1
SPCRN Annual Report 2013-14
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Contents
Section Page
1 Introduction 4
2 Network Strategy 5
3 Studies recruiting through SPCRN 2013-14 6
3.1 SPCRN national studies (recruiting from more than one node) 8
3.2 SPCRN local studies (recruiting from one node only) 14
3.3 SPCRN total studies (local and national combined) 20
3.4 Commercially funded studies 20
4 Patient recruitment 21
5 Practices participating in SPCRN studies 2013-14 22
5.1 GP practice recruitment 22
5.2 Dental practices 23
5.3 Episodes of practice activity 23
5.4 Deprivation and urban/rural scores of GP practices 24
5.4.1 Deprivation status 26
5.4.2 Urban/rural scores 26
6 SPCRN/SDRN Primary Care initiative 27
7 NHS Tayside Pilot Research Site Initiative (RSI)
28
8 Evaluation of SPCRN staff input into studies 2013-14 by researchers 29
9 Collaboration with other networks 29
10 Service Support Costs (SSC) budget 2013-14 30
11 Looking to the Future 31
12 References 31
Appendices
Appendix Page
1 SPCRN Core Staff 32
2 Deprivation status and urban/rural scores for practices participating in SPCRN studies in 2013-14, by node 34
3 Evaluation forms for SPCRN Studies 2013-14 39
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List of Tables
Table Page
1 SPCRN National Studies 2013-14 8
2 East SPCRN Node Local Studies 14
3 North SPCRN Node Local Studies 16
4 North East SPCRN Node Local Studies 17
5 South East SPCRN Node Local Studies 18
6 West SPCRN Node Local Studies 19
7 Number of national and local studies recruited to in 2013-14 per node 20
8 Number of on-going and new studies national and local studies recruited to in 2013-14 per node 20
9 Number of patients invited and recruited to studies by study type (local or national) and by node 21
10 Number of practices taking part in studies, by number of studies, 2013-14 22
11 Number of GP practice ‘episodes’ of SPCRN study activity 2013-14 24
12 Urban/rural status classification 25
13 Studies in which SPCRN have collaborated with other Scottish Topic-Specific Research Networks 30
14 SSC budget summary 1 April 2013-31 March 2014 31
List of Figures
Figure Page
1 Number of eligibly funded national and local studies recruited to by SPCRN 2006-14 7
2 Number of commercially funded studies recruiting through SPCRN 2008-14 20
3 Number of patients recruited to SPCRN studies 2006-14 21
4 Number of GP practices participating in SPCRN adopted studies 2013-14, by number of studies 23
5 Number of GP practice ‘episodes’ of SPCRN study activity 2006-14 24
6 Deprivation status for practices participating in SPCRN studies 2013-14 against all practices 26
7 Urban/rural category for all practices participating in SPCRN studies 2013-14 27
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1. Introduction
The Scottish Primary care Research Network (originally Scottish Practices and Professionals
Involved in Research, SPPIRe) was established in 2002 as a framework to co-ordinate
national research activity in primary care. The overall aim of SPCRN is to increase the
amount of research relevant to patient care undertaken in a primary care setting.
SPCRN facilitates the timely, appropriate and effective recruitment and follow-up of patients
in primary care settings and covers the entire range of clinical research areas.
SPCRN works with a wide range of primary care health professionals and promotes high
quality research in areas for which primary care has particular responsibility. These include
disease prevention, health promotion, screening and early diagnosis, as well as the
management of long-term conditions, such as arthritis and heart disease.
SPCRN is funded by the Chief Scientist Office (CSO), centrally managed from the Division
of Population Health Sciences at the University of Dundee and operationally managed at a
regional level by the five nodes based in the East, North, North East, South East and West
of Scotland.
The Director of SPCRN Prof Frank Sullivan moved to a post at the University of Toronto in
February 2014. Following a review by CSO of NHS Research Scotland infrastructure in
2013, Research Network Clinical Leads will gradually be replaced by National Research
Champions. Prof Bruce Guthrie was recently appointed as the Primary Care Clinical
Champion from May 2014. SPCRN appointed Morag Place as the new Research Officer in
the South East node in March 2014.
A list of SPCRN core staff with contact details can be found in Appendix 1.
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2. Network Strategy
The overarching aim of the Scottish Primary Care Research Network (SPCRN) is to increase
the amount of research relevant to patient care undertaken in a primary care setting. The
number of studies in the SPCRN portfolio has increased from 60 in 2012-13 to 68 in 2013-
14, an increase of 13%. SPCRN’s success is attributable to the mechanisms it has
developed to minimise the administrative workload for practices agreeing to participate in
research. SPCRN staff provide GP and dental practices with an expert service to undertake
searches of their electronic databases to identify potentially eligible patients and prepare
Reserch Ethics Service approved letters to be sent out by the practice. SPCRN staff all have
NHS substantive or honorary contracts, and work on behalf of the healthcare team under
practice staff supervision. Searches are undertaken at each GP or dental practice and the
list generated by the search is screened by a clinician before invitation letters are sent out by
the practice. SPCRN has three main areas of work:
a) Supporting the research done by primary care researchers. 24 (35%) studies in
2013/14 involved research questions which are of direct relevance to primary care
and include primary care academic researchers as principal investigators. 14 (58%)
of these studies involved practice staff in participant-related research procedures
specified in the protocol, including recruitment and obtaining informed consent from
patients.
b) Supporting specialist or condition-focused researchers who need to identify and
recruit patients in primary care. 45 (66%) studies in 2013/14 were in this category,
with the participating practices acted as Patient Identification Centres (PICs)
responsible for the identification and initial invitation of potential participants who are
subsequently consented by a different site which delivers the research procedures.
Although the patients recruited to these studies are usually referred on to secondary
care for consent and study procedures, SPCRN facilitation both provides the
opportunity for patients who do not attend secondary care to participate in this
research, and makes possible studies where secondary recruitment alone would not
be adequate. SPCRN collaborates with a number of research-active secondary care
clinicians in a broad range of disciplines, many of whom rely on the network to
identify and invite a significant number of study participants.
c) Increasing the capacity of practices to deliver research with less direct network
support, including identifying and recruiting patients, and where appropriate,
delivering the research themselves.
SPCRN’s aim is to have a balanced portfolio of current work in terms of supporting primary
care and specialist researchers, while developing capacity wherever possible (described in
section 6 below). SPCRN collaborates with academic researchers, primary and secondary
care practitioners, and industry. SPCRN has been highly collaborative across all primary
care disciplines and have worked with the topic specific networks as well as clinical and
basic scientists more widely to ensure that protocols developed elsewhere can be
operationalised in primary care.
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3. Studies recruiting through SPCRN during 2013-14 From 1 April 2012 to 31 March 2013, 68 high quality studies of relevance to primary care
recruited through SPCRN; 38 were on going before 1 April 2013 and 30 were new studies
added to the SPCRN portfolio between 1 April 2013 and 31 March 2014.
Of the 37 national studies (recruiting from more than one SPCRN Node), 11 were added to
the portfolio 2013-14.
Of the 31 local studies (recruiting from only one SPCRN Node) in 2013-14, 12 were on going
before 1 April 2013 and 19 were new studies adopted onto the SPCRN portfolio after 1 April
2013. 16 local studies were undertaken in the East node, 3 in the North node, 2 in the North
East node, 5 in South East node, and 5 in West node.
Thirteen (19%) of the studies recruiting through SPCRN in 2013-14 were commercially
funded, 12 of which were new studies which were adopted after 1 April 2013.
In 2013-14, 26 (38%) of the studies in the SPCRN portfolio were recruiting in Scotland and
other parts of the UK.
Of the 68 studies recruiting through SPCRN in 2013-14, 24 (35%) involved research
questions which are of direct relevance to primary care and include primary care academic
researchers as principal investigators. Of these 24 studies, 14 (21% of the total number of
studies) involved practice staff in participant-related research procedures specified in the
protocol, including recruitment and obtaining informed consent from patients.
In the remaining 45 studies (66%) the participating practices acted as Patient Identification
Centres (PICs) i.e. responsible for the identification of potential participants who are
subsequently invited to take part in research through a different site which takes on
responsibility for seeking consent and undertaking research procedures. Although the
patients recruited to these studies are usually referred on to secondary care for consent and
study procedures, they provide the opportunity for patients to participate in research.
The number of studies that SPCRN has recruited to has gradually increased since 2011-12
(Figure 1). The number of new studies adopted annually has increased from 24 in 2011-12
to 30 in 2013-14, with the number of national studies increasing from 21 to 37 in this period
and the number of local studies remaining level at 31.
