targeted exercise intervention to be evaluated in a clinical trial.
Haemophilia Arthropathy: Inter-rater Repeatability Of an Ultrasound Imaging Score (HORUS): The aim of
this multicentre study lead by Dr David Stephensen aims to determine the inter-rater repeatability of the
HEAD-US score performed by haemophilia physiotherapists who have undergone a short training
programme and to evaluate the association of the HEAD-US with the clinical examination, Haemophilia
Joint Health Score.
Development of a peri-operative isometric-resistance exercise intervention programme (Basic Exercise
Training To Enhance Recovery - BETTER) for patients undergoing elective abdominal and thoracic surgery
for cancer: In collaboration with colleagues at Maidstone & Tunbridge Wells NHS Trust and the University
of Kent, Dr David Stephensen is aiming to improve functional outcomes for this patient group by exploring
the feasibility of a RCT.
Participation in NIHR Portfolio research
ITP Registry: An observational investigation of disease progression, treatment effectiveness and co-morbid
conditions of ITP. (UKCRN ID 14145)
GAPP: Study involving genotyping and platelet phenotyping in patients with mild bleeding disorders.
(UKCRN ID 9858)
AHEAD: Non-interventional, multi-centre international study to describe the natural history of haemophilia
A disease and long term outcomes in terms of effectiveness, safety and quality of life. (UKCRN ID 12416)
So-Fit: Multi-centre study comparing haemophiliac joint scores, prophylaxis treatment regimes and links to
physical activity and quality of life in children and adolescents with haemophilia. In addition the monitoring
of the methodology of the collection of data by these young patients is being studied. (UKCRN ID 16059)
Nurse facilitated adherence therapy for haemophilia (AnThem) Trial: Will determine if nurse facilitated
adherence therapy for haemophilia improves patient adherence to clotting factor replacement therapy,
clinical appointments and health advice; and, affects the level of patient engagement and ownership of
treatment. (UKCRN ID 12708)
Rivaroxaban Observational Safety Evaluation Study (ROSE): Monitor the Safety and Utilization of
Rivaroxaban (Xarelto®) for the Prevention of Stroke in Patients with AF, Treatment of DVT and PE, and the
Prevention of Recurrent DVT and PE (UKCRN ID 13911). An observational study to monitor the safety and
EKHUFT Research & Development Annual Report 2014-15
Author: Dr Tim Doulton, Director of Research & Development
Page 19 of 40
efficacy of rivaroxaban versus warfarin therapy for treatment of venous thromboembolism and stroke
prevention in atrial fibrillation.
BRIDGE Study NIHR BioResource- Rare Diseases (NIHRBR-RD) study: Genetic analysis of inherited platelet
conditions (UKCRN ID 11131). A thrombogenomics study to identify novel genes causing rare bleeding
disorders and platelet function defects.
FIT-RIGEL 047: Phase 3, Multi-Centre, Randomized, Double-Blind, Placebo-Controlled, Study of
Fostamatinib Disodium in the Treatment of Persistent/Chronic ITP (UKCRN ID 13685)
FIT-RIGEL 049: Follow on study from the FIT-RIGEL 047 (UKCRN ID 16835)
Other research output (conference proceedings, abstracts, poster & oral presentations; invited lectures;
invited contributions to books etc.):
Conference proceedings
European Association of Haemophilia and Associated Disorders (EAHAD) Congress, Helsinki, Feb, 2015
THE AHEAD STUDY: INTERIM RESULTS AFTER ONE YEAR OF OBSERVATION
J. Oldenburg, D. Tsakiris, C. Hermans, K. Khair, M.G. Mazzucconi, L. Abad-Franch, A. Loew-Baselli on behalf
of the AHEAD study group.
Haemophilia Chartered Physiotherapists Association Annual Scientific Meeting, February 2015
INFLUENCE OF LOWER LIMB JOINT BLEEDING ON PHYSICAL FUNCTION IN YOUNG BOYS WITH
HAEMOPHILIA
Stephensen, Taylor , Bladen, Drechsler
British Society For Haematology Annual Scientific Meeting 2015
BURDEN OF THROMBOEMBOLISM AND THROMBOPROPHYLAXIS AT EKHUFT IN PATIENTS WITH MYELOMA
TREATED WITH IMMUNOMODULATORY DRUG CONTAINING REGIMES BETWEEN 2009 AND 2014. A
RETROSPECTIVE STUDY.
CA Roughley, M Capomir, J Lindsay, C Pocock, V Ratnyake, K Saied, G Evans
British Society For Haematology Annual Scientific Meeting 2015
PROSPECTIVE AUDIT OF RIVAROXABAN AS THROMBOPROPHYLAXIS AND TREATMENT DURING MYELOMA
THERAPY WITH IMMUNOMODULATORY DRUGS AT EKHUFT. CA Roughley, M Capomir, J Lindsay, C Pocock,
V Ratnyake, K Saied, G Evans
British Society For Haematology Annual Scientific Meeting 2015
THROMBOPOEITIN RECEPTOR AGONISTS IN IMMUNE THROMBOCYTOPENIC PURPURA. OUR EXPERIENCE
AT EKHUFT.
T Vatopolou, K Fletcher, K Kaminaris, G Evans
Grant awards during 2014-15:
2015 – 2016
Pfizer Haemophilia Investigator-Initiated Research Program; £11,905
Stephensen, Bowles, Classey, Taylor, Hooper, Wells, Patel
Haemophilia Arthropathy – Inter-rater Repeatability of an Ultrasound Imaging Score
(HORUS) Study
2014 – 2016
Kent University Hospitals NHS Foundation Trust Research Session Scheme; £25,636
Stephensen & Swaine
EKHUFT Research & Development Annual Report 2014-15
Author: Dr Tim Doulton, Director of Research & Development
Page 20 of 40
STABLE (Stability Training And Balanced Locomotion Exercises) intervention programme to
reduce falls and balance dysfunction in people with haemophilia
2015 – 2018
NIHR Research for Patient Benefit (RfPB) Programme: PB-PG-0613-31107; £338,000
Ali, Swaine, Stephensen, Hashem, Sherrington
Development of a peri-operative isometric-resistance exercise intervention programme
(Basic Exercise Training To Enhance Recovery - BETTER) for patients undergoing elective
abdominal and thoracic surgery for cancer
2012 – 2015
William Scholl Podiatric Research & Development Endowment Fund; £132,403
Izod, Drechsler, Stephensen, Bowen
What is the impact of early adult rheumatoid arthritis on the biomechanical and functional
characteristics of the foot & leg?
