Introduction - Oxford Health NHS FTOxford Health NHS ...€¦ · Web viewThe last six months has...

PUBLIC – NOT TO BE REMOVED UNTIL END OF BOARD MEETING

Report to the Meeting of theOxford Health NHS Foundation Trust

Board of Directors

25 September 2019

Research and Development Report

For information

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BOD 96/2019(Agenda item: 17)


Executive Summary

The last six months has seen the submission of the year two National Institute of Health Research (NIHR) Oxford Health Biomedical Research Centre (BRC) annual report based on the full level of funding (year one was only 50%) and an additional £1m in relation to UK-CRIS. Work to establish a Brain Health Centre (BHC) was one of its key deliverables and a new BRC Manager joins in October 2019.

CRIStal Health Limited was incorporated as an Oxford University spinout with external investment and NIHR approval.

The NIHR Clinical Research Facility (CRF) continues as both an NIHR award in its own right and as the physical infrastructure “heart” of the BRC at the Warneford. Prof. Andrea Cipriani has been appointed as acting CRF Director until a substantive appointment.

The Oxford NIHR Collaboration in Leadership in Applied Health Research and Care (CLAHRC) led by Professor Richard Hobbs comes to an end in September 2019 but this will be replaced by an Applied Research Collaboratives (ARCs) award which commences in October 2019 (£9m over five years)

The NIHR Community Healthcare MedTech and IVD Co-operative (MIC) is continuing to make progress against its objectives

The Research Management Group is proving a value asset in steering the strategic and scientific direction of research undertaken within OHFT and its partners by bringing together key stakeholders from the various NIHR infrastructures, AHSC, AHSN, University of Oxford, Oxford Brookes University and the clinical services

The Trust continues to provide robust research support to enable researcher to conduct studies within OHFT, with regular pipeline meetings to establish feasibility for each study taking into consideration scientific and strategic importance to patients, the organisations and its partners.

R&D reported a contribution to overheads of £79k for FY19, compared to budgeted expenditure of £129k, generating a £208k Favourable Variance.

OHFT continues to support the Oxford Academic Health Science Network with developments in Mental Health

Governance Route/Approval Process

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The report is a biannual update report to the Board for Research and Development taking place or being hosted within the Trust and is for information

Statutory or Regulatory responsibilitiesResearch and Development is aligned to its regulatory responsibilities in undertaking research and is compliant with contractual obligations

RecommendationThe Board is asked to note the report.

Author and Title: Bill Wells and John Geddes Lead Executive Director: Mark Hancock

1. Strategic Objectives – this report relates to or provides assurance and evidence against the following Strategic Objective(s) of the Trust:

3) Delivering Innovation, Learning and Teaching(Goals: the impact of the AHSN, AHSC and CLAHRC will be maximised; we will collaborate in research and innovation; and we will deliver high quality teaching)

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Introduction......................................................................................................................................................7

1 Networks and Collaborations...................................................................................................................7

1.1 Oxford Academic Health Science Network (OAHSN)........................................................................7

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

1.1 Oxford Institute of Nursing, Midwifery and Allied Health Research.................................................9

2 National Institute of Health Research Infrastructure.............................................................................13

2.1 NIHR Oxford cognitive health Clinical Research Facility (CRF)........................................................13

2.2 NIHR Biomedical Research Centre (BRC)........................................................................................16

2.3 NIHR Collaboration in Leadership in Applied Health Research and Care (CLAHRC)........................27

2.4 NIHR Applied Research Collaboration Oxford and Thames Valley (OTV ARC).................................28

2.5 NIHR MedTech and In Vitro Diagnostic Co-operatives (MIC)..........................................................28

2.6 NIHR Clinical Research Network (CRN) based performance...........................................................30

3 Research Set Up, Management and Governance...................................................................................31

3.1 Research Set Up..............................................................................................................................31

3.2 Case Records Interactive Search (CRIS) (Lead: Tanya Smith)..........................................................32

3.3 Consent to discuss participation in research (Lead Professor Andrea Cipriani)..............................33

4 Trust Governance and Reporting Mechanisms......................................................................................36

4.1 Reporting and Governance.............................................................................................................36

5 Finance...................................................................................................................................................36

5.1 Research Income............................................................................................................................36

5.2 FY20 Income Budget.......................................................................................................................37

5.3 Performance...................................................................................................................................38

5.4 Biomedical Research Centre (BRC).................................................................................................38

5.5 Collaboration in Leadership in Applied Health Research & Care (CLAHRC)....................................38

5.6 Applied Research Collaborations (ARC)..........................................................................................38

5.7 Research Capability Funding (RCF)..................................................................................................38

5.8 Clinical Research Facility (CRF)........................................................................................................39

5.9 I4I....................................................................................................................................................39

5.10 Medtech and In vitro diagnostic Co-operative (MIC)......................................................................39

5.11 Clinical Research Network: Thames Valley and South Midlands (CRN)...........................................39

5.12 Grant Income..................................................................................................................................39

5.13 Study Delivery.................................................................................................................................40

5.14 Oxford Academic Health Science Network (OAHSN)......................................................................40

Infrastructure Funding Timeframes...........................................................................................................40

6 Communications....................................................................................................................................41

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7 Intellectual Property Management........................................................................................................41

8 Staffing...................................................................................................................................................42

9 Estates...................................................................................................................................................42

10 Staff Survey............................................................................................................................................42

Introduction Participation in research produces widespread benefits for patients and, more generally, improvements in quality of care. Oxford Health NHS FT is a leading research-active mental and community trust has strong

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strategic research links both to the University of Oxford, which is the top-rated University in the THE World University Rankings and Oxford Brookes University.

1 Networks and Collaborations

1.1 Oxford Academic Health Science Network (OAHSN)

Oxford AHSN works to ensure that mental health has a significant focus in its work. Below we highlight mental health work that is either hosted within OHFT or of relevance to the trust.

Oxford AHSN Anxiety and Depression (A&D) Network

The A&D Network is hosted by OHFT. Professor David Clark is Clinical Lead, Ineke Wolsey is the Network Manager and all IAPT (Improving Access to Psychological Therapies) services across Thames Valley and Milton Keynes are active members. The overarching objective of the network is to continuously improve patient outcomes, working very closely with its active Patient Forum. Building on the last report to the Board, when much detail was provided on various projects that the Anxiety and Depression Network is driving forward, this report will provide an update on some of the most recently initiated projects, all of which have a strong focus on relapse prevention/ staying well after patients have been discharged.

A new step 2 (Guided Self-help) Staying Well protocol: This work has progressed greatly in the past 10 months and all services across Thames Valley and Milton Keynes will start introducing a much improved, new protocol focused on supporting patients to stay well after step 2 IAPT treatment ends. This new, evidence-based protocol will guide step 2 therapists (Psychological Wellbeing Practitioners) in working with their patients from early on in treatment to promote and plan self-management strategies for looking after oneself after treatment has ended. It describes session by session what they need to cover with the patient. A new, evidence informed ‘Staying Well workbook’ has been designed for use during therapy and a training video for PWPs has also been completed. Piloting and evaluation to start early October with full roll-out planned early 2020.

The Paddle therapy support app: The Paddle app and the Paddle website, including instruction video, are now ready for release and will be piloted with a small number of patients early October, with full roll-out planned early 2020. Paddle helps patients to get the most out of treatment by storing and organising treatment-related information in one secure location. It also helps patients to continue to use the skills and tools learnt during therapy after discharge by making this information more accessible, including an SOS button when a patient may need urgent access to strategies for de-escalating e.g. panic attacks

New digital therapies: The A&D Network is supporting the roll-out of a number of digital web-based therapies which have shown to be as effective in clinical trials as face to face therapy. To date these include Social Anxiety Disorder and Post Traumatic Stress Disorder (currently as part of a clinical trial). The A&D Network is also supporting early trials with Virtual Reality treatments e.g. for phobia of heights.

Improving Access to Psychological therapies for older adults: It has been widely documented that older adults are under-represented in people seeking/ being referred for psychological treatments for a variety of reasons and, in response, the Oxford AHSN has now launched the ‘Improving Access to Psychological therapies for older adults’ project, bringing together all IAPT services, secondary care psychology services for older adults, care homes and others to explore ways in which more older adults can benefit from psychological therapies. This also supports the Long-Term Plan ambition of wider access to IAPT for long term conditions.

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Dementia

Work continues within the AHSN although the Dementia Network no longer exists in its previous form.

Dementia webinars We recently held two webinars on Safer prescribing in Older Adults – covering dementia, depression and psychosis, presented by Lex Moon, Clinical Services Pharmacist at OHFT. Webinars can be watched live or on-demand and over the years that the programme has been running, over 50 webinars have taken place, with over 1,000 live attendees and over 900 views of webinar recordings.

Best practice network for Care homes in-reach teams This network which has been in place since 2016, is aimed at supporting the health teams (including OHFT’s Care Home Support Service) that in-reach into care homes, helping care homes to provide better care to people living with dementia. The network holds quarterly meetings for sharing of best practice and CPD for these teams. At our most recent meeting, Kris Silvester, Clinical Lead of Oxford Health’s Oxfordshire Care Home Support Service spoke of her experience of the implementation of NEWS2 (National Early Warning Score to detect deterioration) in a nursing home with a high level of residents with advanced dementia.

Mental Health Care for Emergency Department Frequent Attenders–Regional Collaborative

This project, to improve care for patients frequently attending ED, was successful last autumn in bidding for funding from the Q Exchange programme run by the Health Foundation. The main aims of the project are sharing of best practice across the area, involving service users to devise strategies to understand and better meet their needs, and analysis of data to identify variation and overlap between departments.

Work to date has included

reviewing the literature to look at what has worked well elsewhere

working with service users who have frequently attended ED in the past to find out what helped them most

developing a psycho-social assessment form that can be used in ED to help teams understand the drivers of patients frequently attending ED. This will allow EDs to address relevant issues, with the aim of reducing the need for individuals to attend ED. The final product was developed with service user/patient representation, psychiatrist, psychologists and ED involvement

holding a multi-disciplinary event with speakers from Wales, Bristol, Cambridge, Bath, Oxford and Milton Keynes, discussing different at models of working, psychological input, managing medically unexplained symptoms, third sector involvement and what ED data tells us

inputting to the Thames Valley and Surrey Care Records Partnership about how that initiative can improve the continuity of care for patients frequently attending more than one ED

analysis of data including looking at the extent of patients frequently attending more than one ED within the region, the presenting conditions that are most common, frequency of admitted

supporting introduction of new frequent attender programme.

The project is due to complete in November 2019.

Integrated mental health care and policing teams

This is a national initiative being rolled out by AHSNs, in which police are integrated within a mental health team to work with high impact users of services helping them towards safer and healthier lives. We are exploring whether this initiative that can be rolled out within Oxford AHSN’s area. Nationally a model is known as SIM is being implemented, and there is interest locally in the model in place in Hampshire.

The Oxford AHSN is participating in National teleconferences and meetings which are proving very valuable.

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Early Intervention in Psychosis: Improving Quality and Safety during transfers

The AHSN is supporting a project within the Early Intervention in Psychosis Thames Valley network on improving quality and safety during patient transfers, in particular between EIP teams when a patient moves. A form has been developed which can be used by teams initially across the Thames Valley to ensure all the necessary information has been transferred and work is undergoing to embed this. There have also been discussions with the Thames Valley & Surrey Care Records Partnership to establish ways in which wider sharing of care records can be of benefit within EIP services.

Sleepio

Innovate UK has funded a collaborative partnership which has enabled free direct access to Sleepio, an evidence-based sleep improvement programme, for the 2.7 million adults living and working within the Oxford AHSN footprint. This project (the ‘Sleepio project’) is jointly delivered by Oxford AHSN and Big Health and is supported by NHS England. The AHSN is working in partnership with Big Health to explore the best ways for people experiencing insomnia to access the online cognitive behavioural therapy-based digital therapeutic Sleepio. Since the launch of the project on World Mental Health Day (10 October 2018) over 11,000 people have engaged with Sleepio via the link www.sleepio.com/nhs . Oxford AHSN is working with GPs, and primary and mental health NHS staff, local employers, and third sector organisations, to explore how the NHS can expand the provision of digital medicines, like Sleepio, at scale. A digital and traditional media campaign, using Facebook, Instagram and local radio stations, has been rolled out in August 2019 to seek wider engagement and assess how such channels might influence uptake.

