· web viewparticipation in research produces widespread benefits for patients and, more...

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Report to the Meeting of theOxford Health NHS Foundation Trust

Board of Directors

24 June 2015

Research and Development Report

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1 Clinical Quality and Care Participation in research produces widespread benefits for patients and, more generally, improvements in quality of care. A consumer poll of 3,000 people in England, commissioned by the NIHR and published in September 2014, reported that 95% of those responding stated that it is very important that the NHS carries out clinical research; with 85% of people agreeing that they would be very or somewhat willing to take part in research if they were diagnosed with a medical condition or disease. Oxford health NHS Foundation Trust has strong links to the University of Oxford, a thriving R&D department and a Clinical Research Facility which enables high quality research to take place for the benefit of patients and carers.

2 Networks and Collaborations

2.1 Oxford Academic Health Science Network (OAHSN)

Oxford Health is hosting three OAHSN themes;

Early intervention led by Prof Belinda Lennox and Sarah Amani.

Anxiety and Depression led by Prof David Clark and Ineke Wolsey.

Dementia led by Dr Rupert McShane.

2.1.1 Early Intervention Theme

The Early Intervention in Mental Health Network brings together local experts on adolescent and young adult’s mental health and those with experience in system-wide transformation with the purpose of improving outcomes for young people with mental health problems via Early Intervention in Psychosis (EIP) services.

The Early Intervention network is jointly led by Dr Belinda Lennox (Consultant Psychiatrist, Oxford Health NHS Foundation Trust) and Dr Mark Allsopp (Consultant Psychiatrist, Berkshire Healthcare NHS Foundation Trust) and is managed by Sarah Amani

The outcome objective is to improve health and social outcomes for patients with first episode psychosis, including duration of untreated symptoms, symptom reduction, and engagement with education and employment. The measurable metrics specifically look at NEETs (Not in Education or Employment) - the % NEETs of people in EIP services vs the % of NEETs not in EIP services.

2.1.1.1 Communications have included the following:

Network Event 31st March 2015 Monthly Network Business meeting Bi-monthly EIP Practice Group Bi-monthly Extending EI Group Bi-monthly Transition Work Group

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Ad-hoc Research Work Group Ad-hoc, CCG, GP and Operational Managers Regular Twitter feed (14K followers) Quarterly EI Newsletter

2.1.1.2 Project performance Indicators

a) PID 1 Enhancing care continuity and extending the model of early Intervention

Metric Timing StatusTrust level action plans for improving care continuity agreed

January 2015

Complete - Trust level action plans for improving care continuity agreed (15th Jan 2015). Action Plans submitted to EIP Best Practice Group 13th March

Improved care continuity in young people with psychosis in a single NHS Trust

July 2015

(April 2015)

Delayed – Single Trust selected is Oxford. Data will be sought from EPR implementation due April 2015; data will be available in July 2015

Improved care continuity in young people with a mental illness other than psychosis, in a single NHS Trust

April 2016 In progress – Plans to focus on eating disorders as next mental illness in line with national priority. Preliminary discussion in progress within Network team on how best to support and implement improvements.

b) PID 2 Common Assessment

Metric Timing Status90% staff working in EIS trained in standardized clinical assessment of psychosis.

December 2014

Completed March 2015. Further training planned in June 2015 to capture remaining 10%

Completion of baseline data on new assessments

July 2015

(April 2015)

Delayed due to agreement on National Common Assessment and implementation of EPR across participating Trusts. Confirmation of National Common Assessment will be available in the next few weeks. Trusts in the Oxford AHSN region will use a common assessment that exceeds the national requirement. Oxford Health planned implementation June 2015, Berkshire September 2015 (Source: EIP Best Practice Group May 2015)

New patients entering EIS fulfilling criteria for EIS on standardized clinical assessment

July 2015

(April 2015)

Delayed due to issues identified above

Agree baseline data metrics and IT data collection methods

July 2015(December 2014)

Delayed - Local metrics agreed but KPI delayed due to pending decision on National Common Assessment and implementation of EPR in April 2015

c) PID 3 – Reduce Variation

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Metric Timing StatusIdentify baseline for care quality measure across AHSN

January 2015 Complete

Action plan for improving care quality in each Mental Health Trust

August 2015

(April 2015)

Due - This is being linked in with the South England EIP-P work action plans. To be discussed at EIP Best Practice Meeting on 10th

July 2015

Fidelity to services to the EIPS model of care (NIMHE) and narrative report from services on pressures on maintaining NICE compliance

December 2014

Complete

Re-measure care quality October 2015

Reduction in variation of care quality for EIPS across AHSN

April 2016

Percentage of young people in employment or education after 3 years EIP compared to peers

April 2016

d) PID 4 Research Recruitment

Metric Timing StatusResearch champions identified in EIP teams August 2014 CompleteNumber of research studies and current activity identified October 2014 CompleteDatabase of research ready participants in EIP July 2015Accruals to Portfolio research studies April 2016Number of research studies active in EIP (increase) April 2015 Due

Additional Outcomes – Clinical Lead and Network Team to support NHS England (South) Early Intervention in Psychosis Preparedness programme.

2.1.1.3 Budget

Total budget allocated £210k. The theme will be extended to March 2016 without the need for additional funding. Funding released by support for Clinical Lead and Network Manager by South East EIP may be used to support EI Enhancing Care Continuity project Chair and PPIEE post.

2.1.1.4 Future Plans

Development of a detailed plan to extend the EIP model to Eating Disorders Development of the EIP Champions deliverables and KPIs Publication of HSJ article – ‘Demonstrating the effectiveness of Early Intervention

Psychosis services using health system analytics’ Development of local EIP Preparedness plan

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2.1.1.5 Key risks to successful delivery

Impact of EIP programme on Oxford AHSN EI Network delivery – Mitigating action: scope of EIP project and team responsible for delivery has been clarified. OAHSN to provide interim Network Management support.

Agreement of National Common Assessment criteria and assessment, and Implementation of EPR across the Trusts to allow data collection, are significant factors in the timely delivery of PID 2 (Common Assessment) and PID 3 (Reduce Variation). EPR implementation deadline is October 2015. PIDs timeframes may need to be revised.

2.1.2 Anxiety and Depression Theme

This theme covers three areas:

2.1.2.1 Understanding outcome variability and improving recovery rates for Talking Therapies (IAPT)

The initial aim of the PID was to improve the overall recovery rate achieved in the IAPT services by 5%. Two distinct activities were planned. First a series of enhancing recovery workshops would allow the clinical leads of the services to share learning and hear about relevant research findings. Second the download and analysis of one years’ data from the services in order to identify any additional lessons and act upon them.

The aim has already been exceeded and there are three enhancing recovery workshops ongoing with agreed follow up plans after each workshop. The overall recovery rate has increased from 46 to 54%. These enhancing workshops will continue with the launch of a series of skills training events for therapists in the IAPT services. The first is focused on improving diagnostic accuracy; some analysis of the national data showed an associated higher recovery rate overall. Other workshops that are planned cover enhancing therapist skills to treat depression, post-traumatic stress disorder, social anxiety disorder, specific phobias and distress in couples. Two of the workshops will be delivered by Professor Clark and his team and will cover the treatments they have pioneered. The other three workshops are being conducted by world leading authorities in the relevant condition from Europe and North America.

Relevant permissions are no in place for downloading 15 months of data from each of the IAPT services and a statistician has been appointed to conduct detailed analysis to identify new lessons.

2.1.2.2 Supporting local service innovation and disseminating successes throughout the region

The deliverable for this project was to ensure that each of the IAPT services adopts a new service innovation. This is progressing on track with all services now adopting new initiatives

Milton Keynes: CBT-1 Buckinghamshire: Diabetes Oxfordshire: COPD Luton: Psychological Perspectives in Primary Care (PPiPCare)

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Berkshire: Enhanced diabetes care and MUS treatments

Implementation plans are currently being completed and necessary training is being set up.

2.1.2.3 Improving data completeness in CYP IAPT

Work is ongoing with the CAHMS services and the CYP IAPT (Children and Young People’s Improving Access to Psychological Therapies) collaborative to increase the average data completeness of paired outcome data (i.e. pre and post treatment) across the OAHSN patch by 10%.

The national database for CYP IAPT (Children and Young People’s Improving Access to Psychological Therapies) cannot be used for baseline data due to incomplete and meaningless data that is not fit for the desired purpose. Therefore it was decided to work with data extracted directly from the CAMHS services. This has been a time consuming and complicated piece of work as all localities have different systems internally and have fragmented systems that do not record all of the required data in one place. For example, admissions and discharges may be in one place, but any recorded outcome measures in another. The data is nearly complete for Q4 which more realistically reflects actual activity in the services and will be used as a baseline. Good progress has been made due to the support from the Network in addressing these data collection issues. Meetings with all services are being planned to explore baselines and agree on an improvement plan for recording and submitting paired (pre and post treatment) outcome data.

2.1.3 Dementia Theme

2.1.3.1 Successes

The Memory Services Accreditation Programme. The Dementia Network has stimulated, and provided funding to support, Oxford Health’s attempt to gain accreditation of 5 memory clinics. This has been ably led by Maureen Cundell, the deadline for uploading data is June 2nd and it looks as if most, if not all, teams will meet this. This process has already helped to identify areas where we could do better. The process will complete in September 2015.

A webinar programme is established. A joint bid to HETV and the Clinical Research Network has resulted in the purchase of kit (suitcases containing an ipad, projector, microphone and speakers) which make it possible for small teams to attend webinars together. This is at the point of starting to be used. The forthcoming programme includes clinicopathological conferences, and an emphasis on reducing variation in the diagnosis of Mild Cognitive Impairment in secondary care.

Charities. The Young Dementia charity in Berkshire has secured agreement from commissioners to support it. This is a major achievement for Dr Jacqui Hussey and her team in Berkshire. Oxfordshire also has a similar charity: Young Dementia UK (YDUK). The Berkshire charity has found that giving the charity staff honorary NHS contracts and access to relevant patient records has been a significant element in improving quality of care. It has been proposed that Oxford Health does the same for YDUK. We are currently trying to identify someone who would be prepared to take on nominal line management for these workers. Bucks has no service for this group. We propose to try to involve Bucks

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commissioners in the September 2015 event with a view to highlighting this variation in provision and presenting the economic case as it is established in Berkshire.

2.1.3.2 Other Developments

The data capture project which is developing the use of texting as a platform for getting direct data from carers (e.g. on resource utilisation) has been sluggish in a pilot phase, partly due to consent to contact issues. It has been agreed that this should be given until March to ‘sink or swim’.

The eSilverBook initiative has been dropped. As it was a piece of IT development, the AHSN did not think this was an appropriate use of Clinical Network resources.