2012 – 2015
William Scholl Podiatric Research & Development Endowment Fund; £220,340
Bowen, Arden, Dohoughty, Drechsler, Stephensen
Prevalence and risk factors for radiographic foot osteoarthritis in middle-aged women: the
Chingford Study
2011 – 2014
NIHR Clinical Lectureship for Allied Health Professionals; £99,440
Stephensen
Development of outcome tools and an evaluation pathway to monitor clinical progression in
young boys with haemophilia
Higher degree supervision during 2014-15:
Stephensen, University of East London, Are there changes in muscle function and gait in adolescents with
haemophilia? (PhD, Suckling, awarded February 2015)
Stephensen, University of East London, Alterations in muscle and gait characteristics in young adults with
haemophilia: Impact of continued prophylaxis (PhD, Chatzifragou, 2012-)
Stephensen, University of East London, What is the impact of early adult rheumatoid arthritis on the
biomechanical and functional characteristics of the foot and lower limb? (PhD, Izod, 2013-)
EKHUFT Research & Development Annual Report 2014-15
Author: Dr Tim Doulton, Director of Research & Development
Page 21 of 40
Dr Rakesh Raman & colleagues, Oncology (Solid Tumour) Research Team
This year has been both challenging and rewarding for the Solid Tumour Research Team. We have attracted
outside funding in order to recruit a Clinical Trials Officer to support the colorectal cancer study portfolio,
and the team has now expanded to encompass the gynaecological oncology team at QEQM Hospital.
The Solid Oncology Research Team Back row, left to right: Louise Allen, Nikki Crisp, Sarah Lines, Margaret
Lipsham, Bonny Appleby, Louise Gladwell, Dr Rakesh Raman; Middle Row: Karen Robinson,
Hilary Zurakovsky, Sue Drakeley – Lead Cancer Research Nurse; Front Row: Cindy Slater
East Kent Hospitals Oncology research activity has continued to perform well in 2014-15 and not only have
they met their recruitment targets, but have exceeded recruitment in a number of studies:

RADICALS – A randomised controlled trial in prostate cancer. East Kent are amongst the top 10 highest
international recruiters with a total recruitment of 87 patients.

As a Trust, EKHUFT is amongst the top recruiters into the PERSEPHONE breast cancer trial which is not
always easy to recruit into as the experimental arm gives less treatment than the current gold
Standard. 70 patients had been recruited up to end March 2015.

We have recruited almost 100 patients into the practice changing prostate cancer trial STAMPEDE, the
abstract of which has recently been presented at American Society of Clinical Oncology (ASCO).
The total recruitment for cancer studies within the Trust for the year 2014-15 was 190, as indicated in the
individual tumour sites illustrated below.
EKHUFT Research & Development Annual Report 2014-15
Author: Dr Tim Doulton, Director of Research & Development
Page 22 of 40
We look forward to the continued expansion of the team to meet the ever-increasing requirements of
complex cancer trials.
Dr Eve Hutton, Child Health
This year I have focused on dissemination of the findings from the NIHR, Research for Patient Benefit Study
‘The effectiveness of a postural care education programme for parents and teachers of children with
physical disabilities’ which concluded in 2013. Papers have been accepted at national and international
conferences (poster and oral presentations). I have been working with the co-investigators on a series of
publications. We have one article published in Child, Care Health & Development and a further article in
preparation. The study was included as an example of good practice in the annual Parliamentary report
‘Research & Development in Assistive Technology’ Department of Health (2013-14). This report has impact
on policy and practice in the field of assistive technology and it is a mark of esteem that the study was
included.
The research partners (CCCU, EKHUFT, UoK) submitted applications for Higher Education Innovation
Funding (HEIF) from Canterbury Christ Church University and the University of Kent in September 2014 and
we were successful in securing funding. This has enabled the development of a business case to support the
sustainable development of the postural care training programme. The intention is to improve care for
children with disabilities, not only in East Kent but to identify a sustainable way of providing the training
within the wider NHS. There is considerable interest from across the UK for this novel training programme
amongst therapists and educators and we anticipate that later this year we will be in a position to take
plans for commercialisation forward. The HEIF project has strengthened the collaboration between the
partners laying the foundations for further research in this area.
Other research output (conference proceedings, abstracts, poster & oral presentations; invited lectures;
invited contributions to books etc.):
Conference oral presentations
Hutton E and Crombie, S (2014) Researching together, inter-professional research in postural care for
children with disabilities. APCP and CYPF specialist sections conference. November 21st. Edinburgh.
Hutton E, Hotham S, and Hamilton West K (2014) The effectiveness of a postural care training package in
supporting parents and educators optimise function and promote the well-being and participation of
EKHUFT Research & Development Annual Report 2014-15
Author: Dr Tim Doulton, Director of Research & Development
Page 23 of 40
disabled children at school and in the home. ‘Count me in’ childhood occupations conference. 19-20th May.
The Royal Society of Medicine. Wimpole Street. London.
Public Lecture
Hutton E (2014) ‘New ways of working in paediatric occupational therapy’. Canterbury Christ Church
University. July 26th.
Hutton E ( 2014) ‘Involving parents in research about their children’. Organised by Kent Health. Canterbury
Christ Church University.
Grant awards during 2014-15:
Higher Education Innovation Funding. £3,100.00, November 2014- July 2015. Lead Applicant. ‘Postural Care
training programme – proposed feasibility study for commercialisation’. In collaboration with the University
of Kent & Canterbury Christ Church University
New high degree supervision during 2014-15:
PhD Site Supervisor. Kikuba M, ‘A Multi-method inquiry to develop a training package on squatting
positions to increase the likelihood of normal vaginal births: an innovation study.’ Continuing Professional
Development Centre, University of Oxford.
Dr Vimal Vasu, Neonatal Medicine
The neonatal unit has continued to be active in clinical research recruiting to NIHR portfolio studies (Speed
of increasing milk feeds - SIFT Trial and the Platelets for Neonatal Transfusion - PLANET 2 Trial). 48 patients
were recruited to the SIFT and, so far, 5 patients have been recruited to the PLANET 2. We are hoping to
begin recruitment to the Enteral Lactoferrin In Neonates (ELFIN) trial which is a large multicentre RCT of
prophylactic enteral lactoferrin supplementation to reduce late onset sepsis in preterm infants.
In addition, our collaboration with the School of Biosciences at University of Kent continues and we are
about to embark upon a pilot study to establish the feasibility of using neonatal urine samples to extract
DNA to measure DNA methylation.
