Clinical Quality and Care - Oxford Health NHS Foundation Trust€¦ · Web viewTheme 5: Emerging...

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Report to the Meeting of theOxford Health NHS Foundation Trust

Board of Directors

28 September 2016

Research and Development Report

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BOD 114/2016(agenda item: 15)

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1 Clinical Quality and Care...............................................................................................4

2 Networks and Collaborations........................................................................................4

2.1 Oxford Academic Health Science Network (OAHSN).............................................4

2.2 Method...................................................................................................................5

2.3 Deliverables............................................................................................................6

2.4 Oxford Academic Health Sciences Centre (AHSC).................................................9

3 National Institute for Health Research Infrastructure (NIHR)......................................10

3.1 OXFORD NIHR Collaboration in Leadership in Applied Health Research and Care (CLAHRC).......................................................................................................................10

3.2 NIHR Diagnostic Evidence Co-operative (DEC)...................................................14

3.3 NIHR Oxford cognitive health Clinical Research Facility (CRF)............................16

3.4 NIHR Biomedical Research Centre.......................................................................19

3.5 NIHR Clinical Research Network (CRN)...............................................................20

4 Research Governance................................................................................................20

4.1 R&D Governance Group.......................................................................................20

4.2 Contract Review Processes..................................................................................21

5 Studies and Participant Recruitment...........................................................................23

5.1 Studies..................................................................................................................23

5.2 Participant Recruitment.........................................................................................23

5.3 Grant Applications and Awards.............................................................................24

5.4 NIHR Metrics and Targets.....................................................................................24

6 Pharmacy....................................................................................................................25

7 Case Records Interactive Search (CRIS)....................................................................26

8 Finance.......................................................................................................................26

8.1 FY17 Performance................................................................................................27

8.2 Research Capability Funding (RCF).....................................................................27

8.3 FY17 RCF Allocation.............................................................................................27

8.4 Clinical Research Facility (CRF)...........................................................................28

8.5 Clinical Research Network: Thames Valley and South Midlands (CRN)...............28

8.6 Financial Risks and Issues....................................................................................28

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8.7 Redundancy Costs................................................................................................29

8.8 Collaboration in Leadership in Applied Health Research and Care (CLAHRC)....29

8.9 Oxford Academic Health Science Network (OAHSN)...........................................31

8.10 External Finance Activities.................................................................................32

9 Estates........................................................................................................................32

10 Staffing.....................................................................................................................32

11 Communications.......................................................................................................32

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1 Clinical Quality and Care Participation in research produces widespread benefits for patients and, more generally, improvements in quality of care. A Censuswide comsumer poll of 3,000 people in England, commissioned by the NIHR published data in September 2014 saying that 95% of those as responding stated that it is very important that the NHS carries out clinical research, with 85% or people agreeing that they would be very or somewhat willing to take part if they were diagnosed with a medical condition or disease. This accounted for the main factor that was most likely to motivate them into taking part, along with if a friend/family member was taken seriously ill and didn’t have the treatment they needed. The majority of those surveyed said that clinical research takes place within the NHS, Universities and Clinical Trials Units. Oxford health NHS FT has strong links to the University of Oxford, which has been rated as the world’s best university for clinical, pre-clinical and health subjects for the past 5 years (2011- 2016 THE World University Rankings), top ranked in the Research Excellence Framework 2014 for research quality in Psychology, Psychiatry and Neuroscience and third highest University in the areas of mental health and dementia in the RAND report commissioned by NIHR in 2015. In addition Oxford Health NHS Foundation Trust was the top ranked mental health Trust in the Mental Health Highlight Area in the NIHR RAND report

2 Networks and Collaborations

2.1 Oxford Academic Health Science Network (OAHSN) Oxford Health NHS FT is hosting three OAHSN themes;

Early intervention led by Prof Belinda Lennox and Sarah Amani

Anxiety and Depression led by Prof David Clark and Ineke Wolsey

Dementia led by Dr Rupert McShane

2.1.1 Early Intervention Theme

The Oxford AHSN Early Intervention in Psychosis (EIP) Network succeeded in bidding for an extension to operate until March 2018, having demonstrated value added to the local health system and to the wider South of England region.

2.1.1.1 Thames Valley EIP Network Objectives

The local EIP Network has three primary objectives for Berkshire, Oxfordshire, Buckinghamshire and Milton Keynes:

Reduce unwarranted outcome variability;

Support adoption of service innovation;

Improve patient experience and outcomes

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2.1.1.2 South of England Early Intervention in Psychosis Programme

The AHSN EIP Network is additionally commissioned by NHS England (South) to support 50 CCGs and 16 providers across the South of England to evidence achievement of both elements of the standards:

A maximum wait of two weeks from referral to treatment

Treatment delivered in accordance with NICE guidelines for psychosis and schizophrenia.

2.1.1.3 South of England EIP Objectives

For 2016-17, the South Region EIP Programme objectives are to:

Support and maintain Quality Improvement networks that provide a platform for sharing good practice,

Support Trusts and commissioners to evidence delivery of NICE interventions against the regional and national baseline established in 2015;

Allocate £250,000 Health Education England (HEE) funding to develop the workforce’s capabilities to deliver NICE interventions for psychosis;

Support NHS England local teams to monitor implementation of the standards, ensuring that both elements of the standards are being met;

2.2 Method

The South EIP Programme works in partnership with existing networks to maintain platforms for exchanging ideas and expertise, defining optimal clinical pathways and service models. The programme has developed partnerships with national and local Health Education England (HEE) teams in order to build staff capacity and competencies required to deliver on the standards.

The EIP programme maintains a whole system overview in order to identify emerging problems as they arise and provide data to support planning and performance management activity. Whilst the programme provides expert advice to NHS England, the ongoing monitoring and assurance function remains with NHS England Operations and Delivery managers.

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2.3 Deliverables

Objective In Scope Out of Scope

Support and maintain Quality Improvement networks that provide platforms for sharing best practice,

Monthly sub-region Clinical Group Meetings Bi-monthly regional EIP Clinical Webex Bi-monthly regional IT and IM Webex Quarterly regional EIP Programme Board

meetings Annual EIP Sustainability Workshops Peer exchange visits

Support Trusts and commissioners to evidence delivery of NICE interventions against the regional and national baseline established in 2015;

• EIP Service Audit using EIP Matrix V2.0 https://eip-matrix.time4recovery.com

• Quarterly reports on achievement of standards• Examples of Service Models and Specifications• Case studies

Reports based on Mental Health Minimum Data Set and SNOMED codes

Allocate Health Education England (HEE) funding to develop the workforce’s capabilities to deliver NICE interventions for psychosis

• Training workshops for Physical Health Monitoring, Employment Support and Psychosis Assessments

• Train the trainer sessions• Quarterly Workforce Reports

Support NHS England’s (South) local teams to monitor implementation of the standards, ensuring that both elements of the standards are being met

• Expert advice for NHS England local area teams• Support to develop assurance templates• Feedback on commissioner submissions

Assurance and performance management

2.3.1 Anxiety and Depression Theme

The Anxiety and Depression Network has been awarded a further two years funding to continue its work in improving patient outcomes and reducing variation in psychological treatments for common mental health disorders (Improving Access to Psychological Therapies - IAPT services).

2.3.1.1 Project 1: Enhancing recovery rates in IAPT services

The A&D network is pleased to report that all services within the Oxford AHSN Network have maintained their enhanced recovery rates over the past six months. Importantly, an additional 2,659 patients recovered during Jan 2014-Nov 2015 despite a 16% increase in the number of patients accessing IAPT services and no additional budget, providing an estimated £755,494 reduction in healthcare expenditure. The Network has now started its’ Durability of Clinical Gains and Employment project which will follow-up patients at six and 12 months after discharge. All Oxford AHSN IAPT member services are taking part in this and one of the core objectives is to understand relapse rate for depression and work with the Oxford Mindfulness Centre to explore characteristics of patients at higher risk of

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https://eip-matrix.time4recovery.com/

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relapse who should be offered a course of mindfulness based cognitive therapy earlier on after treatment for depression. The aim is to develop guidelines for all services based on our findings.