Following a 25% cut in overall network funding, the deltaG project to improve taste of a novel food for dementia was not thought to have the necessary priority.

A detailed proposal for an Open University Tier 3/Tier 4 online course for experienced staff was not funded by HETV.

The adoption of ‘clinical safety’ related messages on screen savers, as is used in Berkshire Healthcare, foundered on the conflict between this and a Trust policy on conserving the energy required for screensavers.

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

The CLAHRC is led by Professor Richard Hobbs (CLAHRC Director) and supported by Alex Gardiner (CLAHRC Manager) within the Department of Primary Care at the University of Oxford.

The following are relevant extracts taken from the 2014/15 CLAHRC annual return submitted in May 2015:

2.2.1 Progress against CLAHRC Objectives

We have made good progress against our short term aims, recruiting and part funding 3 Academic Clinical Fellowships (ACF’s), 4 DPhil’s, and a junior clinical academic as ‘researcher in residence’ in the Emergency Multidisciplinary Unit (OHFT). In addition to this, 5 further matched funded ACF’s are working within our host trust supporting CLAHRC projects and benefitting from the academic expertise and training support provided by the CLAHRC. Future plans include the recruitment of a senior academic with matched funds to lead a cross cutting complex evaluation theme and the development (with key stakeholders) of a second multi-morbidities cross cutting theme with the emphasis on informing priority setting for our CCG partners’ procurement.

Our medium term aims of generating high quality evidence for clinical and cost effectiveness has already shown impact through the NIHR CLAHRC Oxford Early Intervention and Service Redesign Theme/AHSN collaboration Early Intervention in Psychosis project lead by the CLAHRC Deputy Director, Professor Belinda Lennox. We have also increased the number of projects across the CLAHRC from the original number of 19 to a current total of 32. We will be addressing this aim in our 2 year review in addition

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to expanding our portfolio of current work to address key public health priorities, with a focus on multi-morbidities.

The NIHR CLAHRC Oxford research programme is driven by our long term aims to build research capacity within the NHS, to support evidence based commissioning and service development and to build an infrastructure to enable the responsiveness of services to patients’ reports of experiences and outcomes at the local level. Progress towards these aims has already been made: discussions have taken place with Oxfordshire CCG to identify their main priorities for the future which will inform the review taking place at the end of year 2 of the CLAHRC and shape the direction of the final 3 years of the programme; the Said training programme detailed in the training section below was developed in conjunction with Oxford Health NHS Foundation Trust to embed a culture of research within the clinical teams and to provide the expertise and support to enable them to identify and overcome barriers to change and to successfully implement innovation with the aim of creating a ‘knowledge ripple effect’ supporting others within their organisations to do the same.

2.2.2 Changes to the NIHR CLAHRC Strategy

There have been no substantive changes to the strategy, however we are driving towards strengthening both our local and UK wide Infrastructure links and level of industry involvement. We aim to be to be flexible, responsive and useful to the NHS and to achieve these goals we need to be quick at responding when new projects appear, whilst still maintaining capacity development for the future. The areas for development going forward are:

Increasing the number of experienced Principal Investigators Developing relationships with stakeholders, both new and historical Working more closely with other CLAHRC’s Developing relationships and opportunities with Industry

2.2.3 Developments in implementing the NIHR CLAHRC strategy

The Research Excellence Framework results for 2014 highlighted that the NIHR CLAHRC Oxford is a strong centre for academic excellence with 3 of the areas hosting CLAHRC themes and key CLAHRC projects being ranked as world leading (4*) in this exercise – Department of Psychiatry, Department of Public Health and the Department of Primary Care Health Sciences. During the first year we have worked towards the vision of ‘One NIHR’ strengthening our infrastructure collaborations to provide a vehicle for excellence. This is evidenced by some of the new projects being supported by the NIHR CLAHRC, for example POPS2 which was only possible due to our strong working collaborations with other CLAHRC’s, the School for Primary Care Research and the Thames Valley Local Clinical Research Network. In addition our collaborative projects with the Oxford AHSN has seen the NIHR CLAHRC work closely with NHS England, successfully building new clinical networks e.g. Out of Hospital Care and Early Psychosis leading the access and waiting time gold standard.

2.2.4 Training initiatives and Developments

The NIHR CLAHRC themes are currently in the process of identifying a new training lead. This is an extremely important role within the CLAHRC and so important that the right

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person is appointed to the role. Until the appointment to this role, Alex Gardiner CLAHRC Senior Manager will be the key contact for training.

In March 2015 the NIHR CLAHRC Oxford piloted a unique leadership training course developed in conjunction with the Said Business School and Oxford Health NHS Foundation Trust, and hosted at the Said. The aims of this course were to plug a knowledge gap identified between junior and senior levels of management across the whole trust structure (clinical and non-clinical), to provide the skills for trust managers to drive the implementation of new research and to provide a network of support with researchers to help give context and expert support with understanding novel research and its implications for the NHS.

2.2.5 NIHR CLAHRC Oxford’s top three achievements were:

Number of high impact papers – 4 papers were published in The Lancet, all of which will have impact on the provision and delivery of services in palliative care and physiotherapy treatments;

Early Intervention in Psychosis Service – this exemplar project is an early win informing national policy, and leading to the formation of the national expert reference group;

BBC Horizon ‘What’s the Right Diet for You?’ – this ground-breaking social experiment launched the OxFab trial and will provide a platform for new projects in the third year of the CLAHRC.

2.2.6 Matched Funding Highlights

Early Intervention in Psychosis – match funded by the Oxford AHSN has already had significant impact on the provision of care young people with psychosis in addition to leading to the development of new national guidelines;

Emergency Multidisciplinary Unit – matched funded by Oxford Health NHS FT, Oxfordshire CCG, the Oxford AHSN and the NIHR BRC Oxford. In addition to the main EMU evaluation project and development of a commissioning model in underway to provide decision support for commissioners and acute and community providers. The EMU innovative model of care has received interest in roll out both in the UK and overseas and won the Guardian Innovation Award for Service Delivery;

Depression Care for People with Cancer – matched funded by Oxford University Hospitals NHS Trust and the Oxford AHSN, this unique and innovative screening and treatment programme piloted by the Oxford Cancer Centre has provided high quality, evidenced-based integrated care for patients with mental and physical comorbidity.

2.3 NIHR Diagnostic Evidence Co-operative (DEC)

The DEC is led by Dr. Ann Van den Bruel (Senior Clinical Research Fellow) within the Department of Primary Care at the University of Oxford.

The following are key extracts from the 2014/15 annual return submitted in May 2015:

2.3.1 Short term objectives:

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Identify new IVDs (in-vitro diagnostics) relevant to primary care: Our horizon scanning programme has produced eight reports on diagnostic tests in primary care. In addition, we have interacted with eight diagnostic companies who are developing new IVDs to advise them on primary care applicability.

Produce rapid technology assessments: the horizon scanning programme has published eight reports so far. Topics range from point-of-care malaria tests to calprotectin and cardiac markers. Ongoing horizon scanning reports include point-of-care streptococcal A tests for sore throat, point-of-care tuberculosis tests and point-of-care respiratory panel tests.

Hold annual stakeholder meeting: the next UK Diagnostics Forum was held from 19-20th May 2015. As for the previous editions, the Forum was again jointly organised with NICE, the British In-Vitro Diagnostics Association and Innovate UK (formerly Technology Strategy Board). This year’s theme focused on how to create value by introducing new tests in healthcare. The Forum was attended by 120 delegates and was fully booked 1 month in advance.

Hold annual 3-day educational course: the first annual 3-day course was held from 22-24 September 2014 in Queen’s College, Oxford. The course was aimed at all professionals working on diagnostic tests including people working in industry, academia, funding bodies, test regulation. The course was attended by 19 participants, of whom 10 were from the diagnostics industry, three from another DEC, three from HTA agencies (UK and Europe) and three clinicians. A more detailed evaluation report of this course is added as an appendix.

Produce case studies: our case study on the Abingdon Emergency Multidisciplinary Unit (EMU) has well progressed since the previous annual report. This unit, which was awarded the 2013 Guardian Healthcare Innovation Award, provides care for elderly patients with multimorbidity and frailty. The unit combines a multidisciplinary assessment with point-of-care in vitro diagnostics to assess patients’ health status and their care needs. The impact of the point-of-care tests is being evaluated using a variety of methods including analyses of hospital admission rates, method comparison studies on correlation between point-of-care and classic laboratory results, and qualitative analyses of care processes.

Medium term objectives:

Direct academic and industry research efforts towards unmet needs: we have published the first results of our international survey in 2014. We have seen large interest from industry for these results, and the paper’s full text, which was published open access to facilitate dissemination, has been downloaded 3367 times since its publication. We have now analysed additional data for the UK, including which point-of-care tests general practitioners would like to monitor chronic conditions and to refer patients to secondary care. The results of these analyses have been submitted for publication.

Consolidate platform approach primary care assessment Develop consultation service for industry: we have set up a consultation service for

industry that includes a variety of services, including advice on primary care application of new IVDs, in collaboration with ISIS consulting.

Long term objectives

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We have consolidated our expertise in diagnostic test evaluation. A major strength of our research team is the multidisciplinary approach, including clinicians working in various settings of the NHS, methodologists and statisticians, health economists, qualitative researchers and clinical biochemists. We have established important links both nationally and internationally, including collaborations with the other DECs and the Birmingham Biostatistics group, with the HTA Diagnostic Tests and Screening panel and methods group, with the international STARD group on reporting diagnostic test evaluations, the Amsterdam Clinical Epidemiology Department, the Utrecht Department of Epidemiology. In addition, we have intensified our industry outreach programme by appointing a new researcher (Dr Philip Turner) who now oversees all industry liaison activities.

Significant developments in implementing the strategy

We have established a strong regional collaborative approach which allows diagnostic companies to receive advice from very early stage development up to pre-market. For this purpose, we have established links with ISIS Consulting to signpost new diagnostic inventions to our DEC for early stage advice, and with the Oxford AHSN and CLAHRC for late stage implementation advice.

Major grant awards received as a consequence of NIHR DEC funding

Translational Research Fellows in acute ambulatory care, NIHR Oxford BRC RCF £57k

Nursing Translational Research Fellow, NIHR Oxford BRC RCF £43k Postdoctoral health economist, Oxford University Hospitals RCF £48k Innovate UK Small Business Research Initiative: Home-based monitoring for the

early detection of severe neutropenia in patients receiving chemotherapy to enable intervention and avoidance of adverse events. Lead Participant Philips Electronics UK Limited, DEC collaborators Prof Chris Price and Dr Jane Wolstenholme. £2.0m

Prime Minister’s Challenge Fund: Oxford Clinical Commissioning Group. Strategies for reducing hospital admissions including better diagnostic assessment. £4.9m

2.4 NIHR Oxford cognative health Clinical Research Facility (CRF)

The NIHR CRF is led by Professor John Geddes.