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Figure 1: Number of Eligibly Funded National and Local Studies recruited to by SPCRN 2006-14
0
10
20
30
40
50
60
70
80
2006-072007-082008-092009-102010-112011-122012-132013-14
Number of national and local Studies recruited to by SPCRN 2006-14
Local
National
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3.1 SPCRN National Studies (recruiting from more than one node)
The national studies that SPCRN facilitated in 2013-14 are summarised in Table 1. The initials of the relevant nodes in given are in brackets
following the study title. The numbers of practices, patients invited and patients recruited may appear to be inconsistent for some studies due to
recruitment activities falling over more than one reporting period.
Table 1: SPCRN National Studies 2013-14
Study Title CI Funder UKCRN ID Practices
recruited
Patients
recruited
On-going prior to 1 April 2013
UK component of EUDRAGENE: studying the pharmacogenetics of selected adverse drug reactions (ADRs): identifying possible cases of ADRs through primary care databases and hospitals across the UK (E, N, NE, SE, W) PIC
Dr Mariam Molokhia, London School of Hygiene and Tropical Medicine
NIHR - Research Capacity Development Serious Adverse Events Consortium
4412 0 E-1 SE-1 Total=2
PATHWAY 1: Monotherapy vs Dual Therapy for Initial Treatment for Hypertension (E, SE, W) PIC
Prof Morris Brown, University of Cambridge
British Heart Foundation
4499 E-0 SE-2 W-2 Total=4
E-3 SE-20 W-2 Total=25
PATHWAY 2: Prevention and treatment of Hypertension with algorithm based therapy (Pathway) Number 2. A multicentre Phase 4 study of optimal treatment of drug resistant hypertension (E, SE , W ) PIC
Prof Morris Brown University of Cambridge
British Heart Foundation
4500 E-1 SE-3 W-2 Total=6
E-3 SE-4 W-1 Total=8
PATHWAY 3: A multicentre phase 4 study of comparison of single and combination diuretics in low - rennin hypertension (E, SE, W) PIC
Prof Morris Brown, University of Cambridge
British Heart Foundation
4501 E-3 SE-7 W-3 Total=13
E-17 SE-10 W-11 Total=38
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INTERSTROKE: Importance of conventional and emerging risk factors for stroke in different regions of the world and in different ethnic groups: a case controlled study (NE, W) PIC
Prof Peter Langhorne, Geriatric Medicine, University of Glasgow
Chest Heart & Stroke Scotland
8705 NE-0 W-2 Total=2
NE-19 W-89 Total=108
INTERVAL (2): Dental Recalls Trial (Investigation of NICE Technologies for Enabling Risk Variable Adjusted Length Dental Recall Trial) (E, N, NE, SE, W)
Prof Nigel Pitts / Prof Jan Clarkson University of Dundee
NIHR HTA 11395 E-2 N-6 NE-1 SE-1 W-5 Total=15
E-113 N-114 NE-21 SE-95 W-253 Total-596
TELESCOT Diabetes: The impact of a telemetric monitoring service in type 2 Diabetes: randomised controlled trial with nested qualitative study (SE, W)
Dr Brian McKinstry, University of Edinburgh
CSO 9556 SE-2 W-0 Total=2
SE-26 W-3 Total-29
SEARCH: A population based study of genetic predisposition and gene-environment interactions in breast cancer (E, N, NE, SE, W) PIC
Dr Paul Pharoah, University of Cambridge
Cancer Research UK
1390 E-2 N-1 NE-1 SE-6 W-0 Total=10
E-1 N-0 NE-0 SE-0 W-0 Total=1
SEARCH: A Population Based Study Of Genetic Predisposition And Gene-Environment Interactions In Endometral Cancer (E, N, NE, SE, W) PIC
Dr Paul Pharoah, University of Cambridge
Cancer Research UK
1390 E-2 N-1 NE-1 SE-6 W-0 Total=10
E-0 N-0 NE-0 SE-3 W-0 Total=3
SEARCH: A Population Based Study Of Genetic Predisposition And Gene-Environment Interactions In Cancer (Malignant Melanoma) (E, N, NE, SE, W) PIC
Dr Paul Pharoah, University of Cambridge
Cancer Research UK
1390 E-2 N-1 NE-1 SE-3 W-0 Total=7
E-18 N-4 NE-0 SE-13 W-0 Total=35
SEARCH: A Population Based Study Of Genetic Predisposition And Gene-Environment Interactions In Ovarian Cancer (E, N, NE, SE, W) PIC
Dr Paul Pharoah, University of Cambridge
Cancer Research UK
1390 E-2 N-1 NE-1 SE-6
E-1 N-1 NE-1 SE-3
10
W-0 Total=10
W-0 Total=6
eLung: Antibiotics for exacerbations of chronic obstructive pulmonary disease: a pilot trial of randomised evaluations of accepted choices in treatment (E, N, NE, SE, W)
Dr Tjeerd Van Staa, GPRD, MHRA, London
NIHR Health Technology Assessment
9909 E-0 N-0 NE-0 SE-0 W-0 Total=0
E-0 N-0 NE-0 SE-0 W-20 Total=20
RETRO-PRO: Comparison of two statins by randomising patients with primary hypercholesterolaemia and high CVD risk between simvastatin and atorvastatin (E, N, NE, SE, W)
Dr Tjeerd Van Staa, GPRD, MHRA, London
NIHR Health Technology Assessment
9910 E-0 N-0 NE-0 SE-0 W-0 Total=0
E-0 N-0 NE-0 SE-6 W-31 Total-37
Improving the Quality of Dentistry (IQuaD): A multicentre randomised controlled trial comparing oral hygiene advice and periodontal instrumentation for the prevention and management of periodontal disease in dentate adults attending dental primary care (E, N, NE, SE, W)
Prof Jan Clarkson, University of Dundee
NIHR Health Technology Assessment
10273 E-6 N-2 NE-1 SE-4 W-2 Total=15
E-57 N-151 NE-4 SE-100 W-54 Total=366
Health in Groups: A Longitudinal and Cross-National Study (E, SE) PIC
Professor Fabio Sani, University of Dundee
ESRC 12391 E-3 SE-0 Total=3
E-641 SE-0 Total=641
Does oral sodium bicarbonate therapy improve function and quality of life in older patients with chronic kidney disease and low-grade acidosis? A multicentre randomised placebo controlled trial (E, N, NE) PIC
Dr Miles Witham, University of Dundee
HTA 12363 E-18 N-2 NE-12 Total=32
E-0 N-0 NE-0 Total=0
Azalea: A randomised, double-blind, placebo-controlled study to evaluate the efficacy of oral azithromycin (500 Mg OD) as a supplement to standard care for adult patients with acute exacerbations of asthma (W, England) PIC
Prof Sebastian Johnston, Imperial College, London
NIHR Efficacy and Mechanism Evaluation
11358 W-0 Total=0
W-0 Total=0
COSMOS: A prospective exploration of the experiences of continence services in people with multiple sclerosis with a primary focus on the factors affecting the continuity of use of intermittent self-catheterisation (E, N, NE, SE, W)
Dr Doreen McClurg, Glasgow Caledonian University
Multiple Sclerosis Society
11610 E-2 N-5 NE-8 SE-4 W-2 Total=21
E-1 N-2 NE-2 Total=5
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GARFIELD: Global anticoagulant registry in the field (E, NE, SE, UK Multicentre) (E, NE, SE)
Prof David Fitzmaurice, University of Birmingham
Thrombosis Research Institute
9879 E-0 NE-0 SE-0 Total=0
E-6 NE-0 SE-2 Total-8
Validating the CARE measure with Practice Nurses in Primary Care (E, W)
Dr Bridie Fitzpatrick, University of Glasgow
Scottish Government
12949 E-0 W-0 Total=0
E-50 W-0 Total=50
NHS 24 Study: Managing symptoms in the community: examining the role of NHS 24 (E, N, NE, SE, W)
Dr Alison Elliot, University of Aberdeen
CSO 12886 E-3 N-3 NE-2 SE-2 W-3 Total=13
E-272 N-172 NE-194 SE-104 W-237 Total=979
CREAM: Children with eczema, antibiotic management study (E, NE, England and Wales)