2.3.1.2 Dissemination of new service innovations

Health economics evaluation of the Heart2Heart and the Diabetes projects have now been completed and papers have been submitted for publication. There is also limited data available for the MUS project. The A&D Network had started a more comprehensive piece of work on the Diabetes project in partnership with David Stuckler (Professor of Political Economy and Sociology, Department of Sociology, University of Oxford) but this has been cancelled as national opportunities now take precedence. All three Thames Valley services and their CCGs have been invited to submit proposals for expansion of IAPT funding which is characterized by providing new, co-located, integrated services for people suffering with Long term Conditions and co-morbid anxiety/depression. A key requirement will be the collection of health utilisation data from the beginning and working closely with our services, the CCGs and Prof. Stuckler to design and implement data collection.

2.3.1.3 Collecting Routine outcome Measures in CAMHs: CYP IAPT project

Despite problems in data collection it has now been possible to compare collection of Routine Outcome Measures for CYP Jan-March 2015 to Jan-March 2016 and are very pleased to report that Oxford Health has improved their ROMs collection by 3 % (from 24% to 27%). Work continues with all CAMHs services to continuously improve ROMs collection.

2.3.2 Dementia Theme

2.3.2.1 Memory Services National Accreditation Programme

This work in OHFT and MK was the lead project highlighted for the Oxford AHSN in the AHSN atlas of Solutions in Healthcare, a platform to promote the best examples from across the AHSN (http://atlas.ahsnnetwork.com/spreading-best-practice-in-dementia-care/). In addition it appeared in the national AHSNs collective Impact Report 2016 (http://www.ahsnnetwork.com/wp-content/uploads/2014/12/AHSN-Impact-Report-2016.pdfn)

In the current (interim) round of self- appraisal teams are being helped to take ownership of the data requirements and supplying each team with centrally available data where possible.

2.3.2.2 Network of care home in-reach teams

Work continues with the care home in-reach program with Lucy Garrod visiting numerous sites within the AHSN area, drawing together the community of in-reach workers, and getting buy-in for the projects generated by that community.

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http://www.ahsnnetwork.com/wp-content/uploads/2014/12/AHSN-Impact-Report-2016.pdfn

http://www.ahsnnetwork.com/wp-content/uploads/2014/12/AHSN-Impact-Report-2016.pdfn

http://atlas.ahsnnetwork.com/spreading-best-practice-in-dementia-care/

http://atlas.ahsnnetwork.com/spreading-best-practice-in-dementia-care/

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2.3.2.3 Long term conditions questionnaire

The validation of a DH supported questionnaire for the assessment of the value of all services and projects in dementia is being led by Professor Ray Fitzpatrick and supported by the AHSN with an ethics submission having been prepared.

2.3.2.4 Frontotemporal dementia

Dr Pamina Mitter has been developing pathway recommendations for diagnosing frontotemporal dementia, with the help of a small group of clinicians from around the Thames Valley.

2.3.2.5 Webinars

Over the last six months webinars on the following topics have been presented

Telecare Primary Progressive Aphasia (PPA) and the role of the Speech & Language

Therapist in a Memory Clinic Dementia and Depression A case-based webinar on dementia sub-types including clinic-pathological

correlation An audit of scans from Berkshire and Diagnostic Boundaries in Dementia

80% of survey responders said they had changed practice in at least a small way as a result of attending one or more of our webinars.

There have been technical and institutional problems in finding a suitable host for all videos of previous lectures can sit.

2.3.2.6 Post diagnostic support network

An initial workshop will be held in October for professionals involved in provision of early post-diagnostic support. Dr Candy Stone, Consultant Clinical Psychologist is leading this project, which is anticipated will generate improvement projects in teams from around the AHSN geography.

2.3.2.7 Young People With Dementia – Learning from Berks charity

The AHSN Dementia theme is funding places on a training course in mid Sept being run by YPWD, with the aim of making more services available specifically for younger people with dementia. One person from OHFT in Bucks, and two from Young Dementia UK (Oxon) will be attending the training, however, planned secondees from Alzheimer’s Society Bucks have withdrawn.

2.3.2.8 Conference

There will a half day AHSN conference (Kassam/Unipart/High Wycombe) on Driving and cognitive impairment on 18th or 25th January. Current programme TBC: Telemetrics, 100 year old drivers, computerised testing, DVLA, Older Drivers Task Force, Alistair Burns Dementia Czar.

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2.3.2.9 Innovation – linked to the AHSN

Driving safety triage. A pilot scheme of an established commercial computerised cognitive test system is being investigated. This will help us to decide rationally whether people are safe to drive, unsafe to drive or need an on-road assessment. The evidence for this Canadian system is much better than for any other. Although the pilot is free, the cost charged by the company is ~£29 per test and suggestion for potential funders is being sought.

Telemetric research to develop and validate a telemetric signature which identifies unsafe older drivers in in the early viability assessment phase, looking at

a. a company which makes a telemetric dongle (connects to cigarette lighter) b. the national network of on-road driving assessment centres, and possibly

also c. the Deep and Frequent Phenotyping studyd. potential funding from Ageas.

2.4 Oxford Academic Health Sciences Centre (AHSC)

The Oxford AHSC is a partnership within Oxford of Oxford Health NHS FT, Oxford University Hospitals NHS FT, University of Oxford and Oxford Brooke University.

The partners are in the process of coordinating their organisations’ master plans, with a particular focus on the relationships across Headington to ensure the best possible placement and plans for clinical services, staff, teaching and research facilities. They are supporting the following themes:

Theme 1: Big Data: Delivering the Digital Medicine Revolution led by Professor Martin Landray

Theme2: Building Novel NHS, University and Industry Relationships led by Professor Chas Bountra

Theme 3: Modulating Immune Response for Patient Benefit led by Professor Paul Klenerman

Theme 4: Managing the Epidemic of Chronic Disease led by Professor Stephen MacMahon and Professor Kazem Rahimi

Theme 5: Emerging Infections and Antimicrobial Resistance led by Dr Peter Horby

Theme 6: Cognitive Health: Maintaining Cognitive Function in Health and Disease led by Professor John Geddes

The AHSC will continue to make progress into 2016/17, combining the institutions’ individual strengths in world‐class science, research, training and clinical expertise to address 21st healthcare challenges. In particular, it will continue to support the shortlisted BRC bids from Oxford University Hospitals and the University of Oxford and Oxford Health and the University of Oxford.

A Chief Operating Officer, Dr Glenn Wells has joined the AHSC over the summer and will lead the future developments.

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3 National Institute for Health Research (NIHR) Infrastructure 3.1 OXFORD NIHR Collaboration in Leadership in Applied Health Research and

Care (CLAHRC)

3.1.1 Phase 2 Update

Following the Phase 1 and 2 review process, there has been a minor restructuring of the CLAHRC with the addition of a new Theme – Theme 6: Health Behaviours, Diet and Obesity lead by Professor Susan Jebb. As outlined in the main CLAHRC DH contract, permission for this change was applied for and has now been granted by DH. A variation to contract has been signed. Permission to publically launch the Phase 2 projects has been requested but as yet has not been granted. Press releases and a new look website have been created and are ready to go live immediately once DH permission has been received.

3.1.2 Phase 2 Project Update

Phase 2 projects are progressing well and are monitored for progress against stated milestones and finance on a monthly basis.

3.1.2.1 The m e 1 – Service Redesign

Professor Belinda Lennox has replaced Professor John Geddes as Theme Lead for this Theme. Professor Geddes has now joined the CLAHRC Management Board.