The following are key extracts from the 2014/15 annual return submitted in May 2015:

2.4.1 Progress Against short, medium and long term objectives

Short-term objectives

‘To underpin the capacity of the Oxford experimental neuroscience clinical research facility and to manage support staff efficiently across the facility’.

The Lead R&D Nurse/CRF Matron came into post 18 months ago. This senior nursing appointment has allowed development of the research nursing team to provide a broader range of skills to researchers. Newly appointed research nurses have come from different specialisms e.g. thrombosis research and ‘early intervention in psychosis’ mental health. Junior nursing staff is supported through their preceptorship, NMC exams and registration. A number of nursing staff are either in the process of gaining postgraduate qualifications (e.g. including MSc, MRes, Professional Doctorate) or are planning to do so. This skill mix

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allows the CRF to deliver research more efficiently. The Matron is developing other roles in the wider research organisations and local NHS Trusts. For example, she is an active member of the CRN workforce development on behalf of Oxford Health NHS FT and has undertaken training to deliver the NIHR GCP training program locally.

The main provision of research nurses is for the eight-bedded site of the NIHR Oxford CRF located at the Warneford hospital – a psychiatric hospital. However the CRF also includes The Charles Wolfson Centre led by Professor Peter Brown. The successful appointment of a suitably qualified research nurse to support the Charles Wolfson centre was proving a challenge, this resulted in the rethinking of collaborative support across the sites. The solution was the appointment of a full time band 6 research nurse, who works across the sites. This allows cross cover, expansion of skills and improved efficiency in terms of staff management.

The CRF provides training opportunities to staff from CRN Funded Division 4, in particular staff employed within DENDRON under the previous CLRN structure. DENDRON research nurses spend time on the CRF to gain experience in a variety of trials from experimental medicine to later phase commercial studies.

The Lead R&D Nurse/CRF Matron is closely involved in the line management of seven Research Assistants. Two of these are for the Early Intervention Service funded by the CRN to support one of the themes of the Oxford AHSN. The other five are funded by Oxford Health NHS Foundation Trust and are embedded within clinical teams. This is an illustration of how the Lead R&D Nurse/CRF Matron of the CRF works across organisations to improve active collaboration.

‘To support major new investments by Oxford University in translational neuroscience to facilitate the delivery of advances in diagnostic and interventional procedure to clinic in the area of neurological and psychiatric disorders’

One of the major initiatives planned for 2015 is the expansion and conversion of OHBA (Oxford centre for Human Brain Activity http://www.ohba.ox.ac.uk/) on the Warneford site into a Translational Cognitive Neuroscience Imaging Centre. This £3.9 million venture, has attracted £2 million of central University funding matched by £1.9 million from the University Department of Psychiatry will see a state-of-the-art research-purposed 3-Tesla magnetic resonance imaging (MRI) scanner added to the magneto-encephalography (MEG) system and an upgrading of the OHBA facility. The new multi-modal facility will link-up world-class discovery science and clinical care, by making cutting-edge multi-modal brain-imaging technology available for experimental medicine studies, clinical trials and innovative clinical care. The new Centre will provide much needed increased MRI capacity for large-scale neuroscience projects to deliver high impact science to benefit patients by improving patient access to high-throughput multimodal brain imaging. An important aim is to achieve a step-change in developing multimodal imaging-based biomarkers relevant to a wide spectrum of disorders of cognitive health and increasingly required for early phase commercial studies.

The 2014-15 financial year has been spent laying the groundwork for the new development, which is now mid-programme. The planning application was submitted in March 2015, and the construction work is scheduled for July-December 2015, ready for opening in January 2016. This development will increase the capability for neuroscience

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research in Oxford and will be much more convenient for participants who currently have to travel across Oxford from the CRF for MRI.

‘To support complex later phase trials of pharmacological and psychological interventions to establish efficacy and the mediators and moderators of change’.

The CRF continues to support later phase trials, that are not feasible in routine clinical care, this has included repeat business from existing pharmaceutical companies and Clinical Research Organisations in addition to the establishing new links with other companies.

‘To integrate the clinical and research governance of the CRF with the Joint Research Office of the Oxford Biomedical Research Centre’

The Head of R&D Finance continues to work with the CRF and provides invaluable links between the NIHR, CRF, the NHS Trusts (Oxford University Hospitals - OUH- NHS Trust and Oxford Health NHS Foundation Trust - OHFT) and University of Oxford. He continues to play a key role in supporting the financial elements of grant application across the organisations, in addition to providing support for determining occupancy across the four sites of the CRF.

Oxford Health NHS FT has sourced support from the JRO for monitoring of research studies ongoing within the CRF in addition to setting up an agreement for the JRO to provide legal advice on non-standard contracts, subcontracts between external organisations and reviewing NIHR Standard template contract where pharmaceutical companies are requesting additional clauses to the agreements

A research team lead by Prof Heidi Johansen-Berg is part of the Functional Neurosciences & Imaging subtheme of the BRC. Several of our patient research projects conducted in the CRF are funded by contributions from the BRC. In addition the group have ongoing collaboration with the Cognitive Health Working Group (head: Kia Nobre), another theme of the BRC.

Discussions are evolving on how this collaboration can be extended are ongoing.

‘To create, for the first time, an Oxford research partnership integrating neuroscience research across the Oxford University Hospitals NHS Trust, Oxford Health NHS Foundation Trust, the University of Oxford (Experimental Psychology, Neurology and Psychiatry), Oxford Brookes and the local Clinical Commissioning Groups’

Excellence in both basic and translational research across the Oxford Neuroscience partnership is reflected in the outcome of the Research Excellence Framework (REF) 2014 exercise which highlighted the University of Oxford’s world leading position in Psychology, Psychiatry and Neuroscience. In this area the University ranked first place in the UK in the overall quality of the submission, and had the highest proportion of world leading research. A score of 100% was given for the quality of the research and training environment and 95% of the submission was rated as world leading or internationally excellent. This is an outstanding performance and reflects excellence in both basic and translational research. There is increasing collaboration across OUH NHS Trust, Oxford Health NHS FT, Oxford University and Oxford Brookes University under the aegis of the Oxford Academic Health Science Centre. .

Medium term objectives

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‘To produce a step change in Oxford translational neuroscience, harnessing cutting edge advances in neuroscience from world class Departments, supported by state-of-the-art technical platforms and research facilities to deliver benefits for patients’

The CRF is a central component of the development of translational neuroscience collaborations and resources across Oxford. Over the last 12 months, developments have accelerated and mental and cognitive health are now firmly at the centre of Oxford’s overall strategy. We have continued to build research capacity in dementia and cognitive health via the Oxford AHSC Cognitive Health theme (Lead: Geddes) and OxDARE consortium. Professor John Gallacher, principal investigator of Dementia Platform UK has recently moved to Oxford. Professors Simon Lovestone and Chas Bountra of the Structural Genomics Consortium (SGC) (http://www.thesgc.org/scientists/groups/oxford/) have successfully obtained £10 million funding from Alzheimer’s Research UK for a Drug Discovery Institute which will be based in the Target Discovery Institute http://www.tdi.ox.ac.uk/home and provides an innovative, precompetitive and collaborative approach to drug discovery. Professor Noel Buckley has been recruited to build capacity in target discovery. The NIHR supported D-CRIS informatics programme will shortly be implemented in Oxford and the leadership (Mike Denis and Simon Lovestone) is now based in Oxford. The major EU IMI EPAD adaptive trial award has now been made and is co-led from Oxford. These developments are truly transformational and we believe that Oxford is well on the way to being an internationally leading centre of dementia research.

Although the developments in translational dementia research are perhaps most striking, there has also been continued development of our excellence in other areas. These include:

Psychological treatment research, with the recruitment of Professor Willem Kuyken (and associated Wellcome Trust Strategic Award) building on the established critical mass - including, for example, Professor David Clark’s pioneering and high impact development of Increasing Access to Psychological Treatments (IAPT), Prof Chris Fairburn’s innovative work on improving training in psychotherapy among other world class researchers increasingly using the CRF.

Mood disorders - building on the established and continuing work in depressive disorders (Profs Cowen, Goodwin, Harmer) and bipolar disorder (Geddes, Goodwin) with the new CONBRIO Wellcome Strategic Award (Harrison, Geddes, Nobre, Harmer et al) which brings integrates deep phenotyping with large scale epidemiological studies to transform our understanding ion mood instability and to develop new experimental medicine models.

Further developments underway in developmental disorders (Stein, Newton, Scerif) and early psychosis (Lennox, Broome, Harrison)

Underpinning all this major expansion of academic research programmes is a commitment to provide the required underpinning infrastructure to complement the CRF. The University of Oxford and Oxford Health NHS Foundation Trust are working together on a joint masterplan for development of the Warneford site, which occupies a strategic and central position on the Headington Academic Health Campus, as a centre for translational neuroscience.

Long term objectives

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‘To successfully apply for a new Biomedical Research Unit dedicated to Cognitive Health, strongly coupled to the Oxford Biomedical Research Centre and focused on delivering Oxford University benefits for patients Research areas to be supported by the CRF’

The CRF is at the core of our plans to develop translational cognitive neuroscience in Oxford. We plan to expand translational cognitive neuroscience research which uses the CRF. Regular planning/steering meetings have been established between Oxford Health NHS FT and the University of Oxford to develop an application for a Biomedical Research Unit/Centre in the next funding round to focus on mental and cognitive health. Scientific themes are being selected and developed, and to infrastructure developed across both organisations to integrate research more fully and to increase the active involvement of patients in research.

Progress with leadership, governance and management arrangements

Professor John Geddes continues to provide strong leadership of the CRF and links to the Oxford BRC and OUH Trust via the BRC Steering Committee. Professor Geddes is supported by the Head of R&D, Emma Stratful, and Leads for the CRF sites, Dr. Mary Jane Attenburrow, Professors David Clark, Glyn Humphreys and Peter Brown. This group along with the Head of R&D Finance and Matron for the CRF form the core membership of the CRF Management Board which meets on a regular basis to discuss key operational and strategic developments. There is strong emphasis on training and developing staff and the Matron for the CRF is an active member of the NIHR workforce development programme. The Head of R&D/Senior CRF Manager has also embarked on an executive MBA, supported by the Trust and OUH BRC. Following the retirement of the Research Governance Manager at OHFT in December 2014 the Trust appointed a new senior manager, Victoria Rush, who joined in June 2014. With this appointment there is focus on improving efficiency in managing studies and producing required metrics. For example; ensuring alignment of study and recruitment figures between the Trust and the NIHR portfolio studies, developing more structured ways in which to capture key and relevant data surrounding study approvals, including database development and alignment with systems created within the OUH. The Governance Manager is leading on the transition of the Trust into the HRA processes for research governance and as such has instigated meetings to address feasibility of studies being undertaken within the Trust in line with the proposed HRA agenda. The Research Governance Group has been re-established to oversee all research governance processes, issues and updates within the Trust, including setting up of risk based monitoring of studies and a safety review group for non-commercial studies. More robust processes have been developed regarding the sponsorship of individual studies to ensure the Trust is able to fulfil its obligations.