Prof Nick Francis, university of Cardiff, Prof Frank Sullivan, University of Dundee
HTA 11233 E-25 NE-3 Total=28
E-3 NE-0 Total=3
Diabetes Care in UK Universities (E, NE, SE, W) Dr Khin Swe Myint, Norfolk and Norwich University Hospitals NHS Trust
Diabetes UK 12790 E-4 SE-4 W-0 Total=8
E-4 SE-14 W-0 Total=18
GP understanding and management of patients who self-harm: a qualitative study (NE, SE)
Prof Stephen Platt, University of Edinburgh
CSO 14377 NE-14 SE-6 Total=20
NE-15 SE-7 Total=22
Attitudes and understanding regarding the HPV vaccine and cervical screening: a survey of young women in Scotland (E, N, NE, SE, W)
Dr Christine Campbell, University of Edinburgh
CSO 14380 E-11 N-8 NE-5 SE-7 W-22 Total=53
E-206 N-122 NE-114 SE-170 W-393 Total=1005
Four Fold Asthma: The clinical and cost effectiveness of
temporarily quadrupling the dose of inhaled steroid to
prevent asthma exacerbations; a pragmatic,
Dr Tim Harrison,
University of
NIHR HTA 14257 NE-12 Total=12
NE-67 Total=67
12
randomised, normal case controlled, clinical trial (NE,
England)
Nottingham
Started after 1 April 2013
ECLS: Detection in blood of autoantibodies to tumour antigens as a case-finding method in lung cancer using the EarlyCDT-Lung test (E, W)
Prof Frank Sullivan, University of Dundee
CSO 14532 E-17 W-48 Total=65
E-937 W-984 Total-1921
BIBS Study: Benefits of Incentives for Breastfeeding and Smoking cessation in pregnancy (E, N, NE, SE, W)
Prof Pat Hoddinott, University of Stirling
NIHR 12316 Electronic distribution of survey by SPCRN to healthcare professionals
E - 55 N - 32 NE- 102 SE - 65 W- 30 Total-284
RESTART: REstart or STop Antiplatelets Randomised Trial (E, N, NE, SE, W) PIC
Dr Al-Shahi Salman, University of Edinburgh
BHF 14297 N/A N/A
FAST - A prospective, randomised, open-label, blinded endpoint (PROBE) clinical trial evaluating long term cardiovascular safety of febuxostat in comparison with allopurinol in patients with chronic symptomatic hyperuricaemia (E, N, NE, SE, W) PIC
Prof Tom Macdonald, University of Dundee
Menarini International Operations Luxembourg SA
11338 E-4 N-1 NE-0 SE-5 W-0 Total=10
E-29 N-9 NE-13 SE-11 W-35 Total=97
EAVE: Early estimation of pandemic influenza Antiviral and Vaccine Effectiveness Project (E, N, NE, SE, W)
Dr Colin Simpson, University of Edinburgh
NIHR HTA 15523 E-7 N-3 NE-0 SE-2 W-1 Total=13
N/A
TWICS: A randomised, doubleblind placebo controlled trial of the effectiveness of low dose oral theophylline as an adjunct to inhaled corticosteroids in preventing exacerbations of chronic obstructive pulmonary disease (NE, W) PIC
Prof Graham Devereux, University of Aberdeen
NIHR HTA 14832 NE-8 W-0 Total=8
NE-20 W-0 Total=20
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A randomised, double-blind, 12-week, parallel-group, placebo-controlled, study of the efficacy and safety of RO4917523 in patients with Fragile X Syndrome (E, SE) (COMMERCIAL) PIC
Mrs Saffra Knox, King’s College, London
F. Hoffman La Roche Ltd
12328 E-9 SE-2 Total=11
E-0 SE-0 Total=0
ALL-HEART: Allopurinol and cardiovascular outcomes in patients with ischaemic heart disease (E, N, NE, SE, W) PIC
Dr Isla Mackenzie, University of Dundee
NIHR HTA 15328 E-23 N-5 NE-0 SE-0 W-3 Total=31
E-170 N-0 NE-0 SE-0 W-0 Total=170
FOURIER: A double-blind, randomized, placebo-controlled, multicenter study assessing the impact of additional LDL-cholesterol reduction on major cardiovascular events when AMG 145 is used in combination with statin therapy in patients with clinically evident cardiovascular disease (COMMERCIAL) (N, SE) PIC
Dr Derek Connolly, Sandwell General Hospital Lyndon West Bromwich
Amgen Ltd 12662 N-2 SE-0 Total=2
N-2 SE-0 Total=2
ELIOT: A 12-week, randomized, open-label, parallel-group study to evaluate the mastery of inhaler technique for Budesonide Formoterol (BF) SPIROMAX® (160/4.5 and 320/9 mcg) as compared to SYMBICORT® TURBOHALER® (200/6 and 400/12 mcg) as treatment for adult patients with asthma (The Easy Low Instruction Over Time Study) (E, SE, W) (COMMERCIAL)
Prof David Price, University of Cambridge
Teva Pharmaceuticals
16198 E-2 SE-0 W-0 Total=2
In set-up
TRAM: Reducing binge drinking among disadvantaged men through an intervention delivered by mobile phone: a multi-centre randomised controlled trial (E, W) PIC
Prof Iain Crombie, University of Dundee
NIHR 15088 E-8 W-2 Total=10
E-17 W-0 Total=17
TOTAL E-156 N-41 NE-70 SE-72 W-97 Total=436
E-2591 N-605 NE-574 SE-648 W-2378 Total=6796
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3.2 SPCRN Local Studies (recruiting from one node only) The local studies that SPCRN facilitated in 2013-14 are summarised by Node in Tables - below: Table 2: East SPCRN Node Local Studies
Study Title CI Funder UKCRN ID Practices
recruited Patients recruited
On-going prior to 1 April 2013
ALL ACS (Allopurinol in acute coronary syndrome): Allopurinol as a possible new therapy for acute coronary syndrome: the next steps PIC
Prof Allan Struthers, University of Dundee
BHF 11948 14 10
ANDA2: Evaluation of effects of chronic dose exposure to cardioselective and noncardioselective beta blockers on measures of cardiopulmonary function in moderate to severe COPD PIC
Prof Brian Lipworth, University of Dundee
Tenovus Scotland 13886 9 14
ICS in COPD: the effect of inhaled steroids on microbial community composition and antimicrobial peptides PIC
Dr Stuart Schembri, University of Dundee
Tenovus Scotland 14165 1 0
Vitamin K status and markers of vascular function in patients with and without postural hypotension PIC
Dr Matthew Lambert, University of Dundee
British Geriatrics Society
11958 4 49
Asthma Goals and Quality of Life: Can eliciting and
addressing health-related goals improve asthma control
and asthma-related quality of life? Feasibility Phase II
pilot randomised controlled trial of a brief intervention
Dr Gaylor
Hoskins,
University of
Stirling
CSO 12814 0 19
15
Started after 1 April 2013
A phase 1, randomised, double-blind, placebo-controlled study evaluating CNTO 3157 in healthy normal and asthmatic subjects inoculated with Human Rhinovirus Type 16 (COMMERCIAL) PIC
Not named Janssen-Cilag International
2 0
A 6 month, randomised, double blind, placebo controlled, multicentre, parallel group, phase II study with an optional safety extension treatment period up to 6 months, to evaluate the efficacy, safety and tolerability of 3 different doses of AZD5069 twice daily as add on treatment to medium to high dose inhaled corticosteroids (ICS) and long acting beta 2 agonists (LABA) in patients with uncontrolled persistent asthma (COMMERCIAL) PIC
Not named AstraZeneca AB 13798 4 0
SPIR-OA: The Effect of Spironolactone on Pain in Older People with Osteoarthritis PIC
Prof Marion McMurdo, University of Dundee
Arthritis Research
UK
15324 10 24
Consulting on the development of a novel visual intervention and activity plan to increase physical activity among inactive young people with asthma: Can visualisation encourage physical activity in patients with asthma?