Other research output (conference proceedings, abstracts, poster & oral presentations; invited lectures;
invited contributions to books etc.):
Lectures
Telomere biology in preterm infants. 1st October 2014. Presentation at the Kent Health Research
Symposium (invited)
Abstracts
Turner KJ, George S, Greenall J, Griffin DK, Vasu V, “Is preterm birth associated with accelerated telomere
shortening?” presented at the Spring meeting of the Neonatal Society (19th March 2015)
Higher degree supervision during 2014-15:
Dr Vasu has co-supervised a PhD student at the University of Kent (Kara Turner) who submitted her Thesis
entitled “Telomere length and distribution in three developmental stages” and was awarded her PhD
recently.
EKHUFT Research & Development Annual Report 2014-15
Author: Dr Tim Doulton, Director of Research & Development
Page 24 of 40
Nicky Wood, Psychological Services in Child Development & Paediatrics
Psychological Services in Child Development & Paediatrics have had an active research year. We have
developed our book based on our previous two projects about barriers to participation in children with
cerebral palsy.
Our treatment study looking at the effectiveness of hypnosis in children who wet the bed has been fully
recruited to, early indications are that for the majority of children with primary enuresis the intervention is
moving them significantly towards partial or almost complete dryness at night.
We have undertaken two separate audits of Child Health multi-disciplinary autism assessment and
diagnostic pathways and service delivery in East Kent.
We have just started a service evaluation asking teenagers with diabetes type 1 about their experiences of
clinic services in East Kent in line with National Paediatric Diabetes Audit Peer Review recommendations.
We have just gained ethical approval for an upcoming study which looks at perceptions of family carers
regarding challenging behaviour displayed by children with autism.
We have collaborated with the Psychology Department, University of Kent in research which looks at
predictors of imagination and creativity in children with autism.
We continue to be involved in studies run by the Tizard Centre, University of Kent – acting as Principal
Investigators on two parent intervention studies of children with developmental disability. Also with Tizard,
we are involved jointly in a grant application to RfPB - Research for Patient Benefit looking at the
adaptation and feasibility trial of FRIENDS for Life (an anxiety management and resilience building
programme) adapted for children and young people with learning disabilities.
We are collaborating with the Drama Department, School of Arts, University of Kent, to an extension of
their ‘Imagining Autism’ project, which looks at the benefits of immersive environments in improving social
communication win children with autism.
Other research output (conference proceedings, abstracts, poster & oral presentations; invited lectures;
invited contributions to books etc.):
We undertook podium presentations of the findings of our cerebral palsy studies at the Occupational
Therapy Show conference in November 2014; at the Kent Community Health Trust Clinical Audit &
Research Conference October 2014, and at a seminar at the Centre for Health Services Studies, University
of Kent, November 2014.
EKHUFT Research & Development Annual Report 2014-15
Author: Dr Tim Doulton, Director of Research & Development
Page 25 of 40
CLINICAL SUPPORT SERVICES DIVISION
Professor Fritz Mühlschlegel, Consultant Microbiologist
On behalf of colleagues Alistair Balfour, Sarah Stevens, Mark Baker, Julie Hawes-Reekie, Leila
Williams & Campbell Gourlay (Departments of Surgery, Speech and Language Therapy &
Pharmacy, EKHUFT and Kent Community Health NHS Trust; School of Biosciences, University of
Kent)
A multi-disciplinary approach to clinical management and research of surgical voice prosthesis failure
A total laryngectomy is the surgical removal of the larynx, usually to treat cancer. Surgical voice restoration
(SVR) is the “gold standard” in speech restoration and involves insertion of silicone voice prostheses. The
voice prosthesis can fail and oesophageal contents leak into the airway. The most common cause of early
prosthesis failure is due to Candida colonisation of the device and there are no nationally agreed guidelines
or pathways for managing this. A team of specialists from Microbiology, ENT, Cell Biology (University of
Kent), Pharmacy and Speech and Language Therapy, have formed the East Kent Voice Prosthesis Infection
Management MDT. This team has considered the evidence-base (and reached consensus where the
evidence-base is lacking) to devise a clinical care pathway for managing voice prosthesis failure. This has led
to an up to six-fold increase in voice prosthesis lifespan improving patient care and reducing costs. We
integrate basic research into our approach to underpin and facilitate clinical practice. The research aims to
determine how Candida colonise voice prosthesis and develop into a treatment‐refractory bio‐film that
leading on to device failure. By using a high-throughput model we investigate how elevated levels of CO2, as
found in exhaled breath, trigger Candida to form a biofilm on the voice prosthesis and looks into
biomaterials preventing and novel ways of early detection of biofilms. We are working towards influencing
national practice in this specialist field.
The team represents a fantastic combination of talent from a variety of disciplines coming together and
“pooling” expertise in order to comprehensively address a clinical question – a combination of basic
sciences & clinical research and clinical practice at its very best!
EKHUFT Research & Development Annual Report 2014-15
Author: Dr Tim Doulton, Director of Research & Development
Page 26 of 40
The Kent Fungal Group From left to right: Daniel (PhD student, School of Biosciences, University of Kent);
Julie Hawkes-Reekie (Lead Antimicrobial Pharmacist); Thazhath Veettil Madhusoodanan (ENT Nurse
Practitioner); Dr Campbell Gourlay (Senior Lecturer, School of Biosciences, University of Kent); Prof Fritz
Muhlschlegel (Consultant Microbiologist); Viktoria (PhD student, School of Biosciences and School of
Electronic Engineering, University of Kent); Sarah Stevens (Macmillan Speech and Language Therapist); Mr
Alistair Balfour (Consultant ENT surgeon); Leila Williams (Speech and Language Therapist)
Dr Matthew Strutt, Consultant Microbiologist
Project: “Characterizing overactive bladder syndrome with a view to better diagnostics and treatment”
Joint project with University of Greenwich School of Pharmacy (Dr Scott Wildman) and Medway NHS
Foundation Trust (Prof. Jonathan Duckett) evaluating role of occult intracellular infection and nucleotide
release from uroepithelium. We are determining, using mid-stream urine samples (MSU), and where
possible catheterised urine samples (CSU), from carefully characterized patients with OAB and
asymptomatic controls:
1. Whether intracellular bacteria are found in shed urothelial cells of OAB patients, and not asymptomatic
patients (using histology and microscopy).
2. The species of bacteria (extracellular and intracellular) present (through sediment culture of urine
samples and PCR).
3. The urinary concentration of nucleotides (by means of a luciferin-luciferase bioassay).
Project: “Factors affecting decay of antibody titres in non-dialysed CKD patients following hepatitis B
vaccination”
Study in conjunction with Dr Doulton and recipient of EKHUFT-University of Kent studentship grant looking
at persistence of hepatitis B immunity following vaccination in non-dialysed chronic kidney disease
patients. This study, undertaken by Natasha Hunt (2nd year undergraduate, University of Kent) looked at
factors influencing longevity of immunity following primary immunisation course against hepatitis B and
effectiveness of further boosters. The results will be presented by Dr Doulton at the British Renal Society in
June 2015.