Changes to the strategy and significant developments in implementing the strategy

Oxford Health NHS FT executive board continues to receive biannual R&D reports, including a stronger emphasis on the outcomes and impact on clinical care as a result of research studies. The Research Implementation Manager, Alexandra Forrest was appointed in November, 2014. This important role includes coordinating the delivery of the ‘research opportunity’ message to all clinicians and service users, helping researchers identify recruitment methods and coordinating research delivery by collaborating with key members of the NIHR CRN, NIHR CRF and researchers from the key University Departments and NHS Trusts. In order to achieve the aims of the role Oxford Health

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NHSFT supports five RAs embedded within clinical teams in Adult Mental Health who are managed by the Research Implementation Manager.

In addition the NIHR CRN has funded an additional two research assistants to support the early intervention service within the organisation who are also managed by the Research Implementation Manager. The Research Assistants have been key in the successful undertaking and delivering of an NIHR portfolio study looking at hospital admissions (COFI).

The R&D Strategy Forum continues to meet twice a year, with a focus on developing the NIHR BRU application and improving relationships between OUH, University of Oxford, Brooke University and OHFT for the increasing nurse delivered research and nursing lead research within Oxford.

A R&D Senior Management Team (SMT), consisting of the Director of R&D and CRF (John Geddes), Head of R&D and Senior Manager of the CRF (Emma Stratful), Deputy Director of R&D and Clinical Director for the CRN (Belinda Lennox), Clinical Lead for CRF (Mary Jane Attenburrow), Research Governance Manager (Vicky Rush), Head of R&D Finance (Bill Wells), Lead R&D Nurse and CRF Matron (Cindy Whitbread) and Clinical Trials Pharmacist (Orla McDonald) for OHFT has been established to provide assurances on research governance and to resolve any queries related to the set up and conduct of studies within the organisation, in addition to assessing the risk associated with complex studies and provide decisions on whether to host the study. The SMT also oversees the R&D finances and decides on strategic expenditure where appropriate as some studies in the CRF may offer training opportunities or special scientific interest that.

Key developments over the last year

The new Research Governance Manager implemented a number of meetings and systems to track studies through the research process from expressions of interest to study set up and NHS permission. These meeting include representation from the Research Delivery Managers of the CRN. Groups review individual studies and where decisions cannot be reached they are referred to the SMT.

Significant successes and difficulties or barriers to progress experienced;

Studies increasingly require a range of techniques and skills in order to fulfil protocol requirements for ‘deep phenotyping’. The EU Innovative Medicine Initiative StemBANCC programme uses the CRF to take skin biopies to grow Induced pluripotent stem cells derived from fibroblasts. CRF medics and research nurses have worked with Oxford University Hospitals NHS Trust, Oxford University Department of Psychiatry and Oxford University Department of Physiology, Anatomy and Genetics to acquire the skills and knowledge to be able to deliver this research. This study would not have been possible without the CRF and recruitment is going well.

Enhancements to the delivery of research

Patient experience on the CRF Warneford site has been captured by asking if patients will consider completing a questionnaire on exit. The questionnaire has been developed using the UK CRF Network guidance and INVOLVE (www.invo.org.uk/) and has evolved with the CRF now using version 2. The feedback has been subject to audit with a very favourable patient satisfaction. Areas where patient comments have been action is the erecting of a

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notice board in the waiting area in addition to a drinks making facility where participants are able to help themselves to hot drinks rather than feeling they need to disturb busy staff

Intellectual assets

As the CRF has been established relatively recently therefore outputs are yet to be firmly established. Although Professors Lovestone, Geddes, Hinds and Gallacher) are working with Apple to develop widely applicable apps (using ResearchKit) to provide sensitive measures of cognitive function and mood for use in early phase and adaptive clinical trials in mood disorder and dementia

Major grant awards received as a consequence of NIHR funding.

The Cognitive Neuropsychology Centre within the Charles Wolfson Clinical Research Facility at the John Radcliffe hospital and part of the NIHR oxford cognitive health CRF continues to receive substantial numbers of outpatients who come through from the cognitive screening programme we are running. There has been a slight fall in the number of outpatient visits due to the Stroke Association funded TMS-neglect project coming to a follow-up only stage and to our setting-up a nationwide RCT comparing outcomes after stroke for patients given different types of cognitive screening (the OCS-care programme). However we have a new Wellcome Trust funded screening project which has just got underway which will ensure that out outpatient visits are maintained into the future. The first papers on the Oxford Cognitive Screen are just being published and will continue over the next year to consolidate the wide-spreading impact of our NIHR-supported work.

2.4.2 Research Projects and Outputs P1Vital: Sunovion SEP 361-104: A randomized, double-blind, placebo-controlled,

single-dose, study of the effects SEP-363856 and amisulpride on BOLD-fMRI signal in healthy male and female volunteers with high or low schizotype characteristics. Recruitment commenced at the end of March 2014 with 34 out of 54 recruited during the year. There were problems recruiting to the High Schizotype arm of the study as the participants were often on medication, which excluded them, and they are a population that is hard to engage but efforts are ongoing

AbbVie: A Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging, Parallel-Group, Phase 2 Study of the Safety and Efficacy of ABT-126 in the Treatment of Cognitive Deficits in Schizophrenia (CDS) in Non-smokers. This study has currently managed to over recruit to the target of three participants by one

Long-term safety and efficacy of ABT-126 in subjects with schizophrenia: a double blind extension study for subjects completing study M10-855. Recruitment to this extension study was restrictive due to low number entering the initial study and only one out of the three was recruited.

TAK: A randomised, double-blind, placebo- controlled, phase 3 study to evaluate the efficacy and safety of once a day, TAK-375 (Ramelteon) tablet for sublingual administration (TAK-375SL tablet) 0.1mg and 0.4mg as an adjunctive therapy in the treatment of acute depressive episodes associated with bipolar 1 disorder in adult subjects. Although only one out of the five participants was recruited the CRF were the only UK team to recruit to this study and the study was closed early

ATLAS: A pragmatic randomised double-blind trial of Antipsychotic Treatment of very Late-onset Schizophrenia-like psychosis. This study has recruited one of the

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three participants required due to a smaller than anticipated potential inclusion population.

ACTIONS: Antidepressant controlled trial for negative symptoms in schizophrenia. Currently 5 participants have been recruited and efforts to increase participation are ongoing

Merck EPOCH: A randomised placebo controlled parallel group double blind efficacy and safety trial of MK8931 in subjects with mild to moderate Alzheimer’s disease. Currently eight out of the 10 participants have been recruited

StemBANCC: Stem cells for Biological Assays of Novel drugs and predictive toxicology. This is going very well with 22 out of 40 participants recruited.

Mosaic: Comparison of the Maudsley Model of Treatment for Adults with Anorexia Nervosa has recruited 13 that was handed over from Mental Health Research Network when the CRNs were reconfigured.

MAPP Mood Action Psychology a case series investigation of brief imagery-focused cognitive therapy (imCT) for Bipolar Disorder. Study has recruited all 15 of the target participants

Glutathione 2 study: Comparison of Glutathione levels in patients diagnosed with Bipolar Affective Disorder and healthy volunteers. This study has completed recruitment of 90 participants within the year. The CRF was instrumental in providing facilities and staff for this study to be undertaken to a high level of quality assurance at short notice. OXTEXT-6: Randomised controlled trial of facilitated integrated mood management (FIMM) versus manualised integrated mood management (MIMM) in bipolar disorder. This study has been supported by the CRF and has recruited 25 participants

OXTEXT-6: Randomised controlled trial of facilitated integrated mood management (FIMM) versus manualised integrated mood management (MIMM) in bipolar disorder. This study has been supported by the CRF and managed to recruit 25 participants

SearchLyte/FlashLyte: A Phase III, multi-centre, randomized, 24 week, double-blind, parallel-group, placebo controlled study to evaluate efficacy and safety of RO4917838 in stable patients with persistent, predominant negative symptoms of schizophrenia treated with antipsychotics followed by a 28 week, double-blind treatment period. Despite co-ordinated extensive pre-screening efforts the study was only able to recruit two out of the six participants. The study closed in April 2014

TWILYTE RO4917838 Phase III, multi-centre, randomized, 12-week, double-blind, parallel-group, placebo-controlled study to evaluate the efficacy and safety of RO4917838 in patients with sub-optimally controlled symptoms of schizophrenia treated with antipsychotics followed by a 40-week double-blind, parallel-group, placebo-controlled treatment period. Due to the high intensity of the study visits the CRF has managed to recruit one out of the six participants

Professor Humphreys is leading a new area of research for developing a new screen for impairments in social cognition in brain injured individuals (stroke and dementia). Currently there is no standardised measurement of social cognition in these populations. In a new Wellcome Trust Senior Investigator award the group will be developing a clinical

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instrument that can be used at the bedside that is not confounded by problems in language or attention/neglect. The adoption of the OCS as a measurement of choice to assess cognition after stroke – in over 30 trusts across the UK has been successful

The TMS neglect project is due to be completed in January 2016. The CRF has been vital to provide the infra-structure support for this project – secretarial support for liaising with hospital, arranging follow-up visits etc.

The OxCADAT team (PI Professor David Clark) has completed a randomized controlled trial comparing the world leading face-to-face cognitive therapy for social anxiety disorder (CT-SAD) with an internet version of the same treatment (iCT-SAD). Analysis is ongoing. However, it is clear that iCT-SAD is highly effective. Approximately 70% of patients reach recovery criteria, which is considerably better than the rate (44%) currently reported for SAD patients seen in the government's Improving Access to Psychological Therapies (IAPT) programme. OxCADAT is in the process of refining the internet programme based on patient feedback that was received during the RCT. Once the refinement is complete, iCT-SAD will be made available in a phased way to local IAPT services, followed by a national roll-out. All of the data will be stored on our servers so it will be possible to evaluate the success of a rapid translation from basic research to routine clinical implementation.

Key scientific or clinical outputs of work carried that has come to light in the last year

Heidi Johansen-Berg research team have a paper currently under review that describes positive results of a RCT of tDCS (brain stimulation) combined with a structured physiotherapy-like motor training intervention which produced significant long-lasting improvements in chronic stroke patients' upper limb function. It is expected that this work to have a significant scientific impact. The work was conducted entirely within the CRF testing facilities in the West Wing of the JR.

