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    2013/14 Clinical Research Annual Report November 2014 Public Board - 1 -



    Report to the Trust Board November 2014

    Sponsoring Director: Director of Nursing and Patient Safety.

    Author: Head of Research and Clinical Effectiveness.

    Purpose of the report: Update the Trust board on research activity and implementation of the Trust Research Strategy.

    Key Issues and Recommendations:

    In 2013/14, the Trust actively participated in fourteen national portfolio studies and recruited 150 participants and secured funding of 101,494 from the Clinical Research Network plus research grants to the value of 44,998, including 42k from Roche for participation in a very successful commercial trial. From April 2014 Somerset Partnership is a member of the South West Peninsula Clinical Research Network (covering the counties of Cornwall, Devon and Somerset). To date, the Trust has secured funding of 121,709 for 2014/15 from SWP: CRN to support research, and is receiving funding from the South Petherton League of Friends to employ a WTE 0.2 Band 6 Stroke Research Nurse. The Trust is actively participating in 13 portfolio studies, the National Confidential Inquiry into Suicide and Homicide and a number of own account studies The Board are asked to note the concerns regarding excess treatment costs (paragraph 3.8).

    Actions required by the Board:

    The Board are asked to note this report.

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    CLINICAL RESEARCH REPORT 1. BACKGROUND 1.1 The Trust has identified research as a key business objective within the

    Innovation theme, with a commitment to: Develop the Trusts arrangements for research and strengthen academic links.

    1.2 To support this the Board approved a Research Strategy in November 2014 (see Appendix A), and the Clinical Research Group (a sub group of the Clinical and Social Care Effectiveness Group) has been monitoring progress against this strategy.

    1.3 From April 2014, the network to support clinical research was restructured. In practice this means that Comprehensive Local Research Networks and topic specific research networks were replaced by a smaller number of Local Clinical Research Networks (LCRN) through which the National Institute for Health Research (NIHR) allocate funding to NHS Trusts who are participating in nationally recognised and funded research studies (portfolio studies). Somerset, along with Devon and Cornwall is part of the Clinical Research Network: South West Peninsula (CRN: SWP). The five year contract to host the CRN: SWP was awarded to the Royal Devon and Exeter NHS Foundation Trust.

    1.4 As a member of NIHR CRN: SWP, Somerset Partnership receives a funding allocation from the network to cover the management and approval of nationally recognised and funded research studies (portfolio studies), and to cover the costs of supporting the delivery of portfolio studies.

    1.5 Following the restructuring of NIHR networks, Somerset Partnership is now a member of the South West Peninsula Collaboration for Leadership in Applied Health Research and Care (PenCLAHRC) which is a consortium of NHS organisations and Universities in the region. The Head of Research and Clinical Effectiveness represents the Trust on the management board, and there has been some good collaboration on identifying and prioritising clinical research questions.

    1.6 Although not exclusively related to clinical research, the Trust is also a partner organisation in the South West Academic Health Science Network (AHSN) which is engaged in a number of pre-research projects, including a mapping of services provided to people with dementia with which the clinical research team is assisting.

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    2. TRUST PERFORMANCE 2.1 In 2013/14, the Trust actively participated in fourteen national portfolio

    studies and recruited 150 participants to national portfolio studies. This was 25% over the target. This compares with participating in sixteen national portfolio studies and recruiting 106 participants in 2012/13. In addition the Trust acted as a Patient Identification Centre (PIC) for a number of studies for which no recruitment is credited.

    2.2 All new portfolio studies were approved (following rigorous governance checks) within the target set of 30 days.

    2.3 Since April 2014 the CRN: SWP have not set Trust recruitment targets, preferring instead to monitor recruitment performance across the network in order to encourage collaborative working between member Trusts.

    2.4 A highlight of the past year has been the successful involvement in a commercial trail sponsored by Roche. Impact of Illness was a cross sectional survey and retrospective review of patients with persistent symptoms of schizophrenia to estimate their medical resource utilisation and burden of illness. The Principal Investigator was Dr Philip Van Driel who, with the support of the Clinical Research team, recruited the required number of patients within the timescale required and generated 41,848 of income for the Trust.