A health economic evaluation will be conducted at the end of the project later this year. A variety of large organisations - including Unipart, Oxfordshire County Council, West Berkshire Council, and Buckinghamshire Healthcare NHS Trust - have now rolled-out Sleepio to their staff and contacts.

Industry

The Strategic and Industry Partnerships element of the AHSN supports the development of partnerships between academia, industry and the NHS across the development pathway for new products and services. In practice this covers new medicines, diagnostics, medtech and digital health innovations. This includes supporting new products and services which have potential to improve mental health services.

1.2 Oxford Academic Health Sciences Centre (AHSC)

The ASHC will submit a separate report to the Board regarding activity across the four-partner organization in Oxford. These reports will be on a biannual basis

1.1 Oxford Institute of Nursing, Midwifery and Allied Health Research

BackgroundThe Oxford Institute of Nursing, Midwifery and Allied Health Research (OxINMAHR) is an Oxford Brookes University (OBU) led partnership that comprises a number of research centres and research groups that undertake multi-disciplinary research (across professional groups and scientific disciplines) to generate new and impactful knowledge. Professor Paul Carding was appointed as the Director of OxINMAHR in January 2019. OxINMAHR is in the process of establishing an External Advisory Board and we are pleased that Chief Nurse Marie Crofts and Professor John Geddes have agreed to be a members. We are in discussion with other OHFT senior staff at the time of writing.

The aims of OxINMAHR are to:

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http://www.sleepio.com/nhs


Produce world-class research which aligns with government and international health and social care priorities

Conduct research that changes clinical practice and influences service delivery policy

Build a community of inter-disciplinary research scholars to facilitate integration and maximise impact

Develop research capacity within and across professions, disciplines and departments

OxINMAHR researchers take a broad, holistic view of health, to encompass physical, psychological, emotional, spiritual, cultural and social elements; and, consider health and illness to occur in the context of family life. Thus, health issues and challenges are viewed as being concerns for individuals, as well as their families and communities. OxINMAHR academics view public involvement (including patients, carers and families) as a key aspect of research, which is encouraged at each stage of the research process. There are two distinct areas of Public Involvement to meet both AHP and Nursing programmes of research.

OxINMAHR comprises Three Research Centres:

The Centre for Movement, Occupational and Rehabilitation Sciences (Centre Director: Prof Helen Dawes)

This centre currently includes four research themes with 15 externally funded PhD students and funding from Research Councils, the NIHR, Charities and the EU and hosts the Smart Oxford Clinical Allied Technology and Trial Services Unit (OxCATTS).

OxCATTS: is an exciting development led by an experienced, multidisciplinary team with a strong focus on successful collaborations and partnerships with a vision is to enable timely efficient development and evaluation of local, national and international technology innovations for allied health professions and nursing. https://www.brookes.ac.uk/shssw/research/centres-and-groups/mores/oxcatts/

Themes are Clinical Applied Nutrition (Lead: Dr S Coe), Clinical Exercise and Rehabilitation (Lead: Dr J Collett), Movement Science (Lead: Dr P Esser) and Occupational Science (Lead: Beatrix Ruckli)

The Centre for Nursing, Health and Social Care Research (Centre Director: Dr Mary Malone)

This centre currently includes three research groups with 19 PhD students and funding from NIHR, Research Councils, Cancer UK, MacMillan Trust, British Heart Foundation, NSPCC, Florence Nightingale Foundation, Health Education England and Local and National Charities.

Themes are Supportive Care (Lead: Prof E Watson), Children and Families (Lead: Prof J Appleton) and Nursing Practice (Lead: Dr H Walthall)

The Oxford Brookes Centre for Nutrition and Health

(Centre Director: currently vacant)

Several other Research Groups exit with funding from Research Councils, AHMRC, NIHR and national charities. These include Prevention Science Research Group (Lead: Prof D Foxcroft), Cardiorespiratory Research Group (Lead: Dr S Moosari), Sport, Exercise and Physical Activity Research Group (Lead: Dr P Wright), Radiation Biology, Genetic instability and Cellular Communication Research Group (Lead: Prof M Kadhim)

Other research groups (or representatives) including relevant areas of Health Psychology and Biological and Medical Sciences.

OxINMAHR, research activity continues to contribute to the strategic and operational objectives of both Oxford Health Foundation Trust (OHFT) and OBU. We are keen to continue to collaborate with OHFT to

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https://www.brookes.ac.uk/shssw/research/centres-and-groups/mores/oxcatts/


create and develop clinical academic appointments for nurses and AHPs. To this end we have worked closely with OHFT to ensure that the newly appointed Head of Research Delivery at OHFT (Dr C Henshall) is also an established senior nursing research fellow at OBU. Across OxINMAHR a wide range of research degrees are undertaken and supervised through the involved Research Centres and Research Groups in collaboration with OHFT

Recent activity:For Centre for Movement, Occupational and Rehabilitation Sciences

- Clinical Applied Nutrition (Lead: Dr S Coe: [email protected] )

There are several projects on going looking into pediatric neurological and autoimmune conditions include pediatric Multiple Sclerosis, Cerebral Palsy (CP) and Rheumatoid Arthritis and lifestyle interventions including diet and exercise for improving the symptoms of the conditions. Current studies include ‘stand up for CP’ a study looking at breaking up sitting time with physical activity and the effects on glucose metabolism and cognition to develop an intervention for schools. A PhD student will begin in Sept 2019 who will look at diet and exercise interventions for improving fatiguing symptoms in adults with Parkinson’s. There are also projects looking at large data sets including diet patterns over the lifestyle on impact on later life quality of movement.

- Clinical Exercise and Rehabilitation (Lead: Dr J Collett: [email protected]). This research group focuses on developing and evaluating exercise interventions and exercise response in health and disease. The research covers a range of populations and settings, from community services for sedentary people including physiological/neurophysiological mechanism testing in the lab and in adults and children with neurological and degenerative conditions. Recently completed studies include ‘Fit to study’ a randomised controlled study to test the impact of a teacher training intervention designed to try to optimise the content of PE for brain and cognitive function during secondary school (Year 8) Physical Education (PE) lessons. The intervention took place in 104 Schools in England (https://www.fit-to-study.org). Ongoing Studies include evaluating the ‘First Steps’ Program being rolled out nationally for those newly diagnosed with Parkinson’s (https://www.parkinsons.org.uk/professionals/first-steps-people-newly-diagnosed-parkinsons) and OxSOCRATES a study looking at Obesity & Cardiometabolic Risk factors in Adolescents and an exercise intervention in schools. Projects in developed includes working with colleagues at the OUH and OH to implement core measures across the stroke pathway.

- Movement Science (Lead: Dr P Esser: [email protected] ). This research group leads on measuring quality and quantity of movement in various national and international studies (e.g.MRC Insight46, SABRE, Whitehall II) concerned with general ageing, Multiple Sclerosis, Parkinson’s Disease and Diabetes and children with movement difficulties. In addition, this group undertakes the continuous development of novel and bespoke outcome measurements, algorithms and data analysis programmes for both academic researchers (both nationally and internationally) as well as allied health professionals and commercial companies. An example study involved screening movement skills in approximately 2000 adolescence n mainstream schools. The screening identified those with and without co-ordinations problems and compared the response to an exercise intervention and the ability to leatn a novel motor task. A new area linked to strategies and mechanics of falling in the elderly with and without existing conditions. Hereby the focus lies in the neural and mechanistic approaches, followed by a bespoke community intervention to assess fall risk reduction in the ageing population

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mailto:[email protected]




- Occupational Science (Lead: Beatrix Ruckli)

The Occupational Sciences group is underpinned by two themes:

Understanding how people's engagement and participation in their everyday activities support their health and well being

- Contributing to and developing evidence-based interventions to enable engagement in meaningful occupations.

- Current project includes development of a smart ecological momentary assessment of fatigue in those with acquired brain injury in order understand and how fatigue limits participation in social, leisure and work activities and developing an intervention for young people who are experiencing the early stages of mental health problems. Projects in development include working the OT team at OH investigate ‘off the shelf’ digital technology for supporting / improving health behaviors people in the community.

For Centre for Nursing, Health and Social Care Research

- Supportive Care (Lead: Prof E Watson: [email protected] ). This group conducts local, national and international collaborative studies seeking to understand the experiences and needs of people affected by cancer, and developing and trialling interventions to improve outcomes. Recent examples include: a large national PROMS study, Life after prostate cancer diagnosis, which has provided detailed information on the quality of life of 35,000 men following a prostate cancer diagnosis, informing local and national policy and service improvements; an ongoing collaborative study between OHFT/OBU is using the Case Records Interactive Search (CRIS) database to identify the frequency and type of mental health services accessed by people with a dual cancer and mental health diagnosis compared with people with a mental health diagnosis alone; a national survey exploring the supportive care needs of patients with pancreatic cancer. NIHR funding has also recently been secured for a new programme of research which will build on previous research and develop and trial an intervention designed to support women with breast cancer with adherence to adjuvant endocrine therapy, thus reducing risk of recurrence and mortality.

- Children and Families (Lead: Prof J Appleton: [email protected] ). This group undertake research in areas such as safeguarding, child protection, child health, looked-after children, and the role of the family unit including parenting, school, and community influence on child wellbeing. The group is interested in research that makes a difference to the lives of children and families and improves health outcomes. Our family-focused research covers additional topics such as substance misuse, family community services and the development of resilience. Much of our work takes place in family homes, schools and with the wider community including health, social care and voluntary services.

- Nursing Practice (Lead: Dr H Walthall: [email protected]) . This research group operates under the overarching focus of nursing chronic illness with the two key themes being cardiorespiratory disease and diabetes. Members of the group have recently been successful in securing funding to further develop PROMs for cardiorespiratory patients (reliability and validity) and examine the palliative provision for end stage chronic disease (non-cancer) patients. The group also has a keen interest in mental health issues pertaining to chronic illness.

The Prevention Science Research Group (Lead: Prof David Foxcroft: [email protected] ) carry out national and international research studies into the causes, consequences, and prevention of poor physical and mental health. The focus of the group is to promote healthy behaviours with a view to preventing or mitigating lifestyle risks to health and wellbeing. The scope of the group spans the harms

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associated with substance misuse (e.g. alcohol, tobacco, illicit drugs), lifestyle behaviours (e.g. poor diet, lack of exercise), and poor mental health.

Ongoing project work with the Oxford Centre for Spirituality and Wellbeing (OCSW) led by Dr Guy Harrison relates to supporting leaders to maintain positive culture and training/ CPD in spiritually integrated patient care. Dr Harrison and Prof Carding have recently submitted a research grant to The John Templeton Foundation in USA.

Possible areas of OHFT/OxINMAHR joint strategic direction are:

Recruitment of AHPs and nurses from OHFT to PhD studentships

Exploring further potential for clinical academic roles

Engagement of clinical staff in research and support from management teams

2 National Institute of Health Research Infrastructure

2.1 NIHR Oxford cognitive health Clinical Research Facility (CRF)

The CRF is a single managed entity hosted by OUH in partnership with OHFT. The CRF provides a flexible and integrated neuroscience resource that facilitates the efficient and timely conduct of experimental neuroscience research including high intensity early phase experimental medicine research and early phase clinical trials. The CRF’s aim is to be fully aligned with the strategy of OH-BRC to enable, encourage and facilitate high intensity research working with principal investigators and commercial partners

The primary objective of the CRF is to deliver new therapies tailored to individual patient needs by breaking down disciplinary boundaries, capitalising on scientific, technical and infrastructural capabilities that cut across disorders.

Short-term objectives: To build further our capability in translational neuroscience, to facilitate the objectives of OH-BRC.

Medium-term objectives: To realise plans for purpose built integrated and coordinated neuroscience research and clinical facilities across Oxford. Work has been initiated for a joint University-NHS Masterplan to develop the Warneford as a Brain Health Centre for translational neuroscience.

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

2.1.1 Outputs

Activity data submitted in the 18-19 show 46 studies were undertaken and 61 peer-reviewed articles were published where authors received support from the CRF.

The NIHR funded CRF provides specialist facilities to undertake high intensity clinical studies in mental health and cognition, including dementia, focusing on an experimental medicine design. Most studies are non-commercially sponsored.