Dr Neelan Das, Interventional Radiology
I am currently the Principal Investigator for an actively recruiting NIHR Portfolio study (UK ROPE) as well as
being co-investigator of a second Portfolio (BASIL 2) study. I am PI for two further studies (PAVE and BASIL
3) which are due to start in the New Year.
UK ROPE: This is a registry based study approved by NIHR/NICE/BSIR/BAUS, looking at prostatic arterial
embolisation (PAE) for the treatment of BPH. It is a comparator study of the traditional TURP and PAE. We
are the largest UK recruiter for the TURP arm and are the third largest recruiter for the PAE arm. This study
was opened in June 2014 but locally started in December 2015. Target recruitment is for 15 to each arm.
Currently, I have achieved 25 to the TURP arm and 11 to the PAE arm.
BASIL 2: This trial is assessing surgical bypass versus endovascular treatment for infra-popliteal
atherosclerotic disease.
EKHUFT Research & Development Annual Report 2014-15
Author: Dr Tim Doulton, Director of Research & Development
Page 27 of 40
PAVE: I have been selected to be the local PI for this site and I expect to recruit 2 patients per month
minimum. Recruitment starts in January.
BASIL 3: I have been selected as the local PI for this trial investigating what is the best endovascular therapy
for patients presenting with severe limb ischaemia. Total recruitment target in this multicentre trial will be
861.
Ben Chitambira, Senior Physiotherapist in Stroke, Richard Stevens Ward
My research focus is the use of optokinetic chart stimulation in stroke and other neurological conditions.
Preliminary evidence suggests that dense parietal strokes that do not simultaneously involve the temporal
lobe recover voluntary movements from complete paralysis when treated with the optokinetic chart based
OKCSIB protocol. This is a huge benefit to stroke patients as it prevents dense strokes from leading to
permanent impairment and disability which often lead to depression. Dramatic results are also being seen
in critical illness polyneuropathy and traumatic brain injuries where minimally conscious and completely
paralysed traumatic brain injuries have regained at least assisted mobility and function. The OKCSIB
protocol is less intensive hence it provides value for money in that more patients can be seen. For the
health economy the potential benefits are huge as preventing permanent impairment and disability saves
on care costs.
The research has led to optokinetic chart stimulation being directly requested for by consultants whenever
they have seen patients with balance problems whether from ears or from the processors of the ears in the
brain. There is more awareness of the benefits of optokinetic chart stimulation at the William Harvey
Hospital. On an international scale there are increasing enquiries from patients’ relatives in Europe to have
this form of treatment. Links are starting to develop with other clinicians in Europe as a result of the
interest generated by the research.
Other research output (conference proceedings, abstracts, poster & oral presentations; invited lectures;
invited contributions to books etc.):
2 poster presentations, 1 locally and one in Spain
2 invited oral presentations , 1 in Italy and 1 in the UK
1 invited keynote speaker invitation in the UK
1 original research publication in press
1 invited contribution to a book
2 scientific journals editorship
Helen Oakes, Physiotherapy
‘A comparative study exploring whether group acupuncture and physiotherapy care has comparable
outcomes to individual targeted acupuncture and physiotherapy care with regards to numerical rating scale
(NRS) pain scores and Measure Yourself Medical Outcome Profile (MYMOP) scores for patients with low
back pain.’
The group acupuncture treatment was found to be non inferior to the individual targeted acupuncture with
regard to the primary outcome measure; the NRS scores at 1-5 weeks but not at 5 weeks. The results were
uncertain whether the group acupuncture MYMOP scores were non inferior; non inferiority could not be
established. The MYMOP scores are individual to the patient and measure main symptom, an activity that is
problematic, wellbeing and medication usage. As with both outcome measures at 5 weeks non inferiority
could not be established it may be more appropriate to offer individualised targeted acupuncture. 30% of
the patients in the group acupuncture group reduced their medication by the end of their treatment
EKHUFT Research & Development Annual Report 2014-15
Author: Dr Tim Doulton, Director of Research & Development
Page 28 of 40
compared to 42% reducing their medication in the individual targeted acupuncture group. In conclusion the
results of this study suggest that individual targeted acupuncture and physiotherapy may be a better
treatment option than group acupuncture and physiotherapy. This research project confirmed that our
current method of providing the treatment on a one to one basis is better than offering group treatment.
Through publication in the Journal Acupuncture in Physiotherapy we hope to share these findings
throughout the UK.
Other research output (conference proceedings, abstracts, poster & oral presentations; invited lectures;
invited contributions to books etc.):
The findings are due to be published in the Autumn 2015 edition of the peer reviewed journal Acupuncture
in Physiotherapy and as a poster at the therapies clinical excellence day in September.
CORPORATE DIVISION
Dan Marsden, Risk and Legal, Quality and Operations
My Healthcare Passport is a paper based tool to enable ward staff in working with patients with learning
disabilities, who may be less able to give a full verbal history. A participatory action research methodology
has been employed to engage a Co-Researcher Team, including people with learning disabilities, clinical and
administrative EKHUFT staff, a parent carer and a nursing home manager.
The Co-Researcher team has been looking at the implementation and evaluation of My Healthcare
Passport, and had consulted with stakeholders across the whole system. Three spirals of activity are being
pursued:1)
Making Improvements to My Healthcare Passport
2)
Raising awareness and usage of My Healthcare Passport
3)
Using IT systems for delivery of this information.
The latter is leading to a joint project with Dr Chris Farmer (Associate Medical Director for IT) to test a third
party patient held record system with a sensor embedded in a bracelet.
Other significant findings relate to the barriers to participation in research activity within the NHS,
particularly for those with learning disabilities, but also more recently other non NHS employees.
Other research output (conference proceedings, abstracts, poster & oral presentations; invited lectures;
invited contributions to books etc.):
This work has been presented at two regional conferences, and a poster has been presented at a national
conference.
OTHER
Rose Ward, Pilgrims Hospice
In 2014 Pilgrims Hospice participated in NIHR Portfolio study The Validity and Reliability of the IPOS
(Integrated Palliative care Outcome Scale; PI Dr Claire Butler, Honorary Consultant in Palliative Care for
EKHUFT, Medical Director Pilgrims Hospices). Funded by an NIHR Programme Grant for Applied Research,
the study was part of an ongoing programme to develop and validate a patient centred, nationally
applicable case-mix classification for adult palliative care provision. Chief Investigator was Dr Fliss Murtagh,
Clinical Senior Lecturer, King's College London Department of Palliative Care, Policy and Rehabilitation.
