NHS Research Scotland (NRS)
Stroke Research Network
Annual Report 2012
NRS SRN was commissioned by the Chief Scientist Office (CSO)
of the Scottish Government to improve the quality and increase
the quantity of stroke research in Scotland, as part of the UK
Clinical Research Collaboration (UKCRC)
Contents
Introduction
Section 1
Executive Summary
Section 2
CSO Stroke Network Objectives
Section 3
Generic Objectives
Date Recording
Infrastructure
Patient, Carer and Public Involvement
Specific Objectives
High Quality New Studies
NIHR SRN/NRS SRN joint ‘Writing Group
Clinical Trials of Significance
Potential Breakthroughs
Scottish Success in Health/Medical Research
3.1
3.2
3.3
3.4
3.5
3.5.1
3.5.2
3.5.3
3.5.4
SSRN Overview 2011/12
Section 4
Portfolio Development
Section 5
Service Development
Section 6
Training Strategy
Section 7
Public Awareness and Publicity
Section 8
Next years SSRN forward plan 2012/13
Section 9
2
Introduction
Section 1
NHS Research Scotland (NRS) Stroke Research Network
NHS Research Scotland (NRS) Stroke Research Network is funded by the Chief Scientist Office.
The SSRN was designed to compliment developments in the rest of the UK but has a distinct
and separate structure from the English local research networks.
Background
The UK Clinical Research Collaboration (UKCRC) was established in April 2004 as a partnership
between Government, the Charity sector, the Private sector and the Public. The aim of this
organisation was to make the UK the best place in the world to do clinical research by
harnessing the potential of the National Health Service. A key element in this vision was the
creation of the UK Clinical Research Network which included a specific topic area in Stroke.
Bids were invited to form the lead organisation for the UK Stroke Research Network (UKSRN).
This was awarded in April 2005 to a multicentre collaboration led by Prof. Gary Ford in
Newcastle but including Scottish based researchers and facilities (Prof. Kennedy Lees, Prof.
Ian Ford, Robertson Centre for Biostatistics, Prof. Peter Langhorne and Prof. Joanna
Wardlaw).
In parallel with the UK SRN developments, a complimentary proposal was developed in
Scotland by a Committee convened by the Chief Scientist Office (CSO).
This Committee
comprised of Peter Langhorne, Kennedy Lees, Peter Sandercock, Martin Dennis, Gillian Mead,
Joanna Wardlaw, Keith Muir, Ron MacWalter and Mary Jo MacLeod plus Roma Armstrong from
the CSO. A proposal was submitted to the CSO in September 2005. In this proposal it was
recognised that Scotland provides an obvious focus for a Stroke Research Network, hereafter
referred to as the NRS Stroke Research Network (SRN) and the proposal was designed to
compliment developments in the rest of the UK.
3
NRS Stroke Research Network
Glasgow hosts the NRS Stroke Research Network (SSRN) for which Professor Matthew Walters
(University of Glasgow) is the clinical lead and Claire McFarlane is the network manager. The
Scottish Stroke Research Network Coordinating Centre is based in Glasgow at Glasgow Royal
Infirmary.
NRS SRN is steered by an Executive Group which represent four regional research committees:
East Scotland, North East Scotland, South East of Scotland and West of Scotland. The
Executive Group aims to include key stroke researchers in Scotland, plus representatives from
the Chief Scientists Office and Chest, Heart and Stroke Scotland and The Stroke Association.
Mission Statement
“NRS Stroke Research Network aims to expand stroke research in Scotland whilst
ensuring it is of high quality, timely and better tailored to the needs of the people
of Scotland” [Professor Peter Langhorne 2007]
National aims include:
Raise awareness of stroke research and improve stroke care
Maintaining and enhancing the quality of research
Improving the efficiency of research
Improving research coordination
Improving the integration of research
Widening research participation
4
Executive Summary
Section 2
NRS SRN enjoyed a productive year in 2011/12 Recruitment targets were met and exceeded,
a strong and balanced trial portfolio was maintained, and our stakeholders were successfully
engaged at a number of national meetings and events. These achievements were made
against the backdrop of an evolving and increasingly challenging environment for clinical
research. During 2011/2012 the network continued to evolve, introducing new initiatives
better to align it with its core goals and better to prepare the network for the future. This
programme of adaptive change will continue over the next 3 year funding allocation with a
view to sustained success.
NRS SRN currently comprises 20 active research sites throughout Scotland with 30 studies
open to recruitment (including two co-adopted studies) on our SRN portfolio. Two of these
are commercial studies, and 18 are Scottish led. Twenty two of the trials are Randomised
Controlled Trials (RCTs), 11 of which are Scottish led. The study pipeline comprises 33 (one
of which is commercial) new trials at various stages of development.
Highlights of Scottish Stroke Research in 2011/12 include the IST3 trial, designed, initiated
and lead by the University of Edinburgh. IST3 completed recruitment at the end of July 2011
having included 3035 patients, making it the largest ever trial of intravenous thrombolysis for
stroke (the largest previous trial included 800 patients). The trial team presented the main
results at the European Stroke Conference in Lisbon on the 25th May 2012, with simultaneous
publication of the main results paper in the Lancet. The trial showed that, for the types of
patient recruited in IST-3, despite the early hazard (chiefly intracranial haemorrhage),
thrombolysis with iv rt-PA within six hours improved functional outcome (as assessed by the
Oxford Handicap Scale) at six months. Benefit was greatest among patients treated within 3
hours, and overall, benefit did not appear to be diminished among patients aged over 80
years. Global media coverage of the results has been extensive, and it is clear the results will
have an impact on acute stroke care worldwide, not least since the trial provides randomised
evidence to support the use of thrombolysis in patients aged over 80 (who are excluded from
treatment according to the current EU approval for rt-PA).The findings will have significant
implications for clinicians worldwide.
Another Scottish study of global significance adopted last year was the PISCES (Pilot
Investigation of Stem Cells in Stroke) study which is the world’s first fully regulated clinical trial
of a neural stem cell therapy for disabling stroke. PISCES is an adopted UKSRN trial and
supported by the network. This is a Scottish led study led by Professor Keith Muir, SINAPSE
Professor of Clinical Imaging & Consultant Neurologist, who is the UK Chief Investigator for
the trial which is being undertaken at the Institute of Neurological Sciences, Southern General
Hospital in Glasgow. The trial is a "first in man" safety study that will test increasing doses of
the foetal neural stem cell line CTX0E03 administered by direct injection into the brain.
5
This study further enhances Scotland’s reputation for world class translational research in
Stroke. A number of other SSRN studies are worthy of particular note, and these are
highlighted further on in this year’s report.
The CLOTS-3 trial aims to find out whether Intermittent Pneumatic Compression reduces the
risk of a person admitted to hospital with a stroke developing a deep vein thrombosis. This
elegant study of a simple intervention is also led from Scotland, is recruiting ahead of schedule
and may have significant implications for clinical practice when it reports in 2014.
2012 will also see the initiation of a series of major new adopted trials, such as FOCUS,
EuroHYP-1 and RESTART, in which network-supported Scottish investigators will play a leading
role.
Since its inception in 2006 the Scottish Stroke Research Network has developed an enviable
track record of support for world-class stroke research and the breadth, depth and quality of
our study portfolio suggests that the stroke research community of Scotland will continue to
thrive despite challenging times.
2.1 Executive Committee
NRS Stroke Research Network has been established by a small executive group (see above)
which has subsequently been expanded to include representatives from the Chief Scientist
Office and Chest Heart & Stroke Scotland and more recently The Stroke Association, plus
representation from key specialities. We anticipate this will continue to be supplemented with
representatives of patient’s organisations and from other healthcare professions.
2.2 Regional Stroke Research Committees
NRS SRN has a devolved structure which incorporates regional research committees located in
Glasgow & West Scotland, Edinburgh & South East Scotland, Tayside & East Scotland and
Grampian & North Scotland. These committees include research active (or potentially active)
clinicians, representatives of the NHS R&D Departments, representatives of the local CRF, and
representatives of the Stroke Managed Clinical Networks (MCNs). It is envisaged that these
regional committees will provide the local knowledge and expertise to ensure the objectives of
the Scottish Stroke Research Network are met.
2.3 Overview of the NRS SRN Coordinating Centre
Glasgow hosts NRS SRN for which Professor Peter Langhorne (University of Glasgow) was the
clinical lead from April 2006 – June 2010. In June 2010 Professor Matthew Walters, Professor
of Clinical Pharmacology, University of Glasgow took over this role and Claire McFarlane
continues as network manager. Liz Ronald is the West of Scotland and Grampian SSRN
Coordinator and Bridget Colam is SSRN Coordinator for South East Scotland,based in the
Western General Hospital Edinburgh. The NRS Stroke Research Network Coordinating Centre
is based in Glasgow Royal Infirmary.
6
The role of the coordinating centre is to:

Provide leadership to the Stroke Research Network

Establish, develop and quality assure the Regional Research Networks in Scotland

Promote and manage the SRN on behalf of the CSO in Scotland

Coordinate network participation in research projects

Promote the active involvement of patients and the public in research

Manage internal and external relationships

Work with the NIHR CRN Coordinating Centre to achieve the aims of the NIHR CRC CC
and CSO
NRS SRN Portfolio Administrator/PA
NRS SRN Portfolio Administrator/PA Karen McBurnie took
over the role of Portfolio
Administrator in January 2010 being responsible for all NRS SRN Scottish led studies initialised
onto the UKCRN portfolio database and all accrual data for Scottish lead trials is entered onto
the UKCRN database on a monthly basis. The Portfolio Administrator/PA is also responsible for
the day to day administrative tasks in the central office, organising SRN annual events and
providing a central point of access for information on SSRN trial portfolio information, training
opportunities and course bookings.
Table 1:
SSRN Co-ordinating Centre (Glasgow) at April 2012
Position
Post holder
WTE
Professor Matthew
Up to 2
Walters
sessions
Network Manager
Claire McFarlane
0.8
January 2007
Network Coordinator
Liz Ronald
0.8
February 2007
SSRN Clinical Lead
Appointment
June 2010
Bridget Colam
Network Coordinator
(Based at WGHE)
0.6
Trials Coordinator
Boutique Trials
0.2
Karen McBurnie
1.0
SSRN Portfolio
Administrator/PA
7
Sep 2009
June 2008
CSO Stroke Network Objectives 2011/12
Section 3
STROKE NETWORK OBJECTIVES [CSO APPENDIX C]
For the purpose of the following objectives, a high quality clinical study is defined as one that
is funded by either an eligible funder or one that is commercially sponsored and funded.
GENERIC OBJECTIVES
3.1 Data Recording
To work in conjunction with NHS R&D offices to ensure that:
1.1 All high quality clinical studies within the Network's topic specific area are entered on the
UKCRN database immediately following R&D approval;
Network response:
The NRS SRN Portfolio Administrator is responsible for:

Initialising and publish all Scottish led SRN stroke studies onto the UKCRN
Portfolio Database and Recruitment Data Contact (RDC) for such studies working
closely with the NIHR SRN Portfolio Administrator

Establishing whether eligible funding has become available for all Scottish led
stroke studies and liaising with the Chief Investigator of the trial, providing the
UKCRN study criteria documentation and application form for adoption onto UK
SRN Portfolio for Scottish led stroke trials only

Submitting UK SRN adoption application to NIHR SRN Portfolio CC and tracking
individual studies through the adoption process

Responsible for liaising with local R&D and/or investigator having being given
notification of a new study

Liaising with Scottish Network Manager and Clinical Lead in deciding whether a
study is suitable for adoption and notify R&D or investigator of decision. (note: if
not eligible for adoption SRN will notify R&D/investigator and R&D will initialise,
publish, maintain and be responsible for uploading accrual for the study onto the
UKCRN database

Collating all study specific related documentation and submitting to NIHR Stroke
Research Network Coordinating Centre (NIHR SRN PMC meets 3 x monthly)

