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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)

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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


4500 E-1 SE-3 W-2 Total=6


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


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


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


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


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


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


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


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

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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


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


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


recruited Patients recruited


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


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


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


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


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


Sanofi Aventis 15871 In set-up

TOTAL 57 120

Table 3: North SPCRN Node Local Studies




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


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


Epidemiology, prevalence and characteristics of heart failure with preserved ejection fraction PIC

Prof Michael Frenneaux, University of Aberdeen


10043

4 965


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



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


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

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Table 6: West SPCRN Node Local Studies

Study Title CI Funder UKCRN ID Practices recruited

Patients recruited


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


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)

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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

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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

http://www.sdrn.org.uk/

http://www.scotcrn.org/

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

http://www.isdscotland.org/Health-Topics/General-Practice/Practices-and-Their-Populations/

http://www.isdscotland.org/Health-Topics/General-Practice/Practices-and-Their-Populations/

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]

mailto:[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


be improved?

It was fairly straightforward, although the form is a little

lengthy and not all sections were applicable.



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.


into your study?

224 through SPCRN




Yes


SPCRN?

No


Application procedure Good






Our experience has been of exceptional support and

facilitation.


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


be improved?

Marie Pitkethly in The Mackenzie Building (Ninewells

Hospital) was extremely helpful in all respects, so the

process was easy and straightforward.



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.


into your study?

1824




Yes


SPCRN?

No



Ability to facilitate recruitment Good





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.


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



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



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.


into your study?

1877 in Scotland and North East England




Yes


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.







Knowledge of dental practice software for identifying

participants could be improved.


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


be improved?

No, it is fine.



Yes

If Yes, please outline these difficulties - Room requirements for research nurses at practices.


into your study?

SE – 181

W - 18




Yes


SPCRN?

No




Value added by SPCRN Good





researcher

COSMOS: Experiences of continence services in people with MS

Chief Investigator Tasneem Irshad



be improved?



Yes

If Yes, please outline these difficulties - We over-estimated the number of eligible/responding

patients


into your study?

52




Yes


SPCRN?

No




45






researcher

NHS 24: Managing symptoms in the community: examining the role of NHS 24

Chief Investigator Dr Alison Elliot



be improved?



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.


into your study?

1188 completed questionnaires




Yes


SPCRN?

No









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


be improved?

None, I found it very straightforward.



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.


into your study?

30




Yes


SPCRN?

No









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


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.



Yes

If Yes, please outline these difficulties - Rare disorder – practices may not routinely see this

patient population as they are under specialist care.


into your study?

0




Yes


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.


Ability to facilitate recruitment Poor

Value added by SPCRN Poor

Communication with SPCRN Satisfactory




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


be improved?



No

If Yes, please outline these difficulties - Although we applied to the SPCRN, we recruited the

practices ourselves


into your study?

20 practice nurses

Would you use SPCRN again?




SPCRN?

If yes please explain - Good

Application procedure N/A

Ability to facilitate recruitment N/A


Communication with SPCRN




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


be improved?



No



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




Yes


SPCRN?

No

If yes please explain - Good




Communication with SPCRN




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


be improved?

No



No



into your study?

49




Yes

Did you encounter any problems using No

49

SPCRN?









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


be improved?

No



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.


into your study?

180




Yes


SPCRN?

No









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.

spcrn annual report 2013-14 - sp… · university of cambridge british heart foundation 4499 e-0...

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