EKHUFT Research & Development Annual Report 2014-15
Author: Dr Tim Doulton, Director of Research & Development
Page 29 of 40
The study aimed to provide a validated, reliable assessment tool (the IPOS) for global measurement of
palliative care concerns, and incorporated two previously validated and widely used assessment tools, the
core POS and the POS symptom module.
Questionnaires were completed at two different time points by patients and health care professionals
(HCPs) in the in-patient unit and community settings. Versions of the questionnaires differed between
patients and HCPs, and also across the time points and settings.
Despite being a vulnerable and frail patient group, palliative care patients are pleased to participate in
research and the Hospice recruited well, success which has resulted in Pilgrims Hospices being invited to
participate further with Dr Murtagh in the ongoing programme.
Also following previous success, the Hospice has been invited to participate in CTIMP BreatheMOR-HF
investigating the efficacy of morphine for the relief of breathlessness in patients with stable chronic heart
failure. Working closely with EKHUFT and KCHT the Hospice hopes to open recruitment in October 2015.
Other research output (conference proceedings, abstracts, poster & oral presentations; invited lectures;
invited contributions to books etc.):
In March 2015 the summary of findings was published for the NIHR Portfolio study Evaluation Of Pilgrims
Hospices Rapid Response Service which examined whether the introduction of a Hospice rapid response
service to provide care for patients in their own homes in the last days of life resulted in an increase in the
number of patients dying in their preferred place of death. This can be accessed by following the link
https://kar.kent.ac.uk/47799/ . Other peer-reviewed journal articles from the project have also been
published since April 2015.
EKHUFT Research & Development Annual Report 2014-15
Author: Dr Tim Doulton, Director of Research & Development
Page 30 of 40
5.
Peer-reviewed publications from April 2013 to March 2014
1. AlHassany AA. Night blindness due to vitamin A deficiency associated with copper deficiency
myelopathy secondary to bowel bypass surgery. BMJ Case Rep. 2014 Apr 29;2014. pii: bcr2013202478.
doi: 10.1136/bcr-2013-202478.
2. Alshaer IM, Kilbride HS, Stevens PE, Eaglestone G, Knight S, Carter JL, Delaney MP, Farmer CK, Irving J,
O'Riordan SE, Dalton RN, Lamb EJ. External validation of the Berlin equations for estimation of GFR in
the elderly. Am J Kidney Dis. 2014 May;63(5):862-5. doi: 10.1053/j.ajkd.2014.01.013. Epub 2014 Feb 12.
3. Ardeshna KM, Qian W, Smith P, Braganca N, Lowry L, Patrick P, Warden J, Stevens L, Pocock CF, Miall F,
Cunningham D, Davies J, Jack A, Stephens R, Walewski J, Ferhanoglu B, Bradstock K, Linch DC. Rituximab
versus a watch-and-wait approach in patients with advanced-stage, asymptomatic, non-bulky follicular
lymphoma: an open-label randomised phase 3 trial. Lancet Oncol. 2014 Apr;15(4):424-35. doi:
10.1016/S1470-2045(14)70027-0. Epub 2014 Mar 4.
4. Ashworth N, Bland J, Chapman K, Tardif G. What about steroids? CMAJ. 2015 Feb 3;187(2):131. doi:
10.1503/cmaj.115-0001.
5. Bachmann A, Tubaro A, Barber N, d'Ancona F, Muir G, Witzsch U, Grimm MO, Benejam J, Stolzenburg
JU, Riddick A, Pahernik S, Roelink H, Ameye F, Saussine C, Bruyère F, Loidl W, Larner T, Gogoi NK,
Hindley R, Muschter R, Thorpe A, Shrotri N, Graham S, Hamann M, Miller K, Schostak M, Capitán C,
Knispel H, Thomas JA. 180-W XPS GreenLight laser vaporisation versus transurethral resection of the
prostate for the treatment of benign prostatic obstruction: 6-month safety and efficacy results of a
European Multicentre Randomised Trial--the GOLIATH study. Eur Urol. 2014 May;65(5):931-42. doi:
10.1016/j.eururo.2013.10.040. Epub 2013 Nov 11.
6. Bates T, Evans T, Lagord C, Monypenny I, Kearins O, Lawrence G. A population based study of variations
in operation rates for breast cancer, of comorbidity and prognosis at diagnosis: failure to operate for
early breast cancer in older women. Eur J Surg Oncol. 2014 Oct;40(10):1230-6. doi:
10.1016/j.ejso.2014.06.001. Epub 2014 Jun 26.
7. Bedford M, Stevens PE, Wheeler TW, Farmer CK. What is the real impact of acute kidney injury? BMC
Nephrol. 2014 Jun 21;15:95. doi: 10.1186/1471-2369-15-95.
8. Benson PE, Javidi H, DiBiase AT. What is the value of orthodontic treatment? Br Dent J. 2015 Feb
16;218(3):185-90. doi: 10.1038/sj.bdj.2015.43.
9. Bland JD, Rudolfer SM. Ultrasound imaging of the median nerve as a prognostic factor for carpal tunnel
decompression. Muscle Nerve. 2014 May;49(5):741-4. doi: 10.1002/mus.24058
10. Bland JD, Rudolfer S, Weller P. Prospective analysis of the accuracy of diagnosis of carpal tunnel
syndrome using a web-based questionnaire. BMJ Open. 2014 Aug 20;4(8):e005141. doi:
10.1136/bmjopen-2014-005141.
11. Byrd JC, Brown JR, O'Brien S, Barrientos JC, Kay NE, Reddy NM, Coutre S, Tam CS, Mulligan SP, Jaeger U,
Devereux S, Barr PM, Furman RR, Kipps TJ, Cymbalista F, Pocock C, Thornton P, Caligaris-Cappio F,
Robak T, Delgado J, Schuster SJ, Montillo M, Schuh A, de Vos S, Gill D, Bloor A, Dearden C, Moreno C,
Jones JJ, Chu AD, Fardis M, McGreivy J, Clow F, James DF, Hillmen P; RESONATE Investigators. Ibrutinib
EKHUFT Research & Development Annual Report 2014-15
Author: Dr Tim Doulton, Director of Research & Development
Page 31 of 40
versus ofatumumab in previously treated chronic lymphoid leukemia. N Engl J Med. 2014 Jul
17;371(3):213-23. doi: 10.1056/NEJMoa1400376. Epub 2014 May 31.