The CRF has developed to enable several specialist activities including undertaking intensive psychiatric rating scales, physical monitoring, lumbar punctures and, more recently, IV infusions.

Studies range from an experimental medicine design testing novel compounds (late Phase 1/Phase 2, not ‘first-in-man) and clinical trials to longitudinal cohort studies

Open Studies

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Study Full name Funding Disease area BRC Phase

EPAD European Prevention of Alzheimer’s Dementia (EPAD) Longitudinal Cohort Study (LCS)

IMI Joint Undertaking

Alzheimer’s Dementia

Yes Experimental medicine

PREVENT PREVention of dementia by ENvironmental intervention and Therapy

Alzheimer's Society

Alzheimer’s Dementia


Restart The effects of PF-04995274 on emotional processing in treatment-resistant, medicated, depressed patients

Medical Research Council

Treatment Resistant Depression


Restand The effects of PF-04995274 on emotional processing in un-medicated depressed patients


Depression Yes Experimental medicine

OxCams The Oxford Study of Calcium Channel Antagonism, Cognition, Mood Instability and Sleep

Wellcome Trust and OH BRC

Mood Instability Yes Experimental medicine

Esketamine 3008

An Open-label Long-term Extension Safety Study of Intranasal Esketamine in

Janssen Treatment resistant depression

No Phase 3

LQD A trial comparing the clinical and cost effectiveness of lithium and quetiapine augmentation in treatment resistant depression

NIHR Health Technology Assessment (HTA)

Treatment resistant depression

No Phase 4

Alkermes A trial to Evaluate the Effect of ALKS 3831 Compared to Olanzapine on Body Weight in Young Adults with Schizophrenia, Schizophreniform, or Bipolar I Disorder Who are Early in Their Illness

Alkermes Schizophrenia, Schizophreniform and Bipolar I

No Trial

BI-Cact A trial to examine the efficacy and safety of BI 425809 with adjunctive Computerized Cognitive Training treatment period in patients with schizophrenia

Boehringer Ingelheim

Schizophrenia No Experimental medicine

SINAPPS2 A trial of intravenous immunoglobulins and rituximab in patients with antibody-associated psychosisrecruiting takes place in OUH, but intravenous immunoglobulin/placebo infusions are delivered at the CRF


Treatment resistant psychosis

Yes Trial

Studies in Set-up


NTAD New therapeutics in Alzheimer’s disease: MEG biomarker platform development

DPUK and ARUK

Alzheimer’s Disease/MCI

Yes Observational

ATP A trial of the efficacy of a novel CNS-penetrant P2X7 receptor antagonist, in people

Wellcome Trust and Janssen

Treatment resistant depression

Tbc Experimental medicine

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with major depressive disorderDFP Deep and Frequent Phenotyping;

Combinatorial Biomarkers for Dementia Experimental Medicine

MRC and NIHR

Dementia Yes Experimental medicine

PAX-BD A trial of pramipexole in addition to mood stabilisers for patients with treatment resistant bipolar depression

NIHR Health Technology Assessment

Bipolar disorder (treatment resistant bipolar depression)


MICAD A study to characterise the biomarker effects of the CSF-1 receptor antagonist JNJ-40346527 in participants with mild cognitive impairment

Wellcome and Janssen

Alzheimer’s Disease


PAX-D A trial evaluating the efficacy and mechanism of pramipexole as add-on treatment for people with treatment resistant depression

NIHR EME Treatment resistant depression


2.1.2 Other activity

The CRF hosts two sleep studies which take place overnight and at weekends.

It is also now running the following research study at the Whiteleaf centre in Aylesbury which provides greater opportunities to staff and patients in Buckinghamshire to get involved in research.


Mission AD A 24-Month Study to Evaluate the Efficacy and Safety of E2609 in Subjects with Early Alzheimer’s Disease

Eisai Ltd Alzheimer’s dementia

No Phase 3

2.1.3 Occupancy

The 19/20 Q1 occupancy at the Warneford was 61% (18/19 69% with Q1 71%). The current lower occupancy is a result of staff recruitment difficulties and studies not having started as expected. There are a number of studies in the pipeline due to start this year.

Occupancy at the OHCRF is reviewed and planned each month to ensure best use of available resources

2.1.4 CRF strategy

The current award of £3.7m (Apr17–Mar22) included funding to develop CRF activity at OUH but an appropriate location has not been identified, therefore over the last two years funding has been reallocated to the Acute Vascular Imaging Centre (AVIC) at the JR.

Professor John Geddes initiated the set-up of the CRF in 2011, led the two successful NIHR funding applications and has provided leadership as the CRF Director since 2012. Professor Geddes has now stepped down from this role and Professor Andrea Cipriani has been appointed as Acting CRF Director.

Professor Cipriani is in the process of reviewing the management and staffing structure of the unit and is planning a mid-term review which will set the direction of travel for the final two and half years of the current award and the renewal.

2.2 NIHR Biomedical Research Centre (BRC)

The Oxford Health BRC, a partnership between OHFT and University of Oxford commenced in April 2017 with funding of £12.8m (Apr17–Mar 22). An additional one-off £1m was awarded in FY19 to provide a sustainable solution to UK-CRIS.

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The hub of the new centre is at the Warneford Hospital site which also houses the University of Oxford’s Department of Psychiatry and its associated research centers and facilities.

The BRC strategy is 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.

2.2.1 Overview of Activity

Short –term objectives

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

Deliver a fully developed Patient & Public Involvement strategy Establish an effective clinical interface for the BRC between basic research and clinical care

Progress towards short term objectives:

The BRC Steering Committee includes strong patient involvement and continues to provide strategic direction and oversight

Planned an externally-chaired, peer-reviewed, mid-term review to ensure the BRC continues to deliver world class research meeting mental health research priorities

The BRC Theme Leaders meetings identify collaboration opportunities and facilitate cross-theme funding of staff delivering high levels of efficiency and value for money.

The BRC supported 156 studies in year 2 (83 in year 1), the submission of 23 (£11.6m) approved grants in year 2 (36 in year 1) and leveraged £15.8m of project funding in year 2 (£16,3m in year 1) as a result of the infrastructure and vision provided by the BRC

The BRC has continued to support initiatives within the NIHR Oxford cognitive health CRF (CRF), including the development of Treatment Resistant Depression (TRD) clinics to increase opportunities for patients to become involved in translational research

The BRC has worked with the CRF to increase the services provided within the CRF to include IV infusions for experimental immunotherapy of psychosis

The BRC Director has helped to create and is the deputy chair of the new Mental Health Translational Research Collaborative (TRC) with the aim of which is to drive effective collaboration in experimental medicine across the UK via the NIHR BRC and CRF network and similar infrastructure in Wales and Scotland.

The BRC provided the project lead (Dr Michael Browning) for Treatment Resistant Depression as part of the Mental Health Translational Research Collaborative (TRC)

The BRC contributed to the Psychosis element of the Mental Health Translational Research Collaborative (TRC)

Longer term objectives include realising the vision of a Brain Health Centre on the Warneford site and we have made significant progress towards the opening of the Brain Health Centre as a joint clinical-research service in Year 3.

2.2.2 BRC Themes

2.2.2.1 Adult Mental Health: Innovation in Diagnosis and Treatment (Theme Lead: Professor Paul Harrison)

Progress against objectives

increased portfolio of studies to 26, (10 completed; 6 new). 11 studies we have assisted with laboratory assays.

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provided pilot funding or enhanced support for 8 studies. published 24 papers, including many in leading journals such as Lancet Psychiatry and Nature

Neuroscience. produced 6 more standard operating procedures and support for ethics and R&D applications,

encapsulation, and neuroimaging analysis.

We are further growing capacity via involvement in the new TRC-MH. We have contributed fully to the Training (e.g. via participation in OxCEMM) and PPI cross-cutting themes (e.g. integration of PPI into most adopted studies).

The one short-term objective where work is still ongoing concerns expansion of the collection and study of biosensor data.

Medium term objectives: to implement and expand our precision approach to diagnosis, prognosis, and treatment of mental disorders, embedded within the Oxford Brain Health Centre (BHC).

We are working with the Older Adults and Imaging themes on development of the BHC and its extension into our mood disorder research clinics. Initial outputs are anticipated for 2019-2020.

In the past year we continued to work towards our medium-term goals

Year 3 Plans

The coming year will see an enhanced focus on the overall goal of the theme to use innovative methods in adult mental health research. This will be delivered by:

Alignment and integration with the work and outputs of the MRC Pathfinder award. The ongoing expansion of, and improved support for, the True Colours digital platform, and

development of the new ‘Mezurio’ app. Collaboration with the Alan Turing Institute. Using digital methods to enhance the inpatient ward environment, in collaboration with

bioengineers and NHS staff Work closely with the other themes and the TRC-MH.

2.2.2.2 Older adults and dementia (Theme Lead: Professor Clare Mackay)


Brain Health Centre:

The pilot of our integrated clinical-research service for memory clinic patients is due to start late 2019. We have:

signed Memorandum of Understanding (MOU) outlining the responsibilities and agreements between the OU and OH

Installed IT infrastructure that connects the Oxford Centre for Human Brain Activity (OHBA) to NHS networks.

Developed optimized assessments with the Cognitive Neuroscience and Neuroimaging theme Established the workflow for reporting by OUH neuroradiology, Adapted the clinical triage process to direct patients to the BHC for their assessments Submitted the ethical application and data access policies to set up the BHC research database Expanded the team and PPI advisory group (details below)

Pharmacological interventions:

The Dementias Platform UK (DPUK) Clinical Studies Register (CSR), now named GreatMinds, has launched to provide a register of volunteers with extensive existing health data for recruitment to dementia-focused clinical research. Baseline recruitment has completed for the PREVENT study and is ongoing for the European Prevention of Alzheimer’s Disease (EPAD) study. The delayed Deep and Frequent Phenotyping (DFP) study is now on track to open imminently.

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Several new large-scale projects are currently being set up, including ‘Amyloid Imaging in PREVENT’ (AIP), (sub-set of the PREVENT participants to undergo PET-CT), and ‘Microglial CSF1R in Alzheimer’s Disease’ (MICAD), - an RCT to characterise the biomarker effects of a CSF-1 receptor agonist in participants with MCI.

Non-pharmacological interventions:

Data collection is now completed for the REtirement in ACTion (REACT) MRI sub-study, with results under embargo until completion of the full trial. The DISCO study produced significant improvements in sleep and subjective cognitive functioning following online CBT for insomnia (paper in preparation).

The LifeBrain consortium has qualitatively assessed adults understanding of concepts of brain health and preventative adoption of lifestyle changes.

Several new projects investigating modifiable factors on later life brain health are in preparation. The Heart-Brain study will use MRI to investigate whether poor cardiovascular health in mid-life leads to lower cerebrovascular reactivity (CVR) in older ages (>65 years). Mobile Technologies for Assessment of Cognition (MTAC) is a sub-study of PREVENT study exploring the usability of smart-phone based applications and Bluetooth beacons positioned around the home to track cognition and function.

Patient and Public Involvement (PPI; further details in PPIE section of report):

The BHC has established a PPI advisory panel, comprised of people living with dementia, carers and interested members of the public and has appointed a PPI representative to the BHC working group. The BHC advisory panel has substantially contributed to the ethics application, developed a BHC PPI strategy and co-developed an abstract accepted for presentation at the Alzheimer’s Society conference.

The Friends of OxDARE (Oxford Ageing and Dementia Research) registry continues to support ongoing research studies in this and other BRC themes.

2.2.2.3 Precision Psychological Treatments (Theme Lead: Professor Anke Ehlers)


Virtual reality (VR) lab and digital platform for psychological therapies

The BRC-funded virtual reality Laboratory (Dr. Avitor Rovira) facilitates the use of VR in the treatment of psychological problems. Current projects include Freeman’s work on VR in paranoia, Stein’s work on parental training, Stein and Bowes’ work on bullying, and Murphy’s work on binge eating.

Recruitment of a web developer for the development of a digital platform for psychological treatments has not been possible due to lack of qualified applicants. We have therefore worked with two IT companies (FRY-IT and Whiskered Wizard) to create a generic version of the online treatment programmes developed by Clark and Ehlers in Wellcome Trust funded research, now used for several projects. Current studies focus on online psychological therapies for PTSD, social anxiety disorder, prolonged grief and perinatal anxiety and depression.