Prof Brian Wilson, University of Stirling
CSO 4 2
ECHO: A Double-blind, Randomised, Placebo-controlled, Phase 3 Trial in Patients with Chronic Idiopathic Constipation to Demonstrate the Efficacy and Safety of Elobixibat 5 mg and 10 mg for 26 Weeks (COMMERCIAL) PIC
Prof Robin Spiller University of Nottingham
Ferring Pharmaceuticals
14604 2 0
PREFACE: Preventing falls with ACE inhibitor. Do ACE inhibitors reduce postural instability in older people? PIC
Dr Deepa Sumukadas, University of Dundee
CSO 14318 7 2
A 24-week international, multi-center, randomized, parallel-group, double-blind trial to evaluate metformin extended release monotherapy compared to metformin immediate release monotherapy in adult subjects with Type 2 diabetes who have inadequate glycaemic control
Dr Suki Balendra Imperial College School of Medicine, London
Bristol-Myers-Squibb
15706 In set-up
16
with diet and exercise (COMMERCIAL) PIC
CARMELINA: Cardiovascular safety and renal microvascular outcome with Linagliptin, 5 mg once daily in patients with Type 2 diabetes mellitus at high cardiovascular risk (COMMERCIAL) PIC
Dr Suki Balendra Imperial College School of Medicine, London
Boehringer Ingelheim Ltd
12382 In set-up
DEVOTE: A trial comparing cardiovascular safety of insulin degludec versus insulin glargine in subjects with type 2 diabetes at high risk of cardiovascular events (COMMERCIAL) PIC
Dr Suki Balendra Imperial College School of Medicine, London
Novo Nordisk 15828 In set-up
IMPERIUM: An Individualized treatMent aProach for older patients: A randomized, controlled study in type 2 diabetes Mellitus (COMMERCIAL) PIC
Dr Suki Balendra Imperial College School of Medicine, London
Eli Lilly 15691 In set-up
LIXOLAN-O: A randomized 30 week, active-controlled, open-label, 3-treatment arm, parallel-group multicentre study comparing the efficacy and safety of insulin glargine/ lixisenatide fixed ratio combination to insulin glargine alone and to lixisenatide alone on top of metformin in patients with Type 2 Diabetes Mellitus (EFC12404 / Lixilan-O) (COMMERCIAL) PIC
Dr Suki Balendra Imperial College School of Medicine, London
Sanofi Aventis 15871 In set-up
TOTAL 57 120
Table 3: North SPCRN Node Local Studies
Study Title CI Funder UKCRN ID Practices
recruited Patients recruited
On-going prior to 1 April 2013
XANTUS-Xarelto® on prevention of stroke and non-central nervous system systemic embolism in patients with non-valvular atrial fibrillation (COMMERCIAL) PIC
Prof A John Camm St George's Hosptial Medical School, London
BAYER Plc 12227 10 14
17
Started after 1 April 2013
TOPS: A Personal and Social Interaction Survey of Older Adults with and without LOng-term Pain in Primary Care in NHS Highland
Dr Alasdair Mort, Centre for Health Science, NHS Highland
RCUK 15323 7 699
LAVOLTA I/II: A phase iii, randomized, double-blind, placebo controlled study to assess the efficacy and safety of Lebrikizumab in patients with uncontrolled asthma who are on inhaled corticosteroids and a second controller medication (COMMERCIAL) PIC
Prof Ian Sabroe, University of Sheffield
F. Hoffmann-la Roche
15644 In set-up
TOTAL 17 713
Table 4: North East SPCRN Node Local Studies
Study Title CI Funder UKCRN ID Practices Patients
recruited
On-going prior to 1 April 2013
Epidemiology, prevalence and characteristics of heart failure with preserved ejection fraction PIC
Prof Michael Frenneaux, University of Aberdeen
British Heart Foundation
10043
4 965
Started after 1 April 2013
The Effects of Inorganic Nitrite on cardiac and skeletal
muscle: Physiology, pharmacology and therapeutic
potential in patients suffering from Angina PIC
Prof Michael
Frenneaux,
University of
Aberdeen
MRC 13271 5 24
TOTAL 9 989
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Table 5: South East SPCRN Node Local Studies
Study Title CI Funder UKCRN ID Practices
recruited Patients recruited
Ongoing before 1 April 2013
ERICA: Evaluation of the Role of Inflammation in non pulmonary disease manifestations in Chronic Airways disease (COPD) PIC
Dr Ian Wilkinson, University of Cambridge
European Commission: Innovative Medicine's Initiative (IMI)
1101 3 57
Started after 1 April 2013
The Benefit of Minocycline on Negative Symptoms in Schizophrenia: Extent and Mechanisms PIC
Prof Bill Deakin, University of Manchester
NIHR Efficacy and Mechanism Evaluation
10411 In set-up
DexFEM – Dexamethasone for excessive menstruation PIC
Prof Hilary Critchley, University of Edinburgh
MRC 14349 In set-up
Development of FDG-PET/CT Imaging methodology for early assessment of lung anti-inflammatory activity of novel agents in COPD PIC
Professor William MacNee, University of Edinburgh
Pfizer Pharmaceuticals
1 Just starting
TOTAL 4 57
19
Table 6: West SPCRN Node Local Studies
Study Title CI Funder UKCRN ID Practices recruited
Patients recruited
On-going prior to 1 April 2013
CLICD: Counselling versus Low-Intensity Cognitive Behaviour Therapy for persistent subthreshold and mild depression: A pilot/feasibility randomised controlled trial PIC
Dr Elizabeth Freire, University of Aberdeen
CSO 13996 6 35
PROVALID: Multi-national Prospective Cohort Study in Patients with Type 2 diabetes for validation of bio-markers PIC
Dr Patrick Mark, University of Glasgow
European Union 12068 8 142
Understanding treatment burden in people with stroke
Dr Katie Gallacher, University of Glasgow
CSO 11609 7 29
Living Well with Multiple Morbidity: the Development and Evaluation of a Primary Care-Based Complex Intervention to Support Patients with Multiple Morbidities
Prof Stewart Mercer, University of Glasgow
CSO 1
Started after 1 April 2013
RAISIN: RCT of Asthma Internet Self Care Intervention
Dr Deborah Morrison, University of Glasgow
CSO 14084 20 51
IN-MINDD: INnovative, Midlife Intervention for Dementia
Deterrence
Prof Kate O’Donnell, University of Glasgow
European Union In set-up
TOTAL 41 258
PIC - the participating practices acted as Patient Identification Centres (PICs)
20
3.3 Total studies (local and national combined) The figures from the Tables in Sections 3.1 and 3.2 are summarised in Table 7 and Table 8: Table 7: Number of national and local studies recruited to in 2013-14 per Node
Node
Study type
Total National Local
East 28 16 44
North 17 3 20
North East 22 2 24
South East 26 4 30
West 27 6 33
Table 8: Number of on-going and new studies national and local studies
recruited to in 2013-14
On-going prior to April 2013
Started after April 2013
Total
National 26 11 37
Local 12 19 31
Total 38 30 68
3.4 Commercially funded studies The number of commercially funded studies recruiting patients through SPCRN has increased from 7 in 2012-13 to 13 in 2013-14 (Figure 2). Figure 2: Number of commercially funded studies supported by SPCRN 2008-14
21
4. Patient Recruitment Sending invitations to participate in studies on behalf of GP practices can be very labour
intensive for SPCRN staff. Across the network in 2013-14, 73,946 invitations were sent out
(X of the invitations were facilitated by the Safe Haven within the Health Informatics Centre
in Dundee – this was for the Health in Groups and Bicarbonate Therapy studies, see Table
1) with an average of 12% of patients eventually being recruited to studies (Table 9)
Table 9: Number of patients invited and recruited to studies by study type and
node 2013-14
Node Local studies National studies All studies
Patients invited
Patients recruited
% Patients invited
Patients recruited
% Patients invited
Patients recruited
%
East 3699 120 3% 23,747 2591 11% 27,446 2711 10%
North 5286
1702
32% 2797
1179
42% 8083
2881 36%
South East
190 57 30% 1679 648 39% 1870 705 38%
West 6628 258 4% 29,919 2378 8% 36,547 2636 7%
Total 15803 2137 14% 58142 6796 12% 73946 8933 12%
There has been a substantial increase in the number of patients recruited to SPCRN-
supported studies from 6,188 in 2012-13 to 8, 933 in 2013-14 (44%) (Figure 3). This is
largely due to a few studies with a large recruitment target (e.g. Early Detection of Lung
Cancer, HPV Vaccine survey, NHS24 Managing Symptoms in the Community and Heart
Failure with Preserved Ejection Fraction (see Tables 1-6).
Figure 3: Number of patients recruited to SPCRN studies 2006-14
0
2000
4000
6000
8000
10000
12000
14000
16000
2006-07 2007-08 2008-09 2009-10 2010-11 2011-12 2012-13 2013-14
Number of patients recruited 2006-14
22
The number of patients SPCRN is able to recruit to studies depends on both the number and
the type of study on the portfolio. The study targets for patient recruitment are highly
variable and the amount of SPCRN resource required per study is not necessarily related to
the number of patients recruited.