12. Campbell CM, DiBiase A, Fleming PS. Concomitant dilaceration, transposition, and intraosseous
migration: report of a patient treated with maxillary canine-central incisor substitution. Am J Orthod
Dentofacial Orthop. 2014 Oct;146(4):514-21. doi: 10.1016/j.ajodo.2013.11.024.
13. Carter GD, Jones J, Ketheeswaran M, Shannon J, Singh B, Kearney E, Berry JL. Automated immunoassays
for 25-hydroxyvitamin D (25-OHD): Do plasticisers interfere? J Steroid Biochem Mol Biol. 2014 Nov 13.
pii: S0960-0760(14)00263-5. doi: 10.1016/j.jsbmb.2014.11.008. [Epub ahead of print]
14. Carter JL, Lamb EJ. Evaluating new biomarkers for acute kidney injury: putting the horse before the
cart. Am J Kidney Dis. 2014 Apr;63(4):543-6. doi: 10.1053/j.ajkd.2014.01.005.
15. Carville S, Wonderling D, Stevens P; Guideline Development Group. Early identification and
management of chronic kidney disease in adults: summary of updated NICE guidance. BMJ. 2014 Jul
24;349:g4507. doi: 10.1136/bmj.g4507
16. Chitambira B. Does use of the optokinetic chart stimulation based OKCSIB protocol improve recovery of
upper and lower limb movements, function and quality of life at 3 year follow up in dense strokes? A
retrospective case control series. NeuroRehabilitation. 2014;35(3):451-8. doi: 10.3233/NRE-141135
17. Chow V, Khan S, Balogun A, Mitchell D, Mühlschlegel FA. Invasive rhino-orbito-cerebral mucormycosis
in a diabetic patient - the need for prompt treatment. Med Mycol Case Rep. 2014 Dec 23;8:5-9. doi:
10.1016/j.mmcr.2014.12.002. eCollection 2015 Jun.
18. De Cock R, Fajgenbaum MA. Calcification of Rayner hydrophilic acrylic intra-ocular lenses after
Descemet's stripping automated endothelial keratoplasty. Eye (Lond). 2014 Nov;28(11):1383-4. doi:
10.1038/eye.2014.175. Epub 2014 Aug 1..
19. Delaney MP, Stevens PE, Witham H, Judge C, Eaglestone G, Carter J, Bassett P, Lamb EJ. SERUM
CYSTATIN C DOES NOT PREDICT MORTALITY OR TREATMENT FAILURE IN PERITONEAL DIALYSIS: A
PROSPECTIVE STUDY. Perit Dial Int. 2014 Sep 2. pii: pdi.2014.00071. [Epub ahead of print]
20. de Lusignan S, Sun B, Pearce C, Farmer C, Steven P, Jones S. Coding errors in an analysis of the impact of
pay-for-performance on the care for long-term cardiovascular disease: a case study. Inform Prim Care.
2014;21(2):92-101. doi: 10.14236/jhi.v21i2.62.
21. Desai M, John B, Evans G, Eddy B. Prostate cancer: beware of disseminated intravascular coagulation.
BMJ Case Rep. 2015 Mar 27;2015. pii: bcr2014206814. doi: 10.1136/bcr-2014-206814.
22. Doulton TW, Farmer CK, Stevens PE. Self-management in Chronic Disease: Clear Benefits for Blood
Pressure Control in CKD. Am J Kidney Dis. 2015 Jul; 661(1):12-14. doi: 10.1053/j.ajkd.2015.01.006.
Epub 2015 Feb 19
23. Drummond MW, Pocock C, Boissinot M, Mills J, Brown J, Cauchy P, Cross NC, Hartley S, Kell J, Szubert A,
Cockerill PN, Bowen DT. A multi-centre phase 2 study of azacitidine in chronic myelomonocytic
leukaemia. Leukemia. 2014 Jul;28(7):1570-2. doi: 10.1038/leu.2014.85. Epub 2014 Feb 26
EKHUFT Research & Development Annual Report 2014-15
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Page 32 of 40
24. Durai R, Doughan S. Using mastoid swab to protect ureter during laparoscopic colectomy. Ann R Coll
Surg Engl. 2014 Nov;96(8):621. doi: 10.1308/003588414X14055925059273.
25. Durai R, Thomas D, Doughan S. Fishing method of appendix extraction during laparoscopy. Ann R Coll
Surg Engl. 2014 Apr;96(3):247. doi: 10.1308/003588414X13814021679915.
26. Ellis P, Jenkins K. An overview of NICE guidance: acute kidney injury. Br J Nurs. 2014 Sep 1124;23(16):904-6. doi: 10.12968/bjon.2014.23.16.904.
27. Fang S, Argiris K, Padgham N. How we do it: the absorbable gelatin sponge cube, an effective and
economical approach to packing in ear surgery. J Laryngol Otol. 2014 May;128(5):475-7. doi:
10.1017/S0022215114000759. Epub 2014 May 1.
28. Graham S, Ye S, Qian M, Sanford AR, Di Tullio MR, Sacco RL, Mann DL, Levin B, Pullicino PM,
Freudenberger RS, Teerlink JR, Mohr JP, Labovitz AJ, Lip GY, Estol CJ, Lok DJ, Ponikowski P, Anker SD,
Thompson JL, Homma S; WARCEF Investigators. Cognitive function in ambulatory patients with systolic
heart failure: insights from the warfarin versus aspirin in reduced cardiac ejection fraction (WARCEF)
trial. PLoS One. 2014 Nov 26;9(11):e113447. doi: 10.1371/journal.pone.0113447. eCollection 2014.
29. Hadjiphilippou S, Odogwu SE, Dand P. Doctors' attitudes towards prescribing opioids for refractory
dyspnoea: a single-centred study. BMJ Support Palliat Care. 2014 Mar 6. doi: 10.1136/bmjspcare-2013000565. [Epub ahead of print]
30. Hafiji J, Hussain W, Salmon P. Reconstruction of perioral defects post-Mohs micrographic surgery: a
dermatological surgeon's approach. Br J Dermatol. 2015 Jan;172(1):145-50. doi: 10.1111/bjd.13197.
Epub 2014 Nov 30.
31. Hafiji J, Hussain W, Salmon P. Mohs surgery spares the orbicularis oris muscle, optimizing cosmetic and
functional outcomes for tumours in the perioral region: a series of 407 cases and reconstructions by
dermatological surgeons. Br J Dermatol. 2015 Jan;172(1):294-6. doi: 10.1111/bjd.13218. Epub 2014
Nov 30.