Project Code Project Title Project Lead

P2-1.01 Ethnographic evaluation of patients presenting to EMU Margaret Glogowska

P2-1.02 ECHO Jane Fossey

P2-1.03 Dignity Plus Jane Fossey

P2-1.04Clinical Decision Making in Ambulatory Care; A Case Study of Clinicians providing Ambulatory Emergency Care in Urgent Care Settings in Oxfordshire (EMU)

Sara McKelvie

P2-1.05 Evaluation of mental health (CAMHS) in Oxon schools Mina Fazel

P2-1.06 Foxweb Seena Fazel

P2-1.07 Evaluation of implementation of CAMHS services in Bucks (Phase 1 Core) Angela Aristidou

P2-1.08 Evaluation of integrated CAMHS model in Buckinghamshire

Dr Apostolos Tsiachristas

P2-1.09 Modelling the impact within the NHS of a heart failure risk score and serum natriuretic peptide

Dr Phillip Turner / Professor Ann Van den

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screening in the identification of patients who would benefit from heart failure prevention strategies (Phase 2 funded)

Bruel

P2-1.10 Health economic evaluation of self-harm Professor Keith Hawton

P2-1.11 EBCD in EIP Belinda Lennox

3.1.2.2 T heme 2 – Health Behaviours, Physical Activity and Rehabilitation

Theme Lead Professor Sarah Lamb


P2-2.01 Preventing falls and fragility fractures Sarah Lamb

P2-2.02 Self-directed and supervised exercise treatments for rheumatoid arthritis (SARAH) Ester Williamson

P2-2.03 iBeST Implementation of improved pathways of care for sub-acute and chronic low back pain Beth Fordham

P2-2.04DAPA (Dementia And Physical Activity) extended qualitative study and implementation research (Phase 1 funding extension)

Sarah Lamb

P2-2.05 CORKA COmmunity based Rehabilitation after Knee Arthroplasty Sarah Lamb

P2-2.06 PROSPER Exercise to prevent shoulder problems in patients undergoing breast cancer treatment Sarah Lamb

P2-2.07

GRASP - Clinical and cost effectiveness of progressive exercise compared to best practice advice, with or without corticosteroid injection, for the treatment of rotator cuff disorders: a 2x2 factorial randomised controlled trial

Sarah Lamb

3.1.2.3 Theme 3 – Patient Reported Outcome Measures

Theme Lead – Professor Ray Fitzpatrick

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P2-3.01 Implementing evidence from patient experience and reported outcomes Ray Fitzpatrick

3.1.2.4 Theme 4 – Multi Morbidity

Theme Lead – Professor Michael Sharpe


P2-4.01 Implementing a new evidence-based depression management programme for patients with cancer Michael Sharpe

P2-4.02Depression and other symptoms in patients with cancer: deriving clinically useful information from existing datasets

Michael Sharpe

P2-4.03 Improving clinician and patient communication in palliative care Katy Burke

P2-4.04

How can we best address prolonged acute hospital stays in older inpatients with medical-psychiatric multimorbidity?: A pragmatic multicentre randomised controlled trial to compare the effectiveness and cost-effectiveness of Proactive Liaison Psychiatry with usual care.

Jane Walker

3.1.2.5 Theme 5 – Patient Self Management

Theme Lead – Professor Richard McManus


P2-5.01 Optimising Treatment for Mild Systolic hypertension in the Elderly James Sheppard

P2-5.02 OPTIMUM-BP Louise Pealing

P2-5.03 CollabOrative Care Model for Bipolar DisOrder (COMBO)

Mary Jane Attenburrow

P2-5.04What are the factors related to the adoption of technology-based approaches to self-management in the NHS? (COMPLETED 30/06/2016)

Jasmine Harvey

P2-5.05Can self-management following gestational hypertension improve control and detection of raised BP? SNAP-HT Trial development pilot study

Alex Cairns

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P2-5.06Does provision of lifetime risk information influence future self-management behaviour in type 2 diabetes?

Thomas Rouyard

P2-5.07 Novel Strategies to Improve the Diagnosis and Management of Hypertension Ali Albasri

3.1.2.6 Theme 6 – Health Behaviours, Diet and Obesity

Theme Lead – Professor Susan Jebb


P2-6.01 Development of a meal replacement programme to offer in primary care for weight management Nerys Astbury

P2-6.02Development and feasibility testing of an intervention to support people to lose weight through daily weighing

Paul Aveyard

P2-6.03 Primary Care Shopping Intervention for Cardiovascular Disease: PC-SHOP

Carmen Piernas Sanchez

P2-6.04

What triggers people to try to lose weight, what methods do they use, and how successful are they? The Oxford Food and Activity Behaviours (OxFAB) Study

Jamie Hartman-Boyce

3.1.2.7 General Update

The CLAHRC continues to generate impact in the form of academic publications, patient benefit and cost savings to the NHS.

In a recent NIHR 10@10 publication, the NIHR CLAHRC Oxford was successful in having 2 impact case studies selected for inclusion:

Improving outcomes for people with first episode psychosis – Cross CLAHRC working from West Midlands, East of England and Oxford, resulting in improved health and social outcomes for over 8,000 people in England each year and an associated cost saving of £57.5 million per year.

Back Skills Training (iBest) – Implementation of improved pathways of care for the sub-acute and chronic back pain – Oxford CLAHRC, resulting in the pn-line package, accredited by the British Psychological Society for training health care professionals. The project is currently being rolled out nationally across the NHS. There are more than 290 clinicians, from over 100 trusts across the UK signed up for training. The sites span England, Scotland and Wales. We are also working with

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a number of international groups and providing training to physiotherapists managing low back pain.

3.2 NIHR Diagnostic Evidence Co-operative (DEC)

During the last 12 months a number of activities have taken place under the DEC:

3.2.1 Horizon Scanning programme

This program is focusing on identifying new IVDs relevant to primary care, which produces and publishes horizon scan reports on new in-vitro diagnostics that might have relevance in primary care. The output of these reports, are published on the DEC website and includes peer reviewed publications in the British Journal of General Practice, topic submissions to funding bodies, and grant applications. This is an ongoing programme which will continue in the next financial year.

3.2.2 Unmet clinical needs assessment

This project is looking at assessing unmet clinical needs for point-of-care tests in primary care Estimating which point-of-care IVD tests general practitioners would like to use for diagnosis, monitoring and referral decisions. Based on the data that had been collected during the previous financial years, additional analyses were performed for the UK sample only. The analyses have been finalised and a manuscript has been succesfully submitted to Family Practice.

3.2.3 Evidence gaps in diagnostic test evaluation

This work is looking at a systematic review based on all available Horizon Scanning reports, and identifying what the evidence gaps are in diagnostic test evaluation. Data collection is nearly finished although completion has been hampered by key staff leaving the department to take up posts elsewhere. The data extraction is expected to finish during the summer and analyses to be complete by October.

3.2.4 Evidence synthesis for economic modelling

This is a systematic review exisiting HTA reports that include a diagnostic test economic evaluation Data collection has been completed and analyses are being conducted at the moment. An abstract of the project results has been submitted for an international conference on diagnostic test methodology.

3.2.5 Cost-effectiveness of a new test for myeloma diagnosis

This study is in collaboration with Binding Site who have developed a new test which assists in the diagnosis of myeloma. Myeloma is now one of the cancer types with the longest diagnostic delay and this new test may potentially quicken the diagnostic process. The project is conducted at the John Radcliffe Hospital Oxford with the pathology lab. The contribution of the Oxford DEC is to provide statistical expertise in the analyses of diagnostic accuracy, and health economics expertise in the analyses of cost-effectiveness. Data collection is in its final stages, with the expectation that we will stop recruiting new patients in May. Follow-up data will be collected for another six months but preliminary analyses on a partial data set will start concurrently.

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3.2.6 The impact of point-of-care tests on ambulatory care

This systematic review aims to collate all available evidence on the potential impact of point-of-care tests on ambulatory care. The hypothesis is that POC tests have more effects than simply providing results faster than a classic laboratory test. Mapping those changes will assist in planning impact studies better in the future. eligible studies from our literature search are currently being identified, after which data extraction and analyses will commence. Due to the very broad nature of the question, the resulted will be stratified depending on the clinical domain, and anticipate there will be enough data to publish at least three papers from this review.

3.2.7 Assessing unmet clinical needs for point-of-care tests in community pharmacists

This project builds on the unmet clinical needs assessment in general practice. Pharmacies could potentially offer point-of-care tests for a range of conditions, and some have already set up testing protocols with local general practices for diabetes or cholesterol testing. Whether pharmacists are welcoming of tests and how they expect these tests to be managed in unknown. The survey is currently being developed, and contacts with professional bodies established.

3.2.8 CRP point-of-care tests in out-of-hours home visits

This feasibility study has been funded by the Health Foundation and aims to evaluate the feasibility, acceptability and potential impact of point-of-care CRP testing in out-of-hours home visits. We will record testing frequeny and patient acceptability, and collect follow-up outcomes such as hospital admission, re-consultation rates and antiotic prescription rates. The protocol is currently being written and data collection will commence after the later this year.