Compiling reports for the SSRN Executive Committee, SSRN Director and SSRN
Manager
1.2 Trial participant accrual data is entered onto the UKCRN database every month
Network Response:
The NRS SRN Portfolio Administrator is responsible for:
8

Monitoring study targets: Target date for studies to be ‘initialised’ and
published will depend on the date they are adopted – PMC meet every three
months – the aim is that once adopted they will be initialised immediately

Ensuring timely and accurate monthly accrual uploads for study recruitment
for all Scottish led trials on the UKCRN Portfolio, working closely with the
study Chief Investigators/Principle Investigators to achieve this - 95% of our
studies recruitment is uploaded on time i.e. within the month required

Ensuring continuous maintenance, including updating current data of the
studies on the UKCRN Portfolio Database

Liaising with local and regional R&D Departments to ensure accurate and
timely maintenance of the UKCRN Portfolio Database
3.2 Infrastructure
To enhance the Network's infrastructure to:
2.1 Increase the capability of the Network to conduct a range of high quality clinical
studies, including collaborative studies with other Networks
Network Response:
In order to increase the capability of the network to conduct a range of high quality clinical
studies we have explored imaginative use of research support. Additional resources are a key
element to increasing recruitment into trials but enrolment is just the initial stage, if we wish
to ensure our trials are run to the highest quality an increase to staff resources is crucial to
achieving quality follow-up data which is essential to ensuring the continuing success of stroke
research in Scotland. We have initiated some generic support of stroke trials to provide
support to busy clinicians and thereby maximising recruitment and quality of data.
The provision of one consultant PA and and additional 0.5 research nurse time to complement
the existing research nurse support within the Acute Stroke Units has proved to help increase
recruitment at sites which currently either have a full or part-time nurse. This can provide
protected time for a ward based doctor and mean that all potential patients could be recruited
(especially for more complex clinical trials). This model has proved highly successful over the
past 2-3yrs in Lothian, Grampian and the West of Scotland. Funding preclude the provision of
this level of support to all SRN: currently only 4 out of the 20 sites have additional provision.
Potential synergy exists between the SSRN and the new NRS Career Researcher scheme.
Clinicians with a primary interest in stroke have been appointed to the NRS Career Researcher
Scheme across Scotland and the SSRN will work with these individuals to the mutual benefit of
both initiatives
9
NRS SRN will continue to utilise the support of R&D research nurse services to participate in
SSRN adopted trials. This has proved successful over the past 2-3 years were we have had the
support of Ayrshire and Arran and Grampian R&D research nurses recruiting to SRN adopted
trials.
Current partnerships NRS SRN has with other Networks and funders:
As well as maintaining established links with the other Scottish Topic Research Network
Managers (face to face meetings 2-3 times of year,) NRS SRN have collaborated with the
many of the Topic Research Networks in Scotland on co-adopted studies, also working with
Clinical Research Facilities, charity organisations and large research projects such as
Generation Scotland. We are continually looking at new opportunities to form partnerships
with other organisations and to discuss new stroke projects with various researchers and
external research/clinical groups regarding the potential opportunities for working together
and providing help in developing studies.
Examples of this collaboration includes:
INTERSTROKE Study: Importance of Conventional and Emerging Risk Factors for Stroke in
Different Regions of the World and in Different Ethnic Groups: A Case-control Study - This is a
worldwide research study, conducted by The Population Health Research Institute, Hamilton,
Canada. The study is aiming to find out more about how lifestyle, medical conditions (e.g.
blood pressure and cholesterol) and genes act together to influence the development of stroke
around the world. In June 2010 Professor Peter Langhorne opened up the study in 8 hospitals
across Scotland funded by CHSS one year later a further 3 sites were opened in Scotland.
NRS SRN adopted the study and provided study coordination and research nurse time. The
est. target for Scotland was 250 patients/250 controls over a 2 year period. Recruitment was
extremely successful and Scotland ranks 5th of 31 participating countries behind only China,
India, Ecuador and Poland in global recruitment. Following this success Professor Langhorne
secured a grant from TSA for an additional grant to open up 8 English sites in Jan 2012.
This study also involves the NRS SRN Research Nurses who recruit suitable patients into the
study in Scotland and NIHR SRN Research Nurses who recruit patients in England, the Scottish
Primary Care Network who help identify suitable controls for the study from GP databases, the
Glasgow, Aberdeen and more recently Exeter Clinical Research Facilities who recruit controls
for the study across the UK. We also formed a partnership with the Generation Scotland (GS)
Project who also helped to identify suitable controls from the GS database.
The Scottish SRN has a well-developed partnership with Chest, Heart & Stroke Scotland
(CHSS). CHSS have funded several rehabilitation studies in priority areas as a direct request
from Scottish researchers. David Clark, Chief Executive of CHSS is also member of the NRS
SRN Executive Committee.
10
NRS SRN has a well-developed partnership with The Stroke Association (TSA), as evidenced by
collaborative working for UK Stroke Forum, appointment of lay members to Clinical Studies
Groups and funding of the SRN Patient Carer & Public Involvement Manager with the aim of
developing a Patient Carer and Public Involvement group within Scotland in keeping with the
UK SRN strategy. In March 2012 the Scottish Director of The Stroke Association became an
official member of the NRS SRN Executive Committee.
2.2 Help expedite the efficient and timely coordination of high quality clinical studies,
including their approval, start-up and also recruitment to target and timescale;
Network Response:
The NRS SRN Coordinating Centre responsibilities include:

Establishing early interaction with study investigators and coordinating teams of new
(pre adoption) and adopted trials, using local SRN knowledge of previous recruitment
track records and suitability of sites, knowledge of site specific information including
annual admission records, resources, providing assistance in relation to EOI
submissions, site feasibility, realistic recruitment targets

Delivering assistance from our SRN Regional Coordinators providing knowledge,
expertise and practical assistance on MHRA applications, IRAS applications, Ethics
submission, NRS and CSP submissions

Project management of trial progress - A main part of the NRS SRN Coordinators remit
is to monitoring timelines of NRS, Ethics and regional R&D SSI submission, to
continually monitor the process of such submissions and to liaise with the individual
organisations above to help expedite the efficient and timely coordination of high
quality clinical studies, including their approval, start-up and also recruitment to target
and timescale

Working closely with NRS and regional R&D coordinators in regards to early
notification of new trials which are pending on SRN portfolio, site specific issues
relating to imaging and pharmacy

Providing support from the SSRN Manager and Coordinators in relation to Site
Initiation Visits (SIV), monitoring/close out visits, trail specific issues relating to data
queries, changes in protocol procedures and any issues relating to outstanding data

Monitoring individual site recruitment on a monthly basis, assisting with any site
specific problems with staffing resources, recruitment, data quality (currently only able
to offer assistance with this via notification from trial coordinating teams – action NRS
SRN has been working closely to make improvements in this particular area via
discussions with trial Chief Investigators and their respective trial coordinating teams –
this is underway and making an impact with specific regard to the swift resolution of
local difficulties.

Participating
in
NIHR
SRN
Portfolio
monthly
teleconferences
and
UK
SRN
Directors/Clinical Leads/NW Managers/Trial Coordinator Meetings which are held on a
11
frequent basis (monthly) hosted by NHIR SRN CC in England

Facilitating and attending monthly trial specific teleconferences involving SRN research
nurses, SRN manager/coordinators and trial coordinating teams

Provide regular NRS SRN Study Meetings (e.g. face to face meetings with SRN
Research Nurses, Coordinators, Portfolio Coordinator and Manager)
2.3 Ensure broad geographical coverage of the Network.
NRS SRN currently comprises 20 research active NHS hospital sites throughout Scotland which
includes all 4 of the major NHS Health Boards alongside NHS Fife, NHS Forth Valley, NHS
Lanarkshire and NHS Ayrshire.
3.3 Patient Involvement
To increase patient involvement in the work of the Network.
Patient, Carer and Public Involvement
Background
The Stroke Research Network (SRN) Clinical Studies Group (of which the Scottish SRN are part
of) are the primary, but not sole, route through which non commercial SRN clinical studies are
considered and recommendations made to the SRN Adoption Committee. The Patient, Carer &
Public Involvement CSG have the over-arching role of supporting involvement in all of the
other CSGs. The processes for the leadership and membership of these Groups have been
established to promote transparency, encourage participation and ensure Groups understand
and are well equipped to undertake their role.
The key principles underpinning the membership and the aims and objectives of the Patient,
Carer and Public Involvement (PCPI) Clinical Studies Group are listed below.
Aims and Objectives
The Group aims to bring together the expertise and enthusiasm necessary to establish them
as an authoritative voice in the stroke research community as well as in patient, carer and
public involvement. The group has the following objectives:

ensure patient, carer and public involvement in activities throughout the SRN

support and oversee recruitment of lay members to the SRN

be responsible for developing and overseeing a portfolio of studies

consider studies proposed by others and advise the SRN Study Adoption Committee
where required

receive inputs from UKCRN, SRN directors and stroke research funders

provide patient, carer and public involvement specific advice, as required, to SRN
Operational Steering Group and SRN Directors

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undergo peer review of the overall portfolio 3-yearly [UKSRN]
Progress to date from the UKSRN PCPI Strategy report ‘The Next Five Years 2010 2015’ [Zena Jones UKSRN PCPI Manager]
The PCPI working party was dissolved in January 2007 and open recruitment to the PCPI CSG
commenced. The inaugural meeting of the PCPI CSG took place in July 2007.
PCPI Clinical Studies Group
The PCPI CSG replaced the PCPI working party in April 2007 and has a remit to:
 Ensure patient, carer and public involvement in activities throughout the NIHR
SRN

Support and oversee recruitment of lay members to the NIHR SRN

Consider studies proposed by others and advise the NIHR SRN Study Adoption
Committee where required

Receive inputs from NIHR CRN, NIHR SRN Directors and stroke research funders

Provide patient, carer and public involvement specific advice, as required, to NIHR
SRN Operational Steering Group and NIHR SRN Directors
The PCPI Strategy was ratified at OSG in November 2006 with the following Vision, Aims and
Objectives:
Vision
‘The views and perspectives of people who have had a stroke, their carers and the public are
embedded throughout all levels of the Stroke Research Network and all stages of the research
process. Researchers in stroke are developed and equipped to involve these people in the
work of the Stroke Research Network and the research process.’
Aims
1. To ensure that the views and perspectives of stroke patients, carers and the public are
embedded throughout the NIHR SRN at all levels and at all stages of the research
process both locally and nationally.
2. To develop and equip researchers to inform and involve stroke patients, carers and
the public in stroke research throughout the NIHR SRN and at all stages of the
research process both locally and nationally.
3. To develop systems to inform and involve stroke patients, carers and the public in
stroke research at all stages of the research process both locally and nationally.
Successes

The recruitment of the lay members resulted in the appointment of 15 individuals who
are a great asset to the organisation. This initiative has also further embedded our
working partnership with The Stroke Association.

13
The Network Managers throughout the UK have all developed an infrastructure and
appointed lay members to their networks, so involvement is achieved at all levels.

Lay member activity involved with national and local NIHR SRN activities and
participation in CSGs.

The PCPI CSG recruitment has also been a success and there have already been four
grant proposals tendered.

The lay members attended UK Stroke Forum as part of their induction and training
process. It was invaluable in setting the scene for the lay members.