Development of novel internet implementations of psychological therapies

We have made good progress with developing a range of new online treatments:

Programmes for internet-delivered cognitive therapy for social anxiety disorder in adolescents (Clark and Leigh) and digital CBT for binge eating disorder (Murphy and Fairburn) were developed and successfully piloted.

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Freeman’s group worked with patients to design a new VR automated treatment for patients with psychosis who have withdrawn from everyday activities, which will be tested in a large multi-centre trial, funded by the NIHR i4i programme.

Stein and Rovira are working on the development of a VR programme for parents with depression or anxiety in the perinatal period that is designed to enhance their responses to infant facial expressions. Stein’s group have also developed an online version of their behavioural activation manual and materials for perinatal depression.

Internet-delivered cognitive therapy for prolonged grief disorder (Ehlers and Smith), Internet-delivered cognitive therapy for PTSD in military populations (Ehlers, Murray and Wild) are in development.

Kuyken’s group are developing a series of digital resources on mindfulness for young people to communicate what mindfulness is and how it might be used to support mental health and wellbeing to young people.

Randomised controlled trials (RCTs)

The theme supported several RCTs of digital interventions:

Freeman’s group completed a trial of virtual reality (VR) therapy of height phobia (Freeman et al., 2018), which showed large treatment effects.

Clark and Thew’s trial found that therapist-assisted digital cognitive therapy for social anxiety disorder is as effective in an Asian cultural context (Hong-Kong) as in a previous UK-based trial.

Espie’s group completed the DIALS trial of online treatment for insomnia (Espie et al., 2018). Freeman’s group started a VR treatment trial (THRIVE) of automated therapy for patients with

psychosis who have persecutory delusions. Ehlers’s STOP-PTSD trial compares the efficacy of internet-delivered cognitive therapy for PTSD,

internet-delivered stress management therapy for PTSD, and a wait-list condition. Kuyken’s trial is investigating the effects of low intensity mindfulness training (Finding Peace in a

Frantic World) on student mental health and wellbeing. Wild’s PREVENT-PTSD trial investigates the efficacy of a new online resilience training the

prevention of PTSD and depression in paramedics. Stein’s Insika Yomama cluster randomised trial investigates whether the combined intervention of

behavioural activation and a parenting programme for HIV-positive mothers with perinatal depression leads to reductions in depression and improved infant cognitive development

Analyses to identify moderators and mediators of outcomes:

Kuyken’s group is analysing data from the MYRIAD Trial to examine the role of school-level factors (such as school climate and quality, school-level deprivation, school size and school support for personal, social, health and economic education) on changes in mental health over a 1-year follow-up period.

Ehlers and Clark’s group are investigating processes of change in internet-delivered cognitive therapy.

Development of internet-based therapist training

Clark’s and Ehlers’s groups are developing an online training site for the implementation of effective treatments for anxiety disorders (https://oxcadatresources.com)

Kuyken’s group have developed an implementation resource for those interested in implementing MBCT in health service settings MBCT http://www.implementing-mbct.com/, which will include resources for those implementing MBCT in other settings including schools.

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http://www.implementing-mbct.com/

https://oxcadatresources.com/


2.2.3 BRC Cross Cutting Themes

2.2.3.1 Informatics/digital health (Theme Lead: Professor Andrea Cipriani)


Several developments have influenced of the Digital theme:

The MRC Pathfinder broadened the scope of the theme to make better use of mental health data from both adults and adolescents.

Biomarkers:

Using data from EMIF1000 and AddNeuroMed, we have validated previously targeted biomarkers and developed new untargeted ones to identify Alzheimer's disease and PET Abeta positive patients.

Using independent cohorts from Array Express, we have developed new biomarkers that improve disease classification accuracy by identifying RNA transcription patterns.

We published a review of biomarker work [Shi et al., 2018], and another paper is under review. We have collaborated with Southampton University and J&J in testing CSF1R Inhibition targets to

treat Alzheimer’s disease in rodent models (JAK-STAT project, paper under review).

The digital theme shares with the Cognitive Neuroscience and Imaging theme the ambition to acquire and analyse high-quality brain imaging datasets in mental health. A new DPhil student (WIN Centre) is working under MRC Pathfinder to exploit the massive dataset (N>20K) of the UK Biobank in relation to mood disorders.

Under the Digital Phenotyping sub-theme, Mezurio, which incorporates mood-monitoring and cognitive tests into a mobile phone app, has been developed to include secure remote video-capture of facial expressions for automated analysis of emotions (ethics application in progress). Remote digital phenotyping also received substantial attention via GameChanger, which recruited healthy members of the public to download an app and play brain games.

Although we are awaiting a qualified programmer to develop the platform for psychological therapies, important foundation work is underway. The Consent for Recontact (C4RC) pilot study introduced a new form on Carenotes to record whether patients are happy to be contacted for research, testing the feasibility of implementing the form into clinical practice. This study involved 4 Oxford Health sites and is now being evaluated using online surveys and focus groups.

We worked closely with the Oxford AHSN to establish a six-system partnership covering a population of 3.8m, which was selected by NHS England as one of five Local Health And Care Record Exemplars. Our approach capitalised on strengths in research and industry engagement. We are committed to creating a longitudinal health/social care record, ensuring data interoperability, information governance and technical standards. We are working to establish an ecosystem for advanced data science, developing apps for patients, and a Personal Health Record platform with full scale de-personalised records.

The UKCRIS initiative has progressed three core aims: Scaling the Collaboration Network; Augmenting the data set; and Sustainability. 12 NHS Trusts are now in partnership with 2.6m deidentified records. A team was established to enhance data management and data science, and a networking event was organised. 3 research studies are approved with UK Biobank, integration is completed with IAPT data and HIC acute data at OUH BRC. Plans are underway to link with True Colours and QResearch, a national primary care database. A sustainability model has been developed to enable long-term value for the NHS, in partnership with industry, and academia. CRIStal Health Ltd incorporated will have private sector investment.

The BRC continues to lead development of the True Colours in both research and service contexts. Despite more than 30000 users, and being shortlisted for a BMJ digital innovation award, True Colours lacked a sustainability model. However, after a 6-month programme led by Mike Denis, the relevant stakeholders

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committed to resourcing True Colours sustainably, involving both Oxford NHS Trusts, with a potential long-term outcome of a spinoff company. A new joint leadership team is being established.

We are developing an internet-based system to help doctors and patients choose the best antidepressant (PRADA). With advanced analysis of existing data, considering efficacy, adverse events, and patient specifics and preferences, we will tailor the choice of medication to the individual. We have developed innovative statistical and artificial intelligence approaches to analyse the data and are linking relevant observational datasets: CRIS and QResearch. We have published the protocol of the project and explored qualitatively the value of the digital decision support tool.

Extending the scope of the theme to adolescents, iSAM aims to provide an analysis platform of real-world data from school pupils. We are now working with OHNHSFT, Oxfordshire county council, and UKCRIS to de-identify and link several data sources. Ultimately, iSAM intends to provide clinicians and schools with an algorithm for identifying risk of mental health disorders, to direct support where it is needed most, improving mental health trajectories.

2.2.3.2 Neuroimaging and Cognitive Neuroscience (Theme Lead: Professor Kia Nobre)


Development of a suite of sensitive fine-grained cognitive and imaging measures of brain structure and function:

The theme continued to develop and refine sensitive cognitive measures of spatial memory, sustained attention, and emotional deficits, which have or will shortly be applied in a range of patient populations. A new program of work developing virtual reality platforms for cognitive phenotyping is also underway.

New Fellowship for Suri, who developed the application with support from the BRC to install specialist MRI equipment at the Oxford Centre for Human Brain Activity. The Heart-Brain study will investigate the association of mid-life cardiovascular health with brain health in later life. This work aims to evaluate novel MRI biomarkers for dementia clinical trials and inform personalised strategies for managing cardiovascular health to delay dementia.

Establish an apps- and web-based platform for cognitive testing:

A standardized battery of sensitive cognitive measures for the Brain Health Centre (BHC) has been developed, and pilot testing is underway, supported by OxDARE research assistants (Older Adults and Dementia theme). This battery will eventually be hosted online, which will facilitate ‘waiting-list’ assessment and remote follow-ups for BHC patients, and remote testing of large numbers of research participants more generally.

Apply magnetoencephalography (MEG) methods for charactering functional connectivity in brain networks and dynamics of brain states:

MEG has continued to be applied in clinical populations with mood disorders and dementias. This theme is contributing to the ‘BioFIND’ project, which will define harmonised acquisition and analysis procedures for MEG and EEG (electroencephalography) to identify sensitive and specific biomarkers of neurodegeneration.

Work is ongoing to establish novel MEG analysis methods to explore changes in spontaneous and task-modulated neuronal oscillations in a range of clinical disorders. We have published a tutorial paper detailing the analysis pipeline for dynamic functional connectivity analysis (Quinn et al., 2018), which has since been applied to a range of clinical datasets including the Oxford contribution to the BioFIND project and the COMET project on mood-instability.

Applying cognitive-phenotyping tests to large populations for validation and for identification of cognitive markers of risk and of progression of disorders of mental health

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Cognitive-phenotyping tests characterising changes with age developed by this theme have been applied to over 2000 participants from the NIHR BioResources using tablet-based tests

Work on cognitive phenotyping of genetic susceptibly for Alzheimer’s disease (Zokaei et al., 2018, 2019) is being expanded in a new project testing a large sample from the Oxford Biobank with mobile phone-based tests of working memory and long-term memory.

Establishing a pipeline for integrating imaging measures into clinically relevant tools

The theme developed the BHC’s MRI imaging protocol, which will be aligned with the UK Biobank to facilitate use of the existing large cohort as normative population data. Continued collaboration with colleagues in OUH Neuroradiolgy and the NIHR Oxford BRC Imaging Cross-Cutting theme will lead to integration of quantitative brain information into clinical reports.

Ongoing work with colleagues in the NIHR Oxford BRC Imaging Cross-cutting theme on harmonisation of MRI measures in the Dementias Platform UK (DPUK) will facilitate large-scale analyses of combined cohort data.

The theme has overseen the purchase and delivery of a new state-of-the-art MEG scanner in January 2019. Installation will take place in September 2019.

2.2.3.3 Clinical research infrastructure and experimental medicine (Theme Lead: Professor Catherine Harmer)


In the last year, we have developed our experimental medicine capability by:

The appointment of a neuroimaging support specialist for experimental medicine studies who has also developed structures for open science, archiving and sharing code, sequences and paradigms, using the open science framework resources to facilitate transparency and reproducibility. We have set up fortnightly ‘drop-in’ analysis clinics and started a new journal club (translational neuroimaging) to facilitate collaboration between preclinical and clinical imaging applications and to ensure our clinical studies in patients are based on the best discovery science. This has resulted in an increase in expertise in neuroimaging techniques and the quality of our translational work.

Funding a statistician dedicated to experimental medicine and early clinical trials (Milensu Shanyinde). This has helped to leverage funding including our recent successful bid for a MRC Experimental Medicine Challenge Grant (1.2M).

Adopting 23 studies in the experimental medicine theme, and these have been supported by our project manager including the development and use of standard operating procedures for good practice in experimental medicine.

Increasing the capacity of our pharmacy: 5 BRC medicines trials are currently open (2 CTIMPs and 3 non-CTIMPS); four of which are dispensed from the pharmacy. These are single site studies; all lead pharmacy site activities take place locally. Pharmacy has also supported planning for two 2 large CTIMPs in preparation (PAX-D and ATP).

Validate experimental medicine models of established pharmacological and psychological treatments across mood disorders, psychosis, cognitive impairment, insomnia and anxiety.

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In February 2019, awarded a 1.2M joint grant from MRC and J&J to develop experimental medicine models for fast acting antidepressant treatments. Current models for screening new treatments in depression are based on the effects of SSRI antidepressants which take time before they improve symptoms, whereas emerging work supports a new generation of treatments which work much faster. This programme of work will validate new markers for use in screening programmes of novel fast acting agents.

Completed phase 1 of the UCB grant developing novel experimental medicine markers for cognitive impairment in Parkinson’s Disease and are in the planning stage of applying these models to new molecule discovery programmes with UCB, Belgium.

During this first year of the BRC award developed a new model to explore the effects of established and novel agents on markers of stress. This new task validated in Oxford has now been incorporated into a J&J Phase 1 study for novel compound development and the results are being presented at the British Association for Psychopharmacology meeting 2019.