3.2.9 Innovate UK funded project with Mologic Ltd

The Oxford Dec contributed extensively to the application process of this collaborative project will modeling the theoretical cost effectiveness of a novel urine-based diagnostic into the care pathway for patients with chronic obstructive pulmonary disease (COPD). The company is working to develop a diagnostic test which could be used by patients to monitor their condition in the community. The aim is to identify patients' pulmonary exacerbations earlier than currently possible, and to stratify those experiencing exacerbations to the most appropriate treatment, thereby reducing morbidity and slowing the deterioration of their condition. An initial project start-up meeting has been held at the headquarters of Mologic Ltd, with both clinical and non-clinical research input from DEC Oxford. DEC health economists have begun the process of reviewing the literature relevant to the model.

3.2.10 CLAHRC Phase 2 funded project

The DEC Oxford as lead and Roche Diagnostics Ltd as partner are working collaboratively on a project that aims to examine whether the introduction of low-cutoff natriuretic peptide screening together with collaborative care in primary care services would be cost effective in the context of the NHS for the prevention of heart failure. This will be accomplished using data from the Irish trial to attempt to identify risk factors which could help to identify those most at risk to focus testing and to examine the cost-effectiveness of the proposed

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intervention in primary care in the NHS. The study also aims to retest biobank samples from the Irish trial for NT-proBNP (BNP having been used in the trial) to examine the most appropriate cutoff for NT-proBNP and to examine how the two biomarkers might correlate.

3.3 NIHR Oxford cognitive health Clinical Research Facility (CRF)

The CRF objective is to provide a flexible and integrated neuroscience resource that facilitates the efficient and timely conduct of experimental neuroscience including early phase development of psychological and pharmacological treatments for cognitive and mental disorders, with a proportion of the resource allocated to industry sponsored high intensity trials. The main research areas for which support was planned included; translational research on social anxiety disorder and PTSD; developing digital phenotypes for mood disorder; investigating sleep disturbance and circadian rhythm in neuropsychiatric disorders; developing novel screening tools for post brain injury and stroke in order to aid rehabilitation; investigate the mechanisms underlying attention, memory and decision-making, common problems in many brain disorders.

3.3.1 Outputs

Data submitted for the annual return on activity between 1st April 2015 and 31st march 2016 shows that 44 studies were undertaken, with 2902 subjects recruited to those studies during the time frame. In addition the CRF has produced 37 publications in peer reviewed journals.

The CRF provides specialist clinical research study and trial support for many activities for a range of studies, including both commercial and non-commercial sponsors studies, with a focus on experimental medicine.

Some key examples of the research undertaken are

3.3.1.1 A randomised, double-blind, placebo-controlled, single-dose, study of the effects of SEP 363856 and Amisulpride on bold fMRI signal in healthy male and female volunteers with high or low schizotype characteristics.

This study was a collaboration between UO and p1Vital (SME) funded commercially (Sunovion). This was the first phase 1 study incorporating markers of efficacy with a novel candidate treatment (SEP 363856) for positive and negative symptoms in schizophrenia. Preclinical data suggested key effects of this compound on neurochemical and behavioural markers for schizophrenia, but its effects on humans were unknown.

3.3.1.2 Exploration of the short-term physical and psychological effects of lithium in mood instability. (OXLITH) The Oxford Lithium Trial is a double-blind, randomised, placebo-controlled study of 6-week lithium treatment in participants with bipolar disorder and mood instability, designed to develop a valid experimental medicine model for bipolar disorder.

The aim is to identify early clinical, neurocognitive and biological effects that may predict treatment response and inform drug development. The capacity to deliver this trial is an example of the CRF being central to the integration of both translational neuroscience and the clinical service, e.g. specialist scanning expertise and facilities are on site as is the Bipolar Disorder Research Clinic. OXLITH’s aim is to improve the understanding of

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underlying mechanisms in bipolar disorder and inform badly needed new drug treatments for mood stabilisation.

3.3.1.3 Stem cells for Biological Assays of Novel drugs and predictive toxicology, ( www.stembancc.org )

This is a high profile EU Innovative Medicines Initiative (IMI), biorepository cohort study. The aim of the project is to generate and characterize 1,500 human induced pluripotent stem (iPS) cell lines to improve the drug development process in neuropsychiatry and other disorders. StemBANCC partners include pharmaceutical companies (e.g. Roche, Merck, Eli Lilly, Pfizer, Astra Zeneca), research institutions and small and medium enterprises. The CRF has recruited and screened the Bipolar Cohort to target and are completing the follow up phase of the study.

3.3.1.4 Collaborative Oxford Network for Bipolar Research to Improve Outcomes (CONBRIO)

The cognitive neuroscience of mood instability. COMET ('Cognition and Mood Evolution across Time') aims to explore mood instability and cognitive function in individuals who show symptoms of mood disorder, and compares this to individuals without mood instability thereby identifying novel phenotypes. Mood instability and cognitive function is assessed using daily app-based tasks presented on an iPad, as well as MRI and MEG neuroimaging. “Wearable" technologies are used to capture activity patterns and physical state to better understand the underlying neurobiology and physiology of mood instability as well as identify potential treatment targets.

3.3.1.5 A clinical biomarker study of immunological phenotypes associated with monoaminergic anti-depressant response, and the brain and cognitive phenotypes associated with variation in peripheral C-reactive protein (CRP) levels, in patients with major depressive disorder (MDD)

This study (BIOdep) is designed to identify peripheral and central markers of neuroinflammation in depression and is a ‘Wellcome Trust Consortium for Neuroimmunology of Mood Disorders and Alzheimer’s Disease’ study a public-private partnership with collaborations between 7 academic and 4 industry partners (Janssen, Lundbeck, GSK, Pfizer) looking at the effect of inflammation on Alzheimer’s disease and treatment-resistant depression.

3.3.1.6 Investigating the physiological effects of tACS using TMS (transcranial magnetic stimulation)

This study investigates the physiological underpinnings of oscillatory activity in the brain, using TMS to probe excitatory and inhibitory activity, before, during and after driving oscillations at specific frequencies using transcranial alternating current stimulation (tACS). The work will not only allow us to understand more about the pathophysiological processes underlying abnormalities in a range of clinical conditions, the first step in developing treatment strategies, but will allow us also to explore the potential of driving oscillatory activity using tACS as a putative therapeutic intervention.

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3.3.1.7 Improving patient assessment after stroke: The Cambridge and Oxford Automated Screening Test (COAST).

COAST a collaboration with an SME OUNCE technology, aims to develop an automated screening test on a tablet platform, integrating the Oxford Cognitive Screen and the Cambridge cognitive battery BRIDGE.

3.3.1.8 Industry Funded Studies

Industry funded high intensity trials over the past year have been primarily in dementia research. They included A randomised, placebo-controlled, parallel-group, double-blind, efficacy and safety trial of MK-8931 in subjects with mild to moderate Alzheimer's disease. (EPOCH). MK-8931 is a BACE-1 inhibitor which aims to slow the progression of Alzheimer's Disease by reducing cerebral amyloid production, and therefore the formation of amyloid plaques, which are a key pathological marker of AD.

3.3.1.9 Psychological Studies

The psychological treatment research conducted on OxCADAT benefits from a close collaborative relationship with the AHSN Depression and Anxiety Network. This network oversees all of the Improving Access to Psychological Therapies services in the Thames Valley area (12 Clinical Commissioning Groups and treatment of over 30,000 patients per year). This ensures that the treatment developments that arise from OxCADAT’s research are rapidly disseminated in the local NHS with the outcomes that they achieve being closely monitored

3.3.2 Occupancy

The occupancy metrics reported in the 2015/16 NIHR annual return reflected a weighted average across the three sites which make up the Oxford Cognitive Health Clinical Research Facility. Data for the Warneford site is collected electronically with data for the non-Warneford sites collected annually via a manual process.

The 2015/16 occupancy of 62% reflected a 3% increase on the 59% reported for FY15.

The Warneford site is the largest element of the Facility and its occupancy during the period was 44% compared to 36% for the previous year.

3.3.3 Renewal of CRF funding

An application for the renewal and expansion of the CRf was submitted in June, with the outcome expected in September 2016 for funding to commence in April 2017. The objects of the bid were to sustain current activity and expand further into acute medical services via the Oxford University Hospital NHS FT, who host the funding.

3.3.3.1 Short-term objectives

To build further our capability in translational neuroscience, to support phase Ib-III trials of pharmacological and psychological interventions and, working in partnership, to create a seamless cross- Academic Health Science Centre ecosystem for clinical research in Oxford. A specific, overarching objective is to ensure that the CH-CRF is closely aligned with our plans for the £250 million UK Dementia Research Institute. We are expanding our capabilities at the John Radcliffe Hospital, to support more medically intensive

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experimental medicine studies in neuroscience. This development will also allow us to expand our clinical focus to include neurological conditions including multiple sclerosis, epilepsy, stroke and Parkinson’s Disease.