2.4.3 Occupancy and Visits

The occupancy and visits data reported in the 2013/14 annual return reflected only three of the four sites which make up the Oxford Cognitive Health Clinical Research Facility due to a lack of resources at the Charles Wolfson Centre making it difficult to capture the relevant data. This year the Centre has been able to provide the data required allowing the 2014/15 return to include all fours sites.

The 2014/2015 occupancy was 60% compared to the 56% reported for 2013/14. This is a composite figure encompassing the following 4 sites. The total number of visits reported for 2014/15 is broadly in line with last year.

2.4.4 Patient and public involvement and Engagement

Patient and public involvement

Embedding PPI into the Research Life Cycle is a priority and the CRF is part of a developing strategy that will address this across the oxford neuroscience and NIHR community. There is work to do in this area.

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In the meantime links have been established between the various NIHR infrastructures within Thames Valley in order to share resources and ideas for Patient and Public Involvement (PPI). The Cognitive Neuropsychology Centre has a PPI panel that advices on study design and participant information sheets for a specific study conducted on the CRF Warneford site. The newly appointed research assistants who are embedded in clinical teams AMHTs and EIS services across Oxford and Buckinghamshire have asked AMHT service users to review their research promotional materials. OHBA, researchers from which use the CRF, continues to hold focus groups to provide the public with a platform to discuss research and any concerns they have and to have input into the development of new cognitive tests.

There are a range of websites available for patients and the public to find out more information about research and how to take part in it; Join Dementia Research (joindemetiaresearch.nihr.ac.uk) and Patients Active in Research (patientsactiveinresearch.org.uk) information are displayed on boards in the waiting room at the CRF. Further to this, information about research studies can be found at Oxford Dementia and Ageing Research (OxDARE), and members of the public can sign up to become a 'Friend of OxDARE'.

CRF staff members have attended various PPI events this year, including the INVOLVE conference and the CRN Mental Health National Scientific Meeting fringe events. Attending these events has enabled staff working on the CRF to gain a more in-depth view how service users can have a role in research and how it can work in different Trusts across the country

The CRF Warneford site Clinical Lead is taking part in an ongoing James Lind Alliance (JLA) Priority Setting Partnership (PSP) for Bipolar Disorder. She is a member of the steering group for the Bipolar PSP along with a researcher at Oxford University Dept of Psychiatry, colleagues from Leeds NHS Trust, patient representatives, charitable organisations and representatives from the JLA. The Steering group comprises patients and their representatives rather than an emphasis on clinicians and researchers. The PSP is supported by the Oxford James Lind Alliance hub at the OUH BRC who have established experience in undertaking PSPs. The James Lind Alliance (funded by the NIHR) PSPs use a recognised methodology to generate patient driven prioritised research questions

Public engagement

Oxford Health NHS FT have 7 research assistants who are embedded within the adult mental health teams and the early intervention services across Oxford and Buckinghamshire. They are able to disseminate research information and opportunities directly to staff and patients across the county and this has led to and increased the quantity and diversity of studies available to patients under the care of these teams. They also ensure that updated information about research opportunities for patients is displayed across the Trust notice boards.

An audit was conducted on the Warneford site CRF to examine participants’ experience of research and to use their insight to remove barriers to participation and improve their experience of being in research. The feedback from this was very positive. The results were relayed to the staff enabling positive change to their practice and the environment, for example, a new coffee vending machine has been purchased for the waiting room.

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The Warneford CRF will be hosted an Open Day in May in line with NIHR International Clinical Trials Day. Presentations included patients who described their experience of taking part in research the Director of Patient Involvement at the NIHR Oxford Biomedical Research Centre. There were posters and information leaflets displayed throughout the day and researchers from various groups demonstrated some of their work

The Experimental Psychology and John Radcliffe West Wing sites have held events to coincide with national awareness days, such as during Brain Awareness Week, a school open day was held. The Oxford Biomedical Research Centre also held a public engagement day on brain diseases and worked together with the Functional Neurosurgery Team in Oxford to put together interactive stalls for the public at University College of London Hospitals Science Market in the summer last year.

The CRF at the Warneford site hosted an open day in line with International Clinical Trials day in May 2015. The day was another successful event with a variety of speakers including presentations and talks ranging from NIHR networks, what it is like to participate in research study, specific study overviews, global initiative for Alzheimer’s disease, and research governance. The CRF also displayed posters and demonstrations from researchers.

The Bipolar Research Clinic, a specialist clinic led by Professor John Geddes now takes place on the CRF Warneford site. The position of the clinic on the CRF allows ready access to information and skills to inform patients about research opportunities many of which are directly relevant to the clinic population.

2.4.5 Training

The Lead R&D Nurse, Cindy Whitbread, and Research Governance Manager, Victoria Rush for Oxford Health NHS FT have embarked on a Leadership and Management accredited course at the University of Oxford Said Business School. The course has been arranged and funded by the Oxford CLAHRC

Occupational Therapists in the region have been trained in using the Oxford Cognitive Screen, developed with CRF support, and we have had over 120 downloads of the screen from NHS practitioners. The screen has been adopted in Hong Kong, Italy, Germany, Spain and Brazil, none of which would have taken place without support from the NIHR CRF. In addition, Dr Nele Demeyere, who has been supported by the CRF, has just gained a Stroke Association Lord Leonard and Lady Estelle Wolfson Foundation Lectureship, to forge new translational research into cognitive deficits and recovery after stroke, enabling us to build even stronger links with practitioners.

All year one research students in our Heidi Johansen-Berg research group attend the FMRIB Graduate Training Course - a series of lectures, tutorials, and hands-on practical sessions to teach students about neuroimaging data acquisition and analysis.

The Plasticity Group at FMRIB runs a quarterly Skills Training Programme. This involves one half day session, and provides trainees with training in skills related to clinical research, including reviewing a paper, responding to reviews, interview skills, and presentation skills.

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2.4.6 Links with Industry

CRF staff have met with Covance (CRO) to discuss collaboration to increase competitiveness/attractiveness of UK to industry.

We are working with Roche (via Profs Catherine Harmer and Guy Goodwin) to develop experimental medicine models for bipolar disorder.

We (Lovestone/Geddes/Hinds/Gallacher) are working with Apple to develop widely applicable apps (using ResearchKit) to provide sensitive measures of cognitive function and mood for use in early phase and adaptive clinical trials in mood disorder and dementia

Professor Glyn Humphreys is leading interactions with P1vital, Arctic Shores and Ounce technology.

In addition the CRF at the Warneford site continues to work with P1Vital to support the delivery of the third study

During 2014/15 we have worked with 3 UK Small and Medium Enterprises (SMEs), although it is recognised that is an area for improvement

New strategic partnerships between your NIHR CRF and industry during financial year 2014/15

Professor Glyn Humphreys is collaborating with P1vital on the EU initial training Network where they are one of our partners – developing new assessments of attention. The team are also collaborating with a gaming company, Artic Shores, in developing new game-like cognitive assessments. Tests designed in collaboration with them are currently being piloted on our stroke population.

There are collaborating with Isis Innovations to roll out the Oxford Cognitive Screen we have developed under the CRF. We have had 120 uptakes of the OCS from the Isis website.

In addition there are collaborations with Ounce Technology who are developing a new tablet neuropsychology test we have designed – termed COAST – for application in the NHS (Wellcome Trust funding). We are currently piloting a beta test version.

The CRF at the Warneford site is heavily involved in the undertaking of highly complex Phase III clinical trials that would not have provided an opportunity for the NHS organisation to routinely host due to a community based service delivery model. The CRF has been essential in supporting such research

Key examples of studies active in financial year 2014/15

The CRF has undertaken 12 commercial contract research studies

The EU Initial training Network in collaboration with P1vital is in the progress of developing and applying new tests of attention and new computer-based

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rehabilitation strategies to enhance the diagnosis and treatment of attention problems.

The Wellcome Trust funding for the development of COAST with Ounce Technology as a collaborative partner

2.4.7 Links with Other NIHR Infrastructure

The Head of R&D/Senior Manager (Emma Stratful) of the CRF took over the project management role of the NIHR funded D-CRIS implementation for Oxford Health NHSFT CRIS partner in October 2014. CRIS - Case-Records-Interactive-Search is an application that allows interrogation of the Electronic Health Record, strips all patient identifiable information and allows researchers to generate data from a searchable repository hosted by SLaM. CRIS was developed originally at South London and Maudesley Trust (SLaM) with the aim of including four further partner trusts to generate powerful potential for outcomes based research in a real life situation. The system has proven efficacy as the CRIS output from SLaM has resulted in over forty peer reviewed primary research publications. Through appropriate leadership the project has progressed significantly and has been submitted for ethical review. If approval is gained CRIS will be a very valuable asset in progressing research including that carried out on the CRF.

The Oxford AHSC Theme 6 – Cognitive Health: Maintaining Cognitive function in health and disease, continues to build research capacity in dementia and cognitive health and provided integration between Universities and the NHS Trusts, including the Oxford AHSN (dementia lead – Dr Rupert McShane) and was initially facilitated by the Oxford BRC Cognitive Health working group. In addition the Oxford CLAHRC, Oxford Dementia and Ageing Research (OxDARE) was created as a vehicle to coordinate dementia research and translation across Oxford. Both the working group and its various projects continue to benefit from the NIHR CRF, bringing together Oxford Health NHS Foundation Trust, Oxford University Hospitals NHS Trust, and multiple departments of the University of Oxford (Psychiatry, Experimental Psychology, and Clinical Neurosciences). The facilities provide the full range of services required for experimental neuroscience, are fully integrated with the Oxford Biomedical Research Centre

The CHA exercise testing laboratory is integrated into the NIHR Oxford cognitive health CRF: http://oxford.crf.nihr.ac.uk/the-charles-wolfson-clinical-research-facility; both Dr Clare Mackay and Dr Claire Sexton have presented at the NIHR Oxford cognitive health CRF seminar series this year.

Towards the end of 2014 the Senior Managers from the Oxford BRC, DEC, CLAHRC and CRN initiated a quarterly meeting to discuss issues and ways of aligning the NIHR infrastructures within the local area and to increase collaboration

2.4.8 Impact in Healthcare Provision

The Oxford Cognitive Screen is routinely clinically used by Occupational therapists to measure cognition after stroke

The OCS is also not being used in large-scale trials internationally – in Hong Kong, South Africa, Italy and Spain. Here it is being used as a frontline measure of cognitive change in (respectively) stroke, HIV infection individuals, dementia and traumatic brain injury.

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The OCS-care trial has the potential to change NHS practice for measuring cognition after stroke and for improving outcome by facilitating early diagnosis and intervention and by providing extra information for patients and carers about the management of their clinical position.