Work with the Precision Psychological Therapies theme to support the collection of cognitive measures of efficacy and response prediction within on-line data capture platforms

Our objective was to reduce the division between psychological and pharmacological treatment research across disorders and to harmonise frameworks and methods for assessment, thereby building a foundation for the future generation of joint treatment approaches.

We have collaborated and supplied experimental medicine markers for a large online trial of CBT for insomnia (Kyle; Espie); as well as a marker of relapse prevention in depression with mindfulness treatment (Kuyken). We have completed a study exploring the potential for a positive psychological intervention (Kaltenboek) and in the combination of pharmacological and psychological treatments for anxiety (Reinecke)

2.2.3.4 Patient and Public Involvement and Ethics (Theme Lead: Professor Ilina Singh)

Our Patients and Research Group (PAR) has continued to support the delivery of the PPIE Strategy. The group has ten patient, carer and public members and six research staff members. It is co-chaired by a patient/carer member and a staff member, with support from the PPI Manager and PPI Theme Lead.

Progress in the Strategy has been made across all objectives and a report published on the BRC website. Key activities include:

PAR reviewed how it operates in relation to the NIHR Standards for Public Involvement (Nov18). We undertook a review of the group to ensure members are supported and it operates effectively

We launched a register to connect BRC researchers with PPI contributors and to support high-quality PPI activity (Nov18). We provided PPI support to 18 projects and worked with 33 PPI contributors

A PPI small grants programme was launched to support PPI in the early stages of research and 9 awards made

PAR members worked with the Training theme to co-deliver a PPI session as part of the Oxford Short Course in Experimental Medicine in Mental Health

We’ve worked with local NIHR partners and PPI contributors to co-develop a series of 8 PPI Workshops covering stages of the research cycle

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PAR has contributed to a NEUROSEC project exploring Ethics and Collaborations in mental health research

Examples of how patients, carers and the public have been actively involved in our research include:

The Brain Health Centre (BHC) established a PPI panel, of people living with dementia, carers and public members. The group has provided crucial feedback on the ‘standard’ documentation which will be used at the BHC (information sheets and consent form) which was considered inappropriate for the BHC population, who will be patients with memory problems. This gave the research team a set of suggested amendments, and the justification to agree these substantial changes with University Research Governance, who were keen to address the PPI input.

The RESTAND and RESTART studies presented their research at a PAR meeting. Following this involvement, the research team made changes to the recruitment materials to improve their communication, and to how they inform people who are not eligible to participate (to provide a clear explanation of why this is). A member of this team has now joined the PAR group.

Specific examples of how patients, carers and the public have been actively engaged in our research include:

The OxDARE (Oxford Dementia and Ageing Research) research team and a clinician delivered an educational prevention talk to family members of residents of a local care home (Jan19). Attendees said the event allowed them to ask questions of experts that they otherwise wouldn’t have had the opportunity for.

The Older Adults and Dementia theme have developed a ‘Brain Fitness Module’ to engage the public in brain ageing and dementia research by delivering relevant content, with personal value, within community settings (e.g. GP surgeries). Age UK Oxfordshire has expressed an interest in the modules being delivered across their network.

The Clinical Research Infrastructure and Experimental Medicine theme have taken their research on emotional decision-making to schools and community events. Using a range of activities (including plasticine brain modelling and a balloon game) they have explained the tasks used in their studies, and the reason they use these to evaluate new treatments for depression. This has led to conversations on broader issues regarding mental health treatment, which have fed into their ongoing public engagement. This project won the Department of Psychiatry Award for public engagement and science communication.

Examples of how we have kept patients and public informed about our research include:

An Open Day (May18), in partnership with the CRF, sharing research across the BRC’s 6 themes with a broad audience including public members.

PPI contributors were invited to the Department of Psychiatry 50th Anniversary event (Mar19). We worked with the Mental Elf to share podcasts and discussions from the event with a public audience.

OxDARE keeps the public informed about our ageing and dementia research. It communicates recent research findings in quarterly newsletters, at community events, on the OxDARE website, and via Twitter.

The Brain and Cognition Laboratory, led by Theme Lead Professor Kia Nobre, runs a blog detailing new publications and research news.

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2.2.3.5 Education and Training (Theme Lead: Professor Elizabeth Tunbridge)

Our priority in the last year has been to establish the bespoke training courses that form the core of the capacity development plans outlined in our application and which were highly commended by the panel. These are the Oxford Course in Experimental Medicine for Mental Health (OxCEMM) and the MSc in Translational Neuroscience. We have been successful in establishing both of these: OxCEMM ran for the first time in January 2019, and the first intake of the MSc in Translational Neuroscience will begin the course in October 2019.

OxCEMM is a short course designed to provide attendees with the practical information they need to design, conduct and analyse experimental medicine studies. Our aim was to attract attendees with diverse backgrounds, and from across the UK. We were successful in achieving both of these aims: our 22 attendees came from a range of backgrounds, including psychiatrists, nurses, pharmacists, other allied health professionals and basic scientists, and from across England (including other parts of the NIHR infrastructure). Given its success, we plan to rerun OxCEMM, essentially unchanged, in January 2020.

Our plans for the coming year are to establish the Experimental Medicine Network – a community for individuals from diverse backgrounds to share expertise to further experimental medicine in mental health. All OxCEMM attendees expressed a desire to be part of this network. In addition, we are thinking about how we might best address other training needs, particularly support for grant applications, since this is an area raised by a number of our OxCEMM attendees.

Being a new and relatively small BRC, we continue to have relatively few Academy Members, although numbers are beginning to grow. Most notably, we have successfully established a new doctoral studentship jointly funded by our BRC and Wolfson College, Oxford. Our first student on this programme started his DPhil studies in October 2018.

2.2.3.6 UK-CRIS (Theme Lead: Mike Denis)

The scope of activities to be carried out were agreed with NIHR in March 2018 and focused on five elements, each of which were designed to support the development of a sustainability model for CRIS in future years.

Core Support Team

The Core Team has been established to strengthen engagement with the UK-CRIS Network member Trusts whilst offering support for users through training and other development activities. The team comprises several members including; Training and Support Lead, Natural Language Processing Lead, CRIS Research Lead with support from other specialists to meet identified needs.

The aim was to improve their internal capabilities and knowledge of how they could gain the most from the system. A delivery plan was designed and implemented to provide workshops and training for all users of CRIS. Additional workshops included; SQL, Natural Language Processing (NLP) and OHDSI tools including Observational Medical Outcomes Partnership (OMOP) Common Data Model (CDM).

A priority task was to develop the NLP capabilities across the Network enabling users to understand the process of structuring the unstructured data within the records whilst establishing a Network wide approach to development and adoption.

Migration to New Hosting Platform

Approaching the end of the three-year agreement, we were already progressing a robust procurement process in March 2018 to identify a suitable provider who was able to offer a streamlined infrastructure model with the required secure environment whilst providing immediate savings for the programme.

Following a market appraisal eight possible providers were considered and after evaluation two data centres were shortlisted. Following further activity UKSeRP at Swansea University were identified as the preferred solution.

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The contract for supply of services was signed 17th September 2018. The development environment was built, tested and delivered first, followed by the production environment and data migration.

Sustainability Model - NewCo

Progress to establish CRIStal Health Limited has continued through the year requiring engagement with NIHR and the participating Trusts. The development of a viable business plan relating to a University spin-out, identification of a lead investor and investment secured have been achieved with completion of the spin out process expected in April 2019.

Research Enhancements through Data Linkage

Successful implementation of a dynamic linkage model with UK-Biobank (UKB) identified an immediate match of 15,000 subjects. Three research projects are being progressed;

UK-CRIS/UK Biobank Projects

1. Modelling dementia risk in real-world clinical and population-level data. 2. UKB CRIS-Depression. A pilot study on identifying the biomarkers associated with (non) response to

treatment in patients with treatment resistant depression and major depressive disorder3. UKB-CRIS-Validation. A pilot study on validation of the outputs of the named entity recognition (NER)

algorithm by matching extracted results with those similar available in the UKB.

Furthermore, we are delighted to report we have successfully implemented linkage with NIHR-HIC (Oxford). In addition, we achieved successful integration of IAPT data within the Core CRIS platform. As we prepare to close down programme activity we shall also be finalising a linkage model between Avon and Wiltshire NHS Foundation Trust (AWP) CRIS data and Avon Longitudinal Study of Parents and Children (ALSPAC) data.

Partnering: South London and Maudsley NHS Foundation Trust (SLaM)

We have engaged with SLAM throughout the year in discussions centred on joining the programme. We’ve agreed an Information Governance model that would support their data being included and are agreeing a joint project that would support meaningful collaboration.

More recently, SLaM have been engaged in discussions with the set-up of CRIStal Health Limited and have indicated their willingness to engage in a number of leadership positions within CRIStal Health Limited. We believe with this level of collaboration we will ensure that the two biomedical research centres will work together in shaping the plans of CRIStal Health Limited.

Whilst growing the Network was out of agreed scope for this year’s programme we are delighted to report that Birmingham and Solihull Mental Health NHS Foundation Trust joined the CRIS Network contributing over 400,000 records. Additionally following significant engagement Cardiff and Vale University Health Board are expected to join the Network shortly.

2.3 NIHR Collaboration in Leadership in Applied Health Research and Care (CLAHRC)

2.3.1 Governance

Theme reviews by the CLAHRC Management Board were completed; 1 and 5 on 4 March 2019 and themes 2 and 3 on 4 June 2019 (summaries below)

The CLAHRC programme ends 30 September; final reporting requirements have yet to be announced by NIHR.

2.3.2 Theme 1–Early Intervention and Service Redesign – Prof Belinda Lennox

The multidisciplinary team and effective support from statisticians/evaluators were key to the success of this theme. The Oxford Healthcare Improvement Unit (OHI) now aims to embed evidence-based service redesign.

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Impact highlights include presentation of the systematic review of Mental Health Street Triage to the National Police Chiefs’ Council and the Self harm project.

Discussion around this theme identified a number of learning points for the future including:

Academic Clinical Fellowships in public health Industrial funding challenges Implications of bottom up and top down approaches Importance of regular dialogue between research and implementation to capture wider impact

2.3.3 Theme 5-Patient Self-Management– Prof Richard McManus

This theme had good academic output and leveraged 2 programme grants. Research student successes (6) and PPI innovation were highlights

Discussion focused on Data provision Health Economics Industry connections Development of the theme in the proposed ARC

2.3.4 Theme 2 – Behaviour Change – Exercise and Rehabilitation – Prof Sallie LambThe Theme lead made a comprehensive presentation; CLAHRC funding has been used to augment trials and programme grants to enable impact on health policy and practice. Additional work and analysis has been conducted to answer important questions relating to implementation. Highlights include:

iSARAH e-learning resource for therapists to support adoption of intervention in clinical practice SARAH service evaluation to assess impact of implementing the intervention in practiceiBeST online training for therapists – now on FutureLearn platformBeST service evaluation

1.1.5 Theme 3 – Patient Experience and Patient Reported Outcomes – Prof Ray Fitzpatrick

Theme 3 focused on ways to capture and convey patients’ views and experiences in order to improve both research and services. Two broad and complementary emphases underpinned the theme: (i) the patient’s perspective on the outcomes of services and (ii) his or her experiences of how services are delivered. The theme has leveraged additional funding, had impact nationally through Versus Arthritis and established extended links to public health and social care for the Oxford and Thames Valley ARC set to run 2019-2024.

2.4 NIHR Applied Research Collaboration Oxford and Thames Valley (OTV ARC)

Final decisions were announced under embargo in May. Draft contracts have been reviewed and the main agreement from the funder and is awaiting signature by the Trust.

CLAHRC activity to underpin the ARC is underway with several collaborative workshops planned for September and October 2019

2.5 NIHR MedTech and In Vitro Diagnostic Co-operatives (MIC)

2.5.1 Industry consultations

The NIHR Community Healthcare MedTech and IVD Co-operative has held 3 formal company consultations in the last six months and engaged approximately 30 organisations during the joint Medical Sciences

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Division/MIC-hosted Academic Industry Meeting Day (AIMday) on Antimicrobial Resistance which took place on the 4th of July in Oxford.