5. Practices participating in SPCRN studies 2013-14
5.1 GP Practice Recruitment
The number of GP practices that have participated in studies adopted by SPCRN in 2013-14
are shown by Node in Table 10, by number of studies that they have taken part in. The
values are expressed as a percentage of total practices in each NHS Board using ISD GP
practice details published 17 December 20131.
Table 10: Number of practices taking part in studies, by number of studies, 2013-
14
Node Health board
No. studies per practice Practices taking part in studies
All practices List size >=2000
1 2 3 4 5+ Total n % took part Total n
% took part
East Fife 14 3 1 0 1 19/58 33 18/56 32
Forth Valley 8 6 1 2 0 17/56 30 16/50 32
Tayside 9 12 9 4 12 46/67 69 42/64 66
North Highland 8 3 5 0 2 18/100 18 18/52 35
Western Isles*
0 0 0 0 0 0/10 0 0/5 0
North East
Grampian 14 6 5 2 5 32/79 41 29/69 42
Orkney* 2 0 0 0 0 2/10 20 1/4 25
Shetland 3 0 0 0 0 3/10 30 1/4 25
South East
Lothian 17 2 0 5 4 28/125 23 29/123 24
Borders 0 0 0 0 0 0/23 0 0/21 0
West
GG and C 47 18 5 4 2 76/260 29 72/239 30
D and G* 0 0 0 0 0 0/34 0 0/30 0
A and A 4 1 0 0 0 5/55 9 5/52 10
Lanarkshire 6 0 0 0 0 6/97 6 6/89 7
Totals 132 51 26 17 26 252/984 26 236/858 29
*Health Boards that were not invited to studies during 2013-14 due to a lack of suitable
studies.
In 2013-14, 252 GP practices took part in at least one study adopted by SPCRN (Figure 4).
This represents 26% of all practices and 29% of practices with a list size of ≥2000 patients
(Table 10) and represents a decrease from 273 practices in 2012-13 (29% of all practices
and 32% of practices with a list size ≥2000).
23
Figure 4: Number of GP practices participating in SPCRN adopted studies
2013-14, by number of studies
GP practices participating in SPCRN studies by
number of studies 2013-14 (total practices 252)
1
2
3
4
5
6
7
8
9
10
13
Number of studies per practice
5.2 Dental practices
SPCRN facilitated three dental studies during 2013-2014 involving 35 dental practices. All
nodes have at least one research-active dental practice. The majority of dental practices
took part in one study in 2013-14 (29) and 6 practices participated in two studies.
5.3 Episodes of Practice Activity
The total number of ‘episodes’ of GP practice activity in relation to SPCRN studies was 539
in 2013-14, compared with 651 in 2012-13. Please note that the number of ‘episodes’ is not
the same as the total number of practices that have helped with research, as many practices
have taken part in more than one study (Section 5.1).
The number of episodes of GP practice activity in relation to SPCRN studies from 2006-14 is
given in Figure 5 and a summary of the 2013-14 ‘episodes’ by Node and type of study (local
or national) is given in Table 11.
24
Figure 5: Number of GP practice ‘episodes’ of SPCRN study activity 2006-14
0
100
200
300
400
500
600
700
800
2006-07 2007-08 2008-09 2009-10 2010-11 2011-12 2012-13 2013-14
Episodes of Practice Activity 2006-14
Table 11: Number of GP practice ‘episodes’ of SPCRN study activity
2013-14
Node Local studies National studies Total
East 57 151 208
North 17 26 43
North East 30 55 85
South East 4 67 71
West 42 90 132
Total 150 389 539
5.4 Deprivation and Urban/rural scores for GP practices participating in SPCRN
studies 2013-14
The percentage of practice patients living in datazones defined as the 15% most deprived
(population weighted) was calculated using the Deprivation Status of Practice Populations
According to the Scottish Index of Multiple Deprivation (SIMD) 20121.
Modal Urban/Rural category based on numbers of patients in each rural category, per
practice was calculated using the Urban/Rural Status of Practice Populations According to
the Scottish Executive 2007-2008 Urban/Rural Classification2 (Table 12).
25
Table 12: Urban/Rural Status classification urban1 Large Urban Areas - Settlements of over 125,000 people.
urban2 Other Urban Areas - Settlements of 10,000 to 125,000 people.
urban3 Accessible Small Towns - Settlements of between 3,000 and 10,000 people and within 30 minutes drive of a settlement of 10,000 or more.
urban4 Remote Small Towns - Settlements of between 3,000 and 10,000 people and with a drive time of between 30 and 60 minutes to a settlement of 10,000 or more.
urban5 Very Remote Small Towns - Settlements of between 3,000 and 10,000 people and with a drive time of over 60 minutes to a settlement of 10,000 or more.
urban6 Accessible Rural - Settlements of less than 3,000 people and within 30 minutes drive of a settlement of 10,000 or more.
urban7 Remote Rural - Settlements of less than 3,000 people and with a drive time of between 30 and 60 minutes to a settlement of 10,000 or more.
urban8 Very Remote Rural - Settlements of less than 3,000 people and with a drive time of over 60 minutes to a settlement of 10,000 or more.
SPCRN aims to recruit the type of practice requested by researchers in terms of rurality,
deprivation and list size. For many studies the preferred practice type is large and urban,
often for practical reasons; travel costs for patients attending repeated appointments at the
study centre (usually the local hospital) can become prohibitively expensive if rural practices
are involved, and large urban areas can often provide the largest number of patients most
quickly, which is critical for some studies. In addition, for studies that require researchers to
make multiple practice visits small, remote practices may be impractical. Some Nodes find
that practices in more deprived areas are less likely to take part in research, usually citing
competing pressures on their time.
26
5.4.1 Deprivation status
The deprivation status for all practices participating in SPCRN studies against all practices in
2013-14 are shown in Figure 7. The majority of practices recruited by SPCRN are in the
least deprived category i.e. less than10% of their patients living in the 15 % most deprived
datazones. The spread of deprivation varies widely across nodes with the largest
concentration of deprived practices in the West Node and the smallest in the North and
North East Nodes. A full set of graphs showing deprivation status for GP practices
participating in SPCRN studies 2013-14 by node are included in Appendix 2.
Figure 6: Deprivation status for practices participating in SPCRN studies 2013-14 against all practices
5.4.2 Urban/rural scores
The urban/rural scores for all practices participating in SPCRN studies in 2013-14 are shown
in Figure 8. The majority of practices recruited by SPCRN are located in large urban areas.
The spread of rurality varies widely across nodes, with the highest concentration in the North
Node. A full set of graphs showing urban/rural scores for GP practices participating in
SPCRN studies 2013-14 by node are included in Appendix 2.
27
Figure 7: Urban/rural category for all practices participating in SPCRN studies
2013-14
6. SPCRN/SDRN Primary Care Initiative
SPCRN and the Scottish Diabetes Research Network (SDRN) are running a joint initiative to
increase capacity for diabetes research in primary care. In the initial phase the scheme will
focus on running commercial studies in the initial phase hosted in selected practices in NHS
Fife, Lothian and Tayside with a rollout programme if successful. This involves SPCRN staff
identifying patients via searches of electronic practice databases and Diabetes Specialist
Research Nurses working in GP practices to run studies and will:
• give patients more opportunities to participate in research.
• enhance capacity for diabetes researcher by complementing secondary care activity
in terms of both the number of potential participants and reaching patient populations
not accessible in secondary care (for example, newly diagnosed type 2 diabetes)
• allow practices to be involved in research in an efficient way, while providing an
income stream to invest in capacity for future studies
Progress: Six GP practices have been recruited as pilot sites (3 in Tayside, 1 in Fife and 2
in Lothian) and 12 GPs at these sites have completed GCP certification. The first study is
underway in three practices, two in Tayside and one in Fife and all have recruited patients.
The second study is only taking part in one practice in Scotland and has recently started
recruiting
GPs are very enthusiastic about the initiative and have been very helpful in recruiting
patients. The economic return is attractive to the practices and early forecasting suggests
28
that the initiative can be self-financing within the year. Practices are benefitting from having a
diabetes specialist research nurse there on a weekly basis and the nurses appreciate the
opportunity to work out in the community.
7. NHS Tayside Pilot Research Site Initiative (RSI) The majority of primary care professionals identify advantages for their patients taking part in
research, including access to novel therapies and contributing to the research evidence
base. However, the majority of GPs are independent contractors and there is no equivalent
of secondary care job planning or R&D resources to create the space for GPs to do
research. The factors that encourage primary care professionals to engage in research are:
a research question that is interesting and relevant to their patients, support from SPCRN or
experienced research nurses to ensure that they can efficiently contribute, and appropriate
contribution to the time used by way of either service support cost payments or per patient
fees for commercial studies.