    3. FUNDING

    3.1 The conducting of high quality, nationally recognised research within the NHS is intended to be cost-neutral for NHS organisations. Funding is available from the NIHR CRN: SWP to support the provision of research management and governance and additional funding is awarded to Trusts in order to support the delivery of portfolio studies.

    3.2 In spite of a general reduction in the allocation of funds to member organisations since 2013, Somerset Partnership successfully negotiated an increase in funding for 2014/15 compared to 2013/14 see the table below.

    NIHR funding received 2009/10 15,920 2010/11 79,865 2011/12 99,750 2012/13 114,467 2013/14 101,494 2014/15 107,916

    3.3 Depending on the nature of individual studies, the Trust may

    additionally receive funding from specific study grants (including

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    2013/14 Clinical Research Annual Report November 2014 Public Board - 5 -

    commercial trials) to cover research costs and can apply to the CRN: SWP for contingency funding to cover service support costs.

    3.4 In 2013/14, in addition to the NIHR funding of 101,494, the Trust received research grants to the value of 44,998 for participation in:

    a commercial trial Impact of Illness sponsored by Roche 41,848;

    a Parkinsons Disease study at Taunton and Somerset NHS

    Foundation Trust where Somerset Partnership Speech and Language Therapist provided the research intervention 2,400;

    a non-portfolio study into a Therapeutic Engagement Questionnaire

    in mental health inpatient services, part funded by Dept. of Health 750.

    3.5 In 2014/15, contingency funding to the value of 13,793 has been

    successfully negotiated with the network bringing the total funding from the CRN: SWP of 121,709. This contingency funding will enable support of: Big Cactus, a Speech and Language Therapy study;

    extras, a Stroke study; e-Sibling, a psychosis study; EMAS, a memory assessment service study; a renal dietetics study.

    3.6 The Department of Health publication Attributing the costs of health

    and social care Research & Development (AcoRD) published in May 2012 (Gateway reference 17533) identifies NHS Treatment Costs as the patient care costs which would continue to be incurred if the patient care service in question continued to be provided after the R&D activity had stopped. These costs must be met by the NHS, with the cost of any treatment provided over and above standard care regarded as excess treatment costs (ETCs).

    3.7 From 1 April 2013 all Clinical Commissioning Groups (CCGs) have a duty to "ensure the treatment costs for patients who are taking part in research are covered" although a framework to fund ETCs is still being developed. Somerset Partnership has applied to Somerset Clinical Commissioning Group for ETCs relating to several non-commercial portfolio studies since April 2014 without success. It should be noted that other CCGs have funded ETCs for the same studies being undertaken in other NHS organisations.

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    3.8 The Trust is working with Somerset CCG to agree a process for the

    consideration and agreement of ETCs. The Board are asked to note that the Trust will maintain a record of all excess treatment costs incurred and are working with the SWP: CRN to address this issue.


    4.1 The current staffing complement is as follows: Head of Research & Clinical Effectiveness (0.2 WTE);

    Lead Research Nurse (full time) appointed August 2014; Research Governance Officer (0.7 WTE) appointed October

    2014; Clinical Studies Officer (full time).

    In addition, from April 2014 the League of Friends of South Petherton Hospital has funded a Stroke Research Nurse post (0.2 WTE). 5. RESEARCH SEMINARS

    5.1 To encourage and promote interest in research within the Trust,

    Research Seminars are held twice per year; in April and October.

    5.2 The April 2014 seminar at Canalside, Bridgwater was attended by 36 delegates from a variety of professional and service backgrounds. Speakers included: Professor Stuart Logan, chair of PenCLAHRC; Su Craddock of University Hospitals of Leicester NHS Trust researching the DESMOND programme; Professor Chris Dickens, University of Exeter outlining the STEPWISE programme; Kanch Sharma, Neurology Research Registrar at Frenchay Hospital on dementia research; Dr Lucy Knight, Specialist Registrar in Old Age Psychiatry outlining her own research into domestic abuse after the onset of dementia; Heather Tinkler, Clinical Studies Officer for the Trust on the success of the Impact of Illness commercial trail; Ralph Hammond, Clinical Specialist Physiotherapist on Professional identity post Francis report.