2.5.2 Publications

The MIC team has published the following papers since the submission of the last report

Nicholson BD, Jones NR, Protheroe A, Joseph J, Roberts NW, Van den Bruel A, et al. The diagnostic performance of current tumour markers in surveillance for recurrent testicular cancer: A diagnostic test accuracy systematic review. Cancer epidemiology. 2019;59:15-21.

Roope LSJ, Smith RD, Pouwels KB, Buchanan J, Abel L, Eibich P, Butler CC, Tan PS, Walker AS, Robotham JV, Wordsworth S. The challenge of antimicrobial resistance: What economics can contribute. Science. 2019;364:6435

2.5.3 Events / Engagement

The Acute Adult Ambulatory Care and Future Hospital clinical theme (Professor Dan Lasserson lead) delivered a workshop entitled ‘Ultrasound: Delivering the Diagnostics Strategy of the Future’. The workshop took place on the 28th March 2019 in Birmingham, with key talks delivered by Dr Tony Newman-Sanders (NHSE National Clinical Director for Diagnostics) and Professor Alison Noble (Technikos Professor of Biomedical Engineering, University of Oxford). Oral presentations delivered by leaders in the field of point-of-care ultrasound development and clinical use sandwiched interactive workshops. The event was attended by three providers of point-of-care ultrasound equipment (GE-Healthcare; Esaote; Fujifilm) who supplied equipment for hands-on familiarization sessions for attendees with model patients (pre-screened volunteers). The event incorporated accelerated learning round-table discussions where MIC staff explored barriers and facilitators to the use of point-of-care ultrasound in acute care with attendees. The event had 100 registered attendees.

The MIC co-hosted an Academic Industry Meeting Day (AIMday) with the Medical Sciences Division which focused on measures to address antimicrobial resistance. The event took place on the 4 th July and began with a plenary talk delivered by MIC Clinical Director, Professor Chris Butler. The meeting was attended by a large number of companies, academics and key funders of AMR research (The Wellcome Trust).

The MIC Acute Paediatrics Clinical Theme hosted a workshop on the 2nd of May 2019 at Trinity College Oxford which explored potential solutions to the challenge of collecting clean-catch urine samples from paediatric patients. The workshop was co-hosted by the NIHR Children and Young People MIC, which is based in Sheffield and incorporated paediatric specialists, GPs, engineers, designers, public representatives, a paediatric healthcare charity, and a manufacturer of urine collection devices. The outcomes of the workshop are being taken forward by the MIC in collaboration with colleagues from the Institute of Biomedical Engineering (Oxford) through their Biodesign Fellowship program.

Dr Thomas Fanshawe (Senior Statistician) and Dr Philip Turner attended the annual global meeting of BSI (British Standards Institute), which took place in Oxfordshire on the 03/06/19 on the invitation of Dr Erica Conway, Global Head for In Vitro Diagnostic Medical Devices. Drs Fanshawe and Turner delivered a workshop on the performance evaluation of diagnostics to the Global Diagnostic Medical Devices team, making particular reference to the implications of the new CE-IVD Regulations, which govern the certification of in-vitro diagnostic tests.

Dr Joseph Butler, Dr Simone de Cassan, Professor Belinda Lennox and Dr Philip Turner attended the Oxford Health NHSFT Physical Health in Serious Mental Illness Conference on the 24th June 2019 in Aylesbury. Dr Joseph Butler presented the CArdiovascular scReening in MEntal IllNess project. MIC

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staff also hosted an accelerated learning workshop with clinical staff to identify clinical needs in this patient group.

Dr Philip Turner attended the BIVDA (British In-vitro Diagnostics Association) Near Patient Testing Working Party meeting on the 18/07/19, where he contributed to discussions, particularly around the proposed withdrawal of POC HbA1c testing for the management of patients with T2 diabetes. Dr Turner also introduced the MIC Diagnostic Evidence Workshops to attendees; these training workshops will take place in September 2019.

2.5.4 Recent funding The NIHR MIC was awarded funding through the MRC Proximity to Discovery program to provide

bursaries to small and medium-sized diagnostics companies to fund their attendance at the MIC annual diagnostic evidence workshops. Sufficient funds were awarded to support the attendance of 16 company representatives. Bursaries were awarded to applicants through open completion in July 2019.

2.5.5 Selected Projects

Working with Professor Belinda Lennox (key researcher MIC Long-Term Conditions clinical theme), the MIC is carrying out a project based in OHFT which is focusing on improving access to physical healthcare screening (lipids and HbA1c) for patients with severe mental illness. The CARMEN project is underpinned by community delivery of these tests through a portable point-of-care diagnostic system which can be taken to patients’ homes. The CARMEN team has completed the first 6-months of evaluation and is currently analyzing data, with initial analyses suggesting that the intervention has had a positive impact in terms of numbers of patients receiving a full physical health check in the intervention region when compared to controls.

The ADVANCE project is an EIT Health (EU Horizon 2020 program) funded innovation project which is being led by MIC director Professor Chris Butler to further develop and clinically evaluate a novel rapid diagnostic test for urinary tract infection. The Quantitative Urinary Tract Infection (qUTI) test, has the potential to guide appropriate treatment of this common infection through provision of a more definitive diagnosis and antibiotic sensitivity test at the point of care. The project began in July 2019 in collaboration with the Specialist Antimicrobial Chemotherapy Unit (Public Health Wales), the Region Uppsala (and Uppsala University) and Astrego Diagnostics AB. The project will conclude in December 2020.

2.6 NIHR Clinical Research Network (CRN) based performance

2018-19 was a record-breaking year nationally with 870,250 participants taking part in NIHR CRN supported clinical research studies - the highest number on record and an increase of over 140,000 on the prior year. LCRN recruitment in 2018-19 was particularly strong with over 63,000 (target 45,000) participants recruited to NIHR CRN Portfolio studies which made the network the third highest recruiting network per head of population.

An overall target for recruitment of 50,000 has been set for 2019-20. This includes a recruitment target of 1,550 for Dementias and Neurodegeneration (DeNDRoN) studies and 2,000 for commercial studies

Oxford Health were ranked 4th highest Mental Health Trust in 18/19 in terms of both the number of studies running and the number of participants recruited.

Mental Health Trust Studies

South London and Maudsley NHS Foundation Trust 106Midlands Partnership NHS Foundation Trust 77Cambridgeshire and Peterborough NHS Foundation Trust 66

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Oxford Health NHS Foundation Trust 62

Notes: Midlands included 30 Musculoskeletal studies Cambridge, 11 studies spread across 6 non-Dementia or MH specialties Oxford Health, 4 studies spread across 3 non-Dementia or MH specialties

Mental Health Trust Participants South London and Maudsley NHS Foundation Trust 22,482Sussex Partnership NHS Foundation Trust 3,998Northumberland, Tyne and Wear NHS Foundation Trust 3,174Oxford Health NHS Foundation Trust 2,898

Notes: Northumberland, 390 recruits to Public Health specialty Oxford Health, 12 recruits across 2 non-Dementia & MH specialties

Breaking the results down further provides the following results

Studies RecruitmentMental Health & Dementia 2nd 3rd

Mental Health Only 2nd 3rd

Dementia only 4th 8th

There is a reduction nationally in the number of studies available but in an effort to try and address the OH position nationally we have created a Business Development group which meets monthly. This group looks at participants (including equality and diversity), delivery capacity, Trust engagement and raising the R&D profile, study and grant opportunities, collaboration and networking, commercial awareness and developing the OHFT offer.

3 Research Set Up, Management and Governance

3.1 Research Set Up

Work has taken place in streamlining research set up activities to ensure that research is available to patients and easily accessible to teams across our care portfolio. This is vital in improving research engagement.

The team has mapped and communicated the study set up processes and procedures to ensure that they are more user friendly. These systems include mechanisms to significantly reduced our study set up time, ensure studies are set up on time, recruit to target and are delivered efficiently.

This year, the goal is to ensure that studies take no longer than 4 weeks to set up from the date a full set of documents are provided to the date our teams are clear to start recruitment.

Study set up and performance

Studies and participant recruitment

2016/2017 2017/2018 2018/2019 2019/2020*Number of Open Studies 62 73 75 82

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Number of Participants 2510 2252 2383 637

*YTD as of August 2019. There are issues nationally in reporting accuracy which we understand will be mitigated in Q3 (CRN and NIHR are aware that this is causing inaccuracies in reporting)

Number of studies approved

Year Number of Studies approved 2016-2017 42017-2018 342018-2019 412019-2020 25 (at August 2019)

Health Research Authority (HRA)

There has been a backlog in joint HRA/ethics approvals since the process was centrally merged in June. We anticipate this clearing in the coming months but have noticed an impact in studies coming to the set-up phase.

Contracting

Contracting, while good throughout Q1, has lagged over the summer due to staffing issues in the OUH Contracts team. They have recently recruited, and we have once again refined the way that we are working with them to mitigate any more delays.

Staff

The study set up team continues to feel the impact of staffing shortages due to sickness and family related time off. The Manager is working with HR to manage these issues, but unfortunately at times this hinders our progress and activity significantly and without notice.

3.2 Case Records Interactive Search (CRIS) (Lead: Tanya Smith)

The Oxford team includes a CRIS Data Administrator who supports new users of CRIS to set up their user accounts, projects and conducts the audits and 2 CRIS Academic Support and Data Analysts who provide support to CRIS researchers in framing their CRIS question and running more complex searches and extracting relevant data for users to subsequently analyse.

The Oxford CRIS Oversight Group meetings are held bi-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, a carer/patient representative, representatives from the trust Clinical Directorates, Trust Audit Team, Trust Pharmacy team and academic leads from the University.

To date the CRIS have received appropriate approvals to conduct 60 UK CRIS applications, 33 research questions, 11 service evaluation, 16 clinical audit questions. We currently have 25 active CRIS searches and 63 active CRIS users.

Oxford Health NHS FT has been using the CRIS system since 2015 as a tool to access and interrogate clinical records for research proposals, service evaluations and clinical audits. During this time the system has been provided by the University of Oxford and funded by various research awards.

In FY19 the NIHR provided funding to the Oxford Health BRC to develop a sustainable platform for CRIS going forward. The solution agreed by the NIHR was the creation of Cristal Health Ltd as the vehicle to supply and support CRIS in the future. The current contracts with the University for the provision of this service come to an end on 19 September 2019.

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CRIS will now by provided by Cristal Health and the Trust are currently in the process of agreeing a contract where the plan is that they will provide the CRIS service at nil cost but allow them to provide Industry with numerical access to Trust Data

Natural Language Processing (NLP) work - This provides CRIS users with an automatic text reading facility for extracting and providing the context for relevant data currently only available within the free text fields of a medical record.

Work continues in locating all mentions of drugs within the clinical notes and whether they are being prescribed, mentioned or ‘PRN’ along with their dose. For Anti depressants and anti psychotic drugs, this work is now almost complete and is currently used to support POMH clinical audits in providing clinicians with targeted information to enable them to answer the audit questions, substantially reducing their time. Future plans are will subsequently enable all CRIS Network Trusts to run across their own data to also benefit from this work. The work has on locating MMSE and MOCA cognitive scores is also complete and in use where research studies require the scores locating.

CRIS SQL Training – Oxford have been instrumental in developing the recent SQL training workshops as well as supporting with additional external linkage work.

Staff have developed a 2-day programme to train CRIS researchers across our Network. They delivered a workshop to CRIS researchers from across the UK CRIS Network, in March and the materials generated from this workshop are now available on the CRIS Network Resource pages to support all CRIS researchers.

Virtual Desktop Environment – CRIS researchers have now moved onto the Swansea University - UK Secure Research Platform (UK SeRP) facility where they can securely conduct their searches and store their extracts. This facility also provides additional analysis and NLP tools.

We continue to offer an additional Microsoft Azure virtual desktop facility, created by Oxford Health Trust IT department, for our NLP scientists which has adequate resource to support their work.

The Consent for re-contact pilot is reviewed below. There is a form in CareNotes and patients were being asked whether they are interested in being contacted about research in the future.

Improving Access to Psychological Therapies (IAPT) linkage – Oxford CRIS is now linked to a static set of IAPT data (Oxford and Buck service). We are now conducting a service evaluation linking data across both IAPT and Mental Health Services to understand “What are the treatment gains in IAPT services?” and “Do the patients who have made a reliable improvement in an IAPT service maintain those gains or do they represent within IAPT or other services?” working closely with the Jo Ryder and John Pimm from the IAPT services.