The PCPI Manager visits the local stroke research networks in England and the Stroke
Research Networks in Scotland and Northern Ireland.
A report on current PCPI
activity in these networks is completed annually to ensure that all aspects of
involvement are captured. She responds to requests for information from within the
NIHR SRN and other TCRNs as well as providing a monthly update to the LRNs
through the Network Managers and individual

PCPI leads.
NRS SRN has a part-time Patient Carer Patient Information (PCPI) Officer, whose role is to
increase the involvement of patients in every aspect of the SSRN. The SSRN PCPI strategy is
to actively promote and encourage the participation of patients, carers and the public in the
Scottish Stroke Research Network. Liz Ronald, SRN WOS Coordinator took on this role in 2008
and has already reviewed the NHS Education for Scotland PCPI strategy for information on the
best way to engage the public in the SRN.
The network has successfully worked together with TSA and CHSS on two World Stroke Day
events which have brought together NMAHP, MCN and the DORIS research team to present to
Stroke patients and their carers from all over Scotland.
Funders with a focused interest in stroke research are encouraged to liaise with the SSRN
Network Manager and the Director of the Scottish SRN directly.
Scottish SRN Summary update on patient, carer and public involvement
PCPI:
Plans are in place to involve lay members not only in the dissemination of netywork-related
information, but also in the network’s executive functions Lay members will be invited to join
a number of committees, including the World Stroke Day events committee . This is being
taken forward with guidance from Chest Heart and Stroke Scotland.
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Scottish Stroke Research Network – World Stroke Day
World Stroke Day is organised by the World Stroke Organisation to highlight that not only can
stroke be prevented, but that stroke survivors can fully recover and regain their quality of life
with the appropriate long-term care and support. The event aims to raise global awareness of
stroke prevention and encourage optimal management of stroke patients.
Following on from a successful event in 2009, the SSRN held a Lunch Time Discussion for
their second World Stroke Day Event on Thursday 28 October 2010 at the British Heart
Foundation Building at the University of Glasgow.
Around 35 stroke patients and their carers attended in addition to 14 health care
professionals. The programme started with coffee and a warm welcome and an introduction
from Professor Matthew Walters, Director of the Scottish Stroke Research Network and
Professor of Clinical Pharmacology. After presentations from Bridget St George, Research
Assistant NMAHP of Glasgow Caledonian University on ‘ Life after Stroke in Scotland’’, Professor
Walters returned to give a talk on ‘Imaging of stroke patients – where we’ve been and where
we’re going’ which many people commented on the evaluation forms as being the highlight of
the day.
Lunch followed and during this time Professor Walters took interested parties on a tour of the
excellent facilities at the BHF Glasgow Cardiovascular Research Centre Building. The Centre
provides a multidisciplinary research environment and state-of-the-art experimental and
clinical facilities to further vital research into cardiovascular disease and stroke. The tour
ended with a visit to the MRI scanner, which is a key tool in the stroke research programme at
the University of Glasgow.
15
Kathleen Frew, Chest, Heart & Stroke Scotland, Katrina Brennan MCN Scottish
Manager, MaddyHalliday, Director of the Stroke Association, Professor Matthew
Walters, Director of the SSRN and Bridget St George, Glasgow Caledonian
University.
16
The day finished with discussion time, during which patients and their carers were able to
question the panel, (Professor Walters, Maddy Halliday, Director of the Stroke Association,
Kathleen Frew, Chest, Heart & Stroke Scotland, Bridget St George, Glasgow Caledonian
University and Katrina Brennan MCN Scottish Manager) on different aspects of stroke care and
treatment.
User Involvement:
Dr Gillian Mead (Royal Infirmary of Edinburgh) included ‘user involvement’ in her rehabilitation
Fatigue After Stroke study which is now part of the UK SRN portfolio. She initially sent a
questionnaire to members of the Patient and Carer Forum of the Stroke MCN. The feedback
she received confirmed that they perceived fatigue after stroke as an important area for
research with no effective treatment available.
The feedback was also used in the grant
application and Dr Mead has set up a users’ group of patients and carers to meet regularly
with the researchers over the 34-month project to help advise on all aspects of it.
Dr Mead’s new project FOCUS will continue this interaction with the service user and carer
group which was set up for the fatigue after stroke study. The research group have invited
members of this group to comment on the name of the trial and 6 month follow-up forms; and
are awaiting responses. They intend to invite members of this group to participate in a new
User Group to oversee FOCUS, and they will also seek new members for the FOCUS User
group through liaison with Chest Heart & Stroke Scotland nurses who follow-up people with
stroke after discharge from hospital. Professor Helen Rodgers will advise on how best to utilise
the expertise of the NIHR SRN Patient, Carer and Public Involvement Group in all stages of the
research process from writing the protocol to dissemination.
3.4 SPECIFIC OBJECTIVES
Patient recruitment
4.1 To increase annually the number of patients recruited to high quality clinical studies
supported by the Network by at least 12.5% per annum over the 2010/11 baseline;
Network Response:
NRS SRN recruitment in 2011/12 have meet national targets set out by the CSO and are in line
with NIHR SRN High Level Objectives (HLO) which were approved by the UK CRN Coordinating
Centre. HLO no.1 was a target of 10,000 participants (9,000 England).only), to studies where
the UK SRN is the main network providing support. NRS SRN has achieved over 10% of the
total UK target.
17
In order to meet the UK-wide annual total recruitment target of 10,000 patients of whom 6500
to be recruited to RCTs, the following numbers of patients need to be recruited quarterly:
Total number of patients 2500 of whom recruited into RCTs 1625
For quarter three, the UK-wide targets for the RCT and overall number of patients recruited
have been met (Table 1a, Figure 1)
For England (including Scotland) a minimum annual target for each network has been set at
450 patients recruited into RCT studies (113 per quarter) and an aspirational target has been
set as 450 + 45 per million population of each network. Aspirational targets for each network
are:
Table 1. [2011/12]
Local Research Network
North East SRN
North West SRN
South East SRN
South West SRN
Thames SRN
Trent SRN
West Midlands SRN
Yorkshire SRN
Scottish SRN
Aspirational
Annual RCT target
567
761
846
675
905
792
689
621
684
Aspirational Quarterly RCT target
142
190
211
169
227
198
172
155
171
The minimum (and aspirational) recruitment targets for NRS SRN in 2011/12 were 450 (684)
for randomised controlled trials (RCTs). At the end of this reporting year March 2012 the
Scottish SRN has exceeded the minimum target for patients recruited into RCTs target for all
studies. From April 2011 – March 2012 for patients who count towards the primary target
(i.e. excluding healthy volunteers and controls) the SSRN has a total of 1182 patients
recruited into trials of which 586 have been recruited into RCTs. The total recruitment of all
Scottish patients recruited into SSRN trials was 1415.
18
SSRN RCT V NON RCT April 2011 - March 2012
RCT
NON RCT
AIAS
ARUBA
Augmented Visual Feedback in Upper Limb Stroke
Rehab
Augmented Visual Feedback with Gait Training in SubAcute Stroke
AVERT
Biomechanics visualisation in AFO tuning for stroke
CADISS
CLOTS-3
DARS
DIASS-4 (SRN014)
ECG-AF
ENOS
GOTH
HAIST
IAMSS
IRIS
IST-3
Music Therapy for Acute Stroke Patients PILOT
PATCH Rustam
RTEASE
SOS
STASH
STITCH-II
SWIFT CAST
TARDIS
ATTEST
BARRIERS AND FACILITATORS
PISCES
DNA LACUNAR
EOL
INTERSTROKE
LINCHPIN
MILD STROKE STUDY 2
Physical Activity After Stroke
Fatigue After Stroke
POSH
TELEMEDICINE
POPSTA
STUDY ACCRUAL TARGET GROUPS
Subjects who DO COUNT towards primary target
(RCT 586 + Non RCT 596)
Plus subjects who DO NOT count towards primary
target
SSRN Total Accrual 2011-2012
The 2010 Scottish Stroke Audit figures show that there were over 10,322 stroke admissions in
Scotland in 2010, which means we are now recruiting around 12% of stroke patients into
stroke studies.
19
TOTALS
1182
233
1415
4.2 For at least 80% of new commercial studies receiving Network support, achieve
recruitment targets within target timescales.
Network Response:
In 2011/12 SSRN portfolio comprised of 2 commercial trials:
DIAS4 with a total recruitment period running over 4 years and 7 months (June 2009-Dec
2013)and a target of recruiting an average of 4 patients per 12 month period of recruitment
from each active site within the UK Stroke Research Network.
PISCES (total recruitment target over a 24 month period 12 patients). Currently PISCES has a
total of 8 patients recruited into the trial.
Recruitment into both of these trials continues.
3.5 High Quality New Studies
To increase year on year the number of high quality non-commercial and commercial clinical
studies (including UK-wide studies) from the 2010/11 baseline.
Network Response:
We will continue to deliver on a number of measures which we put in to support the network
in 2006/12 and continue to build on increasing the number of high quality non-commercial and
commercial clinical studies (including UK-wide studies) over the next 3 years.
The Current Reporting Year
(April 2011 – March 2012) has seen the success of some of the previous year’s efforts. Trials
such as the Mild Stroke Study 2, AIAS, IAMSS, CLOTS-3,DARS, AVERT, INTERSTROKE, Fatigue
After Stroke, , POSH, ECG-AF, Physical Activity After Stroke, DARS, Barriers and facilitators to
physical activity after stroke, Music Therapy for Acute Stroke patients (Pilot), DNA Lacunar,
Telemedicine and a number of other Scottish-led studies have continued to enable the
network to expand the trial portfolio and increase recruitment.
The SSRN portfolio also includes academic and commercial clinical trials which by their nature
are complex, and intricate such as PISCES, DIAS4, ARUBA, ATTEST, IST-3, IRIS, STASH,
STICHll, HAIST and PATCH.
Over the years we have actively encouraged investigators and the universities throughout
Scotland to alert us of any new trials which they may be developing themselves and asking
them to work with us in processing them through our adoption process. This has allowed us to
gain a fuller appreciation of stroke research activity in Scotland.
Scottish Led Studies
Hospitals such as the Western Infirmary Glasgow are following success of enrolment to the
CSO-funded ECG-AF trial, they continue follow-up of the 100 patients in this trial, and are
seeking funding to extend the trial across UK. This follows an invitation by HTA to submit a
full proposal.
20
Robotic Therapy Early After Stroke Events (RTEASE)
This randomised controlled trial with blinded endpoint assessment will assess feasibility and
gather early efficacy data for robot-assisted kinematic therapy early after stroke. Robot
assisted-kinematic therapy is being compared to standard care early after stroke in those with
limb impairment (within one week of stroke symptoms). Eighty participants will be randomised
by 7 days from ictus to robotic therapy plus standard care or standard care on a 1:1 basis. Drs
Dawson and Hughes are leading on it locally at the Western Infirmary Glasgow. Recruitment
began in March 2012 and network adoption is being sought.
The Biomarkers in Stroke Programme (BISP)
This research programme will apply new proteomic, metabolomic, transcriptomic and
bioinformatic techniques to carefully phenotyped patients with suspected stroke. The aim is to
identify biomarkers that facilitate diagnosis and predict outcome.
This prospective cohort
study will include 500 patients with suspected stroke. Blood and urine samples collected at
standardised intervals will be subjected to proteomic and metabolomic analysis using mass
spectometry and to gene expression and microRNA analysis. Integrated multimarker models
will be developed and then validated in attempt to provide clinical useful diagnostic tests.
This study has begun and funding has been sought from the Wellcome trust and if funded,
network adoption will be sought.
The EUROHYP-1 has been funded by the EU FP7 programme and preparations are underway
to get this set up across Scotland (and UK).Responsible for the handling training and
outcomes adjudication of the NIH CLEAR-III, ECASS-4 EXTEND and FP7 EUROHYP trials and
have also submitted an expression of interest to ENCHANTED, and expect to participate in
ECASS-4 EXTEND.
The SSRN is working closely with the Safe Implementation of Thrombolysis in Stroke (SITS)
group and expect to bring on board SITS-WATCH and SITS-OPEN. SITS-OPEN has strong
device industry links.
The Southern General Hospital currently have three research nurses and three clinical
research fellows active in stroke, with a clinical lecturer in neurology and the need to recruit
three additional research fellows and three project managers to support new projects and
grants in the coming months.
Current local trials activity includes:

Interstroke

DNA Lacunar stroke study

ATTEST (locally led trial)

PISCES (human neural stem cell trial)

DIAS 4
21
Projects that they are leading for the UK and due to start in the next 12 months:

PISTE (intra-arterial thrombectomy for acute stroke)

WAKE-UP (EU FP7 funded clinical trial in patients waking with stroke, assessed by
MRI)