3.3.3.2 Medium-term objectives:

To realise plans for purpose built integrated and coordinated neuroscience research and clinical facilities across Oxford. We have initiated a joint University-NHS Masterplan to develop the Warneford as a Brain Health Centre for translational neuroscience. The Masterplan is driving our joint development, the first stage of which is the £4.5 million upgrade of the Oxford Centre for Human Brain Activity (opened April 2016). At the John Radcliffe Hospital, a key objective is to support medically intensive, including first-in-man studies.

3.3.3.3 Long-term objective

To deliver an efficient translational pipeline, fuelled by Oxford’s unrivalled scientific infrastructure and expertise, deploying the very best science to deliver new therapies for patients mental, cognitive and neurological disorders.

3.4 NIHR Biomedical Research Centre

Oxford Health NHS FT in partnership with the University of Oxford have been awarded £12.8 million for a new NIHR Oxford Health BRC dedicated to mental health and dementia. It is a great achievement to have succeeded in such a highly competitive process. The two organisations will work together to establish a new NIHR BRC, one of only two across the country dedicated to mental health and dementia.

NIHR Oxford Health BRC will build on the groundbreaking work here in Oxford, and provides wonderful opportunities to deliver on our promise to develop fundamentally new treatments for mental disorders and dementia.

The strategy outlined in the application was to bring the best science to the complex problems facing research into mental disorders and dementia with the aim to use digital and other new technologies to produce scalable solutions with global application and transform our discovery science into new treatments and diagnostic tools, delivering precision care that is strongly informed by patient involvement, ethical and economic consideration.

3.4.1.1 Overarching short – term objectives

Establish the Oxford Health NIHR BRC with effective management structure and cross-theme collaboration, ensuring that infrastructure is developed to facilitate conduct of externally funded research.

Deliver a fully developed Patient & Public Involvement strategy

Establish an effective clinical interface for the BRC between basic research and clinical care

3.4.1.2 Long Term Objectives

Deliver high level of leveraged funding and value for money from NIHR investment

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Provide demonstrable and effective translation of basic science into benefits for patients

Realise our vision of a Brain Health Centre on the Warneford site

Transform research in psychiatry by incorporating the full potential of biomedical concepts and advances

3.5 NIHR Clinical Research Network (CRN)

The NIHR CRN provide the Trust with funding for key positions within the Trust in addition to supporting a variety of research delivery staff employed within the organisations. The primary focus of the CRN is the support of research delivery for NIHR portfolio studies. Within Oxford Health NHS FT it remians to be integral part of the dementia and mental health research portfolio as part of Division 4, which is thriving within the trust and continues to grow in terms of study numbers, variety and complexity.

There is already a wide variety of adult mental health portfolio studies running in OHFT and a number of dementia studies but areas that are being considered for growth are in Early Intervention and Childrens and Young Persons services, with additional resources being invested. The joint investment by the trust and the CRN the clinical teams research assistant posts has proved to be a success, and has enabled key recruitment support on a variety of studies, never before experienced. This has been rewarded by being shortlisted for a prestigious Health Service Journal award for work on enabling more patients to take part in vital research into mental health, an area which has until now seen fewer take this opportunity. Mental health problems account for over a quarter of all illness nationally (28%), but where services are less well funded (18% of NHS spending) and mental health research gets just 5.5% of total UK health research spending.

Additional areas for growth for dementia studies remain in repurposing drugs, for use in Alzheimer's, and a focus on improving the lives of carers of people with dementia, as well as phase 2 studies of novel drugs for dementia management and prevention.

It is also hoped that the CRN can aid in the development and support of non-mental health research within the services provided within the older adult directorate within the Trust.

Work is also taking place to investigate the potential of a single finance model for the use across the Thames Valley for the costing of commercial research to help support NHS organisations with fewer studies and less experience.

4 Research Governance 4.1 R&D Governance Group

The R&D Governance group is established with a member of each of the clinical directorates now identified and attending quarterly meetings. The Group serves primarily as an assurance group to review research ongoing within the Trust. The Terms of Reference and membership is due to be reviewed within the next few months to take into account the new meetings structures within R&D. Attendance and representation from all members has been inconsistent and discussions are ongoing as how to increase involvement going forward and how the research governance structure will develop pending successful NIHR infrastructure awards.

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OHFT are working closely with the Joint Research Office (OUH and UO) to streamline processes and working practices across the organisations.

A summary paper of the R&D Governance Group meetings and research in general are submitted to the Quality Sub Committee: Effectiveness

4.2 Contract Review Processes

An agreement between OHFT and OUH to undertake the review of non-standard or modified contracts from a legal perspective to ensure the Trust obligations are appropriate is ongoing and working effectively.

4.2.1 Expressions of Interest

The Trust regularly receives requests to ascertain whether it is interested or has the potential capacity or clinical service to deliver a research project. Once completed the sponsor will determine whether they want to pursue the setting up of the study within the Trust and will conduct a site visit to review facilities etc. Once the sponsor has satisfied their requirements it may lead to the set up and conduct of the study within the Trust.

1st April 2015 to 31st March 2016

1st April 2016 to date

Number of Expressions of interest 101 44

Number of Expressions of interest that led to study set up

67 6

4.2.2 Pipeline Meetings

Routine Pipeline meetings have been suspended and replaced by a similar more comprehensive process for assessing capacity and capability of research taking place within the Trust. It is determined by means of specific directorate and finance authorization for all studies. If the study is a clinical trial involving drugs feasibility will also be assessed by the CRF Clinical Lead, Division 4 Research Delivery Manager and the NIHR Mental Health Lead, TV&SMCRN.

4.2.3 HRA

The approvals process for research to commence in the NHS in England has changed.

NHS permission is now provided by a Non Department Public Body called, Health Research Authority (HRA), which replaces the local R&D approval process whereby NHS permission is granted by individual Trusts. This process applies to all NHS research led from England (there is a slightly different process for NHS research led from other areas of the UK – please check the HRA website if this applies to your research project).

The new HRA process has not been without its issues and has taken some time to bed in and for Trusts to fully understand the implications and to develop new systems to accommodate this new process. The HRA has been inundated with requests for approvals and has acknowledged a large backlog of studies that are yet to be processed.

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In terms of the R&D office processes we would expect Sponsors to provide a completed Statement of Activity (SoA) form at the earliest opportunity to the R&D office.

The R&D team will then conduct a feasibility assessment ahead of HRA approval being issued. Once HRA approval is in place the R&D office will issue a letter confirming capacity and capability. In addition the Trust will provide the sponsor with a pdf copy of the agreed SoA form, which will form an agreement between the Trust and the sponsor for the research project ahead of the research commencing. The SoA form should be the same version as that listed in the HRA approval letter.

If the sponsor requires a more formal contract to be in place then the sponsor should forward a copy of the agreement to the R&D office at the earliest opportunity. The Trust will expect sponsors to use the standard commercial and non-commercial model agreements to be used where appropriate. A full costing template will need to be completed and provided at the same time to enable the contract and costing review to commence ahead of HRA approval. Once the contract is fully executed the Trust will issue a formal letter confirming capacity and capability ahead of the research commencing.

The R&D team will work with researchers and sponsors to ensure a swift process of confirming the Trust’s capacity and capability to deliver the study to time and target. We will require that authorisation has been obtained from the appropriate Service Director, responsible for the Directorate where the research activity will take place before Trust Management Approval is provided to the research team.

4.2.4 R&D Data Capture

Oxford University Hospitals NHS FT, supported by the NIHR CRN, developed the Research Portfolio Management System (RPMS), a database capable of monitoring the lifecycle and recruitment of a research study. The RPMS runs on the OXNET server, a secure NHS server system. The database is fully functional and being used to its full potential to provide reports and data on research activity, including recruitment, to ensure a more robust and accurate understanding of research activity taking place within the Trust. The database is due to be upgraded in the coming year and the expectation is that the new and improved database will enable more data to be captured than the current system allows.

4.2.5 Monitoring and Auditing of research projects

Progress, although slow is being made on the monitoring and auditing of research projects, hosted and sponsored by the Trust, with staff members booked onto training courses during October. This will be followed up with in house supervision and competency reviews to ensure appropriate compliance and high standards.