32. Hargroves, D, Ward L. Anticoagulants for stroke prevention in patients with atrial fibrillation. British
Journal of Neuroscience Nursing 04/2015; 11(Sup2):31-37. DOI: 10.12968/bjnn.2015.11.Sup2.31
33. Hasegawa H, Samuel M, Douiri A, Ashkan K. Patients' Expectations in Subthalamic Nucleus Deep Brain
Stimulation Surgery for Parkinson Disease. World Neurosurg. 2014 Dec;82(6):1295-1299.e2. doi:
10.1016/j.wneu.2014.02.001. Epub 2014 Feb 8.
34. Hess, K.C., J. Liu, G. Manfredi, F.A. Mühlschlegel, J. Buck, L.R. Levin, A. Barrientos. 2014. A mitochondrial
CO2-adenylyl cyclase-cAMP signalosome controls yeast normoxic cytochrome c oxidase activity. FASEB
J. 28:4369-4380.
35. Hillmen P, Gribben JG, Follows GA, Milligan D, Sayala HA, Moreton P, Oscier DG, Dearden CE, Kennedy
DB, Pettitt AR, Nathwani A, Varghese A, Cohen D, Rawstron A, Oertel S, Pocock CF. Rituximab plus
chlorambucil as first-line treatment for chronic lymphocytic leukemia: Final analysis of an open-label
phase II study. J Clin Oncol. 2014 Apr 20;32(12):1236-41. doi: 10.1200/JCO.2013.49.6547. Epub 2014
Mar 17
EKHUFT Research & Development Annual Report 2014-15
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36. Hobbs H, Bassett P, Wheeler T, Bedford M, Irving J, Stevens PE, Farmer CK. Do acute elevations of
serum creatinine in primary care engender an increased mortality risk? BMC Nephrol. 2014 Dec
22;15(1):206. doi: 10.1186/1471-2369-15-206.
37. Hoskin PJ, Kirkwood AA, Popova B, Smith P, Robinson M, Gallop-Evans E, Coltart S, Illidge T, Madhavan
K, Brammer C, Diez P, Jack A, Syndikus I. 4 Gy versus 24 Gy radiotherapy for patients with indolent
lymphoma (FORT): a randomised phase 3 non-inferiority trial. Lancet Oncol. 2014 Apr;15(4):457-63.
doi: 10.1016/S1470-2045(14)70036-1. Epub 2014 Feb 24.
38. Jesani A, DiBiase AT, Cobourne MT, Newton T. Perceived changes by peer group of social impact
associated with combined orthodontic-surgical correction of class III malocclusion. J Dent. 2014 May 27.
pii: S0300-5712(14)00134-1. doi: 10.1016/j.jdent.2014.05.002. [Epub ahead of print]
39. Johnston GA, on behalf of the BSCA. The rise in prevalence of contact allergy to methylisothiazolinone
in the British Isles. Contact Dermatitis 2014; 70(4):238-40
40. Kerr M, Bedford M, Matthews B, O'Donoghue D. The economic impact of acute kidney injury in
England. Nephrol Dial Transplant. 2014 Jul;29(7):1362-8. doi: 10.1093/ndt/gfu016. Epub 2014 Apr 21.
41. Juniat V, Andrew N. Not just a red eye. BMJ Case Rep. 2014 Apr 3;2014. pii: bcr2013203363. doi:
10.1136/bcr-2013-203363.
42. Kumar R, Shrestha AK, Basu S. Giant midline abdominal incisional herniae repair through combined
retro-rectus mesh placement and components separation: experience from a single centre. Hernia.
2014 Oct;18(5):631-6. doi: 10.1007/s10029-014-1239-3. Epub 2014 Mar 28
43. Kumaran N, Larkin G, Hollick EJ. Sterile postoperative endophthalmitis following HOYA IOL insertion.Eye
(Lond). 2014 Nov;28(11):1382. doi: 10.1038/eye.2014.170. Epub 2014 Jul 25.
44. Lamb EJ, Delaney MP. Does PTH Offer Additive Value to ALP Measurement in Assessing CKD-MBD? Perit
Dial Int. 2014 11-12;34(7):687-691.
45. Lamb EJ, Stevens PE. Estimating and measuring glomerular filtration rate: methods of measurement
and markers for estimation. Curr Opin Nephrol Hypertens. 2014 May;23(3):258-66. doi:
0.1097/01.mnh.0000444813.72626.88.
46. Lamb EJ, Stevens PE, Deeks J. What is the best glomerular filtration marker to identify people with
chronic kidney disease most likely to have poor outcomes? BMJ 2015;350:g7667. doi:
10.1136/bmj.g7667
47. Lau YF, Senaratne J, Ghatwary T. Endograft Limb Occlusion in EVAR: Iliac Tortuosity Quantified by Three
Different Indices on the Basis of Pre-operative CTA. Eur J Vasc Endovasc Surg. 2014 Dec;48(6):711-2.
doi: 10.1016/j.ejvs.2014.08.021. Epub 2014 Sep 23.
48. Lee RT, Barnes E, DiBiase A, Govender R, Qureshi U. An extended period of functional appliance
therapy: a controlled clinical trial comparing the Twin Block and Dynamax appliances. Eur J Orthod.
2014 ct;36(5):512-21. doi: 10.1093/ejo/cjs076. Epub 2013 Jan 4.
49. Macdougall IC, Casadevall N, Locatelli F, Combe C, London GM, Di Paolo S, Kribben A, Fliser D, Messner
H, McNeil J, Stevens P, Santoro A, De Francisco AL, Percheson P, Potamianou A, Foucher A, Fife D, Mérit
EKHUFT Research & Development Annual Report 2014-15
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V, Vercammen E; PRIMS study group. Incidence of erythropoietin antibody-mediated pure red cell
aplasia: the Prospective Immunogenicity Surveillance Registry (PRIMS). Nephrol Dial Transplant. 2015
Mar;30(3):451-60. doi: 10.1093/ndt/gfu297. Epub 2014 Sep 19.
50. Mangam S, Marzouk D. A simple, safe and effective bedside technique to achieve haemostasis in
serious colorectal anastomotic bleeding. Ann R Coll Surg Engl. 2014 Apr;96(3):249. doi:
10.1308/003588414X13814021679915.Oliveira B, Ali T. A difficult diagnosis to SPOT. QJM. 2014
Dec;107(12):1011-3. doi: 10.1093/qjmed/hcs063. Epub 2012 Mar 29.
51. Mangam S, Marzouk D. A simple, safe and effective bedside technique to achieve haemostasis in
serious colorectal anastomotic bleeding. Ann R Coll Surg Engl. 2014 Apr;96(3):249. doi:
10.1308/003588414X13814021679915.