3.3 Consent to discuss participation in research (Lead Professor Andrea Cipriani)

Since the last report, we have completed the analysis of the pilot study and have drafted the manuscript, which has been submitted to the international scientific journal Evidence-Based Mental Health (BMJ Group).

Here below a summary of the article, which will be circulated in full once published.

Patients who take part in research have improved clinical outcomes, and research active Trusts have lower mortality rates and do better in overall performance. However, recruitment to research within the National Health Service (NHS) can be challenging and involves several barriers, especially in mental health. New strategies to improve access to research for all patients became a key priority for Oxford Health NHS Foundation Trust, in collaboration with the Digital/Informatics Theme of the Oxford Health Biomedical Research Centre. One potential strategy is to adopt an opt-in approach by asking patients for consent to discuss participation in research (CDPR). This process needs to be streamlined and to empower all clinical staff, not just research active clinicians, to talk to patients about research so that patients are properly informed about the potential benefits of taking part in studies.

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In order to use an opt-in approach of asking patients their permission to contact them about research opportunities, we needed to introduce a way to record the patient’s consent. Utilising a system already used by clinical staff within the Trust, we used the electronic patient health records system called Carenotes, which records all patient data, and added a new form where CDPR could be recorded. The new form was developed after a consultation period with several key stakeholders, including representatives from Oxford Health Research & Development, clinicians, and the Clinical Record Interactive System (CRIS) oversight committee (which includes patients and people with lived experience of mental health issues from the Trust). The form contained two tick box questions; “Do you consent to being contacted about research opportunities?”, and “Do you consent to be contacted after discharge?” It also included a section to record the patient’s capacity to answer CDPR and a consultee section.

To understand whether the form was something that could and would be used by clinical staff, and whether this opt-in approach was of value to patients and staff, our feasibility study was developed. We also aimed to identify whether alternative strategies to engaging patients in research opportunities should be considered such as the opt-out approach

This was a mixed methods study consisting of three phases: 1) quantitative data capture of the number of patients who were offered the opt-in approach by clinicians (via the CDPR form), 2) an online staff survey and 3) qualitative focus groups with patients at each pilot site. The protocol of the study was drafted in advance and is reported in the Appendix.

Four pilot sites were randomly selected by the researchers that were representative of a range of mental health clinical services and patients across the Trust; two memory clinics (MC), an Adult Mental Health Team (AMHT), and an Acute Adult ward (AA). All four pilot sites consisted of staff with a diverse range of roles and clinical expertise, who had daily access to Carenotes via an electronic device or computer.

Phase 1: An introductory visit took place at each pilot site, where staff were shown the location of the CDPR form on Carenotes, trained in how and when to potentially ask the opt-in question, and provided with CDPR leaflets with contact details of the CDPR study team. Staff were encouraged to develop their own implementation strategy depending on their service type about when they wished to ask the question (e.g., assessment visit; during treatment; discharge).

Phase 2: All staff who agreed to take part in the study were subsequently sent the online staff survey.

Phase 3: UK Clinical Record Interactive Search (UK-CRIS) was used to search Carenotes to identify patients who had opted-in during Phase 1. These patients were contacted by phone by a researcher (SW) about taking part in a focus group, and if interested were sent a participant information leaflet by email or post. Due to a very low uptake of CDPR at one of the pilot sites, focus groups only took place at three of the sites. Memory clinic patients were invited to attend with a study partner/carer if they wished.

Data collection was undertaken sequentially between the three study phases: Phase 1 between July-December 2018, Phase 2 between May-June 2019 and Phase 3 in June 2019.

Phase 1. Clinical staff discussed the opt-in approach with any Oxford Health patients attending clinical services at each of the pilot sites, for the duration of the six-month study. This excluded patients who lacked capacity, required a consultee during the discussion, or any patients who were under the age of 18.

Phase 2. Staff feedback was collected through an online survey sent by email, containing ten questions about the CDPR form and implementation (https://www.surveymonkey.co.uk/r/YZ2JVVZ). All survey responses were confidential and anonymous. Staff were given one month to complete the questionnaire, with non-responders receiving two email reminders.

Phase 3. Three separate focus groups were held in a meeting room at each of the clinical services (AA, MC, AMHT) which was familiar to the participating patients. The groups were facilitated a researcher (SW) and member of clinical staff. Written informed consent was obtained for all participants, and participants were asked for oral permission to audio record the session. The groups lasted no more than an hour, refreshments were provided, and participants were reimbursed £20 for participation, plus travel expenses.

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Results

Across all four pilot sites 1,779 patients attended services during the pilot period. Of these only 197 (11.1%) had a CDPR form completed by staff and 143 (8.1%) opted-in to being contacted about research. Table 1 shows the age, gender and diagnostic information for patients attending pilot sites, and for patients who completed CDPR forms. Form completion was not evenly spread across the staff who participated in the pilot. At the AMHT, one staff member (clinical research assistant) completed 38 out of 53 (71.7%) forms; of these 96.9% patients opted-in. At another MC pilot site one staff member (nurse) completed 32 out of 68 (47.1%) forms; of these 74.8% patients opted-in.

The questionnaire was sent to 47 members of staff who had taken part in phase 1 and the overall response rate was 27 (57.4%). Approximately, 17 (62.9%) were senior clinicians, 6 (22.2%) were junior clinicians, 3 (11.1%) were research staff, and one (3.7%) was a member of the administration team. The two most frequently agreed with statements about the form were that “it wasn’t clear whether it needed to be saved or confirmed on Carenotes” (35.2%), and “it wasn’t clear what needed to be filled out or left blank” (35.2%). Nineteen (70.4%) respondents found the form easy to find on Carenotes, and 20 (74.1%) said that prompts on Carenotes would help them remember to complete it. In terms of implementing the opt-in approach using the CDPR form, 14 (51.8%) said that they found it neither easy nor difficult to do. Overall, 95.9% (26 out of 27) agreed with the statement that research is essential for improving the clinical care offered by their service.

Overall, 18 patients took part in the focus groups. The average age of the participants was 48.9 years, and the sample was predominantly male (72.2%) and White British (88.9%). The main themes to emerge from the data set about the CDPR pilot were ‘patient choice’, ‘trust in the system’, ‘respect for patient journey’, ‘perception of research’ and ‘recruitment efficiency’.

Some participants said they would know how to respond to the opt-in question straight away, whilst others said they would prefer time to consider it, might want more information about what taking part in research would involve and what type of studies they might be invited to and indicated that perhaps the clinic environment was not the best place for this.

The NHS and all its’ related research activity seemed to be faceless system to most patients, so they trusted some methods of contact from this system over others and would like this preference to be recorded on their CDPR form.

The majority preferred written contact in the form of an email or postal letter. Patient preferences about who asked them the CDPR question by was based on the level of trust they had with different types of staff. The MC group had high levels of trust in the memory service and were largely indifferent to who they were asked by, whereas the inpatients did not trust clinicians (due to being under section or medication disputes) so preferred being asked by a support worker. The AMHT group indicated that they would be more likely to opt-in if they were approached by a trusted healthcare professional.

The timing of being asked the CDPR question was important in terms of respecting when the patient’s clinical needs take priority over research, and generally assessments were seen as not appropriate.

There was limited understanding about the links between research and improved treatment and clinical care, but there was a consensus that research and improving recruitment was important.

Finally, participants highlighted the need for research contact to be efficient by maintaining up to date records of their personal information on Carenotes.

Comment

The discordance between the generally positive views towards the opt-in approach and the very low completion rate limits the feasibility of CDPR as a strategy to improve access to research for real-world patients. Findings indicate that although the concept of the opt-in approach is positively received, it is not

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very successful in the clinical setting. Phase 1 data showed that only 11.10% of patients attending services had a CDPR form completed for them. This falls vastly short of being able to infer that the majority of patients were systemically and comprehensively being asked the CDPR question as part of their routine clinical care.

Phase 2 feedback indicated that the low completion rate was due to a perceived lack of time to ask the CDPR question, a lack of clarity about who should be asking the question and when, a lack of awareness and interest in research and its relevance to their patients, a lack of understanding about CDPR, and a poor user experience of the Carenotes system dissuading staff to implement a new form easily and confidently.

The types of staff involved may also explain the differences between form completion rates at each of the pilot sites, and opt-in rates because the research-active staff were more comfortable talking about research, and/or had allocated time to do so. Although the aim of CDPR was that all staff would ask the question, the reality was that only a handful of staff did so. This implies that building in specific time for all clinical staff to discuss research with patients may be beneficial. The clinical context of the service may also have played a vital role in supporting the CDPR activity. Services where patients are prescribed more medication, or may be under section, could lead to strained clinical relationships and make it harder for staff to prioritise talking about research, and for patients to trust and engage with researchers. This suggests that more training and support is required to equip all staff with skills needed to engage with the task as part of, not in conflict with, their routine clinical practice.

The Phase 3 findings highlighted how the opt-in approach was generally well received by patients. However, patients raised several points about potential improvements to the CDPR form and suggestions for effective implementation of the opt-in approach. As long as these improvements to the opt-in approach focused on the values of trust, choice, efficiency and respect for the patient journey, there was general consensus that more patients asked the question would choose to opt-in, and roll-out of the approach across the trust would be more acceptable.

Conclusions

whilst modifications may be made to the current opt-in approach in order to improve its’ feasibility, such as improving the form, and providing more training and support to staff, further work needs to be done to ensure that the majority of patients are being offered opportunities to take part in research that might improve their healthcare outcomes. Other strategies to improve access to research for all patients should be considered, including an opt-out approach, whereby all patients are initially contacted by Research and Development departments to inform them that there are research opportunities available to them should they wish to find out more.

4 Trust Governance and Reporting Mechanisms

4.1 Reporting and Governance

The Research Management Group (RMG) is a high-level committee established to drive the collaborative research strategy across the Trust and local areas. It is responsible for the strategic and scientific direction of the research undertaken with or in partnership with OHFT.

The meetings bring together academics and clinical services with mutual interest in particular projects or work streams to increase engagement between clinical services and research for open discussion about the synergistic and collaborative working to deliver patient benefit through research endeavors.

The RMG receives information and assurances from the various research activities undertaken in conjunction with OHFT, including the OHFT BRC, CRF, CLAHRC, DEC, TV&SM CRN, Case Records Interactive Search (CRIS), Research Feasibility, Set-Up, Delivery and Management (including quality assurance), Pharmacy and Research Finance.

A summary of these reports is submitted to the Quality Sub Committee: Effectiveness on a quarterly basis.

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The RMG was noted by the NIHR BRC feedback as noteworthy and worth sharing with colleges nationally.

5 Finance

5.1 Research Income

Over the last ten years, OHFT income generated from research activity has grown from just under £2m in FY10 to an FY20 budget of £11.6m.

Income over the period FY10 to FY14 was largely from a small number of grants but over the last six years these have been replaced by infrastructure awards, providing the opportunity to support more research activity and generate leveraged income.

FY10 Actual

FY11 Actual

FY12 Actual

FY13 Actual

FY14 Actual

FY15 Actual

FY16 Actual

FY17 Actual

FY18 Actual

FY19 Actual

FY20 Budget

0

2

4

6

8

10

12

14

Oxford Health Research Income FY10-FY20

Years

Mill

ions

£'s

5.2 FY20 Income Budget

The FY20 Income budget of £11.6m is made-up and managed as follows:

FY20 Income Budget £kManagement of Funds £k jSMT kPC Other Total

National Institute for Health Research (NIHR)Biomedical Research Centre (BRC) 2,846 2,846 Collaboration in Leadership in Applied Health Research & Care (CLAHRC) 1,000 1,000 Applied Research Collaboration (ARC) 824 824 Research Capability Funding (RCF) 767 661 1,428 Grant income 548 967 1,514 Clinical Research Facility (CRF) 748 748 Gamechanger (I4I) 1,234 1,234 Medtech and InVitro Diagnostic Co-Operative (MIC) 249 249

NIHR -Total 6,143 3,700 - 9,843 Clinical Research Netw ork : Core Funding 830 830 Clinical Research Netw ork : Hosting of Primary Care Research Partnership 390 390 Study Delivery 91 91 Other Grants 483 483

1,404 - 390 1,794 Grand Total 7,547 3,700 390 11,637

Management of Funds

Note 1: SMT (R&D Senior Management Team) made up of Prof. John Geddes (R&D Director), Bill Wells (Head of R&D), Prof. Andrea Cipriani (Associate Director of R&D), Vanessa Raymont and Dr Cathy Henshall (CRF Manager).