    5.3 Feedback form the event was very positive and included the following comments: Great half day with informative presentations;

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    Much improved on last year, as it was less theoretical and based on real-life research projects. Good mix of internal and external speakers.;

    Wasnt aware of all the research activity within the Trust. Need

    to make junior doctors more aware. 5.4 The October 2014 seminar at the Education Centre, South Petherton

    Hospital was attended by 38 delegates from a variety of professional and service backgrounds. Speakers included: Mike Visick, Divisional Manager for CRN:SWP about the support provided from the NIHR Clinical Research Network; Ian Evans, Consultant Nurse and Tania Collin, Stroke Research Nurse on stroke research at South Petherton; Carinna Vickers, Lead Research Nurse on research in Somerset Partnership; a carer (via video) on how participating in research helped her mum; Andy Harewood on the Suicide and Homicide NCI 2014 Report. Sarah Dean and other colleagues from PenCLAHRC also led a workshop on Turning clinical uncertainties into research questions.

    5.5 All those who responded to an evaluation questionnaire stated that the seminar provided information that they didnt know before and gave an idea of what research the Trust is doing. 94% stated that the seminar had increased their interest in research and that they would recommend the Research Seminar to their colleagues. The following positive comments were added: Excellent seminar, always enthused by the excellent attendance

    of Sompar staff.; PenCLARHC session was excellent.; Well done - a really good informative morning. It was well

    structured and well-paced. Thank you. 6. CURRENT RESEARCH ACTIVITY 6.1 There are currently 13 portfolio studies*1 approved, open and recruiting

    in Somerset Partnership and a further two in set up. There are a number of other commercial and non-commercial portfolio studies under consideration and review. *1 Portfolio Studies are projects that: are funded by national funding organisations (i.e. the National Institute for Health Research, the Research Council or charities); have undergone rigorous peer review; are of clear benefit to NHS patients; are registered on the Integrated Research Application System - IRAS. The projects normally recruit from across the UK.

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    6.2 List of current portfolio studies:

    *2 PI/LC = Principal Investigator/Local Collaborator SPT No.

    Title Status PI/LC *2

    011 Detecting susceptibility genes for late onset Alzheimer's disease

    Open Dr Antony Christopher

    062 Brains for Dementia Research: Longitudinal assessment of potential brain donors brain bank initiative

    Open Dr Antony Christopher

    072 DPIM: DNA Polymorphism in Mental Illness: Genetic case control & brain imaging studies of schizophrenia, bi polar and also a healthy control arm to provide a comparison to the other recruited arms in order to discover if genetic markers can be found in people with mental illness.

    Open Dr Waqar Ahmed

    110 DNA in LD: DNA variation in adults with Learning Disability Open

    Dr Jayne Kerridge

    132 Molecular Genetics of Adverse Drug Reactions: Defining the genetic and non-genetic risk factors predisposing to adverse drug reactions in order to develop strategies for individualisation of drug therapy to maximise benefits and minimise harms.

    Open Dr Rosemary Brook

    136 PRESSURE 2: Pressure Relieving Support Surfaces: a Randomised Evaluation 2 Open Sally Irving

    138 RADAR: Reducing pathology in Alzheimers Disease through angiotensin targeting Open

    Dr Antony Christopher

    142 Effect of Passive Immunisation on the Progression of Mild Alzheimers Disease: Solanezumab Vs Placebo (RICE)

    Open Dr Kim Porter

    144 EXTRAS: A trial to evaluate an extended rehabilitation service for stroke patients. Open Ian Evans

    147 STAMP-2: Sedentary Time and Metabolic Health in People with type 2 diabetes. Open Su Down

    149 E-Sibling: An online information and peer support resource for siblings of individuals affected by first episode psychosis

    Open Dr Frank Burbach

    151 Renal Nutrition: Prospective Investigation of Patient-centred and medical outcomes in the Elderly with advanced Renal disease: Improving Outcomes in Older Adults with reduced Kidney disease.

    Open Linda Carter

    154 MAS: Evaluation of Memory Assessment Services Open Karen Mackie 150 Big Cactus: A study to assess the clinical and cost

    effectiveness of aphasia computer treatment versus usual stimulation or attention control long term post stroke

    In set up

    Adult SLT service

    133 STEPWISE: A multicentre, open labelled, individually randomised trial of a group lifestyle education programme in people with schizophrenia including those with first episode psychosis

    In set up

    Dr Mike C...


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