4.2.6 Safety committee

It was agreed by the Governance Group that an initial review of all SAEs provided to the Trust involving Trust participants would be undertaken by the Research Governance Manager and the Lead Research Pharmacist. The SAE reports will be assessed for trends and potential areas of concern and will be presented to the Governance Group for discussion and decision making if deemed necessary. The Trust’s Ulysses system has been modified to include elements of research and will also be a source of information on

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patient safety as the Trust policy is to provide details on serious adverse events involving Trust patients onto the Trust’s patient records to maintain safety oversight.

5 Studies and Participant Recruitment 5.1 Studies

The number of research studies ongoing within the Trust at the end of July 2016 was 104, 63 of which are adopted onto the NIHR portfolio. The graph below shows the increase in the number of portfolio studies over the last six years

5.2 Participant Recruitment

The figure below shows the number of participants recruited to research studies over the past six years. The NIHR publishes league tables on an annual basis and these appear different to the figures collected internally due to reporting differences and potential lag time. Currently the number of participants recruited to NIHR portfolio studies for the first five months of 2016/2016 is 1187 into NIHR portfolio studies and 295 participants into non portfolio studies.

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2010 2011 2012 2013 2014 2015 20160

500

1000

1500

2000

2500

3000

3500

NIHR portfolioNon NIHR PortfolioNIHR league data

5.3 Grant Applications and Awards

Since November 2014 the Trust has been involved in 64 grant applications of various sizes including the BRC and CRF, Trust led and sub-contracted applications and fellowships for individual members of staff. The source of these applications is outlined in the table below.

Source of Applications FY15 (5 months) FY16 (12mths) FY17 (4mths) TotalOxford Health 6 10 6 22Department of Primary Care 2 3 1 6Department of Psychiatry 5 9 - 14Oxford Brookes - 1 - 1University of Reading - 1 - 1Oxford Health sub-contracted 2 11 7 21Total 15 35 14 65

The outcome of these applications is shown in the table below:

Outcome of Applications FY15 (5 months) FY16 (12mths) FY17 (4mths) TotalAwarded 1 10 1 12Unsuccessful 14 19 3 36Withdrawn - 5 - 5Submitted (outcome unknown) - 1 3 4Work-in-progress - - 5 6On-Hold - - 2 2Total 15 35 14 65

During the last 21 months 12 grant applications were successful. In FY16 we were advised of 9 of these and in FY17 3. The destination of the funding for these applications is Trust & and the Department of Psychiatry (10) £911k and the Department of Primary Care (2) £5.1m

The funding will be received from The Health Foundation (£150k), Chief Scientific Officer of Scotland (£34k), NIHR (£5,078k), OSRC (£1.5k) and the remaining £725k will be via sub-contracts from other organsiations

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5.4 NIHR Metrics and Targets

NHS organisations are expected to provide the NIHR with quarterly Performance Initiation and Delivery (PID) reports, detailing the number of studies that recruit the first participant into a clinical trial within 70 days of the organisation receiving a valid research application and the number of studies recruiting the expected number of participants (time to target). The last quarter where data is available (Q4 2015/2016) demonstrates a consistent approach to meeting the 70 day target, where 10 studies were set up during the quarter. During the same period two studies closed, one of which met the recruitment target.

There is an expectation that these metrics will continue under the HRA processes, although receipt of a full research document set is not as easy to capture to changes in HRA process.

Q3 2013/14

Q4 2013/14

Q1 2014/15

Q2 2014/15

Q3 2014/15

Q4 2014/15

Q1 2015/16

Q2 2015/16

Q3 2015/16

Q4 2015/16

0

20

40

60

80

100

120

Initiating (70 day target) Delivering (time to target)

Perc

enta

ge m

eetin

g ta

rget

6 Pharmacy The trust pharmacy team provides a wide variety of research support for clinicians in the trust and in the university. The pharmacy research team comprises of 1 ½ WTE pharmacists and a part time pharmacy technician. On a daily basis this team manages the clinical trials medicines in the dispensary ensuring that they are handled according to Good Clinical Practice standards. They support monitoring and inspection visits by new and current research teams and complete regular audit and training cycles to ensure standards are upheld. They review and develop trust and departmental policies and procedures relating to clinical trial medicines management. The lead research pharmacist works closely with trust and university based research clinicians who are developing trials involving medicines and provides advise on a wide range of medicines governance issues, including ethical and legal restrictions and drug handling requirements for GCP, guidance on medicines distribution in keeping with GDP (good distribution practice) and issues relating to medicines preparation and manufacture in keeping with GMP (Good Manufacturing Practice). The team provides regularly reviews and comments on protocols and grant applications as they are developed and advises on a variety of medicines and pharmacy related costs for researchers submitting grant applications. On behalf of

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researchers, the lead research pharmacist liaises with national and international manufacturers, and with national and local medicines distributers and with other trust pharmacy departments or national advisory bodies where required in addition to advising the university ethics committee (CUREC) on medicines issues in research applications. She also advises the trust research governance group on medicines safety issues, and supports the pharmacy and research teams to appropriately report incidents involving clinical trials and medicines. The pharmacy department has developed links with Reading and Bath University and through these connections supports colleagues and university researchers to undertake pharmacy practice research for the benefit of the trust and its clients.

7 Case Records Interactive Search (CRIS) CRIS oversight group meetings are attended monthly to discuss submitted applications and monitor the audit of CRIS searches. The group is chaired by the Medical Director and Caldicott Guardian and is attended by the CRIS Coordinator, Director of IT, Head of Information Governance, Head of R&D, two Carer/patient representatives, representatives from the trust Clinical Directorates, Trust Audit Team and University.

To date 6 applications have been approved by the Oversight Group, five of which are research questions and one service evaluation question. CRIS users currently have access to a static data set from five years of Rio electronic health records and testing has now started on UK CRIS which will move to a live data set via CareNote and also offer opportunities for federated searches with the participating UK CRIS Trusts. The planned live date for UK CRIS is 30th September 2016.

The CRIS coordinator (Tanya Smith) is currently working closely with researchers, Trust clinicians and the clinical audit team to further promote CRIS. She will be running two workshops at the Annual Medical Staffing Conference on 5th October 2016 at Sudbury House Hotel in Faringdon to provide an overview of CRIS to encourage further applications.

Work is also on-going to establish a natural language processing (NLP) facility. This will provide the researchers with an automatic text reading facility for extracting relevant data from the free text fields within CRIS. Data processing agreements are being drawn up with the potential collaborators at Wolverhampton and Manchester University who hope to provide the expertise in utilising our CRIS data using NLP software.

Consent for Contact is in progress, awaiting CareNotes to be updated so that this information can be captured, in accordance with the CRIS ethics application. The clinical teams will then be contacted regarding this process.

8 Finance The Trust receives research funding from various commercial and non-commercial sources. These funding streams are outlined in the table below along with the amounts reflected the FY17 budget.

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The NIHR, Department of Health and CRN require the completion of detailed quarterly and annual returns to ensure all funding is used appropriately and within the year awarded. Any unused funding would need to be returned to the relevant funding organisation.

8.1 FY17 Performance

At the end of period 5 the R&D performance is broadly in line with budget and it is expected to meet its budgeted £72k contribution to overheads target this financial year.

8.2 Research Capability Funding (RCF)

Research active NHS organisations receive RCF to enable them to meet some, or all, of the research-related component of the salary of their researchers and research support staff working on clinical and applied health research, where that component is not already provided by another funding source.

The annual RCF allocation combines a percentage of the NIHR funding received in the previous calendar year with an allowance for each Senior Investigator associated with Trust.