ClotBuster (adjunctive transcranial ultrasound in patients undergoing IV thrombolysis)

PRACTISE (evaluation of advanced CT imaging on thrombolysis selection)

Local projects due to start imminently:

Evaluation of oxygen challenge MRI in volunteers, stroke patients, and those with
carotid artery disease

We have therefore expanded our range of trials and remain committed to advanced,
imaging-based translational projects. [Professor Keith Muir, SINAPSE Professor of
Clinical Imaging & Consultant Neurologist]
University led trials
NRS SRN have a vigorous and expanding programme of engagement with Scottish
Universities. Our shared aim is to promote and facilitate university-led trials within the SRN
portfolio.
In the past year Lanarkshire R&D, MCN, AHPs and SRN researchers have been
working closely with Strathclyde University, participating in The Swift Cast Trial, Biomachanics
Visualisation in AFO Tunning for Stroke (AFO), Augmented Visual Feedback in Upper Limb
Stroke Rehabilitation, Augmented Visual Feedback with Gait Training in Sub-acute Stroke and
all NRS SRN adopted trials. Trials such as The End of Life Study and Understanding the Role of
Users in Implementing Evidence into Practice led from Glasgow University have worked
extremely well within the current portfolio. All of which have all recruited successfully with the
expertise and commitment of SRN research nurses, AHPs and university research fellows
helping to screen, consent and recruit patients into the trials and with the dedication of
university principle investigators, local co-investigators all working together to enable us to
conduct high quality clinical studies throughout Scotland and the UK. To date 16 university led
trials have been adaopted by the network.
Dr Fiona Cooper
AIAS
Professor Philip Rowe
Augmented visual feedback with gait training in sub-acute stroke
Professor Philip Rowe
Professor Philip Rowe
Dr Jacqui Morris
Professor Lorraine Smith
Eileen Cowey
Lynne Legg
Lesley Scobbie
22
Augmented visual feedback in upper limb stroke rehabilitation
Biomechanics visualisation in AFO tuning for stroke
Barriers and Facilitators to
Physical activity after stroke
The impact of a dying care pathway on end of life care following
stroke
Glasgow Cargivers Cohort Study
Goal setting in community based stroke rehabilitation
Dr Marion Brady
INSPIRE
Dr Neshika Samarasekera
Professor Catherine MacKenzie
LINCHPIN
Living with Dysarthria
Dr Moira Kinear
PHARMACIST LED STUDY
Dr Marion Brady
SOCLE
Professor Valerie Pomeroy
Dr Andrew Kerr
SWIFT CAST
Dr Frederike van Wijck
Dr Frederike van Wijck
Oral Feeding Difficulties
Physical activity for non-ambulatory stroke survivors living at home:
feasibility, effects and experiences
3.5.1 NIHR SRN/NRS SRN joint ‘Writing Group’
One of the successful applications was led by Dr Gillian Mead Reader in Geriatric
Medicine/Consultant Stroke PhysicianEdinburgh. Of the 14 members who applied (including Dr
Mead) 12 are based in Scotland.
The project is called FOCUS - A multicentre randomised trial to establish the effect(s) of
routine administration of Fluoxetine in patients with a recent stroke. FLuoxetine Or Control
Unlocks Stroke (FOCUS)
Members of the research group include Professor Martin Dennis (Co-PI), Dr Marian Brady,
Professor John Forbes, Dr Maree Hackett, Professor Allan House, Dr Steff Lewis, Dr Malcolm
MacLeod, Ms Hazel Milligan, Mr David Perry, Professor Peter Sandercock, Professor Frank
Sullivan, Dr Frederike van Wijck, Professor Caroline Watkins.
The group aims to establish whether fluoxetine 20mg given daily for 6 months improves
outcomes in a much broader group of stroke patients than those enrolled in FLAME, both with
and without motor deficits, having the more modest intensity rehabilitation available in the UK.
They also aim to establish if any benefits persist beyond the treatment period.
The proposed trial will answer the overarching question about the effect of fluoxetine on
modified Rankin score, and will also be powered to answer secondary questions about effect
of fluoxetine in subgroups e.g. motor deficits, sensory deficits, language deficits, visual
deficits. This efficient study design offers excellent value for money.
The multidisciplinary team includes researchers from internationally recognised institutions
who have expertise in major multicentre stroke trials (Dennis, Sandercock), trials of complex
interventions in stroke (Mead, Dennis, vanWijck), depression after stroke (Hackett, House),
23
systematic reviews in humans (Sandercock, Mead & Hackett) and systematic reviews in
animals (MacLeod). The statistician (Lewis), of Edinburgh Clinical Trials Unit, a Registered
Clinical Trials Unit, has extensive experience in stroke trials. Professor Forbes brings
internationally recognised expertise in health economic analysis of large stroke trials. Professor
Watkins leads NIHR-funded stroke research, and Professor Sullivan (Scottish Primary Care
Network) will advise how to maximise collection of follow-up data by general practitioners. Mr
Perry will design the study IT systems and randomisation service, Ms Milligan (pharmacy) will
advise on procurement and delivery of drug and placebo, and Dr Brady will advise on
language outcomes and will design aphasia-friendly patient information sheets. Some of these
researchers have not worked together before, thus offering opportunities for fruitful new
collaborations that may lead to further stroke trials. The trial will start recruiting the first of its
3000 patients in July 2012 and will be initially opened in sites across the UK.
3.5.2 Clinical Trials of Significance
Every year we aim to highlight the clinical trials of global significance which are being run from
Scotland. We have asked the Executive Committee to highlight their successes and their plans
for development over the next few years in regards to research on specific therapeutic
interventions likely to become clinically available within 3-5 years and address a significant
area of disease burden. The 4 obvious ones are ECASS3, CLOTS, IST-3 and PISCES. The first
two have the potential to influence clinical practice in stroke treatment and improve stroke
outcomes across the world. PISCES is a cutting-edge translational study of a potentially
revolutionary regenerative treatment. These trials justify the claim that Scotland punches
above its weight in stroke research.
IST-3
The IST-3 trial of clotbusting treatment for acute stroke was funded by the MRC and
conducted within the NIHR framework.
It completed recruitment in mid 2011, with 3035
patients recruited (1617 (53%) of whom were aged over 80 years), making it far the largest
trial of this intervention ever undertaken. The findings will have huge implications for the
management of stroke worldwide, and represent a major step forward in our understanding of
this complex and challenging therapy. About one third of all acute strokes in the developed
world occur in people aged over 80 years and this trial has provided the first large-scale
randomised evidence to support the use of thrombolytic therapy in this group. As such the
IST-3 trial has will widen the use of this effective therapy. [Professor Peter Sandercock, MA,
DM, FRCPE, FMedSci, Professor of Medical Neurology and Honorary Consultant Neurologist,
Director, Edinburgh Neuroscience]
24
CLOTS Trials
The UKSRN supported recruitment and follow up of stroke patients in the MRC/CSO/CHSS
funded CLOTS trials 1 and 2. The CLOTS trials aimed to assess the effectiveness of external
compression to reduce the risk of DVT in stroke patients who are admitted to hospital and
who are immobile. At least 10% of immobile stroke patients will develop a proximal DVT,
putting them at risk of life threatening pulmonary emboli.
Clots trial 1 which enrolled over 2500 patients compared the rate of post stroke DVT in
patients given Long compression stockings compared with patients treated without stockings.
It showed that Long stockings do not reduce the risk of DVT after stroke and moreover their
use is associated with an increase in pressure sores on the patient’s legs. Following the
publication of these results in Lancet in June 2009, NICE withdrew their provisional
recommendation that stroke patients should be treated with stockings. The results of this trial
have influenced the treatment of stroke patients – about 50% of who will be immobile and at
risk of DVT, around the world. The results have influenced national guidelines in US, Italy,
Singapore, Australia, Canada and New Zealand
Clots trial 2 which enrolled over 3000 patients compared the rate of post stroke DVT in
patients given Long compression stockings compared with patients treated with Short
stockings. It showed that the DVT rate was significantly lower with Long stockings than Short
stockings. The full results appeared in the Annals of Internal Medicine in Sept 2010. This is
an important finding since although it may not influence stocking use in stroke, where Trial 1
has shown little benefit, this is the first trial to have compared long and short stockings.
Currently, due to the lack of evidence of a difference in effectiveness and a lower cost
associated with Short stockings, the NHS purchases huge numbers of Short stockings for DVT
prophylaxis in patients undergoing surgery. 75% of stockings purchased by NHS Scotland are
short, and evidence suggests that this is true of most health services. It is therefore likely that
the majority of patients are being treated with the less effective length of stocking and many
patients will be dying from potentially preventable pulmonary emboli.
The ongoing CLOTS 3 trial aims to establish whether intermittent pneumatic
compression reduces the risk of post stroke DVT. It is recruiting well and will report in
2014.
Fatigue After Stroke
A longitudinal Cohort Study of Frequency, Prognosis and Relationship With physical Activity
and physical de-conditioning. The SSRN has supported a prospective cohort study of poststroke fatigue, led by Dr Gillian Mead at University of Edinburgh. Post-stroke fatigue affects
around 40% of stroke survivors. Dr Mead's team has demonstrated, for the first time, that
fatigue is associated with reduced levels of physical activity. Thus, fatigue might be due, in
part, to physical deconditioning. This result is important as it justifies the development of
physical activity interventions to treat post-stroke fatigue.
25
PISCES (Pilot Investigation of Stem Cells in Stroke)
This study is the world’s first fully regulated clinical trial of a neural stem cell therapy for
disabling stroke. The trial is a "first in man" safety study that will test increasing doses of the
foetal neural stem cell line CTX0E03 administered by direct injection into the brain, in a
planned sample of 12 patients. Further trial details are available at:
http://www.clinicaltrials.gov/ct2/show/NCT01151124?term=PISCES&rank=2
Subjects have to be men over 60 years of age with disabling ischaemic stroke between 6
months and 5 years earlier. 8 patients have undergone stem cell implantation so far in the trial
since it commenced in November 2010, and the first dose cohort will be completed when all
12 patients have been recruited into the trial.
The MASH-2 Trial, Magnesium for aneurysmal subarachnoid haemorrhage (MASH-2): a
randomised placebo-controlled trial. The study results were presented at the European Stroke
Conference in Lisbon this year.
Magnesium sulphate is a neuroprotective agent that might improve outcome after aneurysmal
subarachnoid haemorrhage by reducing the occurrence or improving the outcome of delayed
cerebral ischaemia. We did a trial to test whether magnesium therapy improves outcome after
aneurysmal subarachnoid haemorrhage.
1204 patients were enrolled, one of whom had his treatment allocation lost. 606 patients were
assigned to the magnesium group (two lost to follow-up), 597 to the placebo (one lost to
follow-up). 158 patients (26·2%) had poor outcome in the magnesium group compared with
151 (25·3%) in the placebo group (risk ratio [RR] 1·03, 95% CI 0·85—1·25). Our updated
meta-analysis of seven randomised trials involving 2047 patients shows that magnesium is not
superior to placebo for reduction of poor outcome after aneurysmal subarachnoid
haemorrhage (RR 0·96, 95% CI 0·86—1·08). Intravenous magnesium sulphate does not
improve clinical outcome after aneurysmal subarachnoid haemorrhage, therefore routine
administration of magnesium cannot be recommended.
26
3.5.3 Potential Breakthroughs
Dr Jesse Dawson, Clinical Senior Lecturer in Medicine, Western Infirmary, Glasgow is one of
the lead investigators for the ALLO IMT Trial: The effect of allopurinol on carotid ultrasound
intima-thickness and markers of endothelial function in patients with recent stroke.
Dr Dawson comments that many stroke patients suffer a second stroke or a heart attack,
despite taking all currently available preventative treatments. There is a great need for
innovative approaches to improve stroke prevention. Allopurinol, a drug already used to treat
painful joint problems due to gout, may promote healthier blood vessels and so reduce risk of
stroke. It is safe to give allopurinol after stroke and preliminary evidence supports the
assertion that allopurinol improves the function of blood vessels. The next step is to confirm
that allopurinol influences blood vessels of most stroke patients in a sustained and beneficial
manner. That will then justify testing for reduction in stroke recurrence rates in large numbers
of patients.
The research team are currently assessing whether allopurinol affects the thickness of the wall
of the main artery supplying blood to the brain (the carotid artery). Arterial thickness indicates
the extent of arterial disease: the greater this thickness the higher the risk of stroke. They
measure thickness using ultrasound. They believe that a drug which limits arterial thickness
can reasonably be expected to reduce stroke risk.
The trial is being coordinated by the Stroke Trials team at the Western Infirmary in Glasgow
with support from the UK Stroke Research Network. This project is therefore a key step in the
evaluation of a much needed promising additional preventative treatment. If allopurinol is
effective it could be readily incorporated into practice: it is a well tolerated, established and
cheap drug that most patients could take. The study is now completed and they hope to have
results in July this year and if indicated, would submit funding for a large scale clinical trial.
The coordinating team at the Western Infirmary Glasgow would first aim to seek support for a
writing group with other members of the network. The trial results will be published later in
2012.
Section 4
Overview April 2011 to March 2012:
The initial NRS SRN objectives established in 2006 have all been met:

Develop process, advertise and appoint the post of Research Network
Manager.