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Note.2: (PC) Primary Care, CLAHRC/ARC lead by Professor Richard Hobbs, MIC led by Gail Hayward and 4 NIHR grants, led by Prof. Richard McManus, Prof Andrew Farmer, Dr Claire Friedmann Smith & Dr Ben Goldacre

5.3 Performance

R&D reported a contribution to overheads of £79k for FY19, compared to budgeted expenditure of £129k, generating a £208k Favourable Variance.

As at Month 4 in FY20 expenditure was £39k compared to a budget of £79k, generating a favourable variance of £40k. Currently the expectation is that R&D will have a £40k favourable Year end variance.

5.4 Biomedical Research Centre (BRC)

The BRC commenced in April 2017, (£12.8m over 5 years), and is led by Professor John Geddes from the Department of Psychiatry. The FY19 funding of £2.8m was increased to £3.8m by the NIHR to support the development of a sustainable platform for UK CRIS. This funding was non-recurrent, and funding in FY20 is back to £2.8m.

5.5 Collaboration in Leadership in Applied Health Research & Care (CLAHRC)

The CLAHRC commenced in January 2014 and following a successful extension application it runs until September 2019. FY20 Funding is £1 million.

5.6 Applied Research Collaborations (ARC)

In May 2019, OHFT was informed that it was successful in its application for ARC funding, (which replaces the CLAHRC), by the NIHR. The total award is £9 million spread over 5 years, with £824k in FY20, starting on 1 October 2019. Detailed work is on-going with Theme leads, to agree the Year 1 budgets from the award.

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

The FY20 RCF allocation of £1,428m showed an increase of £223k on FY19. This was generated from an additional Senior Investigator Award (Prof Anke Ehlers) £75k, the full year effect of the BRC funding £111k and additional Grant Income £37k. The FY20 award was split between the Trust & Department of Psychiatry (including CLAHRC) £767k and the Department of Primary Care £661k.

Following a review of RCF by the Department of Health (DH), the amounts based on Infrastructure awards will reduce over the coming years, the Senior Investigators element will be removed. The grants element remains unchanged.

Despite this, with additional RCF received from the BRC Infrastructure award, we expect Trust RCF to increase in FY21, to approximately £1.6 million, from increases in Grant income. This will then drop, quite significantly thereafter, as Senior Investigator Awards element is removed at the end of the 5-year award period.

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FY19 FY20 FY21 FY22 FY230

200400600800

10001200140016001800

RCF Funding Forecast

Infrastucture Senior Investigator Grants

Year

£000

's

5.8 Clinical Research Facility (CRF)

CRF funding commenced in April 2017 (£3.7m over 5 years, FY20 £748k). This award is hosted by OUH but managed in its entirety by OHFT with the bulk of the funding being used for activity based at the Warneford. Funding was planned to be used for development of CRF facilities at the OUH however due to problems in identifying suitable space funding was reallocated to other areas selected as part of a competition in FY19. This included supporting the Oxford Acute Vascular Imaging Centre and ongoing research in movement disorders and neurodegenerative disease.

5.9 I4I

The I4I award “Immersive virtual reality to transform the lives of patients with psychosis” (£3,9m over 4 years, FY20 £1.2m) commenced in June 2018, and is led by Professor Daniel Freeman (Department of Psychiatry).

5.10 Medtech and In vitro diagnostic Co-operative (MIC)

The NIHR funded MIC started in January 2018 and is led by Gail Hayward from the Department of Primary Care (£1.2m over 5 years, FY20 £250k).

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

The FY20 core CRN budget of £830k funds Service Support Activity (primarily patient recruitment). It is currently predicted that only £790k will be utilized by OHFT with the balance being returned to the CRN.

CRN Network staff such as the Thames Valley Primary Care Research Partnership are hosted by the Trust but not under the management of the R&D Senior Management Team. their costs are recovered on a direct cost basis from the CRN (FY20 budget £329k).

The CRN is also supporting, the Oxford Health project, to involve more Consultants in Research. This is funding 1 session of 4 Consultants, for 9 months, which will hopefully promote new PI’s within the Trust.

5.12 Grant Income

OHFT is the lead site for the following awards:

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Trust/Dept of Psychiatry

Dr. Valeria Frighi (Dept of Psychiatry) “Fractures in people with intellectual disabilities” (£152k, FY20 £41k) Prof. Paul Stallard (University of Bath). “A comparison of usual care versus usual care plus a smartphone self-

harm prevention app (Blue Ice) in Young adolescents aged 12-17 who self-harm” (£350k, FY20 £66k) Prof. Cathy Creswell (Dept of Experimental Psychology) “Development and evaluation of a pathway from

‘universal screening’ to online intervention for children with anxiety problems (£2.5m, FY20 £439K) Dr. Felicity Waite (Dept of Psychiatry) “Preventing psychosis in young people at ultra-high-risk attending NHS

mental health services: a feasibility study of a novel intervention target” (£251k, FY20 £30K)

Dept of Primary Care Prof. Richard McManus (Dept of Primary Care). “Optimising the monitoring and management of raised blood

pressure during and after pregnancy” (£2.5m, FY20 £631k) Prof. Andrew Farmer (Dept of Primary Care). “Supporting people with type 2 diabetes in effective use of their

medicine through a system comprising mobile health technology integrated with clinical care” (£2.5m, FY20 £307k)

Dr. Claire Friedmann Smith (Dept of Primary Care) “Safety-netting in Primary Care: A realistic review of the contexts and mechanisms on its effectiveness (£150k, FY20 £42K)

Dr. Ben Goldacre (Dept of Primary Care) “Identifying, explaining and addressing unwarranted variation in GP prescribing behavior: a mixed methods programme with low-cost RCTs” (£150k, FY20 £30K)

In addition to several small sub-contracted applications two have been submitted with OHFT as lead, these are detailed in the table below:

Investigator Study Title Funder Funding

Sarah Lay-Flurrie Comparing approaches to identify frail older adults in England NIHR 149,765

Louise Johns Improving the quality of interrelations between parents with psychosis and their very young children

NIHR £446,735

5.13 Study Delivery

The Study delivery function is led by Prof. Andrea Cipriani (Associate Director of R&D), Dr. Cathy Henshall (CRF Manager) and Claudia Hurducas (Interim Study delivery manager). This brings together commercial and non-commercial study income generated from resources funded by the CRN, CRF and BRC. The NIHR funders expect income generated to be recycled for the benefit of research.

5.14 Oxford Academic Health Science Network (OAHSN)

The Anxiety and Depression network will be funded in FY20 by the AHSN & others £86k and CLAHRC £27k with a further £62k available from the AHSN in FY21

Infrastructure Funding Timeframes

Infrastucture or Award Current Funding timeframe Total ValueCLAHRC Jan 2013 to Sept 2019 £10.5mMIC Jan 2018 to Dec 2022 £1.2mCRF April 2017 to March 2022 £3.7mBRC April 2017 to March 2022 £13.5mARC Oct 2019 to Sept 2024 £9.0m

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6 Communications A new dedicated R&D communications and engagement manager (Catherine Kernot), was appointed in February and has now been in post in the Communications Team for 5 months. Catherine is working closely with colleagues in the research and development team as well as with BRC theme leads and the University of Oxford Department of Psychiatry communications lead to build understanding and support for Oxford Health’s research work.

In preparation for the BRC’s mid-term review in October, there has been a focus on updating the BRC website to showcase the achievements of the first half of the funding cycle. This includes development of the site to profile current work and recent publications, an update to the site’s branding in line with new NIHR guidelines, and the revision of research theme summaries. The new content will be published in September with further development work continuing over the next few months. In addition, research related news stories have featured regularly on the BRC and Oxford Health websites over the last months supported by social media activity.

A project to work with an external agency to produce accessible ‘good news’ stories for the website is close to completion. Three plain English case studies were produced for submission in the BRC and CRF annual reports. Along with two further case studies these will be published online along with the other updates to the BRC website in September. After obtaining quotes to produce accompanying film clips the plan to do this was put on hold due to the high costs involved.

The Oxford Health BRC open day took place in May as part of NIHR Be Part of Research Campaign. The event held at St Anne’s College was attended by around a hundred researchers, clinicians, patients and members of the public. The BRC was also represented with a stand at the OUH BRC open day on 24 th May at the John Radcliffe Hospital. Research and development stands are planned for HealthFest and the trust AGM in September.

Media coverage of Oxford Health’s research activity has included the launch of Professor Daniel Freeman’s gameChange clinical trial which was covered widely in the local press and featured on BBC South Today on 27th June. There was also considerable press interest in Professor Andrea Cipriani’s paper Optimal dose of selective serotonin reuptake inhibitors, venlafaxine, and mirtazapine in major depression: a systematic review and dose-response meta-analysis published in The Lancet Psychiatry in June. This was covered by ITV news, The Mail and The Sun as well as on local radio. Most recently coverage has appeared in The Guardian, The Sun and The Mail of Professor Rupert McShane’s study, undertaken in collaboration with NIHR Maudsley BRC, of the monitoring of patients taking ketamine to treat depression. The paper Exploring patients’ and carers’ views about the clinical use of ketamine to inform policy and practical decisions: mixed-methods study was co-authored by Claire Murray, Patient and Public Involvement Manager at Oxford Health.

Research and Development pages have been created on the Oxford Health staff intranet and include links to resources for researchers as well as information about getting involved in research and key contacts in the department. These pages will continue to be developed with input from colleagues across R&D. The creating of an intranet presence is the first step in a campaign which will be take shape over the next months to increase engagement with research within Oxford Health.

7 Intellectual Property Management OFHT is becoming more involved in the process of IP Management, where there are three cores elements;

Contracting, which is undertaken by OUH contracts under a service level agreement

Identification and Management, which involves the Head of R&D

Exploitation, which is manage by Oxford University Innovations under the Framework Intellectual Property Agreement (FIPA)

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The Head of R&D is involved in all three elements and reports to the Director of Finance and the Director of Corporate Affairs.

Recent developments have included the creation of CRIStal Health as a spin-out from the BRC and the collaboration agreement in relation to Daniel Freemans I4I virtual reality grant.

The NIHR are becoming more focused on IP and expected “the host Trust should be visibly involved in any IP related conversations”

8 Staffing Professor Andrea Cipriani has been appointed as acting CRF Director

Professor Cathy Creswell joined the Departments of Experimental Psychology and Psychiatry. She is a lead in the ARC and brings with her a large programme grant “Development and evaluation of a pathway from 'universal screening' to online intervention for children with anxiety problems” to Oxford

Dr Cathy Henshall’s NIHR 70@70 Senior Nurse Research Leader award (May 19- Apr 22) has now started. The aims of the 70@70 Programme are to:

o strengthen the research voice and influence of nurses in NHS provider organisationso enhance the connection between the research perspectives of NHS nurses with NIHR

research agendas champion the promotion of an embedded research active culture among nursing staff

o encourage and support innovation and research implementation in pursuit of the delivery of high quality, evidenced based nursing and healthcare practice.

Vanessa Raymont is now the NIHR Dementia and Mental Health Lead for the Thames Valley and South Midlands Clinical Research Network (CRN).

Helen Jones (Research Delivery Manager) started maternity leave in July and her role is being covered by Claudia Hurducas

Jen Potts returned from maternity leave in April to the post of patient engagement manager

Nick Raven was appointed to Senior R&D Accountant

9 Estates Following expansion to cover key roles R&D’s need for more space at the Warneford is becoming urgent. There is an immediate short-term problem and a longer strategic pressure in relation to the new build. Communication is on-going with the Estates department.

10 Staff Survey Three research related questions were included in the staff survey last year. The positive indication is that over 85% of respondents thought research was important in improving the outcomes for our patients but we need to do some work on how much people know about research within the Trust (38.2% have no knowledge). This will be picked up as part of the wider business development group work.

Authors and Title: Professor John Geddes, Director of R&D and the NIHR BRC

Bill Wells, Head of R&D and NIHR BRC Manager

Dr Mark Hancock, Medical Director

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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:

THIS PAPER MAY BE PUBLISHED UNDER FOI

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

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