8.3 FY17 RCF Allocation

The FY17 RCF allocation is £1.045m which is a reduction of £0.365m on FY16 as detailed below:

Reduced study related RCF (£366k) Less study income (£359k), reduced NIHR rate (£7k)Increased Infrastructure related RCF £151k More infrastructure income £178k, reduced NIHR rate (£27k)Reduced Senior Investigator RCF (£150k) Net reduction of two investigators at £75k eachTotal (£365k)

The Trust splits its RCF income between that earned by the Trust and Department of Psychiatry and that from the Department of Primary Care, the breakdown and year on year movements are shown in the table below:

FY17 Department of Psychiatry \ Trust (including CLAHRC)

Department of Primary Care Total

Senior Investigators (SI) Keith Hawton, Guy Goodwin, John Sue Ziebland, David Mant,

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Type FY17National Institute for Health ResearchStudy income Department of Psychiatry & Trust -Study income Department of Primary Care 604Clinical Research Facility via OUH 717CLAHRC 2,000RCF - Department of Psychiatry \ Trust \ CLAHRC 741RCF - Department of Primary Care 304NIHR Final Payments 180Total 4,546OtherTVCLRN \ CRN 1,204CRF (non-NIHR Income) 79Health Foundation 109Sub-contracted grants 224Dendron related 177Total 6,339

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Geddes, Mike Sharpe Trisha Greenhalgh, Andrew Farmer

SI related RCF (£75k) £0.300m £0.300m £0.600mStudy funding £0.284m -

Study related RCF £0.095m - £0.095mInfrastructure funding - CLAHRC

DEC£2.0m

£0.271mInfrastructure related RCF £0.308m £0.042m £0.350mStrategic contribution £0.037m (£0.037m) -Total £0.740m £0.305m £1,045mFY16 £1,115m £0.295m £1,410mIncrease \ (Decrease) on FY16 (£0.375m) £0.010m (£0.365m)

8.4 Clinical Research Facility (CRF)

The NIHR CRF encompasses activities taking place at the Department of Experimental Psychology (OxCADAT and OxCNC) and the Charles Wolfson Clinical Neuroscience Facility at the John Radcliffe Hospital as well as those on the Warneford site. The Warneford site CRF operates as one unit containing eight clinical rooms, pharmacy area, meeting room and associated office space although it is funded from a combination of NIHR and non-NIHR sources as detail below.

FY17 BudgetExpenditure (901)NIHR Funding (funding in place until Mar 2017) 717CRN: TV SM annual funding 98Research Capability Funding (RCF) 84Total Non-NIHR income 76Total Income 975Contribution to overheads 74Margin after CRF accommodation and Finance support 8%

The CRN: TV SM has reduced the CRF funding from last years £204k to £98k in FY17 as a result some staff have had to be funded from RCF.

The table below details the research income received from non-NIHR studies taking place within the CRF at the end of Period 5.

8.5 Clinical Research Network: Thames Valley and South Midlands (CRN)

The budgeted FY17 funding from the CRN is £1,242k and is detailed in the table below:

Division Specialty FY17 Budget (£k)Division 4 Mental Health 461

Dendron and Neurological disorders (Dendron) 137Division-wide (Division 4) 200

Division 5 Primary Care and Ageing 344Cross-Divisional 62

Total 1,204

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8.6 Financial Risks and Issues

8.6.1 R&D Income Summary FY17/8

The level of research funding is predicted to drop by £890k between FY17 and FY18. The significant reductions are due to the Clinical Research Facility funding coming to an end (re-applied)(£717k), no NIHR Final Payments due next year (£180k) and reduced Department of Psychiatry\Trust CLAHRC RCF (£310k) following the completion of all NIHR studies. The lower RCF will reduce the Trusts flexibility and ability to potentially pump-prime certain areas of research.

Note: CRN & Commercial, NIHR sub-contracted and other income is assumed to remain constant but will be reviewed in detail as part of the FY18 budget process.

8.7 Redundancy Costs

Where staff are funded from time limited awards there is a potential redundancy risk. This has always been monitored along with HR to identify and mitigate the risk on a case-by-case basis, however at this point in time the big uncertainty is the outcome of the CRF renewal application. If this is unsuccessful it will result in the loss of funding for a large number of staff. The Trust is also contracted to delivering a number of studies using these resources.

The CRN reduced their level of funding for CRF staff this financial year and are looking to review their funding for the Trust R&D Governance Team and pharmacy support. The Head of R&D Finance and the Head of R&D have been requesting regular meetings with the CRN Chief Operating Officer to clarify the CRNs plans and a meeting will hopefully take place in September. Again this could have an impact on staff funding.

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Type FY17 FY18 ChangeNational Institute for Health ResearchStudy income Department of Psychiatry & Trust -Study income Department of Primary Care 604 1,015 411Clinical Research Facility via OUH 717 - (717)CLAHRC 2,000 2,000 -RCF - Department of Psychiatry \ Trust \ CLAHRC 741 575 (175)RCF - Department of Primary Care 304 366 (134)NIHR Final Payments 180 - (180)Total 4,546 3,956 (590)OtherTVCLRN \ CRN 1,204 1,204 -CRF 79 79 -Health Foundation 109 - (109)Sub-contracted grants 224 70 (154)Dendron related 177 140 (37)Total 6,339 5,449 (890)

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8.8 Collaboration in Leadership in Applied Health Research and Care (CLAHRC)

In January 2014 the Trust began receiving funding from the NIHR in relation to the CLAHRC which is led by Professor Richard Hobbs from the University of Oxford, Department of Primary Care.

8.8.1 CLAHRC Budgets

The approval and release of CLAHRC theme budgets has been undertaking in two phases. Phase 1 was in late 2014 for the first 2 ¼ years and phase 2 in late 2015 following the planned mid-term review for the remaining 2 ¾ years. The two phase budgets are listed below:

Phase 1 Budgets Theme Lead FY14 (3 mths) FY15 FY16Better Management of Psychiatric comorbidities

Mike Sharpe 14 161 370

Health Behavior and Behavioral Interventions

Sarah Lamb 38 168 336

Early Intervention and Service Innovation

John Geddes 16 144 318

Patient Self-Management (Chronic Disease)

Richard McManus

46 226 380

Patient experience and PROMS Ray Fitzpatrick 55 187 346Central and Support Costs Richard Hobbs 81 364 250Total 250 1,250 2,000

Phase 2 Budgets Theme Lead FY17 FY18 FY19 (9 months)

Total

Service redesign Belinda Lennox

312 135 104 551

Behavior change – exercise and rehab Sarah Lamb 267 248 160 677PROMS Ray Fitzpatrick 191 229 182 601Multi-morbidity Mike Sharpe 123 118 101 342Patient self-management Richard

McManus362 356 175 893

Behavior change – weight and obesity Susan Jepp 268 217 155 641Central and Support Costs Richard Hobbs 477 697 623 1,795Total 2,000 2,000 1,500 5,500

Phase 2 Project Budgets FY17 FY18 FY19 TotalClinical Decision Making in Ambulatory Care; 3

4 3

5 29 97

Risk stratification in heart failure prevention strategies 102

102

Preventing falls and fragility fractures 47

50

39 136

Self-directed and supervised exercise treatments for rheumatoid arthritis. (SARAH)

63

70

58 191

Implementation of improved pathways of care for sub-acute and 9 7 25 197

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chronic low back pain (iBeST) 4 8Implementing evidence from patient experience and reported outcomes

141

179

144 464

Implementing a new evidence-based depression management programme for patients with cancer

73

68

64 205

CollabOrative Care Model for Bipolar DisOrder (COMBO) 86

79

165

OPtimising Treatment for Mild Systolic hypertension in the Elderly 156

171

52 379

OPTIMUM-BP 70

56

86 212

Breath acetone trial 101

97

79 277

Meal replacements for weight management 52

52

Self-weighing 42

31

9 83

PC-SHOP study 43

59

44 147

8.8.2 Performance

The actual expenditure will be in line with budget at year end.

8.8.2.1 Matched Funding

A fundamental requirement of the CLAHRC is the need to demonstrate matched funding committed by other organisations which is linked to CLAHRC activities. In total this needs to be at least to the same level as the NIHR funding. Matched funding provides resources to support the proposed themes of research, implementation or a mix of both. Based on current information the amounts identified to date are shown in the table below along with the minimum required by the NIHR and the amounts included in the application:

Matched Funding (£k) 2016/17 2017/18 2018/19 Total

Matched Funding identified 1,677 961 658 3,296

Minimum required by the NIHR 2,000 2,000 1,500 5,500

Included within the application 2,078 2,075 1,606 5,759

Identification of Matched funding is an on-going process involving the CLAHRC Manager and the Head of R&D Finance and following the mid-term review and the inclusion of the new projects a larger piece of work needs to take place to revise the current data (by Oct 2016). There are number of projects in set-up which will attract large amounts of matched funding and are confident that the required amounts will be achieved.

8.9 Oxford Academic Health Science Network (OAHSN)

Oxford Health is hosting three of the 9 OAHSN Clinical Networks. These are Dementia; Early Intervention in Mental Health; and Anxiety and Depression (detailed below).