Establish regional research committees.

Identify potential research active centres.

Agree a broad approach to the allocation of resources to research active
centres.
27

Raise the profile of Scottish Stroke Research Network.

Survey current research activity.

Develop a Broad Study Portfolio
4.1 Staff training and quality assurance
The NRS SRN Study Meetings and annual meetings are provided for the stroke
research
network community and are intended to be an additional source of training for the research
nurses, AHPs and investigators where by the network will invite trial coordinators from the
various different SRN adopted stroke trials (UK wide) to attend SRN meetings, give a
presentation and update on their particular studies and give the opportunity for a discussion to
take place following the presentation between the coordinators and the research nurses. At
the end of the meetings NRS SRN staff meetings are held.
Other areas of development include staff training and quality assurance. Since Nov 2008
Guidelines have been in place for each site across Scotland along with a SSRN File containing
relevant GCP, regulatory information and site file maintenance guidance, which is reviewed
and updated annually. GCP training records and clinical research training/courses are routinely
recorded by our research staff and our central records are updated annually via regular site
visits and end of year reports. From the initial set up of the network we have supplied a SSRN
Training Log which we have instructed the research nurse to keep up-to-date and file in their
SSRN Site File. The SSRN research nurses also submit an up-to-date copy of their training logs
on an annual basis, which we hold centrally alongside a copy of their GCP certificates.
4.2 SSRN Ward Partnership Initiatiative
In 2009 the Scottish Stroke Research Network (SSRN) became involved in discussion with Dr
Grace Lindsay, Reader in Nursing, Caledonian University and Lead Research Nurse for NHS
Greater Glasgow to discuss the potential to expand stroke research in Scotland, whilst
ensuring it is of high quality, timely and better tailored to the people of Scotland. We also
endeavour to explore ways to increase stroke patient and carer participation in our research so
that everybody has an equal opportunity to participate.
The result was the creation of the
Ward Partnership Initiative (WPI).
Aims:
•
to encourage more ward nurses to take an active role in stroke research in Scotland
•
to support ward nurses with training to take part in stroke research
•
to raise awareness of the Scottish Stroke Research Network
28
The history behind this initiative was the limited financial resources available which do not
allow the SSRN to support research nurse provision in every stroke ward in Scotland. The
project was developed to evaluate how aware ward staff were of the SSRN and its research
studies. It also aimed to discover how ward staff could best engage with the SSRN.
Ward Partnership Initiative: Phase 1 – ongoing
•
an awareness raising pilot questionnaire was sent out to Senior Qualified Nurses
•
20 responses received – Stirling, Lothian, Borders and Glasgow
Six questions were asked, including regarding qualified nursing staff becoming involved in
raising awareness of stroke research, and if there would be support for nurses undertaking
some stroke-specific accredited training for this, e.g. linking to nurses CPD/KSF.
Pilot Questionnaire Feedback:
A very positive response was received together with some useful and helpful comments which
will be taken forward to the next stage of the initiative.
Respondents felt that Clinical Nurse Specialists would be best placed to taken on the role of
raising awareness of stroke research within hospital wards and there was resounding support
for CPD/KSF accreditation. However, it was acknowledged that finding a suitable time for
training would have to be reviewed as often lunchtimes or self-directed learning are not
suitable due to protected meal times or other on-line training commitments.
It was felt that the Scottish Stroke Research Network could make a positive impact at ward
level by, for example: integrating the SSRN more into the clinical arena; raising awareness
about how the SSRN works; making research more meaningful for nurses; general support
and feedback about new research and research results, also funding a stroke research nurse
or supporting a ‘link nurse’ on the ward.
Follow up

Provide feedback from original questionnaire

Create the second phase questionnaire

Produce a paper from the results
Results from the evaluation will be used to tailor the work of the SSRN and help to further
enhance the relationship of the SSRN with the stroke ward staff.
29
4.3 UKSRN Portfolio Development Opportunity – UKSRN Writing Group
The NIHR SRN annually invites applications from the stroke research community with the
explicit aim of developing high quality research proposals intended for submission to eligible
organisations for funding.
Applications are asked to clearly articulate and justify the proposed work to be undertaken.
£25,000 was ring fenced in 2011/12 for this initiative and it was anticipated that up to 10
applications would be funded. NIHR SRN approached the Scottish SRN in early 2011 to
propose the feasibility of the Scotland SRN contributing to funding 2 of the successful Scottish
applicants. This proposal was successful and NRS SRN has since contributed 50% of the
funding award for each project. The money requested was intended to be used to facilitate
proposal generation via workshops, writing committee meetings etc.
Applications were asked to demonstrate interaction with relevant SRN Clinical Studies Groups
and have appropriate methodological input from the Robertson Centre for Biostatistics
(Glasgow University) or Clinical Trials Unit/Research Design Service.
A suitable topic would be in an area of stroke where large scale research projects are likely to
obtain funding in the near future. In particular, multi-centre studies designed to address the
key priorities identified by NIHR SRN (although any stroke related research proposal for multicentre study would be considered):
• Patient, carer and public involvement
• Primary Care studies
• Hyperacute stroke studies
One of the successful applications was led by Dr Gillian Mead Reader in Geriatric
Medicine/Consultant Stroke Physician Edinburgh. Of the 14 members who applied
(including Dr Mead) 12 are based in Scotland.
The project is called FOCUS - A multicentre randomised trial to establish the effect(s) of
routine administration of Fluoxetine in patients with a recent stroke. FLuoxetineOr Control
Unlocks Stroke (FOCUS)
The trial aims to establish whether giving 20mg of Fluoxetine for the first six months after
stroke imporves patient outcomes. A systematic review of over 50 small randomised trials of
specific serotonin reuptake inhibitors performed by the FOCUS trial investigators has provided
encouraging evidence of effectiveness. The trial will start recruiting the first of its 3000
patients in July 2012.
30
The SSRN has provided funding to support the production of a systematic review and metaanalysis of selective serotonin reuptake inhibitors in stroke, led by Dr Gillian Mead at University
of
Edinburgh, for the Cochrane Collaboration. This review is important as it will underpin the
design of large trials of fluoxetine in stroke.
Members of the research group include Professor Martin Dennis (Co-PI), Dr Marian Brady,
Professor John Forbes, Dr Maree Hackett, Professor Allan House, Dr Steff Lewis, Dr Malcolm
MacLeod, Ms Hazel Milligan, Mr David Perry, Professor Peter Sandercock, Professor Frank
Sullivan, Dr Frederike van Wijck, Professor Caroline Watkins.
The trial will start recruiting the first of its 3000 patients in July 2012 and will be initially
opened in sites across the UK.
Portfolio Development
Section 5
The UK SRN portfolio consists of NIHR/NRS partner-funded clinical trials and other welldesigned studies, plus a number of other non-NIHR/NRS partner-funded studies which have
been formally assessed by the UK SRN Study Adoption Committee before being included in the
portfolio. Both international and UK-based studies are included, as are industry and academic
studies.
INTERVENTION STUDIES
Study
RTEASE
Music Therapy in Stroke
Lead Country
Scottish Led
Scottish Led
RCT/Non RCT
RCT
RCT
Sub Topic
Acute
Acute
Status
Open
Open
Scottish Led
Non RCT
Rehabilitation
Open
ATTEST
PATCH
SOS
CLOTS-3
ENOS
HAIST
DIAS-4
STASH
STITCH-II
TARDIS
ARUBA
CADISS
IRIS
PISCES
Biomechanics
visualisation in AFO
tuning for stroke
Scottish Led
Scottish Led
English Led
Scottish Led
English Led
Scottish Led
English Led
English Led
English Led
English Led
Scottish Led
English Led
English Led
Scottish Led
RCT
RCT
RCT
RCT
RCT
RCT
RCT
RCT
RCT
RCT
RCT
RCT
RCT
Non RCT
Acute
Acute
Acute
Acute
Acute
Acute
Acute
Acute
Acute
Acute
Prevention
Prevention
Prevention
Translational
Open
Open
In Set-up
Open
Open
Open
Open
Open
Open
Open
Open
Open
Open
Open
Scottish Led
RCT
Rehabilitation
Open
DARS
AVERT
SWIFT CAST
English Led
Scottish Led
English Led
RCT
RCT
RCT
Rehabilitation
Rehabilitation
Rehabilitation
Open
Open
Open
Goal setting in community
based stroke
rehabilitation
31
OBSERVATION STUDIES
Study
Lead Country
RCT/Non RCT
Sub Topic
Status
Measuring community
-based stroke outcomes
Scottish Led
Non RCT
Rehabilitation
In Set-up
End Of Life
LINCHPIN
INTERSTROKE
Barriers and Facilitators
DNA LACUNAR
Scottish Led
Scottish Led
Scottish Led
Scottish Led
Scottish Led
Non RCT
Non RCT
Non RCT
Non RCT
Non RCT
Acute
Acute
Prevention
Rehabilitation
Translational
Open
Open
Open
Open
Open
INTERVENTION & OBSERVATION STUDIES
Augmented visual feed
back with gait training in
sub-acute stroke
Augmented visual
feedback in upper limb
stroke rehabilitation
Scottish Led
RCT
Rehabilitation
Open
Scottish Led
RCT
Rehabilitation
Open
5.1 Process for academic input into portfolio development within NIHR SRN/NRS
SSRN
NRS SRN has adopted the NIHRSRN/NIHRCRC/NIHRCRN established adoption process for
academic input into the overall portfolio. Academic input into portfolio development is
facilitated through the UK SRN’s Clinical Studies Groups all of which have strong academic
representation. Representation from Scotland is well established with representation from
Northern Ireland/Wales under active review. The majority of CSGs have been meeting either
by teleconference or face-to-face since December 2005. A number of the CSGs have met
jointly in workshops with other key people in their field to work on cross-over issues and
identify priorities for future research, which we would be pleased to share with research
funders.
5.2 Clinical Study Groups
The Clinical Studies Groups (CSGs) focus on eight research strands and each is led by a Chair,
who may also be one of our Associate Directors.
CSGs are responsible for the development of stroke studies within their strand within the
UKSRN portfolio, including identifying gaps and proposing or developing new studies. They
also act as a source of advice for researchers and research funders on the development of
studies and advise the UKSRN Portfolio Management Committee on studies as part of the
Adoption check that UKSRN carries out. Groups have been established for the following seven
strands:

Acute

Prevention

Rehabilitation

Primary Care

Patient, Carer and Public Involvement
32
Portfolio Management Committee
The UK Stroke Research Network Portfolio Management Committee (PMC), which was
previously known as the Study Adoption Committee, is an independent committee convened to
carry out the adoption check that is part of the global checks that a study undergoes before it
can start to recruit participants. The Committee has a duty to oversee the UK SRN portfolio
and ensure that a balance in the types of study adopted is developed and maintained. The
suitability of projects to be adopted into the UK SRN Portfolio is assessed against the criteria
for study adoption.
Membership is drawn from UK SRN Directors, UK Research Network leads, and the NIHR CRN
and NIHR SRN Co-ordinating Centres. The Committee meets regularly to discuss the local
network support that can be provided to adopted studies, and to review the portfolio and its
development.
Acute CSG
The Acute Clinical Studies Group will be responsible for developing and overseeing a portfolio
of studies relating to acute stroke care, identifying gaps in research topics and both proposing
and developing new trials. The group is keen to offer practical support to others in designing,
writing and revising proposals if this is required, but will consider and support studies arising
elsewhere – nationally or internationally - and advise the UK SRN Study Adoption Committee
on these. It will facilitate two-way communication between UK research funders and
researchers and will provide advice on matters relating to acute stroke care to the UK SRN.
The Acute CSG will try to ensure patient and carer involvement in its activities.
Rehabilitation CSG
Stroke rehabilitation research in the United Kingdom is at the forefront of the developing
evidence base for best clinical practice. Historically, rehabilitation research has been a single
centre activity with subsequent limited generalisability. Much of rehabilitation research is still
at pre-clinical and phase 1 level and it is therefore essential that all rehabilitation evaluations
are based on the Medical Research Council framework for complex interventions (MRC, 2000).
Current research capacity and capability levels in the stroke rehabilitation community also
need to be built upon.
The Stroke Research Network has identified rehabilitation research as one of the key areas for
future development. The Rehabilitation Clinical Study Group brings together individuals with
the necessary expertise and enthusiasm to ensure that all potential opportunities for further
development of the evidence base are fully exploited. The Clinical Study Group will develop
and oversee a portfolio of rehabilitation studies, identify gaps in the evidence base and assist
in the development of new trials and other well-designed rehabilitation studies.
33
Prevention CSG
The SRN prevention Clinical Study Group will identify research gaps in knowledge and
evidence related to stroke prevention, propose study questions and in some cases, design and
lead individual studies.
The CSG will also consider and offer advice on submitted academic
and commercial studies during their design stage, whilst taking account of other planned and
ongoing studies. The remit of the CSG will be to cover both primary and secondary prevention.
Primary prevention studies will be those where stroke is the primary outcome (but not where
it is part of a composite vascular outcome). Secondary prevention studies will cover both
ischaemic
and
haemorrhagic
stroke,
and
asymptomatic
and
symptomatic
disease.
Haemorrhage will encompass all pathological types and regions of the brain (parenchymal,
subarachnoid, cavernomatous, arteriovenous malformation) but will exclude bleeding following
trauma. Prevention studies may either be observational, or randomised and controlled, in
nature, and may involve medical, surgical and neuroradiological interventions. The CSG will
meet regularly by teleconference and face-to-face, and will liaise closely with the acute,
rehabilitation and community CSGs.
Primary Care CSG
Much of the primary and secondary prevention of stroke and the longer term care and
rehabilitation takes place in primary care settings, but much of the evidence base is derived
from studies which recruit patients from in-patient or secondary care settings. The aim of the
primary care clinical study group is to stimulate and support primary-care based research
across the whole patient pathway to include primary prevention, acute care, rehabilitation,
secondary prevention and long term care and support. As this is the only clinical study group
that is based around a site of care, it will work closely with the other clinical study groups,
particularly rehabilitation and prevention.
The first steps will be to assess the current research activity in stroke in primary care and
identify the gaps with the purpose of promoting research to address these gaps.
Industry
The UKSRN Stroke Research Network is tasked with developing a world-class infrastructure to
ensure that high-quality research funded by both commercial and non-commercial
organisations receives the support it needs to succeed. Such support will include investment in
the expansion of dedicated clinical research staff within the NHS, and the development of
standard procedures to ensure consistent best practice at network study sites through both
study set up and conduct. [UKSRN]
A Successful Example of Industry and Network Collaboration [UKSRN]
http://www.uksrn.ac.uk/images/files/crf_19-5_fountain%20%283%29.pdf
34
Provenance of CSG priority areas:
The primary research direction of NRS SRN originated from a proposal to the Chief Scientists
Office for establishing a stroke research network in Scotland. The SSRN Executive Committee
liaises closely with the UKSRN. The overall priority areas were developed by CSGs through
input of CSG members and at workshops designed by CSGs to look at this area as outlined
above. This will be under ongoing review and development in light of progress made and
related developments in relevant areas.
5.3 Acknowledgement of Scottish led UKSRN adopted trials 2006 – 2012
Since the creation of the Scottish SRN in 2006 the network has been fortunate to benefit from
numerous Scottish stroke physicians, PhD students, university researchers, AHPs and research
nurses who have allowed us the opportunity to formally adopt commercial/academic led
studies whereby they are the Chief Investigator for the UK. Many of these Scottish led studies
have opened sites across the UK resulting in increased recruitment for the English sites as well
as our Scottish sites. Without the support of these researchers the network portfolio would not
be as strong as it has been over the past 6 years.
Scottish led UKSRN adopted trials 2006 - 2012
Advance Brain Imaging
AIAS
ALLO IMT
ANCROD
ARUBA
ATTEST
Augmented visual
feedback with gait
training in sub-acute
stroke
Augmented visual
feedback in upper limb
stroke rehabilitation
AVERT
Biomechanics
visualisation in AFO
tuning for stroke
35
Professor Joanna Wardlaw
Advanced brain imaging to assess salvageable tissue in acute stroke
- diagnosis and prognosis indicators
Dr Fiona Cooper
A randomised, feasibility, safety and efficacy study of the
Armeo®Spring arm orthosis for acute stroke patients with arm
deficits
Professor Matthew Walters
The effect of allopurinol on carotid ultrasound intima-thickness and
markers of endothelial function in patients with recent stroke
Professor Kennedy Lees
A Randomised, Double-Blind, Placebo-Controlled Study of Ancrod
(Viprinex™) in Subjects Beginning Treatment within 6 Hours of the
Onset of Acute Ischemic Stroke
Dr Rustam Al-Shahi Salman
A randomised trial of unruptured brain arteriovenous malformations
Professor Keith Miur
Alteplase- Tenecteplase Trial Evaluation for Stroke ThrombolysisPilot Phase
Professor Philip Rowe
Augmented visual feedback of biomechanical movement
performance to enhance walking recovery after stroke: a pilot
randomised controlled trial
Professor Philip Rowe
The impact of augmented visual feedback in upper limb
rehabilitation in sub-acute stroke
Professor Peter Langhorne
A Very Early Rehabilitation Trial - A Phase III, multi-centre,
randomised controlled trial of very early rehabilitation after stroke
Professor Philip Rowe
Visualisation to enhance biomechanical tuning of ankle-foot orthoses
(AFO) in stroke - a randomised controlled trial
Barriers and Facilitators
to
Physical activity after
stroke
CEPO
CLOTS-1
CLOTS-2
CLOTS-3
ECG-AF
EOL
FATIGUE AFTER
STROKE
GCCS
Goal setting in
community based
stroke rehabilitation
HAIST
IAMSS
INSPIRE
INTERSTROKE
IST 3
LINCHPIN
36
Dr Jacqui Morris
Exploring the barriers and facilitators to maintaining engagement in
physical activiities after the end of poststroke rehabilitation; a
qualitative study of stroke survivors, caregivers and stroke
physiotherapists
Professor Kennedy Lees
A randomised, double-blind, placebo-controlled, multiple-dose, doseescalation study of the safety, tolerability, and pharmacokinetics of
Lu AA24493 in patients with acute ischemic stroke
Professor Martin Dennis
A Randomised Trial to Establish the Effectiveness of Graduated
Compression Stockings to Prevent Post Stroke Deep Vein
Thrombosis (DVT)
Full length graduated compression stockings in addition to routine
care Or Routine care and avoid the use of graduated compression
stockings
Professor Martin Dennis
A Randomised Trial to Establish the Effectiveness of Graduated
Compression Stockings to Prevent Post Stroke Deep Vein
Thrombosis (DVT)
Full length graduated compression stockings in addition to routine
care Or Below knee graduated compression stockings in addition to
routine care
Professor Martin Dennis
A Randomised Trial to Establish the Effectiveness of Intermittent
Pneumatic Compression to Prevent Post Stroke Deep Vein
Thrombosis (DVT)
Professor Kennedy Lees
Evaluation of electrocardiographic monitoring strategy to identify
atrial fibrillation in patients with recent acute stroke
Eileen Cowey
The impact of a dying care pathway on end of life care following
stroke
Dr Gillian Mead
A longitudinal Cohort Study of Frequency, Prognosis and
Relationship With physical Activity and physical de-conditioning
Professor Peter Langhorne
The Glasgow Caregivers Cohort Study: A study on the impact of
providing care to stroke survivors
Lesley Scobbie
A feasibility and acceptability study of implementing a goal setting
and action planning practice framework.
Dr Malcolm MacLeod
Hypothermia for Acute Ischaemic Stroke Trial - Pilot Phase
Professor Ronan O’Carroll
Improving adherence to medication in stroke survivors
Dr Marion Brady
Incontinence stroke project inspiring rehabilitation excellence
Professor Peter Langhorne
Importance of conventional and emerging risk factors for stroke in
different regions of the world and in different ethnic groups: a case
controlled study
Professor Peter Sandercock
An international multi-centre, randomised, controlled trial to
investigate the safety and efficacy of treatment with intrevenous
recombinant tissue plasminogen activator (rt-PA) within six hours of
onset of acute ischaemic stroke
Dr Neshika Samarasekera
Lothian study of INtraCerebral Haemorrhage Pathology, Imaging
and Neurological outcome
Living with Dysarthria
MASH II
ME-12
Mild Stroke Study 2
Music Therapy for
Acute Stroke Patients
Modified Rankin Study
(CARS)
PATCH
PEDOMETERS IN
STROKE
PERFORM
PHARMACIST LED
STUDY
Physical Activity Levels
After Stroke
PISCES
POPSTA
POSH
RAS
RTEASE
SOCLE
SWIFT CAST
TALECRIS
TELEMEDICINE
37
Professor Catherine MacKenzie
Evaluation of the feasibility of the implementation of a group
intervention programme for stroke patients and carers, addressing
the impact of dysarthria
Dr Rustam Al-Shahi Salman
Magnesium in Aneurysmal Subarachnoid Haemorrhage
Professor Keith Muir
A randomised, placebo-controlled, ascending dose, Phase IIa trial of
SA4503 in patients who have experienced an ischemic stroke within
48 to 60 hours of randomisation
Professor Joanna Wardlaw
Blood-brain barrier dysfunction and cerebral small vessel disease
Charlie Chung
Music therapy for acute stroke patients with severe communication,
cognative or mood disorders
Dr Jesse Dawson
Central Adjudication of modified Rankin Scale Assessments in Acute
Stroke Trials
Dr Rustam Al-Shahi Salman
Platelet Transfusion in Cerebral Haemorrhage
Dr Gillian Mead
Using Pedometers to promote physical activity in patients after
stroke; a pilot study
Professor Kennedy Lees
An international, randomised, double blind, two parallel group study
comparing terutroban 30mg o.d versus aspirin 100mg o.d
administered orally for a 3 year mean duration (event driven only)
Dr Moira Kinear
A randomised exploratory trial of a pharmacist-led home based
clinical medication review in people after stroke
Professor Peter Langhorne
An observational study: monitoring and establishing physical activity
levels in acute stroke patients
Professor Keith Muir
A Phase 1 safety trial of CTX0E03 Drug Product delivered
intracranially in the treatment of patients with stable ischaemic
stroke
Katrina McCormick
Prevalence Of Peripheral arterial disease in Stroke and TIA Audit
Professor Keith Muir
Pathophysiology of acute post-stroke hyperglycaemia in relation to
brain perfusion and arterial patency
Professor R Barbour
Reintegration after stroke: Quality of life, employment and social
capital
DR Jesse Dawson
Robotic Therapy Early After Stroke Events
Dr Marion Brady
Stroke Oral Health Care Tool Evaluation
Professor Valerie Pomeroy / Dr Andrew Kerr
Clinical efficacy of the Soft-Scotch Walking Initial FooT (SWIFT) Cast
on walking recovery early after stroke and the neural-biomechanical
correlates of response
Professor Keith Muir
A Phase 1/2a, Open Label, Dose Escalation, Safety Study of Intrathrombus Plasmin (Human) Administration in Acute, Middle Cerebral
Artery, Ischemic Stroke
Dr Mary Joan MacLeod
Telemedicine for the evaluation of brain attacks
Understanding the role
of users in
implementing evidence
into practice
VERITAS
VITATOPS
Professor Peter Langhorne
Development of a European Implementation Score for measuring
implementation of research into healthcare practice using vascular
disease as an example (EIS).
To understand the role of users in implementing evidence into
practice
Dr Philip White
Vasospasm: endovascular interventional treatment against standard
[medical] management
Professor Kennedy Lees
a multi-centre, randomised, double-blind, placebo-controlled clinical
trial examining the efficacy and safety of multi-vitamin therapy in
secondary stroke prevention
Service Development
Section 6
TELEMEDICINE
Harnessing communication technology to improve the acute care of stroke patients is an
exciting challenge. Telemedicine has the potential significantly to affect the way in which
thrombolytic therapy and other acute strategies are delivered in the future, and is of particular
relevance to the provision of care in remote and rural areas. Decisions over the
implementation of this technology will be expensive and must be informed by high quality
evaluation. Telemedicine developments have been used in several countries to try and
improve access to hyperacute stroke care. Telemedicine projects are now well developed in
Grampian, Lanarkshire and now within the South East Network (Lothian, Fife and Forth Valley,
Borders). The SSRN now hosts a Telemedicine evaluation study led by Dr Mary Joan Macleod
of NHS Grampian and Dr Gillian Mead of NHS Lothian. This study has so far provided early
evidence of acceptability by patients, carers and health care professionals. Ongoing data
collection, in conjunction with data from SSCA, will allow assessment of outcomes and
comparison with face to face treatment.
Telemedicine also offers potential solutions to the challenge of clinical trial recruitment in more
remote areas. As acute stroke trials are mainly conducted in large urban hospital, patients
from more remote areas may be excluded from taking part with deleterious effects on
recruitment and the generalisability of results. Two Scottish centres (Aberdeen and Edinburgh
Royal) have successfully used telemedicine consultations to recruit participants into a large
Scotland-led hyperacute stroke trial (IST-3).
38
SINAPSE
Another service barrier has been accessing imaging for stroke study recruits. The SSRN have
supported the development of SINAPSE and have a seat on their steering committee. The
SSRN are also supportive of and fully engaged with the Scottish Academic Health Sciences
Collaboration, a consortium which comprises Scottish universities and health boards and builds
on the close NHS/academic partnerships which already exist across Scotland. Significant
funding and support for radiology services needed for conducting innovative stroke research in
Scotland has been put in place.
Cardiac evaluation after stroke
Detection of atrial fibrillation (AF) after ischemic stroke is important because anticoagulation is
indicated to reduce the risk of recurrent stroke. However, no consensus exists about the
optimum method for detecting underlying paroxysmal AF not apparent on presentation with
stroke. Evidence suggests that current methods of screening may fail to detect underlying
paroxysmal AF in a substantial proportion of patients. The SSRN has adopted a trial which will
investigate the potential benefit of routine, rigorous and prolonged monitoring of patients with
recent stroke with a view to the early detection and treatment of paroxysmal atrial fibrillation.
The results of this trial may have implications for the investigation of patients with ischaemic
stroke in future.
Training
Section 7
Training and Education
The UKSRN established a Service Development and Training Clinical Studies Group (CSG) in
2007.The CSG established a Training and Education (T&E) sub-group chaired by Anne Forster.
Members:

Anne Forster, SRN Training Lead and CSG Co-Chair, Clinical Lead Yorkshire SRN

ZenaLethbridge, SRN PCPI Manager

Chris Price, Deputy Clinical Lead, North East SRN

Donna Richardson, Network Manager, Trent SRN

Anne Marie Murtagh, Network Manager, South East SRN

Claire McFarlane, Network Manager, Scottish SRN
The remit of the group was to:

Identify training and education needs of stroke research workforce and develop a core
curriculum of comprehensive, high-quality training and education.

Coordinate with UK Clinical Research Network to develop the national programme of
generic training and education.

Work in partnership with existing agencies to develop a programme of stroke-specific
research training.

Devise techniques and material to facilitate delivery of relevant training and education
at a local level.
39

Promote active involvement of patients and public in training and education.
The group developed a training and education strategy which clarified the remit of the group
and the way forward in terms of identifying training needs for the network in the future.
[UKSRN]
The Training and Education CSG has since been disbanded and replaced by the Organisational
Development interim Director Christine Bennett based at the NIHR Clinical Research Network
(CRN) Coordinating Centre. The Directorwill be leading on a business case to develop a
workforce development strategy for the research networks. The strategy will aim to provide a
coherent approach to workforce development. The project will be completed by the end of
May.
This project builds on the work that has already been undertaken by Fiona O’Neill, in the Workforce
Development Team and the Workforce Development Oversight Steering Group. It is not intended to
reopen the debate or duplicate the work completed, but to verify the key strategic issues and the
benefits to CRN of supporting the continued development of network staff.
After reviewing the Oversight Steering Group’s initial work, and consulting with some
stakeholders, it has become clear that workforce activity needs to be linked more clearly with
the new high-level objectives of the CRN. I have therefore been asked to refocus my activity
and help with:

Developing a vision statement for the CRN workforce development;

Identifying the capabilities needed to achieve this vision and the CRN’s overall
objectives;

Identifying the associated training and workforce development activities that will
create a CRN workforce with the required capabilities
Scottish SRN Training Strategy
The Scottish SRN training strategy is continually being reviewed and updated. Currently all of
our researchers are regularly informed via emails of the any research or stroke courses
available and we are able to offer funding for travel/accommodation expenses in the majority
of cases. Regular SSRN Research Nurse Face to Face study Meetings are held. Study
coordinators from the UKSRN adopted trial portfolio are invited to give presentations in
relation to their various trials, which are followed by an opportunity to raise any questions,
problems or issues the researchers might have. All research nurses funded by the SSRN
participating in any of the trials selected for meetings, are expected to attended all
teleconferences and face to face meetings as part of their SRN responsibilities. The aim of the
meetings are to provide additional support to SSRN research nurses across Scotland to
strengthen the infrastructure of the network by continually developing the quality of our
research and increasing our recruitment into stroke trials on a yearly basis.
40
Part of the SSRN research nurses remit it to continually develop their research and clinical
skills and all research staff are actively encouraged and made aware of the Research Nurse
Competency Framework and to access the online Stroke Training and Awareness
Resources (STARS) programme – an e-learning resource which provides a learning tool
for health and social care staff to enable them to become more knowledgeable and skilful in
the challenging area of stroke care. The resource is based on the Stroke Core Competencies
which were published by NHS Education for Scotland (NES) in 2005. There has been a gradual
uptake of Scottish applicants for the courses over the past few years and we are working hard
to promote the courses available by the different organisations e.g. CHSS, Scottish CRFs and
local R&D programme. The SSRN webpage is continually updated to highlight when and where
they are being held.
The STARs (Stroke Training and Resources) Website
Over the last year there has been further development of the STARs (Stroke Training and
Resources) website which offers free on-line stroke training at 3 levels. In the last week
advancing modules covering 5 more topics have been added:





The website offers the following training:

Stroke Core Competencies: aimed at all staff working in stroke care. This resource was
launched in May 2008.

Advancing Modules: aimed primarily at registered nursing and AHP staff working in
stroke services. There are now 10 modules, 5 of which were launched in Autumn.

Thrombolysis Masterclass: aimed at senior staff involved in the decision making
process and delivery of thrombolysis therapy.
The website aims to provide an interactive way of learning using images, quizzes, animations
and video clips which are incorporated into a series of patient scenarios. Throughout the site
there are links to other learning and reference materials. There are optional tests which, if
successfully completed, will award the learner with a certificate. To date over 57,000
41
individuals have used the resources and over 15,000 certificates have been awarded.
http://www.chss.org.uk/education_and_training/stars_project.php [14 April 2011]
Public Awareness and Publicity
Section 8
The Scottish Stroke Research Network (SSRN) 4th Annual Meeting
Showcase of Stroke Studies in the SSRN – the first 4 years
The SSRN hosted the 4th annual conference this year in The Teacher Building, St Enoch
Square, Glasgow on Thursday 04 November 2010.
The conference, attended by over 90 delegates, proved to be an informative and extremely
successful day and was awarded 4 clinical credits by the Royal College of Physicians and
Surgeons, Glasgow. Professor of Clinical Pharmacology and Director of SSRN Professor
Matthew Walters started the day with an introduction to the SSRN.
This was followed by presentations from an impressive line up of speakers from across
Scotland. The presentations covered trials from past, present and the future. Speakers
included: Professor Martin DennisCLOTS/CLOTS 3, Dr Mary Joan MacLeod TELEMEDICINE,
Professor Kennedy LeesVITATOPS, Professor Walters New Strategies for Secondary Prevention
of Stroke, Dr Jesse Dawson CARS, Professor Peter SandercockIST-3, Professor Ian Ford The
Development of Scotland as a Clinical Trial Centre of Excellence, Professor Peter Langhorne
INTERSTROKE/ AVERT, Professor Keith MuirSTEM CELL, Dr Rustam Al-Shahi Salman PATCH
and Dr Malcolm MacLeod HYPOTHERMIA Treatment for Stroke.
42
Due to financial constraints the Scottish SRN with agreement of the CSO lead
decided to focus scarce resources upon core network activities and defer the 2011
annual meeting.
The SRN Executive Committee remain committed to national
events in the future, subject to resource availability.
Apr 2011/Mar 12
National Events
SSRN Posters have been displayed at several events throughout the last year. These include
poster and leaflet display at the Glasgow Clinical Research Facility Open Day on 20 May 11;
SINAPSE Conference in Dundee on 16 June 11; Scottish Stroke Care Audit Annual Meeting,
Edinburgh 20 Sep 11; Scottish Stroke Nurses Forum, Perth 22 Sep 11; Lanarkshire Clinical
Research & Clinical Quality Improvement Conference 6 Oct 11; KnowFife Research &
Knowledge Conference 24 Nov 11; Age and Ageing Conference which took place on 27 Jan 12.
Liz Ronald of the SSRN attended the PPI Meeting in York on 21 June 11 and on 1 Sep 11
Claire Mcfarlane attended the UKSRN Network Leads Meeting held in London.
The staff from the collaborating centre attended the UK Stroke Forum held in Glasgow SECC
for the third year in succession from 29 Nov – 1 Dec 11. On 15 Dec 11 Karen McBurnie and
Liz Ronald attended the IRAS Training Course held at the Glasgow Clinical Research Facility, at
the Western Infirmary.
During November 2011 for three days (15-17 Nov) the Network Staff at the Collaborating
Centre were visited by Elaine Moir from the Chief Scientist Office, Edinburgh. The purpose of
the visit was to shadow the staff in order to gain a greater understanding of the day-to-day
activities of the Network. During this time (16 Nov 11) a Topic Network Managers Meeting
was held in the conference rooms within Glasgow Royal Infirmary.
Future Events
SINAPSE is highlighting the latest medical imaging research both from its centres and the UK
at the SINAPSE Annual Scientific Meeting 2012 on Wed 30 May 2012 at the RCPS, St Vincent
Street, Glasgow.
* Welcome by Professor Keith Muir
* Report on SINAPSE activities: Dr Dave Wyper, SINAPSE Director
* 44 Poster Presentations
* Speakers include:
Prof Anthony Chalmers
Prof David Lurie
Dr Stephanie Rossit
Ms Shona Matthew
Please register via the SINAPSE Website: http://sinapse.ac.uk/
43
UK Stroke Forum 2011
The SSRN exhibited once again at the UK Stroke Forum when it returned to the Scottish
Exhibition and Conference Centre in Glasgow for the sixth UK Stroke Forum Conference in
2011.
The
SSRN
community
was
well
represented
at
this
meeting,
including
presentations of high-quality nurse led research.
Scottish Stroke Nurses Forum 2012 Conference: ‘Back to the Future’
Thu 20 Sep 2012 at the Dewar’s Centre Perth
The programme explores what the future holds for stroke care and stroke nursing. Will we be
replaced by robots? Will we deliver rehabilitation through the TV set? Can we implant a new
brain? And what does the future hold for stroke research? It is open to all interested health
and social care professionals.
Publicity: The new website is now almost complete and will be being used more frequently as
a tool for publishing forthcoming events and advertising available training courses for all
network staff.
Next year - SSRN forward plan 2011 - 2012
Section 9
Funding
The SSRN CSO funding in 2012/13 will be the same as last year, as we highlighted in last
years annual report this poses a real concern that we will not be optimising on recruitment
due to insufficient funding for increased nursing/AHP and Research Fellow protected time.
On a positive note this current funding is secured until March 2015, giving greater security to
network staff and the ability to structure our service development more efficiently.
We highlighted various issues in our 2009/10 report where we had concerns to maintaining
and increasing recruitment in the years to come:

With no scope for a significant increase in funding limits network growth in terms of
increased workforce, limited career path (no scope for promotion for research nurses
within the network) potentially increases risk of experienced qualified research nurses
seeking employment elsewhere.