The OxCADAT team also lead the Oxford AHSN Anxiety & Depression Clinical Network which covers IAPT services in 12 CCGs. During the last year, one of the main projects has been to enhance the overall recovery rates for patients with depression and any of the anxiety disorders who are seen in the local services. The OxCADAT team has provided regular enhancing recovery workshops for local clinicians and has also conducted analyses of local and national data to identify predictors of variability in outcome, which can be used to launch service innovation projects. Over the last 12 months, the recovery rates observed in IAPT services nationally have averaged 45% with no significant change between the beginning and end of the year. By contrast, the 12 CCGs covered by our network have moved from an average recovery rate of 46% to an average of 54%. Detailed plans are in place to move further forward in the coming year.

The OxCADAT team has played a major role in national lobbying for a further expansion in the availability of evidence-based psychological therapies for mental health problems. In the summer, Richard Layard and David Clark published a book entitled "Thrive: The power of evidence-based psychological therapies" which outlined all the clinical and economic arguments they had used to argue for the creation of the IAPT programme and explained the joint benefits of expanding the programme to people with long-term health problems, severe and enduring mental illness, and children and adolescents. The book attracted considerable media attention, including interviews on the Today programme and various television programmes. There was a well-attended parliamentary launch and the main political parties do appear to have committed to the general direction of travel that is laid out in Thrive. The Layard and Clark arguments are also gaining some traction overseas. Sweden has launched some IAPT-like pilot programmes and other countries are considering doing the same. A special updated North American edition of Thrive will be published in Princeton University Press at the beginning of September. It is already attracting favourable publicity among US professional organisations.

2.5 NIHR CRN

The Clinical Research Network (CRN) Thames Valley and South Midlands is within the Oxford AHSN area and is hosted by Oxford University Hospitals NHS Trust, with anticipated annual funding of £13 million. Each of the 15 NIHR CRNs will now cover all therapy areas and allow flexible deployment of resources. Each CRN supports six divisions:

Division 1: CancerDivision 2: Diabetes, stroke, cardiovascular disease, metabolic and endocrine disorders,

renal disordersDivision 3: Children, genetics, hematology, reproductive health and childbirthDivision 4: Dementias and neurodegeneration, mental health, neurological disordersDivision 5: Primary care, ageing, health services and delivery research, oral health and

dentistry, public health, musculoskeletal disorders, dermatologyDivision 6: Anesthesia/peri-operative medicine and pain management, critical care,

injuries/emergencies, surgery, ears/nose/throat, infectious diseases/ microbiology, ophthalmology, respiratory disorders, gastroenterology.

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Progress continues to grow with the dementias and neurodegeneration specialty of Division 4 (previously known as DENDRON) with an increase in the number of expressions of interest being requested, however the Trust is yet to see this converted into the undertaking of the studies. The Clinical Specialty leads for dementia (Dr Rohan Van de Putt) and mental health (Dr Andrew Molodynski) have been appointed from clinical teams within the Trust. CRF continues to support the undertaking of commercial and non-commercial studies being co-ordinated within the field of dementia.

Links are being formed with other Divisional leads (particularly with Division 2 and 5) within the CRN to potentially undertake more community, non-mental health research and primary care.

2.6 NIHR BRC and CRF

Work has already started to consider the Biomedical Research Centre (BRC) application with regular meetings and a planning event timetabled for late July.

The NIHR Clinical Research Facility (CRF) renewal application will be considered in the near future.

3 Research Governance 3.1 R&D Governance Group

The R&D Governance group is established with a member of each of the clinical directorates now identified and attending quarterly meetings. The Group serves primarily as an assurance group to review research ongoing within the Trust.

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

3.2 Contract Review Processes

The agreement between Oxford Health and Oxford University Hospitals to undertake the review of non-standard or modified contracts from a legal perspective to ensure the Trust obligations are appropriate is to be renewed due to the effective working practices this has demonstrated.

3.3 R&D Data Capture Mechanisms

3.3.1 Expressions of Interest

Commercial companies are continually looking for new NHS sites in which to conduct their studies. The initial step is to complete an expression of interest which provides key information about the research servicers that the Trust can offer. If a company requires further information they will request confidentially agreements to be signed and the Trust will undertake a feasibility assessment. In the January report it was mentioned that due to the high level of requests R&D had adopted the default position of saying yes to all requests with a more detailed review if the companies request further information and feasibility. This approach seems to be working well.

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3.3.2 Grant Application Process

In the summer of 2014 R&D developed the following grant application process to help researchers in the completion of funding applications:

1. The Investigator advises R&D of their intension to submit an application a minimum of 6 weeks prior to the submission deadline

2. R&D will confirm receipt and forward the information to John Geddes (R&D Director) for approval to proceed in the development of the application

3. The Investigator works with R&D Finance to establish the value of the application 4. The application is considered by the relevant R&D Study Review Panel5. The completed application is sent to John Geddes (R&D Director) before

submission for final review.6. The investigator arranges for signatures by the relevant Trust officers prior to

submission.

The process was developed to support researchers in costing for their research appropriately within the funding body guidelines in a timely manner and to ensure that deadlines are met.

This process has been followed in the majority of cases however it has recently been identified that due to the increased variety of number of organisations and types of studies being submitted through the Trust there is a greater need to review the non-financial element of applications. It has therefore been agreed to appoint a grants officer, possibly jointly with the Department of Psychiatry to fill this gap. The advantages of this will include making investigators aware of funding opportunities, potentially supporting the application development and a more efficient sign-off process.

3.3.3 Pipeline Meetings

Since the instigation of the pipeline meetings in October 2014 approximately 88 studies have been reviewed by the group for feasibility; 34 were commercial and 54 non-commercial. Of those approximately 39 have been approved to date with 25 not being approved, for varying reasons. The intention is to also track the conversion rate of commercial companies who approach the Trust to undertake research however the data is not available for this report.

The pipeline meetings have been successful in enabling an overview of proposed research studies coming to the Trust, both commercial and non-commercial. The system now in place to review and confirm feasibility has improved the Trust’s ability to support a speedier set-up and approval for research studies, including grant applications and has enabled a much more cohesive approach to researchers from the R&D team as a whole.

These will be replaced by new meetings outlined in the new meeting structure outlined below.

3.3.4 Health Research Authority (HRA)

A change in role for Trusts will mean that NHS Permission will no longer be issued by individual Trusts but will now be undertaken by the HRA. This new role will require greater emphasis on the R&D team to work with researchers ahead of HRA approval by

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confirming that there is capacity and capability to deliver and support research within the Trust and to that end, Pipeline Meetings are in-line with the expectation of the HRA for Trusts to provide this assurance to sponsors and researchers.

3.3.5 R&D Data Capture

The R&D Governance Manager initiated the redevelopment of a database for the capture and tracking of research studies and recruitment within the Trust.

The Research Portfolio Management System (RPMS) was originally initiated and approved by the NIHR and is a database capable of monitoring the lifecycle and recruitment of a research study. The Research and Development Governance team have been working directly with Oxford University Hospitals (OUH) to use this system at Oxford Health (OH) and OUH have agreed to create a standalone system for OH using the RPMS format.

Migration of the initial data set is in progress and once this is complete the data will be tested to regarding the migrations success. The RPMS runs on the OXNET server, a secure NHS server system and a request has been sent to Oxford Health IT Services to make relevant arrangement for this system to run here at Oxford Health.

We are currently awaiting approval by Oxford Health IT Services regarding the OXNET server and service level agreements are being set up between Oxford Health and Oxford University Hospitals. Once the system and service level agreements have been approved we will be in a position to test the data migration and train the Research and Development Governance team to use the new system. We would hope that this will be in use by the end of June.

3.3.6 Monitoring and Auditing of research projects

Due to workload and lack of staffing resource within the R&D governance team it has not been possible to focus attention to the role-out of a robust monitoring and auditing process for hosted and sponsored research within the Trust. However, a number of studies have been identified as requiring a review of governance compliance and the hope is that the governance team will be able to commence the process of contacting and arranging visits with individual PIs within the next couple of months.

Trust sponsorship review processes have been strengthened to ensure that Trust sponsored research is ready for ethical review and approval and to deliver a successful piece of research.

3.3.7 Safety committee

Following the instigation of the Trial Safety Review Group (TSRG), processes for ensuring greater Trust oversight of safety for research studies taking place at the Trust are now in place. The TSRG will commence reviewing SAEs for clinical trials involving investigational medicinal products (CTIMP) taking place at the Trust. An assessment of safety for each CTIMP study will confirm which studies should be requested to provide copies of reported SAEs to R&D for assessment and onward dissemination to the TSRG. Currently there are no studies requiring this review but the expectation is that this will increase as new studies take place at the Trust.

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The TSRG will also review any incident that is reported via the monthly Trust Incident Reports ([email protected]). These reports are now being provided to the R&D governance team who will provide copies of incidents relating to research being conducted at the Trust.

3.4 New Meeting Structure

Over the past 12 months the number of research queries and requests to host studies within the NHS organisation has increased considerably and recent issues have arisen over the decision making processes due to the number of stakeholders both internally and externally. This has led to tensions between teams and individuals as people are not sure of processes that are in place, and who is in a position to be able to provide answers, leading to a variety of emails with too many people copied in and senior manager and directors being involved where they do not necessarily need to be. Therefore, a new meeting structure has been developed to streamline processes and decision making pathways following the flow of information from expressions of interest to set up, through to conduct and review of progress was not a streamline.

The new structure that is being rolled out and tested over the next six to nine months is shown below.

The attendance at the meetings includes the relevant stakeholders in order comprehensive understanding of any issues of undertaking individual studies can be

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addressed with the relevant experts being able to offer insight into solutions. These meeting will be held on a monthly basis where there will be direct communications to the right people in the right place.

3.5 R&D Internal Audit

The R&D department was audited this year, 12 months earlier than anticipated due to change in Trust providers. The final report contains 2 important action points, (1) the need to maintain a more robust study and database (2) redesign of the monitoring and auditing process. Both of these concerns had already been identified by R&D and progress on addressing them is noted above under R&D Data Capture and Monitoring and Auditing of research projects.

4 Studies and Participant Recruitment 4.1 Studies

The Trust is continually considering (pipeline activity), implementing (awaiting approval) and running (open) research studies. These vary in size and complexity and are summarised in the tables below:

Pipeline Activity (December 2014 – May 2015)Expression of interest received \ submitted 9Feasibility assessments 3Rejected internally 1Redirected as PIC 1Site accepted 9Withdrawn 2Total 25

Awaiting Approval (as at June 2015) 10

Open Studies (as at June 2015)Open – recruiting 64Open – in follow up 23Total 87Portfolio 58Non-Portfolio 29Total 87Mental Health 74Community 13Total 87

4.2 Participant Recruitment

The participant recruitment to studies is shown in the table below:

2011/2012 2012/2013 2013/2014 2014/2015

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Portfolio 2,303 1,822 2,763 2,167Non portfolio 53* 359 780 582

4.3 Grant applications

During the period December 2014 to May 2015 14 grant applications were submitted, of which 1 was successful and 1 unsuccessful. We are waiting to be advised of the outcome of the remaining applications.