It is necessary to further integrate research into everyday clinical practice, addressing the
questions which matter to front-line staff and facilitating their participation. Scotland would
benefit from more infrastructure support directly to GP practices in a similar way to the
English GP incentivisation scheme or Research Site Initiative (RSI) as, under current
systems, they act as gatekeepers to patients. The RSI schemes have increased the ability
of primary care sites to deliver research to high standards as the majority of sites in the
schemes have at least one member of staff who is GCP trained and a significant number of
sites have obtained the RCGP “Research Ready” accreditation. There is substantial
evidence that the RSI schemes have been successful in supporting PCRN priorities by:
providing a mechanism for the performance management of multiple small sites; increasing
NHS engagement in research and instilling a research culture in primary care sites; and
enabling more primary care sites to be confident to take on industry studies. NHS Tayside
have agreed to fund a pilot RSI scheme initially to run in 2014-15 with matched funding from
CSO.
Progress: SPCRN have coordinated a competitive process by which GP practices in NHS
Tayside have bid for two levels of funding of either £1k or £3k per annum. Four practices
have been awarded funding at Introductory Level and will in 2013-14 be expected to
complete RCGP Research Ready Accreditation training, ensure that least one GP or
practice nurse completes GCP awareness training, support at least three studies on the
NIHR Portfolio Database and deliver recruitment to agreed targets. Three practices have
been awarded funding at Delivery Site Level 1 and will be expected to support a minimum of
4 studies on the NIHR Portfolio Database, at least 1 of which must involve participants being
identified, recruited, and seen within the practice by a GP or nurse for part or all of the study.
In subsequent years funding for Tayside will be determined by TASC based upon their
evaluation of the scheme’s contribution to the TASC strategy, in particular recruitment of
study subjects to target. If the scheme is proven to be successful in one part of Scotland we
intend that it should be deployed more widely in consultation with the directors of the other
NRS nodes. The overall aim is to develop a "mixed economy" consisting of some practices
contracted to deliver multiple more complex studies per year via membership of an RSI
scheme, and additional practices working with SPCRN on a study by study basis, in order to
increase the overall capacity to effectively deliver the NIHR CRN portfolio.
29
8. Evaluation of SPCRN staff input into studies 2013-14 by researchers
Evaluation forms were sent to the Chief Investigators of all studies facilitated by SPCRN
which had been completed since the last network Annual Report in 2013-14. 13 evaluation
forms were returned, 11 for National Studies and 2 for Local Studies. The responses were
largely very positive as the quotes below demonstrate. The feedback from the evaluation
forms is provided in more detail Appendix 3.
Quotes from research teams:
{SPCRN coordinator} was extremely helpful in all respects, so the process was easy and
straightforward.
It has been a pleasure working with SPCRN to fulfil the reimbursement of service support
costs and for the provision of a recruitment support service for dental practices taking part in
the Trial. The team are always on hand if we have had any queries and practice service
support costs were processed smoothly.
Many thanks to all the SPCRN team for their support throughout the study.
I hope that our past excellent relationship will continue. The majority of paediatrics takes
place in primary care and the SPCRN is a valued member of our child health research team.
SPCRN are grateful to researchers who completed evaluation forms and will use the
information constructively to develop and improve the service provided by the network.
9. Collaboration with other networks To ensure that SPCRN is fully collaborating with the PCRN in England, the SPCRN Manager
is a member of the PCRN managers’ group which meets via teleconference or face-to-face
in London on a monthly basis. The SPCRN Manger is also a member of the Royal College of
General Practice Research Ready Advisory Group. In addition, the SSPC Director and the
SPCRN Manager are members of the UK PCRN Advisory Group (formerly the UKCRN
Operational Steering Group).
In 2013-14, 26 (38%) of the studies in the SPCRN portfolio were recruiting in Scotland and
other parts of the UK (see Section 2). The SPCRN manager works closely with the PCRN
Portfolio Delivery Manager throughout the course of studies recruiting in Scotland and other
parts of the UK to ensure study delivery to time and target and reimbursement of Service
Support costs to the primary care professionals involved. The SPCRN Database
Administrator regularly monitors accrual reporting on the Portfolio Database for primary care
studies led from Scotland and ensures that all studies open to recruitment are uploading
accrual data on a monthly basis. The Database Administrator will provide assistance and
training for researchers if necessary in order to meet this objective.
Within Scotland, SPCRN is represented by the SPCRN Manager at the six-monthly
meetings with CSO and the managers of the other Scottish Topic Specific Research
Networks and at the NHS R&D Advisory Group meetings every 4 months.
30
The SPCRN Manager is a member of the Scottish Topic Research Networks Mangers group
which meets twice each year to discuss common issues and collaboration.
At an operational level, collaboration with the Topic Specific Research Networks is
continuing with collaborative work in 2013-14 on the 8 studies detailed in Table 13.
Table 13: Studies in which SPCRN have collaborated with other Scottish
Topic-Specific Research Networks (see Section 2 for further details)
Scottish Research Network Study title (short)
Diabetes
Diabetes Care in UK Universities
Metformin Study
Stroke
INTERSTROKE
Treatment burden stroke
Children’s Research Network
CREAM
Dementia Clinical research Network
IN-MINDD
CLICD
Fragile-X
10. Service Support Cost (SSC) Budget 2013-14
Prior to 2008, the combination of limited funds in Health Board Support for Science
allocations to meet the service support costs (SSCs) of GP research and a lack of
consistency as to how such funds are reimbursed were identified as barriers to GPs
participating in research.
CSO allowed SPCRN to pilot management of the budget of £80 000 for reimbursement of
service support costs (SSCs) to from 1 July 2008 to 30 June 2009. After a successful pilot
31
phase, CSO it agreed that SPCRN would continue to manage the SSC budget for primary
care studies through NHS Tayside from 1 April 2009.
SPCRN identified the need for additional SSC funds 6 months into the financial year when
the majority of the annual allocation of £80,000 had been spent. CSO provided a further
£99,000 based on estimates of SSC payments likely to be incurred over the remaining 6
month period.
In total, GP practices were reimbursed for participating in 42 eligibly funded primary care
studies from 1 April 2013-1 March 2014. The total expenditure from the SSC budget for
2013-14 was £129,528 resulting in an underspend of £49, 472 (Table 14).
Table 14: SSC budget summary 1 April 2013-31 March 2014
Income Expenditure Underspend
£179,000 £129,528 £49,472
11. Looking to the Future SPCRN will continue to build primary care research capacity and capability across Scotland
in 2013-14 via involvement in the following activities:
Support and develop the NHS Tayside pilot RSI initiative with the intention of rolling
out the scheme to other parts of Scotland if it is proven to be successful. The overall
aim is to develop a "mixed economy" consisting of some practices contracted to
deliver multiple more complex studies per year via membership of an RSI scheme,
and additional practices working with SPCRN on a study by study basis, in order to
increase the overall capacity to effectively deliver the NIHR CRN portfolio.
Develop closer working with colleagues in the Clinical Research Facilities across Scotland to facilitate research studies undertaken in primary care
Continue to work with the Scottish Diabetes Research Network to develop the joint
initiative which aims to deliver diabetes and obesity related, commercially funded
clinical trials in a primary care setting in Scotland.
Continue to assist with recruitment of patients to the Scottish Health Research
Register (SHARE) which is working to create a resource of up to 25% of the Scottish
adult population who consent to the access and use of their electronic health records
in order to identify them as potentially eligible for research projects.