Without the benefit of being able to increase nursing resources at more active sites, it
runs the risk of smaller (less funded) SRN sites being unable to recruit patients into
44
trials due to not having SRN research nurses to cover maternity, sickness and annual
leave.
Forward Plan
We are making provision to adapt to the current funding arrangements. Further reshaping of
the network to maximise efficiency and value for money will be necessary going forward, and
this may involve greater targeting of scarce resources. We will be exploring ways of
maximising the return on SSRN investment through a greater focus on high yield activities and
sites.
To compensate for this we are working hard to pull resources to maximise the potential of
employing a Band 7 SRN Research Lead Nurse initially 0.2 wte for a 1 year period in the first
instance. Responsible for the direct clinical management of network funded nurses, facilitating
site trial portfolio, recruitment, follow up, retention and data quality by offering direct research
nurse support at the individual sites potentially visiting each site on a rotational basis one day
a week and offering the time and expertise to network staff on a one to one basis. Experience
in 2011/12 has demonstrated the benefit of this approach, particularly in enhancing
recruitment figures from less experiences sites, and the proposed appointment will facilitate
future interactions of this nature.
In terms of the risk of smaller (less funded) SRN sites being unable to recruit patients into
trials due to not having SRN research nurses to cover maternity, sickness and annual leave.
Again the lead research nurse’s remit will be to monitor such activity and access the possibility
of near by sites offering additional support in these circumstances and if needed the lead
nurse will stand in as and when required and subject to other work commitments. The
intention would be to increase this role over the next 2-3 years to a full time position.
SRN Grampian forward plan 2011/12
LINKAGE Report
The Research Subgroup of the SSCA Steering Group (MJM, MD, PL, MB) have obtained
funding from CHSS to facilitate linkage of SSCA data with other datasets held within ISD. A
research fellow is being appointed to assist initially with data linkage and validation, and then
with potential linkage projects.
This data will be available primarily for researchers based in
Scotland who have contributed to the Audit, but open to other researchers also. Information
about the SSCA Research subgroup and forms for requesting data are available on the SSCA
website.
Unfortunately there are some stroke research projects ongoing in the regional research
networks which we are not able to adopt due to it not fitting in with the current adoption
criteria in terms of being eligibly funded however since the start of the network we have
aimed to collect information on all stroke research being conducted in Scotland and have
therefore included the following study:
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EPIGENETICS Study Report
The genetic influences on vascular diseases have been of increasing interest as technological
advances have made them easier to study. Improved understanding of what causes atheroma
and predisposes to subsequent vascular events will improve risk assessment and potentially
help develop preventative and disease limiting treatments.
Genome wide association studies in patients with ischaemic heart disease have revealed
associations with regions of chromosomes 1, 2, 3, 6, 9, 10, 12, 19 and 21. GWAS studies in
stroke have found associations with regions of chromosomes 9.
Two shortly to be published
studies have identified genes by GWAS and replication which are implicated in atheroma and
risk of stroke (WTCCC and Metastroke collaborations).
Even well designed genome-wide SNP screens will not be informative about the role of other
components of the regulatory mechanisms of the genome, such as epigenetic modifications.
Epigenetics has been defined as “the structural adaptation of chromosomal regions so as to
register, signal, or perpetuate altered activity states”.
Environmental factors associated with
risk of atheroma and stroke, including diet and smoking, can alter epigenetic patterns.
Whether there is a causal relationship or whether both atheroma and epigenetic changes
result from exposure to environmental factors remains to be proved. Epigenetic modification
by DNA methylation, histone modifications and the action of small non-coding RNAs may alter
the accessibility of gene promoters and regulatory regions, thus altering their expression.
Methylation alters with age, and there is evidence of a genetic component to this. Patients
with CVD have significantly altered global DNA methylation compared to healthy controls, and
high homocysteine levels correlate with DNA hypomethylation and atherosclerosis. These and
other observations suggest that epigenetic change may be important in the development of
CVD.
There is as yet no published work looking at epigenetics and stroke. As a pilot study funded by
NHS Grampian endowments, they have undertaken the following:
Ongoing recruitment of stroke patients admitted to ARI or seen at outpatient clinic
with stroke or TIA (NoSREC 08/S0801/149).
After informed consent patients are
asked to donate blood and buccal samples from which DNA is extracted.
After
collection of phenotypic data, all samples are anonymised before further analysis.
Investigated methylation status of nine genes implicated in cardiovascular disease in
DNA from stroke patients (46 with large vessel disease (LVD); 46 with small vessel
disease (SVD); 46 with cardioembolic stroke (CE)) and 46 controls. Genes implicated
in aging (LINE1 and ER alpha) and in atherosclerosis (SOD3, MTHFR, ALOX15, IL10,
IFNGR1, TNF-alpha), and sinoatrial node development (PITX2) were chosen. IL10 is
significantly hypomethylated (p<0.0001) in all stroke cases and in each subgroup
compared to controls. SOD3 is significantly hypomethylated in LVD patients compared
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to controls and SVD (p=0.046 and 0.002 respectively). MTHFR is hypomethylated in
all stroke subtypes compared to controls (p=0.011). IL10 and MTHFR appear to lose
methylation with age (p< 0.001), but the differences between controls and strokes
remains significant after correction for age. There are no significant differences for the
other genes in this cohort. Thus in this small study, hypomethylation of IL10, MTHFR
and SOD3 are associated with ischaemic stroke.
They now intend to increase study numbers and apply for external funding.
SRN Tayside forward plan 2011/2012
The structure of stroke services in NHS Lothian, NHS Forth Valley and NHS Tayside are in a
process of change.
This is challenging for maintaining recruiting into current studies.
However, the potential for increased recruitment in the longer term is positive through SSRN
staff maintaining close links with the hospitals as the services evolve. This means that there is
an opportunity for more acute trials to be undertaken. Therefore, the aim for the SSRN in
2011/12 will be to maximise non-SSRN staff awareness and support for research as the new
service develops.
Tayside operates two acute sites and both are involved in recruiting for SSRN studies.
There has been a positive response to the various challenges faced by those who recruit for
the studies. Increased meetings with staff on the wards to increase awareness are scheduled,
as well as on-going training of those closely involved in the studies.
SRN South East of Scotland forward plan 2011/12
Focus in the last couple of years has been on increasing awareness of the SSRN and how it
can support existing funded projects which might otherwise struggle to recruit. However, work
during 2009/10 showed that there is the potential to increase the number of studies originating
in Scotland by promoting and facilitating communication with departments linked to Stroke
Units, for example Physiotherapy, Speech and Language Therapy, Pharmacy and further
medical education. Often there are small, local projects that could be developed further with
support, e.g. helping to identify and make contact with stroke research funders and
experienced research academics, also providing practical knowledge of the regulatory
requirements and methods for setting up a new project.
NHS Forth Valley
Stirling Royal Infirmary and Falkirk District General Hospital will be combined at the new Forth
Valley Royal Hospital in Larbert during 2011. This will bring the stroke unit and rehabilitation
services together and it is hoped that the closeness of the two arms will make stroke research
easier. The SSRN aim in 2011/12 is to seek opportunities for maximising the positives of the
move to Larbert for stroke research whilst maintaining recruitment into the current portfolio
studies.
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NHS Lothian
The acute patient pathway will change over next year with the focus being placed on the Royal
Infirmary of Edinburgh for initial assessment of Lothian patients and the planned move of the
Stroke Research Group (including the acute research MRI scanner) from the Western General
Hospital to the Royal Infirmary of Edinburgh. This streamlining of patient flows will provide the
opportunity for greater focus on acute stroke trials, and combined with further developments in
the thrombolysis service, for extending trial recruitment beyond the working day. We propose
to reattribute the SSRN SE staff budget to support the extension of the stroke research
window at this primary stage of the patient pathway in NHS Lothian. Combining this support
with the new telemedicine rota will help to maximise the number of patients recruited into acute
stroke studies.
NHS Fife
NHS Fife Stroke Services and SSRN jointly funded a new Stroke Research Nurse post for 2
days a week. The Nurse was employed for 6 months to support the existing stroke research
studies being undertaken and to help increase the number of patients entering into stroke
studies locally and improve the speed, quality and integration or research ultimately resulting
in improved patient care. The main responsibility for the new nurse concentrated on the DARS
Trial. Maintaining the successful recruitment and running of this trial locally. POPSTA, a local
network adopted trial (which closed in March 2011) presented a poster at the UK Stroke
Forum in Glasgow Dec 2011.
SRN West of Scotland forward plan 2011/12
NHS Ayrshire
R&D Research Nurses continue to support SSRN adopted trials in University Hospitals Ayr and
Crosshouse. There continues to be successful recruitment into the INTERSTROKE study, and
actively recruiting for the CLOTS-3 and PATCH studies. The stroke services will continue to
support other clinical trials as best as possible and have expressed interest in SOS and FOCUS.
Recent restructuring of rehabilitation services and early supported discharge will hopefully
allow research participation in these areas in the future.
NHS Greater Glasgow and Clyde Hospitals
The SSRN has partly funded a Clinical Research Fellow post for a 1 year period to provide
support for the SSRN research nurse and maximise recruitment into SRN adopted trials in east
Glasgow. A dedicated stroke research fellow will also be appointed to West Glasgow to
augment the clinical research team at that site. We will explore contingency plans to cover
sickness absence with the local CRF.
NHS Lanarkshire
NHS Lanarkshire remains committed to expanding its research portfolio over the next 12
months. This work is being supported by two SSRN nurses. Our own R&D department is
currently supporting an additional 0.5 WTE research nurse to assist in recruiting patients at
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Hairmyres Hospital. Strong links with Strathclyde University mean that two rehabilitation
studies are currently in the process of beginning recruitment; these relate to visualisation as a
tool for both upper and lower limb rehabilitation. A passive upper limb “robot” has also now
been placed in Wishaw General Hospital and it is hoped that this will be used in a number of
stroke projects. Eileen Cowey’s End of Life project, linked with Glasgow University is currently
underway. A number of network supported studies continue to recruit and we hope to be one
of the pilot sites for the FOCUS Study as it starts up.
Raising the SSRN profile
Continuing to work with colleagues in the NIHR Stroke Research Network to further develop
the new Scottish NRS SRN website https://ssrn.org.uk .Training link on SSRN website
continually being updated. Published Posters and information leaflets developed (regularly
updated). Successfully producing SSRN publications over the course of 2009 – 2012.
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