52. Mann J, McFadden JP, White JM, White IR, Banerjee P. Baseline series fragrance markers fail to predict
contact allergy. Contact Dermatitis. 2014 May;70(5):276-81. doi: 10.1111/cod.12171.
53. Moran N, Munro N, Lawson K, David AS. Safe management of psychiatrically disturbed patients on nonpsychiatric wards in the UK. BMJ. 2014 Feb 19;348:g1466. doi: 10.1136/bmj.g1466. No abstract
available.
54. Morgan DA, Bates T, Duffy SW, Pinder SE. Addendum to BASOII Trial report. Eur J Cancer. 2014
Sep;50(14):2517-8. doi: 10.1016/j.ejca.2014.05.023. Epub 2014 Jul 11
55. Oliver G. Managing IV pathways through acute and community service collaboration. Br J Nurs. 2014
Jul;23 Suppl 14:S37. doi: 10.12968/bjon.2014.23.Sup14.S37.
56. Price A, Kaski J. How to use...the paediatric ECG. Arch Dis Child Educ Pract Ed. 2014 Apr;99(2):53-60.
doi: 10.1136/archdischild-2013-303707. Epub 2013 Oct 23.
57. Salagierski M. Editorial Comment to Combination of lidocaine suppository and periprostatic nerve block
during transrectal prostate biopsy: a prospective randomized trial. Int J Urol. 2014 Nov;21(11):1130-1.
doi: 10.1111/iju.12541. Epub 2014 Jun 26.
58. Salagierski M. The genetic patterns of bladder cancer. Where do we stand now? Cent European J Urol.
2014;66(4):411-2. doi: 10.5173/ceju.2013.04.art4.
59. Sattianayagam PT, Desmond PV, Jayasekera C, Chen RY. Endoscopic submucosal dissection: experience
in an Australian tertiary center. Ann Gastroenterol. 2014;27(3):212-218.
60. Schmid AB, Bland JD, Bhat MA, Bennett DL. The relationship of nerve fibre pathology to sensory
function in entrapment neuropathy .Brain. 2014 Dec;137(Pt 12):3186-99. doi: 10.1093/brain/awu288.
Epub 2014 Oct 27.
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Page 36 of 40
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EKHUFT Research & Development Annual Report 2014-15
Author: Dr Tim Doulton, Director of Research & Development
Page 37 of 40
Appendix: Financial report - April 2014 to March 2015
CRN:KSS – 2014 -2015
The tabulation below reflects the outturn baseline allocation for the CRN:KSS contract for the financial year
2014 - 2015.
Annual Allocation
£0000,s
Pay Vacancy Factor
Total Pay
Non pay
Host Fees
in-year adjs
Total
Nursing
AC Support
Pharmacy
Radiology
Pathology
686
229
101
(34)
(11)
(5)
652
218
96
27
9
4
26
22
55
18
8
(54)
(5)
(4)
680
241
104
26
22
Total Core Budget
1016
(51)
965
89
81
(63)
1072
Specialty Leads
17
17
Contingency
206
206
RCF
43
43
Overall CRN Allocation
1282
(51)
1231
17
(95)
112
43
89
81
(158)
1244
In-year adjustments (reductions to allocation) were applied to eliminate any excess variances against plan.
These resources were then recycled centrally within the CRN to provide finance for additional funding
requests elsewhere in the network.
EKHUFT Research & Development Annual Report 2014-15
Author: Dr Tim Doulton, Director of Research & Development
Page 38 of 40
Financial Position
The cumulative variance as reported to the CRN:KSS to March 31st 2015 is indicated below:
Annual Allocation
Annual
Budget
Period
Budget
Nursing
AC Support
Pharmacy
Radiology
Pathology
General Non Pay
Host Fees
632
225
101
26
22
36
81
632
225
101
26
22
36
81
618
222
117
20
19
35
81
14
3
(16)
6
3
1
sub-total
1123
1123
1112
11
Vacancy Factor
(51)
(51)
(51)
sub-total
(51)
(51)
(51)
Total Core Budget
1072
1072
1112
Specialty Leads
17
17
17
Contingency
112
112
64
48
43%
RCF
43
43
30
13
31%
Total Other Budget
171
171
110
61
Overall CRN Allocation
1244
1244
1222
21
£0000,s
Period Spend Period Var
(40)
%
2%
1%
(16%)
22%
12%
4%
0%
(4%)
0%
2%
The adverse variance reported for the year to date on core funded budgets is due to the attribution of the
imposed vacancy factor versus actual underspends on pay budgets. This is more than compensated for by
the under-spends on other budget headings that provides an overall favourable variance against plan @
£21k.
EKHUFT Research & Development Annual Report 2014-15
Author: Dr Tim Doulton, Director of Research & Development
Page 39 of 40
Other Income/Direct Receipts
Total income from direct receipts for the period to March 31st 2015 was £2.56 million, broken down as
follows:
£000's
CRN:KSS Baseline Contract
M1 - M3
M4 - M6
M7 - M9
M10 - M12
Total
(284)
(284)
(284)
(175)
(1026)
CRN:KSS Contingeny/RCF
(217)
% Total
(217)
sub-total CRN
(284)
(284)
(501)
(175)
(1244)
49%
NIHR Projects
(63)
(165)
(66)
(80)
(374)
15%
MRC/Other/Non-commercial
(36)
(24)
(28)
(33)
(121)
5%
Commercial
(88)
(190)
(215)
(330)
(823)
32%
Total
(471)
(662)
(810)
(618)
(2562)
100%
The majority of R&D income received (49%) is sourced from the collective funding streams as provided
from the Comprehensive Research Network.
Commercial activity contributed 32% of the overall total with Clinical Haematology providing @ 53% of the
£824k accumulated to date.
Comparison with previous years
A financial comparison of previous annual income receipts for the last several years is shown below.
Yr 0910
Yr 1011
Yr 1112
Yr 1213
CRN:KSS
(718)
(752)
(649)
(709)
(1060)
(1244)
RCF
(175)
(20)
(83)
(100)
(110)
(149)
NIHR Projects
(27)
(214)
(378)
(247)
(456)
(226)
MRC/Other/Non-commercial
(21)
(53)
(42)
(70)
(115)
(121)
Commercial
(143)
(100)
(81)
(346)
(707)
(823)
Total
(1084)
(1139)
(1233)
(1472)
(2447)
(2562)
£000's
Yr 1314
Yr 1415
Source
Jacky Douglas, R&D Finance Officer
EKHUFT Research & Development Annual Report 2014-15
Author: Dr Tim Doulton, Director of Research & Development
Page 40 of 40