In some cases the same application has to be submitted more than once, for example an outline and then a full submission. The tables below only include each study once:

Source of ApplicationTrust 5Department of Psychiatry 4Department of Primary Care 4Brookes University 1Total 14

Funding organisationNIHR 9The Health Foundation 2The Alzheimers Society 2MRC (via Cambridge University) 1Total 14

4.4 NIHR Metrics and Targets

NHS organisations are expected to provide the NIHR with quarterly Performance Initiation and Delivery (PID) reports, detailing the number of studies that recruit the first participant into a clinical trial within 70 days of the organisation receiving a valid research application1 and the number of studies recruiting the expected number of participants (time to target).

Researchers are expected to inform the R&D department of the number of participants recruited to their study, in line with the NHS permission. This data will inform the PID reports that are compiled and published nationally every quarter. The Trust has accountability for delivery of research as the legal entity and cconsistent failure by Trusts to meet these targets may result in a reduction of up to 5% of Research Capability Funding to NHS organisations.

1 A valid research application is a complete research application that has been received by the NHS organisation following its submission via the Integrated Research Application System (IRAS) that enables review by other agencies (including, but not limited to Research Ethics Committee and MHRA approval) to be conducted in parallel with the work on NHS permission by the contractor. For studies going through the NIHR Coordinated System for gaining NHS Permission (CSP) this will include a valid site specific information ford (SSI) and local associated documents as detailed on the IRAS checklist. Non CSP studies are also required to submit a valid application for both study wide and local reviews as detailed on the IRAS checklist.

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The NIHR publish quarterly reports detailing how individual Trusts are meeting the targets and ranking each Trust. The following tables show the data from these reports.

Performance in Initiating CTsQ3 2013 -

2014Q4 2013 -

2014Q1 2014 -

2015Q2 2014-

2015Q3 2014-

2015

Number of trials submitted 12 15 13 10 9

Number of adjusted trials 12 12 8 6 4

% trials excluded from analysis 0 20 38.5 40 55.6

% of adjusted trials meeting benchmark 75 83.3 100 100 100

League * 4 3 3 3 4

League ranking NA 9 11 12 3

National ranking NA 40 41 42 48

*Leagues at Q3 2014-15 League 1 (153-94 total trials submitted)League 2 (85-44 total trials submitted)League 3 (41-16 total trials submitted)League 4 (9-2 total trials submitted)

Performance in Delivering Commercial CTs

Q3 2013 - 2014

Q4 2013-2014

Q1 2014-2015

Q2 2014 - 2015

Q3 2014-2015

Number of trials adjusted 12 12 8 6 4

Minimum number of days for first recruit (VRA to FP) 9 9 9 9 20

Maximum number of days for first recruit (VRA to FP) 124 124 70 70 70

League trust is in 4 3 3 3 4

League ranking NA NA NA 3 5National ranking NA NA NA 5 10

Over the past year the R&D department has made real progress in improving the performance of the Trust against these metrics.

5 A Recent Research Project Development IPS light - Refining individual placement and support (IPS) for UK practice and establishing its cost-effectiveness in a pragmatic, non-inferiority RCT (IPS-LITE TRIAL)

Background

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Individual Placement and Support (IPS) has been repeatedly demonstrated to be the most effective form of mental health vocational rehabilitation. Its no-discharge policy plus fixed caseloads, however, makes it expensive to provide. We tested whether introducing a time limit would significantly alter its clinical and consequently potential cost effectiveness.

Methods

Referrals to an IPS service (RESTORE) were randomly allocated to either standard IPS or to time limited IPS (IPS-LITE). IPS-LITE subjects were referred back to their mental health teams if still unemployed at nine months or after four months employment support. The primary outcome at 18 months was working for one day. Secondary outcomes comprised other vocational measures plus clinical and social functioning. The differential rate of discharge were used to calculate a notional increased capacity and to model potential rates and costs of employment.

Results

123 patients were randomized and data collected on 120 at 18 months. The two groups (IPS-LITE, 62, IPS, 61) were well matched at baseline. Rates of employment were equal at 18 months (IPS-LITE 24, (41%), IPS 27(46%)) at which time 57 (97%) had been discharged from the IPS-LITE service and 16 (28%) from IPS. Only eleven patients (4 IPS-LITE, 7 IPS) obtained their first employment after nine months. There were no significant differences in any other outcomes. IPS-LITE discharges generated a potential capacity increase of 46.5% compared to 12.7% in IPS which would translate into 35.8 returns to work in IPS-LITE compared to 30.6 in IPS over an 18 month period if the rates remained constant.

Conclusions

IPS-LITE is equally effective to IPS and only minimal extra employment is gained by persisting beyond nine months. If released capacity is utilized with similar outcomes IPS-LITE results in an increase 17% in numbers gaining employment within 18 months compared to IPS and will increase with prolonged follow up.

Accepted for publication in BJPsych

6 Case Records Interactive Search The Case Records Interactive Search (CRIS) application takes clinical information from the local, Oxford Health NHS FT (OHFT) EHR, removes patient identifiable information and provides searchable and secure access to data for research and audit purposes. The system allows effective anonymisation and psuedonymisation of data.

CRIS was designed primarily to support three types of usages:

• Type 1: as an anonymised database for secondary analysis• Type 2: to identify potential recruits to research projects from the clinical population • Type 3: to provide contextual clinical information for existing research participants

The CRIS Management Group was established to develop key documentation to enable to Trust to submit an ethics application to enable usage within the Trust for research and audit purposes. The CRIS Management Group has fulfilled its role and will now morph

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into the CRIS Oversight Group who will oversee its usage once ethics approval has been granted.

The security model and information governance assurance framework documents were completed in Quarter 1. These were essential documents required for the drafting and submission of an ethics application. The complete document set was submitted to the research ethics committee (REC) and a meeting was held on 29 th May 2015. A decision is pending.

The newly appointed CRIS Co-ordinator will develop and roll out training for CRIS and support the implementation and adoption within the Trust to enhance service delivery and clinical outcomes.

7 Finance In FY15 the Trust received funding of £6,462k to fund its various R&D activities. This funding is summarised in the table below:

Source FY15 Actual (£k)The National Institute for Health Research (NIHR) 4,305Clinical Research Network: Thames Valley and South Midlands (CRN) 1,500Non-NIHR and Commercial Income 657Total 6,462

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

7.1 FY15 Performance

The FY15 R&D performance generated a contribution to overheads of £268k which compared to the budgeted contribution of £126k generated a favourable variance of £142k. This was made up of a £302k favourable expenditure variance due to delayed study activity partly off-set by a £160k adverse income variance. The adverse income variance was a result of reduced study related income required to support the lower activity levels partly off-set by higher than budgeted non-NIHR income, mainly commercial.

7.2 National Institute for Health Research (NIHR)

The FY15 NIHR Income was made up as follows:

FY15 Actual (£k) Type of Income869 Study Income (Trust & Department of Psychiatry)247 Study Income (Department of Primary Care)717 Clinical Research Facility (CRF)

1,250 Collaboration in Leadership in Applied Health Research and Care (CLAHRC)1,112 Research Capability Funding (RCF) Department of Psychiatry \ Trust generated

89 Research Capability Funding (RCF) Department of Primary Care generated21 Research Capability Funding (RCF) CRF funding generated

4,305 Total NIHR Income

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7.3 Research Capability Funding (RCF)

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

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

In FY15 the Trust ran two schemes, one for RCF generated from Department of Psychiatry and Trust based investigators and a new scheme for RCF generated by Department of Primary Care investigators.

FY14 Department of Psychiatry \ Trust

FY15 Department of Psychiatry (DoP) \ Trust

FY15 Department of Primary Care

(PC)

FY15 Total

Senior Investigators (SI)

Keith Hawton, Guy Goodwin, John Geddes, David Clarke,

Alastair Gray

Keith Hawton, Guy Goodwin, John Geddes, David Clarke, Alastair Gray, Charles Vincent, Simon

Lovestone

Sue Ziebland

SI Funding (£75k) £0.375m £0.525m £0.075m £0.600mStudy Income £1,592m £1,338m £.072mRate 0.405 0.439 0.20 ##Study Related RCF £0.645m £0.587m £0.015m £0.602mTotal RCF £1,020m £1,112m £0.090m £1,202m

## The DEC study in seen as a Centre and attracts a different RCF weighting

The table below shows how the FY15 Department of Psychiatry and Trust RCF allocation was utilized:

FY15 RCF (£k) Trust University TotalFY15 Award 289 823 1,112

Current commitments by RCF categoryThe research-related component of an NIHR Faculty member’s salary, which is not covered by other funding sources

(378) (399) (777)

Meeting the cost of the time of Faculty members in preparing grant proposals (151) (8) (159)

The research-related time of NHS-employed scientific, administrative and secretarial staff who support Faculty members in their NIHR-related work (Includes the mitigation of the cost pressures occurring due to the NIHR withholding final study payments)

(36) (34) (70)

Accommodation costs, finance management costs, and human resource management cost incurred in hosting NIHR-funded research

(96) (10) (106)

Total (372) 372 -

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The use and allocation of RCF is reviewed on a regular basis by the Director of R&D before approval by the R&D Governance Committee. In recent years the drive has been to use RCF strategically for the benefit of research across the Trust, this continued in FY15 but in addition individuals were invited to apply for RCF to support research activities and as a result 4 applications were successful receiving a total allocation £79k. In FY15 RCF was also used to the mitigation of the cost pressures occurring due to the NIHR withholding final study payments (mentioned in more detail under Financial Risks and Issues).

7.4 FY16 RCF Allocation

The FY16 RCF allocation is £1,410k and was generated from activity within the Trust and Department of Psychiatry, Department of Primary Care and by the CLAHRC and is detailed in the table below:

FY16 Department of Psychiatry \ Trust Department of Primary Care CLAHRC TotalSenior Investigators (SI)

Keith Hawton, Guy Goodwin, John Geddes, David Clarke, Charles Vincent,

Simon Lovestone

Sue Ziebland, David Mant, Trisha Greenhalgh, Andrew

FarmerSI Funding (£75k) £0.450m £0.300m £0.750m2014 Funding £1,271m £.196m £1.0m

Study Related RCF £0.461m £0.032m £0.166m £0.660mStrategic contribution £0.037m (£0.037m) -Total RCF £0.948m £0.295m £0.166m £1,410m

The FY16 allocation shows an increase of £208k on the amount awarded for FY15, the changes are shown in the table below:

Type FY15 (£k) FY16 (£k) Var (£k) Comments

Studies & Infrastructure 602 660 58 £166k additional income related to the 2014 CLAHRC funding

partly off-set by lower study income at a reduced funding rate

Senior Investigators 600 750 150Three new Senior Investigators (David Mant, Trisha Greenhalgh, Andrew Farmer) have joined the Trust or changed their associated NHS organisation and one has been removed (Alastair Gray)

Total 1,202 1,410 208

During FY15 it was highlighted that RCF was potentially at risk of being reduced and the FY16 has seen a 1p reduction in the study and infrastructure funding rates coupled with a blanket 10% reduction on the study related element. This had the effect of reducing this years Trust allocation by £89k (rate £25k, blanket reduction £64k).