Network Lead Total Award End Date

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Dementia Dr Rupert McShane

Total £536k£336k up to 31 March 16Additional £200k has been agreed to fund the network until March 18

March 2018

Early Intervention in MH Prof Belinda Lennox

Total £433k£210k up to 31 March 16Additional £211k has been agreed to fund the network until March 18

March 2018

Anxiety & Depression Prof David Clark

Total £490k£220k up until March 16Additional £259k has been agreed to fund the network until March 18

March 2018

The OASHN is seen as a clinical development rather than research and is reported separately in the finance report to the Board. The three networks hosted by the Trust are budgeted and forecast to breakeven

8.10 External Finance Activities

The Head of R&D Finance works with the CRF providing links between the NIHR, CRF, OUH, OHFT and the University of Oxford (UO) and plays a key role in supporting the financial aspects of grant applications and occupancy calculation across the four CRF sites. He is a member of the NIHR CRN: Thames Valley and South Midlands working group which is developing a single costing process for commercial studies making the region more attractive to industry by providing a single point of contact, reducing duplication of effort on cost negotiations and simplifying the addition of supplementary sites.

The Head of R&D Finance presented “The role of research and development in reducing waste and ensuring high value care” at the 2016 NHS R&D Forum with colleagues from NHS England and NIHR which supports the NIHR’s Adding Value in Research framework and he is also a member of the Healthcare Financial Management Association (HFMA), Healthcare Costing for Value Institutes Research and Development Costing Group whose aims include developing a standardised national approach to Research and Development costing.

9 Estates R&D occupy office space near the McInnes which accommodate the R&D governance team, finance, pharmacy, CRIS co-ordinator and researchers when required. Additional space is now occupied by CRN delivery staff including Division 4 and the research assistants. This co-localisation of teams has helped to foster closer working relationship and resolve queries quickly and easily.

10 Staffing In July 2016 the R&D department welcomes, Dr Cathy Henshall. This is an exciting opportunity for the Trust and Brookes University who have jointed funded this new post to support to provide clinical support for the research nursing staff in the CRF and nursing research across the organisations in the development of new studies.

The Research Governance Coordinator has been replaced by two part time members of staff, Mel Brookings and Francesca Hatton following the resignation of the Jana

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Safarikova, who joined the research assistance teams within the Trust. Mrs Brookings has been promoted from within the department and Mrs Hatton has a wealth of experience in a similar role at the Oxford University Hospitals.

The Senior Research Assistant, Ms Leah Marrimer has resigned to take up a Clinical Psychology Doctorate programme at Birmingham University. Claudia Hurducas, a research assistant working within the team has been promoted to take on the more senior role.

11 Communications Since January 2016, work has continued to refine the new R&D website; keeping information up to date for researchers using the ‘Researcher’s Toolkit’ resource, and for the broader public – introducing new features such as latest news stories auto-updating on the homepage. This has meant the homepage remains fresh and reflects the latest developments in Oxford Health R&D.

Work continues in developing a section on the site where all studies connected with Oxford Health can be displayed, therefore providing an opportunity to showcase the variety of studies that Oxford Health NHS FT supports, and offer the public more opportunities to get involved in research. An online form will be available for researchers to complete, and the information will be displayed in a digested form, with useful categories – such as theme, age range, and population – for the public to scan.

R&D Communications led the project to produce five minute films to support the Oxford Health NIHR BRC application and the NIHR CRF reapplication. An independent production company, HobsonCurtis, was commissioned to produce the films to tight briefs and within budget. Both films stressed the close links between the Trust and the University, and the mutually beneficial relationship of having world-class facilities and resources within a mental health trust. The role of John Geddes in advocating for this connection was key, and R&D / Department of Psychiatry Communications Officer’s dual role between Trust and University was optimised in this process.

The group who presented to the panel at the NIHR interviews in July felt that the film gave a compelling introduction to their presentation, and Stuart Bell CBE, Chief Executive of Oxford Health, is delighted with the results, and has requested a re-edited version, suitable for promotion on the Trust’s website and through social media. Work is continuing with this.

There have been a number of awards for researchers linked to Oxford Health NHFT that have been reported on the news section of the R&D website, one of which was picked up and reported by the Oxford Mail.

http://www.oxfordhealth.nhs.uk/news/oxford-health-consultant-psychiatrist-wins-prestigious-prize/

http://www.oxfordmail.co.uk/news/news_bites/14648584.Doctor_and_Oxford_University_researcher_awarded_for_research_on_emotional_disorders/

Oxford Health NHS FT had a strong presence at the Oxford BRC (hosted by OUH) Open Day on 21 April, which R&D helped to co-ordinate:

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[PUBLIC ]

http://www.oxfordhealth.nhs.uk/news/oxford-health-brc-open-day/

There is a continued and growing relationship between R&D Communications and the central Oxford Health NHS FT Communication Team, with devoted resources allocated to promoting research activity within the Trust. The appointment of a fulltime Communications Officer with a research background has greatly enhanced the potential to promote research at Oxford Health NHS FT, in co-ordination with R&D Communications.

Examples of this increased collaboration has enabled increased national and international dissemination of the work that is undertaken, including interviews with Professor Daniel Freeman, clinical psychologist at Oxford Health NHS Foundation Trust regarding the work being carried out using virtual reality to help treat paranoia, which had involved patients attending treatment services at Oxford Health NHS Foundation Trust.

The press release, co-ordinated with the MRC, Oxford Health Communications and Department of Psychiatry Communications, stimulated a huge amount of press interest with TV reports on the BBC and radio reports on BBC Radio 4’s The Today programme, plus widespread newspaper and magazine coverage.

TV: Victoria Derbyshire, BBC 2, 05/05/2016, 10:20 (Around 1:19 on the clock) Interview with Professor Freeman.

Radio: Today, BBC Radio 4, 05/05/2016, 08:44 (Around 2:45 on the clock)Interview with Professor Freeman.

Radio: Newsday, BBC World Service, 05/05/2016, 07:15 (Around 8:12 on the clock)Professor Freeman is interviewed.

Wired UK, 05/05/2016 "The patients had tried standard treatments, like medication, but still had strong paranoia," Daniel Freeman told WIRED.

The Guardian online, 05/05/2016, Virtual reality isn't just for gaming - it could transform mental health treatment Professor Daniel Freeman writes about his research into the use of virtual reality in the treatment of paranoia.

International Business Times, 05/05/2016: Virtual Reality Can Help Treat Severe Paranoia And Phobias, Oxford Study Says

The Independent, 05/05/2016: Virtual reality can treat severe paranoia, says groundbreaking study

Authors and Title: Professor John Geddes, Emma Stratful & Dr Clive Meux

Lead Executive Director: Dr Mark Hancock

1. A risk assessment has been undertaken around the legal issues that this paper presents and there are no issues that need to be referred to the Trust Solicitors.

2. This paper (including all appendices) has been assessed against the Freedom of Information Act and the following applies:

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http://www.bbc.co.uk/iplayer/episode/b079cbcw/victoria-derbyshire-05052016



http://www.independent.co.uk/news/science/virtual-reality-can-treat-severe-paranoia-says-groundbreaking-study-a7014906.html

http://www.independent.co.uk/news/science/virtual-reality-can-treat-severe-paranoia-says-groundbreaking-study-a7014906.html

http://www.ibtimes.co.uk/virtual-reality-can-help-treat-severe-paranoia-phobias-oxford-study-says-1558357

http://www.ibtimes.co.uk/virtual-reality-can-help-treat-severe-paranoia-phobias-oxford-study-says-1558357

https://www.theguardian.com/science/blog/2016/may/05/virtual-reality-isnt-just-for-gaming-it-could-transform-mental-health-treatment

https://www.theguardian.com/science/blog/2016/may/05/virtual-reality-isnt-just-for-gaming-it-could-transform-mental-health-treatment

http://www.wired.co.uk/news/archive/2016-05/05/vr-paranoia-experience/viewgallery/629073

http://www.bbc.co.uk/programmes/p03sfrkb

http://www.bbc.co.uk/programmes/b078zcrp

http://www.oxfordhealth.nhs.uk/news/oxford-health-brc-open-day/

[PUBLIC ]

THIS PAPER MAY BE PUBLISHED UNDER FOI

3. This paper provides assurance and evidence against various Care Quality Commission Outcomes

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