Explore ways of engaging with practices that have not yet taken part in SPCRN
studies
32
12. References
1 http://www.isdscotland.org/Health-Topics/General-Practice/Practices-and-Their-
Populations/
2 http://www.isdscotland.org/isd/6114.html
33
APPENDIX 1
SPCRN Core Staff:
Primary Care Clinical Champion Prof Bruce Guthrie [email protected]
SPCRN Manager Dr Alison Hinds [email protected]
SPCRN Administrator Jill Sutherland [email protected]
SPCRN East Node Coordinator Marie Pitkethly [email protected]
SPCRN North Node Coordinator Samantha Holden [email protected]
SPCRN North East Node Coordinator Amanda Cardy [email protected]
SPCRN South-East Node Coordinator Dr Ellen Drost [email protected]
34
SPCRN South East Research Coordinator Rebecca Skillen [email protected] SPCRN West Coordinator Dr Tracy Ibbotson [email protected]
SPCRN West Coordinator Yvonne McIIvenna [email protected]
SPCRN East and North Research Officer Dr Kim Stringer [email protected]
SPCRN South East Research Officer Morag Place [email protected]
SPCRN West Node Research Officer Janice Reid [email protected]
SPCRN Academic Leads: East Node: Prof Cathy Jackson [email protected] North East Node: Prof Philip Hannaford [email protected] North Node: Prof Phil Wilson [email protected] South East Node: Prof Brian McKinstry [email protected] West Node: Prof Frances Mair [email protected]
35
APPENDIX 2 Deprivation status and urban/rural scores for practices participating in SPCRN studies in 2013-14, by Node EAST NODE Figure 1: Deprivation status for East node practices 2013-14 (NHS Fife, Forth Valley
and Tayside)
Figure 2: Urban/rural category for East node practices 2013-14 (NHS Fife, Forth
Valley and Tayside)
36
NORTH NODE
Figure 3: Deprivation status for North node practices participating in SPCRN
studies 2013-14 (NHS Highland and Western Isles)
Figure 4: Urban/rural category for North node practices 2013-14 (NHS Highland
and Western Isles
37
NORTH EAST NODE Figure 5: Deprivation status for North East node practices 2013-14 (NHS Grampian,
Orkney and Shetland)
Figure 6: Urban/rural category for North East node practices 2013-14 (NHS
Grampian, Orkney and Shetland)
38
SOUTH EAST NODE
Figure 7: Deprivation status for South East node practices 2013-14 (NHS Lothian and Borders)
Figure 8: Urban/rural category for South East node practices 2013-14
(NHSLothian and Borders)
39
WEST NODE
Figure 9: Deprivation status for West node practices 2013-14 (NHS Ayrshire and Arran, Dumfries and Galloway, Greater Glasgow and Clyde, and Lanarkshire)
Figure 10: Urban/rural category for West node practices 2013-14 (NHS Ayrshire and Arran, Dumfries and Galloway, Greater Glasgow and Clyde, and Lanarkshire)
40
APPENDIX 3
Evaluation forms for SPCRN Studies 2013-14
NATIONAL STUDIES
Interstroke - Importance of conventional and emerging risk factors for stroke in different
regions of the world and in different ethnic groups: a case controlled study
Chief Investigator Professor Peter Langhorne/Karen McBurnie
SPCRN Node(s) involved West, North East
Any way application procedure could
be improved?
Have you encountered any difficulties
relating to recruitment?
No
If Yes, please outline these difficulties -
Final numbers of participants recruited
into your study?
589 controls
596 patients
Would you use SPCRN again? Yes
Would you recommend SPCRN to
another research team?
Yes
Did you encounter any problems using
SPCRN?
No
If yes please explain -
Application procedure Excellent
Ability to facilitate recruitment Excellent
Value added by SPCRN Excellent
Communication with SPCRN Excellent
How could services that SPCRN
provide be improved?
Additional comments made by
researcher
BIBS: Benefits of Incentives for Breastfeeding and Smoking cessation. A platform study for
a trial
Chief Investigator Pat Hoddinott
SPCRN Node(s) involved North, East, South East, West, North East
Any way application procedure could
be improved?
It was fairly straightforward, although the form is a little
lengthy and not all sections were applicable.
Have you encountered any difficulties
relating to recruitment?
Yes
If Yes, please outline these difficulties - We administered a web survey of health professionals
to which we received only 497 responses despite
having a recruitment target of 1000. We understand that
this is a common issue, both in surveys of health
41
professionals and in using web-based formats.
Distribution through SPCRN, however, proved most
fruitful for eliciting responses – n=224/497. Whilst we
also approached individual health boards in Scotland
and used a 3rd party company (Binley’s) and informal
networks in North West England, SPCRN invitations
generated a substantial proportion of responses.
Final numbers of participants recruited
into your study?
224 through SPCRN
Would you use SPCRN again? Yes
Would you recommend SPCRN to
another research team?
Yes
Did you encounter any problems using
SPCRN?
No
If yes please explain -
Application procedure Good
Ability to facilitate recruitment Excellent
Value added by SPCRN Excellent
Communication with SPCRN Excellent
How could services that SPCRN
provide be improved?
Our experience has been of exceptional support and
facilitation.
Additional comments made by
researcher
Special thanks to Amanda Cardy for all her help.
Health In Groups: A Longitudinal and Cross-National Study
Chief Investigator Dr. Juliet Wakefield & Prof. Fabio Sani
SPCRN Node(s) involved East, South East
Any way application procedure could
be improved?
Marie Pitkethly in The Mackenzie Building (Ninewells
Hospital) was extremely helpful in all respects, so the
process was easy and straightforward.
Have you encountered any difficulties
relating to recruitment?
Yes
If Yes, please outline these difficulties - The requirements of the Ethics Board reduced our
response rates hugely (compared to the response rates
we predicted). Specifically, we were asked to send out
Participant Information Sheets to each potential
participant on GP-headed paper, which invited
interested participants to complete and return the reply
slip at the bottom on the Information Sheet. We could
then send out questionnaires to those who returned a
reply slip. We would almost certainly have had higher
response rates if we could have sent questionnaires
(complete with Participant Information Sheets and
Permission Forms) to all potential participants.
42
Also, we had particularly low response rates from the
lowest Socio-Economic Status GP surgery on our
recruitment list.
Final numbers of participants recruited
into your study?
1824
Would you use SPCRN again? Yes
Would you recommend SPCRN to
another research team?
Yes
Did you encounter any problems using
SPCRN?
No
If yes please explain -
Application procedure Good
Ability to facilitate recruitment Good
Value added by SPCRN Excellent
Communication with SPCRN Excellent
How could services that SPCRN
provide be improved?
Make researchers more aware of the services on offer.
This is particularly true for non-medical researchers
embarking on research within the NHS. From my
personal experience, this group of researchers require
more help and support than medical researchers (e.g.,
in order to understand the Sponsorship/Ethical process
etc.), so special help should be provided for such
individuals.
Additional comments made by
researcher Marie Pitkethly and Kim Stringer were both incredibly
helpful during our project. As non-medical researchers,
Fabio and I found Marie’s advice about the practicalities
of running the project to be invaluable. Kim visited the
GP surgeries and created lists of potential participants
for us, and taught me how to run searches on the GP’s
Vision software (something I had no idea how to do). I
could email them any time and receive useful advice.
IQUAD: Improving the Quality of Dentistry (IQuaD): A randmonised controlled trial
comparing oral hygiene advice and peridontal instrumentation for the prevention and
management of peridontal disease in dentate adults attending dental primary care.
Chief Investigator Professor Jan Clarkson
SPCRN Node(s) involved North, East, South East, West, North East
Any way application procedure could
be improved?
The application process was very smooth. It was helpful
to meet the team in person to discuss the Trial
requirements and obtain an understanding of the
service support costs available to dental practices
taking part in research.
43
Have you encountered any difficulties
relating to recruitment?
Yes
If Yes, please outline these difficulties - This is the first trial to recruit patients in this way in
dental primary care and as a result it has been a
learning curve for the Trial team, dental practices and
participants. The processes adopted to invite
participants were amended following the recruitment of
the first few dental practices. SPCRN provided a service
for recruited practices to search for eligible patients
using the practice software, however the software used
in dental practices varies from those used in medical
practices.
Final numbers of participants recruited
into your study?
1877 in Scotland and North East England
Would you use SPCRN again? Yes
Would you recommend SPCRN to
another research team?
Yes
Did you encounter any problems using
SPCRN?
Yes
If yes please explain - Some issues initially with the process of identifying
participants and identifying them within recruited
practices due to limited knowledge of the dental practice
software, but this was overcome quite quickly.
Application procedure Excellent
Ability to facilitate recruitment Good
Value added by SPCRN Excellent
Communication with SPCRN Excellent
How could services that SPCRN
provide be improved?
Knowledge of dental practice software for identifying
participants could be improved.
Additional comments made by
researcher It has been a pleasure working with SPCRN to fulfil the
reimbursement of service support costs and for the
provision of a recruitment support service for dental
practices taking part in the Trial. The team are always
on hand if we have had any queries and practice
service support costs were processed smoothly.
44
Telescot Diabetes: The impact of a telemetric monitoring service in type 2 Diabetes.
Randomised controlled trial with nested qualitative study.
Chief Investigator Brian McKinstry/Mary Paterson
SPCRN Node(s) involved North, South East, West
Any way application procedure could
be improved?