Type FY15 Rate (£k)

Rate Reduction (£k) Blanket 10% Reduction (£k)

FY16 Total (£k)

Studies 521 - 0.01 p -13 -47 461Infrastructure 228 - 0.01 p -12 -17 199Senior Investigators 750 750Total 1,499 -25 -64 1,410

7.5 Clinical Research Facility (CRF)

The CRF reporting is split between NIHR and non-NIHR due to its origins and funding sources. On the Warneford site the CRF operates as one unit containing 8 clinical rooms,

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pharmacy, a meeting room and associated office space. The NIHR CRF encompasses activities taking place at the Department of Experimental Psychology (OxCADAT and OxCNC) and the Charles Wolfson Clinical Neuroscience Facility at the John Radcliffe Hospital as well as those on the Warneford site.

Funding for the unit comes from the NIHR, CLRN and Commercial income. The FY15 performance is detailed in the table below (£k).

FY15 Budget FY15 Actual VarianceExpenditure (954) (954) -NIHR Funding (funding in place until Mar 2017) 717 717 -CRN: TV SM annual funding 204 204 -Total Non-NIHR income (detailed below) 92 177 85Total Income 1,013 1,098 85Contribution to overheads 59 144 85Margin after CRF accommodation and Finance support 6% 13%

Commercial price negotiations involve the Head of R&D and the Head of R&D Finance with the final sign-off governed by authorisation limits agreed by the Director of Finance.

7.6 CRF Related non-NIHR Research Study Income

The table below details the research income received from non-NIHR studies taking place within the CRF during FY15.

StudySponsor/Clinical

Research Organisation

£k Funding

FLASHYLYTE RO4917838 in stable patients with persistent, predominant negative symptoms of schizophrenia treated with antipsychotics - Protocol No. NN25310

Roche 37 Industry Contract

Interventional randomised, double-blind, parallel-group, placebo-controlled, exploratory study investigating the effects of LuAA21004 on cognition and BOLD fMRI signals in subjects remitted from depression and controls

Lundbeck 1 Industry Contract

Long-term safety and efficacy of ABT-126 in subjects with schizophrenia: a double blind extension study for subjects completing study M10-855

AbbVie26 Industry

Contract

Stem cells for Biological Assays of Novel drugs and predictive toxicology (STEMBANCC University of Oxford 23 Non-

Commercial

A randomised, double-blind, placebo- controlled, phase 3 study to evaluate the efficacy and safety of once a day, TAK-375 (Ramelteon) tablet for sublingual administration (TAK-375SL tablet) 0.1mg and 0.4mg as an adjunctive therapy in the treatment of acute depressive episodes associated with bipolar 1 disorder in adult subjects (TAK_301)

Takeda 10 Industry Contract

A randomised, double-blind, placebo-controlled, single-dose, study of the efects of SEP 363856 and Amisulprode on bold-FMRI signal in healthy male and female volunteers with high or low schizotype characteristics

Sunovion 72 Industry Contract

Antidepressant controlled trial for negative symptoms in schizophrenia (ACTIONS) University of Oxford 9 Non-

Commercial

TOTAL 177

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

The FY15 Income from the CRN was £1,500 from which a £73k contribution to overheads was received. The details of funding are shown in the table below,

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Type FY15 (£k)

Mental Health 530

Dendron and Neurological disorders (Dendron) 307

Division-wide (Division 4) 250

Primary Care and Ageing 390

Specialty Leads 23Total 1,500

7.8 Financial Risks and Issues

7.8.1 R&D Income Summary FY12-FY17

The level of research funding is predicted to show little movement between FY15 and FY16 however it is predicted to drop by £515k in FY17 due to reduced RCF following the completion of studies. This will reduce the Trusts flexibility and ability to potentially pump-prime certain areas of research.

Source Type FY14 FY15 FY16 FY17

NIHR Study income Department of Psychiatry & Trust 1,786 869 59 -NIHR Study income Department of Primary Care 106 247 280 247NIHR Clinical Research Facility 717 717 717 717NIHR Collaboration in Leadership in Applied Health Research and Care

(CLAHRC)250 1,250 2,000 2,000

NIHR RCF - Department of Psychiatry \ Trust 1,020 1,112 937 535NIHR RCF - Department of Primary Care - 89 295 343NIHR RCF - CLAHRC 166 320NIHR RCF - OUH 21 64NIHR RCF 186 128

Total NIHR 3,879 4,305 4,704 4,290CRN TVCLRN \ CRN 1,992 1,500 1,362 1,362

Other Non-NIHR Study income 752 656 373 272Grand Total 6,623 6,461 6,439 5,924

7.9 Redundancy Costs

There are a few members of staff employed on studies which are coming to an end. This could generate redundancy payments which will not be chargeable to the study. These are being identified and mitigation sought on a case-by-case basis.

7.10 Study Report and Publication dates

A number of studies have or will come to an end between Oct 14 and Mar 15 where the NIHR contract allows the withholding of the final payments until reports are produced and published. The effect of this is that costs will be incurred this financial year but not recovered until future years. Agreement was gained from the DH to fund these pressures from RCF allowing the final payment to be released in the following year on the condition that the funding is used for staff. The studies concerned are shown in the table below.Study End

DateFY15

PressureMitigation FY16

IncomeFY17

IncomeOctet Oct 14 Report submitted Sep 2014 (23) Funded from RCF 54

Friends Dec 14 Report submitted Jan 2015 (51) Funded from RCF 25.5 25.5Wheld Mar 16 Report submission expected (101) Funded from RCF 101

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post Mar 2016Octext Dec 14 Report submission estimated

Summer 2015(71) Funded from RCF 71

ECT Report submission expected Summer 2015

(14) University withholding final invoices

14

Sleep Apr 15 Report submission Summer 2015

(16) University withholding final invoices

16

Total (276) 180.5 126.5

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

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

7.11.1 CLAHRC Budgets

Budgets have been approved and released to the Theme Leads for the first 2 ¼ years ending March 2016. It is planned that there will be a mid-term review by the Executive and Management Board before budgets are released for the final 2 ¾ years.

7.11.2 FY15 Performance

The actual and budgeted expenditure is shown in the table below (£k).

Theme Theme Lead

2013/14Actual

2014/15 Budget

2014/15 Actual

2014/15 Var

2015/16 Budget

2016/17 Budget

2017/18 Budget

2018/19 Budget

Total Forecast

Expenditure

Better Management of Psychiatric comorbidities

Mike Sharpe

14 185 161 24 370 373 369 274 1,585

Health Behavior and Behavioral Interventions

Sarah Lamb

38 180 168 12 336 331 342 278 1,505

Early Intervention and Service Innovation

John Geddes

16 217 144 73 318 412 348 278 1,589

Patient Self-Management (Chronic Disease)

Richard McManus

46 295 226 69 380 321 331 209 1,582

Patient experience and PROMS

Ray Fitzpatrick

55 216 187 29 346 304 301 232 1,454

Central and Support Costs

81 157 364 (207) 250 259 309 229 1,285

Total 250 1,250 1,250 0 2,000 2,000 2,000 1,500 9,000

The reported overspend on central and support cost reflects the re-categorisation of expenditure relating to Health Economics and Statistician support which was budgeted by theme but ultimately charged centrally. The Early Intervention and Service Innovation did underspend due to staff recruitment slippage but the underspend was utilised by unbudgeted additional central and support costs

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7.11.3 Quarterly Reviews

Quarterly review meetings take place between the CLAHRC Manager, Head of R&D finance and the theme leads to review spend to date and agree the forecast activity to ensure total expenditure remains within the financial envelope available. To support this and to monitor performance monthly reports have been developed and are circulated to theme leads to.

7.11.4 Matched Funding

A fundamental requirement of the CLAHRC is the need to demonstrate matched funding committed by other organisations which is linked to CLAHRC activities. In total this needs to be at least to the same level as the NIHR funding. Matched funding provides resources to support the proposed themes of research, implementation or a mix of both. Identification of Matched funding is an on-going process involving the CLAHRC Manager and the Head of R&D Finance. Based on current information the amounts shown in the application and the minimum required by the NIHR have been identified.

Matched Funding (£k) 2013/14 2014/15 2015/16 2016/17 2017/18 2018/19 Total

Matched Funding identified 525 2,000 3,252 1.747 1.733 1,173 10,430

Minimum required by the NIHR 250 1,250 2,000 2,000 2,000 1,500 9,000

Included within the application 519 2,075 2,077 2,078 2,075 1,607 10,431

7.12 Oxford Academic Health Science Network (OAHSN)

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

Although the OASHN is seen as a clinical development, rather than primarily research related activity, it is combined with R&D when reported in the Finance report to the Board and is, therefore included for completeness. The three networks are budgeted and forecast to breakeven the only concern is the £35k Partnerships fees which the Trust has incurred but didn’t budget for causing an adverse variance.

Network Lead Total Award End Date

Dementia Dr Rupert McShane £270k March 2016

Early Intervention in MH Prof Belinda Lennox £210k March 2016

Anxiety & Depression Prof David Clark £220k March 2016

8 Estates The R&D department relocated offices in February to the main hospital building at the Warneford. This has reunited the team into two locations (New office and CRF) and is improving communications and working relationships with the R&D teams. In addition the CRN based staff working within the Trust have been allocated office space next to the

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R&D department and a move is imminent. This will harness closer working relationships with the CRN in research study delivery.

9 Staffing A CRIS Co-ordinator has been appointed to oversee the implementation of the system within the Trust. The post holder will develop training material for auditors and researchers using the system and provide support in using the CRIS and manage the CRIS Oversight Group.

The R&D department had recruited a part time Communications Manager to a joint post with the University of Oxford, Department of Psychiatry. The post holder will hold a substantive contract with the University and support the communication of R&D within the Trust including developing and maintaining the R&D website. The post holder starts in July 2015.

There has been a turnover of nursing staff.

10 Communications Work is continuing with the Trust R&D website with the outsourcing of the building of it due to limited resource and expertise. The new Communications Manager, appointed through the University of Oxford, department of Psychiatry will support this venture going forward.

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

Lead Executive Director: Dr Clive Meux

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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