No, it is fine.
Have you encountered any difficulties
relating to recruitment?
Yes
If Yes, please outline these difficulties - Room requirements for research nurses at practices.
Final numbers of participants recruited
into your study?
SE – 181
W - 18
Would you use SPCRN again? Yes
Would you recommend SPCRN to
another research team?
Yes
Did you encounter any problems using
SPCRN?
No
If yes please explain -
Application procedure Good
Ability to facilitate recruitment Good
Value added by SPCRN Good
Communication with SPCRN Excellent
How could services that SPCRN
provide be improved?
Additional comments made by
researcher
COSMOS: Experiences of continence services in people with MS
Chief Investigator Tasneem Irshad
SPCRN Node(s) involved North, East, South East, West, North East
Any way application procedure could
be improved?
Have you encountered any difficulties
relating to recruitment?
Yes
If Yes, please outline these difficulties - We over-estimated the number of eligible/responding
patients
Final numbers of participants recruited
into your study?
52
Would you use SPCRN again? Yes
Would you recommend SPCRN to
another research team?
Yes
Did you encounter any problems using
SPCRN?
No
If yes please explain -
Application procedure Excellent
Ability to facilitate recruitment Good
45
Value added by SPCRN Good
Communication with SPCRN Excellent
How could services that SPCRN
provide be improved?
Additional comments made by
researcher
NHS 24: Managing symptoms in the community: examining the role of NHS 24
Chief Investigator Dr Alison Elliot
SPCRN Node(s) involved North, East, South East, West, North East
Any way application procedure could
be improved?
Have you encountered any difficulties
relating to recruitment?
Yes
If Yes, please outline these difficulties - No real difficulties as such. The main issue with
recruiting practices is being dependent on the practices
expressing an interest in taking part. So while we were
able to have the correct number of practices in the
different nodes, it would have been good to have a
choice of practices.
Final numbers of participants recruited
into your study?
1188 completed questionnaires
Would you use SPCRN again? Yes
Would you recommend SPCRN to
another research team?
Yes
Did you encounter any problems using
SPCRN?
No
If yes please explain -
Application procedure Good
Ability to facilitate recruitment Good
Value added by SPCRN Good
Communication with SPCRN Excellent
How could services that SPCRN
provide be improved?
Additional comments made by
researcher
General practitioner understanding and management of patients who self-harm: a
qualitative study
Chief Investigator Dr Amy Chandler
SPCRN Node(s) involved South East, North East
Any way application procedure could
be improved?
None, I found it very straightforward.
Have you encountered any difficulties
relating to recruitment?
Yes
If Yes, please outline these difficulties - We faced more challenges in recruiting practices in the
46
South East, response to the study was much lower than
in North East, we supplemented this by using our own
contacts in Lothian (resulting in 5 of the 14 participants
for SE). However we understand that response in North
East was much better than expected, and overall, we
were really pleased with the support of the SPCRN:
recruitment targets were met and completed within time.
Final numbers of participants recruited
into your study?
30
Would you use SPCRN again? Yes
Would you recommend SPCRN to
another research team?
Yes
Did you encounter any problems using
SPCRN?
No
If yes please explain -
Application procedure Excellent
Ability to facilitate recruitment Good
Value added by SPCRN Excellent
Communication with SPCRN Excellent
How could services that SPCRN
provide be improved?
Additional comments made by
researcher
Fragile X: A randomized, souble-blind, 12-week, parallel group, placebo-controlled study of
the efficacy and safety of RO4917523 in patients with Fragile X Syndrome
Chief Investigator Daniella Wallwork
SPCRN Node(s) involved East, South East, West
Any way application procedure could
be improved?
The initial process was not clear in terms of what was
required (in terms of R&D trust approval) for nodes
outside of the areas where approval was already
granted. Not much visibility in terms of metrics –
number of surgeries approached and number
responded.
Have you encountered any difficulties
relating to recruitment?
Yes
If Yes, please outline these difficulties - Rare disorder – practices may not routinely see this
patient population as they are under specialist care.
Final numbers of participants recruited
into your study?
0
Would you use SPCRN again? Yes
Would you recommend SPCRN to
another research team?
Yes
Did you encounter any problems using
SPCRN?
Yes
If yes please explain - Not clear that we needed R&D approval for the nodes
47
outside of where we had sites. This was not explained
at the start.
Application procedure Good
Ability to facilitate recruitment Poor
Value added by SPCRN Poor
Communication with SPCRN Satisfactory
How could services that SPCRN
provide be improved?
Additional comments made by
researcher
Although the SPCRN were not able to recruit, this did
not cost the client anything other than the cost of the
consumables in the preparation of the packs to go to the
patient. We were very up front regarding our
expectations and the contact at SPCRN did negotiate
for us that we would not incur costs if the practice was
searched and there were no patients.
Measuring empathic, person-centred communication in nurses: a study of the validity and
reliability of the CARE measure in practice nurses in primary care
Chief Investigator Annemieke Bikker
SPCRN Node(s) involved East, West
Any way application procedure could
be improved?
Have you encountered any difficulties
relating to recruitment?
No
If Yes, please outline these difficulties - Although we applied to the SPCRN, we recruited the
practices ourselves
Final numbers of participants recruited
into your study?
20 practice nurses
Would you use SPCRN again?
Would you recommend SPCRN to
another research team?
Did you encounter any problems using
SPCRN?
If yes please explain - Good
Application procedure N/A
Ability to facilitate recruitment N/A
Value added by SPCRN Good
Communication with SPCRN
How could services that SPCRN
provide be improved?
Additional comments made by
researcher
The communication with SPCRN was very good.
However, after the initial meeting we decided that for
the current project it would be best to recruit the
practices ourselves. As SPCRN was not involved in the
actual recruitment for our study, I can only comment a
little on our experiences.
48
Barriers to good transitional diabetes care in UK Universities
Chief Investigator Joanne Kellett
SPCRN Node(s) involved East, South East, North East, West
Any way application procedure could
be improved?
Have you encountered any difficulties
relating to recruitment?
No
If Yes, please outline these difficulties -
Final numbers of participants recruited
into your study?
788 across the UK (staff & patients):
East – 7 (3 staff & 4 patients)
North East – 4 (2 staff and 2 patients)
South East – 16 (2 staff and 14 patients)
West - 0
Would you use SPCRN again? Yes
Would you recommend SPCRN to
another research team?
Yes
Did you encounter any problems using
SPCRN?
No
If yes please explain - Good
Application procedure Good
Ability to facilitate recruitment Good
Value added by SPCRN Good
Communication with SPCRN
How could services that SPCRN
provide be improved?
Additional comments made by
researcher
Many thanks to all the SPCRN team for their support
throughout the study.
LOCAL STUDIES – East
Vitamin K status and markers of vascular function in patients with and without postural
hypotension
Chief Investigator Dr Matthew Lambert
SPCRN Node(s) involved East
Any way application procedure could
be improved?
No
Have you encountered any difficulties
relating to recruitment?
No
If Yes, please outline these difficulties -
Final numbers of participants recruited
into your study?
49
Would you use SPCRN again? Yes
Would you recommend SPCRN to
another research team?
Yes
Did you encounter any problems using No
49
SPCRN?
If yes please explain -
Application procedure Good
Ability to facilitate recruitment Excellent
Value added by SPCRN Excellent
Communication with SPCRN Excellent
How could services that SPCRN
provide be improved?
Additional comments made by
researcher
LOCAL STUDIES – North East
WAIT - Parent-determined oral montelukast therapy for preschool wheeze
Chief Investigator Dr Steve Turner
SPCRN Node(s) involved North East
Any way application procedure could
be improved?
No
Have you encountered any difficulties
relating to recruitment?
Yes
If Yes, please outline these difficulties - Via our contact at SPCRN we know that some practices
are keen to engage but not others. We also know that
recruitment is 10% for paediatric studies. These
difficulties are inevitable and I can’t see an easy
solution.
Final numbers of participants recruited
into your study?
180
Would you use SPCRN again? Yes
Would you recommend SPCRN to
another research team?
Yes
Did you encounter any problems using
SPCRN?
No
If yes please explain -
Application procedure Excellent
Ability to facilitate recruitment Excellent
Value added by SPCRN Excellent
Communication with SPCRN Excellent
How could services that SPCRN
provide be improved?
Additional comments made by
researcher
I hope that our past excellent relationship will continue.
The majority of paediatrics takes place in primary care
and the SPCRN is a valued member of our child health
research team.